Annual Report

RNS Number : 1383R

Ovoca Bio PLC

26 June 2020

 

Ovoca Bio plc

("Ovoca" or the "Company")

Publication of 2019 Annual Report

Dublin, Ireland, June 26, 2020 - 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 2019. The Annual Report and Financial Statements can be viewed online at the following link:

http://www.rns-pdf.londonstockexchange.com/rns/1383R_1-2020-6-25.pdf

2019 Highlights

· Successful completion of Phase III study of BP-101 in Russia demonstrating statistically significant improvement in a number of key efficacy outcomes in HSDD

· Filing for approval for the marketing of BP-101 in Russia

· Increase of its interest in the charter capital of its subsidiary, IVIX LLC, which holds the commercial rights to BP-101, to 100.0 per cent of outstanding equity

· Selection of Australia as the most suitable choice for the next stage of clinical development of BP-101, along with identification of European regulatory needs and commissioning of clinical trial drug supplies

· Successful prosecution of intellectual property with granting of patents in the EU and Japan

· Maintenance of strong financial position.

Letter from the CEO

It is my pleasure to provide you with an update on what has been a significant and exciting year for Ovoca Bio.

With the Company's mission now focused on the women's health sector in areas of high unmet medical need, we have been able to make significant progress in the development of BP-101, a novel treatment for women with hypoactive sexual desire disorder (HSDD), a condition characterised by a distressing lack or loss of sexual desire.

HSDD, is one of the most common female sexual problems and is estimated to affect about one in ten premenopausal women. It represents a significant unmet medical need and market opportunity with an estimated ~4 million premenopausal women in the US seeking medical treatment for the condition. The prevalence of HSDD in this population in Europe is similar to the US.

Since the initial acquisition in 2018 of IVIX LLC, the original developer of BP-101, we have made significant progress in the clinical and commercial development of the asset guided by regulatory interactions with the health authorities in the Russian Federation, Germany and the USA. Data from a Russian pivotal Phase III trial of BP-101, which we announced in March 2019, showed that the drug demonstrated a strong efficacy profile in patients with HSDD. Patients reported a significant increase in the number of satisfying sexual events when compared to a placebo controlled group, as well as a significant improvement in sexual desire and reduction of distress associated with low sexual desire.

In September 2019, we were pleased to announce the submission of a marketing authorisation application for BP-101 with the Russian Ministry of Health. If approved, BP-101 could be available for marketing in the Russian Federation towards the end of 2020, an exciting and significant development for the Company.

We look forward to providing further updates, including potential partnering/ licensing opportunities for commercialisation in the Russian Federation, in due course.

Most recently, management's focus has been on establishing international operations in preparation for commencement of a dose ranging study in a western population which is an important step in the development of BP-101 for higher valued healthcare markets. We have elected Australia as the preferred site for this Phase II study, which is expected to further validate the results of the Russian studies and, with completion of the concurrent preclinical studies, provide data fully compliant with the standards of the International Conference on Harmonisation that will ultimately support a clinical programme in the US and EU.

Australia has so far been one of the least affected countries by the COVID-19 pandemic, and based on the present situation there, we are expecting to commence enrolment of patients later this calendar year.

Finally, in March 2020, we were pleased to acquire the remaining minority shareholding in IVIX LLC for a consideration of approximately US$5 million, funded through existing capital resources. This represented a further significant milestone and, with full control of IVIX LLC, places us in a position to accelerate the BP-101 development programme.

Reflecting the company's strategic shift, over the year there have been a number of Board changes to support our growing status in the international biotechnology community as a women's health company.

We again thank Yuri Radchenko and Nikolay Myasoyedov for their greatly valued services to the Board. We have also formalized an advisory board of scientific experts to advise on our current and future pipeline opportunities, and we anticipate further announcements on this in due course.

In these economically unsettled times brought on by the COVID-19 pandemic, it is important to have sound finances, and we are pleased to report that Ovoca Bio plc continues to have a strong capital base. This will be used to support the exciting development of our lead programme, BP-101 in HSDD, and selectively to expand the pipeline where attractive opportunities are identified in women's health. The Board remains highly optimistic for the future of the Company and its potential to realize significant value for our shareholders.

I would like to thank our employees and partners for enabling the strong progress over the course of the year as we continue our goal of addressing significant unmet needs in the women's health sector.

Annual Report

The Annual Report and Financial Statements have been 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 Advisor and Broker)

John Frain / Daragh O'Reilly

Tel: [phone]

Consilium Strategic Communications

Chris Gardner, Chris Welsh, Carina Jurs

[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, 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 filed for approval for the marketing of BP-101 in Russia and is seeking to develop the drug for major global markets - in particular the United States and Europe.

 

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