CADL
Candel TherapeuticsADocument history
Earnings documents stored for CADL.
Investor releaseQuarter not tagged2026-08-13Candel Therapeutics Reports Second Quarter 2026 Financial Results and Recent Corporate Highlights
GlobeNewswire
Candel Therapeutics Reports Second Quarter 2026 Financial Results and Recent Corporate Highlights
Planning to submit a Biologics License Application (BLA) for aglatimagene besadenovec (aglatimagene) in localized, intermediate- to high-risk prostate cancer in Q4 2026 Pivotal phase 3 clinical data published in The Lancet Oncology demonstrated a statistically significant improvement in disease-free survival with aglatimagene plus standard-of-care radiotherapy compared with radiotherapy alone in patients with localized, intermediate- to high-risk prostate cancer Presented supportive clinical data from extended follow-up of the phase 3 clinical trial of aglatimagene in patients with localized, intermediate- to high-risk prostate cancer in a plenary oral presentation at the American Urological Association (AUA) 2026 Annual Meeting in May 2026 Activated first trial site and open enrollment for a global pivotal phase 3 clinical trial (AURORA), evaluating aglatimagene for patients with stage IV non-squamous non-small cell lung cancer (NSCLC) with progressive disease despite pembrolizumab treatment Appointed Mark Sims, a seasoned oncology commercial leader with more than 25 years of global and U.S. cancer franchise experience, as Chief Commercial Officer, to support the potential launch of aglatimagene in localized prostate cancer Advancing to next stage of development planning, with enabling work underway to support a potential randomized phase 2 dose-regimen-finding clinical trial of linoserpaturev in patients with recurrent glioblastoma (rGBM) Cash and cash equivalents of $201.6 million, as of June 30, 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., Aug. 13, 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 second quarter ended June 30, 2026, and provided a corporate update. “This quarter reflects meaningful execution across the company as we advance aglatimagene toward a planned BLA submission in the fourth quarter of 2026 and continue to build the foundation for a potential U.S. commercial launch in localized prostate cancer,” said Paul Peter Tak, M.D., Ph.D., FMedSci, President and CEO of…Read full documentShow less
Planning to submit a Biologics License Application (BLA) for aglatimagene besadenovec (aglatimagene) in localized, intermediate- to high-risk prostate cancer in Q4 2026 Pivotal phase 3 clinical data published in The Lancet Oncology demonstrated a statistically significant improvement in disease-free survival with aglatimagene plus standard-of-care radiotherapy compared with radiotherapy alone in patients with localized, intermediate- to high-risk prostate cancer Presented supportive clinical data from extended follow-up of the phase 3 clinical trial of aglatimagene in patients with localized, intermediate- to high-risk prostate cancer in a plenary oral presentation at the American Urological Association (AUA) 2026 Annual Meeting in May 2026 Activated first trial site and open enrollment for a global pivotal phase 3 clinical trial (AURORA), evaluating aglatimagene for patients with stage IV non-squamous non-small cell lung cancer (NSCLC) with progressive disease despite pembrolizumab treatment Appointed Mark Sims, a seasoned oncology commercial leader with more than 25 years of global and U.S. cancer franchise experience, as Chief Commercial Officer, to support the potential launch of aglatimagene in localized prostate cancer Advancing to next stage of development planning, with enabling work underway to support a potential randomized phase 2 dose-regimen-finding clinical trial of linoserpaturev in patients with recurrent glioblastoma (rGBM) Cash and cash equivalents of $201.6 million, as of June 30, 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., Aug. 13, 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 second quarter ended June 30, 2026, and provided a corporate update. “This quarter reflects meaningful execution across the company as we advance aglatimagene toward a planned BLA submission in the fourth quarter of 2026 and continue to build the foundation for a potential U.S. commercial launch in localized prostate cancer,” said Paul Peter Tak, M.D., Ph.D., FMedSci, President and CEO of Candel. “We believe the extended follow-up data presented at AUA, together with the publication of our pivotal phase 3 results in The Lancet Oncology, further reinforce the potential of aglatimagene to address an important unmet need for patients with intermediate- to high-risk localized prostate cancer. At the same time, the activation of the first trial site for the AURORA phase 3 clinical trial in patients with advanced NSCLC underscores the broader potential of our multimodal immunotherapy platform across solid tumors.” Dr. Tak continued, “We also made important progress in commercial readiness through our appointment of Mark Sims as Chief Commercial Officer, adding deep oncology commercialization and launch experience as we prepare for the next stage of Candel’s growth. With a strong balance sheet, we believe we are well-positioned to execute our operating plan into the first quarter of 2028, including activities intended to support a potential U.S. commercial launch of aglatimagene in 2027, if approved.” Second Quarter 2026 & Recent Highlights Aglatimagene besadenovec – Prostate Cancer Aglatimagene besadenovec – Non-Small Cell Lung Cancer (NSCLC) Linoserpaturev - Recurrent Glioblastoma (rGBM) Recent Corporate Events Anticipated Milestones Abstract showcasing extended biomarker data from the phase 3 clinical trial of aglatimagene in patients with localized prostate cancer to be presented as a poster at the ASTRO Annual Meeting in Q3 2026. The Company expects to present potential long-term survival data from arm C of its phase 1b clinical trial of linoserpaturev in patients with recurrent high-grade glioma (rHGG) in Q4 2026. Submission of a BLA for aglatimagene in prostate cancer is planned for Q4 2026. Financial Results for the Second Quarter Ended June 30, 2026 Research and Development Expenses: Research and development expenses were $19.8 million for the second quarter of 2026 compared to $7.0 million for the second quarter of 2025. The increase was primarily due to higher clinical trial and manufacturing costs, in support of the Company’s aglatimagene programs, and an increase in employee-related expenses. Research and development expenses included a non-cash stock compensation expense of $1.8 million for the second quarter of 2026, as compared to a non-cash stock compensation expense of $0.4 million for the second quarter of 2025. General and Administrative Expenses: General and administrative expenses were $6.9 million for the second quarter of 2026, compared to $4.2 million for the second quarter of 2025. The increase was primarily due to higher commercial readiness costs and an increase in employee-related expenses. General and administrative expenses included non-cash stock compensation expense of $1.0 million for the second quarter of 2026, as compared to a non-cash stock compensation expense of $0.6 million for the second quarter of 2025. Net Income/Loss: Net loss for the second quarter of 2026 was $38.9 million compared to net loss of $4.8 million for the second quarter of 2025 and included net other expense of $12.2 million and net other income of $6.4 million, respectively. The increase in net other expense was primarily related to the change in the fair value of the Company’s warrant liabilities. Cash Position: Cash and cash equivalents, as of June 30, 2026, were $201.6 million compared to $119.7 million as of December 31, 2025. Based on current operating plans, the Company expects that its existing cash and cash equivalents, as of June 30, 2026, will be sufficient to fund operations into Q1 2028. About aglatimagene besadenovec Aglatimagene, Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s tumor. After intratumoral administration, HSV-tk enzyme activity results in conversion of prodrug (valacyclovir) into deoxyribonucleic acid (DNA)-incorporating nucleotide analogs, leading to immunogenic cell death in cells exhibiting DNA damage and proliferating cells, with subsequent release of a variety of tumor (neo)antigens in the tumor microenvironment. At the same time, the adenoviral serotype 5 capsid proteins promote inflammation through the induction of expression of pro-inflammatory cytokines, chemokines, and adhesion molecules. Together, this regimen is designed to induce an individualized and specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ immunization against a variety of tumor antigens. Aglatimagene has the potential to treat a broad range of solid tumors. Encouraging monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. More than 1,000 patients have been dosed with aglatimagene in clinical trials with a favorable tolerability profile to date, supporting the potential for use with standard of care, when indicated. Aglatimagene is currently not approved by the FDA or any other regulatory authority for any use. About linoserpaturev Linoserpaturev is a first-in-class, replication-competent, next-generation oncolytic herpes simplex virus-1 (HSV-1) immunotherapy candidate designed for dual activity for oncolysis and immune activation in a single therapeutic. In October 2023, the Company announced that Nature published results from the ongoing clinical trial where linoserpaturev was reported to be generally well tolerated with no dose-limiting toxicity. In the clinical trial, the investigators observed improved median overall survival compared to historical controls after a single linoserpaturev injection in this therapy-resistant condition1. The Company and academic collaborators are currently supported by the Break Through Cancer foundation to evaluate the effects of repeated linoserpaturev injections in patients with recurrent glioblastoma in an expansion cohort from the phase 1b clinical trial. In October 2025, Science Translational Medicine presented findings from the comprehensive analysis of 97 serial tumor biopsies collected from two patients treated with repeated administrations of linoserpaturev in arm C. Linoserpaturev previously received Fast Track Designation and Orphan Drug Designation for the treatment of rHGG from the U.S. Food and Drug Administration (FDA). About Candel Therapeutics Candel is a clinical-stage biopharmaceutical company focused on developing off-the-shelf multimodal biological immunotherapies that elicit an individualized, systemic anti-tumor immune response to help improve outcomes in patients with 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. Aglatimagene besadenovec (aglatimagene) is the lead product candidate from the adenovirus platform. The Company completed successful phase 2a clinical trials of aglatimagene in non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC), and a pivotal, placebo-controlled, phase 3 clinical trial of aglatimagene in localized prostate cancer, conducted under a Special Protocol Assessment agreed with the FDA and published in The Lancet Oncology. The Company has also initiated a pivotal phase 3 clinical trial in NSCLC. The FDA granted Fast Track Designation and Regenerative Medicine Advanced Therapy Designation to aglatimagene for the treatment of newly diagnosed localized prostate cancer in patients with intermediate- to high-risk disease, Fast Track Designation in NSCLC, and both Fast Track Designation and Orphan Drug Designation to aglatimagene for the treatment of PDAC. Linoserpaturev is the lead product candidate from the HSV platform and is currently in an ongoing phase 1b clinical trial in rHGG. Finally, Candel’s enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new viral immunotherapies for solid tumors. For more information about Candel, visit: www.candeltx.com. Forward-Looking Statements This press release includes certain disclosures that contain “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the timing and advancement of current and future development programs, including the timing and availability of additional data and key data readout milestones and presentations; expectations regarding the submission of the BLA for aglatimagene in intermediate- to high-risk localized prostate cancer; expectations regarding enrollment of the phase 3 AURORA trial evaluating aglatimagene in NSCLC; expectations regarding early biological readouts as predictor of clinical response; expectations regarding the therapeutic benefit of the Company’s platforms, including the ability of its platforms to improve overall survival and/or disease-free survival of patients living with difficult-to-treat solid tumors; expectations regarding the potential benefits conferred by regulatory designations; expectations regarding the potential benefits conferred by the publication of the Company’s findings in The Lancet Oncology; expectations regarding the Company’s ability to prepare and implement commercialization plans for aglatimagene (if approved); and expectations regarding cash runway and expenditures. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the timing and advancement of development programs; expectations regarding the therapeutic benefit of the Company’s programs; that final data from the Company’s preclinical studies and completed clinical trials may differ materially from reported interim data from ongoing studies and trials; the Company’s ability to efficiently discover and develop product candidates; the Company’s ability to obtain and maintain regulatory approval of product candidates; the Company’s ability to maintain its intellectual property; the implementation of the Company’s business model, including strategic plans for the Company’s business and product candidates; the impact of the Company’s existing and any future indebtedness on its ability to operate its business; the Company’s ability to access any future tranches under its debt facility and to comply with all of its obligations thereunder; and other risks identified in the Company’s filings with the U.S. Securities and Exchange Commission (SEC), including the Company’s most recent Annual Report on Form 10-K, any subsequent Quarterly Reports on Form 10-Q, and any subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Investor ContactTheodore JenkinsVice President, Investor Relations and Business DevelopmentCandel Therapeutics, [email protected] Media ContactBen ShannonICR Healthcare [email protected]______________________________1 Ling AL, et al. Nature. 2023;623(7985):157-166
