TIDMOVB
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 EUR6.7 million and the Company also
held equity investments at fair value of EUR6.9 million
-- Total comprehensive loss of EUR15,000 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 EUR2.0 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 EUR6.7 million and the Company also
held equity investments at fair value of EUR6.9 million. The
Company reported a total comprehensive loss of EUR15,000 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 EUR2.2 million. Operating
expenses for the period stood at EUR2.0 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 +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
Consilium Strategic Communications
Chris Gardner, Chris Welsh, Carina Jurs
ovocabio@consilium-comms.com
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 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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END
IR EASNPFALEEFA
(END) Dow Jones Newswires
September 21, 2020 02:00 ET (06:00 GMT)
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