As filed with the Securities andExchange Commission on December 5, 2022.

RegistrationStatement No. [_____]

UNITEDSTATES

SECURITIESAND EXCHANGE COMMISSION

WASHINGTON,D.C. 20549

FormF-1

REGISTRATIONSTATEMENT

UNDER

THESECURITIES ACT OF 1933

OKYOPharma Limited

(Exactname of Registrant as specified in its charter)

NotApplicable

(Translationof Registrant’s name into English)

OKYOPharma Limited

MartelloCourt

AdmiralPark

St.Peter Port

GuernseyGY1 3HB

+44(0)20 7495 2379

(Address,including zip code, and telephone number, including area code, of Registrant’s principal executive offices)

OKYOPharma US, Inc.

420Lexington Avenue, Suite 1405

NewYork, NY 10170

(917)225-9646

(Name,address, including zip code, and telephone number, including area code, of agent for service)

Copiesto:

Approximatedate of commencement of proposed sale to the public: As soon as practicable after this Registration Statement becomes effective.

Ifany of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under theSecurities Act of 1933, check the following box. ☐

Ifthis Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act of 1933, checkthe following box and list the Securities Act of 1933 registration statement number of the earlier effective registration statement forthe same offering. ☐

Ifthis Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act of 1933, check the following box and listthe Securities Act of 1933 registration statement number of the earlier effective registration statement for the same offering. ☐

Ifthis Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act of 1933, check the following box and listthe Securities Act of 1933 registration statement number of the earlier effective registration statement for the same offering. ☐

Indicateby check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933.

Ifan emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registranthas elected not to use the extended transition period* for complying with any new or revised financial accounting standards providedpursuant to Section 7(a)(2)(B) of the Securities Act of 1933. ☐

TheRegistrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until theRegistrant shall file a further amendment which specifically states that this registration statement shall thereafter become effectivein accordance with Section 8(a) of the Securities Act of 1933 or until the registration statement shall become effective on such dateas the Commission, acting pursuant to said Section 8(a), may determine.

Theinformation contained in this preliminary prospectus is not complete and may be changed. These securities may not be sold until the registrationstatement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securitiesand it is not soliciting an offer to buy these securities in any state where the offer or sale is not permitted.

4,484,305American Depositary Shares

Representing291,479,825 Ordinary Shares

OKYOPharma Limited

We are offering 4,484,305 American DepositaryShares, or ADSs, of OKYO Pharma Limited. Each ADS represents 65 ordinary shares. Our ADSs are currently trading on the Nasdaq CapitalMarket, or Nasdaq, under the ticker symbol “OKYO”. On December 2, 2022, the closing sale price of our ADSs was $2.23per share. The public offering price per ADS will be determined through negotiation between us and the underwriters in the offeringand the recent market price used throughout this prospectus may not be indicative of the actual offering price.

Our ordinary shares are admitted to listing on thestandard segment of Official List of the United Kingdom Financial Conduct Authority, or FCA, and to trading on the main market for listedsecurities, or Main Market,of London Stock Exchange plc, or LSE, under the symbol “OKYO.” On December 2, 2022, thelast reported sale price of our ordinary shares was £0.0275 per share (equivalent to $0.033 per ADS based on an exchangerate of £1.00 to $1.2102). For a discussion of the factors considered in determining the public offering price of our ADSs,see “Underwriting”.

Investingin our ADSs involves a high degree of risk. See “Risk Factors” beginning on page 10 of this prospectus for a discussionof information that you should consider before investing in our ADSs.

Neitherthe Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determinedif this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

Weare an “emerging growth company,” or EGC, as defined under applicable Securities and Exchange Commission, or SEC, rules and,as such, have elected to comply with certain reduced public company reporting requirements for this and future filings.

Weare also a “foreign private issuer,” as defined in the Securities Exchange Act of 1934, as amended, or the Exchange Act,and are exempt from certain rules under the Exchange Act that impose certain disclosure obligations and procedural requirements for proxysolicitations under Section 14 of the Exchange Act. In addition, our officers, directors and principal shareholders are exempt from thereporting and “short-swing” profit recovery provisions under Section 16 of the Exchange Act. Moreover, we are not requiredto file periodic reports and financial statements with the SEC as frequently or as promptly as U.S. companies whose securities are registeredunder the Exchange Act.

Wehave granted the representative of the underwriters an over-allotment option to purchase up to an additional 672,645 ADSs fromus at the public offering price, less the underwriting discounts and commissions, within 45 days from the date of this prospectus tocover over-allotments, if any. If the representative of the underwriters exercises their over-allotment option in full, the total underwritingdiscounts and commissions payable will be $          , and the total proceeds to us, beforeexpenses, will be $         .

Theunderwriters expect to deliver our ADSs to purchasers in this offering on or about          , 2022.

ThinkEquity

Thedate of this prospectus is               , 2022

TABLEOF CONTENTS

Weare responsible for the information contained in this prospectus and any free-writing prospectus we prepare or authorize. We have notauthorized anyone to provide you with different information, and we take no responsibility for any other information others may giveyou. We are not making an offer to sell our ADSs in any jurisdiction where the offer or sale is not permitted. For the avoidance of doubt,we are not, making an offer to sell our ordinary shares in any jurisdiction. You should not assume that the information contained inthis prospectus is accurate as of any date other than the date on the front cover of this prospectus, regardless of the time of deliveryof this prospectus or the sale of any ADSs.

Forinvestors outside the United States, we have not done anything that would permit this offering or possession or distribution of thisprospectus in any jurisdiction, other than the United States, where action for that purpose is required. Persons outside the United Stateswho come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, this offering andthe distribution of this prospectus outside the United States.

Weare a non-cellular company limited by shares incorporated under the Companies (Guernsey) Law 2008, or the Guernsey Companies Law, anda majority of our outstanding securities are owned by non-U.S. residents. Under the rules of the SEC, we are currently eligible for treatmentas a “foreign private issuer,” or FPI. As an FPI, we will not be required to file periodic reports and financial statementswith the SEC as frequently or as promptly as domestic registrants whose securities are registered under the Exchange Act.

AboutThis Prospectus

Unlessotherwise indicated or the context otherwise requires, all references in this registration statement to the terms “OKYO,”“OKYO Pharma Limited,” the “Company,” “we,” “us” and “our” refer toOKYO Pharma Limited and our wholly owned subsidiary OKYO Pharma US Inc..

Solelyfor convenience, the trademarks, service marks and trade names in this registration statement may be referred to without the ® and™ symbols, but such references should not be construed as any indicator that their respective owners will not assert, to the fullestextent under applicable law, their rights thereto. This registration statement contains additional trademarks, service marks and tradenames of others, which are the property of their respective owners. We do not intend to use or display other companies’ trademarks,service marks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

Inthis registration statement, unless otherwise stated, all references to “U.S. dollars” or “US$” or “$”or “cents” are to the currency of the United States of America, and all references to “Pounds Sterling” or “£”or “pence” are to the currency of the United Kingdom.

Inthis registration statement, any reference to any provision of any legislation shall include any amendment, modification, re-enactmentor extension thereof. Words importing the singular shall include the plural and vice versa, and words importing the masculine gendershall include the feminine or neutral gender.

SPECIALNOTE REGARDING FORWARD-LOOKING STATEMENTS

OKYOdiscusses in this prospectus its business strategy, market opportunity, capital requirements, product introductions and development plansand the adequacy of the Company’s funding. Other statements contained in this prospectus, which are not historical facts, are alsoforward-looking statements. OKYO has tried, wherever possible, to identify forward-looking statements by terminology such as “may,”“will,” “could,” “should,” “expects,” “anticipates,” “intends,”“plans,” “believes,” “seeks,” “estimates” and other comparable terminology.

OKYOcautions investors that any forward-looking statements presented in this prospectus, or that OKYO may make orally or in writing fromtime to time, are based on the beliefs of, assumptions made by, and information currently available to, OKYO. These statements are basedon assumptions, and the actual outcome will be affected by known and unknown risks, trends, uncertainties and factors that are beyondits control or ability to predict. Although OKYO believes that its assumptions are reasonable, they are not a guarantee of future performance,and some will inevitably prove to be incorrect. As a result, its actual future results can be expected to differ from its expectations,and those differences may be material. Accordingly, investors should use caution in relying on forward-looking statements, which arebased only on known results and trends at the time they are made, to anticipate future results or trends. Certain risks are discussedin this prospectus and also from time to time in OKYO’s other filings with the SEC.

Thisprospectus and all subsequent written and oral forward-looking statements attributable to the Company or any person acting on its behalfare expressly qualified in their entirety by the cautionary statements contained or referred to in this section. The Company does notundertake any obligation to release publicly any revisions to its forward-looking statements to reflect events or circumstances afterthe date of this prospectus.

Inparticular, you should consider the risks provided under “Risk factor summary” in this prospectus and in the Form 20-F forthe fiscal year ended March 31, 2022 as filed with the SEC (the “2022 Form 20-F”) incorporated by referencein this prospectus.

Presentationof Financial Information

Thisprospectus includes our audited consolidated financial statements as of March 31, 2022 and 2021 and for the years ended March31, 2022, 2021 and 2020 which are prepared in accordance with International Financial Reporting Standards, or IFRS, as issuedby the International Accounting Standards Board, or IASB. None of our financial statements were prepared in accordance with generallyaccepted accounting principles in the United States.

Our financial information ispresented in U.S. dollars. For the convenience of the reader, in this prospectus, unless otherwise indicated, translations from PoundsSterling into U.S. dollars were made at the rate of £1.00 to $1.2102 which was the noon buying rate of the Federal ReserveBank of New York on November 25, 2022. Such U.S. dollar amounts are not necessarily indicative of the amounts of U.S. dollarsthat could actually have been purchased upon exchange of Pounds Sterling at the dates indicated.

Wehave made rounding adjustments to some of the figures included in this prospectus. Accordingly, numerical figures shown as totals insome tables may not be an arithmetic aggregation of the figures that preceded them.

PROSPECTUSSUMMARY

Thissummary highlights information contained elsewhere in this prospectus and does not contain all of the information that you should considerin making your investment decision. Before investing in our ADSs or ordinary shares, you should carefully read this entire prospectus,including our consolidated financial statements and the related notes and the information set forth under the sections titled “RiskFactors,” “Special Note Regarding Forward-Looking Statements,” and “Management’s Discussion and Analysisof Financial Condition and Results of Operations,” in each case included elsewhere in this prospectus.

Overview

Weare a preclinical biopharmaceutical company developing next-generation therapeutics to improve the lives of patients suffering from inflammatoryeye diseases and ocular pain. Our research program is focused on a novel G Protein-Coupled Receptor, or GPCR, which we believe playsa key role in the pathology of these inflammatory eye diseases of high unmet medical need. Our therapeutic approach is focused on targetinginflammatory and pain modulation pathways that drive these conditions. We are presently developing OK-101, our lead preclinical productcandidate, for the treatment of dry eye disease (“DED”). We also plan to evaluate its potential in benefiting patients withocular neuropathic pain, uveitis and allergic conjunctivitis. We have also been evaluating OK-201, a bovine adrenal medulla, or BAM,lipidated-peptide preclinical analogue candidate that is currently in developmental stage.

OnFebruary 21, 2018, we announced that we successfully obtained (via assignment from Panetta Partners Ltd., a related party) a licensefrom On Target Therapeutics LLC, or OTT, to patents owned or controlled by OTT and a sub-license from OTT to certain patents licensedby OTT from Tufts Medical Center Inc., or TMC, to support our ophthalmic disease drug programs. These licenses gave us the right to exploitthe intellectual property, or IP estate which is directed to compositions-of-matter and methodologies for treating ocular inflammation,DED, with chemerin or lipid-linked chemerin analogues. We also have a license from TMC to a separate IP estate for treating symptomsof ocular neuropathic pain and uveitis associated pain. On August 6, 2019, we signed a collaborative agreement with TMC on a researchprogram focused on ocular neuropathic pain.

OnJanuary 7, 2021, we announced the appointment of Mr. Gabriele Cerrone as Non-Executive Chairman and Director, and Gary S. Jacob, Ph.D.as Chief Executive Officer and Director. The addition of these two individuals was a significant step for us, highlighting a carefulrealignment of the strategic focus of our research and development program, with the aim of facilitating advancement of both of our preclinicalprograms. We believed this realignment would allow us to file investigational new drug, or IND, applications on our drugcandidates with the U.S. Food and Drug Administration, or FDA, in the shortest time possible.

OK-101

OK-101,our lead preclinical product candidate, is focused on keratoconjunctivitis sicca, commonly referred to as DED, which is a multifactorialdisease caused by an underlying inflammation resulting in the lack of lubrication and moisture in the surface of the eye. DED is oneof the most common ophthalmic conditions encountered in clinical practice. Symptoms of DED include constant discomfort and irritationaccompanied by inflammation of the ocular surface, visual impairment and potential damage to the ocular surface. There are presentlyapproximately 20 million people suffering from DED in the U.S. alone (Farrand et al. AJO 2017; 182:90), with the disease affecting approximatelyup to 34% of the population aged 50+ (Dana et al. AJO 2019; 202:47), and with women representing approximately two-thirds of those affected(Matossian et al. J Womens Health (Larchmt) 2019; 28:502–514). Prevalence of DED is anticipated to increase substantially in thenext 10-20 years due to aging populations in the U.S., Europe, Japan and China and use of contact lenses in the younger population. Webelieve this increase in prevalence of DED represents a major expanding economic burden to public healthcare. According to MarketResearch Report, Dry Eye Disease, December 2020, the global DED market in 2019 was approximately $5.22 billion, with the market sizeexpected to reach $6.54 billion by 2027. In addition, DED causes approximately $3.8 billion annually in healthcare costs and representsa major economic burden to public healthcare, accounting for more than $50 billion to the U.S. economy annually.

Atpresent, there are 5 prescription drugs available to treat DED: 1) Restasis (0.05% cyclosporine), 2) Cequa (0.09% cyclosporine), 3) Xiidra(5% lifitegrast), 4) Tyrvaya (0.03 mg varenicline), and 5) Eysuvis (0.25% loteprednol – a corticosteroid for short term use only).However, DED continues to be a major unmet medical need due to the large number of patients not well served by the treatments availableto them through the medical community.

