Candel Therapeutics, Inc., a biopharmaceutical company specializing in viral immunotherapies for cancer, has released its Form 10-Q report for the third quarter of 2024, outlining financial performance, clinical trial progress, and strategic initiatives. The report emphasizes the company's focus on advancing its lead product candidates, CAN-2409 and CAN-3110, while addressing financial challenges.
Financial Overview
For Q3 2024, Candel Therapeutics reported total operating expenses of $25.2 million, a decrease of $2.8 million compared to the same period in 2023. This reduction is primarily attributed to lower employee-related expenses and clinical development costs resulting from restructuring efforts. The loss from operations improved by $2.8 million year-over-year, amounting to $(25.2) million. However, the net loss increased to $(41.1) million, or $(1.35) per share, compared to $(0.93) in Q3 2023, largely due to changes in the fair value of warrant liability.
Clinical Trial Developments
Candel Therapeutics is actively progressing clinical trials for CAN-2409 and CAN-3110, targeting prostate cancer, non-small cell lung cancer (NSCLC), and pancreatic cancer. CAN-2409 has received fast track and orphan drug designations from the FDA for pancreatic cancer, while CAN-3110 holds the same designations for recurrent high-grade glioma (HGG). Enrollment is complete for the phase 3 trial in prostate cancer and the phase 2 trial in NSCLC, with topline data expected in the fourth quarter of 2024. Enrollment in the pancreatic cancer trial has been paused due to funding considerations, but the company continues to report positive interim data. Updated overall survival data for CAN-2409 in NSCLC and pancreatic cancer is expected in the first quarter of 2025.
Strategic Collaborations and Platform Development
Candel is collaborating with the University of Pennsylvania to leverage its enLIGHTEN™ Discovery Platform to enhance CAR-T cell therapies, aiming to improve treatment outcomes in solid tumors. This collaboration seeks to harness the power of viral immunotherapy to overcome challenges associated with CAR-T cell therapy in solid tumor environments.
Financial Strategy and Outlook
Candel Therapeutics is actively managing its capital through equity offerings and debt management. As of the report, the company has raised $7.7 million through its ATM Program and an additional $2.0 million post-September 30, 2024. The company has a term loan agreement with Silicon Valley Bank, with a current outstanding balance of $13.3 million. The company anticipates the need for additional funding to sustain operations beyond the next year and plans to explore various financing options, including public or private equity, debt financings, government grants, and potential collaborations or licensing arrangements.
Challenges and Risks
Candel Therapeutics faces significant financial risks, with substantial doubt regarding its ability to continue as a going concern beyond the first quarter of 2025 without additional funding. The company is also subject to product development risks associated with CAN-2409 and CAN-3110, which are still in development and have not received regulatory approval. Other risks include market competition, operational challenges related to the recent corporate restructuring, regulatory hurdles, and the need to secure adequate funding to advance its product candidates.
