Candel Therapeutics (CADL) Company Report

Candel Therapeutics reported positive Phase 3 clinical trial results for CAN-2409 in newly diagnosed localized prostate cancer, meeting the primary endpoint of improved disease-free survival.
The company anticipates filing a Biologics License Application (BLA) for CAN-2409 in newly diagnosed localized prostate cancer in Q4 2026.
Manufacturing for CAN-2409 is on track, with successful GMP runs completed and Process Performance Qualification (PPQ) runs scheduled for Q2 2026, supported by FDA alignment on comparability and PPQ strategy.
Additionally, positive data for CAN-2409 was presented in pancreatic cancer and non-small cell lung cancer, with a Phase 3 trial for NSCLC expected to commence in Q2 2026.
Updated overall survival data for CAN-3110 in recurrent glioblastoma is expected in Q4 2026.

Dec 5, 2025, 4:00 PM

Transcript

Candel Therapeutics Updates on Financials, Clinical Pipeline, and Commercialization Strategy

CADL

Product Launch

New Projects/Investments

Guidance Update

Candel Therapeutics reported $87 million in cash and cash equivalents as of September 2025, with an expected cash runway into Q1 2027, and recently secured a term loan facility of up to $130 million.
The Phase 3 clinical trial for CAN-2409 in newly diagnosed intermediate- to high-risk localized prostate cancer achieved its primary endpoint, demonstrating a 30% risk reduction in disease recurrence. The company is on track for BLA submission by the end of 2026 and has received Fast Track and RMAT designations.
Candel is implementing a pre-commercialization roadmap for CAN-2409, with launch readiness activities spanning into 2026 and 2027, aiming for rapid market penetration in community and hospital-based urologic and oncology practices.
Updated clinical data for CAN-2409 in non-small cell lung cancer is anticipated in Q1 2026, and the first patient for a pivotal randomized controlled Phase 3 trial in non-small cell lung cancer is expected in Q2 2026.

Dec 5, 2025, 4:00 PM

Transcript

Candel Therapeutics Updates on Pipeline and Financial Position

CADL

Guidance Update

New Projects/Investments

Product Launch

Candel Therapeutics reported $87 million in cash and cash equivalents as of September 2025, with an expected runway into Q1 2027, and recently secured a term loan facility of up to $130 million.
The company is on track for Biologics License Application (BLA) filing for its lead asset, CAN-2409, in newly diagnosed localized prostate cancer in Q4 2026, following positive Phase III results demonstrating a 30% risk reduction in disease recurrence. CAN-2409 has received Fast Track and Regenerative Medicine Advanced Therapy (RMAT) designations.
Candel anticipates several key clinical data readouts and trial initiations in the coming year, including updated clinical data for non-small cell lung cancer in Q1 2026, updated data from the prostate cancer Phase III study in Q2 2026, and the enrollment of the first patient in a pivotal Phase III trial for CAN-2409 in non-small cell lung cancer in Q2 2026. Updated overall survival data for CAN-3110 in recurrent glioblastoma is expected in Q4 2026.
Commercialization efforts for CAN-2409 are underway, with physicians anticipating broad adoption and payers showing receptiveness to attractive price points. Field team recruitment for launch is planned for late 2026 through 2027.

Dec 5, 2025, 4:00 PM

Transcript

Candel Therapeutics Hosts R&D Day, Provides Pipeline Updates and BLA Timeline

CADL

New Projects/Investments

Guidance Update

Debt Issuance

Candel Therapeutics hosted a virtual R&D Day on December 5, 2025, to detail its viral immunotherapy approach and oncology-focused pipeline.
The company's lead candidate, CAN-2409, achieved positive Phase 3 results in localized, intermediate- to high-risk prostate cancer, demonstrating a 30% reduction in disease recurrence and a 38% reduction in prostate cancer-specific disease recurrence. A Biologics License Application (BLA) for CAN-2409 is anticipated for submission to the FDA in Q4 2026.
CAN-3110, another key pipeline asset, showed positive overall survival data in a Phase 2a clinical trial for therapy-resistant non-small cell lung cancer and proof of concept in recurrent high-grade glioma.
As of September 30, 2025, Candel Therapeutics reported $87.0 million in cash and cash equivalents, with an expected cash runway into Q1 2027, supplemented by a $130 million term loan facility secured in October 2025.

Dec 5, 2025, 1:30 PM

8-K

Candel Therapeutics Provides Clinical and Regulatory Updates at Jefferies 2025 Healthcare Conference

CADL

New Projects/Investments

Product Launch

Guidance Update

Candel Therapeutics announced plans to submit a Biologics License Application (BLA) for its lead candidate, CAN-2409, in prostate cancer in Q4 2026, following positive Phase III trial results demonstrating a 30% improvement in disease-free survival.
The company is set to commence a Phase III pivotal clinical trial for CAN-2409 in therapy-resistant non-small cell lung cancer in Q2 2026, enabled by a $130 million funding agreement with Trinity Capital.
Candel Therapeutics highlighted encouraging long-term survival data for its oncolytic virus, CAN-3110, in recurrent high-grade glioma, with some patients achieving survival beyond 59 months after a single injection.

