Inactive Instrument

Tiziana Life London S.E.

Equities

TILS

GB00BKWNZY55

Biotechnology & Medical Research

Tiziana Life Sciences : Admission of the Issued Share Capital to the Official List (by way of a Standard Listing under Chapter 14 of the Listing Rules) and to trading on the main market for listed securities of the London Stock Exchange

December 18, 2020 at 01:31 pm

THIS PROSPECTUS IS IMPORTANT AND REQUIRES YOUR IMMEDIATE ATTENTION. If you are in any doubt about the contents of this prospectus or the action you should take, you are recommended to seek your own ﬁnancial advice immediately from an appropriately authorised stockbroker, bank manager, solicitor, accountant or other independent ﬁnancial adviser who, if you are taking advice in the United Kingdom ("UK"), is duly authorised under the Financial Services and Markets Act 2000 ("FSMA").

If you have sold or otherwise transferred all of your registered holding of ordinary shares of nominal value 3 pence each (each, an "Ordinary Share") in the capital of Tiziana Life Sciences plc (the "Company" or "Tiziana"), please forward this prospectus at once to the purchaser or transferee or to the bank, stockbroker or other agent through whom or by whom the sale or transfer was made, for delivery to the purchaser or transferee. However, this prospectus and any accompanying documents should not be sent or transmitted in, or into, any jurisdiction where to do so might constitute a violation of local securities law or regulations. If you have sold only part of your holding of Ordinary Shares, please contact the bank, stockbroker or other agent through whom or by whom the sale or transfer was made immediately.

This prospectus comprises a prospectus relating to the Company prepared in accordance with the prospectus regulation rules of the Financial Conduct Authority (the "FCA") made under section 73A of FSMA (the "Prospectus Regulation Rules") and approved by the FCA as competent authority under Regulation (EU) 2017/1129 (the "Prospectus Regulation"). The FCA only approves this prospectus as meeting the standards of completeness, comprehensibility and consistency imposed by the Prospectus Regulation. Such approval shall not be considered an endorsement of the quality of the securities that are the subject of this prospectus. Investors should make their own assessment as to the suitability of investing in the securities.

This prospectus has been ﬁled with the FCA and made available to the public in accordance with Rule 3.2 of the Prospectus Regulation Rules.

The Company's entire issued share capital comprising the Ordinary Shares (the "Existing Issued Share Capital") as at the date of this prospectus is admitted to trading on the AIM market of London Stock Exchange plc (the "London Stock Exchange").

Applications will be made for the Company's entire issued share capital comprising in aggregate 194,612,289 existing Ordinary Shares (the "Existing Ordinary Shares"), of which 67,127,894 Ordinary Shares are represented by American Depositary Shares ("ADSs") and traded on NASDAQ, to be admitted to a Standard Listing on the Ofﬁcial List and to trading on the Main Market of the London Stock Exchange (together, "Admission"). It is expected that Admission will become effective, and that unconditional dealings in the Ordinary Shares will commence, at 8.00 a.m. on 21 January 2021.

The whole of the text of this prospectus should be read by prospective investors. Your attention is speciﬁcally drawn to the discussion of certain risks and other factors that should be considered in connection with an investment in the Ordinary Shares, as set out in Part II - Risk Factors of this prospectus.

The Company and the directors, whose names appear on page 46 of this prospectus (the "Directors"), accept responsibility for the information contained in this prospectus. To the best of the knowledge of the Directors and the Company, the information contained in this prospectus is in accordance with the facts and this prospectus makes no omission likely to affect its import.

Tiziana Life Sciences plc

(Incorporated in England and Wales with registered number 03508592)

Admission of the Issued Share Capital to the Ofﬁcial List

(by way of a Standard Listing under Chapter 14 of the Listing Rules)

and to trading on the main market for listed securities of the London Stock Exchange

Sole Broker and Co-ordinator

Optiva Securities Limited ("Optiva"), which is authorised and regulated by the FCA, is acting solely for the Company and noone else in connection with Admission and will not regard any other person (whether or not a recipient of this prospectus) as a client in relation to Admission and will not be responsible to anyone other than the Company for providing the protections afforded to its clients or for providing advice in relation to Admission or any other matter referred to herein. Optiva has not authorised the contents of, or any part of, this prospectus and no liability whatsoever is accepted by Optiva nor does it make any representation or warranty, express or implied, for the accuracy or completeness of any information or opinion contained in this prospectus or for the omission of any information. Nothing in this prospectus shall be relied upon as a promise or representation in this respect, whether as to the past or the future (without limiting the statutory rights of any person to whom this prospectus is issued). Optiva expressly disclaims all and any responsibility or liability, whether arising in tort, contract or otherwise which it might otherwise have in respect of this prospectus.

A copy of this prospectus is available, subject to certain restrictions relating to persons resident in any Restricted Jurisdiction (as deﬁned below), at the Company's website at https://ir.tizianalifesciences.com/. Neither the content of the Company's website nor any website accessible by hyperlinks to the Company's website is incorporated in, or forms part of, this prospectus.

The Ordinary Shares comprising the Existing Issued Share Capital rank pari passu in all respects. No new Ordinary Shares are being issued in connection with Admission.

This prospectus does not constitute an offer to sell or an invitation to purchase or subscribe for, or the solicitation of an offer or invitation to purchase or subscribe for, Ordinary Shares in any jurisdiction where such an offer or solicitation is unlawful or would impose any unfulﬁlled registration, publication or approval requirements on the Company.

The distribution of this prospectus in or into jurisdictions other than the UK may be restricted by law and therefore persons into whose possession this prospectus comes should inform themselves about and observe any such restrictions. Any failure to comply with these restrictions may constitute a violation of the securities laws of any such jurisdiction.

Notice to overseas shareholders

The ADSs have been the subject of the ﬁling of limited registration statements with the United States Securities and Exchange Commission (the "SEC"). No other Ordinary Shares have not been, and will not be, registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act"). The Ordinary Shares may not be offered or sold in the United States, except to qualiﬁed institutional buyers ("QIBs"), as deﬁned in, and in reliance on, the exemption from the registration requirements of the U.S. Securities Act provided in Rule 144A under the U.S. Securities Act ("Rule 144A") or another exemption from, or in a transaction not subject to, the registration requirements of the U.S. Securities Act. Outside of the United States, the Admission is being made in offshore transactions as deﬁned in Regulation S of the U.S. Securities Act. No actions have been taken to allow a public offering of the Ordinary Shares under the applicable securities laws of any jurisdiction, including Australia, Canada, Japan or South Africa. Subject to certain exceptions, the Ordinary Shares may not be, offered, sold, resold, transferred or distributed, directly or indirectly, within, into or in the United States or to or for the account or beneﬁt of persons in the United States, Australia, Canada, Japan, South Africa or any other jurisdiction where such offer or sale would violate the relevant securities laws of such jurisdiction (a "Restricted Jurisdiction"). This prospectus does not constitute an offer of, or the solicitation of an offer to subscribe for or purchase any of the Ordinary Shares to any person in any Restricted Jurisdiction. The Ordinary Shares have not been recommended by any U.S. federal or state securities commission or regulatory authority. Furthermore, the foregoing authorities have not conﬁrmed the accuracy or determined the adequacy of this prospectus. Any representation to the contrary is a criminal offence in the United States.

No action has been taken or will be taken to permit the possession or distribution of this prospectus (or any other offering or publicity materials relating to the Ordinary Shares) in any Restricted Jurisdiction. Accordingly, neither this prospectus, nor any advertisement, nor any other offering material may be distributed or published in any jurisdiction except under circumstances that will result in compliance with any applicable laws and regulations. Persons into whose possession this prospectus comes should inform themselves about and observe any such restrictions. Any failure to comply with such restrictions may constitute a violation of the securities laws of any such jurisdiction. In particular, no actions have been or will be taken to permit a public offering of the Ordinary Shares under the applicable securities laws of any Restricted Jurisdiction. For a description of these and certain further restrictions on the offer, subscription, sale and transfer of the Ordinary Shares and distribution of this prospectus, please see Part III - Important Information of this prospectus.

Available information for investors in the United States

For so long as any of the Ordinary Shares are in issue and are "restricted securities" within the meaning of Rule 144(a)(3) under the U.S. Securities Act, the Company will, during any period in which it is not subject to section 13 or 15(d) under the U.S. Securities Exchange Act of 1934, as amended (the "U.S. Exchange Act"), nor exempt from reporting under the U.S. Exchange Act pursuant to Rule 12g3-2(b) thereunder, make available to any holder or beneﬁcial owner of an Ordinary Share, or to any prospective purchaser of an Ordinary Share designated by such holder or beneﬁcial owner, the information speciﬁed in, and meeting the requirements of, Rule 144A(d)(4) under the U.S. Securities Act.

A Standard Listing will afford investors in the Company a lower level of regulatory protection than that afforded to investors in companies with listings on the premium segment of the Ofﬁcial List ("Premium Listing") which are subject to additional obligations under the Listing Rules.

PART I	SUMMARY.................................................................................................................	4
PART II	RISK FACTORS ........................................................................................................	11
PART III	IMPORTANT INFORMATION....................................................................................	38
PART IV	EXPECTED TIMETABLE...........................................................................................	45
PART V	DIRECTORS, AGENTS AND ADVISERS ................................................................	46
PART VI	THE COMPANY'S STRATEGY.................................................................................	47
PART VII	THE BOARD OF DIRECTORS AND SENIOR MEMBERS OF MANAGEMENT..	53
PART VIII	THE BUSINESS ........................................................................................................	58
PART IX	REGULATORY AND OPERATING ENVIRONMENT ...............................................	72
PART X	SELECTED FINANCIAL INFORMATION ON THE COMPANY..............................	85
PART XI	SHARE CAPITAL, LIQUIDITY AND CAPITAL RESOURCES.................................	89
PART XII	TAXATION..................................................................................................................	92
PART XIII	CONSEQUENCES OF A STANDARD LISTING......................................................	96
PART XIV ADDITIONAL INFORMATION...................................................................................	97
PART XV	DEFINITIONS ............................................................................................................	129
PART XVI DOCUMENTS INCORPORATED BY REFERENCE ...............................................	133
PART XVII HISTORICAL FINANCIAL INFORMATION ON THE COMPANY ...........................	135

PART I

SUMMARY

This summary is made up of four sections and contains all the sections required to be included in a summary for this type of securities and issuer.

Even though a sub-section may be required to be inserted in the summary because of the type of securities and issuer, it is possible that no relevant information can be given regarding the sub-section. In this case, a short description of the sub-section is included in the summary with the mention of "not applicable".

	INTRODUCTION AND WARNINGS
Name and ISIN of the	The securities are the Ordinary Shares, which have the ISIN GB00BKWNZY55
securities.

Identity and contact	The issuer is Tiziana Life Sciences plc, and its registered address is at 3RD Floor, 11-12 St James's
details of the issuer	Square, London SW1Y 4LB, United Kingdom and telephone number is +44 20 7495 2379. The
	Company's LEI is 213800CED47HI8PIOB36.

Identity and contact	The Company is the person asking for admission to trading of the Ordinary Shares on the Main Market,
details of the offeror	which is a regulated market.

Date of approval of	The prospectus was approved on 18 December 2020.
the prospectus

Identity and contact	The competent authority approving the prospectus is the FCA.
details of the	The FCA's registered address is at 12 Endeavour Square, London E20 1JN, United Kingdom and
competent authority	telephone number is +44 20 7066 1000.
approving the
prospectus

Warnings	This summary should be read as an introduction to the prospectus. Any decision to invest in the
	Ordinary Shares should be based on consideration of the prospectus as a whole. An investor could lose
	all or part of the invested capital. Where a claim relating to the information contained in the prospectus is
	brought before a court, the plaintiff investor might, under national law, have to bear the costs of
	translating the prospectus before legal proceedings are initiated. Civil liability attaches only to those
	persons who have tabled this summary including any translation thereof, but only where the summary is
	misleading, inaccurate or inconsistent, when read together with the other parts of the prospectus, or
	where it does not provide, when read together with the other parts of the prospectus, key information in
	order to aid investors when considering whether to invest in such securities.

	KEY INFORMATION ON THE ISSUER
	Who is the issuer of the securities?
Domicile and legal	The Company was incorporated in England and Wales on 11 February 1998 as a private company with
form	limited liability under the Companies Act 2006 (the "Companies Act") with an indeﬁnite life, and re-
	registered as a public limited company on 8 June 1998. The Company's name was ultimately changed
	to Tiziana Life Sciences plc in 24 April 2014. The Company's LEI is 213800CED47HI8PIOB36.

Principal activities	The Company's mission is to design and deliver next generation therapeutics for oncology and immune
	diseases of high unmet medical needs, by combining its expertise in disease biology and clinical
	development.
	The Company's lead immunotherapeutic candidate, Foralumab (TZLS-401), is being developed for
	Crohn's disease, Pro-MS and autoimmune diseases. The Directors believe that Foralumab is the only
	fully human anti-CD3 monoclonal antibody under clinical development and is expected to minimize
	adverse immune responses in patients.
	Tiziana has recently submitted a patent application on potential use of Foralumab, to improve success
	of chimeric antigen receptor T cells (CAR-T) therapy for cancer and other human diseases. The patent
	application covers inventions related to improving CAR-T expansion and/or survival.
	The Company is accelerating development and cGMP manufacturing of Anti-IL-6r(TZLS-501)
	monoclonal antibody for treatment of COVID-19 and other autoimmune disease.
	The Company's lead product candidate in oncology, Milciclib (TZLS-201), is an orally bioavailable, small
	molecule, broad spectrum inhibitor of cyclin-dependent kinases (CDKs), a family of highly conserved
	enzymes that regulate the cell cycle and cell division, and Src family kinases, involved in regulating cell
	growth and potential transformation of normal cells to cancer cells.
	The Company's product pipeline also included a pre-clinical candidate: StemPrintER™, a multi-gene
	signature diagnostic assay to identify patients at high risk for breast cancer. StemPrintER shows
	superiority to Oncotype Dx in predicting recurrence in ER+/HER2- postmenopausal breast cancer
	patients.

On 29 May 2020 Tiziana announced the spin out of StemPrintER and SPARE (together "StemPrintER") into a separate company (the "Demerger"). The Demerger became effective on 30 October 2020.

The Company employs a lean and virtual research and development 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.

Major shareholders	Each of the following persons, directly or indirectly, has an interest in the Company's capital or voting
	rights which is notiﬁable under English law:				Percentage of
			Number of
				the Existing
			Existing Ordinary		Issued Share
			Shares held as at		Capital held as at
			the date of this		the date of this
	Name		prospectus and		prospectus and
		as at Admission		as at Admission

	Planwise Group Limited	63,297,647	32.53%
	Empory Asset Master, Ltd	10,153,770	5.22%
	Laura Fonda	7,971,966	4.10%
	Morris Silverman	7,994,457	4.08%
	Harold Freedberg	6,296,221	3.24%

Key managing	Dr Kunwar Shailubhai, Chief Executive Ofﬁcer and Chief Scientiﬁc Ofﬁcer
directors

Statutory auditors	Mazars LLP

	What is the key ﬁnancial information regarding the issuer?
Selection of historical	Set out below are details of the signiﬁcant changes in the ﬁnancial position of the Company during, and
key ﬁnancial	subsequent to, the period ended 30 June 2020.
information	* on 24 July 2020, the Company raised £82,379 in cash through the exercise of warrants;

on 31 July 2020 - the Company announced that during the calendar month of July, it had issued a total of 2,043,000 ordinary shares under the Company's ATM sales agreement (announced on 15 April 2020) to meet sales of a total of 408,600 ADSs under the ATM sales agreement, totalling gross proceeds of $4,371,289;
on 5 August 2020, the Company announced the closing of its registered direct offering of ADSs on the NASDAQ Global Market. As of 3 August 2020, the Company issued 11,009,615 ADSs (representing 22,019,230 new ordinary shares of nominal value £0.03 each in the capital of the Company at a price of $5.20 per ADS raising gross proceeds of approximately $57.25 million (before deducting placement agent fees and offering expenses);
on 27 August 2020, the Company, raised £300,000 in cash through the exercise of warrants;
on 21 September 2020, the Company allotted 281,250 Ordinary Shares, credited as fully paid at a price of £1.28 per share in respect of agreements reached with certain members of the scientiﬁc advisory board concerning the commuting of cash fees into equity;
on 16 September 2020, the Company entered into the Demerger Agreement with Accustem Sciences Limited pursuant to the terms of which the Tiziana declared a dividend in specie on the Ordinary Shares equal to the book value (of approximately £3.07m) of Tiziana's shareholding in StemPrintER Sciences Limited, the entity within the Group which holds all of the assets and intellectual property relating to StemPrintER and SPARE and £1.0 million in cash;
on 2 October 2020, resolutions were passed by Shareholders to approve the Demerger and to reduce the amount standing to the share premium account of the Company by £4,000,000 to facilitate the Demerger (the "Capital Reduction"). The Court sanctioned the Capital Reduction on 27 October 2020 and the Demerger became effective on 30 October 2020;
on 20 October 2020, the Company issued 35,714 Ordinary Shares credited as fully paid on the exercise of certain warrants held by the Company's broker, Optiva;
on 21 October 2020, the Company issued 1,750,000 Ordinary Shares of which 1,200,000 Ordinary Shares were issued credited as fully paid at a price of £0.15 per share and 550,000 shares were issued credited as fully paid at a price of £0.35 per share, both in respect of the exercise of share options by Gabriele Cerrone;
on 22 October 2020, the Company issued 285,714 Ordinary Shares credited as fully paid at a price of £0.35 per share on the exercise of warrants;
on 26 October 2020, the Company issued 329,225 shares credited as fully paid at a price of £0.35 per share on the exercise of share options held by, inter alia, Gabriele Cerrone and Keeren Shah;
on 28 October 2020, the Company issued 344,063 Ordinary Shares credited as fully paid at prices between £0.66 and £0.80 per share on the exercise of warrants; and
on 29 October 2020, the Company issued 426,500 Ordinary Shares credited as fully paid at a price of £0.35 per share on the exercise of share options by, inter alia, Dr. Kunwar Shailubhai, Vaseem Palejwala and Jules Jacob.

CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

				Restated	12 months to	12 months to	12 months to
		6 months to	6 months to
		30 June 2020	30 June 2019	31 December	31 December	31 December
		(unaudited)	(unaudited)	2019 (audited)	2018 (audited)	2017 (audited)
Continuing Operations	£'000		£'000		£'000		£'000		£'000

Research and development costs	(760)	(1,507)	(2,910)	(4,132)	(4,672)
Operating expenses	(3,169)	(2,138)	(4,864)	(3,268)	(3,574)
Operating loss
(3,929)	(3,645)	(7,774)	(7,400)	(8,246)
Finance costs	(5)	(5)	(9)	(9)	(9)
Loss before taxation
(3,934)	(3,650)	(7,846)	(7,409)	(8,255)
Taxation		-	27		540		(1,459)	1,485
Loss for the year attributable to

equity owners	(3,934)	(3,623)	(7,306)	(5,950)	(6,770)
Other comprehensive income that


may be classiﬁed to proﬁt and loss
in subsequent periods
Exchange differences on translation of
foreign operations	23		52		129		(113)	-
Total comprehensive loss for the

year attributable to equity owners	(3,911)	(3,571)	(7,177)	(6,063)	(4,770)
Loss per share

Basic and diluted (loss) per share on
continuing operations		(2.6p)	(2.6p)	(5.4p)	(4.7p)	(6.4p)

CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

			Restated	12 months to	12 months to	12 months to
	6 months to	6 months to
	30 June 2020	30 June 2019	31 December	31 December	31 December
	(unaudited)	(unaudited)	2019 (audited)	2018 (audited)	2017 (audited)
	£'000		£'000		£'000		£'000		£'000
ASSETS

Non-Current assets
Property, plant and equipment	5		5		5		6		18
Finance lease receivables	236		-	113		-	-
Right of use asset	308		358		329		-	-
Other non-current assets	217		217		217		217		217

Total non-current assets	766		580		664		223		235
Current assets
Finance lease receivable	-	-	109		-	-
Related party receivable	-	-	245		20		20
Other receivables	2,013		245		124		228		94
Taxation receivable	513		827		513		800		1,434
Cash and cash equivalents	7,200		445		153		4,165		48
Total current assets	9,726		1,517		1,144		5,213		1,596
TOTAL ASSETS
10,492		2,097		1,808		5,436		1,831
EQUITY AND LIABILITIES


Equity
Capital and reserves attributable to
equity holders of the company
Called up share capital	4,992		4,094		4,099		4,094		3,752
Share premium	38,390		25,120		25,194		25,117		18,113
Capital reduction reserve	31,183		31,183		31,183		31,183		31,183
Shares to be issued reserve
(convertible notes)	1,265		1,398		1,099		1,399		1,076
Share based payment reserve
(options)	4,806		3,021		3,850		2,857		2,354
Share based payment reserve
(warrants)	-	-	1,812		-	-
Other reserve	(28,286)	(28,286)	(28,286)	(28,286)	(28,286)
Translation reserve	(90)	(61)	15		(113)	-
Retained earnings	(47,318)	(39,463)	(43,146)	(35,840)	(29,874)
Total equity
4,942		(2,994)	4,180		411		(1,683)
Liabilities


Non-Current liabilities
Lease Liability	308		277		411		-	-
Current liabilities
Trade and other payables	4,597		4,727		4,851		4,673		3,270
Lease liability	322		87		212		-	-
Related party payable	323		-	451		352		244
Other liabilities	-	-	63		-	-
Total current and non-current labilities	5,550		5,091		5,988		5,025		3514
TOTAL EQUITY AND LIABILITIES
10,492		2,097		1,808		5,436		1,831

	CONSOLIDATED STATEMENTS OF CASH FLOWS
					Restated	12 months	12 months	12 months
			6 months to	6 months to	to 31	to 31	to 31
			30 June	30 June	December	December	December
		2020		2019		2019		2018		2017
			(unaudited)	(unaudited)	(audited)	(audited)	(audited)
		£'000		£'000		£'000		£'000		£'000

	Cash ﬂows from operating
	activities
	Total comprehensive loss for
	the period before tax	(3,934)	(3,650)	(7,846)	(7,454)	(8,255)
	Convertible loan interest	215		5		39		9		9
	Loan interest paid as equity		-	-	-	16		-
	Loss on disposal of right of use
	asset		-	-	56		-	-
	Amortisation of right of use asset	21		-	-	-	-
	Shares issued in lieu of fees		-	-	82		41		-
	Share based payment - options	979		164		992		504		419
	Issue of share capital (Loan
	Conversion)	(190)	-	-	-	-
	Cancellation of options	(23)	-	-	-	(105)
	Share based payment - warrants	310		-	-	128		228
	Net (increase) / decrease in
	operating assets - Trade/other
	receivables	(1,894)	3		(100)	(135)	40
	Net increase / (decrease) in
	operating liabilities - Trade/other
	liabilities	(445)	(307)	325		1,592		1,790
	Depreciation	2		7		198		12		11
	Loss on foreign exchange	(105)	56		129		(222)	35
	Lease adjustment		-	-	-	3		(24)
	Net Cash used in operating
	activities	(5,068)	(3,722)	(6,125)	(5,506)	(5,852)
	Cash inﬂow from taxation
		-	-	800		2,093		-
	Net cash used in operating
	activities	(5,064)	(3,722)	(5,325)	(3,413)	(5,852)
	Cash ﬂow from ﬁnancing

	activities
	Proceeds from issuance of
	ordinary shares	10,899		2		-	7,437		1,198
	Proceedings from issuance of
	warrants	1,940		-	1,473		1,132		-
	Proceeds from issuance of
	options	91		-	-	-	-
	Cost of fundraising	(824)	-	-	(1,039)	-
	Repayment of leasing liabilities	7		-	(157)	-	-
	Net cash generated from
	ﬁnancing activities	12,133		2		1,316		7,530		1,198
	Cash ﬂows from investing

	activities
	Acquisition of property, plant and
	equipment	(2)	-	(3)	-	(1)
	Acquisition of other investments		-	-	-	-	-
	Net cash generated from
	investing activities	(2)	-	(3)	-	(1)
	Net increase / (decrease) in

	cash and cash equivalents	7,047		(3,720)	(4,102)	4,117		(4,655)
	Cash and cash equivalents at

	beginning of period	153		4,165		4,165		48		4,703
	Cash and cash equivalents at
	end of period	7,200		455		153		4,165		48

	The unaudited interim ﬁnancial statements of the Company for the six months ended 30 June 2020
	express concern that until and unless the Group secures sufﬁcient investment to fund their clinical trials,
	there is a material uncertainty about the Group's ability to continue as a going concern. However, these
	ﬁnancial statements pre-date the Company raising approximately $57.25 million through the direct
	offering of ADSs on the NASDAQ Global Market. All the proceeds from the fundraising have been
	received by the Company. The Directors expect that the Group has sufﬁcient resources to fund its
	activities (including all clinical trials and programmes and operating expenditure) and execute its
	strategy for at least the next 24 months.

Selected key pro	Not applicable. No pro forma ﬁnancial information is included in this prospectus.
forma ﬁnancial
information

Brief description of	Not applicable. There are no qualiﬁcations in the accountant's report relating to the historical ﬁnancial
any qualiﬁcations in	information.
the audit report

What are the key risks that are speciﬁc to the issuer?

Brief description of	*	The Company is a clinical stage biotechnology company with a limited operating history and has
the most material		no regulatory-approved products authorised for marketing and commercialisation. Its lead product
risk factors speciﬁc		candidates, Foralumab and Milciclib, are at varying stages of development. It is possible that the
to the issuer		Company may never have a product that is commercially successful.
contained in the	*	The Company's public accounting ﬁrm has expressed substantial doubt about the Company's
prospectus

	ability to continue as a going concern, which may hinder the Company's ability to obtain future

		ﬁnancing.
	*	The unaudited interim ﬁnancial statements of the Company for the six months ended 30 June 2020

		express concern that until and unless the Group secures sufﬁcient investment to fund their clinical
		trials, there is a material uncertainty about the Group's ability to continue as a going concern.
		However, these ﬁnancial statements pre-date the Company raising approximately $57.25 million
		through the direct offering of ADSs on the NASDAQ Global Market. All the proceeds from the
		fundraising have been received by the Company. The Directors expect that the Group has
		sufﬁcient resources to fund its activities (including all clinical trials and programmes and operating
		expenditure) and execute its strategy for at least the next 24 months.
	*	Since the Company's inception in May 2013, the Company has incurred signiﬁcant net losses. The

		Company has devoted substantially all of its efforts to research and development of its future
		product candidates, including clinical development of Foralumab and Milciclib, as well as to
		building out the Company's management team and infrastructure. The Company expects that its
		expenses and operating losses will continue to increase, particularly as it continues the R&D of,
		initiates further clinical trials of and seeks marketing approval for, its product candidates. It could
		be several years, if ever, before the Company has a commercialised product candidate.
	*	The Company may need substantial additional funding to complete the development of its product
		candidates, which may not be available on acceptable terms. Failure to obtain this necessary
		capital when needed may force the Company to delay, limit or terminate certain of its product
		development, research operations or future commercialisation efforts.
	*	The Company's current product candidates are being developed to treat oncology and immune
		diseases of high unmet medical need. If these products, once approved for commercialisation, do
		not achieve an adequate level of acceptance, or if the market opportunities for these products is
		smaller than the Company anticipates, the Company 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 generate signiﬁcant revenues.
	*	Before obtaining marketing approval from regulatory authorities for the sale of the Company's
		product candidates, the Company must conduct extensive clinical trials to demonstrate the safety
		and utility of the product candidates. Clinical testing is a time-consuming, expensive and uncertain
		process that takes years to complete, and the Company may never generate the necessary data or
		results required to obtain marketing approval and achieve product sales.
	*	Success in preclinical testing and early clinical trials does not ensure that later clinical trials will
		generate the same results or otherwise provide adequate data to demonstrate the effectiveness
		and safety of the Company's product candidates. The Company cannot predict when, or if, the
		Company will obtain regulatory approval to commercialise its product candidates that have
		completed clinical trials, and the approval may be for a narrower indication than the Company
		seeks, and the Company's approved products will remain subject to regulatory oversight.
	*	The Company's rights to develop and commercialise the Company's product candidates are
		subject to the terms and conditions of licenses granted to the Company by others. For example,
		licenses and sublicenses from Nerviano, Lonza and Novimmune to certain patent rights and
		proprietary technology are crucial to the development of the Company's technology and product
		candidates, including the patents and know-how relating to manufacture. If the Company fails to
		comply with its obligations under its intellectual property licenses with third parties, the Company
		could lose license rights that are important to its business.
	*	Further, these 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 the Company may wish to develop or
		commercialise its technology and product candidates. As a result, the Company may not be able
		to prevent competitors from developing and commercialising competitive products, including in
		territories covered by the Company's licenses.
	*	The Company relies on enrolling patients in its clinical trials and other third parties to conduct its
		clinical trials and manufacture and test its products. The Company's reliance on these third parties
		subjects the Company to delays, disruptions, control oversight risk, contractual relationship risk,
		supply issues and regulatory oversight risk.
	*	The Company does not have a marketing and sales force. If the Company cannot establish
		effective sales, marketing and distribution capabilities or enter into agreements with third parties to
		market, sell and distribute its approved products, the Company may not be successful in
		commercialising its approved products, materially reducing the Company's ability to generate
		product revenue.

