On May 18, 2026 Silexion Therapeutics Corp. (NASDAQ: SLXN) ("Silexion" or the "Company"), a clinical-stage biotechnology company pioneering RNA interference (RNAi) therapies for KRAS-driven cancers, reported an update on recent business developments following the release of its financial results for the first quarter ended March 31, 2026, which were reported on May 15, 2026.
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Recent Milestones & Business Highlights
Israeli Ministry of Health Approval to Initiate Phase 2/3 Clinical Trial of SIL204: On March 24, 2026, Silexion announced that it had received formal approval from the Israeli Ministry of Health to initiate its Phase 2/3 clinical trial evaluating the Company’s lead product candidate SIL204 for the treatment of locally advanced pancreatic cancer. The approval represented a defining regulatory milestone for the Company, marking the transition of SIL204 into clinical-stage development of a next-generation siRNA therapy designed to silence mutated KRAS – a driver present in approximately 90% of pancreatic cancers – and positioning Silexion as a clinical-stage biotechnology company focused on KRAS-driven cancers. The approval followed strong positive anti-tumor activity demonstrated across multiple preclinical models, successful completion of two-species toxicology studies, and constructive regulatory engagement supporting the Phase 2/3 trial design.
Phase 2/3 Clinical Trial Application Submitted to Germany: On April 28, 2026, subsequent to quarter end, the Company announced the successful submission of a Clinical Trial Application (CTA) to Germany for the planned Phase 2/3 clinical trial of SIL204 in patients with locally advanced pancreatic cancer. The CTA was submitted through the EU Clinical Trials Information System (CTIS), with Germany serving as the Reporting Member State leading the scientific assessment of the trial across the European Union. The submission was informed by the positive written Scientific Advice received from Germany’s Federal Institute for Drugs and Medical Devices (BfArM) in December 2025, and was supported by the Company’s comprehensive regulatory and preclinical package, including completed two-species toxicology studies.
Phase 2/3 Trial Initiation Planned for the Second Quarter of 2026: The planned Phase 2/3 clinical study is expected to begin in the second quarter of 2026 and will include an initial safety run-in cohort of approximately 18 patients, followed by expansion into a randomized cohort of approximately 166 patients. The study is designed to evaluate SIL204 in combination with standard chemotherapy in patients with locally advanced pancreatic cancer using Silexion’s dual-route administration approach – combining intratumoral delivery to target primary tumors with systemic administration to address metastatic disease. The Company plans to conduct the trial at leading oncology centers in Germany and across additional EU member states, in parallel with previously announced Israeli sites led by Sheba Medical Center.
Ilan Hadar, Chairman and Chief Executive Officer of Silexion, commented: "The first quarter and the period since represented a defining moment in Silexion’s evolution. With the Israeli Ministry of Health approval to initiate our Phase 2/3 clinical trial of SIL204 in locally advanced pancreatic cancer, and our subsequent submission of a Clinical Trial Application to Germany under the EU Clinical Trials Regulation, we have advanced SIL204 from a preclinical asset into clinical-stage development across two major regulatory jurisdictions. We remain on track to initiate the Phase 2/3 clinical trial in the second quarter of 2026, with the goal of bringing an RNAi-based approach to patients with KRAS-driven cancers who have limited treatment options today."
Mirit Horenshtein Hadar, Chief Financial Officer of Silexion, added: "During the first quarter and subsequent to quarter end, we executed a series of capital-raising and corporate actions designed to support our clinical development plan and our continued Nasdaq listing. These included our May 2026 warrant exercise inducement transaction, additional capital raised under our at-the-market facility, and obtaining shareholder approval for a prospective reverse share split. We continue to evaluate financing alternatives as we work to support the advancement of SIL204 into the clinic in the second quarter of 2026."
Financial Results for the Three Months Ended March 31, 2026
Research and development ("R&D") expenses for the three months ended March 31, 2026, were approximately $1.4 million, compared to approximately $0.6 million for the same period in 2025, an increase of 133.3%. The increase was primarily driven by approximately $0.7 million in higher subcontractor and consultant expenses related to toxicology studies and product development required to support initiation of the planned human clinical trial expected in the second quarter of 2026, including GMP manufacturing of our drug product, as well as approximately $0.1 million in non-cash share-based compensation expenses related to executive officer grants awarded in February 2026.
General and administrative ("G&A") expenses for the three months ended March 31, 2026, were approximately $1.4 million, compared to approximately $1.1 million for the same period in 2025, an increase of 27.3%. The increase was primarily driven by approximately $0.26 million in higher professional services costs, including legal, investor relations, director compensation, and other expenses associated with operating as a public company, as well as approximately $0.2 million in non-cash share-based compensation expenses related to executive officer and director grants awarded in February 2026.
Net loss for the three months ended March 31, 2026, was approximately $2.7 million, compared to approximately $1.7 million for the same period in 2025, an increase of 58.8%. The increase was primarily attributable to higher research and development expenses, primarily related to preparations for the human clinical trial, and higher general and administrative expenses.
Balance Sheet Highlights
Cash and cash equivalents were $2.4 million as of March 31, 2026, compared to $6.0 million as of December 31, 2025. The decrease primarily reflects ongoing operating expenses supporting preclinical and clinical readiness activities for the planned initiation of the Phase 2/3 clinical trial of SIL204.
Subsequent to quarter end, the Company strengthened its balance sheet through a May 2026 warrant exercise inducement transaction generating approximately $1.0 million in gross proceeds and through utilization of its at-the-market facility. The Company has reported that the May 2026 warrant exercise transaction, together with additional equity-increasing transactions effected on or about May 15, 2026, have raised its shareholders’ equity above the $2.5 million minimum under the Nasdaq Capital Market continued listing requirements, which the Company believes constitutes restored compliance with those requirements.
(Press release, Silexion Therapeutics, MAY 18, 2026, View Source [SID1234665848])