Thedevelopment of new drugs to treat DED has been particularly challenging due to the heterogeneous nature of the patient population sufferingfrom DED, and due to the difficulties in demonstrating an improvement in both signs and symptoms of the disease in well-controlled clinicaltrials. The evidence from over 40 years of scientific literature, however, suggests inflammation as the most common underlying elementof DED. Consequently, development of new therapeutic agents that target inflammatory pathways is looking to be an attractive approachin improving symptoms in DED patients. Moreover, large number of dry eye patients suffer from ocular neuropathic pain, making their conditionmore resistant to topical anti-inflammatory therapy, and a drug capable of targeting both of these aspects of DED would be a significantaddition to the ocular-care practitioner’s arsenal for the treatment of DED.

Thechemerin receptor (CMKLR1 or ChemR23) is a chemokine like GCPR expressed on select populations of cells including inflammatory mediators,epithelial and endothelial cells as well as neurons and glial cells in the dorsal root ganglion, spinal cord, and retina. Activationof CMKLR1 by chemerin has been shown to resolve the inflammation and pain in animal models of asthma and pain, respectively. We havebeen pioneering the development of OK-101, a lipidated-chemerin analogue, which is an agonist of CMKLR1, in treating DED and other ocularinflammatory conditions. OK-101 was first identified in a program developed by OTT using membrane-tethered ligand technology.

Toexpand our understanding of the structure-activity relationships of the lipidated-chemerin analogues, such as OK-101, as agonists ofthe chemerin receptor, we synthesized a small library of analogues of OK-101. We screened these analogues in a cell-line based receptorbinding assay to characterize the agonist potency of these lipidated-chemerin analogues. This work has also been coupled to an evaluationof a subset of these analogues’ potential in treating DED by using a variety of preclinical studies and dry eye animal model studies.After evaluating a number of our analogues in a mouse model of acute DED by looking at their ability to reduce corneal permeability,a measure of dry-eye effectiveness, as well as the analogues’ impact on immune response, we determined that OK-101 was in factthe most potent analogue in reducing corneal permeability and down-regulating immune response. In addition, in a separate set of animalmodel experiments, OK-101 was shown to exhibit potent ocular pain-reducing activity in a ciliary nerve ligation mouse model of cornealneuropathic pain. Following these studies, we evaluated the ocular tolerance of OK-101 via repeated ocular instillation in rabbitsfollowed by clinical ophthalmic observations. Rabbit ocular tolerance tests on OK-101 showed no adverse signs such as inflammation, chemosisor hyperemia and no signs of local irritation. With potential anti-inflammatory and neuropathic pain reducing characteristics, we aredeveloping OK-101 for the treatment of DED.

Based on the results from theDED animal model, the neuropathic corneal pain model as well as the rabbit ocular tolerance studies, we moved forward overthe past 18 months with plans to file an IND on OK-101 to treat DED to enable us to begin clinical trials soon thereafter. Duringthe fourth quarter of 2021 we successfully manufactured a 200-gram batch of OK-101 drug substance needed for initiating the IND-enablingstudies that were begun during the first quarter of 2022. In support of this work, we also had previously signed an agreement on April13, 2021, with Ora, Inc., or Ora, a major clinical research organization, or CRO, specializing in ophthalmic drug development who havebeen providing us with the following services over the past 18 months:

Overthe past nine months we accomplished the following:

We recently completed thefinal stages of a concerted effort to complete all IND enabling activities and filed with FDA the IND on OK-101 to treat DED on November18, 2022.

Basedon recent consultations with Ora, we are now planning to commence the first human study with OK-101 in the first quarter of 2023, andbecause the drug is designed to be administered topically, we plan to skip the standard Phase 1 studies typically expected with orallydelivered or injectable drug candidates in non-life-threatening conditions and open the first trial as a Phase 2 clinical trial in DEDpatients (See OKYO Pipeline below). This trial is anticipated to be conducted in approximately 200 to 250 DED patients. The study isbeing designed in conjunction with, and will be managed and monitored by Ora, well known for its leadership of ophthalmic clinical trialactivities. The Phase 2 trial is expected to be completed in 6-9 months from enrollment of the first patient.

OKYOPipeline

OnFebruary 15, 2022, we announced the successful completion of the pre-IND meeting facilitated by Ora with the FDA regarding developmentplans for OK-101 to treat DED. Both nonclinical and clinical development milestones were covered in the pre-IND meeting, with the FDAagreeing that our first human trial would be a Phase 2 safety and efficacy trial in DED patients. The FDA also provided guidance on theplanned protocol for this trial in DED patients, concurring with one particular option OKYO has considered for the protocol which isto designate co-primary efficacy endpoints covering both a sign and a symptom of DED in the clinical trial. Notably, the final decisionto designate any efficacy endpoints as primary endpoints in this trial would be highly significant as should this phase 2 trial thenmeet any prespecified primary endpoints, the trial should considerably affect the timeline to an NDA filing with the FDA for OK-101 totreat DED.

AdditionalApplicable Disease Indications for OK-101

Asecond related ophthalmic disease indication that is the target of our chemerin-based technology is uveitis. Uveitis is the third leadingcause of blindness worldwide. The most common type of uveitis is an inflammation of the iris called iritis (anterior uveitis). Uveitiscan damage vital eye tissue, leading to permanent vision loss. Uveitis is currently treated with corticosteroid eyedrops and injectionsthat reduce inflammation, however, the long-term use of corticosteroids causes risk of cataract and glaucoma, requiring close monitoringfor their potential side effects.

Webelieve that OK-101, in addition to its potential to treat DED, should also be evaluated to treat allergic conjunctivitis and uveitis.Correspondingly, once we have an IND on OK-101 in place and are clinically evaluating OK-101 to treat DED, we also plan to explore thedrug candidate’s potential to suppress the inflammation associated with allergic conjunctivitis and uveitis.

OK-201

MAS-RelatedG Protein-Coupled Receptors, or MRGPRs, mainly expressed in the sensory neurons, are involved in the perception of pain, thus makingthem a promising analgesic target. Activation of MRGPR by Bovine Adrenal Medulla, or BAM, peptide inhibits pain perception by modulatingCa2+ influx. OK-201, a BAM peptide analogue, licensed from TMC on May 1, 2018, is a potent agonist of human MRGPR and a promising candidatefor the treatment of neuropathic and inflammatory pain.

OnAugust 6, 2019, we signed a collaborative agreement with TMC and Pedram Hamrah, MD, Professor of Ophthalmology at Tufts University Schoolof Medicine, Boston, MA as Principal Investigator to evaluate OK-201 and other proprietary lead compounds to suppress corneal neuropathicpain using a mouse ocular pain model recently developed in Dr. Hamrah’s laboratory. Our goal was to further develop this lipidatedpeptide, as well as explore additional analogues, for their potential use in treating ocular pain, and for potentially treating long-termchronic pain.

OnApril 28, 2021, we announced positive results of OK-201, a non-opioid analgesic drug candidate delivered topically in Dr. Hamrah’smouse neuropathic corneal pain model, as a potential drug to treat acute and chronic ocular pain. Importantly, OK-201 demonstrated areduced corneal pain response equivalent to that of gabapentin, a commonly used oral drug for neuropathic pain. These observations demonstratedpreclinical ‘proof-of-concept’ for the topical administration of OK-201 as a potential non-opioid analgesic for ocular pain.Current treatments for corneal pain are limited to short term non-steroidal anti-inflammatory drugs, or NSAIDs, steroids, and oral gabapentinand opioids in severe cases.

Althoughthe results with OK-201 were encouraging, due to subsequent success obtained with OK-101 (see section above on OK-101) in follow-on animalmodel studies utilizing the same mouse corneal neuropathic pain model as for OK-201, we have decided to maintain this drug candidateat the exploratory level while we focus our primary energy on the OK-101 program to treat DED, based on OK-101’s combination ofanti-inflammatory and corneal pain-reducing activities in animal models of these conditions.

SUMMARYOF RISKS AFFECTING OUR BUSINESS

Ourbusiness is subject to a number of risks of which you should be aware before making an investment decision. You should carefully considerall of the information set forth in this prospectus and, in particular, should evaluate the specific factors set forth in the sectiontitled “Risk Factors” before deciding whether to invest in our ADSs. These important risks include, but are not limited to,the following:

●We have only recently committed to our new business and our product candidates are in the early stages of development and it may be someyears until we generate revenue, if at all.

●Our product candidates have not been evaluated in clinical trials and results in the clinic may not be reproduced in human trials.

● Thereis a high degree of failure for product candidates as they progress through clinical trials and clinical trial data may beinterpreted in varying ways which may delay, limit or prevent future regulatory approvals.

● Thedevelopment of pharmaceutical products carries significant risk of failure in early and late stage development programs.

● Weanticipate that we will continue to incur significant losses for the foreseeable future.

● We will need to spend extensively on further research activities and there can be no guarantee that we will have access to sufficient funds to fully realize our research and development plan or to commercialize any products derived from research activities.

● Even if we successfully develop a product which shows efficacy in human subjects there remain high barriers to commercial success.

● We face significant competition from pharmaceutical companies. We have competitors internationally, including major multinational pharmaceutical companies, universities and research institutions. In respect of OK-101 as an indication for the treatment of DED, there are a number of established companies engaged in the development and marketing of preparations addressing the DED market. In addition, there are a wide range of products addressing the DED market currently approved and marketed by a number of large and small pharmaceutical companies.

●The expiration of certain intellectual property rights or an inability to obtain, maintain or enforce adequate intellectual property rights for products that are marketed or in development may result in additional competition from other third-party products. Third parties may have blocking intellectual property rights which could prevent the sale of products by us or require that compensation be paid to such third parties.

● Our product candidates could infringe patents and other intellectual property rights of third parties.

● COVID-19 has adversely affected our business, and any new pandemic, epidemic or outbreak of an infectious disease may further adversely affect our business.

● The relationship of the UK with the EU could impact our ability to operate efficiently in certain jurisdictions or in certain markets.

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

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

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

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

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

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

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

● We do not know whether an active, liquid and orderly trading market will develop for our ADSs or what the market price of our ADSs will be. As a result, it may be difficult for ADS holders to sell their ADSs.

● If you purchase ADSs in this offering, you will suffer immediate dilution of your investment.

● Holders of our ADSs may experience substantial dilution upon the exercise of outstanding options and warrants.

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

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

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

CorporateInformation

Wewere originally incorporated in the British Virgin Islands as a British Virgin Islands Business Company on July 4, 2007 under the BVIBusiness Companies Act 2004 with company number 1415559 under the name Jellon Enterprises, Inc.. Our legal and commercial name was changedto Minor Metals & Mining, Inc. on October 24, 2007, to Emerging Metals Limited on November 28, 2007, to West African Minerals Corporationon December 9, 2011, and to OKYO Pharma Corporation on January 10, 2018. On March 9, 2018, shareholders approved the cancellation ofour AIM listing and migration to Guernsey. On July 3, 2018, following the approval of the Guernsey Companies Registry, we were registeredunder the Guernsey Companies Law under the name OKYO Pharma Limited, as a Guernsey company with limited liability, an indefinite lifeand company number 65220. We are domiciled in Guernsey. On July 17, 2018, our Ordinary Shares were admitted to listing on the standardsegment of the Official List of the FCA and admitted to trading on the Main Market of the London Stock Exchange. We are subject to theTakeover Code.

Ourregistered office is located at Martello Court, Admiral Park, St. Peter Port, Guernsey GY1 3HB and our telephone number is +44 (0) 207495 2379. Our website address is www.okyopharma.com. The reference to our website is an inactive textual reference only and the informationcontained in, or that can be accessed through, our website is not a part of this registration statement. Our agent for service of processin the United States is OKYO Pharma US, Inc.

“OKYO,”the OKYO logo and other trademarks or service marks of OKYO Pharma Limited appearing in this prospectus are the property of OKYO or oursubsidiary. This prospectus contains additional trade names, trademarks and service marks of others, which are the property of theirrespective owners. Solely for convenience, trademarks and trade names referred to in this prospectus may appear without the ® or^TM symbols.

Implicationsof Being an Emerging Growth Company

Weare an EGC as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. As such, we may take advantage of certainexemptions from various reporting requirements that are applicable to other publicly traded entities that are not EGCs. These exemptionsinclude:

Section107 of the JOBS Act also provides that an EGC can take advantage of the extended transition period provided in Section 13(a) of the ExchangeAct, for complying with new or revised accounting standards. As a result, an EGC can delay the adoption of certain accounting standardsuntil those standards would otherwise apply to private companies.

Wewill remain an EGC until the earliest of: (1) the last day of the first fiscal year in which our annual gross revenues exceed $1.07 billion;(2) the last day of 2023; (3) the date that we become a “large accelerated filer” as defined in Rule 12b-2 under the ExchangeAct, which would occur on the last day of any fiscal year that the aggregate worldwide market value of our common equity held by non-affiliatesexceeds $700 million as of the last business day of our most recently completed second fiscal quarter; or (4) the date on which we haveissued more than $1.0 billion in non-convertible debt securities during any three-year period.

Implicationsof Being a Foreign Private Issuer

Wecurrently report under the Exchange Act as a non-U.S.company with FPI status. Even after we no longer qualify as an EGC, as long as we qualify as an FPI under the Exchange Act we will beexempt from certain provisions of the Exchange Act that are applicable to U.S. domestic public companies, including:

FPIsare also exempt from certain more stringent executive compensation disclosure rules. Thus, even if we no longer qualify as an EGC, butremain an FPI, we will continue to be exempt from the more stringent compensation disclosures required of companies that are neitheran EGC nor an FPI.

TheOffering

(1)The number of ordinary shares to be outstanding after this offering is based on 1,415,040,468 ordinary shares outstanding as of November30, 2022, and excludes:

SummaryConsolidated Financial Data

Thefollowing tables set forth our summary consolidated financial data for the periods indicated. We have derived the consolidated statementof operations data for the years ended March 31, 2022, 2021 and 2020 and the consolidated balance sheet data as of March31, 2022 from our audited consolidated financial statements included elsewhere in this prospectus. Our historical results are not necessarilyindicative of the results that should be expected for any future period. You should read the following summary consolidated financialdata together with the audited consolidated financial statements included elsewhere in this prospectus and the sections titled “ExchangeRate Information” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.”

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

ConsolidatedStatement of Operations and Comprehensive Loss Data:

ConsolidatedBalance Sheet Data:

(1) As adjusted to give effect to the sale by us of 4,484,305 ADSs (representing 291,479,825 ordinary shares) at an assumed public offering price of $2.23 per ADS in this offering, which reflects the closing trade price on Nasdaq on December 2, 2022 after deducting the underwriting discounts and commissions and estimated offering expenses payable by us in connection with this offering.

