NEEDHAM, Mass., Feb. 02, 2026 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today announced that on January 31, 2026, the Compensation Committee of Candel’s Board of Directors (the Board) granted to one new employee, stock options to purchase an aggregate of 6,600 shares of the Company’s common stock, with a per share exercise price of ...

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]