Candel Therapeutics Provides Corporate Update and Highlights Strong Pipeline Momentum and Key Value Drivers for 2025

Core Message - Candel Therapeutics highlights recent successes in its viral immunotherapy portfolio, particularly with CAN-2409 and CAN-3110, and provides updates on its cash position and upcoming 2025 milestones [1][2] CAN-2409 - Prostate Cancer - Positive topline phase 3 data for CAN-2409 in intermediate-to-high risk localized prostate cancer showed a 30% reduction in the risk of recurrence or death compared to placebo (p=0.0155) [3] - 80.4% pathological complete responses in 2-year post-treatment biopsies after CAN-2409 administration compared to 63.6% in the control arm (p=0.0015) [3] - The study was conducted under a Special Protocol Assessment (SPA) with FDA agreement, indicating potential for regulatory approval [3] CAN-2409 - Pancreatic Cancer - Updated survival data from phase 2a trial showed median overall survival (mOS) of 28.8 months with CAN-2409 versus 12.5 months in the control group [5] - At 24 months, survival rate was 71.4% in CAN-2409-treated patients versus 16.7% in the control group [5] - At 36 months, estimated survival was 47.6% in the CAN-2409 group versus 16.7% in the control group [5] CAN-2409 - Non-Small Cell Lung Cancer - Phase 2a trial data showed mOS of 20.6 months in patients with progressive disease despite immune checkpoint inhibitor (ICI) treatment, compared to less than 12 months with standard of care (SoC) docetaxel-based chemotherapy [5] - CAN-2409 exhibited a favorable safety and tolerability profile in NSCLC [5] CAN-3110 - Recurrent High-Grade Glioma - Phase 1b trial data showed improved survival compared to historical controls, with 3 out of 6 patients still alive after more than one year (12.2, 13.0, and 18.7 months) [5] - CAN-3110 received Orphan Drug Designation and Fast Track Designation from the FDA [5] CAN-3110 - Melanoma - Preclinical results showed dose-dependent inhibition of tumor growth, with regression observed in 3 out of 8 tumors treated with a high dose of CAN-3110 [5] - CAN-3110 exhibited potent, tumor-specific cytotoxicity in melanoma cell lines [5] enLIGHTEN™ Discovery Platform - Presented data on a new multimodal viral therapeutic candidate encoding IL-12 and IL-15, showing significant tumor growth inhibition and regression in preclinical models [5] - Developed a first-in-class multimodal immunotherapy candidate for the induction of tertiary lymphoid structures (TLS) [5] Cash Position - Cash and cash equivalents as of December 31, 2024, were $102.9 million, compared to$35.4 million as of December 31, 2023 [6] - The company expects its cash to support operations into Q1 2027, including BLA submission for CAN-2409 in prostate cancer [6] 2025 Anticipated Milestones - Updated overall survival data from phase 2a clinical trials in pancreatic cancer and NSCLC expected in Q1 2025 [5][10] - BLA submission for CAN-2409 in prostate cancer on track for Q4 2026 [10] - Overall survival data from phase 1b trial of CAN-3110 in rHGG expected in Q4 2025 [10] About CAN-2409 - CAN-2409 is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the HSV-tk gene to induce a systemic immune response against tumors [7] - More than 1,000 patients have been dosed with CAN-2409, showing a favorable tolerability profile [7] About CAN-3110 - CAN-3110 is a first-in-class, replication-competent HSV-1 oncolytic viral immunotherapy candidate with dual activity for oncolysis and immune activation [9] - It has received FDA Fast Track and Orphan Drug Designations for the treatment of rHGG [9] About enLIGHTEN™ Discovery Platform - The platform leverages human biology and advanced analytics to create new multimodal biological immunotherapies for solid tumors [11] - It has been used to develop candidates like Alpha 201-macro-1 and a TLS inducer for solid tumors [11] About Candel Therapeutics - Candel is a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies for cancer [12] - The company has two clinical-stage platforms: adenovirus-based (CAN-2409) and HSV-based (CAN-3110) [12]