Investor releaseQuarter not tagged2026-08-03Candel Therapeutics to Present Extended Data from Phase 3 Results of Aglatimagene Besadenovec at ASTRO 2026
GlobeNewswire
Candel Therapeutics to Present Extended Data from Phase 3 Results of Aglatimagene Besadenovec at ASTRO 2026
NEEDHAM, Mass., Aug. 03, 2026 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal immunotherapies to improve disease outcomes for patients with cancer, today announced that an abstract was accepted for poster presentation at the 2026 American Society for Radiation Oncology (ASTRO) Annual Meeting, taking place September 26-30, 2026, in Boston, MA. Aglatimagene besadenovec – Localized Prostate Cancer Abstract Title: Quantitative Digital Pathology Defines Immune Activation Following Aglatimagene Besadenovec Immunotherapy in Localized Prostate Cancer Presenter: Francesca Barone, MD, PhD, Chief Scientific Officer, Candel Therapeutics, Needham, MA Session Title: PQA 06: Genitourinary Cancer, Gynecological Cancer and Health Care Access and Engagement Session Date/Time: Tuesday, September 29, 2026; 2:15 PM - 3:30 PM ET Location: Poster Hall – Exhibit Hall A, Thomas M. Menino Convention & Exhibition Center, Boston, MA About Candel Therapeutics Candel is a clinical-stage biopharmaceutical company focused on developing off-the-shelf multimodal biological 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. Aglatimagene besadenovec (aglatimagene) is the lead product candidate from the adenovirus platform. The Company completed successful phase 2a clinical trials of aglatimagene in non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC), and a pivotal, placebo-controlled, phase 3 clinical trial of aglatimagene in localized prostate cancer, conducted under a Special Protocol Assessment agreed with the U.S. Food and Drug Administration (FDA) and published in The Lancet Oncology. The FDA also granted Fast Track Designation and Regenerative Medicine Advanced Therapy Designation to aglatimagene for the treatment of newly diagnosed localized prostate cancer in patients with intermediate- to high-risk disease, Fast Track Designation in NSCLC, and both Fast Track Designation and Orphan Drug Designation to aglatimagene for the treatment of PDAC. Linoserpaturev is the lead product candidate from…Read full documentShow less
NEEDHAM, Mass., Aug. 03, 2026 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal immunotherapies to improve disease outcomes for patients with cancer, today announced that an abstract was accepted for poster presentation at the 2026 American Society for Radiation Oncology (ASTRO) Annual Meeting, taking place September 26-30, 2026, in Boston, MA. Aglatimagene besadenovec – Localized Prostate Cancer Abstract Title: Quantitative Digital Pathology Defines Immune Activation Following Aglatimagene Besadenovec Immunotherapy in Localized Prostate Cancer Presenter: Francesca Barone, MD, PhD, Chief Scientific Officer, Candel Therapeutics, Needham, MA Session Title: PQA 06: Genitourinary Cancer, Gynecological Cancer and Health Care Access and Engagement Session Date/Time: Tuesday, September 29, 2026; 2:15 PM - 3:30 PM ET Location: Poster Hall – Exhibit Hall A, Thomas M. Menino Convention & Exhibition Center, Boston, MA About Candel Therapeutics Candel is a clinical-stage biopharmaceutical company focused on developing off-the-shelf multimodal biological 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. Aglatimagene besadenovec (aglatimagene) is the lead product candidate from the adenovirus platform. The Company completed successful phase 2a clinical trials of aglatimagene in non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC), and a pivotal, placebo-controlled, phase 3 clinical trial of aglatimagene in localized prostate cancer, conducted under a Special Protocol Assessment agreed with the U.S. Food and Drug Administration (FDA) and published in The Lancet Oncology. The FDA also granted Fast Track Designation and Regenerative Medicine Advanced Therapy Designation to aglatimagene for the treatment of newly diagnosed localized prostate cancer in patients with intermediate- to high-risk disease, Fast Track Designation in NSCLC, and both Fast Track Designation and Orphan Drug Designation to aglatimagene for the treatment of PDAC. Linoserpaturev is the lead product candidate from the HSV platform and is currently in an ongoing phase 1b clinical trial in recurrent high-grade glioma, evaluating the effects of repeat linoserpaturev injections. Initial results were published in Nature and Science Translational Medicine and linoserpaturev received Fast Track Designation and Orphan Drug Designation from the FDA. Finally, Candel’s enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new viral immunotherapies for solid tumors. For more information about Candel, visit: www.candeltx.com. Forward-Looking Statements This press release includes certain disclosures that contain “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the timing and advancement of current and future development programs; expectations regarding the therapeutic benefit of the Company’s platforms, including the ability of its platforms to improve overall survival and/or disease-free survival of patients living with difficult-to-treat, solid tumors; and expectations regarding the potential benefits conferred by regulatory designations. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the timing and advancement of development programs; expectations regarding the therapeutic benefit of the Company’s programs; that final data from the Company’s preclinical studies and completed clinical trials may differ materially from reported interim data from ongoing studies and trials; the Company’s ability to efficiently discover and develop product candidates; the Company’s ability to obtain and maintain regulatory approval of product candidates; the Company’s ability to maintain its intellectual property; the implementation of the Company’s business model, including strategic plans for the Company’s business and product candidates; the impact of the Company’s existing and any future indebtedness on its ability to operate its business; the Company’s ability to access any future tranches under its debt facility and to comply with all of its obligations thereunder; and other risks identified in the Company’s filings with the U.S. Securities and Exchange Commission (SEC), including the Company’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, each as filed with the SEC and any subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Investor ContactTheodore JenkinsVice President, Investor Relations, and Business DevelopmentCandel Therapeutics, [email protected] Media ContactBen ShannonICR Healthcare [email protected]
Investor releaseQuarter not tagged2026-05-14Candel Therapeutics Reports First Quarter 2026 Financial Results and Recent Corporate Highlights
GlobeNewswire
Candel Therapeutics Reports First Quarter 2026 Financial Results and Recent Corporate Highlights
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.…Read full documentShow less
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. Tak continued, “On the commercial readiness front, we are encouraged by our progress in building a differentiated, partnership-driven model that leverages the expertise of world-class organizations EVERSANA® and IDEA Pharma. We believe this approach can enhance speed, flexibility, and scalability, positioning Candel for a successful and timely commercial launch of aglatimagene, if approved, for patients with localized prostate cancer.” First Quarter 2026 & Recent Highlights Aglatimagene besadenovec (CAN-2409) – Prostate Cancer The Company continues to advance its pre-BLA readiness initiative, including its Chemistry, Manufacturing, and Controls (CMC) activities, and preparation of clinical study reports and BLA modules. The Company will report follow-up clinical data from its phase 3 trial of aglatimagene in prostate cancer in an oral presentation at the American Urological Association (AUA) 2026 Annual Meeting Plenary Program being held in Washington D.C. from May 15-18, 2026. In Q3 2026, the Company expects to present additional biomarker data. The Company plans to conduct process validation with its Contract Development and Manufacturing Organization in Q2 2026 to enable its anticipated submission of a BLA in Q4 2026. Clinical material from the new process has been manufactured and filled into vials. Candel intends to use this material in the pivotal phase 3 clinical trial in NSCLC. The U.S. Food and Drug Administration (FDA) previously granted Fast Track Designation and Regenerative Medicine Advanced Therapy Designation to aglatimagene for the treatment of localized prostate cancer. The phase 3 clinical trial of aglatimagene in localized prostate cancer was conducted under a Special Protocol Assessment with respect to certain aspects of the study design, agreed with the FDA. Aglatimagene besadenovec (CAN-2409) – Non-Small Cell Lung Cancer (NSCLC) The Company reported an additional 12 months of extended follow-up from its clinical trial of aglatimagene plus valacyclovir in combination with continued ICI therapy in patients with advanced NSCLC, who had an inadequate response to prior ICI treatment. The reported data included: Extended long-term survival observed after an additional year of follow-up in an ongoing phase 2a clinical trial, with 50% of the 46 patients with advanced NSCLC treated per-protocol with aglatimagene surviving beyond 24 months, despite prior inadequate response to ICI and multiple adverse baseline prognostic factors. Among the patients surviving beyond 24 months and with PD-L1 status available, 85% (17/20) had baseline PD-L1 tumor proportion scores (TPS) below 50% (a population typically less responsive to ICI), supporting the potential of aglatimagene to upregulate PD-L1 in the tumor microenvironment and convert non-responders to ICI into responders. Median overall survival (mOS) was 25.4 months in the evaluable patients with inadequate response to ICI in cohorts 1 and 2 (per-protocol population), 21.5 months among evaluable patients exhibiting progressive disease at baseline despite prior ICI therapy (cohort 2), and 25.4 months in the subgroup of patients with non-squamous histology within cohort 2, supporting the rationale for a precision medicine-based design for the phase 3 pivotal trial planned for initiation in June 2026. Post-treatment tumor biopsies demonstrated an increase in pro-inflammatory gene expression, which was significantly associated with long-term survival, supporting activation of inflammatory pathways within the tumor microenvironment following aglatimagene treatment. Expansion of T-cell receptor (TCR) repertoire diversity was observed after treatment both within the tumor and in peripheral blood, consistent with broad activation of anti-tumor immunity through enhanced exposure of tumor antigens following aglatimagene therapy. Following a positive end-of-phase 2 meeting with the FDA in July 2025, the Company is preparing to initiate a pivotal phase 3 clinical trial of aglatimagene in NSCLC in June 2026. The FDA previously granted Fast Track Designation to aglatimagene for the treatment of NSCLC. Linoserpaturev (CAN-3110) - Recurrent High-Grade Glioma (rHGG) In February 2026, at the 7th Annual Glioblastoma Drug Development Summit, the Company shared insights from its herpes simplex virus (HSV)-based platform and its linoserpaturev program through workshop presentations and panel discussions focused on advancing biomarker-driven clinical development in glioblastoma. The Company submitted an IND for linoserpaturev to advance the ongoing development of this asset in rHGG in Q4 2025 and received clearance to proceed from the FDA in Q1 2026. The FDA previously granted Fast Track Designation and Orphan Drug Designation to linoserpaturev in rHGG. Recent Corporate Events In April 2026, the Company announced a commercialization agreement with EVERSANA® to support the potential U.S. launch of aglatimagene in localized prostate cancer. EVERSANA® joins IDEA Pharma, a division of SAI MedPartners, who has been providing path-to-market strategies and strategic positioning for aglatimagene. This operating model gives Candel immediate access to leading commercial capabilities, while maintaining financial flexibility, capital efficiency, and scientific focus that has driven the Company’s progress to date. On February 23, 2026, Candel issued and sold 18,348,624 shares of common stock at a price to the public of $5.45 per share for aggregate gross proceeds of approximately $100 million, which will be used to complete critical launch readiness, medical affairs, pre-commercialization, and commercial activities for aglatimagene in early, localized prostate cancer, ongoing development costs related to the phase 3 trial of aglatimagene in NSCLC, and for general corporate purposes. On February 19, 2026, Candel announced a $100 million royalty funding agreement with funds managed by RTW Investments, LP (RTW), subject to FDA approval of aglatimagene in localized, intermediate- to high-risk, prostate cancer. Under the terms of the agreement, RTW will receive a tiered single digit percentage of annual net sales of aglatimagene in the U.S., subject to a cap. Funds will strengthen the Company’s balance sheet for potential U.S. commercial launch of aglatimagene in intermediate- to high-risk localized prostate cancer. Anticipated Milestones Updated extended follow-up data from the positive phase 3 clinical trial of aglatimagene in patients with localized, intermediate- to high-risk localized prostate cancer, will be reported in an oral presentation at the AUA 2026 Annual Meeting Plenary Program being held in Washington D.C. from May 15-18, 2026. The Company plans to initiate a pivotal phase 3 clinical trial of aglatimagene in patients with metastatic, non-squamous, NSCLC, and progressive disease despite ICI treatment in June 2026. Biomarker data related to the effects of aglatimagene in patients with localized prostate cancer is expected in Q3 2026. The Company expects to present mature mOS data and an update on long-term survivors from arm C of its phase 1b clinical trial of linoserpaturev in patients with rHGG in Q4 2026. Submission of BLA for aglatimagene in prostate cancer is planned for Q4 2026. Financial Results for the First Quarter Ended March 31, 2026 Research and Development Expenses: Research and development expenses were $9.8 million for the first quarter of 2026 compared to $4.0 million for the first quarter of 2025. The increase was primarily due to higher clinical trial and manufacturing costs, in support of the Company’s aglatimagene programs, and an increase in employee-related expenses. Research and development