Silexion Therapeutics Receives Israeli Ministry of Health Approval to Begin Phase 2/3 Trial of SIL204 in Locally Advanced Pancreatic Cancer

Ramat Gan, Israel – March 24, 2026 – Silexion Therapeutics Corp (NASDAQ: SLXN), a clinical-stage life sciences company, announced today that it has received formal approval from the Israeli Ministry of Health to initiate a pivotal Phase 2/3 clinical trial of its lead candidate, SIL204, for the treatment of patients with locally advanced pancreatic cancer. This major regulatory milestone marks a significant advancement in the company’s clinical development program and represents a potentially transformative moment for both the company and patients facing this aggressive cancer.

Key Points for Investors

• Phase 2/3 Clinical Trial Approval: The Ministry of Health approval enables Silexion to commence a combined Phase 2/3 trial of SIL204, targeting locally advanced pancreatic cancer. This progression into late-stage clinical development highlights both the maturity of the company’s R&D and regulatory strategy.
• Potential Market Impact: Pancreatic cancer remains one of the most difficult cancers to treat, with limited effective therapies and a high unmet medical need. A successful trial could position SIL204 as a significant new therapy, potentially opening substantial commercial opportunities for Silexion in global oncology markets.
• NASDAQ Listing: Silexion’s ordinary shares (SLXN) and warrants (SLXNW) are listed on The Nasdaq Stock Market LLC. The ability to maintain this listing is essential for liquidity and ongoing investor confidence.
• Emerging Growth Company: Silexion is classified as an emerging growth company, which may allow it to take advantage of reduced reporting requirements and streamlined compliance obligations.
• Forward-Looking Statements: The company has acknowledged that this announcement contains forward-looking statements, particularly regarding the initiation and potential outcomes of its clinical trial, regulatory developments, future capital requirements, and the ability to maintain its Nasdaq listing. These are subject to a range of risks and uncertainties, including the successful completion of preclinical studies, regulatory hurdles, the need for additional financing, and other factors disclosed in SEC filings.

Important Shareholder Considerations & Potential Price-Sensitive Information

• Milestone Achievement: Approval to start a pivotal Phase 2/3 trial is a significant value inflection point for any biotech company. It not only validates the underlying science and regulatory engagement to date, but also sets the stage for potential partnerships, licensing opportunities, and future fundraising efforts.
• Regulatory and Clinical Risks: While the approval is a positive step, shareholders should be aware of the inherent risks associated with clinical development, including the possibility of trial delays, unforeseen safety or efficacy issues, and the highly competitive nature of the oncology drug development landscape.
• Financial Position: The company has indicated that future capital requirements remain a consideration, and its ability to secure additional funding could directly impact operational progress and shareholder value.
• Potential for Share Price Volatility: Given the price-sensitive nature of late-stage clinical trial announcements, both positive and negative developments in the SIL204 program could drive significant share price movements in the near and medium term.

Contact Information

• Company Contact: Ms. Mirit Horenshtein Hadar, CFO
  Email: [email protected]
• Investor Relations: Arx Investor Relations, North American Equities Desk
  Email: [email protected]

About Silexion Therapeutics

Silexion Therapeutics Corp is a biotechnology company focused on developing innovative therapies for oncology indications with high unmet medical needs. The company, formerly known as Biomotion Sciences, is headquartered in Ramat Gan, Israel, and is listed on Nasdaq under the ticker SLXN.

Disclaimer: This article is for informational purposes only and does not constitute investment advice. The information provided herein is based on official filings and public disclosures by Silexion Therapeutics Corp as of March 24, 2026. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those anticipated. Investors are encouraged to read all publicly available filings and consult with their financial advisers before making investment decisions related to Silexion Therapeutics Corp.

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