Candel Therapeutics (CADL) R&D Day 2025 summary

Pipeline overview and program updates

• Lead asset CAN-2409 is a pan-solid tumor immunotherapy with positive phase III data in localized prostate cancer, promising results in pancreatic and non-small cell lung cancer, and over 1,000 patients dosed in trials, supported by multiple regulatory designations.

• CAN-3110, a replication-competent oncolytic HSV, shows encouraging survival and immune activation in recurrent high-grade glioma, with ongoing studies exploring multiple dosing and initial results published in Nature.

• R&D Day will feature updates on viral immunotherapy platforms and the oncology pipeline, including CAN-2409 and CAN-3110.

• Financially, cash and equivalents of $87M (as of September 2025) and a $130M term loan facility provide runway into Q1 2027.

Clinical trial data and development milestones

• CAN-2409 phase III trial in 745 prostate cancer patients met its primary endpoint (DFS), with a 30% risk reduction in recurrence and strong secondary endpoints, including improved PSA nadir and biopsy outcomes.

• Phase II data in ICI-refractory NSCLC showed median overall survival near two years, with notable abscopal effects and favorable safety.

• CAN-3110 demonstrated long-term survival in glioblastoma, with biomarker data linking immune activation to outcomes; multiple injection regimens are under evaluation and improved median overall survival compared to historical controls.

• Upcoming milestones include updated NSCLC and prostate cancer data in Q2 next year, BLA filing for CAN-2409 in Q4 next year, and mature survival data for CAN-3110 by year-end.

R&D strategy and innovation priorities

• Emphasis on experimental medicine trials to rapidly assess efficacy and mechanistic biomarkers, guiding go/no-go decisions and informing larger pivotal studies.

• enLIGHTEN Discovery Platform leverages HSV-based technology and advanced analytics to create new viral immunotherapies for solid tumors.

• Deep biomarker research is integrated across programs to identify responsive populations and inform future booster strategies.

• Focus on developing off-the-shelf, multimodal immunotherapies to elicit individualized systemic anti-tumor responses.