Aglatimagene besadenovec (CAN-2409) - (ULYSSES)

March 12, 2026: Candel Therapeutics, Inc. (NASDAQ: CADL) reported Q4/full-year 2025 results and outlined upcoming clinical/regulatory catalysts for its oncology viral immunotherapy programs.

Aglatimagene besadenovec (CAN-2409)

• Localized, intermediate- to high-risk prostate cancer: Company reiterated plans to submit a BLA in Q4 2026; expects extended follow-up from its positive Phase 3 trial (prostate cancer-specific disease-free survival, time to salvage therapy, time to metastasis) in Q2 2026 and additional biomarker data in Q3 2026. Process validation by its contract manufacturer is planned for Q2 2026 to support the Q4 2026 BLA.
• Metastatic, non-squamous NSCLC post–immune checkpoint inhibitor progression: Plans to initiate a pivotal Phase 3 trial in Q2 2026 following a positive end-of-Phase 2 FDA meeting (July 2025). Updated median overall survival/“long tail” data from a Phase 2a trial (NCT04495153) expected in Q1 2026.
• Pancreatic cancer (borderline resectable PDAC): Program paused.

Linoserpaturev (CAN-3110) – recurrent high-grade glioma

• FDA IND clearance received in Q1 2026 (IND submitted Q4 2025); mature overall survival data for Arm C expected in Q4 2026.

Financing/runway: $130M term loan facility with Trinity Capital (drawn $50M at close); Feb. 23, 2026 follow-on offering ~$100M gross; Feb. 19, 2026 $100M royalty funding agreement with RTW (contingent on FDA approval of aglatimagene in prostate cancer). Cash of $119.7M at Dec. 31, 2025; with Feb. 2026 equity proceeds, runway into Q1 2028.