CADL

Company plans to submit a Biologics License Application (BLA) for aglatimagene besadenovec (aglatimagene or CAN-2409) in localized, intermediate- to high-risk prostate cancer in Q4 2026 Announced purpose-built commercial partnership with EVERSANA® to support potential U.S. launch of aglatimagene in localized prostate cancer Company reported extended survival tail observed in trial of aglatimagene in advanced non-small cell lung cancer (NSCLC) patients with inadequate response to immune checkpoint inhibitors (ICI) Company to report extended follow-up data from the positive phase 3 clinical trial of aglatimagene in patients with localized, intermediate- to high-risk prostate cancer at the American Urological Association (AUA) 2026 Annual Meeting Plenary Program in May 2026 Company plans to initiate a pivotal phase 3 clinical trial of aglatimagene in patients with progressive, metastatic, NSCLC despite ICI treatment, in Q2 2026 Cash and cash equivalents of $194.8 million, as of March 31, 2026, are expected to be sufficient to fund the Company’s current operating plan into Q1 2028, which includes activities to support the potential commercial launch of aglatimagene in 2027 NEEDHAM, Mass., May 14, 2026 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal immunotherapies to improve outcomes for patients with cancer, today announced financial results for the first quarter ended March 31, 2026, and provided a corporate update. “The quarter was marked by strong execution across our lead clinical programs, commercial readiness efforts, and further strengthening of our balance sheet,” said Paul Peter Tak, M.D., Ph.D., FMedSci, President and CEO of Candel. “Our primary focus remains on preparing for our planned BLA submission in Q4 2026 for aglatimagene in localized, intermediate- to high-risk prostate cancer. In parallel, we continue to follow patients from our phase 3 localized prostate cancer trial, with extended follow up data to be presented in a plenary oral presentation in May 2026 at AUA and additional biomarker data to be announced in Q3 2026. We are also encouraged by the persistent survival tail observed after extended follow-up from our phase 2a NSCLC trial and look forward to the planned initiation of a pivotal NSCLC phase 3 trial in June 2026.” Dr....

Company plans to initiate a pivotal phase 3 clinical trial of aglatimagene besadenovec (aglatimagene or CAN-2409) in patients with progressive, metastatic, non-squamous, non-small cell lung cancer (NSCLC) despite immune checkpoint inhibitor (ICI) treatment, in Q2 2026 Company plans to submit a Biologics License Application (BLA) for aglatimagene in localized, intermediate-to high-risk prostate cancer in Q4 2026 Company announced investigational new drug (IND) clearance for linoserpaturev (CAN-3110) in recurrent high-grade glioma (rHGG) to support enabling work for a potential future randomized controlled phase 2 dose regimen finding study. Entered into a $130 million term loan facility with Trinity Capital Inc. (Trinity Capital) with $50 million drawn down at closing, and access of up to an additional $80 million Cash and cash equivalents of $119.7 million, as of December 31, 2025, together with $93.5 million in net proceeds from the February 2026 follow-on equity offering, strengthens the Company’s financial position and is sufficient to fund the current operating plan into Q1 2028, which includes activities to support the potential commercial launch of aglatimagene in 2027 NEEDHAM, Mass., March 12, 2026 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal immunotherapies to help patients fight cancer, today announced financial results for the fourth quarter and full year ended December 31, 2025, and provided a corporate update. “During the quarter we made meaningful progress across our clinical pipeline and pre-commercial readiness, entering 2026 with strong momentum and a robust set of potential value-driving catalysts,” said Paul Peter Tak, M.D., Ph.D., FMedSci, President and CEO of Candel. “For aglatimagene in localized, intermediate-to high-risk prostate cancer, we continue to work toward a planned BLA submission in Q4 2026. We continue to follow the patients in our phase 3 study for prostate cancer-specific outcomes and expect to share results after extended follow-up in Q2 2026. We also expect to share additional biomarker data from our prostate program in Q3 2026. We plan to initiate a pivotal phase 3 clinical trial of aglatimagene in NSCLC despite ICI treatment in Q2 2026. In a phase 1b clinical trial of linoserpaturev in patients with rHGG,...

