---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-24-274870"
form_type: "8-K"
ticker: "CADL"
cik: "0001841387"
company_name: "Candel Therapeutics, Inc."
filed_at: "2024-12-11T23:59:59+00:00"
generated_at: "2026-05-29T04:47:49.757649+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# Candel's CAN-2409 meets phase 3 prostate cancer endpoint; BLA submission targeted for Q4 2026

## Summary
- Phase 3 trial met primary endpoint: DFS improvement with HR 0.7 (p=0.0155) vs placebo in intermediate-to-high risk localized prostate cancer.
- 14.5% relative improvement in DFS at 54 months; 80.4% pathological complete responses at 2-year biopsy vs 63.6% in control (p=0.0015).
- Phase 2b trial in low-to-intermediate risk active surveillance patients showed numerical improvement but did not reach statistical significance.
- Company intends to initiate FDA discussions and submit Biologics License Application for CAN-2409 in Q4 2026; trial conducted under SPA.
- Safety profile consistent with prior studies; most common adverse events were mild-to-moderate flu-like symptoms, fever, and chills.

## SEC filing metadata
- accession: 0001193125-24-274870
- form_type: 8-K
- ticker: CADL
- cik: 0001841387
- company_name: Candel Therapeutics, Inc.
- filed_at: 2024-12-11T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1841387/000119312524274870/0001193125-24-274870-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1841387/000119312524274870/d901922d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-24-274870
- JSON: https://secwatch.observer/filing/0001193125-24-274870.json
- Plain text: https://secwatch.observer/filing/0001193125-24-274870.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.