NEEDHAM, Mass. — November 13, 2025 — Leads & Copy — Candel Therapeutics, Inc. (Nasdaq: CADL) has announced financial results for the third quarter ended September 30, 2025, and provided a corporate update on its clinical-stage biopharmaceutical activities.
The company, focused on developing multimodal biological immunotherapies to help patients fight cancer, highlighted progress across its clinical pipeline. Key updates include new subgroup analyses from the Phase 3 clinical trial of CAN-2409 in localized prostate cancer, which demonstrated improved prostate cancer-specific disease-free survival (DFS), independent of the radiation therapy modality used. These findings were presented at the American Society for Radiation Oncology (ASTRO) 2025 meeting.
Candel is planning to initiate a pivotal Phase 3 clinical trial of CAN-2409 in patients with metastatic, non-squamous, non-small cell lung cancer (NSCLC) and progressive disease, despite immune checkpoint inhibitor (ICI) treatment, in Q2 2026. The company also announced encouraging updated survival data for patients enrolled in its Phase 1b clinical trial of CAN-3110 (linoserpaturev) in recurrent high-grade glioma (rHGG).
A manuscript published in Science Translational Medicine reported the tissue response to CAN-3110, based on the analysis of serial tumor biopsies from two patients treated with multiple administrations of CAN-3110 in arm C of the Phase 1b clinical trial. The company plans to submit a Biologics License Application (BLA) for CAN-2409 in intermediate-to-high-risk localized prostate cancer in Q4 2026.
Candel has entered into a $130 million term loan facility with Trinity Capital Inc., which includes a $50 million draw down at closing, with access to up to an additional $80 million. As of September 30, 2025, the company’s cash and cash equivalents totaled $87.0 million. This financial position, along with the proceeds from the Trinity Capital debt facility, is expected to fund the initiation of a potentially registrational Phase 3 trial of CAN-2409 in NSCLC and other planned operations into Q1 2027.
Research and development expenses for the third quarter of 2025 were $8.5 million, compared to $5.4 million for the third quarter of 2024. General and administrative expenses were $4.7 million for the third quarter of 2025, compared to $3.3 million for the third quarter of 2024. The net loss for the third quarter of 2025 was $11.3 million, compared to a net loss of $10.6 million for the third quarter of 2024.
Dr. Paul Peter Tak, President and CEO of Candel, noted the strong progress across the company’s clinical pipeline. He mentioned ongoing work toward a planned BLA submission in Q4 2026, and additional supportive data from the positive Phase 3 trial of CAN-2409 in prostate cancer.
The company also strengthened its Research Advisory Board with the appointments of Dr. Carl H. June and Dr. Bali Pulendran.
Candel expects updated data on long-term survivors from its Phase 2 study in NSCLC in Q1 2026 and anticipates initiating the Phase 3 study in Q2 2026. The company will share more details on its progress and strategic vision at its virtual Research and Development event in Q4 2025.
Contact:
Theodore Jenkins
Vice President, Investor Relations and Business Development
Candel Therapeutics, Inc.
tjenkins@candeltx.com
Ben Shannon
ICR Healthcare
CandelPR@icrhealthcare.com
Source: Candel Therapeutics
