Zelluna ASA

Regulatory Filings • Dec 17, 2025

Zelluna Reaches Major Milestone and Submits Clinical Trial Application in the UK for First-in-Human Study of ZI-MA4-1 (ZIMA-101), the World's First MAGE-A4-Targeting TCR-NK Cell Therapy for Solid Tumo

Zelluna Reaches Major Milestone and Submits Clinical Trial Application in the UK for First-in-Human Study of ZI-MA4-1 (ZIMA-101), the World's First MAGE-A4-Targeting TCR-NK Cell Therapy for Solid Tumo

* On track for initial clinical data in mid-2026

* Marks a pivotal step toward scalable, accessible, off-the-shelf cell

therapies for solid tumours

Oslo, Norway, 17 December 2025 - Zelluna (OSE: ZLNA), a company pioneering

allogeneic off-the-shelf cell therapies for cancer, today announced the

submission of its Clinical Trial Application (CTA) to the UK Medicines and

Healthcare products Regulatory Agency (MHRA) for ZI-MA4-1, the Company's lead

candidate.

The CTA submission marks Zelluna's transition from preclinical to clinical

development and represents the successful delivery of all key milestones

communicated for 2025:

* Manufacturing process locked (April 2025)

* Preclinical data package completed and key data published (December 2025)

* GMP clinical batch produced and quality-tested (December 2025)

* Clinical Trial Application submitted to the UK MHRA (December 2025)

ZI-MA4-1 is a novel cell therapy that combines two powerful cancer fighting

mechanisms: precise solid tumour targeting of T cell receptors (TCRs) with the

potent and broad cancer killing ability of Natural Killer (NK) cells. ZI-MA4-1

targets MAGE-A4, a protein found in many solid cancers including lung, ovarian,

head and neck and sarcomas.

"Submitting our first CTA is a transformational moment for Zelluna," said Namir

Hassan, Chief Executive Officer of Zelluna. "ZI-MA4-1 will be the first MAGE-A4-

targeting TCR-NK cell therapy to enter clinical testing globally and represents

the culmination of rigorous scientific, non-clinical, CMC and regulatory work.

Reaching this major milestone is a testament to the unwavering dedication and

talent of the Zelluna team past and present, the guidance of our board, and the

commitment of our investors. I am immensely proud of our team for delivering on

the commitments we set out to achieve this year. We now enter the most important

phase of our journey - demonstrating the potential of TCR-NK therapies for solid

cancer patients."

Zelluna's CTA submission comes as off-the-shelf cell therapies are gaining

significant traction across industry and investors, reflecting a broader shift

toward scalable, accessible cell therapy solutions.

The UK MHRA was selected for its strong track record in advanced therapy

approvals and its collaborative early-phase regulatory pathways, providing an

efficient and supportive environment for pioneering modalities such as TCR-NK

therapies.

About the ZIMA-101 trial:

The Phase I clinical trial will evaluate ZI-MA4-1 in patients with advanced

solid tumours including ovarian cancer, head-and-neck cancer, squamous non-

small-cell lung cancer, and synovial sarcoma. The study will assess safety,

tolerability and early signs of efficacy with initial data expected mid-2026

(subject to regulatory approval).

The trial will be led by Prof. Fiona Thistlethwaite at The Christie NHS

Foundation Trust (Manchester, UK) with participation from Dr. Andrew Furness at

The Royal Marsden (London, UK), both world leading centres for oncology and

early-phase cell therapy clinical research.

"This is an exciting moment, the submission of the CTA is a huge step towards

bringing the ZIMA-101 study into the clinic, " said Prof. Thistlethwaite,

Medical Oncology Consultant within the Experimental Cancer Medicines Team,

Clinical Lead for the Advanced Immunotherapy and Cell Therapy Team, The

Christie, and Chief Investigator for the ZIMA-101 trial. "I am optimistic that

combining the broad tumour-recognition and innate killing activity of NK cells

with a 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."

ZI-MA4-1 has broad intellectual property coverage, including a landmark granted

patent providing dominant protection for Zelluna over the entire TCR-NK field.

About Zelluna ASA

Zelluna ASA (OSE: ZLNA) is a pioneering allogeneic 'off-the-shelf' T Cell

Receptor-based Natural Killer (TCR-NK) cells for the treatment of solid cancers.

The company's platform combines the innate killing power of NK cells with

precise  solid tumour targeting of TCRs, designed to address the limitations of

current cell therapies in solid tumours. The company's lead candidate, ZI-MA4-

1, is the worlds-first MAGE-A4 targeting TCR-NK therapy expected to enter

clinical trials in 2026. Zelluna is headquartered at the Oslo Cancer Cluster

innovation Park in Oslo, Norway and is listed on the Oslo Stock Exchange under

the ticker ZLNA.

For further information, please contact:

Namir Hassan, CEO, Zelluna ASA

Email: namir.hassan@zelluna.com

Phone: +44 7720 687608

Anders Tuv, Chairman, Zelluna ASA

Email: at@radforsk.no

Phone: +47 982 06 826

International media:

Frazer Hall/Mark Swallow - MEDiSTRAVA

Email: zelluna@medistrava.com

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 Geir Christian Melen, Finance

Director of Zelluna ASA, on 17 December 2025 at 17.23 CET.