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Zelluna ASA: Fourth Quarter 2025 – Key regulatory milestone achieved with CTA Submission

12.2.2026 07:00:00 CET | GlobeNewswire by notified | Press release

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Oslo, 12 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 presents its results for the fourth quarter and full year 2025.

Webcast scheduled for 12 February 2026, at 08:30 (CET). Link to webcast here.

Operational Highlights Q4 2025

  • CTA submitted: On 17 December 2025, Zelluna submitted its first Clinical Trial Application (CTA) to the UK MHRA for ZI-MA4-1, the world's first MAGE-A4-targeting TCR-NK cell therapy. Initial Phase I clinical data are expected to emerge from mid-2026.
  • First GMP batch completed: On 12 December 2025, the first GMP batch of ZI-MA4-1 was manufactured and quality-tested for use in the upcoming clinical trial.
  • Preclinical data published: Compelling preclinical data for ZI-MA4-1 published in Immunotherapy Advances in December 2025.
  • Capital raise: NOK 58.2 million raised in November 2025 through private placement and retail offering.

Financial Highlights Q4 2025

  • Total operating expenses: NOK 35.4 million (FY25: NOK 143.8 million)
  • Total loss: NOK 34.6 million (FY25: NOK 140.7 million)
  • Cash and cash equivalents: NOK 78.3 million as of 31 December 2025
  • Financial runway: Into Q1 2027

"Q4 2025 marked the transition to a clinical-stage company with the successful CTA submission for ZI-MA4-1. We have delivered on all key milestones communicated for the year. Our priorities for 2026 are clear: secure regulatory approval, initiate the ZIMA-101 study, and generate initial human data from mid-2026," says CEO Namir Hassan.

Outlook

With the CTA submitted and GMP manufacturing completed, Zelluna is positioned to initiate its first Phase I clinical trial (ZIMA-101) in 2026, subject to regulatory approval. The Company continues to operate in a rapidly evolving off-the-shelf cell therapy landscape, where recent strategic transactions underscore increasing industry interest in scalable cell therapy platforms. The current cash position supports planned operations into Q1 2027.

The quarterly report and presentation will be made publicly available on the Zelluna website. The Company will conduct a webcast on 12 February at 08:30 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:
Namir Hassan, CEO, Zelluna ASA
Email: namir.hassan@zelluna.com
Phone: +44 7720 687608

Geir Chrisitan Melen, CFO, Zelluna ASA
Email: geir.christian.melen@zelluna.com
Phone: +47 913 02 965

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 world's 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.

This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act and the EU Market Abuse Regulation.

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