Candel Therapeutics Inc (NASDAQ:CADL) reported encouraging clinical progress across its cancer immunotherapy pipeline, along with the release of its third quarter 2025 financial results.
The company recently presented new Phase 3 subgroup analyses of CAN-2409 in localized prostate cancer showing statistically significant improvement in disease-free survival and updated survival data from its Phase 1b CAN-3110 trial in recurrent high-grade glioma, underscoring the potential of its multimodal immunotherapies.
At the American Society for Radiation Oncology 2025 meeting, Candel shared that CAN-2409 improved prostate cancer-specific disease-free survival across both conventional and moderate hypofractionated radiation therapy regimens.
The therapy was well tolerated, with severe treatment-related adverse events comparable to placebo. The company is preparing for a Biologics License Application submission for CAN-2409 in localized prostate cancer in Q4 2026 and plans to initiate a pivotal Phase 3 trial in metastatic non-squamous non-small cell lung cancer (NSCLC) in Q2 2026.
For CAN-3110 (linoserpaturev), updated Phase 1b data in recurrent high-grade glioma showed median overall survival of 11.8 to 12 months across treatment arms, with some patients surviving more than three years post-treatment.
A recent Science Translational Medicine publication analyzed serial tumor biopsies from patients receiving multiple CAN-3110 administrations, providing insights into tissue-level responses and supporting a planned randomized Phase 2 trial in recurrent glioblastoma.
Candel also advanced its preclinical programs through presentations at the Society for Immunotherapy of Cancer (SITC) 40th Annual Meeting and strengthened its scientific advisory team with the appointments of Drs. Carl June and Bali Pulendran to its Research Advisory Board.
“This quarter we continued to make strong progress across our clinical pipeline,” Candel CEO Dr Paul Peter Tak said. “We continue to work toward a planned BLA submission in Q4 2026.”
Turning to its financial performance for Q3, Candel reported research and development expenses of $8.5 million for Q3 2025, up from $5.4 million in the same period of 2024, reflecting increased manufacturing, regulatory, and employee-related costs.
General and administrative expenses were $4.7 million, compared with $3.3 million in Q3 2024, due to higher commercial readiness and personnel expenses.
Net loss for the quarter was $11.3 million, compared with $10.6 million in Q3 2024.
Cash and cash equivalents totaled $87 million as of September 30, 2025, supplemented by $50 million drawn from a $130 million term loan facility with Trinity Capital Inc., providing funding for planned operations, including the NSCLC Phase 3 trial, into Q1 2027.
“On the financial front, we were pleased to secure strategic, non-dilutive funding through a five-year, $130 million term loan facility with Trinity Capital, Inc, which strengthens our balance sheet and positions us to advance our key priorities, including the initiation of a pivotal phase 3 clinical trial of CAN-2409 in NSCLC and the potential commercial launch of CAN-2409 in localized prostate cancer,” Dr Tak commented.
Candel anticipates multiple clinical milestones over the coming year, including updated survival and disease-free survival analyses for CAN-2409 in prostate cancer, initiation of the NSCLC Phase 3 trial, and mature overall survival data from the CAN-3110 Phase 1b glioblastoma study.
The company will host a Virtual R&D Day on December 5 to provide additional updates on its pipeline and research programs.