RISKFACTORS

Youshould carefully consider the risks described below, together with all of the other information in this registration statement. The risksand uncertainties below are not the only ones we face. Additional risks and uncertainties not presently known to us or that we believeto be immaterial may also adversely affect our business. If any of the following risks occur, our business, financial condition and resultsof operations could be seriously harmed and potential future investors in our ADSs could lose all or part of their investment. Further,if we fail to meet the expectations of the public market in any given period, the potential market price of our ADSs could decline. Weoperate in a highly competitive environment that involves significant risks and uncertainties, some of which are outside of our control.If any of these risks actually occurs, our business and financial condition could suffer and the potential market price of our ADSs coulddecline.

RisksRelating to Our Business

Wehave only recently committed to our new business and our product candidates are in the early stages of development and it may be someyears until we generate revenue, if at all.

Ourproduct candidates, OK-101 and OK-201, are both very early in the development stage and even the lead product candidate, OK-101, is stillin the pre-clinical stage. Through our scientific collaborators, we have only recently completed initial pre-clinical studies with respectto OK-101 and OK-201 and our ability to generate product revenue, which is not expected to occur for several years, if ever, will dependheavily on the successful development of the product candidates, many stages of clinical trials, regulatory approval and eventual commercialization.We have only recently committed to our new business operating as a life sciences and biotechnology business. We currently generate norevenue from sales of any product and may never be able to develop or commercialize a marketable product.

Ourproduct candidates have not been evaluated in clinical trials and results in the clinic may not be reproduced in human trials.

Theearly stages of our business strategy carry significant risks associated with product candidates which have not been evaluated in humanclinical trials. Not only may encouraging results seen in pre-clinical trials not be indicative of results in later clinical trials butgiven that the product candidates have only been evaluated in mouse models to date, unexpected or adverse effects may be seen once theproduct candidates enter the human clinical trials stage which in turn may create significant hurdles to further development or leadto the abandonment of further development.

Thereis a high degree of failure for product candidates as they progress through clinical trials and clinical trial data may be interpretedin varying ways which may delay, limit or prevent future regulatory approvals.

Manycompanies in the life sciences and biotechnology sector have made significant initial progress only to suffer significant setbacks inlater stage clinical trials and there is a high failure rate for product candidates as they proceed through clinical trials. Data obtainedfrom pre-clinical and clinical activities is subject to varying interpretations which may delay, limit or prevent applications for regulatoryapprovals.

Thedevelopment of pharmaceutical products carries significant risk of failure in early and late stage development programs.

Thedevelopment of pharmaceutical products is inherently uncertain, even in late-stage product development programs. There is a high failurerate in the development of pharmaceutical products and there is a substantial risk of adverse, undesirable, unintended or inconclusiveresults from testing or pre-clinical or clinical trials, which may substantially delay, or halt entirely, or make uneconomic, any furtherdevelopment of our products and may prevent or limit the commercial use of such products.

Whilethe pre-clinical development of OK-101 and initial studies in animal models have been encouraging, the scope of these studies is limited,and significant risks exist that OK-101 may never progress to a commercially viable product. Laboratory studies in animal models carrythe risk that similar results may not be seen or reproduced in future tests and trials, and there can be no guarantee that a successfultest in a mouse or other animal model will be capable of being reproduced in a human clinical trial. Small scale trials and the resultsthereof, can be misleading as to efficacy, safety and other findings, as the outcome may be influenced by laboratory or demographic factorsand not due to the chemistry or biological effect of the drug candidate being evaluated. Larger scale trials often fail to produce thesame positive results seen in small scale trials for a variety of reasons and clinical trials in humans frequently fail to reproduceefficacy seen in animal trials in the laboratory. Failure can often result after significant sums have been expended on research andoften where initial trial results (both in animals and in humans) have shown very encouraging results.

Managementinitially intends to conduct laboratory and pre-clinical trials to establish safety and efficacy of our products. Due to the inherentrisks involved in developing pharmaceutical products, there is a risk that some or all of our products will not ultimately be successfullydeveloped or launched. In addition, the planned clinical trials may fail to show the desired safety and efficacy. This may be the caseeven if the FDA approves an IND application as positive data in animal studies may not be reflected or reproduced in human trials. Successfulcompletion of one stage of development of a pharmaceutical product does not ensure that subsequent stages of development will be successful.Our inability to market any of our products currently under development would adversely affect our business and financial condition.

Weare currently primarily dependent for our short to medium-term success on a single early-stage product, OK-101, which is a research productthat has shown pre-clinical potential but has not yet been tested on humans and has not obtained the necessary approvals required toconduct Phase I clinical trials in humans.

Anycommercial development of OK-101 is highly dependent on a number of factors, including:

Ifany of these milestones are not met, our business, financial condition, prospects and results of operations could be materially adverselyaffected.

RisksRelated to Our Financial Position and Need for Capital.

Wewill need to raise substantial additional capital to develop and commercialize our product candidates and our failure to obtain fundingwhen needed may force us to delay, reduce or eliminate our product development programs or collaboration efforts.

Asof March 31, 2022, our cash and cash equivalents balance was approximately $2.7 million and our working capital was approximately $2.9million. Due to our recurring losses from operations and the expectation that we will continue to incur losses in the future, we willbe required to raise additional capital to complete the development and commercialization of our current product candidates. We havehistorically relied upon private and public sales of our equity, as well as debt financings to fund our operations. In order to raiseadditional capital, we may seek to sell additional equity and/or debt securities or obtain a credit facility or other loan, which wemay not be able to do on favorable terms, or at all. Our ability to obtain additional financing will be subject to a number of factors,including market conditions, our operating performance and investor sentiment. If we are unable to raise additional capital when requiredor on acceptable terms, we may have to significantly delay, scale back or discontinue the development and/or commercialization of ourproduct candidate, restrict our operations or obtain funds by entering into agreements on unfavorable terms. Failure to obtain additionalcapital at acceptable terms would result in a material and adverse impact on our operations.

Ourindependent registered public accounting firm has expressed substantial doubt about our ability to continue as a going concern, whichmay hinder our ability to obtain future financing.

MazarsLLP, our independent registered public accounting firm for the fiscal year ended March 31, 2022, has included an explanatory paragraphin their opinion that accompanies our audited consolidated financial statements as of and for the year ended March 31, 2022, indicatingthat liquidity position post November 2022 raises substantial doubt about our ability to continue as a going concern. If we are unableto improve our liquidity position by December 2022, we may not be able to continue as a going concern. The accompanying consolidatedfinancial statements do not include any adjustments that might result if we are unable to continue as a going concern and, therefore,be required to realize our assets and discharge our liabilities other than in the normal course of business which could cause investorsto suffer the loss of all or a substantial portion of their investment.

Weanticipate that we will continue to incur significant losses for the foreseeable future.

Theamount of our future net losses will depend, in part, on the rate of our future expenditures, including further research and developmentactivity. The amount of net losses will also depend on our success in developing and commercializing OK-101 and other products that generatesignificant revenue. Any failure by us to become and remain profitable could depress the value of the ADSs and could impair our abilityto expand our business, maintain our research and development efforts, diversify our product offerings or continue our operations.

Wewill need to spend extensively on further research activities and there can be no guarantee that we will have access to sufficient fundsto fully realize our research and development plan or to commercialize any products derived from research activities.

Weexpect to incur further significant expenses in connection with our ongoing research and development activities in relation to our productsin development, including the future funding of clinical studies, registration, manufacturing, marketing, sales and distribution. Tofinance fully our strategy, we may require more capital than is available from our existing cash balances.

Accessto adequate additional financing, whether through debt financing, an equity capital raise or a suitable partnering transaction may notbe available to us on acceptable terms, or at all. Further, while the potential economic impact brought by, and the duration of the COVID-19pandemic is difficult to assess or predict, the impact of the COVID-19 pandemic on the global financial markets may reduce our abilityto access capital, which could negatively impact our short-term and long-term liquidity. If we are unable to raise capital, we couldbe forced to delay, reduce or eliminate our research and development programs or commercialization efforts. Any additional equity fundraisingmay be dilutive for our shareholders.

Anyof these events could have a material adverse effect on our business financial condition, prospects and results of operation and maylead us to delay, reduce or abandon research and development programs or commercialization of some of our products.

RisksRelated to Commercialization of Our Product Candidates

Evenif we successfully develop a product which shows efficacy in human subjects there remain high barriers to commercial success

Evenif we were to receive regulatory approval for OK-101 or any other products, we may be unable to commercialize them.

Thereare a number of factors that may inhibit our efforts to commercialize OK-101 or any other products on our own, including:

Whilewe may only seek to enter into arrangements with third parties to perform sales and marketing services in non-core territories, any sucharrangements could result in our product revenues (or the profitability of such product revenues) being lower than if we were to marketand sell the products itself. In addition, we may not be successful in entering into arrangements with third parties to sell and marketour products or may be unable to do so on terms that are favorable to us. Acceptable third parties may fail to devote the necessary resourcesand attention to sell and market our products effectively. If we do not establish sales and marketing capabilities successfully, eitheron our own or in collaboration with third parties, we will not be successful in commercializing our products, which in turn would havea material adverse effect on our business, prospects, financial condition and results of operations.

Wehave also invested and will continue to invest resources into the development of other products, such as OK-201. Even where these productsare successfully developed and marketing approval is secured from relevant regulatory authorities, these products might not achieve commercialsuccess. Factors which could limit commercial success of a product include but are not limited to:

Ifany of the foregoing were to occur, it could materially and adversely affect our business, financial condition, prospects and resultsof operations.

Weface significant competition from pharmaceutical companies. We have competitors internationally, including major multinational pharmaceuticalcompanies, universities and research institutions. In respect of OK-101 as an indication for the treatment of DED, there are a numberof established companies engaged in the development and marketing of preparations addressing the DED market. In addition, there are awide range of products addressing the DED market currently approved and marketed by a number of large and small pharmaceutical companies

Manyof our competitors have substantially greater financial, technical and other resources, such as larger research and development teams,proven marketing and manufacturing organizations and well-established sales forces. Our competitors may succeed in developing, acquiringor licensing drug products that are more effective or less costly than products which we are currently developing or which it may develop.

Establishedpharmaceutical companies may invest heavily to accelerate the discovery and development of products that could make our products lesscompetitive. In addition, any new product that competes with an approved product must demonstrate compelling advantages in efficacy,convenience, tolerability or safety in order to overcome price competition and to be commercially successful. Accordingly, our competitorsmay succeed in obtaining patent protection, receiving approval from the FDA, the European Medicines Agency, or EMA, or that of anotherrelevant regulatory authority or discovering, developing and commercializing pharmaceutical products before we do, which would have amaterial adverse effect on our business.

Theavailability and price of our competitors’ products could limit the demand, and the price we are able to charge, for any of ourproducts, if approved for sale. We will not achieve our business plan if acceptance is inhibited by price competition or the reluctanceof physicians to switch from existing drug products to our products, or if physicians switch to other new drug products or choose toreserve our products for use in limited circumstances. Competition from lower-cost generic pharmaceuticals may also result in significantreductions in sales volumes or prices for our products, which could materially adversely affect our business, prospects, financial conditionand results of operations.

Weare dependent on third party supply, development and manufacturing and clinical service relationships and on single manufacturing sitesfor certain products. Our business strategy utilizes the expertise and resources of third parties in a number of areas, including theconduct of clinical trials, other product development, manufacture and the protection of our intellectual property rights in variousgeographical locations. This strategy creates risks for us by placing critical aspects of our business in the hands of third partieswhom we may not be able to manage or control adequately and who may not always act in our best interests.

Wherewe are dependent upon third parties for the development or manufacture of certain products, our ability to procure our development ormanufacture in a manner which complies with regulatory requirements may be constrained, and our ability to develop and deliver such materialon a timely and competitive basis may be materially adversely affected, which may impact revenues.

Regulatoryrequirements for pharmaceutical products tend to make the substitution of suppliers and contractors costly and time-consuming. Alternativesuppliers may not be able to manufacture products effectively or obtain the necessary manufacturing licenses from relevant regulatoryauthorities. The unavailability of adequate commercial quantities, the inability to develop alternative sources, a reduction or interruptionin supply of contracted services, or a significant increase in the price of materials and services, could have a material adverse effecton our ability to manufacture and market our products or to fulfill orders from our distributors or licensees, which in turn would havea material adverse impact on our cash flows.

Insurancecoverage and reimbursement may be limited, unavailable or may be reduced over time in certain market segments for our products.

Governmentauthorities and third-party payers, such as private health insurers, decide which pharmaceutical products they will cover and the amountof reimbursement. Reimbursement may depend upon a number of factors, including the payer’s determination that use of a productis:

Obtainingcoverage and reimbursement approval for a product from a government or other third- party payer is a time-consuming and costly processthat could require us to provide supporting scientific, clinical and cost-effectiveness data for the use of our products.

Wemay not be able to provide data sufficient to gain acceptance with respect to coverage and reimbursement, or to demonstrate commercialvalue compared to existing established treatments. Even if we are able to furnish the requested data, there is no guarantee that a third-partypayor will cover a product. If reimbursement of our products is unavailable or limited in scope or amount, or if pricing is set at unsatisfactorylevels, we may be unable to achieve or sustain profitability.

Wemay, in the future, seek approval to market our products in the EU, the US and in selected other jurisdictions. In the EU, the pricingof prescription pharmaceuticals is subject to national governmental control and pricing negotiations with governmental authorities can,in some circumstances, take several years after obtaining marketing approval for a product. In addition, market acceptance and salesof our products will depend significantly on the availability of adequate coverage and reimbursement from third-party payers and maybe affected by existing and future healthcare reform measures.

Thecontinuing efforts of governments, insurance companies, managed care organizations and other payers of healthcare services to containor reduce costs of healthcare and/or impose price controls may materially adversely affect our ability to set prices for our products,generate revenues and achieve or maintain profitability. Any reduction in government reimbursement programs may result in a similar reductionin payments from private payers, which may materially adversely affect our business, prospects, financial condition and results of operations.

