OKYO Pharma Ltd 20-F for FY2024

OKYO Pharma Ltd (OKYO)

20-F 2024-08-13 For: 2024-03-31

Added on April 08, 2026

About this 20-F

OKYO Pharma Ltd filed this 20-F on August 13, 2024, covering the fiscal year ended March 31, 2024 (FY2024).

Headline figures

Fiscal year ended March 31, 2024, as reported in this filing, compared with the same period a year earlier where the filing states it.

Net loss: $16.83M; compared with a net loss of $13.27M a year earlier
Diluted EPS: -$0.57; compared with -$0.61 a year earlier

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Title of each class		Name of each exchange on which registered
Ordinary Shares of no par value		NASDAQ Capital Market

Large accelerated filer ☐	Accelerated filer ☐	Non-accelerated filer ☐	Smaller reporting company ☐
			Emerging growth company ☒

PART I
Item 1	Identity of Directors, Senior Management and Advisers	1
Item 2	Offer Statistics and Expected Timetable	1
Item 3	Key Information	1
Item 4	Information on the Company	33
Item 4A	Unresolved Staff Comments	50
Item 5	Operating and Financial Review and Prospects	50
Item 6	Directors, Senior Management and Employees	61
Item 7	Major Shareholders and Related Party Transactions	71
Item 8	Financial Information	72
Item 9	The Listing	73
Item 10	Additional Information	74
Item 11	Quantitative and Qualitative Disclosures About Market Risk	82
Item 12	Description of Securities Other than Equity Securities	83

PART II
Item 13	Defaults, Dividend Arrearages and Delinquencies	84
Item 14	Material Modifications to the Rights of Security Holders and Use of Proceeds	84
Item 15	Controls and Procedures	84
Item 16A	Audit Committee Financial Expert	85
Item 16B	Code of Ethics	85
Item 16C	Principal Accountant Fees and Services	85
Item 16D	Exemptions From the Listing Standards for Audit Committees	85
Item 16E	Purchases of Equity Securities by the Issuer and Affiliated Purchasers	85
Item 16F	Change in Registrant’s Certifying Accountant	85
Item 16G	Corporate Governance	86
Item 16H	Mine Safety Disclosure	86
Item 16k	Cybersecurity	86
Item 16L	Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.	86

PART III
Item 17	Financial Statements	87
Item 18	Financial Statements	87
Item 19	Exhibits	87

	●	the development of product candidates, including statements regarding the timing of initiation, completion and the outcome of clinical studies or trials and related preparatory work, the period during which the results of the trials will become available and our research and development programs;

	●	our ability to obtain and maintain regulatory approval of our product candidates in the indications for which we plan to develop them, and any related restrictions, limitations or warnings in the label of an approved drug or therapy;

	●	our plans to research, develop, manufacture and commercialize our product candidates;

	●	the timing of our regulatory filings for our product candidates;

	●	the size and growth potential of the markets for our product candidates;

	●	our ability to raise additional capital and our ability to continue as a going concern;

	●	our commercialization, marketing and manufacturing capabilities and strategy;

	●	our expectations regarding our ability to obtain and maintain intellectual property protection;

	●	our ability to attract and retain qualified employees and key personnel;

	●	our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately;

	●	our estimates regarding future revenue, expenses and needs for additional financing; and

	●	regulatory developments in the United States, European Union, United Kingdom and foreign countries.

	Years Ended March 31,
	2024			2023			2022 (restated)
	(in thousands except per share data)
Operating expenses:
Research and development	$	(8,244	)	$	(6,338	)	$	(1,609	)
General and administrative		(7,506	)		(6,849	)		(4,608	)
Total operating expenses		(15,750	)		(13,187	)		(6,217	)
Loss from operations		(15,750	)		(13,187	)		(6,217	)
Other income (expense)		(1,053	)		(97	)		-
Tax (charge)/credit		(22	)		12			786
Net loss attributable to ordinary shareholders		(16,825	)		(13,272	)		(5,431	)
Other comprehensive loss:
Foreign currency translation adjustment		141			(441	)		(837	)
Total comprehensive loss		(16,684	)		(13,713	)		(6,268	)

Basic and diluted net loss per ordinary share		(0.57	)		(0.60	)		(0.36	)

