---
schema_version: "secwatch.filing_event.v1"
accession: "0001178913-25-003981"
form_type: "8-K"
ticker: "SLXN"
cik: "0002022416"
company_name: "Silexion Therapeutics Corp"
filed_at: "2025-12-02T23:59:59+00:00"
generated_at: "2026-05-16T15:47:59.798313+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Silexion receives positive BfArM feedback on Phase 2/3 trial design for SIL204 in pancreatic cancer

## Summary
- BfArM written Scientific Advice supports proposed Phase 2/3 study design, dosing, patient population, and CMC.
- Phase 2/3 trial initiation for SIL204 planned for Q2 2026, pending regulatory clearance.
- Regulatory submissions expected in Israel by end of Q4 2025 and in Germany during Q1 2026.
- SIL204 targets KRAS-driven locally advanced pancreatic cancer; momentum builds toward clinical launch.

## SEC filing metadata
- accession: 0001178913-25-003981
- form_type: 8-K
- ticker: SLXN
- cik: 0002022416
- company_name: Silexion Therapeutics Corp
- filed_at: 2025-12-02T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/2022416/000117891325003981/0001178913-25-003981-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/2022416/000117891325003981/zk2534079.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001178913-25-003981
- JSON: https://secwatch.observer/filing/0001178913-25-003981.json
- Plain text: https://secwatch.observer/filing/0001178913-25-003981.txt

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