RisksRelated to Our Intellectual Property

Theexpiration of certain intellectual property rights or an inability to obtain, maintain or enforce adequate intellectual property rightsfor products that are marketed or in development may result in additional competition from other third-party products. Third partiesmay have blocking intellectual property rights which could prevent the sale of products by us or require that compensation be paid tosuch third parties

Theextent of our success will, to a significant degree, depend on our ability to establish, maintain, defend and enforce adequate intellectualproperty rights and to operate without infringing the proprietary or intellectual property rights of third parties. We have been granted,or have in-licensed rights under, a number of key patent families for OK-101 (or other proprietary rights), and patent applications arepending in the U.S., the EU, and certain other jurisdictions. We may develop or acquire further technology or products that are not patentableor otherwise protectable. The strength of patents in the pharmaceutical field involves complex legal and scientific questions and canbe uncertain. Patents or other rights might not be granted under any pending or future applications filed or in-licensed by us and anyclaims allowed might not be sufficiently broad to protect our technologies and products from competition. Competitors may also successfullydesign around key patents held by us, thereby avoiding a claim of infringement. There is a risk that not all relevant prior art has beenidentified with respect to any particular patent or patent application and the existence of such prior art may invalidate any patentsgranted (or result in a patent application not proceeding to grant). Patents or other registerable rights might also be revoked for otherreasons after grant. Third parties may challenge the validity, enforceability or scope of any granted patents. Our defense of our proprietaryrights could involve substantial costs (even if successful) and could result in declarations of invalidity or significantly narrow thescope of those rights, limiting their value.

Competitorsmay have filed applications or been granted patents, or obtained additional patents and proprietary rights, which relate to and couldbe infringed by our products. An adverse outcome with respect to third party rights such as claims of infringement of patents or third-partyproprietary rights by us could subject us to significant liabilities or require us to obtain a license for the continued use of the affectedrights, which may not be available on acceptable terms or at all, or require us to cease commercialization and development efforts, orthe sale of the relevant products, in whole or in part in the relevant jurisdictions.

Wecould be subject to claims for compensation by third parties claiming an ownership interest in the intellectual property rights relatingto a commercially successful product. This may include claims from employee inventors in territories which permit such claims even wherewe own the intellectual property rights in question. Any such failure to defend our proprietary intellectual property could have a materialadverse effect on our business, prospects, financial condition and results of operations.

Wemay not be able to obtain, maintain, defend or enforce the intellectual property rights covering our products

Todate, we have had certain patents licensed to us in jurisdictions we consider to be important to our business. However, we cannot predict:

Whilewe believe that we have novel composition of matter on the OK-101 peptide and novel methods of its use in treating DED, we cannot besure that these patent applications will issue as patents. Each patent office has different patentability requirements, but we believethat the license patent applications contain patentable subject matter. The process for issuance of a patent involves correspondencewith each local patent office in the jurisdictions in which the patent application is filed. That process, patent prosecution, involvesa discussion of any relevant prior art and typically a discussion of the scope of the claims. The patent prosecution process can takeseveral years depending on the jurisdiction and is not in the control of the patent owner, but in the control of the local patent office.We cannot be sure the outcome of the patent prosecution will be successful and result in issued patents.

Patentprotection is of importance to us in maintaining our competitive position in our planned product lines and a failure to obtain or retainadequate protection could have a material adverse effect on our business, prospects, financial condition and results of operations.

Wemay not be able to prevent disclosure of our trade secrets, know-how or other proprietary information.

Werely on trade secret protection to protect our interests in proprietary know-how and in processes for which patents are difficult toobtain or enforce. If we are unable to protect our trade secrets adequately the value of our technology and products could be significantlydiminished. Furthermore, our employees, consultants, contract personnel or third-party partners, either accidentally or through willfulmisconduct, may cause serious damage to our programs and/or our strategy by disclosing confidential information to third parties. Itis also possible that confidential information could be obtained by third parties as a result of breaches of our physical or electronicsecurity systems. Any disclosure of confidential data into the public domain or to third parties could allow third parties to accessconfidential information and use it in competition with us. In addition, others may independently discover the confidential information.Any action to enforce our rights against any misappropriation or unauthorized use and/or disclosure of confidential information is likelyto be time-consuming and expensive, and may ultimately be unsuccessful, or may result in a remedy that is not commercially valuable.Any such loss of confidential information or failure to enforce our rights in relation to such confidential information, or unsatisfactoryoutcome of any related litigation could have a material adverse effect on our business, prospects, financial condition or results ofoperation.

Ourproduct candidates could infringe patents and other intellectual property rights of third parties.

Ourcommercial success depends upon our ability, and the ability of any third party with which we may partner to develop, manufacture, marketand sell our products and use our patent- protected technologies without infringing the patents of third parties.

Ourproducts may infringe or may be alleged to infringe existing patents or patents that may be granted in the future which may result incostly litigation and could result in our having to pay substantial damages or limit our ability to commercialize our products.

Becausesome patent applications in Europe, the U.S. and many foreign jurisdictions may be maintained in secrecy until the patents are issued,patent applications in such jurisdictions are typically not published until 18 months after filing, and publications in the scientificliterature often lag behind actual discoveries. Accordingly, we cannot be certain that others have not filed patents that may cover ourtechnologies, our products or the use of our products. Additionally, pending patent applications which have been published can, subjectto certain limitations, be later amended in a manner that could cover our technologies, our products or the use of our products. As aresult, we may become party to, or threatened with, future adversarial proceedings or litigation regarding patents with respect to ourproducts and technology.

Ifwe are sued for patent infringement, we would need to demonstrate that our products or methods either do not infringe the patent claimsof the relevant patent or that the patent claims are invalid, and we may not be able to do this. If we are found to infringe a thirdparty’s patent, we could be required to obtain a license from such third party to continue developing and marketing our productsand technology or we may elect to enter into such a license in order to settle litigation or in order to resolve disputes prior to litigation.However, we may not be able to obtain any required license on commercially reasonable terms or at all. Even if we are able to obtaina license, it could be non- exclusive, thereby giving our competitors access to the same technologies that are licensed to us and couldrequire us to make substantial royalty payments. We could also be forced, including by court order, to cease commercializing the infringingtechnology or products. A finding of infringement could prevent us from commercializing our products or force us to cease some of ourbusiness operations, which could materially harm our business. Claims that we have misappropriated the confidential information or tradesecrets of third parties could have a similarly negative impact on our business.

Anysuch claims are likely to be expensive to defend, and some of our competitors may be able to sustain the costs of complex patent litigationmore effectively than us can because they have substantially greater resources. Moreover, even if we are successful in defending anyinfringement proceedings, we may incur substantial costs and divert management’s time and attention in doing so, which could materiallyadversely affect our business, prospects, results of operations or financial condition.

RisksRelated to Our Operations

Risksrelating to managing growth, employee matters and other risks relating to our business

Growthmay place significant demands on our management and resources. We expect to experience growth in the number of our employees and thescope of our operations in connection with the continued development and, in due course, the potential commercialization of our products.

Thispotential growth will place a significant strain on our management and operations, and we may have difficulty managing this future potentialgrowth.

Weare highly dependent on our current executive officers and their services are critical to the successful implementation of our productdevelopment and regulatory strategies. While suitable contracts of employment are in place including six to 12 months’ notice periodsfor all executive officers, they may give notice to terminate their employment with us at any time. The loss of the services of any ofour executive officers and our inability to find suitable replacements could harm our business, prospects, financial condition, resultsof operations and ability to achieve the successful development or commercialization of our products.

Challengesin identifying and retaining key personnel could impair our ability to conduct and grow our operations effectively. Our ability to competein the highly competitive pharmaceutical industry depends upon our ability to attract and retain highly qualified management and salesteams. We are intending to recruit our own commercial team and expand our existing central infrastructure team. Many of the other pharmaceuticalcompanies and academic institutions that we compete against for qualified personnel have greater financial and other resources, differentrisk profiles and a longer history in the industry than we do. We might not be able to attract or retain these key persons on conditionsthat are economically acceptable. Our inability to attract and retain these key persons could have a material adverse effect on our business,prospects, financial conditions and results of operation.

COVID-19has adversely affected our business, and any new pandemic, epidemic or outbreak of an infectious disease may further adversely affectour business.

InDecember 2019, a novel strain of coronavirus, COVID-19, spread globally, substantially impacting the global economy and our operations,including interrupting preclinical and clinical trial activities and disrupting our supply chain. The spread of an infectious disease,including COVID-19, may also result in the inability of our suppliers to source or deliver components or raw materials necessary forour clinical supply on a timely basis or at all. In addition, hospitals may reduce staffing and reduce or postpone certain treatmentsin 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 our clinical trials, any of which could materially affect our business,financial condition and results of operations. The extent to which COVID-19 impacts our 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 coronavirusand the actions to contain the coronavirus or treat its impact, among others. A significant pandemic as with COVID-19, or any other infectiousdisease, could result in a widespread health crisis that could adversely affect the economies and financial markets worldwide, resultingin an economic downturn that could impact our business, financial condition and results of operations.

Wemay become subject to product liability claims.

Weface an inherent risk of product liability and associated adverse publicity as a result of the clinical testing of our products and salesof our products once marketing approval is received from relevant regulatory authorities.

Criminalor civil proceedings might be filed against us any by study subjects, patients, relevant regulatory authorities, pharmaceutical companies,and any other third party using or marketing our products. Any such product liability claims may include allegations of defects in manufacturingor design, negligence, strict liability, a breach of warranties and a failure to warn of dangers inherent in the product.

Ifwe cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limitcommercialization of our products, if approved. Even if we successfully defend ourselves against such product liability claims it couldrequire significant financial and management resources. Regardless of the merits or eventual outcome, product liability claims may resultin:

Althoughwe will maintain levels of insurance customary for our sector to cover our current and future business operations, any claim that maybe brought against us could result in a court judgment or settlement in an amount that is not covered, in whole or in part, by our insuranceor that is in excess of the limits of our insurance coverage. Our insurance policies also have various exclusions, and we may be subjectto a product liability claim for which we have no coverage. In such cases, we would have to pay any amounts awarded by a court or negotiatedin a settlement that exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain,sufficient capital to pay such amounts.

Ifwe or our partners, licensees and subcontractors were unable to obtain and maintain appropriate insurance coverage at an acceptable cost,or to protect ourselves in any way against actions for damages, this would seriously affect the marketing of our products and, more generally,be detrimental to our business, prospects, results of operations or financial condition.

Ouremployees, contractors, consultants and commercial partners may engage in misconduct or other improper activities, including non-compliancewith regulatory standards.

Weare exposed to the risk of employees, independent contractors, principal investigators, consultants, commercial partners or vendors engagingin fraud or other misconduct. Misconduct could include intentional failures to comply with FDA or EMA regulations or those of other relevantregulatory authorities, to provide accurate information to the FDA, EMA or other relevant regulatory authorities, or to comply with manufacturingstandards we have established.

Inparticular, sales, marketing and business arrangements in the life sciences and biotechnology sector are subject to extensive laws andregulations intended to prevent fraud, misconduct, bribery and other abusive practices. These laws and regulations may restrict or prohibita wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements.

Employeemisconduct could also involve the improper use of information obtained in the course of clinical studies, which could result in regulatorysanctions and serious harm to our reputation. It is not always possible to identify and deter employee misconduct, and the precautionswe take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protectingus from governmental or relevant regulatory authority investigations or other actions or lawsuits stemming from a failure to be in compliancewith such laws or regulations. If any such actions are instituted against us, and we are not successful in defending ourself or assertingour rights, those actions could have a significant impact on our business, including the imposition of significant fines or other sanctions,and our reputation.

Wemay be vulnerable to disruptions of information technology systems or breaches of data security. We are dependent on information technologysystems and infrastructure to operate our business. In the ordinary course of our business, we collect, store and transmit confidentialinformation, including intellectual property, proprietary business information and personal information. It is important that we do soin a secure manner to maintain confidentiality and integrity of such confidential information. Any failure to do so could adversely affectour business, prospects, results of operation or financial condition.

Therelationship of the UK with the EU could impact our ability to operate efficiently in certain jurisdictions or in certain markets.

TheUK formally exited the EU on January 31, 2020, which is commonly known as Brexit. Under the terms of its departure, the UK entered atransition period during which it continued to follow all EU rules until December 31, 2020, or the Transition Period. On December 30,2020, the UK and EU signed the Trade and Cooperation Agreement, which includes an agreement on free trade between the two parties.

Thereis considerable uncertainty resulting from a lack of precedent and the complexity of the UK and EU’s intertwined legal regimesas to how Brexit (following the Transition Period) will impact the medical devices industry in Europe. Since a significant proportionof the regulatory framework in the UK applicable to our business and product candidates is derived from EU directives and regulations,Brexit could materially impact the regulatory regime with respect to the development, manufacture, importation, approval and commercializationof our product candidates in the UK or the EU. The impact will largely depend on the model and means by which the UK’s relationshipwith the EU is governed post-Brexit and the extent to which the UK chooses to diverge from the EU regulatory framework. For example,following the Transition Period, the UK will no longer be covered by the centralized procedures for obtaining EU-wide marketing authorizationsand our product candidates will therefore require a separate marketing authorization for such products to be marketed in the UK. It isalso unclear as to whether the relevant authorities in the EU and the UK are adequately prepared for the additional administrative burdencaused by Brexit. Any delay in obtaining, or an inability to obtain, any marketing approvals, as a result of Brexit or otherwise, wouldprevent us from, or delay commercialization of, product candidates in the UK and/or the EEA and restrict our ability to generate revenueand achieve and sustain profitability.

Ifany of these outcomes occur, we may be forced to restrict or delay efforts to seek regulatory approval in the UK for its product candidates,which could significantly and materially harm our business. There is a degree of uncertainty regarding the overall impact that Brexitwill have on process to obtain regulatory approval in the UK for product candidates.

Further,the UK’s withdrawal from the EU has resulted in the relocation of the EMA from the UK 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 UK Medicines and HealthcareProducts Regulatory Agency, including delays in granting clinical trial authorization or marketing authorization, disruption of importationand export of medical devices, active substance and other components of new drug formulations, and disruption of the supply chain forclinical trial product and final authorized formulations. The cumulative effects of the disruption to the regulatory framework may addconsiderably to the development lead time to marketing authorization and commercialization of product candidates in the EU and/or theUK. Brexit may also result in a reduction of funding to the EMA once the UK no longer makes financial contributions to EU institutions,such as the EMA. If funding to the EMA is so reduced, it could create delays in the EMA issuing regulatory approvals for our productcandidates and, accordingly, have a material adverse effect on our business, financial condition, results of operations or prospects.