	As of March 31,
	2024			2023			2022
	(in thousands except share and per share data)
Cash and cash equivalents	$	827		$	4,045		$	2,701
Working capital		(5,883	)		(2,060	)		2,942
Total assets		1,541			5,204			4,301
Total shareholders’ equity/(deficit)		(5,880	)		(2,053	)		2,947

	●	the successful conduct of further human trials in the initial indications of Dry Eye Disease (DED);

	●	receipt of marketing approvals for OK-101 in the United States and other jurisdictions where separate approval is required and where we subsequently choose to market OK-101;

	●	launching commercial sales of OK-101, if and when approved;

	●	acceptance of OK-101 by patients, the medical community and third-party payers;

	●	OK-101 competing effectively with existing therapies and in particular with established products addressing the same clinical needs;

	●	OK-101 influencing the treatment guidelines in relevant territories; and

	●	further clinical trials to provide additional data to support commercialization of OK-101 and to permit wider label claims.

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

	●	the inability of sales personnel to obtain access to or persuade adequate numbers of potential practitioners to prescribe any future products;

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

	●	costs of marketing and promotion above those anticipated by us; and

	●	the inability to secure a suitable level of pricing and/or reimbursement approval from the relevant regulatory authorities in the countries we are targeting.

	●	limited market acceptance or a lack of recognition of the unmet medical need for the product amongst prescribers;

	●	new competitor products entering the market;

	●	the number and relative efficacy, safety or cost of competitive products;

	●	an inability to supply a sufficient amount of the product to meet market demand;

	●	insufficient funding being available to market the product adequately;

	●	an inability to enforce intellectual property rights, or the existence of third-party intellectual property rights;

	●	safety concerns arising pre- or post-launch resulting in negative publicity or product withdrawal or narrowing of the product label and the group of persons who may receive the product;

	●	labelling being restricted/narrowed in the future and in the future by regulatory agencies; and

	●	refusals by government or other healthcare payors to fund the purchase of the products by healthcare providers at a commercially viable level (or at all) or otherwise to restrict the availability of approved products on other grounds.

	●	a covered benefit under the payor’s health plan;

	●	safe, effective and medically necessary;

	●	appropriate for the specific patient;

	●	cost-effective; and

	●	neither experimental nor investigational.

	●	the degree and range of protection any patents will afford against competitors and competing technologies, including whether third parties will find ways to invalidate or otherwise circumvent the patents by developing a competitive product that falls outside its scope;

	●	if, or when any patents will be granted;

	●	that granted patents will not be contested, invalidated or found unenforceable;

	●	whether or not others will obtain patents claiming aspects similar to those covered by the Company’s patents and patent applications;

	●	whether we will need to initiate litigation or administrative proceedings, or whether such litigation or proceedings will be initiated by third parties against us, which may be costly and time consuming; and

	●	whether third parties will claim that our technology infringes upon their rights.

	●	decreased demand for our products due to negative public perception;

	●	injury to our reputation;

	●	withdrawal of clinical study participants or difficulties in recruiting new study participants;

	●	initiation of investigations by regulators;

	●	costs to defend or settle the related litigation;

	●	diversion of management’s time and our resources;

	●	substantial monetary awards to patients, study participants or subjects;

	●	product recalls, withdrawals or labelling, marketing or promotional restrictions;

	●	loss of revenues from product sales; or

	●	the inability to commercialize any of our products, if approved.

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

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

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

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

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

	●	suspend or withdraw regulatory approval;

	●	suspend any ongoing clinical trials;

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

	●	restrict the marketing or manufacturing of the product;

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

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

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

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

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

	●	unmet medical needs will be fulfilled; and

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

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

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

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

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

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

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

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

	●	the success of competitive products or technologies;

	●	results of clinical trials of OK-101, OK-201 and any other future product candidate that we develop;

	●	results of clinical trials of product candidates of our competitors;

	●	changes or developments in laws or regulations applicable to OK-101, OK-201 and any other future product candidates that we develop;

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

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

	●	the recruitment or departure of key personnel;

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

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

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

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

	●	market conditions in the biotechnology and pharmaceutical sectors;

	●	general economic, industry and market conditions;

	●	the trading volume of our ordinary shares on the NASDAQ Capital Market ; and

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

	●	increased operating expenses and cash requirements;

	●	the assumption of additional indebtedness or contingent liabilities;

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

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

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

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

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

	●	reduced control for certain aspects of manufacturing activities;

