Clinical Trial Updates - Azer-cel showed a 79% best overall response rate in a Phase 1b trial (N=14)[8, 10] - A 57% overall response/complete response rate was achieved in February 2025 for azer-cel[13] - The company anticipates initiating a pivotal Phase 2/3 registrational trial for azer-cel in CY2026, pending data and regulatory approvals[8] - onCARlytics Phase 1 OASIS trial is currently in Phase 1 in solid cancers in combination with Blinatumomab, showing early results in bile tract cancer and durable stability of disease[8] - VAXINIA received Orphan Drug Designation in September 2024[14] Business and Financial Strategy - The company is out-licensing azer-cel Phase 1b product to Kincell to offset costs and headcount[9] - Cost-cutting measures are ongoing, including headcount reductions and prioritizing programs for value-impacting studies[9] - The company is actively seeking partnering/out-licensing opportunities[9, 14] Upcoming Milestones - Additional Phase 1b azer-cel data is expected to be released in Q3 CY25 and Q4 CY25[14, 16] - An FDA meeting is planned for azer-cel to discuss registrational strategy/pivotal study[8, 16] - The company plans to initiate activity for a registrational/pivotal study for azer-cel[16]