ValiRx plc provided an operational update. Development Pipeline Update: Cytolytix (CLX001): The assessment of formulation options for CLX001 has progressed during First Quarter 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 announced that Cytolytix has been awarded a Knowledge Transfer Voucher ("KTV") grant in conjunction with the Open University. 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.

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 Second Quarter 2024. Due diligence is underway on additional potential pipeline projects. 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.

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 Licensing 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 the company 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. The company 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 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.

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.