secwatch.observer — SEC 8-K summary
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Issuer:     Candel Therapeutics, Inc. (CADL)
CIK:        0001841387
Form:       8-K
Filed at:   2025-05-22T23:59:59+00:00
Accession:  0000950170-25-076458
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Candel's CAN-2409 Phase 3 meets primary endpoint (p=0.0155) in localized prostate cancer; ASCO presentation June 3
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- Statistically significant improvement in DFS (p=0.0155) with 30% risk reduction (HR 0.7) for CAN-2409 plus radiotherapy vs placebo plus radiotherapy.
- Secondary endpoints met: 80.4% pathological complete response at two-year biopsy vs 63.6% control (p=0.0015); higher PSA nadir <0.2 ng/ml (67.1% vs 58.6%, p=0.0164).
- CAN-2409 well tolerated; treatment-related serious adverse events low (1.7% drug arm vs 2.2% control).
- Company plans to submit Biologics License Application for CAN-2409 in Q4 2026.
- Data to be presented at ASCO 2025 oral abstract session on June 3, 2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1841387/000095017025076458/0000950170-25-076458-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1841387/000095017025076458/cadl-20250522.htm
  HTML page:      https://secwatch.observer/filing/0000950170-25-076458

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer