ValiRx Regulatory News (VAL)

2 November 2021

ValiRx PLC ("ValiRx" or the "Company")

Signs Letter of Intent to Sub-License VAL201

London, UK - ValiRx Plc (AIM: VAL), a life science company focusing on early-stage cancer therapeutics and women's health, announces today it has entered into a non-binding letter of intent ("LOI") with TheoremRx Inc. ("TheoremRx"), a recently incorporated company, a next generation drug development Company, to enter into a licence agreement on pre-agreed terms to sub-license ValiRx's legacy asset VAL201 for development in the treatment of cancer (the "Licence Agreement"). Completion of the Licence Agreement is subject to, inter alia, the successful fundraise by TheoremRx.

TheoremRx is private US-based oncology company focused on the discovery and development of new treatments that will benefit patients suffering from cancer. TheoremRx has established a highly integrated approach for the discovery, development and manufacture of peptide and small molecule drugs that modulate targets of clinical interest.

Under this proposed Licence Agreement, TheoremRx will obtain a worldwide licence to ValiRx's VAL201 intellectual property for a novel peptide targeting SRC kinase targeting oncology indications. ValiRx will retain the rights to develop the VAL201 peptide for non-oncology indications, including VAL301 for endometriosis. Subject to successful market authorisation, the potential value of the deal would be in excess of US$61M plus royalties for the first cancer indication alone. Each oncology indication successfully developed to by TheoremRx will generate up to $37.5M of additional value to ValiRx. The proposed deal structure comprises payments on signature of the Licence Agreement plus fees and near-term milestones totalling US$2.2M before the end of 2023, milestones on further clinical and commercial development events, and royalties. The first payments are expected by the end of 2021.

As part of the deal, TheoremRx will enter into a service contract with ValiRx to provide consulting services to TheoremRx to aid technology transfer, formulation for patent extension and continued clinical development of VAL201. 

The LOI details a period of exclusivity during which TheoremRx will complete its due diligence on the scientific and commercial attributes of VAL201, during which ValiRx is restricted from continuing to market the programme to other parties. Completion of the Licence Agreement is also subject to terms and conditions at closing.

The LOI and proposed Licence Agreement therefore remain non-binding and there is no guarantee that this Licence Agreement will be executed or that it will generate material revenues within the expected timeframe or at all.

Dr Suzy Dilly, CEO of ValiRx commented: "Selecting a commercial partner for VAL201 with the right skills, experience and commitment has been a high priority for ValiRx. I am delighted that the team at TheoremRx has really taken the time to understand the science, the additional development needs and the commercial opportunity for VAL201 in oncology. I am looking forward to seeing the programme progress efficiently through the clinical development plan in their hands."

Dr Ken Sorensen, Chairman of TheoremRx stated: "We are very excited to be pursuing an agreement with ValiRx, a company with extensive and proven experience in research and drug development. We look forward to working towards a final agreement and seeing this technology occupy a preeminent position in the market for treating different cancers."

The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014 as it forms part of UK Domestic Law by virtue of the European Union (Withdrawal) Act 2018 ("UK MAR"). The Directors of the Company take responsibility for this announcement.

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Notes for Editors

About ValiRx

ValiRx accelerates the development of treatments in oncology and women's health to improve patient lives. We provide the scientific, financial and commercial framework towards enabling rapid translation of innovative science into clinical development.

With our extensive and proven experience in research and drug development, we select and incubate promising novel drug candidates and guide them through an optimised process of development, from pre-clinical studies to clinic and investor-ready assets.

Integrating science and business

We connect diverse disciplines across scientific, technical and commercial domains, with the aim of achieving a more streamlined, less costly, drug development process. We work closely with our selected collaborators and leverage the combined expertise required for science to advance.

Lead candidates from our portfolio are out-licensed or partnered with investors through ValiRx subsidiary companies for further clinical development and commercialisation. https://www.valirx.com/

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

 About TheoremRx Inc.

TheoremRx Inc. is an oncology company focused on the discovery and development of new treatments that will benefit patients suffering from cancer. TheoremRx has established a highly integrated approach for the discovery, development and manufacture of peptide and small molecule drugs that modulate targets of clinical interest. TheoremRx has built a broad portfolio of novel drugs targeting unmet medical needs in large market indications where it will advance each asset to partnering and licensing to global pharmaceutical companies. The US based company operates out of New York, NY and Montreal, Quebec.

About VAL201

VAL201 is a short peptide being studied as a potential treatment for prostate cancer. The peptide structure is inspired by the naturally occurring androgen receptor and is designed to intercept and prevent the binding of the androgen receptor to SRC kinase - an enzyme implicated in cancerous cell growth pathways. By preventing the androgen-mediated activation of SRC kinase, VAL201 can potentially prevent cancerous cell proliferation (or growth) without interfering with other functions of either the androgen receptor or SRC kinase. This precision method, mimicking a natural process, proposes a high specificity of cancer treatment with a lower side effect profile. VAL201 was licensed from CRT (part of CRUK) in 2010 and developed through preclinical development into this clinical trial in patients with advanced prostate cancer. The study was held at University College Hospital (UCLH), London.

About Prostate Cancer

Around 48,500 men are diagnosed with prostate cancer in the UK each year[1]. In men, it is the most common cancer in the UK. Prostate cancer is most common in older men. On average each year 35 out of 100 (35%) of new cases are in men aged 75 and over.

Cautionary statement

Certain statements made in this announcement are forward-looking statements. Such statements are based on current expectations and assumptions and are subject to a number of risks and uncertainties that could cause actual events or results to differ materially from any expected future events or results expressed or implied in these forward-looking statements. Persons receiving this announcement should not place undue reliance on forward-looking statements. Unless otherwise required by applicable law, regulation or accounting standard, the Company does not undertake to update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.