OKYO Pharma : Half Year Results

20.09.11 - CDC - Interim Financials to 30 June 2011 - clean OKYO Pharma Limited Interim results for the six months to 30 September 2022 London and New York, NY, December 30, 2022 OKYO Pharma Limited (LSE: OKYO, NASDAQ: OKYO), an ophthalmology-focused bio-pharmaceutical company developing OK-101 to treat dry eye disease (DED) to address the significant unmet need in this multi-billion-dollar market, today announces its interim results for the six months ended 30 September 2022. Clinical Updates: OK-101 During the past six months the Group's primary focus has been centered on accomplishing the filing of the investigational new drug (IND) application with the FDA on OK-101 to treat DED. During this period, the Group completed the following: * topical formulation of the OK-101 drug product as well as initial stability studies * finalized the bioanalytical method development to support the OK-101 clinical program * batch manufacture of cGMP OK-101 for clinical trials * toxicokinetic method development * toxicology studies in rabbits and dogs Both nonclinical and clinical development plans on OK-101 were reviewed with the FDA in an earlier Pre-IND meeting in February 2022 facilitated by OKYO's contract research organization, Ora Inc, with the FDA agreeing to a first-in-human Phase 2 trial in DED patients.

The FDA also concurred with OKYO's plans for designating primary and secondary efficacy endpoints covering both a sign and a symptom of DED in the trial's clinical protocol. After considerable effort over the past 18 months, the Group announced on 21 November 2022 the filing of an IND on OK-101 with FDA to treat DED patients. On December 22, 2022 the Group announced that it had received FDA IND clearance for its planned Phase 2 trial in DED, which it expects to initiate in Q1 2023.

The study has been designed in conjunction with, and will be managed and monitored by Ora Inc, well known for its leadership of ophthalmic clinical trial activities. The Phase 2 trial is expected to be completed in 6-9 months from enrollment of the first patient. OK-201: On 6 August 2019, a collaborative agreement was signed with Pedram Hamrah, MD, Professor of Ophthalmology at Tufts University School of Medicine, Boston, MA to evaluate the Group's BAM8-22 analogues, including OK-201, as non-opioid analgesics to suppress corneal neuropathic pain using a mouse ocular pain model developed in Dr.

Hamrah's laboratory. Neuropathic corneal pain is a severe, chronic and debilitating disease with no FDA approved commercially available treatments currently available for this condition. On 28 April 2021 the company announced positive results of OK-201, a non-opioid analgesic drug candidate delivered topically in Dr.

Hamrah's mouse neuropathic corneal pain model, as a potential drug to treat acute and chronic ocular pain. Importantly, OK-201 demonstrated a reduced corneal pain response equivalent to that of gabapentin, a commonly used oral drug for neuropathic pain. These observations demonstrated preclinical 'proof-of-concept' for the topical administration of OK-201 as a potential non-opioid analgesic for ocular pain.

Although the results with OK-201 were encouraging, due to subsequent success obtained with OK-101 in follow-on animal model studies utilizing the same mouse neuropathic corneal pain model, the company decided at the end of 2021 to pause further development of OK-201 to treat ocular neuropathic pain, and to turn its full attention to the development of OK-101 to treat DED. During the past six months the Group has halted any further work on OK-201 as it focuses its full energies on obtaining IND clearance for OK-101 during the fourth quarter of 2022. This IND filing was successfully cleared and announced on 22 December 2022.

Financial Highlights: * Total assets of PS1.6 million (31 March 2022: PS3.3 million) * Cash on hand of PS0.6 million (31 March 2022: PS2.1 million) * During the financial period under review, the Company reported a total comprehensive loss of PS4.6 million (compared to total comprehensive loss of PS1.8 million for the six months ending September 30 2021) 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 URL.

Enquiries: OKYO Pharma Limited Gary S. Jacob, Chief Executive Officer +44 (0)20 7495 2379 Optiva Securities Limited (Broker) Robert Emmet +44 (0)20 3981 4173 LifeSci Advisors (Investor Relations) Irina Koffler Irina Koffler EMAIL +1-917-734-7387 OKYO Pharma Limited Chairman's statement Dear Shareholders, I am pleased to report on the Group's financial results for the six months ended 30 September 2022. Results to 30 September 2022 During the six months ended 30 September 2022, the Group reported a total comprehensive loss of PS4.6 million (30 September 2021: PS1.8 million).

