Core Insights - Candel Therapeutics, Inc. will host a virtual Research and Development (R&D) Event on December 5, 2025, focusing on its viral immunotherapy approach and oncology pipeline [1][2] Company Overview - Candel Therapeutics is a clinical-stage biopharmaceutical company developing multimodal biological immunotherapies aimed at eliciting systemic anti-tumor immune responses [11][12] - The company has two clinical-stage platforms based on genetically modified adenovirus and HSV gene constructs, with CAN-2409 as the lead candidate from the adenovirus platform [12][13] R&D Event Details - The R&D Day will feature presentations from executive leadership, clinical investigators, and scientific advisors, providing an overview of the company's pipeline [2] - Key presentations will include an introduction by Paul Peter Tak, CEO, and discussions on immuno-oncology innovations [2][3] Product Candidates - CAN-2409 is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the HSV-tk gene to tumors, showing potential for treating a broad range of solid tumors [9] - More than 1,000 patients have been dosed with CAN-2409 in clinical trials, demonstrating a favorable tolerability profile [9][12] - CAN-3110 is a first-in-class, replication-competent HSV-1 oncolytic viral immunotherapy candidate, currently in a phase 1b clinical trial for recurrent high-grade glioma [10][13] Clinical Trials and Regulatory Designations - Candel has completed successful phase 2a trials for CAN-2409 in non-small cell lung cancer and pancreatic ductal adenocarcinoma, and a pivotal phase 3 trial in localized prostate cancer [12] - The FDA has granted Fast Track and Regenerative Medicine Advanced Therapy Designations to CAN-2409 for various cancer treatments [12]

Core Insights - Candel Therapeutics reported strong progress in its clinical pipeline and plans to submit a Biologics License Application (BLA) for CAN-2409 in Q4 2026 [2][4][10] Financial Results - For Q3 2025, research and development expenses were $8.5 million, up from $5.4 million in Q3 2024, primarily due to increased manufacturing and regulatory costs [11] - General and administrative expenses rose to $4.7 million in Q3 2025 from $3.3 million in Q3 2024, driven by higher commercial readiness costs [12] - The net loss for Q3 2025 was $11.3 million, compared to a net loss of $10.6 million in Q3 2024 [13] - Cash and cash equivalents as of September 30, 2025, were $87.0 million, down from $102.7 million at the end of 2024, but expected to fund operations into Q1 2027 [14][26] Clinical Developments - Candel presented positive data from the phase 3 trial of CAN-2409 in localized prostate cancer, showing improved disease-free survival (DFS) [4][6] - The company plans to initiate a pivotal phase 3 trial of CAN-2409 in non-small cell lung cancer (NSCLC) in Q2 2026 [4][10] - Encouraging survival data from the phase 1b trial of CAN-3110 in recurrent high-grade glioma (rHGG) was reported, with updated median overall survival of 11.8 months [4][10][20] Strategic Initiatives - Candel secured a $130 million term loan facility with Trinity Capital, with $50 million drawn at closing, to support its clinical trials and operations [2][4][10] - The company strengthened its Research Advisory Board with the appointments of Dr. Carl H. June and Dr. Bali Pulendran, enhancing its commitment to scientific excellence [2][4][10] Upcoming Milestones - The company anticipates updated data on long-term survivors from its phase 2 study in NSCLC in Q1 2026 and plans to submit the BLA for CAN-2409 in prostate cancer in Q4 2026 [8][10]

