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

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]