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STATI UNITI

TITOLI E SCAMBIO
COMMISSIONE

Washington, DC 20549

MODULO 20-F

DICHIARAZIONE DI REGISTRAZIONE AI SENSI DELLA SEZIONE
12 (b) OPPURE (g) DELL'ATTO DI SCAMBIO DI TITOLI DEL 1934

O

RAPPORTO ANNUALE AI SENSI DELLA SEZIONE
13 OR 15 (d) DELL'ATTO DI SCAMBIO DI TITOLI DEL 1934

Per l'esercizio finanziario chiuso al 31 dicembre,
2019

O

RAPPORTO DI TRANSIZIONE AI SENSI DI
SEZIONE 13 O 15 (d) DELL'ATTO DI SCAMBIO DI TITOLI DEL 1934

Per il periodo di transizione da a

O

RAPPORTO SULLA SOCIETÀ SHELL
ALLA SEZIONE 13 O 15 (d) DELL'ATTO DI SCAMBIO DI TITOLI DEL 1934

Numero di fascicolo della Commissione:

tiziana
Life Sciences plc

(Nome esatto del Registrante come specificato in
la sua carta e la traduzione del nome del Registrante in inglese)

Inghilterra e Galles

(Foro competente per incorporazione o organizzazione)

3 ° piano, 11-12 Piazza San Giacomo

London SW1 4LB, Regno Unito

(Indirizzo delle principali sedi esecutive)

Tiziano Lazzaretti

Capo dell'ufficio finanziario

3 ° piano, 11-12 Piazza San Giacomo

London SW1 4LB, Regno Unito

+44 20 7495 2379

(Nome, telefono, e-mail e / o fax
numero e indirizzo del referente dell'azienda)

Copia in:

Ed Lukins

Orrick, Herrington & Sutcliffe (Regno Unito)
LLP

107 Cheapside

London EC2V 6DN

Regno Unito

Titoli registrati o da registrare
ai sensi della Sezione 12 (b) della Legge:

Titolo di ogni classe Nome di ogni scambio su cui registrato
Depositario americano
Azioni, ciascuna rappresentativa

5 azioni ordinarie, del valore nominale di £ 0,03
ogni azione ordinaria, valore nominale di £ 0,03 ciascuno *
NASDAQ Global Market

(*) Non per negoziazione, ma solo in relazione alla quotazione
delle azioni di deposito americane

Titoli registrati o da registrare
ai sensi della Sezione 12 (g) della Legge: Nessuna

Titoli per i quali esiste una segnalazione
obbligo ai sensi dell'articolo 15 (d) della legge: Nessuna

Numero di azioni in circolazione di ciascuna di
le classi di capitale o azioni ordinarie dell'emittente al 31 dicembre 2019: n. 136.654.516 azioni ordinarie.

Indicare con un segno di spunta se il dichiarante
è un noto emittente stagionato, come definito nella Regola 405 del Securities Act.

☐ Sì ☒ No

Se questo rapporto è annuale o in transizione
segnalare, indicare con un segno di spunta se il dichiarante non è tenuto a presentare segnalazioni ai sensi della Sezione 13 o 15 (d) dei Titoli
Legge sugli scambi del 1934.

☒ Sì ☐ No

Indicare con un segno di spunta se il dichiarante
(1) ha presentato tutte le segnalazioni che devono essere archiviate dalla Sezione 13 o 15 (d) del Securities Exchange Act del 1934 durante il precedente
12 mesi (o per un periodo così breve che il dichiarante era tenuto a presentare tali rapporti) e (2) è stato soggetto a tale
requisiti di deposito degli ultimi 90 giorni.

☐ Sì ☐ No

Indicare con un segno di spunta se il dichiarante
ha inviato elettronicamente e pubblicato sul suo sito Web aziendale, se presente, tutti i file di dati interattivi che devono essere inviati
e pubblicato ai sensi della regola 405 del regolamento S-T (§232.405 del presente capitolo) nei 12 mesi precedenti (o per tale periodo più breve
periodo in cui al dichiarante era richiesto di inviare e pubblicare tali file).

☐ Sì ☐ No

Indicare con un segno di spunta se il dichiarante
è un filer accelerato di grandi dimensioni, un filer accelerato o un filer non accelerato, una società di reportistica più piccola o una crescita emergente
azienda. Vedere le definizioni di “filer accelerato di grandi dimensioni,” filer accelerato “,” società di reportistica più piccola “,
e “società emergente in crescita” nella Regola 12b-2 dello Exchange Act.

Filer accelerato grande ☐ Filer accelerato ☐ Filer non accelerato ☐ Società di segnalazione più piccola ☒
Azienda emergente in crescita ☒

Se un'azienda emergente in crescita che si prepara
i suoi rendiconti finanziari in conformità con gli Stati Uniti GAAP, indicano con un segno di spunta se il dichiarante ha scelto di non utilizzare l'estensione
periodo di transizione per il rispetto di qualsiasi principio contabile contabile nuovo o rivisto † previsto ai sensi della Sezione 13 (a)
dello Exchange Act. ☐

† Il termine “nuovo o rivisto
standard di contabilità finanziaria “si riferisce a qualsiasi aggiornamento emesso dal Financial Standarding Standards Board alla sua contabilità
Codificazione degli standard dopo il 5 aprile 2012.

Indicare con un segno di spunta quale base di contabilità
il dichiarante ha utilizzato per preparare i rendiconti finanziari inclusi in questo deposito:

GAAP USA ☐ International Financial Reporting Standards come emessi dal
Comitato internazionale per gli standard contabili ☒
Altro ☐

Se è stato selezionato “Altro”
in risposta alla domanda precedente, indicare con un segno di spunta quale voce di bilancio il dichiarante ha scelto di seguire:

☐ Articolo 17 ☐ Articolo
18

Se si tratta di una relazione annuale, indicare entro
spuntare se il dichiarante è una società di copertura (come definito nella Regola 12b-2 della Legge sugli scambi).

☐ Sì ☒ No

SOMMARIO

INTRODUZIONE

In questo rapporto annuale
sui riferimenti del modulo 20-F a “Tiziana”, “Tiziana Life Sciences plc”, “l'azienda”, “noi”
“Noi” e “nostro” si riferiscono a Tiziana Life Sciences plc e alle sue consociate interamente controllate, Tiziana Therapeutics
Inc., Tiziana Pharma Limited e Longevia Genomics S.r.l.

Solo per comodità,
i marchi, i marchi di servizio e i nomi commerciali in questa dichiarazione di registrazione possono essere indicati senza i simboli ® e ™,
ma tali riferimenti non dovrebbero essere interpretati come un indicatore che i rispettivi proprietari non affermeranno, nella misura massima
secondo la legge applicabile, i loro diritti. Questo rapporto annuale contiene ulteriori marchi, marchi di servizio e nomi commerciali di
altri, che sono di proprietà dei rispettivi proprietari. Non intendiamo utilizzare o visualizzare marchi di altre società,
marchi di servizio e nomi commerciali per implicare una relazione, o avallo o sponsorizzazione da parte nostra, di qualsiasi altra società.

In questo rapporto annuale,
se non diversamente indicato, tutti i riferimenti a “Stati Uniti dollari “o” US $ “o” $ “o” centesimi ”
sono nella valuta degli Stati Uniti d'America e tutti i riferimenti a “Sterline” o “Sterline”
o “£” o “pence” sono nella valuta del Regno Unito.

In questo rapporto annuale,
qualsiasi riferimento a qualsiasi disposizione di qualsiasi legislazione deve includere qualsiasi modifica, modifica, rievocazione o estensione della stessa.
Le parole che importano il singolare includeranno il plurale e viceversa, e le parole che importano il genere maschile includeranno il
genere femminile o neutro.

Dichiarazione relativa a COVID-19
Ritardo di deposito

Tiziana Life Sciences plc ha fatto affidamento sui titoli statunitensi
e l'ordine della Commissione del 25 marzo 2020, della Commissione (scambio n. 34-88465) di rinviare la presentazione della presente relazione annuale sul modulo 20-F.
Le ragioni del nostro rinvio sono illustrate in dettaglio nel nostro modulo 6-K del 1 ° aprile 2020, che è incorporato qui come riferimento. In
in particolare, COVID-19 ha causato gravi interruzioni nei viaggi e nei trasporti e conseguente accesso limitato alle nostre strutture
con un supporto limitato da parte del nostro staff.

Presentazione
di informazioni finanziarie

Questo rapporto annuale
include i nostri bilanci consolidati certificati a partire dal e per gli esercizi chiusi al 31 dicembre 2019 e 2018, che sono preparati
in conformità con gli International Financial Reporting Standards o IFRS, emessi dall'International Accounting Standards Board,
o IASB. Nessuno dei nostri bilanci è stato redatto secondo i principi contabili generalmente accettati negli Stati Uniti
Stati.

Le nostre informazioni finanziarie
è presentato in dollari statunitensi. Per comodità del lettore, in questo prospetto, se non diversamente indicato, traduzioni
da sterline inglesi a dollari statunitensi sono stati fatti al tasso di £ 1,00 a $ 1,2320, che era il tasso di acquisto di mezzogiorno della Federal
Reserve Bank of New York il 29 maggio 2020. Tali importi in dollari statunitensi non sono necessariamente indicativi degli importi in dollari statunitensi
che avrebbe potuto essere effettivamente acquistato al momento dello scambio di sterline alle date indicate.

Abbiamo effettuato l'arrotondamento
adeguamenti di alcune delle cifre incluse nel presente prospetto. Di conseguenza, le cifre numeriche mostrate come totali in alcune tabelle possono
non essere un'aggregazione aritmetica delle figure che le hanno precedute.

cautelativa
DICHIARAZIONE RIGUARDANTE LE DICHIARAZIONI AVANTI

Questo rapporto annuale
contiene dichiarazioni previsionali che comportano rischi e incertezze sostanziali. Tutte le dichiarazioni contenute nella presente relazione annuale,
diverse dalle dichiarazioni di fatti storici, comprese le dichiarazioni relative alla nostra strategia, operazioni future, posizione finanziaria futura,
ricavi futuri, costi previsti, prospettive, piani e obiettivi di gestione sono dichiarazioni previsionali. Le parole “maggio”
“Potrebbe”, “volontà”, “potrebbe”, “vorrebbe”, “dovrebbe”, “aspettarsi”
“Intendi”, “pianifica”, “obiettivo”, “anticipa”, “credi”, “stima”,
“Prevedere”, “potenziale”, “continuare” e “in corso” o negativo di questi termini,
o altra terminologia comparabile intesa a identificare dichiarazioni sul futuro. Queste dichiarazioni comportano rischi noti e sconosciuti,
incertezze e altri fattori importanti che possono causare risultati, livelli di attività, prestazioni o risultati effettivi
essere materialmente diverso dalle informazioni espresse o implicite da queste dichiarazioni previsionali. Le dichiarazioni previsionali
e le opinioni contenute in questa dichiarazione di registrazione si basano sulle informazioni a nostra disposizione alla data della presente registrazione
dichiarazione e, sebbene riteniamo che tali informazioni costituiscano una base ragionevole per tali dichiarazioni, tali informazioni potrebbero essere limitate
o incompleto e le nostre dichiarazioni non devono essere lette per indicare che abbiamo condotto un'indagine esaustiva o revisione di,
tutte le informazioni pertinenti potenzialmente disponibili. Le dichiarazioni previsionali includono dichiarazioni su:

lo sviluppo di Foralumab, anticorpo monoclonale anti-IL6R (TZLS-501), Milciclib, StemPrintER e uno qualsiasi dei nostri altri candidati al prodotto, comprese dichiarazioni relative ai tempi di inizio, completamento ed esito di studi clinici o studi e relativi lavori preparatori, il periodo durante il quale saranno disponibili i risultati delle prove e i nostri programmi di ricerca e sviluppo;

la nostra capacità di ottenere e mantenere l'approvazione normativa dei nostri candidati al prodotto, tra cui Foralumab, anticorpo monoclonale anti-IL6R (TZLS-501), Milciclib, StemPrintER, nelle indicazioni per le quali intendiamo svilupparli e tutte le relative restrizioni, limitazioni o avvertenze nell'etichetta di un farmaco o terapia approvati;

i nostri piani di ricerca, sviluppo, produzione e commercializzazione dei candidati ai nostri prodotti;

la tempistica delle nostre dichiarazioni normative per i candidati dei nostri prodotti;

le dimensioni e il potenziale di crescita dei mercati per i nostri candidati ai prodotti;

la nostra capacità di raccogliere capitale aggiuntivo;

le nostre capacità e strategie di commercializzazione, marketing e produzione;

le nostre aspettative riguardo alla nostra capacità di ottenere e mantenere la protezione della proprietà intellettuale;

la nostra capacità di attrarre e trattenere dipendenti qualificati e personale chiave;

la nostra capacità di contrattare con fornitori e produttori di terze parti e la loro capacità di eseguire adeguatamente;

le nostre stime relative a entrate, spese e necessità future per ulteriori finanziamenti; e

sviluppi normativi negli Stati Uniti, nell'Unione Europea e in paesi stranieri.

Dovresti fare riferimento a
la sezione intitolata “Fattori di rischio” per una discussione di importanti fattori che possono far variare i nostri risultati effettivi
materialmente da quelli espressi o impliciti dalle nostre dichiarazioni previsionali. A causa di questi fattori, non possiamo garantirvi
che le dichiarazioni previsionali in questa dichiarazione di registrazione si dimostreranno accurate.

Inoltre, se il nostro
dichiarazioni previsionali si rivelano inaccurate, l'imprecisione può essere materiale. Alla luce delle significative incertezze nel 2006
queste dichiarazioni previsionali, non dovresti considerare queste dichiarazioni come una rappresentazione o garanzia da parte nostra o di qualsiasi altra persona
che raggiungeremo i nostri obiettivi e piani in qualsiasi periodo di tempo specificato, o affatto. Non ci assumiamo alcun obbligo di aggiornamento pubblico
eventuali dichiarazioni previsionali, a seguito di nuove informazioni, eventi futuri o altro, ad eccezione di quanto richiesto dalla legge.

Dovresti leggere questo
Rapporto annuale e i documenti che abbiamo archiviato come esposti a questo Rapporto annuale completamente e con la consapevolezza che
i nostri risultati futuri effettivi potrebbero essere materialmente diversi da quelli che ci aspettiamo. Qualifichiamo tutte le nostre dichiarazioni previsionali di
queste dichiarazioni cautelative.

PARTE
io

PUNTO 1: IDENTITÀ DEGLI AMMINISTRATORI, GESTIONE SENIOR E CONSULENTI

Non applicabile

PUNTO 2: STATISTICHE DELL'OFFERTA E ORARI PREVISTI

Non applicabile.

ARTICOLO 3: INFORMAZIONI CHIAVE

A. Dati finanziari selezionati

La seguente tabella
sintetizza i nostri dati finanziari consolidati alla data e per i periodi indicati. Il bilancio consolidato
i dati al 31 dicembre 2019 e 2018 e per gli esercizi chiusi al 31 dicembre 2019, 2018 e 2017 sono stati ricavati dal nostro consolidato
bilanci, presentati alla fine della presente Relazione annuale, che sono stati redatti in conformità agli IFRS, come emessi
dallo IASB e sottoposto a revisione in conformità con gli standard del Public Company Accounting Oversight Board (Stati Uniti). Il
dati di bilancio consolidato al 31 dicembre 2016 e 2015 e per gli esercizi chiusi al 31 dicembre 20165 e 2015 hanno
derivato dal nostro bilancio consolidato, che non è presentato nel presente documento, anch'esso redatto in conformità
con gli IFRS emessi dallo IASB.

La nostra valuta funzionale
è la sterlina inglese. Tuttavia, a fini di rendicontazione finanziaria, i nostri rendiconti finanziari, che sono preparati utilizzando il funzionale
valuta, sono stati tradotti in dollari statunitensi. Le nostre attività e passività sono convertite ai tassi di cambio del saldo
data del foglio, le nostre entrate e spese sono tradotte ai tassi di cambio medi per il periodo presentato e gli azionisti
l'equità è tradotta in base ai tassi di cambio storici. Le rettifiche di traduzione non sono incluse nella determinazione dell'utile (perdita) netto
ma sono inclusi nell'adeguamento della conversione in valuta estera ad altre perdite globali, una componente del patrimonio netto.

Transazioni in valuta estera
in valute diverse dalla valuta funzionale vengono convertite nella valuta funzionale utilizzando i tassi di cambio prevalenti
alle date delle transazioni. Differenze di cambio risultanti dal regolamento di tali transazioni e dal
la conversione ai tassi di cambio di fine periodo delle attività e passività monetarie denominate in valuta estera è registrata in generale
e spese amministrative nel prospetto delle operazioni e perdite complessive.

Al 31 dicembre
2019 e 2018, il tasso di cambio rappresentativo è stato rispettivamente di £ 1,00 = $ 1,31870 e £ 1,00 = $ 1,2737.

I nostri risultati storici
non sono necessariamente indicativi dei risultati che potrebbero essere previsti in futuro. Di seguito è stato selezionato il bilancio consolidato
i dati devono essere letti congiuntamente ai nostri bilanci consolidati certificati inclusi alla fine della presente relazione annuale
e le note correlate e la voce 5, “Revisione e prospettive operative e finanziarie” di seguito.

Conto economico consolidato e perdita globale
Dati:

Anni conclusi il 31 dicembre
2019 2018
(Adattato)
2017 (riformulato) 2016 2015
(in migliaia ad eccezione dei dati di condivisione e per azione)
Spese operative:
Ricerca e sviluppo $ (3.714 ) $ (5.510 ) $ (6.015 ) $ (4.007 ) $ (9609 )
Generale e amministrativo (6.207 ) (4.357 ) (4.478 ) (5.872 ) (3.557 )
I costi operativi totali (9921 ) (9867 ) (10.493 ) (9879 ) (13.166 )
Perdita da operazioni (9921 ) (9867 ) (10.493 ) (9879 ) (13.166 )
Altre entrate (spese), al netto (91 ) (12 ) (12 ) (12 ) (28 )
Accantonamento fiscale 689 1.945 1.912 121
Perdita netta attribuibile agli azionisti ordinari (9.323 ) (7934 ) (8593 ) (9770 ) (13.193 )
Altre perdite globali:
Adeguamento della traduzione in valuta estera (27 ) (21 ) 61 650 (3.063 )
Perdita totale totale (9.350 ) (7.955 ) (8.532 ) (9.120 ) (10.130 )
Perdita netta di base e diluita per azione ordinaria (0,07 ) (0,06 ) (0,09 ) (0,11 ) (0.15 )

Dati patrimoniali consolidati:

Al 31 dicembre
2019 2018
(Adattato)
2017 2016 2015
(in migliaia ad eccezione dei dati di condivisione e per azione)
Cassa e disponibilità liquide $ 200 $ 5.304 $ 64 $ 5.802 $ 13.128
Capitale circolante (5.846 ) 513 (2.302 ) 4.054 12.540
Totale attivo 2378 6.920 2.471 6231 13.640
Totale patrimonio netto / (deficit) degli azionisti (5.514 ) 519 (2.278 ) 4.088 12.540

Definiamo il capitale circolante
come attività correnti meno passività correnti.

B. Capitalizzazione e indebitamento

Non applicabile.

C. Ragioni per l'offerta e l'uso di
Ricavo

Non applicabile.

D. Fattori di rischio

La nostra attività è significativa
rischi. È necessario considerare attentamente i rischi descritti di seguito, insieme alle altre informazioni contenute nella presente relazione annuale,
compresi i nostri bilanci e le relative note. Se si verifica uno dei seguenti rischi, le nostre condizioni commerciali, finanziarie,
i risultati delle operazioni e le prospettive di crescita futura potrebbero essere influenzati materialmente e negativamente. Questa relazione annuale contiene anche
dichiarazioni previsionali che comportano rischi e incertezze. I nostri risultati potrebbero differire materialmente da quelli previsti in
queste dichiarazioni previsionali, a seguito di determinati fattori tra cui i rischi descritti di seguito e altrove in questo annuale
Rapporto e altri nostri documenti SEC. Vedere “Dichiarazione cautelativa relativa alle dichiarazioni previsionali” sopra.

Rischi connessi allo sviluppo dei nostri prodotti candidati

Se riscontriamo ritardi sostanziali
nelle prove cliniche dei nostri candidati al prodotto, potremmo non essere in grado di ottenere le necessarie autorizzazioni normative e pertanto non saremo in grado
commercializzare i nostri prodotti candidati in modo tempestivo o per niente.

Prima di ottenere marketing
approvazione da parte delle autorità di regolamentazione per la vendita dei nostri candidati prodotti, dobbiamo dimostrare prove cliniche approfondite
la sicurezza e l'utilità dei candidati al prodotto. I test clinici sono costosi, richiedono molto tempo e sono incerti sul risultato. Noi
non può garantire che qualsiasi sperimentazione clinica sarà condotta come pianificato o completato nei tempi previsti, se non del tutto, come fallimento di uno
o più studi clinici possono verificarsi in qualsiasi fase del test. Eventi che possono impedire il completamento con successo o tempestivo della clinica
lo sviluppo include:

ritardi nel raggiungere un consenso con la Food and Drug Administration degli Stati Uniti, o la FDA, l'Agenzia europea per i medicinali o l'EMA o altre autorità di regolamentazione in merito alla progettazione della sperimentazione;

ritardi nel raggiungimento di un accordo a condizioni accettabili con potenziali organizzazioni di ricerca a contratto, o CRO e siti di studi clinici;

ritardi
in esecuzione dello sviluppo a causa dell'instabilità finanziaria dei nostri CRO, CMO e CDMO

ritardi nell'apertura dei siti di sperimentazione clinica o nell'ottenimento del necessario comitato di revisione istituzionale o approvazione del comitato etico indipendente in ciascun sito di sperimentazione clinica;

ritardi nel reclutamento di pazienti idonei a partecipare ai nostri futuri studi clinici;

imposizione di una sospensione clinica da parte delle autorità di regolamentazione a seguito di un evento avverso grave o dopo un'ispezione delle nostre operazioni di sperimentazione clinica o siti di sperimentazione clinica;

mancato rispetto da parte nostra, di eventuali CRO che assumiamo o di terze parti nel rispetto dei requisiti della sperimentazione clinica;

inadempimento secondo le buone pratiche cliniche o GCP o le linee guida normative applicabili in Europa e in altri mercati internazionali;

ritardi nei test, nella convalida, nella produzione e nella consegna dei candidati ai nostri prodotti ai siti della sperimentazione clinica, compresi i ritardi da parte di terzi con i quali abbiamo contratto per svolgere alcune di tali funzioni;

ritardi nell'avere la completa partecipazione dei pazienti a una sperimentazione clinica o il ritorno per il follow-up post-trattamento;

siti di sperimentazione clinica o pazienti che abbandonano una sperimentazione clinica;

selezione di endpoint clinici che richiedono periodi prolungati di osservazione clinica o analisi dei dati risultanti;

il verificarsi di eventi avversi gravi associati al prodotto candidato che sono considerati superiori ai suoi potenziali benefici;

insorgenza di eventi avversi gravi negli studi clinici della stessa classe di agenti condotti da altri sponsor; e

cambiamenti nei requisiti normativi e nelle linee guida che richiedono la modifica o la presentazione di nuovi protocolli clinici.

Qualsiasi incapacità di successo
lo sviluppo preclinico e clinico completo potrebbe comportare costi aggiuntivi per noi o compromettere la nostra capacità di generare entrate
da vendite di prodotti, pietre miliari regolamentari e di commercializzazione e royalties. Inoltre, se realizziamo produzione o formulazione
modifiche ai nostri candidati prodotti, potrebbe essere necessario condurre ulteriori studi per collegare in precedenza i nostri candidati prodotti modificati
versioni. I ritardi nella sperimentazione clinica potrebbero anche abbreviare eventuali periodi durante i quali potremmo avere il diritto esclusivo di commercializzare i nostri
candidati al prodotto o consentire ai nostri concorrenti di commercializzare i prodotti prima di noi, il che potrebbe compromettere la nostra capacità di successo
commercializzare i nostri prodotti candidati e potrebbe danneggiare la nostra attività, le condizioni finanziarie, i risultati delle operazioni e le prospettive.

Potremmo non riuscire a dimostrare la sicurezza
e l'utilità terapeutica dei nostri candidati al prodotto con soddisfazione delle autorità regolatorie applicabili, che impedirebbe
o ritardare l'approvazione normativa e la commercializzazione.

Prima di ottenere la regolamentazione
approvazioni per la vendita commerciale dei nostri candidati prodotti, dobbiamo dimostrare attraverso preclinici lunghi, complessi e costosi
test e prove cliniche per accertare che i nostri prodotti candidati siano sicuri ed efficaci per l'uso in ciascuna indicazione target. Clinico
i test sono costosi e possono richiedere molti anni per essere completati e il suo esito è intrinsecamente incerto. La maggior parte dei candidati al prodotto
iniziare studi clinici non sono mai stati approvati come prodotti. Se i risultati del nostro processo di registrazione o di futuri studi cardine per
i nostri altri candidati non dimostrano l'utilità terapeutica dei nostri candidati o se vi sono problemi di sicurezza
o eventi avversi gravi associati ai candidati dei nostri prodotti, possiamo:

essere in ritardo nell'ottenere l'approvazione all'immissione in commercio per i nostri prodotti candidati, se del caso;

ottenere l'approvazione per indicazioni o popolazioni di pazienti che non sono così ampie come previsto o desiderato;

ottenere l'approvazione con un'etichettatura che includa restrizioni significative sull'uso o sulla distribuzione o avvertenze di sicurezza;

essere soggetto a ulteriori requisiti di test post-marketing;

essere soggetto a cambiamenti nel modo in cui il prodotto viene somministrato;

essere tenuto a svolgere prove cliniche aggiuntive a supporto dell'approvazione o essere soggetto a ulteriori requisiti di test post-marketing;

chiedere alle autorità di regolamentazione di ritirare o sospendere l'approvazione del prodotto o imporre restrizioni alla sua distribuzione sotto forma di una strategia di valutazione e mitigazione del rischio modificata o REMS;

essere soggetto all'aggiunta di dichiarazioni di etichettatura, quali avvertenze o controindicazioni; o

essere citati in giudizio o subire danni alla nostra reputazione.

Successo negli studi preclinici o
gli studi clinici potrebbero non essere indicativi dei risultati negli studi clinici futuri.

Successo in preclinico
i test e le prime sperimentazioni cliniche non garantiscono che le successive sperimentazioni cliniche genereranno gli stessi risultati o forniranno in altro modo
dati adeguati per dimostrare l'efficacia e la sicurezza del nostro prodotto candidato. Spesso, i candidati al prodotto che hanno mostrato
risultati promettenti nelle prime sperimentazioni cliniche hanno successivamente subito battute d'arresto significative nelle successive sperimentazioni cliniche. Ad oggi, alcuni
delle nostre sperimentazioni cliniche hanno coinvolto popolazioni di piccoli pazienti e, a causa delle dimensioni ridotte del campione in tali sperimentazioni, nel frattempo
i risultati di questi studi clinici possono essere soggetti a sostanziale variabilità e potrebbero non essere indicativi di entrambi i risultati intermedi futuri
o risultati finali. Inoltre, la progettazione di una sperimentazione clinica può determinare se i suoi risultati supporteranno l'approvazione di un prodotto
e i difetti nella progettazione di una sperimentazione clinica potrebbero non diventare evidenti fino a quando la sperimentazione clinica non è ben avanzata. Inoltre,
c'è un alto tasso di fallimento per farmaci e prodotti biologici che procedono attraverso studi clinici. In effetti, molte aziende nel
le industrie farmaceutiche e biotecnologiche hanno subito serie battute d'arresto negli studi clinici in fase avanzata anche dopo aver raggiunto
risultati promettenti nei test preclinici e nelle sperimentazioni cliniche nella fase precedente. Inoltre, i dati ottenuti da preclinici e clinici
le attività sono soggette a interpretazioni diverse, che possono ritardare, limitare o impedire l'approvazione normativa. Inoltre, potremmo provare
ritardi o rigetti normativi a seguito di numerosi fattori, anche a causa di cambiamenti nella politica di regolamentazione durante il periodo di
lo sviluppo del nostro prodotto candidato. Tali ritardi potrebbero avere un impatto negativo sulla nostra attività, sulle nostre condizioni finanziarie, sui risultati delle operazioni
e prospettive.

Dipendiamo dall'arruolamento dei pazienti
nelle nostre sperimentazioni cliniche per i candidati dei nostri prodotti e potrebbe risultare difficile arruolare pazienti nelle nostre sperimentazioni cliniche, il che potrebbe
ritardare o impedirci di procedere con le prove cliniche dei nostri candidati ai prodotti e potrebbe influenzare negativamente la nostra ricerca e sviluppo
sforzi e affari, condizioni finanziarie e risultati delle operazioni.

Identificazione e qualificazione
la partecipazione dei pazienti alle prove cliniche dei nostri candidati al prodotto è fondamentale per il nostro successo. I tempi dei nostri studi clinici
dipende dalla nostra capacità di reclutare pazienti per partecipare e di vederli attraverso il completamento del follow-up richiesto
periodi. Se, per qualsiasi motivo, i pazienti non sono disposti ad arruolarsi nei nostri studi clinici, allora il calendario per il reclutamento di pazienti,
lo svolgimento di studi e l'ottenimento di approvazioni normative per i nostri candidati prodotti può essere ritardato. Questi ritardi potrebbero comportare un aumento
costi, ritardi nell'avanzamento dei candidati ai nostri prodotti, ritardi nella verifica dell'efficacia dei nostri candidati o della risoluzione dei prodotti
di prove cliniche del tutto.

Il nostro prodotto attuale
i candidati sono in fase di sviluppo per il trattamento di oncologia e malattie immunitarie con esigenze mediche insoddisfatte. Tuttavia, potremmo non essere in grado di farlo
avviare o continuare studi clinici se non è possibile arruolare un numero sufficiente di pazienti idonei a partecipare alla clinica
prove richieste dalla FDA, dall'EMA o da altre autorità di regolamentazione. Di conseguenza, potremmo non essere in grado di identificare, reclutare e iscrivere
un numero sufficiente di pazienti, o quelli con le caratteristiche richieste o desiderate, per completare i nostri studi clinici in modo tempestivo
maniera. L'arruolamento dei pazienti può essere influenzato da molti fattori, tra cui:

dimensione della popolazione di pazienti e processo per identificare i pazienti;

criteri di ammissibilità ed esclusione per le nostre sperimentazioni cliniche;

rischi e benefici percepiti dai nostri candidati al prodotto;

gravità della malattia in esame;

prossimità e disponibilità di siti di sperimentazione clinica per potenziali pazienti;

concorrenza con altre sperimentazioni cliniche per i candidati del prodotto che competono nelle stesse aree terapeutiche dei nostri candidati del prodotto;

capacità di ottenere e mantenere il consenso del paziente;

abbandono dei pazienti prima del completamento degli studi clinici;

pratiche di rinvio paziente di medici; e

capacità di monitorare adeguatamente i pazienti durante e dopo il trattamento.

La nostra capacità di successo
initiate, enroll and complete clinical trials in any foreign country is subject to numerous risks unique to conducting business
in foreign countries, including:

difficulty in establishing or managing relationships with CROs and physicians;

different standards for the conduct of clinical trials;

absence in some countries of established groups with sufficient regulatory expertise for review of certain treatment protocols;

inability to locate qualified local consultants, physicians and partners; e

the potential burden of complying with a variety of foreign laws, medical standards and regulatory requirements, including the regulation of pharmaceutical and biotechnology products and treatment.

If we have difficulty
enrolling a sufficient number of patients or finding additional clinical trial sites to conduct our clinical trials as planned,
we may need to delay, limit or terminate ongoing or planned clinical trials, any of which could have an adverse effect on our business,
financial condition, results of operations and prospects.

Our product candidates and the process
for administering our product candidates may cause undesirable side effects or have other properties that could delay or prevent
their regulatory approval, limit their commercial potential or result in significant negative consequences following any potential
marketing approval.

During the conduct
of clinical trials, patients report changes in their health, including illnesses, injuries and discomforts, to their study doctor.
Often, it is not possible to determine whether the product candidate being studied caused these conditions. Regulatory authorities
may draw different conclusions or require additional testing to confirm these determinations. For Milciclib, the most frequent
drug-related side effects reported across studies, at all doses tested, were gastrointestinal, or GI, adverse events (nausea and
diarrhea, followed by less frequent vomiting), neurological effects (mainly tremor, then ataxia, dizziness and dysgeusia), skin
disorders and asthenia, fatigue, headache and anorexia. For Foralumab, the most frequent drug-related side effects reported following
intravenous administration were infusion related reactions, or IRR, including fever, headaches, chills, nausea, vomiting diarrhea
and hypotension considered the result of cytokine release also known as cytokine release syndrome, or CRS. Other adverse events
included reactivation of Epstein-Barr virus (clinically silent); moderate lymphocytopenia, abnormalities in liver function tests.
Since most of these changes are related to the infusion route of administration and dosage level, such systemic toxicities are
not anticipated when administered orally or nasally due to what we assume will be minimal systemic absorption.

In addition, it is
possible that as we test our product candidates in larger, longer and more extensive clinical programs, or as use of these product
candidates becomes more widespread if they receive regulatory approval, illnesses, injuries, discomforts and other adverse events
that were observed in earlier trials, as well as conditions that did not occur or went undetected in previous trials, will be reported
by patients. Many times, side effects are only detectable after investigational products are tested in large-scale, Phase 3 clinical
trials or, in some cases, after they are made available to patients on a commercial scale after approval. If additional clinical
experience indicates that our product candidates cause serious or life-threatening side effects, the development of our product
candidates may fail or be delayed, or, if the product candidate has received regulatory approval, such approval may be revoked,
which would harm our business, prospects, operating results and financial condition.

If in the future we
are unable to demonstrate that such adverse events were caused by the administration process or related procedures, the FDA, EMA
or other regulatory authorities could order us to cease further development of, or deny approval of, our product candidates for
any or all targeted indications. Even if we are able to demonstrate that any serious adverse events are not product-related, such
occurrences could affect patient recruitment or the ability of enrolled patients to complete the clinical trial. Moreover, if we
elect or are required to delay, suspend or terminate any clinical trial of any of our product candidates, the commercial prospects
of such product candidate may be harmed and our ability to generate product revenues from such product candidate may be delayed
or eliminated. Any of these occurrences may harm our ability to develop other product candidates, and may harm our business, financial
condition and prospects.

Additionally, if we
or others later identify undesirable side effects caused by any of our product candidates, several potentially significant negative
consequences could result, including:

regulatory authorities may suspend or withdraw approvals of such product candidate;

regulatory authorities may require additional warnings on the label;

we may be required to change the way a product candidate is administered or conduct additional clinical trials;

we could be sued and held liable for harm caused to patients; e

our reputation may suffer.

Any of these events
could prevent us from achieving or maintaining market acceptance of our product candidates.

Any contamination in our manufacturing
process, shortages of raw materials or failure of any of our key suppliers to deliver necessary components could result in delays
in our clinical development or marketing schedules.

Given the nature of
biologics and NCE manufacturing, there is a risk of contamination. Any contamination could adversely affect our ability to produce
product candidates on schedule and could, therefore, harm our results of operations and cause reputational damage. In addition,
some of the raw materials required in our manufacturing process are derived from biologic sources and are difficult to procure
and may be subject to contamination or recall. A material shortage, contamination, recall or restriction on the use of biologically
derived substances in the manufacture of our product candidates could adversely impact or disrupt the commercial manufacturing
or the production of clinical material, which could adversely affect our development timelines and our business, financial condition,
results of operations and prospects.

Risks Related to Our Financial Position
and Need For Capital

Our independent registered public
accounting firm has expressed substantial doubt about our ability to continue as a going concern, which may hinder our ability
to obtain future financing.

Mazars LLP, our independent
registered public accounting firm for the fiscal year ended December 31, 2019, has included an explanatory paragraph in their opinion
that accompanies our audited consolidated financial statements as of and for the year ended December 31, 2019, indicating that
our current liquidity position raises substantial doubt about our ability to continue as a going concern. If we are unable to improve
our liquidity position, we may not be able to continue as a going concern. The accompanying consolidated financial statements do
not include any adjustments that might result if we are unable to continue as a going concern and, therefore, be required to realize
our assets and discharge our liabilities other than in the normal course of business which could cause investors to suffer the
loss of all or a substantial portion of their investment.

We have incurred net losses in every
year since our inception. We anticipate that we will continue to incur losses for the foreseeable future and may never achieve
or maintain profitability.

We are a clinical
stage biotechnology company with a limited operating history. Since our inception in May 2013, we have incurred significant net
losses. Our net losses were $9.3 million, $8.0 million and $8.6 million for the years ended December 31, 2019, 2018 and 2017,
respectively. As of December 31, 2019, we had an accumulated loss of $60.0 million. We have devoted substantially all of our efforts
to research and development of our product candidates, including clinical development of our lead product candidates, Foralumab
and Milciclib, as well as to building out our management team and infrastructure. We expect that it could be several years, if
ever, before we have a commercialized product candidate. We expect to continue to incur significant expenses and increasing operating
losses for the foreseeable future. These net losses will adversely impact our shareholders’ equity and net assets and may
fluctuate significantly from quarter to quarter and year to year. We anticipate that our expenses will increase substantially
if, and as, we:

continue research and development of Foralumab, including the initiation of our orally administered Phase 2 trials in patients with Crohn’s disease and progressive multiple sclerosis (MS);

initiate a Phase 2b trial for Milciclib in combination with a tyrosine kinase inhibitor (sorafenib or regorafenib) in HCC patients;

accelerate development and cGMP manufacturing of anti-IL6R mAb for treatment of COVID -19 and multiple myeloma and initiate clinical trials and preclinical studies for any additional product candidates that we may pursue in the future;

manufacture our product candidates in accordance with current good manufacturing practices, or cGMP, for clinical trials or potential commercial sales;

Advance development, validation and commercialization
of StemPrintER;

establish a sales, marketing and distribution infrastructure
to commercialize any product candidate for which we may obtain marketing approval;

develop, maintain, expand and protect our intellectual property portfolio;

identify, assess, and acquire or in-license other product candidates and technologies;

secure, maintain or obtain freedom to operate for any in-licensed technologies and products;

address any competing technological and market developments; e

expand our operations in the United States and Europe.

We may never succeed
in any or all of these activities and, even if we do, we may never generate revenues that are significant or large enough to achieve
profitability. If we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual
basis. Our failure to become and remain profitable would decrease the value of our company and could impair our ability to raise
capital, maintain our R&D efforts, expand our business or continue our operations.

We need substantial additional funding
to complete the development of our product candidates, which may not be available on acceptable terms, if at all. Failure to obtain
this necessary capital when needed may force us to delay, limit or terminate certain of our product development, research operations
or future commercialization efforts, if any.

Our operations have
consumed substantial amounts of cash since inception, and we expect our expenses to increase in connection with our ongoing activities,
particularly as we continue the R&D of, initiate further clinical trials of and seek marketing approval for, our product candidates.
In addition, if we obtain marketing approval for our product candidates, we expect to incur significant expenses related to product
sales, marketing, manufacturing and distribution. Furthermore, we expect to incur additional costs associated with operating as
a public company listed on both AIM in the United Kingdom and Nasdaq in the United States. Our future capital requirements will
depend on many factors, including:

the scope, progress, results and costs of laboratory testing, manufacturing, preclinical and clinical development for our current and future product candidates;

the costs, timing and outcome of regulatory review of our product candidates;

the extent to which we acquire or in-license and develop other product candidates and technologies;

our ability to establish and maintain collaborations and license agreements on favorable terms, if at all;

the costs, timing and outcome of potential future commercialization activities, including manufacturing, marketing, sales and distribution for our product candidates for which we receive marketing approval;

the costs of developing, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims; e

the sales price and availability of adequate third-party coverage and reimbursement for our product candidates, if and when approved.

Developing product
candidates and conducting preclinical studies and clinical trials is a time-consuming, expensive and uncertain process that takes
years to complete, and we may never generate the necessary data or results required to obtain marketing approval and achieve product
sales. In addition, our product candidates, if approved, may not achieve commercial success. Our product revenues, if any, will
be derived from or based on sales of product candidates that may not be commercially available for many years, if at all. Accordingly,
we will need to continue to rely on additional financing to achieve our business objectives. Adequate additional financing may
not be available to us on acceptable terms, if at all. To the extent that additional capital is raised through the issuance of
equity or equity-linked securities, the issuance of those securities could result in substantial dilution for our current shareholders
and the terms of any future issuance may include liquidation or other preferences that adversely affect the rights of our current
shareholders. Debt financing, if available, may involve covenants restricting our operations or our ability to incur additional
debt. Any debt or additional equity financing that we raise may contain terms that are not favorable to us or our shareholders.
If we raise additional funds through collaboration and licensing arrangements with third parties, it may be necessary to relinquish
some rights to our technologies or our product candidates or grant licenses on terms that are not favorable to us. Furthermore,
the potential issuance of additional securities in the future, whether equity or debt, by us, or the possibility of such issuance,
may cause the market price of our American Depositary Shares, or ADSs, to decline and existing shareholders may not agree with
our financing plans or the terms of such financings.

If we are unable to
obtain adequate funding on a timely basis, we may be required to significantly curtail, delay or discontinue our R&D programs
of our product candidates or any future commercialization efforts, be unable to expand our operations or be unable to otherwise
capitalize on our business opportunities, as desired, which could harm our business and potentially cause us to discontinue operations.

Our limited operating history and
no history of commercializing pharmaceutical products may make it difficult to evaluate the success of our business to date and
to assess the prospects for our future viability.

Since our inception,
we have devoted substantially all of our resources to developing Foralumab and Milciclib, and our other product candidates, building
our intellectual property portfolio and providing general and administrative support for these operations. Although our R&D
efforts to date have resulted in a pipeline of product candidates, we have not yet demonstrated our ability to successfully complete
Phase 3 or other pivotal clinical trials, obtain regulatory approvals, or commercialize any of our product candidates. In addition,
given our limited operating history, we may encounter unforeseen expenses, difficulties, complications, delays and other known
and unknown factors in achieving our business objectives.

Additionally, we are
not profitable and have incurred losses in each year since our inception, and we expect that our financial condition and operating
results may continue to fluctuate significantly from quarter to quarter and year to year due to a variety of factors, many of which
are beyond our control. Consequently, any predictions you make about our future success or viability may not be as accurate as
they could be if we had a longer operating history.

Risks Related to Our Reliance on Third
Parties

We rely, and expect to continue to
rely, on third parties to conduct our preclinical studies and clinical trials. If these third parties do not successfully carry
out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize
our product candidates.

We have relied upon
and plan to continue to rely upon third parties, including independent clinical investigators and third-party CROs, to conduct
our preclinical studies and clinical trials and to monitor and manage data for our ongoing preclinical and clinical programs. In
engaging these third parties, we typically have to, and expect to have to, negotiate budgets and contracts, which may result in
delays to our development timelines and increases costs. Additionally, there is a limited number of qualified third-party service
providers that specialize or have the expertise required to achieve our business objectives, and so it may be challenging to find
alternative investigators or CROs, or do so on commercially reasonable terms. We rely on these parties for execution of our preclinical
studies and clinical trials, and control only certain aspects of their activities. Nevertheless, we are responsible for ensuring
that each of our preclinical studies and clinical trials is conducted in accordance with the applicable protocol and legal, regulatory
and scientific standards, and our reliance on these third parties does not relieve us of our regulatory responsibilities. We and
our third-party contractors and CROs are required to comply with GCP requirements, which are regulations and guidelines enforced
by the FDA, the Competent Authorities of the Member States of the European Economic Area and comparable foreign regulatory authorities
for all of our product candidates in clinical development. Regulatory authorities enforce these GCP requirements through periodic
inspections of trial sponsors, principal investigators and clinical trial sites. If we fail to exercise adequate oversight over
any of our CROs or if we or any of our CROs fail to comply with applicable GCP requirements, the clinical data generated in our
clinical trials may be deemed unreliable and the FDA, EMA or other regulatory authorities may require us to perform additional
clinical trials before approving our marketing applications. We cannot assure you that upon a regulatory inspection of us or our
CROs or other third parties performing services in connection with our clinical trials, such regulatory authority will determine
that any of our clinical trials complies with GCP regulations. In addition, our clinical trials must be conducted with product
produced under applicable cGMP regulations. Our failure to comply with these regulations may require us to repeat clinical trials,
which would delay the regulatory approval process.

Further, these investigators
and CROs are not our employees and we will not be able to control, other than by contract, the amount of resources, including time,
which they devote to our product candidates and clinical trials. If independent investigators or CROs fail to devote sufficient
resources to the development of our product candidates, or if their performance is substandard, it may delay or compromise the
prospects for approval and commercialization of our product candidates. These investigators and CROs may also have relationships
with other commercial entities, including our competitors, for whom they may also be conducting clinical studies or other drug
development activities, which could affect their performance on our behalf. In addition, the use of third-party service providers
requires us to disclose our proprietary information to these parties, which increases the risk that a competitor will discover
them or that this information will be misappropriated or disclosed.

If any of our relationships
with these third-party CROs terminate, we may not be able to enter into arrangements with alternative CROs or to do so on commercially
reasonable terms. If CROs do not successfully carry out their contractual duties or obligations or meet expected deadlines, if
they need to be replaced or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere
to our clinical protocols, regulatory requirements or for other reasons, our clinical trials may be extended, delayed or terminated
and we may not be able to obtain regulatory approval for or successfully commercialize our product candidates. As a result, our
results of operations and commercial prospects would be harmed, our costs could increase and our ability to generate revenues could
be delayed.

Repeating clinical
trials or switching or engaging additional CROs involves additional cost and requires our management’s time and focus. In
addition, there is a natural transition period when a clinical trial has to be repeated or when a new CRO commences work. As a
result, delays could occur, which could materially impact our ability to meet our desired clinical development timelines.

Our reliance on third parties requires
us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will
be misappropriated or disclosed.

We have engaged contract
manufacturing organizations, or CMOs, to manufacture Foralumab and Milciclib and to perform quality testing, and because we collaborate
with various organizations and academic institutions for the advancement of our platforms, we must, at times, share our proprietary
technology and confidential information, including trade secrets, with them. We seek to protect our proprietary technology, in
part, by entering into confidentiality agreements and, if applicable, material transfer agreements, collaborative research agreements,
consulting agreements or other similar agreements with our collaborators, advisors, employees and consultants prior to beginning
research or disclosing proprietary information. These agreements typically limit the rights of the third parties to use or disclose
our confidential information. Despite the contractual provisions employed when working with third parties, the need to share trade
secrets and other confidential information increases the risk that such trade secrets become known by our competitors, are inadvertently
incorporated into the technology of others or are disclosed or used in violation of these agreements. Given that our proprietary
position is based, in part, on our know-how and trade secrets, a competitor’s discovery of our proprietary technology and
confidential information or other unauthorized use or disclosure of such technology or information would impair our competitive
position and may have an adverse effect on our business, financial condition, results of operations and prospects.

Despite our efforts
to protect our trade secrets, our competitors may discover our trade secrets, either through breach of these agreements, independent
development or publication of information including our trade secrets by third parties. A competitor’s discovery of our trade
secrets would impair our competitive position and have an adverse impact on our business, financial condition, results of operations
and prospects.

We utilize, and expect to continue
to utilize, third parties to conduct our product manufacturing for the foreseeable future, and these third parties may not perform
satisfactorily.

We currently rely on
CMOs for the manufacturing of clinical batches and intend to continue to rely on third parties to manufacture our preclinical study
and clinical trial product supplies. If our current CMOs, or any future third-party manufacturers, do not successfully carry out
their contractual duties, meet expected deadlines or manufacture our product candidates in accordance with regulatory requirements,
or if there are disagreements between us and our CMOs or any future third-party manufacturers, we will not be able to complete,
or may be delayed in completing, the preclinical studies required to support future investigational new drug, or IND, submissions
and the clinical trials required for approval of our product candidates.