Nov 18, 2025, 8:00 AM

Transcript

Candel Therapeutics Reports Positive Phase III Data for CAN-2409 and Outlines 2026 Catalysts

CADL

New Projects/Investments

Product Launch

Debt Issuance

Candel Therapeutics announced positive Phase III clinical trial results for its lead investigational medicine, CAN-2409, in newly diagnosed localized prostate cancer, demonstrating a 30% improvement in disease-free survival and an 80.4% pathological complete response at two years.
The company plans to submit the Biologics License Application (BLA) for CAN-2409 in prostate cancer in Q4 2026.
Candel Therapeutics secured up to $130 million in funding through a deal with Trinity Capital, which will enable the initiation of a Phase III pivotal clinical trial for CAN-2409 in non-small cell lung cancer (NSCLC) in Q2 2026.
Updates on overall survival data for CAN-2409 in NSCLC are expected in Q1 2026, and long-term survival data for CAN-3110 in recurrent high-grade glioma are anticipated in Q4 2026.

Nov 18, 2025, 8:00 AM

Transcript

Candel Therapeutics Reports Q3 2025 Financial Results and Corporate Highlights

CADL

Earnings

Debt Issuance

New Projects/Investments

Candel Therapeutics reported a net loss of $11.3 million for the third quarter ended September 30, 2025.
As of September 30, 2025, the company held $87.0 million in cash and cash equivalents.
In October 2025, Candel entered into a $130 million term loan facility with Trinity Capital Inc., with $50 million drawn at closing. This funding, combined with existing cash, is expected to fund operations into Q1 2027.
Key pipeline milestones include the planned submission of a Biologics License Application (BLA) for CAN-2409 in localized prostate cancer in Q4 2026 and the initiation of a pivotal phase 3 clinical trial of CAN-2409 in non-small cell lung cancer (NSCLC) in Q2 2026.

Nov 13, 2025, 1:15 PM

8-K

Candel Therapeutics Enters $130 Million Term Loan Facility

CADL

Debt Issuance

New Projects/Investments

Candel Therapeutics, Inc. secured a five-year, $130 million term loan facility with Trinity Capital Inc. on October 14, 2025, with $50 million drawn at closing and an additional $80 million available in tranches subject to milestones.
The loan has an initial interest rate of 10.25% per annum and includes a 36-month interest-only period.
This financing, combined with $87.2 million in cash and cash equivalents as of September 30, 2025, is intended to strengthen the balance sheet and fund a phase 3 clinical trial of CAN-2409 in non-small cell lung cancer in Q2 2026, and support a potential launch in early localized prostate cancer.
Additionally, the expiration date of existing warrants was extended to September 30, 2027.

Oct 14, 2025, 12:21 PM

8-K

Candel Therapeutics Announces Positive Interim CAN-3110 Data and Publication

CADL

New Projects/Investments

Candel Therapeutics announced encouraging interim data from its phase 1b clinical trial of CAN-3110 (linoserpaturev) in recurrent glioblastoma and a publication in Science Translational Medicine on October 14, 2025.
The study revealed that CAN-3110 induced dynamic remodeling of the tumor microenvironment, with one patient achieving a complete pathological response.
Updated median overall survival (mOS) for patients receiving a single injection of CAN-3110 was 11.8 months for arm A (n=41) and 12.0 months for arm B (n=9), significantly exceeding the historical benchmark of less than 6 to 9 months.
In arm C, where patients received multiple injections, 4 out of 9 patients were alive at the August 15, 2025 data cutoff.
Candel plans to design a small phase 2 clinical trial for CAN-3110, which has FDA Fast Track Designation and Orphan Drug Designation for recurrent high-grade glioma.

Oct 14, 2025, 12:05 PM

Press Release

Candel Therapeutics Provides Update on Viral Immunotherapies and Financial Runway

CADL

New Projects/Investments

Guidance Update

Candel Therapeutics (CADL) is developing viral immunotherapies for difficult-to-treat solid tumors, including early localized non-metastatic prostate cancer, pancreatic cancer, and non-small cell lung cancer.
The company's lead candidate, CAN2409, demonstrated a 30% risk reduction for disease-free survival (DFS) when combined with radiotherapy in a Phase 3 trial for localized prostate cancer. A Biologics License Application (BLA) submission for this indication is planned for Q4 2026.
In non-small cell lung cancer, CAN2409 showed a median overall survival of more than 25 months in patients who failed standard of care, significantly exceeding the expected less than one year. A pivotal Phase 3 clinical trial is being prepared for this indication.
Candel Therapeutics reported having over $100 million in cash, providing a financial runway into Q1 2027.