Zelluna (ZLNA) Q3 2025 earnings summary

Executive summary

• Raised NOK 58 million in a challenging biotech market, securing funding into Q1 2027 to advance lead asset ZI-MA4-1 into Phase I and expand the pipeline with KKLC1 TCRs acquisition.

• Successfully completed integration and public listing after merger with Ultimovacs ASA; expanded pipeline with acquisition of over 20 KKLC1 TCRs.

• Lead TCR-NK program ZI-MA4-1 targeting MAGE-A4 is on track for CTA submission by year-end 2025, with first patient data expected mid-2026.

• Positive regulatory feedback from MHRA and FDA de-risked clinical entry in the UK and US.

• Manufacturing process for ZI-MA4-1 established, with first GMP batch produced and analytics ongoing.

Financial highlights

• Q3 2025 cash balance was MNOK 47, with the new capital raise extending runway to Q1 2027.

• Q3 EBIT was minus MNOK 40; year-to-date EBIT minus MNOK 101.

• Operating cash flow for Q3 2025 was minus MNOK 29, mainly due to non-cash items like goodwill impairment and share option expenses.

• Payroll and related expenses increased due to higher headcount and restructuring post-merger.

• No revenues generated as the company remains in the R&D phase.

Outlook and guidance

• Proceeds from the capital raise will fund advancement of ZI-MA4-1 into phase 1 clinical trial and pipeline development.

• Initial clinical data expected mid-2026 from first patient cohort; study to begin in first half of 2026.

• Preclinical package for KKLC1 program moved to Q3 2026 to allow comprehensive assessment of newly acquired TCRs.

• Near-term focus is on generating early clinical data to validate the TCR-NK platform and unlock value.

• Current cash position supports operations into Q1 2027.