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Zelluna ASA Reports Second Quarter 2025 Financial Results and Provides General Business Update
Globenewswire· 2025-08-20 05:00
Core Viewpoint - Zelluna is advancing its pioneering allogeneic T-cell receptor-based natural killer (TCR-NK) therapies for cancer treatment, with a focus on achieving clinical readiness and regulatory approvals in the near future [1][5]. Financial Highlights - Total operating expenses for Q2 2025 were MNOK 38.4, with a year-to-date total of MNOK 67.8 [6]. - The total loss for Q2 2025 was MNOK 37.5, bringing the year-to-date loss to MNOK 66.0 [6]. - Net negative cash flow from operations in Q2 2025 was MNOK 59.4, with a net decrease in cash and cash equivalents of MNOK 59.0 during the same period [6]. - As of 30 June 2025, cash and cash equivalents stood at MNOK 76.0, providing a financial runway into Q2 2026, slightly shortened due to one-off costs related to TCR-NK manufacturing development [6]. Business Development - Zelluna is on track for IND/CTA submission in the second half of 2025 and aims to initiate its first-in-human trial in the first half of 2026 [6]. - The company has broadened its regulatory engagement, receiving positive FDA pre-IND feedback in Q2 2024 and submitting a scientific advice briefing package to the UK MHRA in July 2025 [6]. - GMP manufacturing of clinical material commenced in July 2025, enabling the production of hundreds of doses from a single batch [6]. Product Pipeline - The lead program targets MAGE-A4 with "off-the-shelf" TCR-NK therapies for various solid cancers, with additional products in the pipeline [7].