RisksRelated to Government Regulation

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

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

TheFDA, EMA or other regulatory authorities also may approve a product candidate for more limited indications than requested or may imposesignificant limitations in the form of narrow indications, warnings or a risk evaluation and mitigation strategy, or REMS. These regulatoryauthorities may require precautions or contraindications with respect to conditions of use or may grant approval subject to the performanceof costly post-marketing clinical trials. In addition, the FDA, EMA or other regulatory authorities may not approve the labeling claimsthat are necessary or desirable for the successful commercialization of our product candidates. Any of the foregoing scenarios couldharm the commercial prospects for our product candidates and negatively impact our business, financial condition, results of operationsand prospects.

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

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

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

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

Ifour competitors are able to obtain orphan drug exclusivity for products that constitute the same drug and treat the same indicationsas our product candidates, we may not be able to have competing products approved by applicable regulatory authorities for a significantperiod of time. In addition, even if we obtain orphan drug exclusivity for any of our products, such exclusivity may not protect us fromcompetition.

Regulatoryauthorities in some jurisdictions, including the United States and the European Union, may designate products for relatively small patientpopulations as orphan drugs. Under the Orphan Drug Act of 1983, the FDA may designate a product candidate as an orphan drug if it isintended to treat a rare disease or condition, which is generally defined as having a patient population of fewer than 200,000 individualsin the United States, or a patient population greater than 200,000 in the United States where there is no reasonable expectation thatthe cost of developing the drug will be recovered from sales in the United States. In the United States, orphan drug designation entitlesa 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 developmentof products that are intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating conditionaffecting not more than five in 10,000 persons in the European Union. Additionally, orphan drug designation is granted for products intendedfor the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition and when, withoutincentives, it is unlikely that sales of the drug in the European Union would be sufficient to justify the necessary investment in developingthe drug or biologic product. In Europe, orphan drug designation entitles a party to a number of incentives, such as protocol assistanceand scientific advice specifically for designated orphan medicines, and potential fee reductions depending on the status of the sponsor.

Thedesignation 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 candidatesof other companies that treat the same indications as our product candidates prior to our product candidates receiving exclusive marketingapproval.

Generally,if a product candidate with an orphan drug designation receives the first marketing approval for the indication for which it has suchdesignation, the product is entitled to a period of marketing exclusivity, which precludes the FDA or the EMA from approving anothermarketing application for a product that constitutes the same drug treating the same indication for that marketing exclusivity period,except in limited circumstances. If another sponsor receives such approval before we do (regardless of our orphan drug designation),we will be precluded from receiving marketing approval for our product for the applicable exclusivity period. The applicable period isseven years in the United States and 10 years in the European Union. The exclusivity period in the European Union can be reduced to sixyears if a product no longer meets the criteria for orphan drug designation or if the product is sufficiently profitable so that marketexclusivity is no longer justified. Orphan drug exclusivity may be revoked if any regulatory agency determines that the request for designationwas materially defective or if the manufacturer is unable to assure sufficient quantity of the product to meet the needs of patientswith the rare disease or condition.

Evenif we obtain orphan drug exclusivity for a product candidate, that exclusivity may not effectively protect the product candidate fromcompetition 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 oris clinically superior in that it is shown to be safer, more effective or makes a major contribution to patient care. In the EuropeanUnion, marketing authorization may be granted to a similar medicinal product for the same orphan indication if:

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

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

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

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

Ifwe fail to comply with applicable regulatory requirements following approval of our product candidates, a regulatory or enforcement authoritymay:

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

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

Evenif we obtain and maintain approval for our product candidates in a major pharmaceutical market such as the United States, we may neverobtain approval for our product candidates in other major markets.

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

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

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

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

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

Thegranting of a conditional marketing authorization is restricted to situations in which only the clinical part of the application is notyet fully complete. Incomplete preclinical or quality data may only be accepted if duly justified and only in the case of a product intendedto be used in emergency situations in response to public health threats. Conditional marketing authorizations are valid for one year,on a renewable basis. The holder will be required to complete ongoing trials or to conduct new trials with a view to confirming thatthe benefit-risk balance is positive. In addition, specific obligations may be imposed in relation to the collection of pharmacovigilancedata.

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

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

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

Inthe United States, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, or the MMA, changed the way Medicare coversand pays for pharmaceutical products. The MMA expanded Medicare coverage for outpatient drug purchases by adding a new Medicare PartD 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 therapeuticclass in their formularies. The MMA’s cost reduction initiatives and other provisions could decrease the coverage and price thatwe receive for any approved products. While the MMA applies only to drug benefits for Medicare beneficiaries, private payors often followMedicare coverage policy and payment limitations in setting their own reimbursement rates. Therefore, any reduction in reimbursementthat results from the MMA may result in a similar reduction in payments from private payors. Similar regulations or reimbursement policiesmay be enacted in international markets, which could similarly impact our business.

InMarch 2010, the PPACA (as amended by the Health Care and Education Reconciliation Act of 2010) was passed, which substantially changesthe 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 RebateProgram are calculated for drugs that are inhaled, infused, instilled, implanted or injected; (ii) increases the minimum Medicaid rebatesowed by manufacturers under the Medicaid Drug Rebate Program and extends the rebate program to individuals enrolled in Medicaid managedcare organizations; (iii) establishes annual fees and taxes on manufacturers of certain branded prescription drugs; (iv) expands theavailability of lower pricing under the 340B drug pricing program by adding new entities to the program; and (v) establishes a new MedicarePart D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated prices ofapplicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatientdrugs to be covered under Medicare Part D. Additionally, in the United States, the Biologics Price Competition and Innovation Act of2009 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 approvedafter 12 years from the time of approval. This could expose us to potential competition by lower-cost biosimilars even if we commercializea product candidate faster than our competitors. Moreover, the creation of this abbreviated approval pathway does not preclude or delaya third party from pursuing approval of a competitive product candidate via the traditional approval pathway based on their own clinicaltrial data.

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

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

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

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

TheDepartment of Health and Human Services Office of Inspector General issued final regulations on November 30, 2020 to eliminate safe harborprotection under the anti-kickback statute for drug price reductions that pharmaceutical manufacturers pay to Medicare and Medicaid plansponsors and their pharmacy benefit managers. The proposal reflects a clear intent to substantially alter many of the current drug discountand services compensation practices among pharmaceutical manufacturers and Medicare and Medicaid managed care organizations and theirpharmacy benefit managers. The proposal also reflects a skepticism that current drug discount and compensation practices among manufacturersand pharmacy benefit managers are sufficiently transparent to health plans to ensure that all appropriate cost reductions and value ispassed through to health plans and reflected in lower health plans costs and lower premiums for beneficiaries. The Biden Administrationhas delayed the effective date of this rule until January 1, 2023, and a lawsuit initiated by the Pharmaceutical Care Management Administrationhas challenged this final rule. If the regulation becomes effective it could result in lower prices for pharmaceutical products in general.

TheCenters for Medicare and Medicaid Services issued an interim final rule on November 20, 2020 that would tie prices for certain drugsunder Medicare Part B to the lowest price for those drugs available in certain countries that are members of the Organization for EconomicCo-operation and Development. This “most favored nation” drug pricing rule is also the subject of lawsuits, and a federalcourt has placed an injunction on the implementation of the rule. This rule, if finalized, could also result in lower prices for pharmaceuticalproducts in general.

TheBiden Administration will have the opportunity to address these regulations as well as drug pricing, health care access, and other healthcare reform issues. Any further legislative or administrative action to reduce reimbursement or health benefits to beneficiaries underthe Medicare or Medicaid program could affect the payment we could collect from sale of any product in the United States.

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

Weare subject to stringent and changing privacy laws, regulations and standards as well as contractual obligations related to data privacyand security. Our actual or perceived failure to comply with such obligations could harm our reputation, subject us to significant finesand liability, or otherwise adversely affect our business

orprospects.

Weare subject to data privacy and protection laws, regulations, policies and contractual obligations that apply to the collection, transmission,storage, processing and use of personal information or personal data, which among other things, impose certain requirements relatingto the privacy, security and transmission of personal information.

Thelegislative and regulatory landscape for privacy and data protection continues to evolve in jurisdictions worldwide, and there has beenan increasing focus on privacy and data protection issues with the potential to affect our business. Failure to comply with laws, regulationsand other obligations governing personal information could result in enforcement actions against us, including fines, imprisonment ofcompany officials and public censure, processing penalties, claims for damages by affected individuals, damage to our reputation andloss of goodwill, any of which could have a material adverse effect on our business, financial condition, results of operations or prospects.

Theregulatory framework for the collection, use, retention, safeguarding, disclosure, sharing, transfer and other processing of personalinformation worldwide is rapidly evolving and is likely to remain uncertain for the foreseeable future. Globally, virtually every jurisdictionin which we operate has established its own data security and privacy frameworks with which we must comply. For example, the collection,use, disclosure, transfer or other processing of personal data regarding individuals in the European Union, including personal healthdata, is subject to the European Union General Data Protection Regulation (EU) 2016/679, or the GDPR, which took effect across all memberstates of the European Union, or EU, in May 2018 and similar legislation in the United Kingdom. The GDPR is wide-ranging in scope andimposes numerous requirements on companies that process personal data, including requirements relating to processing health and othersensitive data, obtaining consent of the individuals to whom the personal data relates, establishing a legal basis for processing, providinginformation to individuals regarding data processing activities, implementing safeguards to protect the security and confidentialityof personal data that requires the adoption of administrative, physical and technical safeguards, providing notification of data breachesto appropriate data protection authorities or data subjects, establishing means for data subjects to exercise rights in relation to theirpersonal data and taking certain measures when engaging third-party processors. The GDPR increases our obligations with respect to clinicaltrials conducted in the EU by expanding the definition of personal data to include coded data and requiring changes to informed consentpractices and more detailed notices for clinical trial subjects and investigators. In addition, the GDPR also imposes strict rules onthe transfer of personal data to countries outside the European Economic Area, or EEA, including the United States and, as a result,increases the scrutiny for transfers of personal data from clinical trial sites located in the EU to the United States. The United Kingdomand Switzerland have adopted similar restrictions.

Further,Brexit and ongoing developments in the United Kingdom have created uncertainty with regard to data protection regulation in the UnitedKingdom.

Privacyand data security requirements are also either in place or underway in the United States. There are a broad variety of data protectionlaws that may be applicable to our activities, and a range of enforcement agencies at both the state and federal levels that can reviewcompanies for privacy and data security concerns based on general consumer protection laws. The Federal Trade Commission and state attorneysgeneral can all be aggressive in reviewing privacy and data security protections for consumers. New laws also are being considered orhave been implemented at both the state and federal levels. For example, the California Consumer Privacy Act of 2018, or the CCPA, whichbecame effective on January 1, 2020, requires companies that process information on California residents to make new disclosures to consumersabout their data collection, use and sharing practices, provides such individuals with new data privacy rights (including the abilityto opt out of certain disclosures of personal information), imposes new operational requirements for covered businesses, provides a privateright of action for data breaches and creates a statutory damages framework. Virginia became the second state to adopt a comprehensiveprivacy legislation on March 2, 2021 with enactment of the Virginia Consumer Data Protection Act. Many other states are considering similarlegislation, and a broad range of legislative measures also have been introduced at the federal level. Although there are limited exemptionsfor clinical trial data under the CCPA, the CCPA and other similar laws could impact our business activities depending on how it is interpretedand exemplifies the vulnerability of our business to the evolving regulatory environment related to personal data.

Additionally,regulations promulgated pursuant to the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended, establishprivacy and security standards that limit the use and disclosure of individually identifiable health information, or protected healthinformation, and require the implementation of administrative, physical and technological safeguards to protect the privacy of protectedhealth information and ensure the confidentiality, integrity and availability of electronic protected health information. These provisionsmay be applicable to our business or that of our collaborators, service providers, contractors or consultants. Determining whether protectedhealth information has been handled in compliance with applicable privacy standards and our contractual obligations can be complex andmay be subject to changing interpretation. If we are unable to properly protect the privacy and security of protected health information,we could be found to have violated these privacy and security laws and/or breached certain contracts with our business partners (includingas a business associate). Further, if we fail to comply with applicable privacy laws, such as, to the extent applicable, HIPAA privacyand security standards, we could face significant civil and criminal penalties. In the United States, the Department of Health and HumanServices’ and state attorney’s general enforcement activity can result in financial liability and reputational harm, andresponses to such enforcement activity can consume significant internal resources. In addition, state attorneys general are authorizedto bring civil actions seeking either injunctions or damages in response to violations that threaten the privacy of state residents.We cannot be sure how these regulations will be interpreted, enforced or applied to our operations. In addition to the risks associatedwith enforcement activities and potential contractual liabilities, our ongoing efforts to comply with evolving laws and regulations atthe federal and state level may be costly and require ongoing modifications to our policies, procedures and systems.

Giventhe breadth and depth of changes in data protection obligations, preparing for and complying with the GDPR, CCPA and similar laws’requirements are rigorous and time-intensive and require significant resources and a review of our technologies, systems and practices,as well as those of any third-party collaborators, service providers, contractors or consultants that process or transfer personal data.Changes involving the GDPR, CCPA or other laws or regulations associated with the enhanced protection of certain types of sensitive data,such as healthcare data or other personal information from our clinical trials, could require us to change our business practices andput in place additional compliance mechanisms, may interrupt or delay our development, regulatory and commercialization activities andincrease our cost of doing business, and could expose us to government enforcement actions, regulatory investigations, private litigationand significant fines, penalties and remediation costs and could have a material adverse effect on our business, financial conditionor results of operations. Additionally, any failure by our third-party collaborators, service providers, contractors or consultants tocomply with applicable law, regulations or contractual obligations related to data privacy or security could result in proceedings againstus by governmental entities or others, fines, reputational harm and other liabilities.

Wemay publish privacy policies and other documentation regarding our collection, processing, use and disclosure of personal informationand/or other confidential information. Although we endeavor to comply with our published policies and other documentation, we may attimes fail to do so or may be perceived to have failed to do so. Moreover, despite our efforts, we may not be successful in achievingcompliance if our employees or vendors fail to comply with our published policies and documentation. Such failures can subject us topotential foreign, local, state and federal action if they are found to be deceptive, unfair, or misrepresentative of our actual practices.Moreover, subjects about whom we or our partners obtain information, as well as the providers who share this information with us, maycontractually limit our ability to use and disclose the information. Claims that we have violated individuals’ privacy rights orfailed to comply with data protection laws or applicable privacy notices even if we are not found liable, could be expensive and time-consumingto defend and could result in adverse publicity that could harm our business.