In addition to our
current CMOs, we may rely on additional third parties to manufacture ingredients of our product candidates in the future and to
perform quality testing, and reliance on these third parties entails risks to which we would not be subject if we manufactured
the product candidates ourselves, including:

reduced control for certain aspects of manufacturing activities;

termination or nonrenewal of manufacturing and service agreements with third parties in a manner or at a time that is costly or damaging to us; e

disruptions to the operations of our third-party manufacturers and service providers caused by conditions unrelated to our business or operations, including the bankruptcy of the manufacturer or service provider.

Any of these events
could lead to clinical trial delays or failure to obtain regulatory approval or impact our ability to successfully commercialize
any of our product candidates. Some of these events could be the basis for FDA, EMA or other regulatory authority action, including
injunction, recall, seizure or total or partial suspension of product manufacture.

To the extent we rely on a third-party
manufacturing facility for commercial supply, that third party will be subject to significant regulatory oversight with respect
to manufacturing our product candidates.

The preparation of
therapeutics for clinical trials or commercial sale is subject to extensive regulation. Components of a finished therapeutic product
approved for commercial sale or used in late-stage clinical trials must be manufactured in accordance with cGMP requirements. These
regulations govern manufacturing processes and procedures, including record keeping, and the implementation and operation of quality
systems to control and assure the quality of investigational products and products approved for sale. Poor control of production
processes can lead to the introduction of outside agents or other contaminants, or to inadvertent changes in the properties or
stability of a product candidate that may not be detectable in final product testing. To the extent that we utilize third-party
facilities for commercial supply, the third party’s facilities and quality systems must pass an inspection for compliance
with the applicable regulations as a condition of regulatory approval. In addition, the regulatory authorities may, at any time,
audit or inspect the third-party manufacturing facility or the associated quality systems for compliance with the regulations applicable
to the activities being conducted. If, for example, these facilities do not pass a plant inspection, the FDA will not approve the
applicable NDA or biologics license application, or BLA.

We do not directly
control the manufacturing of, and are completely dependent on, our CMOs for compliance with cGMP requirements. If our CMOs cannot
successfully manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA, EMA or
other regulatory authorities, they will not be able to secure and/or maintain regulatory approval for their manufacturing facilities.
In addition, we have no direct control over the ability of our CMOs to maintain adequate quality control, quality assurance and
qualified personnel. Furthermore, all of our CMOs are engaged with other companies to supply and/or manufacture materials or products
for such companies, which exposes our CMOs to regulatory risks for the production of such materials and products. As a result,
failure to meet the regulatory requirements for the production of those materials and products may generally affect the regulatory
clearance of our CMOs’ facilities. Our failure, or the failure of third parties, to comply with applicable regulations could
result in sanctions being imposed on us, including clinical holds, fines, injunctions, civil penalties, delays, suspension or withdrawal
of approvals, license revocation, seizures or recalls of product candidates or products, operating restrictions and criminal prosecutions,
any of which could significantly and adversely affect supplies of our products and product candidates.

Our potential future
dependence upon others for the manufacture of our product candidates may adversely affect our future profit margins and our ability
to commercialize any products that receive regulatory approval on a timely and competitive basis.

Risks Related to Commercialization of
Our Product Candidates

We currently have no marketing and
sales force. If we are unable to establish effective sales, marketing and distribution capabilities or enter into agreements with
third parties to market, sell and distribute our product candidates that may be approved, we may not be successful in commercializing
our product candidates if and when approved, and we may be unable to generate any product revenue.

We currently do not
have a marketing or sales team for the marketing, sales and distribution of any of our product candidates. In order to commercialize
any of our product candidates that may be approved, we intend to build, on a territory-by-territory basis, marketing, sales, distribution,
managerial and other non-technical capabilities or make arrangements with third parties to perform these services. These efforts
will require significant capital expenditures, management resources and time, and we face competition in search for qualified personnel
or third parties to assist with marketing, sales and distribution of any of our product candidates. We may not be successful in
building these capabilities.

There are risks involved
with both establishing our own sales, marketing and distribution capabilities and entering into arrangements with third parties
to perform these services. For example, recruiting and training a sales force is expensive and time consuming and could delay any
product launch. If the commercial launch of a product candidate for which we recruit a sales force and establish marketing and/or
distribution capabilities is delayed or does not occur for any reason, we would have prematurely or unnecessarily incurred these
commercialization expenses. This may be costly, and our investment would be lost if we cannot retain or reposition our sales and
marketing personnel.

Factors that may inhibit
our efforts to commercialize our product candidates on our own include:

our inability to recruit, train and retain adequate numbers of effective sales and marketing personnel;

the inability of sales personnel to obtain access to physicians or persuade adequate numbers of physicians to prescribe any future product that we may develop;

the lack of complementary treatments to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; e

unforeseen costs and expenses associated with creating an independent sales and marketing organization.

If we enter into arrangements
with third parties to perform sales, marketing and distribution services, our product revenue or the profitability to us from these
revenue streams is likely to be lower than if we were to market and sell any product candidates that we develop ourselves. In addition,
we may not be successful in entering into arrangements with third parties to sell and market  our product candidates or may
be unable to do so on terms that are favorable to us. We likely will have little control over such third parties and any of them
may fail to devote the necessary resources and attention to sell and market our product candidates effectively. If we do not establish
sales and marketing capabilities successfully, either on our own or in collaboration with third parties, we may not be successful
in commercializing our product candidates.

We face significant competition in
an environment of rapid technological change and the possibility that our competitors may achieve regulatory approval before us
or develop therapies that are more advanced or effective than ours.

The biotechnology and
pharmaceutical industries are characterized by rapidly changing technologies, significant competition and a strong emphasis on
intellectual property. We face substantial competition from many different sources, including large and specialty pharmaceutical
and biotechnology companies, academic research institutions, government agencies and public and private research institutions.

New developments, including
the development of other pharmaceutical technologies and methods of treating disease, occur in the pharmaceutical and life sciences
industries at a rapid pace. Developments by competitors may render our product candidates obsolete or noncompetitive. We anticipate
that we will face intense and increasing competition as new treatments enter the market and advanced technologies become available.

Many of our potential
competitors, alone or with their strategic partners, have substantially greater financial, technical and other resources, such
as larger R&D, clinical, sales and marketing and manufacturing organizations. These third parties also compete with us in recruiting
and retaining qualified scientific and management personnel, establishing clinical trial sites and patient registration for clinical
trials, as well as in acquiring technologies complementary to, or necessary for, the development of our products. In addition,
mergers and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated
among a smaller number of competitors. Our commercial opportunity could be reduced or eliminated if competitors develop and commercialize
products that are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive than
any product candidate that we may develop. Competitors also may obtain FDA, EMA or other regulatory approval for their products
more rapidly or earlier than we may obtain approval for ours, which could result in our competitors establishing a strong market
position before we are able to enter the market. Additionally, technologies developed by our competitors may render our product
candidates uneconomical or obsolete, and we may not be successful in marketing our product candidates against competitors.

In addition, as a result
of the expiration or successful challenge of our patent rights, we could face more litigation with respect to the validity and/or
scope of patents relating to our competitors’ products. The availability of our competitors’ products could limit the
demand, and the price we are able to charge, for any product candidate that we may develop and commercialize.

The market opportunities for our
product candidates may be smaller than we anticipate.

We focus our R&D
efforts on treatments for cancer and autoimmune disease. Our understanding of both the number of people who have these diseases,
as well as the subset of people with these diseases who have the potential to benefit from treatment with our product candidates,
is based on estimates. These estimates may prove to be incorrect and new studies may reduce the estimated incidence or prevalence
of these diseases. The number of patients in the United States, the European Union and elsewhere may turn out to be lower than
expected, may not be otherwise amenable to treatment with our product candidates or patients may become increasingly difficult
to identify and access, all of which would adversely affect our business, financial condition, results of operations and prospects.

Further, there are
several factors that could contribute to making the actual number of patients who receive our potential products, if and when approved,
less than the potentially addressable market. These include, for example, the lack of widespread availability of, and limited reimbursement
for, new therapies in many underdeveloped markets.

The future commercial success of
our product candidates will depend upon the degree of each product candidates’ market acceptance by physicians, patients,
third-party payors and others in the medical community.

Our product candidates
are at varying stages of development, and we may never have a product that is commercially successful. To date, we have no product
authorized for marketing. Due to the inherent risk in the development of pharmaceutical products, we may never successfully complete
development and commercialization of any of our product candidates. Even with the requisite approvals from the FDA, EMA and other
regulatory authorities internationally, the commercial success of our product candidates will depend, in part, on the acceptance
of physicians, patients and third-party payors of our product candidates as medically necessary, cost-effective and safe. Any product
that we commercialize may not gain acceptance by physicians, patients, third-party payors and others in the medical community.
If these products do not achieve an adequate level of acceptance, we may not generate significant product revenue and may not become
profitable. Even if some product candidates achieve market acceptance, the market may not prove to be large enough to allow us
to generate significant revenues. The degree of market acceptance of our product candidates, if approved for commercial sale, will
depend on several factors, including:

the effectiveness and safety of our product candidates as demonstrated in clinical trials;

the potential and perceived advantages of our product candidates over alternative treatments;

the availability and cost of treatment relative to alternative treatments;

changes in the standard of care for the targeted indications for any product candidate;

the willingness of physicians to prescribe, and the target patient population to try, new therapies;

the prevalence and severity of any side effects;

product labeling or product insert requirements of the FDA, EMA or other regulatory authorities, including any limitations or warnings contained in a product’s approved labeling;

the timing of market introduction of competitive products;

sales, distribution and marketing support;

publicity concerning our product candidates or competing products and treatments;

potential product liability claims;

any restrictions on the use of our products together with other medications; e

favorable third-party payor coverage and adequate reimbursement.

Even if a potential
product displays favorable clinical properties and safety profile in preclinical studies and clinical trials, market acceptance
of the product will not be fully known until after it is launched.

The insurance coverage and reimbursement
status of newly approved products is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for our product
candidates, if approved, could limit our ability to market those products.

We expect that coverage
and adequate reimbursement by government and private payors will be essential for most patients to be able to afford these treatments.
Accordingly, sales of our product candidates will depend substantially, both domestically and abroad, on the extent to which the
costs of our product candidates will be paid by health maintenance, managed care, pharmacy benefit and similar healthcare management
organizations, or will be reimbursed by government authorities, private health coverage insurers and other third-party payors.
Coverage and reimbursement by a third-party payor may depend upon several factors, including the third-party payor’s determination
that use of a product is:

a covered benefit under our health plan;

safe, effective and medically necessary;

appropriate for the specific patient;

cost-effective; e

neither experimental nor investigational.

Obtaining coverage
and reimbursement for a product from third-party payors is a time-consuming and costly process that could require us to provide
to the payor supporting scientific, clinical and cost-effectiveness data. We may not be able to provide data sufficient to gain
acceptance with respect to coverage and reimbursement. If coverage and reimbursement are not available, or are available only at
limited levels, we may not be able to successfully commercialize our product candidates. Even if coverage is provided, the approved
reimbursement amount may not be adequate to realize a sufficient return on our investment.

There is significant
uncertainty related to third-party coverage and reimbursement of newly approved products. In the United States, third-party payors,
including government payors such as the Medicare and Medicaid programs, play an important role in determining the extent to which
new drugs and biologics will be covered and reimbursed. The Medicare and Medicaid programs increasingly are used as models for
how private payors develop their coverage and reimbursement policies. However, no uniform policy of coverage and reimbursement
exists among third-party payors. Therefore, coverage and reimbursement for products can differ significantly from payor to payor.
One payor’s determination to provide coverage for a product does not assure that other payors will also provide coverage,
and adequate reimbursement. It is difficult to predict what the Centers for Medicare and Medicaid Services, or CMS will decide
with respect to coverage and reimbursement for fundamentally novel products such as ours, as there is no body of established practices
and precedents for these types of products. Moreover, reimbursement agencies in the European Union may be more conservative than
the CMS. For example, several cancer drugs have been approved for reimbursement in the United States and have not been approved
for reimbursement in certain European Union, or EU, member states, or Member States. It is difficult to predict what third-party
payors will decide with respect to the coverage and reimbursement for our product candidates.

Also, the containment
of healthcare costs has become a priority of federal, state and foreign governments, and the prices of drugs have been a focus
in this effort. The U.S. government, state legislatures, and foreign governments have shown significant interest in implementing
cost-containment programs to limit the growth of government-paid healthcare costs, including price controls, restrictions on reimbursement
and requirements for substitution of generic products for branded prescription drugs. For example, in the United States, the Patient
Protection and Affordable Care Act of 2010 (as amended by the Health Care and Education Reconciliation Act of 2010), or the PPACA,
contains provisions that may reduce the profitability of products, including, for example, increased rebates for products sold
to Medicaid programs, extension of Medicaid rebates to Medicaid managed care plans, mandatory discounts for certain Medicare Part
D beneficiaries and annual fees based on pharmaceutical companies’ share of sales to federal health care programs. Further,
there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products,
which has resulted in several recent congressional inquiries and proposed federal and state legislation designed to, among other
things, bring more transparency to product pricing, contain the cost of drugs, review the relationship between pricing and manufacturer
patient programs, and reform government program reimbursement methodologies for products.

Outside the United
States, international operations generally are subject to extensive government price controls and other market regulations and
increasing emphasis on cost-containment initiatives in the European Union, Canada and other countries may put pricing pressure
on us. In many countries, the prices of medical products are subject to varying price control mechanisms as part of national health
systems. In general, the prices of medicines under such systems are substantially lower than in the United States. Other countries
allow companies to fix their own prices for medical products but monitor and control company profits. Additional foreign price
controls or other changes in pricing regulation could restrict the amount that we are able to charge for our product candidates.
Accordingly, in markets outside the United States, the reimbursement for our product candidates may be reduced compared with the
United States and may be insufficient to generate commercially reasonable product revenues.

In addition, there
can be considerable pressure by governments and other stakeholders on prices and reimbursement levels, including as part of cost
containment measures. Political, economic and regulatory developments may further complicate pricing negotiations, and pricing
negotiations may continue after reimbursement has been obtained. Reference pricing used by various Member States and parallel distribution,
or arbitrage between low-priced and high-priced Member States, can further reduce prices. To obtain reimbursement or pricing approval
in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness of our product candidates
to other available therapies. If reimbursement of our products is unavailable or limited in scope or amount, or if pricing is set
at unsatisfactory levels, our business could be harmed.

Moreover, increasing
efforts by government and third-party payors in the United States and abroad to cap or reduce healthcare costs may cause such organizations
to limit both coverage and the level of reimbursement for new products approved and, as a result, they may not cover or provide
adequate payment for our product candidates.

Payors increasingly
are considering new metrics as the basis for reimbursement rates, such as average sales price, average manufacturer price and actual
acquisition cost. The existing data for reimbursement based on some of these metrics is relatively limited, although certain states
have begun to survey acquisition cost data for the purpose of setting Medicaid reimbursement rates, and CMS has begun making pharmacy
National Average Drug Acquisition Cost and National Average Retail Price data publicly available on at least a monthly basis. Therefore,
it may be difficult to project the impact of these evolving reimbursement metrics on the willingness of payors to cover product
candidates that we or our partners are able to commercialize. We expect to experience pricing pressures in connection with the
sale of any of our product candidates due to the trend toward managed healthcare, the increasing influence of health maintenance
organizations and additional legislative changes. The downward pressure on healthcare costs in general, particularly prescription
drugs and surgical procedures and other treatments, has become intense. As a result, increasingly high barriers are being erected
to the entry of new products such as ours.

Risks Related to Our Intellectual Property

Our rights to develop and commercialize
our product candidates are subject to the terms and conditions of licenses granted to us by others. If we fail to comply with our
obligations under our existing and any future intellectual property licenses with third parties, we could lose license rights that
are important to the business.

We are heavily reliant
upon licenses and sublicenses from Nerviano, Lonza and Novimmune to certain patent rights and proprietary technology that are important
or necessary to the development of our technology and product candidates, including the patents and know-how relating to manufacture.
These and other licenses may not provide exclusive rights to use such intellectual property and technology or may not provide exclusive
rights to use such intellectual property and technology in all relevant fields of use and in all territories in which we may wish
to develop or commercialize our technology and product candidates in the future. As a result, we may not be able to prevent competitors
from developing and commercializing competitive products, including in territories covered by our licenses.

In some circumstances,
we may not have the right to control the preparation, filing and prosecution of patent applications, or to maintain the patents,
covering technology that we license from third parties. If our licensors fail to maintain such patents or patent applications,
or lose rights to those patents or patent applications, the rights we have licensed may be reduced or eliminated and our right
to develop and commercialize any of our product candidates that are the subject of such licensed rights could be adversely affected.
In addition to the foregoing, the risks associated with patent rights that we license from third parties will also apply to patent
rights we may own in the future.

Licenses to additional
third-party technology and materials that may be required for our development programs, including additional technology and materials
owned by any of our current licensors, may not be available in the future or may not be available on commercially reasonable terms,
or at all, which could have an adverse effect on our business and financial condition.

If we are unable to obtain and maintain
patent protection for our current product candidates, any future product candidates we may develop and our technology, or if the
scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize products and
technology similar or identical to ours.

Our success depends,
in large part, on our ability to seek, obtain and maintain patent protection in the United States and other countries with respect
to our product candidates and to future innovation related to our manufacturing technology. Our licensors have sought, and we intend
to seek to protect our proprietary position by filing patent applications in the United States, the United Kingdom and elsewhere,
related to certain technologies and our product candidates that are important to our business. Our current patent portfolio contains
a limited number of patent applications, all of which are in-licensed from third parties and relate to either composition of matter,
formulation, method of use or process of manufacturing Foralumab, Milciclib and a fully human anti-interleukin-6 receptor, or IL-6r,
mAb. However, the risks associated with patent rights generally apply to patent rights that we in-license now or in the future,
as well as patent rights that we may own in the future. Moreover, the risks apply with respect to patent rights and other intellectual
property applicable to our product candidates, as well as to any intellectual property rights that we may acquire in the future
related to future product candidates, if any. We have filed a new patent application covering the composition of matter of Foralumab.
However, this application is pending and there is no guarantee that the U.S. Patent and Trademark Office, or USPTO, will grant
this application.

The patent prosecution
process is expensive, time-consuming, and complex, and we may not be able to file, prosecute, maintain, enforce or license all
necessary or desirable patent applications at a reasonable cost or in a timely manner.

In some cases, the
work of certain academic researchers in the oncology and immunology fields has entered the public domain, which we believe precludes
our ability to obtain patent protection for certain inventions relating to such work.

Consequently, we will
not be able to assert any such patents to prevent others from using our technology for, and developing and marketing competing
products to treat, these indications. It is also possible that we will fail to identify patentable aspects of our R&D output
before it is too late to obtain patent protection.

Our existing license
agreements impose, and we expect that future license agreements will impose, various due diligence, development and commercialization
timelines, insurance, milestone payments, royalties, and other obligations on us. See the description in the section titled “Business-Collaboration
and License Agreements” herein. If we fail to comply with our obligations under these agreements, or we are subject to a
bankruptcy, or, in some cases, under other circumstances, the licensor may have the right to terminate the license, in which event
we would not be able to market product candidates covered by the license. In addition, certain of these license agreements are
not assignable by us without the consent of the respective licensor, which may have an adverse effect on our ability to engage
in certain transactions.

The patent position
of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions and has,
in recent years, been the subject of much litigation. As a result, the issuance, scope, validity, enforceability and commercial
value of any patent rights are highly uncertain. Our licensed patent applications may not result in patents being issued which
protect our technology or product candidates, effectively prevent others from commercializing competitive technologies and product
candidates or otherwise provide any competitive advantage. In fact, patent applications may not issue as patents at all. Even assuming
patents issue from patent applications in which we have rights, changes in either the patent laws or interpretation of the patent
laws in the United States and other countries may diminish the value of our patents or narrow the scope of our patent protection.

Other parties have
developed technologies that may be related or competitive to our own and such parties may have filed or may file patent applications,
or may have received or may receive patents, claiming inventions that may overlap or conflict with those claimed in our own patent
applications or issued patents. We may not be aware of all third-party intellectual property rights potentially relating to our
current and future product candidates.

Publications of discoveries
in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and in other
jurisdictions are typically not published until 18 months after filing, or, in some cases, not at all. Therefore, we cannot know
with certainty whether the inventors of our licensed patents and applications were the first to make the inventions claimed in
those patents or pending patent applications, or that they were the first to file for patent protection of such inventions. Similarly,
should we own any patents or patent applications in the future, we may not be certain that we were the first to file for patent
protection for the inventions claimed in such patents or patent applications. As a result, the issuance, scope, validity and commercial
value of our patent rights cannot be predicted with any certainty.

The degree of patent
protection we require to successfully compete in the marketplace may be unavailable or severely limited in some cases and may not
adequately protect our rights or permit us to gain or keep any competitive advantage. We cannot provide any assurances that any
of our licensed patents have, or that any of our pending licensed patent applications that mature into issued patents will include,
claims with a scope sufficient to protect our product candidates or otherwise provide any competitive advantage. In addition, the
laws of foreign countries may not protect our rights to the same extent as the laws of the United States. Furthermore, patents
have a limited lifespan. In the United States, the natural expiration of a patent is generally 20 years after it is filed. Various
extensions may be available; however, the life of a patent, and the protection it affords, is limited. Given the amount of time
required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might
expire before or shortly after such candidates are commercialized. As a result, our licensed patent portfolio may not provide us
with adequate and continuing patent protection sufficient to exclude others from commercializing products similar to our product
candidates, including “highly similar,” or biosimilar, versions of such products. In addition, the intellectual property
portfolio licensed to us by Nerviano and Novimmune may be used by them or licensed to third parties, and such third parties may
have certain enforcement rights. Thus, patents licensed to us could be put at risk of being invalidated or interpreted narrowly
in litigation filed by or against our licensors or another licensee or in administrative proceedings brought by or against our
licensors or another licensee in response to such litigation or for other reasons.

Even if we acquire
patent protection that we expect should enable us to maintain some competitive advantage, third parties, including competitors,
may challenge the validity, enforceability or scope thereof, which may result in such patents being narrowed, invalidated or held
unenforceable. In litigation, a competitor could claim that our patents, if issued, are not valid for several reasons. If a court
agrees, we would lose our rights to those challenged patents.

The issuance of a patent
is not conclusive as to its inventorship, scope, validity or enforceability and our licensed patents may be challenged in courts
or patent offices in the United States and abroad. For example, we may be subject to a third-party submission of prior art to the
USPTO challenging the validity of one or more claims of our licensed patents. Such submissions may also be made prior to a patent’s
issuance, precluding the granting of a patent based on one of our pending licensed patent applications. We may become involved
in opposition, derivation, re-examination, inter partes review, post-grant review or interference proceedings challenging the patent
rights of others from whom we have obtained licenses to such rights. Competitors may claim that they invented the inventions claimed
in our licensed issued patents or patent applications prior to the inventors of such patents or applications. A competitor who
can establish an earlier filing or invention date may also claim that we are infringing their patents and that we therefore cannot
practice our technology as claimed under our licensed patents, if issued. Competitors may also contest our licensed patents, if
issued, by showing that the invention was not patent-eligible, was not novel, was obvious or that the patent claims failed any
other requirement for patentability.

An adverse determination
by former employees or consultants asserting ownership rights to our patents may result in loss of exclusivity or freedom to operate
or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit our ability to stop
others from using or commercializing similar technology and therapeutics, without payment to us, or could limit the duration of
the patent protection covering our technology and product candidates. Such challenges may also result in our inability to manufacture
or commercialize our product candidates without infringing third-party patent rights. In addition, if the breadth or strength of
protection provided by our patents and patent applications is threatened, it could dissuade companies from collaborating with us
to license, develop or commercialize current or future product candidates.

Even if they are unchallenged,
our licensed patents and pending patent applications, if issued, may not provide us with any meaningful protection or prevent competitors
from designing around our patent claims to circumvent our licensed patents by developing similar or alternative technologies or
therapeutics in a non-infringing manner. For example, a third party may develop a competitive therapeutic that provides benefits
similar to one or more of our product candidates but that uses a different antibody or molecular active ingredient that falls outside
the scope of our patent protection. If the patent protection provided by the patents and patent applications we hold or pursue
with respect to our product candidates is not sufficiently broad to impede such competition, our ability to successfully commercialize
our product candidates could be negatively affected, which would harm our business.

Our intellectual property licenses
with third parties may be subject to disagreements over contract interpretation, which could narrow the scope of our rights to
the relevant intellectual property or technology or increase our financial or other obligations to our licensors.

We currently depend,
and will continue to depend, on our license agreements whereby we obtain rights in certain patents and patent applications owned
by them. Further development and commercialization of our current product candidates may, and development of any future product
candidates will, require us to enter into additional license or collaboration agreements. The agreements under which we currently
license intellectual property or technology from third parties are complex, and certain provisions in such agreements may be susceptible
to multiple interpretations. The resolution of any contract interpretation disagreement that may arise could narrow what we believe
to be the scope of our rights to the relevant intellectual property or technology, or increase what we believe to be our financial
or other obligations under the relevant agreement, either of which could have an adverse effect on our business, financial condition,
results of operations and prospects.

If any of our licenses
or material relationships or any in-licenses upon which our licenses are based are terminated or breached, we may:

lose our rights to develop and market our product candidates;

lose patent protection for our product candidates;

experience significant delays in the development or commercialization of our product candidates;

not be able to obtain any other licenses on acceptable terms, if at all; o

incur liability for damages.

In addition, a third
party may in the future bring claims that our performance under our license agreements, including our sponsoring of clinical trials,
interferes with such third party’s rights under its agreement with one of our licensors. If any such claim were successful,
it may adversely affect our rights and ability to advance our product candidates as clinical candidates or subject us to liability
for monetary damages, any of which would have an adverse effect on our business, financial condition, results of operations and
prospects.

These risks apply to
any agreements that we may enter into in the future for our current or any future product candidates. If we experience any of the
foregoing, it could have a negative impact on our business, financial condition, results or operations and prospects.

If we fail to comply with our obligations
in the agreements under which we license intellectual property rights from third parties or otherwise experience disruptions to
our business relationships with our licensors, we could lose license rights that are important to our business.

We have entered into
license agreements with third parties and may need to obtain additional licenses from one or more of these same third parties or
from others to advance our research or allow commercialization of our product candidates. It is possible that we may be unable
to obtain additional licenses at a reasonable cost or on reasonable terms, if at all. In that event, we may be required to expend
significant time and resources to redesign our product candidates or the methods for manufacturing them or to develop or license
replacement technology, all of which may not be feasible on a technical or commercial basis. If we are unable to do so, we may
be unable to develop or commercialize our product candidates, which would harm our business. We cannot provide any assurances that
third-party patents or other intellectual property rights do not exist which might be enforced against our current product candidates
or future product candidates, resulting in either an injunction prohibiting our manufacture or sales, or, with respect to our sales,
an obligation on our part to pay royalties and/or other forms of compensation to third parties.

In each of our existing
license agreements, and we expect in our future agreements, patent prosecution of our licensed technology is controlled solely
by the licensor, and we may be required to reimburse the licensor for their costs of patent prosecution. If our licensors fail
to obtain and maintain patent or other protection for the proprietary intellectual property we license from them, we could lose
our rights to the intellectual property, or our exclusivity with respect to those rights, and our competitors could market competing
products using the intellectual property. Our license agreements with Nerviano and Novimmune also require us to meet development
thresholds to maintain each license, including establishing a set timeline for developing and commercializing product candidates.
Disputes may arise regarding intellectual property subject to a licensing agreement, including:

the scope of rights granted under the license agreement and other interpretation-related issues;

the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;

the sublicensing of patent and other rights pursuant to our collaborative development relationships;

our diligence obligations under the license agreements and what activities satisfy those diligence obligations;

the inventorship or ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners; e

the priority of invention of patented technology.

If disputes over intellectual
property that we have licensed prevent or impair our ability to maintain our current licensing arrangements on acceptable terms,
we may be unable to successfully develop and commercialize our product candidates.

We may not be successful in obtaining
or maintaining necessary rights to our product candidates through acquisitions and in-licenses.

We currently have certain
rights to the intellectual property, through licenses from third parties, to develop our product candidates. Because our programs
may require the use of additional proprietary rights held by these or other third parties, the growth of our business likely will
depend, in part, on our ability to acquire, in-license or use these proprietary rights. We may be unable to acquire or in-license
any compositions, methods of use, processes or other intellectual property rights from third parties that we identify as necessary
for our product candidates. The licensing or acquisition of third-party intellectual property rights is a competitive area, and
several more established companies may pursue strategies to license or acquire third-party intellectual property rights that we
may consider attractive. These established companies may have a competitive advantage over us due to their size, capital resources
and greater clinical development and commercialization capabilities. In addition, companies that perceive us to be a competitor
may be unwilling to assign or license rights to us. We also may be unable to license or acquire third-party intellectual property
rights on terms that would allow us to make an appropriate return on our investment.

We may collaborate
with non-profit and academic institutions to accelerate our preclinical R&D under written agreements with these institutions.
These institutions may provide us with an option to negotiate a license to any of the institution’s rights in technology
resulting from the collaboration. Regardless of such option, we may be unable to negotiate a license within the specified timeframe
or under terms that are acceptable to us. If we are unable to do so, the institution may offer the intellectual property rights
to other parties, potentially blocking our ability to pursue our program.

If we are unable to
successfully obtain rights to required third-party intellectual property or maintain the existing intellectual property rights
we have, we may have to abandon development of our product candidates and our business, financial condition, results of operations
and prospects could suffer. Moreover, to the extent that we seek to develop other product candidates in the future, we will likely
require acquisition or in-license of additional proprietary rights held by third parties.

Obtaining and maintaining our patent
protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by government
patent agencies, and our patent protection could be reduced or eliminated as a result of non-compliance with these requirements.

Periodic maintenance
fees, renewal fees, annuity fees and various other government fees on patents and/or applications will be due to be paid to the
USPTO and various government patent agencies outside of the United States over the lifetime of our licensed patents and/or applications
and any patent rights we may own in the future. We rely on our outside counsel or our licensing partners to pay these fees due
to non-U.S. patent agencies. The USPTO and various non-U.S. government patent agencies require compliance with several procedural,
documentary, fee payment and other similar provisions during the patent application process. We employ reputable law firms and
other professionals to help us comply and we are also dependent on our licensors to take the necessary action to comply with these
requirements with respect to our licensed intellectual property. In many cases, an inadvertent lapse can be cured by payment of
a late fee or by other means in accordance with the applicable rules. There are situations, however, in which non-compliance can
result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the
relevant jurisdiction. In such an event, potential competitors might be able to enter the market and this circumstance could have
an adverse effect on our business.

We may not be able to protect our
intellectual property rights throughout the world.

Filing, prosecuting
and defending patents on product candidates in all countries throughout the world would be prohibitively expensive, and our intellectual
property rights in some countries outside the United States could be less extensive than those in the United States. In some cases,
we may not be able to obtain patent protection for certain licensed technology outside the United States. In addition, the laws
of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United
States, even in jurisdictions where we do pursue patent protection. Consequently, we may not be able to prevent third parties from
practicing our inventions in all countries outside the United States, even in jurisdictions where we do pursue patent protection
or from selling or importing products made using our inventions in and into the United States or other jurisdictions.

Competitors may use
our technologies in jurisdictions where we have not pursued and obtained patent protection to develop their own products and, further,
may export otherwise infringing products to territories where we have patent protection, but enforcement is not as strong as that
in the United States. These products may compete with our product candidates, and our patents or other intellectual property rights
may not be effective or sufficient to prevent them from competing.

Many companies have
encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems
of certain countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets and other
intellectual property protection, particularly those relating to biotechnology products, which could make it difficult for us to
stop the infringement of our patents, if pursued and obtained, or marketing of competing products in violation of our proprietary
rights generally. Moreover, many countries have compulsory licensing laws under which a patent owner may be compelled to grant
licenses to third parties. Many countries limit the enforceability of patents against government agencies or government contractors.
In these countries, the patent owner may have limited remedies, which could materially diminish the value of such patent. If we
or any of our licensors is forced to grant a license to third parties with respect to any patents relevant to our business, our
competitive position may be impaired, and our business and results of operations may be adversely affected.

In addition, proceedings
to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from
other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications
at risk of not issuing and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we
initiate, and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce
our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual
property that we develop or license.

We may not be able to protect our
trade secrets in court.

In addition to the
protection afforded by patents, we rely on trade secret protection and confidentiality agreements to protect proprietary know-how
that is not patentable or that we elect not to patent, processes for which patents are difficult to enforce and any other elements
of our product candidate discovery and development processes that involve proprietary know-how, information or technology that
is not covered by patents. However, trade secrets can be difficult to protect and some courts inside and outside the United States
are less willing or unwilling to protect trade secrets. We seek to protect our proprietary technology and processes, in part, by
entering into confidentiality agreements with our employees, consultants, scientific advisors and contractors. However, we may
not be able to prevent the unauthorized disclosure or use of our technical know-how or other trade secrets by the parties to these
agreements, despite the existence generally of confidentiality agreements and other contractual restrictions.

Monitoring unauthorized
uses and disclosures is difficult and we do not know whether the steps we have taken to protect our proprietary technologies will
be effective. If any of the collaborators, scientific advisors, employees and consultants who are parties to these agreements breach
or violate the terms of any of these agreements, we may not have adequate remedies for any such breach or violation. As a result,
we could lose our trade secrets.

We cannot guarantee
that we have entered into such agreements with each party that may have or have had access to our trade secrets or proprietary
technology and processes. We also seek to preserve the integrity and confidentiality of our data and trade secrets by maintaining
physical security of our premises and physical and electronic security of our information technology systems. While we have confidence
in these individuals, organizations and systems, agreements and security measures, they may still be breached, and we may not have
adequate remedies for any breach.

In addition, our trade
secrets may otherwise become known or be independently discovered by competitors. Competitors could purchase our product candidates
and attempt to replicate some or all of the competitive advantages we derive from our development efforts, willfully infringe our
intellectual property rights, design around our protected technology or develop their own competitive technologies that fall outside
of our intellectual property rights. If any of our trade secrets were to be lawfully obtained or independently developed by a competitor,
we would have no right to prevent them, or those to whom they communicate such trade secrets, from using that technology or information
to compete with us. If our trade secrets are not adequately protected so as to protect our market against competitors’ therapeutics,
our competitive position could be adversely affected, as could our business.

Third parties may initiate legal
proceedings alleging that we are infringing their intellectual property rights.

Our commercial success
depends upon our ability and the ability of our future collaborators to develop, manufacture, market and sell our product candidates
and use our proprietary technologies without infringing the proprietary rights and intellectual property of third parties. Il
biotechnology and pharmaceutical industries are characterized by extensive and complex litigation regarding patents and other intellectual
property rights. We may in the future become party to, or be threatened with, adversarial proceedings or litigation regarding intellectual
property rights with respect to our product candidates and technology, including interference proceedings, post grant review and
inter partes review before the USPTO. Our competitors or other third parties may assert infringement claims against us, alleging
that our therapeutics, manufacturing methods, formulations or administration methods are covered by their patents. Given the vast
number of patents in our field of technology, we cannot be certain or guarantee that we do not infringe existing patents or that
we will not infringe patents that may be granted in the future. Since this area is competitive and of strong interest to pharmaceutical
and biotechnology companies, there will likely be additional patent applications filed and additional patents granted in the future,
as well as additional R&D programs expected in the future. Furthermore, because patent applications can take many years to
issue, may be confidential for 18 months or more after filing and can be revised before issuance, there may be applications now
pending which may later result in issued patents that may be infringed by the manufacture, use, sale or importation of our product
candidates and we may or may not be aware of such patents. If a patent holder believes the manufacture, use, sale or importation
of one of our product candidates infringes its patent, the patent holder may sue us even if we have licensed other patent protection
for our technology. Moreover, we may face patent infringement claims from non-practicing entities that have no relevant product
revenue and against whom our licensed patent portfolio may therefore have no deterrent effect.

It is also possible
that we have failed to identify relevant third-party patents or applications. For example, applications filed before November 29,
2000 and certain applications filed after that date that will not be filed outside the United States may remain confidential until
patents issue. Moreover, it is difficult for industry participants, including us, to identify all third-party patent rights that
may be relevant to our product candidates and technologies because patent searching is imperfect due to differences in terminology
among patents, incomplete databases and the difficulty in assessing the meaning of patent claims. We may fail to identify relevant
patents or patent applications or may identify pending patent applications of potential interest but incorrectly predict the likelihood
that such patent applications may issue with claims of relevance to our technology. In addition, we may be unaware of one or more
issued patents that would be infringed by the manufacture, sale or use of a current or future product candidate, or we may incorrectly
conclude that a third-party patent is invalid, unenforceable or not infringed by our activities. Additionally, pending patent applications
that have been published can, subject to certain limitations, be later amended in a manner that could cover our technologies, our
product candidates or the use of our product candidates.

Third parties may assert
infringement claims against us based on existing patents or patents that may be granted in the future, regardless of their merit.
There is a risk that third parties may choose to engage in litigation with us to enforce or to otherwise assert their patent or
other intellectual property rights against us. Even if we believe such claims are without merit, a court of competent jurisdiction
could hold that these third-party patents are valid, enforceable and infringed, which could adversely affect our ability to commercialize
our product candidates. In order to successfully challenge the validity of any such U.S. patent in federal court, we would need
to overcome a presumption of validity. As this burden is a high one requiring us to present clear and convincing evidence as to
the invalidity of any such U.S. patent claim, there is no assurance that a court of competent jurisdiction would invalidate the
claims of any such U.S. patent. Similarly, there is no assurance that a court of competent jurisdiction would find that product
candidates or our technology did not infringe a third-party patent.

Patent and other types
of intellectual property litigation can involve complex factual and legal questions, and their outcome is uncertain. If we are
found or believe there is a risk that we may be found, to infringe a third party’s valid and enforceable intellectual property
rights, we could be required or may choose to obtain a license from such third party to continue developing, manufacturing and
marketing our product candidates and technology. However, we may not be able to obtain any required license on commercially reasonable
terms or at all. Even if we were able to obtain a license, it could be non-exclusive, thereby giving our competitors and other
third parties access to the same technologies licensed to us, and it could require us to make substantial licensing and royalty
payments. We could be forced, including by court order, to cease developing, manufacturing and commercializing the infringing technology
or product candidate. In addition, we could be found liable for monetary damages, including treble damages and attorneys’
fees, if we are found to have willfully infringed a patent or other intellectual property right. A finding of infringement could
prevent us from manufacturing and commercializing our product candidates or force us to cease some or all of our business operations,
which could harm our business. Claims that we have misappropriated the confidential information or trade secrets of third parties
could have a similar negative impact on our business, financial condition, results of operations and prospects.

Intellectual property litigation
could cause us to spend substantial resources and distract our personnel from their normal responsibilities.

Litigation or other
legal proceedings relating to intellectual property claims, with or without merit, are unpredictable and generally expensive and
time-consuming. Competitors may infringe our patents or the patents of our licensing partners, should such patents issue, or we
may be required to defend against claims of infringement. To counter infringement or unauthorized use claims or to defend against
claims of infringement can be expensive and time consuming. Even if resolved in our favor, litigation or other legal proceedings
relating to intellectual property claims may cause us to incur significant expenses and could distract our technical and management
personnel from their normal responsibilities. Furthermore, because of the substantial amount of discovery required in connection
with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure
during this type of litigation. In addition, there could be public announcements of the results of hearings, motions or other interim
proceedings or developments and if securities analysts or investors perceive these results to be negative, it could have a substantial
adverse effect on us. Such litigation or proceedings could substantially increase our operating losses and reduce the resources
available for development activities or any future sales, marketing or distribution activities.

We may not have sufficient
financial or other resources to adequately conduct such litigation or proceedings. Some of our competitors may be able to sustain
the costs of such litigation or proceedings more effectively than we can because of their greater financial resources and more
mature and developed intellectual property portfolios.

Accordingly, despite
our efforts, we may not be able to prevent third parties from infringing, misappropriating or successfully challenging our intellectual
property rights. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have
a negative impact on our ability to compete in the marketplace.

We may be subject to claims asserting
that our employees, consultants or advisors have wrongfully used or disclosed alleged trade secrets of their current or former
employers or claims asserting ownership of what we regard as our own intellectual property.

Certain of our employees,
consultants or advisors are currently, or were previously, employed at universities or other biotechnology or pharmaceutical companies,
including our competitors or potential competitors, as well as our academic partners. Although we try to ensure that our employees,
consultants and advisors do not use the proprietary information or know-how of others in their work for us, we may be subject to
claims that these individuals or we have used or disclosed intellectual property, including trade secrets or other proprietary
information, of any such individual’s current or former employer. Litigation may be necessary to defend against these claims.
If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights.
An inability to incorporate such technologies or features would harm our business and may prevent us from successfully obtaining
necessary regulatory approvals and commercializing our product candidates. In addition, we may lose personnel as a result of such
claims, and any such litigation or the threat thereof may adversely affect our ability to hire employees or contract with independent
contractors. A loss of key personnel or their work product could hamper or prevent our ability to obtain necessary regulatory approvals
and commercialize our product candidates, which would have an adverse effect on our business, results of operations and financial
condition. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction
to management.

In addition, while
it is our policy to require our employees and contractors who may be involved in the conception or development of intellectual
property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement
with each party who, in fact, conceives or develops intellectual property that we regard as our own. Moreover, even when we obtain
agreements assigning intellectual property to us, the assignment of intellectual property rights may not be self-executing or the
assignment agreements may be breached, and we may be forced to bring claims against third parties, or defend claims that they may
bring against us, to determine the ownership of what we regard as our intellectual property. Furthermore, individuals executing
agreements with us may have pre-existing or competing obligations to a third party, such as an academic institution, and thus an
agreement with us may be ineffective in perfecting ownership of inventions developed by that individual. Disputes about the ownership
of intellectual property that we may own may have an adverse effect on our business.

Changes in U.S. patent law could
diminish the value of patents in general, thereby impairing our ability to protect our product candidates.

Recent patent reform
legislation could increase the uncertainties and costs surrounding the prosecution of patent applications and the enforcement or
defense of issued patents. On September 16, 2011, the Leahy-Smith America Invents Act, or the Leahy-Smith Act, was signed into
law. The Leahy-Smith Act includes several significant changes to U.S. patent law. These include provisions that affect the way
patent applications are prosecuted and also may affect patent litigation. These also include provisions that switched the United
States from a “first-to-invent” system to a “first-to-file” system, allow third-party submission of prior
art to the USPTO during patent prosecution and set forth additional procedures to attack the validity of a patent through various
post-grant proceedings administered by the USPTO. Under a first-to-file system, assuming the other requirements for patentability
are met, the first inventor to file a patent application generally will be entitled to the patent on an invention regardless of
whether another inventor had made the invention earlier. The USPTO developed new regulations and procedures to govern administration
of the Leahy-Smith Act, and many of the substantive changes to patent law associated with the Leahy-Smith Act, and in particular,
the first-to-file provisions, only became effective on March 16, 2013.

Accordingly, it is
not clear what, if any, impact the Leahy-Smith Act will have on the operation of our business. However, the Leahy-Smith Act and
its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement
or defense of our issued patents, all of which could have a negative impact effect on our business, financial condition, results
of operations and prospects.

Additionally, the U.S.
Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available in certain
circumstances or weakening the rights of patent owners in certain situations. In addition to increasing uncertainty with regard
to our ability to obtain patents in the future, the combination of new federal legislation, federal court decisions, and guidance
from the USPTO has created uncertainty with respect to the value of patents, once obtained. Depending on the decisions by the U.S.
Congress, federal courts, and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would
weaken our ability to obtain new patents or enforce our existing patents and patents we might obtain in the future.

If our trademarks and trade names
are not adequately protected, then we may not be able to build name recognition in our markets of interest.

We do not currently
have any registered trademarks and we have not filed any trademark applications to date. Any trademark applications in the United
States, Europe and in other foreign jurisdictions where we may file may not be allowed or may subsequently be opposed. Once filed
and registered, our trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be
infringing on other marks. As a means to enforce our trademark rights and prevent infringement, we may be required to file trademark
claims against third parties or initiate trademark opposition proceedings. This can be expensive and time-consuming, particularly
for a company of our size. We may not be able to protect our rights to these trademarks and trade names, which we need to build
name recognition among potential partners or customers in our markets of interest. At times, competitors may adopt trade names
or trademarks similar to ours, thereby impeding our ability to build brand identity and possibly leading to market confusion. In
addition, there could be potential trade name or trademark infringement claims brought by owners of other registered trademarks
or trademarks that incorporate variations of our registered or unregistered trademarks or trade names. Over the long term, if we
are unable to establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively
and our business may be adversely affected. Our efforts to enforce or protect our proprietary rights related to trademarks, trade
secrets, domain names, copyrights or other intellectual property may be ineffective and could result in substantial costs and diversion
of resources.

Intellectual property rights and
regulatory exclusivity rights do not necessarily address all potential threats
.

The degree of future
protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations and
may not adequately protect our business or permit us to maintain our competitive advantage. For example:

others may be able to make products that are similar to our product candidates but that are not covered by the claims of the patents that we license or may own in the future;

we, or our license partners or future collaborators, might not have been the first to make the inventions covered by the issued patent or pending patent applications that we license or may own in the future;

we, or our license partners or future collaborators, might not have been the first to file patent applications covering certain of our or their inventions;

others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our owned or licensed intellectual property rights;

others may circumvent our regulatory exclusivities, such as by pursuing approval of a competitive product candidate via the traditional approval pathway based on their own clinical data, rather than relying on the abbreviated pathway provided for biosimilar applicants;

it is possible that our pending licensed patent applications or those that we may own in the future will not lead to issued patents;

issued patents that we hold rights to now or in the future may be held invalid or unenforceable, including as a result of legal challenges by our competitors;

others may have access to the same intellectual property rights licensed to us on a non-exclusive basis;

our competitors might conduct R&D activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets;

we may not develop additional proprietary technologies that are patentable;

the patents or other intellectual property rights of others may have an adverse effect on our business; o

we may choose not to file a patent for certain trade secrets or know-how, and a third party may subsequently file a patent covering such intellectual property.

Should any of these
events occur, they could significantly harm our business, financial condition, results of operations and prospects.

Risks Related to Government Regulation

Even if we complete the necessary
clinical trials, we cannot predict when, or if, we will obtain regulatory approval to commercialize our product candidates and
the approval may be for a narrower indication than we seek.

We cannot commercialize
a product candidate until the appropriate regulatory authorities have reviewed and approved the product candidate. The FDA must
review and approve any new pharmaceutical product before it can be marketed and sold in the United States. The FDA regulatory review
and approval process, which includes evaluation of preclinical studies and clinical trials of a product candidate and proposed
labeling, as well as the evaluation of the manufacturing process and manufacturers’ facilities, all of which is lengthy,
expensive and uncertain. To obtain approval, we must, among other things, demonstrate with substantial evidence from well-controlled
clinical trials that the product candidate is both safe and effective for each indication where approval is sought. Even if our
product candidates meet the FDA’s safety and effectiveness endpoints in clinical trials, the FDA may not complete their review
processes in a timely manner, or we may not be able to obtain regulatory approval. The FDA has substantial discretion in the review
and approval process and may refuse to file our application for substantive review or may determine after review of our data that
our application is insufficient to allow approval of our product candidates. The FDA may require that we conduct additional preclinical
studies, clinical trials or manufacturing validation studies and submit that data before it will reconsider our application. Additional
delays may result if an FDA Advisory Committee or other regulatory authority recommends non-approval or restrictions on approval.
In addition, we may experience delays or rejections based upon additional government regulation from future legislation or administrative
action, or changes in regulatory authority policy during the period of product development, clinical trials and the review process.

