Ovoca Bio Regulatory News (OVB)

8 August 2019

Ovoca Bio plc

("Ovoca" or the "Company")

AGM Statement

Ovoca Bio plc (LSE: OVB; ISE: OVXA) will hold its Annual General Meeting ("AGM") at 12.00 p.m. today at Buswells Hotel, 23-25 Molesworth Steet, Dublin, Ireland. At the AGM, Kirill Golovanov, Chief Executive of Ovoca, will make the following statement:

"At today's AGM, it is an opportunity to reflect on a year of great operational progress for Ovoca and to reaffirm some of our expected milestones. Key to the company's future strategic direction has been the acquisition of IVIX LLC, with its investigational drug, Libicore (BP-101), for female sexual dysfunction. In March of this year, we executed on the final part of the transaction disclosed at the time of the initial investment, namely the purchase of a further 9.9% of IVIX to bring our shareholding to 59.9%. Simultaneously, we announced the top line results of IVIX's Phase 3 trial of Libicore in Russia, showing achievement of primary and key secondary endpoints without concern for the safety profile. IVIX had enrolled this study comfortably ahead of schedule, and the study was successfully completed early.

With the positive outcome of the Phase 3 study, this has allowed the focus to shift to completing the filing package for marketing authorization in the first launch market, namely the Russian Federation. As indicated in previous statements, Ovoca currently intends to file with the Russian Ministry of Health later this quarter. The usual length of time before an approval decision is issued by the Ministry is approximately 12 months after the date of application filing. During the intervening period, Ovoca will be implementing its plans for Libicore in the rest of the world, supporting further pre-clinical and clinical studies necessary before filing for marketing authorisation in the West."

ENDS

For further information:

Ovoca Bio plc

Kirill Golovanov (Chief Executive)

Tel +353 1 661 9819

info@ovocabio.com

Davy (Nominated Adviser, Euronext Growth Advisor and Broker)

John Frain / Daragh O'Reilly

Tel: +353 1 679 6363

About IVIX: 

IVIX, a Russian‐incorporated company, was formed in 2012 and since that time has sought to develop and subsequently commercialize a proprietary drug candidate, BP-101 (known as "Libicore"), for the treatment of female sexual dysfunction. Libicore is a novel synthetic peptide, administered through a nasal spray. Clinical studies completed to-date have demonstrated statistically significant efficacy in the treatment of a major form of female sexual dysfunction. So far, IVIX has reached and completed Phase III clinical studies in Russia for Libicore. It now intends to seek approval for the marketing of Libicore in the Russian market, as well seek to expand its use internationally.