Norway-based pharmaceutical company Zelluna (OSE:ZLNA), a developer of allogeneic 'off-the-shelf' T-cell receptor-based natural killer (TCR-NK) therapies for the treatment of cancer, on Wednesday announced its results for the second quarter of 2025, together with a general business update.

The company said that it is on track toward IND/CTA submission in the second half of 2025 and first-in-human trial initiation in the first half of 2026.

Following positive FDA pre-IND feedback (Q2 2024), Zelluna submitted a scientific advice briefing package to the UK MHRA in July 2025 for ZI-MA4-1.

Zelluna initiated GMP manufacturing of clinical material in July 2025, a major step in clinical readiness. Its scalable platform developed with Catalent can deliver hundreds of doses from a single batch.

The company also said that it was moving to operational readiness ahead of IND/CTA submission.

Total operating expenses for the second quarter amounted to NOK38.4m in Q2 2025, and NOK67.8m in the year to date (YTD). Total loss was NOK37.5m for the period and NOK66.0m YTD.

Net negative cash flow from operations was NOK59.4m in Q2 2025, and net decrease in cash and cash equivalents, excluding currency effects, was NOK59.0m. As of the end of June 2025, cash and cash equivalents amounted to NOK76.0m.

The current cash is expected to give a financial runway into Q2 2026, slightly shortened from the previously guided 'through Q2 2026' due to some one-off cost elements mainly related to investment in the successful development of the TCR-NK manufacturing process. The expected financial runway reflects that the cash burn rate is forecasted to come down significantly from the Q2 2025 level, Zelluna said.