*	The Company faces signiﬁcant competition in an environment of rapid technological change and

	the possibility that the Company's competitors may achieve regulatory approval before the
	Company does, obtain more favourable regulatory approvals, or develop more advanced or
	effective therapies.
*	If the Company is unable to obtain and maintain patent protection for its product candidates and its
	technology, protect its intellectual property rights, or if the scope of its patent protection is not
	sufﬁciently broad, the Company's competitors could develop and commercialise similar products
	and technology that could impair the Company's proﬁtability or revenue generation.
*	The Company may not be successful in its efforts to identify or discover new, additional product
	candidates and may fail to capitalise on programs or product candidates that may be a greater
	commercial opportunity or for which there is a greater likelihood of success. Research programs to
	identify new product candidates require substantial technical, ﬁnancial and human resources, and
	the Company may fail to identify other potential product candidates for clinical development.

	KEY INFORMATION ON THE SECURITIES
	What are the main features of the securities?
Type, class and ISIN	The shares are Ordinary Shares with a nominal value of 3 pence each in the capital of the Company.
	Applications will be made for the Ordinary Shares to be admitted to the Ofﬁcial List with a Standard
	Listing and to trading on the main market for listed securities of the London Stock Exchange. The
	Ordinary Shares are registered with ISIN GB00BKWNZY55, SEDOL code BKWNZYZ5 and TIDM TILS.

Currency,	UK Pounds Sterling with nominal value of 3 pence each. 194,612,289 Ordinary Shares have been
denomination, par	issued at the date of this prospectus (the "Existing Ordinary Shares"), all of which have been fully paid
value, and the term	up. The term of the securities is perpetual.
of the securities

Rights attached to	Shareholders have the right to receive notice of and to attend and vote at any meetings of Shareholders.
the securities	Each Shareholder entitled to attend and being present in person or by proxy at a meeting will, upon a
	show of hands, have one vote and upon a poll each such Shareholder present in person or by proxy will
	have one vote for each Ordinary Share held by such Shareholder. If two or more persons hold an
	Ordinary Share jointly, the vote of the senior who tenders a vote whether in person or by proxy, shall be
	accepted to the exclusion of the other joint holders. Pre-emption rights have been disapplied pursuant to
	the special resolutions passed at the annual general meeting of the Company held on 16 July 2020 (the
	"2019 AGM"). Subject to the Companies Act, on a winding-up of the Company the assets available for
	distribution shall be distributed, provided there are sufﬁcient assets available, ﬁrst to the holders of
	Ordinary Shares in an amount up to 1 pence per share in respect of each fully paid up Ordinary Share.
	If, following these distributions to holders of Ordinary Shares there are any assets of the Company still
	available, they shall be distributed to the holders of Ordinary Shares pro rata to the number of such fully
	paid up Ordinary Shares held (by each holder as the case may be) relative to the total number of issued
	and fully paid up Ordinary Shares.

Relative seniority of	Not applicable. The Company does not have any other securities in issue or liens over its assets and so
the securities in the	the Ordinary Shares are not subordinated in the Company's capital structure as at the date of this
issuer's capital	prospectus and will not be immediately following Admission.
structure in the
event of insolvency

Restrictions on the	Not applicable. The Ordinary Shares are freely transferable and tradable and there are no restrictions
free transferability of	on transfer. Each Shareholder may transfer all or any of their Ordinary Shares which are in certiﬁcated
the securities	form by means of an instrument of transfer in any usual form or in any other form which the Directors
	may approve. Each Shareholder may transfer all or any of their Ordinary Shares which are in
	uncertiﬁcated form by means of a 'relevant system' (i.e., the CREST System) in such manner provided
	for, and subject as provided in, the Uncertiﬁcated Securities Regulations 2001 (SI 2001 No. 3755) (the
	"CREST Regulations").

Dividend or pay-out	The Company's current intention is to retain any earnings for use in its business operations, and the
policy	Company does not anticipate declaring any dividends until the Company is generating signiﬁcant
	revenue.

	Where will the securities be traded?
Application for	Upon publication of this prospectus the AIM trading facility for the Existing Issued Share Capital will be
admission to trading	cancelled, and applications will be made for the admission of the Existing Issued Share Capital to a
	Standard Listing on the Ofﬁcial List and to trading on the Main Market of the London Stock Exchange. It
	is expected that Admission will become effective and that unconditional dealings will commence on the
	Main Market of the London Stock Exchange at 8.00 a.m. on 21 January 2021. The Ordinary Shares will
	not be listed on any other regulated market. ADSs (each representing two Ordinary Shares will continue
	to be traded on the NASDAQ Capital Market segment under the symbol TLSA.

Identity of other	The Company is seeking admission to trading of the Ordinary Shares on the Main Market. The Ordinary
markets where the	Shares are currently admitted to trading on AIM
securities are or are	American Depositary Shares, each representing 2 Ordinary Shares, are listed for trading on the Nasdaq
to be traded
Global Market.


	What are the key risks speciﬁc to the securities?
Brief description of	The Company has outstanding warrants and options. These convertible instruments will have a material
the most material	dilutive effect on Shareholders when and if they are exercised. If all outstanding warrants and options
risk factors speciﬁc	were exercised, the 18,207,169 Ordinary Shares to be issued would represent 8.6 per cent. of the total
to the securities	Existing Issued Share Capital (as so enlarged) of the Company.
contained in the
prospectus

KEY INFORMATION ON THE OFFER OF SECURITIES TO THE PUBLIC AND/OR THE ADMISSION TO TRADING ON

THE LONDON STOCK EXCHANGE

Under which conditions and timetable can I invest in this security?

General terms and	Not applicable
conditions

Expected timetable	Publication of this prospectus	18 December 2020
of the offer	Cancellation of the AIM trading facility	7:00 a.m. on 21 January 2021
	Admission and commencement of dealings in Ordinary Shares	8:00 a.m. on 21 January 2021

Details of admission	Application will be made for the Ordinary Shares to be admitted to a Standard Listing on the Ofﬁcial List
to trading on a	and to trading on the Main Market of the London Stock Exchange. It is expected that Admission will
regulated market	become effective and that dealings in Ordinary Shares will commence at 8:00 a.m. on 21 January 2020.

Plan for distribution	Not applicable. There will be no offering or distribution of the Ordinary Shares in connection with
	Admission.

Amount and	Not applicable. There will be no offering or distribution of the Ordinary Shares in connection with
percentage of	Admission.
immediate dilution
resulting from the
offer

Estimate of total	The expenses of Admission will be borne by the Company in full. These expenses (including listing and
expenses of the	admission fees, printing, and professional advisory fees, including legal fees, and any other applicable
issue and/or offer	expenses) are not expected to exceed £175,000.

	Why is this prospectus being produced?
Reasons for the offer	This prospectus is being produced solely in connection with the admission of the Issued Share Capital
or for the admission	to a Standard Listing on the Ofﬁcial List and to trading on the Main Market of the London Stock
to trading on a	Exchange. In 2018, the Company joined NASDAQ and much of the Company's activities are now
regulated market	carried on in the USA. The Company sees itself as an international issuer and that it is now the time to
	move from AIM to the Main Market as a natural development in its corporate evolution.

Use and estimated	Not applicable.
net amount of the
proceeds

Indication of whether	Not applicable.
the offer is subject
to an underwriting
agreement

Indication of the	Not applicable.
most material
conﬂicts of interests
relating to the offer
or admission to
trading

PART II

RISK FACTORS

Investment in the Company and the Ordinary Shares carries a signiﬁcant degree of risk, including risks in relation to the Company's business strategy, risks relating to taxation and risks relating to the Ordinary Shares.

Prospective investors should note that the risks relating to the Company, its industry and the Ordinary Shares summarised in Part I - Summary of this prospectus are the risks that the Directors believe to be the most essential to an assessment by a prospective investor of whether to consider an investment in the Ordinary Shares. However, as the risks which the Company faces relate to events and depend on circumstances that may or may not occur in the future, prospective investors should consider not only the information on the key risks summarised in Part I - Summary of this prospectus but also, inter alia, the risks and uncertainties described below.

The risks referred to below are those risks the Company and the Directors consider to be the material risks relating to the Company. However, there may be additional risks that the Company and the Directors do not currently consider to be material or of which the Company and the Directors are not currently aware that may adversely affect the Company's business, ﬁnancial condition, results of operations or prospects. Investors should review this prospectus carefully and in its entirety and consult with their professional advisers before acquiring any Ordinary Shares. If any of the risks referred to in this prospectus were to occur, the results of operations, ﬁnancial condition and prospects of the Company could be materially adversely affected. If that were to be the case, the trading price of the Ordinary Shares and/or the level of dividends or distributions (if any) received from the Ordinary Shares could decline signiﬁcantly. Further, investors could lose all or part of their investment.

PART A. RISKS RELATED TO THE DEVELOPMENT OF THE COMPANY'S

PRODUCT CANDIDATES

If the Company encounters substantial delays in clinical trials of its product candidates, or fails to demonstrate the safety and therapeutic utility of its product candidates to the satisfaction of applicable regulatory authorities, the Company may be unable to obtain required regulatory approvals, and therefore will be unable to commercialise its product candidates on a timely basis or at all.

Before obtaining marketing approval from regulatory authorities for the sale of the Company's product candidates, the Company must conduct extensive clinical trials to demonstrate the safety and utility of the product candidates. Clinical testing is expensive, time-consuming and uncertain as to outcome. The Company cannot guarantee that any clinical trials will be conducted as planned or completed on schedule, if at all, as a failure of one or more clinical trials can occur at any stage of testing.

Events that may prevent successful or timely completion of clinical development include:

delays in reaching a consensus with the U.S. Food and Drug Administration ("FDA"), European Medicines Agency ("EMA"), or other regulatory authorities on trial design;
delays in reaching agreement on acceptable terms with prospective contract research organisations ("CROs") and clinical trial sites;
delays in execution of development due to ﬁnancial instability of the Company's CROs or contract manufacturing organisations ("CMOs");
delays in opening clinical trial sites or obtaining required institutional review board or independent ethics committee approval at each clinical trial site;
delays in recruiting suitable patients to participate in the Company's future clinical trials;
imposition of a clinical hold by regulatory authorities as a result of a serious adverse event or after an inspection of the Company's clinical trial operations or clinical trial sites;
failure by the Company, any CROs or any other third parties to adhere to clinical trial requirements;
failure to perform in accordance with good clinical practice ("cGCP") or applicable regulatory guidelines;
delays in the testing, validation, manufacturing and delivery of the Company's product candidates to the clinical trial sites;
delays in having patients complete participation in a clinical trial or return for post-treatmentfollow-up;
clinical trial sites or patients dropping out of a clinical trial;
selection of clinical endpoints that require prolonged periods of clinical observation or analysis of the resulting data;
occurrence of serious adverse events associated with the product candidate that are viewed to outweigh its potential beneﬁts;
occurrence of serious adverse events in clinical trials of the same class of agents conducted by other sponsors; and
changes in regulatory requirements and guidance that require amending or submitting new clinical protocols.

Any inability to successfully complete preclinical and clinical development, such as registrational trial or future pivotal trials failing to demonstrate therapeutic utility of its product candidates or revealing safety concerns or serious adverse events associated with the its product candidates, could result in additional costs or impair the Company's ability to generate revenues from product sales, regulatory and commercialisation milestones and royalties. Speciﬁcally, the Company may:

*	be delayed in obtaining marketing approval for the Company's product candidates, if at all;

obtain approval for indications or patient populations that are not as broad as intended or desired;
obtain approval with labelling that includes signiﬁcant use or distribution restrictions or safety warnings;
be subject to additional post-marketing testing requirements;
be subject to changes in the way the product is administered;
be required to perform additional clinical trials to support approval or be subject to additional post-marketing testing requirements;
have regulatory authorities withdraw or suspend their approval of the product or impose restrictions on its distribution in the form of a modiﬁed risk evaluation and mitigation strategy ("REMS");
be subject to the addition of labelling statements, such as warnings or contraindications; or
be sued or experience damage to the Company's reputation.

In addition, if the Company makes manufacturing or formulation changes to its product candidates, the Company may need to conduct additional studies to bridge the Company's modiﬁed product candidates to earlier versions. Clinical trial delays also could shorten any periods during which the Company may have the exclusive right to commercialise the Company's product candidates or allow the Company's competitors to bring products to market before the Company do, which could impair the Company's ability to successfully commercialise the Company's product candidates and may harm the Company's business, ﬁnancial condition, results of operations and prospects.

Success in preclinical studies or clinical trials may not be indicative of results in future clinical trials.

Success in preclinical testing and early clinical trials does not ensure that later clinical trials will generate the same results or otherwise provide adequate data to demonstrate the effectiveness and safety of the Company's product candidate. Frequently, product candidates that have shown promising results in early clinical trials have subsequently suffered signiﬁcant setbacks in later clinical trials. To date, some of the Company's clinical trials have involved small patient populations and because of the small sample size in such trials, the interim results of these clinical trials may be subject to substantial variability and may not be indicative of either future interim results or ﬁnal results. In addition, the design of a clinical trial can determine whether its results will support approval of a product and ﬂaws in the design of a clinical trial may not become apparent until the clinical trial is well advanced. In addition, there is a high failure rate for drugs and biologic products proceeding through clinical trials. Many companies in the pharmaceutical and biotechnology industries have suffered signiﬁcant setbacks in late-stage clinical trials even after achieving promising results in preclinical testing and earlier-stage clinical trials. Moreover, data obtained from preclinical and clinical activities is subject to varying interpretations, which may delay, limit or prevent regulatory approval. In addition, the Company may experience regulatory delays or rejections as a result of many factors, including due to changes in regulatory policy during the period of the Company's product candidate development. Any such delays could negatively impact the Company's business, ﬁnancial condition, results of operations and prospects.

The Company depends on enrolling patients in the Company's clinical trials for its product candidates. If delays continue for a material period of time, they could materially adversely affect the Company's R&D efforts and business, ﬁnancial condition and results of operations.

Identifying and qualifying patients to participate in clinical trials of the Company's product candidates is critical to the Company's success. The timing of the Company's clinical trials depends on the Company's ability to recruit patients to participate, and to see those patients through the completion of required follow-up periods. If, for any reason, patients are unwilling or unable to enrol in the Company's clinical trials, then the timeline for recruiting patients, conducting studies and obtaining regulatory approvals for the Company's product candidates may be delayed. These delays could result in increased costs, delays in advancing the Company's product candidates, delays in testing the effectiveness of the Company's product candidates or termination of clinical trials altogether. For example, the COVID-19 pandemic has delayed enrolment in the Company's clinical trials, which were already delayed due to related government orders and site policies, and some patients may

be unwilling or unable to travel to study sites, enrol in the Company's trials or be unable to comply with clinical trial protocols if quarantines impede patient movement or interrupt healthcare services.

The Company's current product candidates are being developed to treat oncology and immune diseases of high unmet medical need. However, the Company may not be able to initiate or continue clinical trials if the Company cannot enrol a sufﬁcient number of eligible patients to participate in the required clinical trials. As a result, the Company may not be able to identify, recruit and enrol a sufﬁcient number of patients, or those with required or desired characteristics, to complete the Company's clinical trials in a timely manner. In addition to COVID-19 related delays, patient enrolment can be affected by many other factors, including:

size of the patient population and process for identifying patients;

eligibility and exclusion criteria for the Company's clinical trials;

perceived risks and beneﬁts of the Company's product candidates;

severity of the disease under investigation;

proximity and availability of clinical trial sites for prospective patients;

competition with other clinical trials for product candidates competing in the same therapeutic areas as the Company's product candidates;

ability to obtain and maintain patient consent;

patient drop-outs prior to completion of clinical trials;

patient referral practices of physicians; and

ability to monitor patients adequately during and after treatment.

The Company's ability to successfully initiate, enrol 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; and

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

The Company's product candidates and the process for administering the Company's 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 ("GI"), adverse events (nausea and diarrhoea, 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 ("IRR"), including fever, headaches, chills, nausea, vomiting diarrhoea and hypotension considered the result of cytokine release also known as cytokine release syndrome ("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 the Company assumes will be minimal systemic absorption.

In addition, it is possible that as the Company tests its 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, patients will report 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. 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 the Company's product candidates cause serious or life-threatening side effects, the development of the Company's product candidates may fail or be delayed, or, if the product candidate has received regulatory approval, such approval may be revoked, which would harm the Company's business, prospects, operating results and ﬁnancial condition.

If the Company is 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 the Company to cease further development of, or deny approval of, the Company's product candidates for any or all targeted indications. Even if the Company were 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 the Company elects or is required to delay, suspend or terminate any clinical trial of any of the Company's product candidates, the commercial prospects of such product candidate may be harmed and the Company's ability to generate product revenues from such product candidate may be delayed or eliminated. Any of these occurrences may harm the Company's ability to develop other product candidates, and may harm the Company's business, ﬁnancial condition and prospects.

Additionally, if the Company or others later identify undesirable side effects caused by any of the Company's 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;

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

the Company could be sued and held liable for harm caused to patients; and

the Company's reputation may suffer.

Any of these events could prevent the Company from achieving or maintaining market acceptance of its product candidates.

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

Given the nature of biologics and new chemical entity manufacturing, there is a risk of contamination. Any contamination could adversely affect the Company's ability to produce product candidates on schedule and could, therefore, harm the Company's results of operations and cause reputational damage. In addition, some of the raw materials required in the Company's 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 the Company's product candidates could adversely impact or disrupt the commercial manufacturing or the production of clinical material, which could adversely affect the Company's development timelines and the Company's business, ﬁnancial condition, results of operations and prospects.

PART B. RISKS RELATED TO THE COMPANY'S FINANCIAL POSITION AND NEED

FOR CAPITAL

The Company's independent registered public accounting ﬁrm has expressed substantial doubt about the Company's ability to continue as a going concern, which may hinder the Company's ability to obtain future ﬁnancing.

Mazars LLP, the Company's independent registered public accounting ﬁrm for the ﬁscal year ended 31 December 2019, has included an explanatory paragraph in their opinion that accompanies the Company's audited consolidated ﬁnancial statements as of and for the year ended 31 December 2019, indicating that the Company's current liquidity position raises substantial doubt about the Company's ability to continue as a going concern. If the Company were unable to improve its liquidity position, the Company may not be able to continue as a going concern. The accompanying consolidated ﬁnancial statements do not include any adjustments that might result if the Company were unable to continue as a going concern and, therefore, be required to realise its assets and discharge its liabilities other than in the normal course of business.

However, the Company is currently able to continue as a going concern and there is sufﬁcient working capital available to the Group for the Group's present requirements for at least 12 months from the date of this prospectus. In August 2020, the Company raised approximately $57.25 million through the direct offering of ADSs on the NASDAQ Global Market. All the proceeds from the fundraising have been received by the Company. The Directors expect that the Group has sufﬁcient resources to fund its activities (including all clinical trials and programmes and operating expenditure) and execute its strategy for at least the next 24 months. The Directors do not expect that further funds will have to be raised following Admission within the 12 months from the date of this prospectus.

If the Company is unable to continue as a going concern it may enter into administration, receivership or other insolvency process, which may cause investors to suffer the loss of all or a substantial portion of their investment in the Company.

The Company's ﬁnancial statements have previously disclosed concern about the Company's ability to continue as a going concern.

The unaudited interim ﬁnancial statements of the Company for the six months ended 30 June 2020 express concern that until and unless the Group secures sufﬁcient investment to fund their clinical trials, there is a material uncertainty about the Group's ability to continue as a going concern. The Company also notes that the Company incurred losses during the year and has net liabilities at the year end. The Company is in the early stages of developing its business focusing on the discovery and development of novel molecules that treat human disease in oncology and immunology. The Directors expect the Company to incur further losses and to require signiﬁcant capital expenditure in continuing to develop clinical stage development therapeutic candidates in both oncology and immunology. The Company has successfully funded clinical trials to date and in August 2020 secured approximately $57.25 million additional investment for purposes of continuing to fund their clinical trials moving forward. All the proceeds from the fundraising have been received by the Company.

The Directors have prepared cash ﬂow projections that include the costs associated with the continued clinical trials and additional investment to fund that operation. On the basis of those projections, the Directors expect that following the ﬁnancing in August 2020, the Group has sufﬁcient resources to fund its activities (including all clinical trials and programmes and operating expenditure) and execute its strategy for at least the next 24 months.

The Company has incurred net losses in every year since its inception. The Company anticipates that it will continue to incur losses for the foreseeable future and may never achieve or maintain proﬁtability.

The Company is a clinical stage biotechnology company with a limited operating history. Since the Company's inception in May 2013, the Company has incurred signiﬁcant net losses. The Company's net losses were $9.3 million, $8.0 million and $8.6 million for the years ended 31 December 2019, 2018 and 2017, respectively. As of 31 December 2019, the Company had an accumulated loss of $60.0 million. The Company has devoted substantially all of its efforts to research and development of its product candidates, including clinical development of its lead product candidates, Foralumab

and Milciclib, as well as to building out the Company's management team and infrastructure. The Company expects that it could be several years, if ever, before it has a commercialised product candidate. The Company expects to continue to incur signiﬁcant expenses and increasing operating losses for the foreseeable future. These net losses will adversely impact the Company's shareholders' equity and net assets and may ﬂuctuate signiﬁcantly from quarter to quarter and year to year.

The Company anticipates that its expenses will increase substantially if, and as, the Company:

continues research and development of Foralumab, including the initiation of the Company's orally administered Phase 2 trials in patients with Crohn's disease and progressive multiple sclerosis (MS);
initiates a Phase 2b trial for Milciclib in combination with a tyrosine kinase inhibitor (sorafenib or regorafenib) in HCC patients;
accelerates 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 the Company may pursue in the future;
manufactures its product candidates in accordance with current GMPs for clinical trials or potential commercial sales;
establishes a sales, marketing and distribution infrastructure to commercialise any product candidate for which it may obtain marketing approval;
develops, maintains, expands and protects its intellectual property portfolio;
identiﬁes, assesses, and acquires or in-licenses other product candidates and technologies;
secures, maintains or obtains freedom to operate for any in-licensed technologies and products;
addresses any competing technological and market developments; and
expands its operations in the United States and Europe.

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

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

The Company's operations have consumed substantial amounts of cash since inception, and the Company expects its expenses to increase in connection with its ongoing activities, particularly as it continues the R&D of, initiates further clinical trials of and seeks marketing approval for, its product candidates. In addition, if the Company obtains marketing approval for its product candidates, the Company expects to incur signiﬁcant expenses related to product sales, marketing, manufacturing and distribution. Furthermore, the Company expects to incur additional costs associated with operating as a public company listed on both the Main Market of the London Stock Exchange in the U.K. and NASDAQ in the United States. The Company's future capital requirements will depend on many factors, including:

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

the costs, timing and outcome of regulatory review of the Company's product candidates;

the extent to which the Company acquires or in-licenses and develops other product candidates and technologies;

the Company's ability to establish and maintain collaborations and license agreements on favourable terms, if at all;

the costs, timing and outcome of potential future commercialisation activities, including manufacturing, marketing, sales and distribution for the Company's product candidates for which the Company receives marketing approval;

the costs of developing, maintaining and enforcing the Company's intellectual property rights and defending intellectual property-related claims; and

the sales price and availability of adequate third-party coverage and reimbursement for the Company's 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 the Company may never generate the necessary data or results required to obtain marketing approval and achieve product sales. In addition, the Company's product candidates, if approved, may not achieve commercial success. The Company's 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. Further to the raise of approximately $57.25 million through the direct offering of ADSs on the NASDAQ Global Market in August 2020, the Directors expect that the Company will continue to rely on additional ﬁnancing to achieve its business objectives, which may be inadequate or on unfavourable terms. The Company does not expect to raise further signiﬁcant ﬁnance in the 18 months from the date of this prospectus, however it may take advantage of at-the-market facilities on NASDAQ if opportunistic to do so. Furthermore, the potential economic impact brought by, and the duration of the COVID-19 pandemic is difﬁcult to assess or predict. While the Directors are of the opinion that the working capital available to the Group is sufﬁcient for the Group's present requirements, and that the impact of the COVID-19 pandemic does not pose a risk to the Group's working capital in the 24 months following the date of this prospectus, the impact of the COVID-19 pandemic on the global ﬁnancial markets may reduce the Company's ability to access capital in the future, which could negatively impact the Group's medium-term and long-term liquidity.

If the Company is unable to obtain adequate funding on a timely basis, the Company may be required to signiﬁcantly curtail, delay or discontinue its R&D programs of its product candidates or any future commercialisation efforts, be unable to expand its operations or be unable to otherwise capitalise on its business opportunities, as desired, which could harm the Company's business and potentially cause a discontinuation of operations.

The Company may be unable to use net operating loss and tax credit carry forwards and certain built-in losses to reduce future tax payments or beneﬁt from favourable United Kingdom ("U.K.") tax legislation.

As a U.K. resident trading entity, the Company is subject to U.K. corporate taxation. Due to the nature of the Company's business, it has generated losses since inception. As of 31 December 2019, the Company had cumulative carryforward tax losses of $27.4 million. Subject to any relevant restrictions, the Company expects these to be available to carry forward and offset against future operating proﬁts. As a company that carries out extensive research and development activities, the Company beneﬁts from the U.K. research and development tax credit regime for small and medium- sized companies, whereby the Company is able to surrender the trading losses that arise from its qualifying research and development activities for a payable tax credit of up to 33.35 per cent. 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 per cent. The majority of the Company's pipeline research, clinical trials management and manufacturing development activities are eligible for inclusion within these tax credit cash rebate claims. The Company's ability to continue to claim payable research and development tax credits in the future may be limited because the Company may no longer qualify as a small or medium-sized company.

The Company may beneﬁt in the future from the U.K.'s "patent box" regime, which allows certain proﬁts attributable to revenues from patented products to be taxed at an effective rate of 10 per cent. The Company is the exclusive licensee or owner of several patent applications which, if issued, would cover the Company's 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 the Company's research and development expenditures, the Company expects a long-term lower rate of corporation tax to apply. 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 the Company is unable to qualify for such advantageous tax legislation, or the Company is unable to use net operating loss and tax credit, the amount of tax it pays and its results of operations would be adversely affected.

PART C. RISKS RELATED TO THE TRIALS, MANUFACTURING

AND TESTING OF ITS PRODUCTS

The Company relies on third parties to conduct its preclinical studies and clinical trials and manufacture and test its products.

