REG - ValiRx PLC - Agreement to License VAL401 to Ambrose Healthcare

ValiRxAnnouncement

05/12/2023 07:15

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RNS Number : 6386V  ValiRx PLC  05 December 2023

ValiRx PLC

("ValiRx" or the "Company")

Agreement to License VAL401 to Ambrose Healthcare

London, UK - ValiRx Plc (AIM: VAL), a life science company focusing on cancer
therapeutics and women's health, announces that ValiSeek Limited ("ValiSeek"),
has entered into an exclusive Option Agreement to license VAL401 with Ambrose
Healthcare Limited ("Ambrose Healthcare"), a private UK specialist
pharmaceutical company.

Ambrose Healthcare is seeking to develop new treatments for rare diseases and
patients managed in hospitals and specialist care. The company, incorporated
in 2022, has an internationally experienced leadership team with deep
knowledge of the pharmaceutical industry.

Under the Option Agreement, Ambrose Healthcare has a 12-month period of
exclusivity under which it may exercise the option to execute a global,
exclusive license of Valiseek's VAL401 asset under pre-agreed terms.

ValiSeek has received an undisclosed, small fee, settled through the issue of
shares in Ambrose Healthcare. Subject to the exercise of the Option by Ambrose
Healthcare, the agreement details clinical and commercial milestone payments
to be made to ValiSeek totalling a value of up to £16 million plus royalties.

Under the licensing terms, Ambrose Healthcare commits to completing
development and commercialisation of VAL401 at Ambrose's cost.

Dr Suzy Dilly, CEO of ValiRx commented: "I'm delighted to have agreed this
path to development of VAL401 with Ambrose Healthcare.  I'm looking forward
to seeing the project develop under Ambrose Healthcare's experienced
oversight, combining clinical development and commercial experience."

Toby Wilson Waterworth, CEO of Ambrose Healthcare says, "We are excited to
build on ValiRx's initial clinical development to bring a much-needed new
treatment option to late-stage cancer patients.  VAL401 has a strong safety
and clinical profile, and a novel delivery formulation. It is a good fit for
the rare disease product portfolio that Ambrose is developing."

 

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.

 

For more information, please contact:

 

 ValiRx plc and ValiSeek Limited                     Tel: +44 (0) 2476 796496

                                                     www.valirx.com (http://www.valirx.com)

 Dr Suzanne Dilly, CEO                               Suzanne.Dilly@valirx.com (mailto:Suzanne.Dilly@valirx.com)

 Ambrose Healthcare Ltd                              Tel: +44 (0) 7775 881813

                                                     www.ambrosehc.com (http://www.ambrosehc.com/)

 Adam Michael, Director of Communications            adam.michael@ambrosehc.com (mailto:adam.michael@ambrosehc.com)

 V Formation (Public Relations)                      +44 (0) 115 787 0206

                                                     www.vformation.biz (http://www.vformation.biz)

 Lucy Wharton - Senior PR Executive

 Sue Carr - Director                                 lucy@vformation.biz

                                                     sue@vformation.biz
 Cairn Financial Advisers LLP (Nominated Adviser)    Tel: +44 (0) 20 7213 0880

 Liam Murray/Jo Turner/Ludovico Lazzaretti

 Cavendish Securities plc (Joint Broker)             Tel: +44 (0) 20 7397 8900

 Dale Bellis/Michael Johnson (Sales)

 Callum Davidson/Giles Balleny (Corporate Finance)
 Turner Pope Investments (Joint Broker)              Tel: +44 (0) 20 3657 0050

 James Pope / Andy Thacker

 

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 (http://www.valirx.com)

About Ambrose Healthcare Limited

Ambrose Healthcare is a specialist pharmaceutical company, developing new
treatments for rare diseases and patients managed in hospitals and specialist
care.

The company has an experienced leadership team with deep knowledge of the
pharmaceutical industry and a track record of success, supported by an
international network of rare disease experts and organisations.

 

Ambrose Healthcare is focused on acquiring late stage drug assets with a
minimum of Phase 2 data and that have novel applications in rare diseases.

Ambrose Healthcare is working towards becoming a centre of excellence and a
premier rare disease company. Read more on the company's approach in its
recently published white paper:
https://ambrosehc.com/wp-content/uploads/2023/11/Ambrose-HC-New-opportunities-in-rare-disease-drug-treatment_Nov-2023.pdf
(https://ambrosehc.com/wp-content/uploads/2023/11/Ambrose-HC-New-opportunities-in-rare-disease-drug-treatment_Nov-2023.pdf)
 

For further information, visit: www.ambrosehc.com (https://ambrosehc.com/)

 

About ValiSeek

ValiSeek Limited ("ValiSeek") is a joint venture  company between ValiRx Plc
and Tangent Reprofiling Limited, part of the SEEK Group. ValiSeek was formed
to progress the drug VAL401 through its remaining preclinical development and
towards Phase II trials for the treatment of lung cancer and other oncology
indications.

ValiRx holds 55.5% of the issued share capital of ValiSeek, Tangent holds
37.0% and Suzy Dilly, CEO and director of ValiRx holds 7.5% of the issued
share capital of ValiSeek. Suzy Dilly holds approximately 5% of the issued
share capital of Tangent.

About VAL401

VAL401 is the reformulation of the established anti-psychotic drug
risperidone. Formulated into a lipid-filled capsule for oral, once daily
administration, VAL401 enables an anti-cancer activity, via cancer cell
metabolism enzyme, Hydroxysteroid-dehydrogenase type 10 (HSD10), not seen with
conventional risperidone.

VAL401 has completed a pilot Phase 2 clinical trial, treating patients with
end-stage non-small cell lung cancer. These patients demonstrated a
statistically significant improvement in overall survival from diagnosis over
case-matched control patients in the same clinics; and showed improvements in
quality of life during treatment.

Identifying quality of life improvement in nausea, pain and appetite, has
identified pancreatic adenocarcinoma to be a preferred disease to assess in
the next clinical trial of VAL401.

The VAL401 asset consists of clinical data and intellectual property,
including the patent portfolio, technical specifications and know-how.

 

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.

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