Presented new subgroup analyses from phase 3 clinical trial of CAN-2409 in localized prostate cancer at the American Society for Radiation Oncology (ASTRO) 2025 meeting, demonstrating improved prostate cancer-specific disease-free survival (DFS), independent of radiation therapy modality utilized Company plans to initiate pivotal phase 3 clinical trial of CAN-2409 in patients with metastatic, non-squamous, non-small cell lung cancer (NSCLC) and progressive disease, despite immune checkpoint inhibitor (ICI) treatment, in Q2 2026 Announced encouraging updated survival data for patients enrolled in its phase 1b clinical trial of CAN-3110 (linoserpaturev) in recurrent high-grade glioma (rHGG) Manuscript published in the scientific journal Science Translational Medicine, reporting the tissue response to CAN-3110 based on the analysis of serial tumor biopsies from two patients treated with multiple administrations of CAN-3110 in arm C of the phase 1b clinical trial Plan to submit a Biologics License Application (BLA) for CAN-2409 in intermediate-to-high-risk localized prostate cancer in Q4 2026 Entered into a $130 million term loan facility with Trinity Capital Inc. for a $50 million drawn down at closing, with access to up to an additional $80 million Cash and cash equivalents of $87.0M, as of September 30, 2025, plus the upfront proceeds from the Trinity Capital debt facility, strengthens the Company’s financial position to fund initiation of potentially registrational phase 3 trial of CAN-2409 in NSCLC and other planned operations into Q1 2027 NEEDHAM, Mass., Nov. 13, 2025 (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, announced today financial results for the third quarter ended September 30, 2025, and provided a corporate update. “This quarter we continued to make strong progress across our clinical pipeline,” said Paul Peter Tak, M.D., Ph.D., FMedSci, President and CEO of Candel. “We continue to work toward a planned BLA submission in Q4 2026. We presented additional supportive data from our positive phase 3 trial of CAN-2409 in newly diagnosed, localized prostate cancer during an oral presentation at the Association of Radiation Oncology (ASTRO) Annual Meeting, demonstrating that CAN-240...

NEEDHAM, Mass., Sept. 17, 2025 (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 an abstract was accepted for an oral presentation at the 2025 American Society for Radiation Oncology (ASTRO) Annual Meeting, taking place from September 27 to October 1, 2025, in San Francisco, CA. The oral presentation will feature data from the Company’s phase 3 clinical trial of CAN-2409 in patients with intermediate-to-high-risk localized prostate cancer. Details are as follows: CAN-2409 – Localized Prostate Cancer Abstract Title: Phase 3, Randomized, Placebo Controlled Clinical Trial of CAN-2409+Prodrug in Combination with Standard of Care External Beam Radiation (EBRT) for Newly Diagnosed Localized Prostate Cancer Presenter: Glen Gejerman, MD, MBA, Hackensack University Medical Center, Hackensack, NJ Session Title: SS 03 - GU 1: Advances in Localized Prostate Cancer Session Date/Time: Sunday, September 28, 2025; 2:30 PM - 2:40 PM PT Location: Room 24, Moscone Center, San Francisco, CA The abstract has also been selected for inclusion in ASTRO’s Science Highlights - Genitourinary Cancer session on Sunday, September 28 at 8:00 a.m. PT in Room 24, which will provide a high-level overview of top-rated research in the field. About Candel Therapeutics Candel is a clinical-stage biopharmaceutical company focused on developing off-the-shelf, multimodal viral immunotherapies that elicit an individualized, systemic anti-tumor immune response to help patients fight cancer. Candel has established two clinical-stage multimodal biological immunotherapy platforms based on novel, genetically modified adenovirus and herpes simplex virus (HSV) gene constructs, respectively. CAN-2409 is the lead product candidate from the adenovirus platform. The Company recently completed a pivotal, placebo-controlled, phase 3 clinical trial of CAN-2409 in localized prostate cancer, conducted under a Special Protocol Assessment agreed with the U.S. Food and Drug Administration (FDA), which achieved the primary endpoint supported by secondary endpoints. The Company also reported successful phase 2a clinical trials of CAN-2409 in non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC). The FDA also...

