Q2 2025 Zelluna ASA Earnings Call Transcript
Key Points
- Zelluna ASA (OSL:ZLNA) is on track for a clinical trial application filing for its lead program ZI-MA4-1 in the second half of 2025, with patient data expected in the first half of 2026.
- The company has successfully completed key pre-clinical investigations and initiated GMP production of a clinical batch, marking significant progress towards clinical trial readiness.
- Zelluna ASA has broadened its regulatory engagement, receiving positive feedback from the FDA and submitting a scientific advice briefing package to UK regulatory authorities.
- The TCR-NK platform is designed to address solid tumors and overcome cancer escape, offering a scalable and accessible therapy option.
- Zelluna ASA holds a strong patent portfolio, providing protection for its TCR-NK therapeutic approach, which is unique in the market.
- The company reported a negative operating profit of NOK38 million for the second quarter and a year-to-date loss of NOK68 million.
- Zelluna ASA's cash position of NOK76 million is expected to provide financial runway only into the second quarter of 2026, indicating potential future funding needs.
- The operating cash flow was negative NOK59 million in the second quarter, highlighting significant cash burn.
- R&D costs have increased due to higher CMC development expenses and milestone payments for clinical trials.
- The financial results are complicated by the recent acquisition and integration of cellular immunotherapy, affecting comparability with previous periods.
Good morning and welcome to Zelluna's second quarter 2025 business updates and financial results. My name is Namir Hassan, the CEO of Zelluna, and I'm joined by Hans Eid, the CFO. Can I have the next slide, please?
And the next one. So what we'll be covering with you today are the key events over the second quarter of 2025. A reminder on the TCR-NK technology and pipeline. We'll provide a financial update, and summarize at the end of the next slide please.
And the next So perhaps two of the key messages that we would like to communicate from the second quarter are shown here. The first key message is excitingly we are on track for a clinical trial application filing for our lead program ZI-MA4-1. And scheduled for some time in the second half of 2025, which means we are on track for generating that all important, human data in the first half of 2026.
This is a very exciting moment for the for the company on the cusp of generating patient data for our novel platform technology, and it's exceptionally exciting when we think
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