On November 4, 2026 Zelluna (OSE: ZLNA), a clinical-stage company pioneering allogeneic "off-the-shelf" T Cell Receptor-based Natural Killer (TCR-NK) cell therapies for the treatment of solid cancers, reported its results for the third quarter 2026.

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Webcast scheduled for 5 November 2026 at 09:00 (CET). Link to webcast here.

Operational Highlights:

ZIMA-101 recruitment and dosing on track: Two of the three patients required at Dose Level 1 have now been successfully dosed, the second following the reporting period, with dosing of a third patient planned during Q4 2026 to complete this dose level. More than 30 patients have been screened for HLA-A2 and/or MAGE-A4 expression, with potential patients identified across all four target indications (ovarian cancer, squamous non-small cell lung cancer, synovial sarcoma and head and neck cancer), demonstrating strong clinical site engagement and supporting continued recruitment momentum. Subject to completion of Dose Level 1 and a favourable subsequent safety review by the Independent Data Monitoring Committee (IDMC), Zelluna expects to begin and complete recruitment and dosing at Dose Level 2, representing a threefold increase in the administered cell dose compared with Dose Level 1, during Q1 through early Q2 2027.
No dose-limiting toxicities to date: ZI-MA4-1 has been well tolerated, with no dose-limiting toxicities reported in the two patients treated. On 17 August 2026, the Independent Data Monitoring Committee (IDMC) completed its planned safety review of the first patient and recommended continued recruitment at Dose Level 1.
Initial observations from patient samples: Preliminary blood measurements indicate cell kinetics consistent with expectations, alongside early changes in circulating pro-inflammatory immune markers following ZI-MA4-1 infusion. Clinical follow-up is ongoing, including further tumour imaging assessments and the collection and analysis of translational data from patients treated at Dose Level 1.
External clinical evidence supports TCR-NK therapeutic potential: Researchers at MD Anderson Cancer Center have reported a complete response in a heavily pre-treated multiple myeloma patient treated with an independently developed TCR-NK therapy. While generated in a different disease setting, this provides an encouraging external clinical demonstration that the TCR-NK approach can deliver anti-tumour activity in late-stage cancer patients.
Awarded NOK 15.6 million grant by the Research Council of Norway to further advance TCR-NK manufacturing: Following the reporting period, on 4 November 2026, Zelluna was awarded NOK 15.6 million in a grant by the Research Council of Norway. Funding will enable further manufacturing development and support Zelluna’s commercial strategy to make off-the-shelf TCR-NK cell therapies broadly accessible to patients with solid cancers. The award, which is subject to final contract negotiations, follows another grant awarded by the Research Council of Norway in June 2026 earlier this year to support the ZIMA-101 clinical programme.
Manufacturing process successfully executed at new CDMO: Following the reporting period, an initial manufacturing run was successfully completed at Zelluna’s new CDMO, an important step towards establishing manufacturing capabilities at the new facility and highlighting the potential transferability of Zelluna’s manufacturing process across sites, an important TCR-NK platform attribute supporting future scalability, manufacturing flexibility and cost efficiency. Analytical and functional characterisation of the resulting product is ongoing.
ZIMA-101 featured at leading international oncology conferences: Following the reporting period, the design of the ongoing ZIMA-101 Phase 1 study of ZI-MA4-1 was presented by Professor Fiona Thistlethwaite, Chief Investigator of the study at The Christie NHS Foundation Trust, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026 in Madrid. A further poster presentation outlining the design of the study is scheduled for the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in November 2026.
Martin Welschof elected as new Board member: At an Extraordinary General Meeting held on 9 September 2026, Martin Welschof, CEO of BioInvent International AB, was elected as a new member of the Board, replacing Hans Ivar Robinson, who has stepped down from the Board. Martin Welschof has previously served as CEO of Affitech A/S and Opsona Therapeutics, holds a PhD in recombinant antibody technology and brings extensive international experience from executive leadership in clinical-stage and listed biotechnology companies.
Financial Highlights Q3 2026:

Total operating expenses: MNOK 28.8 in Q3 2026 and MNOK 69.2 YTD
Total loss: MNOK 29.0 in Q3 2026 and MNOK 69.0 YTD
Cash and cash equivalents: MNOK 60.4 as of 30 September 2026
Net negative cash flow from operations: MNOK 25.5 in Q3 2026
Financial runway: Into Q3 2027
Expected grants and tax credits: SkatteFUNN tax credits of MNOK 5.2 related to 2025 expected in Q4 2026, as well as the first payments under the MNOK 16 grant awarded by the Research Council of Norway in June 2026, with the remainder expected in 2027
Share issue to Inven2: On 4 August 2026, 446,752 new shares were issued at NOK 19.78 per share to settle EUR 791,666.70 under the option and license agreement with Inven2, triggered by the dosing of the first patient

"The third quarter marked Zelluna’s transition into a clinical-stage biotechnology company. We have now treated two patients in ZIMA-101, with no dose-limiting toxicities reported to date. Recruitment is on track, supported by strong engagement from our clinical sites and investigators driving continued progress towards completion of our first dose cohort and preparations for dose escalation.

Our immediate priority is to complete Dose Level 1 and progress towards a threefold higher dose, subject to independent safety review. This will be an important next step in exploring the therapeutic potential of TCR-NK for patients with solid tumours. We are also encouraged by emerging external clinical evidence, including the complete response reported with an independent TCR-NK therapy, demonstrating the potential of this approach to deliver meaningful anti-tumour activity in patients. With our differentiated platform, continued clinical execution, and sustained strategic interest in off-the-shelf cell therapies we believe Zelluna is well positioned to create value for patients and shareholders as clinical data builds" says CEO Namir Hassan.

"It is encouraging to see the progress in recruitment to the ZIMA-101 study, with patients being identified across several solid tumour indications. As an early-phase clinical trial evaluating a novel TCR-NK cell therapy, our initial focus is on establishing safety and progressing through dose escalation. We look forward to building on this early experience as the study advances." Prof. Fiona Thistlethwaite, Chief Investigator, ZIMA-101.

Outlook

Zelluna enters the final quarter of 2026 with encouraging initial clinical observations and recruitment and dosing progressing on track in the first-in-human ZIMA-101 study. The Company’s immediate priority is to complete Dose Level 1 and advance to Dose Level 2, where recruitment and dosing are expected to take place from Q1 through early Q2 2027, subject to completion of Dose Level 1 and a favourable subsequent IDMC safety review. The encouraging initial observations at the lowest planned dose level support continued dose escalation. Ongoing clinical and translational assessments of patients treated at Dose Level 1, together with data from higher dose levels, are expected to build a more comprehensive understanding of the safety and therapeutic potential of ZI-MA4-1. In parallel, Zelluna continues to strengthen its manufacturing capabilities and advance its TCR-NK pipeline, including the evaluation of AI-engineered TCR candidates targeting KKLC1. Zelluna’s cash position is expected to fund planned operations into the third quarter of 2027.

The quarterly report and presentation materials will be made publicly available on the Zelluna website at 07:00 CET on 5 November 2026. The Company will host a webcast on 5 November at 09:00 CET, and questions can be submitted during the event. The webcast recording will remain available on the Company’s website after the event.

(Press release, Zelluna Immunotherapy, NOV 4, 2026, View Source [SID1234674238])