Zelluna ASA

Earnings Release • Dec 12, 2025

Zelluna Completes First GMP Batch of ZI-MA4-1, a Novel TCR-NK Cell Therapy, to Treat Patients in Upcoming First-in-Human Trial

Zelluna Completes First GMP Batch of ZI-MA4-1, a Novel TCR-NK Cell Therapy, to Treat Patients in Upcoming First-in-Human Trial

* On track to file a Clinical Trial Application (CTA) by year end 2025, with

initial clinical data expected mid-2026

* Important step in developing scalable and accessible 'off-the-shelf' cell

therapy for patients with solid tumours

Oslo, Norway, 12 December, 2025 - Zelluna (OSE: ZLNA), a company pioneering

allogeneic "off-the-shelf" T Cell Receptor-based Natural Killer (TCR-NK) cell

therapies for the treatment of cancer, today announced the successful

manufacture and QC (Quality Control) testing of the first GMP (Good

Manufacturing Practice) batch of its lead candidate, ZI-MA4-1. This material is

intended for use in Zelluna's upcoming first-in-human clinical trial, marking a

major milestone in the company's progress toward regulatory submission and

patient dosing.

The GMP batch was successfully produced using Zelluna's proprietary

manufacturing process, which was finalised and locked in April 2025. The process

is designed to deliver high-quality TCR-NK products, with the ability to

generate hundreds of doses from a single manufacturing run, offering both broad

patient access and cost-of-goods advantages.

"Having our first GMP batch in storage and ready for our first clinical trial

fills us with hope and excitement as we move closer to bringing our TCR-NK

therapies to patients," said Emilie Gauthy, Head of CMC at Zelluna. "This

successful GMP run, backed by our robust development data, strengthens our

confidence in delivering safe, potent, and consistent therapies at a scale

capable of meeting patient's needs."

ZI-MA4-1 is the world's first MAGE-A4-targeting TCR-NK therapy, designed to

harness both the innate cancer-killing properties of NK cells and the precision

targeting of affinity-enhanced TCRs. The therapy aims to overcome key challenges

facing current cell therapies in solid tumours, including tumour heterogeneity

and antigen loss, while offering an anticipated favourable safety profile and

broad patient access.

"As we approach CTA submission, this achievement represents the final

operational step on our path to the clinic," said Namir Hassan, CEO of Zelluna.

"Together with our compelling preclinical data showing ZI-MA4-1's potent and

selective activity in solid tumour models, this milestone underscores the

strength of our science, our process, and our team. We believe ZI-MA4-1 is a

highly differentiated therapy with the potential to redefine what is possible

for patients with solid tumours. This is a proud and energising moment for

everyone at Zelluna."

Zelluna remains on track to submit a CTA for ZI-MA4-1 in 2H 2025 with initial

clinical data expected mid-2026.

About Zelluna ASA

Zelluna ASA (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

Email: namir.hassan@zelluna.com

Phone: +44 7720 687608

For media enquiries, please contact:

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 Joachim Midttun, Finance

manager of Zelluna ASA, on 12 December 2025 at 12.58 CET.