SLXN) Soars on Update and First Quarter Results

The stock makes the Nasdaq top percentage gainers list on news,
currently trading at 0.4629+0.1939 (+72.08%) on volume of over 300
Million shares as of this report.

Silexion Therapeutics provided 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.

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.”

Full news release

Research biotech stocks at Investorideas.com’s free stock
directory

https://www.investorideas.com/BIS/Stock_List.asp