Presented positive results from the phase 3 randomized, placebo-controlled clinical trial of CAN-2409 (aglatimagene besadenovec) in localized prostate cancer, during an oral presentation at the 2025 Annual Meeting of the American Society of Clinical Oncology (ASCO) Received FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for CAN-2409 for the treatment of prostate cancer Preparations on track for Biologics License Application (BLA) for CAN-2409 in intermediate-to-high-risk localized prostate cancer, with submission expected in Q4 2026 Received Orphan Designation for CAN-2409 for the treatment of pancreatic cancer from the European Medicines Agency (EMA) Cash and cash equivalents of $100.7 million, as of June 30, 2025, will be sufficient to fund operations into Q1 2027 NEEDHAM, Mass., Aug. 14, 2025 (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, announced today financial results for the second quarter ended June 30, 2025, and provided a corporate update. “This quarter marked several pivotal achievements for Candel, highlighted by the FDA RMAT Designation for CAN-2409, and being selected for an oral presentation at ASCO, reflecting the strength of the data based on our pivotal phase 3 clinical trial in localized prostate cancer,” said Paul Peter Tak, M.D. Ph.D. FMedSci, President and CEO of Candel. “Further, the addition of Dr. Maha Radhakrishnan to our Board of Directors, as well as the appointment of Charles Schoch as Chief Financial Officer, further strengthens our organization as we accelerate our pre-commercialization activities and advance toward BLA submission, anticipated in Q4 2026.” Dr. Tak continued, “The positive results from our clinical trials in prostate cancer, pancreatic cancer, and non-small cell lung cancer reinforce the therapeutic potential of CAN-2409 as a novel therapy. With the proceeds from our recent registered direct offering being utilized to support pre-commercialization and launch readiness activities, and with multiple regulatory designations, we believe we are well-positioned to execute on our near-term milestones and advance toward our goal of bringing this important treatment option to patients with prostate cancer.” Second Quarter 2025 & Recent...

NEEDHAM, Mass., May 22, 2025 (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 results from the Company’s positive phase 3 clinical trial of aglatimagene besadenovec (CAN-2409) in patients with intermediate-to-high-risk localized prostate cancer will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting taking place in Chicago, IL, from May 30 to June 3, 2025. The objective of this study was to assess whether adding CAN-2409 in combination with the prodrug valacyclovir to standard of care radiation therapy could improve the proportion of patients achieving disease-free survival (DFS) among those pursuing curative treatment for newly diagnosed localized prostate cancer. The selection of DFS as the primary endpoint was a key element of the Special Protocol Assessment (SPA) agreed with the U.S. Food and Drug Administration (FDA). The Company’s phase 3 clinical trial met its primary endpoint and secondary endpoints and demonstrated statistically significant improvement in DFS (p=0.0155) with a 30% reduction (HR 0.7) in the risk for prostate cancer recurrence or death due to any cause in patients who received CAN-2409 (n=496) compared to placebo (n=249). These results were initially announced in December 2024. This is the first multicenter, randomized phase 3 trial in over 20 years to meet both primary and secondary endpoints in localized prostate cancer, potentially redefining treatment for intermediate-to-high-risk patients with prostate cancer who seek curative therapy to avoid cancer-related anxiety, salvage treatments associated with toxicity, and disease progression. Glen Gejerman, M.D., MBA, Co-Director of Urologic Oncology at Hackensack Meridian Health, and one of the principal investigators of the study, stated: “The improvement in disease-free survival shown in this trial is not only statistically significant, but also clinically meaningful. The clinical findings were reinforced by tissue analysis: CAN-2409 led to a significantly higher rate of pathological clinical response in two-year biopsy samples compared to placebo, indicating that the cancer may have been eliminated at the microscopic level. Effective local control of prostate c...