The Group's shareholders' equity at 30 September 2022 stood at a deficit of PS0.3 million (31 March 2022: PS2.2 million). Cash was PS0.6m at the end of the period (31 March 2022: PS2.1 million). On 19 May 2022, the Group announced the successful dual listing of OKYO Pharma Limited.

on the U.S. Nasdaq stock exchange, concurrent with a successful capital raise of USD $2.5 million. In August 2022, the Group secured a short-term credit facility from Tiziana Life Sciences, a related party, for $2m in order to support short term liquidity.

At 30 September 2022 none of this credit facility had been drawn down. COVID-19 We remain cognisant of the impact of coronavirus (COVID-19) on our operations and have taken the steps necessary to maintain the integrity of the Group's assets and the health and wellbeing of our employees. COVID-19 has not had a material impact on the capability of our research partners ability to commence the next stage of our pre-clinical pipeline.

Indeed, the Group has successfully raised additional funds during this pandemic, with a $2.5m raise in May 2022. Operations in Review OK-101 Project On 6 December 2021 the Group announced that it anticipated the filing of an IND between October and December 2022 on OK-101 for the treatment of dry eye disease ('DED') and initiating a Phase 2 human clinical efficacy trial in DED patients soon thereafter. The trial is anticipated to be conducted in approximately 100 to 200 DED patients and the study is being designed in conjunction with, and will be managed and monitored by Ora, Inc., well known for its expert leadership of clinical trial activities.

The Phase 2 trial is expected to be completed in 6-8 months from enrollment of the first patient. Because the drug is designed to be administered topically to DED patients, and with the help of Ora's deeply knowledgeable team with a proven track record of advancing drug development for dry eye as well as other ophthalmic indications, the Group anticipated that standard Phase 1 studies typically expected with orally delivered drug candidates in non-life-threatening conditions would not be required and, hence, opening the first human trial with OK-101 as a Phase 2 efficacy trial in DED patients. On 13 December 2021 the Group announced that its drug candidate OK-101, which was developed to treat DED through its anti-inflammatory mode of action, also shows potent ocular pain reducing property in a mouse model of corneal neuropathic pain, establishing the potential of OK-101 to treat both pain and inflammation, the most common symptoms of DED.

This work involved a collaboration with Pedram Hamrah, MD, Interim Chair of Ophthalmology, cornea specialist, and clinician-scientist at Tufts Medical Center, Boston. OK-101 was found to suppress corneal pain in a ciliary nerve ligation mouse model of neuropathic corneal pain developed in Dr. Hamrah's laboratory.

OK-101 was topically administered to mice in contrast to the positive control gabapentin which was administered via intraperitoneal injection. Pain relief was evaluated by an eye-wipe count, and OK-101 was shown to reduce corneal pain essentially equivalent to that of gabapentin, a commonly used oral drug for neuropathic pain. Notably, the drug concentration of OK-101 used in this study was identical to that used in mouse models of DED that demonstrated ocular anti-inflammatory activity.

Ocular pain, which can exhibit as a severe, chronic or debilitating condition in patients suffering from a host of ophthalmic conditions, is presently treated by various topical and systemic treatments in an off-label fashion. There are no FDA-approved commercial treatments currently available for this condition. The company is excited about these positive results with OK-101 in our neuropathic corneal pain model of this disease, as it indicates that OK-101's potential to benefit patients with DED may derive from not only its anti-inflammatory activity, but also its pain-reducing potential as well.