The FDA, EMA or other
regulatory authorities also may approve a product candidate for more limited indications than requested or may impose significant
limitations in the form of narrow indications, warnings or a REMS. These regulatory authorities may require precautions or contraindications
with respect to conditions of use or may grant approval subject to the performance of costly post-marketing clinical trials. In
addition, the FDA, EMA or other regulatory authorities may not approve the labeling claims that are necessary or desirable for
the successful commercialization of our product candidates. Any of the foregoing scenarios could harm the commercial prospects
for our product candidates and negatively impact our business, financial condition, results of operations and prospects.

Delays in obtaining regulatory approval
of our manufacturing process and facility or disruptions in our manufacturing process may delay or disrupt our product development
and commercialization efforts.

We do not currently
operate manufacturing facilities for clinical or commercial production of our product candidates. Before we can begin to commercially
manufacture our product candidates, whether in a third-party facility or in our own facility, if and when established, we must
obtain regulatory approval from the FDA for our manufacturing process and facility. A manufacturing authorization must also be
obtained from the appropriate European Union regulatory authorities and from other foreign regulatory authorities, as applicable.
In order to obtain approval, we will need to ensure that all of our processes, methods and equipment are compliant with cGMP, and
perform extensive audits of vendors, contract laboratories and suppliers. If any of our vendors, contract laboratories or suppliers
are found to be non-compliant with cGMP, we may experience delays or disruptions in manufacturing while we work with these third
parties to remedy the violation or while we work to identify suitable replacement vendors. The cGMP requirements govern quality
control of the manufacturing process and documentation policies and procedures. In complying with cGMP, we will be obligated to
expend time, money and effort in production, record keeping and quality assurance to confirm that the product meets applicable
specifications and other requirements. If we fail to comply with these requirements, we would be subject to possible regulatory
action and may not be permitted to sell any product candidate that we may develop.

If we or our third-party
manufacturers fail to comply with applicable cGMP regulations, the FDA, EMA and other regulatory authorities can impose regulatory
sanctions including, among other things, refusal to approve a pending application for a new product candidate or suspension or
revocation of a pre-existing approval. Such an occurrence may cause our business, financial condition, results of operations and
prospects to be harmed.

Additionally, if the
supply of our products from our third-party manufacturers to us is interrupted for any reason, including due to regulatory requirements
or actions (including recalls), adverse financial developments at or affecting the supplier, failure by the supplier to comply
with cGMPs, contamination, business interruptions or labor shortages or disputes, there could be a significant disruption in commercial
supply of our products. We do not currently have a backup manufacturer of our product candidate supply for clinical trials or commercial
sale. An alternative manufacturer would need to be qualified through a supplement to its regulatory filing, which could result
in further delays. The regulatory authorities also may require additional clinical trials if a new manufacturer is relied upon
for commercial production. Switching manufacturers may involve substantial costs and could result in a delay in our desired clinical
and commercial timelines.

If our competitors are able to obtain
orphan drug exclusivity for products that constitute the same drug and treat the same indications as our product candidates, we
may not be able to have competing products approved by applicable regulatory authorities for a significant period of time. In addition,
even if we obtain orphan drug exclusivity for any of our products, such exclusivity may not protect us from competition.

Regulatory authorities
in some jurisdictions, including the United States and the European Union, may designate products for relatively small patient
populations as orphan drugs. Under the Orphan Drug Act of 1983, the FDA may designate a product candidate as an orphan drug if
it is intended to treat a rare disease or condition, which is generally defined as having a patient population of fewer than 200,000
individuals in the United States, or a patient population greater than 200,000 in the United States where there is no reasonable
expectation that the cost of developing the drug will be recovered from sales in the United States. In the United States, orphan
drug designation entitles a party to financial incentives such as opportunities for grant funding towards clinical trial costs,
tax advantages and user-fee waivers. In the European Union, the EMA’s Committee for Orphan Medicinal Products grants orphan
drug designation to promote the development of products that are intended for the diagnosis, prevention or treatment of a life-threatening
or chronically debilitating condition affecting not more than five in 10,000 persons in the European Union. Additionally, orphan
drug designation is granted for products intended for the diagnosis, prevention or treatment of a life-threatening, seriously debilitating
or serious and chronic condition and when, without incentives, it is unlikely that sales of the drug in the European Union would
be sufficient to justify the necessary investment in developing the drug or biologic product. In Europe, orphan drug designation
entitles a party to a number of incentives, such as protocol assistance and scientific advice specifically for designated orphan
medicines, and potential fee reductions depending on the status of the sponsor.

The designation as
an orphan product does not guarantee that any regulatory agency will accelerate regulatory review of, or ultimately approve, that
product candidate, nor does it limit the ability of any regulatory agency to grant orphan drug designation to product candidates
of other companies that treat the same indications as our product candidates prior to our product candidates receiving exclusive
marketing approval.

Generally, if a product
candidate with an orphan drug designation receives the first marketing approval for the indication for which it has such designation,
the product is entitled to a period of marketing exclusivity, which precludes the FDA or the EMA from approving another marketing
application for a product that constitutes the same drug treating the same indication for that marketing exclusivity period, except
in limited circumstances. If another sponsor receives such approval before we do (regardless of our orphan drug designation), we
will be precluded from receiving marketing approval for our product for the applicable exclusivity period. The applicable period
is seven years in the United States and ten years in the European Union. The exclusivity period in the European Union can be reduced
to six years if a product no longer meets the criteria for orphan drug designation or if the product is sufficiently profitable
so that market exclusivity is no longer justified. Orphan drug exclusivity may be revoked if any regulatory agency determines that
the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantity of the product
to meet the needs of patients with the rare disease or condition.

Even if we obtain orphan
drug exclusivity for a product candidate, that exclusivity may not effectively protect the product candidate from competition because
different drugs can be approved for the same condition. In the United States, even after an orphan drug is approved, the FDA may
subsequently approve another drug for the same condition if the FDA concludes that the latter drug is not the same drug or is clinically
superior in that it is shown to be safer, more effective or makes a major contribution to patient care. In the European Union,
marketing authorization may be granted to a similar medicinal product for the same orphan indication if:

the second applicant can establish in its application that its medicinal product, although similar to the orphan medicinal product already authorized, is safer, more effective or otherwise clinically superior;

the holder of the marketing authorization for the original orphan medicinal product consents to a second orphan medicinal product application; o

the holder of the marketing authorization for the original orphan medicinal product cannot supply sufficient quantities of orphan medicinal product.

Even if we obtain regulatory approval
for a product candidate, our product candidates will remain subject to regulatory oversight.

Even if we obtain regulatory
approval for our product candidates, they will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging,
storage, advertising, promotion, sampling, record-keeping and submission of safety and other post-market information. Any regulatory
approvals that we receive for our product candidates may also be subject to limitations on the approved indicated uses for which
the product may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing,
including Phase 4 clinical trials, and surveillance to monitor the quality, safety and clinical effectiveness of the product.

Some of our product
candidates are classified as biologics in the United States, and therefore, can only be sold if we obtain a BLA from the FDA. Il
holder of an approved BLA also must submit new or supplemental applications and obtain FDA approval for certain changes to the
approved product, product labeling or manufacturing process. In addition, the holder of a BLA must comply with the FDA’s
advertising and promotion requirements, such as those related to the prohibition on promoting products for uses or in patient populations
that are not described in the product’s approved labeling (known as “off-label use”). Advertising and promotional
materials must comply with FDA rules and are subject to FDA review, in addition to other potentially applicable federal and state
laws.

In addition, product
manufacturers and their facilities are subject to payment of user fees and continual review and periodic inspections by the FDA
and other regulatory authorities for compliance with cGMP requirements and adherence to commitments made in the BLA or foreign
marketing application. If we, or a regulatory authority, discover previously unknown problems with a product, such as adverse events
of unanticipated severity or frequency, or problems with the facility where the product is manufactured or if a regulatory authority
disagrees with the promotion, marketing or labeling of that product (in addition to our being obligated as holder of a BLA to monitor
and report adverse events and any failure of a product to meet the BLA specifications), a regulatory authority may impose restrictions
relative to that product, the manufacturing facility or us, including requiring recall or withdrawal of the product from the market
or suspension of manufacturing.

If we fail to comply
with applicable regulatory requirements following approval of our product candidates, a regulatory or enforcement authority may:

issue a warning letter asserting that we are in violation of the law;

seek an injunction or impose administrative, civil or criminal penalties or monetary fines;

suspend or withdraw regulatory approval;

suspend any ongoing clinical trials;

refuse to approve a pending BLA or comparable foreign marketing application (or any supplements thereto) submitted by us or our strategic partners;

restrict the marketing or manufacturing of the product;

seize or detain the product or otherwise require the withdrawal of the product from the market;

refuse to permit the import or export of the product; o

refuse to allow us to enter into supply contracts, including government contracts.

Any government investigation
of alleged violations of law could require us to expend significant time and resources in response and could generate negative
publicity. The occurrence of any event or penalty described above may inhibit our ability to commercialize our product candidates
and adversely affect our business, financial condition, results of operations and prospects.

In addition, the FDA’s
policies, and those of the EMA and other regulatory authorities, may change and additional government regulations may be enacted
that could prevent, limit or delay regulatory approval of our product candidates. We cannot predict the likelihood, nature or extent
of government regulation that may arise from future legislation or administrative action, either in the United States or abroad.
If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we
are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained and we may not achieve
or sustain profitability, which would negatively impact our business, financial condition, results of operations and prospects.

Even if we obtain and maintain approval
for our product candidates in a major pharmaceutical market such as the United States, we may never obtain approval for our product
candidates in other major markets.

In order to market
any products in a country or territory, we must establish and comply with numerous and varying regulatory requirements of such
countries or territories regarding safety and effectiveness. Clinical trials conducted in one country may not be accepted by regulatory
authorities in other countries, and regulatory approval in one country does not mean that regulatory approval will be obtained
in any other country. Approval procedures vary among countries and can involve additional product testing and validation and additional
administrative review periods. Seeking regulatory approvals in all major markets could result in significant delays, difficulties
and costs for us and may require additional preclinical studies or clinical trials, which would be costly and time consuming. Regulatory
requirements can vary widely from country to country and could delay or prevent the introduction of our product candidates in those
countries. For example, in many jurisdictions outside of the United States, a product candidate must be approved for reimbursement
before it can be approved for sale in that jurisdiction. In some cases, the price that we intend to charge for our products would
also be subject to approval. Satisfying these and other regulatory requirements is costly, time consuming, uncertain and subject
to unanticipated delays. In addition, our failure to obtain regulatory approval in any country may delay or have negative effects
on the process for regulatory approval in other countries. We currently do not have any product candidates approved for sale in
any jurisdiction, whether in the United States, Europe or any other international markets, and we do not have experience in obtaining
regulatory approval in international markets. If we fail to comply with regulatory requirements in international markets or to
obtain and maintain required approvals, our target market will be reduced and our ability to realize the full market potential
of our product candidates will be compromised.

We may seek a conditional marketing
authorization in Europe for some or all of our current product candidates, but we may not be able to obtain or maintain such designation.

As part of its marketing
authorization process, the EMA may grant marketing authorizations for certain categories of medicinal products on the basis of
less complete data than is normally required, when doing so may meet unmet medical needs of patients and serve the interest of
public health. In such cases, it is possible for the Committee for Medicinal Products for Human Use, or CHMP, to recommend the
granting of a marketing authorization, subject to certain specific obligations to be reviewed annually, which is referred to as
a conditional marketing authorization.

This may apply to medicinal
products for human use that fall under the jurisdiction of the EMA, including those that aim at the treatment, the prevention,
or the medical diagnosis of seriously debilitating or life-threatening diseases and those designated as orphan medicinal products.

A conditional marketing
authorization may be granted when the CHMP finds that, although comprehensive clinical data referring to the safety and therapeutic
utility of the medicinal product have not been supplied, all the following requirements are met:

the risk-benefit balance of the medicinal product is positive;

it is likely that the applicant will be in a position to provide the comprehensive clinical data;

unmet medical needs will be fulfilled; e

the benefit to public health of the immediate availability on the market of the medicinal product concerned outweighs the risk inherent in the fact that additional data is still required.

The granting of a conditional
marketing authorization is restricted to situations in which only the clinical part of the application is not yet fully complete.
Incomplete preclinical or quality data may only be accepted if duly justified and only in the case of a product intended to be
used in emergency situations in response to public health threats. Conditional marketing authorizations are valid for one year,
on a renewable basis. The holder will be required to complete ongoing trials or to conduct new trials with a view to confirming
that the benefit-risk balance is positive. In addition, specific obligations may be imposed in relation to the collection of pharmacovigilance
data.

Granting a conditional
marketing authorization allows medicines to reach patients with unmet medical needs earlier than might otherwise be the case and
will ensure that additional data on a product is generated, submitted, assessed and acted upon.

Healthcare legislative reform measures
may have a negative impact on our business and results of operations.

In the United States
and some foreign jurisdictions, there have been, and continue to be, several legislative and regulatory changes and proposed changes
regarding the healthcare system that could prevent or delay marketing approval of our product candidates, restrict or regulate
post-approval activities and affect our ability to profitably sell any product candidates for which we obtain marketing approval.

In the United States,
the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, or the MMA, changed the way Medicare covers and pays
for pharmaceutical products. The MMA expanded Medicare coverage for outpatient drug purchases by adding a new Medicare Part D program
and introduced a new reimbursement methodology based on average sales prices for Medicare Part B physician-administered drugs.
In addition, the MMA authorized Medicare Part D prescription drug plans to limit the number of drugs that will be covered in any
therapeutic class in their formularies. The MMA’s cost reduction initiatives and other provisions could decrease the coverage
and price that we receive for any approved products. While the MMA applies only to drug benefits for Medicare beneficiaries, private
payors often follow Medicare coverage policy and payment limitations in setting their own reimbursement rates. Therefore, any reduction
in reimbursement that results from the MMA may result in a similar reduction in payments from private payors. Similar regulations
or reimbursement policies may be enacted in international markets, which could similarly impact our business.

More recently, in March
2010, the PPACA (as amended by the Health Care and Education Reconciliation Act of 2010) was passed, which substantially changes
the way healthcare is financed by both the government and private insurers, and significantly impacts the U.S. pharmaceutical industry.
The PPACA, among other things: (i) addresses a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate
Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected; (ii) increases the minimum Medicaid
rebates owed by manufacturers under the Medicaid Drug Rebate Program and extends the rebate program to individuals enrolled in
Medicaid managed care organizations; (iii) establishes annual fees and taxes on manufacturers of certain branded prescription drugs;
(iv) expands the availability of lower pricing under the 340B drug pricing program by adding new entities to the program; and (v)
establishes a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts
off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for
the manufacturer’s outpatient drugs to be covered under Medicare Part D. Additionally, in the United States, the Biologics
Price Competition and Innovation Act of 2009 created an abbreviated approval pathway for biologic products that are demonstrated
to be biosimilar or “interchangeable” with an FDA-approved biologic product. This new pathway could allow competitors
to reference data from biologic products already approved after 12 years from the time of approval. This could expose us to potential
competition by lower-cost biosimilars even if we commercialize a product candidate faster than our competitors. Moreover, the creation
of this abbreviated approval pathway does not preclude or delay a third party from pursuing approval of a competitive product candidate
via the traditional approval pathway based on their own clinical trial data.

Additional changes
that may affect our business include those governing enrollments in federal healthcare programs, reimbursement changes, rules regarding
prescription drug benefits under the health insurance exchanges and fraud and abuse and enforcement. Continued implementation of
the PPACA and the passage of additional laws and regulations may result in the expansion of new programs such as Medicare payment
for performance initiatives, and may impact existing government healthcare programs, such as by improving the physician quality
reporting system and feedback program.

For each state that
does not choose to expand its Medicaid program, there likely will be fewer insured patients overall, which could impact the sales,
business and financial condition of manufacturers of branded prescription drugs. Where patients receive insurance coverage under
any of the new options made available through the PPACA, manufacturers may be required to pay Medicaid rebates on that resulting
drug utilization. The U.S. federal government also has announced delays in the implementation of key provisions of the PPACA. Il
implications of these delays for our and our potential partners’ business and financial condition, if any, are not yet clear.

In addition, there
have been judicial and congressional challenges to certain aspects of the PPACA, and we expect the current administration and Congress
will likely continue to seek legislative and regulatory changes, including repeal and replacement of certain provisions of the
PPACA. In January 2017, President Trump signed an Executive Order directing federal agencies with authorities and responsibilities
under the PPACA to waive, defer, grant exemptions from, or delay the implementation of any provision of the PPACA that would impose
a fiscal or regulatory burden on states, individuals, healthcare providers, health insurers, or manufacturers of pharmaceuticals
or medical devices. More recently, the U.S. House of Representatives passed legislation known as the American Health Care Act of
2017, and Senate Republicans have released a draft bill known as the Better Care Reconciliation Act of 2017, each of which would
repeal certain aspects of the PPACA if ultimately enacted. The prospects for enactment of these legislative initiatives remain
uncertain. Further, Congress also could consider other legislation to replace elements of the PPACA. We cannot know how efforts
to repeal and replace the PPACA or any future healthcare reform legislation will impact our business.

We expect that the
PPACA, as well as other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria
and in additional downward pressure on the price that we receive for any approved product. Any reduction in reimbursement from
Medicare or other government programs may result in a similar reduction in payments from private payors. The implementation of
cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability,
or commercialize our products.

We expect that additional
state and federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and
state governments will pay for healthcare products and services, which could result in reduced demand for our product candidates
or additional pricing pressures.

We are subject to governmental regulation
and other legal obligations related to privacy, data protection and data security. Our actual or perceived failure to comply with
such obligations could harm our business.

We are subject to diverse
laws and regulations relating to data privacy and security in the EU, and shortly in the European Economic Area, including the
GDPR. New global privacy rules are being enacted and existing ones are being updated and strengthened. We are likely to be required
to expend capital and other resources to ensure ongoing compliance with these laws and regulations.

The GDPR applies extraterritorially
and implements stringent operational requirements for controllers and processors of personal data. For example, the GDPR: (i) requires
detailed disclosures to data subjects; (ii) requires disclosure of the legal basis on which personal data is processed; (iii) makes
it harder to obtain valid consent for processing; (iv) requires the appointment of a data protection officers where sensitive personal
data (i.e. health data) is processed on a large scale; (v) provides more robust rights for data subjects; (vi) introduces mandatory
data breach notification through the EU; (vii) imposes additional obligations when contracting with service providers; and (viii)
requires an appropriate privacy governance framework to be implemented including policies, procedures, training and data audit.
The GDPR permits Member State derogations for certain issues and, accordingly, we are also subject to EU national laws relating
to the processing of certain data such as genetic data, biometric data and data concerning health. Complying with these numerous,
complex and often changing regulations is expensive and difficult. Failure by us, or our partners or service providers, to comply
with the GDPR could result in regulatory investigations, enforcement notices and/ or fines of up to the higher of 20,000,000 Euros
or up to 4% of our total worldwide annual turnover. In addition to the foregoing, any breach of privacy laws or data security laws,
particularly those resulting in any security incident or breach involving the misappropriation, loss or other unauthorized use
or disclosure of sensitive or confidential patient or consumer information, could have a material adverse effect on our business,
reputation and financial condition.

As a data controller,
we are accountable for any third party data service providers we engage to process personal data on our behalf. We attempt to address
the associated risks by performing security assessments, detailed due diligence and regularly performing privacy and security reviews
of its vendors and requiring all such third-party providers with data access to sign agreements, including business associate agreements,
and where required under EU law, obligating them to only process data according to our instructions and to take sufficient security
measures to protect such data. There is no assurance that these contractual measures and our own privacy and security-related safeguards
will protect us from the risks associated with the third-party processing, storage and transmission of such information. Any violation
of data or security laws by our third party processors could have a material adverse effect on our business and result in the fines
and penalties outlined above. We are also subject to evolving European privacy laws on electronic marketing and cookies. The EU
is in the process of replacing the e-Privacy Directive (2002/58/EC) with a new set of rules taking the form of a regulation, which
will be directly implemented in the laws of each Member State. The draft e-Privacy Regulation imposes strict opt-in marketing rules
with limited exceptions for business-to-business communications, alters rules on third-party cookies, web beacons and similar technology
and significantly increases fining powers to the same levels as GDPR (i.e. the greater of 20,000,000 Euros or 4% of total global
annual revenue). While the e-Privacy Regulation was originally intended to be adopted on May 25, 2018 (alongside the GDPR), it
is still going through the European legislative process and commentators now expect it to be adopted during the second half of
2020 or during 2021 following a transition period.

We are subject to the U.K. Bribery
Act, the U.S. Foreign Corrupt Practices Act and other anti-corruption laws, as well as export control laws, import and customs
laws, trade and economic sanctions laws and other laws governing our operations.

Our operations are
subject to anti-corruption laws, including the U.K. Bribery Act 2010, or the U.K. Bribery Act, the U.S. Foreign Corrupt Practices
Act of 1977, or the FCPA, the U.S. domestic bribery statute contained in 18 §201, the U.S. Travel Act, and other anti-corruption
laws that apply in countries where we do business. The U.K. Bribery Act, the FCPA and these other laws generally prohibit us and
our employees and intermediaries from authorizing, promising, offering, or providing, directly or indirectly, improper or prohibited
payments, or anything else of value, to government officials or other persons to obtain or retain business or gain some other business
advantage. Under the U.K. Bribery Act, we may also be liable for failing to prevent a person associated with us from committing
a bribery offense. We and our commercial partners operate in a number of jurisdictions that pose a high risk of potential U.K.
Bribery Act or FCPA violations, and we participate in collaborations and relationships with third parties whose corrupt or illegal
activities could potentially subject us to liability under the U.K. Bribery Act, FCPA or local anti-corruption laws, even if we
do not explicitly authorize or have actual knowledge of such activities. In addition, we cannot predict the nature, scope or effect
of future regulatory requirements to which our international operations might be subject or the manner in which existing laws might
be administered or interpreted.

We are also subject
to other laws and regulations governing our international operations, including regulations administered by the governments of
the United Kingdom and the United States, and authorities in the European Union, including applicable export control regulations,
economic sanctions and embargoes on certain countries and persons, anti-money laundering laws, import and customs requirements
and currency exchange regulations, collectively referred to as the Trade Control laws.

There is no assurance
that we will be completely effective in ensuring our compliance with all applicable anti-corruption laws, including the U.K. Bribery
Act, the FCPA or other legal requirements, including Trade Control laws. If we are not in compliance with the U.K. Bribery Act,
the FCPA and other anti-corruption laws or Trade Control laws, we may be subject to criminal and civil penalties, disgorgement
and other sanctions and remedial measures, and legal expenses, which could have an adverse impact on our business, financial condition,
results of operations and liquidity. Likewise, any investigation of any potential violations of the U.K. Bribery Act, the FCPA,
other anti-corruption laws or Trade Control laws by United Kingdom, United States or other authorities could also have an adverse
impact on our reputation, our business, results of operations and financial condition.

Our relationships with customers,
physicians and third-party payors will be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws,
false claims laws, health information privacy and security laws and other healthcare laws and regulations. If we are found in violation
of these laws and regulations, we may be required to pay a penalty or be suspended from participation in federal or state healthcare
programs, which may adversely affect our business, financial condition and results of operations.

If we obtain FDA approval
for our product candidates and begin commercializing them in the United States, our operations will be directly, or indirectly
through our prescribers, customers and purchasers, subject to various federal and state fraud and abuse laws and regulations, including,
without limitation, the federal Anti-Kickback Statute, the federal civil and criminal laws and Physician Payments Sunshine Act
of 2010 and regulations. These laws will impact, among other things, our proposed sales, marketing and educational programs. In
addition, we may be subject to patient privacy laws by both the U.S. federal government and the states in which we conduct our
business. The laws that will affect our operations include, but are not limited to:

the federal Anti-Kickback Statute, which prohibits, among other things, persons or entities from knowingly and willfully soliciting, receiving, offering or paying any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind, in return for either the referral of an individual, or the purchase, leasing, furnishing or arranging for the purchase, lease or order of a good, facility, item or service reimbursable under a federal healthcare program, such as the Medicare and Medicaid programs. This statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on the one hand, and prescribers, purchasers and formulary managers on the other. The PPACA amended the intent requirement of the federal Anti-Kickback Statute, such that a person or entity no longer needs to have actual knowledge of this statute or specific intent to violate it;

federal civil and criminal false claims laws and civil monetary penalty laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment or approval from Medicare, Medicaid or other government payors that are false or fraudulent. The PPACA provides, and recent government cases against pharmaceutical and medical device manufacturers support the view that federal Anti-Kickback Statute violations and certain marketing practices, including off-label promotion, may implicate the False Claims Act of 1863;

the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created new federal criminal statutes that prohibit, among other things, a person from knowingly and willfully executing a scheme or from making false or fraudulent statements to defraud any healthcare benefit program, regardless of the payor (e.g., public or private);

HIPAA (as amended by the Health Information Technology for Economic and Clinical Health Act of 2009), and their implementing regulations, which impose certain requirements relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization by entities subject to the rule, such as health plans, health care clearinghouses and health care providers, and their respective business associates that perform certain functions or activities that involve the use or disclosure of protected health information on their behalf;

federal transparency laws, including the federal Physician Payment Sunshine Act, that require certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to report annually to the CMS information related to: (i) payments or other “transfers of value” made to physicians and teaching hospitals and (ii) ownership and investment interests held by physicians and their immediate family members;

federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers; e

state and foreign law equivalents of each of the above federal laws, state and local laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures, and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.

Efforts to ensure that
our business arrangements with third parties will comply with applicable healthcare laws and regulations will involve substantial
costs. Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible
that some of our business activities could be subject to challenge under one or more of such laws. It is possible that governmental
authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law involving
applicable fraud and abuse or other healthcare laws and regulations. If our operations are found to be in violation of any of these
laws or any other governmental regulations that may apply to us, we may be subject to significant criminal, civil and administrative
sanctions including monetary penalties, damages, fines, disgorgement, individual imprisonment, and exclusion from participation
in government funded healthcare programs, such as Medicare and Medicaid, additional reporting requirements and oversight if we
become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws,
reputational harm, and we may be required to curtail or restructure our operations, any of which could adversely affect our ability
to operate our business and our results of operations.

The risk of our being
found in violation of these laws is increased by the fact that many of them have not been fully interpreted by the regulatory authorities
or the courts, and their provisions are open to a variety of interpretations. Any action against us for violation of these laws,
even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s
attention from the operation of our business. The shifting compliance environment and the need to build and maintain robust and
expandable systems to comply with multiple jurisdictions with different compliance and/or reporting requirements increases the
possibility that a healthcare company may run afoul of one or more of the requirements.

If we fail to comply with environmental,
health and safety laws and regulations, we could become subject to fines or penalties or incur substantial costs.

We are subject to numerous
environmental, health and safety laws and regulations, including those governing laboratory procedures and the generation, handling,
use, storage, treatment, manufacture, transportation and disposal of, and exposure to, hazardous materials and wastes, as well
as laws and regulations relating to occupational health and safety. We contract with third parties that conduct operations on our
behalf that involve the use of hazardous and flammable materials, including chemicals and biologic materials. Our contractors also
produce and dispose of hazardous waste products. We cannot eliminate the risk of contamination or injury from these materials.
In the event of contamination or injury resulting from our contractors’ use of hazardous materials, we could be held liable
for any resulting damages and any liability could exceed our resources, and our clinical trials or regulatory approvals could be
suspended. We also could incur significant costs associated with civil or criminal fines and penalties. Our third-party contractors
may not carry specific biological or hazardous waste insurance coverage, and their property, casualty and general liability insurance
policies specifically exclude coverage for damages and fines arising from biological or hazardous waste exposure or contamination.

Although we maintain
workers’ compensation insurance for certain costs and expenses, we may incur due to injuries to our employees resulting from
the use of hazardous materials or other work-related injuries, this insurance may not provide adequate coverage against potential
liabilities. We do not maintain insurance for toxic tort claims that may be asserted against us in connection with our storage
or disposal of biologic, hazardous or radioactive materials.

In addition, we may
incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations, which
have tended to become more stringent over time. These current or future laws and regulations may impair our research, development
or production efforts. Failure to comply with these laws and regulations also may result in substantial fines, penalties or other
sanctions or liabilities, which could adversely affect our business, financial condition, results of operations and prospects.

Risks Related to our Business Operations

We may not be successful in our efforts
to identify or discover additional product candidates and may fail to capitalize on programs or product candidates that may be
a greater commercial opportunity or for which there is a greater likelihood of success.

The success of our business
depends upon our ability to identify, develop and commercialize product candidates. Research programs to identify new product candidates
require substantial technical, financial and human resources. Although a substantial amount of our efforts will focus on the continued
preclinical and clinical testing and potential approval of our product candidates, a key element of our long-term growth strategy
is to develop and market additional products and product candidates. However, we may fail to identify other potential product candidates
for clinical development for several reasons. For example, our research may be unsuccessful in identifying potential product candidates
or our potential product candidates may be shown to have harmful side effects, may be commercially impracticable to manufacture
or may have other characteristics that may make the products unmarketable or unlikely to receive marketing approval.

Additionally, because we
have limited resources, we may forego or delay pursuit of opportunities with certain programs or product candidates or for indications
that later prove to have greater commercial potential. Our spending on current and future R&D programs may not yield any commercially
viable products. If we do not accurately evaluate the commercial potential for a particular product candidate, we may relinquish
valuable rights to that product candidate through strategic collaboration, licensing or other arrangements in cases in which it
would have been more advantageous for us to retain sole development and commercialization rights to such product candidate. Alternatively,
we may allocate internal resources to a product candidate in a therapeutic area in which it would have been more advantageous to
enter into a partnering arrangement.

Our long-term growth strategy
to develop and market additional products and product candidates is heavily dependent on precise, accurate and reliable scientific
data to identify, select and develop promising pharmaceutical product candidates and products. Our business decisions may therefore
be adversely influenced by improper or fraudulent scientific data sourced from third parties. Any irregularities in the scientific
data used by us to determine our focus in R&D of product candidates and products could have a material adverse effect on our
business, prospects, financial condition and results of operations.

If any of these events
occur, we may be forced to abandon our development efforts with respect to a particular product candidate or fail to develop a
potentially successful product candidate, which could have a negative impact on our business, financial condition, results of operations
and prospects.

Our future success depends on our ability
to retain key employees, consultants and advisors and to recruit, retain and motivate qualified personnel.

Our ability to compete
in the highly competitive biotechnology and pharmaceutical industries depends upon our ability to attract and retain highly qualified
managerial, scientific and medical personnel. While we have entered into employment agreements with each of our executive officers,
any of them could leave our employment at any time. We currently do not have “key person” insurance on any of our employees.
The loss of the services of one or more of our current employees might impede the achievement of our research, development and
commercialization objectives.

Recruiting and retaining
other qualified employees, consultants and advisors for our business, including scientific and technical personnel, also will be
critical to our success. We may not be able to attract and retain personnel on acceptable terms given the competition among numerous
pharmaceutical and biotechnology companies and academic institutions for individuals with similar skill sets. In addition, failure
to succeed in preclinical studies or clinical trials or applications for marketing approval may make it more challenging to recruit
and retain qualified personnel. The inability to recruit, or loss of services of certain executives, key employees, consultants
or advisors, may impede the progress of our research, development and commercialization objectives and have an adverse effect on
our business, financial condition, results of operations and prospects.

If we are unable to manage expected growth
in the scale and complexity of our operations, our performance may suffer
.

At December 31, 2019, we
had 4 full-time employees, who  were engaged in R&D activities. If we are successful in executing our business strategy,
we will need to expand our managerial, operational, financial and other systems and resources to manage our operations, continue
our R&D activities and, in the longer term, build a commercial infrastructure to support commercialization of any of our product
candidates that are approved for sale. Future growth would impose significant added responsibilities on members of management and,
to a potentially significant extent, divert our management and business development resources away from their current uses. It
is likely that our management, finance, development personnel, systems and facilities currently in place may not be adequate to
support this future growth. Our need to effectively manage our operations, growth and any future product candidates requires that
we continue to develop more robust business processes and improve our systems and procedures in each of these areas, to attract
and retain sufficient numbers of talented employees and to expand the group of contractors we use.

We may be unable to successfully
implement these tasks on a larger scale and, accordingly, may not achieve our research, development and growth goals.

Our employees, principal investigators,
consultants and commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory
standards and requirements and insider trading, which could have a material adverse impact on our business.

We are exposed to the risk
of fraud or other misconduct by our employees, principal investigators, consultants and commercial partners. Misconduct by these
parties could include intentional failures to: comply with FDA or EMA regulations or the regulations applicable in other jurisdictions,
provide accurate information to the FDA, EMA and other regulatory authorities, comply with healthcare fraud and abuse laws and
regulations in the United States and abroad, report financial information or data accurately or disclose unauthorized activities
to us. In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations
intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices. These laws and regulations restrict
or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other
business arrangements. Such misconduct also could involve the improper use of information obtained in the course of clinical trials
or interactions with the FDA, EMA or other regulatory authorities, which could result in regulatory sanctions and cause serious
harm to our reputation. Additionally, we are subject to the risk that a person could allege fraud or other misconduct, even in
none occurred. We have adopted a code of conduct applicable to all of our employees, but it is not always possible to identify
and deter employee misconduct, and the precautions we take to detect and prevent these activities may not be effective in controlling
unknown or unmanaged risks or losses or in protecting us from government investigations or other actions or lawsuits stemming from
a failure to comply with these laws or regulations. If any such actions are instituted against us, and we are not successful in
defending ourselves or asserting our rights, those actions could have a significant impact on our business, financial condition,
results of operations and prospects, including the imposition of significant criminal, civil and administrative sanctions, such
as monetary penalties, damages, fines, disgorgement, individual imprisonment, and exclusion from participation in government funded
healthcare programs, such as Medicare and Medicaid, additional reporting requirements and oversight if we become subject to a corporate
integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, reputational harm, and we may
be required to curtail or restructure our operations. We are also subject to the data privacy regime in the EU, which imposes obligations
and restrictions on the collection and use of personal data relating to individuals located in the EU and includes the General
Data Protection Regulation, or the GDPR, and any national laws implementing or supplementing the GDPR. If we do not comply with
our obligations under the EU privacy regime, we could be exposed to significant fines and we may be the subject of litigation and/or
adverse publicity, which could have a material adverse effect on our reputation and business.

Product liability lawsuits against us
could cause us to incur substantial liabilities and could limit commercialization of any product candidate that we may develop.

We face an inherent risk
of product liability exposure related to the testing of our current and future product candidates in clinical trials and may face
an even greater risk if we commercialize any product candidate that we may develop. For example, we may be sued if our current
or future product candidates cause or are perceived to cause injury or are found to be otherwise unsuitable during clinical testing,
manufacturing, marketing or sale. Any such product liability claims may include allegations of defects in manufacturing, defects
in design, a failure to warn of dangers inherent in the product, negligence, strict liability or a breach of warranties. Claims
could also be asserted under state consumer protection acts. If we cannot successfully defend ourselves against product liability
claims, we could incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:

decreased demand for any product candidate that we may develop;

substantial monetary awards to trial participants or patients;

significant time and costs to defend the related litigation;

withdrawal of clinical trial participants;

the inability to commercialize any product candidates that we may develop; o

injury to our reputation and significant negative media attention.

Although we maintain product
liability insurance coverage, such insurance may not be adequate to cover all liabilities that we may incur. We anticipate that
we will need to increase our insurance coverage each time we commence a clinical trial and if we successfully commercialize any
product candidate. Insurance coverage is increasingly expensive. We may not be able to maintain insurance coverage at a reasonable
cost or in an amount adequate to satisfy any liability that may arise.

Legal, political and economic uncertainty
surrounding the planned exit of the United Kingdom or the U.K., from the European Union, or EU, may be a source of instability
in international markets, create significant currency fluctuations, adversely affect our operations in the U.K. and pose additional
risks to our business, revenue, financial condition, and results of operations.

Following a national
referendum and enactment of legislation by the government of the United Kingdom, the United Kingdom formally withdrew from the
EU on January 31, 2020 and entered into a transition period during which it will continue its ongoing and complex negotiations
with the EU relating to the future trading relationship between the parties. Significant political and economic uncertainty remains
about whether the terms of the relationship will differ materially from the terms before withdrawal, as well as about the possibility
that a so-called “no deal” separation will occur if negotiations are not completed by the end of the transition period.
These developments have created significant uncertainty about the future relationship between the United Kingdom and the EU. Lack
of clarity about future U.K. laws and regulations as the United Kingdom determines which EU-derived laws and regulations to replace
or replicate as part of a withdrawal, including financial laws and regulations, tax and free trade agreements, intellectual property
rights, supply chain logistics, environmental, health and safety laws and regulations, immigration laws and employment laws, could
further decrease foreign direct investment in the United Kingdom, increase costs, depress economic activity and restrict our access
to capital. These developments, or the perception that any of them could occur, have had and may continue to have a significant
adverse effect on global economic conditions and the stability of global financial markets, and could significantly reduce global
market liquidity and restrict the ability of key market participants to operate in certain financial markets. Asset valuations,
currency exchange rates and credit ratings may be especially subject to increased market volatility. Any of these factors could
have a significant adverse effect on our business, financial condition, results of operations and prospects.

Further, the United Kingdom’s withdrawal from the EU has resulted in the relocation of the EMA from
the United Kingdom to the Netherlands. This relocation has caused, and may continue to cause, disruption in the administrative
and medical scientific links between the EMA and the U.K. Medicines and Healthcare products Regulatory Agency, including delays
in granting clinical trial authorization or marketing authorization, disruption of importation and export of active substance and
other components of new drug formulations, and disruption of the supply chain for clinical trial product and final authorized formulations.
The cumulative effects of the disruption to the regulatory framework may add considerably to the development lead time to marketing
authorization and commercialization of products in the EU and/or the United Kingdom.

A pandemic, epidemic or outbreak of an infectious disease,
such as COVID-19, may materially and adversely affect our business and operations.

The recent outbreak of
COVID-19 originated in Wuhan, China, in December 2019 and has since spread to multiple countries, including the United States and
several European countries. On March 11, 2020, the World Health Organization declared the outbreak a pandemic. The COVID-19 pandemic
is affecting the United States and global economies and may affect our operations and those of third parties on which we rely,
including by causing disruptions in the supply of our product candidates and the conduct of future clinical trials. Disruptions
caused by the COVID-19 pandemic may increase the likelihood that we encounter such difficulties or delays in initiating, enrolling,
conducting or completing our planned and ongoing preclinical studies and clinical trials, as applicable.

In addition, the COVID-19
pandemic may affect the operations of the FDA and other health authorities, which could result in delays of reviews and approvals,
including with respect to our product candidates. Additionally, while the potential economic impact brought by, and the duration
of the COVID-19 pandemic is difficult to assess or predict, the impact of the COVID-19 pandemic on the global financial markets
may reduce our ability to access capital, which could negatively impact our short-term and long-term liquidity. The ultimate impact
of the COVID-19 pandemic is highly uncertain and subject to change. We do not yet know the full extent of potential delays or impacts
on our business, financing or clinical trial activities or on healthcare systems or the global economy as a whole. However, these
effects could have a material impact on our liquidity, capital resources, operations and business and those of the third parties
on which we rely.

We may re-incorporate in another jurisdiction,
and the laws of such jurisdiction will likely govern all of our material agreements and we may not be able to enforce our legal
rights.

We may relocate the home
jurisdiction of our business from the United Kingdom to another jurisdiction. We have announced that we have appointed advisers
in relation to an intended redomicile of the Company to Bermuda, which is anticipated to occur by the second quarter of 2020.

Exchange rate fluctuations may materially
affect our results of operations and financial condition.

Owing to the international
scope of our operations, fluctuations in exchange rates, particularly between Pounds Sterling and the U.S. dollar, may adversely
affect us. Although we are based in the United Kingdom, we may source R&D, manufacturing, consulting and other services from
the United States and the European Union. Further, potential future revenue may be derived from abroad, particularly from the United
States. As a result, our business and the potential value of our ADSs may be affected by fluctuations in foreign exchange rates
not only between the Pounds Sterling and the U.S. dollar, but also the euro, which may have a significant impact on our results
of operations and cash flows from period to period. Currently, we do not have any exchange rate hedging arrangements in place.

Our internal computer systems, or those
of our collaborators or other contractors or consultants, may fail or suffer security breaches, which could result in a material
disruption of our product development programs.

Our internal computer systems
and those of our current and any future collaborators and other contractors or consultants are vulnerable to damage from computer
viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures. While we have not
experienced any such material system failure, accident or security breach to date, if such an event were to occur and cause interruptions
in our operations, it could result in a material disruption of our development programs and our business operations, whether due
to a loss of our trade secrets or other proprietary information or other similar disruptions. For example, the loss of clinical
trial data from completed or future clinical trials could result in delays in our regulatory approval efforts and significantly
increase our costs to recover or reproduce the data. To the extent that any disruption or security breach were to result in a loss
of, or damage to, our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur
liability, our competitive position could be harmed, and the further development and commercialization of our product candidates
could be delayed.

Risks Related to the Ownership of Our Securities

The prices of the ADSs and our ordinary
shares may be volatile and fluctuate substantially, which could result in substantial losses for holders of the ADSs and our ordinary
shares.

The market prices of the
ADSs on the Nasdaq Global Market and of our ordinary shares on AIM may be volatile and fluctuate substantially. The stock market
in general and the market for smaller pharmaceutical and biotechnology companies in particular have experienced extreme volatility
that has often been unrelated to the operating performance of particular companies. As a result of this volatility, holders of
the ADSs and our ordinary shares may not be able to sell their ADSs or ordinary shares at or above

the price at which they were purchased. Il
market price for the ADSs and ordinary shares may be influenced by many factors, including:

the success of competitive products or technologies;

results of clinical trials of Foralumab, anti-IL6R mAb (TZLS-501), StemPrintER, Milciclib and and any other future product candidate that we develop;

results of clinical trials of product candidates of our competitors;

changes or developments in laws or regulations applicable to Foralumab, anti-IL6R mAb (TZLS-501), StemPrintER, Milciclib and any other future product candidates that we develop;

our entry into, and the success of, any collaboration agreements with third parties;

developments or disputes concerning patent applications, issued patents or other proprietary rights;

the recruitment or departure of key personnel;

the level of expenses related to any of our product candidates or clinical development programs;

the results of our efforts to discover, develop, acquire or in-license additional product candidates, products or technologies;

actual or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts;

variations in our financial results or those of companies that are perceived to be similar to us;

market conditions in the biotechnology and pharmaceutical sectors;

general economic, industry and market conditions;

the trading volume of ADSs on the Nasdaq Global Market and of our ordinary shares on AIM; e

the other factors described in this “Risk Factors” section.

The dual listing of our ordinary shares
and the ADSs may adversely affect the liquidity and value of the ADSs.

The ADSs are traded on
the Nasdaq Global Market, and our ordinary shares are listed on AIM. The dual listing of our ordinary shares and the ADSs may dilute
the liquidity of these securities in one or both markets and may adversely affect the maintenance of an active trading market for
the ADSs in the United States. The price of the ADSs could also be adversely affected by trading in our ordinary shares on AIM.
Although our ordinary shares are currently listed on AIM, we may decide at some point in the future to delist our ordinary shares
from AIM, and our ordinary shareholders may approve such delisting. We cannot predict the effect such delisting of our ordinary
shares on AIM would have on the market price of the ADSs on the Nasdaq Global Market.

Securities traded on AIM may carry a higher risk than shares
traded on other exchanges that may impact the value of your investment.

Our ordinary shares are
currently traded on AIM. Investment in equities traded on AIM is perceived by some to carry a higher risk than an investment in
equities quoted on exchanges with more stringent listing requirements, such as the London Stock Exchange, New York Stock Exchange
or the Nasdaq Stock Market. This is because AIM imposes less stringent corporate governance and ongoing reporting requirements
than those other exchanges. In addition, AIM requires only semi-annual, rather than quarterly, financial reporting. You should
be aware that the value of our ordinary shares may be influenced by many factors, some of which may be specific to us and some
of which may affect AIM-listed companies generally, including the depth and liquidity of the market, our performance, a large or
small volume of trading in our ordinary shares, legislative changes and general economic, political or regulatory conditions, and
that the prices may be volatile and subject to extensive fluctuations. Therefore, the market price of our ordinary shares underlying
the ADSs may not reflect the underlying value of our company.

Holders of our ADSs have fewer rights
than our shareholders and must act through the depositary to exercise their rights.

Holders of our ADSs do
not have the same rights as our shareholders and may only exercise their voting rights with respect to the underlying ordinary
shares in accordance with the provisions of the deposit agreement. Holders of the ADSs will appoint the depositary or its nominee
as their representative to exercise the voting rights attaching to the ordinary shares represented by the ADSs. When a general
meeting is convened, if you hold ADSs, you may not receive sufficient notice of a shareholders’ meeting to permit you to
withdraw the ordinary shares underlying your ADSs to allow you to vote with respect to any specific matter. We will make all commercially
reasonable efforts to cause the depositary to extend voting rights to you in a timely manner, but we cannot assure you that you
will receive voting materials in time to instruct the depositary to vote, and it is possible that you, or persons who hold their
ADSs through brokers, dealers or other third parties, will not have the opportunity to exercise a right to vote. Furthermore, the
depositary will not be liable for any failure to carry out any instructions to vote, for the manner in which any vote is cast or
for the effect of any such vote. As a result, you may not be able to exercise your right to vote and you may lack recourse if your
ADSs are not voted as you request. In addition, in your capacity as an ADS holder, you will not be able to call a shareholders’
meeting.

The rights of our shareholders may differ
from the rights typically offered to shareholders of a U.S. corporation.

We are incorporated under
English law. The rights of holders of ordinary shares and, therefore, certain of the rights of any potential future holders of
ADSs, are governed by English law, including the provisions of the U.K. Companies Act 2006, or the Companies Act, and by our Articles
of Association, or Articles. These rights differ in certain respects from the rights of shareholders in typical U.S. corporations.
See “Description of Share Capital and Articles of Association-Differences in Corporate Law” in this report for a description
of the principal differences between the provisions of the Companies Act applicable to us and, for example, the Delaware General
Corporation Law relating to stockholders’ rights and protections.

If we engage in future acquisitions or
strategic partnerships, this may increase our capital requirements, dilute our AIM shareholders, cause us to incur debt or assume
contingent liabilities and subject us to other risks.

We intend to continue to
evaluate various acquisitions and strategic partnerships, including licensing or acquiring complementary drugs, intellectual property
rights, technologies or businesses. Any potential acquisition or strategic partnership may entail numerous risks, including:

increased operating expenses and cash requirements;

the assumption of additional indebtedness or contingent liabilities;

assimilation of operations, intellectual property and drugs of an acquired company, including difficulties associated with integrating new personnel;

the diversion of our management’s attention from our existing drug programs and initiatives in pursuing such a strategic partnership, merger or acquisition;

retention of key employees, the loss of key personnel and uncertainties in our ability to maintain key business relationships;

risks and uncertainties associated with the other party to such a transaction, including the prospects of that party and their existing drugs or drug candidates and regulatory approvals; e

our inability to generate revenue from acquired technology and/or drugs sufficient to meet our objectives in undertaking the acquisition or even to offset the associated acquisition and maintenance costs.

As an FPI, we are
exempt from a number of rules under the U.S. securities laws and are permitted to file less information with the SEC than U.S.
public companies
.

