TIDMOVB
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
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 EUR5.8 million (US$7.1 million) and the Company
retained cash and liquid investments at fair value of EUR3.7
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 .
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
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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END
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