Itis possible that new and existing laws may be interpreted and applied in a manner that is inconsistent with our practices and our effortsto comply with the evolving data protection rules may be unsuccessful. If so, this could result in government-imposed fines, or penaltiesor orders requiring that we change our practices, which could adversely affect our business. We must devote significant resources tounderstanding and complying with this changing landscape. Failure to comply with federal, state and foreign laws regarding privacy andsecurity of personal information could expose us to government-imposed fines and penalties under such laws, penalties or orders requiringthat we change our practices, claims for damages or other liabilities, regulatory investigations and enforcement actions, litigationand significant costs for remediation, reputational harm, diminished profits and earnings, additional reporting requirements and/or oversight,any of which could adversely affect our business, our results of operations or prospects. We also face a threat of consumer class actionsrelated to these laws and the overall protection of personal data. Even if we are not determined to have violated these laws, governmentinvestigations into these issues typically require the expenditure of significant resources and generate negative publicity. Any of theforegoing could have a materially adverse effect on our reputation and our business, financial condition, results of operations or prospects.

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

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

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

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

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

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

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

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

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

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

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

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

Computersystem failures, cyber-attacks or deficiencies in our or related parties’ cyber security could result in a material disruptionof our product development programs, compromise sensitive information related to our business or trigger contractual and legal obligations,any of which could potentially expose us to liability or reputational harm or otherwise adversely affect our business and financial results.

Wehave implemented our security measures designed to protect the information (including but not limited to intellectual property, proprietarybusiness information and personal information) in our possession, custody or control. Our internal computer systems and those of currentand future third parties (such as vendors, CROs, collaborators or others) on which we rely may fail and are vulnerable to breakdown,breach, interruption or damage from computer viruses, computer hackers, malicious code, employee error or malfeasance, theft or misuse,denial-of-service attacks, sophisticated nation-state and nation-state-supported actors, unauthorized access, natural disasters, terrorism,war, telecommunication and electrical failures or other compromise. Despite our security practices, there is a risk that we may be subjectto phishing and other cyberattacks in the future. The risk of a security breach or disruption, particularly through cyber-attacks orcyber intrusion, including by computer hackers, foreign governments and cyber terrorists, has generally increased as the number, intensityand sophistication of attempted attacks and intrusions from around the world have increased.

Wemay not be able to anticipate all types of security threats, and we may not be able to implement preventive measures effective againstall such security threats. The techniques used by cyber criminals change frequently, may not be recognized until launched, and can originatefrom a wide variety of sources, including outside groups such as external service providers, organized crime affiliates, terrorist organizationsor hostile foreign governments or agencies. Our information technology and other internal infrastructure systems, including corporatefirewalls, servers, leased lines and connection to the Internet, face the risk of systemic failure that could disrupt our operations.If such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our developmentprograms and our business operations. For example, the loss of clinical trial data from completed or future clinical trials could resultin delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. Likewise, we relyon third parties for the manufacture of our product candidates or any future product candidates and to conduct clinical trials, and similarevents relating to their computer systems could also have a material adverse effect on our business.

Tothe extent that any disruption or security breach were to result in a loss of, or damage to, our data or applications, or inappropriateuse, disclosure of or access to confidential or proprietary information, we could incur liability, our competitive position could beharmed and the further development and commercialization of our product candidates or any future product candidates could be hinderedor delayed. If we were to experience a significant cybersecurity breach of our information systems or data, the costs associated withthe investigation, remediation and potential notification of the breach to counterparties, data subjects, regulators or others couldbe material. In addition, our remediation efforts may not be successful. Moreover, if the information technology systems of our vendors,CROs, collaborators or other contractors or consultants become subject to disruptions or security breaches, we may have insufficientrecourse against such third parties and we may have to expend significant resources to mitigate the impact of such an event, and to developand implement protections to prevent future events of this nature from occurring. If we do not allocate and effectively manage the resourcesnecessary to build and sustain the proper technology and cybersecurity infrastructure, we could suffer significant business disruption,including transaction errors, supply chain or manufacturing interruptions, processing inefficiencies, data loss or the loss of or damageto intellectual property or other proprietary information. Furthermore, any such event that leads to unauthorized access, use, or disclosureof personal information, including personal information regarding clinical trial participants or employees, could harm our reputation,compel us to comply with federal and/or state breach notification laws and foreign law equivalents, cause us to breach our contractualobligations, subject us to mandatory corrective action, and otherwise subject us to liability under laws, regulations and contracts thatprotect the privacy and security of personal information, which could result in significant legal and financial exposure and reputationaldamages. As cyber threats continue to evolve, we may be required to incur significant additional expenses in order to enhance our protectivemeasures or to remediate any information security vulnerability.

Thefinancial exposure from the events referenced above could either not be insured against or not be fully covered through any insurancethat we maintain. There can be no assurance that the limitations of liability in our contracts would be enforceable or adequate or wouldotherwise protect us from liabilities or damages as a result of the events referenced above.

Inaddition, in response to the ongoing COVID-19 pandemic, varying parts of our workforce are currently working remotely on a part- or full-timebasis. This could increase our cyber security risk, create data accessibility concerns, and make us more susceptible to communicationdisruptions. Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations orprospects.

RisksRelated to the Ownership of Our Securities

Holdersof our ADSs may experience substantial dilution upon the exercise of outstanding options, warrants and convertible loan notes.

As of November 30, 2022,there were 81,820,000 ordinary shares issuable upon the exercise of share options at exercise prices of between $0.054and $0.188 per ordinary share of which 24,375,000 ordinary shares are currently exercisable and 57,445,000 are exercisablebetween January 6, 2023 and January 31, 2032. In addition, there were 35,909,090 ordinary shares that currently may be issued upon theexercise of warrants to purchase ordinary shares at exercise prices of between $0.033 and $0.054 per ordinary share. Theexercise of such options and warrants will result in dilution of your investment. As a result of this dilution, you may receive significantlyless than the full purchase price you paid for our securities in the event of liquidation.

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

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

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

Weare incorporated under the laws of Guernsey. The rights of holders of ordinary shares and, therefore, certain of the rights of any potentialfuture holders of ADSs, are governed by the laws of Guernsey, including the provisions of the Guernsey Companies Law, and by our Memorandumand Articles of Incorporation, or Articles. These rights differ in certain respects from the rights of shareholders in typical U.S. corporations.See “Description of Share Capital and Memorandum and Articles of Incorporation —-Differences in Corporate Law” in thisreport for a description of the principal differences between the provisions of the Guernsey Companies Law applicable to us and, forexample, the Delaware General Corporation Law relating to stockholders’ rights and protections.

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

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

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

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

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

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

Weare entitled to rely on a provision in Nasdaq’s corporate governance rules that allows us to follow the laws of Guernsey and rulesapplicable to companies admitted to listing on the standard segment of the Official List of the FCA and to trading on the Main Marketof the London Stock Exchange, including, but not limited to, the Listing Rules and the Disclosure Guidance and Transparency Rules, orDTRs, of the FCA with regard to certain aspects of corporate governance. This allows us to follow certain corporate governance practicesthat differ in significant respects from the corporate governance requirements applicable to U.S. companies listed on Nasdaq.

Forexample, we have elected to rely on the exemption allowing us to follow the laws of Guernsey and rules applicable to companies admittedto listing on the standard segment of the Official List of the FCA and to trading on the Main Market of the London Stock Exchange insteadof Nasdaq regulations that require a listed U.S. company to (i) have a majority of the board of directors consist of independent directors,(ii) require non-management directors to meet on a regular basis without management present and (iii) promptly disclose any waivers ofthe code for directors or executive officers that should address certain specified items.

Inaccordance with our Nasdaq listing, our audit committee is required to comply with the provisions of Section 301 of the Sarbanes-OxleyAct and Rule 10A-3 of the Exchange Act, both of which are also applicable to Nasdaq-listed U.S. companies. Because we have elected torely on the exemption allowing us to follow the laws of Guernsey and rules applicable to companies admitted to listing on the standardsegment of the Official List of the FCA and to trading on the Main Market of the London Stock Exchange, however, our audit committeeis not subject to additional Nasdaq requirements applicable to listed U.S. companies, including an affirmative determination that allmembers of the audit committee are “independent,” using more stringent criteria than those applicable to us as an FPI. Furthermore,Nasdaq’s corporate governance rules require listed U.S. companies to, among other things, seek shareholder approval for the implementationof certain equity compensation plans and issuances of ordinary shares, however as an FPI, we may elect to follow the laws of Guernseyand rules applicable to companies admitted to listing on the Main Market of the London Stock Exchange in lieu of these Nasdaq requirements.

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

Asan FPI, we are not required to comply with all of the periodic disclosure and current reporting requirements of the Exchange Act applicableto U.S. domestic issuers. We may no longer be an FPI as early as September 30, 2023 (the end of our second fiscal quarter in the fiscalyear following this Nasdaq listing), which would require us to comply with all of the periodic disclosure and current reporting requirementsof the Exchange Act applicable to U.S. domestic issuers as of April 1, 2024. In order to maintain our current status as an FPI, either(a) a majority of our outstanding voting securities must be either directly or indirectly owned of record by non-residents of the UnitedStates or (b)(i) a majority of our executive officers or directors cannot be U.S. citizens or residents, (ii) more than 50% of our assetsmust be located outside the United States and (iii) our business must be administered principally outside the United States. If we loseour status as an FPI, we would be required to comply with the Exchange Act reporting and other requirements applicable to U.S. domesticissuers, which are more detailed and extensive than the requirements for FPIs. We may also be required to make changes in our corporategovernance practices in accordance with various SEC and Nasdaq rules. The regulatory and compliance costs to us under U.S. securitieslaws if we are required to comply with the reporting requirements applicable to a U.S. domestic issuer may be significantly higher thanthe cost we would incur as an FPI. As a result, we expect that a loss of FPI status would increase our legal and financial compliancecosts and is likely to make some activities highly time-consuming and costly. We also expect that if we were required to comply withthe rules and regulations applicable to U.S. domestic issuers, it would make it more difficult and expensive for us to obtain directorand officer liability insurance, and we may be required to accept reduced coverage or incur substantially higher costs to obtain coverage.These rules and regulations could also make it more difficult for us to attract and retain qualified members of our board of directors.

Weare an emerging growth company within the meaning of the Securities Act of 1933, or the Securities Act, and will take advantage of certainreduced reporting requirements.

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

Ifwe fail to establish and maintain proper internal controls, our ability to produce accurate financial statements or comply with applicableregulations could be impaired.

Section404(a) of the Sarbanes-Oxley Act, or Section 404(a), requires that beginning with our second annual report following our IPO, managementassess and report annually on the effectiveness of our internal control over financial reporting and identify any material weaknessesin our internal control over financial reporting. Although Section 404(b) of the Sarbanes-Oxley Act, or Section 404(b), requires ourindependent registered public accounting firm to issue an annual report that addresses the effectiveness of our internal control overfinancial reporting, we have opted to rely on the exemptions provided in the JOBS Act, and consequently will not be required to complywith SEC rules that implement Section 404(b) until such time as we are no longer an EGC.

Weexpect our first Section 404(a) assessment will take place for our annual report for the fiscal year ending March 31, 2023. The presenceof material weaknesses could result in financial statement errors which, in turn, could lead to errors in our financial reports, delaysin our financial reporting, which could require us to restate our operating results or our auditors may be required to issue a qualifiedaudit report. We might not identify one or more material weaknesses in our internal controls in connection with evaluating our compliancewith Section 404 (a). In order to maintain and improve the effectiveness of our disclosure controls and procedures and internal controlover financial reporting, we will need to expend significant resources and provide significant management oversight.

Implementingany appropriate changes to our internal control may require specific compliance training of our directors and employees, entail substantialcosts in order to modify our existing accounting systems, take a significant period of time to complete and divert management’sattention from other business concerns. These changes may not, however, be effective in maintaining the adequacy of our internal control.

Ifeither we are unable to conclude that we have effective internal control over financial reporting or, at the appropriate time, our independentauditors are unwilling or unable to provide us with an unqualified report on the effectiveness of our internal control over financialreporting as required by Section 404(b), then in the event we have decided to make an offering of our ADSs following our Nasdaq listing,investors may lose confidence in our operating results, the price of our ADSs could decline and we may be subject to litigation or regulatoryenforcement actions. In addition, if we are unable to meet the requirements of Section 404, we may not be able to remain listed on Nasdaq.

Wewill incur significant increased costs as a result of operating as a company that publicly listed on Nasdaq in the United States, andour management will be required to devote substantial time to new compliance initiatives.

Asa U.S. public company, and particularly after we no longer qualify as an EGC, we will incur significant legal, accounting and other expensesthat we did not incur previously. The Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act of 1987, thelisting requirements of Nasdaq and other applicable securities rules and regulations impose various requirements on non-U.S. reportingpublic companies, including the establishment and maintenance of effective disclosure and financial controls and corporate governancepractices. Our senior management and other personnel will need to devote a substantial amount of time to these compliance initiatives.

Moreover,these rules and regulations will increase our legal and financial compliance costs and will make some activities more time-consumingand costly. For example, we expect that these rules and regulations may make it more difficult and more expensive for us to obtain directorand officer liability insurance, which in turn could make it more difficult for us to attract and retain qualified senior managementpersonnel or members for our board of directors.

However,these rules and regulations are often subject to varying interpretations, in many cases due to their lack of specificity, and, as a result,their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies. This could resultin continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governancepractices.

Pursuantto Section 404, we will be required to furnish a report by our senior management on our internal control over financial reporting. However,while we remain an EGC, we will not be required to include an attestation report on internal control over financial reporting issuedby our independent registered public accounting firm. To prepare for eventual compliance with Section 404, once we no longer qualifyas an EGC, we will be engaged in a process to document and evaluate our internal control over financial reporting, which is both costlyand challenging. In this regard, we will need to continue to dedicate internal resources, potentially engage outside consultants andadopt a detailed work plan to assess and document the adequacy of internal control over financial reporting, continue steps to improvecontrol processes as appropriate, validate through testing that controls are functioning as documented and implement a continuous reportingand improvement process for internal control over financial reporting. Despite our efforts, there is a risk that we will not be ableto conclude, within the prescribed timeframe or at all, that our internal control over financial reporting is effective as required bySection 404. If we identify one or more material weaknesses, it could result in an adverse reaction in the financial markets due to aloss of confidence in the reliability of our financial statements.

