Annual Report and Notice of AGM

RNS Number : 8971C

Ovoca Bio PLC

24 June 2021

 

Ovoca Bio plc

("Ovoca" or the "Company")

Publication of 2020 Annual Report

and

Notice of AGM

Dublin, Ireland, June 24, 2021 - 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 2020. The Annual Report and Financial Statements can be viewed online at the following link:

http://www.rns-pdf.londonstockexchange.com/rns/8971C_1-2021-6-23.pdf

2020 Highlights

In its second full year as a biotechnology company, Ovoca focused on achieving strong results in the following areas:

• First patient enrollment in the Phase II dose ranging study assessing BP-101 being conducted in Australia and New Zealand

• Marketing Authorisation ("MA") application for BP-101 updated and refiled with the Russian Ministry of Health (the "Minzdrav")

• Maintenance of a strong financial position 

Letter from the CEO

My report this year takes account of my combined role as CEO and Interim Chairman following the unexpected passing last Autumn of former Executive Chairman, colleague and friend, Dr. Mikhail Mogutov. Indeed, 2020 was a year marked by sadness and great uncertainty due to the impact of the global COVID-19 pandemic, but despite this, Ovoca has maintained its focus on developing novel treatments in areas of unmet medical need in the women's health sector, making steady progress in the development of BP-101, a novel treatment for women with hypoactive sexual desire disorder (HSDD).

HSDD is one of the most common female sexual problems and is estimated to affect about one in ten premenopausal women. Treatments are few and far between, so if approved, BP-101 can be expected to be a welcome addition to the treatment options available to an estimated 4 million premenopausal women in the US seeking medical treatment for the condition, as well as similarly affected population in Europe and other regions around the world.

In the market where BP-101's development for the treatment of HSDD is most advanced, Russia, our Marketing Authorization application is under review by the Russian Ministry of Health and we can expect a decision by the end of this calendar year. This filing specifically addressed issues raised by the Ministry, which we believe are now remedied and pave the way towards approval to commercialize the product in the Russian Federation. To this end, the Company will partner with an established pharmaceutical company in Russia best able to commercialize BP-101 as quickly as possible after approval. Discussions are progressing with a leading local candidate that can both manufacture and distribute BP-101.

With respect to development in the rest of the world, in January 2021 we announced the first patient had been enrolled in our clinical study to help validate BP-101 internationally. The Phase II dose ranging study is now recruiting patients in Australia and New Zealand and has been designed to investigate BP-101 administered daily at a range of doses, evaluating the effect of the drug on lack or loss of sexual desire. This double-blind placebo-controlled study is our largest yet with a goal to enrol 476 patients across 13 sites. The successful organization, approval and start-up of the study was a considerable achievement against a highly uncertain backdrop due to COVID-19, and this is entirely due to the hard work and commitment of our colleagues and partners in those countries and the UK and Russia, representing a true international effort. Upon launch of the trial we were pleased to see widespread media coverage reporting on BP-101 and the clinical study across multiple news outlets in Australia, including national TV. This highlighted the high level of interest in female sexual dysfunction, the imbalance in treatment options between men and women and BP-101 as a potential remedy.

At the moment, our focus with BP-101 is focused entirely on HSDD. However, a review of clinical data from the Phase II and Phase III trials conducted in Russia shows the drug's potential application in the treatment of Female Orgasmic Disorder. Orgasmic absence or difficulty, with or without distress, is a common occurrence. Nationally representative studies indicate that orgasmic difficulty affects 16-28% of women in the United States, Europe, Central and South America, and Mainland China. To help realize BP-101's full potential, the Company is exploring the best way to investigate BP-101's beneficial activity in this area of high unmet need, second only to sexual desire disorders in being the most frequently reported women's sexual dysfunction.

The Board remains mindful of the economically unsettled times that have been brought on by the COVID-19 pandemic, and its existing commitments such as to the ongoing Phase II dose ranging studies. We continue to closely monitor patient recruitment in Australia and New Zealand to ensure we have an accurate assessment of how long until clinical study completion, our next major development milestone. Therefore, we are being cautious in how we deploy current resources, and to ensure we have adequate means to support the current stage of development of BP-101. We are pleased to report that Ovoca Bio plc has maintained a strong capital base since we last reported. Expansion into new opportunities in women's health will only be pursued provided enough incremental capital is available after satisfying the Group's current plans and needs.

We remain optimistic about future trading prospects and operating conditions, tempered only by the delays and uncertainty occasioned by the continuing pandemic. There is, however, no expectation that COVID-19 will prevent us from our achieving our goal of relieving the suffering caused by female sexual dysfunction and, ultimately, our vision to become 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.

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 course of a disrupted 2020 due to COVID-19.  We are all looking forward to greater personal interactions once global conditions allow, and to more usual business conditions. In the meantime, we wish all our stakeholders good health while we continue to work toward developing shareholder value

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 .

Notice of Annual General Meeting

The Notice of Annual General Meeting ("AGM"), containing details of the resolutions to be proposed at the AGM, has also been published and will shortly be posted to shareholders. The Notice of AGM is also available on the Company's website at www.ovocabio.com . The AGM will be held at the registered office of the Company, 17 Pembroke Street Upper, Dublin 2, Ireland at 2.30pm on 29 July 2021.

AGM Procedures in light of Coronavirus (COVID-19)

Due to the continuation of the Irish Government's Covid-19 restrictions in relation to public gatherings and to prioritise the health and safety of our shareholders, employees and other stakeholders, the Board is requesting that shareholders do not physically attend the AGM and instead submit a proxy form in favour of the Chairman to ensure they can vote and be represented at the AGM without attending in person. Further information on how to appoint a proxy and the timelines by which proxies must be received are contained in the Notice of AGM.

It will be possible to listen to the proceedings of this year's AGM remotely using a teleconference facility provided by the Company. Shareholders will not be able to use this facility to vote, ask questions or table resolutions. Information on how to register for this teleconference facility is available on the Company's website at www.ovocabio.com/agm-registration .  

All shareholders will be able to submit questions in advance of the AGM in writing by email to the Company Secretary at [e-mail]   to be received no later than 5.00pm on Tuesday, 27 July 2021. All correspondence should include sufficient information to identify the shareholders on the Register of Members. Questions submitted using these methods will be addressed by the Chairman at the AGM where possible.

As the situation is evolving and the Irish Government guidance may change, shareholders are encouraged to check the Company's website for any further updates regarding the AGM.

End

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).

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 is seeking to develop the drug for major global markets - in particular the United States and Europe, as well as obtain marketing approval in the Russian Federation. 

 

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