Regulatory clearance enables start of clinical testing and marks transition to clinical-stage companyOn 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 Clinic ...

Core Insights - Zelluna has transitioned to a clinical-stage company with the successful submission of its first Clinical Trial Application (CTA) for ZI-MA4-1, marking a significant milestone in its development of T Cell Receptor-based Natural Killer (TCR-NK) cell therapies for solid cancers [4][8] - The company aims to secure regulatory approval, initiate the ZIMA-101 study, and generate initial human data by mid-2026, indicating a clear strategic focus for the upcoming year [4][5] Operational Highlights Q4 2025 - The first GMP batch of ZI-MA4-1 was completed and quality-tested for use in the upcoming clinical trial [8] - Compelling preclinical data for ZI-MA4-1 was published in Immunotherapy Advances in December 2025, showcasing the potential of the therapy [8] Financial Highlights Q4 2025 - Zelluna raised NOK 58.2 million in November 2025 through private placement and retail offering [8] - Total operating expenses for the quarter were NOK 35.4 million, with a total loss of NOK 34.6 million for the quarter and NOK 140.7 million for the full year [8] - As of December 31, 2025, the company had cash and cash equivalents of NOK 78.3 million, providing a financial runway into Q1 2027 [8] Outlook - With the CTA submitted and GMP manufacturing completed, Zelluna is positioned to initiate its first Phase I clinical trial (ZIMA-101) in 2026, pending regulatory approval [5] - The company operates in a rapidly evolving off-the-shelf cell therapy landscape, with increasing industry interest in scalable cell therapy platforms [5]

Core Insights - Zelluna has announced a clinical partnership with Medpace to support the first clinical trial of its lead product candidate, ZI-MA4-1, which is an allogeneic T Cell Receptor-based Natural Killer (TCR-NK) cell therapy for solid cancers [1][3][9] Company Overview - Zelluna ASA is pioneering TCR-NK cell therapies targeting solid cancers, with ZI-MA4-1 being the world's first MAGE-A4 targeting TCR-NK therapy [7] - The company is headquartered in Oslo, Norway, and is listed on the Oslo Stock Exchange under the ticker ZLNA [7] Clinical Development - The partnership with Medpace is a strategic move for Zelluna as it transitions from preclinical to clinical stage, providing access to necessary infrastructure and expertise for executing a complex cell therapy trial [3][6] - The planned Phase 1 study will assess safety, tolerability, and early signs of clinical activity in patients with advanced solid cancers, including lung cancer, ovarian cancer, head and neck cancer, and sarcomas [5][9] - Initial clinical data from the study is expected to emerge from mid-2026, marking the first clinical validation of Zelluna's proprietary TCR-NK platform [5][9] Medpace's Role - Medpace will provide comprehensive clinical development services, including clinical operations, trial management, regulatory support, data management, and pharmacovigilance [3][9] - Medpace has a strong track record in early-phase development and oncology, which aligns with Zelluna's goals for the ZI-MA4-1 study [6][10]

Core Viewpoint - Zelluna ASA has granted a total of 75,000 new share options to two employees as part of a long-term incentive program approved by the General Meeting on 29 April 2025 [1][2]. Group 1: Share Options Details - The total number of options outstanding now represents 5.5% of the Company's outstanding share capital [2]. - Each option allows the holder to acquire one share in the Company, granted without consideration [3]. - The vesting schedule stipulates that 25% of the options will vest after one year, another 25% after two years, 25% after three years, and the final 25% after four years, contingent on the holder's continued employment [3]. Group 2: Financial Terms - The exercise price for the options is set at NOK 14.48 per share, based on the volume-weighted average price over the past 30 calendar days [4]. - Options not exercised within 7 years from the grant date will lapse and become void [4]. Group 3: Recipients of Options - Chief Financial Officer Geir Christian Melen has been granted 55,000 share options, while Chief Technology Officer Emilie Gauthy has received 20,000 share options [4].

