Zelluna (ZLNA) Capital Markets Update 2026 summary

Strategic focus and platform differentiation

• Advancing a next-generation, off-the-shelf TCR-NK cell therapy platform targeting high unmet need in solid tumors, with initial clinical data expected from mid-2026.

• Lead program targets MAGE-A4, a clinically validated antigen present in multiple solid tumor types, aiming to address high unmet medical needs and potentially over 50,000 treatable patients in key markets.

• Platform combines TCR targeting and NK cell cytotoxicity, enabling dual mechanisms to overcome tumor heterogeneity and escape, with preclinical data showing outperformance of clinical benchmarks.

• Proprietary manufacturing process enables scalable, cryopreserved production of hundreds of doses per batch, reducing cost per dose and supporting repeat dosing.

• Strong IP position with granted patents covering TCR insertion into NK cells, positioning for significant value creation similar to the CAR-T space.

Clinical development and milestones

• First-in-human Phase I dose escalation study (ZIMA-101) in advanced, heavily pre-treated solid tumor patients, focusing on lung, ovarian, sarcoma, and head and neck cancers, with initial patient dosing expected in Q2 2026.

• Patients must be double positive for MAGE-A4 and HLA-A2; about 30% of tumor cells typically express MAGE-A4, and 50% of patients are HLA-A2 positive.

• Three doses administered per patient, with safety and mechanism of action as primary endpoints; option for retreatment based on response.

• Leading UK clinical sites (The Christie and The Royal Marsden) and experienced investigators engaged, leveraging established referral networks and pre-screening processes.

• Key milestones include manufacturing lock, clinical site engagement, regulatory approvals, and initial patient data, all progressing on schedule.

Scientific and regulatory positioning

• Platform leverages clinically validated biology: TCRs proven in solid tumors and NK cells with established safety and efficacy in liquid cancers.

• Regulatory approvals in place for UK clinical studies, with positive FDA feedback supporting potential US expansion.

• Safety profile of NK-based therapies supports outpatient potential, repeat dosing, and broader patient access compared to autologous CAR-T approaches.

• Early indicators of success in first patients include favorable safety, proof of mechanism, and potential efficacy signals at higher doses.

• Platform and pipeline are positioned for rapid clinical advancement and value creation, leveraging validated biology and scalable manufacturing.