Zelluna Receives UK MHRA and Ethics Approval to Initiate ZIMA-101 First-in-Human Clinical Trial

20 Feb 2026 14:30 CET

* Regulatory clearance enables start of clinical testing and marks transition
to clinical-stage company
* On track for initial clinical data to emerge from mid-2026

Oslo, Norway, 20 February 2026 - Zelluna (OSE: ZLNA), a company pioneering
allogeneic "off-the-shelf" T Cell Receptor-based Natural Killer (TCR-NK) cell
therapies for the treatment of solid cancers, today announced that the Medicines
and Healthcare products Regulatory Agency (MHRA) and Research Ethics Committee
(REC) has approved the Company's Clinical Trial Application (CTA) for ZIMA-101,
a first-in-human Phase 1 clinical trial evaluating ZI-MA4-1, Zelluna's lead TCR-
NK product candidate.

Highlights:

* MHRA and Ethics approvals enable Zelluna to initiate first-in-human clinical
trial in the UK
* Marks Zelluna's transition from preclinical to clinical-stage development
* First clinical evaluation of Zelluna's proprietary TCR-NK platform
technology
* Trial to assess safety and preliminary activity in patients with advanced
solid cancers
* Initial clinical data expected to emerge from mid-2026

The approvals allow Zelluna to initiate the ZIMA-101 study in the United
Kingdom, marking a key milestone in the Company's transition from preclinical to
clinical-stage development and representing the first clinical evaluation of its
proprietary TCR-NK platform.

ZIMA-101 is designed to assess the safety, tolerability, and preliminary
clinical activity of ZI-MA4-1 in patients with advanced solid cancers, including
lung cancer, ovarian cancer, head and neck cancer, and sarcomas.

"The MHRA and Ethics Committee approvals represent a significant milestone for
Zelluna and reflects the strength of the work the team has delivered across
science, manufacturing, and regulatory execution," said Namir Hassan, CEO of
Zelluna ASA. "Importantly, this first-in-human study is designed not only to
evaluate ZI-MA4-1 as a product candidate, but also to generate critical clinical
insight into the broader potential of our TCR-NK platform. We now move into an
important phase of clinical execution and learning for Zelluna as we initiate
our first clinical programme and begin to generate clinical insights into the
broader potential of our TCR-NK platform"

ZI-MA4-1 is an off-the-shelf cell therapy that combines two powerful cancer
fighting mechanisms: the precise solid tumour targeting of T cell receptors
(TCRs) with the potent and broad cancer killing ability of Natural Killer (NK)
cells. This approach is designed to address key limitations that have prevented
existing cell therapies from working effectively in solid tumours. ZI-MA4-1
targets MAGE-A4, a protein found in many solid cancers including lung, ovarian,
head and neck and sarcomas.

ZI-MA4-1 has broad intellectual property coverage, including a landmark granted
patent providing dominant protection for Zelluna over the entire TCR-NK field.

The UK MHRA offers a well-established regulatory framework for advanced
therapies, including early-phase clinical development of Advanced Therapy
Medicinal Products (ATMPs), providing an efficient and supportive environment
for pioneering modalities such as TCR-NK therapies.

About the ZIMA-101 trial:

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.

"I am delighted that the ZIMA-101 study has received MHRA approval. This is an
important step that brings us close to opening the study to patient
recruitment.' 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. "ZI-MA4-1 combines the broad tumour-recognition and innate cytotoxic
capacity of NK cells with a tumour-specific TCR which I am optimistic will
provide potent anti-tumour activity while minimising the risk of tumour escape."

The Company expects clinical data to emerge from mid-2026.

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 (mailto:namir.hassan@zelluna.com)

Phone: +44 7720 687608

Anders Tuv, Chairman, Zelluna ASA

Email: at@radforsk.no (mailto:at@radforsk.no)

Phone: +47 982 06 826

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 20 February 2026 at 14.30 CET.

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