expenses included a non-cash stock compensation expense of $0.6 million for the first quarter of 2026, as compared to a non-cash stock compensation expense of ($0.1) million for the first quarter of 2025. General and Administrative Expenses: General and administrative expenses were $6.4 million for the first quarter of 2026, compared to $4.1 million for the first quarter of 2025. The increase was primarily due to higher commercial readiness costs and an increase in employee-related expenses. General and administrative expenses included non-cash stock compensation expense of $0.8 million for the first quarter of 2026, as compared to a non-cash stock compensation expense of $0.4 million for the first quarter of 2025. Net Income/Loss: Net loss for the first quarter of 2026 was $8.9 million compared to net income of $7.4 million for the first quarter of 2025 and included net other income of $7.4 million and $15.5 million, respectively. The decrease in net other income was primarily related to the change in the fair value of the Company’s warrant liabilities. Cash Position: Cash and cash equivalents, as of March 31, 2026, were $194.8 million compared to $119.7 million as of December 31, 2025. Based on current operating plans, the Company expects that its existing cash and cash equivalents, as of March 31, 2026, will be sufficient to fund operations into Q1 2028. About aglatimagene besadenovec (CAN-2409) Aglatimagene, Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s tumor. After intratumoral administration, HSV-tk enzyme activity results in conversion of prodrug (valacyclovir) into deoxyribonucleic acid (DNA)-incorporating nucleotide analogs, leading to immunogenic cell death in cells exhibiting DNA damage and proliferating cells, with subsequent release of a variety of tumor (neo)antigens in the tumor microenvironment. At the same time, the adenoviral serotype 5 capsid proteins promote inflammation through the induction of expression of pro-inflammatory cytokines, chemokines, and adhesion molecules. Together, this regimen is designed to induce an individualized and specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ immunization against a variety of tumor antigens. Aglatimagene has the potential to treat a broad range of solid tumors. Encouraging monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. More than 1,000 patients have been dosed with aglatimagene in clinical trials with a favorable tolerability profile to date, supporting the potential for use with standard of care, when indicated. Aglatimagene is currently not approved by the FDA or any other regulatory authority for any use. About linoserpaturev (CAN-3110) Linoserpaturev is a first-in-class, replication-competent, next-generation oncolytic herpes simplex virus-1 (HSV-1) immunotherapy candidate designed for dual activity for oncolysis and immune activation in a single therapeutic. In October 2023, the Company announced that Nature published results from the ongoing clinical trial where linoserpaturev was reported to be generally well tolerated with no dose-limiting toxicity. In the clinical trial, the investigators observed improved median overall survival compared to historical controls after a single linoserpaturev injection in this therapy-resistant condition1. The Company and academic collaborators are currently supported by the Break Through Cancer foundation to evaluate the effects of repeated linoserpaturev injections in patients with recurrent glioblastoma in an expansion cohort from the phase 1b clinical trial. In October 2025, Science Translational Medicine presented findings from the comprehensive analysis of 97 serial tumor biopsies collected from two patients treated with repeated administrations of linoserpaturev in arm C. Linoserpaturev previously received Fast Track Designation and Orphan Drug Designation for the treatment of rHGG from the U.S. Food and Drug Administration (FDA). About Candel Therapeutics Candel is a clinical-stage biopharmaceutical company focused on developing off-the-shelf multimodal biological 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. Aglatimagene besadenovec (aglatimagene or CAN-2409) is the lead product candidate from the adenovirus platform. The Company recently completed successful phase 2a clinical trials of aglatimagene in non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC), and a pivotal, placebo-controlled, phase 3 clinical trial of aglatimagene in localized prostate cancer, conducted under a Special Protocol Assessment agreed with the FDA. The FDA also granted Fast Track Designation and Regenerative Medicine Advanced Therapy Designation to aglatimagene for the treatment of newly diagnosed localized prostate cancer in patients with intermediate- to high-risk disease, Fast Track Designation in NSCLC, and both Fast Track Designation and Orphan Drug Designation to aglatimagene for the treatment of PDAC. Linoserpaturev (CAN-3110) is the lead product candidate from the HSV platform and is currently in an ongoing phase 1b clinical trial in rHGG. Finally, Candel’s enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new viral immunotherapies for solid tumors. For more information about Candel, visit: www.candeltx.com. Forward-Looking Statements This press release includes certain disclosures that contain “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the timing and advancement of current and future development programs, including the timing and availability of additional data and key data readout milestones and presentations; expectations regarding the submission of the BLA for CAN-2409 in intermediate-to-high-risk localized prostate cancer; expectations regarding early biological readouts as predictor of clinical response; expectations regarding the therapeutic benefit of the Company’s platforms, including the ability of its platforms to improve overall survival and/or disease-free survival of patients living with difficult-to-treat solid tumors; expectations regarding the potential benefits conferred by regulatory designations; expectations regarding the royalty funding agreement with RTW and the intended and potential benefits thereof; expectations regarding the Company’s ability to prepare and implement commercialization plans for aglatimagene in partnership with EVERSANA and IDEA and the potential benefits and duration of such partnerships; and expectations regarding cash runway and expenditures. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the timing and advancement of development programs; expectations regarding the therapeutic benefit of the Company’s programs; that final data from the Company’s preclinical studies and completed clinical trials may differ materially from reported interim data from ongoing studies and trials; the Company’s ability to efficiently discover and develop product candidates; the Company’s ability to obtain and maintain regulatory approval of product candidates; the Company’s ability to maintain its intellectual property; the implementation of the Company’s business model, including strategic plans for the Company’s business and product candidates; the impact of the Company’s existing and any future indebtedness on its ability to operate its business; the Company’s ability to access any future tranches under its debt facility and to comply with all of its obligations thereunder; and other risks identified in the Company’s filings with the U.S. Securities and Exchange Commission (SEC), including the Company’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, each as filed with the SEC and any subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Investor Contact Theodore Jenkins Vice President, Investor Relations and Business Development Candel Therapeutics, Inc. [email protected] Media Contact Ben Shannon ICR Healthcare [email protected] ___________________________ 1 Ling AL, et al. Nature. 2023;623(7985):157-166
Investor releaseQuarter not tagged2026-03-12Candel Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Recent Corporate Highlights
GlobeNewswire
Candel Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Recent Corporate Highlights
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,…Read full documentShow less
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, we reported encouraging survival data, supported by sophisticated serial brain biopsy analyses, and we expect to announce mature overall survival data for Arm C in Q4 2026. We submitted an IND for linoserpaturev in Q4 2025 to advance the development of this asset in rHGG and received clearance from the U.S. Food and Drug Administration in Q1 2026.” Dr. Tak continued, “We were pleased to strengthen the Company’s financial position with the additional strategic funding from the term loan facility with Trinity Capital, the institutionally focused follow-on equity offering in February 2026, and our royalty financing agreement with funds managed by RTW Investments, LP. This further strengthens our balance sheet, brings new institutional investors into the Company, and positions us to advance our key priorities, including the initiation of a pivotal phase 3 clinical trial of aglatimagene in NSCLC and preparation for a potential commercial launch of aglatimagene in localized prostate cancer.” Fourth Quarter 2025 & Recent Highlights Aglatimagene besadenovec (CAN-2409) – Prostate Cancer The Company continues to advance its pre-BLA readiness initiative, including its Chemistry, Manufacturing, and Controls (CMC) activities, and preparation of clinical study reports and BLA modules. The Company will present follow-up clinical data from its phase 3 trial of aglatimagene in prostate cancer in Q2 2026 and novel biomarker data in Q3 2026. The Company’s control manufacturer plans to conduct process validation in Q2 2026 to potentially enable filing of a BLA in Q4 2026. The Company’s control manufacturer has manufactured four large-scale batches to date. Clinical material from the new process has been manufactured and filled. Candel intends to use this material in the pivotal phase 3 clinical trial in NSCLC. The U.S. Food and Drug Administration (FDA) previously granted Fast Track Designation and Regenerative Medicine Advanced Therapy Designation to aglatimagene for the treatment of localized prostate cancer. The phase 3 clinical trial of aglatimagene in localized prostate cancer was conducted under a Special Protocol Assessment with respect to the study design, agreed with the FDA. Aglatimagene besadenovec (CAN-2409) – Non-Small Cell Lung Cancer (NSCLC) Following a positive end-of-phase 2 meeting with the FDA in July 2025, the Company is preparing to initiate a pivotal phase 3 clinical trial of aglatimagene in NSCLC in Q2 2026. The FDA previously granted Fast Track Designation to aglatimagene for the treatment of NSCLC. Aglatimagene besadenovec (CAN-2409) – Pancreatic Cancer The Company previously generated encouraging data based on a randomized controlled phase 2a clinical trial of aglatimagene in borderline resectable pancreatic cancer (PDAC). The FDA previously granted Fast Track Designation and Orphan Drug Designation to aglatimagene for the treatment of PDAC, and the European Medicines Agency granted Orphan Designation for aglatimagene for the treatment of pancreatic cancer in July 2025. With Candel’s top priorities focused on prostate cancer and NSCLC, the Company has paused the PDAC program. Linoserpaturev (CAN-3110) - Recurrent High-Grade Glioma (rHGG) In February 2026, at the 7th Annual Glioblastoma Drug Development Summit, the Company shared insights from its herpes simplex virus (HSV)-based platform and its linoserpaturev program through workshop presentations and panel discussions focused on advancing biomarker-driven clinical development in glioblastoma. The Company submitted an IND for linoserpaturev to advance the development of this asset in rHGG in Q4 2025 and received clearance from the FDA in Q1 2026. The FDA previously granted Fast Track Designation and Orphan Drug Designation to linoserpaturev in rHGG. Recent Corporate Events On February 23, 2026, Candel issued and sold 18,348,624 shares of common stock at a price to the public of $5.45 per share for aggregate gross proceeds of approximately $100 million, which will be used to complete critical launch readiness, medical affairs, pre-commercialization, and commercial activities for aglatimagene in early, localized prostate cancer, ongoing development costs related to the phase 3 trial of aglatimagene in NSCLC, and for general corporate purposes. On February 19, 2026, Candel announced a $100 million royalty funding agreement with funds managed by RTW Investments, LP (RTW), subject to FDA approval of aglatimagene in localized, intermediate-to high-risk, prostate cancer. Under the terms of the agreement, RTW will receive a tiered single digit percentage of annual net sales of aglatimagene in the U.S., subject to a cap. Funds will strengthen the Company’s balance sheet for potential U.S. commercial launch of aglatimagene in intermediate- to high-risk localized prostate cancer. On December 5, 2025, Candel hosted a virtual Research and Development (R&D) Event, which included presentations and panel discussions from its executive leadership, clinical investigators, scientific advisors, and key collaborators. The event provided an extensive overview of Candel’s viral immunotherapy approach and oncology focused pipeline. Click here to view the event. Anticipated Milestones Updated mOS data and potential long tail of survival from the phase 2a open-label clinical trial of aglatimagene in patients with stage III/IV NSCLC who had progressed despite ICI treatment (NCT04495153) is expected in Q1 2026. Updated extended follow-up data on prostate cancer-specific disease-free survival, time to salvage anti-cancer therapy, and time to metastasis from the positive phase 3 clinical trial of aglatimagene in patients with localized, intermediate- to high-risk prostate cancer is expected in Q2 2026. The Company plans to initiate a pivotal phase 3 clinical trial of aglatimagene in patients with metastatic, non-squamous, NSCLC and progressive disease despite ICI treatment in Q2 2026. Biomarker data related to the effects of aglatimagene in patients with localized prostate cancer is expected in Q3 2026. The Company expects to present mature mOS data and an update on long-term survivors from arm C of its phase 1b clinical trial of linoserpaturev in patients with rHGG in Q4 2026. Submission of BLA for aglatimagene in prostate cancer is planned for Q4 2026. Financial Results for the Fourth Quarter and Full Year Ended December 31, 2025 Research and Development Expenses: Research and development expenses were $11.0 million for the fourth quarter of 2025 compared