Candel Therapeutics presented positive phase 3 trial results for CAN-2409 in localized prostate cancer, receiving FDA RMAT Designation and Orphan Designation for pancreatic cancer in 2025. BLA submission planned for Q4 2026. Cash and cash equivalents of $100.7 million as of June 30, 2025, will fund operations into Q1 2027.

Key highlights include positive outcomes in prostate, lung, and pancreatic cancer trials for CAN-2409. Data shows a significant improvement in disease-free survival in prostate cancer patients. In non-small cell lung cancer, CAN-2409 showed improved overall survival compared to standard treatment. In pancreatic cancer, patients treated with CAN-2409 had a longer median overall survival than those in the control group.

Financially, Candel reported a net loss of $4.8 million for the second quarter of 2025, with $100.7 million in cash and cash equivalents as of June 30, 2025. Research and development expenses were $7.0 million, while general and administrative expenses were $4.2 million for the same period. The company expects its current cash reserves to fund operations into Q1 2027.

CAN-2409 is a promising immunotherapy candidate designed to induce a systemic anti-tumor immune response. It has shown favorable results in preclinical and clinical settings, with over 1,000 patients dosed. The company’s other candidate, CAN-3110, is a next-gen oncolytic viral immunotherapy being evaluated in recurrent high-grade glioma patients. Candel aims to submit a BLA for CAN-2409 in prostate cancer in Q4 2026.

Read more at GlobeNewswire: Candel Therapeutics Reports Second Quarter 2025 Financial