Candel Therapeutics strengthens balance sheet as lead cancer therapy advances

Core Viewpoint - Candel Therapeutics Inc is making significant strides in advancing its lead cancer immunotherapy, with plans for new phase 3 trials and a regulatory filing, while reporting its financial results for Q4 and full year 2025 [1] Clinical Development - The company plans to initiate a pivotal phase 3 clinical trial for its lead candidate, aglatimagene besadenovec (CAN-2409), targeting patients with progressive metastatic non-squamous non-small cell lung cancer (NSCLC) who have failed prior treatments, set for Q2 2026 [2] - A Biologics License Application (BLA) for aglatimagene in localized intermediate- to high-risk prostate cancer is expected to be submitted in Q4 2026 [2] - Preparations for the regulatory filing for aglatimagene in prostate cancer are ongoing, including work on chemistry, manufacturing, and controls, as well as clinical study reports [3] - Follow-up clinical data from the phase 3 prostate cancer trial is anticipated in Q2 2026, with biomarker data expected in Q3 2026 [3] - The FDA has granted Fast Track and Regenerative Medicine Advanced Therapy designations for aglatimagene in localized prostate cancer and Fast Track designation for NSCLC [4] Financial Position - Candel raised approximately $100 million through a follow-on equity offering in February 2026 and entered a $130 million term loan facility, drawing $50 million at closing [8] - A $100 million royalty funding deal was secured, contingent on FDA approval of aglatimagene in localized prostate cancer, with RTW Investments receiving a capped, tiered single-digit percentage of annual US net sales [9] - Research and development expenses for Q4 2025 totaled $11 million, up from $4.8 million in Q4 2024, with full-year R&D expenses increasing to $30.5 million from $19.3 million [11] - General and administrative expenses rose to $4.7 million in Q4 2025 from $3.3 million a year earlier, with full-year G&A expenses increasing to $17.8 million from $14.1 million [12] - The company reported a net loss of $29.5 million for Q4 2025, compared to a net loss of $14.1 million in Q4 2024, while the full-year net loss narrowed to $38.2 million from $55.2 million in 2024 [13] - Candel ended 2025 with $119.7 million in cash and cash equivalents, compared to $102.7 million at the end of 2024, with existing cash expected to fund operations into Q1 2028 [14]