Candel Therapeutics (CADL) investor relations material

Pipeline overview and clinical progress

• Aglatimagene besadenovec (CAN-2409) is an off-the-shelf immunotherapy with positive phase 3 results in intermediate- to high-risk localized prostate cancer, and promising phase 2a data in pancreatic and non-small cell lung cancer (NSCLC).

• Linoserpaturev (CAN-3110), an oncolytic HSV-1, showed proof of concept in recurrent high-grade glioma, with Fast Track and Orphan Drug Designations.

• Both assets have received multiple FDA designations, including RMAT, Fast Track, and Orphan Drug, supporting regulatory momentum.

• The company has a robust pipeline with programs in solid tumors and brain cancers, and is advancing a “pipeline in a product” strategy.

• Cash runway extends into Q1 2028, supported by recent financing and royalty agreements.

Aglatimagene in prostate cancer: clinical and commercial highlights

• Phase 3 trial (n=745) in intermediate- to high-risk localized prostate cancer met its primary endpoint, showing a 30% reduction in disease recurrence risk (HR=0.70, p=0.0155).

• Significant improvements in prostate cancer-specific DFS (HR=0.62, p=0.0046), PSA nadir rates, and pathological complete response at 2 years (80% vs 63%).

• Safety profile was favorable, with most adverse events mild to moderate and comparable to placebo.

• Extended follow-up showed delayed biochemical failure, lower metastasis rates, and improved time to salvage therapy.

• Commercialization planning is underway, with strong payor and physician support, and a U.S. addressable market estimated at $10–16 billion.

Aglatimagene in NSCLC: clinical data and opportunity

• Phase 2a trial in ICI-refractory stage III/IV NSCLC showed mOS of 25.4 months (per protocol), and 21.5 months in patients with progressive disease, exceeding historical controls.

• Abscopal effects observed in ~two-thirds of patients, with systemic regression of uninjected lesions.

• Non-squamous NSCLC patients derived the greatest benefit, with mOS of 25.4 months (per protocol) and 16.7 months (ITT), compared to 9.9–12.3 months for SoC.

• Safety profile was favorable, with most treatment-related adverse events grade 1–2.

• Phase 3 trial in metastatic non-squamous NSCLC is planned, comparing aglatimagene plus pembrolizumab to docetaxel.