Candel Therapeutics Inc (NASDAQ:CADL) said on Thursday it is preparing to submit a Biologics License Application (BLA) for its lead candidate, CAN-2409, in prostate cancer, as the company pushes forward with late-stage development across multiple cancer indications.
CEO Paul Peter Tak said the company enters 2025 “well-resourced with a clear direction,” focusing on regulatory readiness for CAN-2409’s potential approval.
The therapy, which showed a 30% reduction in prostate cancer recurrence risk in a phase 3 trial, could become a new standard of care if approved.
“Our primary focus for the year is working toward readiness to submit CAN-2409’s BLA for prostate cancer, a key opportunity to address a very significant unmet need and opportunity for value creation,” Tak said in a statement.
Candel is also planning a larger late-stage trial for CAN-2409 in pancreatic cancer after final phase 2a data showed a more than twofold increase in median overall survival compared to standard treatment. Meanwhile, the company expects final survival and biomarker data this quarter from its phase 2a trial in non-small cell lung cancer, which could inform future trials.
In glioma, Candel plans to report a clinical and biomarker update for CAN-3110 in late 2025, while advancing preclinical work through its enLIGHTEN Discovery Platform.
4Q results
For the quarter ended December 31, 2024, Candel reported a net loss of $14.1 million compared to $11.1 million a year earlier, primarily due to changes in the fair value of warrant liabilities.
“Last year was transformational for Candel, driven by our team’s incredible focus and execution of the company’s key priorities,” said Tak.
“We delivered positive data across our platforms, including pivotal topline Phase 3 data for CAN-2409 in intermediate-to-high-risk localized prostate cancer in December, which we believe shows the potential of CAN-2409, if approved, to redefine the current standard of care for patients with prostate cancer.”
With $102.7 million in cash following a December public offering, Candel expects to fund operations into early 2027 as it pursues regulatory approvals and expands its clinical programs.