Emv Capital Regulatory News (EMVC)

For immediate release

EMV Capital plc

("EMVC" or the "Company")

PDS Biotech Initiates VERSATILE-003 Phase 3 Clinical Trial Evaluating Versamune® HPV in HPV16-Positive Head and Neck Cancer

First-ever HPV16-positive head and neck cancer Phase 3 clinical trial

EMV Capital plc (AIM: EMVC), the deeptech and life sciences VC investment group, reports that its portfolio company PDS Biotechnology Corporation (Nasdaq: PDSB) - a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, and in which it holds a 2.3% direct holding - has announced the initiation of the VERSATILE-003 Phase 3 clinical trial. The trial is now open to patient enrollment.

Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech, said:

"We are thrilled to share that the first trial site has been initiated, and activation of additional clinical sites continues. Considering the strength and durability of the clinical responses in our VERSATILE-002 study, we are pleased to get this registrational trial underway. We are confident in the potential of our innovative combination therapy to improve patient outcomes and enhance the standard of care."

VERSATILE-003 is a global, multi-centre, randomized, controlled and open-label Phase 3 pivotal trial designed to evaluate the safety and efficacy of Versamune® HPV in combination with pembrolizumab as a first-line treatment for recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma ("HNSCC"). The trial is designed to enroll approximately 350 patients into either the investigational arm or into a control arm receiving pembrolizumab alone at a 2:1 ratio. The primary endpoint is overall survival, and secondary endpoints include objective response rate, progression free survival, disease control rate and duration of response. Katharine Price, M.D., Associate Professor of Oncology, Head and Neck Disease Group, Mayo Clinic Comprehensive Cancer Centre will serve as the trial's Principal Investigator.

Kirk Shepard, M.D., Chief Medical Officer of PDS Biotech, said:

"Advancing into Phase 3 is a significant milestone in our mission to improve treatment options for patients with HPV16-positive recurrent/metastatic HNSCC, and we are optimistic about the potential of Versamune® HPV in combination with pembrolizumab to enhance immune response and deliver meaningful clinical benefits."

Versamune® HPV is an HPV-specific T cell stimulating immunotherapy delivered subcutaneously that has shown the potential to stimulate high levels of HPV16-specific CD8+ and CD4+ T cells within patients by activating multiple immune pathways. Based on data from the VERSATILE-002 Phase 2, open-label, multicenter trial, the U.S. Food and Drug Administration granted Versamune® HPV Fast Track designation, making it eligible for Priority Review at the time of Biologics License Application (BLA) submission.

For more information on VERSATILE-003, visit ClinicalTrials.gov (Identifier: NCT06790966).

A full version of PDS Biotech's announcement can be accessed here: 

https://pdsbiotech.com/index.php/investors/news-center/press-releases/press-releases1/132-2025-news/973-iotechnitiates003hase3linicalrial20250307  

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About EMV Capital plc (EMVC)

EMV Capital plc, formerly known as NetScientific plc, is a deep tech and life sciences venture capital investment group with an international portfolio of high-growth companies.

With a strategic focus on generating superior returns for investors from the fast-growing sectors and technologies that will define our future; EMV Capital invests in, manages and strengthens early stage IP-rich companies.

EMV Capital holds both direct equity stakes and carried interest in its portfolio companies, creating an evergreen structure that supports extensive growth and value creation. EMV Capital's investment thesis is realised through these capital sources:

· capital-efficient investments through Group balance sheet;

· fund management of the Evergreen EIS and Martlet Capital Funds;

· syndicated investments leveraging its network of third-party investors.

EMV Capital's approach is characterised by its proactive management style, aiming to advance portfolio companies to critical value inflection points by actively engaging with them. Companies are supported through Board representation and the use of its Value Creation Services practice.

Headquartered in London, with a Cambridge presence and strong international links, EMV Capital is quoted on the AIM market of the London Stock Exchange.

www.emvcapital.com

About PDS Biotechnology

PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers. The Company plans to initiate a pivotal clinical trial to advance its lead program in advanced HPV16-positive head and neck squamous cell cancers. PDS Biotech's lead investigational targeted immunotherapy Versamune® HPV is being developed in combination with a standard-of-care immune checkpoint inhibitor, and also in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor.

www.pdsbiotech.com