Candel Therapeutics Inc (NASDAQ:CADL) is advancing plans to bring its lead cancer immunotherapy toward potential commercialization, outlining new phase 3 trials and a planned regulatory filing while reporting its fourth quarter and full-year 2025 financial results.
“During the quarter, we made meaningful progress across our clinical pipeline and pre-commercial readiness, entering 2026 with strong momentum and a robust set of potential value-driving catalysts,” Candel CEO Paul Peter Tak said in a statement.
The clinical-stage biopharmaceutical company said it plans to initiate a pivotal phase 3 clinical trial of its lead candidate, aglatimagene besadenovec (CAN-2409), in patients with progressive metastatic non-squamous non-small cell lung cancer (NSCLC) who have failed immune checkpoint inhibitor treatment in the second quarter of 2026. The company also intends to submit a Biologics License Application (BLA) for the therapy in localized intermediate- to high-risk prostate cancer in the fourth quarter of 2026.
Candel said it continues preparations for a potential regulatory filing for aglatimagene in prostate cancer, 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 company noted that the US Food and Drug Administration 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.
In NSCLC, Candel is preparing the phase 3 trial following a positive end-of-phase 2 meeting with the FDA in July 2025. Updated survival data from a phase 2a trial in patients with stage III or IV NSCLC who progressed despite immune checkpoint inhibitor treatment is expected in the first quarter of 2026.
The company is also advancing its second program, linoserpaturev (CAN-3110), an investigational therapy for recurrent high-grade glioma. Candel said 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.
Candel added that it 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.
During the period, the company strengthened its financial position through several financing initiatives. In February 2026, Candel raised approximately $100 million in gross proceeds through a follow-on equity offering. 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.
In a separate agreement, Candel secured a $100 million royalty funding deal with funds managed by RTW Investments, contingent on FDA approval of aglatimagene in localized prostate cancer. Under the terms of the agreement, RTW would receive a capped, tiered single-digit percentage of annual US net sales.
“We were pleased to strengthen the company’s financial position with the additional strategic funding from the term loan facility with Trinity Capital, the institutionally focused follow-on equity offering in February 2026, and our royalty financing agreement with funds managed by RTW Investments,” Tak said.
“This further strengthens our balance sheet, brings new institutional investors into the company, and positions us to advance our key priorities, including the initiation of a pivotal phase 3 clinical trial of aglatimagene in NSCLC and preparation for a potential commercial launch of aglatimagene in localized prostate cancer.”
For the fourth quarter of 2025, research and development expenses totaled $11 million, compared with $4.8 million in the same period of 2024. For the full year, R&D expenses increased to $30.5 million from $19.3 million in 2024, primarily reflecting higher manufacturing, clinical trial, and regulatory costs associated with the aglatimagene programs.
General and administrative expenses were $4.7 million in the fourth quarter of 2025, up from $3.3 million a year earlier, while full-year G&A expenses rose to $17.8 million from $14.1 million. The increases were largely attributed to higher commercial readiness costs, professional fees, and employee-related expenses.
Candel reported a net loss of $29.5 million for the fourth quarter of 2025, compared with a net loss of $14.1 million in the same quarter of 2024. For the full year, net loss narrowed to $38.2 million from $55.2 million in 2024, largely due to changes in the fair value of the company’s warrant liabilities.
The company ended 2025 with $119.7 million in cash and cash equivalents, compared with $102.7 million at the end of 2024. Candel said its existing cash, together with proceeds from the February 2026 equity offering, is expected to fund operations into the first quarter of 2028, including activities related to the potential commercial launch of aglatimagene in 2027.