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Silexion Therapeutics Corp Presents Corporate Overview and SIL204 Clinical Trial Plans
SLXN
New Projects/Investments
- Silexion Therapeutics Corp (SLXN) presented its corporate overview, highlighting its lead product, SIL204, a first-in-class, isoform selective, pan KRAS silencer designed to tackle the most common oncogenic driver in human cancers, the mutated KRAS gene.
- The company plans to initiate a Phase 2/3 clinical trial for SIL204 in Q2 2026, with the safety run-in segment expected to complete by Q4 2026.
- Toxicology studies for SIL204 have been completed, establishing safety margins of up to 11-fold over the clinical starting dose and demonstrating favorable tolerability with no systemic toxicity or organ damage observed.
- Patent protection for SIL204 is expected until 2043, with an estimated extension to 2048.
4 days ago
Silexion Therapeutics Highlights 2025 Achievements and Outlines 2026 Milestones
SLXN
New Projects/Investments
Delisting/Listing Issues
- Silexion Therapeutics Corp released a letter to shareholders detailing significant achievements in 2025, including positive preclinical data for its lead asset, SIL204, which demonstrated over 90% inhibition of cancer cell growth across multiple KRAS mutations and cancer types.
- The company successfully completed regulatory toxicology studies and received positive feedback from Germany's BfArM on its Phase 2/3 trial design for SIL204, positioning it for human clinical trials.
- Silexion Therapeutics raised over $18 million in aggregate financing during 2025 and regained full Nasdaq compliance.
- The company plans to initiate a Phase 2/3 clinical trial for SIL204 in locally advanced pancreatic cancer (LAPC) in the first half of 2026, targeting an estimated $30+ billion global KRAS-driven cancer market.
Jan 6, 2026, 1:24 PM
Silexion Therapeutics Submits Phase 2/3 Clinical Trial Application for SIL204 in Israel
SLXN
New Projects/Investments
- Silexion Therapeutics submitted a regulatory application in Israel on December 16, 2025, for its planned Phase 2/3 clinical trial of SIL204 in patients with locally advanced pancreatic cancer (LAPC).
- This submission represents a key regulatory milestone, advancing the company toward initiating human trials with SIL204, which are planned for the second quarter of 2026.
- The application is supported by recent successful toxicology studies confirming no systemic organ toxicity and positive feedback from German regulatory authorities.
- Silexion plans to file regulatory applications in Germany and the European Union in Q1 2026, with U.S. expansion anticipated after the safety run-in in Israel and Germany.
Dec 16, 2025, 1:48 PM
Silexion Therapeutics Receives Positive German Regulatory Feedback for Pancreatic Cancer Trial
SLXN
New Projects/Investments
Product Launch
Guidance Update
- Silexion Therapeutics Corp. received positive Scientific Advice from the German Federal Institute for Drugs and Medical Devices (BfArM) on the design of its Phase 2/3 clinical trial for SIL204, a lead candidate for locally advanced pancreatic cancer.
- This feedback provides regulatory clarity and will be incorporated into upcoming regulatory submissions.
- The company expects to complete regulatory submissions to the Israeli Ministry of Health by the end of Q4 2025 and in Germany during Q1 2026.
- Silexion remains on track to initiate the Phase 2/3 clinical trial of SIL204 in Q2 2026, pending regulatory clearance.
Dec 2, 2025, 1:33 PM
Silexion Therapeutics Completes Toxicology Studies for SIL204
SLXN
New Projects/Investments
- Silexion Therapeutics Corp. (SLXN) announced on November 25, 2025, the successful completion of toxicology studies for SIL204, its next-generation RNA silencing therapy targeting KRAS-driven cancers.
- The two-species toxicology studies confirmed no systemic organ toxicity from SIL204, which is a critical step for advancing the therapy.
- This milestone enables Silexion to proceed with planned regulatory submissions to Israel and Germany and remain on track to initiate a Phase 2/3 clinical trial for SIL204 in locally advanced pancreatic cancer in Q2 2026.
