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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.Key clinical developments
CAN-2409 achieved primary endpoint of disease-free survival in a Phase 3 trial for prostate cancer, with a 30% improvement and strong statistical significance.
Secondary endpoints showed a 38% improvement in prostate cancer-specific disease-free survival and an 80.4% pathological complete response rate at two years.
CAN-2409 demonstrated significant survival benefits in borderline resectable pancreatic cancer and therapy-resistant non-small cell lung cancer.
CAN-3110, a novel oncolytic HSV-1 virus, showed promising results in recurrent high-grade glioma, with new data on repeated injections expected by Q4.
Both investigational medicines received Fast Track and Orphan Drug designations, with RMAT designation for CAN-2409 in prostate cancer.
Regulatory and commercialization progress
BLA submission for CAN-2409 in prostate cancer is planned for Q4 next year, with manufacturing scale-up and product stability underway.
Engaged with FDA and EMA, securing SPA agreement and orphan designation in Europe for pancreatic cancer.
Pre-commercialization activities are ongoing, including engagement with payers, healthcare professionals, and patients.
Protocols for Phase 3 trials in non-small cell lung cancer and Phase 2B/3 in pancreatic cancer are being finalized, with trial initiation contingent on non-dilutive funding.
Financial and organizational highlights
Over $100 million in cash with a runway into Q1 2027.
Strong executive team and high-profile Research Advisory Board, including Nobel laureate Jim Allison.
Robust IP protection and data exclusivity for both CAN-2409 and CAN-3110.
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