Announced accepted oral presentation of positive phase 3 randomized placebo controlled clinical trial results of CAN-2409 (aglatimagene besadenovec) in localized prostate cancer at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting Preparations on track for Biologics License Application (BLA) for CAN-2409 in intermediate-to-high-risk localized prostate cancer, with submission expected in Q4 2026 Recently announced both prolonged median overall survival (mOS) and a long tail of survival in an open label phase 2a clinical trial of CAN-2409 in advanced non-small cell lung cancer (NSCLC) patients, non-responsive to immune checkpoint inhibitor (ICI) treatment, particularly those patients with non-squamous histology Recently announced notable improvement in mOS after experimental treatment with CAN-2409 compared to the control group based on a randomized controlled phase 2a clinical trial of CAN-2409 in borderline resectable pancreatic adenocarcinoma (PDAC) Recent publication in Neuro-Oncology of encouraging clinical and immunological biomarker data based on a phase 1b clinical trial of the combination of CAN-2409 and nivolumab plus standard of care in newly diagnosed high-grade glioma On track to report biomarker and initial survival data from ongoing phase 1b clinical trial evaluating repeat doses of CAN-3110 in patients with recurrent high-grade glioma (rHGG), expected in Q4 2025 NEEDHAM, Mass., May 13, 2025 (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, announced today financial results for the first quarter ended March 31, 2025, and provided a corporate update. “During the quarter, we continued our strong momentum of compelling clinical evidence, reinforcing our promising pipeline of pan solid tumor immunotherapies,” said Paul Peter Tak, MD PhD FMedSci, President and CEO of Candel. “Our primary focus for 2025 remains on working toward CAN-2409’s BLA submission for prostate cancer, which we believe represents a very significant unmet medical need and opportunity for value creation. In this indication, we observed the ability of CAN-2409 to reduce the risk of prostate cancer recurrence compared to standard of care, through meeting the primary endpoint agreed with the FDA un...

NEEDHAM, Mass., April 23, 2025 (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 an abstract was accepted for an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 30 to June 3, 2025, in Chicago, IL. The oral presentation will feature data from the Company’s phase 3 clinical trial of CAN-2409 in patients with intermediate-to-high risk localized prostate cancer. Details are as follows: CAN-2409 – Localized Prostate Cancer Abstract Title: Phase 3, randomized, placebo-controlled clinical trial of CAN-2409+prodrug in combination with standard-of-care external beam radiation therapy (EBRT) for newly diagnosed localized prostate cancer Presenter: Theodore DeWeese, M.D. *, the Francis Watt Baker, M.D., and Lenox D. Baker Jr., M.D., Dean of the Medical Faculty and CEO, Johns Hopkins Medicine Session Title: Oral Abstract Session – Genitourinary Cancer – Prostate, Testicular, and Penile Session Date/Time: Tuesday, June 3, 2025; 9:45 AM - 12:45 PM CT Location: Hall A, McCormick Place Convention Center, Chicago, IL Full abstracts will be released by ASCO on Thursday, May 22, 2025, at 5:00 PM ET. Details from the presentations will be available following the event on the Candel website at Candel Media. * Dr. DeWeese has no relationship with Candel, other than serving as the national principal investigator for Candel’s phase 3 clinical trial of CAN-2409 in patients with intermediate-to-high risk localized prostate cancer. He has never received reimbursements, consulting fees, or EAB fees from Candel, and he has no shares of common stock, options to purchase common stock or other stake in Candel. About CAN-2409 CAN-2409, Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational, off-the-shelf, replication-defective adenovirus engineered to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s specific tumor and induce an individualized, systemic immune response against the tumor. HSV-tk is an enzyme that locally converts orally administered valacyclovir into a toxic nucleotide analogue that kills nearby cancer cells. Together, this regimen is designed to induce an individu...