REG - ValiRx PLC - Quarterly Operational Update

ValiRxAnnouncement

31/03/2023 07:00

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20230331:nRSe8283Ua&default-theme=true

RNS Number : 8283U  ValiRx PLC  31 March 2023

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

Quarterly Operational 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.

Inaphaea BioLabs

Following the launch of our wholly owned subsidiary Inaphaea BioLabs Limited
("Inaphaea") announced on 1 March 2023, its facility in MediCity (Nottingham)
has been fitted out to conduct a range of cell-based assays.  The Lead
Scientist and Senior Scientist are working full time in the lab to validate
the equipment and assays, supported by the ValiRx senior scientific management
team.

Dr Andrew Carnegie has commenced full time employment with Inaphaea to develop
the commercial strategy, including surveying the market needs, assessing
innovative technology and securing business opportunities.

Initial cell-based assays services are expected to be operational during Q2
2023. Inaphaea is also investigating additional innovative technologies to
in-license, which will enhance the data generation capabilities of Inaphaea as
a translational contract research organisation (tCRO™).

Inaphaea will be attending BioTrinity in London, an OBN event, in April 2023
as an exhibitor to market the services and conduct conversations with
potential customers.

Evaluation Projects

Evaluation Agreement with Hokkaido University (Japan) (Announced: 16 December
2021, extension announced 6 December 2022)

The extension of the Evaluation Agreement with Hokkaido University has allowed
ValiRx to continue experimental testing.  Product development has continued
and a supply of material in a suitable salt form has been achieved.
Pre-formulation assays are underway and biological testing in Inaphaea's lab
is scheduled to commence in Q2 2023.

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

This evaluation project has completed the 12 months scheduled for scientific
evaluation which included expansion of the IP protection, computational
binding assays, chemical synthesis, in-vitro and in-vivo biological testing.
Discussions are in process with the University of Barcelona to confirm the
next steps for the technology which will be reported on in due course.

Pre-clinical Assets

CLX001 (triple negative breast cancer)

CLX001 has commenced a full pre-clinical development programme to progress the
asset towards clinical trials.  All work will be managed by the ValiRx
subsidiary, Cytolytix Limited.

CLX001 is a peptide that is intended to be delivered in a nanoformulation.
While the nanoformulation is undergoing further optimisation, the unformulated
peptide continues to undergo biological testing. Safety screen data generated
in Q1 2023 confirms no immediate toxicology concerns.  Regulatory planning
activities have also been commenced.

When the formulated CLX001 is available, further in-vitro and in-vivo testing
can commence.

VAL301 (endometriosis)

VAL301 has been undergoing pre-clinical cell-based assays at a third-party
Contract Research Organisation (CRO) under supervision by ValiRx; this work is
now scheduled to be transferred to the Inaphaea facility at MediCity in April
2023 to continue testing. The programme of work is designed to complement
historical data and to progress the project towards formal pre-clinical
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 pre-clinical tests. The encouraging initial results will
be published in an academic journal in due course.  These pre-clinical
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 ("TheoremRx") 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.

 

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.

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  UPDEALDEDDXDEFA