Annual Financial Report

RNS Number : 7116Q

Ovoca Bio PLC

30 June 2022

 

Ovoca Bio plc

("Ovoca" or the "Company")

Publication of 2021 Annual Report

Dublin, Ireland, June 30, 2022 - Ovoca Bio, a biopharmaceutical company with a focus on women's health, announces the publication of its Annual Report and Financial Statements for the year ended 31 December 2021. The Annual Report and Financial Statements can be viewed online at the following link:

http://www.rns-pdf.londonstockexchange.com/rns/7116Q_1-2022-6-29.pdf

2021 Highlights

Throughout the reporting period Ovoca Bio focused on the continued clinical and regulatory development of Orenetide (BP-101 / "Desirix"), achieving strong results in the following areas:

· Marketing Authorisation application for Orenetide approved by the Russian Ministry of Health.

· Continuing enrolment into the Phase II dose ranging study assessing Orenetide being conducted in Australia and New Zealand, with 85% of patients recruited and on track to completion in mid-2022.

· Investment in a new manufacturing process and source in Europe to support the planned Orenetide development globally.

· Strengthening the Board with the appointments of Anastasia Levashova and Kristina Zakurdaeva as Non-Executive Directors.

· Maintenance of a strong financial position. 

Letter from the CEO

As CEO and Interim Chairman of Ovoca, I would like to begin my review of the past year by once again acknowledging the tragic ongoing events in Ukraine and Russia, and reiterating the Board's hope for a peaceful resolution to the conflict as soon as possible.

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.

However, the wide-ranging economic sanctions and trade restrictions imposed on Russia by the global community, as well as counter-measures imposed by Russia against the US, UK, EU and some other countries may introduce some additional risks on Ovoca and its ability to further operate in Russia. In the event of realization some economic and political risks, it cannot be excluded that Ovoca operations in Russia can be limited, suspended or terminated. We will continue to closely monitor the situation and its impact on Ovoca and will provide a timely update should any additional risks to the business be identified.

Throughout the year, Ovoca has continued its focus on progressing the development of Orenetide (BP-101 / 'Desirix'), the Company's novel treatment for hypoactive sexual desire disorder (HSDD), a condition characterised by a distressing lack or loss of sexual desire that is estimated to affect as many as one in ten premenopausal women.

In February 2022, we were pleased to announce that Orenetide was granted marketing authorisation approval by the Russian Ministry of Health ("Minzdrav") for the treatment of HSDD in premenopausal women. Minzdrav approved the medical prescription of Orenetide, administered through a nasal spray, to patients in the Russian Federation under the trade name 'Desirix'.

Marketing authorisation approval for Orenetide in Russia is a welcome development for HSDD patients and we welcome Minzdrav's decision. Moving forward, we intend to engage in distribution agreements for the commercialisation of the Desirix treatment in Russia, however, these commercial plans are exposed to volatile economic and political risks of Russian operations.

While we are delighted to have received our first regulatory approval, our principal focus has been the continuation of our development programme for Orenetide in wider international markets, which we believe have great potential to generate significant shareholder value. In January 2021 we enrolled the first patient in a Phase II dose ranging study in Australia and New Zealand.

This 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 up to 476 participating patients across 13 sites. Recruitment into the study has been impacted by the COVID-19 pandemic and associated restrictions, but we are pleased to confirm that at the time of writing the study had reached over 85% enrolment, with completion of enrolment anticipated by mid-2022.

Over the past year we have also made a number of important changes to the Board and senior leadership team at Ovoca, preparing the Company for the next phase in its development.

Mr. Leonid Skoptsov and Dr. Romulo Colindres made a decision to step down as a Non-Executive Directors in November-December 2021. And Chris Wiltshire resigned from the Board and his role of Chief Business Officer in February 2022.

In November 2021 we welcomed Anastasia Levashova to the Board as a Non-Executive Director. Anastasia has deep asset management and investment banking experience and has long-standing relationships with financial institutions, private investors and other capital market participants. We look forward to working with Anastasia as we continue our development activities for Orenetide in major global markets.

In January this year we welcomed Dr. Kristina Zakurdaeva to our Board. Dr. Zakurdaeva brings extensive expertise in biotech and drug development in the USA and globally. Her appointment significantly adds to the complementary skill sets and breadth of perspectives on the Board of Ovoca Bio.

I am pleased to report that Ovoca retains a sustainable financial position, which supports the Company in pursuing its ongoing and planned R&D activities throughout 2022. 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.

Finally, I would once again like to thank our employees and partners for their invaluable contributions to the steady progress of the Group over the past year. With an approved product primed for commercialisation and promising Phase II trial nearing completion, I believe we are well positioned to achieve our vision of becoming a leader in the research and development of, and commercial partner of choice for, novel medicines in areas of high unmet need that affect women.

Annual Report

The Annual Report and Financial Statements will shortly be posted to shareholders and are also available online at the Company's website , www.ovocabio.com .

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For further information:

Ovoca Bio plc

Kirill Golovanov (Chief Executive)

Tel [phone]

[e-mail]

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

Ivan Murphy / Daragh O'Reilly

Tel: [phone]

Consilium Strategic Communications

Chris Gardner / Chris Welsh

[e-mail]

Tel: [phone]

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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