ValiRx Regulatory News (VAL)

ValiRx PLC

("ValiRx" or the "Company")

Commercial update

London, UK - ValiRx Plc (AIM: VAL), a life sciences company focusing on early-stage cancer therapeutics and women's health, announces that, further to the announcement on 3 April 2025, the Company has established a new wholly owned subsidiary Blue Ribbon Bio Limited ("Blue Ribbon").

Blue Ribbon has been incorporated to house all Prostate Cancer associated assets from ValiRx Plc which will initially consist of existing Intellectual Property for Val201, exclusively licensed to ValiRx by Cancer Research Horizons in 2010. The Company plans to file new application-based patents for Val201 which will be held by Blue Ribbon.

A detailed technical and market assessment has been conducted for Val201 as part of a comprehensive review of ValiRx's current and potential assets and concluded that there is a still a strong rationale for Val201 within the treatment pathway for prostate cancer. A critical path plan to expedite validation of improvements to Val201 to create additional value, extend patent coverage and position for partnering is now in place.

A notice of allowance has also been received for Canadian "Medical Use" patent (application No. 2,853,671) for the treatment of non-cancerous conditions relating to the use of the Val201 peptide in endometriosis (Val301).

Mark Eccleston, CEO of ValiRx commented "We have an opportunity to build a broader prostate cancer focussed portfolio based on current and future pan cancer assets that can be applied in this indication. Having worked on the original pre-clinical development of Val201, I am pleased that there is still a market opportunity for this asset, and we intend to rapidly complete the planned work required to get this back into the clinic in new and improved form. This will build on the initial data package and key opinion leader feedback developed in the earlier clinical trial and development will be applicable to all applications of the peptide, including in endometriosis, so I also pleased to announce notification that our Canadian patent will be granted. We will leverage the combined experience and resources of our tCRO, Inaphaea Biolabs, including the prostate cancer Patient Derived Models that we are developing in partnership with the Open University, with the advanced non animal 3D-culture testing capabilities we have brought in through our capability partners. Several of our current assets, those in our repurposing program with Dominion and other assets under consideration for evaluation and in-licensing can be applied across various stages of prostate cancer as well as our core focus in women's health. By ringfencing these assets in a portfolio approach we believe that we can create significant value and attract partners for clinical development."

Tony Hickson, Chief Business Officer of Cancer Research Horizons, commented: "Cancer Research Horizons is committed to bringing new drugs to market and supports the development of drugs at all stages, especially in areas of high unmet clinical need. Hormone therapies such as Enzalutamide and Abiraterone have transformed prostate cancer treatment, but most patients eventually become resistant to this form of therapy and there remains an unmet need for new drugs to overcome drug resistance. Val201 has a unique mechanism of action and can be positioned to address these resistant forms of cancer, as well as potentially earlier stages of the disease to mitigate the side effects seen under hormone ablation. We are pleased that ValiRx and Blue Ribbon Bio will continue with the development of a version of the therapy optimised for clinical impact."

The Directors of the Company take responsibility for this announcement.

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Notes for Editors

About ValiRx

ValiRx is a life science company focused on early-stage cancer therapeutics and women's health, accelerating the translation of innovative science into impactful medicines to improve patient lives.

ValiRx provides the scientific, financial, and commercial framework for enabling rapid translation of innovative science into clinical development.

Using its extensive and proven experience in research and drug development, the team at ValiRx selects and incubates promising novel drug candidates and guides them through an optimised process of development, from pre-clinical studies to clinic and investor-ready assets.

ValiRx connects diverse disciplines across scientific, technical, and commercial domains, with the aim of achieving a more streamlined, less costly, drug development process. The team works closely with carefully selected collaborators and leverages the combined expertise required for science to advance.

Lead candidates from ValiRx's portfolio are outlicensed or partnered with investors through ValiRx subsidiary companies for further clinical development and commercialisation.

ValiRx listed on the AIM Market of the London Stock Exchange in October 2006 and trades under the ticker symbol: VAL.

For further information, visit: www.valirx.com