Candel Therapeutics Inc (NASDAQ:CADL) said on Thursday it plans to seek US approval for its lead cancer drug CAN-2409 in late 2026, after a key Phase 3 prostate cancer trial succeeded and the FDA granted it Regenerative Medicine Advanced Therapy (RMAT) status.
The clinical-stage biotech reported a narrower second-quarter loss, backed by stronger trial results and financing that will help support launch readiness activities.
The company ended the quarter with $100.7 million in cash, expected to fund operations into early 2027.
“This quarter marked several pivotal achievements for Candel,” said CEO Paul Peter Tak, highlighting the trial data presented at the American Society of Clinical Oncology’s annual meeting and new executive appointments aimed at strengthening its pre-commercial operations.
CAN-2409 is being tested across multiple tumor types. In prostate cancer, the therapy improved disease-free survival by 30% compared with placebo, in combination with standard radiation, under a trial protocol agreed with the FDA that could support a biologics license application (BLA).
The therapy also showed encouraging survival benefits in pancreatic and non-small cell lung cancers, with some patients experiencing long-term remissions.
The company reported a second-quarter net loss of $4.8 million, compared with $22.2 million a year earlier, helped by a $6.4 million gain from changes in the fair value of warrant liabilities.
Research and development expenses rose to $7 million from $5 million, while general and administrative expenses increased to $4.2 million from $3.6 million.
Candel is preparing manufacturing and regulatory documentation to support its planned prostate cancer BLA submission in the fourth quarter of 2026, while advancing other programs, including CAN-3110 for recurrent high-grade glioma, with new data expected later this year.
The company raised $15 million in June through a direct offering to healthcare-focused institutional investors, and named Charles Schoch as CFO and Maha Radhakrishnan to its board.
“The positive results from our clinical trials in prostate cancer, pancreatic cancer, and non-small cell lung cancer reinforce the therapeutic potential of CAN-2409 as a novel therapy,” CEO Tak added.
“With the proceeds from our recent registered direct offering being utilized to support pre-commercialization and launch readiness activities, and with multiple regulatory designations, we believe we are well-positioned to execute on our near-term milestones and advance toward our goal of bringing this important treatment option to patients with prostate cancer.”