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

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

●	Statistically significant drug effects were observed in FDA-recognized efficacy endpoints as early as the 15-day first visit after dosing. OK-101 demonstrated superiority when compared to placebo across at least two symptoms of DED including burning measured by the Ora Calibra^©4-symptom questionnaire as well as burning/stinging measured by a visual analogue scale as early as Day 15 (p = 0.04 and p=0.03, respectively).
●	A statistically significant improvement in blurred vision was also achieved at Day 29 (p = 0.01). OK-101 also demonstrated superiority when compared to placebo in the sign endpoint of total conjunctival staining as measured by the Ora Calibra^© Staining Scale as early as Day 29 (p = 0.034).
●	Regarding the safety profile of the drug, OK-101 exhibited placebo-like tolerability with a very low adverse event profile and no drug-related severe ocular TEAEs were seen .
●	Additionally, fewer subjects in the OK-101 treated arm discontinued study medication (2.5%) compared to discontinuations in the placebo treated patients (3.8%). This first-in-human trial of OK-101 established a clear and informed path for further development in Phase 3 registration trials.

●	In this press release, the Company reported additional OK-101 (0.05%) data, including conjunctival staining measured at Day 85 (p=0.056) demonstrating durability in this sign endpoint.
●	In addition, there were significant improvements in burning/stinging (p = 0.01, 0.006, 0.003 and 0.01 at Days 15, 29, 57 and 85, respectively) and in blurred vision (p = 0.09, 0.01, 0.03 and 0.06 at Days 15, 29, 57 and 85, respectively) which demonstrated sustained improvements throughout the trial.
●	Additional data analyses also showed statistically significant improvement in ocular pain measured by VAS that was durable throughout the trial with p values = 0.03, 0.04 and 0.01 at Days 29, 57 and 85, respectively. Furthermore, OK-101 improved tear film break-up time (TFBUT) as early as Day 15 and the improvement lasted throughout the trial with p values = 0.01, 0.05, 0.02, and 0.03 at Days 15, 29, 57 and 85, respectively.
●	Notably, it has been traditionally difficult to demonstrate durable statistical significance for the measurement of increase in TFBUT in clinical trials of DED treatments, due mainly to patient-to-patient variability. The positive results observed in this trial carry particular significance as OK-101’s proposed mechanism-of-action involves the normalization of goblet cell density as well as generating a healthier conjunctiva, a reduction of ocular pain, and ocular anti-inflammatory activity. An increase in goblet cell density should be expected to lead to an increase in mucin production, playing a key role in stabilizing the corneal tear film.
●	Moreover, data obtained from daily symptom diaries maintained by patients during the trial, commonly referred to as patient-reported outcome data, confirmed several of the DED symptoms also measured in the clinic, exhibiting significant improvements as early as Day 1 through Day 15 for pain, burning/stinging, eye dryness and itching, with p values of 0.01, 0.06, 0.005 and 0.009, respectively. This observation of statistically significant improvements in multiple DED symptoms as measured both from clinic visits and as reported by patients at home was striking.
●	Lastly, OK-101 was extremely well tolerated with a drop comfort score of 2.3 after 2 minutes post-instillation which is comparable to those of artificial tear results as measured by the Ora Calibra^© Drop Comfort Scale¹ of 0–10, with a value of 0 being most comfortable and 10 being least comfortable.

●	The trial, once started, is anticipated to take 6-9 months to conduct, and is anticipated to have a minor budgetary impact, with a total cost for the trial, including cost of drug manufacture and formulation, amounting to under $2 million.
●	NCP remains a major unmet medical need for the ocular community, as there is no FDA approved drug to treat NCP and this trial provides the opportunity to quickly establish OK-101’s potential to treat this condition.

●	Notably, our initial IND submission to FDA proposed an open-label design for the clinical trial. Based on positive feedback from FDA, the Phase 2 study is now designed as a single-center, double-masked, randomized, 12-week placebo-controlled trial comparing OK-101 to placebo in NCP patients.
●	A total of 48 patients are planned for the study, with NCP disease confirmed via confocal microscopy. The primary endpoint will be measured utilizing VAS pain relief scores.
●	These protocol changes will enable a statistically valid demonstration of a true drug effect of OK-101 on NCP symptoms. OKYO Pharma is presently scheduling this trial to begin in Q3 2024.

