REG - Ovoca Bio PLC - Annual Financial Report

Ovoca BioAnnouncement

30/06/2022 07:00

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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
(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 (http://www.ovocabio.com) .

 

 

End

 

For further information:

Ovoca Bio plc

Kirill Golovanov (Chief Executive)

Tel +353 1 661 9819

info@ovocabio.com (mailto: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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