Core Insights - Candel Therapeutics is set to present three key studies at the Society for Immunotherapy of Cancer (SITC) 40th Anniversary Annual Meeting, highlighting its advancements in cancer immunotherapy [1][2][3] Company Developments - Candel's presentations will showcase its leadership in developing novel therapeutics that utilize multi-omics insights and artificial intelligence to enhance understanding of tumor microenvironments and biomarkers [2][3] - The company plans to submit a Biologics License Application (BLA) for its lead product candidate, CAN-2409, for the treatment of newly diagnosed localized prostate cancer in Q4 2026 [4][8] Clinical Trial Results - Positive phase 3 clinical trial data for CAN-2409 in localized prostate cancer will be presented, achieving its primary endpoint and supported by secondary endpoints [4][8] - A phase 2a open-label clinical trial of CAN-2409 in patients with stage III/IV non-small cell lung cancer (NSCLC) will also be discussed, integrating over 3,000 data points to understand clinical and biological responses [6][9] Key Findings - In the NSCLC trial, patients with non-squamous histology showed greater immune response and improved survival compared to those with squamous histology, supporting further investigation in this subgroup [7][14] - The enLIGHTEN™ Discovery Platform demonstrated a 60% tumor growth suppression in preclinical models, indicating its potential for precision immunotherapy design [10][15] Product Information - CAN-2409 is an investigational, off-the-shelf biological immunotherapy designed to induce a systemic anti-tumor immune response, with over 1,000 patients dosed in clinical trials showing a favorable tolerability profile [12][16] - The enLIGHTEN™ Discovery Platform aims to create new multimodal biological immunotherapies by leveraging human biology and advanced analytics [18]

Core Insights - Candel Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies for cancer treatment [3][4] - The company will present at the Jefferies Global Healthcare Conference on November 18, 2025 [1][2] Company Overview - Candel specializes in off-the-shelf, multimodal viral immunotherapies that aim to elicit individualized, systemic anti-tumor immune responses [3] - The company has two clinical-stage platforms based on genetically modified adenovirus and herpes simplex virus (HSV) [3] Clinical Trials and Designations - Candel has completed successful phase 2a clinical trials for its lead product candidate CAN-2409 in non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC) [4] - CAN-2409 has received Fast Track Designation from the FDA for treating PDAC and stage III/IV NSCLC in specific patient populations [4] - The FDA has also granted Regenerative Medicine Advanced Therapy (RMAT) Designation and Orphan Drug Designation to CAN-2409 for localized prostate cancer and PDAC, respectively [4] Additional Product Candidates - CAN-3110, the lead candidate from the HSV platform, is currently in a phase 1b clinical trial for recurrent high-grade glioma and has received Fast Track and Orphan Drug Designations from the FDA [5] - Candel's enLIGHTEN™ Discovery Platform is designed to create new viral immunotherapies for solid tumors using advanced analytics [5]

Core Viewpoint - Candel Therapeutics has secured a five-year, $130 million term loan facility with Trinity Capital to enhance its financial position and support the initiation of pivotal clinical trials for its lead product candidate, CAN-2409, in non-small cell lung cancer (NSCLC) and localized prostate cancer [1][2][3]. Financial Details - The loan facility consists of four tranches, with an initial draw of $50 million at closing, and an additional $80 million available based on the achievement of specific milestones [2][6]. - The interest rate on the loan is set at 10.25% per annum, with an interest-only period of 36 months, extendable for an additional 12 months upon meeting certain commercial milestones [2]. Strategic Implications - The financing will allow the company to initiate a pivotal phase 3 clinical trial of CAN-2409 in NSCLC in Q2 2026 and prepare for a potential Biologics License Application submission for prostate cancer in Q4 2026 [3][9]. - Candel Therapeutics aims to focus its resources on early localized prostate cancer and NSCLC, while seeking external partnerships for the development of CAN-2409 in pancreatic ductal adenocarcinoma (PDAC) [3][9]. Clinical Development - Candel has completed successful phase 2a clinical trials for CAN-2409 in both NSCLC and PDAC, and is advancing towards a pivotal phase 3 trial for localized prostate cancer [9]. - The company has received multiple designations from the FDA, including Fast Track and Orphan Drug Designation for CAN-2409 in various indications [9]. Company Overview - Candel Therapeutics is a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to combat cancer, with its lead product candidate being CAN-2409 from its adenovirus platform [8].