to $4.8 million for the fourth quarter of 2024, and $30.5 million for the full year 2025 compared to $19.3 million for the full year 2024. The increase was primarily due to higher manufacturing, clinical trial and regulatory costs, in support of the Company’s aglatimagene programs, and an increase in employee-related expenses. Research and development expenses included a non-cash stock compensation expense of $0.7 million and $1.5 million for the fourth quarter and full year of 2025, respectively, as compared to a non-cash stock compensation expense of $0.8 million and $3.3 million for the fourth quarter and full year of 2024, respectively. General and Administrative Expenses: General and administrative expenses were $4.7 million for the fourth quarter of 2025, compared to $3.3 million for the fourth quarter of 2024, and $17.8 million for the full year 2025 compared to $14.1 million for the full year 2024. The increase was primarily due to an increase in commercial readiness costs and employee-related expenses, as well as higher professional and consulting fees. General and administrative expenses included non-cash stock compensation expense of $0.6 million and $2.3 million for the fourth quarter and full year of 2025, respectively, as compared to a non-cash stock compensation expense of $0.4 million and $2.0 million for the fourth quarter and full year of 2024, respectively. Net Loss: Net loss for the fourth quarter of 2025 was $29.5 million compared to a net loss of $14.1 million for the fourth quarter of 2024 and included net other expense of $13.7 million and net other expense of $5.9 million, respectively. Net loss for the full year 2025 was $38.2 million compared to a net loss of $55.2 million for the full year 2024 and included net other income of $10.1 million and net other expense of $21.8 million, respectively. The change from net other expense in 2024, to net other income in 2025, is primarily related to the change in the fair value of the Company’s warrant liabilities. Cash Position: Cash and cash equivalents, as of December 31, 2025, were $119.7 million compared to $102.7 million as of December 31, 2024. Based on current operating plans, the Company expects that its existing cash and cash equivalents, as of December 31, 2025, together with proceeds from the follow-on equity offering in February 2026, will be sufficient to fund operations into Q1 2028. About aglatimagene besadenovec (CAN-2409) Aglatimagene, Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s tumor. After intratumoral administration, HSV-tk enzyme activity results in conversion of prodrug (valacyclovir) into deoxyribonucleic acid (DNA)-incorporating nucleotide analogs, leading to immunogenic cell death in cells exhibiting DNA damage and proliferating cells, with subsequent release of a variety of tumor (neo)antigens in the tumor microenvironment. At the same time, the adenoviral serotype 5 capsid protein promotes inflammation through the induction of expression of pro-inflammatory cytokines, chemokines, and adhesion molecules. Together, this regimen is designed to induce an individualized and specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ immunization against a variety of tumor antigens. Aglatimagene has the potential to treat a broad range of solid tumors. Encouraging monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. More than 1,000 patients have been dosed with aglatimagene in clinical trials with a favorable tolerability profile to date, supporting the potential for combination with standard of care, when indicated. About linoserpaturev (CAN-3110) Linoserpaturev is a first-in-class, replication-competent, next-generation oncolytic herpes simplex virus-1 (HSV-1) immunotherapy candidate designed for dual activity for oncolysis and immune activation in a single therapeutic. In October 2023, the Company announced that Nature published results from the ongoing clinical trial where linoserpaturev was reported to be generally well tolerated with no dose-limiting toxicity. In the clinical trial, the investigators observed improved median overall survival compared to historical controls after a single linoserpaturev injection in this therapy-resistant condition.1 The Company and academic collaborators are currently supported by the Break Through Cancer foundation to evaluate the effects of repeated linoserpaturev injections in patients with recurrent glioblastoma in an expansion cohort from the phase 1b clinical trial. In October 2025, Science Translational Medicine presented findings from the comprehensive analysis of 97 serial tumor biopsies collected from two patients treated with repeated administrations of linoserpaturev in arm C. Linoserpaturev previously received Fast Track Designation and Orphan Drug Designation for the treatment of rHGG from the U.S. Food and Drug Administration (FDA). About the enLIGHTEN™ Discovery Platform The enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new multimodal biological immunotherapies for solid tumors. The enLIGHTEN™ Discovery Platform has been designed to deconvolute the characteristics of the tumor microenvironment related to clinical outcomes. These characteristics are rapidly translated into optimized multi-gene payloads of tumor modulators that can be delivered to the tumor microenvironment for specific indications, disease stages, and rationally designed therapeutic combinations. About Candel Therapeutics Candel is a clinical-stage biopharmaceutical company focused on developing off-the-shelf multimodal biological 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. Aglatimagene besadenovec (CAN-2409 or aglatimagene) is the lead product candidate from the adenovirus platform. The Company recently completed successful phase 2a clinical trials of aglatimagene in non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC), and a pivotal, placebo-controlled, phase 3 clinical trial of aglatimagene in localized prostate cancer, conducted under a Special Protocol Assessment agreed with the FDA. The FDA also granted Fast Track Designation and Regenerative Medicine Advanced Therapy Designation to aglatimagene for the treatment of newly diagnosed localized prostate cancer in patients with intermediate- to high-risk disease, Fast Track Designation in NSCLC, and both Fast Track Designation and Orphan Drug Designation for the treatment of PDAC. Linoserpaturev (CAN-3110) is the lead product candidate from the HSV platform and is currently in an ongoing phase 1b clinical trial in rHGG. Finally, Candel’s enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new viral immunotherapies for solid tumors. For more information about Candel, visit: www.candeltx.com. Forward-Looking Statements This press release includes certain disclosures that contain “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the timing and advancement of current and future development programs, including the timing and availability of additional data and key data readout milestones and presentations; expectations regarding the submission of the BLA for CAN-2409 in intermediate-to-high-risk localized prostate cancer; expectations regarding early biological readouts as predictor of clinical response; expectations regarding the therapeutic benefit of the Company’s platforms, including the ability of its platforms to improve overall survival and/or disease-free survival of patients living with difficult-to-treat solid tumors; expectations regarding the potential benefits conferred by regulatory designations; expectations regarding the royalty funding agreement with RTW and the intended and potential benefits thereof; and expectations regarding cash runway and expenditures. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the timing and advancement of development programs; expectations regarding the therapeutic benefit of the Company’s programs; that final data from the Company’s preclinical studies and completed clinical trials may differ materially from reported interim data from ongoing studies and trials; the Company’s ability to efficiently discover and develop product candidates; the Company’s ability to obtain and maintain regulatory approval of product candidates; the Company’s ability to maintain its intellectual property; the implementation of the Company’s business model, including strategic plans for the Company’s business and product candidates; the impact of the Company’s existing and any future indebtedness on its ability to operate its business; the Company’s ability to access any future tranches under its debt facility and to comply with all of its obligations thereunder; and other risks identified in the Company’s filings with the U.S. Securities and Exchange Commission (SEC), including the Company’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, each as filed with the SEC and any subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Investor Contact Theodore Jenkins Vice President, Investor Relations and Business Development Candel Therapeutics, Inc. [email protected] Media Contact Ben Shannon ICR Healthcare [email protected] ______________________________ 1 Ling AL, et al. Nature. 2023;623(7985):157-166
Investor releaseQuarter not tagged2025-11-13Candel Therapeutics Reports Third Quarter 2025 Financial Results and Recent Corporate Highlights
GlobeNewswire
Candel Therapeutics Reports Third Quarter 2025 Financial Results and Recent Corporate Highlights
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…Read full documentShow less
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-2409 improved prostate cancer-specific DFS, independent of the type of external beam radiation therapy used, extending the results presented during an oral presentation at the American Society of Clinical Oncology Annual Meeting. We also presented data during an invited lecture at the Annual Meeting of the Prostate Cancer Foundation. We continue to follow the patients enrolled in the phase 3 study for prostate cancer-specific outcomes and expect the first results after extended follow-up in Q2 2026. In addition, in collaboration with the U.S. Food and Drug Administration, we designed a supportive, mechanistic clinical trial of CAN-2409 in localized prostate cancer. We plan to release immunologic biomarker data from this study in Q3 2026. Furthermore, we reported encouraging survival data from our phase 1b clinical trial of CAN-3110 in patients with rHGG, most of whom had recurrent glioblastoma, supported by sophisticated brain biopsy analyses. Mature overall survival data for Arm C are expected in Q4 2026. Together, the data supports the design of a randomized controlled phase 2 clinical trial of CAN-3110 in recurrent glioblastoma. Finally, we strengthened our Research Advisory Board with the appointments of Dr. Carl H. June and Dr. Bali Pulendran, underscoring our continuous commitment to scientific excellence and to advancing immunotherapies that may meaningfully improve the lives of patients with devastating cancers.” Dr. Tak continued, “On the financial front, we were pleased to secure strategic, non-dilutive funding through a five-year, $130 million term loan facility with Trinity Capital, Inc., which strengthens our balance sheet and positions us to advance our key priorities, including the initiation of a pivotal phase 3 clinical trial of CAN-2409 in NSCLC and the potential commercial launch of CAN-2409 in localized prostate cancer. We expect updated data on long-term survivors from our phase 2 study in NSCLC in Q1 2026 and anticipate initiation of the phase 3 study in Q2 2026. We look forward to sharing more details on our progress and strategic vision at our virtual Research and Development event in Q4 2025.” Third Quarter 2025 & Recent Highlights CAN-2409 (aglatimagene besadenovec) – Prostate Cancer In an oral presentation at the 2025 ASTRO Annual Meeting, the Company presented subgroup analyses focused on the radiation regimen used during its positive phase 3 clinical trial of CAN-2409 in patients with intermediate-to-high-risk localized prostate cancer. Data were presented by Glen Gejerman, M.D., M.B.A., Co-Director of Urologic Oncology at Hackensack Meridian Health and one of the principal investigators of the study. CAN-2409 demonstrated statistically significant improvement in prostate cancer-specific DFS (Hazard Ratio (HR) 0.62; p=0.0046). Effects were observed with both moderate hypo-fractionated external beam radiation therapy (EBRT) (HR 0.52, CI 0.30 - 0.93, p=0.0236) and conventional EBRT (HR 0.76, CI 0.53 - 1.07, p=0.1131). CAN-2409 administration was safe across radiation therapy modalities, with both conventional radiation therapy (~78 Gy in 2 Gy fractions, ~72% of patients) and moderate hypofractionated radiation therapy (60 Gy in 3 Gy fractions, ~25% of patients), showing similar tolerability profiles. Grade ≥ 3 treatment related adverse events were similar in the CAN-2409 plus valacyclovir and placebo arms with both hypofractionated (1.6% vs. 1.9%) and standard EBRT (1.8% vs. 1.1%), respectively. The U.S. Food and Drug Administration (FDA) previously granted Fast Track Designation and Regenerative Medicine Advanced Therapy Designation to CAN-2409 for the treatment of prostate cancer; the phase 3 clinical trial of CAN-2409 in localized prostate cancer was conducted under a Special Protocol Assessment agreed to with the FDA. The Company is advancing its pre-BLA readiness, including through its Chemistry, Manufacturing, and Controls (CMC) activities, and preparation of clinical study reports and BLA modules. CAN-2409 – Non-Small Cell Lung Cancer (NSCLC) Following a positive end-of-phase 2 meeting with the FDA in July 2025, the Company is preparing to initiate a pivotal phase 3 clinical trial of CAN-2409 in NSCLC in Q2 2026. The FDA previously granted Fast Track Designation to CAN-2409 for the treatment of NSCLC. CAN-2409 - Pancreatic Cancer The Company previously generated encouraging data based on a randomized controlled phase 2a clinical trial of CAN-2409 in borderline resectable pancreatic cancer (PDAC). The FDA previously granted Fast Track Designation and Orphan Drug Designation to CAN-2409 for the treatment of PDAC and the European Medicines Agency granted Orphan Designation for CAN-2409 for the treatment of pancreatic cancer in July 2025. With Candel’s top priorities focused on prostate cancer and NSCLC, the Company will pause the PDAC program, unless it is funded through external, non-dilutive funding. CAN-3110 (linoserpaturev) - Recurrent High-Grade Glioma (rHGG) In October 2025, the Company reported encouraging updated survival data for all patients enrolled in its phase 1b clinical trial of CAN-3110 in rHGG: Updated median overall survival (mOS) was 11.8 months (CI: 8.3–14.9) for arm A (n = 