Candel Therapeutics Reports $55.2 Million Net Loss for 2024, Highlights Positive Clinical Trial Data

Candel Therapeutics, Inc. reported a net loss of $55.2 million for the year ended December 31, 2024, compared to a net loss of $37.9 million in 2023. Research and development expenses decreased by $5.2 million to $19.3 million in 2024, primarily due to lower clinical development costs for CAN-2409 and reduced employee-related expenses following a corporate restructuring. General and administrative expenses increased by $0.2 million to $14.1 million, mainly due to higher professional and consulting fees. The company's cash and cash equivalents totaled $102.7 million as of December 31, 2024, and they expect this to fund operations into the first quarter of 2027.

Significant developments during the year included positive topline data from a Phase 3 clinical trial of CAN-2409 in localized prostate cancer, showing a statistically significant improvement in disease-free survival. The company also reported positive Phase 2 data for CAN-2409 in non-small cell lung cancer (NSCLC), demonstrating prolonged overall survival compared to historical controls. In pancreatic cancer, final data from a Phase 2 trial showed a median overall survival of 31.4 months in the CAN-2409 group versus 12.5 months in the control group. The company paused enrollment in the pancreatic cancer trial in March 2023 due to cost management initiatives. Additionally, Candel received fast track designation from the FDA for CAN-2409 in NSCLC and pancreatic cancer, and for CAN-3110 in recurrent high-grade glioma (HGG). Orphan drug designation was also granted for CAN-2409 in pancreatic cancer and CAN-3110 in recurrent HGG.

Candel Therapeutics' lead product candidate, CAN-2409, is an off-the-shelf adenovirus immunotherapy currently in clinical trials for prostate cancer, NSCLC, and pancreatic cancer. CAN-3110, an HSV-based immunotherapy, is in a Phase 1b trial for recurrent HGG. The company also highlighted its enLIGHTEN™ Discovery Platform, which is generating additional novel viral immunotherapy candidates. As of December 31, 2024, Candel employed 38 people, with 28 in research and development. The company completed a corporate restructuring in November 2023, resulting in a 45% reduction in workforce.

The company's strategy focuses on advancing the late-stage development of CAN-2409 and CAN-3110, seeking regulatory approval, and building its pipeline through the enLIGHTEN™ platform. Candel intends to commercialize its products in major markets, including the United States, Europe, and Asia. They plan to submit a biologics license application for CAN-2409 in the fourth quarter of 2026. The company's financial performance is heavily reliant on the success of its clinical trials and subsequent regulatory approvals.

Candel's 10-K filing details numerous risk factors, including the inherent uncertainties of clinical trials, the need for substantial additional funding, competition from larger pharmaceutical companies, regulatory hurdles, and the complexities of commercialization. The company acknowledges the potential for significant fluctuations in quarterly and annual operating results and the possibility that it may never achieve profitability. The filing also discusses the company's intellectual property portfolio, collaborations, and compliance with various regulations, including those related to data privacy and cybersecurity.