UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
6-K
REPORT
OF FOREIGN PRIVATE ISSUER
PURSUANT
TO RULE 13a-16 OR 15d-16
UNDER
THE SECURITIES EXCHANGE ACT OF 1934
August
2023
Commission
File Number: 001-41386
OKYO
Pharma LTD
(Exact
Name of Registrant as Specified in Its Charter)
9th
Floor
107
Cheapside
London
EC2V
6DN
(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): ☐
INFORMATION
CONTAINED IN THIS REPORT ON FORM 6-K
On
August 15, 2023, OKYO Pharma LTD (the “Company”) issued this 6K announcing, financial results for the twelve months
ended March 31, 2023 and provided a corporate update on its lead program in development., 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.
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:
August 15, 2023 |
By: |
/s/
Keeren Shah |
|
Name: |
Keeren
Shah |
|
Title: |
Chief
Financial Officer |
EXHIBIT
INDEX
Exhibit
99.1
OKYO
Pharma Limited Reports Annual Results for the Twelve Months Ended March 31, 2023
London
and New York, NY, August 15 2023 – OKYO Pharma Limited (NASDAQ: OKYO), an ophthalmology-focused bio-pharmaceutical company which
is developing OK-101 to treat dry eye disease (“DED”) to address the significant unmet need in this multi-billion-dollar
market, today announced financial results for the twelve months ended March 31, 2023 and provided a corporate update on its lead program
in development.
Gary
Jacob, Chief Executive Officer of OKYO, commented, “We are very pleased at the advancements we have made with our flagship drug
OK-101 to treat DED this year. On May 2, 2023, we announced the initiation of our first clinical trial of OK-101 to treat DED. This trial
is a 240 patient, phase 2, multi-center, randomized, double-masked, placebo-controlled trial in patients with DED. This summer we are
expecting to see considerable enrollment of patients in the ongoing trial and are presently on track to have top line data released in
Q4 2023. I am also excited about OK-101’s dual combination of anti-inflammatory ocular activity and neuropathic corneal pain (NCP)
reducing activity. NCP is a debilitating condition characterized by chronic and severe eye discomfort, leading to decreased quality of
life for affected individuals. There is presently no FDA approved drug to treat NCP and we were pleased to recently announce our plan
to open a small trial of OK-101 to treat patients with NCP at Tufts Medical Center in Boston. We remain steadfast in our dedication to
advancing groundbreaking ocular solutions that have the potential to transform patients’ lives. Our team’s resilience and
unwavering focus on research and development will continue to be the driving force behind our progress. We are actively exploring opportunities
to optimize our operational efficiency and enhance our partnerships within the industry. Thank you to our employees, partners, and shareholders
for their continued support as we work diligently to bring about a new treatment to benefit the many millions of patients suffering from
DED.”
2023
Developments Related to OK-101
In
April:
● | OKYO
announced 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 DED. |
In
May:
● | OKYO
announced that the first patient has been screened 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 DED. |
| |
● | OKYO
announced that two presentations were to be given on OK-101 at the American Society of Cataract
and Refractive Surgery (ASCRS 2023) in San Diego, CA, May 5-8, 2023. |
In
June:
● | OKYO
announced that patients were now being dosed in the randomized portion of the phase 2, multi-center,
double-masked, placebo-controlled trial of topical ocular OK-101 to treat DED, following
the two-week placebo run-in period intended to minimize the placebo effect. |
In
July:
● | OKYO
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 patients with neuropathic corneal pain
(“NCP”). The Investigational New Drug (“IND”) application for NCP
is planned to be filed in Q4 of 2023, with study enrollment planned to commence shortly after
IND allowance by the FDA. |
2023
Year End Financial Results
● | For
the twelve months ended 31 March 2023 OKYO reported a loss of $13.7 million compared to $6.3
million in the twelve months ended 31 March 2022. |
● | Research
and development (R&D) expenses increased to $6.3 million for the twelve months ended
31 March 2023 compared to $1.6 million in the twelve months ended 31 March 2022. The increase
is primarily related to the efforts involved in filing an IND for OK-101 in DED. |
● | OKYO
ended the period with $4.0 million cash as of 31 March 2023 as compared to $2.7 million on
31 March 2022. |
OKYO’s
Annual Report on Form 20-F can be accessed by visiting either the SEC’s website at www.sec.gov or the Investors section of the
Company’s website at https://okyopharma.com/investors/corporate-governance/corporate-documents/ .
About
OK-101
OK-101
is a lipid conjugated chemerin peptide agonist 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 NCP; 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 Pharma
OKYO
Pharma Limited (NASDAQ: OKYO) is a life sciences company listed on the NASDAQ capital market. 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.
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 inquiries:
OKYO
Pharma Ltd
Gary
S. Jacob, Ph.D., CEO
U.S.
(917) 497-7560
email:
gjacob@okyopharma.com
Paul
Spencer, Business Development and Investor Relations
+44 (0) 207 495 2379
email: info@okyopharma.com
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