20-F: OKYO Pharma Reports Fiscal Year 2024 Results, Highlights Progress in Dry Eye Disease and Neuropathic Corneal Pain Programs

Sentiment:

Annual Results 13 August 2024 4:30 PM

OKYO Pharma's fiscal year 2024 results highlight advancements in their OK-101 clinical program for dry eye disease and neuropathic corneal pain, despite ongoing financial challenges.

Capital raiseThe company is actively pursuing additional financing to continue its operations and clinical development programs.The company may seek to sell additional equity and/or debt securities or obtain a credit facility or other loan.

Worse than expectedThe company's independent auditor has expressed substantial doubt about its ability to continue as a going concern.The company has a significant accumulated deficit and net loss for the year.The company's cash and cash equivalents are limited, raising concerns about near-term funding.

Summary

OKYO Pharma Limited has released its fiscal year 2024 results, showcasing progress in its clinical-stage biopharmaceutical endeavors.
The company is focused on developing next-generation therapeutics for inflammatory eye diseases and ocular pain, particularly targeting a novel G Protein-Coupled Receptor (GPCR).
Their lead product candidate, OK-101, is being developed for dry-eye disease (DED) and neuropathic corneal pain (NCP).
A Phase 2b trial of OK-101 for DED showed statistically significant improvements in both sign and symptom endpoints.
The company has filed an Investigational New Drug (IND) application with the FDA for OK-101 to treat NCP, with a Phase 2 trial planned for Q3 2024.
The company's cash and cash equivalents as of March 31, 2024, were approximately $0.8 million.
The company faces financial challenges, with an accumulated deficit of $143 million and a net loss for the year of $16.8 million.
The independent auditor has expressed substantial doubt about the company's ability to continue as a going concern.
The company is actively pursuing additional financing to continue its operations and clinical development programs.

Sentiment

Score: 4

Explanation: While the clinical trial results are promising, the significant financial challenges and going concern uncertainty weigh heavily on the overall sentiment.

Positives

OK-101 achieved statistically significant results in a Phase 2b trial for dry eye disease, showing promise for treating both signs and symptoms.
The FDA has cleared the Investigational New Drug (IND) application for OK-101 to treat neuropathic corneal pain, paving the way for a Phase 2 trial.
The company has a strong intellectual property portfolio with several issued patents and pending applications.
The company has a Scientific Advisory Board with leading experts in ophthalmology to guide clinical development.

Negatives

The company has a significant accumulated deficit of $143 million and a net loss for the year of $16.8 million.
The independent auditor has expressed substantial doubt about the company's ability to continue as a going concern.
The company's cash and cash equivalents as of March 31, 2024, were approximately $0.8 million, raising concerns about near-term funding.

Risks

The company's ability to continue as a going concern is uncertain due to its limited cash reserves and ongoing operating losses.
The company's product candidates are in the early stages of development and may not be successfully commercialized.
The company faces significant competition from other pharmaceutical companies.
The company is dependent on third-party suppliers and manufacturers.
The company may be subject to product liability claims.
The company is subject to stringent and changing privacy laws, regulations and standards as well as contractual obligations related to data privacy and security.

Future Outlook

The company plans to initiate a Phase 2 trial of OK-101 for neuropathic corneal pain in Q3 2024 and is actively pursuing additional financing to support its operations and clinical development programs.

Management Comments

Three distinguished ophthalmologists have joined OKYOs Scientific Advisory board (SAB).
These prominent corneal surgeons and leaders in the field of ophthalmology will be providing key input to OKYOs management regarding further clinical development of OK-101 as we continue to focus our efforts on the advancement of OK-101 for the millions of patients who suffer from DED and NCP.

Industry Context

The dry eye disease market is a significant and growing market with a high unmet medical need, with the global DED market in 2023 was approximately $7.0 billion, with the market size expected to reach $13 billion by 2032. OKYO Pharma is positioning itself to address this market with its novel therapeutic approach.

Comparison to Industry Standards

The global DED market in 2023 was approximately $7.0 billion, with the market size expected to reach $13 billion by 2032, according to Fortune Business Insights, 2024 Report ID FB102413.
There are presently 7 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), 5) Meibo (Perflurohexyloctane ophthalmic solution), 6) Vevye (0.1% cyclosporine), and 7) Eysuvis (0.25% loteprednol a corticosteroid for short term use only).
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).

Related Party Transactions

The company shares premises and other resources with Tiziana Life Sciences Ltd and there is a shared services agreement in place between the Company and Tiziana Life Sciences Ltd.
In August 2022, Tiziana Life Sciences Ltd issued a short-term credit facility to OKYO Pharma for $2m to support short term liquidity.
The principal of $2,000k plus accrued interest of $1,150k were converted into 2,100,000 Ordinary Shares, with no par value, of OKYO Pharma Ltd on October 25.2023.