Core Insights - Trinity Capital Inc. has committed $130 million in growth capital to Candel Therapeutics, a clinical-stage biopharmaceutical company focused on viral immunotherapies for cancer treatment [1][4] Company Overview - Candel Therapeutics is developing off-the-shelf cancer treatments that utilize the patient's immune system to combat various cancers, including prostate, pancreatic, lung, and brain cancer [2][6] - The company has received multiple FDA designations for its therapies, including Regenerative Medicine Advanced Therapy Designation and Fast Track Designation for localized prostate cancer and non-small cell lung cancer [2][6] Investment Details - The investment from Trinity Capital will support the clinical development of Candel's lead therapy, CAN-2409, and activities related to its pre-commercialization and launch for prostate cancer, pending regulatory approval [3][4] - This partnership is seen as a pivotal moment for Candel, enhancing its financial position and accelerating the advancement of its innovative therapies [4] Clinical Development - Candel's CAN-2409 has completed successful phase 2a clinical trials for non-small cell lung cancer and pancreatic ductal adenocarcinoma, and is undergoing a pivotal phase 3 trial for localized prostate cancer [6] - CAN-3110, another product candidate, is currently in a phase 1b clinical trial for recurrent high-grade glioma and has received Fast Track and Orphan Drug Designations from the FDA [6] Strategic Positioning - Trinity Capital aims to deliver consistent returns through investments in growth-oriented companies across various sectors, including life sciences, having deployed over $4.7 billion across more than 420 investments since its inception [5]

Core Insights - Candel Therapeutics, Inc. is set to present findings from its enLIGHTEN™ Discovery Platform and data from the CAN-2409 program in non-small cell lung cancer (NSCLC) at the Society for Immunotherapy of Cancer's 40th Anniversary Annual Meeting in November 2025 [1][2] Group 1: Clinical Trials and Presentations - Candel will showcase positive phase 3 clinical trial data of CAN-2409 for intermediate-to-high-risk localized prostate cancer during an invited faculty presentation [2][3] - Two poster presentations will occur on November 7, 2025, focusing on the integration of machine learning in cancer immunotherapy and the immune response to CAN-2409 in NSCLC [2][3] Group 2: Product Development and Regulatory Designations - CAN-2409 is the lead candidate from Candel's adenovirus platform, having completed successful phase 2a trials in NSCLC and pancreatic ductal adenocarcinoma (PDAC) [4] - The FDA has granted multiple designations to CAN-2409, including Regenerative Medicine Advanced Therapy Designation for localized prostate cancer and Fast Track Designation for both NSCLC and prostate cancer [4] Group 3: Company Overview and Research Focus - Candel Therapeutics specializes in developing off-the-shelf multimodal biological immunotherapies aimed at eliciting systemic anti-tumor immune responses [4][5] - The company has established two clinical-stage platforms based on genetically modified adenovirus and herpes simplex virus (HSV) gene constructs [4][5]

Core Insights - CAN-2409 demonstrated improved disease-free survival in patients with intermediate-to-high-risk localized prostate cancer compared to placebo, regardless of the radiation therapy modality used [1][2][5] - The study represents the first significant advancement in localized, non-metastatic prostate cancer treatment in over 20 years [2][5] Clinical Trial Details - The phase 3 clinical trial (NCT01436968) enrolled 745 patients, randomized 2:1 to receive either CAN-2409 plus valacyclovir with standard care or standard care alone [2] - The trial achieved a 30% improvement in disease-free survival (HR 0.7, p=0.0155) and a 38% improvement in prostate cancer-specific disease-free survival (HR 0.62, p=0.0046) [2] - At two years, the pathological complete response rates were 80.4% in the treatment group compared to 63.6% in the control group (p=0.0015) [2] Efficacy and Safety - CAN-2409's efficacy was maintained across different radiation modalities, including moderate hypofractionated radiation, which is more convenient for patients [4][5] - Safety profiles were similar between treatment and control groups, with grade ≥ 3 treatment-related adverse events being comparable [6] Regulatory and Development Plans - The company plans to submit a Biologics License Application for CAN-2409 in Q4 2026 [5] - CAN-2409 has received various designations from the FDA, including Regenerative Medicine Advanced Therapy Designation and Fast Track Designation for multiple cancer types [8]

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]