OKYO Pharma(OKYO) - 2025 Q4 - Annual Report

PART I This part details the company's financial performance, operational overview, and governance structure Key Information This section presents selected financial data and a comprehensive list of risk factors, including those related to product development, financial position, and regulatory hurdles Selected Financial Data This section presents selected financial data for the fiscal years ended March 31, 2023, 2024, and 2025, showing consistent operating losses and a working capital deficit Consolidated Statement of Operations and Comprehensive Loss Data (in thousands except per share data) | | 2025 | 2024 | 2023 | | :--- | :--- | :--- | :--- | | Total operating expenses | $(7,092) | $(15,750) | $(13,187) | | Net loss attributable to ordinary shareholders | $(4,706) | $(16,825) | $(13,272) | | Total comprehensive loss | $(4,865) | $(16,684) | $(13,713) | | Basic and diluted net loss per ordinary share | $(0.20) | $(0.57) | $(0.61) | Consolidated Balance Sheet Data (in thousands) | | As of March 31, 2025 | As of March 31, 2024 | As of March 31, 2023 | | :--- | :--- | :--- | :--- | | Cash and cash equivalents | $1,561 | $827 | $4,045 | | Working capital | $(5,552) | $(5,883) | $(2,060) | | Total assets | $3,677 | $1,541 | $5,204 | | Total shareholders' equity/(deficit) | $(5,550) | $(5,880) | $(2,053) | Risk Factors The company faces significant risks across its business, financials, commercialization efforts, intellectual property, operations, and regulatory landscape - The company's product candidates, urcosimod (OK-101) and OK-201, are in early development stages, and it may be several years before any revenue is generated, if at all[42][43] - The company will need to raise substantial additional capital, as of March 31, 2025, cash and cash equivalents were approximately $1.6 million with a working capital deficit of $5.6 million[48] - The independent registered public accounting firm has expressed substantial doubt about the company's ability to continue as a going concern due to its liquidity position post-July 2026[49] - The company faces significant competition from major multinational pharmaceutical companies with substantially greater financial and technical resources[58] - The company is dependent on third parties for clinical trials, manufacturing, and supply, creating risks related to control, quality, and potential supply interruptions[61][63][102] - The company is subject to extensive government regulation, including lengthy and uncertain FDA approval processes and potential negative impacts from healthcare reforms[100][101][123] - As a Foreign Private Issuer (FPI), the company is exempt from certain SEC disclosure and governance rules, potentially offering less information and protection to shareholders[173][178] Information on the Company This section provides an overview of OKYO Pharma, a clinical-stage biopharmaceutical company developing therapeutics for inflammatory eye diseases and ocular pain History and Development of the Company This section outlines the company's incorporation history, name changes, and transition to NASDAQ as its principal trading market - The company was incorporated in Guernsey on July 3, 2018, under the name OKYO Pharma Limited[217] - Since May 22, 2023, the principal trading market for the company's ordinary shares has been the NASDAQ Capital Market[217] Business Overview OKYO Pharma is a clinical-stage biopharmaceutical company developing therapeutics for inflammatory eye diseases and ocular pain - OKYO is a clinical-stage biopharmaceutical company focused on inflammatory eye diseases and ocular pain, targeting the G Protein-Coupled Receptor (GPCR) known as CMKLR1 (or ChemR23)[221] - The lead product candidate, urcosimod (formerly OK-101), is a lipidated peptide designed to block ChemR23's role in ocular pain and inflammation[221] - The clinical development focus for urcosimod has shifted from Dry Eye Disease (DED) to Neuropathic Corneal Pain (NCP), a major unmet medical need with no current FDA-approved topical drugs[224][231][232] - On May 1, 2025, the FDA granted Fast Track designation to urcosimod for the treatment of NCP, which facilitates development and expedites review[245] - Results from the 18-patient Phase 2 trial for NCP showed that the 0.05% urcosimod group had a mean pain score reduction of 5.5 on a 10-point VAS scale, compared to a 2.75 reduction in the placebo group[246][249][250] - The company's intellectual property portfolio includes 8 issued patents and 15 pending applications in the U.S. and abroad, with key patents for urcosimod expiring between 2034 and 2041[264][265] Organizational Structure OKYO Pharma Limited has one wholly-owned subsidiary, OKYO Pharma US Inc, a clinical-stage biotechnology company based in