Interim Results

RNS Number : 4870Z

Ovoca Bio PLC

21 September 2020

 

Ovoca Bio plc

("Ovoca" or the "Company")

Interim Results for the six months ended 30 June 2020

Dublin, Ireland, 21 September, 2020 - Ovoca Bio, a biopharmaceutical company with a focus on women's health, is pleased to announce its interim financial statements and report covering the six-months ending 30 June 2020.

Please click on the following link to view the full Half Year Report:

http://www.rns-pdf.londonstockexchange.com/rns/4870Z_1-2020-9-18.pdf

Highlights:

· Continued progress towards commencement of a Phase II dose ranging study of BP-101 in Australia

· 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 €6.7 million and the Company also held equity investments at fair value of €6.9 million

· Total comprehensive loss of €15,000 for the first six-months of 2020 adjusting for movements in exchange rates and the fair value of equity securities held by the Company

· Operating expenses for the period stood at €2.0 million, reflecting the Company's increased spend on the preclinical and clinical development of BP-101

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 Europe.

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 March 2020. We have been fully focussed on continuing the preclinical and clinical development of BP-101 throughout the period.

A marketing authorisation (MA) application for BP-101 was filed with the Russian Ministry of Health in September 2019 after the drug returned positive data from a pivotal Phase III trial conducted in Russia. The data showed that BP-101 demonstrated a strong efficacy profile in premenopausal 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.

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 Australia. We have been working closely with our selected local Clinical Research Organisation and Australian experts in the treatment of HSDD, enabling us to produce the detailed documentation to support the clinical trial and identify suitable patient enrollment sites in Australia and New Zealand.  Also, the Company has entered into drug supply agreements with two UK contract manufacturers for the finished BP-101 product to be tested in the clinical trial, using the active pharmaceutical ingredient produced by our Swiss manufacturer. All of these companies have extensive experience in successfully producing drugs like ours for clinical trials.  

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 30 June 2020, cash and cash equivalents were recorded at a fair value of €6.7 million and the Company also held equity investments at fair value of €6.9 million. The Company reported a total comprehensive loss of €15,000 for the first six-months of 2020, strengthened by an increase in the fair value of equity securities held by the Company; these securities are held in the precious metals sector which has performed strongly during the global pandemic. During the period, the Company disposed of 145,000 shares in Polymetal International plc, with the net proceeds from the sales   amounting to €2.2 million.   Operating expenses for the period stood at €2.0 million, reflecting the Company's increased spend on the preclinical and clinical development of BP-101 for Western markets.

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.

Sincerely,

Kirill Golovanov

CEO

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), 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 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.

 

END

 

 

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