41) and 12.0 months (CI: 10.0–NA) for arm B (n = 9) after a single injection of CAN-3110, consistent with previously reported data for arms A and B. At the time of data cutoff (August 15, 2025), one patient from arm A and one patient from arm B were still alive after prolonged follow-up (59.2 and 42.4 months, respectively, after CAN-3110 administration). The FDA previously granted Fast Track Designation and Orphan Drug Designation to CAN-3110 in recurrent high-grade glioma based on an earlier data cut. At data cutoff as of August 15, 2025, 9 patients in arm C had received multiple administrations of CAN-3110. At the 1×10⁸ PFU dose, 3 patients received 4 injections, 1 patient received 5 injections, and 2 patients received 6 injections. At the 1×10⁷ PFU dose, 1 patient received 4 injections, and 2 patients received 5 injections. Median follow-up was 8.9 months. Four out of 9 patients were alive at time of data cutoff (range 3.1-28.2 months after initiation of CAN-3110 treatment). Five patients had died, of which 3 died more than one year after initiation of CAN-3110 treatment (range 5.5-21.8 months). Candel also announced the scientific publication, “Serial Multiomics Uncovers Anti-Glioblastoma Responses Not Evident by Routine Clinical Analyses,” in the journal Science Translational Medicine. Led by E. Antonio Chiocca, M.D., Ph.D., Executive Director of the Center for Tumors of the Nervous System at the Mass General Brigham Cancer Institute, as part of the multi-institutional Break Through Cancer Accelerating GBM Therapies Through Serial Biopsies TeamLab, the publication presents findings from the comprehensive analysis of 97 serial tumor biopsies collected from two patients treated with repeated administrations of CAN-3110 in arm C of the ongoing phase 1b clinical trial (NCT03152318). Together, the encouraging data supports the Company’s plans to design a randomized controlled phase 2 clinical trial of CAN-3110 in recurrent glioblastoma. Recent Corporate Events The Company presented insights into the third preclinical candidate from its enLIGHTEN™ Discovery Platform in a mouse model of breast cancer, as well as additional data from the CAN-2409 program in NSCLC, through two accepted poster presentations, along with an invited faculty presentation and panel discussion by Paul Peter Tak, M.D., Ph.D., FMedSci, Candel’s President and CEO, showcasing the phase 3 clinical trial of CAN-2409 in newly diagnosed, localized prostate cancer at the Society for Immunotherapy of Cancer’s (SITC) 40th Anniversary Annual Meeting. In October 2025, Candel entered into a $130 million term loan facility with Trinity Capital Inc. (Nasdaq: TRIN). The loan facility consists of four tranches, with the first tranche of $50 million drawn upon closing of the agreement. The second and third tranches totaling $50 million in the aggregate are available to be drawn subject to the achievement of certain regulatory, clinical and operational milestones, subject to certain conditions precedent described in the agreement, and the fourth tranche of $30 million is available at the lender’s discretion. The loan facility has a five-year term with an interest-only period of 36 months, which is extendable for an additional 12 months upon the achievement of a certain commercial milestone. The loan facility contains customary representations, warranties, covenants, and events of default. In September 2025, the Company appointed Carl H. June, M.D., to its Research Advisory Board (RAB). Dr. June is an internationally recognized expert in cancer immunotherapy, and a pioneer in developing the first FDA-approved CAR-T cell therapy. In October 2025, the Company appointed Bali Pulendran, Ph.D., to its RAB. Dr. Pulendran is an internationally recognized expert in systems immunology and vaccinology, who has pioneered the use of systems’ approaches to understand human immune responses. Anticipated Milestones Candel will host a Virtual R&D Day on Friday, December 5, 2025. Updated mOS data and “long tail” of survival analysis from the phase 2a open-label clinical trial of CAN-2409 in patients with stage III/IV NSCLC who had progressed, despite ICI treatment (NCT04495153) is expected in Q1 2026. Updated data on prostate cancer-specific DFS, time to salvage anti-cancer therapy, and time to metastasis from the positive phase 3 clinical trial of CAN-2409 in patients with intermediate-to-high-risk localized prostate cancer after extended follow-up is expected in Q2 2026. The Company plans to initiate a pivotal phase 3 clinical trial of CAN-2409 in NSCLC in Q2 2026. Data on local and systemic biomarkers of immune activation from a mechanistic, supportive clinical trial of CAN-2409 in patients with localized prostate cancer, is expected in Q3 2026. The Company expects to present mature mOS data and an update on long-term survivors from arm C of its phase 1b clinical trial of CAN-3110 in patients with recurrent glioblastoma in Q4 2026. Submission of BLA for CAN-2409 in prostate cancer is expected in Q4 2026. Financial Results for the Third Quarter Ended September 30, 2025 Research and Development Expenses: Research and development expenses were $8.5 million for the third quarter of 2025 compared to $5.4 million for the third quarter of 2024. The increase was primarily due to an increase in manufacturing and regulatory costs, in support of the Company’s CAN-2409 programs, and an increase in employee-related expenses, as well as an increase in depreciation and loss on the disposal and sale of fixed assets. Research and development expenses included a non-cash stock compensation expense of $0.5 million for the third quarter of 2025 compared to a non-cash stock compensation expense of $0.6 million for the third quarter of 2024. General and Administrative Expenses: General and administrative expenses were $4.7 million for the third quarter of 2025, compared to $3.3 million for the third quarter of 2024. The increase was primarily due to an increase in commercial readiness costs as well as an increase in employee-related expenses. General and administrative expenses included non-cash stock compensation expense of $0.6 million for the third quarter of 2025 compared to $0.5 million for the third quarter of 2024. Net Loss: Net loss for the third quarter of 2025 was $11.3 million compared to a net loss of $10.6 million for the third quarter of 2024 and included net other income of $1.9 million and net other expense of $1.9 million, respectively. The change from net other expense in 2024 to net other income in 2025 was primarily related to the change in the fair value of the Company’s warrant liability and an increase in interest income. Cash Position: Cash and cash equivalents, as of September 30, 2025, were $87.0 million compared to $102.7 million as of December 31, 2024. Based on current operating plans, including the initiation of a potentially registrational phase 3 trial in NSCLC, the Company expects that its existing cash and cash equivalents, as of September 30, 2025, together with proceeds from the upfront tranche of the Trinity debt facility, will be sufficient to fund operations into Q1 2027. About CAN-2409 CAN-2409 (aglatimagene besadenovec), Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s tumor. After intratumoral administration, HSV-tk enzyme activity results in conversion of prodrug (valacyclovir) into deoxyribonucleic acid (DNA)-incorporating nucleotide analogs, leading to immunogenic cell death in cells exhibiting DNA damage and proliferating cells, with subsequent release of a variety of tumor (neo)antigens in the tumor microenvironment. At the same time, the adenoviral serotype 5 capsid protein promotes inflammation through the induction of expression of pro-inflammatory cytokines, chemokines, and adhesion molecules. Together, this regimen is designed to induce an individualized and specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ immunization against a variety of tumor antigens. CAN-2409 has the potential to treat a broad range of solid tumors. Encouraging monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. More than 1,000 patients have been dosed with CAN-2409 in clinical trials with a favorable tolerability profile to date, supporting the potential for combination with standard of care, when indicated. About CAN-3110 CAN-3110 (linoserpaturev) is a first-in-class, replication-competent herpes simplex virus-1 (HSV-1) next-generation oncolytic viral immunotherapy candidate designed for dual activity for oncolysis and immune activation in a single therapeutic. In October 2023, the Company announced that Nature published results from the ongoing clinical trial where CAN-3110 was reported to be generally well tolerated with no dose-limiting toxicity. In the clinical trial, the investigators observed improved mOS compared to historical controls after a single CAN-3110 injection in this therapy-resistant condition.1 The Company and academic collaborators are currently supported by the Break Through Cancer foundation. About the enLIGHTEN™ Discovery Platform The enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new multimodal biological immunotherapies for solid tumors. The enLIGHTEN™ Discovery Platform has been designed to deconvolute the characteristics of the tumor microenvironment related to clinical outcomes. These characteristics are rapidly translated into optimized multi-gene payloads of tumor modulators that can be delivered to the tumor microenvironment for specific indications, disease stages, and rationally designed therapeutic combinations. About Candel Therapeutics Candel is a clinical-stage biopharmaceutical company focused on developing off-the-shelf multimodal biological 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 (aglatimagene besadenovec) is the lead product candidate from the adenovirus platform. The Company recently completed successful phase 2a clinical trials of CAN-2409 in non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC), and a pivotal, placebo-controlled, phase 3 clinical trial of CAN-2409 in localized prostate cancer, conducted under a Special Protocol Assessment agreed with the FDA. The FDA also granted Fast Track Designation and Regenerative Medicine Advanced Therapy Designation to CAN-2409 for the treatment of newly diagnosed localized prostate cancer in patients with intermediate-to-high-risk disease, Fast Track Designation in NSCLC and prostate cancer, and both Fast Track Designation and Orphan Drug Designation to CAN-2409 for the treatment of PDAC. CAN-3110 (linoserpaturev) is the lead product candidate from the HSV platform and is currently in an ongoing phase 1b clinical trial in recurrent high-grade glioma, evaluating the effects of repeat CAN-3110 injections. Initial results were published in Nature and Science Translational Medicine and CAN-3110 received Fast Track Designation and Orphan Drug Designation from the FDA. Finally, Candel’s enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new viral immunotherapies for solid tumors. For more information about Candel, visit: www.candeltx.com. Forward-Looking Statements This press release includes certain disclosures that contain “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the timing and advancement of current and future development programs, including the timing and availability of additional data and key data readout milestones and presentations; expectations regarding the submission of the BLA for CAN-2409 in intermediate-to-high-risk localized prostate cancer; expectations regarding early biological readouts as predictor of clinical response; expectations regarding the therapeutic benefit of the Company’s platforms, including the ability of its platforms to improve overall survival and/or disease-free survival of patients living with difficult-to-treat solid tumors; expectations regarding the potential benefits conferred by regulatory designations; and expectations regarding cash runway and expenditures. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the timing and advancement of development programs; expectations regarding the therapeutic benefit of the Company’s programs; that final data from the Company’s preclinical studies and completed clinical trials may differ materially from reported interim data from ongoing studies and trials; the Company’s ability to efficiently discover and develop product candidates; the Company’s ability to obtain and maintain regulatory approval of product candidates; the Company’s ability to maintain its intellectual property; the implementation of the Company’s business model, including strategic plans for the Company’s business and product candidates; the impact of the Company’s existing and any future indebtedness on its ability to operate its business; the Company’s ability to access any future tranches under its debt facility and to comply with all of its obligations thereunder; and other risks identified in the Company’s filings with the U.S. Securities and Exchange Commission (SEC), including the Company’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, each as filed with the SEC and any subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Investor Contact Theodore Jenkins Vice President, Investor Relations and Business Development Candel Therapeutics, Inc. [email protected] Media Contact Ben Shannon ICR Healthcare [email protected] ______________________________ 1 Ling AL, et al. Nature. 2023;623(7985):157-166
Investor releaseQuarter not tagged2025-09-17Candel Therapeutics to Present Phase 3 Results of CAN-2409 in Localized Prostate Cancer at ASTRO 2025
GlobeNewswire
Candel Therapeutics to Present Phase 3 Results of CAN-2409 in Localized Prostate Cancer at ASTRO 2025
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…Read full documentShow less
