REG - ValiRx PLC - Business Update

ValiRxAnnouncement

20/05/2024 12:00

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RNS Number : 1205P  ValiRx PLC  20 May 2024

20 May 2024

VALIRX PLC

("ValiRx" or the "Company")

Business Update

ValiRx plc (the "Company") (AIM: VAL), a life sciences company focusing on
early-stage cancer therapeutics and women's health, is today pleased to
provide an operational update.

Development Pipeline Update

Cytolytix (CLX001)

The assessment of formulation options for CLX001 has progressed during Q1
2024, with the lead formulation now demonstrated to have activity against
cancer cells.  Testing is ongoing to assess the safety of the formulated
product.

ValiRx is also pleased to announce that Cytolytix has been awarded a Knowledge
Transfer Voucher ("KTV") grant in conjunction with the Open University. This
initial grant is being used in a pilot study to assess the effectiveness of
Cytolytix's cancer-specific lytic peptides in Neuroendocrine Prostate Cancer
("NEPC"). NEPC is a highly aggressive form of cancer with a typical survival
rate of less than one year.  Unfortunately, there are currently no available
therapies for NEPC which shares similar characteristics with triple-negative
breast cancer, such as hormone independence, and a high likelihood of
metastasis. This research will assess CLX001 with and without the formulation
to better understand the mechanism and to assess the breadth of activity of
the product against an additional cancer type.

These assessments will assist in defining whether the lead formulation is
appropriate for further development and progression into formal preclinical
studies.

Evaluation Projects

During the first quarter of 2024, two new evaluation projects have been added,
from Dundee University to study a series of molecules proposed with proposed
pro-senescence activity and from Imperial College London to evaluate a series
of dual kinase inhibitor candidates.  The agreement with Dundee announced on
12 February 2024 also includes an over-arching agreement to assess and
routinely evaluate further opportunities originating from the Dundee Drug
Discovery Unit.  Testing on both new programmes has commenced in Inaphaea
BioLabs and at external partners.

The evaluation work continues on the projects from StingRay and the University
of Barcelona, with the latter expected to conclude in Q2 2024. Due diligence
is underway on additional potential pipeline projects.

We are pleased with the continued interest shown in the ValiRx approach to
assessing innovative technology, which has resulted in broadening of the
evaluation pipeline into some exciting new approaches for the treatment of
cancer.

Clinical Stage Assets

VAL201 remains subject to the Letter of Intent ("LoI") with TheoremRx Inc. The
Board maintains regular communication with the TheoremRx team to determine
whether there is continuing progress to secure the necessary financing, which
will enable the proposed merger with EUDA Health and the VAL201 sub-license to
complete. The sub-license contains provisions for upfront and early-stage
milestone payment and will release the payment for work already conducted
under the previously announced service agreement as well as a commitment for
future service provision.

In June 2023, ValiRx announced the carve-out of the Greater China region from
the exclusivity clause in the TheoremRx LOI. This enables the Company to
re-commence active marketing of the project in this region in order to explore
additional sources of revenue.

VAL401 is subject of an Option Agreement LoI with Ambrose Healthcare as
announced on 5 December 2023. Under this Option Agreement, Ambrose Healthcare
has a 12-month period in which to exercise their option to license VAL401.
During the first quarter of 2024, the Company has provided assistance to
Ambrose with due diligence for potential investors and to commence strategic
planning for their subsequent clinical trials.

Inaphaea BioLabs

Commercial Update

The number of prospective clients in the sales pipeline for Inaphaea's
services and products is continuing to grow, with 11 at an advanced stage of
discussion. This includes both screening and licencing of patient derived
cells ("PDC"). Interest has been expressed from a range of end users,
including biotech companies, large pharma and large CROs. The latter sector is
of particular importance as we believe their requirements are substantive and
likely to lead to longer term product supply relationships.  Although the
needs of the individual clients are varied, their decision-making timelines
have been impacted by a number of factors, both internal and external, and
generally characterised by longer lead times. We maintain regular dialogue
with all key clients and, subject to their indicated decision processes and
timelines, anticipate that several of the pipeline opportunities could be
executed in H2 2024.

