TIDMOVB
RNS Number : 8971C
Ovoca Bio PLC
24 June 2021
Ovoca Bio plc
("Ovoca" or the "Company")
Publication of 2020 Annual Report
and
Notice of AGM
Dublin, Ireland, June 24, 2021 - 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 2020. The Annual Report and Financial Statements can be
viewed online at the following link:
http://www.rns-pdf.londonstockexchange.com/rns/8971C_1-2021-6-23.pdf
2020 Highlights
In its second full year as a biotechnology company, Ovoca
focused on achieving strong results in the following areas:
-- First patient enrollment in the Phase II dose ranging study
assessing BP-101 being conducted in Australia and New Zealand
-- Marketing Authorisation ("MA") application for BP-101 updated
and refiled with the Russian Ministry of Health (the
"Minzdrav")
-- Maintenance of a strong financial position
Letter from the CEO
My report this year takes account of my combined role as CEO and
Interim Chairman following the unexpected passing last Autumn of
former Executive Chairman, colleague and friend, Dr. Mikhail
Mogutov. Indeed, 2020 was a year marked by sadness and great
uncertainty due to the impact of the global COVID-19 pandemic, but
despite this, Ovoca has maintained its focus on developing novel
treatments in areas of unmet medical need in the women's health
sector, making steady progress in the development of BP-101, a
novel treatment for women with hypoactive sexual desire disorder
(HSDD).
HSDD is one of the most common female sexual problems and is
estimated to affect about one in ten premenopausal women.
Treatments are few and far between, so if approved, BP-101 can be
expected to be a welcome addition to the treatment options
available to an estimated 4 million premenopausal women in the US
seeking medical treatment for the condition, as well as similarly
affected population in Europe and other regions around the
world.
In the market where BP-101's development for the treatment of
HSDD is most advanced, Russia, our Marketing Authorization
application is under review by the Russian Ministry of Health and
we can expect a decision by the end of this calendar year. This
filing specifically addressed issues raised by the Ministry, which
we believe are now remedied and pave the way towards approval to
commercialize the product in the Russian Federation. To this end,
the Company will partner with an established pharmaceutical company
in Russia best able to commercialize BP-101 as quickly as possible
after approval. Discussions are progressing with a leading local
candidate that can both manufacture and distribute BP-101.
With respect to development in the rest of the world, in January
2021 we announced the first patient had been enrolled in our
clinical study to help validate BP-101 internationally. The Phase
II dose ranging study is now recruiting patients in Australia and
New Zealand and has been designed to investigate BP-101
administered daily at a range of doses, evaluating the effect of
the drug on lack or loss of sexual desire. This double-blind
placebo-controlled study is our largest yet with a goal to enrol
476 patients across 13 sites. The successful organization, approval
and start-up of the study was a considerable achievement against a
highly uncertain backdrop due to COVID-19, and this is entirely due
to the hard work and commitment of our colleagues and partners in
those countries and the UK and Russia, representing a true
international effort. Upon launch of the trial we were pleased to
see widespread media coverage reporting on BP-101 and the clinical
study across multiple news outlets in Australia, including national
TV. This highlighted the high level of interest in female sexual
dysfunction, the imbalance in treatment options between men and
women and BP-101 as a potential remedy.
At the moment, our focus with BP-101 is focused entirely on
HSDD. However, a review of clinical data from the Phase II and
Phase III trials conducted in Russia shows the drug's potential
application in the treatment of Female Orgasmic Disorder. Orgasmic
absence or difficulty, with or without distress, is a common
occurrence. Nationally representative studies indicate that
orgasmic difficulty affects 16-28% of women in the United States,
Europe, Central and South America, and Mainland China. To help
realize BP-101's full potential, the Company is exploring the best
way to investigate BP-101's beneficial activity in this area of
high unmet need, second only to sexual desire disorders in being
the most frequently reported women's sexual dysfunction.
The Board remains mindful of the economically unsettled times
that have been brought on by the COVID-19 pandemic, and its
existing commitments such as to the ongoing Phase II dose ranging
studies. We continue to closely monitor patient recruitment in
Australia and New Zealand to ensure we have an accurate assessment
of how long until clinical study completion, our next major
development milestone. Therefore, we are being cautious in how we
deploy current resources, and to ensure we have adequate means to
support the current stage of development of BP-101. We are pleased
to report that Ovoca Bio plc has maintained a strong capital base
since we last reported. Expansion into new opportunities in women's
health will only be pursued provided enough incremental capital is
available after satisfying the Group's current plans and needs.
We remain optimistic about future trading prospects and
operating conditions, tempered only by the delays and uncertainty
occasioned by the continuing pandemic. There is, however, no
expectation that COVID-19 will prevent us from our achieving our
goal of relieving the suffering caused by female sexual dysfunction
and, ultimately, our vision to become 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.
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 course of a disrupted 2020 due to COVID-19.
We are all looking forward to greater personal interactions once
global conditions allow, and to more usual business conditions. In
the meantime, we wish all our stakeholders good health while we
continue to work toward developing shareholder value
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 .
Notice of Annual General Meeting
The Notice of Annual General Meeting ("AGM"), containing details
of the resolutions to be proposed at the AGM, has also been
published and will shortly be posted to shareholders. The Notice of
AGM is also available on the Company's website at www.ovocabio.com
. The AGM will be held at the registered office of the Company, 17
Pembroke Street Upper, Dublin 2, Ireland at 2.30pm on 29 July
2021.
AGM Procedures in light of Coronavirus (COVID-19)
Due to the continuation of the Irish Government's Covid-19
restrictions in relation to public gatherings and to prioritise the
health and safety of our shareholders, employees and other
stakeholders, the Board is requesting that shareholders do not
physically attend the AGM and instead submit a proxy form in favour
of the Chairman to ensure they can vote and be represented at the
AGM without attending in person. Further information on how to
appoint a proxy and the timelines by which proxies must be received
are contained in the Notice of AGM.
It will be possible to listen to the proceedings of this year's
AGM remotely using a teleconference facility provided by the
Company. Shareholders will not be able to use this facility to
vote, ask questions or table resolutions. Information on how to
register for this teleconference facility is available on the
Company's website at www.ovocabio.com/agm-registration .
All shareholders will be able to submit questions in advance of
the AGM in writing by email to the Company
Secretary at info@ovocabio.com to be received no later than 5.00pm on Tuesday, 27 July 2021. All correspondence should include sufficient information to identify the shareholders on the Register of Members. Questions submitted using these methods will be addressed by the Chairman at the AGM where possible.
As the situation is evolving and the Irish Government guidance
may change, shareholders are encouraged to check the Company's
website for any further updates regarding the AGM.
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).
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
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