Silexion Therapeutics Corp filed SEC Form 8-K: Regulation FD Disclosure, Other Events, Financial Statements and Exhibits

 

On March 28, 2025, Silexion Therapeutics Corp (the “Company”) posted to its website (https://silexion.com/) an updated corporate presentation. A copy of the presentation is furnished with this Form 8-K as Exhibit 99.1 and is incorporated herein by reference. On the same day, the Company issued a press release entitled “Silexion Therapeutics Unveils Innovative Expanded Development Plan for SIL204 Based on Recently Groundbreaking Preclinical Data” A copy of the press release is furnished with this Form 8-K as Exhibit 99.2 and is incorporated herein by reference.

 

In accordance with General Instruction B.2 of Form 8-K, the information in this Current Report on Form 8-K that is furnished pursuant to this Item 7.01, including Exhibit 99.1 and 99.2, shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

On March 28, 2025, the Company announced an expanded development plan for its next-generation siRNA candidate, SIL204. This strategy integrates systemic administration to target metastatic progression with intratumoral administration to focus on primary tumors, offering a comprehensive approach to treating KRAS-driven pancreatic cancer. The decision to expand the development plan follows recently reported promising preclinical findings demonstrating that systemic administration of SIL204 significantly inhibits tumor growth in clinically relevant orthotopic models of pancreatic cancer. This dual-route approach is designed to address the aggressive nature of KRAS-driven cancers, which are characterized by high mortality and limited treatment options.

Building on the Phase 2 clinical results from its first-generation product (siG12DLoder) and the recent orthotopic model studies showing SIL204's ability to reduce metastases, the Company plans to conduct additional toxicology and pharmacodynamic studies throughout the remainder of 2025, followed by potential regulatory submissions to the Israel Ministry of Health in the second half of 2025 and to the European Union in the first half of 2026. These submissions would initiate the next stage of clinical development for SIL204 in patients with advanced localized KRAS-driven pancreatic cancer.

Cautionary Note Regarding Forward-Looking Statements

This Report of Foreign Private Issuer on Form 6-K contains statements forward-looking statements within the meaning of the federal securities laws including statements regarding the Company’s business strategy, ongoing studies and plans to initiate further studies and make regulatory submissions. Forward-looking statements involve a number of risks, uncertainties, and assumptions, and actual results or events may differ materially from those projected or implied in those statements. Important factors that could cause such differences include, but are not limited to: (i) the Company’s ability to successfully complete preclinical studies and initiate clinical trials; (ii) the Company’s strategy, future operations, financial position, projected costs, prospects, and plans; (iii) the impact of the regulatory environment and compliance complexities; (iv) expectations regarding future partnerships or other relationships with third parties; (v) the Company’s future capital requirements and sources and uses of cash, including its ability to obtain additional capital; and (vi) other risks and uncertainties set forth in the documents filed or to be filed with the SEC by the company, including the Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 18, 2025. The Company cautions you against placing undue reliance on forward-looking statements, which reflect current beliefs and are based on information currently available as of the date a forward-looking statement is made. Forward-looking statements set forth herein speak only as of the date they are made. The Company undertakes no obligation to revise forward-looking statements to reflect future events, changes in circumstances, or changes in beliefs, except as otherwise required by law.

 

(d) Exhibits