The Company relies upon third parties, including independent clinical investigators and third-party CROs, to conduct its preclinical studies and clinical trials and to monitor and manage data for its ongoing preclinical and clinical programs. There are a limited number of qualiﬁed third-party service providers that specialise or have the expertise required to achieve the Company's business objectives, and so it may be challenging to ﬁnd alternative investigators or CROs or do so on commercially reasonable terms. The Company relies on these parties for execution of its preclinical studies and clinical trials. The Company is responsible for ensuring that each of its preclinical studies and clinical trials is conducted in accordance with the applicable protocol and legal, regulatory and scientiﬁc standards, and the Company's reliance on these third parties does not relieve the Company of the Company's regulatory responsibilities; however, the Company controls only certain aspects of their activities. Regulatory authorities enforce their cGCP requirements through periodic inspections of trial sponsors, principal investigators and clinical trial sites. If any of the Company's CROs fail to comply with applicable cGCP requirements, the clinical data generated in the Company's clinical trials may be deemed unreliable, and the FDA, EMA or other regulatory authorities may require the Company to perform additional clinical trials before approving the Company's marketing applications, which would delay the regulatory approval process. Repeating clinical trials or switching or engaging additional CROs involves additional cost, creates a transition period and requires the Company's management's time and focus, which could materially impact the Company's ability to meet its desired clinical development timelines.

In addition, the Company has engaged CMOs to manufacture Foralumab and Milciclib and to perform quality testing. Because the Company collaborates with various organisations and academic institutions for the advancement of its platforms, the Company must share its proprietary technology and conﬁdential information, including trade secrets, with them. The Company seeks to protect its 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 the Company's 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 the Company's 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 the Company's competitors, are inadvertently incorporated into the technology of others or are disclosed or used in violation of these agreements. Given that the Company's proprietary position is based, in part, on the Company's know-how and trade secrets, a competitor's discovery of the Company's proprietary technology and conﬁdential information or other unauthorised use or disclosure of such technology or information would impair its competitive position and may have an adverse effect on the Company's business, ﬁnancial condition, results of operations and prospects.

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

reduced control for certain aspects of manufacturing activities, including control over CMOs to maintain adequate quality control, quality assurance and qualiﬁed personnel;

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

disruptions to the operations of the Company's third-party manufacturers and service providers caused by conditions unrelated to the Company's 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 the Company's ability to successfully commercialise its 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.

PART D. RISKS RELATED TO COMMERCIALISATION

OF THE COMPANY'S PRODUCT CANDIDATES

The Company does not have a marketing and sales force. If the Company cannot establish effective sales, marketing and distribution capabilities or enter into agreements with third parties to market, sell and distribute the Company's product candidates that may be approved, the Company may not be successful in commercialising the Company's product candidates if and when approved, and the Company may be unable to generate any product revenue.

The Company does not have a marketing or sales team for the marketing, sales and distribution of any of its product candidates. The Company intends 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 the Company faces competition in its search for qualiﬁed personnel or third parties to assist with marketing, sales and distribution of its product candidates.

There are risks involved with both establishing the Company's 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 the Company recruits a sales force and establishes marketing and/or distribution capabilities is delayed or does not occur for any reason, the Company would have prematurely or unnecessarily incurred these commercialisation expenses. This may be costly, and the Company's investment would be lost if the Company cannot retain or reposition the Company's sales and marketing personnel.

Factors that may inhibit the Company's efforts to commercialise its product candidates on its own include:

the Company's 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 the Company may develop;
the lack of complementary treatments to be offered by sales personnel, which may put the Company at a competitive disadvantage relative to companies with more extensive product lines; and
unforeseen costs and expenses associated with creating an independent sales and marketing organisation.

If the Company enters into arrangements with third parties to perform sales, marketing and distribution services, the Company's product revenue or the proﬁtability to the Company from these revenue streams is likely to be lower than if the Company were to market and sell any product candidates that it develops itself. In addition, the Company may not be successful in entering into arrangements with third parties to sell and market the Company's product candidates or may be unable to do so on favourable terms. The Company 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 the Company's product candidates effectively. If the Company does not establish sales and marketing capabilities successfully, either on its own or in collaboration with third parties, the Company may not be successful in commercialising its product candidates.

The Company faces signiﬁcant competition in an environment of rapid technological change and the possibility that the Company's competitors may achieve regulatory approval before the Company does, obtain more favourable regulatory approvals, or develop more advanced or effective therapies.

The biotechnology and pharmaceutical industries are characterised by rapidly changing technologies, signiﬁcant competition and a strong emphasis on intellectual property. The Company faces 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 the Company's product candidates obsolete or non- competitive. The Company anticipates that it will face intense and increasing competition as new treatments enter the market and advanced technologies become available.

Many of the Company's 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 organisations. These third parties also compete with the Company 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 the Company's 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. The Company's commercial opportunity could be reduced or eliminated if competitors develop and commercialise 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 the Company may develop. Competitors also may obtain FDA, EMA or other regulatory approval for their products more rapidly or earlier than the Company may obtain its approval, which could result in the Company's competitors establishing a strong market position before the Company can enter the market. Additionally, technologies developed by the Company's competitors may render the Company's product candidates uneconomical or obsolete, and the Company may not be successful in marketing the Company's product candidates against competitors.

If the Company's competitors obtain orphan drug exclusivity for products that constitute the same drug and treat the same indications as the Company's product candidates, the Company may not be able to have competing products approved by applicable regulatory authorities for a signiﬁcant period of time. In addition, even if the Company obtains orphan drug exclusivity for any of its products, such exclusivity may not protect it from competition. Regulatory authorities in the United States and the European Union may designate products for relatively small patient populations as orphan drugs, as further discussed under Part IX - Regulatory and Operating Environment. If a competitor receives orphan drug approval before the Company does, it will be precluded from receiving marketing approval for its product for the applicable exclusivity period. If the Company obtains 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. Any such limitations on the Company's ability to commercialise its products.

The market opportunities for the Company's product candidates may be smaller than the Company anticipates.

The Company focus its R&D efforts on treatments for cancer and autoimmune disease. The Company's 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 the Company's 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 the Company's product candidates or patients may become increasingly difﬁcult to identify and access, all of which would adversely affect the Company's 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 the Company's potential products, if and when approved, less than the potentially addressable market, such as the lack of widespread availability of, and limited reimbursement for, new therapies in many underdeveloped markets.

The future commercial success of the Company's 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.

The Company has no product authorised for marketing; its product candidates are at varying stages of development, and the Company may never have a product that is commercially successful. The commercial success of the Company's product candidates will depend, in part, their acceptance by

physicians, patients and third-party payors as medically necessary, cost-effective and safe. If these products do not achieve an adequate level of acceptance, the Company 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 generate signiﬁcant revenues. The degree of market acceptance of the Company's product candidates, if approved for commercial sale, will depend on several factors, including:

the effectiveness and safety of the Company's product candidates as demonstrated in clinical trials;
the potential and perceived advantages of the Company's 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 labelling or product insert requirements of the FDA, EMA or other regulatory authorities, including any limitations or warnings contained in a product's approved labelling;
the timing of market introduction of competitive products;
sales, distribution and marketing support;
publicity concerning the Company's product candidates or competing products and treatments;
potential product liability claims;
any restrictions on the use of the Company's products together with other medications; and
favourable third-party payor coverage and adequate reimbursement.

Even if a potential product displays favourable 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 the Company's approved product candidates could limit the Company's ability to market those products.

The Company expects that coverage and adequate reimbursement by government and private payors will be essential for most patients to be able to afford the Company's approved product candidates. Accordingly, sales of the Company's product candidates will depend substantially, both domestically and abroad, on the extent to which the costs of the Company's product candidates will be paid by health maintenance, managed care, pharmacy beneﬁt and similar healthcare management organisations, or will be reimbursed by government authorities, private health coverage insurers and other third-party payors. For a discussion of the insurance coverage and reimbursement situation for pharmaceutical products in the United States and Europe, see Part IX - Regulatory and Operating Environment. 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:

covered beneﬁt under the Company's health plan; safe, effective and medically necessary; appropriate for the speciﬁc patient; cost-effective; and
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 the Company to provide to the payor supporting scientiﬁc, clinical and cost-effectiveness data. The Company 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, the Company may not be able to successfully commercialise the Company's product candidates. Even if coverage is provided, the approved reimbursement amount may not be adequate to realise a sufﬁcient return on the Company's investment.

PART E. RISKS RELATED TO THE COMPANY'S INTELLECTUAL PROPERTY

The Company's rights to develop and commercialise the Company's product candidates are subject to the terms and conditions of licenses granted to the Company by others. If the Company fail to comply with its obligations under its existing and any future intellectual property licenses with third parties, the Company could lose license rights that are important to the business.

The Company is 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 the Company's 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 the Company may wish to develop or commercialise its technology and product candidates in the future. As a result, the Company may not be able to prevent competitors from developing and commercialising competitive products, including in territories covered by the Company's licenses.

In some circumstances, the Company may not have the right to control the preparation, ﬁling and prosecution of patent applications, or to maintain the patents, covering technology that the Company license from third parties. If the Company's licensors fail to maintain such patents or patent applications, or lose rights to those patents or patent applications, the rights the Company has licensed may be reduced or eliminated and the Company's right to develop and commercialise any of the Company's 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 the Company license from third parties will also apply to patent rights the Company may own in the future.

Licenses to additional third-party technology and materials that may be required for the Company's development programs, including additional technology and materials owned by any of the Company's 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 the Company's business and ﬁnancial condition.

If the Company is unable to obtain and maintain patent protection for its product candidates and its technology, or if the scope of its patent protection is not sufﬁciently broad, the Company's competitors could develop and commercialise similar products and technology.

The Company's success depends, in large part, on its ability to seek, obtain and maintain patent protection in the United States and other countries with respect to its product candidates and to future innovation related to its manufacturing technology. The Company's licensors have sought, and the Company intends to seek, to protect the Company's proprietary position by ﬁling patent applications in the United States, the U.K. and elsewhere, related to certain technologies and the Company's product candidates that are important to its business. The Company's 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 the Company in-licenses now or in the future, as well as patent rights that the Company may own in the future. Moreover, the risks apply with respect to patent rights and other intellectual property applicable to the Company's product candidates, as well as to any intellectual property rights that the Company may acquire in the future related to future product candidates, if any.

The patent prosecution process is expensive, time-consuming, and complex, and the Company 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. 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 United States Patent and Trademark Ofﬁce ("USPTO") and various government patent agencies outside of the United States over the lifetime of the Company's licensed patents and/or applications and any patent rights the Company may own in the future. Failing to pay required fees could cause patent rights to expire.

Filing, prosecuting and defending patents on product candidates in all countries throughout the world would be prohibitively expensive, and the Company's intellectual property rights in some countries outside the United States could be less extensive than those in the United States. The Company may not be able to prevent third parties from practicing the Company's inventions in all countries outside the United States, and competitors may use the Company's technologies in jurisdictions where the Company has not pursued and obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where the Company has patent protection, but enforcement is not as strong as that in the United States. These products may compete with the Company's product candidates, and the Company's patents or other intellectual property rights may not be effective or sufﬁcient to prevent them from competing.

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

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

The Company's existing license agreements impose, and the Company expect that future license agreements will impose, various assignment restrictions, due diligence, development and commercialisation timelines, insurance, milestone payments, royalties, and other obligations, as further discussed under paragraph 16 of Part XIV - Additional Information. If the Company fails to comply with its obligations under these agreements, the licensor can terminate the license, preventing the Company from marketing product candidates covered by the license.

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. The Company has ﬁled a new patent application covering the composition of matter of Foralumab that remains pending and may not be granted. The Company's licensed patent applications may not result in patents being issued which protect the Company's technology or product candidates, effectively prevent others from commercialising 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 the Company has 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 the Company's patents or narrow the scope of the Company's patent protection.

Other parties have developed technologies that may be related or competitive to the Company's 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 the Company's own patent applications or issued patents. The Company may not be aware of all third- party intellectual property rights potentially relating to the Company's 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, the Company cannot know with certainty whether the inventors of its 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 the Company own any patents or patent applications in the future, the Company may not be certain that it was 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 the Company's patent rights cannot be predicted with any certainty.

The degree of patent protection the Company requires to successfully compete in the marketplace may be unavailable or severely limited in some cases and may not adequately protect the Company's rights or permit the Company to gain or keep any competitive advantage. The Company cannot provide any assurances that any of the Company's licensed patents have, or that any of the

Company's pending licensed patent applications that mature into issued patents will include, claims with a scope sufﬁcient to protect the Company's product candidates or otherwise provide any competitive advantage. In addition, the laws of foreign countries may not protect the Company's 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 commercialised. As a result, the Company's licensed patent portfolio may not provide the Company with adequate and continuing patent protection sufﬁcient to exclude others from commercialising products similar to the Company's product candidates, including "highly similar," or biosimilar, versions of such products. In addition, the intellectual property portfolio licensed to the Company 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 the Company could be put at risk of being invalidated or interpreted narrowly in litigation ﬁled by or against the Company's licensors or another licensee or in administrative proceedings brought by or against the Company's licensors or another licensee in response to such litigation or for other reasons.

Even if the Company acquires patent protection that it expects will 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 the Company's patents, if issued, are not valid for several reasons. If a court agrees, the Company would lose the Company's rights to those challenged patents.

The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability and the Company's licensed patents may be challenged in courts or patent ofﬁces in the United States and abroad. For example, the Company may be subject to a third-party submission of prior art to the USPTO challenging the validity of one or more claims of the Company's licensed patents. Such submissions may also be made prior to a patent's issuance, precluding the granting of a patent based on one of the Company's pending licensed patent applications. The Company 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 the Company has obtained licenses to such rights. Competitors may claim that they invented the inventions claimed in the Company's 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 the Company are infringing their patents and that the Company therefore cannot practice the Company's technology as claimed under the Company's licensed patents, if issued. Competitors may also contest the Company's 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 the Company's 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 its ability to stop others from using or commercialising similar technology and therapeutics, without payment to the Company, or could limit the duration of the patent protection covering its technology and product candidates. Such challenges may also result in the Company's inability to manufacture or commercialise its product candidates without infringing third-party patent rights. In addition, if the breadth or strength of protection provided by the Company's patents and patent applications is threatened, it could dissuade companies from collaborating with the Company to license, develop or commercialise current or future product candidates.

Even if they are unchallenged, the Company's licensed patents and pending patent applications, if issued, may not provide the Company with any meaningful protection or prevent competitors from designing around the Company's patent claims to circumvent its 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 the Company's product candidates but that uses a different antibody or molecular active ingredient that falls outside the scope of the Company's patent protection. If the patent protection provided by the

patents and patent applications the Company holds or pursues with respect its product candidates is not sufﬁciently broad to impede such competition, the Company's ability to successfully commercialise its product candidates could be negatively affected, which would harm the Company's business.

The Company's intellectual property licenses with third parties may be subject to disagreements over contract interpretation or terminated.

The Company depends on license agreements whereby it obtains rights in certain patents and patent applications owned by third parties. Further development and commercialisation of the Company's product candidates will require the Company to enter into license or collaboration agreements, which 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 the Company believes to be the scope of its rights to the relevant intellectual property or technology, or increase what the Company believes to be its ﬁnancial or other obligations under the relevant agreement, either of which could have an adverse effect on the Company's business, ﬁnancial condition, results of operations and prospects.

If any of the Company's licenses or material relationships or any in-licenses upon which the Company's licenses are based are terminated or breached, the Company may:

lose the Company's rights to develop and market the Company's product candidates;

lose patent protection for the Company's product candidates;

experience signiﬁcant delays in the development or commercialisation of the Company's product candidates;

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

incur liability for damages.

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

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

The Company's license agreements with Nerviano and Novimmune also require the Company to meet development thresholds to maintain each license, including establishing a set timeline for developing and commercialising 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 the Company's 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 the Company's collaborative development relationships;

the Company's 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 the Company's licensors and the Company and the Company's partners; and

the priority of invention of patented technology.

If disputes over intellectual property that the Company has licensed prevent or impair the Company's ability to maintain the Company's current licensing arrangements on acceptable terms, the Company may be unable to successfully develop and commercialise the Company's product candidates.

The Company may not be able to protect its intellectual property rights.

In addition to the protection afforded by patents, the Company relies on trade secret protection and conﬁdentiality agreements to protect proprietary know-how that is not patentable or that the Company elects not to patent, processes for which patents are difﬁcult to enforce and any other elements of the Company's product candidate discovery and development processes that involve proprietary know-how, information or technology that is not covered by patents. 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, and the Company could lose its trade secrets protection. In addition, the Company's trade secrets may otherwise become known or be independently discovered by competitors.

Competitors could purchase the Company's product candidates and attempt to replicate some or all of the competitive advantages the Company derives from the Company's development efforts, wilfully infringe the Company's intellectual property rights, design around the Company's protected technology or develop their own competitive technologies that fall outside of the Company's intellectual property rights. If the Company are unable to successfully protect its intellectual property rights, the Company may have to abandon development of its product candidates and the Company's business, ﬁnancial condition, results of operations and prospects could suffer and its competitive position could be adversely affected.

Third parties may initiate legal proceedings alleging that the Company infringes their intellectual property rights.

The biotechnology and pharmaceutical industries are characterised by extensive and complex litigation regarding patents and other intellectual property rights. The Company may in the future become party to, or be threatened with, adversarial proceedings or litigation regarding intellectual property rights with respect to the Company's product candidates and technology, alleging that the Company's therapeutics, manufacturing methods, formulations or administration methods are covered by their patents. Given the vast number of patents in the Company's ﬁeld of technology, the Company cannot be certain or guarantee that the Company do not infringe existing patents or that the Company 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 the Company's product candidates and the Company may not be aware of such patents. If a patent holder believes the manufacture, use, sale or importation of one of the Company's product candidates infringes its patent, the patent holder may sue the Company even if the Company has licensed other patent protection for the Company's technology. Moreover, the Company may face patent infringement claims from non-practicing entities that have no relevant product revenue and against whom the Company's licensed patent portfolio may therefore have no deterrent effect.

Patent litigations, with or without merit, are complex, unpredictable, generally expensive and time- consuming. Any such litigation could substantially increase the Company's operating losses and reduce the resources available for development activities or any future sales, marketing or distribution activities. If the Company is found or believes there is a risk that it may be found to infringe a third party's patent or intellectual property rights, the Company could be required or may choose to obtain a license from such third party to continue developing, manufacturing and marketing the Company's product candidates and technology. However, the Company may not be able to obtain any required license on commercially reasonable terms or at all. Even if the Company were able to obtain a license, it could be non-exclusive, thereby giving the Company's competitors and other third parties access to the same technologies licensed to the Company, and it could require the Company to make substantial licensing and royalty payments. The Company could be forced, including by court order, to cease developing, manufacturing and commercialising

the infringing technology or product candidate. In addition, the Company could be found liable for monetary damages, including treble damages and attorneys' fees, if the Company is found to have wilfully infringed a patent or other intellectual property right. A ﬁnding of infringement could prevent the Company from manufacturing and commercialising the Company's product candidates or force the Company to cease some or all of the Company's business operations, which could harm the Company's business. Claims that the Company has misappropriated the conﬁdential information or trade secrets of third parties could have a similar negative impact on the Company's business, ﬁnancial condition, results of operations and prospects.

PART F. RISKS RELATED TO GOVERNMENT REGULATION

The Company cannot predict when, or if, the Company will obtain regulatory approval to commercialise its product candidates that have completed clinical trials, and the approval may be for a narrower indication than the Company seeks.

The Company cannot commercialise a product candidate that has completed the necessary clinical trials until the appropriate regulatory authorities have reviewed and approved the product candidate. For a discussion of the regulatory review process, see Part IX - Regulatory and Operating Environment. Even if the Company's 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 the Company may not be able to obtain regulatory approval. The FDA has substantial discretion in the review and approval process and may refuse to ﬁle the Company's application for substantive review or may determine after review of the Company's data that the Company's application is insufﬁcient to allow approval of the Company's product candidates. The FDA may require that the Company conduct additional preclinical studies, clinical trials or manufacturing validation studies and submit that data before it will reconsider the Company's application. Additional delays may result if an FDA Advisory Committee or other regulatory authority recommends non-approval or restrictions on approval. In addition, the Company 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. 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 the Company's product candidates.

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 labelling claims that are necessary or desirable for the successful commercialisation of the Company's product candidates. Any of the foregoing scenarios could harm the commercial prospects for the Company's product candidates and negatively impact the Company's business, ﬁnancial condition, results of operations and prospects.

Further, 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 the Company and may require additional preclinical studies or clinical trials, which would be costly and time consuming. Satisfying these and other regulatory requirements is costly, time consuming, uncertain and subject to unanticipated delays, and failing to receive regulatory approvals in other major markets would limit the market available to the Company for its products.

Delays in obtaining regulatory approval of the Company's manufacturing process and facility or disruptions in the Company's manufacturing process may delay or disrupt the Company's product development and commercialisation efforts.

The Company does not currently operate manufacturing facilities for clinical or commercial production of its product candidates. Before the Company can begin to commercially manufacture its product candidates, whether in a third-party facility or in its own facility, if and when established, the Company must obtain regulatory approval from the FDA for the Company's manufacturing process and facility. A manufacturing authorisation must also be obtained from the appropriate European Union regulatory authorities and from other applicable foreign regulatory authorities. In order to obtain approval, the Company will need to ensure that its processes, methods and equipment are compliant with cGMP, and perform extensive audits of vendors, contract laboratories and suppliers. If any of the Company's vendors, contract laboratories or suppliers are found to be non-compliant with cGMP, the Company may experience delays or disruptions in manufacturing while the Company work with these third parties to remedy the violation or while the Company 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, the

Company 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 the Company fails to comply with these requirements, the Company would be subject to possible regulatory action and may not be permitted to sell any product candidate that the Company may develop.

If the Company or its third-party manufacturers fail to comply with applicable cGMP regulations, regulatory authorities can impose regulatory sanctions, which could include a 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 the Company's business, ﬁnancial condition, results of operations and prospects to be harmed.

Additionally, the Company's products may be subject to signiﬁcant disruption due to an interruption in the supply of the Company's products from its third-party manufacturers to the Company, including due to COVID-19pandemic-related delays to the global supply chain or government measures imposed to address the spread of the virus, or 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 labour shortages or disputes. The Company does not currently have a backup manufacturer of its 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 the Company's desired clinical and commercial timelines.

Even if the Company obtains regulatory approval for a product candidate, the Company's product candidates will remain subject to regulatory oversight.

Even if the Company obtains regulatory approval for its product candidates, they will be subject to ongoing regulatory requirements for manufacturing, labelling, packaging, storage, advertising, promotion, sampling, record-keeping and submission of safety and other post-market information. Any regulatory approvals that the Company receives for its 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. For a discussion of regulatory oversight, see Part IX - Regulatory and Operating Environment.

Any government investigation of alleged violations of law could require the Company to expend signiﬁcant time and resources in response and could generate negative publicity. The occurrence of any event or penalty described above may inhibit the Company's ability to commercialise its product candidates and adversely affect its 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 the Company's product candidates. The Company cannot predict the likelihood, nature or extent of government regulation that may arise from any future legislation or administrative action. If the Company is slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if the Company is not able to maintain regulatory compliance, the Company may lose any marketing approval that it may have obtained and the Company may not achieve or sustain proﬁtability, which would negatively impact the Company's business, ﬁnancial condition, results of operations and prospects.

The Company's 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 the Company violates these laws and regulations, it may be required to pay a penalty or be suspended from participation in federal or state healthcare programs, which may adversely affect the Company's business, ﬁnancial condition and results of operations.

If the Company commercialises its products in the United States, its operations will be directly, or indirectly through the Company's prescribers, customers and purchasers, subject to various federal and state fraud, abuse and patient privacy laws and regulations, which are discussed under Part IX

Regulatory and Operating Environment, that will impact, among other things, the Company's proposed sales, marketing and educational programs. Efforts to ensure that the Company's business arrangements with third parties will comply with applicable healthcare laws and regulations will involve substantial costs. The Company's business activities could be challenged under these laws in part due to their breadth and the narrowness of the statutory exceptions and safe harbours available, the lack of robust interpretation by the regulatory authorities or the courts, and potential for a variety of interpretations, which could lead governmental authorities to conclude that the Company's business practices are not in compliance. 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 the Company's operations are found
to be in violation of any of these laws or any other governmental regulations that may apply to the Company, the Company 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 the Company becomes subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, reputational harm, and the Company may be required to curtail or restructure its operations, any of which could adversely affect the Company's ability to operate the Company's business and the Company's results of operations. Any action against the Company for violation of these laws, even if the Company successfully defends against it, could cause the Company to incur signiﬁcant legal expenses and divert the Company's management's attention from the operation of the Company's business.

PART G. RISKS RELATED TO THE COMPANY'S BUSINESS OPERATIONS

The Company may not be successful in its efforts to identify or discover additional product candidates and may fail to capitalise 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 the Company's business depends upon the Company's ability to identify, develop and commercialise product candidates. Research programs to identify new product candidates require substantial technical, ﬁnancial and human resources. Although a substantial amount of the Company's efforts will focus on the continued preclinical and clinical testing and potential approval of the Company's product candidates, a key element of the Company's long-term growth strategy is to develop and market additional products and product candidates. However, the Company may fail to identify other potential product candidates for clinical development for several reasons. For example, the Company's research may be unsuccessful in identifying potential product candidates or the Company's 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 the Company has limited resources, the Company may forego or delay pursuit of opportunities with certain programs or product candidates or for indications that later prove to have greater commercial potential. The Company's spending on current and future R&D programs may not yield any commercially viable products. If the Company does not accurately evaluate the commercial potential for a particular product candidate, the Company 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 the Company to retain sole development and commercialisation rights to such product candidate. Alternatively, the Company 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.

The Company's 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. The Company's 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 the Company to determine its focus in R&D of product candidates and products could have a material adverse effect on the Company's business, prospects, ﬁnancial condition and results of operations.

If any of these events occur, the Company may be forced to abandon the Company's 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 the Company's business, ﬁnancial condition, results of operations and prospects.

COVID-19 has adversely affected the Company's business, and any new pandemic, epidemic or outbreak of an infectious disease may further adversely affect its business.

In December 2019, a novel strain of coronavirus, COVID-19, spread globally, substantially impacting the global economy and the Company's operations, including interrupting preclinical and clinical trial activities and disrupting the Company's supply chain. The spread of an infectious disease, including COVID-19, may also result in the inability of the Company's suppliers to source or deliver components or raw materials necessary for its clinical supply on a timely basis or at all. In addition, hospitals may reduce stafﬁng and reduce or postpone certain treatments in response to the spread of an infectious disease. Such events may result in a period of business disruption, and in reduced operations, or doctors and medical providers may be unwilling to participate in the Company's clinical trials, any of which could materially affect the Company's business, ﬁnancial condition and results of operations. The extent to which COVID-19 impacts the Company's business will depend on future developments, which are highly uncertain and cannot be predicted, including new information which may emerge concerning the severity of the coronavirus and the actions to contain the coronavirus or treat its impact, among others. A signiﬁcant pandemic as with COVID-19, or any other infectious disease, could result in a widespread health crisis that could adversely affect the economies and ﬁnancial markets worldwide, resulting in an economic downturn that could impact the Company's business, ﬁnancial condition and results of operations, however the Company's current cash resources are sufﬁcient for its planned activities for at least the 24 month period from

the date of this prospectus and, accordingly, this risk does not have the potential to impact the Company's working capital position in the next 24 months.

Product liability lawsuits against the Company could cause it to incur substantial liabilities and could limit commercialisation of any product candidate that it may develop.

The Company faces an inherent risk of product liability exposure related to the testing of the Company's current and future product candidates in clinical trials and may face an even greater risk if the Company commercialise any product candidate that the Company may develop. For example, the Company may be sued if its 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 the Company cannot successfully defend itself against product liability claims, the Company could incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:

decreased demand for any product candidate that the Company may develop;

loss of revenue;

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 commercialise any product candidates that the Company may develop; or

injury to the Company's reputation and signiﬁcant negative media attention.

Although the Company maintains product liability insurance coverage, such insurance may not be adequate to cover all liabilities that the Company may incur. The Company anticipates that it will need to increase its insurance coverage each time it commences a clinical trial and if it successfully commercialises any product candidate. Insurance coverage is increasingly expensive. The Company 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 U.K.'s planned exit from the European Union may be a source of instability in international markets, create signiﬁcant currency ﬂuctuations, adversely affect the Company's operations in the U.K. and pose additional risks to the Company's business, revenue, ﬁnancial condition, and results of operations.

