VALIRX PLC

("ValiRx", "the Company" or "the Group")

HALF YEARLY REPORT FOR THE PERIOD ENDED 30 JUNE 2025

London, UK., 2025: ValiRx Plc (AIM: VAL), a life science company, which focuses on clinical stage cancer therapeutic development, taking proprietary and novel technology for precision medicines towards commercialisation and partnering, today announces its unaudited Half Yearly Report for the period ended 30 June 2025 and provides an update on significant post-period events.

HIGHLIGHTS

Operational Highlights

·      Implementation of a full strategic and operational review

·      New evaluation agreement for a delivery platform and CB2 agonist signed

·      Letter of Intent for Val201 terminated with TheoremRx

·      License Agreement for Val 401 signed with Ambrose Healthcare

·      Partnered with US based Omios Biologics to evaluate Cytolytix peptide in viral delivery system

·      Inaphaea Biobank Evaluation and Commercial use agreements signed with ScreenIn3D, Cellomatics and Dominion Biotech

·      Partnership signed with Dominion Biotech to develop Inaphaea 3k-screen drug repurposed assets

Financial Highlights

·      Research and developments costs (excluding employee costs) £105,489 (2024: £121,490)

·      Administrative expenses £828,444 (2024: £947,565)

·      Share-based payment charge £nil (2024: £18,994)

·      Loss before income taxation of £931,135 (2024: £1,052,006)

·      Total comprehensive loss for the period of £838,434 (2024: £970,908)

·      Loss per share from continuing operations of 0.22p (2024: Loss - 0.74p)

·      Cash and cash equivalents at 30 June 2025 of £518,794 (2024: £809,147)

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.

*** ENDS ***

For more information, please contact:

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 

CHAIRMAN AND CHIEF EXECUTIVE OFFICER'S STATEMENT FOR THE HALF YEAR ENDED 30 JUNE 2025

The first half of 2025 has seen significant progress on the evolution of ValiRx and its subsidiaries following the major strategic review, initiated in Q4 2024, designed to improve operational efficiency and enable us to generate near-term revenue, build long-term value, and ultimately improve patient outcomes. A key pillar of this has been the expansion of Inaphaea's network of capability partners. These partnerships deliver three fundamental benefits to the Group:

i)              access to a wider customer base through referrals;

ii)             access to advanced testing capabilities for internal and client programs; and

iii)            partnered development opportunities.

In addition, we are actively working to create value from Inaphaea's assets, including its properitary data sets. Finally, we have refined our engagement model for evaluation and development programs which incorporate pre-agreed, financial upside on evaluation work where we can add significant value to an asset, if that asset is not in-licensed by ValiRx but is ultimately licensed externally.

There have been further changes to the board as Adrian de Courcey stepped down as a Non-Executive Director and Cathy Tralau-Stewart transitioned to a Non-Executive Director after our full time Director of Research was hired to replace her as part time CSO. The streamlined board now comprises two Executive directors, one Non-Executive Director and a Non-Executive Chairman.

As a result of the operational overhaul, completed at the end of Q1 2025, three positions were made redundant - including the Head of Operations & IT, the Preclinical Project manager and the Head of Strategic Commercial development. The responsibilities of these roles have been distributed across the remaining core team members and a new technician hired to support Inaphaea after the loss of a Senior scientist at the end of 2024. These combined changes represent a saving of around £200,000 in salaries going forward. Further significant overhead reductions, as a result of board changes in the second half of 2024, are reflected in the £120,000 reduction in administrative costs for the period with most of the additional savings from the operational review coming through post period, in the second half of 2025, due to notice periods and statutory redundancy payments. The resulting lean core team has significantly improved operational efficiency, working across the Group to support technical and commercial activities supported by three industry recognised advisors.

A key objective of the strategic review was our renewed commitment to the development of therapeutic assets as well as realising the potential of the assets within ValiRx's subsidiary, Inaphaea Biolabs Limited ("Inaphaea"). To best achieve this commitment, we have applied a stringent set of commercial and technical criteria to assessing both ongoing and new potential evaluation agreements, as well as decisions on in-licensing and SPV/JV formation, to maximise potential success and value through these early phases. Our Director of Research, with her background in translational drug development at Cancer Research Horizons, has been central to enabling this improved decision-making process.

