REG - Ovoca Bio PLC - Annual Financial Report

Ovoca BioAnnouncement

30/06/2023 07:00

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RNS Number : 4529E  Ovoca Bio PLC  30 June 2023

Ovoca Bio plc

 

("Ovoca" or the "Company")

 

 

Publication of 2022 Annual Report

 

Dublin, Ireland, June 30, 2023 - 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 2022. The Annual Report
and Financial Statements can be viewed online at the following link:

 

http://www.rns-pdf.londonstockexchange.com/rns/4529E_1-2023-6-29.pdf
(http://www.rns-pdf.londonstockexchange.com/rns/4529E_1-2023-6-29.pdf)

 

2022 Highlights

 

During the reporting period, Ovoca dedicated its efforts to the ongoing
clinical and regulatory development of our lead product Orenetide (BP-101),
with notable highlights including the following:

 

·      Continuing enrolment into the Phase II dose ranging study
assessing Orenetide being conducted in Australia and New Zealand. All
participants were successfully recruited by July 2022 and data collection
completed in December 2022. The results of the study are currently being
finalised and are currently expected to be available by August 2023.

·      Further investment in developing a manufacturing process in
Europe to support the planned development of Orenetide for global markets.

·      Ovoca's subsidiary, IVIX, obtained Marketing Authorization for
Orenetide in Russia under the trade name "Desirix" in late February 2022.
Subsequently, all necessary permissions for commencing commercial sales were
obtained in mid-2022. However, Ovoca encountered challenges in establishing a
commercial partnership for sales of Orenetide in Russia due to the
Russia-Ukraine conflict and from the subsequent international sanctions
imposed on the Russian economy and financial system.

·      Maintenance of a sustainable financial position.
 

 

Letter from the CEO

 

As CEO of Ovoca, I would like to begin my review of the Company's activities
in 2022 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. Despite challenges for the Company and its
operations arising as a result, I am proud of the way all the team here at
Ovoca continued to focus on advancing key areas for the development of
Orenetide during the last financial year.

 

During 2022, we continued to progress our ongoing Phase II dose ranging study
being undertaken in Australia and New Zealand. The recruitment of participants
into the study finished in July 2022, with all required study data collection
activities then completed in December. The study results are currently
expected to be delivered in August 2023.

 

This Phase II study is being conducted in Australia and New Zealand to
investigate our lead product candidate Orenetide, a novel treatment for
premenopausal women with hypoactive sexual desire disorder ("HSDD"). This
double-blind placebo-controlled study enrolled 453 participants. The
objectives of the study are to evaluate the effect of three different doses of
Orenetide versus a placebo on a number of clinically relevant and validated
endpoints being assessed between a four-week baseline period and after four
weeks of daily dosing, and then again after a further eight weeks of
no-treatment follow-up. The drug supplied for this study has been outsourced
to well-established manufacturers in Switzerland and the UK.

 

Ovoca has also undertaken strategic investment and collaboration with one of
the leading European peptide manufacturers to develop an enhanced
manufacturing process for Orenetide, aiming to improve its production process.
The first key objective is to deliver sufficient material to support the
upcoming long-term toxicological assessments, as required by the US Food and
Drug Association and regulatory authorities in Europe and, from a strategic
perspective, to secure our future clinical development and commercialization
plans for Orenetide internationally.

 

The tragic events in Ukraine and the subsequent international sanctions
imposed on the Russian economy and financial system completely changed the
paradigm of the Company's operations in Russia during the course of 2022.
Russian Marketing Authorisation was granted for Orenetide in February 2022
under trade name of "Desirix", and all requisite permissions to start
commercial sales were collected in mid-2022. However, following the
developments arising as a result of the conflict in Ukraine, the Company found
itself unable to adequately finance any activities related to the
manufacturing, marketing or sale of Orenetide in Russia due to the disruption
of financial transactions between EU and Russia. This led to substantial
difficulties in securing a licensing agreement with Russian commercial
partners and resulted in an inability to generate sales of Desirix in Russia.

 

As announced by the Company in March 2023, a strategic decision to sell
certain Russian assets related to its clinical development product Orenetide,
namely the Russian patents for Orenetide, the results of completed scientific
development of Orenetide in Russia, together with the right to own a Russian
Marketing Authorization for Orenetide in Russia was taken and approved by
Company Board in March 2023.

 

Following completion of the disposal, Company is in the process of ceasing its
operations in Russia and will continue to focus on progressing the development
of Orenetide in the major international markets.

 

Despite the difficulties that have arisen, these events have not affected
Ovoca's global operations due to our international team and the Company's
presence in Ireland, UK, Australia, as well as Russia. Our subsidiaries in
Russia accounted for only 10% of the Group's cashflow in 2021, with a
decreasing role throughout 2022, and the Company has no affiliation nor
receives any funding from the Russian state, and is 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.

 

The Company continued to manage its resources carefully throughout 2022 and
management has remained vigilant to the potential impact of the ongoing
conflict in Ukraine. Expenditure increased during the year, principally due to
costs associated with the ongoing Phase II study being conducted in Australia
and New Zealand. As a result, the total comprehensive loss for the full year
in 2022 was €5.8 million (US$7.1 million) and the Company retained cash and
liquid investments at fair value of €3.7 million (US$4.0 million) as at 31
December 2022. During 2022, the Company also disposed of its remaining
holdings of ordinary shares of Polymetal International plc.

 

Finally, we were pleased to welcome Kristina Zakurdaeva to the Board as a new
Non-Executive Director in January 2022 and the Company's management and Board
governance remained stable throughout 2022.

 

I would like to conclude by thanking our employees and partners for their
support and contributions to the Group over the past year, in what have been
challenging circumstance. We look forward to receiving the results from the
Phase II trials for Orenetide and updating the market on these in due course
and I continue to believe Ovoca is 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

 

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 (earlier - BP-101), a novel synthetic
peptide administered through a nasal spray, is clinically validated, with
earlier conducted regional Phase II and Phase III studies 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.

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