Candel Therapeutics, Inc. - CADL STOCK NEWS

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.

Candel Therapeutics (NASDAQ: CADL) reported its Q4 and full year 2024 financial results, highlighting significant clinical progress across its pipeline. The company announced positive phase 3 data for CAN-2409 in prostate cancer, showing a 30% reduction in cancer recurrence risk and 80.4% pathological complete responses. In pancreatic cancer, CAN-2409 demonstrated notable survival improvements, with median overall survival of 31.4 months versus 12.5 months in the control group.

Financial highlights include:

• Q4 2024 R&D expenses: $4.8M (vs $7.3M in Q4 2023)
• Q4 2024 net loss: $14.1M (vs $11.1M in Q4 2023)
• Cash position: $102.7M as of December 31, 2024
• Runway extended into Q1 2027

Key upcoming milestones include final overall survival data for CAN-2409 in NSCLC (Q1 2025) and biomarker data for CAN-3110 in high-grade glioma (Q4 2025). The company plans to submit a BLA for CAN-2409 in prostate cancer in Q4 2026.

Candel Therapeutics (NASDAQ: CADL) has announced positive final survival data from its Phase 2 clinical trial of CAN-2409 in non-metastatic pancreatic cancer. The randomized controlled study showed a remarkable improvement in estimated median overall survival - 31.4 months in the CAN-2409 treatment group versus only 12.5 months in the control group for patients with borderline resectable pancreatic ductal adenocarcinoma (PDAC).

Notably, three of seven patients treated with CAN-2409 were still alive at 66.0, 63.6, and 35.8 months after enrollment, with survival from diagnosis reaching 73.5, 68.8, and 41.3 months respectively. This survival duration significantly exceeds expectations for standard pancreatic cancer treatment.

CAN-2409, a first-in-class multimodal immunotherapy designed for in situ vaccination against the patient's tumor, demonstrated a favorable safety profile and has previously received both Fast Track Designation and Orphan Drug Designation from the FDA for PDAC treatment. Based on these promising results, Candel plans to prepare for a larger, late-stage randomized controlled clinical trial of CAN-2409 in PDAC.

Candel Therapeutics (NASDAQ: CADL) provided a corporate update highlighting pipeline progress and 2025 milestones. The company reported positive phase 3 data for CAN-2409 in prostate cancer, showing a 30% reduction in cancer recurrence risk and 80.4% pathological complete responses. Updated survival data for CAN-2409 in pancreatic cancer showed median overall survival of 28.8 months versus 12.5 months in the control group.

Key upcoming milestones include updated overall survival data for CAN-2409 in pancreatic cancer and non-small cell lung cancer (Q1 2025), overall survival data for CAN-3110 in recurrent high-grade glioma (Q4 2025), and BLA submission for CAN-2409 in prostate cancer (Q4 2026). The company's cash position of $102.9M as of December 31, 2024, is expected to fund operations into Q1 2027.

Candel Therapeutics (NASDAQ: CADL) has successfully closed its public offering, selling 12,000,001 shares of common stock at $6.00 per share and 3,333,333 pre-funded warrants at $5.99 per warrant. The offering includes 2,000,000 additional shares from the full exercise of the underwriters' option. The company raised approximately $92 million in gross proceeds before deducting expenses.

The funds will be used to advance product development, including the preparation of a Biologics License Application for CAN-2409 in prostate cancer, and for general corporate purposes. The offering was managed by Citigroup, BofA Securities, and Canaccord Genuity as joint bookrunners, with H.C. Wainwright & Co. as lead manager.

Candel Therapeutics (CADL) has announced the pricing of a public offering, consisting of 10,000,001 shares of common stock at $6.00 per share and pre-funded warrants to purchase 3,333,333 shares at $5.99 per warrant. The offering is expected to generate approximately $80 million in gross proceeds and close around December 16, 2024. The company has granted underwriters a 30-day option to purchase up to 2,000,000 additional shares. Proceeds will fund product development, including preparation for a Biologics License Application for CAN-2409 in prostate cancer, and general corporate purposes. The offering is led by joint bookrunning managers Citigroup, BofA Securities, and Canaccord Genuity.