Core Viewpoint - Candel Therapeutics, Inc. announced the acceptance of an abstract for an oral presentation at the 2025 ASTRO Annual Meeting, focusing on data from its phase 3 clinical trial of CAN-2409 for localized prostate cancer [1][3] Company Overview - Candel Therapeutics is a clinical-stage biopharmaceutical company developing multimodal biological immunotherapies to combat cancer [4] - The company has two clinical-stage platforms based on genetically modified adenovirus and herpes simplex virus (HSV) [4] Clinical Trial Highlights - The phase 3 clinical trial of CAN-2409 for localized prostate cancer was pivotal and placebo-controlled, achieving its primary endpoint along with supportive secondary endpoints [5] - CAN-2409 has received multiple designations from the FDA, including Regenerative Medicine Advanced Therapy Designation for localized prostate cancer and Fast Track Designation for non-small cell lung cancer and pancreatic ductal adenocarcinoma [5] Upcoming Presentation Details - The oral presentation will take place on September 28, 2025, at 2:30 PM PT, featuring the title "Phase 3, Randomized, Placebo Controlled Clinical Trial of CAN-2409+Prodrug in Combination with Standard of Care External Beam Radiation for Newly Diagnosed Localized Prostate Cancer" [9]

Core Insights - Candel Therapeutics, Inc. has appointed Dr. Carl H. June to its Research Advisory Board, enhancing its expertise in cancer immunotherapy [1][2][3] - Dr. June is recognized for his contributions to CAR-T cell therapy and will support Candel's development of its lead candidates, CAN-2409 and CAN-3110 [1][2][3] Company Overview - Candel is a clinical-stage biopharmaceutical company focused on developing multimodal viral immunotherapies to combat cancer [4] - The company has two clinical-stage platforms based on genetically modified adenovirus and herpes simplex virus (HSV) [4] Product Development - CAN-2409 is the lead candidate from the adenovirus platform, currently advancing through clinical trials for various solid tumors, including non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC) [5][6] - CAN-2409 has received Fast Track Designation from the FDA for multiple indications, including stage III/IV NSCLC and localized prostate cancer [5] - CAN-3110, the lead candidate from the HSV platform, is in a phase 1b clinical trial for recurrent high-grade glioma and has also received Fast Track and Orphan Drug Designations from the FDA [6] Future Plans - Candel anticipates submitting a Biologics License Application (BLA) for CAN-2409 for prostate cancer in Q4 2026 [3]

Summary of Candel Therapeutics Conference Call Company Overview - Candel Therapeutics (CADL) is a clinical-stage biotech company focused on developing viral immunotherapy for difficult-to-treat cancers, utilizing two main platforms: HSV and adenoviral [1] Key Assets and Development Pipeline - The most advanced asset is CAN2409, an adenoviral platform targeting prostate cancer, with positive Phase 3 data recently unveiled and a BLA submission expected by the end of 2026 [2] - CAN2409 is also in development for non-small cell lung cancer (NSCLC) and pancreatic cancer, with fast track designation for all indications [3] - Another asset, CAN310, is a classical oncolytic virus in development for recurrent high-grade glioma [3] Clinical Data and Efficacy - CAN2409 has been administered to over 1,000 patients and shows synergy with radiation therapy, particularly in prostate cancer [4][5] - In NSCLC, a significant reduction of nearly 50% in tumor volume was observed in treated patients [6] - In recurrent high-grade glioma, median overall survival of at least 12 months was achieved with a single injection, compared to a median survival of 6-9 months in untreated patients [7] Discovery Platform - The Enlighten platform utilizes AI for data mining to design viral immunotherapies, aiming to combine with checkpoint inhibitors or cellular therapies for challenging cancers [7] Prostate Cancer Opportunity - Prostate cancer represents a multi-billion dollar opportunity due to the high prevalence and unmet medical need, especially in localized cases [11] - The trial included 745 patients, showing a 30% reduction in disease recurrence or death compared to placebo [14] - Significant effects on PSA levels, a key biomarker for recurrence, were noted, with a higher percentage of patients achieving pathological complete response [15] Safety and Tolerability - CAN2409 demonstrated a favorable safety profile, comparable to a prostate biopsy, with good tolerability among patients [15] Future Plans and Financials - Candel is ramping up CMC activities in preparation for commercial launch and is engaging with KOLs and medical affairs [16] - The company reported cash and cash equivalents of $92 million as of December, sufficient to support BLA submission in 2026 [22] Additional Insights - The pancreatic cancer trial indicated a significant improvement in median overall survival, with ongoing plans for a larger Phase 2 trial [17] - In lung cancer, adding CAN2409 to treatment for patients not responding to checkpoint inhibitors resulted in a median overall survival of 21 months, doubling expectations [20] Leadership and Achievements - The leadership team has extensive experience in drug development, and the company has exceeded its previous clinical milestones [21] Regulatory Engagement - Continuous discussions with the FDA regarding the BLA submission process are ongoing, focusing on CMC manufacturing and clinical package preparation [23][24]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Table of Contents As filed with the Securities and Exchange Commission on January 23, 2024 Registration No. 333-276350 Washington, D.C. 20549 AMENDMENT NO.2 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 CG ONCOLOGY, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2836 37-1611499 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identi ...

Table of Contents As filed with the Securities and Exchange Commission on January 18, 2024 Registration No. 333-276350 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO.1 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 CG ONCOLOGY, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2836 37-1611499 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identi ...

Table of Contents As filed with the Securities and Exchange Commission on January 2, 2024 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 CG ONCOLOGY, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2836 37-1611499 (I.R.S. Employer Identification No.) 400 Spec ...