Silexion Secures Phase 2/3 SIL204 Trial Approval, Q1 R&D Spending Soars 133%
Silexion Therapeutics secured Israeli Ministry of Health approval on March 24 to initiate its Phase 2/3 trial of SIL204 in locally advanced pancreatic cancer and filed a CTA in Germany via CTIS on April 28. R&D expenses rose 133% year-over-year to $1.4 million in Q1 2026 to support trial preparation.
1. Regulatory Milestones for SIL204
On March 24, Silexion received approval from the Israeli Ministry of Health to initiate its Phase 2/3 clinical trial of SIL204 in locally advanced pancreatic cancer, then submitted a CTA in Germany on April 28 via the EU Clinical Trials Information System, backed by positive BfArM scientific advice and completed two-species toxicology studies.
2. Phase 2/3 Trial Design and Timeline
The trial is slated to begin in Q2 2026, starting with an approximate 18-patient safety run-in cohort followed by a 166-patient randomized cohort; it will evaluate SIL204 in combination with standard chemotherapy using intratumoral and systemic delivery across leading oncology centers in Israel, Germany and other EU member states.
3. Q1 2026 Financial Results
Research and development expenses rose to $1.4 million in Q1 2026, up 133% from $0.6 million a year earlier, driven by increased subcontractor and consultant costs for toxicology studies and GMP manufacturing to support impending clinical trials.
4. Corporate Financing and Listing Actions
Since quarter end, the company executed a warrant exercise inducement, raised additional capital under its at-the-market facility, obtained shareholder approval for a potential reverse share split and continues to evaluate financing alternatives to fund the upcoming Phase 2/3 trial.