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]

Core Viewpoint - Candel Therapeutics, Inc. is actively engaging with investors through participation in multiple upcoming conferences, highlighting its focus on developing innovative immunotherapies for cancer treatment [1][2]. Group 1: Company Overview - Candel Therapeutics is a clinical-stage biopharmaceutical company dedicated to creating off-the-shelf multimodal biological immunotherapies aimed at eliciting systemic anti-tumor immune responses [3]. - The company has developed two clinical-stage platforms based on genetically modified adenovirus and herpes simplex virus (HSV) gene constructs [3]. Group 2: Product Development - Candel's lead product candidate, CAN-2409, has successfully completed phase 2a clinical trials for non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC), and is undergoing a pivotal phase 3 trial for localized prostate cancer [4]. - CAN-2409 has received several designations from the FDA, including Regenerative Medicine Advanced Therapy Designation for localized prostate cancer, and Fast Track Designation for both NSCLC and prostate cancer [4]. - The second lead product candidate, CAN-3110, is currently in a phase 1b clinical trial for recurrent high-grade glioma (rHGG) and has also received Fast Track and Orphan Drug Designations from the FDA [5]. Group 3: Upcoming Events - Candel Therapeutics will participate in the following investor conferences: - Citi's 2025 Biopharma Back to School Conference on September 3, 2025, at 9:00 AM ET [2]. - Cantor Global Healthcare Conference on September 4, 2025, at 8:00 AM ET [2]. - H.C. Wainwright 27th Annual Global Investment Conference on September 5, 2025, at 7:00 AM ET [2]. - Live webcasts of these presentations will be available and archived for up to 90 days [2].

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 Canaccord Genuity 45th Annual Growth Conference from August 12-14, 2025 [1][2] Company Overview - Candel Therapeutics specializes in off-the-shelf multimodal biological 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] Product Development - CAN-2409 is the lead product candidate from the adenovirus platform, which has completed successful phase 2a trials in non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC) [4] - A pivotal phase 3 trial of CAN-2409 in localized prostate cancer has been conducted under a Special Protocol Assessment (SPA) with the FDA, and it received Regenerative Medicine Advanced Therapy (RMAT) Designation in May 2025 [4] - CAN-3110 is the lead candidate from the HSV platform, currently in a phase 1b trial for recurrent high-grade glioma (rHGG), and has received Fast Track and Orphan Drug Designations from the FDA [5] Discovery Platform - Candel's enLIGHTEN™ Discovery Platform utilizes human biology and advanced analytics to develop new viral immunotherapies for solid tumors [5]

Core Viewpoint - Candel Therapeutics has received Orphan Designation from the European Medicines Agency (EMA) for its investigational drug CAN-2409 for the treatment of pancreatic cancer, complementing its existing FDA designations, highlighting the significant unmet medical need in this area [1][5]. Group 1: Regulatory Designations - CAN-2409 has received Orphan Drug Designation and Fast Track Designation from the FDA for pancreatic ductal adenocarcinoma (PDAC) [1][5]. - The EMA's Orphan Designation provides benefits such as reduced regulatory fees, clinical protocol assistance, and up to 10 years of market exclusivity in the EU if approved [4]. Group 2: Clinical Trial Results - In a phase 2a clinical trial, CAN-2409 plus valacyclovir showed a median overall survival (OS) of 31.4 months compared to 12.5 months in the control arm, indicating significant survival benefits [3]. - Three out of seven patients treated with CAN-2409 were alive at the data cut-off, with survival times of 66.0, 63.6, and 35.8 months, suggesting a long tail of survival [3]. Group 3: Mechanism of Action - CAN-2409 is a replication-defective adenovirus designed to deliver the HSV-tk gene to tumor cells, leading to immunogenic cell death and the release of tumor antigens [2][6]. - The treatment aims to induce a systemic immune response against multiple therapy-resistant solid tumors, including prostate cancer and non-small cell lung cancer (NSCLC) [2][7]. Group 4: Company Overview - Candel Therapeutics focuses on developing off-the-shelf multimodal biological immunotherapies to elicit individualized anti-tumor immune responses [8]. - The company has established two clinical-stage platforms based on genetically modified adenovirus and HSV gene constructs, with CAN-2409 being the lead candidate from the adenovirus platform [8].

Core Insights - Candel Therapeutics, Inc. has been added to multiple Russell indexes as part of the 2025 Russell US Indexes annual reconstitution, effective June 30, 2025, which reflects the company's progress in clinical programs and discovery efforts in cancer immunotherapy [1][2][3] Company Overview - Candel is a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to elicit systemic anti-tumor immune responses [4] - The company has established two clinical-stage platforms based on genetically modified adenovirus and herpes simplex virus (HSV) gene constructs [4] Clinical Development - Candel's lead product candidate, CAN-2409, has completed successful phase 2a clinical trials in non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC) [5] - A pivotal phase 3 clinical trial of CAN-2409 in localized prostate cancer is ongoing under a Special Protocol Assessment (SPA) with the FDA [5] - CAN-2409 has received Fast Track Designation from the FDA for multiple indications, including treatment-resistant PDAC and localized prostate cancer [5] Strategic Importance of Index Inclusion - Inclusion in the Russell Value indexes is expected to enhance Candel's engagement with the investment community and support its pre-commercialization efforts for CAN-2409 [3] - Russell indexes are widely utilized by investment managers and institutional investors, with approximately $10.6 trillion in assets benchmarked against them [3] Future Prospects - The company is preparing for a potential submission of a Biologics License Application for CAN-2409 and continues to advance its innovative immunotherapy platform across various solid tumors [3] - Candel's enLIGHTEN™ Discovery Platform aims to leverage human biology and advanced analytics to create new viral immunotherapies for solid tumors [6]