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 granted Regenerative Medicine Advanced Therapy Designation to CAN-2409 for the treatment of newly diagnosed localized prostate cancer in patients with intermediate-to-high-risk disease. The FDA had previously granted Fast Track Designation to CAN-2409 in NSCLC and prostate cancer, and Fast Track Designation and Orphan Drug Designation to CAN-2409 in PDAC. CAN-3110 is the lead product candidate from the HSV platform and is currently in an ongoing phase 1b clinical trial in recurrent high-grade glioma. Initial results were published in Nature and CAN-3110 received Fast Track Designation and Orphan Drug Designation from the FDA. Finally, Candel’s enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new viral immunotherapies for solid tumors. For more information about Candel, visit: www.candeltx.com. Forward-Looking Statements This press release includes certain disclosures that contain “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the timing and advancement of current and future development programs; expectations regarding the therapeutic benefit of the Company’s platforms, including the ability of its platforms to improve overall survival and/or disease-free survival of patients living with difficult-to-treat solid tumors; and expectations regarding the potential benefits conferred by regulatory designations. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the timing and advancement of development programs; expectations regarding the therapeutic benefit of the Company’s programs; that final data from the Company’s preclinical studies and completed clinical trials may differ materially from reported interim data from ongoing studies and trials; the Company’s ability to efficiently discover and develop product candidates; the Company’s ability to obtain and maintain regulatory approval of product candidates; the Company’s ability to maintain its intellectual property; the implementation of the Company’s business model, including strategic plans for the Company’s business and product candidates; and other risks identified in the Company’s filings with the U.S. Securities and Exchange Commission (SEC), including the Company’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, each as filed with the SEC and any subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Investor Contact Theodore Jenkins Vice President, Investor Relations and Business Development Candel Therapeutics, Inc. [email protected] Media Contact Ben Shannon Vice President ICR Healthcare [email protected]
Investor releaseQuarter not tagged2025-08-14Candel Therapeutics Reports Second Quarter 2025 Financial Results and Recent Corporate Highlights
GlobeNewswire
Candel Therapeutics Reports Second Quarter 2025 Financial Results and Recent Corporate Highlights
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…Read full documentShow less
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 Highlights CAN-2409 – Prostate Cancer In an oral presentation at the 2025 ASCO Annual Meeting on June 3, 2025, in Chicago, IL, the Company reported phase 3 results from the CAN-2409 clinical trial in intermediate-to-high risk localized prostate cancer. The primary endpoint, agreed with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA), was met, with a statistically significant improvement of 30% in disease-free survival among CAN-2409 recipients (HR 0.70, p=0.0155) when compared to placebo, both in combination with standard-of-care external beam radiation therapy. This data was supported by secondary endpoints. On June 3, 2025, Candel hosted a conference call featuring perspectives from leading prostate cancer specialists, John E. Sylvester, M.D., Atlantic Urology Clinics, Myrtle Beach, South Carolina, and Ronald F. Tutrone, Jr., M.D., FACS, CPI, National Medical Director of Clinical Research, United Urology Group, Towson, Maryland. Both physicians were principal investigators on the trial. The call replay can be accessed here. This phase 3 study was conducted under a SPA agreed with the FDA, meaning that certain data generated from this study could be sufficient for the Company to seek regulatory approval for CAN-2409 in this indication. The Company is advancing its pre-BLA readiness, including through Chemistry, Manufacturing, and Controls (CMC) activities and documentation, and preparation of clinical study reports. In May, the Company received RMAT Designation from the FDA for CAN-2409 for the treatment of newly diagnosed, localized prostate cancer in patients with intermediate-to-high-risk disease. The FDA previously granted Fast Track Designation for CAN-2409 for the treatment of localized primary prostate cancer. The Company continues to work toward a BLA submission for CAN-2409 in prostate cancer in Q4 2026. CAN-2409 – Non-Small Cell Lung Cancer (NSCLC) In March, the Company reported positive overall survival data from its phase 2a clinical trial of CAN-2409 in patients with stage III/IV NSCLC inadequately responding to ICI treatment. In patients with an inadequate response to ICI treatment (Cohorts 1+2, n=46), median overall survival (mOS) was 24.5 months. In patients with progressive disease, despite ICI treatment (Cohort 2, n=41), mOS was 21.5 months, which is markedly longer than the 9.8–11.8 months of survival reported in published literature1,2 in the same patient population receiving standard of care of docetaxel chemotherapy. 37% of patients with progressive disease at enrollment were still alive > 24 months after CAN-2409 treatment at the time of the March 3, 2025 data cut, suggesting a long tail of survival. 14/15 patients with overall survival > 24 months and 9/9 patients with overall survival > 30 months had non-squamous NSCLC. In patients with non-squamous NSCLC and progressive disease despite ICI (cohort 2, n=33), observed mOS was 25.4 months after CAN-2409 treatment. A decrease in the size of uninjected tumors was observed in 69% of patients with multiple lesions (n=35), indicating that a local injection is associated with a systemic anti-tumor immune response. CAN-2409 maintained its generally favorable safety and tolerability profile throughout the extended follow-up period. The FDA previously granted Fast Track Designation for CAN-2409 for the treatment of NSCLC. CAN-2409 - Pancreatic Cancer In February 2025, the Company reported positive overall survival data from the randomized, controlled, phase 2a clinical trial of CAN-2409 in borderline resectable pancreatic ductal adenocarcinoma (PDAC). Patients who had received experimental treatment with CAN-2409 and chemoradiotherapy achieved a mOS of 31.4 months versus 12.5 months observed in the control arm treated with chemoradiotherapy. Notably, three out of seven patients in the CAN-2409 arm were long-term survivors and remained alive at 66.0, 63.6, and 35.8 months post-treatment, whereas only one out of six patients from the control arm was still alive at the time of data cut-off (February 20, 2025). Patients in the CAN-2409 arm were stable at the time of last follow up with minimal maintenance therapy and, despite previous recurrence, experienced extended and ongoing post-progression survival, further highlighting the sustained benefit of CAN-2409, even in metastatic disease. The FDA previously granted Orphan Drug Designation and Fast Track Designation for CAN-2409 in borderline resectable PDAC. The EMA granted Orphan Designation for CAN-2409 for the treatment of pancreatic cancer in July 2025. Recent Corporate Events In June 2025, the Company completed a registered direct offering, of approximately 3.2 million shares of its common stock, to a select group of existing healthcare-focused institutional investors, executive officers, and directors of the Company, at a price per share of $4.67, resulting in gross proceeds of approximately $15 million, before deducting offering expenses payable by the Company. In June 2025, the Company appointed Charles Schoch as Chief Financial Officer (CFO). Mr. Schoch previously served as interim CFO of Candel. He will continue to be instrumental as the Company advances its clinical pipeline and prepares for BLA submission of CAN-2409 in localized prostate cancer, anticipated in Q4 2026. In June 2025, the Company appointed Maha Radhakrishnan, M.D., to its Board of Directors. Dr. Radhakrishnan has significant expertise in product development and commercialization. Anticipated Milestones Additional clinical and biomarker activity data from an ongoing phase 1b clinical trial evaluating repeat doses of CAN-3110 in patients with recurrent high-grade glioma (rHGG), is expected in Q4 2025. Candel plans to host a virtual Research and Development event in Q4 2025. Submission of BLA for CAN-2409 in prostate cancer expected in Q4 2026. Financial Results for the Second Quarter Ended June 30, 2025 Research and Development Expenses: Research and development expenses were $7.0 million for the second quarter of 2025 compared to $5.0 million for the second quarter of 2024. The increase was primarily due to an increase in manufacturing costs in support of the Company’s CAN-2409 programs, partially offset by a decrease in employee-related expenses, which was driven primarily from a reduction in stock-based compensation expense. Research and development expenses included a non-cash stock compensation expense of $0.4 million for the second quarter of 2025 compared to a non-cash stock compensation expense of $1.3 million for the second quarter of 2024. General and Administrative Expenses: General and administrative expenses were $4.2 million for the second quarter of 2025, compared to $3.6 million for the second quarter of 2024. The increase was primarily due to an increase in commercial readiness costs as well as higher professional and consulting fees. General and administrative expenses included non-cash stock compensation expense of $0.6 million for both the second quarter of 2025 and the second quarter of 2024. Net Loss: Net loss for the second quarter of 2025 was $4.8 million compared to a net loss of $22.2 million for the second quarter of 2024 and included net other income of $6.4 million and net other expense of $13.7 million, respectively. The decrease in net loss was primarily related to the change in the fair value of the Company’s warrant liability. Cash Position: Cash and cash equivalents, as of June 30, 2025, were $100.7 million compared to $102.7 million as of December 31, 2024. Based on current plans and assumptions, the Company expects that its existing cash and cash equivalents will be sufficient to fund operations into Q1 2027, including the Company’s expected submission of the BLA for CAN-2409 in intermediate-to-high-risk prostate cancer to the FDA in Q4 2026. About CAN-2409 CAN-2409 (aglatimagene besadenovec), Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s tumor. After intratumoral administration, HSV-tk enzyme activity results in conversion of prodrug (valacyclovir) into deoxyribonucleic acid (DNA)-incorporating nucleotide analogs, leading to immunogenic cell death in cells exhibiting DNA damage and proliferating cells, with subsequent release of a variety of tumor (neo)antigens in the tumor microenvironment. At the same time, the adenoviral serotype 5 capsid protein promotes inflammation through the induction of expression of pro-inflammatory cytokines, chemokines, and adhesion molecules. Together, this regimen is designed to induce an individualized and specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ immunization against a variety of tumor antigens. CAN-2409 has the potential to treat a broad range of solid tumors. Encouraging monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. More than 1,000 patients have been dosed with CAN-2409 with a favorable tolerability profile to date, supporting the potential for combination with standard of care, when indicated. About CAN-3110 CAN-3110 is a first-in-class, replication-competent herpes simplex virus-1 (HSV-1) next-generation oncolytic viral immunotherapy candidate designed for dual activity for oncolysis and immune activation in a single therapeutic. CAN-3110 is being evaluated in a phase 1b clinical trial in patients with rHGG. In October 2023, the Company announced that Nature published results from this ongoing clinical trial. CAN-3110 was well tolerated with no dose-limiting toxicity reported. In the clinical trial, the investigators observed improved median overall survival compared to historical controls after a single CAN-3110 injection in this therapy-resistant condition.3 The Company and academic collaborators are currently evaluating the effects of repeat CAN-3110 injections in rHGG, supported by the Break Through Cancer foundation. CAN-3110 has previously received FDA Fast Track Designation and Orphan Drug Designation for the treatment of rHGG. About Candel Therapeutics Candel is a clinical-stage biopharmaceutical company focused on developing off-the-shelf multimodal biological 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 successful phase 2a clinical trials of CAN-2409 in NSCLC and PDAC, and a pivotal, placebo-controlled, phase 3 clinical trial of CAN-2409 in localized prostate cancer, conducted under a SPA agreed with the FDA. The FDA also granted RMAT Designation to CAN-2409 for the treatment of newly diagnosed localized prostate cancer in patients with intermediate-to-high-risk disease, Fast Track Designation in NSCLC and prostate cancer, and both Fast Track and Orphan Drug Designation to CAN-2409 for the treatment of PDAC. CAN-3110 is the lead product candidate from the HSV platform and is currently in an ongoing phase 1b clinical trial in rHGG. Initial results were published in Nature and CAN-3110 received Fast Track Designation and Orphan Drug Designation from the FDA. Finally, Candel’s enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new viral immunotherapies for solid tumors. For more information about Candel, visit: www.candeltx.com Forward-Looking Statements This press release includes certain disclosures that contain “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the timing and advancement of current and future development programs, including the timing and availability of additional data and key data readout milestones and presentations; expectations regarding the submission of the BLA for CAN-2409 in intermediate-to-high-risk localized prostate cancer; expectations regarding early biological readouts as predictor of clinical response; expectations regarding the therapeutic benefit of the Company’s platforms, including the ability of its platforms to improve overall survival and/or disease-free survival of patients living with difficult-to-treat solid tumors; expectations regarding the potential benefits conferred by regulatory designations; and expectations regarding cash runway and expenditures. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the timing and advancement of development programs; expectations regarding the therapeutic benefit of the Company’s programs; that final data from the Company’s preclinical studies and completed clinical trials may differ materially from reported interim data from ongoing studies and trials; the Company’s ability to efficiently discover and develop product candidates; the Company’s ability to obtain and maintain regulatory approval of product candidates; the Company’s ability to maintain its intellectual property; the implementation of the Company’s business model, including strategic plans for the Company’s business and product candidates; and other risks identified in the Company’s filings with the U.S. Securities and Exchange Commission (SEC), including the Company’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, each as filed with the SEC and any subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Investor Contact Theodore Jenkins Vice President, Investor Relations and Business Development Candel Therapeutics, Inc. [email protected] Media Contact Ben Shannon Vice President ICR Healthcare [email protected] ______________________________ 1 Paz-Ares LG et al. J Clin Oncol 2024;42:2860-2872 2 Ahn MJ et al. J Clin Onc 2024;43:260-272 3 Ling AL, et al. Nature. 2023;623(7985):157-166