Following a national referendum and enactment of legislation by the U.K. government, the U.K. formally withdrew from the European Union on 31 January 2020 and entered into a transition period during which it will continue its ongoing and complex negotiations with the European Union relating to their future trading relationship. 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, together with delays in negotiations caused by the COVID-19 pandemic, have created signiﬁcant uncertainty about the future relationship between the U.K. and the European Union. Lack of clarity about future U.K. laws and regulations, as the U.K. determines which European Union-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 U.K., increase costs, depress economic activity and restrict the Company's 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 the Company's business, ﬁnancial condition, results of operations and prospects.

Further, the U.K.'s withdrawal from the European Union has resulted in the relocation of the EMA from the U.K. 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 authorisation or marketing authorisation, 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 authorised formulations. The cumulative effects of the disruption to the regulatory framework may add considerably to the development lead time to marketing authorisation and commercialisation of products in the European Union and/or the U.K.

PART H. RISKS RELATED TO THE OWNERSHIP OF THE COMPANY'S SHARES

The Company has a number of outstanding warrants and options which, if exercised and/or converted could have a material dilutive effect on existing Shareholders.

The Company has outstanding 1,183,491 warrants over Ordinary Shares and 17,023,678 options over Ordinary Shares. These convertible instruments will have a material dilutive effect on Shareholders when and if they are exercised. If all outstanding warrants and options were exercised, the 18,207,169 Ordinary Shares to be issued would represent 8.6 per cent. of the total Existing Issued Share Capital (as so enlarged) of the Company.

The prices of the Company's ordinary shares may be volatile and ﬂuctuate substantially, which could result in substantial losses for the Company's ordinary shareholders.

The market prices of the Company's ordinary shares on the Main Market of the London Stock Exchange 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, shareholders may not be able to sell their ordinary shares at or above the price at which they were purchased. The market price for the ordinary shares may be inﬂuenced by any of the factors discussed above.

PART III

IMPORTANT INFORMATION

The distribution of this prospectus may be restricted by law in certain jurisdictions and therefore persons into whose possession this prospectus comes should inform themselves about and observe any restrictions, including those set out below. Any failure to comply with these restrictions may constitute a violation of the securities laws of any such jurisdiction.

General

No action has been or will be taken in any jurisdiction that would permit a public offering of the Ordinary Shares. Neither this prospectus nor any other offering material or advertisement in connection with the Ordinary Shares may be distributed or published in or from any country or jurisdiction except under circumstances that will result in compliance with any and all applicable rules and regulations of any such country or jurisdiction. Any failure to comply with these restrictions may constitute a violation of the securities laws of any such jurisdiction. This prospectus does not constitute an offer to subscribe for any of the Ordinary Shares to any person in any jurisdiction.

This prospectus has been approved by the FCA as a prospectus which may be used to offer securities to the public for the purposes of section 85 of FSMA, and of the Prospectus Regulation. No arrangement has however been made with the competent authority in any other member states of the European Economic Area ("EEA Member States") (or any other jurisdiction) for the use of this prospectus as an approved prospectus in such jurisdiction and accordingly no public offer is to be made in such jurisdiction. Issue or circulation of this prospectus may be prohibited in Restricted Jurisdictions and in countries other than those in relation to which notices are given below.

For the attention of all investors

In deciding whether or not to invest in Ordinary Shares, prospective investors should rely only on the information contained in this prospectus. No person has been authorised to give any information or make any representations other than as contained in this prospectus and, if given or made, such information or representations must not be relied on as having been authorised by the Company, the Directors or Optiva. Without prejudice to the Company's obligations under the FSMA, the Prospectus Regulation Rules, the Listing Rules and the Disclosure Guidance and Transparency Rules, neither the delivery or this prospectus, shall not, under any circumstances, create any implication that there has been no change in the affairs of the Company since the date of this prospectus or that the information in this prospectus is correct as at any time after its date.

In making an investment decision, prospective investors must rely on their own examination of the Company. The contents of this prospectus are not to be construed as advice relating to legal, ﬁnancial, taxation, accounting, regulatory, investment or any other matter.

Prospective investors must rely upon their own representatives, including their own legal and ﬁnancial advisers and accountants, as to legal, tax, ﬁnancial, investment or any other related matters concerning the Company and an investment therein.

An investment in the Company should be regarded as a long-term investment. There can be no assurance that the Company's objectives and acquisition, ﬁnancing and business strategies will be achieved.

It should be remembered that the price of the Ordinary Shares and any income from such Ordinary Shares can go down as well as up.

This prospectus should be read in its entirety before making any investment in the Ordinary Shares. All Shareholders are entitled to the beneﬁt of, are bound by, and are deemed to have notice of, the provisions of the Company's articles of association, which prospective investors should review.

European Economic Area

Pursuant to the Prospectus Regulation, an offer to the public of the Ordinary Shares may only be made once the prospectus has been passported in an EEA Member State of in accordance with the Prospectus Regulation. For any other EEA Member State an offer to the public in that EEA Member State of any Ordinary Shares may only be made at any time under the following

exemptions under the Prospectus Regulation, if they have been implemented in that EEA Member State:

to any legal entity which is a Qualiﬁed Investor, within the meaning of Article 2(e) of the Prospectus Regulation;
to fewer than 150 natural or legal persons (other than Qualiﬁed Investors, within the meaning of Article 2(e) of the Prospectus Regulation) in such EEA Member State subject to obtaining prior consent of the Company for any such offer; or
in any other circumstances falling within Article 1(4) of the Prospectus Regulation,

provided that no such offer of Ordinary Shares shall result in a requirement for the publication by the Company of a prospectus pursuant to Article 3 of the Prospectus Regulation and each person who initially acquires Ordinary Shares or to whom any offer is made will be deemed to have represented, warranted and agreed with Optiva and the Company that it is a "Qualiﬁed Investor" within the meaning of Article 2(e) of the Prospectus Regulation.

For the purposes of this provision, the expression an 'offer to the public' in relation to any offer of Ordinary Shares in any EEA Member State means the communication in any form and by any means of sufﬁcient information on the terms of the offer and any Ordinary Shares to be offered so as to enable an investor to decide to purchase or subscribe for the Ordinary Shares and the expression "Prospectus Regulation" means Regulation (EU) 2017/1129.

This prospectus may not be used for, or in connection with, and does not constitute, any offer of Ordinary Shares or an invitation to purchase or subscribe for any Ordinary Shares in any EEA Member State.

The distribution of this prospectus in other jurisdictions may be restricted by law and therefore persons into whose possession this prospectus comes should inform themselves about and observe any such restrictions.

United Kingdom

This prospectus comprises a prospectus relating to the Company prepared in accordance with the Prospectus Regulation Rules and approved by the FCA under section 87A of FSMA. This prospectus has been ﬁled with the FCA and made available to the public in accordance with Rule 3.2 of the Prospectus Regulation Rules.

There will be no offer to the public of the Ordinary Shares in the United Kingdom. This prospectus has been produced for the sole purpose of the admission of the issued share capital of the Company to the Ofﬁcial List and not for any other purpose.

United States

The Ordinary Shares (other than those Ordinary Shares which underly the ADSs in issue) have not been and will not be registered under the US Securities Act, or the securities laws of any state or other jurisdiction of the United States. Subject to certain exceptions, the Ordinary Shares may not be, offered, sold, resold, transferred or distributed, directly or indirectly, within, into or in the United States or to or for the account or beneﬁt of persons in the United States.

The Ordinary Shares may not be taken up, offered, sold, resold, transferred or distributed, directly or indirectly within, into or in the United States except pursuant to an exemption from, or in a transaction that is not subject to, the registration requirements of the US Securities Act. There will be no public offer in the United States.

The Ordinary Shares have not been approved or disapproved by the US Securities and Exchange Commission, any State securities commission in the United States or any other US regulatory authority, nor have any of the foregoing authorities passed comment upon or endorsed the merits of the Ordinary Shares or adequacy of this prospectus. Any representations to the contrary is a criminal offence in the United States.

Canada

The Ordinary Shares may be sold only to purchasers purchasing, or deemed to be purchasing, as principal that are accredited investors, as deﬁned in National Instrument 45-106 Prospectus

Exemptions or subsection 73.3(1) of the Securities Act of 1990 (Ontario), and are permitted clients, as deﬁned in National Instrument 31-103 Registration Requirements, Exemptions and Ongoing Registrant Obligations. Any resale of the Ordinary Shares must be made in accordance with an exemption from, or in a transaction not subject to, the prospectus requirements of applicable securities laws.

Securities legislation in certain provinces or territories of Canada may provide a purchaser with remedies for rescission or damages if this prospectus (including any amendment thereto) contains a misrepresentation, provided that the remedies for rescission or damages are exercised by the purchaser within the time limit prescribed by the securities legislation of the purchaser's province or territory. The purchaser should refer to any applicable provisions of the securities legislation of the purchaser's province or territory for particulars of these rights or consult with a legal advisor.

Pursuant to section 3A.3 (or, in the case of securities issued or guaranteed by the government of a non-Canadian jurisdiction, section 3A.4) of National Instrument 33-105 Underwriting Conﬂicts (NI 33- 105), Optiva is not required to comply with the disclosure requirements of NI 33-105 regarding underwriter conﬂicts of interest in connection with the Ordinary Shares.

Australia

This prospectus does not constitute a prospectus or other disclosure document under the Corporations Act 2001 (Cth) ("Australian Corporations Act") and does not purport to include the information required of a disclosure document under the Australian Corporations Act. This prospectus has not been, and will not be, lodged with the Australian Securities and Investments Commission (whether as a disclosure document under the Australian Corporations Act or otherwise). Any offer in Australia of the Ordinary Shares under this prospectus or otherwise may only be made to persons who are "sophisticated investors" (within the meaning of section 708(8) of the Australian Corporations Act), to "professional investors" (within the meaning of section 708(11) of the Australian Corporations Act) or otherwise pursuant to one or more exemptions under section 708 of the Australian Corporations Act so that it is lawful to offer the Ordinary Shares in Australia without disclosure to investors under Part 6D.2 of the Australian Corporations Act.

Any offer for on-sale of the Ordinary Shares that is received in Australia within 12 months after their issue by the Company is likely to need prospectus disclosure to investors under Part 6D.2 of the Australian Corporations Act, unless such offer for on-sale in Australia is conducted in reliance on a prospectus disclosure exemption under section 708 of the Australian Corporations Act or otherwise. Any persons acquiring Ordinary Shares should observe such Australian on-sale restrictions.

The Company is not licensed in Australia to provide ﬁnancial product advice in relation to the Ordinary Shares. Any advice contained in this prospectus is general advice only. This prospectus has been prepared without taking account of any investor's objectives, ﬁnancial situation or needs, and before making an investment decision on the basis of this prospectus, investors should consider the appropriateness of the information in this prospectus, having regard to their own objectives, ﬁnancial situation and needs. No cooling off period applies to an acquisition of the Ordinary Shares.

Japan

The Ordinary Shares have not been and will not be registered under the Financial Instruments and Exchange Act of Japan (Act No. 25 of 1948, as amended (the "FIEA")). Neither the Ordinary Shares nor any interest therein may be offered or sold, directly or indirectly, in Japan or to, or for the beneﬁt of, any resident of Japan (which term as used herein means any person resident in Japan, including any corporation or entity organised under the laws of Japan), or to others for reoffering or resale, directly or indirectly, in Japan or to, or for the beneﬁt of, a resident of Japan except pursuant to an exemption from the registration requirements of, and otherwise in compliance with, the FIEA and any other applicable laws, regulations and ministerial guidelines of Japan.

South Africa

This prospectus will not be registered as a prospectus in terms of the Companies Act 1973 in South Africa and as such, any offer of Ordinary Shares in South Africa may only be made if it shall not be capable of being construed as an offer to the public as envisaged by section 144 of such

Act. Furthermore, any offer or sale of the Ordinary Shares shall be subject to compliance with South African exchange control regulations.

General

No action has been or will be taken in any jurisdiction that would permit a public offering of the Ordinary Shares, or possession or distribution of this prospectus or any other offering material, in any country or jurisdiction where action for that purpose is required. Accordingly, the Ordinary Shares may not be offered or sold, directly or indirectly, and neither this prospectus nor any other offering material or advertisement in connection with the Ordinary Shares may be distributed or published in or from any Restricted Jurisdiction.

Persons into whose possession this prospectus comes should inform themselves about and observe any restrictions on the distribution of this prospectus and the offer of Ordinary Shares, including those in the paragraphs above. Any failure to comply with these restrictions may constitute a violation of the securities laws of any such jurisdiction. This prospectus does not constitute an offer to subscribe for or purchase any of the Ordinary Shares offered hereby to any person in any Restricted Jurisdiction.

Information to distributors

Solely for the purposes of the product governance requirements contained within: (a) MiFID II;

Articles 9 and 10 of Commission Delegated Directive (EU) 2017/593 supplementing MiFID II;
and local implementing measures (together, the "MiFID II Product Governance Requirements"), and disclaiming all and any liability, whether arising in tort, contract or otherwise, which any "manufacturer" (for the purposes of the MiFID II Product Governance Requirements) may otherwise have with respect thereto, the Ordinary Shares have been subject to a product approval process, which has determined that such Ordinary Shares are: (i) compatible with an end target
market of retail investors and investors who meet the criteria of professional clients and eligible counterparties, each as deﬁned in MiFID II; and (ii) eligible for distribution through all distribution channels as are permitted by MiFID II (the "Target Market Assessment"). Notwithstanding the Target Market Assessment, distributors should note that: the price of the Ordinary Shares may decline and investors could lose all or part of their investment; the Ordinary Shares offer no guaranteed income and no capital protection; and an investment in the Ordinary Shares is
compatible only with investors who do not need a guaranteed income or capital protection, who (either alone or in conjunction with an appropriate ﬁnancial or other adviser) are capable of evaluating the merits and risks of such an investment and who have sufﬁcient resources to be able to bear any losses that may result therefrom. The Target Market Assessment is without prejudice to the requirements of any contractual, legal or regulatory selling restrictions in relation to the Ordinary Shares. Furthermore, it is noted that, notwithstanding the Target Market Assessment, Optiva will only procure investors who meet the criteria of professional clients and eligible counterparties.

For the avoidance of doubt, the Target Market Assessment does not constitute: (a) an assessment of suitability or appropriateness for the purposes of MiFID II; or (b) a recommendation to any investor or group of investors to invest in, or purchase, or take any other action whatsoever with respect to the Ordinary Shares.

Optiva is responsible for undertaking its own target market assessment in respect of the Ordinary Shares and determining appropriate distribution channels.

Rounding

Percentages in tables have been rounded and accordingly may not add up to 100 per cent. Certain ﬁnancial data have also been rounded. As a result of this rounding, the totals of data presented in this prospectus may vary slightly from the actual arithmetic totals of such data.

Data protection

The Company may delegate certain administrative functions to third parties and will require such third parties to comply with data protection and regulatory requirements of any jurisdiction in which data processing occurs. Such information will be held and processed by the Company (or any third party, functionary or agent appointed by the Company) for the following purposes:

verifying the identity of the prospective investor to comply with statutory and regulatory requirements in relation to anti-money laundering procedures;
carrying out the business of the Company and the administering of interests in the Company;
meeting the legal, regulatory, reporting and/or ﬁnancial obligations of the Company in the UK or elsewhere; and
disclosing personal data to other functionaries of, or advisers to, the Company to operate and/ or administer the Company.

Where appropriate it may be necessary for the Company (or any third party, functionary or agent appointed by the Company) to:

disclose personal data to third party service providers, agents or functionaries appointed by the Company to provide services to prospective investors; and
transfer personal data outside of the European Economic Area to countries or territories which do not offer the same level of protection for the rights and freedoms of prospective investors as the UK.

If the Company (or any third party, functionary or agent appointed by the Company) discloses personal data to such a third party, agent or functionary and/or makes such a transfer of personal data it will use reasonable endeavours to ensure that any third party, agent or functionary to whom the relevant personal data is disclosed or transferred is contractually bound to provide an adequate level of protection in respect of such personal data.

In providing such personal data, investors will be deemed to have agreed to the processing of such personal data in the manner described above. Prospective investors are responsible for informing any third-party individual to whom the personal data relates of the disclosure and use of such data in accordance with these provisions.

Presentation of ﬁnancial information

Prospective investors should consult their own professional advisers to gain an understanding of the ﬁnancial information contained in this prospectus. An overview of the basis for presentation of ﬁnancial information in this prospectus is set out below. Part X - Selected Historical Financial Information on the Company of this prospectus presents selected ﬁnancial information extracted without material adjustment from (i) the unaudited interim historical ﬁnancial information of the Company for the six months ended 30 June 2019, 30 June 2020, and (ii) the audited historical ﬁnancial information of the Company for the 12 month periods ended 31 December 2017, 31 December 2018; and 31 December 2019, both of which are incorporated by reference in Part XVI - Documents Incorporated by Reference of this prospectus.

The ﬁnancial and volume information in this prospectus, including in a number of tables, has been rounded to the nearest whole number or the nearest decimal place. The sum of the numbers in a column in a table may not conform exactly to the total ﬁgure given for that column. In addition, certain percentages presented in the tables in this prospectus reﬂect calculations based on the underlying information prior to rounding, and, accordingly, may not conform exactly to the percentages that would be derived if the relevant calculations were based upon the rounded numbers.

Market data

Where information contained in this prospectus has been sourced from a third party, the Company and the Directors conﬁrm that such information has been accurately reproduced and, so far as they are aware and have been able to ascertain from information published by that third party, no facts have been omitted which would render the reproduced information inaccurate or misleading.

CREST

CREST is a paperless settlement procedure enabling securities to be evidenced otherwise than by a certiﬁcate and transferred otherwise than by written instrument. The Articles permit the holding of Ordinary Shares under the CREST system. The Ordinary Shares are admitted to CREST and accordingly, settlement of transactions in the Ordinary Shares following Admission may take place within the CREST system if any investor so wishes.

CREST is a voluntary system and Shareholders who wish to receive and retain certiﬁcates for their Ordinary Shares will be able to do so. Shareholders may elect to receive Ordinary Shares in uncertiﬁcated form if such Shareholder is a system-member (as deﬁned in the CREST Regulations) in relation to CREST.

Transferability

The Ordinary Shares are freely transferable and tradable and there are no restrictions on transfer.

International Financial Reporting Standards

As required by the Companies Act and Article 4 of the European Union ("EU") International Accounting Standards Regulation, the ﬁnancial statements of the Company are prepared in accordance with International Financial Reporting Standards as adopted by the EU ("IFRS") issued by the International Accounting Standards Board ("IASB") and interpretations issued by the International Financial Reporting Interpretations Committee of the IASB as adopted by the EU.

Incorporation of information by reference

The contents of the Company's website (www.tizianalifesciences.com), unless speciﬁcally incorporated by reference, any website mentioned in this prospectus or any website directly or indirectly linked to these websites have not been veriﬁed and do not form part of this prospectus, and prospective investors should not rely on them.

Forward-looking statements

This prospectus includes statements that are, or may be deemed to be, 'forward-looking statements'. In some cases, these forward-looking statements can be identiﬁed by the use of forward-looking terminology, including the terms 'targets', 'believes', 'estimates', 'anticipates', 'expects', 'intends', 'may', 'will', 'should' or, in each case, their negative or other variations or comparable terminology. They appear in a number of places throughout the document and include statements regarding the intentions, beliefs or current expectations of the Company and the Board concerning, inter alia: (i) the Company's objective, acquisition and ﬁnancing strategies, results of operations, ﬁnancial condition, capital resources, prospects, capital appreciation of the Ordinary Shares and dividends; and (ii) future deal ﬂow and implementation of active management strategies. By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. Forward-looking statements are not guarantees of future performance. The Company's actual performance, results of operations, ﬁnancial condition, distributions to Shareholders and the development of its ﬁnancing strategies may differ materially from the forward- looking statements contained in this prospectus. In addition, even if the Company's actual performance, results of operations, ﬁnancial condition, distributions to Shareholders and the development of its ﬁnancing strategies are consistent with the forward-looking statements contained in this prospectus, those results or developments may not be indicative of results or developments in subsequent periods.

Prospective investors should carefully review Part II - Risk Factors of this prospectus for a discussion of additional factors that could cause the Company's actual results to differ materially, before making an investment decision. For the avoidance of doubt, nothing appearing under the heading "Forward-looking statements" constitutes a qualiﬁcation of the working capital statement set out in paragraph 10 of Part XIV - Additional Information of this prospectus.

Forward looking statements contained in this prospectus apply only as at the date of this prospectus. Subject to any obligations under the Listing Rules, the Market Abuse Regulation (EU 596/2014)(the "Market Abuse Regulation"), the Disclosure Guidance and Transparency Rules and the Prospectus Regulation Rules, the Company undertakes no obligation publicly to

update or review any forward-looking statement, whether as a result of new information, future developments or otherwise.

Currency

Unless otherwise indicated, all references in this prospectus to:

"UK Pounds Sterling", "Pounds Sterling", "pound", "pence", "GBP", "£" or "p" is to the lawful currency of the United Kingdom; and
"US Dollars", "US$", "$" or "cents" is to the lawful currency of the United States.

PART IV

EXPECTED TIMETABLE

Publication of this prospectus	18 December 2020
Ordinary Shares cease to be traded on AIM	7.00 a.m. on 21 January 2021
Admission and commencement of dealings in Ordinary Shares	8.00 a.m. on 21 January 2021

All references to time in this prospectus are to London time, unless otherwise stated. Any changes to the expected timetable will be notiﬁed by the Company through an RIS.

ADMISSION STATISTICS

Number of Existing Ordinary Shares in issue	194,612,289
Number of warrants in issue prior to and at Admission	1,183,491
Number of options in issue prior to and at Admission	17,023,678
Market capitalisation at Admission (1)	£163,474,322.84
Ordinary Shares represented by ADSs as a percentage of Issued
Share Capital	34.49%

-----

The market capitalisation of the Company at any given time will depend on the market price of the Ordinary Shares at that time and is based on the mid-market closing price of the Ordinary Shares as traded on AIM on 17 December 2020, being the last practical date prior to the publication of this Prospectus. There can be no assurance that the market price of an Ordinary Share will trade at the same price as they previously traded in AIM.

DEALING CODES
The dealing codes for the Ordinary Shares will be as follows:
ISIN	GB00BKWNZY55
SEDOL code	BKWNZY5
TIDM	TILS
LEI	213800CED47HI8PIOB36

PART V

DIRECTORS, AGENTS AND ADVISERS

Directors	Gabriele Cerrone (Executive Chairman)
	Kunwar Shailubhai PhD (Executive Director)
	Willy Simon (Non-Executive Director)
	John Brancaccio (Non-Executive Director)
Registered Ofﬁce and Company Secretary	Accomplish Secretaries Limited
	3rd Floor, 11-12 St James's Square
	London SW1Y 4LB
Sole Broker and Co-ordinator	Optiva Securities Limited
	49 Berkeley Square
	Mayfair
	London W1J 5AZ
Auditors and Reporting Accountants	Mazars LLP
	Tower Bridge House
	St Katharine's Way
	London, E1W 1DD
Solicitors to the Company	Orrick Herrington & Sutcliffe (UK) LLP
	107 Cheapside
	London EC2V 6DN
Registrar	Link Market Services
	65 Gresham Street
	London EC2V 7NQ

PART VI

THE COMPANY'S STRATEGY

1. Introduction

Tiziana Life Sciences plc is development of novel molecules

a biotechnology company that focuses on the discovery and that treat human disease in oncology and immunology.

Since its incorporation in 1998, the Company strove to generate revenue from Colostrinin, which was initially developed as a pharmaceutical compound to treat Alzheimer's disease. Whilst efﬁcacy had been shown in a number of trials, it became apparent that, as a consequence of its complex nature, Colostrinin could not be characterised and therefore produced to the exacting standards demanded for a pharmaceutical product. As a consequence, the Company set out in 2003 to develop a nutraceutical business based on convincing clinical data. The ﬁrst licensing deal was signed in 2006 and the product was ﬁrst marketed in Australia in July 2007, the US in October 2007 and since then in Cyprus, Poland, the UK, Turkey and India. However, sales of the products did not reach the levels anticipated by the Company.

In the period from December 2010 to February 2011, the Company decided that Shareholders' interests would be better served by establishing a different business model. Accordingly, the Company decided to change the business of the Company to that of an investing company. In order to do this the Company demerged its business in respect of Colostrinin into a newly incorporated company with shares in that business being transferred to the then shareholders of the Company. Following the demerger, the Company adopted an investing policy pursuant to which the Company targeted small cap and special opportunities with a bias towards basic resources and oil and gas companies, predominantly on AIM. The Company continued its business as an investing company and sought to identify investments that ultimately increase shareholder value.

On 24 April 2014, the Company acquired Tiziana Pharma Limited ("TPL") via a reverse takeover (as deﬁned in the AIM Rules). TPL was formed in November 2013 as a vehicle to acquire and exploit certain intellectual property in biotechnology. The acquisition of TPL had the effect of changing the status of the Company from an investing company under the AIM Rules to an operating company with a material trading activity. Since the acquisition of TPL, the Group's operations have thereafter constituted exclusively those of TPL.

On 22 December 2014, the Company in-licensed the molecule Foralumab, the only fully human engineered anti-human CD3 antibody in clinical development, from Novimmune SA. Foralumab targets the CD3 epsilon (CD3ε) receptor, which is a recognised approach for modulating T-Cell response and achieving immunosuppression. Foralumab is a Phase 2 asset with potential application in a wide range of autoimmune and inﬂammatory disease, such as multiple sclerosis, type-1 diabetes, inﬂammatory bowel disease, psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable.

On 20 January 2015, the Company in-licensed Milciclib from Nerviano Medical Sciences. The compound blocks the action of a speciﬁc set of enzymes known as cyclin-dependent kinases (CDKs), which are involved in the process of cell division, as well as a number of other protein kinases. Milciclib has an unusual kinase inhibitory proﬁle making it active against other receptors such as, tyrosine kinase, src family and splicing kinases. Milciclib completed phase2 clinical trials for thymic carcinoma in patients previously treated with chemotherapy and has orphan drug designation for this indication is US and EU.

To date, Milciclib has been studied in a total of eight 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.

The Company 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.

The Phase 2a trial was completed in June 2019 with clinical safety and efﬁcacy result reported in July 2019. 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 drug treatment approach in patients with HCC.

TZLS-501 (formerly NI-1201), a fully human anti-interleukin-6 receptor (anti-IL6R) monoclonal antibody (mAb) was acquired from Novimmune, a Swiss biotechnology company, in 2017. In March 2020, the Company announced that it is expediting development of TZLS-501for treatment of inﬂammation and lung damage in patients infected with coronavirus COVID-19(SARS-CoV-2). The Company plans to administer TZLS-501 as an aerosol directly to the site of inﬂammation using a nebulizer or metered inhaler.

In April 2020 the Company acquired all intellectual property relating to a nanoparticle-based formulation of Actinomycin D (Act D; a.k.a. Dactinomycin), from Rasna Therapeutics, Inc. ("Rasna") to expand its pipeline.

Act D, an antibiotic drug, approved initially for infectious diseases in the United States in 1964. Subsequently, this antibiotic was shown to exhibit anti-cancer activity in 1974. Since then the drug has been used to treat various types of cancer. Since Act D is a potent inhibitor of RNA synthesis, may have potential for treatment of COVID-19 patients either alone or in combination with TZLS-501 inhalation treatment.

2. Company strategy Objectives

The Company is a dual-listed clinical stage biotechnology company that specializes in the developing transformative therapies for autoimmune and inﬂammatory diseases, degenerative diseases and cancer related to the liver. The Company's clinical pipeline includes drug assets for Crohn's Disease, COVID-19 and Progressive Multiple Sclerosis and Hepatocellular Carcinoma. The Company is led by a team of highly qualiﬁed executives with extensive drug development and commercialization experience.

Mission

The Company's mission is to bring breakthrough therapies with the aim of treating Crohn's Disease, COVID-19,Pro-MS and HCC and optimizing health outcomes.

