Candel Therapeutics Secures $100M Royalty Funding as CAN-2409 Advances Toward BLA

Candel Therapeutics Inc (NASDAQ:CADL) announced a $100 million royalty-based funding agreement with funds managed by RTW Investments to support the potential U.S. launch of its lead candidate aglatimagene besadenovec (CAN-2409) for intermediate- to high-risk localized prostate cancer, contingent on future FDA marketing approval. The company is advancing plans to bring the therapy toward potential commercialization, with a biologics license application (BLA) submission planned for the fourth quarter of 2026.

Under the deal, RTW will receive tiered single-digit royalties on U.S. net sales of CAN-2409 up to a $250 million cap. The transaction includes provisions for a buy-out option if Candel undergoes a change of control or sells CAN-2409 rights, allowing termination of the royalty agreement for specified payments up to the cap. The structure activates only upon regulatory approval and other closing conditions. Candel estimated unaudited cash and cash equivalents of about $119.7 million as of December 31, 2025.

Candel reported updated survival data from its phase 2a clinical trial in advanced non-small cell lung cancer (NSCLC). Among 46 evaluable patients, median overall survival was 25.4 months in cohorts 1 and 2, 21.5 months in patients with progressive disease at baseline despite prior immunotherapy, and 25.4 months in patients with non-squamous histology within cohort 2. The historical reference median overall survival is 9.8-11.8 months. Fifty percent of patients remained alive at 24 months, 35% survived beyond 30 months, 26% survived beyond 36 months, 24% survived beyond 40 months, and 13% survived beyond 50 months. The data showed improvement from the prior data cutoff where 39% of patients were alive at 24 months. Among patients surviving beyond 24 months, 85% had a baseline PD-L1 TPS below 50%. Tumor biopsies showed enhanced interferon signaling and antigen-presenting cell activation, including marked increases in the expression of IFNγ, CSF1, CX3CL1, and IL1β. The analysis also showed TCR repertoire expansion both within the tumor and peripheral blood.

Candel plans to initiate a pivotal phase 3 clinical trial of CAN-2409 in patients with progressive metastatic non-squamous non-small cell lung cancer who have failed immune checkpoint inhibitor treatment in the second quarter of 2026. The company also intends to submit a BLA for the therapy in localized intermediate- to high-risk prostate cancer in the fourth quarter of 2026. Candel continues preparations for the regulatory filing, including chemistry, manufacturing and controls work, as well as preparation of clinical study reports and other BLA modules. Follow-up clinical data from the phase 3 prostate cancer trial is expected in the second quarter of 2026, with biomarker data anticipated in the third quarter. The FDA has previously granted Fast Track and Regenerative Medicine Advanced Therapy designations for aglatimagene in localized prostate cancer, as well as Fast Track designation for NSCLC. Candel is preparing the phase 3 NSCLC trial following a positive end-of-phase 2 meeting with the FDA in July 2025. An abstract from the phase 3 prostate cancer trial was accepted for oral presentation at the American Urological Association 2026 Annual Meeting.

In February 2026, Candel raised approximately $100 million in gross proceeds through a follow-on equity offering, which was priced at $5.45 per share. The company also entered a $130 million term loan facility with Trinity Capital, drawing $50 million at closing with access to up to an additional $80 million. These financing activities strengthen the company's balance sheet ahead of potential commercialization.

Candel is also advancing its second program, linoserpaturev (CAN-3110), an investigational therapy for recurrent high-grade glioma. The FDA cleared an investigational new drug application for the therapy in the first quarter of 2026, which could support future randomized phase 2 development. The company has paused development of aglatimagene in pancreatic cancer to prioritize the prostate cancer and NSCLC programs, despite earlier encouraging data from a phase 2a trial in borderline resectable pancreatic cancer.

Candel Therapeutics is a clinical-stage biopharmaceutical company focused on developing off-the-shelf multimodal biological immunotherapies that elicit individualized systemic anti-tumor immune responses to help patients fight cancer. Its pipeline is built on adenovirus and herpes simplex virus gene-therapy platforms, led by aglatimagene besadenovec for localized prostate cancer, non-small cell lung cancer and pancreatic ductal adenocarcinoma, and linoserpaturev for recurrent high-grade glioma, alongside its HSV-based enLIGHTEN Discovery Platform for new viral immunotherapies for solid tumors.