TIDMOVB
RNS Number : 7116Q
Ovoca Bio PLC
30 June 2022
Ovoca Bio plc
("Ovoca" or the "Company")
Publication of 2021 Annual Report
Dublin, Ireland, June 30, 2022 - Ovoca Bio, a biopharmaceutical
company with a focus on women's health, announces the publication
of its Annual Report and Financial Statements for the year ended 31
December 2021. The Annual Report and Financial Statements can be
viewed online at the following link:
http://www.rns-pdf.londonstockexchange.com/rns/7116Q_1-2022-6-29.pdf
2021 Highlights
Throughout the reporting period Ovoca Bio focused on the
continued clinical and regulatory development of Orenetide (BP-101
/ "Desirix"), achieving strong results in the following areas:
-- Marketing Authorisation application for Orenetide approved by
the Russian Ministry of Health.
-- Continuing enrolment into the Phase II dose ranging study
assessing Orenetide being conducted in Australia and New Zealand,
with 85% of patients recruited and on track to completion in
mid-2022.
-- Investment in a new manufacturing process and source in
Europe to support the planned Orenetide development globally.
-- Strengthening the Board with the appointments of Anastasia
Levashova and Kristina Zakurdaeva as Non-Executive Directors.
-- Maintenance of a strong financial position.
Letter from the CEO
As CEO and Interim Chairman of Ovoca, I would like to begin my
review of the past year by once again acknowledging the tragic
ongoing events in Ukraine and Russia, and reiterating the Board's
hope for a peaceful resolution to the conflict as soon as
possible.
As we made clear in our statement to the market in March, Ovoca
has a truly international team and operations, with a presence in
Ireland, UK, Australia, as well as Russia. Our subsidiaries in
Russia accounted for only 10% of the Group's cashflow this past
year, have no affiliation and receive no funding from the Russian
state and are not currently subject to EU, US or other
international sanctions or restrictions. No member of the Board,
management or any of the Company's substantial shareholders are on
the list of sanctioned individuals.
However, the wide-ranging economic sanctions and trade
restrictions imposed on Russia by the global community, as well as
counter-measures imposed by Russia against the US, UK, EU and some
other countries may introduce some additional risks on Ovoca and
its ability to further operate in Russia. In the event of
realization some economic and political risks, it cannot be
excluded that Ovoca operations in Russia can be limited, suspended
or terminated. We will continue to closely monitor the situation
and its impact on Ovoca and will provide a timely update should any
additional risks to the business be identified.
Throughout the year, Ovoca has continued its focus on
progressing the development of Orenetide (BP-101 / 'Desirix'), the
Company's 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.
In February 2022, we were pleased to announce that Orenetide was
granted marketing authorisation approval by the Russian Ministry of
Health ("Minzdrav") for the treatment of HSDD in premenopausal
women. Minzdrav approved the medical prescription of Orenetide,
administered through a nasal spray, to patients in the Russian
Federation under the trade name 'Desirix'.
Marketing authorisation approval for Orenetide in Russia is a
welcome development for HSDD patients and we welcome Minzdrav's
decision. Moving forward, we intend to engage in distribution
agreements for the commercialisation of the Desirix treatment in
Russia, however, these commercial plans are exposed to volatile
economic and political risks of Russian operations.
While we are delighted to have received our first regulatory
approval, our principal focus has been the continuation of our
development programme for Orenetide in wider international markets,
which we believe have great potential to generate significant
shareholder value. In January 2021 we enrolled the first patient in
a Phase II dose ranging study in Australia and New Zealand.
This study is investigating Orenetide administered daily at a
range of doses, evaluating the effect of the drug on lack or loss
of sexual desire experienced in up to 476 participating patients
across 13 sites. Recruitment into the study has been impacted by
the COVID-19 pandemic and associated restrictions, but we are
pleased to confirm that at the time of writing the study had
reached over 85% enrolment, with completion of enrolment
anticipated by mid-2022.
Over the past year we have also made a number of important
changes to the Board and senior leadership team at Ovoca, preparing
the Company for the next phase in its development.
Mr. Leonid Skoptsov and Dr. Romulo Colindres made a decision to
step down as a Non-Executive Directors in November-December 2021.
And Chris Wiltshire resigned from the Board and his role of Chief
Business Officer in February 2022.
In November 2021 we welcomed Anastasia Levashova to the Board as
a Non-Executive Director. Anastasia has deep asset management and
investment banking experience and has long-standing relationships
with financial institutions, private investors and other capital
market participants. We look forward to working with Anastasia as
we continue our development activities for Orenetide in major
global markets.
In January this year we welcomed Dr. Kristina Zakurdaeva to our
Board. Dr. Zakurdaeva brings extensive expertise in biotech and
drug development in the USA and globally. Her appointment
significantly adds to the complementary skill sets and breadth of
perspectives on the Board of Ovoca Bio.
I am pleased to report that Ovoca retains a sustainable
financial position, which supports the Company in pursuing its
ongoing and planned R&D activities throughout 2022. As ever the
Board will remain cautious in its deployment of financial resources
in order to ensure the Company has the means to support the
continuing clinical development of Orenetide.
Finally, I would once again like to thank our employees and
partners for their invaluable contributions to the steady progress
of the Group over the past year. With an approved product primed
for commercialisation and promising Phase II trial nearing
completion, I believe we are well positioned to achieve our vision
of becoming a leader in the research and development of, and
commercial partner of choice for, novel medicines in areas of high
unmet need that affect women.
Annual Report
The Annual Report and Financial Statements will shortly be
posted to shareholders and are also available online at the
Company's website , www.ovocabio.com .
End
For further information:
Ovoca Bio plc
Kirill Golovanov (Chief Executive)
Tel +353 1 661 9819
info@ovocabio.com
Davy (Nominated Adviser, Euronext Growth Listing Sponsor and
Broker)
Ivan Murphy / Daragh O'Reilly
Tel: +353 1 679 6363
Consilium Strategic Communications
Chris Gardner / Chris Welsh
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, Orenetide (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 has been granted marketing approval in the Russian
Federation and is seeking to develop the drug for major global
markets - in particular the United States and Europe.
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END
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