We are an FPI, as defined
in the SEC rules and regulations and, consequently, we are not subject to all of the disclosure requirements applicable to companies
organized within the United States. For example, we are exempt from certain rules under the Exchange Act, that regulate disclosure
obligations and procedural requirements related to the solicitation of proxies, consents or authorizations applicable to a security
registered under the Exchange Act. In addition, our officers and directors are exempt from the reporting and “short-swing”
profit recovery provisions of Section 16 of the Exchange Act and related rules with respect to their purchases and sales of our
securities. Moreover, we are not required to file periodic reports and financial statements with the SEC as frequently or as promptly
as U.S. public companies. Accordingly, there may be less publicly available information concerning our company than there is for
U.S. public companies.

As an FPI, we will file
an annual report on Form 20-F within four months of the close of each fiscal year ended December 31 and reports on Form 6-K relating
to certain material events promptly after we publicly announce these events. However, because of the above exemptions for FPIs,
our ADS holders will not be afforded the same protections or information generally available to investors holding shares in public
companies organized in the United States.

While we are an FPI, we are not subject
to certain Nasdaq corporate governance rules applicable to U.S. listed companies.

We are entitled to rely
on a provision in Nasdaq’s corporate governance rules that allows us to follow English corporate law and the Companies Act
with regard to certain aspects of corporate governance. This allows us to follow certain corporate governance practices that differ
in significant respects from the corporate governance requirements applicable to U.S. companies listed on Nasdaq.

For example, we are exempt
from Nasdaq regulations that require a listed U.S. company to (i) have a majority of the board of directors consist of independent
directors, (ii) require non-management directors to meet on a regular basis without management present and (iii) promptly disclose
any waivers of the code for directors or executive officers that should address certain specified items.

In accordance with our
Nasdaq listing, our audit committee is required to comply with the provisions of Section 301 of the Sarbanes-Oxley Act and Rule
10A-3 of the Exchange Act, both of which are also applicable to Nasdaq-listed U.S. companies. Because we are an FPI, however, our
audit committee is not subject to additional Nasdaq requirements applicable to listed U.S. companies, including an affirmative
determination that all members of the audit committee are “independent,” using more stringent criteria than those applicable
to us as an FPI. Furthermore, Nasdaq’s corporate governance rules require listed U.S. companies to, among other things, seek
shareholder approval for the implementation of certain equity compensation plans and issuances of ordinary shares, which we are
not required to follow as an FPI.

We may lose our FPI status, which would
then require us to comply with the Exchange Act’s domestic reporting regime and cause us to incur significant legal, accounting
and other expenses.

As an FPI, we are not required to comply with all of the periodic
disclosure and current reporting requirements of the Exchange Act applicable to U.S. domestic issuers. In order to maintain our
current status as an FPI, either (a) a majority of our ADSs must be either directly or indirectly owned of record by non-residents
of the United States or (b)(i) a majority of our executive officers or directors cannot be U.S. citizens or residents, (ii) more
than 50% of our assets must be located outside the United States and (iii) our business must be administered principally outside
the United States. If we lose our status as an FPI, we would be required to comply with the Exchange Act reporting and other requirements
applicable to U.S. domestic issuers, which are more detailed and extensive than the requirements for FPIs. We may also be required
to make changes in our corporate governance practices in accordance with various SEC and Nasdaq rules. The regulatory and compliance
costs to us under U.S. securities laws if we are required to comply with the reporting requirements applicable to a U.S. domestic
issuer may be significantly higher than the cost we would incur as an FPI. As a result, we expect that a loss of FPI status would
increase our legal and financial compliance costs and is likely to make some activities highly time consuming and costly. We also
expect that if we were required to comply with the rules and regulations applicable to U.S. domestic issuers, it would make it
more difficult and expensive for us to obtain director and officer liability insurance, and we may be required to accept reduced
coverage or incur substantially higher costs to obtain coverage. These rules and regulations could also make it more difficult
for us to attract and retain qualified members of our board of directors.

We are an emerging growth company within
the meaning of the Securities Act of 1933 and will take advantage of certain reduced reporting requirements.

We are an EGC, as defined
in the JOBS Act. For as long as we continue to be an EGC, we may take advantage of exemptions from various reporting requirements
that are applicable to other public companies that are not EGCs, including not being required to comply with the auditor attestation
requirements of Section 404 of the Sarbanes-Oxley Act, or Section 404, exemptions from the requirements of holding a nonbinding
advisory vote on executive compensation and shareholder approval of any golden parachute payments not previously approved. As an
EGC, we are required to report only two years of financial results and selected financial data compared to three and five years,
respectively, for comparable data reported by other public companies. We may take advantage of these exemptions until we are no
longer an EGC. We could be an EGC for up to five years, although circumstances could cause us to lose that status earlier, including
if the aggregate market value of our ADSs held by non-affiliates exceeds $700 million as of any June 30 (the end of our second
fiscal quarter) before that time, in which case we would no longer be an EGC as of the following December 31 (our fiscal year-end).
We cannot predict if investors will find our ADSs less attractive because we may rely on these exemptions. If some investors find
our ADSs less attractive as a result, there may be a less active trading market for our ADSs and the price of our ADSs may be more
volatile in the event that we decide to make an offering of our ADSs following our Nasdaq listing.

If we fail to establish
and maintain proper internal controls, our ability to produce accurate financial statements or comply with applicable regulations
could be impaired.

Section 404(a) of the Sarbanes-Oxley
Act, or Section 404(a), requires that beginning with our second annual report following our IPO, management assess and report annually
on the effectiveness of our internal control over financial reporting and identify any material weaknesses in our internal control
over financial reporting. Although Section 404(b) of the Sarbanes-Oxley Act, or Section 404(b), requires our independent registered
public accounting firm to issue an annual report that addresses the effectiveness of our internal control over financial reporting,
we have opted to rely on the exemptions provided in the JOBS Act, and consequently will not be required to comply with SEC rules
that implement Section 404(b) until such time as we are no longer an EGC.

Pursuant to Section 404,
we will be required to furnish a report by our senior management on our internal control over financial reporting. However, while
we remain an EGC, we will not be required to include an attestation report on internal control over financial reporting issued
by our independent registered public accounting firm. To prepare for eventual compliance with Section 404, once we no longer qualify
as an EGC, we will be engaged in a process to document and evaluate our internal control over financial reporting, which is both
costly and challenging.

In this regard, we will
need to continue to dedicate internal resources, potentially engage outside consultants and adopt a detailed work plan to assess
and document the adequacy of internal control over financial reporting, continue steps to improve control processes as appropriate,
validate through testing that controls are functioning as documented and implement a continuous reporting and improvement process
for internal control over financial reporting. Despite our efforts, there is a risk that we will not be able to conclude, within
the prescribed timeframe or at all, that our internal control over financial reporting is effective as required by Section 404.
If we identify one or more material weaknesses, it could result in an adverse reaction in the financial markets due to a loss of
confidence in the reliability of our financial statements.

Our 10% or more
stockholders and management own a significant percentage of our stock and are able to exercise significant influence over matters
subject to stockholder approval.

As of the date of this
annual report, our executive officers, directors and 10% or more stockholders, together with their respective affiliates, owned
approximately 43% of our outstanding securities. Accordingly, this group of security holders will be able to exert a significant
degree of influence over our management and affairs and over matters requiring security holder approval, including the election
of our Board of Directors, future issuances of our securities, declaration of dividends and approval of other significant corporate
transactions. As a result, if these shareholders were to choose to act together, they would be able to exert significant influence
over matters submitted to our shareholders for approval, as well as our management and affairs. For example, these persons, if
they choose to act together, would exercise sufficient voting power to influence the election of directors and approve any merger,
consolidation or sale of all or substantially all of our assets. This concentration of ownership control may:

delay, defer or prevent a change in control;
entrench our management and board of directors; o
impede a merger, consolidation, takeover or other business combination involving us that other shareholders may desire.

Panetta
Partners Limited, Planwise Group Limited and Gabriele Cerrone are considered to be a “concert party” for the purposes
of the Takeover Code, or the Cerrone Concert Party. The Cerrone Concert Party holds shares carrying voting rights equal to approximately
46.7%. Accordingly, the Cerrone Concert Party will not, save in limited circumstances, be able to acquire further interests in
shares carrying voting rights without being obliged to extend offers, on the basis set out in Rules 9.3, 9.4 and 9.5 of the Takeover
Code, to the holders of any class of equity share capital, whether voting or non-voting, and also to the holders of any other class
of transferable securities carrying voting rights.

ADSs holders may not be entitled to a
jury trial with respect to claims arising under the deposit agreement, which could augur less favorable results to the plaintiff(s)
in any such action.

The deposit agreement governing
the ADSs representing our ordinary shares provides that holders and beneficial owners of ADSs irrevocably waive the right to a
trial by jury in any legal proceeding arising out of or relating to the deposit agreement or the ADSs, including claims under federal
securities laws, against us or the depositary to the fullest extent permitted by applicable law. If this jury trial waiver provision
is prohibited by applicable law, an action could nevertheless proceed under the terms of the deposit agreement with a jury trial.
To our knowledge, the enforceability of a jury trial waiver under the federal securities laws has not been finally adjudicated
by a federal court. However, we believe that a jury trial waiver provision is generally enforceable under the laws of the State
of New York, which govern the deposit agreement, by a court of the State of New York or a federal court, which have non-exclusive
jurisdiction over matters arising under the deposit agreement, applying such law. In determining whether to enforce a jury trial
waiver provision, New York courts and federal courts will consider whether the visibility of the jury trial waiver provision within
the agreement is sufficiently prominent such that a party has knowingly waived any right to trial by jury. We believe that this
is the case with respect to the deposit agreement and the ADSs. In addition, New York courts will not enforce a jury trial waiver
provision in order to bar a viable setoff or counterclaim sounding in fraud or one which is based upon a creditor’s negligence
in failing to liquidate collateral upon a guarantor’s demand, or in the case of an intentional tort claim (as opposed to
a contract dispute), none of which we believe are applicable in the case of the deposit agreement or the ADSs. No condition, stipulation
or provision of the deposit agreement or ADSs serves as a waiver by any holder or beneficial owner of ADSs or by us or the depositary
of compliance with any provision of the federal securities laws. If you or any other holder or beneficial owner of ADSs brings
a claim against us or the depositary in connection with matters arising under the deposit agreement or the ADSs, you or such other
holder or beneficial owner may not be entitled to a jury trial with respect to such claims, which may have the effect of limiting
and discouraging lawsuits against us and / or the depositary. If a lawsuit is brought against us and / or the depositary under
the deposit agreement, it may be heard only by a judge or justice of the applicable trial court, which would be conducted according
to different civil procedures and may augur different results than a trial by jury would have had, including results that could
be less favorable to the plaintiff(s) in any such action, depending on, among other things, the nature of the claims, the judge
or justice hearing such claims, and the venue of the hearing.

Claims of U.S. civil liabilities may
not be enforceable against us.

We are incorporated under
English law. Certain members of our board of directors and senior management are non-residents of the United States, and all or
a substantial portion of our assets and the assets of such persons are located outside the United States. As a result, it may not
be possible to serve process on such persons or us in the United States or to enforce judgments obtained in U.S. courts against
them or us based on civil liability provisions of the securities laws of the United States. As a result, it may not be possible
for investors to effect service of process within the United States upon such persons or to enforce judgments obtained in U.S.
courts against them or us, including judgments predicated upon the civil liability provisions of the U.S. federal securities laws.

The United States and the
United Kingdom do not currently have a treaty providing for recognition and enforcement of judgments (other than arbitration awards)
in civil and commercial matters. Consequently, a final judgment for payment given by a court in the United States, whether or not
predicated solely upon U.S. securities laws, would not automatically be recognized or enforceable in the United Kingdom. In addition,
uncertainty exists as to whether U.K. courts would entertain original actions brought in the United Kingdom against us or our directors
or senior management predicated upon the securities laws of the United States or any state in the United States. Any final and
conclusive monetary judgment for a definite sum obtained against us in U.S. courts would be treated by the courts of the United
Kingdom as a cause of action in itself and sued upon as a debt at common law so that no retrial of the issues would be necessary,
provided that certain requirements are met. Whether these requirements are met in respect of a judgment based upon the civil liability
provisions of the U.S. securities laws, including whether the award of monetary damages under such laws would constitute a penalty,
is an issue for the court making such decision. If an English court gives judgment for the sum payable under a U.S. judgment, the
English judgment will be enforceable by methods generally available for this purpose. These methods generally permit the English
court discretion to prescribe the manner of enforcement.

As a result, U.S. investors
may not be able to enforce against us or our senior management, board of directors or certain experts named herein who are residents
of the United Kingdom or countries other than the United States any judgments obtained in U.S. courts in civil and commercial matters,
including judgments under the U.S. federal securities laws.

If we are a passive foreign investment
company, there could be adverse U.S. federal income tax consequences to U.S. holders.

Under the Internal Revenue
Code of 1986, or the Internal Revenue Code, we will be a PFIC for any taxable year in which (1) 75% or more of our gross income
consists of passive income or (2) 50% or more of the average quarterly value of our assets consists of assets that produce, or
are held for the production of, passive income. For purposes of these tests, passive income includes dividends, interest, gains
from the sale or exchange of investment property and certain rents and royalties. In addition, for purposes of the above calculations,
a non-U.S. corporation that directly or indirectly owns at least 25% by value of the shares of another corporation is treated as
if it held its proportionate share of the assets and received directly its proportionate share of the income of such other corporation.
If we are a PFIC for any taxable year during which a U.S. Holder (as defined below under “Material Income Tax Considerations-Material
U.S. Federal Income Tax Considerations for U.S. Holders”) holds our shares, the U.S. Holder may be subject to adverse tax
consequences regardless of whether we continue to qualify as a PFIC, including ineligibility for any preferred tax rates on capital
gains or on actual or deemed dividends, interest charges on certain taxes treated as deferred, and additional reporting requirements.

We believe that we were
a PFIC for our taxable year ended December 31, 2019 but cannot provide any assurances regarding our PFIC status for any past, current
or future taxable years. The determination of whether we are a PFIC is a fact-intensive determination made on an annual basis applying
principles and methodologies which in some circumstances are unclear and subject to varying interpretation. In particular, the
characterization of our assets as active or passive may depend in part on our current and intended future business plans, which
are subject to change. In addition, for our current and future taxable years, the total value of our assets for PFIC testing purposes
may be determined in part by reference to the market price of our ordinary shares or ADSs from time to time, which may fluctuate
considerably. Under the income test, our status as a PFIC depends on the composition of our income which will depend on the transactions
we enter into in the future and our corporate structure. The composition of our income and assets is also affected by how, and
how quickly, we spend the cash we raise in any offering.

In certain circumstances,
a U.S. Holder of shares in a PFIC may alleviate some of the adverse tax consequences described above by making a qualified electing
fund, or QEF, election to include in income its pro rata share of the corporation’s income on a current basis. However, a
U.S. Holder may make a QEF election with respect to our ordinary shares or ADSs only if we agree to furnish such U.S. Holder annually
with a PFIC annual information statement as specified in the applicable U.S. Treasury Regulations. We currently do not intend to
prepare or provide the information that would enable U.S. Holders to make a QEF election if we are treated as a PFIC for any taxable
year, and prospective investors should assume that a QEF election will not be available.

For further discussion
of the PFIC rules and the adverse U.S. federal income tax consequences in the event we are classified as a PFIC, see the section
of this report entitled “Material Income Tax Considerations-Material U.S. Federal Income Considerations For U.S. Holders.”

We may be unable to use net operating
loss and tax credit carryforwards and certain built-in losses to reduce future tax payments or benefit from favorable U.K. tax
legislation.

As
a U.K. resident trading entity, we are subject to U.K. corporate taxation. Due to the nature of our business, we have generated
losses since inception. As of December 31, 2019, we had cumulative carryforward tax losses of $27.4 million Subject to any
relevant restrictions, we expect these to be available to carry forward and offset against future operating profits. As a company
that carries out extensive research and development activities, we benefit from the U.K. research and development tax credit regime
for small and medium-sized companies, whereby we are able to surrender the trading losses that arise from our qualifying research
and development activities for a payable tax credit of up to 33.35% of eligible research and development expenditures. Qualifying
expenditures largely comprise employment costs for research staff, consumables and certain internal overhead costs incurred as
part of research projects. Certain subcontracted qualifying research expenditures are eligible for a cash rebate of up to 21.67%.
The majority of our pipeline research, clinical trials management and manufacturing development activities are eligible for inclusion
within these tax credit cash rebate claims. Our ability to continue to claim payable research and development tax credits in the
future may be limited because we may no longer qualify as a small or medium-sized company.

We may benefit in the future
from the United Kingdom’s “patent box” regime, which allows certain profits attributable to revenues from patented
products to be taxed at an effective rate of 10%. We are the exclusive licensee or owner of several patent applications which,
if issued, would cover our product candidates, and accordingly, future upfront fees, milestone fees, product revenues and royalties
could be taxed at this tax rate. When taken in combination with the enhanced relief available on our research and development expenditures,
we expect a long-term lower rate of corporation tax to apply to us. If, however, there are unexpected adverse changes to the U.K.
research and development tax credit regime or the “patent box” regime, or for any reason we are unable to qualify for
such advantageous tax legislation, or we are unable to use net operating loss and tax credit

Changes and uncertainties in the tax
system in the countries in which we have operations could materially adversely affect our financial condition and results of operations,
and reduce net returns to our shareholders.

Our tax position could
be adversely impacted by changes in tax rates, tax laws, tax practice, tax treaties or tax regulations or changes in the interpretation
thereof by the tax authorities in the United Kingdom, the United States and other jurisdictions as well as being affected by certain
changes currently proposed by the Organization for Economic Co-operation and Development and their action plan on Base Erosion
and Profit Shifting. Such changes may become more likely as a result of recent economic trends in the jurisdictions in which we
operate, particularly if such trends continue.

Our actual effective tax
rate may vary from our expectation and that variance may be material. A number of factors may increase our future effective tax
rates, including: (1) the jurisdictions in which profits are determined to be earned and taxed; (2) the resolution of issues arising
from any future tax audits with various tax authorities; (3) changes in the valuation of our deferred tax assets and liabilities;
(4) increases in expenses not deductible for tax purposes, including transaction costs and impairments of goodwill in connection
with acquisitions; (5) changes in the taxation of share-based compensation; (6) changes in tax laws or the interpretation of such
tax laws, and changes in generally accepted accounting principles; and (7) challenges to the transfer pricing policies related
to our structure.

A tax authority may disagree
with tax positions that we have taken, which could result in increased tax liabilities. For example, Her Majesty’s Revenue
& Customs, or HMRC, the U.S. Internal Revenue Service, or IRS, or another tax authority could challenge our allocation of income
by tax jurisdiction and the amounts paid between our affiliated companies pursuant to our intercompany arrangements and transfer
pricing policies, including methodologies for valuing developed technology and amounts paid with respect to our intellectual property
development. Similarly, a tax authority could assert that we are subject to tax in a jurisdiction where we believe we have not
established a taxable connection, often referred to as a “permanent establishment” under international tax treaties,
and such an assertion, if successful, could increase our expected tax liability in one or more jurisdictions.

A tax authority may take
the position that material income tax liabilities, interest and penalties are payable by us, for example where there has been a
technical violation of contradictory laws and regulations that are relatively new and have not been subject to extensive review
or interpretation, in which case we expect that we might contest such assessment. High-profile companies can be particularly vulnerable
to aggressive application of unclear requirements. Many companies must negotiate their tax bills with tax inspectors who may demand
higher taxes than applicable law appears to provide. Contesting such an assessment may be lengthy and costly and if we were unsuccessful
in disputing the assessment, the implications could increase our anticipated effective tax rate, where applicable.

ITEM 4: INFORMATION ON THE COMPANY

A. History and Development of the Company

We were originally incorporated
under the laws of England and Wales on February 11, 1998, with the goal of leveraging the expertise of our management team as well
as Napoleone Ferrara, M.D., Arun Sanyal, M.D., Howard Weiner, M.D. and Kevan Herold, M.D., and to acquire and exploit certain intellectual
property in biotechnology. We subsequently changed our name to Tiziana Life Sciences plc in April 2014 as a result of the acquisition
of Tiziana Pharma Limited in April 2014.

Our registered office is
located at 3rd Floor, 11-12 St James’s Square, London SW1Y 4LB and our telephone number is +44 20 7495 2379.

The SEC maintains an Internet
site that contains reports, proxy and information statements, and other information regarding issuers, such as we, that file electronically,
with the SEC at www.sec.gov. Our website address is www.tizianalifesciences.com. The reference to our website is an inactive
textual reference only and the information contained in, or that can be accessed through, our website is not a part of this annual
report.

Our agent for service of
process in the United States is Tiziana Therapeutics, Inc, 420 Lexington Avenue, Suite 2525, New York, NY 10170.

B. Business Overview

Overview

We
are a biotechnology company that is focused on the discovery and development of novel molecules and related diagnostics to treat
high unmet medical needs in oncology and immunology. Our lead product candidate in immunology is Foralumab (TZLS-401), which we
believe is the only fully human anti-CD3 monoclonal antibody, or mAb, in clinical development. MAbs represent a single pure antibody
produced by single clones and are an important class of human therapeutics for treating cancers and autoimmune diseases. In addition,
we are accelerating development of another fully human monoclonal antibody anti-IL6R (TZLS-501) to treat acute inflammation resulting
from infection with viral agents such as Coronaviruses. Antibodies produced in animals for use in humans, lead to strong, immune
responses limiting their effectiveness and potentially leading to severe side effects. A process known as “humanization”
removes most of the animal components of the antibody thereby lowering the immune response from the human immune system. The entire
omission of other animal material, as in fully human antibodies, is the optimal goal to avoid incompatibility with the human immune
system. Our lead product candidate in oncology is Milciclib (TZLS-201), which is an orally bioavailable, small molecule broad
spectrum inhibitor of cyclin-dependent kinases, or CDKs, and Src family kinases. CDKs are a highly conserved family of enzymes
that phosphorylate a specific group of proteins that are involved in regulating the cell cycle. The cell cycle is a series of
events that takes place in cells leading to division and duplication of its DNA to produce two daughter cells. Src family kinases
are non-receptor tyrosine kinase proteins encoded by the Src gene also involved in regulating cell growth and potential transformation
of normal cells to cancer cells. We have a drug discovery pipeline of small molecule new chemical entities, or NCEs, and biologics.
We employ a lean and virtual research and development, or R&D, model using highly experienced teams of experts for each business
function to maximize value accretion by focusing resources on the drug discovery and development processes. Our mission is to
design and deliver next generation therapeutics and diagnostics for oncology and immune diseases of high unmet medical need by
combining deep understanding of disease biology with clinical development expertise.

We are developing
Foralumab, for which we in-licensed the intellectual property from Novimmune SA, or Novimmune, in December 2014, as a potential
treatment for neurodegenerative diseases such as progressive Multiple Sclerosis (pMS) and Crohn’s disease. As the only fully
human engineered human anti-CD3 mAb in clinical development, Foralumab has significant potential advantages such as a shorter
treatment duration and reduced immunogenicity. We believe that oral or intranasal administration of Foralumab has the potential
to reduce inflammation while minimizing the toxicity and related side effects. To date, Foralumab has been studied in one Phase
1 and two Phase 2a clinical trials conducted by Novimmune in 68 patients dosed by the intravenous route of administration. In
these trials, Foralumab was observed to be safe and well-tolerated and produced immunologic effects consistent with potential
clinical benefit while demonstrating mild to moderate infusion related reactions, or IRRs. With completion of the intravenous
dosing for Phase 2a trial in Crohn’s Disease, Foralumab’s ability to modulate T-cell response enables potential extension
into a wide range of other autoimmune and inflammatory diseases, such as GvHD, ulcerative colitis, multiple sclerosis, type-1
diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis.

Foralumab is being developed
as both an immunosuppressive and immunomodulatory agent, with therapeutic benefits of rendering T-cells unable to orchestrate an
immune response and induction of immune tolerance via maintenance of regulatory T-cells. There is further potential for Foralumab
to be combined with the Company’s TZLS-501, a fully human anti-IL-6R mAB in development to target autoimmune and inflammatory
diseases.

In November 2016, Tiziana
announced new data for oral efficacy in humanized mouse models with Foralumab, a major milestone and a potential breakthrough
for the treatment of NASH and autoimmune disease. This unique oral technology stimulates the natural gut immune system and potentially
provides a therapeutic effect in inflammatory and autoimmune diseases with greatly reduced toxicity. Positive therapeutic effects
with Foralumab were consistently demonstrated in animal studies conducted by Prof. Kevan Herold (Yale University) and Prof. Howard
Weiner (Harvard University).

On
16 April, 2018, the Group entered into an exclusive license agreement with The Brigham and Women’s Hospital, Inc. relating
to a novel formulation of Foralumab dosed in a medical device for nasal administration. An investigational new drug application
(IND) for the first-in-human evaluation of the nasal administration of Foralumab in healthy volunteers for progressive multiple
sclerosis indication was filed in the second quarter of 2018. Subsequent to IND approval, a single-site, double-blind, placebo-controlled,
dose-ranging Phase 1 trial with nasally administered Foralumab at 10, 50 and 250 µg per day, consecutively for 5 days to
evaluate biomarkers of immunomodulation of clinical responses was initiated in November 2018. The trial conducted at the Brigham
and Women's Hospital, Harvard Medical School, Boston, MA, in healthy volunteers. 18 subjects received Foralumab treatment and 9
patients received placebo. The study was completed in September 2019. Phase 1 clinical data demonstrated that nasally administered
Foralumab, was well-tolerated and no drug-related safety issues were reported at any of the doses. No drug-related changes were
observed in vital signs among subjects at predose, during treatment and at discharge. Nasally administered Foralumab at the 50
µg dose suppressed cytotoxic CD8+ as well as perforin-secreting CD8+ cells, which have been implicated in neurodegeneration
in multiple sclerosis (MS). Treatment at 50
mg
stimulated production of anti-inflammatory cytokine IL-10 and suppressed production of pro-inflammatory cytokine IFN-γ. Taken
together, the treatment showed significant positive effects on the biomarkers for activation of mucosal immunity, which are capable
of inducing site-targeted immunomodulation to elicit anti-inflammatory effects. Based on the results we intend to conduct a Phase
2 trial in progressive MS patients starting in Q4 2020.

An enteric-coated
capsule formulation using a proprietary and novel technology has been developed for oral administration of Foralumab. cGMP manufacturing
of clinical trial materials for a Phase 1 study has been completed and an IND was submitted in March 2019.

On September 9, 2019,
the FDA granted approval to initiate the Phase I clinical trials to evaluate the safety and pharmacokinetics of oral Foralumab
at 1.25, 2.5 and 5.0 mg/day as a single ascending dose study. The study was completed in December 2019 at Brigham and Women’s
Hospital (Boston, MA USA). Formulated Foralumab powder encapsulated in enteric-coated capsule was well-tolerated at all doses tested
and there were no drug-related safety issues observed even at the highest dose of 5 mg in this trial. Based on successful Phase
1 data, we intend to conduct a Phase 2 study using Crohn’s Disease patients starting in Q2 2021.

We are accelerating development
of a fully human mAb targeting the IL-6R (TZLS-501) for which the intellectual property was licensed from Novimmune in January
2017. This fully human mAb has a novel mechanism of action, binding to both the membrane-bound and soluble forms of the IL-6R as
well as depleting circulating levels of the IL-6 in the blood. Excessive production of IL-6 is regarded as a key driver of acute
inflammation resulting from infection with viral agents such as Coronaviruses and of chronic inflammation, associated with autoimmune
diseases such as multiple myeloma, oncology indications and rheumatoid arthritis, and we believe that TZLS-501 may have potential
therapeutic value for these indications.

In preclinical studies,
TZLS-501 demonstrated the potential for overcoming the limitations of other IL-6 blocking pathway drugs. Compared to tocilizumab
and sarilumab, while binding to the membrane-bound IL-6R complex, TZLS-501 has been observed to have a higher affinity for the
soluble IL-6 receptor from antibody binding studies conducted in cell culture. TZLS-501 also demonstrated the potential to block
or reduce IL-6 signaling in mouse models of inflammation. The soluble form of IL-6 has been implicated to have a larger role in
disease progression compared to the membrane- bound form (Kallen, K.J. (2002). “The role of trans-signaling via the agonistic
soluble IL-6 receptor in human diseases.” Biochimica et Biophysica Acta. 1592 (3): 323–343.)

The Company is advancing development of TZLS-501
in light of the coronavirus pandemic that originated in Wuhan China in December 2019. Coronavirus disease 2019 (COVID-19) is a
highly contagious disease attributed to transmission of Severe UNcute Respiratory Syndrome Coronavirus
2 (SARS-CoV-2).

Certain patients infected
with coronavirus COVID-19 may develop an uncontrolled immune response (“cytokine storm”) resulting in severe damage
to lung tissue which could lead to respiratory failure. Early clinical studies conducted by doctors in China suggest
that anti-IL6R mAb may be used in clinical practice for treatment of COVID-19.  Consequently, China's National Health
Commission has recommended the use of Roche's blockbuster drug, Actemra® for treatment of patients infected with COVID-19,
with serious lung damage and elevated IL6 levels. Actemra® was first approved by the
FDA in 2010 for rheumatoid arthritis.
Besides Actemra®,
Sanofi and Regeneron are currently exploring Kevzara
®,
an FDA-approved anti-IL-6 receptor therapy for rheumatoid arthritis, for treatment of severe COVID-19. The Company believes that
of TZLS-501 may have greater clinical effect than Actemra
® o
Kevzara
® based on higher binding
affinity for IL6 receptor complex compared to Actemra
® e
Kevzara
®. Also TZLS-501 reduces
circulating levels of IL6 via the trans-signaling pathways.

We are developing Milciclib, for which we in-licensed
the intellectual property from Nerviano Medical Sciences S.r.l., or Nerviano, in January 2015, as a potential treatment for hepatocellular
carcinoma, or HCC. A novel feature of Milciclib is its ability to reduce levels of microRNAs, miR-221 and miR-222. MicroRNAs are
small RNA molecules that play a significant role in the regulation of gene expression. miR-221 and miR-222 are believed to be linked
to the development of blood supply (angiogenesis) in cancer tumors. Levels of these microRNAs are consistently elevated in HCC
patients and may contribute towards resistance to treatment with Sorafenib, a multikinase inhibitor (a drug which may inhibit the
cellular division and proliferation associated with certain cancers) often prescribed to HCC patients as the Standard of Care (SOC).

To date, Milciclib has been studied in a total
of eight completed Phase 1 and 2 clinical trials in 316 patients. In these trials, Milciclib was observed to be well-tolerated
and showed initial signals of anti-tumour action. Prior to in-licensing, Milciclib was granted orphan designation by the European
Commission and by the U.S. Food and Drug Administration (“FDA”) for the treatment of malignant thymoma and an aggressive
form of thymic carcinoma in patients previously treated with chemotherapy. In two Phase 2a trials, CDKO-125a-006 and CDKO125a-007,
Milciclib showed signs of slowing disease progression and acceptable safety.

The Group initiated a Phase 2a trial (CDKO-125a-010)
of Milciclib safety and tolerability as a single therapy in Sorafenib-resistant patients with HCC in the first half of 2017. Typically,
this population of patients have an advanced form of the disease with poor prognosis and an average overall survival expectancy
of 3-5 months In May 2018, the Independent Data Monitor committee (IDMC) completed an interim analysis of tolerability data from
the first eleven treated patients and recommended expansion of the initial cohort to an additional 20 patients to complete the
trial enrolment, which was completed in December 2018.

In March 2019, the
Independent Monitoring Committee, or IDMC, reviewed safety data from patients as of February 26, 2019 and concluded that the
administration of Milciclib to patients with advanced HCC was not associated with unexpected signs or signals of toxicity. 28 out
of 31 treated patients were evaluable, 14 completed the 6-month duration study. The most frequent adverse events such as diarrhea,
ascites, nausea, fatigue, asthenia, fever, ataxia, headache, and rash were manageable. No drug-related deaths were recorded.

The Phase 2a trial was completed in June 2019
with clinical safety result reported in July 2019 and efficacy results reported in September 2019.

The clinical activity
assessment in evaluable patients was based on the independent radiological review using the modified Response Evaluation Criteria
in Solid Tumors (mRECIST).

14 out of 28 (50%) evaluable patients completed 6-month
duration of the trial.

Both median TTP and PFS were 5.9 months (95% Confidence
Interval (“CI”) 1.5-6.7 months) out of the 6-months duration of the trial.

16 of 28 (57.1%) evaluable patients showed 'Stable Disease'

One patient (3.6%) showed unconfirmed 'Partial Response'
(PR).

17 of 28 (60.7%) evaluable patients showed 'Clinical Benefit
Rate' defined as CBR=CR+PR+SD (with CR representing Complete Remission).

Since overexpression of
CDKs and dysregulation in pRB pathway (regulates transcription factors critical for cell cycle progression) are prominently associated
with tumor cell resistance to certain chemotherapeutic drugs, inhibition of multiple CDKs is an appealing approach to improve
clinical responses in cancer patient’s refractory to existing treatment options. A Phase 1 dose-escalation study of
Milciclib in combination with gemcitabine in patients with refractory solid tumors exhibited clinical activity in patients including
those refractory to gemcitabine. We plan to explore a combination treatment of milciclib and a tyrosine kinase inhibitor (either
Sorafenib or Regorafenib) in patients with HCC in Q2 2021.

StemPrintER is a multi-gene
signature assay intended for use in patients diagnosed with estrogen-receptor positive ER+/HER2 negative breast cancers. The Group
believes this in-vitro prognostic test will be used in conjunction with clinical evaluation to identify those patients at increased
risk for early and/or late metastasis. StemPrintER is designed to help physicians distinguish ER+/HER2 negative patients:

with an elevated risk of early recurrence (<5 years) who could benefit from chemotherapy in addition to hormonal therapy

with a high risk of late recurrence who could benefit from prolonged endocrine treatment up to 10 years

with a low risk of early recurrence who might be spared chemotherapy or be eligible for less aggressive treatments

The diagnostic has a unique biological basis,
being based on the detection of cancer stem cell markers, uses a reliable platform (qRT- PCR, FFPE), and has been evaluated in
an initial retrospective validation study using a consecutive cohort of approximately 2,400 patients with breast cancer. The development
team is preparing for a retrospective validation study using an independent cohort and has conducted a pre- submission meeting
with the FDA. Additionally, studies have been completed evaluating the prognostic capabilities of StemPrintER compared to competing
technologies in large cohorts of ER+/HER2 negative patients. The results demonstrated the superiority of StemPrintER stem cell
based genomic prognostic tool versus the market leader, Oncotype DX, in predicting recurrence in ER+/HER2- postmenopausal breast
cancer patients.

Our Competitive Strengths

Our mission is to design
and deliver next generation therapeutics and diagnostics for oncology and immune diseases of high unmet medical need by combining
deep understanding of disease biology with clinical development expertise. We believe the following strengths will allow us to
continue to pursue this mission:

Advanced, novel pipeline. We have an advanced pipeline of novel and proprietary drug candidates, including antibodies and small molecules, to address high unmet medical needs in the inflammation, autoimmune and oncology markets with significant commercial potential.

Proprietary technology. Our proprietary technology enables the development of alternative routes of administration of antibodies, including oral delivery. We believe that oral and nasal routes of delivery will alleviate the significant time and cost burden associated with other routes of administration, including intravenous delivery.

Broad and engaged network of experts. Our strong relationships with key opinion leaders contribute to our clinical development efforts and position us well to support our products, if approved. Dr. Napoleone Ferrara, Dr. Arun Sanyal, Dr. Kevan Herold, and Dr. Howard Weiner are among   the thought leaders on our scientific advisory committee.

Specialized expertise and focus on oncology and inflammation. Our management team, including Dr. Kunwar Shailubhai, Jules Jacob, and Dr. Vaseem Palejwala, has considerable experience translating technologies from bench to market, and managing the global administration of clinical trials.

Strong intellectual property and know-how. We believe our proprietary intellectual property portfolio, in-licensed from Nerviano and Novimmune, provides us with a substantial competitive advantage for the commercial development of small molecule NCEs, and biologics, as well as expanded possibilities for new development programs in the future. We have retained the worldwide development and commercialization rights to all of our product candidates. We have submitted additional patent applications to further strengthen our intellectual property.

Lean research and development model, designed to maximize value. We employ a lean and virtual R&D model using highly experienced teams of experts for each business function to maximize value accretion by focusing resources on the drug discovery and development processes.

Our Strategy

Our goal is to become a
leading biotechnology company focused on developing and delivering therapies and related diagnostics in both oncology and immunology.
The key elements of our strategy to achieve this goal are to:

Advance the clinical development of orally
administered Foralumab for the treatment of Crohn’s disease using a novel and proprietary oral formulation by initiating
a Phase 2 trial in the second quarter of 2021. In addition, a Phase 1 trial for the first-in-human evaluation of the intranasal
administration of Foralumab in healthy volunteers, for neurodegenerative disease indications such as progressive MS, was initiated
in November 2018. The study was completed in September 2019 and a Phase 2 study in progressive MS patients is planned to start
in Q4 2020 with results anticipated in Q2 2021.

Accelerate development and cGMP manufacturing
of our product candidate, TZLS-501, a fully human mAb targeting the IL-6 receptor (a biological mAb which may control the proteins
involved in cell signaling relevant to many inflammatory diseases and cancers), for treatment of inflammatory and oncology indications
such as COVID-19 and multiple myeloma, respectively.

Continue to advance the clinical development
and obtain regulatory approval for our lead oncology product candidate, Milciclib, as a monotherapy in HCC and as a combination
therapy for the treatment of refractory solid tumors (being cancers which are non-responsive or become resistant to treatment)
by initiating a planned Phase 2b trial in combination with a tyrosine kinase inhibitor such as Sorafenib or Regorafenib.

Continue development of platform drug
delivery technologies that provide competitive advantage over existing approved products, e.g. inhalation delivery and enteric
delivery of mAbs.

Advance
StemPrintER prognostic testing technology through testing of larger cohorts of breast cancer ER+/HER2 negative patients and controlled
testing against competitive technologies

Continue to leverage relationships
with key opinion leaders to promote clinical trial success and enhance future commercialization.

Opportunistically identify and acquire or in-license complimentary product and technology candidates.

Seek orphan drug, fast track or breakthrough designation for our product candidates where warranted.

Our Product Candidates

Our product candidate pipeline
is set forth below:

DEVELOPMENT PIPELINE

Foralumab (TZLS-401 formerly known as NI-0401)

We believe Foralumab is
the only fully human anti-CD3 mAb in clinical development, in contrast to the previous non-human or humanized anti-CD3 mAbs. Foralumab
targets the CD3 epsilon (CD3ε) receptor, which is a recognized approach for modulating T-Cell response and achieving immunosuppression.
We believe Foralumab could have broad application to autoimmune and inflammatory diseases, such as NASH, Crohn’s disease,
MS, type-1 diabetes, or T1D, inflammatory bowel disease, psoriasis and rheumatoid arthritis, where modulation of a T-cell response
is desirable. In July 2017, we announced publication of a research article in, Clinical Immunology, entitled: “Oral treatment
with Foralumab, a fully human anti-CD3 mAb, prevents skin xenograft rejection in humanized mice.” We believe this is the
first-ever published report demonstrating the potential of oral therapy with Foralumab for inflammatory diseases such as NASH and
is based on the landmark discovery by Prof. Howard Weiner of Harvard University, one of our Scientific Advisory Committee members.

On April 16, 2018, the
Group entered into an exclusive license agreement with The Brigham and Women’s Hospital, Inc. relating to a novel formulation
of Foralumab dosed in a medical device for nasal administration. An investigational new drug application (IND) for the first-in-human
evaluation of the nasal administration of Foralumab in healthy volunteers for progressive multiple sclerosis indication was filed
in the second quarter of 2018. Subsequent to IND approval, a single-site, double-blind, placebo-controlled, dose-ranging Phase
1 trial with nasally administered Foralumab at 10, 50 and 250 µg per day, consecutively for 5 days to evaluate biomarkers
of immunomodulation of clinical responses was initiated in November 2018. The trial conducted at the Brigham and Women's Hospital,
Harvard Medical School, Boston, MA, in healthy volunteers. 18 subjects received Foralumab treatment and 9 patients received placebo.
The study was completed in September 2019. Phase 1 clinical data demonstrated that nasally administered Foralumab, was well-tolerated
and no drug-related safety issues were reported at any of the doses. No drug-related changes were observed in vital signs among
subjects at predose, during treatment and at discharge. The mean blood pressure (BP) during the 5 days of treatment were; Cohort
A (10 µg/d):124/73, Cohort B (50 µg/d): 119/67 and Cohort C (250 µg/d):113/65 compared to placebo:118/67). Heart
rates, respiratory rates and oral temperatures were unchanged among the 3 cohorts compared to the placebo. Nasally administered
Foralumab at the 50 µg dose suppressed cytotoxic CD8+ as well as perforin secreting CD8+ cells, which have been implicated
in neurodegeneration in multiple sclerosis (MS). Treatment at 50 mg stimulated production of anti-inflammatory cytokine IL-10
and suppressed production of pro-inflammatory cytokine IFN-γ. Taken together, the treatment showed significant positive
effects on the biomarkers for activation of mucosal immunity, which are capable of inducing site-targeted immunomodulation to
elicit anti-inflammatory effects. Based on the results we intend to conduct a Phase 2 trial in progressive MS patients starting
in Q4 2020.

An enteric-coated capsule formulation using
a proprietary and novel technology has been developed for oral administration of Foralumab. cGMP manufacturing of clinical trial
materials for a Phase 1 study has been completed and an IND has been submitted in March 2019.

On September 9, 2019, the FDA granted
approval to initiate the Phase I clinical trials to evaluate the safety and pharmacokinetics of oral Foralumab at 1.25, 2.5 and
5.0 mg/day as a single ascending dose study. The study was completed in December 2019 at Brigham and Women’s Hospital (Boston,
MA USA). Formulated Foralumab powder encapsulated in enteric-coated capsule was well-tolerated at all doses tested and there were
no drug-related safety issues observed even at the highest dose of 5 mg in this trial. Based on successful Phase 1 data, we intend
to conduct a Phase 2 study using Crohn’s Disease patients starting in the second quarter of 2021.

Crohn’s Disease

Crohn’s disease is
a relapsing, transmural inflammatory disease of the gastrointestinal mucosa that can affect all parts of the intestinal tract as
well as extra-intestinal organs. Crohn’s disease affects between 400,000 and 600,000 people in North America. Prevalence
estimates for Northern Europe have ranged from 27–48 per 100,000. Although the incidence and prevalence of Crohn’s
disease are beginning to stabilize in high-incidence areas such as northern Europe and North America, they continue to rise in
low-incidence areas such as southern Europe, Asia, and much of the developing world. Differences in incidence across age, time,
and geographic region suggest that environmental factors significantly modify the expression of Crohn’s disease. The strongest
environmental factors identified are cigarette smoking and appendectomy. The disease affects slightly more females than males and
is most commonly diagnosed in young adults, e.g. late adolescence to the third decade of life (Kim, S.C. and G.D. Ferry. Gastroenterology
(June 2004) 126 (6): 1550-1560). Although the exact etiology remains unknown, the occurrence of Crohn’s disease is strongly
associated with mutations of a receptor for microbial pathogens (NOD2) that lead to increased activation of antigen presenting
cells and a defect in the release of antimicrobial defensins. It is now widely accepted that as a result of this altered balance
of immune homeostasis, exposure to commensal bacterial antigens causes increased stimulation and proliferation of mucosal T-lymphocytes,
leading to immune inflammation. Additional pathogenic mechanisms may include a defect in T-cell programmed death, or apoptosis,
and possibly a defect in regulatory T-cell function.

Crohn’s disease usually
presents as acute or chronic bowel inflammation then the inflammatory process evolves toward one of two patterns of the disease:
a fibrostenotic-obstructing pattern or a penetrating-fistulous pattern, each with different treatments and prognoses. The site
of disease influences the clinical manifestations and can include diarrhea, abdominal pain, fever, clinical signs of bowel obstruction,
as well as passage of blood or mucus or both.

At least 25% patients with
Crohn’s disease will develop extraintestinal disease manifestations which usually respond to treatment of the underlying
disease (e.g. arthritis, uveitis, primary sclerosing cholangitis) (Harrison’s Principles of Internal Medicine 2008).

Crohn’s disease is
histologically characterized by a discontinuous transmural granulomatous inflammation of the intestinal wall, but typical granulomas
are found on mucosal biopsies in a minority of subjects. Surgical resection reveals granulomas in about half of cases (Harrison’s
17th edition).

The pharmacological management
of Crohn’s disease is based on the control of the inflammatory process. Current treatment regimens include:

anti-inflammatory drugs (e.g. corticosteroids, aminosalicylates), which are the first-line treatment to induce remission in acute active disease;

immunosuppressants such as azathioprine, 6-mercaptopurine and methotrexate (Feagan, 2000) which are used to maintain remission or treating chronic active disease; biologic immunotherapies (e.g. anti-TNF mAbs including infliximab and adalimumab) which are used to induce and maintain remission.

All of these treatments
have limited long-term efficacy and potential for serious adverse effects (Targan, 1997; Present, 1999).

Previously reported studies
using anti-cluster definition 4, or anti-CD4, and tumor necrosis factor, or TNF, binding mAbs provide a strong rationale for targeting
T-cells in Crohn’s disease (van Deventer et. al. Intl. J. Clin. Pharm. (1997) 19(2): 55-9). It is now known that TNF targeting
mAbs in Crohn’s disease and IBD are effective because of the bringing about of programmed cell death (apoptosis) of activated
T-lymphocytes rather than neutralization of soluble TNF (Chowers et.al., Current Drug Targets (2010) 11: 138-142; Atreya et. al.
Gastroenterology (2011) 141 (6): 2026-2038.

In addition, there are
few published clinical data on the use of anti-CD3 mAbs in subjects with Crohn’s disease. One product in development, visilizumab
(Nuvion®, PDL Biopharma) has been tested in the clinical setting. Two studies with visilizumab in patients with severe Crohn’s
disease have been performed: An open-label study (ClinicalTrials.gov Identifier: NCT00267709) in patients with Crohn’s disease
having peri-anal fistulas and an open-label study (ClinicalTrials.gov Identifier: NCT00267722) in patients with moderate-to-severe
inflammatory, non-structuring, non-penetrating Crohn’s disease. Eighteen patients were expected to be enrolled in each study.

Preliminary
results from the second study suggested that two 10 μg/kg doses of visilizumab administered by IV bolus injection on consecutive
days appeared to have clinical activity. Ten of the 14 patients reported a clinical response by day 59, as determined by a drop
in the Crohn’s disease Activity Index, or CDAI score, of 100 points. Five patients achieved a complete remission, as defined
by a CDAI score of <150 during the 59 days. Of note, two patients who never responded to infliximab, as well as seven patients who lost their response to infliximab, responded to visilizumab.

Multiple
Sclerosis

MS
is an inflammatory-mediated demyelinating disease of the human central nervous system. The disease develops in young adults with
a complex predisposing genetic trait and most likely involves an environmental insult such as a viral infection to trigger the
disease. The activation of CD4+ autoreactive T cells and their differentiation are crucial initial steps in the progression of
this disease. The therapeutic use of monoclonal antibodies was initially viewed with great skepticism owing to the high rates
of sensitization against mouse proteins, their pharmacokinetic properties, and the difficulties in their production. However,
most of these problems have been overcome, and monoclonal antibodies are now among the most promising therapies for MS.