During the past six months the Group's primary focus has been centered on further work to accomplish the filing of the investigational new drug (IND) application with the FDA on OK-101 to treat dry eye disease (DED). During this period, the Group accomplished the following: 1) completed topical formulation of the OK-101 drug product as well as initial stability studies, 2) finalized the bioanalytical method development to support the OK-101 clinical program, 3) completed batch manufacture of cGMP OK-101 for clinical trials, 4) completed toxicokinetic method development, 5) completed toxicokinetic method development, 6) completed toxicology studies in rabbits and dogs, and 7) completed stability studies of formulated OK-101. Both nonclinical and clinical development plans on OK-101 were reviewed with the FDA in an earlier Pre-IND meeting in February of this year facilitated by OKYO's contract research organization, Ora Inc, with the FDA agreeing to a first-in-human Phase 2 trial in DED patients.

The FDA also concurred with OKYO's plans for designating primary and secondary efficacy endpoints covering both a sign and a symptom of DED in the trial's clinical protocol. Notably, after considerable effort over the past 18 months the Group announced on 21 November 2022 the filing of the IND on OK-101 with the FDA to treat DED patients. The Group is presently preparing for the initiation of a Phase 2 trial with OK-101 to treat DED patients between January and March 2023.

The study has been designed in conjunction with, and will be managed and monitored by Ora Inc, well known for its leadership of ophthalmic clinical trial activities. The Phase 2 trial is anticipated to be conducted in approximately 240 DED patients and is expected to be completed in 6-8 months from enrollment of the first patient. OK-201 Project The company has decided at this time to postpone for the time being further drug development of OK-201 and focus its full resources on the development of its lead drug candidate OK-101 to treat DED patients.

Summary OKYO is focusing its G-protein coupled technology platform on the development of innovative therapies for inflammatory DED and ocular neuropathic pain management. We set as our goal the filing of an IND on OK-101 to treat DED by the fourth calendar quarter of 2022, and the opening of a Phase two efficacy trial in DED patients in the first calendar quarter of 2023. To do this, over the past six months the company completed all pre-IND work needed to support the filing of the IND.

A key component of this strategy was retaining the services of Ora Inc., a world-class ophthalmology contract research organization, to guide the company's upcoming product development and lead the regulatory strategy of OK-101 for the treatment of DED. Notably, after considerable effort over the past 18 months, the Group announced on 21 November 2022 the filing of the IND on OK-101 with FDA to treat DED patients. The Group is presently preparing for the initiation of a Phase 2 trial with OK-101 to treat DED patients between January and March 2023.

The study has been designed in conjunction with, and will be managed and monitored by Ora Inc, well known for its leadership of ophthalmic clinical trial activities. The Phase 2 trial which is planned to enroll 240 DED patients is expected to be completed in 6-8 months from enrollment of the first patient. OKYO believes that obtaining positive clinical data demonstrating the potential of OK-101 to treat DED through a successful Phase 2 clinical trial in DED patients is expected to bring considerable value to its shareholders based on OKYO's success in the clinic.

Other items Principal risks and uncertainties The Group's principal risks and uncertainties, which could impact the Group for the remainder of the current financial year, are identified on page 14-15 of OKYO Pharma Limited's Annual Report for the year ended 31 March 2022 which is available on the Company's website. These risks are as follows: clinical studies fail to generate encouraging data, ability to scale up the Group, intellectual property risk, competition risk, funding risk and dependence on key personnel. The Directors have reviewed these principal risks and uncertainties and the Directors confirm the risks are still applicable for the remainder of the year.

Important Events On May 19, 2022, the Group announced the successful dual listing of OKYO Pharma Limited. on the U.S. Nasdaq stock exchange, concurrent with a successful capital raise of USD $2.5 million of gross proceeds.

On November 18, 2022, the Group successfully filed its IND application with the U.S. Food and Drug Administration (FDA) for the development of OK-101 to treat dry eye disease (DED). On December 18, 2022, having received no comments from FDA, the Group became authorized to commence its clinical program.

Related party transactions Tiziana Life Sciences Ltd is a related party as the entity is controlled by a person that has significant influence over the Group. The Company shares premises and other resources with Tiziana Life Sciences Ltd and there is a shared services agreement in place between Company and Tiziana Life Sciences Ltd for the six months ended September 30, 2022, the Company had incurred PS60,718 worth of costs in relation to this agreement and as at September 30, 2022, PS112,439 was due to Tiziana Life Sciences Ltd. In August 2022, the Group secured a short-term credit facility from Tiziana Life Sciences, a related party, for $2m in order to support short term liquidity.

