Ambrose Exercise Option on VAL401

London, UK - ValiRx Plc (AIM: VAL), a life science company focusing on early-stage cancer therapeutics and women's health is pleased to announce that, further to the extension to the Letter of Intent ("LOI") with Ambrose Healthcare Ltd ("Ambrose") announced on 20 November 2024, Ambrose has now served notice to ValiSeek Limited ("Valiseek") to exercise their option ("Option") to licence Valiseek's VAL401 asset under the pre-agreed terms of the Option Agreement announced on 5 December 2023.

Under the terms of the Option Agreement and following exercise of the Option, ValiRx and Ambrose have entered into an Intellectual Property Licence Agreement for VAL401 under which ValiRx will receive 576,000 ordinary shares in Ambrose with clinical and commercial milestone payments to be made to Valiseek totalling a value of up to £16 million plus royalties.

Ambrose is a private UK specialist pharmaceutical company, incorporated in October 2022 and focussed on developing new treatments for rare diseases and patients managed in hospitals and specialist care. The initial £6 million milestones are payable in cash or the equivalent value in new ordinary shares in Ambrose with the issue price determined by the latest issue of shares in Ambrose, at the discretion of Ambrose. Payment of milestones in cash is subject to Ambrose raising capital in due course.

ValiSeek is a 54.14% subsidiary joint venture of ValiRx alongside Tangent Reprofiling (a member of the SEEK Group), its sole asset is VAL 401 which is the repurposed Risperidone asset which in a novel lipid formulation is seen to have anticancer effect across a number of indications.

Under the License Agreement, Ambrose Healthcare will meet all future patent costs and commits to completing development and commercialisation of VAL401 at Ambrose's cost.

Mark Eccleston, CEO of ValiRx commented "We are pleased to be able to complete this technology license for VAL401 with Ambrose and we have been working to identify multiple funding partners to progress VAL401 through the various clinical stages with several options under discussion. In addition, we are also exploring short term opportunities to support a funded preclinical validation for VAL401 through our wholly owned subsidiary, Inaphaea Biolabs Limited, which has 19 pancreatic Patient Derived Cell models. These models can be applied in 3D systems as New Approach Methods which are receiving growing support from the FDA in support for IND submissions."

Toby Wilson Waterworth, CEO of Ambrose Healthcare commented "Ambrose Healthcare is excited to announce the exercise of the option and enter a licensing agreement to develop and commercialise for VAL401 globally. This strategic partnership underscores Ambrose Healthcare's commitment to pioneering innovative rare disease therapies that enhance patient outcomes. This licensing deal marks an important step in our mission to accelerate safe and effective treatment to rare disease populations, including Oncology. For example, pancreatic cancer, one of the deadliest is considered a rare disease.

VAL401 has demonstrated potential therapeutic benefits in a late-stage non-small cell lung cancer clinical trial. Broadening the potential for VAL401, Ambrose intends to work with ValiRx's Inaphaea to generate pre-clinical evidence in multiple other cancer indications, starting with pancreatic models. We are eager to accelerate its development, with expanded clinical trials and expedited regulatory submissions, to broaden the impact of this innovative therapy to patients worldwide."

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