Autoimmune
and Inflammatory Diseases

Autoimmune
diseases are primarily due to a malfunction when the immune system attacks certain cells in the body as foreign invaders. Questo
can result in irreparable damage to critical organs and tissues eventually resulting in autoimmune diseases.

In
humans, CD3-epsilon is encoded by the CD3ε gene on Chromosome 11. The CD3ε molecule, along with four other membrane-bound
polypeptides (CD3-gamma, -delta, -zeta, and -eta) form the CD3 complex, which is associated with the T-cell receptor. Upon antigen
bindings, the CD3 complex sends signals through the cell membrane to the cytoplasm inside the T-cell. This leads to activation
of the T-cell that rapidly divides to produce new T-cells sensitized to fight the particular antigen to which the TCR was exposed.
While T-cell activation is critical for the human immune system to properly fight bacterial, viral or parasitic infections, abnormal
T-cell induction can cause and worsen numerous human diseases, including T-cell lymphoma and leukemia, human malignancies, autoimmune
disorders, cardiovascular disease and transplant rejection.

Our
Solution

We
believe Foralumab is the only fully human anti-CD3 mAb in clinical development. Since the discovery of the hybridoma technology,
a method to generate large quantities of a single (monoclonal) antibody, the production and manufacture of mAbs has become widely
available showing promise in several autoimmune and inflammatory disease clinical trials and therapeutic utility in animal models.
The first murine anti-CD3 mAb (IgG2a) was developed and approved by the FDA in 1985 under the name of muromonab, OKT3, (Ortho
Kung T3; Orthoclone®) to treat allograft rejection in kidney, liver and heart transplantation by exerting its potent immunosuppressive
effects, mainly due to depletion of T-cells in tissues and thereby preventing rejection of the allografts. Subsequently, OKT3
was administered in clinical trials to patients with MS, T1D, inflammatory bowel disease, rheumatoid arthritis and NASH. Although
showing promise to alleviate the disease process, the mAb being of murine origin and extremely immunogenic in humans, was associated
with a wide range of side effects that included the typical Cytokine Release Syndrom (CRS) or flu-like syndrome, limiting its
clinical development. The side effect profile of OKT3 is a consequence of T-cell activation resulting in the release of numerous
cytokines into the systemic circulation. These shortcomings of the murine OKT3 led to the development of a new generation of anti-CD3
mAbs using genetic engineering of the mAb structure, as depicted below.

Foralumab
dosed intravenously has been observed to alter T-cell function via antigenic modulation, that is, removal of the CD3/TCR complex
from the T-cell surface. Modulation has two therapeutic benefits:

It transiently renders
the T-cells incapable of recognizing an antigen and thus unable to orchestrate an immune response such as an allograft rejection;
e

It has a favorable
long-term effect on generation and maintenance of regulatory T-cells, a specialized subset of T-cells that promote immunological
tolerance.

In
comparison with the two other anti-CD3 mAbs evaluated in patients with T1D (otelixizumab and teplizumab), Foralumab, being fully
human, was less mitogenic (capable of causing cell division), therefore allowing re-treatment, and to have a better risk/benefit
profile. As such, Foralumab was previously developed by Novimmune as an intravenous formulation for the treatment of autoimmune
indications: Crohn’s disease and in renal allograft recipients.

Further,
recent data from studies conducted in the laboratories of our Scientific Advisory Committee members, Prof. Howard Weiner of Harvard
University and Prof. Kevan Herold of Yale University, suggest that oral administration of Foralumab has the potential for therapeutic
utility while minimizing toxicity associated with intravenous administration, such as CRS. Importantly, recent clinical studies
conducted by Prof. Yaron Ilan with oral administration of anti-CD3 (OKT3; murine mAb) in HCV infected patients (non-respondents)
and in NASH patients suggested that the treatment was well-tolerated and produced immunologic effects consistent with potential
clinical benefits.

In
addition, increasing appreciation for the gut-liver cross-talk and of its role in the initiation of NASH-associated inflammation
and fibrogenesis has led to the understanding that systemic inflammatory processes can be alleviated by modulating the gut immune
system, without inducing generalized immunosuppression. This has been achieved in multiple approaches, including oral administration
of fatty liver-derived proteins, anti-CD3 antibodies, TNF, fusion protein, anti-lipopolysaccharide antibodies, glucosylceramide,
delayed-release mercaptopurine and soy-derived extracts. Several of these compounds were shown to be effective in patients with
NASH.

Orally
administered OKT3 was evaluated in a Phase 2 trial in 36 patients with NASH and type 2 diabetes and was found to be well tolerated.
Increases in regulatory T-cell markers consistent with induction of regulatory T-cells was observed as well as increases in other
anti-inflammatory markers. Although not powered sufficiently to evaluate efficacy endpoints, positive trends were observed including
lowering of liver enzymes and lowering of glucose levels (Lalazar et.al, J. Clin. Immunol. (2015) 34 (4):399-407).

More
recent animal studies conducted separately by Prof. Howard Weiner and Prof. Kevan Herold demonstrated therapeutic utility of orally
administered Foralumab for immune-inflammatory diseases. Our strategy is to build on these findings to develop orally administered
Foralumab for the treatment of Crohn’s disease and other autoimmune diseases. We believe Foralumab may also be combined
with our other product candidate, TZLS-501, a fully human anti-IL-6R mAb, for the treatment of rheumatoid arthritis and other
diseases.

On
April 16, 2018, the Group entered into an exclusive license agreement with The Brigham and Women’s Hospital, Inc. relating
to a novel formulation of Foralumab dosed in a medical device for nasal administration. An investigational new drug application
(IND) for the first-in-human evaluation of the nasal administration of Foralumab in healthy volunteers for progressive multiple
sclerosis indication was filed in the second quarter of 2018. Subsequent to IND approval, a single-site, double-blind, placebo-controlled,
dose-ranging Phase 1 trial with nasally administered Foralumab at 10, 50 and 250 µg per day, consecutively for 5 days to
evaluate biomarkers of immunomodulation of clinical responses was initiated in November 2018. The trial conducted at the Brigham
and Women’s Hospital, Harvard Medical School, Boston, MA, in healthy volunteers. 18 subjects received Foralumab treatment
and 9 patients received placebo. The study was completed in September 2019. Phase 1 clinical data demonstrated that nasally administered
Foralumab, was well-tolerated and no drug-related safety issues were reported at any of the doses. No drug-related changes were
observed in vital signs among subjects at Predose, during treatment and at discharge. The mean blood pressure (BP) during the
5 days of treatment were; Cohort A (10 µg/d):124/73, Cohort B (50 µg/d): 119/67 and Cohort C (250 µg/d):113/65
compared to placebo:118/67). Heart rates, respiratory rates and oral temperatures were unchanged among the 3 cohorts compared
to the placebo. Nasally administered Foralumab at the 50µg dose suppressed cytotoxic CD8+ as well as perforin secreting
CD8+ cells, which have been implicated in neurodegeneration in multiple sclerosis (MS). Treatment at 50
mg
stimulated production of anti-inflammatory cytokine IL-10 and suppressed production of pro-inflammatory cytokine IFN-γ.
Taken together, the treatment showed significant positive effects on the biomarkers for activation of mucosal immunity, which
are capable of inducing site-targeted immunomodulation to elicit anti-inflammatory effects. Based on the results we anticipate
initiating a Phase 2 trial in progressive MS patients in Q4 2020.

An
enteric-coated capsule formulation using a proprietary and novel technology has been developed for oral administration of Foralumab.
cGMP manufacturing of clinical trial materials for a Phase 1 study has been completed and an IND has been submitted in March 2019.

On
September 9, 2019, the FDA granted approval to initiate the Phase I clinical trials to evaluate the safety and pharmacokinetics
of oral Foralumab at 1.25, 2.5 and 5.0 mg/day as a single ascending dose study. The study was completed in December 2019 at Brigham
and Women’s Hospital (Boston, MA USA). Formulated Foralumab powder encapsulated in enteric-coated capsule was well-tolerated
at all doses tested and there were no drug-related safety issues observed even at the highest dose of 5 mg in this trial. Based
on successful Phase 1 data, we intend to conduct a Phase 2 study using Crohn’s Disease patients starting in the second quarter
of 2021.

Clinical
Development Plan

Phase
1 Clinical Trial for Oral Foralumab in Healthy Volunteers

Questo
Phase 1 trial, conducted at the Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA, was a single-site, double-blind,
placebo-controlled, single ascending dose (“SAD”) study in healthy subjects in which Foralumab was orally administered
at 1.25, 2.5 and 5.0 mg per dose as enteric-coated capsules. The primary endpoint of the Phase 1 study is safety and tolerability
of Foralumab in humans. Each cohort comprised of 4 subjects, of whom 3 received Foralumab treatment and 1 received a placebo capsule.
All subjects completed the trial without any safety concerns at any of the doses.

A Phase 2a trial is expected to be initiated
in the second quarter of 2021 with the intent to treat patients with Crohn’s disease.

Proposed
Phase 2 Clinical Trial for Oral Foralumab Treatment of Crohn’s Disease

Il
proposed Phase 2 clinical trial for Foralumab is a randomized, placebo-controlled, four-arm, double-blind study. Subjects (48)
will be randomized (1:1:1:1) to receive either a once daily oral placebo or Foralumab dose of 1.25 mg, 2.5 mg or 5.0 mg for 30
consecutive days. Patients will record adverse events and daily administration of study medication in a subject diary. This will
serve as a measure of compliance and record of adverse events and tolerability. Patients will be followed up for 30 days following
completion of treatment. Study visits performed on Days 14, 30 and 60 of the study, will monitor metabolic parameters (body mass
index and waist circumference), serum lipid profiles, immunological markers (C-reactive protein and an array of cytokines), hepatic
enzymes and functions (13C-methacetin breath test and liver steatosis/fibrosis), which will be compared to baseline
levels (Day 1).

Il
safety and tolerability of the treatment regimen is the primary endpoint and will be determined by monitoring vital signs, laboratory
values, adverse events and physical findings throughout the study. In addition, efficacy/immunomodulatory activity will be established
using the following criteria: (1) reduced Day 30 serum alanine aminotransferase (ALT) levels; (2) reduced hemoglobin A1c; (3)
improved homeostasis model assessment (HOMA); (4) HOMA of insulin resistance (HOMA-IR) scores; as well as (5) levels of T cells
and cytokines as compared to baseline (Day 1).

Phase 1 Clinical Trial of Nasally-Administered
Foralumab for Treatment of Multiple Sclerosis

Questo
Phase 1 trial, conducted at the Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, was a single-site, double-blind,
placebo-controlled, dose-ranging study with nasally administered Foralumab at 10, 50 and 250 µg per day, consecutively for
5 days in healthy volunteers for the treatment of progressive multiple sclerosis (pMS). 18 subjects received Foralumab treatment
and 9 patients received placebo. All nasal doses were well tolerated. Biomarker analysis showed significant positive immune effects,
that were most prominent in the 50 mg cohort with minimal immunomodulatory effects at the 10 µg and 250 µg doses.
 Prominent results included:

Treatment
was well-tolerated and no drug-related safety issues were reported at any of the doses.

No
drug-related changes were observed in vital signs among subjects at predose, during treatment and at discharge. The mean blood
pressure (BP) during the 5 days of treatment were; Cohort A (10 µg/d):124/73, Cohort B (50 µg/d): 119/67 and Cohort
C (250 µg/d):113/65 compared to placebo:118/67). Heart rates, respiratory rates and oral temperatures were unchanged among
the 3 cohorts compared to the placebo.

Nasally
administered Foralumab at the 50 µg dose suppressed cytotoxic CD8+ as well as perforin secreting CD8+ cells, which have
been implicated in neurodegeneration in multiple sclerosis (MS).

Treatment
at 50 mg stimulated production of anti-inflammatory cytokine IL-10 and suppressed  production of pro-inflammatory cytokine
IFN-γ.

Taken
together, these results suggest stimulation of Tregs that are needed to provide clinical benefits

A Phase
2a trial is planned to be initiated in Q4 2020.

Intravenous
Foralumab has been studied in a total of three Phase 1 and Phase 2 clinical trials conducted by Novimmune. A total of 68 patients
were exposed to Foralumab:

Study
NI-0401-01:
a Phase 1/2a randomized, double-blind, placebo-controlled and dose escalation study NI-0401-01 in subjects with
moderate to severe active CD. The study was completed and 33 subjects were exposed to Foralumab. The study NI-0401-01 was designed
to assess tolerability of Foralumab and was not powered to evaluate efficacy parameters included the proportion of patients achieving,
clinical response and change from baseline of Crohn’s Disease Endoscopy Index of Severity. A trend, although not statistically
significant, was seen when analyzing the clinical response and endoscopic response. Single and repeat intravenous doses of 0.05,
0.1, 0.5, 1.0, 2.0 and 10.0 mg Foralumab were administered to subjects and serum pharmacokinetics evaluated for up to five days.
Limited pharmacokinetic data was collected, however it was observed that at doses over 1.0 mg, severe infusion related reactions
(IRRs) were observed that led to discontinuation of the 2 and 10 mg groups. Therefore, the 1.0 mg dose was considered the MTD
in this study. CD3 modulation on CD4 positive and CD8 positive T cells was related to Foralumab dose. There was a dose response
for the reduction of peripheral T-cell (CD2 positive) count. The main adverse events were infusion related reactions related to
the route of administration of the drug.

Study
NI-0401-02:
an open-label, dose titration, multicenter Phase 1 study of Foralumab for the treatment of subjects with biopsy-proven
acute cellular renal allograft rejection (BpACR). The study was completed and 11 subjects were exposed to Foralumab. Patients
were dosed with 1.0 mg, 1.5 mg, 2.0 mg and 2.5 mg of Foralumab daily for five days and most were pre-treated with methylprednisolone.
The data from study NI-0401-02 has confirmed the dose response in terms of CD3 modulation and reduction of peripheral T-cell count.
A CD3 modulation of up to 90% was achieved at study NI-0401-02 day five with a daily dose of 2.5 mg during the 5 days of treatment
period. Although there was no dose-response relationship, treatment with foralumab seems to be globally effective to reverse protocol
defined acute cellular rejection and in the mormalization of serum creatinine levels, a primary efficacy objective. The main adverse
events were infusion related reactions in patients that were not premedication with prednisolone.

Study
NI-0401-03:
a Phase 2a study with an open label dose escalation phase followed by a double-blind phase to assess safety and
efficacy of Foralumab in subjects with moderate to severe active CD. The study NI-0401-03 was completed and 24 subjects were exposed
to Foralumab. 74% of patients had achieved a clinical response at week 2 and 87% of patients at week 4. At weeks 6, 8 and 12 the
proportion of patients with a clinical response decreased to 75%, 70% and 67%, respectively. 30% of patients had achieved clinical
remission at week 2, 42% by weeks 4, 38% by week 6, 43% at week 8 and 46% at week 12. Treatment failures were 12.5%. There was
a reduction in the mean Crohn’s Disease Activity Index (CDAI) scores in all treatment cohorts and an overall improvement
in the Crohn’s Disease Endoscopic Index of Severity (CDEIS) scores across all treatment groups following 5 daily doses of
Foralumab treatment. Pharmacokinetic evaluations were performed, and no dose-response relationship was established due to variability
between patients. The observed half-life of Foralumab was approximately 180 hours. A rapid and almost complete disappearance of
CD45 positive lymphocytes, CD3 positive T-cells, CD3 positive and CD4 positive helper T-cells and CD3 positive and CD8 positive
cytotoxic T-cells from the circulation was observed was observed within 24 hours of infusion for all dose cohorts. The lowest
unit dose in the study NI-0401-03 was equivalent to the 1 mg daily unit dose that was the maximum tolerated dose in study NI-0401-01.
Pre-medication with prednisolone reduced the severity and frequency of infusion related reactions.

In
two Phase 2a trials conducted by Novimmune, patients with Crohn’s disease and renal allograft rejection in kidney transplants
demonstrated Foralumab’s immunomodulatory activity in humans. We have decided not to pursue evaluation of intravenous Foralumab
in Crohn’s Disease because we believe the market for this disease is saturated by other FDA approved drugs. Further, while
intravenous administration of antibodies has been widely used, side effects from the intravenous administration still are prevalent
as well as patient compliant issues come into play. We intend to move forward with an oral formulation of Foralumab for treatment
of Crohn’s disease.

Two
of Novimmune’s clinical trials were in patients with Crohn’s disease and the third clinical trial was conducted in
patients undergoing kidney transplantation and suffering with renal allograft rejection. Sixty-eight subjects with active Crohn’s
disease and 11 subjects with acute cellular renal allograft rejection were treated with Foralumab. The route of administration
of Foralumab in these studies was via intravenous administration.

In
these trials, it was observed that:

The short-term tolerability
profile of Foralumab was very similar to those reported with other anti CD3 antibodies and no new emerging concerns have been
identified.

Total daily doses
of up to 1mg (~ 500 µg/m2) per patient were generally well tolerated without corticosteroid premedication. The most
common adverse events following exposure to Foralumab were IRRs, which occurred in all patients treated with the compound.
In the majority of cases, these symptoms were mild (66%) in intensity and were reported following the first two infusions
of the 5-infusion treatment course. The number of affected patients and the severity of symptoms tended to increase with increasing
dose level, or DL.

A clear reduction
of CRS and its associated IRRs were observed with steroid pre-medication. All patients who received pre-medication with steroids
had mild or no IRRs, and CRS was reduced. Only one patient who did not receive steroid pre-medication had significant levels
of CRS, in particularly IL-6.

Usage of steroid pre-medication allows the administration
of higher doses.

Both the magnitude and duration of CD3 modulation
increased in a dose related manner.

No anti-drug antibodies were detected.

Prior
Clinical Experience

Oral
anti-CD3 antibodies, as opposed to the narrow therapeutic window of its intravenous counterpart, have been shown to impact the
gut immune system and mesenteric lymph nodes, thereby promoting regulatory T-cells activity, without inducing immunosuppression.
The treatment alleviated experimental autoimmune encephalitis and T1D mellitus, which was associated with regulatory T-cells induction.
Orally and nasally administered anti-CD3 suppressed autoantibody production in a mouse lupus model. Oral anti-CD3 yielded reduced
pancreatic hyperplasia, hepatic fat accumulation and muscle inflammation in a leptin-deficient model of NASH and diabetes.

Pharmacology
Summary (In Vitro Studies)

Il
key conclusions arising from the non-clinical studies of Foralumab by Novimmune are:

Foralumab is a specific
anti-CD3 epsilon mAb, as it binds to human T-cells and the recombinant human CD3 epsilon chain, and can be displaced by another
specific anti-CD3 epsilon mAb, muromonab CD3.

When bound to its
target, Foralumab triggers calcium flux into the cell and modulates the CD3/TCR complex causing its’ transient removal
from the cell surface.

The combination
of the two-point mutations introduced into the Fc portion (the constant region of the antibody that has limited structural
variability and is responsible for adverse side effects) of Foralumab, resulting in the abrogation of the binding to Fc gamma
receptors, and C1q, consequently eliminates T-cell proliferation and the release of numerous cytokines including TNF, and
interferon gamma, or IFNγ in vitro.

Foralumab does not
cross react with CD3 molecules expressed by T-cells of other species including baboon, Rhesus monkey, Cynomolgus
monkey, rabbit, dog, rat and mouse. As a consequence, options for the most relevant species selection for pharmacology
and toxicology assessment of Foralumab are limited. Novimmune addressed this limitation by studying LCD3 transgenic mice.
This transgenic mouse line expresses the human as well as the mouse CD3 epsilon chain on the surface of their T-cells.

Using a transgenic
line of mice expressing both human and mouse CD3 molecules (1:1 ratio) at the surface of T-cell (LCD3), following a
single intravenous injection, Foralumab dose dependently:

Modifies human CD3
epsilon expression; that is, more than 80% of the cell surface protein was removed within 24 hours when given at a saturating
dose. This modulation was transient as receptor expression levels returned to baseline values within 7 days of dosing.

Caused a reduction
of 70-80% in the number of circulating T-cells when given at a saturating dose. The maximal effect was observed at hour 6
post dose. Cell counts returned to baseline levels within 3.5 days.

Demonstrated a half-life
of 1.4 and 1.7 days for doses of 5 and 200 µg per mouse, respectively. This seemingly short half-life is similar to
that observed in vivo for other anti-CD3 mAbs and reflects internalization of Foralumab by the human CD3 molecule on the T-cells
of these transgenic mice. It was therefore expected that Foralumab will be internalized by human T-cells in patients and consequently
have a half-life comparable to other therapeutic anti-CD3 mAbs.

Milciclib
(TZLS-201)

Milciclib
is an orally bioavailable, small molecule broad spectrum inhibitor of CDKs (CDKs): 1, 2, 4, 5 and 7 and Src family kinases. CDKs
are a family of highly conserved enzymes that are involved in regulating the cell cycle, which is a series of events that takes
place in cells leading to division and duplication of its DNA to produce two daughter cells. Src family kinases regulate cell
growth and potential transformation of normal cells to cancer cells. A novel feature of Milciclib is its ability to reduce microRNAs,
miR-221 and miR-222, that silence gene expression. miR-221 and miR-222 promote the formation of blood vessels (angiogenesis) that
are important for spread of cancer cells (metastasis). Levels of these microRNAs are consistently increased in HCC patients and
may contribute towards resistance to treatment with Sorafenib. As a result, we are investigating Milciclib both as a monotherapy
and plan a combination treatment with Sorafenib. To date, Milciclib has been studied in a total of eight completed and ongoing
Phase 1 and Phase 2 clinical trials in 316 patients. In these trials, Milciclib was observed to be well-tolerated and showed initial
signals of anti-tumor action. We initiated a Phase 2a trial (CDKO-125a-010) for Milciclib as a single therapy in patients with
HCC in the second half of 2017 and expect to initiate a Phase 2b trial (TZLS (201)-125a-011) for Milciclib in combination with
tyrosine kinase inhibitor (Sorafenib or Regorafenib) in patients with HCC in 2021.

Hepatocellular
Cancer

We
are initially developing Milciclib for the treatment of HCC. HCC, or liver cancer, is the sixth most common worldwide and second
most leading cause of death in the United States. Liver cancer incidence and death rates are steadily rising. As of 2012, rates
of new liver cancer cases went up 38% from 2003 to 2012 according to the Centers for Disease Control and Prevention.

Most
HCC patients present with advanced disease and do not benefit from transplantation, surgical resection, or locoregional therapies.
The SOC, Sorafenib and Lenvatinib, are approved in the United States and EU for advanced HCC patients but have a limited impact
on overall survival.

Il
primary risk factor for HCC is hepatic cirrhosis, with an estimated 78% of HCC cases and 57% of cases of liver cirrhosis caused
by chronic infection with hepatitis B virus or HCV. Recently, the combination of insulin resistance, hypertension, dyslipidemia
and obesity, termed “metabolic syndrome,” has also been recognized as a cause of NAFLD, which is the most common liver
disease, cirrhosis and HCC. The following graphic represents the progression from a healthy liver to NAFLD, NASH and HCC.

Generally,
cancer is primarily due to deficiencies in cell cycle control, eventually resulting in transformation of normal cells to rapidly
growing cancer cells. Therapeutic intervention to control cell cycle has long been anticipated as effective cancer therapies.
CDKs are a family of enzymes first discovered as regulators of the cell cycle. CDKs have been found to be overexpressed in a variety
of human diseases with abnormal cell growth such as cancers, viral infections, neurodegenerative disorders and other proliferative
diseases. We believe that modulating CDK activity with targeted therapies is an attractive strategy to reinforce cell cycle control
and decrease the rate of abnormal proliferation of cancer cells. The first FDA approval in March 2015 of a CDK inhibitor for palbociclib,
and more recently in 2017, ribociclib, for a type of breast cancer, has led to great interest in the development of this class
of drugs as oncology therapeutics.

Our
Solution

Milciclib
is an oral, broad-spectrum inhibitor of CDKs, as well as several other protein kinases responsible for controlling cell growth
and replication. Milciclib has an unusual kinase inhibitory profile making it active against other receptors such as, tyrosine
kinase, Src family and splicing kinases, which play a role in cell growth and transformation from normal to cancerous cell types.

In
tumor cells exposed to Milciclib, a block in G1 phase (first phase of the growth cycle where the cell synthesizes messenger RNA
and proteins before cell division) of the cell cycle was observed, supporting the postulated mechanism of action of the compound
as determined in biochemical assays. Additionally, Milciclib was able to modulate the phosphorylation of the Retinoblastoma protein,
a substrate of the CDK/cyclin complex as well as to reduce phosphorylation status of proteins of the TRKa signaling pathway in
cells expressing the tyrosine kinase receptor. These results supported that Milciclib was active against several families of protein
kinases that actively controlled cell growth and transformation from normal to cancerous cell types. This is important because
many chemotherapeutic agents are effective at only a single point in the cell cycle, allowing cells to “escape” the
biochemical blockage through alternative biochemical pathways.

Significant
anti-tumor activity was observed in all tested preclinical animal models with different oral treatment schedules of Milciclib.
Cancerous cell types were transplanted into immunosuppressed animals and the number and volume of cancerous lesions were evaluated
by magnetic resonance imaging after oral administration of Milciclib at different dose levels (DLs) and dose schedules compared
to untreated, control animals. In various human xenograft and transgenic models (prostate cancer, lung adenocarcinoma and hepatocarcinoma),
consistent tumor growth inhibition, up to 91%, (evaluated by measuring the number and volume of tumors for treated animals versus
control animals) was observed -with repeat daily treatment at tolerated doses. Similar results were obtained in a mammary carcinoma
model (stasis and partial remission in 58% and 25% of the primary tumors, respectively) with repeat daily dosing. In an orthotopic
mouse model of HCC, statistically significant reduction in tumor growth was observed following five weeks of treatment with Milciclib
(-20% reduction,30mg/kg/day),sorafenib (-20% reduction, 20 mg/kg/day) vs combination of Milciclib with Sorafenib (-38% reduction)
as compared to vehicle control. The treatment also reduced serum levels of human alpha-fetoprotein. Preliminary mechanistic and
gene expression studies suggest that downregulation of miR-221, miR-222 by Milciclib results in upregulation of its molecular
targets, cyclin dependent kinase inhibitors p27 and p57. Additionally, Milciclib treatment upregulated relative expression of
tumor suppressors p21 and p53, which are important regulators of cellular proliferation. Milciclib treatment reduced expression
of pAKT, c-Myc and cyclin D1, which are known to be overexpressed in HCC tumor tissues. These preclinical data demonstrating the
synergistic effect of Milciclib with Sorafenib were presented at the AASLD meeting in November 2018. Clinical safety and efficacy
outcomes from the Phase 2a trial have been submitted for presentation at the ASCO 2020 Scientific Meeting.

Clinical
Development Plan

Phase
2a Clinical Trial (CDKO-125a-010) for Milciclib as a Monotherapy for the Treatment of HCC

In
July 2017, we initiated dosing in a single-arm, multicenter, Phase 2a clinical trial (CDK-125a-010) for Milciclib in adult patients
with unresectable or metastatic HCC and good liver function. The trial is studying the tolerability and safety of Milciclib in
these adult patients. As of 2019, we have enrolled and treated 30 patients at sites in Italy, Greece and Israel. Eligible patients
are receiving Milciclib orally, 100 mg/day for four consecutive days a week (four days on followed by three days off) for a total
of 12 weeks.

The primary
endpoint for the study was the overall tolerability profile, evaluated based on laboratory findings and adverse events emerging
during the trial. The occurrence of adverse events and laboratory tests wasl performed weekly during treatment. All the enrolled
patients who received at least one drug administration were evaluated for safety. An interim evaluation of tolerability and adverse
events was undertaken when the 10th patient had completed the first cycle of treatment. A second interim evaluation was conducted
when 20 evaluable patients completed their first cycle of treatment. Enrollment of additional patients was allowed after a positive
safety evaluation of the first 10 patients by an IDMC. On December 8, 2017 we announced the results of the first interim review
by the IDMC that treatment with Milciclib was well-tolerated with no drug-related serious adverse events. The IDMC recommended
continuing with the trial. The second IDMC meeting held on January 25, 2018 recommended that all patients (first cohort) who received
at least one dose of Milciclib should be assessed for safety and tolerability at the end of protocol mandated follow up before
enrolling the second cohort. The IDMC reconvened on its scheduled date on May 9, 2018 to evaluate the complete safety data for
all 11 patients who completed the study mandated visits. The IDMC concluded that safety and tolerability profile of Milciclib
in the first cohort, was acceptable and that there were no safety signals that precluded continuation of enrollment of the remaining
cohorts as planned. The IDMC was also informed of the patients who opted to continue Milciclib on “compassionate use basis.”
Four patients completed protocol mandated treatment (six cycles, six months). Three of these patients and their health care-provider/investigator
opted to continue treatment with Milciclib (compassionate use) with approval of their local Ethics Committee. These three patients
have completed treatment with milciclib for 9, 13, and 16 months, respectively. Based on this IDMC assessment, the study actively
enrolled 20 more patients. Secondary endpoints include Objective Tumor Response Rate, based on the modified Response Evaluation
Criteria in Solid Tumors, or mRECIST, a set of criteria developed to assess tumor response in HCC. In this study, objective response
by RECIST was evaluated as supportive analysis, along with several secondary parameters. The decrease in alpha-fetoprotein, or
AFP, as compared to baseline in patients with high AFP at baseline was also considered, based on reports suggesting a better outcome
for patients who achieve an AFP response. As an exploratory endpoint, the expression of micro-RNAs and their possible association
with Milciclib treatment was investigated.  The trial successfully met the primary endpoint that oral treatment with Milciclib
was well tolerated with manageable toxicities and no recorded drug related deaths. The secondary endpoints for clinical activity
assessment were based on the independent radiological review using the modified Response Evaluation Criteria in Solid Tumors (mRECIST)
Positive demonstrated clinical activity included:

1. 50%
(14 out of 28) evaluable patients completed 6-month duration of the trial.

2. 64%
(9 out of 14) patients requested and were approved by their respective ethical committees to continue the treatment.

3. Both
median time to progression (TTP) and progression free survival (PFS) were 5.9 months (95% Confidence Interval (“CI”)
1.5-6.7 months) out of the 6-months duration of the trial.

4. Approximately
57% of evaluable patients showed ’Stable Disease’ (SD; met at least once in an 8-week interval) and 3.6% patients showed ‘Partial
Response’ (PR).

5. Approximately
61% of patients showed ‘Clinical Benefit Rate’ defined as CBR=CR+PR+SD (with CR representing Complete Remission).

6. Five
patients on compassionate use continued the treatment for a total of 9, 9, 11, 13 and 16 months, respectively. Two patients continuing
the treatment have reached 16 months.

Phase
2b Clinical Trial (TZLS (201)-125a-011) for Milciclib as a Combination Therapy with Sorafenib or Regorafenib for the Treatment
of HCC

In
2021, we intend to initiate a randomized, multicenter study to explore tolerability and antitumor activity, of Milciclib in combination
with Sorafenib or Regorafenib, administered as first-line systemic therapy in adult patients with recurrent, unresectable or metastatic
HCC and good liver function.

Sorafenib
(Nexavar®) is the standard of care for treatment of HCC, yet treatment extends survival probability from 7.9 months (placebo
control) to 10.7 months (Llovet et al. N Engl J Med (2008) 359:378-390). There is a need for improvement which may be realized
by combination of Milciclib with Sorafenib. Milciclib modulates cell cycle, DNA replication and growth factor receptor cell signaling
(Albanese et.al, Mol. Cancer Therap. (2010) 9(8):2243-54). Sorafenib is a multikinase inhibitor which has demonstrated both anti-proliferative
and anti-angiogenic properties in vitro and in vivo. The combination of Sorafenib with Milciclib should exert a combined anti-proliferative
effect on tumor cells, involving targets different from the ones modulated by Milciclib, together with antiangiogenesis properties.

Clinical
Data

Milciclib
has been studied in a total of eight completed Phase 1 and Phase 2 clinical trials in approximately 316 patients. Milciclib was
observed to be well tolerated by patients with thymoma in Phase 1 and Phase 2 clinical trials.

Phase
1 Development

Milciclib
has been investigated in each of the below, open-label, multi-center, non-randomized, dose-escalation Phase 1 clinical trials.

Trial Patient
Population
Treatment Schedule / Dosing Key
Findings
CDKO-125a-001

Advanced/metastatic
solid tumors

37
patients

1st
Schedule: Orally, once daily

for
7 consecutive days every 14 days in a 2-week cycle at escalating doses of 50, 100,

150,
200 and 300 mg

2nd
Schedule: Orally, once daily for 4 consecutive

days
a week for 3 weeks in a 4-week cycle at escalating doses of 150, 180 and 200 mg

Pharmacokinetics:

Comparable
plasma pharmacokinetic parameters between the two schedules were observed.

Il
exposure to Milciclib increased with the dose and there was a 3-fold accumulation in the daily systemic exposure after
repeated dosing, in good agreement with expectations on the basis of the half-life of the compound (24-43 h).

Clinical
observations:

No
objective responses were achieved on 1st schedule; Disease stabilizations, defined as cancer disease that is neither increasing
nor decreasing in extent or severity, was observed in 6 of 14 evaluable patients (42.9%).

UN
partial response, or PR, was achieved in 2 out of 14 evaluable patients (14.3%) on 2nd schedule; Disease stabilization
(no change in extent or severity of disease state) was reported in 3 patients (21.4%), all treated at 180 mg/day DL, including
a stabilization lasting 31 weeks in a patient with pancreatic cancer and stable disease, or SD, lasting 29 weeks in a
patient with carcinoid.

Trial Patient
Population
Treatment Schedule / Dosing Key
Findings
CDKO-125a-002 Recurrent
malignant glioma 28 patients (Phase 1)
Escalating
oral doses of 18, 36, 54 and 72 mg/m2 once a day for 14 consecutive days followed by 7 days of rest in a 3-week cycle

Pharmacokinetics:

Results
indicated that the pharmacokinetics of Milciclib was dose-independent in the dose range 18


72 mg/m2.

34
patients (Phase 2)

54
mg/m2 (RP2D)

Systemic
exposure values of Milciclib maleate accumulated by a factor of 3

Clinical
observations:

Phase
1: No evidence of clinical effect was observed in all the 28 treated patients. However 5 patients seemed to have benefitted
from therapy with SD observed (no change in extent or severity of cancer).

Phase
2: One out of 34 patients achieved the primary endpoint. PFS at 6 months or PFS-6 rate was 2.9%. No complete response,
or CR (disappearance of all signs of cancer in response to treatment) or PR (decrease in tumor size or extent of cancer
in the body) were reported. 4 patients showed SD as best overall response (11.8%). Prolonged SD (≥ 6 months) was observed
in one patient whose SD lasted for 24.9 months.

Safety:

34
patients were enrolled and treated: 29 patients of non-Enzyme Inducing Anti-Epileptic Drugs, or non-EIAED, population
and 5 of EIAEDs population. The primary clinical endpoint was not met. Only one patient (non-EIAEDs) achieved the study
primary endpoint out of 34 treated patients. PFS-6 rate evaluated in the treated patients was 2.9% (95% CI, 0.07-15.33).
No CR or PR was reported; 4 patients in the treated patients showed SD as best overall response on treatment (11.8%).
Prolonged SDs (≥6 months) was observed in one patient whose SD lasted for 24.9 months. Median OS in treated patients
was 7.03 months (95% CI, 5.72-10.58). The exploration of the role play by potential prognostic factors, such as Karnofsky Performance
Scale (≥90 vs. <90), age (<40 vs. ≥40) and interval between initial diagnosis and current recurrence (≥52 weeks vs. <52 weeks) indicated a better survival outcome for patients whose interval between initial diagnosis and current recurrence was (≥52 weeks). Given the non-comparative nature of the study, it cannot be said whether the treatment played any role in this result.

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influence of other factors cannot be excluded but was not apparent in the current sample.

Trial Patient
Population
Treatment Schedule / Dosing Key
Findings
CDKO-125a-003

Advanced/metastatic
solid tumors

30
patients

1st
Schedule: Orally, once daily

for
21 consecutive days followed by 7 days of rest in a 4-week cycle at escalating doses of 16 and 24 mg/m2

2nd
Schedule: Orally, once daily for 14 consecutive days followed by 7 days of rest in a

3-week
cycle at escalating doses of 24, 48, 54 and 72 mg/m2

Pharmacokinetics:

No
differences in the pharmacokinetics were observed between the two schedules after both single and repeated dosing.

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systemic exposure to Milciclib (amount of Milciclib available systemically in the patient) increased with dose in terms
of both Cmax (maximum concentration of Milciclib in plasma) and daily Area Under the Plasma Drug Concentration, or AUC,
vs Time Curve, a measure of drug bioavailability without deviations from dose-proportionality (plasma concentration changes
in a linear relationship to amount of drug dosed).

After
repeated administrations, Milciclib Cmax and AUC accumulated by a factor of 2-4, independent of the dose-level.

Clinical
observations:

No
objective (measurable) responses were achieved. SDs were reported in 5 out of 16 evaluable patients (31.3%), starting
from the dose of 48 mg/m2/day. One disease stabilization maintained for 12 cycles (10.5 months) at 48 mg/m2/day, was achieved
in a parotid gland patient.

CDKO-125a-004

Advanced/metastatic
solid tumors

16
patients

Orally
administered at 45, 60 and 80 mg/m2 once daily for 7 days on / 7 days off (Days 1 to 7 and 15 to 21) in a 4-week cycle
in combination with fixed dose of IV gemcitabine (1000 mg/m2/day) on Days 1, 8, 15

over
30 minutes every 4 weeks

Pharmacokinetics:

Pharmacokinetic
parameters (Cmax, AUC) of Milciclib after Milciclib maleate/ gemcitabine combination were consistent with those previously
observed after Milciclib maleate administration as single agent, suggesting no influence of gemcitabine on the pharmacokinetics
of the compound.

Clinical
observations:

One
PR in 14 evaluable patients (7.1%) and one SD in 10 patients (71.4%).

Disease
stabilizations lasting z 6 months were recorded in 4 cases (28.6%) in thyroid, prostatic, pancreatic carcinoma and peritoneal
mesothelioma, in 2 of them lasting 13.4 months (peritoneal mesothelioma) and 14.3 months (prostate cancer).

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PR and 3 of the 4 long lasting disease stabilizations were obtained at the recommended Phase 2 dose (RP2D) of 80 mg/m2/day
plus 1000 mg/m2/day gemcitabine, supporting development of combination therapies with Milciclib in advanced cancer patients.

Results
of trial CDKO-125a-004 were published: S. Aspeslagh et.al. Cancer Chemother. Pharmacol (2017) 79: 1257-1265

Phase
2 Development

Trial Patient
Population
Treatment Schedule / Dosing Key
Findings
CDKO-125a-005

Malignant
pleural mesothelioma

38
patients

150
mg/day orally

administered
for 7 consecutive days every 14 days in 2-week cycles

Pharmacokinetics:

Plasma
levels of Milciclib were comparable to those previously obtained in the Phase 1 study CDK0-125a-001 at the same dosage
and with the same schedule, confirming the reliability of the pharmacokinetic profile of the compound.

Clinical
observations:

No
objective responses were reported; prolonged SDs were observed in 2 patients, lasting 8.9 months and 8.7 months, respectively.

CDKO-125a-006

Trial
cutoff: 1/9/2017

Malignant
B3 thymoma / thymic carcinoma

72
patients

Single
agent (flat dose)

150
mg once daily

7days
on/7days off q2wks

Clinical
Observations:

Treatment
with Milciclib met the primary endpoint of PFS at 3 months (PFS-3). 56 of 72 treated patients had median PFS of 5.78 months
with upper and lower 95% confidence limits of 3.48 months and 7.89 months, respectively. The secondary endpoint, OS, was
also met in this trial. 36 of 72 patients (50%) had median OS of 24.44 months with upper and lower 95% confidence limits
of 22.05 and 54.55 months, respectively. Five patients from this study are continuing treatment with Milciclib.

CDKO-125a-007

Trial
cutoff: 1/9/2017

Malignant
B3 thymoma / thymic carcinoma

30
patients

Single
agent (flat dose)

150
mg once daily

7days
on/7days off q2wks

Clinical
Observations:

Treatment
with Milciclib met the primary endpoint of PFS-3. 18 of 30 patients had median PFS of 5.65 months with upper and lower
95% confidence limits of 3.94 months and 17.45 months, respectively. The secondary endpoint, OS, was met in this trial.
18 of 30 treated patients (54.5%) had OS of 48 months. Upper and lower 95% confidence limits could not be calculated because
the median survival probability was not reached.

Trial Patient
Population
Treatment Schedule / Dosing Key
Findings
CDKO-125a-010 Recurrent
or metastatic unresectable HCC

Single
agent (flat dose)

100
mg once daily

4days
on/3days off x 4 wks q4 wks

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trial successfully met the primary endpoint that oral treatment with Milciclib was well tolerated with manageable toxicities and
no recorded drug related deaths.

●   The
secondary endpoints for clinical activity assessment were based on the independent radiological review using the modified
Response Evaluation Criteria in Solid Tumors (mRECIST)

●    Positive demonstrated clinical activity included:

1.   50% (14 out of 28) evaluable patients completed 6-month duration of the trial.

2.   64% (9 out of 14) patients requested and were approved by their respective ethical committees to continue the treatment.

3.   Both median time to progression (TTP) and progression free survival (PFS) were 5.9 months (95% Confidence Interval (“CI”)
1.5-6.7 months) out of the 6-months duration of the trial.

4.   Approximately 57% of evaluable patients showed ’Stable Disease’ (SD; met at least once in an 8-week interval) and 3.6%
patients showed ‘Partial Response’ (PR).

5.   Approximately
61% of patients showed ‘Clinical Benefit Rate’ defined as CBR=CR+PR+SD (with CR representing Complete Remission).

6.   Five patients on compassionate use continued the treatment for a total of 9, 9, 11, 13 and 16 months, respectively. Two
patients continuing the treatment have reached 16 months.

Fonte:
Milciclib Investigators Brochure version 14

Safety

Complessivamente,
Milciclib has indicated a similar pattern of toxicity across studies. Consistent with preclinical findings, the safety profile
of the compound in humans is characterized by a dose-limiting neurological toxicity and, to a lesser extent, by GI toxicity. Asthenia
(weakness) and fatigue have also been observed, as well as effects on liver, especially with prolonged schedules of administration.
Mild/moderate tremors are a common finding, reported also at recommended Phase 2 doses (RP2Ds) (only one case of grade 3), whereas
ataxia (loss of muscle control and balance) was observed primarily during the first dose-escalation study (one case of grade 3
ataxia occurred also at the RP2D in the combination study CDKO-125a-004 and one in CDKO-125a-006 trial). Both tremor and ataxia
were generally reversible in all cases in up to 7-9 days, upon drug discontinuation or dose reduction in some cases. Grade 1-2
dizziness was also reported, with only one grade 3 occurrence, overall. Mild dysgeusia (disorder of sense of taste) is another
event that was reported across studies, as well as headache and anorexia (loss of appetite). Grade 3 myasthenia (muscle weakness)
was also reported in two patients. Nausea and/or vomiting and/or diarrhea were mostly of grade 1-2 in severity and were manageable
with appropriate therapy. Diarrhea was occasionally severe, leading to dehydration in several instances. Skin disorders were also
reported across studies; the events were mainly of grade 1-2 in severity except for one case of grade 3 rash maculopapular and
one case grade 3 of erythema multiforme. Hematological toxicity was mainly represented by lymphocytes (white blood cells) decrease
and, to a lesser extent by all the other hematological parameters. Severe thrombocytopenia (decrease in number of platelets in
blood) was sporadically observed, especially at the highest doses tested and in combination with gemcitabine. Effects on liver
were dose-dependent and mainly represented by transient transaminase elevation (with bilirubin slightly less affected). ALT/AST
(liver enzymes measured to monitor liver damage) elevations were usually mild using the 7 days on / 7 days off schedule (even
if prolonged transaminases (liver enzymes) were occasionally observed). The more prolonged administrations were associated with
a more frequent and pronounced effect on liver function tests. Asymptomatic grade 3-4 lipase (a pancreatic enzyme that breaks
down fats, measured to monitor pancreatic function) elevations were sometimes reported, without clinical manifestation. No important
effects on renal function were noted.

Monitoring
of visual function was performed through visual acuity, funduscopy (ophthalmic examination of the back of the eye) and, in a subset
of studies, electroretinography examinations, or ERG. Overall, no clinically relevant abnormalities for these parameters emerged
during treatment across studies, except for ERG worsening, compared to baseline, observed in three patients, who for this reason
discontinued study treatment as per protocol, and one case of retinal detachment reported as a serious event in one patient (CDKO-125a-006
trial) and assessed as probably related to Milciclib maleate.

Our
interim review in trial CDKD-125A-010, as noted above, found Milciclib to be well-tolerated with no drug-related serious adverse
events in 6 patients with unresectable or metastatic HCC who had concluded a first cycle of treatment with Milciclib.

Phase
2 Data in Thymoma and Thymic Carcinoma

Thymomas
and thymic carcinomas are tumors that originate in epithelial cells of the thymus gland. Generally, thymoma does not spread beyond
the thymus, while thymic carcinoma, represents an aggressive cancer that metastasizes rapidly and poses treatment challenges.
Both cancers are rare, and it is estimated that together they account for ~400 cases per year in the US, or about 1.5 persons
per million diagnosed with thymoma/thymic carcinoma. Patients more often present with advanced disease, with a 5-year survival
of 30% to 50%. Standard primary treatment for patients with these types of tumors is surgical resection. Depending on tumor stage,
treatment options include the use of radiation therapy and chemotherapy with or without surgery. First line of chemotherapy treatment
is the combination of cisplatin, doxorubicin and cyclophosphamide for thymoma. For thymic carcinoma the first line of treatment
is the combination of paclitaxel and carboplatin.

Milciclib
met its primary endpoints in two Phase 2 clinical trials in patients with thymic carcinoma and thymoma. Clinical trials, CDKO-125A-006
(72 patients) and CDKO-125A-007 (30 patients) in patients with thymic carcinoma and thymoma, respectively, were conducted in the
US, France and Italy. Monotherapy treatment regimen with Milciclib (150mg/day; 7 days on / 7 days off) was well-tolerated. Seven
patients (5 patients in the CDKO-125A-006 study and 2 patients in the CDKO-125A-007) have been continuing treatment with Milciclib
for more than 2 years with excellent tolerance profile. Among these, 2 patients have been treated with Milciclib for approximately
5 years, demonstrating tolerability of the drug for long term treatment.

In
trial CDKO-125A-006, 56 of 72 treated patients had median PFS of 5.78 months with upper and lower 95% confidence limits of 3.48
and months, respectively. In trial CDKO-125A-007, 18 of 30 treated patients had median PFS of 5.65 months with upper and lower
95% confidence limits of 3.94 and 17.45 months, respectively. These results materially exceeded the median PFS> 10.2 weeks
established for monotherapy with pemetrexed. The OS secondary endpoint was also met in both trials. In trial CDKO-125A-006, 36
of 72 (50%) treated patients had median OS of 24.44 months with upper and lower 95% confidence limits of 22.05 and 53.55 months,
respectively. In trial CDKO-125A-007, 18 of 30 patients had an OS (54.5%) of 48 months. As a median was not reached, the 95% confidence
limits could not be calculated.

Both
clinical studies demonstrated that treatment with Milciclib met PFS as the primary endpoint and OS as a secondary endpoint.

Preclinical
Data

Il
pharmacokinetics of Milciclib were investigated in mouse, rat, dog and monkey models after single intravenous and oral administration
of the compound. Since the compound is intended for the oral administration route, the pharmacokinetics were further characterized
after single and repeated oral administrations. These preclinical studies were performed with Milciclib formulated as maleate
or mono/di/tri-hydrochloride salt. Following intravenous administration, Milciclib was characterized by a moderate clearance in
mice, rats and monkeys and a high clearance in dogs. The volume of distribution was higher than the total body water in all tested
species, suggesting an extensive tissue distribution. Following oral administration to rats and monkeys, Milciclib crossed the
blood-brain barrier and distributed in the brain. In all species, Milciclib plasma levels increased largely in direct proportion
with the dose.