Vision

The Company envisions becoming a leader in advancing innovative, best-in-class medicines for patients with life threatening diseases.

Foralumab mAb

Foralumab is a fully human anti-CD3 monoclonal antibody (mAb) that the Company is using for the treatment of Crohn' sdisease, neurodegenerative diseases and treatment of COVID-19-induced inﬂammation. The Company has recently completed two Phase 1 clinical trials: one for progressive MS indication with nasal administration and the other for Crohn's disease indication, with enteric coated capsules administered orally. Clinical protocol for Phase 2 nasal clinical trial for progressive MS indication is ﬁnalized. The brieﬁng package and protocol were submitted to FDA on 22 July 2020 requesting type C meeting and FDA response expected by mid-October, 2020. The trial is anticipated to begin in Q4 2020. Additionally, the Company plans to evaluate the use of foralumab to treat lung inﬂammation in COVID-19 patients in an investigator initiated trial in Brazil in Q4 2020. Foralumab has demonstrated ability to activate regulatory T cells that systemically circulate to elicit targeted immunomodulation providing therapeutic beneﬁt to patients.

The Company has recently submitted a patent application on potential use of Foralumab, to improve success of chimeric antigen receptor T cells (CAR-T) therapy for cancer and other human diseases. The patent application covers inventions related to improving CAR-T expansion and/or survival. Foralumab administered alone or co-administered in combination with co-stimulatory molecules, such as an anti-IL-6 receptor monoclonal antibody, an anti-CD28 monoclonal antibody or speciﬁc inhibitors of signaling pathways of phosphatidylinositol 3-kinase (PI3K), protein kinase B (AKT), or mammalian target to improve success of CAR-T therapy.

Anti IL-6R mAb

Anti IL-6R is a fully human mAb, which binds to both the membrane-bound and soluble forms of the IL6R and depletes circulating levels of the IL-6 in the blood. The Company is accelerating development in Anti IL-6R mAb as a treatment of COVID-19. The treatment utilizes a novel mode of

administration using hand-held nebulizer to deliver aerosolized anti-IL6R mAb solution to inﬂamed tissue of deep lung. On 9 April 2020, the Company announced ﬁling of patent application in support of treatment of COVID-19 utilizing Anti-IL6R via inhaled delivery (Kunwar Shailubhai, inventor).

Initial work on CMO selection, technology transfer and transfer of lead cell line candidate from Novimmune to CMO initiated in April 2020. STC Biologics is expanding the cell line, establishing monoclonality, screening for cell line stability and antibody titer and expanding the monoclonal cell line to larger scale for development and cGMP manufacturing. Concurrently they are purifying a batch of monoclonal antibody from the 70L Novimmune pilot batch, manufactured using the lead, non-clonal cell line. STC's generic downstream process is being used for the puriﬁcation of test article for Inhalation Safety Toxicology studies using Cynomolgus monkeys at ITR Laboratories Canada in December 2020.

Work at Sciarra Laboratories in Hicksville, NY was initiated in May 2020 to evaluate two hand-held nebulizer devices for use in the study and characterizing physical/performance characteristics of the aerosol. Sciarra will execute cGMP manufacturing of drug product solution, packaging and ICH stability studies in Q1 2021.

In July 2020, the Company engaged FHI Clinical as CRO to conduct phase1/2 clinical trials of TZLS-501 in for the COVID-19 indication. Phase1/2 adaptive trial with sites located mostly ex-US in COVID-19 hot spots to speed enrollment to start in Q1 2021.

Milciclib

Milciclib is the Company's Phase 2 clinical candidate for the treatment of multiple cancer indications such as hepatocellular carcinoma, thymic cancer and thymoma. Milciclib, a pan cyclin-dependent kinases (CDK) inhibitor, has demonstrated potent anti-tumour activity as a monotherapy as well as combination therapy. To date, Milciclib has been studied in eight 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. Milciclib has been granted orphan designation by the European Commission and by the FDA for the treatment of malignant thymoma and an aggressive form of thymic carcinoma in patients previously treated with chemotherapy. Milciclib is also being used for treatment of recurrent HCC in liver transplant patients in an investigator-initiated clinical trial. The safety and clinical activity of combination treatment of Milciclib with Regorafenib in liver transplant patients with recurrent HCC has been evaluated showing combination treatment was well tolerated with manageable toxicities. Safety and clinical activity data was presented at Virtual ASCO 2020 conference.

3. Short-term objectives

The Company's 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 the Company's 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.
Evaluate the safety and clinical utility of nasally-administered Foralumab for treatment of cytokine-storm induced lung inﬂammation in COVID-19 patients in an investigator-driven clinical trial to be conducted in Brazil in Q4 2020. The collaborative clinical study will investigate
nasally administered Foralumab either alone or in combination with orally administered dexamethasone in COVID-19 patients. In view of the importance and urgency, scientiﬁc teams at the Harvard Medical School, Santa Casa de Misericórdia de Santos Hospital (Jabaquara, Santos, Brazil) and at the Company are closely collaborating to facilitate initiation of this study in expedited time frames. This clinical trial will be coordinated by the team at INTRIALS, a leading, full-service Latin America Clinical Research Organisation, (CRO) based in Sao Paulo City, Brazil. The clinical data from this trial is expected to be available by the end of 2020.

Accelerate development and cGMP manufacturing of its 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. cGMP manufacturing has commenced and the Company is simultaneously developing inhalation delivery directly to the lungs using a nebulizer and conducting the inhalation safety
toxicology studies in Cynomolgus monkeys. Completion of these studies will enable the Company to ﬁle an IND and initiate a clinical trial in COVID-19 patients by Q1 2021.
Continue to advance the clinical development and obtain regulatory approval for the Company's 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 monoclonal antibodies (mAbs).
Continue to evaluate alternative, non-parenteral routes of mAb administration, namely oral, nasal and inhalation routes, to facilitate topical or local therapeutic action.
Continue to leverage relationships with key opinion leaders to promote clinical trial success and enhance future commercialisation.
Opportunistically identify and acquire or in-license complimentary product and technology candidates.
Seek orphan drug, fast track or breakthrough designation for its product candidates where warranted.

4. Market background

Crohn's disease is an inﬂammatory bowel disease (IBD) that refers to a chronic inﬂammatory condition of the gastrointestinal tract causing inﬂammation in the digestive tract. The global inﬂammatory bowel disease treatment market size was valued at USD 15.9 billion in 2018 and is expected to register a compound annual growth rate of 4.4 per cent. from 2018 to 2026 (source: Grand View Research, Inc., "Inﬂammatory Bowel Disease Treatment Market Size, Share & Trends Analysis Report By Type (Ulcerative Colitis, Crohn's Disease), By Route of Administration, By Distribution Channel, And Segment Forecasts, 2019 - 2026, published June 2019). Market participants include Shire; AbbViee Inc.; Celgene, Eli Lilly and Company; Pﬁzer Inc.; and Gilead Sciences. These participants are involved in research and development to introduce and commercialize better versions of existing products.

The global COVID-19 current therapy market is expected to grow from $10.83 billion in 2019 to $16.51 billion in 2020 at a compound annual growth of 52.5 per cent. (source: The Business Research Company, "Coronavirus (COVID-19) Current Therapy Global Market Report 2020: COVID 19 Growth and Change, published July 2020). The COVID-19 pandemic and the global focus to treat the widespread cases is a key market driver.

The compounds and medications that are under investigation to treat Covid-19 can be grouped into three broad categories - antivirals, immune-system based and vaccines. The anti-virals including Darunavir, Favipiravir, Hydroxychloroquine and chloroquine, Lopinavir, and Remdesivir (GS-5734), immune system-related therapies including Tocilizumab, Tocilizumab, and Vitamin C, and other medications are currently being evaluated as therapies. Three key drugs are currently in phase III, of which are two small molecule-based drugs, Remdesivir by Gilead Sciences Inc. and Favipiravir by Fujiﬁlm Toyama Chemical Co Ltd, and Sarilumab, a monoclonal antibody by Regeneron Pharmaceutical. With regards to the prophylactic vaccine pipeline, more than 90 per cent. are in early-stage development (discovery and preclinical), and only three in Phase II. These three COVID- 19 vaccines are being developed by Sinovac Biotech Ltd, the University of Oxford, and the third vaccine, named CIGB-2020, is being developed by the Center for Genetic Engineering and Biotechnology.

Globally the size of liver cancer therapeutics market was worth USD $680.84 million in 2019 with an estimated compound annual growth rate of 9.1 per cent., to reach USD $1,052.3 million by 2024

(source: Market Data Forecast, "Global Liver Cancer Therapeutics Size & Growth (2019 - 2024), published February 2020). Malignant tumors of the liver are primarily adenocarcinomas, with two major cell types: hepatocellular carcinoma (HCC), and cholangiocarcinoma. Liver cancer is the third- leading cause of cancer-related deaths, and HCC accounts for 85 per cent. of all primary liver cancers. It occurs mainly due to hepatitis C infection, and to a lesser extent hepatitis B and alcohol. While surgical resection and liver transplantation are potentially curative therapies for early-stage HCC, the majority of diagnoses take place at a disease stage that is too advanced for these treatments. Technological advancements and the routine liver function tests are now resulting in the early detection of hepatocellular carcinoma. The increase in incidences of hepatocellular carcinoma associated with hepatitis C virus are expected to grow the hepatocellular carcinoma treatment market during 2016-2026.

Bayer AG is one of the leading provider of hepatocellular carcinoma (HCC) treatment drugs. Some of the key players in hepatocellular carcinoma treatment market are Novartis Pharmaceuticals, Merck & Co., Inc., Bristol-Myers Squibb Company, AbbVie Inc., Johnson & Johnson Pvt. Ltd., Celgen Corporation, Amgen Inc., Teva pharmaceutical Industries Ltd., Pﬁzer Inc., and Takeda Pharmaceutical Co. Ltd. These companies focuses on the priority areas of the antiviral and oncology in order to address unmet medical needs.

The global Multiple Sclerosis (MS) Therapeutics market was valued at USD $21.92 billion in 2019 and is expected to reach USD $26.69 billion by year 2027, at a compound annual growth rate of

2.5 per cent. (source: Reports and Data, "Multiple Sclerosis Therapeutics Market Analysis, By Product Type (Immuno-modulators, Immunosuppressant), By Mode of Administration Type (Injectable, Intravenous), By Distribution Channel (Healthcare Providers, Online Pharmacies), Forecast To 2017-2027", published July 2020). Multiple Sclerosis is a disabling condition of the central nervous system that impairs the ﬂow of information within the brain and between the body and the brain. The MS therapeutics market covers the drugs that are being used for the treatment

of this disease or to reduce the complications associated with the same. Key participants include Biogen Idec; Pﬁzer Inc.; Teva Pharmaceutical Industries Ltd.; Sanoﬁ Aventis; Bayer Healthcare AG; Merck; Novartis AG; and AbbVie Inc.

5. Dividend policy

The Company intends to pay dividends on the Ordinary Shares at such times (if any) and in such amounts (if any) as the Board determines appropriate in its absolute discretion. The Company's current intention is to retain any earnings for use in its business operations, and the Company does not anticipate declaring any dividends until the Company is generating signiﬁcant revenue. The Company will only pay dividends to the extent that to do so is in accordance with all applicable laws.

6. Corporate governance

The Company has adopted a corporate governance structure more fully outlined in Part VII - The Board of Directors and Senior Members of Management of this prospectus. The key features of its structure are:

The Directors recognise the importance of sound corporate governance and the Company will comply with the provisions of the Corporate Governance Code for Small and Mid-Size Quoted Companies ("QCA Code"), as published by the Quoted Companies Alliance. The Company has also established a remuneration committee, an audit committee and an AIM Rules compliance committee with formally delegated duties and responsibilities.

The Remuneration Committee will meet not less than twice each year. The committee will be responsible for the review and recommendation of the scale and structure of remuneration for senior management, including any bonus arrangements or the award of share options with due regard to the interests of the Shareholders and the Company's performance.

The Audit, Risk and Disclosure Committee will meet not less than three times a year. The committee will be responsible for making recommendations to the Board on the appointment of auditors and the audit fee and for ensuring that the Company's ﬁnancial performance is properly monitored and reported. In addition, the Audit Committee will receive and review reports from management and the auditors relating to the interim report, the annual report and accounts and the Company's internal control systems.

The Nomination Committee will meet not less than two times a year. The committee will lead the process for Board appointments and make recommendations to the Board.

The Company recognises that it no longer complies with the QCA Code in relation to independent non-executive directors requirement but will seek to rectify this situation as soon as possible.

PART VII

THE BOARD OF DIRECTORS AND SENIOR MEMBERS OF MANAGEMENT

The Directors

The Board, collectively, has signiﬁcant experience in the pharmaceutical sector.

The Directors of the Company have all been selected for their extensive experience in their specialised ﬁelds, making the Board well rounded and balanced. The Board has a strong track record of developing and bringing pharmaceutical products to market. The composition of the Board is regularly reviewed through the nomination committee. The wide range of skills among the Directors helps to further the business and strategic development of the Company as well as address any anticipated issued in the foreseeable future.

All Directors are expected to provide a sufﬁcient amount of time to the Company to fully exhibit and fulﬁl their duties. Each Director's time spent is reviewed annually prior to recommending their reelection to the shareholders.

Details of the Directors are listed below.

Gabriele Cerrone (age 48, date of birth: 2 February 1972)

Mr. Cerrone has a successful track record and extensive experience in the ﬁnancing and restructuring of micro-cap biotechnology companies. He has founded nine biotechnology companies in oncology, infectious diseases and molecular diagnostics, and has taken six of these companies to the NASDAQ Market and one to the AIM Market in London. Mr. Cerrone Co-Founded Trovagene, Inc. (NASDAQ: TROV), a molecular diagnostic company and served as its Co-Chairman; he was a Co-Founder and served as Chairman of both Synergy Pharmaceuticals, Inc. (NASDAQ: SGYP) and Callisto Pharmaceuticals, Inc. (OTCMKTS: CLSP), and was a Director of and led the restructuring of Siga Technologies, Inc. (NASDAQ: SIGA). Mr. Cerrone also co-founded FermaVir Pharmaceuticals, Inc. and served as Chairman of the board 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 Myers Squibb Co in 2012.

Mr Cerrone is the Executive Chairman and Co-Founder of Gensignia Life Sciences, Inc., a molecular diagnostics company focused on oncology using microRNA technology; Chairman and Co-Founder of Rasna Therapeutics Limited, a company focused on the development of therapeutics for leukaemias; Co-Founder of ContraVir Pharmaceuticals, Inc. (Nasdaq: CTRV); and Founder of BioVitas Capital Ltd.

Dr Kunwar Shailubhai (age 63, date of birth: 2 September 1957)

Kunwar Shailubhai, Ph.D., M.B.A. serves as Chief Executive Ofﬁcer and Chief Scientiﬁc Ofﬁcer of the Company, and is also an Executive Director of the Company. Dr. Shailubhai brings more than 25 years of experience within the life science industry, combined with a distinguished track record of success in translating drugs from concept through commercialisation to market. He also currently serves as CEO of Rasna Therapeutics, Inc., a developer of therapeutics to address the high unmet need that exists for Acute myeloid leukaemia and other forms of leukemia.

Dr. Shailubhai has been serving as a member of board of the Company since 2015. He actively played key roles in development of growth strategies through several key licensings of technologies and drug candidates. Dr. Shailubhai steered the company through prioritisation of projects to focus on novel drug candidates for treatment of autoimmune and inﬂammatory diseases and cancer.

As Co-Founder, EVP and CSO of Synergy Pharmaceuticals, Inc. (NASDAQ: SGYP) he led the non- clinical, CMC and clinical development of Trulance™ from inception to approval by the FDA, having co-invented and pioneered Synergy's platform technology for functional GI disorders, inﬂammatory bowel disease, GI cancer and other human diseases. Dr. Shailubhai as the Chief Architect of the IP estate, directed all aspects of IP management, including timely submission of patent applications, directing ofﬁce actions and coordinating with IP attorneys.

Earlier, from 2003 until 2008, Dr. Shailubhai served as senior vice president, Drug Discovery and from 2001 to 2003, he held the position of Vice President, Drug Discovery at Synergy, where he

pioneered therapeutic applications of GC-C agonists in a variety of human diseases such as asthma, chronic obstructive pulmonary diseaseand cholesterol lowering.

Prior to Synergy, he was with Monsanto Company, serving as Group Leader, Cancer Prevention and 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 from the University of Baroda, India, and his MBA from the University of Missouri, St. Louis. He has more than 20 issued patents and over 50 peer- reviewed publications.

Willy Simon (age 69, date of birth: 11 May 1951)

Willy Jules Simon is a banker and worked at Kredietbank N.V. and Citibank London before serving as an executive member of the board of Generale Bank NL from 1997 to 1999 and as the Chief Executive of Fortis Investment Management from 1999 to 2002. He acted as Chairman of Bank Oyens & van Eeghen from 2002 to 2004. From 2004 until 2012, he served as a Non-Executive Director of Redi & Partners Ltd., a fund of funds. He was previously Chairman of AIM-traded Velox3 plc (formerly 24/7 Gaming Group Holdings plc) until 2015 and had been a director of Playlogic Entertainment Inc., a NASDAQ OTC listed company.

John Brancaccio (age 72, date of birth: 8 March 1948)

Mr. Brancaccio, retired CPA, is a ﬁnancial executive with extensive international and domestic experience in pharmaceutical and biotechnology for privately and publicly held companies. From 2000 to 2002, Mr. Brancaccio was the Chief Financial Ofﬁcer/Chief Operating Ofﬁcer of Eline Group, an entertainment and media company. From May 2002 until March 2004, Mr. Brancaccio was the Chief Financial Ofﬁcer of Memory Pharmaceuticals Corp., a biotechnology company. From April 2004 until May 2017, Mr. Brancaccio was the Chief Financial Ofﬁcer of Accelerated Technologies, Inc., an incubator for medical device companies.

Mr. Brancaccio is currently a director of Cardiff Oncology, Inc., Rasna Therapeutics, Inc., OKYO Pharma LTD and Hepion Pharmaceuticals, Inc.

Senior Management Team

The Company's current senior management team (the "Senior Managers"), in addition to the Directors listed above, is as follows:

Jules S. Jacob (age 68), 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 (age 64) - Director*, Clinical Operations

Dr. Palejwala is currently the Director of Clinical Operations at the Company. From January 2017 to January 2019, he served as Director, Non-Clinical Studies of the company. He has over 20 years of experience in drug discovery and development. 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 participated actively in preparation of the nonclinical pharmacology section of the NDA for Trulance®. From 2001 to 2012, Dr. Palejwala served as discovery scientist/ manager at Aventis/Sanoﬁ-Aventis, a 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 Bachelor's degree in microbiology and chemistry from Bombay University, as well as a Master of Science degree and a Ph.D. degree in microbiology from the Maharaja Sayajirao University of Baroda.

Keeren Shah (age 44) - Finance Director*

Keeren Shah serves as the Finance Director at the Company, having previously served as the Group Controller from June 2016 to July 2020. Prior to joining the Company, Ms. Shah spent 10 years at Visa, Inc. as a Senior Leader in its ﬁnance team where she was responsible for key ﬁnancial controller activities, FP&A and core processes as well as leading and participating in key transformation programmes and Visa's IPO. Before joining Visa, Ms. Shah has also held a variety of ﬁnance positions at other leading companies including Arthur Andersen and BBC Worldwide.

She holds a Bachelor of arts with honours in Economics and is a member of the Chartered Institute of Management Accountants.

* Title of director but not a statutory director of the Company

Strategic decisions

Members and responsibility

The Directors are responsible for carrying out the Company's objectives, implementing its business strategy in relation to the development of its product candidates and conducting the Company's overall supervision. The Board will provide leadership within a framework of prudent and effective controls. The Board will establish the corporate governance values of the Company and will have overall responsibility for setting the Company's strategic aims, deﬁning the business plan and strategy and managing the ﬁnancial and operational resources of the Company.

Frequency of meetings

The Board will schedule quarterly meetings and will hold additional meetings as and when required. The expectation is that this will not result in more than four meetings of the Board each year.

Corporate governance

Audit Committee

The Audit Committee of the Board comprises of John Brancaccio and Willy Simon. It is chaired by John Brancaccio, and is responsible for:

monitoring the quality of internal controls and ensuring the ﬁnancial performance of the Group is properly measured and reported on;
consideration of the Directors' risk assessment and suggesting items for discussion at the full Board;
receipt and review of reports from the Company's management and auditors relating to the
interim and annual accounts, including a review of accounting policies, accounting treatment and disclosures in the ﬁnancial reports;
consideration of the accounting and internal control systems in use throughout the Company and its subsidiaries; and
overseeing the Company's relationship with external auditors, including making recommendations to the Board as to the appointment or re-appointment of the external auditors, reviewing their terms of engagement, and monitoring the external auditors' independence, objectivity and effectiveness.

The Audit Committee meets not less than twice in each ﬁnancial year and has unrestricted access to the Company's auditors.

Nomination Committee

The Nomination Committee of the Board comprises of Gabriele Cerrone and Willy Simon. It is chaired by Gabriele Cerrone, and is responsible for:

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; and
developing corporate governance guidelines.

Remuneration Committee

The Remuneration Committee of the Board comprises of Willy Simon and John Brancaccio. It is chaired by Willy Simon, and is responsible for:

the review of the performance of the executive directors;
recommendations to the Board on matters relating to the remuneration and terms of service of the executive directors; and
recommendations to the Board on proposals for the granting of share options and other equity incentives pursuant to any share option scheme or equity incentive scheme in operation from time to time.

In making their recommendations the Remuneration Committee will have due regard to the interests of the Shareholders and the performance of the Company.

The Company has adopted and will operate a share dealing code governing the share dealings of the Directors of the Company and applicable employees with a view to ensuring compliance with the Market Abuse Regulation.

The Company has adopted a share dealing policy regulating trading and conﬁdentiality of inside information for the Directors and other persons discharging managerial responsibilities (and their persons closely associated) which contains provisions appropriate for a company whose shares are admitted to trading on the Ofﬁcial List (particularly relating to dealing during closed periods which will be in line with the Market Abuse Regulation). The Company will take all reasonable steps to ensure compliance by the Directors and any relevant employees with the terms of that share dealing policy.

Scientiﬁc advisory board

The Board is assisted in its approach to its scientiﬁc strategy. The members of the Scientiﬁc Advisory Board are as follows:

Howard Weiner MD - Harvard Medical School

Dr. Howard Weiner is the Robert L. Kroc Professor of Neurology at the Harvard Medical School, Director and Founder of the Partners Multiple Sclerosis (MS) Center and Co-Director of the Ann Romney Center for Neurologic Diseases at Brigham & Women's Hospital in Boston. The Partners MS Center is the ﬁrst integrated MS Center that combines clinical care, MRI imaging and immune monitoring to the MS patient as part of the 2000 patient CLIMB cohort study. He has pioneered immunotherapy in MS and has investigated immune mechanisms in nervous system diseases including MS, Alzheimer's disease, amyotrophic lateral sclerosis, stroke and brain tumours. He has also pioneered the investigation of the mucosal immune system for the treatment of autoimmune and other diseases and the use of anti-CD3 to induce regulatory T cells for the treatment of these diseases.

Kevan Herold MD - Yale University

Dr. Kevan Herold is Professor of Immunobiology and of Medicine (Endocrinology) as well as Deputy Director, Yale Center for Clinical Investigation, Director of the Yale Diabetes Center and Director of the TrialNet Center at Yale. His investigative work has focused on developing new ways to prevent and treat autoimmune diseases, using novel translational immunologic and metabolic approaches to prevent progression, in particular anti-CD3 monoclonal antibody therapy. His clinical interests are in the management of endocrine diseases, and he is involved in a number of national and international clinical studies of new treatments.

Arun Sanyal MD - Virginia Commonwealth University

Charles Caravati Distinguished Professor and Chair, Division of Gastroenterology, Hepatology and Nutrition at Virginia Commonwealth University School of Medicine. Dr Sanyal is a world leader in the ﬁeld of liver disease.

Professor Napoleone Ferrara, MD - University of California's Moores Cancer Center in San Diego

Dr Ferrara is Senior Deputy Director for Basic Sciences at University of California's Moores Cancer Center in San Diego; and Distinguished Professor of Pathology at the University of California's School of Medicine, also in San Diego. Dr Ferrara's research led to the development of the anti- VEGF monoclonal antibody bevacizumab (Avastin®) which was initially approved for the treatment of colorectal cancers, now one of the top ten selling global pharmaceutical products and won the 2010 Lasker Award for his work on VEGF.

PART VIII

THE BUSINESS

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. Current estimates for Northern Europe have ranged from 27-48 people per 100,000.

Although the exact etiology remains unknown, the occurrence of Crohn's disease is strongly associated with mutations of a receptor for microbial pathogens (nucleotide-binding oligomerization domain containing protein 2 - NOD2) that recognizes microbial pathogens leading to increased activation of antigen presenting cells. 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 inﬂammatory responses.

The pharmacological management of Crohn's disease is based on the control of the inﬂammatory process. The current leading biologic immunotherapies, Humira® (adalimumab) and Remicade® (inﬂiximab) are administered parenterally to target Tumor Necrosis Factora(TNFa) to induce and maintain disease remission.

The Company intends to orally administer Foralumab to the small and large intestine via an enteric- coated capsule formulation. Foralumab binds locally to dendritic cells (antigen-presenting cells) lining the GI tract, inducing regulatory T cells supporting immunomodulation locally as well as systemically, it also has the ability to act topically to produce anti-inﬂammatory effects. The Company has completed a Phase 1 trial, conducted at the Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. The trial was a single-site,double-blind,placebo-controlled, single ascending dose 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. 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.

The Company has been granted the ﬁrst-ever patent on the transformational technology for Oral Delivery of all Anti-CD3 monoclonal antibodies for treatment of human diseases.

Crohn's immune modulation

Progressive Multiple Sclerosis

MS is an inﬂammatory-mediated demyelinating disease of the human central nervous system (CNS). The disease develops in young adults with a predisposing genetic trait and most likely involves an environmental insult such as a viral infection to trigger the disease.

The innate immune system plays a central role in the chronic central nervous system inﬂammation that drives neurological disability in progressive forms of multiple sclerosis, for which there are no effective treatments. The mucosal immune system is a unique tolerogenic organ that provides a physiological approach for the induction of regulatory T cells. Nasal administration of CD3-speciﬁc antibody ameliorates disease via an IL-10-dependent effect that is mediated by the induction of regulatory T cells that share a similar transcriptional proﬁle to Tr1 regulatory cells and that suppress the astrocyte inﬂammatory transcriptional program. Treatment results in an attenuated inﬂammatory milieu in the central nervous system, decreased microglia activation, reduced recruitment of peripheral monocytes, stabilization of the blood-brain barrier and less neurodegeneration.

The Company conducted a Phase 1 trial, at the Brigham and Women's Hospital, Harvard Medical School, Boston, MA. The trial 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.

COVID-19

Coronavirus disease 2019 (COVID-19) is a highly contagious disease attributed to transmission of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). The disease originated in Wuhan China, in December 2019, and has spread globally, creating an ongoing pandemic. As of 28 April 2020, 3 million cases have been tracked in 185 countries. More than 200,000 deaths have been recorded and greater than 900,000 people have recovered after infection.

The lungs are target organs for COVID-19 infection, owing in large part to virus entering alveolar cells via the enzyme angiotensin-converting enzyme 2 (ACE2). As the disease progresses, respiratory failure and death may follow.

Certain patients infected with COVID-19 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 mAbs 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 IL-6 levels. Actemra was ﬁrst approved by the FDA in 2010 for rheumatoid arthritis. Besides Actemra®, Sanoﬁ and Regeneron are currently exploring Kevzara®, an FDA-approvedanti-IL-6 receptor mAb therapy for rheumatoid arthritis, for treatment of severe COVID-19.

