8-K - Silexion Therapeutics Ltd. | StockGist

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Silexion Therapeutics Corp. received approval from the Israeli Ministry of Health to initiate a Phase 2/3 clinical trial of SIL204 for locally advanced pancreatic cancer. This regulatory milestone advances SIL204 into clinical-stage development as a next-generation RNAi therapy targeting KRAS mutations present in over 90% of pancreatic cancers.

Key Takeaways

1Israeli Ministry of Health approval received on March 24, 2026, for Phase 2/3 trial of SIL204

2Trial targets locally advanced pancreatic cancer with KRAS mutations in over 90% of cases

3Positive preclinical results showed significant anti-tumor activity in multiple models

4Successful completion of toxicology studies

5Expects to initiate trial in second quarter of 2026

6Plans to submit Phase 2/3 application in Germany by end of current quarter

Current Report Details

Event Type

Regulation Fd

Exhibits Only

Disclosure

Voluntary

Variant

8-K

Items Reported

7.01

of this Form 8-K, including the information in the press release, shall not be deemed to be incorporated by reference in the filings of the registrant under the

Regulation Fd

9.01

Financial Statements and Exhibits (d) Exhibits 99.1 Press Release dated March 24, 2026 104 Cover Page Interactive Data File (formatted in Inline XBRL) SIGNATURE

Exhibits Only

Source Document

Exhibits (2)

8-K

99.1

EXHIBIT 99.1