The CTA was submitted through the EU Clinical Trials Information System (CTIS), with Germany serving as the Reporting Member State - the country that will lead the scientific assessment of the trial across the European Union.

The submission represents a pivotal regulatory milestone in Silexion's clinical development program and marks the Company's entry into the European regulatory process for its next-generation siRNA therapy targeting mutated KRAS. The filing was informed by the positive Scientific Advice received from Germany's Federal Institute for Drugs and Medical Devices (BfArM, Bundesinstitut für Arzneimittel und Medizinprodukte) announced in December 2025, and follows the recent approval from the Israeli Ministry of Health to initiate the same Phase 2/3 trial in Israel.

The application is supported by a comprehensive regulatory package, including completed two-species toxicology studies confirming no systemic organ toxicity, and extensive preclinical data. Upon approval, Silexion plans to conduct the trial at leading oncology centers in Germany and across additional EU member states, in parallel with its previously announced Israeli sites led by Sheba Medical Center. Overall Phase 2/3 trial initiation remains planned for the second quarter of 2026.

"The successful submission of our Phase 2/3 clinical trial application to Germany is a defining milestone that extends SIL204's development into Europe and positions Silexion to advance one of the most innovative RNAi programs in KRAS-driven cancer across multiple major jurisdictions," said Ilan Hadar, Chairman and Chief Executive Officer of Silexion Therapeutics. "Germany is widely regarded as one of the most rigorous and respected regulatory environments in the world, and its role as our Reporting Member State under the EU Clinical Trials Regulation provides a strong foundation for our broader European Phase 2/3 program. With the recent Israeli Ministry of Health approval in hand and now our European filing successfully in place, we are executing against every pillar of our 2026 regulatory roadmap as we prepare to initiate the Phase 2/3 trial in the second quarter of this year."

The planned Phase 2/3 trial will evaluate SIL204 in combination with standard-of-care chemotherapy in patients with LAPC, using Silexion's innovative dual-route administration strategy - combining intratumoral delivery to target primary tumors with systemic administration to address metastatic disease. The study is structured as a safety run-in followed by a randomized cohort.  Pancreatic cancer remains one of the most lethal malignancies, with a five-year survival rate below 13% and more than 80% of pancreatic cancer mortality driven by metastatic disease. KRAS mutations are present in approximately 90% of pancreatic cancers, 45% of colorectal cancers, and 30-35% of lung adenocarcinomas, representing one of the largest and most persistent unmet needs in oncology.