US-based Candel Therapeutics (Nasdaq: CADL) is preparing for the prospective approval of lead pipeline candidate aglatimagene besadenovec (CAN-2409) by announcing both a public stock offering and a royalty agreement, with both deals set to net USD 100 million.
Aglatimagene bedadenovec is an adenoviral replication-defective engineered gene construct, encoding the thymidine kinase gene derived from herpes simplex virus (HSV), under development as an off-the-shelf personalized vaccine for a range of solid tumor types. The drug has already achieved primary endpoint in a Phase III trial for prostate cancer, and is being readied for an approval filing later this year.
The public offering , expected to close February 23, 2026, will raise USD 100 million grosss by issuing 18.3 million shares priced at USD 5.45 per share. Proceeds will be directed towards launch readiness, medical affairs, pre-commercialization, and commercial activities for aglatimagene in prostate cancer, as well as ongoing development costs related to the Phase III trial of aglatimagene in non-small cell lung cancer (NSCLC).
In a separate announcement, Candel announced a USD 100 million royalty funding agreement with RTW Investments LP (RTW), contingent upon to aglatimagene securing approval for the prostate cancer indication.
Company overview and pipeline
Candel Therapeutics is a clinical-stage biopharmaceutical company headquartered in Needham, Massachusetts, focused on developing multimodal biological immunotherapies for oncology indications. The Candel Therapeutics cancer immunotherapy approach is built on two clinical-stage platforms: an adenovirus-based platform and a herpes simplex virus (HSV)-based platform. The company also operates an iterative HSV-based discovery platform called enLIGHTEN.
The lead asset, aglatimagene besadenovec (CAN-2409), is derived from the adenovirus platform and is administered intratumorally in combination with valacyclovir. In localized prostate cancer, aglatimagene has completed a pivotal, placebo-controlled Phase III clinical trial conducted under a Special Protocol Assessment agreed with the US FDA. The FDA has granted Fast Track Designation and Regenerative Medicine Advanced Therapy Designation to aglatimagene for the treatment of newly diagnosed, localized prostate cancer in patients with intermediate- to high-risk disease.
In NSCLC, aglatimagene has completed a Phase II clinical trial in Stage III/IV disease in combination with standard-of-care immune checkpoint inhibitors. The FDA has granted Fast Track Designation for this indication. A Phase III trial in NSCLC is ongoing, with development costs partially funded by proceeds from the current offering. Aglatimagene is also under evaluation in a Phase II trial (ULYSSES) in prostate cancer patients on active surveillance. The FDA has also granted both Fast Track Designation and Orphan Drug Designation for aglatimagene in pancreatic ductal adenocarcinoma, where a Phase II trial has been completed.
From the HSV platform, the second clinical-stage candidate, CAN-3110 (rQNestin34.5v.2), is an oncolytic HSV-1-based therapy currently in a Phase I clinical trial in recurrent high-grade glioma, with the primary endpoint of maximum tolerated dose determination. Candel has partnered with Batavia Biosciences to develop a scalable manufacturing process for CAN-3110 using Batavia’s HIP-Vax platform.