New York Subsidiary Information | Name | Principal activity | Registered address | Shareholding | Country of incorporation | | :--- | :--- | :--- | :--- | :--- | | OKYO Pharma US Inc. | Clinical stage biotechnology company | 420 Lexington Avenue Suite 1402 New York, NY 10170 | 100% | USA | Property, Plant and Equipment The company's material tangible fixed assets consist of a leased CEO office in New York, NY, with a 2-month tenure - The company leases a CEO office at 420 Lexington Avenue, New York, NY, on a 2-month tenure[323] Operating and Financial Review and Prospects This section analyzes the company's financial condition, results of operations, and liquidity, highlighting ongoing net losses and going concern uncertainties Results of Operations For the year ended March 31, 2025, OKYO reported a net loss of $4.7 million, a significant reduction from the $16.8 million loss in 2024 Comparison of Years Ended March 31, 2025 and 2024 (in thousands) | | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Research and development | $(2,254) | $(8,244) | $5,989 | | General and administrative | $(4,838) | $(7,506) | $2,669 | | Total Operating expenses | $(7,092) | $(15,750) | $8,658 | | Tax (charge)/credit | $3,264 | $(22) | $3,286 | | Net Loss | $(4,706) | $(16,825) | $12,119 | Comparison of Years Ended March 31, 2024 and 2023 (in thousands) | | 2024 | 2023 | Change | | :--- | :--- | :--- | :--- | | Research and development | $(8,244) | $(6,338) | $(1,906) | | General and administrative | $(7,506) | $(6,850) | $(657) | | Total Operating expenses | $(15,750) | $(13,187) | $(2,563) | | Net Loss | $(16,825) | $(13,272) | $(3,553) | - R&D expenses decreased by $6.0 million in FY2025 due to the completion of the DED clinical trial and the start of a smaller, less costly NCP trial[350] - G&A expenses decreased by $2.7 million in FY2025, mainly due to lower bonuses, reduced D&O insurance premiums, and decreased consultancy spend[351] Liquidity and Capital Resources As of March 31, 2025, the company had $1.6 million in cash and cash equivalents, with operations funded primarily through equity sales and convertible loan notes - As of March 31, 2025, the company had cash and cash equivalents of $1,560,902[361] Summary of Cash Flows (in thousands) | | Year ended March 31, 2025 | Year ended March 31, 2024 | Year ended March 31, 2023 | | :--- | :--- | :--- | :--- | | Net cash used in operating activities | $(1,811) | $(9,491) | $(7,695) | | Net cash provided by financing activities | $2,656 | $6,209 | $9,323 | | Net (decrease)/increase in cash and cash equivalents | $844 | $(3,282) | $1,622 | - The company has experienced net losses and significant cash outflows, with an accumulated deficit of $143 million as of March 31, 2025, raising substantial doubt about its ability to continue as a going concern without additional funding[370][371] - Post March 31, 2025, the company raised an additional $2.7 million through its At-The-Market (ATM) facility[362] - During FY2025, the company raised $950,000 through the issuance of convertible loan notes and received net proceeds of $1.7 million from the sale of ordinary shares[361][367] Contractual Obligations As of March 31, 2025, the company had no contractual obligations for borrowings or operating leases, a change from the prior year Contractual Obligations as of March 31, 2025 (in thousands) | | Total | Less than 1 Year | Between 1 and 5 Years | More than 5 Years | | :--- | :--- | :--- | :--- | :--- | | Borrowings | $ - | $ - | $ - | $ - | | Operating lease obligations | $ - | $ - | $ - | $ - | Contractual Obligations as of March 31, 2024 (in thousands) | | Total | Less than 1 Year | Between 1 and 5 Years | More than 5 Years | | :--- | :--- | :--- | :--- | :--- | | Borrowings | $ - | $ - | $ - | $ - | | Operating lease obligations | $ 7 | $ 7 | $ - | $ - | Directors, Senior Management and Employees This section details the company's leadership, compensation, governance structures, and employee count as of March 31, 2025 Directors and Senior Management The company is led by a team of experienced professionals in the biotechnology and pharmaceutical industries, including Gabriele Cerrone and Dr Gary S Jacob - Gabriele Cerrone, the Non-Executive Chairman, is a founder of multiple biotechnology companies and has extensive experience listing them on public markets[389] - Dr Gary S Jacob, CEO and Executive Director, has over 35 years of experience in the pharmaceutical and biotechnology industries[390] - Dr Raj Patil, Chief Scientific Officer, has over 15 years of ophthalmic drug development experience[391] Compensation For the fiscal year ended March 31, 2025, total compensation for the Non-Executive Chairman and Directors included fees, bonuses, and stock option awards Non-Executive Director Compensation