Anuncio • Jul 14
Zelluna ASA Doses First Solid Tumour Patient with ZI-MA4-1 in the ZIMA-101 Phase 1 trial Zelluna ASA announced that the first patient has been given the first dose in ZIMA-101, the Company’s first-in-human Phase 1 clinical trial evaluating ZI-MA4-1, Zelluna’s lead TCR-NK product candidate. The first patient was treated at The Christie NHS Foundation Trust in the United Kingdom, the largest single site cancer centre in Europe and the lead clinical site for the study. ZIMA-101 is evaluating ZI-MA4-1, the world's first MAGE-A4-targeting TCR-NK cell therapy to enter clinical development, in patients with advanced MAGE-A4-positive solid tumours. MAGE-A4 is present in several common cancer types, including ovarian cancer, squamous non-small cell lung cancer, synovial sarcoma and head and neck cancer. ZIMA-101 also represents the first clinical evaluation of Zelluna's proprietary TCR-NK platform and builds on years of scientific innovation, preclinical research and manufacturing development. The study is now active at two clinical sites in the United Kingdom: The Christie and The Royal Marsden NHS Foundation Trusts. Patient identification, pre-screening and screening activities continue across all four tumour indications included in the ZIMA-101 study. Zelluna expects initial clinical data from the ZIMA-101 study to emerge from mid-2026. ZIMA-101 is a first-in-human, multicentre Phase 1 dose-escalation study evaluating the safety, tolerability and preliminary anti-tumour activity of ZI-MA4-1 in patients with advanced MAGE-A4-positive solid tumours. The study is being conducted at The Christie and The Royal Marsden NHS Foundation Trusts in the United Kingdom. The study follows a dose escalation design (3+3) with three predefined dose levels and three patients per dose level. Each patient will receive three doses on Days 1, 4 and 8 of a treatment cycle. For the first patient at each dose level, an Independent Data Monitoring Committee will review the patient's data following completion of the initial safety observation period before providing recommendations on enrolment of the remaining two patients at that dose level. ZI-MA4-1 is Zelluna's lead allogeneic (off the shelf) TCR-NK product candidate and the world's first MAGE-A4-targeting TCR-NK cell therapy in clinical development. The product combines the innate tumour-killing properties of NK cells with precision tumour targeting enabled by affinity engineered T cell receptors (TCRs), with the goal of addressing key limitations of existing cell therapies in solid tumours, including scalability, tumour targeting and access. Anuncio • Jun 29
Zelluna Activates Second Clinical Site For ZIMA-101 Phase 1 Clinical Trial Evaluating ZI-MA4-1 Zelluna announced that The Royal Marsden NHS Foundation Trust has been activated as the second clinical site in the ZIMA-101 Phase 1 clinical trial evaluating ZI-MA4-1, Zelluna's lead TCR-NK product candidate. The activation of this second clinical site further expands the Company's clinical execution capabilities and patient recruitment capacity as ZIMA-101 progresses through its early stages. The site will soon be in a position to actively identify and screen patients with suitable tumour types, characteristics (including expression of the MAGE-A4 antigen and HLA-A*02 positivity) and disease stage for potential enrolment. The activation of The Royal Marsden follows the activation of the first clinical site, The Christie NHS Foundation Trust. With both sites now activated, the ZIMA-101 programme has full clinical execution capability across two of the UK's leading cancer centres. ZIMA-101 is a first-in-human Phase 1 clinical trial evaluating ZI-MA4-1, Zelluna's lead TCR-NK product candidate and the world's first MAGE-A4-targeting TCR-NK therapy in clinical development. The study marks the first clinical evaluation of Zelluna's proprietary TCR-NK platform. Zelluna remains on track for initial clinical data from the ZIMA-101 study to emerge from mid-2026. Anuncio • Jun 27
Zelluna Reports Final Readout From Legacy Ultimovacs DOVACC Phase II Trial For UV1 Cancer Vaccine Zelluna announced that the NSGO-CTU sponsored Phase II DOVACC clinical trial (NCT04742075) investigating the Ultimovacs UV1 cancer vaccine, inherited through the business combination between the two companies in 2025, did not meet the primary endpoint. The investigator-led Phase II DOVACC study evaluating UV1 in BRCAwt platinum sensitive recurrent ovarian cancer did not meet its primary endpoint of progression free survival (PFS). The DOVACC readout represents the final Phase II outcome for the UV1 programme; all five Phase II studies evaluating UV1 did not meet their primary endpoints. Aside from minimal costs associated with completing the remaining study close-out activities, Zelluna does not expect to incur any further material costs related to the UV1 programme which is now considered concluded. The DOVACC trial tested the cancer vaccine UV1 in patients with BRCAwt platinum sensitive recurrent ovarian cancer. The goal was to assess whether UV1, given alongside two established cancer medicines, could slow disease progression better than standard treatment alone. The DOVACC readout represents the fifth Phase II study evaluating UV1 that has not met its primary endpoint. New Risk • Jun 21
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 44% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 24% per year over the past 5 years. Shareholders have been substantially diluted in the past year (44% increase in shares outstanding). Revenue is less than US$1m (kr8.0k revenue, or US$826). Minor Risks Share price has been volatile over the past 3 months (10% average weekly change). Market cap is less than US$100m (€50.3m market cap, or US$57.7m). Board Change • May 20
