UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant
to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of report (Date of earliest event reported): January 28, 2025
Silexion Therapeutics Corp
(Exact name of registrant as specified in its charter)
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Cayman Islands
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001-42253
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N/A
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(State or other jurisdiction
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(Commission File Number)
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(I.R.S. Employer
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of incorporation)
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Identification No.)
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12 Abba Hillel Road
Ramat-Gan, Israel
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5250606
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(Address of principal executive offices)
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(Zip Code)
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+972-8-6286005
(Registrant’s telephone number, including area code)
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K is
intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐
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Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
☐
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which
registered
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Ordinary Shares, par value $0.0009 per share
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SLXN |
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The Nasdaq Stock Market LLC
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Warrants exercisable for Ordinary Shares at an exercise price of $103.50 per share
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SLXNW
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The Nasdaq Stock Market LLC
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Indicate by check mark whether the registrant is an
emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if
the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 7.01 Regulation FD Disclosure.
On January 28, 2025, Silexion
Therapeutics Corp issued a press release entitled “Silexion Therapeutics Reports Strong Tumor Growth Reduction from Systemic Administration of SIL-204 in Preclinical Pancreatic Cancer Models.” A copy of the press release is furnished with this Form 8-K as Exhibit 99.1 and is incorporated herein by reference.
The information in Item 7.01 of this Form 8-K, including the information in the press release furnished pursuant to
this Item 7.01 of Form 8-K, shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that section. Furthermore, the information in Item 7.01 of this Form 8-K,
including the information in the press release, shall not be deemed to be incorporated by reference in the filings of the registrant under the Securities Act of 1933.
Item 9.01 Financial Statements and Exhibits
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104
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Cover Page Interactive Data File (formatted in Inline XBRL)
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Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to
be signed on its behalf by the undersigned hereunto duly authorized.
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SILEXION THERAPEUTICS CORP
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Date: January 28, 2025
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/s/ Ilan Hadar
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Name:
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Ilan Hadar
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Title:
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Chief Executive Officer
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Silexion Therapeutics Reports Strong Tumor Growth Reduction from Systemic
Administration of SIL-204 in Preclinical Pancreatic Cancer Models
New preclinical findings provide validation for Silexion’s new systemic administration approach
for SIL-204, demonstrating inhibition of tumor growth in a clinically relevant orthotopic model;
Further studies aim to evaluate its impact on metastases
Grand Cayman, Cayman Islands, January 28,
2025 – Silexion Therapeutics Corp. (NASDAQ: SLXN) (“Silexion” or the “Company”), a clinical-stage biotechnology company pioneering RNA interference (RNAi) therapies for KRAS-driven cancers, today announced promising new preclinical data for
SIL-204, its next-generation siRNA therapeutic candidate. The findings contribute to validating systemic administration as an effective delivery approach, demonstrating significant tumor growth reduction in orthotopic pancreatic cancer models, a
platform designed to mimic human cancer progression.
This data underscores SIL-204’s potential to address one of the most aggressive and challenging cancers, validating its ability to target
KRAS mutations systemically while achieving prolonged therapeutic activity. While the current data shows robust tumor growth inhibition, further studies aim to evaluate its impact on metastases, which the Company is cautiously optimisic about.
The Company is actively exploring how this promising data can inform an expanded next-generation treatment strategy for KRAS-driven cancers
and expects to announce details of its expanded development plan shortly.
Key Preclinical Data Highlights
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SIL-204 administered in an extended release formulation reduced tumor growth by ~50% after 30 days, with ~50% of tumors showing complete necrosis, in human pancreatic
tumors harboring a G12D mutation xenografted into mice.
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SIL-204 administered subcutaneously inhibited tumor growth in mouse metastatic pancreatic orthotopic models.
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A single systemic administration of SIL-204 maintained effective drug levels in rat plasma and tissues for over 56 days.
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SIL-204 inhibits key oncogenic KRAS mutations, including G12D, G12V, G12R, Q61H, and G13D.
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Intratumoral administration of SIL-204 microparticles reduced tumor cell numbers by ~3-fold, tumor area by ~1.5-fold, and increased tumor necrosis by ~5-fold after 15
days in human pancreatic cancer xenograft harboring a KRAS G12V mutation in mice.
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“We are thrilled to share these results, which showcase systemic administration as an effective method for targeting KRAS-driven cancers,”
Mitchell Shirvan, Ph.D., CSO of Silexion. “By demonstrating robust tumor growth inhibition in a clinically relevant model, SIL-204 shows significant potential to address advanced cancers. We look forward to future studies evaluating its impact on
metastatic progression.”
About Silexion Therapeutics
Silexion Therapeutics is a pioneering clinical-stage, oncology-focused biotechnology company developing innovative RNA interference (RNAi)
therapies to treat solid tumors driven by KRAS mutations, the most common oncogenic driver in human cancers. The company's first-generation product, LODER™, has shown promising results in a Phase 2 trial for non-resectable pancreatic cancer. Silexion
is also advancing its next-generation siRNA candidate, SIL-204, designed to target a broader range of KRAS mutations and showing significant potential in preclinical studies. The company remains committed to pushing the boundaries of therapeutic
innovation in oncology, with a focus on improving outcomes for patients with difficult-to-treat cancers. For more information please visit: https://silexion.com
Notice Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the federal securities laws. All statements other than
statements of historical fact contained in this communication, including statements regarding Silexion’s business strategy and ongoing studies are forward-looking statements. These forward-looking statements are generally identified by terminology
such as "may", "should", "could", "might", "plan", "possible", "project", "strive", "budget", "forecast", "expect", "intend", "will", "estimate", "anticipate", "believe", "predict", "potential" or "continue", or the negatives of these terms or
variations of them or similar terminology. 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) Silexion’s ability to successfully complete preclinical studies and initiate clinical trials; (ii) Silexion’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) Silexion’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 proxy statement/prospectus filed with the SEC on July
17, 2024. Silexion 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. Silexion 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.
Company Contact
Silexion Therapeutics Corp
Ms. Mirit Horenshtein Hadar, CFO
mirit@silexion.com
Capital Markets & IR Contact
Arx | Capital Markets Advisors
North American Equities Desk
silexion@arxadvisory.com