Trading conditions in 2025 remain challenging with significant uncertainty due to the macro political environment. Commercial grant opportunities in the UK and US are stagnant although there are indications this may improve in Q4 2025. Despite this, ValiRx and its group companies have been able to secure (and continue to explore) multiple pump priming awards through its academic partners, notably the Knowledge Voucher scheme through The Open University and Queen Mary Impact Fund. Whilst no direct funding has passed to ValiRx, it is important to recognise that this funding is progressing programs that would otherwise require funding through ValiRx, thereby offsetting capital requirements, as well as supporting further grant applications. In addition, post period, R&D tax credits of £138,000 have been received.

The uncertainty around funding is impacting our potential customers resulting in lower than anticipated uptake of Inaphaea's services. The Collaborative Services model that Inaphaea is developing with partners continues to expand with several requests for quotes received and although multiple quotes were provided, no new projects were initiated during the period. The contract with Amply, announced on 24 November 2024, is expected to complete post period with a balancing payment of approximately £30,000.

The technical team at Inaphaea continue to develop the PDC biobank with the establishment of a new quality control and characterisation protocol. This value-add approach is being recognised by potential customers, particularly licensees for the PDCs and, post period, Cellomatics Biosciences Ltd have a set of 6 Colorectal cancer PDCs in house for evaluation ahead of potential roll out to their customer base which would trigger a commercial use license. Inaphaea is also working to enhance its internal and partnered capabilities with a particular focus on New Approach Methodologies which are increasingly supported by the regulatory agencies following the lead taken by the FDA as they announced their intention to phase out animal testing with more effective, human relevant methods. We are leveraging these capabilities for our evaluation and development programs, particularly around the CytoLytix where ScreenIn3D and, post period, VoxCell partnerships are being used to evaluate CytoLytix formulations at no, or low, cost relative to outsourcing. A new format, hybrid evaluation/development agreement will now be deployed which retains upside on work performed by ValiRx (through Inaphaea or externally) should an asset be returned and subsequently licensed. This model has been well received and recognised as a value adding approach to early-stage academic and commercial programmes.

In addition to product and service revenue, we continue to explore ways to realise the untapped potential of additional assets within Inaphaea. In May 2025, we announced a deal with Dominion Biotech Ltd ("Dominion") to exploit a data set from a proprietary screen of around 3,000 FDA approved, or late-stage non-oncology clinical assets, in a selection of PDCs. Inaphaea's expanded capabilities will be critical for the 3k-screening programmes, whilst exemplifying capabilities to support external revenue generation discussions.

Post period, Inaphaea licensed its PredictRx™ personalised cancer therapy selection approach to Dominion with initial revenues possible in Q4 2025.

Evaluation Projects:

Imperial College London

The Agreement, focused on investigating a lead series of dual-kinase inhibitor candidates. Although showing initial promise, under the new evaluation criteria the programme was deemed too early stage, and the Company decided to return the project to the university researchers for further development, with no further financial commitment from the Company. The parties agreed to terminate the current collaboration agreement and revert responsibility for maintaining the intellectual property to Imperial College London as announced on 24 February 2025.

Dundee University

A key decision point for in-licensing the asset is determination of the precise mechanism of action of the asset which requires access to techniques and equipment that we do not currently possess. In January 2025, following demonstration of activity in Inaphaea BioLabs facility, ValiRx agreed a one-year extension with the University of Dundee until 9 February 2026 to continue the mechanism of action studies for the prosenescence asset with the research group of Professor Bishop (Professor of Senescence and Director of the Queen Mary University London Phenotypic Screening Facility), supported by a £50,000 grant from the Queen Mary University London Impact Fund and £9,000 from ValiRx.

One new evaluation agreement was initiated in the first half of 2025

Altus HealthCare

On 29 January 2025, the Company entered into a broad evaluation and option agreement with Altus Healthcare, initially focussed on a formulation technology and repositioning of an anti-inflammatory CB₂ agonist (TA-A001) for use in cancer. The SmartCelle™ formulation platform is being evaluated for its ability to enhance the solubility, potency and targeting of a series of drug candidates including ValiRx's CLX001 cytolytic peptide. Experimental design and planning have been completed, and evaluation will be performed on a range of Patient Derived Cells (PDCs) by ValiRx's subsidiary Inaphaea BioLabs in Q4, with lead candidates then being tested in vivo through collaborative partners to assess safety, biodistribution and efficacy. ValiRx has an option to license the technologies for the treatment of certain cancers.