Stakeholder Impact

Shareholders face potential dilution from future equity offerings.
Employees may be affected by potential cost reductions or restructuring.
Patients with dry eye disease and neuropathic corneal pain could benefit from successful development and commercialization of OK-101.
Suppliers and manufacturers may be impacted by the company's financial situation.

Next Steps

Initiate Phase 2 trial of OK-101 for neuropathic corneal pain in Q3 2024.
Pursue additional financing to support operations and clinical development programs.
Continue clinical development of OK-101 for dry eye disease and neuropathic corneal pain.

Key Dates

Date	Description
2007-07-04	Originally incorporated in the British Virgin Islands as Jellon Enterprises, Inc.
2018-03-09	Shareholders approved the cancellation of AIM listing and migration to Guernsey.
2018-05-01	Entered into an assignment of the Sublicense with Panetta Partners Limited.
2018-07-03	Registered under the Guernsey Companies Law under the name OKYO Pharma Limited.
2018-07-17	Ordinary Shares admitted to listing on the standard segment of the Official List of the FCA and admitted to trading on the standard listing of the Main Market of the London Stock Exchange.
2019-08-06	Signed a collaborative agreement with Tufts Medical Center to evaluate OKYOs BAM8-22 analogues, including OK-201.
2020-01-31	UK formally exited the EU (Brexit).
2020-12-30	UK and EU signed the Trade and Cooperation Agreement.
2021-01-06	Appointment agreement with Gabriele Cerrone to serve as Non-Executive Chairman.
2021-03-02	Virginia became the second state to adopt a comprehensive privacy legislation with enactment of the Virginia Consumer Data Protection Act.
2021-03-22	Raj Patil appointed as Chief Scientific Officer.
2021-04-28	Announced positive results of OK-201 in a mouse neuropathic corneal pain model.
2021-07-20	John Brancaccio appointed as Non-Executive Director.
2021-12-01	Bernard Denoyer appointed as Non-Executive Director.
2022-05-17	American Depositary Shares, or ADSs, have been trading on the NASDAQ Capital Market under the symbol OKYO.
2022-05-22	Delisted from the standard segment of the Main Market of the London Stock Exchange and had a sole listing on the NASDAQ capital market.
2022-08-01	Entered into a short-term credit facility with a related party for $2m to support short term liquidity.
2023-02-23	Patent No. 10,899,796 entitled Compounds and Methods for Treating Pain was issued by the United States Patent and Trademark Office.
2023-05-02	Announced that the first patient has been screened for our Phase 2b, multi-center, randomized, double-blinded, placebo-controlled trial of OK-101.
2023-06-06	Announced that patients in the ongoing phase 2b trial were now being dosed in the randomized portion of the phase 2b, multi-center, double-masked, placebo-controlled trial of topical ocular OK-101 to treat DED.
2023-07-28	Announced a new agreement with Tufts Medical Center to conduct a 40-patient open-label clinical trial evaluating the efficacy and safety of OK-101 in subjects with neuropathic corneal pain (NCP).
2023-09-08	Announced that we had completed full enrollment of patients in the randomized portion of the Phase 2b multi-center, double-masked, placebo-controlled clinical trial of topical ocular OK-101 to treat DED.
2023-10-05	Announced that over 95% of randomized DED patients (230 patients) in the ongoing 240-patient DED trial had completed 4 weeks of dosing in the planned 12-week dosing study.
2023-10-09	Announced the filing of the IND with the FDA for the development of OK-101 to treat NCP.
2023-10-25	The loan from Tiziana Life Sciences Ltd was converted into Oridinary Shares in OKYO with accrued interest at a rate of 20%.
2023-12-04	Announced the last patient of the ongoing 240-patient double-blind placebo-controlled phase 2b clinical trial of OK-101 to treat DED had completed the 12-week OK-101 dosing study.
2024-01-01	The effective date of this rule has been delayed until January 1, 2023, and a lawsuit initiated by the Pharmaceutical Care Management Administration has challenged this final rule.
2024-01-08	Announced OK-101 successfully achieved statistical significance for both sign and symptom endpoints in its first-in-human phase 2b trial of OK-101 in patients with DED.
2024-01-31	Announced that following the positive safety and efficacy results in the Phase 2b trial of OK-101 to treat DED, three distinguished ophthalmologists have joined OKYOs Scientific Advisory board (SAB).
2024-02-09	Announced that the U.S. Food and Drug Administration (FDA) has cleared OK-101 as its first Investigational New Drug (IND) application for the treatment of NCP.
2024-03-22	Announced additional key findings from analyses of the clinical data set from the 240 patient Phase 2, randomized, double-masked, placebo-controlled trial evaluating the safety and efficacy of OK-101 ophthalmic solution in patients with DED.

Keywords

OKYO Pharma, OK-101, Dry Eye Disease, Neuropathic Corneal Pain, Clinical Trials, Financial Results, Biopharmaceutical, GPCR, FDA, Research and Development

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