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WKN: A40H8H | ISIN: BE0974487192 | Ticker-Symbol: TG40
Frankfurt
18.03.25
21:49 Uhr
0,141 Euro
+0,009
+6,66 %
Branche
Pharma
Aktienmarkt
Sonstige
1-Jahres-Chart
OXURION NV Chart 1 Jahr
5-Tage-Chart
OXURION NV 5-Tage-Chart
Actusnews Wire
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OXURION: Oxurion signs a letter of intent for the planned acquisition of a biometrics-focused CRO

Finanznachrichten News

Louvain, BELGIUM - March 18, 2025 - 6:30 PM CET, Oxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company headquartered in Leuven, announces the signing of a letter of intent (LOI) for the planned acquisition of a majority stake in a Contract Research Organization (CRO) specialized in clinical data management and biometric analysis. This planned acquisition aligns with Oxurion's strategy to expand its expertise by developing an integrated offering for pharmaceutical and biotech players.

An acquisition to equip Oxurion with new expertise

The target company, based in France and active for over 15 years, is recognized for its expertise in biometrics applied to clinical trials and advanced data management in the healthcare sector. It operates across the entire clinical data lifecycle, from collection to submission to health authorities, integrating advanced validation processes and regulatory analysis. The company supports more than 20 industrial and academic partners across various sectors, including pharmaceuticals, medical devices, cosmetics, and non-health products. It offers comprehensive solutions for clinical data management, statistical analysis, and regulatory submissions, ensuring seamless compliance with international standards (CDISC[1], MedDRA, WHO-Drug).

The company excels in data validation and standardization, as well as in producing actionable regulatory reports to ensure compliance and acceptance of clinical trials by health authorities such as the EMA and FDA.

Its strength lies in a multidisciplinary team of data managers, biostatisticians, and experienced project managers, who ensure optimized clinical trial management. The company provides full supervision of trials, from protocol development strategy and methodology to patient modeling and randomization, as well as optimizing regulatory submissions. The CRO also integrates advanced artificial intelligence mechanisms, enhancing data quality and relevance through sophisticated validation algorithms. These technologies are developed under a strict ethical framework, ensuring regulatory compliance while maximizing the reliability of results.

A strategic eCRF platform for clinical trial optimization

Additionally, the CRO has developed a proprietary electronic Case Report Form (eCRF) platform, a strategic digital tool that accelerates and simplifies clinical trial management.

In a context where data standardization and regulatory rigor are essential, this platform ensures patient data traceability, enhances clinical result quality, and speeds up regulatory submissions to health authorities (EMA, FDA).

Its architecture is designed to optimize clinical trial processes by integrating advanced features, including:

  • Secure data entry compliant with CDISC standards
  • Automated management of randomization and blinding
  • Real-time report generation and visualization of inclusion trends
  • A mobile-friendly, multilingual interface facilitating patient monitoring and communication with investigators

This eCRF could thus become a major differentiating factor for the group formed by Oxurion, leveraging this tool to conduct smoother, more efficient clinical trials in full compliance with international regulatory requirements.

This acquisition would allow Oxurion to integrate a profitable and growing business, with stable revenue over the past three years at €1 million[2] and a positive net result.

Transaction structure

  • Oxurion plans to acquire 70% of the target company's share capital.
  • The transaction values the target company at €650,000 on a 100% basis.

Although Oxurion's management will maximize the use of non-dilutive instruments, the transaction will have a dilutive effect on shareholders, the extent of which remains to be determined. The objective of this potential transaction is to offset dilution through value creation for shareholders. As of today, Oxurion has not yet secured the financing for this transaction.

The signing of the final documentation is expected by the end of June 2025 at the latest.

The transaction is subject to due diligence (financial, legal, technical), set to begin in March 2025, with completion expected by the end of April 2025. It also requires the agreement of the involved parties on legal documentation and, where applicable, the fulfillment of legal conditions (such as worker information procedures and foreign direct investment procedures for strategic French assets).

Oxurion has been granted an exclusivity period until June 30, 2025, during which the target company and its sellers commit not to engage in discussions with third parties regarding any competing transaction.

A strategic lever for Oxurion's growth

De target aims to double its revenue over the next three years by strengthening its commercial capabilities and expanding its client network. The company plans to accelerate its business development and expansion efforts through a dedicated sales team and an optimized marketing strategy to enhance its market positioning.

"With this acquisition, Oxurion could strengthen its position in clinical trial management and biometric analysis. Integrating this CRO into our ecosystem would allow us not only to optimize the collection and analysis of clinical data but also to accelerate and enhance the regulatory submission process. With its advanced capabilities in statistical analysis and data modeling, this new technological asset will enable us to produce actionable results faster while ensuring their reliability and compliance with international regulatory standards. This strategic advantage could position Oxurion as a key player in supporting biopharmaceutical companies in accelerating their clinical developments," said Pascal Ghoson, CEO of Oxurion.

This target complements ongoing discussions since July 2024 with a CRO active in Beta cell research. Oxurion is also in advanced discussions with several French targets that have shown interest in its strategic project.

Oxurion will provide regular updates on the progress of these transactions and keep the market informed of the next steps.

About Oxurion

Oxurion (Euronext Brussels: OXUR) is engaged in developing next-generation standard of care ophthalmic therapies for the treatment of retinal disease. Oxurion is based in Leuven, Belgium. More information is available at www.oxurion.com.

Important information about forward-looking statements

Certain statements in this press release may be considered "forward-looking". Such forward-looking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the Company's Annual Report. This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of Oxurion in any jurisdiction. No securities of Oxurion may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. state securities laws.

For further information please contact:

Oxurion NV
Pascal Ghoson
Chief Executive Officer
Pascal.ghoson@oxurion.com

[1] Clinical Data Interchange Standards Consortium$

[2] Closing at the end of May of each calendar year.

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Full and original release in PDF format:
https://www.actusnews.com/documents_communiques/ACTUS-0-90502-oxurion_pr-loi-axiodis_en_180325.pdf

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