The Company intends to accelerate the development of hand-held nebulizer inhalation technology to deliver stable aerosols of TZLS-501(anti-IL-6R mAb) and potentially other antiviral drugs such as remdesivir directly to lungs to treat COVID-19 by Q2 2021. The Company believes TZLS-501 (anti- IL6R mAb) combined with this newly introduced inhalation technology may rapidly inhibit inﬂammation in lungs and in combination with intravenous administration may deplete circulating levels of IL-6 and potentially halt progression of COVID-19-mediated lung damage and death. The Company is also evaluating the utility of nasally-administered foralumab to reduce inﬂammation in lungs and improve respiratory function in COVID-19 patients in an investigator's trail in Brazil in Q4 2020.

Hepatocellular cancer

The Company is developing Milciclib for the treatment of HCC, the world's most common primary cancer and a leading cause of cancer-related death in the United States. The primary risk factor for HCC is hepatic cirrhosis. The American Cancer Society predicts approximately 42,810 new cases of live cancer will be diagnosed in 2020, of which approximately 30,160 will die.

The Company has completed a Phase 2a trial in sorafenib-resistant HCC patients where, 14 patients completed treatments as per the protocol, 9 were approved for compassionate use and no drug related deaths occurred. The Company presented the Phase 2a clinical data at the 2020 Virtual American Society of Clinical Oncology (ASCO) conference.

The Company anticipates initiating Phase 2b in HCC patients with Milciclib in combination with a tyrosine kinase inhibitor (regorafenib or sorafenib) in 2Q 2021.

Milciclib is also being used in combination with regorafenib for treatment of liver transplant patients with recurrent HCC in an investigator-initiated clinical trial, as reported in an abstract presented at the 2020 ASCO Virtual Meeting. The Company intends to conduct a larger trial in liver transplant patients with recurrent HCC using this drug combination.

Drug Pipeline

Foralumab

The Company's patented oral formulation of fully human anti-CD3 mAb, Foralumab is a game changer for the treatment of Crohn's Disease, autoimmune diseases and other inﬂammatory diseases by potentially improving efﬁcacy and reduced toxicity. Foralumab modulates the immune response, reducing inﬂammation locally and systemically, through interaction with the mucosal immune system. The Company anticipates the initiation of a Phase 2 trial with nasally administered Foralumab in progressive multiple sclerosis (pro-MS) in Q4 2020. Phase 2 trial with orally administered Foralumab for Crohn's indication is anticipated to be initiated soon. An investigator's trial with nasally administered Foralumab for treatment of inﬂammation in lungs of COVID-19 patients is expected to begin in Brazil in Q4 2020.

Anti IL-6R mAb

The Company's Anti IL-6R, an mAb, binds to both membrane-bound and soluble forms of IL-6R, an inﬂammatory cytokine driving chronic inﬂammation associated with autoimmune disease and cancer,

reducing circulating levels of the cytokine. Anti IL-6r antibody can potentially be used in combination with Foralumab or other anti-inﬂammatory and anti-infective agents as therapy for COVID-19, multiple myeloma, arthritis, lupus and oncology indications. Excessive production of IL-6 is regarded as a key driver of chronic inﬂammation and is believed to be associated with severe lung damage observed with COVID-19 infections and acute respiratory illness. China's National Health Commission has recommended the use of anti-IL6-R mAbs for treatment of inﬂammation and elevated cytokine levels ("cytokine storm") in COVID-19 patients. A recent study also reported that COVID-19 infection caused clusters of severe respiratory illness like ARDS. The Company aims to complete the development of inhalation technology to deliver stable aerosols directly into the lungs by Q2 2021.

Milciclib

The Company's Milciclib is a potent, small molecule inhibitor of multiple cyclin-dependent kinases (CDKs), tropomycin receptor kinases and Src family kinases controlling cell growth and malignant progression of cancer. Milciclib has demonstrated safety in 316 patients with advanced solid cancers in Phase 1 and 2 studies and shown indications of efﬁcacy. In two, completed, Phase 2 thymic cancer trials, Milciclib successfully increased overall survival and met both primary and secondary endpoints. While the current standard of care for hepatocellular carcinoma (HCC), the most common liver cancer, is only effective in a small percentage of patients, Milciclib has the potential to be broadly effective because it targets the underlying cause of disease. A unique feature of Milciclib is its ability to reduce microRNAs, miR-221 and miR-222, that promote the formation of blood vessels (angiogenesis) to facilitate the spread of cancer cells Levels of these microRNAs are consistently increased in HCC patients and may contribute towards resistance to treatment with Sorafenib. The Company intends to initiate Phase 2b in HCC patients with Milciclib in combination with a TKI in Q2 2021.

Foralumab

The Company's Foralumab is the world's ﬁrst and only, fully human anti-CD3 antibody and can be delivered orally, making it a potential game changer in the treatment of Crohn's Disease and other autoimmune diseases through higher efﬁcacy and reduced toxicity. The United States Patent and Trademark Ofﬁce has granted a patent covering its proprietary formulation for oral administration. Additionally, the Company is employing another revolutionary approach to treat patients with neurodegenerative diseases such as progressive MS (pro-MS) by delivering Foralumab via nasal administration. Foralumab modulates the immune response, reducing inﬂammation locally and systemically, through interaction with the gastrointestinal and nasal mucosal immune system. The Company anticipates the initiation of a Phase 2 trial with nasally administered Foralumab in progressive multiple sclerosis (pro-MS) in Q2 2021. Phase 2 trial with orally administered Foralumab for Crohn's indication is anticipated to be initiated soon.

On 19 June 2020, the Company announced that patent 10,688,186 titled "Anti-CD3 formulations", Inventor: Kunwar Shailubhai, is the ﬁrst-ever to be granted on anti-CD3 formulations and covers oral administration with lyophilized and stabilized free-ﬂowing powder of Foralumab or any other anti-CD3 mAb, encapsulated in enteric-coated capsules, for treatment of human diseases. In addition, the stabilized liquid formulation of Foralumab and other anti-CD3 mAbs for nasal administration is also covered in this patent. These formulation technologies have the potential to transform immunotherapies, which currently can only be administered intravenously or subcutaneously.

Completed Phase 1 Clinical Trial: Nasal Administration of Foralumab for the Treatment of Multiple Sclerosis

The completed Phase 1 clinical trial of Foralumab in healthy volunteers was a single center, single arm, ascending dose study in which low doses (10, 50 and 250 µg/dose) of Foralumab and placebo were nasally administered for 5 consecutive days. Subjects were monitored for tolerance and immunological effects. The primary endpoint of the Phase 1 study is safety, tolerability and biomarkers of immunomodulation of clinical responses of intra nasally administered Foralumab.

Interim results have indicated no drug-related safety issues so far. Topline results were reported on 10 September 2019. All nasal doses were well tolerated. Biomarker analysis showed signiﬁcant positive immune effects, that were most prominent in the 50 µg cohort with minimal immunomodulatory effects at the 10 µg and 250 µg doses. These results suggested stimulation of Tregs that are needed to provide clinical beneﬁts. Phase 2a trials will be initiated in Q4 2020 for the treatment of MS.

Completed Phase 1 Clinical Trial: Oral Administration of Foralumab in Healthy Volunteers

An enteric-coated capsule formulation has been developed for oral administration of Foralumab. A single-center, ascending dose Phase 1 trial in healthy subjects administered, either enteric capsule formulation of Foralumab at 1.25, 2.5 and 5.0 mg/dose or placebo was initiated on 2 December 2019. The primary endpoint of the trial was safety and tolerability of oral Foralumab in humans. Results of the Phase 1 Trial were reported on 20 January 2020 The proprietary oral formulation, comprising the lyophilized and stabilized free-ﬂowing powder of formulated Foralumab encapsulated in an enteric-coated capsule, was well-tolerated at all doses tested and there were no drug-related safety issues even at the highest dose of 5 mg in this trial. Based on the positive outcome of the Phase 1 trial, a Phase 2 trial in Crohn's Disease patients is expected to begin in Q2/Q3 2021.

Prior Novimmune Clinical Trials using Intravenous Foralumab

Intravenous Foralumab has been studied in one Phase 1 and two Phase 2 clinical trials conducted by Novimmune. A total of 68 patients were administered Foralumab.

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 with reduction in the Crohn's Disease Activity Index (CDAI) scores in patients. The most common adverse events following exposure to Foralumab were Infusion Related Reactions (IRRs).

The Company's Anti IL-6R mAb, binds to both membrane-bound and soluble forms of IL-6R, an inﬂammatory cytokine driving chronic inﬂammation associated with autoimmune disease and cancer, reducing circulating levels of the cytokine. Anti-IL-6R antibody can potentially be used in combination with Foralumab or other anti-inﬂammatory and anti-infective agents as therapy for COVID-19, multiple myeloma, arthritis, lupus and oncology indications. Excessive production of IL-6 is regarded as a key driver of chronic inﬂammation and is believed to be associated with severe lung damage observed with COVID-19 infections and acute respiratory illness. China's National Health Commission has recommended the use of anti-IL6-R mAbs for treatment of inﬂammation and elevated cytokine levels ("cytokine storm") in COVID-19 patients. A recent study also reported that COVID-19 infection caused clusters of severe respiratory illness like ARDS. The Company aims to complete the development of inhalation technology to deliver stable aerosols of TZLS-501 and potentially other antiviral drugs such as remdesivir directly into the lungs by Q2 2021.

In light of the coronavirus pandemic, the Company is accelerating GMP manufacturing of its anti-IL- 6R mAb concurrently with developing an inhalation technology for direct delivery of the antibody into the lungs using a handheld inhaler or nebulizer for treatment of patients with COVID-19.

Manufacturing of clinical supplies for a Phase 1 study is anticipated to be complete the ﬁrst quarter of 2021, at which time the Company plans to submit an application with the FDA for an Investigational New Drug ("IND") program, by which the Company intends to obtain permission to start human clinical trials.

A unique feature of Milciclib is its ability to reduce microRNAs, miR-221 and miR-222, that promote the formation of blood vessels (angiogenesis) to facilitate the spread of cancer cells. Levels of these microRNAs are consistently increased in HCC patients and may contribute towards resistance to treatment with Sorafenib.

Safety and clinical activity of combination treatment of Milciclib with Regorafenib in liver transplant patients with recurrent HCC has also been evaluated in an investigator originated liver transplant patient recurrent HCC trial. Combination treatment was well tolerated with manageable toxicities. Safety and clinical activity data were presented at Virtual ASCO 2020 conference. The Company intends to initiate Phase 2b clinical trial in liver transplant recurrent HCC patients with Milciclib in combination with a Regorafenib in the second quarter of 2021.

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

The Company completed a Phase 2a trial (CDKO-125a-010) of Milciclib safety and tolerability as a single therapy in sorafenib-resistant patients with HCC (https://clinicaltrials.gov/ct2/show/ NCT01011439). 28 out of 31 treated patients were evaluable, 14 completed the 6-month duration study. Oral treatment with Milciclib was well-tolerated with manageable toxicities. No drug-related

deaths were recorded. The most frequent drug-related adverse events such as: diarrhoea, nausea, retinal haemorrhage, fatigue, asthenia, chills, ataxia, headache, rash. 64 per cent. of patients (9 patients) were approved for compassionate use treatment by their respective ethical committees. Seven of 9 patients on drug treatment between 9 and 416 months. As of 31 August 2020, 2 patients were in the 23rd month of treatment. Objective tumour assessments according to the mRECIST guideline and the conventional RECIST 1.1 criteria has been conducted by Independent Central Review and data is available.

The Company intends to initiate Phase 2b in HCC patients with Milciclib in combination with a Tyrosine-Kinase Inhibitor (TKI), such as Sorafenib or Regorafenib, in the second quarter of 2021.

Milciclib was granted orphan designation by the European Commission and by the FDA for the treatment of thymic carcinoma. In two Phase 2a trials, Milciclib exceeded efﬁcacy endpoints, showed signs of slowing disease progression and acceptable safety.

Intellectual Property

Family	Subject	Priority	Status	Expires	Jurisdiction

	Methods of Use	2004	Issued	2025	Australia, Canada, China. Hong Kong,
	(Autoimmune or				Israel, Japan, Mexico, Norway,
	inﬂammatory diseases				Singapore, South Africa, Ukraine,
	and disorders)				Armenia, Austria, Azerbaijan, Belgium,
					Belarus, Switzerland, Germany,
					Denmark, Spain, France, United
					Kingdom, Ireland, Italy, Kyrgyzstan,
					Kazakhstan, Luxembourg, Moldova,
					Netherlands, Portugal, Russian
					Federation, Sweden, Tajikistan,
					Turkmenistan

	Composition and	2004	Issued /	2025	US, Armenia, Australia, Austria,
	methods of use		Pending		Azerbaijan, Belarus, Brazil, Canada,
					China, Denmark, France, Germany,
					Hong Kong, India, Israel, Italy, Japan,
					Kazakhstan, Kyrgyzstan, Mexico,
					Moldova, Netherlands, Norway,
Foralumab					Republic of Korea, Russian
				Federation, Singapore, South Africa,
TZLS-401					Spain, Switzerland, Tajikistan,
					Turkmenistan and Ukraine
					Pending: Japan (divisional), Singapore
					(divisional), US (divisional)

	Methods of Use (in	2011	Pending	2032	US
	combination with anti-IL-
	6/IL-6R antibodies)

	Formulations and dosing	2016	Pending	2037	US (allowed), Australia, Canada,
	regimen				China, Europe, Hong Kong, Israel,
					Japan

	Methods of Use (CNS	2017	Pending	2038	National
	disorders)

	Methods of Use	2018	Pending	2039	PCT
	(gastrointestinal /
	autoimmune /
	inﬂammatory)

	Composition of matter,	2003	Issued /	2024	US, Europe, Eurasia, Africa, Algeria,
	methods of use, process		Pending		Argentina, Australia, Barbados,
	of manufacturing				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, Trinidad & Tobago, Tunisia,
					Ukraine, Uzbekistan, Vietnam
Milciclib					Allowed: Brazil
				Pending: US, Brazil, Egypt, Thailand,
TZLS-201
				Venezuela


	Methods of use (multiple	2008; 2009	Issued	2029; 2030	US, EU, China, Hong Kong, Japan
	indications)

	Methods of use	2008; 2009	Issued /	2029; 2030	US, EU, China, Hong Kong, Japan
	(combination therapies		Pending
	with cytotoxics)				Pending: EU

	Compositions of related	2009	Issued	2030	US, EU, China, Hong Kong, Japan
	entities, formulations and
	methods of treatment

	Methods of use	2006	Issued	2027	US, EU, China, Japan
	(combination therapies

Family	Subject	Priority	Status	Expires	Jurisdiction

	with therapeutic
	antibodies)

	Formulations of milciclib	2017	Pending	2038	US
	and therapeutic				Pending: EU, Canada, Japan
	combinations of the
	same for use in the
	treatment of cancer

Anti IL-6/IL - 6R	Composition of Matter	2009	Issued	2029	US, Austria, Australia, Belgium,
Antibody TZLS-	and Methods of use				Canada, China, Denmark, France,
501					Germany, India, Ireland, Italy, Japan
					Luxembourg, Mexico, Netherland,
					Spain, Sweden, Switzerland and UK
					Pending: US (divisional), Japan
					(divisional)

StemPrinter	Methods and Kits	2016	Pending	2037	US, EU, Canada
	Comprising Gene
	Signature for Stratifying
	Breast Cancer Patients

Actinomycin D	Use of Actinomycin D in	2015	Issued/	2036	US, France, Germany, Italy,
	the Treatment of Acute		Pending		Netherlands, Spain, Sweden,
	Myeloid Leukemia				Switzerland, and UK
					Pending: US (divisional), Australia,
					Canada, Japan

	Actinomycin D	2016	Pending	2037	US, EU, Canada, Japan
	Compositions and Use of
	the Same in the
	Treatment of
	Myelodysplactic
	Syndrome and Acute
	Myeloid Leukemia

The Company has 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.

The Company also has 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, the Company has 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, the Company has 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.

The Company has 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.

The Company also has 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, the Company has 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.

The Company owns and has rights to a fourth 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.

The Company has rights to a patent family that discloses methods of using TZLS-501 to treat various disorders, licensed from Novimmune. This 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.

PART IX

REGULATORY AND OPERATING ENVIRONMENT

Overview

Government authorities in most jurisdictions extensively regulate the research, development, clinical testing, manufacture, distribution and marketing of pharmaceutical products such as those that the company is developing. Obtaining regulatory approvals and ensuring subsequent compliance with applicable laws and regulations requires the expenditure of substantial time and ﬁnancial and managerial resources. Regulatory requirements in different jurisdictions vary, and the timing and success of efforts to obtain regulatory approvals can be highly uncertain. Development of a successful drug candidate, from identiﬁcation of a candidate drug compound, through preclinical and clinical testing, to registration, typically takes more than ten years.

Drug development is a highly structured process divided into two major stages, preclinical and clinical. In the preclinical stage, the toxicology and mode of action of an active compound is evaluated. The clinical stage is designed to prove the safety of any new pharmaceutical, determine dosage requirements and, predominantly in the later phases, prove its therapeutic utility. This stage is carried out in three phases, which, as a developer moves through the phases, require increasingly large, complex, expensive and time-consuming clinical studies. During Phase 1, the product candidate is initially given to a small number of healthy human subjects or patients and tested for safety, tolerance, absorption, metabolism, distribution and excretion. During Phase 2, additional trials are conducted in a larger, but still relatively limited, patient population to verify that the product candidate has the desired effect and to identify optimal dosage levels. Furthermore, possible adverse effects and safety risks are identiﬁed. The therapeutic utility of the product candidate for speciﬁc targeted diseases is also studied in more depth. During Phase 3, trials are undertaken to further evaluate dosage, to provide statistically signiﬁcant evidence of clinical effectiveness and to further study the safety in an expanded patient population at multiple clinical trial sites. Phase 3 trials may require several hundreds or thousands of patients and are therefore the most expensive and time-consuming to conduct. At any time during one of the phases, a trial may produce a negative result, in which case the developer may choose to end the development project.

Following completion of the Phase 3 trials, the developer submits all the preclinical and clinical trial documentation as well as extensive data characterizing the manufacturing process to the regulator to seek regulatory approval to market the formulation as a pharmaceutical product. The regulator reviews all the information related to the safety of the active compound, and whether the pharmacological effect claimed by the developer on the proposed label can be substantiated by the results of the clinical trials. The regulator has the option to decide to approve the application as requested, ask for changes to the claims made by the developer, ask for more information, require that further clinical trials are undertaken, or refuse to approve the formulation for sale.

Even after initial regulatory approval has been obtained, further studies, including Phase 4 post- approval safety studies, may be required to provide additional data on safety and will be required to gain approval for the use of a product as a treatment for clinical indications other than those for which the product was initially tested. There are also continuing, annual user fee requirements for any marketed products and the establishments at which such products are manufactured, as well as new application fees for supplemental applications with clinical data. In addition, regulatory authorities require post-marketing reporting to monitor the adverse effects of the product. Results of post-approval programs may limit or expand the further marketing of the products. Further, if there are any modiﬁcations to the product, including changes in indication, manufacturing process or labeling, or a change in the manufacturing facility, an application seeking approval of such changes or, as the case may be, notiﬁcation, must be submitted to the relevant regulatory authorities before the modiﬁed product can be commercialized. Moreover, an approved drug product may be subject to a REMS, which could impose a number of post-approval obligations, including (among other things) a communication plan for physicians regarding safe use of the drug, distribution and use restrictions, and/or periodic assessments of the effectiveness of the REMS. Finally, studies may be required as a contingency of regulatory approval (post-approval commitments), and completion of these studies within a regulator mandated time frame may be required.

European Union

The development, marketing and sale of medicinal products in the EU is subject to extensive pre and post marketing regulation by regulatory authorities at both the EU and national levels. The requirements, regulatory approvals and processes governing the conduct of clinical trials, product licensing, pricing and reimbursement vary from country to country, although there is some degree of EU wide harmonization.

Clinical Trials

Clinical trials of medicinal products in the EU must be conducted in accordance with EU and national regulations, focusing in particular on traceability, apply to clinical trials of advanced therapy medicinal products. If the sponsor of the clinical trial is not established within the EU, it must appoint an entity within the EU to act as its legal representative. The sponsor must take out a clinical trial insurance policy and, in most EU countries, the sponsor is liable to provide 'no fault' compensation to any study subject injured in the clinical trial.

Prior to commencing a clinical trial, the sponsor must obtain a clinical trial authorization from the relevant regulatory authority, and a positive opinion from an independent ethics committee. The application for a clinical trial authorization must include, among other things, a copy of the trial protocol and an investigational medicinal product dossier containing information about the manufacture and quality of the medicinal product under investigation. Currently, clinical trial authorization applications must be submitted to the regulatory authority in each Member State in which the trial will be conducted. Under the new Regulation on Clinical Trials, which has been delayed and now is not currently expected to take effect until mid-2021, there will be a centralized application procedure where one national authority takes the lead in reviewing the application and the other national authorities have only a limited involvement. Any substantial changes to the trial protocol or other information submitted with the clinical trial applications must be notiﬁed to or approved by the relevant competent authorities and ethics committees. Medicines used in clinical trials must be manufactured in accordance with cGMP.

Marketing Approval

In the EU medicinal products can only be commercialized after obtaining a marketing approval. There are three procedures for obtaining marketing approvals: the centralised procedure, the decentralised procedure and the mutual recognition procedure/national procedure.

The Community marketing authorization, which is issued by the European Commission through the centralized procedure, based on the opinion of the CHMP of the EMA, is valid throughout the entire territory of the EU. The centralized procedure is mandatory for certain types of products, such as biotechnology medicinal products, orphan medicinal products, and medicinal products containing a new active substance indicated for the treatment of AIDS, cancer, neurodegenerative disorders, diabetes, autoimmune and viral diseases. The centralized procedure is optional for products containing a new active substance not yet authorized in the EU, or for products that constitute a signiﬁcant therapeutic, scientiﬁc or technical innovation or which are in the interest of public health in the EU.

Marketing approvals obtained using the decentralized procedure are available for products not falling within the mandatory scope of the Centralized Procedure. An identical dossier is submitted to the regulatory authorities of each of the Member States in which the marketing approval is sought, one of which is selected by the applicant as the Reference Member State ("RMS"). The competent authority of the RMS prepares a draft assessment report, a draft summary of the product characteristics and a draft of the labelling and package leaﬂet, which are sent to the other the concerned Member States, or CMSs, for their approval. A CMS can raise an objection, based on the assessment report, the summary of product characteristics, the labelling and the package leaﬂet on the grounds of potential serious risk to public health. If no such objections are raised the product will be granted a national marketing authorization in the RMS and all of the selected CMSs. Where a product has already been authorized for marketing in a Member State, this decentralized procedure approval can be recognized in other Member States through the mutual recognition procedure.

Marketing approvals obtained using the national procedure are issued by a single regulatory authority of one of the Member States and only apply to the territory covered by the relevant regulatory authority. They are available for products not falling within the mandatory scope of the

centralized procedure. Once a product has been authorized for marketing in a Member State through the national procedure, any application in another Member State must be by the mutual recognition procedure whereby the marketing approval can also be recognized in other Member States through the mutual recognition procedure.

Under the procedures described above, before granting the marketing approval, the EMA or the relevant regulatory authority of the Member States of the EU makes an assessment of the risk- beneﬁt balance of the product on the basis of scientiﬁc criteria concerning its quality, safety and therapeutic utility.

The holder of a marketing authorization in any Member State of the EU is subject to various obligations under applicable EU regulations, such as pharmacovigilance obligations, requiring it to, among other things, report and maintain detailed records of adverse reactions, and to submit periodic safety update reports to the regulatory authorities. The holder must also ensure that the manufacturing and batch release of its product is in compliance with the applicable requirements. The marketing approval holder is further obligated to ensure that the advertising and promotion of its products complies with applicable laws, which can differ from Member State to Member State of the EU.

Data Exclusivity

A Marketing Authorisation Application ("MAA") is an application submitted by a drug manufacturer seeking permission to bring a medicinal product (for example, a new medicine or generic medicine) to the market. MAAs for generic medicinal products in the EU do not need to include the results of preclinical and clinical trials, but instead can refer to the data included in the marketing approval of a reference product for which regulatory data exclusivity has expired. If a marketing approval is granted for a medicinal product containing a new active substance, that product beneﬁts from eight years of data exclusivity, during which generic MAAs referring to the data of that product may not be accepted by the regulatory authorities, and a further two years of market exclusivity, during which such generic products may not be placed on the market. The two-year period may be extended to three years if during the ﬁrst eight years a new therapeutic indication with signiﬁcant clinical beneﬁt over existing therapies is approved.

There is a special regime for biosimilars, or biological medicinal products that are similar to a reference medicinal product but that do not meet the deﬁnition of a generic medicinal product, for example, because of differences in raw materials or manufacturing processes. For such products, the results of appropriate preclinical or clinical trials must be provided, and guidelines from the EMA detail the type of quantity of supplementary data to be provided for different types of biological product. There are no such guidelines for complex biological products, such as gene or cell therapy medicinal products, and so it is unlikely that biosimilars of those products will currently be approved in the EU. However, guidance from the EMA states that they will be considered in the future in light of the scientiﬁc knowledge and regulatory experience gained at the time.

Orphan Medicinal Products

The EMA's Committee for Orphan Medicinal Products ("COMP"), may recommend orphan medicinal product designation to promote the development of products that are intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions affecting not more than ﬁve in 10,000 persons in the EU. Additionally, 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 product in the EU would be sufﬁcient to justify the necessary investment in developing the medicinal product. The COMP may only recommend orphan medicinal product designation when the product in question offers a signiﬁcant clinical beneﬁt over existing approved products for the relevant indication. Following a positive opinion by the COMP, the European Commission adopts a decision granting orphan status. The COMP will reassess orphan status in parallel with EMA review of a marketing authorization application and orphan status may be withdrawn at that stage if it no longer fulﬁls the orphan criteria (for instance because in the meantime a new product was approved for the indication and no convincing data are available to demonstrate a signiﬁcant beneﬁt over that product). Orphan medicinal product designation entitles a party to ﬁnancial incentives such as reduction of fees or fee waivers and ten years of market exclusivity is granted following marketing authorization. During this period, the competent authorities may not accept or approve any similar medicinal product, unless it offers a signiﬁcant clinical beneﬁt. This period may be redacted to six

years if the orphan medicinal product designation criteria are no longer met, including where it is shown that the product is sufﬁciently proﬁtable not to justify maintenance of market exclusivity.

United States

Standard Procedure

In the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act of 1938 and its implementing regulations. In order to request approval for marketing a new drug in the United States, a company must submit to the FDA a new drug application ("NDA") or a biologics license application ("BLA"). BLAs relate to biological products while NDAs generally pertain to traditional small molecule drugs. Both an NDA and a BLA are comprehensive documents describing a drug or biological product that has already passed through several clinical trials. The process of obtaining regulatory approvals and the subsequent compliance with applicable federal, state, local and foreign statutes and regulations requires the expenditure of substantial time and ﬁnancial resources. Failure to comply with the applicable U.S. requirements at any time during the product development process, approval process or after approval, may subject an applicant to a variety of administrative or judicial sanctions, such as the FDA's refusal to approve pending NDAs, withdrawal of an approval, imposition of a clinical hold, issuance of warning letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, ﬁnes, refusals of government contracts, restitution, disgorgement or civil or criminal penalties.

The process required by the FDA before a drug may be marketed in the United States generally involves the following:

completion of preclinical laboratory studies, animal studies and formulation studies in compliance with the FDA's good laboratory practice regulations;
submission to the FDA of an IND, which must become effective before human clinical trials may begin;
approval by the institutional review board at each clinical site before each trial may be initiated;
performance of adequate and well-controlled human clinical trials in accordance with applicable IND and other clinical trial-related regulations, sometimes referred to as GCPs to establish the safety and clinical utility of the proposed product candidate for its proposed indication;
submission to the FDA of a BLA or an NDA;
satisfactory completion of an FDA pre-approval inspection of the production facility or facilities where the product is produced to assess compliance with the FDA's cGMP requirements to assure that the facilities, methods and controls are adequate to preserve the product's identity, strength, quality, purity and potency;
potential FDA audit of the preclinical and/or clinical trial sites that generated the data in support of the NDA; and
FDA review and approval of the BLA or NDA prior to any commercial marketing or sale of the product in the United States.
Once an approval is granted, the FDA may withdraw the approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market. Other potential consequences include, among other things:
restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls;
ﬁnes, warning letters or holds on post-approval clinical trials;
refusal of the FDA to approve pending NDAs or supplements to approved NDAs, or suspension or revocation of product approvals;
product seizure or detention, or refusal to permit the import or export of products; or
injunctions or the imposition of civil or criminal penalties.