Core Viewpoint - Zelluna is set to present its fourth quarter 2025 results on February 12, 2026, highlighting its focus on pioneering T-cell receptor-based natural killer therapies for cancer treatment [1] Group 1: Company Presentation - The webcast presentation will be available live on the company's website at 08:30 CET on February 12, 2026 [1] - A recording of the webcast will be accessible on the company's website after the event, allowing participants to submit questions during the presentation [1] Group 2: Financial Reporting - The quarterly report and presentation materials will be published on the company's website at 07:00 CET on the same day as the presentation [2]

Core Insights - Zelluna has promoted Emilie Gauthy to Chief Technology Officer (CTO), effective immediately, recognizing her contributions to the company's manufacturing and CMC capabilities since joining in 2022 [1][4] Company Developments - As CTO, Gauthy will lead Zelluna's manufacturing and CMC strategy, focusing on advancing the clinical development program, scaling up manufacturing capacity, and expanding the TCR-NK pipeline [2] - Under Gauthy's leadership, Zelluna has established a scalable manufacturing process and analytical capabilities, which facilitated the submission of its Clinical Trial Application (CTA) for ZI-MA4-1 to the UK MHRA in December 2025 [3] - Key achievements include locking the manufacturing process, producing and quality-testing a GMP clinical batch, and establishing the CMC foundation for the first-in-human clinical trial, with initial data expected from mid-2026 [3] Leadership Statements - CEO Namir Hassan highlighted Gauthy's central role in building the manufacturing and CMC capabilities that enabled the submission of the first CTA, emphasizing her leadership in establishing the foundation for clinical development [4] - Emilie Gauthy expressed pride in the team's achievements since 2022, noting the submission of the first CTA as a major milestone and the strong manufacturing foundations built for the scalable TCR-NK platform [4] Company Overview - Zelluna ASA is pioneering allogeneic "off-the-shelf" T Cell Receptor-based Natural Killer (TCR-NK) cell therapies for solid cancers, with its lead candidate ZI-MA4-1 being the world's first MAGE-A4 targeting TCR-NK therapy [5] - The company submitted its Clinical Trial Application to the UK MHRA in December 2025, with initial clinical data expected to emerge from mid-2026 [5]

Core Viewpoint - Zelluna ASA has successfully completed a private placement of 5,500,000 new shares and allocated 315,639 new shares through a retail offering via the PrimaryBid platform [2]. Group 1 - The Financial Supervisory Authority of Norway has approved the prospectus for the listing of the new shares [3]. - The prospectus will be available on the company's website for investors [3]. - Contact information for the CEO and Chairman of Zelluna ASA is provided for further inquiries [3].

Core Insights - Zelluna has successfully manufactured and quality controlled the first GMP batch of its lead candidate, ZI-MA4-1, intended for its first-in-human clinical trial, marking a significant milestone in the company's development process [1][4] - The proprietary manufacturing process allows for the generation of hundreds of doses from a single run, enhancing patient access and reducing costs [2][5] - ZI-MA4-1 is the first MAGE-A4-targeting TCR-NK therapy, designed to address challenges in treating solid tumors, including tumor heterogeneity and antigen loss, while maintaining a favorable safety profile [3][4] Company Overview - Zelluna ASA is a biotechnology company focused on developing allogeneic "off-the-shelf" T Cell Receptor-based Natural Killer (TCR-NK) cell therapies for cancer treatment [5] - The company aims to combine the innate killing power of NK cells with the precision targeting of TCRs to overcome limitations of current therapies, particularly in solid tumors [5] - Zelluna plans to submit a Clinical Trial Application (CTA) for ZI-MA4-1 in the second half of 2025, with initial clinical data expected by mid-2026 [4][6]

Core Viewpoint - The company has decided not to proceed with the Subsequent Offering due to the trading performance of its shares, which have remained at or below the subscription price from the Private Placement for an extended period [2][3]. Group 1 - The board of directors resolved to cancel the Subsequent Offering [2]. - The cancellation is attributed to the company's shares trading at or below the subscription price for a significant duration and volume [3]. - Shareholders have had the opportunity to mitigate the dilutive impact of the Private Placement by purchasing shares in the market at prices equal to or lower than the proposed subscription price for the Subsequent Offering [3].

Core Insights - Zelluna has appointed Geir Christian Melen as the new Chief Financial Officer, effective January 1, 2026, succeeding Hans Vassgård Eid who will step down at the end of December 2025 [1][2][3] Company Overview - Zelluna ASA is a biotechnology company focused on developing allogeneic "off-the-shelf" T Cell Receptor-based Natural Killer (TCR-NK) cell therapies for cancer treatment [4] - The company's lead program, ZI-MA4-1, targets the MAGE-A4 tumor antigen and is expected to enter clinical trials in 2026 [4] Leadership Transition - Geir Christian Melen has over seven years of experience with Zelluna as Finance Director and possesses a strong understanding of the company's TCR-NK platform and financial strategy [2][3] - The CEO of Zelluna, Namir Hassan, expressed appreciation for Hans Vassgård Eid's contributions, particularly in integrating Zelluna and Ultimovacs and preparing the company for clinical development [2]