Third Quarter 2025 Business Update

Highlights

• Positive MHRA feedback and strengthened clinical strategy supporting UK clinical development

In October 2025 (post period announcement), Zelluna announced it had received positive scientific advice from the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA). The feedback provided alignment across the preclinical, manufacturing, clinical, and regulatory strategy for ZI-MA4-1 and supports the planned Clinical Trial Application (CTA) submission later this year, with patient data planned for mid 2026.

• Preparations for first-in-human trial progressing

The Company has advanced preparations for its first-in-human trial of ZI-MA4-1 through engagement with leading UK cancer centres. Professor Fiona Thistlethwaite (The Christie, Manchester) has been appointed as proposed Chief Investigator, with The Christie serving as lead site. Together with Dr. Andrew Furness at The Royal Marsden Hospital, London, both globally recognised leaders in oncology and early-phase cell therapy, Zelluna has shaped a robust trial design and development strategy for ZI-MA4-1.

• GMP manufacturing of clinical material initiated

In July 2025, Zelluna initiated GMP manufacturing of the clinical batch for the planned Phase I trial. This milestone builds on the previously completed manufacturing process lock-down announced in April 2025 and marks a major step in Zelluna's clinical readiness and capability to deliver off-the-shelf cell therapies to patients (also shared in the Q2 2025 report).

• Pipeline expansion through strategic acquisition

During Q3, Zelluna acquired a portfolio of characterised TCRs targeting KKLC1 from a highly experienced TCR-focused biotechnology company with decades of expertise in the field. KKLC1 is a clinically validated cancer antigen that complements MAGE-A4, offering a potential opportunity to broaden Zelluna's TCR-NK pipeline and expand its reach to additional patient populations.

Financial highlights

• Total operating expenses amounted to MNOK 39.7 in Q3 2025, and MNOK 101.0 YTD. Total loss was MNOK 39.3 for the period and MNOK 98.7 YTD.
• Net negative cash flow from operations was MNOK 29.0 in Q3 2025, and net decrease in cash and cash equivalents, excluding currency effects, was MNOK 28.9 during Q3 2025. Cash and cash equivalents amounted to MNOK 47.2 as per 30 September 2025.
• The current cash is as previously reported expected to give a financial runway into Q2 2026.
  

The quarterly report and presentation will be made be publicly available on the Zelluna website. The Company will conduct a webcast on 4 November at 09:00 CET, and questions can be submitted throughout the event. The webcast will be archived for replay following the conference call. Link to webcast here.

For further information, please see or contact:

Namir Hassan, CEO, Zelluna ASA
Email: ...
Phone: +44 7720 687608

Hans Vassgård Eid, CFO, Zelluna ASA
Email: ...
Phone: +47 482 48632

About Zelluna ASA

Zelluna's mission is to deliver transformative treatments with the capacity to cure advanced solid cancers, in a safe and cost-efficient manner, to patients on a global scale. The Company aims to do this by combining the most powerful elements of the immune system through pioneering the development of“off-the-shelf” T-cell receptor (TCR) guided natural killer (NK) cell therapies (TCR-NK). The TCR-NK platform offers a unique mechanism of action with broad cancer detection capability to overcome the diversity of tumours and will be used“off-the-shelf” to overcome scaling limitations of current cell therapies. The lead programme is a world's first MAGE-A4 targeting“off-the-shelf” TCR-NK for the treatment of various solid cancers; a pipeline of earlier products follows. The Company is led by a management team of biotech entrepreneurs with deep experience in discovery through clinical development of TCR and cell-based therapies including marketed products.

This stock exchange announcement was published by Joachim Midttun, Financial Manager at Zelluna ASA, on 3 November 2025 at 16:38 CET.

Attachment

• Zelluna-ASA-Q325-Report