Candel Therapeutics (CADL) investor relations material

Pipeline overview and clinical progress

• Aglatimagene besadenovec (CAN-2409) demonstrated positive phase 3 results in localized, intermediate- to high-risk prostate cancer, and positive overall survival in phase 2a trials for pancreatic and therapy-resistant non-small cell lung cancer (NSCLC).

• Linoserpaturev (CAN-3110), an oncolytic HSV-1, showed proof of concept in recurrent high-grade glioma, with encouraging survival data and publications in top journals.

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

• The company is advancing a "pipeline in a product" strategy, targeting several large oncology indications.

• Precommercialization activities and funding agreements are in place to support future launches.

Financial position and funding

• Cash and cash equivalents stood at $119.7 million as of December 31, 2025, with additional funds from a February 2026 equity offering expected to provide runway into Q1 2028.

• Entered a $130 million term loan facility and a $100 million royalty funding agreement, contingent on regulatory approval.

• Low-cost manufacturing and strong IP protection (patents through 2034/2036, 12 years data exclusivity) support long-term value.

Prostate cancer: clinical and commercial opportunity

• Phase 3 trial in intermediate- to high-risk, localized prostate cancer (n=745) met its primary endpoint, showing a 30% risk reduction in disease recurrence (HR 0.70, p=0.0155) and a 38% reduction in prostate cancer-specific recurrence (HR 0.62, p=0.0046).

• Significant improvements in PSA nadir rates and pathological complete response at 2 years (80.4% vs 63.6% for placebo, p=0.0015).

• Well-tolerated safety profile with lower rates of serious adverse events and treatment discontinuation compared to placebo.

• U.S. addressable market estimated at $10–16 billion, with payor feedback supporting broad reimbursement and pricing in line with other prostate cancer therapies.

• Pre-launch activities include market access, stakeholder engagement, and payer strategy, with BLA submission expected in Q4 2026.