Preclinical
toxicology studies conducted with Milciclib have shown that the hemolymphopoietic system, the GI tract and the male reproductive
organs are the major target organs considered related to the pharmacological activity of the compound in all species. The effects
on the hemolymphopoietic system and GI tract were reversible after drug withdrawal. Reversibility could not be demonstrated in
the male reproductive organs at the end of the 2-3-week recovery period because of the longtime of maturation of the seminiferous
epithelium. Additional toxicities, that are considered not related to the mechanism of action of the compound, were Central Nervous
System, or CNS, ocular and renal toxicities. In addition, hemorrhages in different organs were observed in dogs and monkeys. Clinical
signs of CNS toxicity were observed at high doses given as single or repeated administrations in all species.

Our
Preclinical Programs

Anti-IL6R
Fully Human mAb TZLS-501 (formerly known as NI-1201)

TZLS-501
is a fully human mAb targeting the IL-6R. We licensed the intellectual property from Novimmune in January 2017. This fully human
mAb has a novel mechanism of action, binding to both the membrane-bound and soluble forms of the IL-6R and depleting circulating
levels of the IL-6 in the blood. An excessive production of IL-6 is regarded as a key driver of chronic inflammation, associated
with autoimmune diseases such as multiple myeloma, oncology indications and rheumatoid arthritis, and we believe that TZLS-501
may have potential therapeutic value for these indications.

In
preclinical studies, TZLS-501 demonstrated the potential for overcoming the limitations of other IL-6 blocking pathway drugs.
Compared to tocilizumab and sarilumab, while binding to the membrane-bound IL-6R complex, TZLS-501 has been observed to have a
higher affinity for the soluble IL-6 receptor from antibody binding studies conducted in cell culture. TZLS-501 also demonstrated
the potential to block or reduce IL-6 signaling in mouse models of inflammation. The soluble form of IL-6 has been implicated
to have a larger role in disease progression compared to the membrane- bound form (Kallen, K.J. (2002). “The role of transsignaling
via the agonistic soluble IL-6 receptor in human diseases.” Biochimica et Biophysica Acta. 1592 (3): 323–343.).

We intend to accelerate
development and cGMP manufacturing of TZLS-501 for treatment of “cytokine storm”-induced lung damage in COVID-19 patients
by aerosol delivery to lung and for treatment of multiple myeloma patients by the parenteral route of administration

StemPrintER™

StemPrintER
is a multi-gene signature assay intended for use in patients diagnosed with estrogen-receptor positive ER+/HER2 negative breast
cancers. We believe this in-vitro prognostic test will be used in conjunction with clinical evaluation to identify those patients
at increased risk for early and/or late metastasis. StemPrintER is designed to help physicians distinguish ER+/HER2 negative patients:

with an elevated
risk of early recurrence (<5 years) who could benefit from chemotherapy in addition to hormonal therapy;

with a high risk of late recurrence who could
benefit from prolonged endocrine treatment up to 10 years; e

with a low risk of early recurrence who might
be spared chemotherapy or be eligible for less aggressive treatments.

Our diagnostic has
a novel biological basis, being based on the detection of cancer stem cell markers, uses a reliable platform (qRT-PCR, FFPE),
and has been evaluated in an initial retrospective validation study using a consecutive cohort of approximately 2400 patients
with breast cancer. Our development team is preparing for a retrospective validation study using an independent cohort and has
conducted a pre-submission meeting with the FDA., Studies have been completed evaluating the prognostic capabilities of StemPrintER
compared to competing technologies in large cohorts of ER+/HER2 negative patients. The results demonstrated the superiority of
StemPrintER stem cell based genomic prognostic tool versus the market leader, Oncotype DX, in predicting recurrence in ER+/HER2-
postmenopausal breast cancer patients.

Manufacturing

We
believe our current CMOs will be able to fully meet our current clinical trial needs and anticipated future commercial demand
for Foralumab, TZLS-501 and Milciclib in a cost-effective manner.

.

UN
large-scale cGMP manufacturing of Foralumab drug substance has been accomplished and we have produced sufficient purified material
for completing all clinical studies up to Phase 3. This material was produced by Lonza Group AG using a proprietary cell culture
technology. The Foralumab material is highly stable when stored at -80oC for several years. A novel and proprietary
formulation suitable for oral administration of Foralumab has been developed. We have completed cGMP manufacturing of formulated
drug product for nasal and oral routes of administration for Phase I clinical studies.

We
have also achieved cGMP manufacturing of Milciclib at pilot scale. The chemical scheme for manufacturing is well characterized
with reproducible yields. This method has been used for producing drug substance to supply the ongoing clinical studies. The chemical
process is very cost-effective and can be scaled-up for much larger scale needed for commercialization.

Competition

Il
biotechnology and pharmaceutical industries are characterized by rapidly changing technologies, significant competition and a
strong emphasis on intellectual property. We face substantial competition from many different sources, including large and specialty
pharmaceutical and biotechnology companies, academic research institutions, government agencies and public and private research
institutions.

We
are aware of a number of companies focused on developing therapies in various indications. Any advances made by a competitor may
be used to develop therapies that could compete against any of our product candidates.

For
our specific product candidates, the main competitors include:

Sorafenib and Lenvatinib
are currently the standards of use therapy for HCC but the drugs exhibit severe toxicities and patients often develop resistance
to the treatment with Sorafenib. As a result, there is an immediate need for improvement in treatment for HCC.

We believe that
Foralumab is currently the only fully human anti-CD3 mAb in clinical development for treatment of Crohn’s disease, progressive
MS and other autoimmune and inflammatory diseases.

Many
of our potential competitors, alone or with their strategic partners, have substantially greater financial, technical and other
resources than we do, such as larger R&D, clinical, marketing and manufacturing organizations. Mergers and acquisitions in
the biotechnology and pharmaceutical industries may result in even more resources being concentrated among a smaller number of
competitors. Our commercial opportunity could be reduced or eliminated if competitors develop and commercialize products that
are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive than any products
that we may develop. Competitors also may obtain FDA or other regulatory approval for their products more rapidly than we may
obtain approval for ours, which could result in our competitors establishing a strong market position before we are able to enter
the market. Additionally, technologies developed by our competitors may render our potential product candidates uneconomical or
obsolete, and we may not be successful in marketing our product candidates against competitors.

Intellectual
Property

We
strive to protect and enhance the proprietary technologies, inventions and improvements that we believe are important to our business,
including seeking, maintaining and defending patent rights, whether developed internally or licensed from third parties. Our policy
is to seek to protect our proprietary position by, among other methods, pursuing and obtaining patent protection in the United
States and in jurisdictions outside of the United States related to our proprietary technology, inventions, improvements, platforms
and our product candidates that are important to the development and implementation of our.

As
of February 6, 2020 our intellectual property portfolio was made up as follows:

We
have rights to a patent family that discloses the Milciclib compound, methods of using the compound, and processes for making
the compound under license from Nerviano (which is further described below). This patent family includes five granted U.S. patents,
one granted European patent, and one granted Eurasian patent. This patent family also includes granted patents in Africa (African
Intellectual Property Organization, African Regional Intellectual Property Organization), Algeria, Argentina, Australia, Barbados,
Bosnia & Herzegovina, Canada, Colombia, Costa Rica, Croatia, Cuba, Ecuador, Georgia, Iceland, India, Indonesia, Israel, Japan,
Korea, Kosovo, Malaysia, Mexico, Mongolia, Montenegro, New Zealand, Nicaragua, Norway, Pakistan, Philippines, Serbia, Singapore,
South Africa, Sri Lanka, Taiwan, Tunisia, Ukraine, Uzbekistan, and Vietnam. Several applications are pending in the U.S. and other
countries in this family. The patents in this family will expire in April 2024, excluding any patent term adjustment and patent
term extension in the U.S. and similar regulatory extensions available in several other jurisdictions, such as Europe.

We
also have rights to a second patent family which covers related entities, such as salts and crystal forms, of Milciclib, and methods
of using the salts and crystal forms. This patent family comprises one granted U.S. patent and one granted patent in each of Europe,
China, Japan, and Hong Kong. The patents in this family will expire in April 2030, excluding any patent term adjustment and patent
term extension in the U.S. and several other jurisdictions, such as Europe.

In
addition, we have rights to five patent families which cover methods of using Milciclib in the treatment of multiple indications.
These patent families comprise five granted U.S. patents, and granted patents in Europe, China, Hong Kong, and Japan, and one
pending patent application in Europe. The patents in these families will expire between February 2027 and March 2030, excluding
any patent term adjustment and patent term extension in the U.S. and similar regulatory extensions available in several other
jurisdictions, such as Europe.

Among
the above five patent families, two families also cover combination therapies of Milciclib with cytotoxic agents. These families
comprise two granted U.S. patents, and granted patents in Europe, China, Hong Kong, and Japan. The patents in these families will
expire between November 2029 and March 2030, excluding any patent term adjustment and patent term extension in the U.S. and similar
regulatory extensions available in several other jurisdictions, such as Europe.

One
family of the above five patent families also covers combination therapies of Milciclib with therapeutic antibodies. This patent
family includes one granted U.S. patent, and granted patents in Europe, China, and Japan. The patents in this family will expire
in February 2027, excluding any patent term adjustment and patent term extension in the U.S. and similar regulatory extensions
available in several other jurisdictions, such as Europe.

In
addition, we have rights to a patent family which covers methods of using Milciclib together with a second anti-cancer agent in
the treatment of cancer. This patent family includes one pending application in the U.S and one pending international application.
The patent applications in this family, if issued as patents, will expire in December 2038, excluding any patent term adjustment
and patent term extension in the U.S. and similar regulatory extensions available in several other jurisdictions, such as Europe.

We
have rights to a first patent family that disclose methods of using Foralumab, licensed from Novimmune (which is further described
below). This patent family includes, one granted European patent, and one granted Eurasian patent. This patent family also includes
granted patents in Australia, Canada, China, Hong Kong, Israel, Japan, Mexico, Norway, Singapore, South Africa, Ukraine, and Portugal.
The patents in this family will expire in April 2025, excluding any patent term extensions available in several jurisdictions,
such as Europe.

We
also have rights to a second patent family that discloses the Foralumab compound and methods of using the compound also licensed
from Novimmune. This patent family comprises three granted U.S. patent one granted European patent, and one granted Eurasian patent.
This patent family also includes granted patents in Australia, Canada, China, Hong Kong, India, Israel, Japan, Mexico, Norway,
Republic of Korea, Singapore, South Africa, and Ukraine. Applications are pending in Brazil, Japan, Singapore and U.S. The patents
in these families will expire in June 2025, excluding any patent term adjustment in the U.S. and patent term extensions available
in the U.S. and several other jurisdictions, such as Europe.

In
addition, we have rights to a third patent family that discloses combination therapies of Foralumab with Il-6 or IL-6R antibodies
licensed from Novimmune. This patent family has one pending U.S. application. The patents in these families will expire in January
2032, excluding any patent term adjustment and patent term extensions available in the U.S.

We
own and have right to a forth patent family that discloses formulations of Foralumab and dosing regimens for treating various
disorders. This patent family has applications pending in the U.S, Australia, Canada, China, Europe, Israel and Japan. The patents
in these families will expire in August 2037, excluding any patent term adjustment and patent term extensions available in the
U.S and several other jurisdictions

We
have rights to a patent family that discloses methods of using TZLS-501 to treat various disorders, licensed from Novimmune. Questo
patent family includes, four granted U.S. patents and one granted European patent. This patent family also includes granted patents
in Australia, Canada, China, Japan and Mexico. Applications are pending in U.S. and India. The patents in this family will expire
in May 2029, excluding any patent term extensions available in several jurisdictions, such as Europe.

Individual
patents extend for varying periods depending on the date of filing of the patent application or the date of patent issuance and
the legal term of patents in the countries in which they are obtained. Generally, patents issued for regularly filed applications
in the United States are granted a term of 20 years from the earliest effective non-provisional filing date. In addition, in certain
instances, a patent term can be extended to recapture a portion of the USPTO delay in issuing the patent as well as a portion
of the term effectively lost as a result of the FDA regulatory review period. However, as to the FDA component, the restoration
period cannot be longer than five years and the total patent term including the restoration period must not exceed 14 years following
FDA approval. The duration of foreign patents varies in accordance with provisions of applicable local law, but typically is also
20 years from the earliest effective filing date. However, the actual protection afforded by a patent varies on a product by product
basis, from country to country and depends upon many factors, including the type of patent, the scope of its coverage, the availability
of regulatory-related extensions, the availability of legal remedies in a particular country and the validity and enforceability
of the patent.

Furthermore,
we rely upon trade secrets and know-how and continuing technological innovation to develop and maintain our competitive position.
We seek to protect our proprietary information, in part, using confidentiality agreements with our collaborators, employees and
consultants and invention assignment agreements with our employees. We also have confidentiality agreements or invention assignment
agreements with our collaborators and selected consultants. These agreements are designed to protect our proprietary information
and, in the case of the invention assignment agreements, to grant us ownership of technologies that are developed through a relationship
with a third party. These agreements may be breached, and we may not have adequate remedies for any breach. In addition, our trade
secrets may otherwise become known or be independently discovered by competitors. To the extent that our collaborators, employees
and consultants use intellectual property owned by others in their work for us, disputes may arise as to the rights in related
or resulting know-how and inventions.

Our
commercial success will also depend in part on not infringing upon the proprietary rights of third parties. It is uncertain whether
the issuance of any third-party patent would require us to alter our development or commercial strategies, or our product candidates
or processes, obtain licenses or cease certain activities. Our breach of any license agreements or failure to obtain a license
to proprietary rights that we may require to develop or commercialize our future product candidates may have an adverse impact
on us. If third parties have prepared and filed patent applications prior to March 16, 2013 in the United States that also claim
technology to which we have rights, we may have to participate in interference proceedings in the USPTO, to determine priority
of invention. For more information, see “Risk Factors—Risks Related to Our Intellectual Property.”

Material
Agreements

Nerviano
Agreement

In
January 2015, we entered into an agreement with Nerviano, or the Nerviano Agreement, pursuant to which we obtained a worldwide,
exclusive license to patents owned or controlled by Nerviano, or the Nerviano License to develop and commercialize products and
services incorporating Milciclib as an active ingredient, and any product or service controlled or owned by Nerviano that is used
to diagnose or assess responsiveness to Milciclib therapy or dosage. The Nerviano License confers the right on us grant sub-licenses,
and otherwise to employ third party manufacturers and distributors to produce and sell licensed products and services.

Each
party to the Nerviano Agreement agreed to a development plan, or the Nerviano Development Plan, approved by a joint development
committee, or the JDC. The JDC is comprised of at least two members of each party, meets at least twice a year and endeavors to
make decisions by consensus, save that where there is a disagreement with respect to any aspect of the licensed products or services
we shall have a deciding vote.

Under
the Nerviano Development Plan, we (or, as the case may be, our sub-licensee(s)) are obliged to use commercially reasonable efforts
to develop and commercialize a licensed product or service in at least one therapeutic indication that arises out of the Nerviano
Development Plan, and Nerviano is obliged to use commercially reasonable efforts to manufacture such product(s) or service(s).
Pursuant to the Nerviano Development Plan, we have sole responsibility for costs for further clinical development and Nerviano
is obliged to perform Phase 2 studies of licensed products and services, save that the amounts to be invoiced by Nerviano to us
for Phase 2 studies shall be commercially reasonable and not be greater than a low-double-digit percentage in excess than amounts
estimated to be invoiced by another reputable clinical research organization.

During
the term of the Nerviano Development Plan, or the Nerviano Exclusivity Period, we and our affiliates may not, directly or indirectly,
develop, make, use, sell, offer for sale or import any small molecule compound or other biological or chemical molecule other
than Milciclib that directly binds to, with an affinity indicated by an IC50 of 100nM or less, and modulates the following specified
pharmacological targets hit by Milciclib: Cdk-2, Cdc-4 and Cdc6.

Upon
entry into the Nerviano Agreement, we paid an upfront, non-refundable initial license fee of $3,500,000 to Nerviano. We issued
4,233,616 of ordinary shares, fully paid with a nominal value of three pence each, or the Consideration Shares, to Nerviano at
an issue price of 50.5 pence (equivalent to an aggregate value of £2,137,976.08).

Nerviano
granted us an option, or the Nerviano Option, to buy-back all the Consideration Shares for a de minimis aggregate consideration
exercisable on written notice at any time after the earlier of:

(i) an unsuccessful
Phase 2 trial for HCC or breast cancer with a licensed product or service and the concomitant decision of the company, our
affiliates or sub-licensees to discontinue development of a licensed product or service;

(ii) the fifth anniversary
of the Nerviano Agreement, (provided that if on such date a Phase 2 trial has commenced but has not been completed our ability
to exercise the Nerviano Option shall be delayed until the outcome of the Phase 2 trial has become clear); o

(iii) our abandonment of any licensed product or service
for bona fide scientific reasons.

The Nerviano Option
cannot be exercised if any of the following events (each, a Release Event), occurs:

(i) un'
successful completion of a Phase 2 trial for HCC or breast cancer with a licensed product or service, where such successful
conclusion renders the licensed product or service eligible for entry into a Phase 3 trial with no further clinical study;
o

(ii) our abandonment
of the development of, or failure to exercise commercially reasonable efforts develop any, licensed product or service, save
for where we have bona fide scientific reasons.

The Nerviano Option
effectively allows us to recover the Consideration Shares if it transpires that Milciclib proves to be unsuccessful in the indications
for which we licensed it or we fail to see satisfactory results in a period of 5 years from the date of the license agreement.

Prior to a Release
Event, Nerviano has agreed to not transfer, dispose of, or grant options or other rights over directly or indirectly any interests
in the Consideration Shares nor to derive any financial benefit from the Shares, but is entitled to exercise all voting rights
arising from the Consideration Shares.

Following a Release
Event, Nerviano has agreed to a 12 month lock-up, or the Nerviano Lock-Up, in respect of the Consideration Shares, subject to
customary exceptions, including the prior written consent of the company and our nominated adviser from time to time (which consent
may be approved, provided or provided subject to conditions as each may determine in its absolute discretion), acceptance of takeover
bids, share buy-backs by the company, or where required by law.

Following the lapse
of the term of the Nerviano Lock-Up, Nerviano has agreed to not directly or indirectly, transfer, sell, mortgage, charge or otherwise
dispose of more than 10% of the Consideration Shares (i.e. 423,362 ordinary shares) per calendar month, and to utilize the company’s
broker from time to time to execute those transactions in respect of the legal and or beneficial ownership or any other interest
in the Consideration Shares so as to ensure an orderly market.

We are obligated to
pay Nerviano the following additional amounts in respect of the first licensed product or service which achieves the stated development
milestones:

(a) $100,000
upon initiation, first patient dosed, or FPD, of the first Phase 3 registration trial in thymic carcinoma.

(b) $4,000,000
upon FPD of the first Phase 3 registration trial in HCC.

(c) $6,000,000
upon FPD of the first Phase 3 registration trial in breast cancer.

(d) Upon
the first NDA equivalent in: thymic carcinoma, $900,000; HCC, $9,000,000; breast cancer, $15,000,000.

We are obliged to
pay Nerviano a low-single-digit percentage royalty fee of the annual net sales of licensed products or services, subject to certain
royalty off-sets on a country-by-country basis and, subject to certain exclusions, a low-double-digit percentage of sub-licensing
revenues from the sale of licensed products or services for the life of the licensed patents.

During the Nerviano
Exclusivity Period, we have the right to terminate activities and funding to Nerviano after 24 months from the beginning of the
Nerviano Exclusivity Period but not prior thereto. If we exercise our termination right, we are obliged to transfer to Nerviano
all relevant data, licensed products and services and an exclusive license pertaining to the licensed product or services, and
Nerviano shall pay us a low-single-digit percentage royalty on annual net sales of licensed products and services, subject to
certain exceptions.

Following the expiry
of the Nerviano Exclusivity Period, we may terminate the Nerviano Agreement at any time on 90 days’ written notice, and
either party may terminate the Nerviano Agreement for material breach by the other party of any material obligation or condition
of the Nerviano Agreement by written notice, subject to a 45 day cure period for a payment breach, and a 120 day cure period for
any other breach.

Absent early termination,
the Nerviano Agreement shall remain in force until the later of, in all countries in which licensed products and services are
marketed pursuant to the Nerviano Agreement, (a) the expiration of the last claim in an issued, unexpired patent within the licensed
patents, subject to certain exceptions, which covers the sale of such licensed products or services, or (b) five years from the
date of first commercial sale of such licensed product or service in such country.

Novimmune CD3 Agreement

In December 2014,
we entered into a license and sublicense agreement with Novimmune, or the Novimmune CD3 Agreement, pursuant to which we obtained
a worldwide, exclusive license to certain patents owned or controlled by Novimmune, or the Novimmune CD3 License, together with
a sublicense to certain patent licenses from Bristol-Myers Squibb Company, or BMS, or the BMS CD3 Sublicense, and any associated
know-how, biologic materials, clinical data or other technology relating to CD3 receptor mAbs and their use in order to research,
develop and commercialize products and services. The Novimmune CD3 License and BMS CD3 Sublicense both confer the right to us
to grant sublicenses, and otherwise to employ third party manufacturers and distributors to produce and sell licensed products
and services, respectively.

Pursuant to the Novimmune
CD3 Agreement, Novimmune granted the BMS CD3 Sub-License to us. Novimmune effected such grant pursuant to a research and commercialization
agreement between Novimmune and BMS dated September 20, 2014, or the BMS R&C Agreement, and the agreement for the exclusive
commercial license for the CD3 licensed product (NI-0401) between Novimmune and BMS dated February 2005.

Under the Novimmune
CD3 Agreement, we have full control and authority over the research, development and commercialization of licensed products and
services, and are required to exercise commercially reasonable efforts to commercialize such licensed products and services at
all times.

Upon our entry into
the Novimmune CD3 Agreement we paid an upfront fee of $750,000 to Novimmune (to be on paid by Novimmune to BMS pursuant to the
terms of the BMS R&C Agreement), and a further upfront fee of $500,000 to Novimmune. We are required to pay Novimmune installments
of $250,000 on each of the 14 month, 26 month and 38 month anniversaries of the date of the Novimmune CD3 Agreement. For the term
of the Novimmune Agreement, we are obligated to pay to Novimmune a royalty of a low-single-digit percentage on net sales of licensed
products and services, together with any amounts owed to BMS incurred pursuant to the BMS CD3 Sub-License.

We may terminate the
Novimmune CD3 Agreement at any time on 90 days’ written notice, and either party may terminate the Novimmune CD3 Agreement
by written notice for a payment breach or any other breach, subject to 45 day and 120 day cure periods, respectively. Absent early
termination, the Novimmune CD3 Agreement will continue until the later of, in all countries in which licensed products are marketed
pursuant to the Novimmune CD3 Agreement, (a) the expiration of the last claim in an issued, unexpired patent within the licensed
patents or a claim that has not been pending more than five years, subject to certain exceptions, which covers the sale of such
licensed product or service, or (b) the end of any market exclusivity period granted by the relevant governmental authority in
a country that prevents another party from marketing the same licensed product or service.

Novimmune IL-6r Agreement

In December 2016,
we entered into a license and sublicense agreement with Novimmune, or the Novimmune IL-6r Agreement, pursuant to which we obtained
a worldwide, exclusive license to certain patents owned or controlled by Novimmune, or the Novimmune IL-6r License, together with
a sub-license to certain patent licenses from BMS, or the BMS IL-6r Sub-License, and any associated know-how, biologic materials,
clinical data or other technology relating to IL-6r mAbs and their use in order to research, develop, commercialize products and
services. The Novimmune IL-6r License and BMS IL-6r Sub-License both confer the right to us to grant sub-licenses, and otherwise
to employ third party manufacturers and distributors to produce and sell licensed products and services, respectively.

Pursuant to the Novimmune
IL-6r Agreement, Novimmune granted the BMS IL-6r Sub-License. Novimmune effected such grant pursuant to the BMS R&C Agreement
and the agreement for the IL-6r exclusive commercial license for the IL-6r antibody licensed product (NI-1201) between Novimmune
and BMS dated September 20, 2009, or the IL-6r Commercial License Agreement.

Under the Novimmune
IL-6r Agreement, we have full control and authority over the research, development and commercialization of licensed products
and services, and are required to exercise commercially reasonable efforts to commercialize such licensed products and services
at all times.

Upon our entry into
the Novimmune IL-6r Agreement we paid an upfront fee of $100,000 to Novimmune. For the term of the Novimmune IL-6r Agreement,
we are obligated to pay to Novimmune a royalty of a low-single-digit percentage on net sales of licensed products and services,
or low-double-digit percentage of any sub-license royalty revenue which we receive that arises from sales of licensed products
and services, together with any amounts owed to BMS incurred pursuant to the BMS IL-6r Sub-License.

The BMS R&C Agreement
and the IL-6r Commercial License Agreement were amended pursuant to an agreement between Novimmune and BMS dated December 2016,
or the Novimmune Amendment Agreement. Pursuant to the Novimmune Amendment Agreement, in the event that Novimmune (or, as the case
may be, a sublicensee) commercializes a combination product comprising NI-1201 and NI-0401, then such product shall be subject
to a single royalty.

We may terminate the
Novimmune IL-6r Agreement at any time on 90 days’ written notice, and either party may terminate the Novimmune IL-6r Agreement
by written notice for a payment breach or any other breach, subject to 45 day and 120 day cure periods, respectively. Absent early
termination, the Novimmune IL-6r Agreement will continue until the later of, in all countries in which licensed products are marketed
pursuant to the Novimmune IL-6r Agreement, (a) the expiration of the last claim in an issued, unexpired patent within the licensed
patents or a claim that has not been pending more than five years, subject to certain exceptions, which covers the sale of such
licensed product or service, or (b) the end of any market exclusivity period granted by the relevant governmental authority in
a country that prevents another party from marketing the same licensed product or service.

Brigham and Women’s Hospital
License

On May 29, 2018, we
entered into a license agreement, or the BWH License, with BWH pursuant to which we obtained a worldwide exclusive license to
a patent owned by BWH for a novel technology discovered by Dr. Howard Weiner. The patent relates to a formulation of Foralumab
in a medical device developed for nasal administration of Foralumab. The BWH License extends to any associated know-how, clinical
data and use in order to research, develop and commercialize products and services. The BWH License confers on us the right to
grant sub-licenses, and otherwise to employ third party manufacturers and distributors to sell licensed products and services.

Under the BWH License
we have full control and amnesty over the research, development and commercialization of licensed products and services and are
required to exercise commercially reasonable efforts to commercialize such licensed products and services at all times.

Upon our entry into
the BWH License we paid an upfront fee of $10,000 to BWH. We are required to pay annual maintenance fees, all ongoing patent maintenance
and prosecution costs and a low single-digit royalty on annual net sales (and a 12% royalty of non-royalty sub-license revenues
for the life of the intellectual property). We are also obliged to make certain milestone payments of: (a) US$300,000 within 60
days of first patient enrolled in a Phase 1 human clinical trial; (b) US$600,000 within 60 days of first patient enrolled in a
Phase 2 human clinical trial; (c) US$1,500,000 within 60 days of first patient enrolled in a Phase 3 clinical trial; and (d) US$3,000,000
within 60 days of first commercial sale of a licensed product.

We may terminate the
BWH License at any time on 90 days’ written notice, and either party may terminate the BWH License by written notice for
payment or other breach, subject to a 60 day cure period. Absent early termination the BWH License will remain in effect until
the date on which all patents and filed patent applications have expired or been abandoned.

C. Organizational Structure

The following table sets out details of the Company’s
significant subsidiaries:

Name Principal activity Registered address Percentage
shareholding
Country of
incorporation
Tiziana Pharma Limited Clinical stage biotechnology company 3rd
Floor, 11-12 St
James’s Square,
London, SW1Y 4LB
100 % England & Wales
Tiziana Therapeutics Inc. Clinical stage biotechnology company 420 Lexington Avenue
Suite 2525
New York, NY 10170
100 % USA
Longevia Genomics S.r.l. Biotechnology discovery company Via Constantinopli 42
09100- Cagliria (CA)
100 % Italy

D. Property, Plant and Equipment

The below table contains
information regarding existing or planned material tangible fixed assets owned or leased by Tiziana and its subsidiaries. We believe
that suitable additional or substitute space will be available as needed to accommodate any future expansion of our operations.

Location Tenure Principal
Use
Size
55 Park Lane, Suite 14a,
London W1K 1NA, United
Kingdom
Annual Lease Principal Office 652 square feet
420 Lexington Avenue
Suite 2525
New York, United States
Five year lease Principal Office 3,011 square feet
3805 Old Easton
Road, Doylestown,
PA, United States
Annual lease Research & Development Centre 408 square feet

ITEM 4A: UNRESOLVED STAFF COMMENTS

Not applicable.

ITEM 5: OPERATING AND FINANCIAL REVIEW AND PROSPECTS

You should read
the following discussion and analysis of our financial condition and results of operations together with “Selected Consolidated
Financial Data” and our consolidated financial statements and the related notes thereto appearing at the end of this Annual
Report. We present our consolidated financial statements in U.S. dollars and in accordance with International Financial Reporting
Standards, or IFRS, as issued by the International Accounting Standards Board, or IASB.

Some information
included in this discussion and analysis, including statements regarding industry outlook, our expectations regarding our future
performance, liquidity and capital resources and other statements regarding our plans and strategy for our business and related
financing, are forward-looking statements. These forward-looking statements are subject to numerous risks and uncertainties. You
should read the “Risk Factors” section of this Annual Report for a discussion of important factors that could cause
actual results to differ materially from the results described in or implied by the forward-looking statements contained in the
following discussion and analysis.

We maintain our
books and records in Pounds Sterling, and we prepare our financial statements in accordance with IFRS as issued by the IASB. We
report our financial results in U.S. dollars.

Overview

Introduction to Tiziana

We are a biotechnology
company that is focused on the discovery and development of novel molecules and related diagnostics to treat high unmet medical
needs in oncology and immunology. Our lead product candidate in immunology is Foralumab (TZLS-401), which we believe is the only
fully human anti-CD3 monoclonal antibody, or mAb, in clinical development. MAbs represent a single pure antibody produced by single
clones and are an important class of human therapeutics for treating cancers and autoimmune diseases. Generation of antibodies
for use in humans developed in animals, leads to strong, immune responses limiting their effectiveness and potentially leading
to severe side effects. A process known as “humanization” removes most of the animal components of the antibody thereby
lowering the immune response from the human immune system. The entire omission of other animal material, as in fully human antibodies,
is the optimal goal to avoid incompatibility with the human immune system. Our lead product candidate in oncology is Milciclib
(TZLS-201), which is an orally bioavailable, small molecule broad spectrum inhibitor of cyclin-dependent kinases, or CDKs, and
Src family kinases. CDKs are a highly conserved family of enzymes that phosphorylate a specific group of proteins that are involved
in regulating the cell cycle. The cell cycle is a series of events that takes place in cells leading to division and duplication
of its DNA to produce two daughter cells. Src family kinases are non-receptor tyrosine kinase proteins encoded by the Src gene
also involved in regulating cell growth and potential transformation of normal cells to cancer cells. We also have a drug discovery
pipeline of small molecule NCEs, and biologics. We employ a lean and virtual research and development, or R&D, model using
highly experienced teams of experts for each business function to maximize value accretion by focusing resources on the drug discovery
and development processes. Our mission is to design and deliver next generation therapeutics and diagnostics for oncology and
immune diseases of high unmet medical need by combining deep understanding of disease biology with clinical development expertise.

We are developing
Foralumab, for which we in-licensed the intellectual property from Novimmune SA, or Novimmune, in December 2014, as a potential
treatment for neurodegenerative diseases such as progressive Multiple Sclerosis (pMS) and Crohn’s disease. As the only fully
human engineered human anti-CD3 mAB in clinical development, Foralumab has significant potential advantages such as a shorter
treatment duration and reduced immunogenicity. We believe that oral or intranasal administration of Foralumab has the potential
to reduce inflammation while minimizing the toxicity and related side effects. To date, Foralumab has been studied in one Phase
1 and two Phase 2a clinical trials conducted by Novimmune in 68 patients dosed by the intravenous route of administration. In
these trials, Foralumab was observed to be safe and well-tolerated and produced immunologic effects consistent with potential
clinical benefit while demonstrating mild to moderate infusion related reactions, or IRR.With completion of the intravenous dosing
for Phase 2a trial in Crohn’s Disease, Foralumab’s ability to modulate T-cell response enables potential extension
into a wide range of other autoimmune and inflammatory diseases, such as GvHD, ulcerative colitis, multiple sclerosis, type-1
diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis

We
have completed 2 Phase 1 single-site, double-blind, placebo-controlled trials in healthy volunteers conducted at the Brigham and
Women's Hospital, Harvard Medical School, Boston, MA. The first trial was a dose-ranging study with nasally administered Foralumab
at 10, 50 and 250 µg per day, consecutively for 5 days for the treatment of progressive multiple sclerosis (pMS). Eighteen
subjects received Foralumab treatment and 9 patients received placebo. All nasal doses were well tolerated and no drug-related
safety issues were reported at any of the doses. Biomarker analysis showed significant positive immune effects, that were most
prominent in the 50
mg
cohort with minimal immunomodulatory effects at the 10 µg and 250 µg doses. A Phase 2a trial will be initiated in
Q4 2020. The second also conducted at the Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA, was a single-site,
double-blind, placebo-controlled, single ascending dose (“SAD”) study in healthy subjects in which Foralumab was orally
administered at 1.25, 2.5 and 5.0 mg per dose as enteric-coated capsules. The primary endpoint of the Phase 1 study was safety
and tolerability of Foralumab in humans. Each cohort comprised of 4 subjects, of whom 3 received Foralumab treatment and 1 received
a placebo capsule. All subjects completed the trial without any safety concerns at any of the doses.

We are developing
Milciclib, for which we in-licensed the intellectual property from Nerviano, in January 2015, as a potential treatment for HCC.
A novel feature of Milciclib is its ability to reduce levels of microRNAs, miR-221 and miR-222. MicroRNAs are small RNA molecules
that play a significant role in the regulation of gene expression. miR-221 and miR-222 are believed to be linked to the development
of blood supply in cancer tumors. Levels of these microRNAs are consistently elevated in HCC patients and may contribute towards
resistance to treatment with Sorafenib, a multikinase inhibitor (a drug which may inhibit the cellular division and proliferation
associated with certain cancers) often prescribed to HCC patients as the Standard of Care. To date, Milciclib has been studied
in a total of eight completed Phase 1 and Phase 2 clinical trials in a total of 316 patients conducted by Nerviano. In these trials,
Milciclib was well-tolerated with minimal adverse events. The last Phase 2a trial was initiated as a monotherapy in patients with
HCC in the fourth quarter of 2017 and successfully completed in June 2019. The trial met primary and secondary end points. A Phase
2b trial for Milciclib in combination with a tyrosine kinase inhibitor (Sorafenib or Regorafenib) in patients with HCC is anticipated
to be initiated in 2021.

Cumulative Patient
Exposure in Completed Milciclib Clinical Studies:

Clinical Study Drug Indication Number of
Patients Treated
CDKO-125a-001 Phase 1 Milciclib Solid tumors 37
CDKO-125a-002 Phase 1 / Phase 2 Milciclib Malignant glioma (Phase 1)
Glioblastoma (Phase 2)
62
CDKO-125a-003 Phase 1 Milciclib Solid tumors 30
CDKO-125a-004 Phase 1 Milciclib + gemcitabine Solid tumors 16
CDKO-125a-005/-0061/-0071 Phase 2 Milciclib Malignant Pleural Mesothelioma (-005)
Thymic carcinoma and malignant thymoma (-0061 and
-0071)
140
CDKO-125a-010 Phase 2 Milciclib HCC monotherapy 31
Total Patients Exposed 316

Source: Development Safety Update Report
No. 8, February 28, 2019, Tiziana Life Sciences PLC; Investigator Brochure, Version 14, 2019.

Since our inception
in March 2014, we have devoted substantially all our resources to conducting preclinical studies and clinical trials, organizing
and staffing our company, business planning, raising capital and establishing our intellectual property portfolio. We do not have
any products approved for sale and have not generated any revenue from product sales. We have funded our operations to date primarily
with proceeds from the sale of ordinary shares. Through December 31, 2018, we had received net cash proceeds of $39.7 million
from sales of our ordinary shares, issuance of convertible loans, short term loans and warrants.

Since our inception,
we have incurred operating losses. Our net loss after taxation was $8.0 million for the year ended December 31, 2018, $8.7m for
the year ended December 31, 2017 and $9.8m for the year ended December 31, 2016 respectively. As of December 31, 2018, we had
cash and cash equivalents of $5.3 million.

We expect to continue
to incur significant expenses for the foreseeable future as we advance our product candidates through preclinical and clinical
development and seek regulatory approval and pursue commercialization of any approved product candidates. In addition, if we obtain
marketing approval for any of our product candidates, we expect to incur significant commercialization expenses related to product
manufacturing, marketing, sales and distribution.

Trend information

Recent developments

In March 2019, we announced the submission of an IND to
the FDA to initiate a Phase 1 clinical trial of enteric-coated capsules of Foralumab in healthy volunteers. This Phase 1 trial,
conducted at the Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA, was a single-site, double-blind,
placebo-controlled, single ascending dose (“SAD”) study in healthy subjects in which Foralumab was orally administered
at 1.25, 2.5 and 5.0 mg per dose as enteric-coated capsules. The primary endpoint of the Phase 1 study is safety and tolerability
of Foralumab in humans. Each cohort comprised of 4 subjects, of whom 3 received Foralumab treatment and 1 received a placebo capsule.
All subjects completed the trial without any safety concerns at any of the doses.

We plan to launch a Phase 2 l clinical trial to study the potential
of the oral administration of Foralumab in Crohn’s Disease in Q2 2021.

Legal proceedings

From time to time,
we may be a party to litigation or subject to claims incident to the ordinary course of business. Although the results of litigation
and claims cannot be predicted with certainty, we currently believe that the final outcome of these ordinary course matters will
not have a material adverse effect on our business. Regardless of the outcome, litigation can have an adverse impact on us because
of defense and settlement costs, diversion of management resources and other factors. We are not currently a party to any material
legal proceedings.

Foreign currency translations

Items included in
the financial statements are measured using the currency of the primary economic environment in which the entity operates (the
functional currency). The consolidated financial statements are presented in U.S. dollars, which is our presentation currency.

Foreign currency transactions
are translated into the functional currency using exchange rates prevailing at the dates of the transactions. Foreign exchange
gains and losses resulting from the settlement of foreign currency transactions and from the translation at year-end exchange
rates of monetary assets and liabilities denominated in foreign currencies are recognized in the income statement.

The financial statements
of overseas subsidiary undertakings are translated into U.S. dollars on the following basis:

Assets and liabilities at the rate of exchange
ruling at the year-end date.

Profit and loss account items at the average
rate of exchange for the year.

Exchange differences
arising from the translation of the net investment in foreign entities, borrowings and other currency instruments designated as
hedges of such investments, are taken to equity (and recognized in the statement of comprehensive income) on consolidation.

Components of Our Results of Operations

Revenues

To date, we have not
generated any revenue from product sales and do not expect to generate any revenue from the sale of products in the near future.
If our development efforts for our product candidates are successful and result in regulatory approval, we may generate revenue
in the future from product sales.

Operating Expenses

Research and Development Expenses

R&D expenses consist
primarily of costs incurred in connection with the R&D of our product candidates and are expensed as incurred. These expenses
consist of:

expenses incurred
under agreements with CROs, CMOs, as well as investigative sites and consultants that conduct our clinical trials, preclinical
studies and other scientific development services;

manufacturing scale-up
expenses and the cost of acquiring and manufacturing materials for preclinical studies and clinical trial materials;

employee-related
expenses, including salaries, related benefits, travel and share-based compensation expense for employees engaged in R&D
functions;

costs related to compliance with regulatory
requirements;

facilities costs, depreciation and other expenses,
which include rent and utilities; e

fees for maintaining our third-party licensing
agreements.

We recognize external
development costs based on an evaluation of the progress to completion of specific tasks using information provided to us by our
service providers.

Our direct R&D
expenses are tracked on a program-by-program basis for our product candidates and consist primarily of external costs, such as
fees paid to outside consultants, CROs and CMOs in connection with our preclinical development, manufacturing and clinical development
activities. Our direct R&D expenses by program also include fees incurred under our license agreements. We do not allocate
employee costs or facility expenses, including depreciation or other indirect costs, to specific programs because these costs
are deployed across multiple programs and, as such, are not separately classified. We use internal resources primarily to oversee
the R&D as well as for managing our preclinical development, process development, manufacturing and clinical development activities.
These employees work across multiple programs and, therefore, we do not track their costs by program.

The table below summarizes
our R&D expenses incurred by program:

Year ended December 31,
2019 2018 2017 2016
Direct research and development expense by program: (in thousands)
Foralumab $ 1,750 $ 2,261 $ 1,202 $ 715
Milciclib 1,916 2,581 2,625 1,542
BCL-3 347 714
TZLS-0501 39
StemPrintER 9 166 1,201 529
Total direct research and development expense $ 3,714 $ 5,008 $ 5,375 $ 3,500
Indirect research and development expense 502 640 507
Total research and development expense $ 3,714 $ 5,510 $ 6,015 $ 4,007

R&D activities
are central to our business model. Product candidates in later stages of clinical development generally have higher development
costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical
trials and related product manufacturing expenses. As a result, we expect that our R&D expenses will increase substantially
over the next several years as we increase personnel costs and prepare for regulatory filings related to our product candidates.
We also expect to incur additional expenses related to milestone, royalty payments and maintenance fees payable to third parties
with whom we have entered into license agreements to acquire the rights related to our product candidates.

The successful development
and commercialization of our product candidates is highly uncertain. At this time, we cannot reasonably estimate or know the nature,
timing and costs of the efforts that will be necessary to complete the preclinical and clinical development of any of our product
candidates or when, if ever, material net cash inflows may commence from any of our product candidates. This uncertainty is due
to the numerous risks and uncertainties associated with development and commercialization, including the uncertainty of:

the scope, progress,
outcome and costs of our preclinical development activities, clinical trials and other R&D activities;

establishing an
appropriate safety profile with IND- and CTA-enabling studies;

successful patient
enrollment in, and the initiation and completion of, clinical trials;

the timing, receipt
and terms of any marketing approvals from applicable regulatory authorities;

establishing commercial
manufacturing capabilities or making arrangements with third-party manufacturers;

development and
timely delivery of commercial-grade drug formulations that can be used in our clinical trials and for commercial launch;

obtaining, maintaining,
defending and enforcing patent claims and other intellectual property rights;

significant and
changing government regulation;

launching commercial
sales of our product candidates, if and when approved, whether alone or in collaboration with others; e

maintaining a continued
acceptable safety profile of the product candidates following approval.

We may never succeed
in achieving regulatory approval for any of our product candidates. We may obtain unexpected results from our clinical trials.
We may elect to discontinue, delay or modify clinical trials.

General and Administrative Expenses

General and administrative
expenses consist primarily of salaries, related benefits, travel and share-based compensation expense for personnel in executive,
finance and administrative functions. General and administrative expenses also include professional fees for legal, consulting,
accounting and audit services.

We anticipate that
our general and administrative expenses will increase in the future as we increase our headcount to support our continued research
activities and development of our product candidates. We also anticipate that we will incur increased accounting, audit, legal,
regulatory, compliance, director and officer insurance costs, as well as investor and public relations expenses associated with
being a public company.

Other Income (Expense)

Other expense consists
of interest on a convertible loan note.

Taxation

The tax expense for
a period represents the total of current taxation and deferred taxation. The charges in respect of current taxation are based
on the estimated taxable profit for the relevant year. Taxable profit for the year is based on the profit as shown in the income
statement, as adjusted for items of income or expenditure which are not deductible or chargeable for tax purposes. The current
tax liability for the year is calculated using tax rates which have either been enacted or substantively enacted at the relevant
balance sheet date.

Under UK tax legislation,
small and medium entity R&D relief allows us to claim back up to 14.5% of our surrenderable losses as a tax cash credit.

A. Results of Operations

The results of operations that follow
reflect the historic periods under review and should not be taken as indicative of future performance.

Comparison of Years Ended December
31, 2019 and 2018

The following tables summarizes our results
of operations for the years ended December 31, 2019 and 2018:

Year Ended December 31,
2019 2018 (restated) Change
(in thousands)
Operating Expenses:
Research and development $ (3,714 ) $ (5,510 ) $ 1,796
General and administrative $ (6,207 ) $ (4,357 ) $ (1,850 )
Total Operating expenses $ (9,921 ) $ (9,867 ) $ (54 )
Other Income/ (Expense) (91 ) (12 ) (79 )
Tax credit 689 1,945 (1,256 )
Net Loss $ (9,323 ) $ (7,934 ) $ (1,389 )
Other comprehensive loss:
Foreign currency translation adjustment (27 ) (21 ) (48 )
Total Comprehensive (Loss)/Profit $ (9,350 ) $ (7,955 ) $ (1,341 )

Research and Development Expenses

Research and development activities were $3.7 million for the
year ended December 31, 2019 compared to $5.5 million for the year ended December 31, 2018. In the year ended December 31, 2018
the research and development activities were focused on the Milciclib and Foralumab clinical trials, which had a high cost base
associated with them. These were completed by the beginning of 2019.

General and Administrative Expenses

General and administrative expenses were $6.2 million and $4.4
million for the years ended December 31, 2019 and 2018, respectively. The increase of $1.8m is predominantly attributable to a
higher charge of the fair value of options from the prior year of $0.6m, due to a number of unvested forfeitures in the prior year,
a movement in the realized foreign currency expense of $0.6m, additional expenses due to the adoption of IFRS16 of $0.2m and an
increase in insurance expenditure of $0.2m due to additional cover for the NASDAQ listing.

Income Tax Credit

Income tax credits of $0.7 million and $1.9 million are recognized
for the years ended December 31, 2019 and 2018, respectively. The credits are obtained at a rate of 14.5% of 230% of our qualifying
research and development expenditure. The decrease in the provision is due primarily to the decrease in qualifying research and
development expenditure incurred in the year ending December 31, 2019.

Comparison of Years Ended December
31, 2018 and 2017

The following tables summarizes our results
of operations for the years ended December 31, 2018 and 2017:

Year Ended December 31,

2018

(restated)

2017 (restated) Change
(in thousands)
Operating Expenses:
Research and development $ (5,510 ) $ (6,015 ) $ 505
General and administrative $ (4,357 ) $ (4,478 ) $ 244
Total Operating expenses $ (9,867 ) $ (10,493 ) $ 749
Other Income/ (Expense) (12 ) (12 )
Tax credit 1,945 1,912 33
Net Loss $ (7,934 ) $ (8,593 ) $ 782
Other comprehensive loss:
Foreign currency translation adjustment (20 ) 61 (90 )
Total Comprehensive (Loss)/Profit $ (7,955 ) $ (8,532 ) $ 691

Research and Development Expenses

Research and development activities were $5.5 million for the
year ended December 31, 2018 compared to $6 million for the year ended December 31, 2017. In the year ended December 31, 2018 the
research and development activities were focused on the Milciclib and Foralumab projects. The slowdown in activities for StemPrinER
enabled an extra $1m to be used for the continuation of Phase 2 clinical trials in Foralumab.

General and Administrative Expenses

General and administrative
expenses were $4.4 million and $4.5 million for the years ended December 31, 2018 and 2017, respectively. Within general and administrative
expenses, there were decreases in consultancy fees of $0.2m.

