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OKYO Pharma Limited (NASDAQ: OKYO) is a clinical-stage biopharmaceutical company dedicated to developing groundbreaking therapies for inflammatory eye diseases and chronic pain conditions. The company is at the forefront of creating innovative treatments for Dry Eye Disease (DED) and Neuropathic Corneal Pain (NCP), both of which represent significant unmet medical needs in the ophthalmology sector.
One of OKYO Pharma's hallmark achievements is its development of the OK-101 ophthalmic solution. This drug candidate has shown promising results in pre-clinical studies, demonstrating dual-action anti-inflammatory and neuropathic corneal pain-reducing activities. The ongoing Phase 2 clinical trials are aimed at establishing the safety and efficacy of OK-101 in treating DED and NCP. Notably, these trials have successfully completed patient enrollment, with top-line results expected soon.
OKYO Pharma's approach leverages a unique membrane-anchored-peptide technology to ensure the prolonged presence of the drug in the ocular environment, thereby enhancing its therapeutic impact. In recent studies, OK-101 has exhibited statistically significant improvements in multiple dry eye-related symptoms, including stinging, burning, and blurred vision, as well as a notable reduction in conjunctival staining. These promising outcomes pave the way for future Phase 3 registration trials.
Financially, OKYO Pharma is well-positioned, with its ordinary shares listed on the NASDAQ Capital Market. The company continues to forge strategic partnerships and collaborations to bolster its research and development efforts. With a robust pipeline and a commitment to addressing the complex biology of eye diseases, OKYO Pharma stands as a pioneering entity in the biopharmaceutical landscape.
The latest developments include positive safety and efficacy results from the Phase 2 trials of OK-101, and the recent FDA clearance for OK-101's Investigational New Drug (IND) application for treating NCP. These milestones underscore the potential of OKYO Pharma's innovative solutions to significantly improve patient outcomes.
On March 13, 2023, OKYO Pharma announced a public offering of 3,503,665 American Depositary Shares (ADSs) at $1.50 each, aiming to raise approximately $5.3 million. The offering is set to close on March 15, 2023. The funds will primarily support the Phase 2 clinical trial of OK-101 for inflammatory dry eye diseases and will also cover general corporate expenses. Additionally, the company completed a concurrent offering in the UK, securing $0.3 million from the sale of 13,836,156 ordinary shares to management and directors. The registration statement for the ADSs was filed with the SEC and became effective on March 8, 2023.
OKYO Pharma Limited (LSE: OKYO; NASDAQ: OKYO) announced that its GMP packaged drug OK-101 for treating dry eye disease (DED) has cleared customs in the U.S. The company is preparing for its first-in-human Phase 2 clinical trial, with randomization codes being generated and clinical sites being authorized. Anticipated timelines include the first patient visit in Q1 2023 and top-line data release in Q4 2023. OK-101 aims to address significant unmet needs in the multi-billion-dollar DED market, leveraging its unique design to enhance drug retention in the ocular environment.
OKYO Pharma has appointed Dr. Jay S. Pepose, a leading ophthalmologist, to its Scientific Advisory Board to guide clinical programs for OK-101, a treatment for dry eye disease. Dr. Pepose brings nearly 40 years of experience and a robust background in clinical trials for ophthalmic conditions. The company plans to initiate enrollment for its Phase 2 clinical trial for OK-101 within Q1 2023. This strategic appointment aims to enhance the profile of OK-101 amidst a multi-billion-dollar market with significant unmet needs. Dr. Pepose's insights on ocular inflammation and pain management are expected to drive the development of this promising therapy.
OKYO Pharma Limited (LSE: OKYO; NASDAQ: OKYO) announced that CEO Gary S. Jacob, Ph.D., will present on the therapeutic potential of OK-101 for dry eye disease at the GPCRs-Targeted Drug Discovery Summit on February 22, 2023, in Boston. His presentation follows that of Dr. Alan Kopin, who will share insights on the discovery and testing of OK-101. Recently, OKYO received FDA clearance for its Investigational New Drug (IND) application to initiate a Phase 2 clinical trial for OK-101, aiming to address the significant unmet need in treating dry eye disease.
OKYO Pharma Limited (LSE: OKYO, NASDAQ: OKYO) has announced its interim results for the six months ending September 30, 2022. The company has achieved FDA IND clearance for its Phase 2 trial of OK-101 to treat Dry Eye Disease (DED), expected to begin in Q1 2023. Financially, OKYO reported total assets of £1.6 million and cash of £0.6 million, with a comprehensive loss of £4.6 million. The company has halted further development of OK-201 to focus resources on OK-101.
OKYO Pharma Limited has received FDA clearance to start a Phase 2 clinical trial for OK-101, a treatment for Dry Eye Disease (DED). This first-in-human study will assess both efficacy endpoints relating to the signs and symptoms of DED. The trial is set to begin in Q1 2023, aiming to demonstrate OK-101's potential as a novel treatment option for patients inadequately addressed by existing medications. The company emphasizes that success in this trial could expedite the filing for a new drug application (NDA) with the FDA.
OKYO Pharma Limited (LSE: OKYO; NASDAQ: OKYO) announced its participation in the Biotech Showcase in San Francisco from January 9-11, 2023. The company focuses on developing OK-101 to treat dry eye disease, addressing significant unmet needs in this multi-billion-dollar market. CEO Dr. Gary Jacob and other executives will present and hold 1x1 institutional investor meetings during the event. Attendees can schedule meetings online. The event highlights OKYO's commitment to innovation in treating inflammatory dry eye diseases.
OKYO Pharma Limited (LSE: OKYO; NASDAQ: OKYO) has filed a Form F-1 registration statement with the SEC for a secondary public offering of its American Depositary Shares (ADSs). Each ADS will represent 65 ordinary shares. The offering's size and price are yet to be determined and depend on market conditions. This offering, approved by shareholders at the September 2022 AGM, will allow OKYO's shares to continue trading on the LSE and NASDAQ. ThinkEquity is the sole bookrunning manager, and the offering will not be available in the EEA or UK to the public.
OKYO Pharma Limited (LSE: OKYO; NASDAQ: OKYO) appointed PKF Littlejohn LLP as its new independent auditor effective immediately. The board approved PKF for the financial year ending March 31, 2023, with re-appointment subject to shareholder approval at the next AGM in 2023. The previous auditor, Mazars LLP, confirmed no matters for the Company’s members or creditors. OKYO thanks Mazars for their service. This announcement contains inside information under UK market regulations.
OKYO Pharma Limited (LSE: OKYO; NASDAQ: OKYO) has awarded Chief Scientific Officer Raj Patil 5,000,000 options with an exercise price of 6.25 pence per share, recognizing his contribution to the recent IND filing for OK-101, aimed at treating dry eye disease. The options vest immediately and have a five-year lifespan. This move highlights the company's advancement in developing therapies for the significant unmet needs in the dry eye market, which is valued in the billions. The announcement complies with UK MAR regulations.
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