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NEEDHAM, Mass. - Candel Therapeutics, Inc. (NASDAQ:CADL), a clinical-stage biotechnology company with a market capitalization of $304 million, announced Monday that its experimental cancer treatment CAN-2409 demonstrated improved disease-free survival in patients with intermediate-to-high-risk localized prostate cancer, regardless of the radiation therapy method used. According to InvestingPro data, the company maintains a strong financial position with more cash than debt on its balance sheet.
The company presented subgroup analyses from its phase 3 clinical trial at the 2025 Annual Meeting of the American Society for Radiation Oncology (ASTRO), showing a 30% improvement in disease-free survival compared to placebo when added to standard radiotherapy.
The randomized, double-blind trial enrolled 745 patients and achieved its primary endpoint with statistical significance (HR 0.7, p=0.0155). The data also showed a 38% improvement in prostate cancer-specific disease-free survival (HR 0.62, p=0.0046).
According to the subgroup analysis, CAN-2409’s efficacy was consistent whether patients received conventional radiation therapy or moderate hypofractionated radiation therapy, with similar safety profiles across both modalities.
"The activity of CAN-2409 was maintained with moderate hypofractionated radiation, which is more convenient for patients," said Dr. Glen Gejerman, Co-Director of Urologic Oncology at Hackensack Meridian Health and a principal investigator of the study.
The treatment demonstrated pathological complete response rates of 80.4% at two years compared to 63.6% in the control arm (p=0.0015).
CAN-2409 is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase gene to a patient’s tumor, inducing immunogenic cell death when combined with the prodrug valacyclovir.
Candel expects to submit a Biologics License Application to the FDA in the fourth quarter of 2026, according to the company’s statement. The FDA has previously granted the treatment Regenerative Medicine Advanced Therapy Designation and Fast Track Designation for prostate cancer. Analysts tracked by InvestingPro maintain a Strong Buy consensus on the stock, with price targets ranging from $7 to $25 per share. The company is scheduled to report its next earnings on November 6, 2025.
The company noted that current standard-of-care radiation therapy for this cancer type has remained largely unchanged for over 20 years, with approximately 30% of patients experiencing disease recurrence within 10 years. With a robust current ratio of 7.04, InvestingPro analysis shows Candel’s liquid assets significantly exceed its short-term obligations, providing financial flexibility to advance its clinical programs. Get access to 6 additional InvestingPro Tips and comprehensive financial metrics to make more informed investment decisions.
In other recent news, Candel Therapeutics, Inc. announced that it will present data from its phase 3 clinical trial of CAN-2409 for intermediate-to-high-risk localized prostate cancer at the American Society for Radiation Oncology Annual Meeting. Additionally, the European Medicines Agency has granted Orphan Designation to Candel’s CAN-2409 therapy for pancreatic cancer treatment, adding to its existing U.S. FDA Orphan Drug Designation and Fast Track Designation. Freedom Broker has initiated coverage on Candel Therapeutics with a Buy rating, citing the company’s oncolytic immunotherapy platform and its primary asset, CAN-2409, as key factors. Brookline Capital Markets also initiated coverage with a Buy rating, focusing on Candel’s development of viral immunotherapies. Furthermore, Candel Therapeutics has been added to multiple Russell value indexes, including the Russell 2500 Value Index and the Russell Small Cap Value Index, as part of the 2025 Russell US Indexes annual reconstitution.
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