SLXN News & Events

Silexion Therapeutics released a letter to shareholders from Chairman and Chief Executive Officer, Ilan Hadar. "2025 was a transformational year for Silexion Therapeutics. We positioned our lead asset, SIL204, to enter human clinical trials in the first half of 2026, bringing us significantly closer to delivering breakthrough treatments for some of the most aggressive and difficult-to-treat cancers... We believe the long-term broader addressable market for our solution may exceed $30 billion annually when considering pancreatic, colorectal, and lung cancer treatment globally... Throughout 2025, we generated compelling preclinical evidence demonstrating SIL204's exceptional potency and broad applicability. Our pre-clinical results showed significant inhibition of cancer cell growth in human cancer cell line models, which consistently exceeded 90% across multiple models. We validated activity against eight distinct KRAS mutations, including G12D, G12V, G12R, G12C, G13C, G12A, Q61H, and G13D... As recently reported, we have completed our regulatory submissions in Israel to initiate our Phase 2/3 clinical trial of SIL204 in locally advanced pancreatic cancer. We anticipate receiving a response during the first quarter of 2026, with clinical trial commencement planned for the first half of 2026. Additional regulatory submissions to Germany are planned for the first quarter of 2026, with additional European Union submissions expected later in 2026 and a U.S. IND submission anticipated in the second half of 2026... We believe that the human data generated during the first stage of our clinical program in 2026 will be critical in demonstrating the potential of our approach and may serve as a foundation for future strategic collaborations and financing as we work to advance SIL204 toward a first-in-class and first-line therapy for pancreatic cancer."

Silexion Therapeutics announced the initiation of its regulatory application in Israel for its planned Phase 2/3 clinical trial of SIL204 in patients with locally advanced pancreatic cancer, LAPC, based on the positive Scientific Advice response received from the German Federal Institute for Drugs and Medical Devices, BfArM. The submission represents a key regulatory milestone in the Company's clinical development program and advances Silexion toward initiating human trials with SIL204, which are planned for the second quarter of 2026. The application is further supported by two recently completed species toxicology studies confirming no systemic organ toxicity. Silexion plans to file regulatory applications in Germany and the European Union in the first quarter of 2026, with expansion to U.S. clinical sites anticipated following completion of the safety run-in in Israel and Germany.

Silexion Therapeutics announced that it has received formal written Scientific Advice from the German Federal Institute for Drugs and Medical Devices regarding the proposed design of the Company's planned Phase 2/3 clinical trial for SIL204, the Company's lead product candidate for locally advanced pancreatic cancer. The guidance follows the Company's Scientific Advice meeting held with BfArM recently and provides significant regulatory clarity as Silexion prepares its Phase 2/3 clinical trial submissions. The positive response from BfArM is an important milestone for supporting the acceptability of the proposed Phase 2/3 study design, based on the supporting safety data, and manufacturing specifications. The written feedback covers several core components of the program, including clinical design, dosing plans, patient population strategy, nonclinical support, and CMC/manufacturing considerations, and will be incorporated into Silexion's upcoming regulatory submissions in Israel, which are expected by the end of 2025, and in Germany, which are expected during the first quarter of 2026.