Candel Therapeutics (CADL) Corporate Presentation summary

Pipeline overview and corporate highlights

• CAN-2409 is an off-the-shelf, pan-solid tumor therapy with positive phase 3 data in prostate cancer and phase 2a data in pancreatic and NSCLC, with multiple FDA designations and a "pipeline in a product" strategy advancing several indications.

• CAN-3110 is an oncolytic HSV-1 virus with proof of concept in recurrent high-grade glioma, published in top journals, and holds Fast Track and Orphan Drug Designations.

• Cash and cash equivalents of $87.2 million as of September 30, 2025, with expected runway into Q1 2027; pre-commercialization activities for CAN-2409 are underway.

• Strong executive team and scientific advisory board, with robust IP protection and low-cost manufacturing.

CAN-2409: Prostate cancer phase 3 results and commercial opportunity

• Phase 3 trial in intermediate/high-risk localized prostate cancer (n=745) achieved primary endpoint: 30% reduction in disease recurrence (HR 0.70, p=0.0155).

• Significant improvements in prostate-specific outcomes (HR 0.62, p=0.0046), PSA nadir rates, and pathological complete response at 2 years (80.4% vs. 63.6%, p=0.0015).

• Safety profile is favorable, with lower incidence of serious adverse events and treatment discontinuation compared to placebo.

• Addressable U.S. market estimated at $10–16 billion, with strong payor and physician support for reimbursement and broad market access.

• Commercialization model leverages external partners to maximize launch impact while conserving capital; BLA submission expected Q4 2026.

CAN-2409: Pancreatic and NSCLC clinical data

• In borderline resectable pancreatic cancer, phase 2a trial showed median OS of 31.4 months for CAN-2409 vs. 12.5 months for control, with 71.4% 24-month survival rate.

• CAN-2409 induced strong immune responses in tumors and was well tolerated, with no dose-limiting toxicities.

• In NSCLC patients with inadequate response to ICI, median OS was 24.5 months (all), 21.5 months (progressive disease), and 25.4 months (non-squamous), exceeding historical controls.

• Abscopal effects observed in ~two-thirds of patients with multiple lesions, supporting systemic immune activation.