6-K
OKYO Pharma Ltd (OKYO)
UNITEDSTATES
SECURITIESAND EXCHANGE COMMISSION
Washington,D.C. 20549
FORM6-K
REPORTOF FOREIGN PRIVATE ISSUER
PURSUANTTO RULE 13a-16 OR 15d-16
UNDERTHE SECURITIES EXCHANGE ACT OF 1934
April2023
CommissionFile Number: 001-41386
OKYOPharma LTD
(Exact Name of Registrant as Specified in Its Charter)
9^th^Floor
107Cheapside
London
EC2V6DN
(Address of registrant’s principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
INFORMATIONCONTAINED IN THIS REPORT ON FORM 6-K
On April 25, 2023, OKYO Pharma LTD (the “Company”) issued this 6K announcing the, Activation of First Clinical Trial Site in the U.S. for the Phase 2 Trial Evaluating OK-101 for the Treatment of Dry Eye Disease, a copy of which is furnished as Exhibit 99.1
The Announcement is furnished herewith as Exhibit 99.1 to this Report on Form 6-K. The information in the attached Exhibits 99.1 is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, except as otherwise set forth herein or as shall be expressly set forth by specific reference in such a filing.
| 2 |
| --- |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| OKYO Pharma LTD | ||
|---|---|---|
| Date:<br> April 25 2023 | By: | /s/ Keeren Shah |
| Name: | Keeren<br> Shah | |
| Title: | Chief<br> Financial Officer |
| 3 |
| --- |
EXHIBITINDEX
| Exhibit No. | Description |
|---|---|
| 99.1 | News Announcement, dated April 25, 2023 |
| 4 |
| --- |
Exhibit 99.1

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FORTHE PURPOSES OF ARTICLE 7 OF REGULATION 2014/596/EU WHICH IS PART OF DOMESTIC UK LAW PURSUANT TO THE MARKET ABUSE (AMENDMENT) (EU EXIT)REGULATIONS (SI 2019/310) (UK MAR). UPON THE PUBLICATION OF THIS ANNOUNCEMENT, THIS INSIDE INFORMATION (AS DEFINED IN UK MAR) IS NOW CONSIDEREDTO BE IN THE PUBLIC DOMAIN.
OKYO Pharma Announces Activation of First ClinicalTrial Site in the U.S. for the Phase 2 Trial Evaluating OK-101 for the Treatment of Dry Eye Disease
London and New York, NY, April 25, 2023 – OKYO Pharma Limited (LSE: OKYO; NASDAQ: OKYO or the “Company”), an ophthalmology-focused bio-pharmaceutical company which is developing OK-101 to treat dry eye disease to address the significant unmet need in this multi-billion-dollar market, today announces the activation of the first clinical trial site in the U.S. for its phase 2, multi-center, randomized, double-blinded, placebo-controlled trial, evaluating the efficacy and safety of OK-101 ophthalmic solution in subjects with dry eye disease. First patient first visit is presently expected to occur within the next two weeks.
“Our primary focus continues to be on advancing the clinical development of OK-101 as a potential treatment option for dry eye disease, a chronic ocular condition that affects roughly 700 million people worldwide,” said Gary S. Jacob, Ph.D., CEO of OKYO Pharma. “With the activation of our first clinical site we are now very close to the opening of the OK-101 phase 2 trial and are looking forward to initiating enrollment and completing the trial before the end of the year.”
About OK-101
OK-101 is a lipid conjugated chemerin peptide antagonist of the ChemR23 G-protein coupled receptor which is typically found on immune cells of the eye responsible for the inflammatory response. OK-101 was developed using a membrane-anchored-peptide (MAP) technology to produce a novel long-acting drug candidate for treating dry eye disease. OK-101 has been shown to produce anti-inflammatory and pain-reducing activities in mouse models of dry eye disease and corneal neuropathic pain; and is designed to combat washout through the inclusion of the lipid ‘anchor’ contained in the candidate drug molecule to enhance the residence time of OK-101 within the ocular environment.
About OKYO
OKYO Pharma Limited (LSE: OKYO; NASDAQ: OKYO) is a life sciences company admitted to listing on NASDAQ and on the standard segment of the Official List of the UK Financial Conduct Authority and to trading on the main market for listed securities of London Stock Exchange plc. OKYO is focusing on the discovery and development of novel molecules to treat inflammatory dry eye diseases and chronic pain. For further information, please visit www.okyopharma.com.
| -1- |
| --- |
Forward-Looking Statements
Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company’s current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as ‘anticipates,’ ‘expects,’ ‘intends,’ ‘plans,’ ‘believes,’ ‘seeks,’ ‘estimates,’ and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company’s control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.
For further information, please visit the Company’s website at www.okyopharma.com
The person who arranged for the release of this announcement on behalf of the Company was Gary S. Jacob, Ph.D., Chief Executive Officer of OKYO.
Enquiries:
| OKYO Pharma Limited | Gary S. Jacob, Ph.D., Chief Executive Officer | +44 (0)20 7495 2379 |
|---|---|---|
| Investor Relations | Paul Spencer | +44 (0)20 7495 2379 |
| Optiva Securities Limited (Broker) | Robert Emmet | +44 (0)20 3981 4173 |
| -2- |
| --- |