Ovoca Bio PLC - Interim Results
Ovoca Bio plc
("Ovoca" or the "Company")
Interim Results for the six months ended
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· Continued progress towards commencement of a Phase II dose ranging study of BP-101 in
· Acquisition of remaining interest in IVIX LLC ("IVIX"), increasing Ovoca's overall holding in IVIX to 100%
· Cash and cash equivalents at the end of the period were recorded at a fair value of
· Total comprehensive loss of
· Operating expenses for the period stood at
Letter from the CEO
During the period we have continued to make significant progress in the development of BP-101, a 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.
With limited treatment options available, HSDD represents a significant unmet medical need for women around the world. In the US alone an estimated ~4 million premenopausal women are seeking medical treatment for the condition, with a similar prevalence in
BP-101 is a novel synthetic peptide for the treatment of HSDD that is administered through a nasal spray. Ovoca now has full control over BP-101 after acquiring the remaining minority stake in IVIX, the original developer, in
A marketing authorisation (MA) application for BP-101 was filed with the Russian Ministry of Health in
We will provide further information on the Russian MA application in due course, but Management's key focus during the period has been on laying the groundwork for a successful clinical development programme for BP-101 in high value Western markets.
In particular, during the period we have made substantial progress in setting up our Phase II dose ranging study in
We are undertaking the Australian study in order to further validate the results of the Russian studies as well as test a range of doses and, with completion of the concurrent preclinical studies, this will provide data fully compliant with the standards of the International Conference on Harmonisation supportive of a clinical programme in the US and EU. We are expecting to commence enrollment of patients in the last quarter of this calendar year but remain mindful of the potential for the ongoing COVID-19 global pandemic to impact timelines should further lockdowns or restrictions on movement ensue.
During the period we continued to manage our resources carefully, especially in light of the global pandemic. We are pleased to report that the Company has been able to operate without interruption and has not thus far been materially impacted by the global crisis. Ovoca remains in a strong financial position with sufficient funds to meet our current needs and selectively expand the pipeline where attractive opportunities are identified in women's health. As of
Overall we are continuing to make great progress and the Board remains confident about the future prospects 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 first half of the year as we continue our goal of addressing significant unmet needs in the women's health sector.
For further information:
Ovoca Bio plc
Tel +353 1 661 9819
Davy (Nominated Adviser, Euronext Growth Advisor and Broker)
Tel: +353 1 679 6363
Consilium Strategic Communications
Tel: +44 (0)20 3709 5700
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
Ovoca Bio is seeking to develop the drug for major global markets - in particular
Quick facts: Ovoca Bio
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