Further Evaluation Projects

StingRay Bio

Post period, a new style of agreement has been established with StingRay Bio ("StingRay") following completion of the initial evaluation agreement at the end of 2024. In-silico lead optimization of potency and target selectivity, and in-vitro based experiments will be performed on lead StingRay drug compounds, identified during the first agreement, over a period of up to 12 months. Results will be jointly owned by ValiRx and StingRay with an option to license the technology, under pre-agreed terms, into a Special Purpose Vehicle jointly owned with StingRay. On completion of IND enabling studies, ValiRx's ownership will increase to 75%.

Whilst the cost of the work will be borne by ValiRx and rights will return to StingRay if ValiRx does not proceed to license, under this new format agreement if StingRay secures alternative investment within 12 months of the evaluation's completion, ValiRx will be entitled to a cash payment of 1.5x its total investment (estimated at £150,000, including outsourced work and internal resources). Under this new approach, each partner retains the right to seek additional funding for the asset which can lead to earlier partnering opportunities in the SPV or transition from an evaluation to a revenue generating service contract.

ValiRx is in active discussions for a further three evaluation programmes under the new form of agreement.

Preclinical stage Assets:

A key focus for CLX001 was development and selection of a lead formulation. Four formats are under evaluation; the original format developed by King's College based on PEGylated-Polylactide-Glycolide Resomers™; an in-house lipid-based formulation; the Altus Smartcelle™ formulation and a novel virus-based format. Valirx is working directly with the suppliers of the key Resomers to select the optimal version for efficacy and stability.

Development and evaluation of the second-generation, lipid delivery platform has been completed and, post period, materials scheduled for evaluation in Screenin3D's UpScale3D lab-on-a-chip platform including Inaphaea's Triple Negative Breast Cancer Patient Derived Cell models provided under the Evaluation and Commercial Use agreement announced on 3 February 2025. The evaluation will include assessment of the potential to activate the host immune system through immunogenic cell death.

Altus will complete Smartcelle formulation testing in Q4 2025.  A first partnering agreement for CLX001 was signed on 3 June focusing on incorporating Cytolytix's Oncolytic Peptide technology into Omios Biologics next-generation Oncolytic Virus platform and is expected to take up to 12 months and Omios has an option to enter into an Oncolytic Peptide License Agreement to continue using Cytolytix technology. This signifies an exciting new opportunity for ValiRx and Cytolytix to further expand its portfolio and commercialise its portfolio of innovative cancer therapeutics

Legacy stage assets:

VAL201 in prostate cancer

The letter of Intent with TheoremRx was terminated by ValiRx on 2 April 2025. An extensive review of the VAL201 technical and market position highlighted that the asset is still highly relevant across the treatment pathway for prostate cancer and a critical path plan put in place to expedite validation of improvements to VAL201 to create additional value, extend patent coverage and position for partnering. Post period, with the support of Cancer Research Horizons, the assets were placed in Blue Ribbon Bio, a new SPV established to house the Group's current and future prostate cancer associated assets. Work has begun on synthesis of VAL201 2.0 to be followed by a limited series of preclinical testing to demonstrate improved preclinical performance and position for licensing and support new IP filings to extend patent life. Options to fund Blue Ribbon independently of ValiRx are being explored.

VAL401 in adenocarcinoma

Ambrose Healthcare Ltd ("Ambrose") exercised its option on VAL 401 which was out licensed under pre-agreed terms. As part of the agreement, ValiRx received 576,000 ordinary shares in Ambrose, as announced on 19 June 2025, with clinical and commercial milestone payments to be made to Valiseek totalling up to £16 million plus royalties. In addition to supporting Ambrose to identify funding partners, post period, a detailed proposal for preclinical validation of VAL401 in pancreatic cancer has been submitted by Inaphaea Biolabs. The fully costed proposal leverages Inaphaea's 19 pancreatic cancer Patient derived cell models, 3D cell culture and digital Twin NAMS capabilities.

Clinical stage Assets:

3k Screen

Post period, a set of 250 leads from the 3k-screen of FDA approved or non-oncology late-stage clinical assets has been identified by Inaphaea and Dominion. These assets have been stratified based on activity, oral availability and freedom to operate with respect to the current patent position to give a "top 10" list of low hanging fruit assets where we can achieve some quick wins from established drugs with validated human safety profiles for inclusion in the next phase which included testing of full dose response curves in selected Patient Derived Models at Inaphaea and Dominion. The data generated will be processed in TwinEdge's digital twin AI platform to support new patent filings and initial commercial discussions with potential licensees for, what would be, phase 2 ready assets as well as application for non-dilutive grant funding to support further development of these and other assets from the 3K screen.

ValiRx Plc

Consolidated statement of comprehensive income

ValiRx Plc

Consolidated statement of financial position