Candel Therapeutics, Inc. 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 CAN-2409 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.

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 tostandard 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 the company continue advancing regulatory preparations in anticipation of submitting a Biologics License Application for CAN-2409 in the fourth quarter of 2026, company 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=0.01 55; 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 the mortality due to a significant significant improvement in DFS in the second quarter of 2026.