Income Tax Credit

Income tax credits
of $1.9 million and $1.9 million are recognized for the years ended December 31, 2018 and 2017, respectively. The credits are
obtained at a rate of 14.5% of 230% of our qualifying research and development expenditure.

B. Liquidity and Capital Resources

Since our inception,
we have not generated any revenue and have incurred operating losses and negative cash flows from our operations. We have funded
our operations to date primarily with proceeds from the sale of ordinary shares, American Depository Shares, or ADSs, and convertible
loan notes.

As of December 31,
2019, we had cash and cash equivalents of $0.2 million.

Through December 31,
2019, we had received net cash proceeds of $1.9 million from the issuance of convertible loan notes.

Cash Flows

The following table
summarizes our cash flows for each of the periods presented:

Year ended December 31,
2019 2018 (restated) 2017
Net cash used in operating activities $ (6,796 ) $ (4,602 ) $ (7,533 )
Net cash used in investing activities (4 ) (1 )
Net cash provided by financing activities 1,680 10,091 1,542
Effect of exchange rate changes on cash and cash equivalents 16 (249 ) 254 )
Net (decrease)/increase in cash and cash equivalents $ (5,104 ) $ 5,240 $ (5,738 )

Net Cash Used in Operating Activities

Our use of cash in each of the years ended December 31, 2019,
2018 and 2017, resulted primarily from our net losses, adjusted for non-cash charges and changes in components of working capital.
Net cash used in operating activities of $6.8 million during the year ended December 31, 2019 increased by $2.2 million compared
to the year ended December 31, 2018.

Our use of cash in
each of the years ended December 31, 2018 and 2017 resulted primarily from our net losses, adjusted for non-cash charges and changes
in components of working capital. Net cash used in operating activities of $4.6 million during the year ended December 31, 2018
decreased by $3.0 million compared to the year ended December 31, 2017. The decrease in net cash used in operating activities
was primarily due to the cash inflow from the R&D taxation credit.

Net Cash Used in Investing Activities

During the year ended December 31, 2019,
we used $0.4 million of cash in investing activities for the purchases of property and equipment.

Net Cash Provided by Financing Activities

During the years ended
December 31, 2019 and 2018, net cash provided by financing activities was $1.7 million and $10.1 million, respectively, consisting
of net cash proceeds from our sale and issuance of ordinary shares and ADS’s and convertible loan notes.

During the years ended
December 31, 2018 and 2017, net cash provided by financing activities was $10.1 million and $1.5 million, respectively, consisting
of net cash proceeds from our sale and issuance of ordinary shares and ADS’s and convertible loan notes.

Funding Requirements

We expect our expenses
to increase substantially in connection with our ongoing activities, particularly as we advance the preclinical activities, manufacturing
and clinical trials of our product candidates and as we:

seek regulatory
approvals for any product candidates that successfully complete clinical trials;

establish a sales,
marketing and distribution infrastructure in anticipation of commercializing any product candidates for which we may obtain
marketing approval and intend to commercialize on our own or jointly;

hire additional
clinical, medical and development personnel;

expand our infrastructure
and facilities to accommodate our growing employee base; e

maintain, expand
and protect our intellectual property portfolio.

We believe that our
existing cash, will enable us to fund our operating expenses and capital expenditure requirements for the foreseeable future.
We have based these estimates on assumptions that may prove to be wrong, and we could utilize our available capital resources
sooner than we expect. If we receive regulatory approval for our other product candidates, we expect to incur significant commercialization
expenses related to product manufacturing, sales, marketing and distribution.

Because of the numerous
risks and uncertainties associated with research, development and commercialization of pharmaceutical product candidates, we are
unable to estimate the exact amount of our working capital requirements. Our future funding requirements will depend on and could
increase significantly as a result of many factors, including:

the scope, progress,
outcome and costs of our preclinical development activities, clinical trials and other research and development activities;

the costs, timing,
receipt and terms of any marketing approvals from applicable regulatory authorities;

the costs of future
activities, including product sales, marketing, manufacturing and distribution, for any of our product candidates for which
we receive marketing approval;

the revenue, if
any, received from commercial sale of our products, should any of our product candidates receive marketing approval;

the costs and timing
of hiring new employees to support our continued growth;

the costs of preparing,
filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual
property-related claims; e

the extent to which
we acquire technologies.

Until such time, if
ever, that we can generate product revenue sufficient to achieve profitability, we expect to finance our cash needs through equity
offerings. To the extent that we raise additional capital through the sale of equity, your ownership interest will be diluted.
If we raise additional funds through other third-party funding, collaboration agreements, strategic alliances, licensing arrangements
or marketing and distribution arrangements, we may have to relinquish valuable rights to our technologies, future revenue streams,
research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise
additional funds through equity financings when needed, we may be required to delay, limit, reduce or terminate our product development
or future commercialization efforts or grant rights to develop and market products or product candidates that we would otherwise
prefer to develop and market ourselves.

Borrowings

On October 31, 2019,
we entered into a fixed term unsecured loan agreement with existing shareholders for $1,849,782 at an interest rate of 16% per
annum to be repaid no later than 36 months after the date of the agreement.

The loans were converted into ordinary
shares in April 2020.

C. Research and Development Expenses, Patents and Licenses,
etc.

See “Item 4.B.—Intellectual
Property,” “Item 4.B.—Research and Development,” and “Item 5. Operating and Financial Review and
Prospects.”

D. Trend Information

See “Item 5. Operating and Financial
Review and Prospects—Trend Information.”

E. Off-Balance Sheet Arrangements

We did not have during the periods presented,
and we do not currently have, any off-balance sheet arrangements, as defined in the rules and regulations of the SEC.

F. Tabular Disclosure of Contractual Obligations

The following table summarizes our contractual
commitments and obligations as of December 31, 2019 and 2018.

As at December 31, 2019
(in thousands) Total Less than
1 Year
Between 1 and 5 Years More than
5 Years
Borrowings
Operating lease obligations $ 870 $ 301 $ 569
Total $ 870 $ 301 $ 569

As at December 31, 2018
(in thousands) Total Less than
1 Year
Between 1 and 5 Years More than
5 Years
Borrowings
Operating lease obligations $ 1,114 $ 423 $ 691
Total $ 1,114 $ 423 $ 691

Please refer to “Item
4.B. Business Overview” and “Item 10.C. Material Contracts” for further details.

G. Safe Harbor

This Annual Report
on Form 20-F contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E
of the Exchange Act and as defined in the Private Securities Litigation Reform Act of 1995. See the section titled “Cautionary
Statement Regarding Forward-Looking Statements”.

ITEM 6: DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES

A. Directors and Senior Management

The following table
sets forth information regarding our directors as of the date of this annual report.

Name Age Position
Gabriele Marco Antonio Cerrone MBA (2) 47 Executive Chairman
Willy Simon (3) 69 Non-Executive Director
Gregor MacRae 58

Non-Executive Director

Dr. Kunwar Shailubhai MBA (1),(2) 63 Chief Executive Officer, Chief Scientific Officer and Executive Director

(1) Remuneration
Committee member
(2) Nominating
Committee member
(3) Audit
Committee member

The following table
sets forth information regarding our senior managers as of the date of this annual report:

Name Position
Tiziano Lazzaretti Chief Financial Officer
Jules S. Jacob Senior Director, CMC & Non-Clinical Development
Dr. Vaseem A. Palejwala Director, Clinical operations

Gabriele Marco Antonio Cerrone –
Executive Chairman

Mr. Gabriele Marco
Antonio Cerrone, is the Founder of the company and has been its Executive Chairman since April 2014. Mr. Cerrone has founded nine
biotechnology companies in oncology, infectious diseases and molecular diagnostics, and has listed six of these companies on Nasdaq
and one on AIM. Mr. Cerrone co-founded Trovagene, Inc. a molecular diagnostic company and served as its co-chairman. Mr. Cerrone
was a co-founder and served as chairman of both Synergy Pharmaceuticals, Inc. and Callisto Pharmaceuticals, Inc.), and was a director
of and led the restructuring of Siga Technologies, Inc.). Mr. Cerrone co-founded FermaVir Pharmaceuticals, Inc. and served as chairman
until its merger in September 2007 with Inhibitex, Inc. Mr. Cerrone served as a director of Inhibitex, Inc. until its US$2.5bn
sale to Bristol Myer Squibb in 2012. Mr. Cerrone graduated from New York University’s Stern School of Business with a master
in business administration (MBA).

Willy Simon – Non-Executive
Director

Willy Jules Simon has
served as a Non-Executive Director of the company since November 2015. Mr. Simon has served as non-executive chairman of Bever
Holding B.V. a Dutch listed public company focused on real estate development since August 2007. Mr. Simon served as the Chief
Executive Officer of Fortis Investment Management from January 2000 to July 2002. Mr. Simon worked in banking at Kredietbank N.V.
from August 1975 to December 1983 and at Citibank London from January 1984 to December 1996 before serving as an executive member
of the board of Generale Bank NL from January 1997 to December 1999. From July 2004 until April 2012, he served as a non-executive
director of Redi & Partners Ltd., a fund of funds. Mr. Simon was previously chairman of AIM-traded Velox3 plc (formerly 24/7
Gaming Group Holdings plc), a company focused on publishing and developing gaming software for the mobile gaming industry, from
April 2012 until April 2014. Mr. Simon was a director of Playlogic Entertainment Inc., a Nasdaq listed company focused on developing,
publishing, and selling interactive software games, from December 2003 to September 2111. Mr. Simon acted as chairman of Bank Oyens
& van Eeghen from September 2102 to December 2004. Mr. Simon holds a law degree from the University of Louvain and a post-graduate
degree in European law and economics from Institut des Hautes Etudes Européennes, Strasbourg.

Gregor MacRae – Non-Executive Director

Mr MacRae is a business
adviser, who specialises in taxation and cross border solutions. Presently, Gregor is the Senior Partner of Appledore Wealth Management
LLP which is a London-based high net worth business advisory partnership. Previously, Gregor has been a director of an international
trust company which included holding the position of managing director of the taxation and private client groups. Gregor holds
a degree in Law from University of Birmingham (LLB Hons) and is a qualified Chartered Accountant (ICAEW).

Dr. Kunwar Shailubhai – Chief
Executive Officer, Chief Scientific Officer and Executive Director

Dr. Kunwar Shalilubhai
has served as Chief Executive Officer, Chief Scientific Officer and Executive Director of the company since 2008. Since April,
2017, Dr. Shailubhai has served as Chief Executive Officer of Rasna Therapeutics, Inc. Dr. Shailubhai was a co-founder of Synergy
Pharmaceuticals Inc. and served as Chief Scientific Officer from July 2008 to May 2017. From March 2004 until July 2008, Dr. Shailubhai
served as Senior Vice President, Drug Discovery of Synergy, which at that time was a subsidiary of Callisto Pharmaceuticals, Inc.
(“Synergy DE”). From May 2003 until March 2004, Dr. Shailubhai served as executive vice president, R&D of Synergy
DE. From 2001 to April 2003, Dr. Shailubhai held the position of Vice President, Drug Discovery at Synergy DE where he was chiefly
responsible for the preclinical development of its GC-C agonist program for drugs to treat colon cancer and GI inflammation. Between
1993 and 2000, he was with Monsanto Company, serving as group leader of the cancer chemoprevention group. Dr. Shailubhai previously
served as a senior staff fellow at the National Institutes of Health, and as an assistant professor at the University of Maryland.
Dr. Shailubhai received his Ph.D. in microbiology in 1984 from the University of Baroda, India, and his MBA in 2001 from the University
of Missouri, St. Louis.

Tiziano Lazzaretti – Chief
Financial Officer

Mr. Lazzaretti has
served as Chief Financial Officer of the company and Rasna Therapeutics, Inc., respectively, since March 2016. Mr. Lazzaretti
has extensive experience in the healthcare and pharmaceutical industries and joined the company from Pharmentis Srl, a spin-off
from Teva Ratiopharm, where he served as group finance director from 2011 to 2016. Mr. Lazzaretti was executive director at Alliance
Boots Healthcare, an international pharmacy-led health and beauty group. Mr. Lazzaretti held senior positions at SNIA Spa, Accenture,
and Fiat Group. Mr. Lazzaretti received his bachelor of science (BSc Hons) in accounting and finance from the University of Turin,
Italy, was awarded a master in business administration from Bocconi University, Milan and studied corporate finance at the London
Business School.

Jules S. Jacob – Senior Director,
CMC & Non-Clinical Development

Mr. Jules Jacob has
served as Senior Director of CMC and Non-Clinical Development of the company and Rasna Therapeutics, Inc., respectively, since
July 2017 and has over 25 years of drug development experience. Previously, Mr. Jacob was senior director of product development
at Aprecia Pharmaceuticals Company, a drug delivery technology platform company, from March 2009 to July 2017, where he led the
development of Spritam®, the first FDA-approved dosage form manufactured using 3-dimensional printing, and other 505(b)(2)
pipeline products. Mr. Jacob was director of formulation development at Panacos Pharmaceuticals Inc., a drug company focused on
human immunodeficiency virus, or HIV, and other major human viral diseases, from March 2007 to December 2008, where he worked on
the development of first-in-class maturation inhibitors for the treatment of HIV. Mr. Jacob was a founding scientist, director
of R&D and director of technology development at Spherics, Inc., a pharmaceutical company that engaged in developing and manufacturing
oral pharmaceutical products for CNS conditions, GI disorders, and cancer, from February 2000 to February 2007. Mr. Jacob worked
on the development of bioadhesive dosage forms for treatment of CNS disorders, through the 505(b)(2) regulatory pathway at Spherics
Inc. Mr. Jacob completed his undergraduate degree and graduate education in biological and medical sciences at Brown University
and has an active visiting faculty appointment in the Department of Molecular Pharmacology, Physiology and Biotechnology at Brown
University.

Dr. Vaseem A. Palejwala – Director,
Non-Clinical Studies

Dr. Palejwala has
served as Director, Non-Clinical Studies of the company since January 2017 and has 18 years of experience in drug discovery and
development. Dr. Palejwala also currently serves as director of discovery and preclinical research at Rasna Therapeutics, Inc.
From January 2015 to January 2017, Dr. Palejwala served as director of discovery and preclinical research, and from December 2012
to December 2014 served as associate director of discovery and preclinical research, at Synergy Pharmaceuticals Inc. where he
actively contributed to establishing GI tract-related preclinical animal models for testing the efficacy and validating the mechanism
of action for both plecanatide and dolcanatide. Dr. Palejwala also actively participated in preparation of the nonclinical pharmacology
section of the NDA for Trulance®. From 2001 to 2012, Dr. Palejwala served as discovery scientist/manager at Sanofi S.A., un'
multinational pharmaceutical company, where he advanced both small molecule and biologic programs in immunology, inflammation,
oncology, CNS and metabolic disorders and also contributed to establishing and managing high-throughput gene expression profiling
platform capabilities. Dr. Palejwala holds a degree in microbiology and chemistry from Bombay University, as well as a master
of science degree in microbiology and a Ph.D. in microbiology from the Maharaja Sayajirao University of Baroda.

Family Relationships

There are no family
relationships among any of our executive officers or directors.

Total Compensation
for the Chairman and Non-Executive Directors

The table below sets
out the total remuneration received by the Chairman and the Non-Executive Directors for the year ended December 31, 2019.

Name Position Fees
earned
or paid
in cash
($)
Bonus
earned or
paid in
cash (4)
($)
Options
awarded
($) (1)
Total
($)
Gabriele Cerrone Chairman 102,091 182,473 284,564
Willy Simon Non – Executive Director 48,493 48,493
Ricardo Dalla-Favera (2) Non – Executive Director 3,190 3,190
Leopoldo Zambeletti (3) Non – Executive Director

(1) Represents the fair value of incentive stock options granted during the year to December 31, 2019 using the Black-Scholes model for computing stock-based compensation expense as of the date of grant.
(2) Dr. Dalla-Favera resigned from the board of directors on February 7, 2019.
(3) Mr Zambeletti resigned from the board of directors on November 20, 2019.
(4) Gabriele Cerrone Bonus covers the period from June 6, 2016 to December 31, 2019.

In addition to
the annual bonus disclosed above, the Chairman is also eligible to receive two realisation bonuses as follows:

(a) in the event that, either: (i) the Group raises, in one
or a series of transactions, new equity capital in excess of £20,000,000 (after expenses); or (ii) there is a sale, in one
or a series of transactions, of all or substantially all of the assets (calculated on the basis of book values) of the Group Companies
(or a licence of the same on an exclusive or non-exclusive basis), where the Enterprise Value equals or exceeds £150,000,000;
or (iii) there is a change of control where the Enterprise Value equals or exceeds £150,000,000, in which case the Realisation
Bonus will be the amount equal to the Enterprise Value multiplied by two and a half (2.5) per cent;

(b) In addition to the payment of the Realisation Bonus outlined
above, in the event that, during this Agreement, either: (i) there is a sale, in one or a series of transactions, of all or substantially
all of the assets ( calculated on the basis of book values) of the Group ( or a licence of the same on an exclusive or non-exclusive
basis ), where the Enterprise Value equals or exceeds £300;000,000; or (ii) there is either a change of control
where the Enterprise Value equals or exceeds £300,000,000, the Chairman will be entitled to receive an additional Realisation
Bonus in the amount equal to the Enterprise Value multiplied by three and a half (3.5) per cent.

The Enterprise Value means: (i) in the case of a change of control
resulting in consideration payable to the Group (for example, on a sale of its assets or licensing transaction), the total cash
and non-cash consideration received by the Group; or (ii) in the case of a change of control resulting in consideration payable
to the shareholders of the ordinary shares in the issued share capital of the Group from time to time, the total cash and non-cash
consideration payable to the Shareholders.

Compensation of Executive Directors and Senior Managers

The table below sets
the remuneration of each of the Executive Directors and Senior Managers for the financial year ended December 31, 2019.

Name Position Fees
earned or
paid in
cash
($)
Bonus
earned or
paid in
cash
($)
Options
awarded
($)
Total
($)
Kunwar Shailubhai Executive Director 600,000 210,000 810,000
Tiziano Lazzaretti Chief Financial Officer 135,270 40,581 175,851

The Tiziana Life Sciences plc Employee Share Option Plan
with Non-Employee Sub-Plan and US Sub-Plan

The Tiziana Life Sciences
plc Employee Share Option Plan with Non-Employee Sub-Plan and US Sub-Plan, or the 2016 Plan, was adopted by the Board on March
23, 2016 and approved by shareholders on June 30, 2016 and allows for the grant of options to eligible service providers. The material
terms of the 2016 Plan are summarized below.

Eligibility and Administration

Our employees, consultants
and directors, and employees and consultants of our subsidiaries are eligible to receive options under the 2016 Plan. The 2016
Plan is administered by our board of directors, which may delegate its duties and responsibilities to one or more committees of
our directors and/or officers (referred to collectively as the plan administrator below), subject to the limitations imposed under
the 2016 Plan, stock exchange rules and other applicable laws. The plan administrator has the authority to take all actions and
make all determinations under the 2016 Plan, to interpret the 2016 Plan and option agreements and to adopt, amend and repeal rules
for the administration of the 2016 Plan as it deems advisable. The plan administrator also has the authority to determine which
eligible service providers receive options, to grant options and to set the terms and conditions of all options granted under the
2016 Plan, including any vesting and vesting acceleration provisions, subject to the conditions and limitations in the 2016 Plan.

Shares Available for Options

An aggregate of 10%
of the company’s ordinary share capital from time to time may be placed under options granted under the 2016 Plan. Shares
issued to satisfy the exercise of options granted under the 2016 Plan may be newly issued shares or shares purchased on the open
market

If an option granted
under the 2016 Plan, expires, lapses or is terminated, exchanged for cash, surrendered, canceled without having been fully exercised
or forfeited, any unused shares subject to the option will, as applicable, become or again be available for new grants under the
2016 Plan.

Options

The 2016 Plan provides
for the grant of options. All options granted under the 2016 Plan will be set forth in option agreements, which will detail the
terms and conditions of the options.

Options provide for
the purchase of our ordinary shares in the future at an exercise price set on the grant date. The plan administrator will determine
the number of shares covered by each option, the exercise price of each option and the conditions and limitations applicable to
the exercise of each option

If a holder of options
dies, options may be exercised by the personal representative with 12 months following death in respect of all or such proportion
of the option as the plan administrator may specify to take account of the extent to which any exercise conditions have been achieved
at the relevant date. If a holder of options leaves as a good leaver or the plan administrator allows, options may be exercised
within 90 days in respect of all or such proportion of the option as the plan administrator may specify to take account of the
extent to which any exercise conditions have been achieved at the relevant date

Exercise Conditions

The plan administrator
may specify one or more appropriate exercise conditions that must be satisfied before options may be exercised.

Change of Control and Variation of Share Capital

In the event of a change
of control, the plan administrator may specify whether all or a proportion of options will be exercisable to take account of the
extent to which any exercise conditions have been achieved at the relevant date. Alternatively, holders of options may agree to
accept an offer to exchange options for options to acquire shares in an acquiring company.

If there is a variation
of our ordinary shares the plan administrator may adjust the number of shares under options and/or the exercise price.

Plan Amendment and Termination

Our board of directors
may amend the 2016 Plan at any time; however, the provisions governing eligibility requirements, equity dilution, the basis for
determining the rights of holders of options and the adjustment of options cannot be altered to the advantage of existing or new
holders of options without the prior approval of our shareholders in general meeting. No options may be granted under the 2016
Plan after the tenth anniversary of the date of adoption by our board of directors.

Transferability

Options granted under
the 2016 Plan are generally non-transferrable, except on death. With regard to tax withholding and exercise price obligations arising
in connection with the exercise of options under the 2016 Plan, the plan administrator may, in its discretion, accept cash, wire
transfer or cheque,

Non-Employee Sub-Plan

Under the Non-Employee
Sub-Plan, options may be granted to advisers, consultants and non-executive directors on terms comparable to those described above.

US Sub-Plan

The US Sub-Plan permits
the grant of options to employees, directors and consultants who are US residents and US taxpayers, including potentially tax efficient
Incentive Stock Options (as defined in Section 422 of the Internal Revenue Code of 1986, as amended). A maximum of 9,233,392 ordinary
shares may be issued under the US Sub-Plan (which number shall be the maximum number that may be granted as Incentive Stock Options).

The following table
summarizes: (i) the outstanding number of options and awards under the equity incentive plans; and (ii) the number of ordinary
shares granted to directors, executive officers, and non-executive directors, as of June 1, 2020:

Name Ordinary
Shares
Ordinary
Shares
Underlying
Options
Exercise
Price Per
Ordinary
Share (£)
Grant Date Expiration
Date
Gabriele Cerrone 1,200,000 0.15 25/06/2014 25/06/2024
2,000,000 0.35 25/06/2014 25/06/2024
3,259,403 0.35 06/05/2020 05/05/2028
550,000 0.35 06/05/2020 05/05/2028
Willy Simon
Kunwar Shailubhai 2,500,000 0.35 06/05/2020 05/05/2028
4,700,000 0.35 06/05/2020 05/05/2030
1,800,000 0.35 06/05/2020 05/05/2030
Tiziano Lazzaretti 300,000 0.35 06/05/2020 05/05/2028
100,000 0.35 06/05/2020 05/05/2030

C. Board Practices

Corporate Governance Practices

We are a “foreign
private issuer,” as defined by the SEC. As a result, in accordance with Nasdaq listing requirements, we may rely on home
country governance requirements and certain exemptions thereunder rather than complying with NASDAQ corporate governance standards.
While we voluntarily follow most Nasdaq corporate governance rules, we may choose to take advantage of the following limited exemptions:

Exemption
from filing quarterly reports on Form 10-Q containing unaudited financial and other specified information or current reports on
Form 8-K upon the occurrence of specified significant events.

Exemption from Section 16 rules requiring insiders to file public reports of their stock ownership and trading activities and liability for insiders who profit from trades in a short period of time, which will provide less data in this regard than shareholders of U.S. companies that are subject to the Exchange Act.

Exemption from the Nasdaq requirement requiring disclosure of any waivers of the code of business conduct and ethics for directors and officers.

Exemption from the requirement that our board have a compensation committee that is composed entirely of independent directors with a written charter addressing the committee’s purpose and responsibilities.

Exemption from the requirement to have independent director oversight of director nominations.

We intend to follow
U.K. corporate governance practices in lieu of Nasdaq corporate governance requirements as follows:

We do not intend to follow Nasdaq Rule 5620(c) regarding quorum requirements applicable to meetings of shareholders. Such quorum requirements are not required under English law. In accordance with generally accepted business practice, our Articles of Association will provide alternative quorum requirements that are generally applicable to meetings of shareholders.

We do not intend to follow Nasdaq Rule 5605(b)(2), which requires that independent directors regularly meet in executive sessions where only independent directors are present. Our independent directors may choose to meet in executive sessions at their discretion.

Although we may rely
on certain home country corporate governance practices, we must comply with Nasdaq’s Notification of Noncompliance requirement
(Nasdaq Rule 5625) and the Voting Rights requirement (Nasdaq Rule 5640). Further, we must have an audit committee that satisfies
Nasdaq Rule 5605(c)(3), which addresses audit committee responsibilities and authority and requires that the audit committee consist
of members who meet the independence requirements of Nasdaq Rule 5605(c)(2)(A)(ii).

We intend to take all
actions necessary for us to maintain compliance as a foreign private issuer under the applicable corporate governance requirements
of the Sarbanes-Oxley Act, the rules adopted by the SEC and Nasdaq listing rules. Accordingly, our shareholders will not have the
same protections afforded to shareholders of companies that are subject to all of the corporate governance requirements of Nasdaq.
For an overview of our corporate governance principles, see the section titled “Description of Share Capital and Articles
of Association—Differences in Corporate Law.”

Compliance with the Quoted Companies
Alliance Corporate Governance Code

All companies with
securities admitted to trading on AIM are required to include on their website details of a recognized corporate governance code
that the board of directors of the company has decided to apply, how the company complies with that code, and where it departs
from its chosen corporate governance code an explanation of the reasons for doing so. This information is required to be reviewed
annually.

The company has decided
to apply the Corporate Governance Code published by the Quoted Companies Alliance, or the QCA Code. The QCA Code sets out a standard
of minimum best practice for small and midsize quoted companies.

Composition of Our Board of Directors

Our board of directors
is currently composed of four members. Our board of directors has determined that, of our four directors, none have a relationship
that would interfere with the exercise of independent judgment in carrying out the responsibilities of two of the directors, Mr.
Dalla-Favera and Mr. Simon, and that each of these directors is “independent” as that term is defined under Nasdaq
rules.

In accordance with
our Articles, each of our directors for whom it is the third annual general meeting following the annual general meeting at which
they were elected or last re-elected, or who was appointed by the board since the previous annual general meeting, shall retire
from office but shall be eligible to stand for re-election. See “Description of Share Capital and Articles of Association—Articles
of Association—Board of Directors.”

The expiration of the
current terms of the members of the Board of Directors and the period each member has served in that term are as follows:

Name Year Current
Term Began
Year Current
Term Expires
Gabriele Cerrone 2014 2020
Kunwar Shailubhai 2015 2020
Willy Simon 2016 2020
Gregor MacRae 2020 2020

Commencing with the 2020 annual general
meeting the Company will adopt best practice for corporate governance in its country of incorporation so all directors will retire
and stand for re-election at each annual general meeting (as opposed to reliance upon rotational reappointment).

Committees of Our Board of Directors

Our board of directors
has three standing committees: an audit committee, a remuneration committee and a nominating committee.

Audit Committee

The audit committee,
which consists of, Mr. MacRae and Mr. Simon, assists the board of directors in overseeing our accounting and financial reporting
processes. Mr. Simon serves as chairman of the audit committee. The audit committee consists exclusively of members of our board
who are financially literate, and Mr. Simon is considered an “audit committee financial expert” as defined by applicable
SEC rules and has the requisite financial sophistication as defined under the applicable Nasdaq rules and regulations.

Our board has determined
that all of the members of the audit committee satisfy the “independence” requirements set forth in Rule 10A-3 under
the Exchange Act. The audit committee will be governed by a charter that complies with Nasdaq rules.

The audit committee’s
responsibilities include:

recommending
the appointment of the independent auditor to the general meeting of shareholders;

the appointment, compensation, retention and oversight of any accounting firm engaged for the purpose of preparing or issuing an audit report or performing other audit services;

pre-approving the audit services and non-audit services to be provided by our independent auditor before the auditor is engaged to render such services;

evaluating the independent auditor’s qualifications, performance and independence, and presenting its conclusions to the full board of directors on at least an annual basis;

reviewing and discussing with management and our independent registered public accounting firm our financial statements and our financial reporting process;

reviewing, approving or ratifying any related party transactions.

recommending the appointment of the independent auditor to the general meeting of shareholders; e

the appointment, compensation, retention and oversight of any accounting firm engaged for the purpose of preparing or issuing an audit report or performing other audit services;

Remuneration Committee

The remuneration committee
consists of Mr. MacRae and Mr. Simon. Mr. MacRae serves as chairman of the remuneration committee. Under SEC and Nasdaq rules,
there are heightened independence standards for members of the remuneration committee, including a prohibition against the receipt
of any compensation from us other than standard board member fees.

The remuneration committee’s
responsibilities include:

identifying, reviewing and proposing policies relevant to the compensation and benefits of our directors and executive officers;

evaluating each executive officer’s performance in light of such policies and reporting to the board; e

overseeing and administering our employee share option scheme or equity incentive plans in operation from time to time.

Nominating Committee

The nominating committee
consists of Mr. Cerrone and Mr. Simon. Mr. Simon serves as chairman of the nominating committee. The nominating committee’s
responsibilities include:

drawing up selection criteria and appointment procedures for directors;

recommending nominees for election to our board of directors and its corresponding committees;

assessing the functioning of individual members of our board of directors and executive officers and reporting the results of such assessment to the board of directors; e

developing corporate governance guidelines.

Code of Business Conduct and Ethics

Prior to effectiveness
of this registration statement, we plan to adopt a Code of Business Conduct and Ethics applicable to our employees, executive officers
and directors.

Compensation of Executive Officers and
Directors

For the year ended
December 31, 2018, the aggregate compensation accrued or paid to the members of our board of directors and our executive officers
for services in all capacities was $0.5 million.

Executive Director and Chairman Service and Employment
Agreement

Dr. Kunwar Shailubhai

We entered into an
employment agreement with Dr. Kunwar Shailubhai in May 2017. This agreement entitles Dr. Shailubhai to receive an initial annual
base salary of $600,000 per year. Dr. Shailubhai is eligible to receive an annual bonus of up to 35% of his base salary, such
bonus amount to be determined in the company’s sole discretion. Dr. Shailubhai is also entitled to the same fringe benefits
as we provide to our other executives from time to time and is eligible to receive employee share incentives. The vesting of any
unvested employee share incentives held by Dr. Shailubhai will accelerate in the event his employment is terminated without cause
(as such term is defined in his employment agreement), or if he resigns for good reason (as such term is defined in his employment
agreement) and, in each case, such termination is upon the consummation of or within 12 months following a change of control of
the company. If Dr. Shailubhai’s employment with the company is terminated without cause, or if he resigns for good reason,
Dr. Shailubhai will also be entitled to receive severance equal to continuation of his base salary as then currently in effect
for 12 months following his date of termination and will be eligible for reimbursement for medical coverage premiums for up to
the same period. Dr. Shailubhai, his spouse and eligible dependents are entitled to stay on our health insurance plans for a period
of 12 months following his termination for any reason. Dr. Shailubhai’s severance benefits are conditioned on, among other
things, his execution of our standard separation agreement and a general release of claims in our favor.

The agreement provides
that Dr. Shailubhai’s employment with us is at-will. If required by the company, the agreement further provides that Dr.
Shailubhai will resign from his position on our board of directors effective as of the date of his termination for any reason.
The agreement further contains a six-month non-competition covenant and a 12-month non-solicitation covenant by Dr. Shailubhai.

Gabriele Cerrone

We entered into a Consultancy agreement with Gabriele Cerrone
in June 2016. This agreement entitles Mr. Cerrone to receive a consultancy fee of £80,000 per year. Mr Cerrone is also eligible
to receive an annual bonus of up to 50% of his base salary, such bonus amount to be determined at the discretion of the Board of
Directors.

Additionally, Mr Cerrone is also eligible
to receive two realisation bonuses as follows:

(a) in the event that, either: (i) the Group raises, in one
or a series of transactions, new equity capital in excess of £20,000,000 (after expenses); or (ii) there is a sale, in one
or a series of transactions, of all or substantially all of the assets (calculated on the basis of book values) of the Group Companies
(or a licence of the same on an exclusive or non-exclusive basis), where the Enterprise Value equals or exceeds £150,000,000;
or (iii) there is a change of control where the Enterprise Value equals or exceeds £150,000,000, in which case the Realisation
Bonus will be the amount equal to the Enterprise Value multiplied by two and a half (2.5) per cent;

(b) in addition to the payment of the Realisation Bonus outlined
in paragraph 4.2(a) above, in the event that, during this Agreement, either: (i) there is a sale, in one or a series of transactions,
of all or substantially all of the assets ( calculated on the basis of book values) of the Group ( or a licence of the same on
an exclusive or non-exclusive basis ), where · the Enterprise Value equals or exceeds £300;000,000; or (ii) there
is either a change of control where the Enterprise Value equals or exceeds £300,000,000, the Chairman will be entitled to
receive an additional Realisation Bonus in the amount equal to the Enterprise Value multiplied by three and a half (3.5) per cent.

The Enterprise Value means: (i) in the case of a change of control
resulting in consideration payable to the Group (for example, on a sale of its assets or licensing transaction), the total cash
and non-cash consideration received by the Group; or (ii) in the case of a change of control resulting in consideration payable
to the shareholders of the ordinary shares in the issued share capital of the Group from time to time, the total cash and non-cash
consideration payable to the Shareholders.

Non-Executive Director Service Contracts

The remuneration of
our non-executive directors is determined by our board as a whole, based on a review of current practices in other companies. We
intend to enter into service contracts with our directors for their services or amend and restate any prior service contracts in
place prior to, or as soon as practicable, following the filing of this registration statement.

D. Employees

As of December 31,
2019, 2018 and 2017, we had 8, 9 and 5 employees, respectively. All of our employees were based in the United Kingdom, except
that, as of December 31, 2019, we had 5 employees based outside of the United Kingdom in the US. All of our employees were engaged
in either administrative or R&D functions. None of our employees are covered by a collective bargaining agreement.

Insurance and Indemnification

To the extent permitted
by the Companies Act, we are empowered to indemnify our directors against any liability they incur by reason of their directorship.
We maintain directors’ and officers’ insurance to insure such persons against certain liabilities. We expect to enter
into a deed of indemnity with each of our directors and executive officers prior to, or as soon as practicable, following the filing
of this registration statement.

In addition to such
indemnification, we provide our directors and executive officers with directors’ and officers’ liability insurance.

Insofar as indemnification
of liabilities arising under the Securities Act may be permitted to our board of directors, executive officers, or persons controlling
us pursuant to the foregoing provisions, we have been informed that, in the opinion of the SEC, such indemnification is against
public policy as expressed in the Securities Act and is therefore unenforceable.

E. Share Ownership

See “Item 7.
Major Shareholders and Related Party Transactions.”

ITEM 7: MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS

A. Major Shareholders

The following table
sets forth information relating to the beneficial ownership of our ordinary shares as of June 1, 2020 by:

each person, or group of affiliated persons, known by us to own beneficially 5% or more of our outstanding ordinary shares; e

each member of our board of directors and each of our executive officers.

The number of ordinary
shares beneficially owned by each entity, person, board member, or executive officer is determined in accordance with the rules
of the SEC, and the information is not necessarily indicative of beneficial ownership for any other purpose. Under such rules,
beneficial ownership includes any ordinary shares over which the individual has sole or shared voting power or investment power
as well as any ordinary shares that the individual has the right to acquire within 60 days of June 1, 2020 through the exercise
of any option, warrant or other right. Except as otherwise indicated, and subject to applicable community property laws, the persons
named in the table have sole voting and investment power with respect to all ordinary shares held by that person.

Number of Ordinary Shares Beneficially Owned
Name and address of beneficial owner Shares %
5% or Greater Shareholders:
Gabriele Cerrone(1) 67,571,925 40.03
Executive Officers and Directors:
Gabriele Cerrone(1) 67,571,925 40.03
Willy Simon
Kunwar Shailubhai(2) 2,505,000 1.48
Greg MacRae
Tiziano Lazzaretti(3) 168,666 *
All directors and executive officers as a group (5 persons)(4) 70,378,925 41.69

* Indicates beneficial ownership of less than 1% of the total outstanding ordinary shares.

(1) Mr. Gabriele Cerrone is the ultimate beneficial owner of ordinary shares through Planwise Group Limited and Panetta Partners Limited.
Includes 3,200,000 stock options which are currently exercisable or exercisable within 60 days of June 1, 2020.
(2) Consists of 2,500,000 stock options which are currently exercisable or exercisable within 60 days of June 1, 2020.
(3) Includes of 300,000 stock options which are currently exercisable or exercisable within 60 days of June 1, 2020.
(4) Includes of 6,000,000 stock options which are currently exercisable or exercisable within 60 days of June 1, 2020.

B. Related Party Transactions

The following is a
description of related party transactions we have entered into since January 1, 2018, with the beneficial owners of 5% or more
of our ordinary shares, which are our only voting securities, and senior management and members of our board of directors.

Indemnity Agreements

We have entered into
deeds of indemnity with each of our directors.

Related Person Transaction Policy

Our board of directors
has adopted a written related person transaction policy, effective as of November 9, 2018, the date on which our registration statement
on Form F-1 was declared effective. This policy covers, any transaction or proposed transactions between us and a related person
that are material to us or the related person, including without limitation, purchases of goods or services by or from the related
person or entities in which the related person has a material interest, indebtedness, guarantees of indebtedness and employment
by us of a related person. In reviewing and approving any such transactions, our audit and risk committee is tasked to consider
all relevant facts and circumstances, including, but not limited to, whether the transaction is on terms comparable to those that
could be obtained in an arm’s length transaction and the extent of the related person’s interest in the transaction.

C. Interests of Experts and Counsel

Not applicable.

ITEM 8: FINANCIAL INFORMATION

A. Consolidated Statements and Other Financial Information

See “Item 18.
Financial Statements”.

Legal Proceedings

Save as disclosed in
this paragraph, there are no governmental, legal or arbitration proceedings (including any such proceedings which are pending or
threatened of which the Company is aware), which may have, or have had during the 12 months prior to the date of this registration
statement, a significant effect on the Company’s and/or our financial position or profitability. In addition to the proceedings
set out in this section, the Company is involved in other legal proceedings and claims in the ordinary course of business.

B. Significant Changes

See Note 25 of our
consolidated financial statements at the end of this Annual Report for a description of the significant changes since December
31, 2018.

ITEM 9: THE LISTING

A. Listing Details

The principal trading
market for our ordinary shares is AIM, of the London Stock Exchange, where our ordinary shares have been listed since 2014. The
following table sets forth, for the periods indicated, the reported high and low closing prices on the London Stock Exchange for
our ordinary shares in pounds Sterling. See “Exchange Rate Information” on page 4 for the exchange rates applicable
to the periods set forth below.

Our ordinary shares have been trading on
AIM under the symbol “TILS” since April 24, 2014.

The following table
presents, for the periods indicated, the reported high and low sale prices, including intra-day sales, of our ordinary shares on
AIM in Pounds Sterling and U.S. dollars. For the convenience of the reader, we have translated Pounds Sterling amounts in the table
below into U.S. dollars at the noon buying rate of the Federal Reserve Bank of New York on May 29, 2020, which was £1.00
to $1.2320.

Price Per
Ordinary Share £
Price Per
Ordinary Share $
High Low High Low
Year Ended December 31, 2019
Second Quarter 1.11 0.33 1.37 0.41
First Quarter 0.52 0.40 0.64 0.49
Year Ended December 31, 2019
First Quarter 0.64 0.43 0.79 0.53
Second Quarter 0.76 0.44 0.94 0.54
Third Quarter 0.70 0.48 0.86 0.59
Fourth Quarter 0.50 0.41 0.62 0.51
Year Ended December 31, 2018
First Quarter 1.49 0.82 1.84 1.01
Second Quarter 0.88 0.37 1.08 0.46
Third Quarter 1.45 0.37 1.79 0.46
Fourth Quarter 1.47 0.63 1.81 0.78
Year Ended December 31, 2017
First Quarter 2.10 1.66 2.59 2.05
Second Quarter 2.40 1.65 2.96 2.03
Third Quarter 1.75 1.42 2.16 1.75
Fourth Quarter 1.80 1.39 2.22 1.71
Year Ended December 31, 2016
First Quarter 2.15 1.22 2.65 1.50
Second Quarter 1.61 1.23 1.98 1.52
Third Quarter 2.02 1.35 2.49 1.66
Fourth Quarter 2.16 1.75 2.66 2.16

On May 29, 2020, the
last reported sale price of our ordinary shares on AIM was £1.11 per ordinary share ($1.37 per ordinary share based on the
exchange rate set forth above).

Our American Depositary
Shares, or ADSs, have been trading on the Nasdaq Global Market under the symbol “TLSA” since November 20, 2018. The
following table sets forth, for the periods indicated, the reported high and low closing sale prices of our ADSs on the Nasdaq
Global Market in U.S. dollars. The ADS prices have been adjusted to reflect the 2:1 stock split that took place in October 2019.

Price Per
ADS $
High Low
Monthly:
November 2018 5.595 3.925
December 2018 4.4249 3.35
January 2019 3.55 2.78
February 2019 3.375 2.85
March 2019 3.045 2.5
April 2019 6.75 5.7
May 2019 4.4335 3.2087
June 2019 4.4686 3.6
July 2019 4.0564 3.25
August 2019 3.675 3.1401
September 2019 3.8 2.6782
October 2019 3.59 1.725
November 2019 3.52 2.7013
December 2019 3.13 2.36
January 2020 3.27 2.5
February 2020 2.3923 1.6801
March 2020 5.26 1.71
April 2020 3.4 1.8
May 2020 (through May 29, 2020) 6.61 2.82

On May 29, 2020, the
last reported sale price of our ADS’s on the Nasdaq Global Market was $6.61 per ADS.

B. Plan of Distribution

Not applicable.

C. Markets

Our ordinary shares
are listed on AIM under the symbol “TILS” and our ADSs are listed on the Nasdaq Global Market under the symbol “TLSA.”

D. Selling Shareholders

Not applicable.

E. Dilution

Not applicable.

F. Expenses of the Issue

Not applicable.

ITEM 10: ADDITIONAL INFORMATION

A. Share Capital

Not applicable.

B. Memorandum and Articles of Association

We incorporate by reference
into this Annual Report the description of our amended articles of association contained in our Registration Statement on Form
F-1 originally filed with the SEC on July 26, 2018, as amended.

C. Material Contracts

Except as otherwise
disclosed in this Annual Report (including the exhibits hereto), we are not currently, and have not been in the last two years,
party to any material contract, other than contracts entered into in the ordinary course of business.

D. Exchange Controls

There are no governmental
laws, decrees, regulations or other legislation in the United Kingdom that may affect the import or export of capital, including
the availability of cash and cash equivalents for use by us, or that may affect the remittance of dividends, interest, or other
payments by us to non-resident holders of our ordinary shares or ADSs, other than withholding tax requirements. There is no limitation
imposed by English law or our articles of association on the right of non-residents to hold or vote shares.

E. Taxation

Material U.S. Federal Income Tax Considerations for U.S.
Holders

U.S. Federal Income Tax Considerations
for U.S. Holders

The following discussion
describes the material U.S. federal income tax consequences relating to the ownership and disposition of our ADSs by U.S. Holders.
This discussion applies to U.S. Holders that purchase our ADSs pursuant to this offering and hold such ADSs as capital assets for
tax purposes. This discussion is based on the Internal Revenue Code, U.S. Treasury regulations promulgated thereunder and administrative
and judicial interpretations thereof, and the income tax treaty between the United Kingdom and the United States, or the Treaty,
all as in effect on the date hereof and all of which are subject to change, possibly with retroactive effect. This discussion does
not address all of the U.S. federal income tax consequences that may be relevant to specific U.S. Holders in light of their particular
circumstances or to U.S. Holders subject to special treatment under U.S. federal income tax law (such as certain financial institutions,
insurance companies, dealers or traders in securities or other persons that generally mark their securities to market for U.S.
federal income tax purposes, tax-exempt entities or governmental organizations, retirement plans, regulated investment companies,
real estate investment trusts, grantor trusts, brokers, dealers or traders in securities, commodities, currencies or notional principal
contracts, certain former citizens or long-term residents of the United States, persons who hold our ADSs as part of a “straddle,”
“hedge,” “conversion transaction,” “synthetic security” or integrated investment, persons that
have a “functional currency” other than the U.S. dollar, persons who are subject to the tax accounting rules of Section
451(b) of the Internal Revenue Code, persons that own directly, indirectly or through attribution 10% or more (by vote or value)
of our equity, corporations that accumulate earnings to avoid U.S. federal income tax, partnerships and other pass-through entities,
and investors in such pass-through entities). This discussion does not address any U.S. state or local or non-U.S. tax consequences
or any U.S. federal estate, gift or alternative minimum tax consequences.

As used in this discussion,
the term “U.S. Holder” means a beneficial owner of our ADSs that is, for U.S. federal income tax purposes, (1) an individual
who is a citizen or resident of the United States, (2) a corporation (or entity treated as a corporation for U.S. federal income
tax purposes) created or organized in or under the laws of the United States, any state thereof, or the District of Columbia, (3)
an estate the income of which is subject to U.S. federal income tax regardless of its source or (4) a trust (x) with respect to
which a court within the United States is able to exercise primary supervision over its administration and one or more United States
persons have the authority to control all of its substantial decisions or (y) that has elected under applicable U.S. Treasury regulations
to be treated as a domestic trust for U.S. federal income tax purposes.

If an entity treated
as a partnership for U.S. federal income tax purposes holds our ADSs, the U.S. federal income tax consequences relating to an investment
in such ADSs will depend upon the status and activities of such entity and the particular partner. Any such entity and a partner
in any such entity should consult its own tax advisor regarding the U.S. federal income tax consequences applicable to it (and,
as applicable, its partners) of the purchase, ownership and disposition of our ADSs.

We have not sought,
nor will we seek, a ruling from the IRS with respect to the matters discussed below. There can be no assurance that the IRS will
not take a different position concerning the tax consequences of the purchase, ownership or disposition of the ADSs or that any
such position would not be sustained. Persons considering an investment in our ADSs should consult their own tax advisors as to
the particular tax consequences applicable to them relating to the purchase, ownership and disposition of our ADSs, including the
applicability of U.S. federal, state and local tax laws and non-U.S. tax laws.

Passive Foreign Investment Company Rules

In general, a corporation
organized outside the United States will be treated as a PFIC for any taxable year in which either (1) at least 75% of its gross
income is “passive income,” or the PFIC income test, or (2) on average at least 50% of its assets, determined on a
quarterly basis, are assets that produce passive income or are held for the production of passive income, or the PFIC asset test.
Passive income for this purpose generally includes, among other things, dividends, interest, royalties, rents, and gains from the
sale or exchange of property that give rise to passive income. Assets that produce or are held for the production of passive income
generally include cash, even if held as working capital or raised in a public offering, marketable securities, and other assets
that may produce passive income. Generally, in determining whether a non-U.S. corporation is a PFIC, a proportionate share of the
income and assets of each corporation in which it owns, directly or indirectly, at least a 25% interest (by value) is taken into
account.

