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Silexion Therapeutics (NASDAQ: SLXN) gets positive German input on Phase 2/3 pancreatic cancer trial

Filing Impact
(Neutral)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Silexion Therapeutics Corp filed a current report to share news about its pancreatic cancer program. On December 2, 2025, the company issued a press release titled “Silexion Therapeutics Receives Positive Feedback from German Health Authority on Design of Phase 2/3 Clinical Trial in Pancreatic Cancer.” This indicates that a German health authority has responded favorably to the company’s proposed design for a Phase 2/3 study, an important planning step before running a larger, later-stage trial.

The company is furnishing this press release under a Regulation FD disclosure, meaning it is providing the information broadly to the market. The disclosure is explicitly described as “furnished” rather than “filed,” so it is not subject to certain liability provisions and is not automatically incorporated into other securities law filings.

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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): December 2, 2025

Silexion Therapeutics Corp
(Exact name of registrant as specified in its charter)

Cayman Islands
 
001-42253
 
N/A
(State or other jurisdiction
 
(Commission File Number)
 
(I.R.S. Employer
of incorporation)
 

 
Identification No.)

 

12 Abba Hillel Road

Ramat-Gan, Israel

 
5250606
(Address of principal executive offices)
 
(Zip Code)

+972-3-756-4999
(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:

 


Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 


Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 


Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 


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:

 

Title of each class
 
Trading Symbol(s)
 
Name of each exchange on which registered
Ordinary Shares, par value $0.0135 per share
 
SLXN
 
The Nasdaq Stock Market LLC
Warrants exercisable for Ordinary Shares at an exercise price of $1,552.50 per share
 
SLXNW
 
The Nasdaq Stock Market LLC


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 December 2, 2025, Silexion Therapeutics Corp issued a press release entitled “Silexion Therapeutics Receives Positive Feedback from German Health Authority on Design of Phase 2/3 Clinical Trial in Pancreatic Cancer”. A copy of the press release is furnished as Exhibit 99.1 to this Form 8-K 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, as amended, 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, as amended.

Item 9.01 Financial Statements and Exhibits 
 
(d) Exhibits
 
 
 
99.1

Press Release dated December 2, 2025
 
 
 
104
 
Cover Page Interactive Data File (formatted in Inline XBRL)



SIGNATURE
 
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.
 
 
SILEXION THERAPEUTICS CORP
 
 
Date: December 2, 2025
/s/ Ilan Hadar
 
Name:
Ilan Hadar
 
Title:
Chief Executive Officer
 

FAQ

What did Silexion Therapeutics Corp (SLXN) disclose in this 8-K filing?

Silexion Therapeutics Corp furnished a press release stating it received positive feedback from a German health authority on the design of its planned Phase 2/3 clinical trial in pancreatic cancer.

Which clinical program is mentioned for Silexion Therapeutics Corp (SLXN)?

The filing references a planned Phase 2/3 clinical trial in pancreatic cancer, for which Silexion Therapeutics received positive feedback on the trial design from a German health authority.

How was the information about the German health authority feedback provided by SLXN?

The information was provided through a press release dated December 2, 2025, which Silexion Therapeutics furnished as Exhibit 99.1 to this report under Regulation FD.

Is the Silexion Therapeutics (SLXN) pancreatic cancer trial press release considered filed with the SEC?

No. The company states that the information in Item 7.01, including the press release, is furnished and not deemed “filed” for purposes of Section 18 of the Exchange Act and is not incorporated by reference into other filings.

What securities of Silexion Therapeutics Corp (SLXN) are listed on Nasdaq?

The filing lists Ordinary Shares, par value $0.0135 per share, trading under the symbol SLXN, and warrants exercisable for Ordinary Shares at an exercise price of $1,552.50 per share, trading under the symbol SLXNW on The Nasdaq Stock Market LLC.

What is the purpose of the Regulation FD disclosure for Silexion Therapeutics (SLXN)?

The Regulation FD disclosure allows Silexion Therapeutics to furnish the press release to all investors at the same time, promoting broad, non-selective access to the information about the German health authority’s feedback on its trial design.
Silexion Therapeutics Corp

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Biotechnology
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