REG - Ovoca Bio PLC - Annual Financial Report

Ovoca BioAnnouncement

28/06/2024 07:00

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RNS Number : 2362U  Ovoca Bio PLC  28 June 2024

Ovoca Bio plc

 

("Ovoca" or the "Company")

 

 

Publication of 2023 Annual Report

 

Dublin, Ireland, June 28, 2024  - 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 2023. The Annual Report
and Financial Statements can be viewed online at the following link:

 

http://www.rns-pdf.londonstockexchange.com/rns/2362U_1-2024-6-27.pdf
(http://www.rns-pdf.londonstockexchange.com/rns/2362U_1-2024-6-27.pdf)

 

2023 Highlights:

During 2023, the Ovoca management team focused on the following key areas:

·      Analysis of the data and results from the Phase II dose ranging
study assessing Orenetide in Australia and New Zealand. Unfortunately, the
study delivered negative results in mid-2023, demonstrating no treatment
benefit over the control group. Following further analysis conducted post the
receipt of the results, Ovoca has now determined that further R&D
activities with Orenetide are not likely to result in potential benefits for
the Company, and the Company is therefore taking steps to minimize further
costs by pausing development activities on the asset.

·      Disposal of Russian assets and optimization of corporate
structure - the ongoing sanctions pressure around the Russian economy and
financial system required significant work to be completed during the year,
including the disposal of certain Russian assets which the Company announced
in March 2023, and the Company continues to take steps to optimize its
structure. The Company also plans to maintain the patents, while investigating
opportunities to further commercialize the intellectual property, related to
Orenetide (e.g. through a sale or other options to monetise these assets).

·    Ensuring the Company has sufficient funding to cover its expenditure
as required.

Letter from the CEO

We are pleased to today publish the 2023 Full Year Annual report for Ovoca.

At the beginning of the reporting period - 2023 - the main efforts of the
Company were focused on the active development of Orenetide. It is not
surprising that the events which occurred at the beginning of the 3rd quarter
2023 - the results of a Clinical Trial conducted in Australia and New Zealand
- turned out to be critically important for the Company.

It should be noted that the primary focus of the Company in recent years was
based on the expectation of success with the Australian and NZL Study.
Therefore, all management efforts with partners and contractors were aimed to
allow fast progression after receiving the expected positive results of the
Study, and the financial strategy of the Company had been framed to ensure a
sufficient margin of liquidity at that time.

However, receiving negative Study results was a turning point in the Company's
endeavours to pursue previous strategic goals in the biopharma sector. We have
made a lot of efforts to comprehensively, thoroughly and deeply analyse the
root causes of the Study failure and understand whether there are prospects
for further development of Orenetide.

Unfortunately, following further analysis, we have decided that further
research and development activities in relation to Orenetide do not make sense
in the current environment and we have therefore paused development plans for
the asset. This is immediately reflected in the re-valuation of the Company's
Intangible Assets, as presented in the 2023 Annual Report. However,
significant efforts have been made to maintain the financial stability of the
Company, taking into account Ovoca's contracts and obligations. Such stability
will allow for a reassessment of the Company's strategic prospects, focusing
on minimizing losses for shareholders and finding a potentially profitable new
path.

Significant work has been done to improve the Company's corporate structure
and this work is ongoing. We are progressing analysis to execute on the
planned disposal or reorganisation of the Company's assets historically
located in complicated jurisdictions, while also seeking the settlement of
litigation regarding Taymura . Taken together, this is a rather long and
difficult process, not helped by the ongoing turbulence in the world and the
ever-tightening mutual sanctions pressure between the main jurisdictions of
the Company's assets. However, we expect that this work will bear fruit in the
current year and make the Company better positioned in terms of potential
strategic business opportunities.

Thus, the current efforts of management and Directors are focused on
investigating strategic business opportunities, where current internal
skillsets and competencies can be best used to benefit the Company.

In concluding my statement, I would like to take this opportunity to thank the
management of the Company and the members of the Board of Directors for their
perseverance, hard work despite all difficulties and invaluable contribution
to the further development of Ovoca.

 

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's lead product, Orenetide, a novel synthetic
peptide administered through a nasal spray, that had demonstrated
statistically significant improvement in a number of symptoms associated with
HSDD in the previous clinical trials, recently has failed to demonstrate
treatment benefit over control group in the Phase II study conducted in
Australia and New Zealand.

Following these Study results, the Company has suspended further R&D plans
for Orenetide and is investigating potential strategic opportunities for the
business.

 

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