Ovoca Bio PLC Annual Report and Notice of AGM (7120D)

TIDMOVB

RNS Number : 7120D

Ovoca Bio PLC

28 June 2019

28 June 2019

Ovoca Bio plc

("Ovoca" or the "Company")

Publication of 2018 Annual Report

and

Notice of AGM

Ovoca is pleased to announce the publication of its Annual Report and Financial Statements for the year ended 31 December 2018. Please click on the following link to view the Annual Report and Financial Statements:

http://www.rns-pdf.londonstockexchange.com/rns/7120D_1-2019-6-27.pdf

Highlights 2018:

Since Ovoca announced the acquisition of Russian biotechnology firm, IVIX LLC, on 4th July 2018, Ovoca has made considerable progress in implementing its strategic refocus away from gold mining and development. In particular, Ovoca achieved notable success in the following areas in 2018:

   --      Completion of the acquisition of IVIX on 25th September 2018; 

-- Recruitment of patients ahead of schedule to the Russian Phase 3 clinical trial of BP101, the Company's first drug candidate for the treatment of female sexual dysfunction;

-- External expert review of BP101 preclinical and scientific data has been conducted and a programme identified to address all the regulatory needs for clinical development in the EU and United States.

Letter from the CEO:

With the successful conclusion of last year's acquisition of IVIX LLC ("IVIX") and the re-admission of the enlarged group on Euronext Dublin and the London Stock Exchange, the foundation was put in place for establishing Ovoca as a recognized developer of novel therapeutics for women's health, especially in the area of sexual dysfunction. Our colleagues at IVIX continue to build out our successful BP101 program, which you will have seen in March 2019 comfortably exceeded the efficacy and safety hurdles in its Phase 3 trial in Russia. As a result, we are now preparing to file for the drug's marketing approval in its first country, the Russian Federation, and actively pursuing discussions with potential licensing partners to commercialize there.

Looking more expansively, to realize the large global potential of BP101 and to build Ovoca's future pipeline, the Company will pursue its transformation further into an international biotechnology development company, growing its presence and relationships outside of the home territory. Over the course of this year and into the next, we will be seeking to strengthen our international team and advisers, and increasing our visibility and the familiarity of stakeholders with our exciting story and plans. Shortly, we plan to publish which scientific experts will be advising us on our current and future pipeline opportunities. In parallel with these initiatives, we shall, of course, be completing the remaining essential activities that BP101 requires to make it an attractive partnering candidate globally and worthy of further financing where we choose to retain commercial rights.

We trust you are as enthusiastic as we are about Ovoca's bright prospects in its new form. Moreover, we hope that last year's strong progress and our current plans help reinforce the view that Ovoca should be a company that investors want to be part of during its value-creating future.

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

Annual General Meeting:

The Notice of Annual General Meeting ("AGM") has also been published and will shortly be posted to shareholders. The AGM is convened to be held at Buswells Hotel, 23-25 Molesworth Steet, Dublin 2, Ireland on 8(th) August 2019 at 12.00 p.m. The Notice of AGM contains details of all resolutions to be proposed at the AGM. Copies of the Notice of AGM are also available on the Company's website, www.ovocabio.com.

ENDS

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]

About Ovoca Bio plc

Ovoca Bio plc's goal is to become a leader in the development and commercialization of novel product candidates for the treatment of female sexual dysfunctions. In 2018, Ovoca Bio acquired IVIX and its promising clinical stage asset, Libicore (BP-101), for female sexual dysfunction, an area of significant unmet medical need. The magnitude of demand for treatments for female sexual dysfunction has only recently been recognized, and Ovoca believes it has the potential to become a substantial pharmaceutical market.

About IVIX

IVIX, a Russian--incorporated company, was formed in 2012 and since that time has sought to develop and subsequently commercialise a proprietary drug candidate, BP101 (known as "Libicore"), for the treatment of female sexual dysfunctions. Libicore is a novel synthetic peptide, administrated through a nasal spray. Clinical studies completed to-date have demonstrated statistically significant efficacy in the treatment of major forms of female sexual dysfunction. So far, IVIX has reached and completed Phase II clinical studies in Russia for Libicore. It now intends to complete the ongoing Phase III clinical trial for Libicore, following which it will seek approval for the marketing of Libicore in the Russian market, as well seek to expand its use internationally.

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact [e-mail] or visit www.rns.com.

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June 28, 2019 02:00 ET (06:00 GMT)