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

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

Claimsof U.S. civil liabilities may not be enforceable against us.

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

See“Description of Share Capital and Memorandum and Articles of Incorporation—Enforcement of Civil Liabilities.” Additionally,it may be difficult to assert securities law claims in actions originally instituted outside of the United States. Foreign courts mayrefuse to hear a securities law claim because foreign courts may not be the most appropriate forum in which to bring such a claim. Evenif a foreign court agrees to hear a claim, it may determine that the law of the jurisdiction in which the foreign court resides, andnot U.S. law, is applicable to the claim. Further, if U.S. law is found to be applicable, the content of applicable U.S. law must beproved as a fact, which can be a time-consuming and costly process, and certain matters of procedure would still be governed by the lawof the jurisdiction in which the foreign court resides.

Therights afforded to shareholders are governed by Guernsey law. Not all rights available to shareholders under English law or U.S. lawwill be available to shareholders.

Therights afforded to shareholders will be governed by Guernsey law and by our Articles, and these rights differ in certain respects fromthe rights of shareholders in typical English companies and U.S. corporations. In particular, Guernsey law significantly limits the circumstancesunder which shareholders of companies may bring derivative actions and, in most cases, only the corporation may be the proper claimantor plaintiff for the purposes of maintaining proceedings in respect of any wrongful act committed against it. Neither an individual norany group of shareholders has any right of action in such circumstances. In addition, Guernsey law does not afford appraisal rights todissenting shareholders in the form typically available to shareholders of a U.S. corporation.

Theinsolvency laws of Guernsey and other jurisdictions may not be as favorable to you as the U.S. bankruptcy laws.

Weare incorporated under the laws of Guernsey. In the event of a bankruptcy, insolvency or similar event, proceedings could be initiatedin Guernsey or another relevant jurisdiction. The bankruptcy, insolvency, administrative and other laws of our and our subsidiaries’jurisdictions of organization or incorporation may be materially different from, or in conflict with, each other and those of the UnitedStates, including in the areas of rights of creditors, shareholders, priority of governmental and other creditors and duration of theproceeding. The application of these laws, or any conflict among them, could call into question whether any particular jurisdiction’slaw should apply, adversely affecting your ability to enforce your rights under the ordinary shares underlying our ADSs in those jurisdictionsor limit any amounts that you may receive.

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

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

Wedo not believe that we were a PFIC for our taxable year ended March 31, 2022 but cannot provide any assurances regarding our PFIC statusfor any past, current or future taxable years. The determination of whether we are a PFIC is a fact-intensive determination made on anannual basis applying principles and methodologies which in some circumstances are unclear and subject to varying interpretation. Inparticular, the characterization of our assets as active or passive may depend in part on our current and intended future business plans,which are subject to change. In addition, for our current and future taxable years, the total value of our assets for PFIC testing purposesmay be determined in part by reference to the market price of our ordinary shares or ADSs from time to time, which may fluctuate considerably.Under the income test, our status as a PFIC depends on the composition of our income which will depend on the transactions we enter intoin the future and our corporate structure. The composition of our income and assets is also affected by how, and how quickly, we spendthe cash we raise in any offering.

Incertain circumstances, a U.S. Holder of shares in a PFIC may alleviate some of the adverse tax consequences described above by making,where available, a qualified electing fund, or QEF, election to include in income its pro rata share of the corporation’s incomeon a current basis or a mark-to-market election. A U.S. Holder may make a QEF election with respect to our ordinary shares or ADSs onlyif we agree to furnish such U.S. Holder annually with a PFIC annual information statement as specified in the applicable U.S. TreasuryRegulations. We currently do not intend to prepare or provide the information that would enable U.S. Holders to make a QEF election ifwe are treated as a PFIC for any taxable year, and prospective investors should assume that a QEF election will not be available. A U.S.Holder may be able to make a mark-to-market election with respect to our ADSs if our ADSs are treated as “marketable stock.”Generally, stock will be considered marketable stock if it is “regularly traded” on a “qualified exchange” withinthe meaning of applicable U.S. Treasury regulations. A class of stock is regularly traded during any calendar year during which suchclass of stock is traded, other than in de minimis quantities, on at least 15 days during each calendar quarter. Our ADSs will be marketablestock as long as they remain listed on Nasdaq and are regularly traded. There can be no assurance that out ADSs will be regularly traded.

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

Achange in our tax residence could have a negative effect on our future profitability.

Althoughwe are incorporated under the laws of Guernsey, our affairs are, and are intended to continue to be, managed and controlled in the UnitedKingdom for tax purposes and therefore we are resident in the United Kingdom for U.K. and Guernsey tax purposes. It is possible thatin the future, whether as a result of a change in law or the practice of any relevant tax authority or as a result of any change in theconduct of our affairs or for any other reason, we could become, or be regarded as having become, a resident in a jurisdiction otherthan the United Kingdom. If we cease to be a U.K. tax resident, we may be subject to a charge to U.K. corporation tax on chargeable gainson our assets and to unexpected tax charges in other jurisdictions on our income. Similarly, if the tax residency of any of our subsidiarieswere to change from their current jurisdiction for any of the reasons listed above, we may be subject to a charge to local capital gainstax on the assets.

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

Asa U.K. resident trading entity, we are subject to U.K. corporate taxation. Due to the nature of our business, we have generated lossessince inception. As of March 31, 2022, we had cumulative carryforward tax losses of $15,870,525. Subject to any relevant restrictions,we expect these to be available to carry forward and offset against future operating profits. As a company that carries out extensiveresearch and development activities, we benefit from the U.K. research and development tax credit regime for small and medium-sized companies,whereby we are able to surrender the trading losses that arise from our qualifying research and development activities for a payabletax credit of up to 33.35% of eligible research and development expenditures. Qualifying expenditures largely comprise employment costsfor research staff, consumables and certain internal overhead costs incurred as part of research projects. Certain subcontracted qualifyingresearch expenditures are eligible for a cash rebate of up to 21.67%. The majority of our pipeline research, clinical trials managementand manufacturing development activities are eligible for inclusion within these tax credit cash rebate claims. Our ability to continueto claim payable research and development tax credits in the future may be limited because we may no longer qualify as a small or medium-sizedcompany.

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

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

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

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

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

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

CAUTIONARYSTATEMENT REGARDING FORWARD-LOOKING STATEMENTS

Thisregistration statement contains forward-looking statements that involve substantial risks and uncertainties. All statements containedin this registration statement, other than statements of historical fact, including statements regarding our strategy, future operations,future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements.The words “may,” “might,” “will,” “could,” “would,” “should,”“expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,”“estimate,” “predict,” “potential,” “continue” and “ongoing,” or the negativeof these terms, or other comparable terminology intended to identify statements about the future. These statements involve known andunknown risks, uncertainties and other important factors that may cause our actual results, levels of activity, performance or achievementsto be materially different from the information expressed or implied by these forward-looking statements. The forward-looking statementsand opinions contained in this registration statement are based upon information available to us as of the date of this registrationstatement and, while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete,and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially availablerelevant information. Forward-looking statements include statements about:

Youshould refer to the section titled “Risk Factors” for a discussion of important factors that may cause our actual resultsto differ materially from those expressed or implied by our forward-looking statements. As a result of these factors, we cannot assureyou that the forward-looking statements in this registration statement will prove to be accurate.

Furthermore,if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties inthese forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person thatwe will achieve our objectives and plans in any specified time frame, or at all. We undertake no obligation to publicly update any forward-lookingstatements, whether as a result of new information, future events or otherwise, except as required by law.

Youshould read this registration statement and the documents that we have filed as exhibits to this registration statement completely andwith the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-lookingstatements by these cautionary statements.

MARKETand industry DATA

Certainindustry data and market data included in this prospectus were obtained from independent third-party surveys, market research, publiclyavailable information, reports of governmental agencies, and industry publications and surveys. All of the market data used in this prospectusinvolves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. We believe that theinformation from these industry publications and surveys included in this prospectus is reliable. The industry in which we operate issubject to a high degree of uncertainty and risk due to a variety of factors, including those described in “Risk Factors.”These and other factors could cause results to differ materially from those expressed in the estimates made by the independent partiesand by us.

TRADEMARKS,SERVICE MARKS AND TRADENAMES

Solelyfor convenience, the trademarks, service marks, logos and trade names referred to in this prospectus are without the ® and ™symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicablelaw, our rights or the rights of the applicable licensors to these trademarks, service marks, and trade names. For the avoidance of doubt,“OKYO,” the OKYO logo and other trademarks or service marks of OKYO Pharma Limited appearing in this prospectus are the propertyof OKYO or our subsidiary. This prospectus contains additional trademarks, service marks, and trade names of others, which are the propertyof their respective owners. All trademarks, service marks, and trade names appearing in this prospectus are, to our knowledge, the propertyof their respective owners. We do not intend our use or display of other companies’ trademarks, service marks, copyrights, or tradenames to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

EXCHANGERATE INFORMATION

Fluctuationsin the exchange rate between Pounds Sterling and the U.S. dollar will affect the U.S. dollar amounts received by potential future ownersof our ADSs on conversion of dividends, if any, paid in Pounds Sterling on the ordinary shares and will affect the potential future U.S.dollar price of our ADSs on Nasdaq.

Thetable below shows the period end, average, high and low exchange rates of U.S. dollars per Pound Sterling for the periods shown. Averagerates are computed by using the noon buying rate of the Federal Reserve Bank of New York for the U.S. dollar on the last business dayof each month during the relevant year indicated or each business day during the relevant month indicated. The rates set forth beloware provided solely for your convenience and may differ from the actual rates used in the preparation of our consolidated financial statementsincluded in this registration statement and other financial data appearing in this registration statement.

OnNovember 25 2022 the exchange rate published by the Federal Reserve Bank of New York was $1.2102 per £1.00.

Informationpresented on a constant currency basis in this prospectus is calculated by translating current year results at prior year average exchangerates. Management reviews and analyzes business results excluding the effect of foreign currency translation because they believe thisbetter represents our underlying business trends.

PRICERANGE OF OUR ORDINARY SHARES AND ADSs

The principal trading marketfor our ordinary shares is the Main Market of the LSE, where our ordinary shares have been listed since July 17, 2018 under the symbol“OKYO.” Prior to this date we were listed on the AIM market of the London Stock Exchange since 2014. The following tablesets forth, for the periods indicated, the reported high and low closing prices on the LSE for our ordinary shares in Pounds Sterling.See “Exchange Rate Information” on page 41 for the exchange rates applicable to the periods set forth below.

The following table presents,for the periods indicated, the reported high and low sale prices, including intra-day sales, of our ordinary shares on the LSE in PoundsSterling and U.S. dollars. For the convenience of the reader, we have translated Pounds Sterling amounts in the table below into U.S.dollars at the noon buying rate of the Federal Reserve Bank of New York on November25, 2022 which was £1.00 to $1.2102.

On December 2, 2022, thelast reported sale price of our ordinary shares on LSE was £0.0275 per ordinary share ($0.033 per ordinary share based onthe exchange rate set forth above).

OurAmerican Depositary Shares, or ADSs, have been trading on the Nasdaq Capital Market under the symbol “OKYO” since May 17,2022. The following table sets forth, for the periods indicated, the reported high and low closing sale prices of our ADSs on the NasdaqCapital Market in U.S. dollars.

OnDecember 2, 2022, the last reported sale price of our ADSs on the Nasdaq Capital Market was $2.23 per ADS.

USEOF PROCEEDS

We estimate that the net proceedsfrom this offering will be approximately $8.8 million, or approximately $10.2 million if the underwriters exercise theirover-allotment option in full), assuming a public offering price of $2.23 per ADS, which reflects the closing trade price on Nasdaqon December 2, 2022 after deducting the underwriting discounts and commissions and estimated offering expenses payable by us.

Each$1.00 increase (decrease) in the public offering price per ADS would increase (decrease) our net proceeds, after deducting estimatedunderwriting discounts and commissions and offering expenses, by approximately $4.2 million (assuming no exercise of the over-allotmentoption by the underwriters).

Weintend to use the net proceeds as follows:

Theexpected use of the net proceeds from this offering represents our intentions based upon our current plans and business conditions. Wemay also use a portion of the net proceeds to in-license, acquire, or invest in additional products or assets, businesses, or technologies,although currently we have no specific agreements, commitments, or understandings in this regard. As of the date of this prospectus,we cannot predict with certainty all of the particular uses for the net proceeds to be received upon the closing of this offering orthe amounts that we will actually spend on the uses set forth above. Predicting the costs necessary to develop product candidates canbe difficult. The amounts and timing of our actual expenditures and the extent of clinical development may vary significantly dependingon numerous factors, including the progress of our development efforts, the status of and results from ongoing clinical trials or clinicaltrials we may commence in the future, as well as any collaborations that we may enter into with third parties and any unforeseen cashneeds. As a result, our management will retain broad discretion over the allocation of the net proceeds from this offering.

Weanticipate that our existing cash resources, together with the net proceeds from the offering, will enable us to fund our operating expensesand capital expenditure requirements for at least the 12 months after the date of this prospectus. We have based this estimate on assumptionsthat may prove to be incorrect, and we could use our available capital resources sooner than we currently expect.

Pendingtheir use, we plan to invest the net proceeds from the offering in short- and intermediate-term interest-bearing obligations and certificatesof deposit. The goal with respect to the investment of these net proceeds is capital preservation and liquidity so that such funds arereadily available to fund our operations.

DIVIDENDPOLICY

Wehave never paid or declared any cash dividends on our ordinary shares, and we do not anticipate paying any cash dividends on our ordinaryshares in the foreseeable future. We intend to retain all available funds and any future earnings to fund the development and expansionof our business. Pursuant to the Guernsey Companies Law, we may only pay a dividend if the directors who authorize the dividend makea prior solvency statement in statutory form.

CAPITALIZATION

Youshould read the information in this “Capitalization” section together with “Selected Consolidated Financial Data,”“Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our consolidated financialstatements and the related notes appearing elsewhere in this prospectus.

Thetable below sets forth our cash and short-term deposits and short-term investments and capitalization as of March 31, 2022 derived fromour audited consolidated financial statements included elsewhere in this prospectus:

(1) Each $1.00 increase or decrease in the assumedpublic offering price of $2.23 per ADS in this offering, would increase or decrease the as adjusted total equity andtotal capitalization by approximately $4.2 million after deducting the estimated underwriting discounts and commissions and estimatedoffering expenses payable by us.

