Candel Therapeutics, Inc. Stock Price, News & Analysis

Candel Therapeutics (NASDAQ: CADL) has announced a webcast and conference call scheduled for June 3, 2025, at 1:00PM ET to discuss positive Phase 3 clinical results for their CAN-2409 treatment in localized, intermediate-to-high risk prostate cancer. The results showed a statistically significant 30% reduction in disease recurrence compared to placebo when combined with standard-of-care radiation therapy.

The call will feature insights from principal investigators Dr. John E. Sylvester and Dr. Ronald F. Tutrone, Jr., following Dr. Theodore DeWeese's oral presentation at the 2025 ASCO Annual Meeting. Both featured specialists bring extensive experience in prostate cancer treatment and research, with over two decades of expertise in their respective fields.

Candel Therapeutics (NASDAQ: CADL) announced positive Phase 3 results for CAN-2409 in localized prostate cancer treatment, to be presented at ASCO 2025. The trial met its primary and secondary endpoints, showing a 30% reduction in cancer recurrence or death risk. CAN-2409, combined with valacyclovir and standard radiation therapy, demonstrated statistically significant improvement in disease-free survival (p=0.0155) compared to placebo. Key findings include: 80.4% pathological complete responses vs 63.6% in control, significant increase in PSA nadir achievement (67.1% vs 58.6%), and a favorable safety profile with low treatment-related adverse events (1.7%). This marks the first successful Phase 3 trial in localized prostate cancer in over 20 years, with Candel planning to submit a Biologics License Application in Q4 2026.

Candel Therapeutics (NASDAQ: CADL) reported Q1 2025 financial results and significant clinical progress. The company's lead candidate CAN-2409 showed positive Phase 3 results in prostate cancer, with BLA submission planned for Q4 2026. Notable achievements include: • Promising survival data in pancreatic cancer (PDAC), with median overall survival of 31.4 months vs 12.5 months in control group • Strong results in non-small cell lung cancer (NSCLC), with 24.5-month median overall survival in ICI-inadequate responders • Favorable Phase 1b results in high-grade glioma Financial highlights: Q1 2025 showed net income of $7.4 million compared to $8.2 million loss in Q1 2024. Cash position of $92.2 million expected to fund operations into Q1 2027. R&D expenses were $4.0 million, while G&A expenses reached $4.1 million.

Candel Therapeutics (NASDAQ: CADL), a clinical stage biopharmaceutical company developing biological immunotherapies for cancer treatment, has announced its participation in two major upcoming investor conferences:

1. Bank of America Securities 2025 Health Care Conference in Las Vegas: - Chief Scientific Officer Francesca Barone will present on May 14, 2025, at 4:20 PM PT - Location: Las Vegas, NV

2. Jefferies Global Healthcare Conference in New York: - President and CEO Paul Peter Tak will present on June 5, 2025, at 8:40 AM PT - Location: New York, NY

Live webcasts will be available on Candel's website under the Investors section, with replays archived for up to 90 days after the presentations.

Candel Therapeutics (Nasdaq: CADL) has announced that data from their phase 3 clinical trial of CAN-2409 in patients with intermediate-to-high risk localized prostate cancer will be presented at the 2025 ASCO Annual Meeting. The presentation will feature results from a randomized, placebo-controlled study examining CAN-2409+prodrug combined with standard-of-care external beam radiation therapy (EBRT) for newly diagnosed localized prostate cancer.

The oral presentation will be delivered by Dr. Theodore DeWeese, Dean of Medical Faculty and CEO of Johns Hopkins Medicine, on June 3, 2025, during the Genitourinary Cancer session at McCormick Place Convention Center, Chicago. Full abstracts will be released on May 22, 2025.

Candel Therapeutics (CADL) has published Phase 1b clinical trial results in Neuro-Oncology, evaluating CAN-2409 plus valacyclovir and nivolumab combination with standard care in newly diagnosed high-grade glioma patients.

The trial enrolled 41 patients, with 35 completing the full treatment. Key findings include:

• Median overall survival of 15.1 months for the general population
• A subset of patients with methylated MGMT promoter and gross total tumor resection (n=6) achieved 30.6 months median survival
• Treatment showed immune activation at weeks 3 and 5, including increased naive and effector T cells
• No dose-limiting toxicities were observed for CAN-2409

While Candel is not pursuing CAN-2409 for high-grade glioma due to portfolio prioritization, the company is developing it for localized prostate cancer, pancreatic ductal adenocarcinoma, and non-small cell lung cancer.

Candel Therapeutics reported final survival data from its Phase 2a clinical trial of CAN-2409 in advanced Non-Small Cell Lung Cancer (NSCLC) patients who failed to respond to immune checkpoint inhibitor (ICI) treatment. The study showed remarkable results with median overall survival (mOS) of 24.5 months in the evaluable patient population, significantly exceeding the standard care outcomes.

Key findings include:

• 21.5 months mOS in patients with progressive disease despite ICI therapy, compared to 9.8-11.8 months with standard docetaxel chemotherapy
• 37% of patients survived beyond 2 years after CAN-2409 administration
• 69% of patients showed regression in uninjected tumors (abscopal effect)
• Non-squamous NSCLC patients showed superior outcomes with 25.4 months mOS

The treatment maintained a favorable safety profile throughout the extended follow-up period. The FDA has granted Fast Track Designation for CAN-2409 in combination with ICI treatment for stage III/IV NSCLC patients resistant to first-line PD-(L)1 inhibitor therapy.

Candel Therapeutics (Nasdaq: CADL) has formed a strategic commercial partnership with IDEA Pharma to advance commercialization efforts for CAN-2409. The partnership follows positive phase 3 data for CAN-2409 in intermediate-to-high risk, localized prostate cancer, which demonstrated:

• 30% decrease in disease recurrence
• Statistically significant improvement in disease-free survival
• Higher pathological complete response rate (80.4% vs 63.6% in placebo)

IDEA Pharma will provide strategic commercial input through 2026, supporting Candel's BLA submission for CAN-2409 in prostate cancer. The partnership grants Candel access to IDEA's dedicated team of oncology commercialization experts to optimize go-to-market strategy.

Candel Therapeutics (Nasdaq: CADL) has appointed Dr. Elizabeth M. Jaffee to its Research Advisory Board. Dr. Jaffee, an internationally recognized expert in cancer immunology and pancreatic cancer, currently serves as the Dana and Albert Broccoli Professor of Oncology and Deputy Director at Johns Hopkins' Sidney Kimmel Comprehensive Cancer Center.

The appointment is particularly significant given Candel's focus on borderline resectable pancreatic cancer and follows their recent positive survival data for the CAN-2409 program. Dr. Jaffee's expertise will contribute to designing late-stage clinical trials for this program.

Dr. Jaffee's credentials include serving as past President of the American Association for Cancer Research, co-chair of the Biden Moonshot Blue Ribbon Panel, and Chief Medical Advisor to the Lustgarten Foundation for Pancreatic Cancer Research. She is also a member of the National Academy of Medicine and previously chaired President Biden's Cancer Panel.