FY2025 ($000) | Name | Position | Fees | Options awarded | Other (Bonus) | Total | | :--- | :--- | :--- | :--- | :--- | :--- | | Gabriele Cerrone | Non-Executive Chairman | 450 | - | 472 | 922 | | Willy Simon | Non-Executive Director | 41 | 35 | - | 76 | | John Brancaccio | Non-Executive Director | 40 | 45 | - | 85 | | Bernard Denoyer | Non-Executive Director | 40 | 11 | - | 51 | Executive Director Compensation FY2025 ($000) | Name | Position | Salary | Bonus | Options awarded | Total | | :--- | :--- | :--- | :--- | :--- | :--- | | Gary Jacob | Executive Director | 350 | 100 | 228 | 678 | - Chairman Gabriele Cerrone has a long-term realization bonus agreement, entitling him to 3.5% of the enterprise value if the company is sold for over $275 million, or 6.5% if sold for over $500 million[403][405] - The company operates an Employee Share Option Plan, with options granted having a 10-year life and vesting conditions determined by the Remuneration Committee[414][417][419] Board Practices As a foreign private issuer, OKYO Pharma follows its home country (Guernsey) governance practices in lieu of certain NASDAQ rules, adhering to the QCA Code - The company is a 'foreign private issuer' and relies on home country governance practices, exempting it from certain NASDAQ rules, including requirements for a majority-independent board and shareholder approval for some equity issuances[430][433] - The company has adopted the Quoted Companies Alliance (QCA) Corporate Governance Code[435] - The Board of Directors has three standing committees: Audit, Risk and Disclosure; Remuneration; and Nomination, with the Audit Committee consisting exclusively of independent members[438][439] Employees As of March 31, 2025, OKYO Pharma had four full-time employees, with two in R&D and three in management, administration, and finance - As of March 31, 2025, the company had 4 full-time employees[444] - Employee breakdown: 2 in R&D and 3 in management, administration, and finance, all located in the United States[444] Major Shareholders and Related Party Transactions This section outlines the company's major shareholders and details transactions with related parties, including a shared services agreement Major Shareholders As of June 19, 2025, Gabriele Cerrone was the only shareholder with a beneficial ownership of 5% or more, holding 27.09% of the company's ordinary shares Beneficial Ownership as of June 19, 2025 | Name of beneficial owner | Number of Ordinary Shares Beneficially Owned | % | | :--- | :--- | :--- | | 5% or Greater Shareholders: | | | | Gabriele Cerrone | 10,172,677 | 27.09 | | All directors and executive officers as a group (5 persons) | 10,252,660 | 27.54 | - Gabriele Cerrone is the ultimate beneficial owner of his shares through Planwise Group Limited and Panetta Partners Limited[450] Related Party Transactions The company has engaged in several related party transactions since April 1, 2022, including a shared services agreement with Tiziana Life Sciences Ltd - The company has a Shared Services agreement with Tiziana Life Sciences Ltd, a related party, for services such as payroll and rent[454] - The board has adopted a written policy for reviewing and approving material related person transactions, which is overseen by the audit, risk and disclosure committee[455] Financial Information This section refers to detailed financial statements and confirms no material legal proceedings or significant changes outside of notes - The company's consolidated financial statements and other financial information are detailed under Item 18[457] - There are no governmental, legal, or arbitration proceedings, pending or threatened, that are expected to have a significant effect on the company's financial position or profitability[458] The Listing This section details the company's principal trading market, the NASDAQ Capital Market, and its prior listings - The principal trading market for the company's ordinary shares is the NASDAQ Capital Market under the symbol 'OKYO' since May 22, 2023[460][463] - The company delisted from the Main Market of the London Stock Exchange on May 19, 2023[461] Additional Information This section provides supplementary corporate information, including material contracts, exchange controls, and U.S. and U.K. taxation considerations Taxation This subsection details tax implications for U.S. and U.K. shareholders, including potential PFIC classification for U.S. Holders - For U.S. Holders, the company may be classified as a Passive Foreign Investment Company (PFIC), which carries adverse tax consequences, though the company does not believe it was a PFIC for its 2025 tax year[477][478] - If the company is a PFIC, U.S. Holders could be subject to the 'PFIC excess distribution regime,' resulting in higher taxes and interest