Nov 25, 2025, 2:25 PM
Silexion Therapeutics Corp. Reports Q3 2025 Financial Results and Business Update
SLXN
Earnings
New Projects/Investments
Delisting/Listing Issues
- Silexion Therapeutics Corp. reported a net loss of $3.3 million, or ($2.88) per share, for the third quarter ended September 30, 2025, representing a 72.3% decrease compared to the same period in 2024.
- The company significantly strengthened its balance sheet by raising approximately $9.5 million in gross proceeds during Q3 2025, increasing cash and cash equivalents to $9.2 million and shareholders' equity to $7.0 million as of September 30, 2025.
- Silexion is on track to initiate Phase 2/3 clinical trials for SIL204 in the first half of 2026, with regulatory submissions planned for Q4 2025 in Israel and Q1 2026 in Germany and the EU, supported by new preclinical data demonstrating exceptional efficacy across multiple KRAS-driven cancer types.
- The company also regained full compliance with Nasdaq's minimum bid price and shareholders' equity requirements on September 23, 2025, securing its continued listing.
Nov 12, 2025, 2:07 PM
Silexion Therapeutics announces positive preclinical data for SIL204
SLXN
New Projects/Investments
Guidance Update
- Silexion Therapeutics Corp. announced positive new human cell line data for its drug candidate SIL204, confirming pan-KRAS activity with inhibition rates ranging from 83.5% to 99.7% across eleven human cancer cell lines from five different organ sites.
- The data demonstrated activity against clinically significant KRAS mutations including G12D, G12V, G12R, G12C, G13C, G12A, Q61H, and G13D, with the highest reported activity of 99.7% inhibition in NCIH2009 lung cancer cells.
- This includes the first evidence of activity in gastric cancer (89.2% inhibition in SNU-601 cells) and expanded validation in colorectal cancer, reinforcing SIL204's potential as a single therapeutic approach for multiple KRAS-driven solid tumors.
- The company plans to advance SIL204 towards Phase 2/3 clinical trials in the first half of 2026, with regulatory submissions expected in Q4 2025 for Israel and Q1 2026 for the European Union.
Sep 30, 2025, 1:05 PM
Silexion Therapeutics Corp enters At The Market Offering Agreement
SLXN
- Silexion Therapeutics Corp (SLXN) entered into an At The Market Offering Agreement with H.C. Wainwright & Co., LLC on September 26, 2025.
- This agreement permits SLXN to offer and sell up to $13.17 million of its ordinary shares through Wainwright as an agent.
- Wainwright will receive a cash commission of 3% of the gross sales price of any ordinary shares sold under the agreement.
- Sales will be conducted using "at the market offering" methods, including transactions on The Nasdaq Capital Market.
Sep 26, 2025, 8:05 PM
Silexion Therapeutics Corp Affirms Nasdaq Equity Compliance
SLXN
Delisting/Listing Issues
Equity Issuance
- Silexion Therapeutics Corp (SLXN) has affirmed compliance with Nasdaq Listing Rule 5550(b)(1), reporting a pro forma shareholders' equity of approximately $9.41 million as of July 31, 2025, significantly exceeding the $2.5 million minimum requirement.
- This achievement follows a capital deficiency of $0.7 million as of July 31, 2025, and $0.1 million in shareholders' equity as of June 30, 2025.
- The increase in equity resulted from four significant transactions completed in August and September 2025, including an induced warrant exercise, a public offering, the exercise of Series B ordinary warrants, and the partial conversion of a sponsor promissory note, which collectively added $10.31 million to shareholders' equity.
Sep 15, 2025, 8:35 PM
Silexion Therapeutics Announces Pricing of Public Offering
SLXN
New Projects/Investments
- Silexion Therapeutics Corp. announced the pricing of a public offering of 1,500,000 ordinary shares (or ordinary share equivalents) and accompanying warrants at a combined public offering price of $4.00 per share (or per ordinary share equivalent).
- The offering is expected to generate gross proceeds of $6.0 million and net proceeds of approximately $5.2 million.
- The company intends to use the net proceeds from this offering to advance its pre-clinical studies and for general corporate purposes.
- The offering includes Series A warrants exercisable for five years and Series B warrants exercisable for twelve months, both with an exercise price of $4.00 per share, as well as pre-funded warrants with an exercise price of $0.0001 per share.
Sep 12, 2025, 8:30 PM
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