Candel Therapeutics Inc (NASDAQ:CADL) reported a quarterly profit and said it remains on track to submit a biologics license application (BLA) in late 2026 for its lead cancer therapy, CAN-2409, aimed at treating localized prostate cancer.
The clinical-stage biotech posted net income of $7.4 million for the first quarter ended March 31, compared with a net loss of $8.2 million a year earlier, helped by a $15.5 million gain linked to changes in the fair value of its warrant liability.
Candel said it continues to advance regulatory and commercial preparations for CAN-2409 after the drug met the primary endpoint in a Phase 3 trial in prostate cancer conducted under a Special Protocol Assessment agreement with the US Food and Drug Administration. The positive data will be presented at the ASCO annual meeting later this month.
“Our primary focus for 2025 remains on working toward CAN-2409’s BLA submission for prostate cancer, which we believe represents a very significant unmet medical need and opportunity for value creation,” CEO Paul Peter Tak said in a statement.
Candel is seeing promising data from its mid-stage studies of CAN-2409 in other solid tumors, including pancreatic and non-small cell lung cancers, with survival benefits observed in patients whose disease had progressed despite standard therapies.
In borderline resectable pancreatic cancer, median overall survival reached 31.4 months for patients treated with CAN-2409 and chemoradiotherapy, compared with 12.5 months in the control group. In lung cancer, patients who had progressed after immune checkpoint inhibitor therapy had a median overall survival of 21.5 months, nearly double what is typically reported with chemotherapy alone.
Candel has received multiple FDA Fast Track and Orphan Drug designations for CAN-2409 across indications and in March struck a strategic collaboration with IDEA Pharma to support commercialization efforts.
First-quarter revenue was not reported, in line with expectations for a company focused on drug development. R&D expenses were $4 million, slightly down from $4.1 million a year ago, while general and administrative costs rose to $4.1 million from $3.8 million.
Cash and cash equivalents stood at $92.2 million as of March 31, which Candel said is sufficient to fund operations into the first quarter of 2027.
Candel expects to report data from a Phase 1b trial of its second candidate, CAN-3110, in recurrent high-grade glioma later this year.
Shares of Candel traded 3.8% higher following the release of its Q1 report.