OKYO Pharma Ltd — FY2024 Form 20-F
Reporting period: Fiscal year ended March 31, 2024; filed August 13, 2024. The filing is an annual report, not a quarterly report, and does not provide separate 2023 Q4 results. Financial statements are audited and prepared under IFRS as issued by the IASB, in U.S. dollars.
Business context
OKYO is a pre-revenue, clinical-stage biopharmaceutical company focused on inflammatory eye disease and ocular pain. Its lead candidate, OK-101, is being developed for dry-eye disease (DED) and neuropathic corneal pain (NCP). OK-201 remains at exploratory stage while the company prioritizes OK-101.
Financial performance and position
| Metric (US$) | FY2024 | FY2023 |
|---|---|---|
| Revenue | None | None |
| Research and development expense | $8.24 million | $6.34 million |
| General and administrative expense | $7.51 million | $6.85 million |
| Total operating expenses | $15.75 million | $13.19 million |
| Finance expense | $1.05 million | $0.10 million |
| Net loss | $16.83 million | $13.27 million |
| Basic and diluted loss per share | $(0.57) | $(0.61) |
| Net cash used in operating activities | $9.49 million | $7.70 million |
| Cash and cash equivalents at year-end | $0.83 million | $4.05 million |
| Working capital | $(5.88) million | $(2.06) million |
| Total liabilities | $7.42 million | $7.26 million |
| Shareholders’ equity/(deficit) | $(5.88) million | $(2.05) million |
There were no product sales or operating profit; margins are not meaningful. R&D spending rose 30%, primarily reflecting progress of OK-101 clinical trials. G&A increased 10%, mainly due to additional public and investor-relations activity. Finance expense increased substantially and was attributed to interest on a related-party loan. Operating cash use rose by $1.80 million. Financing provided $6.21 million, principally from ordinary-share issuance; cash declined by $3.28 million over the year.
The $2.0 million related-party loan, plus accrued interest, was converted into 2.1 million ordinary shares in October 2023; no related-party loan balance remained at March 31, 2024. Year-end trade and other payables were $7.06 million, including $6.13 million of trade payables. Contractual obligations listed $7,000 of operating leases and no borrowings.
Material changes and business developments
- In January 2024, OKYO reported that its 240-participant Phase 2b DED trial met statistical significance on selected symptom and sign endpoints. The filing reports improvements in burning/stinging, blurred vision and conjunctival staining, alongside placebo-like tolerability and no drug-related severe ocular adverse events.
- Additional analyses reported sustained improvements in selected measures, including ocular pain and tear-film break-up time. These are company-reported trial results; the filing does not establish regulatory approval or confirm Phase 3 outcomes.
- The FDA cleared the IND for an OK-101 NCP study. The planned Phase 2 trial is randomized, double-masked, placebo-controlled, targets 48 patients, and was scheduled to begin in Q3 2024. The company estimated trial cost below $2 million.
- OK-201 was deprioritized in favor of OK-101. OKYO reported 8 issued patents and 15 pending applications as of August 1, 2023; its OK-101 license includes potential development and sales milestones and royalties.
- Shares outstanding were 33,336,316 at March 31, 2024 and 33,836,316 as of August 8, 2024. The filing attributes 4.16 million shares to FY2024 fundraising, 1.56 million to expenses settled in shares and 2.10 million to the related-party loan conversion.
Outlook, risks and unusual items
- Going concern: The auditor included a going-concern uncertainty paragraph and stated that substantial doubt exists. At July 2024, cash was approximately $0.3 million; the company anticipated $0.4 million of cash receipts by the end of September and cited investor support. Management projected $2.6 million of cash burn from early August through December and said cash would run out in December 2024 without additional financing. Planned measures include raising equity, reducing working-capital costs and deferring liabilities. No assurance is given that funding will be obtained.
- Funding and dilution: The company expects substantial ongoing losses and needs additional capital for development and commercialization. Equity financing could dilute shareholders; alternative financing or partnerships could require relinquishing valuable rights.
- Development and commercialization: OK-101 remains investigational. Clinical results may not be replicated in later trials; regulatory approval, successful manufacturing, market uptake, reimbursement and sufficient financing are uncertain. The company relies on third parties for clinical work and manufacturing and reports no backup manufacturer.
- Related-party compensation: Chairman Gabriele Cerrone received a reported $934,000 bonus settled in shares. His annual consultancy fee increased to £450,000 effective October 2023 from £150,000. Review the terms and governance of these arrangements.
- Controls: Management concluded disclosure controls and internal control over financial reporting were ineffective at March 31, 2024 because of a material weakness involving limited accounting resources, reliance on key staff and inadequate monitoring. Management reported hiring accounting staff and implementing review controls, but remediation was ongoing.
- Other disclosed risks include competition, intellectual-property challenges, regulatory and privacy compliance, foreign-currency exposure, cybersecurity, and the company’s dependence on key personnel and external vendors. The company reported no off-balance-sheet arrangements and no post-balance-sheet events in the financial-statement notes.
Key facts for investors to verify
- Current cash, receipt of the anticipated $0.4 million, investor-support commitments, and any financing completed after the filing date.
- Whether cash runway, payable deferrals and cost reductions are sufficient to address the stated December 2024 funding shortfall.
- Full Phase 2b DED data, endpoint definitions and statistical analysis, and the design, start date, cost and progress of the NCP trial.
- Trade-payable balances and payment terms, related-party balances and transactions, and the economics of the loan conversion and share issuances.
- Progress in remediating the internal-control material weakness and whether subsequent filings identify further weaknesses or corrected errors.
- Reconcile filing inconsistencies: the audited statements report FY2024 net loss of $16.83 million and operating cash use of $9.49 million, while the liquidity narrative contains conflicting figures, including a $168 million net loss and $12.6 million operating cash use. The selected-data table also shows FY2023 loss per share of $(0.60), while the audited statements report $(0.61). The filing text does not provide a clear reconciliation.