Ovoca Bio PLC Interim Results (2324B)

TIDMOVB

RNS Number : 2324B

Ovoca Bio PLC

30 September 2022

Ovoca Bio plc

("Ovoca" or the "Company")

Interim Results for the six months ended 30 June 2022

Dublin, Ireland, 30 September 2022 - Ovoca Bio, a biopharmaceutical company with a focus on women's health, is pleased to announce its interim financial statements and report covering the six-months ending 30 June 2022.

Please click on the following link to view the full Half Year Report:

http://www.rns-pdf.londonstockexchange.com/rns/2324B_1-2022-9-29.pdf

Highlights:

-- Completion of enrollment in Phase II dose ranging study of Orenetide being conducted in Australia and New Zealand:

o 667 women screened in double-blind placebo-controlled study to allow 453 participants to be treated across 13 sites

o Ovoca management team expects enrolled participants will complete the study in Q4 2022 months with the assessment of study results in the first half of 2023

-- Continued investment in new manufacturing processes to establish scalable and improved Orenetide manufacturing process for global markets:

o Ongoing collaboration with leading European peptide manufacturer will support prospective regulatory findings in EU and US as well as longer term clinical development plans

-- Marketing Authorisation for Orenetide under tradename of "Desirix" and all respective permissions to start commercial sales were received from Russian Health Authorities.

-- EUR4.4 (US$4.6) million in cash and cash equivalents as at 30th June 2022, compared to EUR9.3 (US$11.0) million as at 30th June 2021

Letter from the CEO

I am pleased to provide shareholders with an update on Ovoca Bio's operational and financial performance through the first half of 2022.

Our overall strategy remains unchanged, and Ovoca has continued its focus on the clinical development of Orenetide, a first-in-class treatment for women with hypoactive sexual desire disorder (HSDD), a condition characterized by a distressing lack or loss of sexual desire that is estimated to affect as many as one in every ten premenopausal women .

We were delighted to have received our first regulatory approval earlier this year, based on data from two Phase 1 studies, a Phase 2a study and the pivotal Phase 3 study completed in 2019, conducted in Russia, which established the safety and efficacy of Orenetide, a novel synthetic peptide administered via a nasal spray. However, Ovoca's principal focus has been the continuation of our clinical development programme to provide further validation for Orenetide in major international markets. HSDD has been identified by the US Food and Drug Administration as an area of high priority and significant unmet medical need, and we believe the pursuit of this strategy has great potential to generate significant shareholder value.

At the end of July, we were pleased to announce the completion of enrollment into the Company's Phase II dose ranging study of Orenetide being conducted in Australia and New Zealand. The study is investigating Orenetide administered daily at a range of doses, evaluating the effect of the drug on lack or loss of sexual desire experienced in 453 female participants across 13 sites. All enrolled participants have completed the designated course of treatment and Ovoca expects data from the study to become available during the first half of 2023.

The Phase II study will provide data in a Western population fully compliant with the standards of the International Conference on Harmonisation that, if successful in validating the results of the Russian studies and with completion of concurrent preclinical studies, will ultimately support a clinical programme in the US and EU.

With this in mind, we continue advancing to establish scalable and improved Orenetide manufacturing process for western markets, collaborating with one of the leading European peptide manufacturers. This is intended to support the upcoming long-term toxicological assessments, as required by the US Food and Drug Administration and regulatory authorities in Europe and, longer term, our future clinical work and commercialisation plans for Orenetide internationally.

While we are pleased by the significant progress we have made in terms of in clinical development, clearly the ongoing tragic events in Ukraine and Russia are of serious concern.

As we acknowledged in our last update to shareholders, wide-ranging economic sanctions and trade restrictions imposed on Russia by the global community, as well as countermeasures imposed by Russia against the US, UK, EU and some other countries introduce additional risks to Ovoca and the Company's ability to further operate in Russia.

As we made clear in our statement to the market in March, Ovoca has a truly international team and operations, with a presence in Ireland, UK, Australia, as well as Russia. Our subsidiaries in Russia accounted for only 10% of the Group's cashflow this past year, have no affiliation and receive no funding from the Russian state and are not currently subject to EU, US or other international sanctions or restrictions. No member of the Board, management or any of the Company's substantial shareholders are on the list of sanctioned individuals.

As noted above, Marketing Authorisation for Orenetide under tradename of "Desirix" and all respective permissions to start commercial sales were received from Russian Health Authorities in February this year. At present Ovoca is unable to finance any activities related to the manufacturing, marketing or sale of Orenetide in Russia due to the disruption of financial transactions between EU and Russia. We acknowledge that our current inability to finance commercial activities currently limits our ability to generate sales of Desirix in Russia.

Ovoca's board and senior management team is currently assessing various contingency options in relation to its Russian operations, including potential exit options, to the extent that Ovoca's operations in Russia could potentially be limited, suspended or terminated. These discussions are ongoing and we will continue to closely monitor the situation and its impact on Ovoca. We will provide a timely update should any additional risks to the business be identified.

I am pleased to report that Ovoca retains a sustainable financial position. As at 30 June 2022 the Company held cash and cash equivalents of EUR4.4 (US$4.6) million which supports the Company in pursuing its ongoing and planned R&D activities through to 2023. As ever, the Board will remain cautious in its deployment of financial resources in order to ensure the Company has the means to support the continuing clinical development of Orenetide.

Moving forward we will continue to work hard to achieve our vision of building Ovoca Bio into a leader in the research and development of novel medicines in areas of high unmet need that affect women as well as positioning the Company as the commercial partner of choice for others wishing to operate in this fast growing and important area.

I would like to take this opportunity to thank our shareholders for their continue support. We look forward to providing further updates on both our corporate and clinical activities in due course.

End

For further information:

Ovoca Bio plc

Kirill Golovanov (Chief Executive)

Tel +353 1 661 9819

info@ovocabio.com

Davy (Nominated Adviser, Euronext Growth Listing Sponsor and Broker)

Ivan Murphy / Daragh O'Reilly

Tel: +353 1 679 6363

About Ovoca Bio

Ovoca Bio is a European-based biopharmaceutical company with a focus on women's health. The Company is currently developing a novel treatment for women with hypoactive sexual desire disorder (HSDD), a condition characterized by a distressing lack or loss of sexual desire affecting an estimated 4 million premenopausal women in the US alone.

The Company's lead product, Orenetide (BP-101), a novel synthetic peptide administered through a nasal spray, is clinically validated, with Phase II and Phase III studies conducted in Russia demonstrating statistically significant improvement in a number of key efficacy outcomes, including an increase in female sexual desire and reduction of symptoms of distress associated with HSDD.

Ovoca Bio has been granted marketing approval in the Russian Federation and is seeking to develop the drug for major global markets - in particular the United States and Europe.

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