To-date, business development activities have been primarily focused on the UK
and Europe. To supplement this, the commercial team is now extending
activities into the US where the regulatory environment for PDCs and related
services is restrictive for local suppliers, which could provide significant
opportunities for Inaphaea. In support of this initiative, Inaphaea will be
attending the BIO conference in San Diego in June 2024, which is one of the
world's largest biopharma partnering forum.

The sales pipeline also includes several opportunities that would incorporate
services provided through our collaborators and also includes clients
introduced through this network. A new collaborative services agreement has
been signed with DefiniGEN, which enables Inaphaea clients to seamlessly
access the DenfiGEN Opti-heps, a hepatocyte cellular model for testing
toxicity of drug candidates, and also efficacy against liver diseases.

Service contracts for internal ValiRx evaluation projects and Cytolytix
conducted through Inaphaea have generated savings of approximately £247,000
relative to the use of external laboratories.  This is distributed such that
£115,000 savings were recognised during 2023 and £132,000 from 1 January
2024 to 30 April 2024.  There is an expectation by the Board of continued
increases in savings as additional work is conducted on the recently initiated
evaluation projects.  This work benefits from access to Inaphaea's PDCs and
other related experiments and assesses safety, anti-cancer activity and the
mechanism of action of the drug candidates being evaluated.

Scientific Update

As described in the placing in December 2023, Inaphaea is progressing the
necessary work to fully characterise PDCs which have greatest commercial
interest.  An important component of the required data is the testing of PDCs
against a panel of 'standard of care' agents (chemotherapy drugs).
Additionally, each PDC has been extensively tested for cell expansion,
optimisation of growth conditions and composition analysis to establish the
ratio of cancerous to non-cancer supporting cells.

Completed assessments have been incorporated into detailed product information
sheets, which can be readily accessed on the Inaphaea website for ease of
identification and selection by prospective clients.  The first completed set
comprises samples from patients treated for glioblastoma multiforme (GBM), a
type of brain cancer.  Product information sheets for PDCs from ovarian, head
& neck and breast cancer are expected to be added to the active catalogue
over the next quarter.

Operational Efficiency

Having secured funding of £1.8m (gross) at the beginning of 2024, the Company
has been reviewing all corporate activities to optimise cash efficiency and
direct its resources towards building value in both the Inaphaea service
offering and progressing the development pipeline. To this end, ValiRx has
closed the Nuneaton office and is consolidating the central operating office
into the Inaphaea facility at MediCity in Nottingham. In addition, the Company
is assessing options for streamlining a range of back-office functions.
Progress has already been made in reducing the costs of IP management, PR and
IT services.

Shareholder Communication and AGM arrangements

The Annual General meeting will be live streamed by BRR media ensuring that
all shareholders can watch proceedings online, with the recording of the event
scheduled to be made available via the website shortly afterwards.

A shareholder Q&A webinar will also be held prior to the AGM with members
of the senior management team being online to answer live audience questions;
ensuring that shareholders have ample opportunity to discuss the shareholder
resolutions before the voting deadline.  Questions will also be welcomed
around all operational aspects of the company.

Both events will require prior registration, with registration links and full
details available for the AGM, and shortly to be available for the webinar on
the Company's website on https://www.valirx.com/contact.

Summary

The Board believes that the combination of building the evaluation pipeline
and additional sales and marketing initiatives for Inaphaea, together with
prudent management of cash resources, including funds raised in the last
placing, will bear fruit in the second half of 2024 and beyond.

 

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

 Shard Capital Partners LLP (Sole Broker)          Tel: +44 (0) 20 7186 9000

 Damon Heath

 

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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