charges on certain distributions and gains[479] - For U.K. Holders, dividends paid by the company are not subject to U.K. withholding tax[501] - Transfers of the company's ordinary shares are not subject to U.K. stamp duty or stamp duty reserve tax (SDRT)[511][512] Quantitative and Qualitative Disclosures About Market Risk This section discusses the company's market risks, primarily interest rate and foreign currency fluctuations, and its approach to managing them - The company's principal market risks are limited to interest rate fluctuations and foreign currency exchange rate fluctuations[518] - Interest rate risk is considered low due to a conservative investment strategy focused on capital preservation in short-term accounts[519] - The company is exposed to foreign currency exchange risk as its functional currency is Pounds Sterling (£), but its financial statements are presented in U.S. dollars ($), and it does not currently engage in currency hedging[520][523] PART II This part outlines the company's internal controls, governance practices, and cybersecurity measures Controls and Procedures This section confirms the effectiveness of the company's disclosure controls and internal control over financial reporting as of March 31, 2025 - As of March 31, 2025, the CEO and CFO concluded that the company's disclosure controls and procedures were effective[531] - Management concluded that the company maintained effective internal control over financial reporting as of March 31, 2025, with no material weaknesses identified[534] Audit Committee Financial Expert This section identifies John Brancaccio as the board's designated 'audit committee financial expert' - The board of directors has determined that Mr John Brancaccio is an 'audit committee financial expert' as defined in Item 16A of Form 20-F[536] Principal Accountant Fees and Services This section details the fees paid to the principal accountant, PKF Littlejohn LLP, and previous auditor for audit and assurance services Accountant Fees for FY 2025 (in thousands) | Firm | Audit fees | Other assurance services | Total | | :--- | :--- | :--- | :--- | | PKF Littlejohn LLP | 134 | 22 | 156 | | Mazars LLP | - | 27 | 27 | Corporate Governance This section outlines the company's corporate governance practices, including reliance on home country rules as a foreign private issuer - The company follows home country (Guernsey) practices in lieu of certain NASDAQ corporate governance standards[542] - Exemptions taken include not following NASDAQ's quorum requirements for shareholder meetings and not requiring regular meetings of non-management directors without management present[547] Cybersecurity This section describes the company's cybersecurity risk management processes, board oversight, and incident response measures - The Board of Directors retains oversight of cybersecurity, receiving regular briefings from senior leadership and a cybersecurity consultant[549] - The company has an incident response playbook and engages third-party services for penetration testing and security evaluations[549][550] - The company requires its subcontractors to report cybersecurity incidents to assess potential impacts on its operations[551] PART III This part contains the company's audited consolidated financial statements and related notes Financial Statements This section presents the audited consolidated financial statements, including the auditor's 'Going Concern Uncertainty' and detailed financial notes - The independent auditor's report includes a 'Going Concern Uncertainty' paragraph, highlighting that the company requires additional financing to initiate the next phase of clinical trials and for working capital, which raises substantial doubt about its ability to continue as a going concern[565] Consolidated Balance Sheet (as of March 31, 2025) | | $ (in thousands) | | :--- | :--- | | Total current assets | 3,675 | | Total assets | 3,677 | | Total current liabilities | 9,227 | | Total liabilities | 9,227 | | Total shareholders' equity | (5,550) | Consolidated Statement of Operations (for year ended March 31, 2025) | | $ (in thousands) | | :--- | :--- | | Total operating expenses | (7,092) | | Loss from operations before income taxes | (7,970) | | Income tax | 3,264 | | Loss for the year | (4,706) | | Comprehensive loss | (4,865) | - The company has tax losses of $35,852,225 to carry forward against future profits, though no deferred tax asset has been recognized due to uncertainty of recovery[656] - As of March 31, 2025, the company had 1,818,903 options and 563,986 warrants outstanding[682][695] - The company has commitments for milestone payments related to its license agreements, including up to $1.5 million upon enrollment of the first patient in a Phase III trial for OK-101[728][729]