Clinical Trials

Clinical trials involve the administration of the IND to human patients under the supervision of qualiﬁed investigators in accordance with GCP requirements, which include the requirement that all research patients provide their informed consent in writing for their participation in any clinical trial. Clinical trials are conducted under protocols detailing, among other things, the objectives of the trial, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated. A protocol for each clinical trial and any subsequent protocol amendments must be submitted to the FDA as part of the IND. In addition, an institutional review board at each institution participating in the clinical trial must review and approve the plan for any clinical trial before it commences at that institution. Information about certain clinical trials must be submitted within speciﬁc timeframes to the National Institutes of Health for public dissemination on their website. Regulatory authorities, institutional review boards or the sponsor may suspend or terminate a clinical trial at any time on various grounds, including a ﬁnding that the research patients are being exposed to an unacceptable health risk.

Marketing Approval

Assuming successful completion of the required clinical testing, the results of the preclinical studies and clinical trials, together with detailed information relating to the product's chemistry, manufacture, controls ("CMC"), and proposed labelling, among other things, are submitted to the FDA as part of an NDA requesting approval to market the product for one or more indications. In most cases, the submission of an NDA is subject to a substantial application user fee. Under the Prescription Drug User Fee Act guidelines that are currently in effect, the FDA has a goal of ten months from the date of ﬁling of a standard NDA for a new molecular entity to review and act on the submission. This review typically takes twelve months from the date the NDA is submitted to the FDA because the FDA has approximately two months to make a ﬁling decision.

In addition, under the Pediatric Research Equity Act of 2003, certain NDAs or supplements to an NDA must contain data that are adequate to assess the safety and effectiveness of the drug for the claimed indications in all relevant paediatric subpopulations, and to support dosing and administration for each paediatric subpopulation for which the product is safe and effective. The FDA may, on its own initiative or at the request of the applicant, grant deferrals for submission of some or all paediatric data until after approval of the product for use in adults, or full or partial waivers from the paediatric data requirements.

The FDA conducts a preliminary review of all NDAs within the ﬁrst 60 days after submission, before accepting them for ﬁling, to determine whether they are sufﬁciently complete to permit substantive review. The FDA may request additional information rather than accept an NDA for ﬁling. In this event, the application must be resubmitted with the additional information. The resubmitted application is also subject to review before the FDA accepts it for ﬁling. Once the submission is accepted for ﬁling, the FDA begins an in-depth substantive review. The FDA reviews an NDA to determine, among other things, whether the drug is safe and effective and whether the facility in which it is manufactured, processed, packaged or held meets standards designed to assure the product's continued safety, quality and purity.

The FDA may refer an application for a novel drug to an advisory committee. An advisory committee is a panel of independent experts, including clinicians and other scientiﬁc experts, that reviews, evaluates and provides a recommendation as to whether the application should be approved and under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions.

Before approving a BLA or NDA, the FDA typically will inspect the facility or facilities where the product is manufactured. The FDA will not approve an application unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required speciﬁcations. Additionally, before approving an NDA, the FDA may inspect one or more clinical trial sites to assure compliance with GCP requirements.

After evaluating the NDA and all related information, including the advisory committee recommendation, if any, and inspection reports regarding the manufacturing facilities and clinical trial sites, the FDA may issue an approval letter, or, in some cases, a CR letter. A CR letter generally contains a statement of speciﬁc conditions that must be met in order to secure ﬁnal approval of the NDA and may require additional clinical or preclinical testing in order for the FDA to reconsider the

application. Even with submission of this additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval. If and when those conditions have been met to the FDA's satisfaction, the FDA will typically issue an approval letter. An approval letter authorizes commercial marketing of the drug with speciﬁc prescribing information for speciﬁc indications.

Even if the FDA approves a product, it may limit the approved indications for use of the product, require that contraindications, warnings or precautions be included in the product labelling, require that post-approval studies, including Phase 4 clinical trials, be conducted to further assess a drug's safety after approval, require testing and surveillance programs to monitor the product after commercialization, or impose other conditions, including distribution and use restrictions or other risk management mechanisms under a REMS, which can materially affect the potential market and proﬁtability of the product. The FDA may prevent or limit further marketing of a product based on the results of post-marketing studies or surveillance programs. After approval, some types of changes to the approved product, such as adding new indications, manufacturing changes, and additional labelling claims, are subject to further testing requirements and FDA review and approval.

Orphan Drug Designation

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 the Company's product candidates prior to the Company's 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 the Company do (regardless of the Company's orphan drug designation), the Company will be precluded from receiving marketing approval for the Company's 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 the Company obtains 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 authorisation 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; or

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

Post-Approval Requirements for the EU and United States

The FDA and the relevant regulatory authorities in the EU strictly regulate marketing, labelling, advertising and promotion of products that are placed on the market in their respective territories. Drugs may be promoted only for the approved indications and in accordance with the provisions of the approved label. The regulatory authorities actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to signiﬁcant liability.

In addition, drug manufacturers and other entities involved in the manufacture and distribution of approved drugs are required to register their establishments with the relevant regulatory authorities and are subject to periodic unannounced inspections by them to conﬁrm compliance with cGMP requirements. Changes to the manufacturing process are strictly regulated and often require prior approval of the relevant regulatory authorities before being implemented. Regulations laid down by the FDA and the regulatory authorities in the EU also require investigation and correction of any deviations from the requirements of cGMP and impose reporting and documentation requirements upon the marketing approval holder and any third party manufacturers that the marketing approval holder may decide to use.

Some of the Company's product candidates are classiﬁed as biologics in the United States, and therefore, can only be sold if the Company obtain a BLA from the FDA. The holder of an approved BLA also must submit new or supplemental applications and obtain FDA approval for certain changes to the approved product, product labelling 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 labelling (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 the Company, or a regulatory authority, discovers 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 labelling of that product (in addition to the Company's 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 the Company fails to comply with applicable regulatory requirements following approval of the Company's product candidates, a regulatory or enforcement authority may:

issue a warning letter asserting that the Company is 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 the Company's 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; or

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

Other Healthcare Laws in the EU and United States

The Company will also be subject to healthcare regulation and enforcement by the U.S. federal government and the states and governments in the EU and any other countries in which the company conducts its business, including its research, and the marketing and distribution of its product candidates and products once they have obtained an MAA. Failure to comply with these laws, where applicable, can result in the imposition of signiﬁcant civil penalties, criminal penalties, exclusion from participating in health care programs, additional reporting requirements and oversight if the company becomes subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws and other sanctions. The healthcare laws and regulations that may affect the company's ability to operate in the United States include: the federal fraud and abuse laws, including the federal anti-kickback and false claims laws; federal data privacy and security laws; and federal transparency laws related to payments and/or other transfers of value made to physicians and other healthcare professionals and teaching hospitals. Many US states have similar laws and regulations that may differ from each other and federal law in signiﬁcant ways. Moreover, several US states have enacted legislation requiring pharmaceutical manufacturers to, among other things, establish marketing compliance programs, ﬁle periodic reports with the state, and make periodic public disclosures on sales and marketing activities, and prohibiting certain other sales and marketing practices. Rules and legislation covering more or less the same subject matter as those in the United States apply to in countries in the EU and to other countries. These can differ between jurisdictions and can sometimes result in lower or higher exposure in those countries than in the United States. Where a product is sold in a number of countries compliance efforts can therefore be complicated.

The related U.S. laws that will affect the Company's operations include, but are not limited to:

The federal Anti-Kickback Statute, which prohibits, among other things, persons or entities from knowingly and wilfully 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 (as amended by the Health Information Technology for Economic and Clinical Health Act of 2009) ("HIPAA"), which created new federal criminal statutes that prohibit, among other things, a person from
knowingly and wilfully 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 and its 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.

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.

Coverage and Reimbursement in the United States and the EU

Sales of products developed from the Company's product candidates, if approved, will depend, in part, on the extent to which such products will be covered by third party payors, such as government health care authorities, government health care programs, commercial insurance and managed healthcare organizations. These third-party payors are increasingly limiting coverage or reducing reimbursements for medical products and services. In the United States, no uniform policy of coverage and reimbursement for products exists among third party payors. Therefore, coverage and reimbursement for products can differ signiﬁcantly from payor to payor. In addition, the U.S. government, state legislatures and foreign governments have continued implementing cost- containment programs, including price controls, restrictions on reimbursement and requirements for substitution of generic products.

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 ("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 member states. It is difﬁcult to predict what third-party payors will decide with respect to the coverage and reimbursement for the Company's 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) (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.

Governments inﬂuence the price of medicinal products in the EU through their pricing and reimbursement rules and control of national healthcare systems that fund a large part of the cost of those products to consumers. Some jurisdictions operate positive and negative list systems under which products may only be marketed once a reimbursement price has been agreed. To obtain reimbursement or pricing approval, some of these countries may require the completion of clinical trials that compare the cost-effectiveness of a particular product candidate to currently available therapies. Other Member States allow companies to ﬁx their own prices for medicines but monitor and control company proﬁts. The downward pressure on healthcare costs in general in the EU governments inﬂuence the price of medicinal products through their pricing and reimbursement.

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 the Company are able to charge for the Company's product candidates. Accordingly, in markets outside the United States, the reimbursement for the Company's 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, the Company may be required to conduct a clinical trial that compares the cost-effectiveness of the Company's product candidates to other available therapies. If reimbursement of the Company's products is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, the Company's 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 the Company's 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 the Company or the Company's partners are able to commercialise. The Company expect to experience pricing pressures in connection with the sale of any of the Company's 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.

Potential Changes to Healthcare Legislation

In the United States and elsewhere, 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 the Company's product candidates, restrict or regulate post-approval activities and affect the Company's ability to proﬁtably sell any product candidates for which the Company obtain marketing approval.

In the United States, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 ("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 the Company 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 the Company's 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 per cent. 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 the Company commercialise a product candidate faster than the Company's 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 the Company's business include those governing enrolments 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. The implications of these delays for the Company's and the Company's 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 the Company 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. The Company cannot know how efforts to repeal and replace the PPACA or any future healthcare reform legislation will impact the Company's business.

The Company expects 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 the Company receives 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 the Company from being able to generate revenue, attain proﬁtability, or commercialise its products.

The Company expects 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 the Company's product candidates or additional pricing pressures.

Privacy and Data Protection Laws in Europe

The Company is subject to European laws relating to its and its suppliers', partners' and subcontractors' collection, control, processing and other use of personal data (i.e. any data relating to an identiﬁable living individual, whether that individual can be identiﬁed directly or indirectly). The Company is subject to the supervision of local data protection authorities in those jurisdictions where it is established, where it offer goods or services to EU residents and where it monitor the behaviour of individuals in the EU (i.e. undertaking clinical trials). The Company and its suppliers, partners and subcontractors process personal data including in relation to its employees, employees of customers, clinical trial patients, healthcare professionals and employees of suppliers including health and medical information. The data privacy regime in the EU includes the General Data Protection Regulation, or GDPR, the e-Privacy Directive (2002/58/EC) and the e-Privacy Regulation (once in force) and the national laws and regulations implementing or supplementing each of them.

The GDPR requires that personal data is only collected for speciﬁed, explicit and legal purposes as set out in the GDPR or local laws, and the data may then only be processed in a manner consistent with those purposes. The personal data collected and processed must be adequate, relevant and not excessive in relation to the purposes for which it is collected and processed, it must be held securely, not transferred outside of the European Economic Area, (unless certain steps are taken to ensure an adequate level of protection), and must not be retained for longer than necessary for the purposes for which it was collected. In addition, the GDPR requires companies processing personal data to take certain organisational steps to ensure that they have adequate records, policies, security, training and governance frameworks in place to ensure the protection of data subject rights, including as required to respond to complaints and requests from data subjects. For example, the GDPR requires us to make more detailed disclosures to data subjects, requires disclosure of the legal basis on which it can process personal data, makes it harder for us to obtain valid consent for processing, will require the appointment of a data protection ofﬁcer where sensitive personal data (i.e. health data) is processed on a large scale, introduces mandatory data breach notiﬁcation throughout the EU and imposes additional obligations on us when it are contracting with service providers.

In addition, to the extent a company processes, controls or otherwise uses "special category" personal data (including patients' health or medical information, genetic information and biometric information), more stringent rules apply, further limiting the circumstances and the manner in which

a company is legally permitted to process that data. Finally, the GDPR provides a broad right for EEA Member States to create supplemental national laws which may result in divergence across Europe making it harder to maintain a consistent operating model or standard operating procedures. Such laws, for example, may relate to the processing of health, genetic and biometric data, which could further limit its ability to use and share such data or could cause its costs to increase, and harm its business and ﬁnancial condition.

The Company depends on a number of third parties in relation to the provision of its services, a number of which process personal data on its behalf. With each such provider it enters into contractual arrangements to ensure that they only process personal data according to its instructions, and that they have sufﬁcient technical and organizational security measures in place. Where it transfers personal data outside the EU, it does so in compliance with the relevant data export requirements from time to time. The Company take its data protection obligations seriously, as any improper, unlawful or accidental disclosure, loss, alteration or access to, personal data, particularly sensitive personal data (i.e. special category), could negatively impact its business and/ or its reputation.

The Company is also subject to EU laws on personal data export, as it may transfer personal data from the EU to other jurisdictions which are not considered by the European Commission to offer adequate protection of personal data. Such transfers need to be legitimised by a valid transfer mechanism under the GDPR. There is currently ongoing litigation challenging the commonly used transfer mechanisms, the EU Commission approved model clauses. In addition, the U.S. Privacy Shield was recently ruled invalid. As such, it is uncertain how the Privacy Shield framework and/or model clauses will be addressed. These changes may require the Company to ﬁnd alternative bases for the compliant transfer of personal data from the EU to the United States and it is monitoring developments in this area. Invalidation of any mechanism on which it relies could require operational changes and increased costs and may lead to governmental enforcement actions, litigation, ﬁnes and penalties or adverse publicity that could have an adverse effect on its business.

The EU is in the process of replacing the e-Privacy Directive with a new set of rules taking the form of a regulation, which will be directly implemented in the laws of each Member State, without the need for further enactment. The draft e-Privacy Regulation imposes strict opt-in marketing rules with limited exceptions for business-to-business communications and alters rules on third-party cookies, web beacons and similar technology. Regulation of cookies and web beacons may lead to broader restrictions on online research activities, including efforts to understand users' internet usage. The current draft also signiﬁcantly increases ﬁning powers to the same levels as GDPR (i.e. the greater of 20 million Euros or 4 per cent. of total global annual revenue). While no ofﬁcial timeframe has been provided, commentators have stated that the e-Privacy Regulation is likely to be agreed in 2019 and to come into force during the second half of 2020 or during 2021 following a transition period.

There are costs and administrative burdens associated with compliance with the GDPR and the resultant changes in the EU and EEA Member States' national laws and the introduction of the e- Privacy Regulation once it takes effect. Any failure or perceived failure to comply with global privacy laws carries with it the risk of signiﬁcant penalties and sanctions of up to €20 million or 4 per cent. of global turnover. These laws or new interpretations, enactments or supplementary forms of these laws, could create liability for us, could impose additional operational requirements on its business, could affect the manner in which it use and transmit patient information and could increase its cost of doing business. Claims of violations of privacy rights or contractual breaches, even if it is not found liable, could be expensive and time-consuming to defend and could result in adverse publicity that could harm its business.

PART X

SELECTED FINANCIAL INFORMATION ON THE COMPANY

The selected ﬁnancial information set out below has been extracted without material adjustment from the unaudited historical information of the Company for the six month period ended 30 June 2020 and the audited historical ﬁnancial information of the Company for the 12 month period ended 31 December 2019, which is incorporated by reference in Part XVI - Documents Incorporated by Reference of this prospectus.

CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

						12 months to	12 months to	12 months to
				Restated	31 December	31 December	31 December
		6 months to	6 months to	2019		2018		2017
		30 June 2020	30 June 2019	(audited)	(audited)	(audited)
Continuing Operations		(unaudited)	(unaudited)	£'000		£'000		£'000

Research and development
costs
Operating expenses	760		(1,507)	(2,910)	(4,132)	(4,672)
Operating costs
(3,169)	(2,138)	(4,864)	(3,268)	(3,574)
Operating loss
(3,929)	(3,645)	(7,774)	(7,400)	(8,246)

Finance costs	(5)	(5)	(72)	(9)	(9)
Loss before taxation
(3,934)	(3,650)	(7,846)	(7,409)	(8,255)

Taxation		-	27		540		(1,459)	1,485
Loss for the year attributable to

equity owners	(3,934)	(3,623)	(7,306)	(5,950)	(6,770)
Other comprehensive income

that may be classiﬁed to proﬁt
and loss in subsequent periods
Exchange differences on translation
of foreign operations	23		52		129		(113)	-
Total comprehensive loss for the

year attributable to equity
owners	(3,911)	(3,571)	(7,177)	(6,063)	(4,770)
Loss per share


Basic and diluted (loss) per share
on continuing operations		(2.6p)	(2.6p)	(5.4p)	(4.7p)	(6.4p)

CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

					12 months to	12 months to	12 months to
			Restated	31 December	31 December	31 December
	6 months to	6 months to	2019		2018		2017
	30 June 2020	30 June 2019	(audited)	(audited)	(audited)
	(unaudited)	(unaudited)	£'000		£'000		£'000
ASSETS

Non-Current assets
Property, plant and equipment	5		5		5		6		18
Finance lease receivables	236		-	113		-	-
Right of use asset	308		358		329		-	-
Other non-current assets	217		217		217		217		217

Total non-current assets	766		580		664		223		235
Current assets

Finance lease receivable	-	-	109		-	-
Related party receivable	-	-	245		20		20
Other receivables	2,013		245		124		228		94
Taxation receivable	513		827		513		800		1,434
Cash and cash equivalents	7,200		445		153		4,165		48

Total current assets	9,726		1,517		1,144		5,213		1,596
TOTAL ASSETS	10,492		2,097		1,808		5,436		1,831
EQUITY AND LIABILITIES

Equity
Capital and reserves attributable
to equity holders of the company
Called up share capital	4,992		4,094		4,099		4,094		3,752
Share premium	38,390		25,120		25,194		25,117		18,113
Capital reduction reserve	31,183		31,183		31,183		31,183		31,183
Shares to be issued reserve
(convertible notes)	1,265		1,398		1,099		-	-
Share based payment reserve
(options)	4,806		3,021		3,850		2,857		2,354
Share based payment reserve
(warrants)	-	-	1,812		1,399		1,076
Other reserve	(28,286)	(28,286)	(28,286)	(28,286)	(28,286)
Translation reserve	(90)	(61)	15		(113)	-

Retained earnings	(47,318)	(39,463)	(43,146)	(35,840)	(29,874)
Total equity
4,942		(2,994)	4,180		411		(1,683)
Liabilities
Non-Current liabilities
Lease Liability	308		277		411		-	-
Current liabilities
Trade and other payables	4,597		4,727		4,851		4,673		3,270
Lease liability	322		87		212		-	-
Related party payable	323		-	451		352		244
Other liabilities	-	-	63		-	-
Total current and non-current

labilities	5,550		5,091		5,988		5,025		3514
TOTAL EQUITY AND LIABILITIES
10,492		2,097		1,808		5,436		1,831

Set out below are details of the signiﬁcant changes in the ﬁnancial position of the Company during, and subsequent to, the period ended 31 December 2019 and up to the date of this prospectus:

On 16 March 2020, the Company announced the closing of its underwritten follow-on public offering of ADSs on the NASDAQ Global Market. The Company issued 3,333,333 ADSs (representing 16,666,665 new ordinary shares of nominal value £0.03 each in the capital of

the Company) at a price to the public of $3.00 per ADS raising gross proceeds of approximately $10 million (£8m) (before deducting underwriting discount, commissions and offering expenses);

On 15 April 2020, the Company raised £90,500 in connection with the exercise of options by a former director granted under the Company's 2014 share option scheme;
On 24 April 2020, the Company raised £599,435 due to the exercise of 1,712,672 warrants at a price of 35 pence per share;
On 18 May 2020, the Company raised £132,143 due to the exercise of 264,286 warrants at a price of 50 pence per share;
On 2 June 2020, the Company raised £578,700 in respect of the exercise of 1,234,399 warrants at a price of 39 pence and 50 pence per share, The Company also announced that during the calendar month of May, the Company issued a total of 1,743,445 ordinary shares under the Company's ATM sales agreement announced on 15 April 2020 to meet sales of a total of 348,689 ADSs under the ATM sales agreement, totaling gross proceeds of $1,985,004;
On 24 July 2020, the Company raised £82,379 in cash through the exercise of warrants;
On 31 July 2020 - the Company announced that during the calendar month of July, it had issued a total of 2,043,000 ordinary shares under the Company's ATM sales agreement (announced on 15 April 2020) to meet sales of a total of 408,600 ADSs under the ATM sales agreement, totalling gross proceeds of $4,371,289;
On 5 August 2020, the Company announced the closing of its registered direct offering of ADSs on the NASDAQ Global Market. As of 3 August 2020, the Company issued 11,009,615 ADSs (representing 22,019,230 new ordinary shares of nominal value £0.03 each in the capital of the Company at a price of $5.20 per ADS raising gross proceeds of approximately $57.25 million (before deducting placement agent fees and offering expenses);

On 27 August 2020, the Company, raised £300,000 in cash through the exercise of warrants;

On 16 September 2020, the Company entered into the Demerger Agreement with Accustem
Sciences Limited pursuant to the terms of which the Tiziana declared a dividend in specie on the Ordinary Shares equal to the book value (of approximately £3.07m) of Tiziana's shareholding in StemPrintER Sciences Limited, the entity within the Group which holds all of the assets and intellectual property relating to StemPrintER and SPARE and £1.0 million in cash;
On 21 September 2020, the Company allotted 281,250 Ordinary Shares, credited as fully paid
at a price of £1.28 per share in respect of agreements reached with certain members of the scientiﬁc advisory board concerning the commuting of cash fees into equity;
On 2 October 2020, resolutions were passed by Shareholders to approve the Demerger and to reduce the amount standing to the share premium account of the Company by £4,000,000 to facilitate the Demerger (the "Capital Reduction"). The Court sanctioned the Capital Reduction on 27 October 2020 and the Demerger became effective on 30 October 2020;
On 20 October 2020, the Company issued 35,714 Ordinary Shares credited as fully paid on the exercise of certain warrants held by the Company's broker, Optiva;
On 21 October 2020, the Company issued 1,750,000 Ordinary Shares of which 1,200,000 Ordinary Shares were issued credited as fully paid at a price of £0.15 per share and 550,000 shares were issued credited as fully paid at a price of £0.35 per share, both in respect of the exercise of share options by Gabriele Cerrone;
On 22 October 2020, the Company issued 285,714 Ordinary Shares credited as fully paid at a price of £0.35 per share on the exercise of warrants;
On 26 October 2020, the Company issued 329,225 shares credited as fully paid at a price of £0.35 per share on the exercise of share options held by, inter alia, Gabriele Cerrone and Keeren Shah;
On 28 October 2020, the Company issued 344,063 Ordinary Shares credited as fully paid at prices between £0.66 and £0.80 per share on the exercise of warrants; and

On 29 October 2020, the Company issued 426,500 Ordinary Shares credited as fully paid at a price of £0.35 per share on the exercise of share options by, inter alia, Dr. Kunwar Shailubhai, Vaseem Palejwala and Jules Jacob.

PART XI

SHARE CAPITAL, LIQUIDITY AND CAPITAL RESOURCES

Share capital

The Company was incorporated as in England and Wales on 11 February 1998 as a private company with limited liability under the Companies Act with an indeﬁnite life; re-registered as a public limited company on 8 June 1998 under the name Alexander David Investments Plc; and changed its name to Tiziana Life Sciences plc on 23 April 2014 when it acquired TPL via a reverse takeover (as deﬁned in the AIM Rules). TPL was formed in November 2013.

Details of the Company's Existing Issued Share Capital are set out in paragraph 3 of Part XIV - Additional Information of this prospectus. As at Admission, there is expected to be £5,838,368.67 in nominal value of Ordinary Shares, divided into 194,612,289 issued Ordinary Shares of nominal value 3 pence each, all of which will be fully paid up.

All of the issued Ordinary Shares will be in registered form, and capable of being held in certiﬁcated or uncertiﬁcated form. The Registrar will be responsible for maintaining the share register. Temporary documents of title will not be issued. The ISIN of the Ordinary Shares is GB00BKWNZY55. The SEDOL code of the Ordinary Shares is BKWNZY5.

Fully diluted Existing Issued Share Capital

The following table sets out the fully diluted Existing Issued Share Capital as at the date of this prospectus and as at Admission:

				As a
				percentage of
				the Company's
				fully diluted
				Existing
	As of the date			Issued Share
	of this		As of the date	Capital at
	prospectus		of Admission	Admission

Existing Issued Share Capital	194,612,289	194,612,289	91.4%
Existing Options	17,023,678	17,023,678	8.0%
Existing Warrants	1,183,491	1,183,491	0.6%

Accordingly, at Admission the share capital of the Company will be 194,612,289 Ordinary Shares with a total of 18,207,169 warrants and options outstanding. If all the warrants were to be exercised the Company would receive approximately £2,206,892 in cash and the options and warrants would represent 8.6 per cent. of the fully diluted Existing Issued Share Capital (as so enlarged).

Financial position

The ﬁnancial information in respect of the Company upon which Mazars LLP has provided the accountant's report as at 31 December 2019, is set out in- Historical Financial Information on the Company.

Liquidity and capital resources

Sources of cash and liquidity

On 16 March 2020, the Company announced the closing of its underwritten follow-on public offering of ADSs on the NASDAQ Global Market. The Company issued 3,333,333 ADSs (representing 16,666,665 new ordinary shares of nominal value £0.03 each in the capital of the Company) at a price to the public of $3.00 per ADS raising gross proceeds of approximately $10 million (£8 million) (before deducting underwriting discount, commissions and offering expenses).

On 15 April 2020, the Company raised £90,500 in connection with the exercise of options by a former director granted under the Company's 2014 share option scheme.

On 24 April 2020, the Company raised £599,435 due to the exercise of 1,712,672 warrants at a price of 35 pence per share.

On 18 May 2020, the Company raised £132,143 due to the exercise of 264,286 warrants at a price of 50 pence per share.

On 2 June 2020, the Company raised £578,700 in respect of the exercise of 1,234,399 warrants at a price of 39 pence and 50 pence per share. The Company also announced that during the calendar month of May, the Company issued a total of 1,743,445 ordinary shares under the Company's ATM sales agreement announced on 15 April 2020 to meet sales of a total of 348,689 ADSs under the ATM sales agreement, totalling gross proceeds of $1,985,004.

On 24 July 2020, the Company raised £82,379 in cash through the exercise of warrants.

On 31 July 2020, the Company announced that during the calendar month of July, it had issued a total of 2,043,000 ordinary shares under the Company's ATM sales agreement (announced on 15 April 2020) to meet sales of a total of 408,600 ADSs under the ATM sales agreement, totalling gross proceeds of $4,371,289.

On 5 August 2020, the Company announced the closing of its registered direct offering of ADSs on the NASDAQ Global Market. As of 3 August 2020, the Company issued 11,009,615 ADSs (representing 22,019,230 new ordinary shares of nominal value £0.03 each in the capital of the Company at a price of $5.20 per ADS raising gross proceeds of approximately $57.25 million (before deducting placement agent fees and offering expenses).

On 27 August 2020, the Company, raised £300,000 in cash through the exercise of warrants.

On 21 September 2020, the Company allotted 281,250 Ordinary Shares, credited as fully paid at a price of £1.28 per share in respect of agreements reached with certain members of the scientiﬁc advisory board concerning the commuting of cash fees into equity.