No independent directors Following the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 5 non-independent directors. Co-Founder & Chairman Anders Tuv was the last director to join the board, commencing their role in 2025. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model. Anuncio • Mar 27
Zelluna ASA, Annual General Meeting, Apr 23, 2026 Zelluna ASA, Annual General Meeting, Apr 23, 2026, at 09:00 W. Europe Standard Time. Anuncio • Feb 21
Zelluna Receives Uk Mhra and Ethics Approval to Initiate Zima-101 First-In-Human Clinical Trial Zelluna 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 Zelluna-MA4-1, Zelluna's lead TCR-NK product candidate. MHRA and Ethics approvals enable Zelluna to initiate first-in-human clinical trial in the UK, 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, head and neck cancer, and sarcomas. ZIMA-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. ZIMA4-1 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. 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. Anuncio • Feb 05
Zelluna ASA Promotes Emilie Gauthy to Chief Technology Officer Zelluna ASA announced the promotion of Emilie Gauthy to Chief Technology Officer (CTO). Gauthy, who has played a central role in building Zelluna's manufacturing and CMC capabilities since joining in 2022, assumes the role with immediate effect.in her role as CTO, Gauthy will continue to lead Zelluna's manufacturing and CMC strategy as the company advances its clinical development program, scales up manufacturing capacity and expands the pipeline of its off-the-shelf TCR-NK platform. Under Gauthy's leadership, Zelluna has established a scalable manufacturing process and analytical capabilities that enabled the company to successfully submit its Clinical Trial Application (CTA) for ZI-MA4-1 to the UK MHRA in December 2025. Key achievements include locking the manufacturing process, producing and quality-testing a GMP clinical batch, and establishing the CMC foundation for the company's first-in-human clinical trial, with initial data expected to emerge from mid-2026. These achievements also enable the entire TCR-NK platform supporting the continuous development of future programs. Anuncio • Dec 13
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 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. Zelluna remains on track to submit a CTA for ZI-MA4- 1 in 2H 2025 with initial clinical data expected mid-2026. Anuncio • Nov 28
Zelluna Asa Announces CFO Changes Zelluna announced the appointment of Geir Christian Melen as new Chief Financial Officer, effective 01 January 2026. Hans Vassgård Eid will be stepping down as CFO of Zelluna ASA from the end of December 2025 and supporting the transition thereafter. Geir Christian brings extensive senior leadership experience across the Norwegian biotech and life sciences sector, including multiple CFO and CEO roles in both publicly listed and privately held companies including in Algeta and Photocure. Over his career, he has led financial operations, corporate strategy, and capital market engagement for several life science organisations, giving him a deep understanding of the financial, regulatory, and operational demands of the industry.Geir Christian has also been part of Zelluna as Finance Director for over seven years, holding a key leadership role across finance and operations. He brings strong familiarity with Zelluna’s TCR-NK platform, financial strategy, and organisational priorities. Anuncio • Oct 10
Zelluna Receives Positive MHRA Feedback and Strengthens UK Clinical Strategy for ZI-MA4-1 Paving the Way for First-In-Human Trials in the UK Zelluna announced it has received positive feedback from the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) following recent scientific advice. This feedback provides alignment on the preclinical, manufacturing, clinical and regulatory pathway for ZI-MA4-1 and supports Zelluna's planned Clinical Trial Application (CTA) submission later this year. In parallel, Zelluna has advanced preparations for the first-in-human trial of ZI-MA4- 1 by engaging with leading UK cancer centres and appointing Professoriona Thistlethwaite, Medical Oncology Consultant at The Christie in Manchester, as proposed Chief Investigator. The Christie, one of Europe's leading cancer centres and a major hub for advanced cell therapy research, will serve as a lead site for the study. Both Professor Fiona Thistlethwaite at The Christie and Dr. Andrew Furness at The Royal Marsden in London, a global leader in oncology and early-phase cell therapy studies, are expected to play central roles in the trial and have contributed to shaping its design and development strategy. Subject to CTA approval, the proposed Phase I trial will be an open-label, dose-escalation basket study evaluating the safety, tolerability and preliminary efficacy of ZI-MA4 -1 across multiple solid tumours. Prof. Fiona Thistlethwaite, medical Oncology Consultant within the Experimental Cancer Medicines Team (ECMT), Clinical Lead for the Advanced Immunotherapy and Cell Therapy (AICT) Team, The Christie, and proposed Chief Investigator for the planned trial, said "I am genuinely excited to see the progress of ZI-MA 4-1 into the clinic. I am optimistic that the dual killing mechanism of the NK cells and tumour antigen directed TCR will provide with the step-change that need in the solid tumour setting to provide the required level of tumour potential whilst avoiding tumour escape". 
