Silexion Secures Approval for Pancreatic Cancer Drug Trial

Silexion to Launch Phase 2/3 Trial in Q2 2026

Silexion Therapeutics (NASDAQ: SLXN) announced on March 24, 2026, that it received formal approval from the Israeli Ministry of Health to begin a Phase 2/3 clinical trial for SIL204. This approval marks a critical milestone, officially advancing the company to a clinical-stage biotechnology firm and allowing human trials for its lead candidate to commence in the second quarter of 2026. The trial will evaluate the drug's efficacy in treating locally advanced pancreatic cancer, a disease with significant unmet medical need.

This regulatory green light follows a series of positive developments, including strong preclinical data showing significant anti-tumor activity and the successful completion of toxicology studies. The company also plans to expand its regulatory footprint by submitting a Phase 2/3 clinical trial application in Germany by the end of the current quarter, with further filings across the European Union scheduled for early 2027.

SIL204 Targets KRAS Mutations in Over 90% of Cases

SIL204 is an innovative RNA interference (RNAi) therapy designed to silence KRAS gene mutations, which are widely recognized as one of the most challenging targets in oncology. These mutations are the oncogenic driver in over 90% of pancreatic cancers. Unlike highly specific inhibitors, SIL204 is engineered to target a broad spectrum of KRAS mutations, giving it potential applicability across other high-value cancer indications, including colorectal and lung cancers. The planned study will start with a safety run-in cohort of approximately 18 patients before expanding to a randomized cohort of roughly 166 patients.

The receipt of this approval marks a defining and highly significant milestone for Silexion. We are now advancing SIL204 into a pivotal clinical trial with the goal of addressing KRAS-driven cancers at their source.

— Ilan Hadar, Chairman and Chief Executive Officer of Silexion Therapeutics.

Financial Health Bolstered by $18.6M Capital Raise in 2025

The move into clinical trials is supported by a significantly improved financial position. During 2025, Silexion raised over $18.6 million in gross proceeds from public offerings and warrant exercises. The company ended the year with $6.0 million in cash and cash equivalents, a substantial increase from $1.2 million at the end of 2024. This capital provides the necessary runway to fund the planned clinical milestones. The financial strengthening coincided with the company regaining full compliance with Nasdaq listing rules in September 2025, solidifying its standing in the public markets.