OKYO Pharma Ltd. — Form 20-F Summary
Reporting period: Fiscal year ended March 31, 2023. Although the request references 2022 Q4, this filing is an annual report, not a quarterly filing. Financial statements are audited and prepared under IFRS as issued by the IASB, in U.S. dollars. The report was filed August 14, 2023.
Business context and reporting period
OKYO is a pre-revenue, clinical-stage biopharmaceutical company developing therapies for inflammatory eye diseases and ocular pain. Its lead candidate, OK-101, is being developed primarily for dry-eye disease (DED); OK-201 remains at an exploratory preclinical stage. The FDA cleared OK-101’s IND in December 2022 for a first-in-human Phase 2 DED study. The company reported subsequent trial progress and plans in 2023, after the fiscal year-end.
Key financial metrics
| Metric | FY ended March 31, 2023 | FY ended March 31, 2022 |
|---|---|---|
| Revenue | None | None |
| Research and development expense | $6.34 million | $1.61 million, restated |
| General and administrative expense | $6.85 million | $4.61 million |
| Total operating expenses | $13.19 million | $6.22 million |
| Net loss | $13.27 million | $5.43 million |
| Comprehensive loss | $13.71 million | $6.27 million |
| Operating cash flow | $(7.70) million | $(5.47) million |
| Cash and cash equivalents at year-end | $4.05 million | $2.70 million |
| Working capital | $(2.06) million | $2.94 million |
| Total assets | $5.20 million | $4.30 million |
| Total liabilities | $7.26 million | $1.35 million |
| Shareholders’ equity/(deficit) | $(2.05) million | $2.95 million |
With no product revenue, a revenue-based margin is not meaningful; the filing does not provide a clear applicable margin measure. Cash used in investing activities was $5,916. Financing provided $9.32 million, including $7.32 million of net share proceeds and a $2.00 million related-party loan. The related-party loan payable was reported at $2.22 million, including accrued interest. Its stated rate was 16% annually, with an additional 4% default interest if unpaid after six months.
Material changes versus the prior comparable period
- R&D expense rose by approximately $4.73 million as OKYO advanced OK-101 toward clinical testing. G&A expense increased by approximately $2.24 million, primarily reflecting public-company, IPO/listing, legal, compliance, insurance and investor-relations costs.
- Net loss widened by approximately $7.84 million. Operating cash use increased by approximately $2.23 million.
- Cash increased year over year, supported by equity fundraising and related-party borrowing, while working capital moved from a surplus to a deficit and equity moved to a deficit.
- Prior-year R&D and operating expense classifications were restated to reclassify patent-related expenditure into R&D; the filing says this did not change prior-year total operating expenses or results.
- In May 2023, the company moved to a sole Nasdaq listing and consolidated shares 65-for-1. The filing reports 25,553,274 ordinary shares outstanding as of July 27, 2023.
Outlook, risks, contingencies and unusual items
- Going concern and funding: The auditor included a going-concern explanatory paragraph, and management disclosed substantial doubt about the company’s ability to continue as a going concern. The filing states cash was about $1 million on August 1, 2023, forecasts cash exhaustion in October 2023 without additional financing, and projects $7.8 million of cash burn from early August through December. Management planned to seek equity financing, reduce working-capital costs and potentially defer liabilities. Financial statements were prepared on a going-concern basis without adjustments for a possible failure to continue.
- Clinical outlook: The Phase 2 DED trial was planned for approximately 200–240 patients; management expected completion 6–8 months from first-patient enrollment and sought proof of concept. These are expectations, not reported trial results. A separate 40-patient open-label neuropathic corneal pain trial was planned with Tufts Medical Center, subject to an IND filing and FDA allowance.
- Principal risks: OKYO has no approved products or product revenue; candidates remain exposed to clinical, regulatory, manufacturing, intellectual-property, competition and reimbursement risks. The company depends on third parties for clinical work and manufacturing, reports no backup manufacturer, and expects significant additional capital needs and possible shareholder dilution.
- Reporting and governance: Management found disclosure controls and internal control over financial reporting ineffective as of March 31, 2023 because of insufficient accounting resources and oversight. Corrected misstatements were identified during the audit. Management described added staff and review controls as remediation steps but gave no assurance remediation would be completed. The company also changed auditors in November 2022, from Mazars to PKF Littlejohn.
- Unusual items and related parties: FY2023 included $96,687 of interest expense on a related-party loan and a $300,000 chairman bonus. The company reported shared-services and other balances with Tiziana Life Sciences, a related party. No dividends were paid.
Most important facts for investors to verify
- Current cash, cash burn, debt maturity and the status, terms and proceeds of financing after the filing’s August 2023 disclosures.
- Whether OKYO can meet near-term liabilities and fund the DED Phase 2 trial, including any deferred-payables arrangements or cost reductions.
- Actual Phase 2 DED enrollment, completion timing, endpoints and results, and regulatory steps for the proposed neuropathic pain study.
- Whether the disclosed internal-control weaknesses were remediated and whether subsequent reporting identifies further errors or control issues.
- Per-share loss figures: the audited statements report FY2023 loss per share of $0.61, while selected financial data elsewhere in the filing shows $0.60; investors should check the audited presentation and related share-consolidation calculations.
- Related-party loan terms, amounts outstanding and subsequent repayments, and the effect of future equity issuance on dilution.