Zelluna Receives Positive MHRA Feedback and Strengthens UK Clinical Strategy for ZI-MA4-1 Paving the Way for First-in-Human Trials in the UK

• On track to file CTA by year end 2025, with plan to dose first patients and deliver initial data in 2026
• Planned UK trial to be led by Prof. Fiona Thistlethwaite at The Christie NHS Foundation Trust, a European hub for advanced therapies, with participation from Dr. Andrew Furness at The Royal Marsden, a world-renowned centre for oncology and early-phase clinical research

Oslo, Norway, 9 October 2025 – Zelluna (OSE: ZLNA), a company pioneering allogeneic (“off-the-shelf”) T Cell Receptor-based Natural Killer (TCR-NK) cells for the treatment of cancer, today announced it has received positive feedback from the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) following recent scientific advice. This feedback provides alignment on the preclinical, manufacturing, clinical and regulatory pathway for ZI-MA4-1 and supports Zelluna’s planned Clinical Trial Application (CTA) submission later this year.

In parallel, Zelluna has advanced preparations for the first-in-human trial of ZI-MA4-1 by engaging with leading UK cancer centres and appointing Professor Fiona Thistlethwaite, Medical Oncology Consultant at The Christie in Manchester, as proposed Chief Investigator. The Christie, one of Europe’s leading cancer centres and a major hub for advanced cell therapy research, will serve as a lead site for the study. Both Professor Fiona Thistlethwaite at The Christie and Dr. Andrew Furness at The Royal Marsden in London, a global leader in oncology and early-phase cell therapy studies, are expected to play central roles in the trial and have contributed to shaping its design and development strategy.

“Receiving positive scientific advice from the MHRA is an important milestone as we prepare to bring ZI-MA4-1 into the clinic,” said Namir Hassan, CEO of Zelluna. “With the involvement of world-class investigators and centres such as The Christie and The Royal Marsden, we are building strong momentum towards initiating a UK-based trial that could generate the first safety and efficacy data in 2026. This progress showcases the talent and dedication of our team, and our shared commitment to advancing a novel, scalable and accessible “off the shelf” cell therapy for patients with solid tumours.”

Subject to CTA approval, the proposed Phase I trial will be an open-label, dose-escalation basket study evaluating the safety, tolerability and preliminary efficacy of ZI-MA4-1 across multiple solid tumours.

Prof. Fiona Thistlethwaite, Medical Oncology Consultant within the Experimental Cancer Medicines Team (ECMT), Clinical Lead for the Advanced Immunotherapy and Cell Therapy (AICT) Team, The Christie, and proposed Chief Investigator for the planned trial, said “I am genuinely excited to see the progress of ZI-MA4-1 into the clinic. I am optimistic that the dual killing mechanism of the NK cells and tumour antigen directed TCR will provide us with the step-change that we need in the solid tumour setting to provide the required level of tumour potency whilst avoiding tumour escape”

About Zelluna Immunotherapy

Zelluna Immunotherapy (OSE: ZLNA) is a biotechnology company pioneering the development of allogeneic ‘off-the-shelf’ T Cell Receptor-based Natural Killer (TCR-NK) cells for the treatment of cancer. The company’s platform combines the innate killing power of NK cells with the precision targeting of TCRs, designed to address the limitations of current cell therapies, particularly in solid tumours. Zelluna’s proprietary manufacturing process enables scalable, cost-effective production of TCR-NK cell therapies, with potential for broad patient accessibility. The company’s lead program, ZI-MA4-1, targets the MAGE-A4 tumour antigen and is expected to enter clinical trials in 2026. Zelluna is headquartered in Oslo, Norway.

For further information, please contact:

Namir Hassan, CEO, Zelluna ASA

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Hans Vassgård Eid, CFO, Zelluna ASA

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For media enquiries, please contact:

Frazer Hall/Mark Swallow – MEDiSTRAVA

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This information is considered to be inside information pursuant to the EU Market Abuse Regulation and is subject to the disclosure requirements pursuant to Section 5-12 in the Norwegian Securities Trading Act.

This stock exchange announcement was published by Hans Vassgård Eid, CFO of Zelluna ASA, on 9 October 2025 at 07.57 CET.