REG - ValiRx PLC - Quarterly Operational and Strategy Update

ValiRxAnnouncement

06/12/2022 07:00

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RNS Number : 6753I  ValiRx PLC  06 December 2022

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

Quarterly Operational and Strategy Update

London, UK - ValiRx Plc (AIM: VAL), a life science company focusing on
early-stage cancer therapeutics and women's health, today provides an update
on operational activities and strategy.

Evaluation Projects:

The Evaluation Agreement with Hokkaido University (Japan) (Announced: 16
December 2021)

An extension of the Evaluation Agreement with Hokkaido University has been
agreed to allow ValiRx to conduct further experimental testing on the drug
candidate for an additional six-month period.  To date the work has consisted
of product development planning and process development of manufacture;
biological testing will shortly be initiated.

The Evaluation Agreement with the University of Barcelona (Announced: 14
February 2022)

This evaluation project has completed 9 out of the 12 months scheduled for
scientific evaluation.  To date, the work has expanded the IP protection,
executed computational binding assays, conducted chemical synthesis and
initiated biological testing.

Pre-clinical Assets

CLX001 (triple negative breast cancer)

CLX001 has commenced a full preclinical development programme to progress the
asset towards clinical trials.  All work will be managed by the ValiRx
subsidiary, Cytolytix Limited. Larger scale (5g) synthesis has been
successfully completed, and the material is undergoing formulation
optimisation.  The initial CLX001 testing was conducted using a bench-scale
formulation which requires optimisation for industrial and eventual commercial
use.  Regulatory planning activities have been commenced.

Preclinical Project Manager, Zai Ahmad, is tasked to lead the CLX001
development.

VAL301 (endometriosis)

VAL301 is undergoing preclinical cell-based assays under supervision by ValiRx
to confirm the breadth of biological pathways involved.  Utilising newer
cell-based analytical technologies, this programme of work is designed to
complement historical data and to move the project forwards towards formal
preclinical studies.  Additional opportunities to further optimise the drug
candidate have been identified and work is ongoing to assess the potential for
additional patent filings.

BC201 (sepsis)

Under development with Black Cat Bio Limited ("BlackCat Bio") and OncoLytika
Limited ("OncoLytika"), the mechanism of action of BC201 has been investigated
with a wide range of preclinical tests. The encouraging initial results will
be published in an academic journal in due course.  These preclinical
investigations are being funded by BlackCat Bio from recently secured seed
funding and project managed by OncoLytika.  As announced on 2 June 2020,
ValiRx has no financial commitment to the consortium but contributes by
providing samples of the peptide from our surplus clinical trial supplies for
testing.  If successful, ValiRx has a beneficial interest of 40% of the
project.

Clinical Assets

VAL401 (adenocarcinoma)

ValiRx continues active business development activities to seek a partner or
external funding to progress VAL401 through clinical development.  An
external commercial development agency has been assisting ValiRx in this
process.

VAL201 (prostate cancer)

As announced on 2 November 2021, ValiRx entered a Letter of Intent with
TheoremRx Inc to sub-license the use of the VAL201 peptide for all oncology
applications.  The sub-license is conditional on TheoremRx completing a
fund-raise which is ongoing.

 

Strategy update

Currently operating as a virtual Biotech Company, ValiRx out-sources all
testing of current evaluation and pre-clinical projects to a wide range of
external contract research organisations (CROs). The Company is of the view
that this fragmented approach to early-stage drug development is non-optimal
and is assessing options to acquire capabilities and infrastructure to create
a more efficient and effective translational drug development service for both
internal and 3(rd) party use.

ValiRx intends to lease a laboratory to implement the Company's strategy.

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                                          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)

 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

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

 Russell Kerr/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)

 

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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