Although PFIC status
is determined on an annual basis and generally cannot be determined until the end of the taxable year, based on the nature of our
current and expected income and the current and expected value and composition of our assets, we believe we were a PFIC for our
2017 tax year and we expect to be a PFIC for our current taxable year. There can be no assurance that we will not be a PFIC in
future taxable years. Even if we determine that we are not a PFIC for a taxable year, there can be no assurance that the IRS will
agree with our conclusion and that the IRS would not successfully challenge our position. Because of the uncertainties involved
in establishing our PFIC status, our U.S. counsel expresses no opinion regarding our PFIC status, and also expresses no opinion
with respect to our predictions or past determinations regarding our PFIC status.

If we are a PFIC in
any taxable year during which a U.S. Holder owns our ADSs, the U.S. Holder could be liable for additional taxes and interest charges
under the “PFIC excess distribution regime” upon (1) a distribution paid during a taxable year that is greater than
125% of the average annual distributions paid in the three preceding taxable years, or, if shorter, the U.S. Holder’s holding
period for our ADSs, and (2) any gain recognized on a sale, exchange or other disposition, including, under certain circumstances,
a pledge, of our ADSs, whether or not we continue to be a PFIC. Under the PFIC excess distribution regime, the tax on such distribution
or gain would be determined by allocating the distribution or gain ratably over the U.S. Holder’s holding period for our
ADSs. The amount allocated to the current taxable year (i.e., the year in which the distribution occurs or the gain is recognized)
and any year prior to the first taxable year in which we are a PFIC will be taxed as ordinary income earned in the current taxable
year. The amount allocated to other taxable years will be taxed at the highest marginal rates in effect for individuals or corporations,
as applicable, to ordinary income for each such taxable year, and an interest charge, generally applicable to underpayments of
tax, will be added to the tax.

If we are a PFIC for
any year during which a U.S. Holder holds our ADSs, we must generally continue to be treated as a PFIC by that U.S. Holder for
all succeeding years during which the U.S. Holder holds such ADSs, unless we cease to meet the requirements for PFIC status and
the U.S. Holder makes a “deemed sale” election with respect to our ADSs. If the election is made, the U.S. Holder will
be deemed to sell our ADSs it holds at their fair market value on the last day of the last taxable year in which we qualified as
a PFIC, and any gain recognized from such deemed sale would be taxed under the PFIC excess distribution regime. After the deemed
sale election, the U.S. Holder’s ADSs would not be treated as shares of a PFIC unless we subsequently become a PFIC.

If we are a PFIC for
any taxable year during which a U.S. Holder holds our ADSs and one of our non-United States subsidiaries is also a PFIC (i.e.,
a lower-tier PFIC), such U.S. Holder would be treated as owning a proportionate amount (by value) of the shares of the lower-tier
PFIC and would be taxed under the PFIC excess distribution regime on distributions by the lower-tier PFIC and on gain from the
disposition of shares of the lower-tier PFIC even though such U.S. Holder would not receive the proceeds of those distributions
or dispositions. Any of our non-United States subsidiaries that have elected to be disregarded as entities separate from us or
as partnerships for U.S. federal income tax purposes would not be corporations under U.S. federal income tax law and accordingly,
cannot be classified as lower-tier PFICs. However, a non-United States subsidiary that has not made the election may be classified
as a lower-tier PFIC if we are a PFIC during your holding period and the subsidiary meets the PFIC income test or PFIC asset test.

If we are a PFIC, a
U.S. Holder will not be subject to tax under the PFIC excess distribution regime on distributions or gain recognized on our ADSs
if a valid “mark-to-market” election is made by the U.S. Holder for our ADSs. An electing U.S. Holder generally would
take into account as ordinary income each year, the excess of the fair market value of our ADSs held at the end of such taxable
year over the adjusted tax basis of such ADSs. The U.S. Holder would also take into account, as an ordinary loss each year, the
excess of the adjusted tax basis of such ADSs over their fair market value at the end of the taxable year, but only to the extent
of the excess of amounts previously included in income over ordinary losses deducted as a result of the mark-to-market election.
The U.S. Holder’s tax basis in our ADSs would be adjusted annually to reflect any income or loss recognized as a result of
the mark-to-market election. Any gain from a sale, exchange or other disposition of our ADSs in any taxable year in which we are
a PFIC would be treated as ordinary income and any loss from such sale, exchange or other disposition would be treated first as
ordinary loss (to the extent of any net mark-to-market gains previously included in income) and thereafter as capital loss. If,
after having been a PFIC for a taxable year, we cease to be classified as a PFIC because we no longer meet the PFIC income or PFIC
asset test, the U.S. Holder would not be required to take into account any latent gain or loss in the manner described above and
any gain or loss recognized on the sale or exchange of the ADSs would be classified as a capital gain or loss.

A mark-to-market election
is available to a U.S. Holder only for “marketable stock.” Generally, stock will be considered marketable stock if
it is “regularly traded” on a “qualified exchange” within the meaning of applicable U.S. Treasury regulations.
A class of stock is regularly traded during any calendar year during which such class of stock is traded, other than in de minimis
quantities, on at least 15 days during each calendar quarter.

Our ADSs will be marketable
stock as long as they remain listed on Nasdaq and are regularly traded. A mark-to-market election will not apply to the ADSs for
any taxable year during which we are not a PFIC, but will remain in effect with respect to any subsequent taxable year in which
we become a PFIC. Such election will not apply to any of our non-U.S. subsidiaries. Accordingly, a U.S. Holder may continue to
be subject to tax under the PFIC excess distribution regime with respect to any lower-tier PFICs notwithstanding the U.S. Holder’s
mark-to-market election for our ADSs.

The tax consequences
that would apply if we are a PFIC would also be different from those described above if a U.S. Holder were able to make a valid
QEF election. As we do not expect to provide U.S. Holders with the information necessary for a U.S. Holder to make a QEF election,
prospective investors should assume that a QEF election will not be available.

The U.S. federal
income tax rules relating to PFICs are very complex. Prospective U.S. investors are strongly urged to consult their own tax advisors
with respect to the impact of PFIC status on the purchase, ownership and disposition of our ADSs, the consequences to them of an
investment in a PFIC, any elections available with respect to the ADSs and the IRS information reporting obligations with respect
to the purchase, ownership and disposition of ADSs of a PFIC.

Distributions

Subject to the discussion
above under “— Passive Foreign Investment Company Rules,” a U.S. Holder that receives a distribution with respect
to our ADSs generally will be required to include the gross amount of such distribution in gross income as a dividend when actually
or constructively received by the U.S. Holder to the extent of the U.S. Holder’s pro rata share of our current and/or accumulated
earnings and profits (as determined under U.S. federal income tax principles). To the extent a distribution received by a U.S.
Holder is not a dividend because it exceeds the U.S. Holder’s pro rata share of our current and accumulated earnings and
profits, it will be treated first as a tax-free return of capital and reduce (but not below zero) the adjusted tax basis of the
U.S. Holder’s ADSs. To the extent the distribution exceeds the adjusted tax basis of the U.S. Holder’s ADSs, the remainder
will be taxed as capital gain. Because we may not account for our earnings and profits in accordance with U.S. federal income tax
principles, U.S. Holders should expect all distributions to be reported to them as dividends. The amount of a dividend will include
any amounts withheld by the company in respect of United Kingdom taxes.

Distributions on our
ADSs that are treated as dividends generally will constitute income from sources outside the United States for foreign tax credit
purposes and generally will constitute passive category income. Subject to applicable limitations, some of which vary depending
upon the U.S. Holder’s particular circumstances, any United Kingdom income taxes withheld from dividends on ADSs at a rate
not exceeding the rate provided by the Treaty will be creditable against the U.S. Holder’s U.S. federal income tax liability.
The rules governing foreign tax credits are complex and U.S. Holders should consult their tax advisers regarding the creditability
of foreign taxes in their particular circumstances. In lieu of claiming a foreign tax credit, U.S. Holders may, at their election,
deduct foreign taxes, including any United Kingdom income tax, in computing their taxable income, subject to generally applicable
limitations under U.S. law. An election to deduct foreign taxes instead of claiming foreign tax credits applies to all foreign
taxes paid or accrued in the taxable year. The amount of any dividend income paid in a currency other than the U.S. dollar will
be the U.S. dollar amount calculated by reference to the exchange rate in effect on the date of actual or constructive receipt,
regardless of whether the payment is in fact converted into U.S. dollars at that time. If the dividend is converted into U.S. dollars
on the date of receipt, a U.S. holder should not be required to recognize foreign currency gain or loss in respect of the dividend
amount. A U.S. Holder may have foreign currency gain or loss if the dividend is converted into U.S. dollars after the date of receipt.

Distributions paid
on our ADSs will not be eligible for the “dividends received” deduction generally allowed to corporate shareholders
with respect to dividends received from U.S. corporations under the Internal Revenue Code. Dividends paid by a “qualified
foreign corporation’’ to non-corporate U.S. Holders are eligible for taxation at a reduced capital gains rate rather
than the marginal tax rates generally applicable to ordinary income provided that a holding period requirement (more than 60 days
of ownership, without protection from the risk of loss, during the 121-day period beginning 60 days before the ex-dividend date)
and certain other requirements are met. Each U.S. Holder is advised to consult its tax advisors regarding the availability of the
reduced tax rate on dividends to its particular circumstances. However, if we are a PFIC for the taxable year in which the dividend
is paid or the preceding taxable year (see discussion above under “— Passive Foreign Investment Company Rules’’),
we will not be treated as a qualified foreign corporation, and therefore the reduced capital gains tax rate described above will
not apply.

A non-United States
corporation (other than a corporation that is classified as a PFIC for the taxable year in which the dividend is paid or the preceding
taxable year) generally will be considered to be a qualified foreign corporation with respect to any dividend it pays on ADSs that
are readily tradable on an established securities market in the United States.

The amount of any dividend
income that is paid in Pounds Sterling will be the U.S. dollar amount calculated by reference to the exchange rate in effect on
the date of receipt, regardless of whether the payment is in fact converted into U.S. dollars. If the dividend is converted into
U.S. dollars on the date of receipt (actual or constructive), a U.S. Holder should not be required to recognize foreign currency
gain or loss in respect of the dividend income. A U.S. Holder may have foreign currency gain or loss if the dividend is converted
into U.S. dollars after the date of receipt (actual or constructive).

Sale, Exchange or Other Taxable Disposition
of Our ADSs

Subject to the discussion
above under “— Passive Foreign Investment Company Rules,” a U.S. Holder generally will recognize capital gain
or loss for U.S. federal income tax purposes upon the sale, exchange or other disposition of our ADSs in an amount equal to the
difference, if any, between the amount realized (i.e., the amount of cash plus the fair market value of any property received)
on the sale, exchange or other disposition and such U.S. Holder’s adjusted tax basis in the ADSs. Such capital gain or loss
generally will be long-term capital gain taxable at a reduced rate for non-corporate U.S. Holders or long-term capital loss if,
on the date of sale, exchange or other disposition, the ADSs were held by the U.S. Holder for more than one year. Any capital gain
of a non-corporate U.S. Holder that is not long-term capital gain is taxed at ordinary income rates. The deductibility of capital
losses is subject to limitations. Any gain or loss recognized from the sale or other disposition of our ADSs will generally be
gain or loss from sources within the United States for U.S. foreign tax credit purposes.

Medicare Tax

Certain U.S. Holders
that are individuals, estates or trusts and whose income exceeds certain thresholds generally are subject to a 3.8% tax on all
or a portion of their net investment income, which may include their gross dividend income and net gains from the disposition of
our ADSs. If you are a U.S. Holder that is an individual, estate or trust, you are encouraged to consult your tax advisors regarding
the applicability of this Medicare tax to your income and gains in respect of your investment in our ADSs.

Information Reporting and Backup
Withholding

U.S. Holders may be
required to file certain U.S. information reporting returns with the IRS with respect to an investment in our ADSs, including,
among others, IRS Form 8938 (Statement of Specified Foreign Financial Assets). In addition, each U.S. Holder who is a shareholder
of a PFIC must file an annual report containing certain information. U.S. Holders paying more than $100,000 for our ADSs may be
required to file IRS Form 926 (Return by a U.S. Transferor of Property to a Foreign Corporation) reporting this payment. Substantial
penalties and other adverse circumstances may be imposed upon a U.S. Holder that fails to comply with the required information
reporting.

Dividends on and proceeds
from the sale or other disposition of our ADSs generally have to be reported to the IRS unless the U.S. Holder establishes a basis
for exemption. Backup withholding may apply to amounts subject to reporting if the holder (1) fails to provide an accurate U.S.
taxpayer identification number or otherwise establish a basis for exemption, or (2) is described in certain other categories of
persons. However, U.S. Holders that are corporations generally are excluded from these information reporting and backup withholding
tax rules.

Backup withholding
is not an additional tax. Any amounts withheld under the backup withholding rules generally will be allowed as a refund or a credit
against a U.S. Holder’s U.S. federal income tax liability if the required information is furnished by the U.S. Holder on
a timely basis to the IRS.

U.S. Holders should
consult their own tax advisors regarding the backup withholding tax and information reporting rules.

EACH PROSPECTIVE
INVESTOR IS URGED TO CONSULT ITS OWN TAX ADVISOR ABOUT THE TAX CONSEQUENCES TO IT OF AN INVESTMENT IN OUR ADSS IN LIGHT OF THE
INVESTOR’S OWN CIRCUMSTANCES. IN ADDITION, SIGNIFICANT CHANGES IN U.S. FEDERAL INCOME TAX LAWS WERE RECENTLY ENACTED. PROSPECTIVE
INVESTORS SHOULD ALSO CONSULT WITH THEIR TAX ADVISORS WITH RESPECT TO SUCH CHANGES IN U.S. TAX LAW AS WELL AS POTENTIAL CONFORMING
CHANGES IN STATE TAX LAWS.

U.K. Taxation

The following is intended
as a general guide to current U.K. tax law and HM Revenue & Customs, or HMRC, published practice applying as at the date of
this prospectus (both of which are subject to change at any time, possibly with retrospective effect) relating to the holding of
ADSs. It does not constitute legal or tax advice and does not purport to be a complete analysis of all U.K. tax considerations
relating to the holding of ADSs, or all of the circumstances in which holders of ADSs may benefit from an exemption or relief from
U.K. taxation. It is written on the basis that the company does not (and will not) directly or indirectly derive 75% or more of
its qualifying asset value from U.K. land, and that the company is and remains solely resident in the U.K. for tax purposes and
will therefore be subject to the U.K. tax regime and not the U.S. tax regime save as set out above under “U.S. Federal Income
Taxation.”

Except to the extent
that the position of non-U.K. resident persons is expressly referred to, this guide relates only to persons who are resident (and,
in the case of individuals, domiciled or deemed domiciled) for tax purposes solely in the U.K. and do not have a permanent establishment
or fixed base in any other jurisdiction with which the holding of the ADSs is connected, or U.K. Holders, who are absolute beneficial
owners of the ADSs (where the ADSs are not held through an Individual Savings Account or a Self-Invested Personal Pension) and
who hold the ADSs as investments.

This guide may not
relate to certain classes of U.K. Holders, such as (but not limited to):

persons who are connected with the company;

financial institutions;

insurance companies;

charities or tax-exempt organizations;

collective investment schemes;

market makers, intermediaries, brokers or dealers in securities;

persons who have (or are deemed to have) acquired their ADSs by virtue of an office or employment or who are or have been officers or employees of the company or any of its affiliates; e

individuals who are subject to U.K. taxation on a remittance basis.

The decision of the
First-tier Tribunal (Tax Chamber) in HSBC Holdings PLC and The Bank of New York Mellon Corporation v HMRC (2012) cast some
doubt on whether a holder of a depositary receipt is the beneficial owner of the underlying shares. However, based on published
HMRC guidance we would expect that HMRC will regard a holder of ADSs as holding the beneficial interest in the underlying shares
and therefore these paragraphs assume that a holder of ADSs is the beneficial owner of the underlying ordinary shares and any dividends
paid in respect of the underlying ordinary shares (where the dividends are regarded for U.K. purposes as that person’s own
income) for U.K. direct tax purposes.

THESE PARAGRAPHS
ARE A SUMMARY OF CERTAIN U.K. TAX CONSIDERATIONS AND ARE INTENDED AS A GENERAL GUIDE ONLY. IT IS RECOMMENDED THAT ALL HOLDERS OF
ADSs OBTAIN ADVICE AS TO THE CONSEQUENCES OF THE ACQUISITION, OWNERSHIP AND DISPOSAL OF THE ADSs IN THEIR OWN SPECIFIC CIRCUMSTANCES
FROM THEIR OWN TAX ADVISORS. IN PARTICULAR, NON-U.K. RESIDENT OR DOMICILED PERSONS ARE ADVISED TO CONSIDER THE POTENTIAL IMPACT
OF ANY RELEVANT DOUBLE TAXATION AGREEMENTS.

Dividends

Withholding Tax

Dividends paid by the
company will not be subject to any withholding or deduction for or on account of U.K. tax, irrespective of the residence or particular
circumstances of the holders of ADSs.

Income Tax

An individual U.K.
Holder may, depending on his or her particular circumstances, be subject to U.K. tax on dividends received from the company. An
individual holder of ADSs who is not resident for tax purposes in the United Kingdom should not be chargeable to U.K. income tax
on dividends received from the company unless he or she carries on (whether solely or in partnership) a trade, profession or vocation
in the U.K. through a branch or agency to which the ADSs are attributable. There are certain exceptions for trading in the U.K.
through independent agents, such as some brokers and investment managers.

All dividends received
by an individual U.K. Holder from us or from other sources will form part of that U.K. Holder’s total income for income tax
purposes and will constitute the top slice of that income. A nil rate of income tax will apply to the first £2,000 of taxable
dividend income received by the individual U.K. Holder in a tax year. Income within the nil-rate band will be taken into account
in determining whether income in excess of the £2,000 tax-free allowance falls within the basic rate, higher rate or additional
rate tax bands. Dividend income in excess of the tax-free allowance will (subject to the availability of any income tax personal
allowance) be taxed at 7.5 per cent. to the extent that the excess amount falls within the basic rate tax band, 32.5 per cent.
to the extent that the excess amount falls within the higher rate tax band and 38.1 per cent. to the extent that the excess amount
falls within the additional rate tax band.

Corporation Tax

A corporate holder
of ADSs who is not resident for tax purposes in the United Kingdom should not be chargeable to U.K. corporation tax on dividends
received from the company unless it carries on (whether solely or in partnership) a trade in the United Kingdom through a permanent
establishment to which the ADSs are attributable.

Corporate U.K. Holders
should not be subject to U.K. corporation tax on any dividend received from the company so long as the dividends qualify for exemption,
which should be the case, provided the dividends fall within an exempt class and certain conditions are met. If the conditions
for the exemption are not satisfied, or such U.K. Holder elects for an otherwise exempt dividend to be taxable, U.K. corporation
tax will be chargeable on the amount of any dividends (at the current rate of 19%).

Chargeable Gains

A disposal or deemed
disposal of ADSs by a U.K. Holder may, depending on the U.K. Holder’s circumstances and subject to any available exemptions
or reliefs (such as the annual exemption), give rise to a chargeable gain or an allowable loss for the purposes of U.K. capital
gains tax and corporation tax on chargeable gains.

If an individual U.K.
Holder who is subject to U.K. income tax at either the higher or the additional rate is liable to U.K. capital gains tax on the
disposal of ADSs, the current applicable rate will be 20%. For an individual U.K. Holder who is subject to U.K. income tax at the
basic rate and liable to capital gains tax on such disposal, the current applicable rate would be 10%, save to the extent that
any capital gains when aggregated with the U.K. Holder’s other taxable income and gains in the relevant tax year exceed the
unused basic rate tax band. In that case, the rate currently applicable to the excess would be 20%.

If a corporate U.K.
Holder becomes liable to U.K. corporation tax on the disposal (or deemed disposal) of ADSs, the main rate of U.K. corporation tax
(currently 19%) would apply. Indexation allowance is not available in respect of disposals of ADSs acquired on or after January
1, 2018 (and only covers the movement in the retail prices index up until 31 December 2017, in respect of assets acquired prior
to that date). A holder of ADSs which is not resident for tax purposes in the United Kingdom should not normally be liable to U.K.
capital gains tax or corporation tax on chargeable gains on a disposal (or deemed disposal) of ADSs unless the person is carrying
on (whether solely or in partnership) a trade, profession or vocation in the United Kingdom through a branch or agency (or, in
the case of a corporate holder of ADSs, through a permanent establishment) to which the ADSs are attributable. However, an individual
holder of ADSs who is treated as resident outside the United Kingdom for the purposes of a double tax treaty, or who has ceased
to be resident for tax purposes in the United Kingdom for a period of less than five years and who disposes of ADSs during that
period may be liable on his or her return to the United Kingdom to U.K. tax on any capital gain realized (subject to any available
exemption or relief).

Stamp Duty and Stamp Duty Reserve Tax

The discussion below
relates to the holders of our ordinary shares or ADSs wherever resident, however it should be noted that special rules may apply
to certain persons such as market makers, brokers, dealers or intermediaries.

Issue of Shares

No U.K. stamp duty
or stamp duty reserve tax, or SDRT, is payable on the issue of the underlying ordinary shares in the company.

Transfers of Shares

Neither U.K. stamp
duty nor SDRT should arise on transfers of the underlying ordinary shares (including instruments transferring ordinary shares and
agreements to transfer ordinary shares) on the basis that the ordinary shares are admitted to trading on AIM, provided the following
requirements are (and continue to be) met:

the ordinary shares are admitted to trading on AIM, but are not listed on any market (with the term “listed” being construed in accordance with section 99A of the Finance Act 1986), and this has been certified to Euroclear; e
AIM continues to be accepted as a “recognized growth market” as construed in accordance with section 99A of the Finance Act 1986).

In the event that either
of the above requirements is not met, stamp duty or SDRT will generally apply to transfers of, or agreements to transfer, ordinary
shares. Where applicable, the purchaser normally pays the stamp duty or SDRT.

Issue and Transfers of ADSs

No U.K. stamp duty
or SDRT is payable on the issue or transfer of (including an agreement to transfer) ADSs in the company.

F. Dividends and Paying Agents

Not applicable.

G. Statements by Experts

Not applicable

H. Documents on Display

We are subject to the
informational requirements of the Exchange Act. Accordingly, we are required to file reports and other information with the SEC,
including annual reports on Form 20-F and reports on Form 6-K. You may inspect and copy reports and other information filed with
the SEC at the public reference facilities of the SEC located at 100 F Street, N.E., Washington, D.C. 20549. You may also obtain
copies of the documents at prescribed rates by writing to the Public Reference Section of the SEC at 100 F Street, N.E., Washington,
DC 20549. Please call the SEC at 1-800-SEC-0330 for further information on the public reference room. The SEC also maintains a
website at http://www.sec.gov from which certain filings may be accessed.

We also make available
on our website, free of charge, our Annual Report and the text of our reports on Form 6-K, including any amendments to these reports,
as well as certain other SEC filings, as soon as reasonably practicable after they are electronically filed with or furnished to
the SEC. Our website address is “www.tizianalifesciences.com.” The information contained on our website is not incorporated
by reference in this Annual Report.

I. Subsidiary Information

For information on
our subsidiaries, see “Item 4C. Organizational Structure.”

ITEM 11: QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET
RISK

We are exposed to market
risks in the ordinary course of our business, which are principally limited to interest rate fluctuations and foreign currency
exchange rate fluctuations. We maintain significant amounts of cash and cash equivalents that are in excess of federally insured
limits in various currencies, placed with one or more financial institutions for varying periods according to expected liquidity
requirements.

Interest Rate Risk

Our exposure to interest
rate sensitivity is impacted by changes in the underlying U.S. and U.K. bank interest rates. Our surplus cash and cash equivalents
have been invested in interest-bearing savings and money market accounts from time to time. We have not entered into investments
for trading or speculative purposes. Due to the conservative nature of our investment portfolio, which is predicated on capital
preservation of investments with short-term maturities, we do not believe an immediate one percentage point change in interest
rates would have a material effect on the fair market value of our portfolio, and therefore we do not expect our operating results
or cash flows to be significantly affected by changes in market interest rates.

Foreign Currency Exchange Risk

We maintain our consolidated
financial statements in the functional currency pounds Sterling. Monetary assets and liabilities denominated in currencies other
than the functional currency are translated into the functional currency at rates of exchange prevailing at the balance sheet dates.
Non-monetary assets and liabilities denominated in foreign currencies are translated into the functional currency at the exchange
rates prevailing at the date of the transaction. Exchange gains or losses arising from foreign currency transactions are included
in the determination of net income (loss) for the respective periods.

For financial reporting
purposes, our consolidated financial statements are prepared using the functional currency, and translated into the U.S. dollar.
Assets and liabilities are translated at the exchange rates at the balance sheet dates and revenue and expenses are translated
at the average exchange rates and shareholders’ equity is translated based on historical exchange rates. Translation adjustments
are not included in determining net income (loss) but are included in foreign exchange adjustment to accumulate other comprehensive
loss, a component of shareholders’ equity.

We do not currently
engage in currency hedging activities in order to reduce our currency exposure, but we may begin to do so in the future. Instruments
that may be used to hedge future risks may include foreign currency forward and swap contracts. These instruments may be used to
selectively manage risks, but there can be no assurance that we will be fully protected against material foreign currency fluctuations.

ITEM 12: DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES

A. Debt Securities

Not
applicable.

B. Warrants and Rights

Not
applicable.

C. Other Securities

Not
applicable.

D. American Depositary Shares

Fees
and Expenses

JPMorgan
Chase Bank, N.A., or JPMorgan, as depositary, registers and delivers the American Depositary Shares, also referred to as ADSs.
Each ADS represents an ownership interest in a designated number of ordinary shares that are on deposit with the custodian, as
agent of the depositary, under the deposit agreement among ourselves, the depositary and the ADS holders. Each ADS will also represent
any securities, cash or other property deposited with the depositary but which they have not distributed directly to the ADS holders.
The depositary’s office is located at 4 New York Plaza, Floor 12, New York, NY, 10004. A copy of the deposit agreement is
incorporated by reference as an exhibit to this Annual Report on Form 20-F.

Il
depositary may charge each person to whom ADSs are issued, including, without limitation, issuances against deposits of ordinary
shares, issuances in respect of share distributions, rights and other distributions, issuances pursuant to a stock dividend or
stock split declared by us or issuances pursuant to a merger, exchange of securities or any other transaction or event affecting
the ADSs or deposited securities, and each person surrendering ADSs for withdrawal of deposited securities or whose ADSs are cancelled
or reduced for any other reason, $5.00 for each 100 ADSs (or any portion thereof) issued, delivered, reduced, cancelled or surrendered,
as the case may be. The depositary may sell (by public or private sale) sufficient securities and property received in respect
of a share distribution, rights and/or other distribution prior to such deposit to pay such charge.

Il
following additional charges shall be incurred by the ADR holders, by any party depositing or withdrawing ordinary shares or by
any party surrendering ADSs and/or to whom ADSs are issued (including, without limitation, issuance pursuant to a stock dividend
or stock split declared by us or an exchange of stock regarding the ADSs or the deposited securities or a distribution of ADSs),
whichever is applicable:

a fee of U.S.$1.50 per ADR or ADRs for transfers of certificated or direct registration ADRs;

a fee of up to U.S.$0.05 per ADS for any cash distribution made pursuant to the deposit agreement;

an aggregate fee of up to U.S.$0.05 per ADS per calendar year (or portion thereof) for services performed by the depositary in administering the ADRs (which fee may be charged on a periodic basis during each calendar year and shall be assessed against holders of ADRs as of the record date or record dates set by the depositary during each calendar year and shall be payable in the manner described in the next succeeding provision);

a fee for the reimbursement of such fees, charges and expenses as are incurred by the depositary and/or any of its agents (including, without limitation, the custodian and expenses incurred on behalf of holders in connection with compliance with foreign exchange control regulations or any law or regulation relating to foreign investment) in connection with the servicing of the ordinary shares or other deposited securities, the sale of securities (including, without limitation, deposited securities), the delivery of deposited securities or otherwise in connection with the depositary’s or its custodian’s compliance with applicable law, rule or regulation (which fees and charges shall be assessed on a proportionate basis against holders as of the record date or dates set by the depositary and shall be payable at the sole discretion of the depositary by billing such holders or by deducting such charge from one or more cash dividends or other cash distributions);

a fee for the distribution of securities (or the sale of securities in connection with a distribution), such fee being in an amount equal to the $0.05 per ADS issuance fee for the execution and delivery of ADSs which would have been charged as a result of the deposit of such securities (treating all such securities as if they were ordinary shares) but which securities or the net cash proceeds from the sale thereof are instead distributed by the depositary to those holders entitled thereto;

stock transfer or other taxes and other governmental charges;

SWIFT, cable, telex and facsimile transmission and delivery charges incurred at your request in connection with the deposit or delivery of ordinary shares, ADRs or deposited securities;

transfer or registration fees for the registration or transfer of deposited securities on any applicable register in connection with the deposit or withdrawal of deposited securities;

in connection with the conversion of foreign currency into U.S. dollars, JPMorgan Chase Bank, N.A. (“JPMorgan”) shall deduct out of such foreign currency the fees, expenses and other charges charged by it and/or its agent (which may be a division, branch or affiliate) so appointed in connection with such conversion; e

fees of any division, branch or affiliate of the depositary utilized by the depositary to direct, manage and/or execute any public and/or private sale of securities under the deposit agreement.

J.P. Morgan, and/or
its agent may act as principal for such conversion of foreign currency. For further details see https://www.adr.com.

We will pay all other
charges and expenses of the depositary and any agent of the depositary (except the custodian) pursuant to agreements from time
to time between us and the depositary. The charges described above may be amended from time to time by agreement between us and
the depositary. The right of the depositary to receive payment of fees, charges and expenses as provided above shall survive the
termination of the deposit agreement.

The depositary may
make available to us a set amount or a portion of the depositary fees charged in respect of the ADR program or otherwise upon such
terms and conditions as we and the depositary may agree from time to time. The depositary collects its fees for issuance and cancellation
of ADSs directly from investors depositing ordinary shares or surrendering ADSs for the purpose of withdrawal or from intermediaries
acting for them. The depositary collects fees for making distributions to investors by deducting those fees from the amounts distributed
or by selling a portion of distributable property to pay the fees. The depositary may collect its annual fee for depositary services
by deduction from cash distributions, or by directly billing investors, or by charging the book-entry system accounts of participants
acting for them. The depositary will generally set off the amounts owing from distributions made to holders of ADSs. If, however,
no distribution exists and payment owing is not timely received by the depositary, the depositary may refuse to provide any further
services to holders that have not paid those fees and expenses owing until such fees and expenses have been paid. At the discretion
of the depositary, all fees and charges owing under the deposit agreement are due in advance and/or when declared owing by the
depositary.

Payment of Taxes

If any taxes or other
governmental charges (including any penalties and/or interest) shall become payable by or on behalf of the custodian or the depositary
with respect to any ADR, any deposited securities represented by the ADSs evidenced thereby or any distribution thereon, such tax
or other governmental charge shall be paid by the holder thereof to the depositary and by holding or having held an ADR the holder
and all prior holders thereof, jointly and severally, agree to indemnify, defend and save harmless each of the depositary and its
agents in respect thereof. If an ADR holder owes any tax or other governmental charge, the depositary may (i) deduct the amount
thereof from any cash distributions, or (ii) sell deposited securities by public or private sale (after attempting by reasonable
means to notify the ADR holder hereof prior to such sale) and deduct the amount owing from the net proceeds of such sale. In either
case the ADR holder remains liable for any shortfall. If any tax or governmental charge is unpaid, the depositary may also refuse
to effect any registration, registration of transfer, split-up or combination of deposited securities or withdrawal of
deposited securities until such payment is made. If any tax or governmental charge is required to be withheld on any cash distribution,
the depositary may deduct the amount required to be withheld from any cash distribution or, in the case of a non-cash distribution,
sell the distributed property or securities (by public or private sale) in such amounts and in such manner as the depositary deems
necessary and practicable to pay such taxes and distribute any remaining net proceeds or the balance of any such property after
deduction of such taxes to the ADR holders entitled thereto.

By holding an ADR or
an interest therein, you will be agreeing to indemnify us, the depositary, its custodian and any of our or their respective officers,
directors, employees, agents and affiliates against, and hold each of them harmless from, any claims by any governmental authority
with respect to taxes, additions to tax, penalties or interest arising out of any refund of taxes, reduced rate of withholding
at source or other tax benefit obtained.

PART II

ITEM 13: DEFAULTS, DIVIDEND ARREARAGES AN DELINQUENCIES

None.

ITEM 14: MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY
HOLDERS AND USE OF PROCEEDS

None.

ITEM 15: CONTROLS AND PROCEDURES

Evaluation of Disclosure Controls and Procedures

Disclosure Controls and Procedures

The Company’s
management, with the participation of the Company’s Chief Executive Officer and Chief Financial Officer, have evaluated the
effectiveness of the Company’s disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e)
under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) as of December 31, 2019.
Based on that evaluation, the Company’s Chief Executive Officer and the Company’s Chief Financial Officer have concluded
that as of  December 31, 2019, due to the existence of the material weaknesses in the Company’s internal control
over financial reporting described below, the Company’s disclosure controls and procedures were not effective.

Management’s Annual Report on Internal Control over
Financial Reporting

The Company’s management is responsible
for establishing and maintaining adequate internal controls over financial reporting as defined in Rules 13a-15(f) and 15d-15(f)
under the Exchange Act. The Company’s internal control over financial reporting is a process designed to provide reasonable
assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in
accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB),
and IFRIC interpretations as applicable to companies reporting under IFRS.

Because of their inherent limitations,
internal controls over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness
to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree
of compliance with the policies or procedures may deteriorate.

Under the supervision and with the participation
of management, the Company’s Chief Executive Officer and the Company’s Chief Financial Officer, the Company conducted
an evaluation of the effectiveness of its internal control over financial over financial reporting based on the framework described
in Internal Control-Integrated Framework issued by the Commission of Sponsoring Organizations of the Treadway Commission, as revised
in 2013. Based on that evaluation, management has concluded that the Company did not maintain effective internal control over
financial reporting as of the period ended December 31, 2019 due to the existence of the material weaknesses in internal
control over financial reporting described below.

Material Weaknesses

A deficiency in
internal control over financial reporting exists when the design or operation of a control does not allow management or
employees, in the normal course of performing their assigned functions, to prevent or detect misstatements on a timely basis.
A material weakness is a deficiency, or a combination of deficiencies, in internal controls over financial reporting, such
that there is a reasonable possibility that a material misstatement of the Company’s annual or interim financial
statements will not be prevented or detected on a timely basis.

Management has determined
that the Company did not maintain effective internal control over financial reporting as of the period ended December 31,
2019 due to the existence of the following material weaknesses identified by management. The material weaknesses identified
below did not result in a material misstatement of our consolidated financial statements, and management believes that our consolidated
financial statements present fairly the consolidated financial position, results of operations and cash flows for the periods
covered. However, management recognizes that the failure of the internal control over financial reporting to operate effectively
as described below could have resulted in a material misstatement which may not have been detected by our controls:

Lack of Accounting Resources

Due to the limited financial
resources available for expenditure other than research and development, the Company had a lack of accounting resources resulting
in over reliance on professional opinions, a weakness in monitoring controls and other oversight procedures, which resulted in
corrected  misstatements.

Control Environment

The Company did not maintain an effective control environment.
The control environment, which is the responsibility of senior management, sets the tone of the organization, influences the control
consciousness of its people, and is the foundation for all other components of internal control over financial reporting. Our control
environment was ineffective because:

We developed a Code of Ethics policy,which should be communicated
and acknowledged by all employees, officers, and directors on an annual basis; the policy was developed but not communicated or
acknowledged.

We did not timely develop and communicate an employee handbook for employees to consult in the event an issue arises; e
We did not complete formal performance evaluations for employees responsible for governance and internal controls.

Remediation efforts

Management intends to remediate
this item in the following manner:

i. Additional funds have been made available from recent fundraising to enable the Company to address its lack of accounting resources.

ii Periodic assessments will be performed to evaluate the sufficiency of the Company’s accounting resources and needs for recruiting additional personnel, in addition to providing our accounting personnel with regular training over applicable IFRS accounting standards, complex accounting and financial reporting subject matter, and SEC reporting.

iii. Perform a recertification, at least annually, of all employees that they have read and understand the Company’s Code of Ethics.

iv. Develop and maintain an Employee Handbook, for employees to reference.
v. Perform evaluations of all employees who impact Internal Controls over Financial Reporting.

We intend to complete the
remediation of the material weaknesses discussed above as soon as practicable, but we can give no assurance that we will be able
to do so. Designing and implementing effective disclosure controls and procedures is a continuous effort that requires us to anticipate
and react to changes in our business and the economic and regulatory environments and to devote significant resources to maintain
a financial reporting system that adequately satisfies our reporting obligations. The remedial measures that we have taken and
intend to take may not fully address the material weaknesses that we have identified, and material weaknesses in our disclosure
controls and procedures may be identified in the future. Should we discover such conditions, we intend to remediate them as soon
as practicable. We are committed to taking appropriate steps for remediation, as needed.

ITEM 16A: AUDIT COMMITTEE FINANCIAL EXPERT

The members of our
audit committee are Mr Willy Simon and Mr. Gregor MacRae. Mr. Willy Simon is the chair of the audit committee. Each of our
audit committee members satisfies the independence requirements of Rule 5605(a)(2) of the Nasdaq Stock Market Marketplace Rules
and the independence requirements of Rule 10A-3(b)(1) under the Exchange Act. Our board of directors has determined that Mr. Willy
Simon is an “audit committee financial expert” as defined in Item 16A of Form 20-F.

ITEM 16B: CODE OF ETHICS

Our Code of Business
Conduct and Ethics is applicable to all of our employees, officers and directors and is available on our website at https://www.tizianalifesciences.com.
Our Code of Business Conduct and Ethics provides that our directors and officers are expected to avoid any action, position or
interest that conflicts with the interests of our company or gives the appearance of a conflict. Our directors and officers have
an obligation under our Code of Business Conduct and Ethics to advance our company’s interests when the opportunity to do
so arises. We expect that any amendment to this code, or any waivers of its requirements, will be disclosed on our website. Information
contained on, or that can be accessed through, our website is not incorporated by reference into this Annual Report, and you should
not consider information on our website to be part of this Annual Report.

ITEM 16C: PRINCIPAL ACCOUNTANT FEES AND SERVICES

The following table
sets forth, for each of the years indicated, the aggregate fees billed to us for services rendered by Mazars, our independent registered
public accounting firm.

Year Ending December 31,
2019 2018
(in thousands)
Audit fees 104 56
Other assurance services 71 57
Total 175 113

ITEM 16D: EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT
COMMITTEES

Not applicable.

ITEM 16E: PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND
AFFILIATED PURCHASERS

None.

ITEM 16F: CHANGE IN REGISTRANTS CERTIFYING ACCOUNTANT

None.

ITEM 16G: CORPORATE GOVERNANCE

The Sarbanes-Oxley
Act of 2002, as well as related rules subsequently implemented by the SEC, requires foreign private issuers, including our company,
to comply with various corporate governance practices. In addition, Nasdaq rules provide that foreign private issuers may follow
home country practice in lieu of the Nasdaq corporate governance standards, subject to certain exceptions and except to the extent
that such exemptions would be contrary to U.S. federal securities laws. The home country practices followed by our company in lieu
of Nasdaq rules are described below:

We do not follow Nasdaq’s quorum requirements applicable to meetings of shareholders. Such quorum requirements are not required under U.K. law. In accordance with generally accepted business practice, our articles of association provide alternative quorum requirements that are generally applicable to meetings of shareholders.

We do not follow Nasdaq’s requirements that non-management directors meet on a regular basis without management present. Our board of directors may choose to meet in executive session at their discretion.

We do not follow Nasdaq’s requirements to seek shareholder approval for the implementation of certain equity compensation plans, the issuances of ordinary shares under such plans, or in connection with certain private placements of equity securities. In accordance with U.K. law, we are not required to seek shareholder approval to allot ordinary shares in connection with applicable employee equity compensation plans. We will follow U.K. law with respect to any requirement to obtain shareholder approval prior to any private placements of equity securities.

We intend to take all
actions necessary for us to maintain compliance as a foreign private issuer under the applicable corporate governance requirements
of the Sarbanes-Oxley Act of 2002, the rules adopted by the SEC and Nasdaq’s listing standards.

Because we are a foreign
private issuer, our directors and senior management are not subject to short-swing profit and insider trading reporting obligations
under Section 16 of the U.S. Securities Exchange Act of 1934, as amended, or Exchange Act. They are, however, subject to the obligations
to report changes in share ownership under Section 13 of the Exchange Act and related SEC rules.

ITEM 16H: MINE SAFETY DISCLOSURE

Not applicable.

PART III

ITEM 17: FINANCIAL STATEMENTS

We have elected to furnish financial statements
and related information specified in Item 18.

ITEM 18: FINANCIAL STATEMENTS

See the Financial Statements beginning on
page F-1.

ITEM 19: EXHIBITS

Exhibit
No.
Descrizione
3.1 Memorandum and Articles of Association of Tiziana Life Sciences PLC. (incorporated by reference to Exhibit 3.1 to Amendment No. 1 to Form F-1 filed on August 23, 2018).
2.1 Form of Deposit Agreement.  incorporated by reference to Exhibit 4.1 to Amendment No. 2 to Form F-1 filed on September 25, 2018).
2.2 Form of American Depositary Receipt (included in Exhibit 4.1).
4.1 License Agreement relating to Milciclib between Nerviana Medical Services S.r.l. and Tiziana Life Sciences PLC, dated January 2015 (incorporated by reference to Exhibit 10.1 to Amendment No. 1 to Form F-1 filed on August 23, 2018).
4.2 License and Sublicence Agreement relating to CD3 (NI-0401) between Novimmune SA and Tiziana Life Sciences PLC, dated December 2014. incorporated by reference to Exhibit 10.2 to Amendment No. 1 to Form F-1 filed on August 23, 2018).
4.3 License and Sublicence Agreement relating to IL-6r (NI-1201) between Novimmune SA and Tiziana Life Sciences PLC, dated December 2016. (incorporated by reference to Exhibit 10.3 to Amendment No. 1 to Form F-1 filed on August 23, 2018).
4.4 License Agreement relating to a novel formulation of Foralumab in a medical device for nasal administration between The Brigham and Women’s Hospital, Inc. and Tiziana Life Sciences plc, dated April 2018. (incorporated by reference to Exhibit 10.4 to Amendment No. 1 to Form F-1 filed on August 23, 2018).
4.5* Annual Lease for 55 Park Lane, Suite 14a, London W1K 1NA, United Kingdom, dated June 29, 2018.
4.6 Five-Year Lease for 420 Lexington Avenue, Suite 2525, New York, United States, dated August 2, 2016.
4.7 Annual Lease for 3084 Old Easton Road, Doylestown, Pennsylvania, United States, as amended, dated October 1, 2018. (incorporated by reference to Exhibit 10.6 to Amendment No. 1 to Form F-1 filed on August 23, 2018).
4.8 Tiziana Life Sciences plc Employee Share Option Plan, with Non-Employee Sub-Plan and US Sub-Plan, adopted by the Board on 23 March 2016 and approved by shareholders on June 30, 2016. (incorporated by reference to Exhibit 4.7 to Form 20-F filed on April 4, 2019).
4.9 Amended
and Restated Service Agreement dated July 11, 2019, between the Registrant and Dr. Kunwar Shailubhai (incorporated by reference
to Exhibit 10.9 to Amendment No. 2 to Form F-1 filed on July 11, 2019)
4.10 Form of Deed of Indemnity for board members. (incorporated by reference to Exhibit 10.10 to Amendment No. 1 to Form F-1 filed on August 23, 2018).
4.11 ATM Sales Agreement dated April 10, 2020 by and between Tiziana Life Sciences plc and ThinkEquity, a division of Fordham Financial Management, Inc. (incorporated by reference to Exhibit 1.1 to Form 6-K filed on April 14, 2020).
8.1 List of Subsidiaries.
12.1* Certification by the Principal Executive Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a) as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
12.2* Certification by
the Principal Financial Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a) as adopted pursuant to Section
302 of the Sarbanes-Oxley Act of 2002.
13.1* Certification by the Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
13.2* Certification by the Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
15.1* Consent of Mazars LLP.

SIGNATURES

The Registrant hereby
certifies that it meets all of the requirements for filing on Form 20-F and that it has duly caused and authorized the undersigned
to sign this registration statement on its behalf.

Tiziana Life Sciences plc
By: /s/ Kunwar Shailubhai
Kunwar Shailubhai
Chief Executive Officer
Date: June 17, 2020

INDEX TO CONSOLIDATED FINANCIAL STATEMENTS

TIZIANA LIFE SCIENCES PLC

Financial Statements and Notes to Financial
Statements to be provided under separate cover

REPORT OF INDEPENDENT REGISTERED PUBLIC
ACCOUNTING FIRM

The Board of Directors and Shareholders of Tiziana Life Sciences
plc

Opinion on the Consolidated Financial
Statements

We have audited the accompanying consolidated
balance sheet of Tiziana Life Sciences plc and its subsidiaries (the Group) as of December 31, 2019 and 2018, together with the
related consolidated statements of operations and comprehensive loss, changes in shareholders’ equity, and cash flows for
each of the three years in the period ended December 31, 2019, including the related notes (collectively, the consolidated financial
statements). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position
of the Group as of December 31, 2019 and 2018, and the results of its operations and its cash flows for each of the three years
in the period ended December 21, 2019, in conformity with International Financial Reporting Standards as issued by the International
Accounting Standards Board.

Material uncertainty related to going
concern

We draw attention to note 2 in the financial
statements concerning the applicability of the going concern basis of preparation. The Group is pre revenue and its business model
requires significant ongoing expenditure on research and development. In the period to December 31, 2019 the Group incurred losses
after taxation of $9,323,000. At December 31, 2019 the Group had net liabilities of $5,514,000 and cash and cash equivalents of
$200,000. In note 2 the directors explain that to date they have successfully raised funds to finance clinical trials. Subsequent
to the year end the Group has raised $12m in new equity. However, further significant funding will be required to continue their
development programmes and to meet liabilities as they fall due. As the directors are confident that the Group will raise the
additional funding they have prepared the consolidated financial statements on the going concern basis. The Group needs to secure
sufficient investment to fund their clinical trials in full, and ongoing working capital requirements. These conditions indicate
that a material uncertainty exists about the Group’s ability to continue as a going concern beyond 12 months.

Our opinion is not modified in respect
of this matter.

Basis for Opinion

These consolidated financial statements are the responsibility
of the company’s management. Our responsibility is to express an opinion on these consolidated financial statements based
on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB)
and are required to be independent with respect to the Group in accordance with the U.S. federal securities laws and the applicable
rules and regulations of the Securities and Exchange Commission and the PCAOB. The Company is not required to have, nor were we
engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain
an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness
of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.

We conducted our audits in accordance with
the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether
the consolidated financial statements are free of material misstatement, whether due to error or fraud. Our audits included performing
procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud,
and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding
the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles
used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial
statements. We believe that our audits provide a reasonable basis for our opinion.

/s/ Mazars LLP

London, England

17 giugno 2020

TIZIANA LIFE SCIENCES PLC

Consolidated Balance Sheets

(In thousands)

Year ended
December 31,
2019 2018
(restated)
$ $
ASSETS
Current assets:
Cash and cash equivalents 200 5,304
Prepayments and other receivables 165 567
Finance lease receivable 143
Taxation receivable 675 1,018
Related party receivables 322 24
Total current assets 1,505 6,913
Property and Equipment, net 6 7
Finance lease receivable 149
Right of use asset 433