An increase (decrease) of 1,000,000 in the numberof ADSs offered by us in this offering, as set forth on the cover page of this prospectus, would increase (decrease) the as adjustedtotal equity and total capitalization by $2.1 million, assuming no change in the public offering price per ADS and after deductingthe estimated underwriting discounts and commissions payable by us.

Thetable above excludes:

DILUTION

Ifyou invest in our ADSs in this offering, your interest will be diluted to the extent of the difference between the public offering priceper ADS paid by purchasers in this offering and our pro forma as adjusted net tangible book value per ADS after completion of this offering.

AtMarch 31, 2022, we had a historical net tangible book value of $0.002 per ordinary share (equal to $0.13 per ADS). Nettangible book value per ordinary share represents the amount of our total assets less our total liabilities, excluding goodwill and otherintangible assets, divided by the total number of our ordinary shares outstanding as of March 31, 2022.

After giving effect to the saleby us of 4,484,305 ADSs (representing 291,479,825 ordinary shares) at an assumed public offering price of $2.23per ADS in this offering, which reflects the last reported sale price on Nasdaq on December 2, 2022, after deductingthe estimated underwriting discounts and commissions and estimated offering expenses payable by us in connection with this offering,our as adjusted net tangible book value as of March 31, 2022 would have been $11.8 million, (equal to $0.44 per ADS). Thisrepresents an immediate increase in net tangible book value of $0.005 per ordinary share (equal to $0.31 ADS) to existingshareholders and an immediate dilution of $0.03 per ordinary share (equal to $1.79 per ADS) to new investors purchasingADSs in this offering. Dilution per ADS or ordinary share to new investors is determined by subtracting the as adjusted net tangiblebook value per ADS or ordinary share after this offering from the assumed public offering price per ADS paid by new investors.

Thefollowing table illustrates this dilution to new investors purchasing ADSs in this offering.

If the underwriters exercisein full their over-allotment option to purchase an additional 672,645 ADSs, our as adjusted net tangible book value afterthis offering would be $0.008 per ordinary share (equal to $0.49 per ADS), representing an immediate increase in as adjustednet tangible book value of $0.005 per ordinary share (equal to $0.35 per ADS) to existing shareholders and immediate dilutionof $0.03 per ordinary share (equal to $1.74 per ADS).

Each $1.00 increase (decrease)in the assumed public offering price of $2.23 per ADS in this offering, which reflects the last reported sale price on Nasdaqon December, 2, 2022 would increase (decrease) the as adjusted net tangible book value after this offering by $0.15per ADS and the dilution to new investors in this offering by $(0.84) per ADS, assuming that the number of ADSs offered byus in this offering, as set forth on the cover page of this prospectus, remains the same and after deducting the estimated underwritingdiscounts and commissions and estimated offering expenses payable by us.

An increase of 1,000,000 inthe number of ADSs offered by us in this offering, as set forth on the cover page of this prospectus, would increase the as adjustednet tangible book value after this offering by $0.35 per ADS and decrease the dilution to new investors participating in thisoffering by $0.06 per ADS, assuming no change in the assumed public offering price per ADS and after deducting the estimated underwritingdiscounts and commissions and estimated offering expenses payable by us.

A decrease of 1,000,000 in thenumber of ADSs offered by us in this offering, as set forth on the cover page of this prospectus, would decrease the as adjusted nettangible book value after this offering by $0.47 per ADS, and increase the dilution to new investors participating in this offeringby $(0.06) per ADS, assuming no change in the assumed public offering price per ADS and after deducting the estimated underwritingdiscounts and commissions and estimated offering expenses payable by us.

Thetable above excludes:

Tothe extent that share options or warrants are exercised, or we issue additional ADSs or ordinary shares in the future, there will befurther dilution to investors participating in this offering. In addition, we may choose to raise additional capital because of marketconditions or strategic considerations, even if we believe that we have sufficient funds for our current or future operating plans. Ifwe raise additional capital through the sale of equity or convertible debt securities, the issuance of these securities could resultin further dilution to our shareholders.

SELECTEDCONSOLIDATED FINANCIAL DATA

Thefollowing tables set forth our selected consolidated financial data for the periods indicated. We have derived the consolidated statementof comprehensive income for the years ended March 31, 2022, 2021 and 2020 and the consolidated balance sheet data as ofMarch 31, 2022 and 2021 from our audited consolidated financial statements included elsewhere in this prospectus.

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

ConsolidatedStatement of Operations and Comprehensive Loss Data:

ConsolidatedBalance Sheet Data:

MANAGEMENT’SDISCUSSION AND ANALYSIS OF FINANCIAL CONDITION

ANDRESULTS OF OPERATIONS

Thefollowing discussion of our financial condition and results of operations should be read in conjunction with the audited consolidatedhistorical financial statements as of March 31, 2022, 2021 and 2020.

Thefollowing discussion includes forward-looking statements that reflect our plans, estimates and beliefs and involves risks and uncertainties.Our actual results could differ materially from those discussed in these statements. Factors that could cause or contribute to thesedifferences include, but are not limited to, those discussed below and elsewhere in this registration statement, particularly in “RiskFactors” and elsewhere in this prospectus.

Overview

We are a preclinical biopharmaceuticalcompany developing next-generation therapeutics to improve the lives of patients suffering from inflammatory eye diseases and ocularpain. Our research program is focused on a novel G Protein-Coupled Receptor, or GPCR, which we believe plays a key role in the pathologyof these inflammatory eye diseases of high unmet medical need. Our therapeutic approach is focused on targeting inflammatory and painmodulation pathways that drive these conditions. We are presently developing OK-101, our lead preclinical product candidate, for thetreatment of dry-eye disease (DED). On November 18, 2022, we filed a new drug application (IND) with the Food and Drug Administration(FDA) on OK-101 to treat DED, and plan to open a Phase 2 clinical trial of OK-101 in DED patients in the first quarter of 2023.We also plan to evaluate OK-101’s potential in benefiting patients with ocular neuropathic pain, uveitis and allergic conjunctivitis.We have also been evaluating OK-201, a bovine adrenal medulla, or BAM, lipidated-peptide preclinical analogue candidate for the treatmentof neuropathic ocular pain, and plan on maintaining this drug candidate at the exploratory level while we focus our primary energieson the OK-101 program.

OnFebruary 21, 2018, we announced that we successfully obtained (via assignment from Panetta Partners Limited, a related party) a licensefrom OTT to patents owned or controlled by OTT and a sub-license from OTT to certain patents licensed by OTT from TMC to support ourophthalmic disease drug programs. These licenses gave us the right to exploit the IP estate which is directed to compositions-of-matterand methodologies for treating ocular inflammation, DED with chemerin or lipid-linked chemerin analogues. We also have a license fromTMC to a separate IP estate for treating symptoms of ocular neuropathic pain and uveitis associated pain. On August 6, 2019, we signeda collaborative agreement with TMC on a research program focused on ocular neuropathic pain.

Foreigncurrency translations

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

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

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

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

Componentsof Our Results of Operations

Revenues

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

OperatingExpenses

Researchand Development Expenses

Researchand development expenses consist primarily of costs incurred in connection with the research and development of our product candidatesand are expensed as incurred. These expenses consist of:

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

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

Thetable below summarizes our research and development expenses incurred by program:

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

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

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

Generaland Administrative Expenses

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

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

RealizationBonus Expenses

Thisis an extraordinary expense item for this year and includes the expenses for a realization bonus which became payable, triggered by afundraising event during the year.

Impairmentof an asset

Thisis an extraordinary expense item for this year and includes the expenses for the impairment of a non-current asset.

Disposalof Intellectual Property

Thisis an extraordinary expense item for this year and includes the expenses related to the disposal of intellectual property during theyear.

OtherIncome (Expense)

Otherexpense consists of interest on a convertible loan note.

Taxation

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

UnderUK tax legislation, small and medium entity research and development relief allows us to claim back up to 14.5% of our surrenderablelosses as a tax cash credit.

Resultsof Operations

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

Comparisonof Years Ended March 31, 2022 and 2021

Thefollowing tables summarizes our results of operations for the years ended March 31, 2022 and 2021:

Researchand Development Expenses

Researchand development activities were $1,301,178 for the year ended March 31, 2022 compared to $173,821 for the year ended March 31,2021 an increase of $1,127,357. The increase is due to an increase in research and development activity after the temporary pausein research and development activity in 2020 while the Scientific Advisory Board and management team were established.

Generaland Administrative Expenses

Generaland Administrative expenses were $4,916,388 forthe year ended March 31, 2022 as compared to $3,192,385 for the year ended March 31, 2021, an increase of $1,724,003. The increase ispredominantly due to the establishment of a management team and an increase in activity in the Company.

IncomeTax Credit

Incometax credits of $786,521 and $24,994 are recognized for the years ended March 31, 2022 and 2021, respectively. The credits are obtainedat a rate of 14.5% of 230% of our qualifying research and development expenditure, respectively. The increase in the provision is dueprimarily to an increase in qualifying research and development expenditure incurred in the year ending March 31, 2022, plus more qualifyingresearch and development expenditure identified for the year ending March 31, 2021 than was provided for.

Comparisonof Years Ended March 31, 2021 and 2020

Thefollowing tables summarizes our results of operations for the years ended March 31, 2021 and 2020:

Researchand Development Expenses

Researchand development activities were $173,821 for the year ended March 31, 2021 compared to $518,098 for the year ended March 31, 2020. Thedecrease of $344,277 is due to the temporary pause in research and development activity in 2020 while the Scientific Advisory Board andteam were established.

Generaland Administrative Expenses

Generaland administrative expenses were $3,192,385 and $1,016,548 for the year ended March 31, 2021 and 2020. The increase of $2,175,837 ispredominantly due to bonuses accrued of approximately $1,200,000, additional share-based payment charges of approximately $485,000, additionallegal and audit costs of approximately $142,000 and realized foreign exchange approximately $466,000 offset by savings of approximately$103,000.

IncomeTax Credit

Incometax credits of $24,994 and $76,289 are recognized for the years ended March 31, 2021 and 2020, respectively. The credits are obtainedat a rate of 14.5% of 230% of our qualifying research and development expenditure, respectively. The decrease in the provision is dueprimarily to the decrease in qualifying research and development expenditure incurred in the year ending March 31, 2021.

Liquidityand Capital Resources

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

Asof March 31, 2022, we had cash and cash equivalents of $2,700,723.

ThroughMarch 31, 2022, we had received net cash proceeds of $1,378,387 from exercise of warrants.

CashFlows

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

NetCash Used in Operating Activities

Ouruse of cash in each of the years ended March 31, 2022, 2021 and 2020, resulted primarily from our net losses, adjustedfor non-cash charges and changes in components of working capital. Net cash used in operating activities of $5,468,065 during the yearended March 31, 2022 increased by $3,867,867 compared to the year ended March 31, 2021. The increase in net cash used in operating activitieswas primarily due to increased activity.

Ouruse of cash in each of the years ended March 31, 2021 and 2020 resulted primarily from our net losses, adjusted for non-cash chargesand changes in components of working capital. Net cash used in operating activities of $1,600,198 during the year ended March 31, 2021increased by $398,132 compared to the year ended March 31, 2020. The increase in net cash used in operating activities was primarilydue an increase in accruals.

NetCash Used in Investing Activities

Duringthe year ended March 31, 2022, we used $1,669 of cash in investing activities for the purchases of property and equipment.

Duringthe year ended March 31, 2021 we used $18,114 of cash in investing activities for the purchases of property and equipment and a loanto West African Minerals Ltd. During the year ended March 31, 2020, $132,668 was used for the same reason.

NetCash Provided by Financing Activities

Duringthe years ended March 31, 2022 and 2021, net cash provided by financing activities was $2,153,270 and $7,826,938, respectively,consisting of net cash proceeds from our sale and issuance of ordinary shares, entering into fixed term convertible loan agreements andthe exercise of warrants.

During the year endedMarch 31, 2021, and 2020, net cash provided by financing activities was $7,826,939 and $963,310, respectively, consisting of net cashproceeds from our sale and issuance of ordinary shares and entering into fixed term convertible loan agreements.

FundingRequirements

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

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

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

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

Borrowings

OnMay 29, 2020, we entered into a fixed term unsecured loan agreement with existing shareholders for $606,980 at an interest rate of 20%per annum to be repaid no later than 48 months after the date of the agreement. On May 4, 2021, $167,434 of the fixed term loan agreementplus the associated interest accrued, was converted and 62,920,000 shares were issued accordingly at a price of $0.006 per share. OnFebruary 24, 2022, all remaining fixed term loan agreements plus the associated interest accrued were converted and 165,176,000 shareswere issued accordingly at a price of $0.006 per share.

OnJuly 27, 2020, we entered into a fixed term unsecured loan agreement with existing shareholders for $4,828,250 at an interest rate of2.15% per annum to be repaid no later than 36 months after the date of the agreement. On May 4, 2021, the fixed term loan agreement plusthe associated interest accrued, was converted and 43,889,863 shares were issued accordingly at a price of $0.117 per share.

OnAugust 17, 2020, we entered into a fixed term unsecured loan agreement with existing shareholders for $1,982,485 at an interest rateof 2.15% per annum to be repaid no later than 36 months after the date of the agreement. On May 4, 2021 the fixed term loan agreementplus the associated interest accrued, was converted and 18,021,226 shares were issued accordingly at a price of $0.117 per share.

OnSeptember 3, 2020, we entered into a fixed term unsecured loan agreement with existing shareholders for $689,750 at an interest rateof 2.15% per annum to be repaid no later than 36 months after the date of the agreement. On May 4, 2021 the fixed term loan agreementplus the associated interest accrued, was converted and 6,269,980 shares were issued accordingly at a price of $0.117 per share.

Theloans were converted into ordinary shares in May 2021 and February 2022.

InAugust 2022, we secured a short-term credit facility from Tiziana Life Sciences Ltd., a related party, for $2,000,000 in order to supportshort term liquidity. The loan is available for a period of 6 months upon first draw-down and carries an interest rate of 16% per annum,with additional default interest of 4% if the loan is not repaid after the 6-month period.

ContractualObligations

Thefollowing table summarizes our contractual commitments and obligations as of March 31, 2022 and 2021.