Investor releaseQuarter not tagged2025-05-23Candel Therapeutics Presents Positive Phase 3 CAN-2409 Results in Localized Prostate Cancer at ASCO 2025
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Candel Therapeutics Presents Positive Phase 3 CAN-2409 Results in Localized Prostate Cancer at ASCO 2025
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…Read full documentShow less
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 cancer is essential in patients who seek treatment with curative intent, as patients with positive prostate biopsies, two or more years after radical treatment, face a well-established higher risk of disease spreading within the pelvic region, developing distant metastases, and ultimately dying from prostate cancer during long-term follow-up.” Paul Peter Tak, M.D., Ph.D., FMedSci, President and Chief Executive Officer of Candel, said: “We are honored that our pivotal phase 3 CAN-2409 data will be presented at the ASCO Annual Meeting, reinforcing the strength of our previously announced results. There remains a significant unmet need among patients with intermediate-to-high-risk localized prostate cancer treated with curative intent, as approximately 30% experience disease recurrence following radical prostatectomy or radiotherapy. In the phase 3 study, the addition of CAN-2409 plus valacyclovir to standard of care radiotherapy significantly reduced the risk of tumor recurrence, with a generally favorable tolerability profile. The observed improvements in disease-free survival and pathological complete response rates underscore the promise of this innovative immunotherapy. As we continue advancing our regulatory preparations in anticipation of submitting a Biologics License Application for CAN-2409 in the fourth quarter of 2026, our focus remains on bringing this potentially transformative treatment to patients in need of better options.” Key Findings to be Presented at ASCO 2025 Include: Primary Endpoint: Statistically significant improvement in DFS for CAN-2409 plus radiation therapy (n=496) vs. radiation therapy alone (n=249) (p=0.0155; HR 0.7) in the intent to treat population. Secondary & Exploratory Endpoints: DFS improvement was observed both in patients receiving short term androgen deprivation therapy (ADT) and in patients not receiving ADT. In an analysis that focused on prostate-specific outcomes (e.g., censored mortality due to other causes), CAN-2409 showed a highly significant effect (p=0.0046; HR 0.62) on prostate cancer-free survival. Significant increase in the proportion of patients achieving a prostate-specific antigen (PSA) nadir (<0.2 ng/ml) was observed in the treatment arm compared to the placebo control arm (67.1% vs. 58.6%, respectively; p=0.0164). CAN-2409 induced 80.4% pathological complete responses in the two-year post-treatment biopsies compared to 63.6% observed in the control arm (p=0.0015). Safety Profile: CAN-2409 was generally well tolerated, with a low incidence of treatment related, serious adverse events in both arms (1.7% on CAN-2409 + standard of care vs. 2.2% on placebo + standard of care). The most common CAN-2409-related adverse events were flu-like symptoms, fever, and chills, which were generally mild-to-moderate in severity and self-limited. Presentation details: 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 D1, McCormick Place Convention Center, Chicago, IL * 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 any other fees from Candel, and he has no shares of common stock, options to purchase common stock or any other affiliation with Candel. About CAN-2409 CAN-2409 (aglatimagene besadenovec), Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational, off-the-shelf, replication-defective adenovirus designed 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 metabolite that kills nearby cancer cells. Together, this regimen is designed to induce an individualized and specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ immunization against a variety of tumor antigens. Because of its versatility, CAN-2409 has the potential to treat a broad range of solid tumors. Encouraging monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. More than 1,000 patients have been dosed with CAN-2409 with a favorable tolerability profile to date, supporting the potential for combination with other therapeutic strategies. Currently, Candel is evaluating CAN-2409 in non-small cell lung cancer (NSCLC) and borderline resectable pancreatic adenocarcinoma (PDAC) and has recently completed a successful phase 3 clinical trial in localized prostate cancer. CAN-2409 plus prodrug (valacyclovir) has been granted Fast Track Designation by the FDA for the treatment of PDAC, for the treatment of stage III/IV NSCLC in patients who are resistant to first line PD-(L)1 inhibitor therapy and who do not have activating molecular driver mutations or have progressed on directed molecular therapy and for the treatment of localized primary prostate cancer. Candel’s pivotal phase 3 clinical trial in prostate cancer was conducted under a SPA agreed with the FDA. The FDA has also granted Orphan Drug Designation to CAN-2409 for the treatment of PDAC. About Candel Therapeutics Candel is a clinical stage biopharmaceutical company focused on developing off-the-shelf multimodal biological 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 HSV gene constructs, respectively. CAN-2409 is the lead product candidate from the adenovirus platform and recently completed successful phase 2a clinical trials in NSCLC and PDAC, and a pivotal phase 3 clinical trial in localized prostate cancer. CAN-3110 is the lead product candidate from the HSV platform and is currently in an ongoing phase 1b clinical trial in recurrent high-grade glioma. Finally, Candel’s enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new viral immunotherapies for solid tumors. For more information about Candel, visit: www.candeltx.com Forward-Looking Statements This press release includes certain disclosures that contain “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the timing and advancement of current and future development programs; expectations regarding the submission of the BLA for CAN-2409 in intermediate-to-high-risk localized prostate cancer; expectations regarding early biological readouts as predictor of clinical response; and expectations regarding the therapeutic benefit of the Company’s platforms, including the ability of its platforms to improve overall survival and/or disease-free survival of patients living with difficult to treat, solid tumors. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the timing and advancement of development programs; expectations regarding the therapeutic benefit of the Company’s programs; that final data from the Company’s preclinical studies and completed clinical trials may differ materially from reported interim data from ongoing studies and trials; the Company’s ability to efficiently discover and develop product candidates; the Company’s ability to obtain and maintain regulatory approval of product candidates; the Company’s ability to maintain its intellectual property; the implementation of the Company’s business model, including strategic plans for the Company’s business and product candidates; and other risks identified in the Company’s filings with the U.S. Securities and Exchange Commission (SEC), including the Company’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, each as filed with the SEC and any subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Investor Contact:Theodore Jenkins VP, Investor Relations and Business Development Candel Therapeutics, Inc. [email protected] Media Contact:Ben ShannonICR Healthcare [email protected]
Investor releaseQuarter not tagged2025-05-13Candel Therapeutics Reports First Quarter 2025 Financial Results and Recent Corporate Highlights
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Candel Therapeutics Reports First Quarter 2025 Financial Results and Recent Corporate Highlights
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…Read full documentShow less
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 under a Special Protocol Assessment in a phase 3 clinical trial. We are now focusing on executing strategic preparations for potential commercialization, to ensure that, if approved, CAN-2409 is immediately available to patients with localized prostate cancer.” Dr. Tak continued, “CAN-2409, Candel’s most advanced multimodal biological immunotherapy candidate, continues to demonstrate meaningful overall survival benefits in patients with advanced NSCLC, non-responsive to immune checkpoint inhibitors, as well as in patients with borderline resectable PDAC. The totality of data showing notable extension of survival based on both phase 2a clinical trials in NSCLC and PDAC, respectively, suggests that CAN-2409 has the potential to represent a transformative treatment option for patients with difficult-to-treat solid tumors. The FDA Fast Track Designation for each indication further validates the potential of this novel approach to address significant unmet medical needs in oncology.” First Quarter 2025 & Recent Highlights CAN-2409 – Prostate Cancer Positive phase 3 results from the CAN-2409 clinical trial in intermediate-to-high risk localized prostate cancer have been selected for an oral presentation at the upcoming 2025 ASCO Annual Meeting, taking place May 30 to June 3, 2025, in Chicago, IL. This phase 3 study was conducted under a Special Protocol Assessment (SPA) agreed with the U.S. Food and Drug Administration (FDA), meaning that certain data generated from this study could be sufficient for the Company to seek regulatory approval for CAN-2409 in this indication. The Company continues to work toward a Q4 2026 BLA submission for prostate cancer, following the positive topline data from its multicenter, randomized, placebo-controlled phase 3 clinical trial evaluating CAN-2409 in intermediate-to-high-risk localized prostate cancer patients. The FDA previously granted Fast Track Designation for CAN-2409 for the treatment of localized primary prostate cancer. CAN-2409 - Pancreatic Cancer Positive final survival data from the randomized controlled phase 2a clinical trial of CAN-2409 in borderline resectable PDAC demonstrated notable improvement in overall survival compared to standard of care. Patients who had received experimental treatment with CAN-2409 and chemoradiotherapy achieved a mOS of 31.4 months versus 12.5 months observed in the control arm treated with chemoradiotherapy. Notably, three long-term survivors in the CAN-2409 arm remained alive at 66.0, 63.6, and 35.8-months post-treatment, whereas only one patient from the control arm was still alive at the time of data cut-off (February 20, 2025). Patients in the CAN-2409 arm were stable at the time of last follow up with minimal maintenance therapy and, despite previous recurrence, experienced extended and ongoing post-progression survival, further highlighting the sustained benefit of CAN-2409, even in metastatic disease. The FDA previously granted Orphan Drug Designation and Fast Track Designation for CAN-2409 in borderline resectable PDAC. CAN-2409 – Non-Small Cell Lung Cancer In March, the Company reported final survival data from its phase 2a clinical trial of CAN-2409 in patients with stage III/IV NSCLC, inadequately responding to ICI treatment. In patients with an inadequate response to ICI treatment (Cohort 1+2, n=46), mOS was 24.5 months. In patients with progressive disease, despite ICI treatment (Cohort 2, n=41), mOS was 21.5 months, which is markedly longer than the 9.8–11.8 months of survival reported in published literature1,2 in the same patient population receiving standard of care of docetaxel chemotherapy. 37% of patients with progressive disease at enrollment were still alive > 24 months after CAN-2409 treatment at the time of the March 3, 2025 data cut, suggesting a long tail of survival. 14/15 patients with overall survival > 24 months and 9/9 patients with overall survival > 30 months had non-squamous NSCLC. In patients with non-squamous NSCLC and progressive disease despite ICI (cohort 2, n=33), observed mOS was 25.4 months after CAN-2409 treatment. A decrease in the size of uninjected tumors was observed in 69% of patients with multiple lesions (n=35), indicating that a local injection is associated with a systemic anti-tumor immune response. CAN-2409 maintained its generally favorable safety and tolerability profile throughout the extended follow-up period. The FDA previously granted Fast Track Designation for CAN-2409 for the treatment of NSCLC. Recent Corporate Events In March 2025, the Company entered a strategic, commercial collaboration with IDEA Pharma, a Division of SAI MedPartners (IDEA). Under this agreement, IDEA will provide strategic commercial input throughout the development and commercialization process for Candel’s lead asset, CAN-2409. Through this collaboration, Candel will gain access to a dedicated team of experts with extensive experience in oncology commercialization and go-to-market strategy optimization. In March 2025, the Company appointed Elizabeth M. Jaffee, M.D., to its Research Advisory Board (RAB). Dr. Jaffee, an internationally recognized expert in cancer immunology and pancreatic cancer, brings her extensive expertise to the RAB, which is important in light of the Company’s focus on borderline resectable pancreatic cancer. Publication Manuscript published in the March 2025 online edition of Neuro-Oncology, reporting results of a phase 1b clinical trial exploring safety and tolerability of the combination of CAN-2409 plus prodrug (valacyclovir) and nivolumab, in addition to standard of care (neurosurgery, radiotherapy, and temozolomide), in patients with newly diagnosed rHGG. Anticipated Milestones Clinical and biomarker activity data from an ongoing phase 1b clinical trial evaluating repeat doses of CAN-3110 in patients with rHGG expected in Q4 2025. Submission of BLA for CAN-2409 in prostate cancer expected in Q4 2026. Financial Results for the First Quarter Ended March 31, 2025 Research and Development Expenses: Research and development expenses were $4.0 million for the first quarter of 2025 compared