On 20 October 2020, the Company issued 35,714 Ordinary Shares credited as fully paid on the exercise of certain warrants held by the Company's broker, Optiva.

On 21 October 2020, the Company issued 1,750,000 Ordinary Shares of which 1,200,000 Ordinary Shares were issued credited as fully paid at a price of £0.15 per share and 550,000 shares were issued credited as fully paid at a price of £0.35 per share, both in respect of the exercise of share options by Gabriele Cerrone.

On 22 October 2020, the Company issued 285,714 Ordinary Shares credited as fully paid at a price of £0.35 per share on the exercise of warrants.

On 26 October 2020, the Company issued 329,225 shares credited as fully paid at a price of £0.35 per share on the exercise of share options held by, inter alia, Gabriele Cerrone and Keeren Shah.

On 28 October 2020, the Company issued 344,063 Ordinary Shares credited as fully paid at prices between £0.66 and £0.80 per share on the exercise of warrants.

On 29 October 2020, the Company issued 426,500 Ordinary Shares credited as fully paid at a price of £0.35 per share on the exercise of share options by, inter alia, Dr. Kunwar Shailubhai, Vaseem Palejwala and Jules Jacob.

Following the Company's raise of $57.25 million raise on 5 August 2020, the Group has sufﬁcient resources to fund its activities (including all clinical trials and programmes and operating expenditure) for at least the next 24 months. The Company's liquidity sufﬁciently covers the Group's short-term objectives and the clinical studies and trials due to start in 2020 and 2021 (as set out in paragraph 3 of Part VI - The Company's Strategy).

Current Liquidity

The Company's cash balances at 31 October 2020 were approximately £50.6 million, which the Company holds on deposit and in short-dated money market instruments.

Hedging arrangements and risk management

The Company may use forward contracts, options, swaps, caps, collars and ﬂoors or other strategies or forms of derivative instruments to limit its exposure to changes in the relative values of investments that may result from market developments, including changes in prevailing interest rates

and currency exchange rates, as previously described. It is expected that the extent of risk management activities by the Company will vary based on the level of exposure and consideration of risk across the business.

The success of any hedging or other derivative transaction generally will depend on the Company's ability to correctly predict market changes. As a result, while the Company may enter into such a transaction to reduce exposure to market risks, unanticipated market changes may result in poorer overall investment performance than if the transaction had not been executed. In addition, the degree of correlation between price movements of the instruments used in connection with hedging activities and price movements in a position being hedged may vary. Moreover, for a variety of reasons, the Company may not seek, or be successful in establishing, an exact correlation between the instruments used in a hedging or other derivative transactions and the position being hedged and could create new risks of loss. In addition, it may not be possible to fully or perfectly limit the Company's exposure against all changes in the values of its assets, because the values of its assets are likely to ﬂuctuate as a result of a number of factors, some of which will be beyond the Company's control.

PART XII

TAXATION

UK Taxation

The following summary is intended only as a general guide and relates solely to UK tax. It is based on current UK law and published practice of H.M. Revenue & Customs as at the date of this prospectus, each of which may be subject to change, possibly with retrospective effect.

The following paragraphs are not intended to be exhaustive and relate only to certain limited aspects of the UK taxation consequences of acquiring, holding and disposing of the Ordinary Shares and do not constitute legal or tax advice. Except to the extent expressly stated, they apply only to holders of Ordinary Shares who are resident, and in the case of individuals, domiciled, solely in the United Kingdom for UK tax purposes, and who are the absolute beneﬁcial owners of their Ordinary Shares and who do not hold their Ordinary Shares through an individual savings account or a self-invested personal pension ("UK Holders"). The information may not apply to certain classes of UK Holders such as tax exempt entities, collective investment schemes, pension schemes, insurance companies, ﬁnancial institutions, dealers, professional investors, persons who hold Ordinary Shares in connection with a trade, profession or vocation, persons connected with the Company and persons who have acquired (or been deemed to have acquired) their Ordinary Shares by reason of their (or another person's) ofﬁce or employment, to whom special rules may apply.

IT IS RECOMMENDED THAT ALL PROSPECTIVE HOLDERS OF ORDINARY SHARES OBTAIN ADVICE AS TO THE CONSEQUENCES OF THE ACQUISITION, OWNERSHIP AND DISPOSAL OF THE ORDINARY SHARES IN THEIR OWN SPECIFIC CIRCUMSTANCES FROM THEIR OWN TAX ADVISERS. IN PARTICULAR, PROSPECTIVE SHAREHOLDERS WHO MAY BE SUBJECT TO TAX IN A JURISDICTION OTHER THAN THE UNITED KINGDOM 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 UK tax, irrespective of the residence or particular circumstances of the holders of Ordinary Shares.

Income Tax

An individual UK Holder may, depending on his or her particular circumstances, be subject to UK tax on dividends received from the Company.

All dividends received by an individual UK Holder from the Company (or from other sources, except to the extent within an individual savings account, self-invested pension plan or other regime which exempts dividends from tax) will form part of that UK 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 UK Holder in a tax year. Income within this nil-rate band will be taken into account in determining whether income in excess of the £2,000 nil- rate band falls within the basic rate, higher rate or additional rate tax bands. Dividend income in excess of the nil-rate band 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,

per cent. to the extent that the excess amount falls within the higher rate tax band and

per cent. to the extent that the excess amount falls within the additional rate tax band.

An individual holder of Ordinary Shares who is not resident for tax purposes in the United Kingdom should not be chargeable to UK 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 United Kingdom through a branch or agency to which the Ordinary Shares are attributable. There are certain exceptions for trading in the United Kingdom through independent agents, such as some brokers and investment managers.

Corporation Tax

Corporate UK Holders should not be subject to UK corporation tax on any dividend received from the Company so long as the dividends qualify for exemption, which should generally be the case, provided certain conditions (including under anti-avoidance rules) are met. If the conditions for the exemption are not satisﬁed, or such UK Holder elects for an otherwise exempt dividend to be taxable, UK corporation tax will be chargeable on the amount of any dividends (currently at the rate of 19 per cent.).

A corporate holder of Ordinary Shares who is not resident for tax purposes in the United Kingdom should not be within the scope of UK corporation tax in respect of 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 Ordinary Shares are attributable.

Chargeable Gains

If a UK Holder disposes (or is treated as disposing) of some or all of its Ordinary Shares, a liability to tax on chargeable gains may arise, depending on the UK Holder's circumstances and any exemptions or reliefs which may be available.

Individual UK Holders

For an individual UK Holder, a disposal (or deemed disposal) of Ordinary Shares may give rise to a chargeable gain or allowable loss for the purposes of UK capital gains tax. For an individual UK Holder who is subject to UK income tax at either the higher or the additional rate, the current applicable rate of capital gains tax is 20 per cent. For an individual UK Holder who is subject to UK income tax at the basic rate, the current applicable rate would be 10 per cent., save to the extent that any capital gains when aggregated with the UK 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 per cent. An individual UK Holder is entitled to realise an annual exempt amount of gains (£12,300 for the year to 5 April 2021) without being liable to UK capital gains tax.

Corporate UK Holders

For a UK Holder within the charge to UK corporation tax, a disposal (or deemed disposal) of Ordinary Shares may give rise to a chargeable gain or to an allowable loss for the purposes of UK corporation tax. The current rate of UK corporation tax is 19 per cent. Indexation allowance is not available in respect of disposals of Ordinary Shares acquired on or after 1 January 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).

Shareholders who are not UK Resident

A holder of Ordinary Shares who is not resident for tax purposes in the United Kingdom should not normally be liable to UK capital gains tax or corporation tax on chargeable gains on a disposal (or deemed disposal) of Ordinary Shares unless (i) 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 Ordinary Shares, through a permanent establishment) to which the Ordinary Shares are attributable or (ii) in respect of disposals made on or after 6 April 2019, the Company directly or indirectly derives 75 per cent. or more of its qualifying asset value from UK land, in which case a holder may, depending on its circumstances, be liable for non-resident capital gains tax. However, an individual holder of Ordinary Shares who has ceased to be resident for tax purposes in the United Kingdom (including where an individual is treated as resident outside the United Kingdom for the purposes of a double tax treaty) for a period of ﬁve years or less and who disposes of Ordinary Shares during that period may be liable on his or her return to the United Kingdom to UK tax on any capital gain realised (subject to any available exemption or relief).

Stamp Duty and Stamp Duty Reserve Tax

The discussion below relates to holders of Ordinary Shares, wherever resident. However, special rules may apply where Ordinary Shares are issued or transferred to, or to a nominee or agent for, a depositary receipt issuer or clearance service provider, which are brieﬂy summarised below, or persons such as market makers, brokers, dealers or intermediaries.

Issue of Shares

No UK stamp duty or stamp duty reserve tax ("SDRT") should ordinarily be payable on an issue of Ordinary Shares.

Transfers of certiﬁcated Ordinary Shares

Stamp duty at the rate of 0.5 per cent. (rounded up to the next multiple of £5) of the amount or value of the consideration given is generally payable on an instrument transferring Ordinary Shares. An exemption from stamp duty is available on an instrument transferring Ordinary Shares where the amount or value of the consideration is £1,000 or less, and it is certiﬁcated on the instrument that the transaction effected by the instrument does not form part of a larger transaction or series of transactions for which the aggregate consideration exceeds £1,000. A charge to SDRT will also arise on an unconditional agreement to transfer Ordinary Shares (at the rate of 0.5 per cent. of the amount or value of the consideration payable). However, if within six years of the date of the agreement becoming unconditional an instrument of transfer is executed pursuant to the agreement, and stamp duty is paid on that instrument, or the instrument is otherwise exempt, any SDRT already paid will be refunded (generally, but not necessarily, with interest) provided that a claim for repayment is made, and any outstanding liability to SDRT will be cancelled. The purchaser or transferee of Ordinary Shares will generally be accountable for the SDRT. In the absence of contractual agreement no party is legally responsible for the payment of stamp duty as it is not an assessable tax, however, in practice the purchaser or transferee will usually pay stamp duty to ensure that the Company's register of members can be updated by the registrar to show the new ownership.

Ordinary Shares transferred through paperless means including CREST

Paperless transfers of Ordinary Shares, such as those occurring within CREST, are generally liable to SDRT rather than stamp duty, at the rate of 0.5 per cent. of the amount or value of the consideration. CREST is obliged to collect SDRT on relevant transactions settled within the system and to pay this to HMRC. The SDRT charge is generally borne by the purchaser. Under the CREST System, no stamp duty or SDRT will arise on a transfer of Ordinary Shares into the CREST System unless such a transfer is made for consideration in money or money's worth, in which case a liability to SDRT (usually at a rate of 0.5 per cent.) will arise.

Ordinary Shares held through Clearance Systems or Depositary Receipt Arrangements

Special rules apply where Ordinary Shares are issued or transferred to, or to a nominee or agent for, either a person whose business is or includes issuing depositary receipts within Section 67 or Section 93 of the Finance Act 1986 or a person providing a clearance service within Section 70 or Section 96 of the Finance Act 1986, under which SDRT or stamp duty may be charged at a rate of

1.5 per cent. Following litigation, HMRC conﬁrmed that they will no longer seek to apply the 1.5 per cent. SDRT charge on an issue of shares into a clearance service or depositary receipt arrangement on the basis that the charge is not compatible with EU law. It was announced on 22 November 2017 that the government will not seek to reintroduce this charge following the departure of the UK from the European Union.

Based on current published HMRC practice and recent case law, no SDRT is generally payable where the transfer of shares to a clearance service or depositary receipt system is an integral part of an issue of share capital. Any liability for stamp duty or SDRT in respect of such a transfer that is not integral to an issue of share capital will generally be accountable by the clearance service or depositary receipt system operator or their nominee, as the case may be, but will, in practice, be payable by the participants in the clearance service or depositary receipt system.

Transfers of Ordinary Shares within a depositary receipt system or a clearance service that has not made and maintained an election under section 97A of the Finance Act 1986 (a "section 97A election") will be exempt from SDRT and, provided no instrument of transfer is entered into, will not be subject to stamp duty.

Where a clearance service has made and maintained a section 97A election the 1.5 per cent. charge will not apply. Rather, stamp duty or SDRT will be charged at the normal rate of 0.5 per cent. on the transfer of existing shares into and within the clearance service.

Accordingly, speciﬁc professional advice should be sought before incurring a 1.5 per cent. stamp duty or stamp duty reserve tax charge in any circumstances.

Inheritance tax

The Ordinary Shares will be assets situated in the UK for the purposes of UK inheritance tax. A gift of such assets by, or the death of, an individual holder of such assets may (subject to certain exemptions and reliefs) give rise to a liability to UK inheritance tax even if the holder is neither domiciled in the UK nor deemed to be domiciled there under certain rules relating to long residence or previous domicile. For inheritance tax purposes, a transfer of assets at less than full market value may be treated as a gift and particular rules apply to gifts where the donor reserves or retains some beneﬁt.

Special rules also apply to close companies and to trustees of settlements who hold Ordinary Shares, bringing them within the charge to inheritance tax. Shareholders should consult an appropriate tax adviser if they make a gift or transfer at less than market value or intend to hold any Ordinary Shares through trust arrangements. They should also seek professional advice in a situation where there is potential for a double charge to UK inheritance tax and an equivalent tax in another country or if they are in any doubt about their UK inheritance tax position.

PART XIII

CONSEQUENCES OF A STANDARD LISTING

An application will be required to be made for the immediate admission of the Issued Share Capital to a Standard Listing (pursuant to Chapter 14 of the Listing Rules) and to trading on the Main Market of the London Stock Exchange. The Company intends to comply with the Listing Principles set out in Chapter 7 of the Listing Rules at Listing Rule 7.2.1 which apply to all companies with their securities admitted to the Ofﬁcial List. Premium Listing Principles 1 to 6 as set out in Listing Rule 7.2.1AR of the Listing Rules do not apply to the Company.

However, while the Company has a Standard Listing, it is not required to comply with the provisions of, inter alia:

Chapter 8 of the Listing Rules regarding the appointment of a sponsor to guide the Company in understanding and meeting its responsibilities under the Listing Rules in connection with certain matters. The Company has not and does not intend to appoint such a sponsor in connection with the Admission;
Chapter 9 of the Listing Rules relating to the ongoing obligations for companies admitted to the Premium List and therefore does not apply to the Company.
Chapter 10 of the Listing Rules relating to signiﬁcant transactions. It should be noted therefore that an acquisition will not require Shareholder consent, even if Ordinary Shares are being issued as consideration for such acquisition;
Chapter 11 of the Listing Rules regarding related party transactions. Nevertheless, the Company will not enter into any transaction which would constitute a 'related party transaction' as deﬁned in Chapter 11 of the Listing Rules without the speciﬁc prior approval of the Directors;
Chapter 12 of the Listing Rules regarding purchases by the Company of its Ordinary Shares. In particular, the Company has not adopted a policy consistent with the provisions of Listing Rules 12.4.1 and 12.4.2; and
Chapter 13 of the Listing Rules regarding the form and content of circulars to be sent to Shareholders.

It should be noted that the FCA will not have the authority to (and will not) monitor the Company's compliance with any of the Listing Rules which the Company has indicated herein that it intends to comply with on a voluntary basis, nor to impose sanctions in respect of any failure by the Company so to comply. However, the FCA would be able to impose sanctions for non-compliance where the statements regarding compliance in this prospectus are themselves misleading, false or deceptive.

PART XIV

ADDITIONAL INFORMATION

1. RESPONSIBILITY

The Directors, whose names appear on page 46, and the Company accepts responsibility for the information contained in this prospectus. To the best of the knowledge of the Directors and the Company, the information contained in this prospectus is in accordance with the facts and the prospectus makes no omission likely to affect its import.

2. THE COMPANY

The Company was incorporated as in England and Wales on 11 February 1998 as a private company with limited liability under the Companies Act with an indeﬁnite life; re-registered as a public limited company on 8 June 1998 under the name Alexander David Investments Plc;
and changed its name to Tiziana Life Sciences plc on 23 April 2014 when it acquired TPL via a reverse takeover (as deﬁned in the AIM Rules). TPL was formed in November 2013. On 20 November 2018, the Company's ADSs were listed for trading on NASDAQ
The Company is not regulated by the FCA or any ﬁnancial services or other regulator. The Company is subject to the Listing Rules and the Disclosure Guidance and Transparency Rules (and the resulting jurisdiction of the FCA), to the extent such rules apply to companies with a Standard Listing pursuant to Chapter 14 of the Listing Rules.
As at the date of this prospectus, the Company has three, wholly-owned subsidiaries: TPL (England and Wales); Tiziana Therapeutics, Inc. (Delaware, USA); Longevia Genomics SRL (Italy); and StemPrintER Sciences Limited (England and Wales).
The principal legislation under which the Company operates, and pursuant to which the Ordinary Shares have been created, is the Companies Act and the regulations made thereunder. The Company operates in conformity with its constitution.

2.5 The Company's registered ofﬁce is at 3rd Floor, 11-12 St James's Square, London SW1Y 4LB. The Company's telephone number is +44 20 7495 2379.

On incorporation of the Company, Hallmark Secretaries Limited subscribed for 1 Ordinary Share of nominal value £1.00 in the capital of the Company at par and Hallmark Registrars Limited subscribed for 1 Ordinary Share of nominal value £1.00 in the capital of the Company at par.
On 5 March 2018, the Company allotted a total 1,682,813 Ordinary Shares of £0.03 each for a total of £1,466,250.40.
On 27 April 2018, the Company allotted a total of 23,014 Ordinary Shares of £0.03 each for a total of £16,109.80.
On 19 November 2018, the Company allotted a total of 1,515,150 Ordinary Shares of £0.03 each for a total of £1,136,362.50.
On 20th November 2018, the Company allotted a total of 3,538,269 Ordinary Shares of £0.03 each for a total of £2,372,715.20.
On 23rd November 2018, the Company allotted a total of 4,429,100 Ordinary Shares of £0.03 each for a total of £3,321,825.00.
On 11 December 2018, the Company allotted a total of 54,000 Ordinary Shares of £0.03 each for a total amount of £41,566.68.
On 19 November 2019, the Company allotted a total of 190,698 Ordinary Shares of £0.03 each for a total amount of £82,000.14.
On 16 March 2020, the Company allotted 16,666,665 Ordinary Shares of £0.03 each for a total of £7,999,999.20.
On 15 April 2020, the Company allotted 670,950 Ordinary Shares of £0.03 each for a total of £233,541.50.

On 17 April 2020, the Company allotted 150,000 Ordinary Shares of £0.03 each for a total of £82,500.00.
On 20 April 2020, the Company allotted 205,955 Ordinary Shares of £0.03 each for a total of £111,215.70.
On 22 April 2020, the Company allotted 50,000 Ordinary Shares of £0.03 each for a total of £26,000.00.
On 23 April 2020, the Company allotted a total of 6,118,797 Ordinary Shares of £0.03 each for a total of £2,450,007.70.
On 28 April 2020, the Company allotted a total of 250,000 Ordinary Shares of £0.03 each for a total of £135,000.00.
On 5 May 2020, the Company allotted a total of 200,000 Ordinary Shares of £0.03 each for a total of £100,000.00.
On 12 May 2020, the Company allotted a total of 5,180 Ordinary Shares of £0.03 each for a total of £3,522.40.
On 13 May 2020, the Company allotted a total of 14,315 Ordinary Shares of £0.03 each for a total of £9,447.90.
On 18 May 2020, the Company allotted a total of 228,950 Ordinary Shares of £0.03 each for a total of £212,923.50.
On 19 May 2020, the Company allotted a total of 370,000 Ordinary Shares of £0.03 each for a total of £358,900.00.
On 22 May 2020, the Company allotted a total of 264,286 Ordinary Shares of £0.03 each for a total of £132,143.00.
On 26 May 2020, the Company allotted a total of 250,000 Ordinary Shares of £0.03 each for a total of £222,500.00.
On 27 May 2020, the Company allotted a total of 500,000 Ordinary Shares of £0.03 each for a total of £515,000.00.
On 1 June 2020, the Company allotted a total of 175,000 Ordinary Shares of £0.03 each for a total of £189,000.00.
On 2 June 2020, the Company allotted a total of 300,000 Ordinary Shares of £0.03 each for a total of £330,000.00.
On 5 June 2020, the Company allotted a total of 50,000 Ordinary Shares of £0.03 each for a total of £52,500.00.
On 22 June 2020, the Company allotted a total of 250,000 Ordinary Shares of £0.03 each for a total of £267,500.00.
On 30 June 2020, the Company allotted a total of 77,500 Ordinary Shares of £0.03 each for a total of £82,150.00.
On 13 July 2020, the Company allotted a total of 25,000 Ordinary Shares of £0.03 each for a total of £30,250.00.
On 15 July 2020, the Company allotted a total of 375,500 Ordinary Shares of £0.03 each for a total of £554,810.00.
On 16 July 2020, the Company allotted a total of 80,000 Ordinary Shares of £0.03 each for a total of £120,800.00.
On 17 July 2020, the Company allotted a total of 85,000 Ordinary Shares of £0.03 each for a total of £133,450.00.
On 20 July 2020, the Company allotted a total of 550,000 Ordinary Shares of £0.03 each for a total of £940,500.00.
On 21 July 2020, the Company allotted a total of 850,000 Ordinary Shares of £0.03 each for a total of £1,623,500.00.

On 24 July 2020, the Company allotted a total of 88,580 Ordinary Shares of £0.03 each for a total of £82,379.
On 3 August 2020, a registered direct offering was made through the Company's ADS's which resulted in an issue for 22,019,230 Ordinary Shares of £0.03 each for a total of approximately $57.25 million.
On 29 August 2020, the Company allotted a total of 600,000 Ordinary Shares of £0.03 each for a total of £300,000.
On 21 September 2020, the Company allotted 281,250 Ordinary Shares, credited as fully
paid at a price of £1.28 per share in respect of agreements reached with certain members of the scientiﬁc advisory board concerning the commuting of cash fees into equity.
On 2 October 2020, resolutions were passed by Shareholders to approve the Demerger and to reduce the amount standing to the share premium account of the Company by £4,000,000 to facilitate the Demerger (the "Capital Reduction"). The Court sanctioned the Capital Reduction on 27 October 2020 and the Demerger became effective on 30 October 2020.
On 20 October 2020, the Company issued 35,714 Ordinary Shares credited as fully paid on the exercise of certain warrants held by the Company's broker, Optiva.
On 21 October 2020, the Company issued 1,750,000 Ordinary Shares of which 1,200,000 Ordinary Shares were issued credited as fully paid at a price of £0.15 per share and 550,000 shares were issued credited as fully paid at a price of £0.35 per share, both in respect of the exercise of share options by Gabriele Cerrone.
On 22 October 2020, the Company issued 285,714 Ordinary Shares credited as fully paid at a price of £0.35 per share on the exercise of warrants.
On 26 October 2020, the Company issued 329,225 shares credited as fully paid at a price of £0.35 per share on the exercise of share options held by, inter alia, Gabriele Cerrone and Keeren Shah.
On 28 October 2020, the Company issued 344,063 Ordinary Shares credited as fully paid at prices between £0.66 and £0.80 per share on the exercise of warrants.
On 29 October 2020, the Company issued 426,500 Ordinary Shares credited as fully paid at a price of £0.35 per share on the exercise of share options by, inter alia, Dr. Kunwar Shailubhai, Vaseem Palejwala and Jules Jacob.

3. SHARE CAPITAL

3.1 The following table shows the issued and fully paid shares of the Company at the date of this prospectus:

Class		Number	Amount paid

Ordinary Shares	194,612,289	£5,838,368.67

3.2 Pursuant to an ordinary resolution of the Shareholders passed at the 2020 AGM of the Company held on 16 July 2020 the Directors, in accordance with section 551 of the Companies Act, were generally and unconditionally authorised to allot shares in the Company, or to grant rights to subscribe for or to convert any security into shares in the Company ("Rights"):

up to an aggregate nominal amount of £1,623,690; and
comprising equity securities (as deﬁned in section 560 of the Act) up to an aggregate nominal amount of £1,623,690 (such amount to be reduced by the aggregate nominal amount of any allotments or grants made under paragraph (i) of this resolution) in connection with an offer by way of rights issue:
1. to ordinary shareholders in proportion (as nearly as may be practicable) to their existing holdings; and

to holders of other equity securities as required by the rights of those securities or, subject to such rights, as the Directors otherwise consider necessary,

and so that the Directors may impose any limits or restrictions and make any arrangements which they consider necessary or appropriate to deal with treasury shares, fractional entitlements, record dates, legal, regulatory or practical problems in, or under the laws of any territory or any other matter, such authorities to expire at the conclusion of the Company's next AGM after this resolution is passed or, if earlier, 15 months after the passing of this Resolution, but, in each case, so that the Company may make offers or agreements before the authority expires which would or might require shares to be allotted or Rights to be granted after the authority expires, and so that the Directors may allot shares or grant Rights in pursuance of any such offer or agreement notwithstanding that the authority conferred by this resolution has expired.

3.3 Pursuant to a special resolution of the Shareholders passed at the 2020 AGM of the Company held on 16 July 2020:

the Directors, in accordance with sections 570 and 573 of the Companies Act, were generally empowered to allot equity securities (as deﬁned in section 560 of the Companies Act) for cash pursuant to the authorities granted by the resolution in paragraph 3.2 above, and/or sell ordinary shares held by the Company as if section 561 of the Companies Act did not apply to any such allotment or sale provided that this power shall be limited:
1. to the allotment of equity securities in connection with an offer of equity securities (but in the case of an allotment pursuant to the authority granted under paragraph
2. of the resolution in paragraph 3.2 above, such power shall be limited to the allotment of equity securities in connection with an offer by way of rights issue only):
3. 1. to ordinary shareholders in proportion (as nearly as may be practicable) to their existing holdings; and
  2. to holders of other equity securities, as required by the rights of those securities or, subject to such rights, as the Directors otherwise consider necessary,

1. to the allotment (otherwise than in the circumstances set out in paragraph (i) of this resolution) of equity securities or sale of treasury shares pursuant to the authority granted by paragraph (i) of the resolution in paragraph 3.2 above, up to an aggregate nominal amount of £1,000,000, such power to expire at the conclusion of the Company's next AGM after this resolution is passed or, if earlier, 15 months after the passing of this resolution, but so that the Company may make offers or agreements before the power expires which would or might require equity securities to be allotted (and/or treasury shares to be sold) after the power expires and so that the Directors may allot equity securities (and/or sell treasury shares) in pursuance of any such offer or agreement notwithstanding that the power conferred by this authority has expired; and
the Directors, in accordance with sections 570 and 573 of the Companies Act, were generally empowered to allot equity securities (as deﬁned in section 560 of the Companies Act) for cash pursuant to the authorities granted by the resolution in paragraph 3.2 above, and/or sell ordinary shares held by the Company as if section 561 of the Companies Act did not apply to any such allotment or sale provided that this power shall be:

100

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Tiziana Life Sciences plc published this content on 18 December 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 18 December 2020 13:30:02 UTC

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Company Profile

Tiziana Life Sciences Ltd. is a United Kingdom-based clinical-stage biotechnology company. The Company develops transformative therapies for neurodegenerative and lung diseases. Its clinical pipeline includes drug assets for secondary progressive multiple sclerosis, Crohn's Disease and KRAS+ NSCLC. Its pipeline candidates include Foralumab (TZLS-401), Anti IL-6R mAb (TZLS-501) and Milciclib (TZLS-201). Foralumab (TZLS-401) is a fully human anti-CD3 monoclonal antibody (mAb) for the treatment of Crohnâs and neurodegenerative diseases. Its Anti IL-6R mAb (TZLS-501), a fully human mAb binds to both membrane-bound and soluble forms of IL-6R, an inflammatory cytokine driving chronic inflammation associated with autoimmune disease and cancer, reducing circulating levels of the IL-6 cytokine. Milciclib is a potent, small molecule inhibitor of multiple cyclin-dependent kinases (CDKs), tropomycinreceptor kinases and Src family kinases controlling cell growth and malignant progression of cancer.

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