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Candel Therapeutics (CADL) investor relations material
Candel Therapeutics H.C. Wainwright 27th Annual Global Investment Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.H.C. Wainwright 27th Annual Global Investment Conference summary5 Sep, 2025
Key clinical developments
Achieved primary endpoint of disease-free survival in a Phase III trial for CAN-2409 in prostate cancer, with a 30% improvement and strong statistical significance.
CAN-2409 also demonstrated significant benefits in pancreatic and non-small cell lung cancer, with median overall survival improvements to 31.4 and 24.5 months, respectively.
CAN-3110, a novel oncolytic HSV-1 virus, showed promising results in recurrent high-grade glioma, with some patients experiencing long-term survival.
Both lead programs received Fast Track and Orphan Drug designations, and CAN-2409 received RMAT designation from the FDA.
BLA submission for CAN-2409 is targeted for Q4 next year, with manufacturing scale-up and pre-commercialization activities underway.
Regulatory and strategic highlights
Special Protocol Assessment agreement with the FDA for the prostate cancer trial endpoint.
Positive engagement with the European Medicines Agency, resulting in orphan designation for pancreatic cancer.
Ongoing protocol development for Phase III trials in lung and pancreatic cancer, contingent on securing non-dilutive funding.
Strong intellectual property protection and data exclusivity for both CAN-2409 and CAN-3110.
Advisory board includes Nobel laureate and leading experts, supporting governance and decision-making.
Financial and operational position
Cash reserves exceed $100 million, providing runway into Q1 2027.
Manufacturing scale-up for CAN-2409 is progressing, with product stability and readiness for BLA submission.
Pre-commercialization activities are ongoing, engaging payers, healthcare professionals, and patients.
Executive team has extensive experience in drug development and regulatory strategy.
Focused on advancing both clinical and commercial readiness for lead programs.
RMAT: How does it accelerate CAN-2409 approval?
CAN-2409: Non-dilutive funding strategy
CAN-3110: Timeline for NESTIN tumor expansion
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Next Candel Therapeutics earnings date
Q3 202513 Nov, 2025
Next Candel Therapeutics earnings date
Q3 202513 Nov, 2025
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Frequently asked questions
Candel Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing viral immunotherapies for cancer treatment. The company’s approach involves using genetically modified viruses to induce immunogenic cell death in cancer cells, which unmask tumor antigens within an activated microenvironment. This process triggers a systemic and durable immune response against tumors, acting as an in situ vaccination. Candel’s therapies are designed to potentially improve survival rates and maintain the quality of life for patients across various stages of cancer. The company is headquartered in Needham, Massachusetts, and its shares are listed on NASDAQ.
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