	●	$300,000 upon first patient enrolled in a Phase I clinical trial;

	●	$600,000 upon first patient enrolled on a Phase II clinical trial;

	●	$1,500,000 upon first patient enrolled in a Phase III clinical trial; and

	●	$2,500,000 upon first commercial sale of a licensed product.

	●	$2,000,000 on first achievement of annual net sales of $50,000,000;

	●	$4,000,000 on first achievement of annual net sales of $100,000,000;

	●	$6,000,000 on first achievement of annual net sales of $250,000,000;

	●	$10,000,000 on first achievement of annual net sales of $500,000,000; and

	●	$15,000,000 on first achievement of annual net sales of $1,000,000,000.

	●	completion of preclinical laboratory studies, animal studies and formulation studies in compliance with the FDA’s good laboratory practice regulations;

	●	submission to the FDA of an IND, which the FDA must approve before human clinical trials may begin;

	●	approval of the human clinical trial by the institutional review board, or IRB, at each clinical site before each trial may be initiated;

	●	performance of adequate and well-controlled human clinical trials in accordance with applicable IND and other clinical trial-related regulations, sometimes referred to as GCPs to establish the safety and clinical utility of the proposed product candidate for its proposed indication;

	●	submission to the FDA of a BLA or NDA;

	●	satisfactory completion of an FDA pre-approval inspection of the production facility or facilities where the product is produced to assess compliance with the FDA’s cGMP requirements to assure that the facilities, methods and controls are adequate to preserve the product’s identity, strength, quality, purity and potency;

	●	potential FDA audit of the preclinical and/or clinical trial sites that generated the data in support of the NDA; and

	●	FDA review and approval of the BLA or NDA prior to any commercial marketing or sale of the product in the United States.

	●	restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls;

	●	fines, warning letters or holds on post-approval clinical trials;

	●	refusal of the FDA to approve pending NDAs or supplements to approved NDAs, or suspension or revocation of product approvals;

	●	product seizure or detention, or refusal to permit the import or export of products; or

	●	injunctions or the imposition of civil or criminal penalties.

Location		Tenure		Principal use
420 Lexington Avenue Suite 1402 New York, NY 10170		2 Months		CEO Office

	●	Statistically significant drug effects were observed in FDA-recognized efficacy endpoints as early as the 15-day first visit after dosing.
	●	OK-101 demonstrated superiority when compared to placebo across at least two symptoms of DED including burning measured by the Ora Calibra^© 4-symptom questionnaire as well as burning/stinging measured by a visual analogue scale as early as Day 15 (p = 0.04 and p=0.03, respectively).
	●	A statistically significant improvement in blurred vision was also achieved at Day 29 (p = 0.01).
	●	OK-101 also demonstrated superiority when compared to placebo in the sign endpoint of total conjunctival staining as measured by the Ora Calibra^© Staining Scale as early as Day 29 (p = 0.034).
	●	Regarding the safety profile of the drug, OK-101 exhibited placebo-like tolerability with a very low adverse event profile and no drug-related severe adverse events.
	●	Additionally, fewer subjects in the OK-101 treated arm discontinued study medication (2.5%) compared to discontinuations in the placebo treated patients (3.8%).
	●	This first-in-human trial of OK-101 established a clear and informed path for further development in Phase 3 registration trials.

●	Based on positive feedback from FDA, the Phase 2 study is now designed as a single-center, double-masked, randomized, 12-week placebo-controlled trial comparing OK-101 to placebo in NCP patients. A total of 48 patients are planned for the study, with NCP disease confirmed via confocal microscopy. The primary endpoint will be measured utilizing VAS pain relief scores.
●	These protocol changes will enable a statistically valid demonstration of a true drug effect of OK-101 on NCP symptoms. OKYO Pharma is presently scheduling this trial to begin in Q3 2024.

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

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

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

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

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

	●	costs related to compliance with regulatory requirements;

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

	●	fees for maintaining our third-party licensing agreements.

	Year ended March 31,
	2024		2023		2022 (restated)
Direct research and development expense by program:
OK-101	$	8,179,510	$	6,243,753	$	1,514,361
OK-201		64,061		93,945		95,197
Total direct research and development expense	$	8,243,571	$	6,337,698	$	1,609,558

Total research and development expense	$	8,243,571	$	6,337,698	$	1,609,558