The credit facility is available for a period of 6 months upon first draw-down and carries an interest rate of 16% per annum, with additional default interest of 4% if the credit facility is not repaid after the 6-month period. To date of this report, $1m has been drawn down against the credit facility. Going Concern The cash burn rate from the beginning of December 2022 to the end of March 2023 is projected at PS2.8m ($3.3m), and the company projects that without additional financing facilities it will run out of cash in January 2023.

Consequently, in the opinion of the directors there is a material uncertainty that may cause significant doubt about the Group's ability to continue as a going concern. The Directors are confident that the impending OK-101 clinical development program, which is about to get underway in early 2023, should provide various inflection points over a relatively short period of time which can provide financing opportunities. For example, the recent FDA approval in December 2022 of the IND filing of OK-101 to treat DED that was filed on 18 November 2022 has been extremely useful with the ongoing capital raise presently underway with the Company's investment bankers.

The initiation of the Phase II trial of OK-101 in early 2023 along with the release of top-line clinical data from that trial anticipated between October and December 2023 provide additional inflection points for future capital raises. These pivotal events in the primary clinical program for OK-101 have the benefit of being relatively near-term events (which is unusual in the general context of the normal timeframes for Phase II clinical programs to deliver meaningful data points). The Directors have consulted the Company's investment bankers and on December 6, 2022 the Company filed a registration statement with the U.S.

Securities and Exchange Commission for a secondary offering in the US for $12m. To meet the Company's short-term liquidity needs, the Company secured a $2m (approximately PS1.6m) short-term credit facility with a related party in order to bridge any delays in the occurrence of the anticipated clinical milestones for the OK-101 program. The credit facility is available for a period of 6 months upon first draw-down and carries an interest rate of 16% per annum, with additional default interest of 4% if the credit facility is not repaid after the 6-month period.

The credit facility will extend the Company's fixed cost cash burn to April 2023 without the need to raise additional funds. To date, $1m has been drawn down from the credit facility. This facility together with additional working-capital management measures were sufficient to complete the IND application on OK-101 which was filed with FDA on 18 November 2022.

With the completion of the successful IND filing of OK-101 on 18 November 2022 with the FDA, the company is presently in the position of raising funds in the US market, via the financing strategy entered into with the Company's investment bankers. As mentioned above, the Company filed a registration statement with the U.S. Securities and Exchange Commission for a secondary offering in the US for $12m.The necessary steps are being taken to affect such a fundraise.

The Company has considered additional working-capital management and financing measures in case the fundraise is delayed beyond January 2023. Until and unless the Group and Company secures sufficient investment to fund their clinical pipeline, there is a material uncertainty that may cast significant doubt on the Group and Company's ability to continue as a going concern, and therefore, that it may be unable to realize its assets and discharge its liabilities in the normal course of business. Despite this material uncertainty, the Directors conclude that it is appropriate to continue to adopt the going concern basis of accounting as the Directors are confident, based on the previous fund-raising history as well as additional measures already put in place and being planned, that sufficient funds will be forthcoming and accordingly they have prepared these interim consolidated financial statements on a going concern basis.

Statement of Directors' responsibilities The Directors are responsible for preparing the half-yearly financial report in accordance with applicable laws and regulations. The Directors confirm to the best of their knowledge: a) The interim consolidated financial statements, prepared in accordance with International Accounting Standard 34 Interim Financial Reporting give a true and fair view of the assets, liabilities, financial position and profit and loss of the Company and the undertakings included in the consolidation taken as a whole; and b) The Chairman's statement includes a fair review of the development and performance of the business and the position of the Company and the undertakings included in the consolidation taken as a whole, together with a description of the principal risks and uncertainties they face. Gabriele Cerrone Non-Executive Chairman 30 December 2022 5 23 OKYO Pharma Limited Consolidated statement of comprehensive income for the six months ended 30 September 2022 Notes Six months ended 30 September 2022 (unaudited) Six months ended 30 September 2021 (una