to $4.1 million for the first quarter of 2024. The decrease was primarily due to a decrease in employee-related expenses, partially offset by an increase in manufacturing costs, in support of the Company’s CAN-2409 programs. Research and development expenses included a non-cash stock compensation expense of ($0.1) million for the first quarter of 2025, as compared to a non-cash stock compensation expense of $0.6 million for the first quarter of 2024. General and Administrative Expenses: General and administrative expenses were $4.1 million for the first quarter of 2025, compared to $3.8 million for the first quarter of 2024. The increase was primarily due to higher professional and consulting fees. General and administrative expenses included non-cash stock compensation expense of $0.4 million for the first quarter of 2025, as compared to a non-cash stock compensation expense of $0.5 million for the first quarter of 2024. Net Income/Loss: Net income for the first quarter of 2025 was $7.4 million compared to a net loss of $8.2 million for the first quarter of 2024 and included net other income of $15.5 million and net other expense of $0.3 million, respectively. The increase in net income was primarily related to the change in the fair value of the Company’s warrant liability. Cash Position: Cash and cash equivalents, as of March 31, 2025, were $92.2 million, as compared to $102.7 million as of December 31, 2024. Based on current plans and assumptions, the Company expects that its existing cash and cash equivalents will be sufficient to fund its current operating plan into the first quarter of 2027. About CAN-2409 CAN-2409 (aglatimagene besadenovec), Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational, off-the-shelf, replication-defective adenovirus designed 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 metabolite that kills nearby cancer cells. Together, this regimen is designed to induce an individualized and specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ immunization against a variety of tumor antigens. Because of its versatility, CAN-2409 has the potential to treat a broad range of solid tumors. Encouraging monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and ICI have previously been shown in several preclinical and clinical settings. More than 1,000 patients have been dosed with CAN-2409 with a favorable tolerability profile to date, supporting the potential for combination with other therapeutic strategies. Currently, Candel is evaluating CAN-2409 in NSCLC and borderline resectable PDAC and has recently completed a successful phase 3 clinical trial in localized prostate cancer. CAN-2409 plus prodrug (valacyclovir) has been granted Fast Track Designation by the FDA for the treatment of PDAC, stage III/IV NSCLC in patients who are resistant to first line PD-(L)1 inhibitor therapy and who do not have activating molecular driver mutations or have progressed on directed molecular therapy, and localized primary prostate cancer. Candel’s pivotal phase 3 clinical trial in prostate cancer was conducted under a SPA agreed with the FDA. The FDA has also granted Orphan Drug Designation to CAN-2409 for the treatment of PDAC. About CAN-3110 CAN-3110 is a first-in-class, replication-competent herpes simplex virus-1 (HSV-1) next-generation oncolytic viral, immunotherapy candidate designed for dual activity for oncolysis and immune activation in a single therapeutic. CAN-3110 is being evaluated in a phase 1b clinical trial in patients with rHGG. In October 2023, the Company announced that Nature published results from this ongoing clinical trial. CAN-3110 was well tolerated with no dose-limiting toxicity reported. In the clinical trial, the investigators observed improved median overall survival compared to historical controls after a single CAN-3110 injection in this therapy-resistant condition.3 The Company and academic collaborators are currently evaluating the effects of repeat CAN-3110 injections in rHGG, supported by the Break Through Cancer foundation. CAN-3110 has previously received FDA Fast Track Designation and Orphan Drug Designation for the treatment of rHGG. About the enLIGHTEN™ Discovery Platform The enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new multimodal biological immunotherapies for solid tumors. The enLIGHTEN™ Discovery Platform has been designed to deconvolute the characteristics of the tumor microenvironment related to clinical outcomes. These characteristics are rapidly translated into optimized multi-gene payloads of tumor modulators that can be delivered to the tumor microenvironment for specific indications, disease stages, and rationally designed therapeutic combinations. In 2022, the Company announced a discovery partnership with the University of Pennsylvania Center for Cellular Immunotherapies to create new viral immunotherapies that could enhance the efficacy of chimeric antigen receptor T cell (CAR-T) therapy in solid tumors. During the 2023 Society for Immunotherapy of Cancer Annual Meeting and the 2023 International Oncolytic Virotherapy Conference (IOVC) Meeting, Candel presented encouraging data on the first candidate from this platform, Alpha 201-macro-1, which was designed to interfere with the CD47/SIRP1α pathway, in mouse models of breast cancer and lung cancer. During the 2024 American Association for Cancer Research Annual Meeting, Candel presented preclinical data, unveiling the second candidate from the enLIGHTEN™ Discovery Platform, a first-in-class multimodal immunotherapy candidate to induce tertiary lymphoid structures, being developed as a novel therapeutic for solid tumors. Candel also presented data on a multimodal viral therapeutic candidate encoding IL-12 and IL-15 at the 2024 IOVC meeting. About Candel Therapeutics Candel is a clinical stage biopharmaceutical company focused on developing off-the-shelf multimodal biological 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 HSV gene constructs, respectively. CAN-2409 is the lead product candidate from the adenovirus platform and recently completed successful phase 2a clinical trials in NSCLC and PDAC, and a pivotal phase 3 clinical trial in localized prostate cancer. CAN-3110 is the lead product candidate from the HSV platform and is currently in an ongoing phase 1b clinical trial in rHGG. Finally, Candel’s enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new viral immunotherapies for solid tumors. For more information about Candel, visit: www.candeltx.com Forward-Looking Statements This press release includes certain disclosures that contain “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the timing and advancement of current and future development programs, including the timing and availability of additional data and key data readout milestones and presentations; expectations regarding the submission of the BLA for CAN-2409 in intermediate-to-high-risk localized prostate cancer; expectations regarding early biological readouts as predictor of clinical response; expectations regarding the therapeutic benefit of the Company’s platforms, including the ability of its platforms to improve overall survival and/or disease-free survival of patients living with difficult to treat, solid tumors; and expectations regarding cash runway and expenditures. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the timing and advancement of development programs; expectations regarding the therapeutic benefit of the Company’s programs; that final data from the Company’s preclinical studies and completed clinical trials may differ materially from reported interim data from ongoing studies and trials; the Company’s ability to efficiently discover and develop product candidates; the Company’s ability to obtain and maintain regulatory approval of product candidates; the Company’s ability to maintain its intellectual property; the implementation of the Company’s business model, including strategic plans for the Company’s business and product candidates; and other risks identified in the Company’s filings with the U.S. Securities and Exchange Commission (SEC), including the Company’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, each as filed with the SEC and any subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Investor ContactTheodore JenkinsVice President, Investor Relations, and Business DevelopmentCandel Therapeutics, [email protected] Media ContactBen ShannonVice PresidentICR Healthcare [email protected]______________________________ 1 Paz-Ares LG et al. J Clin Oncol 2024;42:2860-28722 Ahn MJ et al. J Clin Onc 2024;43:260-2723 Ling AL, et al. Nature. 2023;623(7985):157-166. (1) Working capital is calculated as current assets, less current liabilities
Investor releaseQuarter not tagged2025-04-24Candel Therapeutics Announces Oral Presentation of Positive Phase 3 CAN-2409 Results in Localized Prostate Cancer at ASCO 2025
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Candel Therapeutics Announces Oral Presentation of Positive Phase 3 CAN-2409 Results in Localized Prostate Cancer at ASCO 2025
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…Read full documentShow less
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 individualized and specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ immunization against a variety of the patient’s own tumor antigens. Because of its versatility, CAN-2409 has the potential to treat a broad range of solid tumors. Encouraging monotherapy activity, as well as combination activity with standard of care (SoC) radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors, have previously been shown in several preclinical and clinical settings. More than 1,000 patients have been dosed with CAN-2409 with a favorable tolerability profile reported to date, supporting the potential for combination with other therapeutic strategies. Candel's clinical development program for CAN-2409 includes completed positive phase 2a clinical trials in both non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC), as well as a positive pivotal randomized, placebo-controlled phase 3 clinical trial of CAN-2409 in localized, non-metastatic prostate cancer. In December 2024, Candel announced that CAN-2409 achieved its primary endpoint in this phase 3 clinical trial in men with intermediate-to-high-risk, localized prostate cancer, demonstrating statistically significant and clinically meaningful improvement in disease-free survival when added to SoC radiation therapy +/- androgen deprivation therapy. In the Company’s randomized controlled phase 2a clinical trial of CAN-2409 in borderline resectable PDAC, positive survival data showed notable improvement with an estimated median overall survival of 31.4 months after experimental treatment with CAN-2409 plus SoC versus 12.5 months in the control group in patients with PDAC who only received SoC. Median survival post-progression was 21.2 months in patients who received CAN-2409 compared to 6.4 months in the control arm. The final survival data from the phase 2a clinical trial of CAN-2409, in patients with stage III/IV NSCLC, showed an mOS of 24.5 months in 46 evaluable patients receiving 2 courses of CAN-2409 (per protocol population; cohort 1 and 2) and 21.5 months in evaluable patients from cohort 2 (n=41) that had progressive disease at baseline, despite Immune Checkpoint Inhibitor treatment. CAN-2409 plus prodrug has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of PDAC, stage III/IV NSCLC in patients who are resistant to first line PD-(L)1 inhibitor therapy and who do not have activating molecular driver mutations or have progressed on directed molecular therapy and localized prostate cancer. The FDA has also granted Orphan Drug Designation to CAN-2409 for the treatment of PDAC. Candel’s pivotal phase 3 clinical trial in newly diagnosed, localized prostate cancer was conducted under a Special Protocol Assessment agreed with the FDA. About Candel Therapeutics Candel is a clinical stage biopharmaceutical company focused on developing off-the-shelf multimodal biological immunotherapies that elicit an individualized, systemic anti-tumor immune response to help patients fight cancer. CAN-2409 is the lead product candidate from the adenovirus platform. CAN-3110 is the lead product candidate from the HSV platform and is currently in an ongoing phase 1b clinical trial in recurrent high-grade glioma (rHGG). In October 2023, the Company announced that Nature published initial results from this ongoing clinical trial: CAN-3110 was well tolerated and the investigators observed nearly two-fold increase in median overall survival compared to historical controls after a single CAN-3110 injection in this therapy-resistant condition.1 Finally, Candel’s enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new viral immunotherapies for solid tumors. For more information about Candel, visit: www.candeltx.com Forward-Looking Statements This press release includes certain disclosures that contain “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the timing and advancement of current and future development programs; including the timing and availability of additional data and key data readout milestones and presentations; expectations regarding early biological readouts as predictor of clinical response; and expectations regarding the therapeutic benefit of the Company’s programs, including the ability of CAN-2409 to treat localized prostate cancer and improve disease-free survival, overall survival, and post-progression survival. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the timing and advancement of development programs; expectations regarding the therapeutic benefit of the Company’s programs; that final data from the Company’s pre-clinical studies and completed clinical trials may differ materially from reported interim data from ongoing studies and trials; the Company’s ability to efficiently discover and develop product candidates; the Company’s ability to obtain and maintain regulatory approval of product candidates; the Company’s ability to maintain its intellectual property; the implementation of the Company’s business model, including strategic plans for the Company’s business and product candidates; and other risks identified in the Company’s filings with the U.S. Securities and Exchange Commission (SEC) including the Company’s most recent Annual Report on Form 10-K filed with the SEC and any subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Investor Contact:Theodore JenkinsVP, Investor Relations and Business DevelopmentCandel Therapeutics, [email protected] Media Contact:Ben ShannonICR [email protected] _____________________________________________1. Ling AL, et al. Nature. 2023;623(7985):157-166.

