On August 13, 2026 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, reported financial results for the second quarter ended June 30, 2026, and provided a corporate update.

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"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

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Aglatimagene besadenovec – Prostate Cancer
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The Company continues to advance its pre-BLA readiness initiative, including its Chemistry, Manufacturing, and Controls (CMC) activities, preparation of clinical study reports, and BLA modules.
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Process validation campaign for drug substance and drug product is being executed at our contract development and manufacturing organization. The campaign is progressing well and is a critical CMC activity to enable the anticipated BLA submission in Q4 2026.
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New clinical material has been produced and is intended to be used in the pivotal phase 3 clinical trial of aglatimagene in NSCLC.
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The Company published results from the randomized, double-blind, placebo-controlled, multicenter pivotal phase 3 clinical trial of aglatimagene in patients with intermediate- to high-risk localized prostate cancer in The Lancet Oncology. These data were initially announced in December 2024 and presented as an oral presentation at ASCO (Free ASCO Whitepaper) 2025.

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The Company presented clinical data from extended follow-up of its phase 3 trial of aglatimagene in prostate cancer in a plenary oral presentation at the AUA 2026 Annual Meeting, held in Washington, D.C. from May 15-18, 2026.
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Among the 745 patients enrolled in the randomized, double-blind, placebo-controlled trial, the aglatimagene arm exhibited a 39% improvement in prostate cancer-specific disease-free survival (PCa-specific DFS) compared to placebo after a median follow-up of 58 months (data as of March 15, 2026).
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The Company observed consistently favorable trends in both the intent to treat and intermediate-risk subgroup populations across all secondary and exploratory endpoints, including time to biochemical failure, time to metastasis, rate of metastasis, and time to salvage anti-cancer therapy (time to new treatment), when comparing the aglatimagene arm with placebo, on top of standard-of-care radiotherapy.
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There were no new safety signals or additional toxicities observed.
For additional information, please refer to Candel’s May 15, 2026, press release.

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The Company will present an abstract delineating extended biomarker analysis from the phase 3 clinical trial of aglatimagene in patients with localized prostate cancer at the 2026 American Society for Radiation Oncology (ASTRO) Annual Meeting in Q3 2026.
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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.
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Aglatimagene besadenovec – Non-Small Cell Lung Cancer (NSCLC)
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In June 2026, the Company activated the first clinical trial site of the global pivotal phase 3 clinical trial (AURORA) (NCT07660094), which will evaluate aglatimagene plus valacyclovir in combination with continued pembrolizumab in patients with metastatic non-squamous NSCLC whose disease has progressed despite treatment with pembrolizumab and platinum-based chemotherapy.
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The randomized, open-label AURORA trial is expected to enroll patients with metastatic stage IV non-squamous NSCLC across approximately 150 sites worldwide, randomized 1:1 to receive either two courses of aglatimagene plus valacyclovir with continued pembrolizumab or standard-of-care docetaxel chemotherapy.
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The study’s primary endpoint is overall survival, with secondary endpoints including safety and quality-of-life assessments (NSCLC-SAQ and EORTC QLQ-30).
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The FDA previously granted Fast Track Designation to aglatimagene for the treatment of NSCLC.
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Linoserpaturev – Recurrent Glioblastoma (rGBM)
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Following FDA clearance of its Investigational New Drug application for linoserpaturev in Q1 2026, the Company is advancing next-stage development planning for rGBM.
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Enabling work is underway to support a potential randomized phase 2 dose-regimen-finding study.
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The clinical trial is expected to inform the optimal number of linoserpaturev administrations and a recommended regimen for future development.
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Recent Corporate Events
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In June 2026, the Company appointed Mark Sims as Chief Commercial Officer. Mr. Sims is a seasoned oncology commercial leader with more than 25 years of experience building and advancing Global and U.S. cancer franchises. He held key leadership roles at AstraZeneca PLC, Novartis AG, and Idenix Pharmaceuticals, Inc.. Mr. Sims’ appointment strengthens the Company’s efforts toward its planned BLA submission in the fourth quarter of 2026 and potential 2027 launch of aglatimagene in localized prostate cancer.
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In April 2026, the Company announced a commercialization agreement with EVERSANA to support the potential U.S. launch of aglatimagene in localized prostate cancer. 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.
Anticipated Milestones

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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.
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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.

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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 varietyof 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).

(Press release, Candel Therapeutics, AUG 13, 2026, View Source [SID1234670061])