OKYO Pharma Limited Reports Annual Results for the Twelve Months Ended March 31, 2023
August 15 2023 - 9:00AM
OKYO Pharma Limited Reports Annual Results for the Twelve Months
Ended March 31, 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 StatementsCertain 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., CEOU.S. (917) 497-7560email:
gjacob@okyopharma.com
Paul Spencer, Business Development and Investor Relations+44 (0)
207 495 2379email: info@okyopharma.com
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