Silexion Therapeutics (NASDAQ: SLXN) submits Israel Phase 2/3 trial app for SIL204

Rhea-AI Filing Summary

Silexion Therapeutics Corp announced it has submitted a Phase 2/3 clinical trial application in Israel for SIL204 in locally advanced pancreatic cancer. This step indicates the company is preparing to test SIL204 in a more advanced clinical setting, combining elements of mid- and late-stage evaluation.

The update was shared through a press release furnished under a Regulation FD disclosure, meaning the company is providing the same information to all market participants at the same time.

Insights

Biotech clinical-development analyst

The SIL204 Phase 2/3 trial application in Israel marks a disclosed advance in Silexion’s development pipeline.

Silexion Therapeutics reported that it has submitted a Phase 2/3 clinical trial application in Israel for SIL204 in locally advanced pancreatic cancer. This suggests the program is moving beyond early safety-focused stages toward a design that can evaluate both efficacy and, potentially, outcomes relevant to later approval decisions.

Phase 2/3 designs typically allow a study to evolve from dose and efficacy exploration into a larger, more definitive stage under a single protocol, subject to regulatory oversight. For SIL204, the focus on locally advanced pancreatic cancer highlights a severe indication where treatment options are limited, making clinical execution and patient enrollment important practical considerations.

The disclosure, made via a press release dated December 16, 2025 and furnished under Regulation FD, ensures broad access to this pipeline update. Future company communications and regulatory feedback will clarify the trial’s final design, timelines, and any conditions set by Israeli authorities.

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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 16, 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 16, 2025, Silexion Therapeutics Corp issued a press release entitled “Silexion Therapeutics Announces Submission of Phase 2/3 Clinical Trial Application to Israel for SIL204 in Locally Advanced 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 16, 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 16, 2025	/s/ Ilan Hadar
	Name:	Ilan Hadar
	Title:	Chief Executive Officer

FAQ

What did Silexion Therapeutics (SLXN) announce regarding SIL204?

Silexion Therapeutics announced that it has submitted a Phase 2/3 clinical trial application in Israel for SIL204 in locally advanced pancreatic cancer.

Which stage of development is SIL204 entering according to the SLXN disclosure?

The company referenced a Phase 2/3 clinical trial application, indicating plans for a study that combines mid- and later-stage clinical evaluation for SIL204.

Where is Silexion seeking approval to conduct the SIL204 Phase 2/3 trial?

Silexion is seeking clearance in Israel through submission of a Phase 2/3 clinical trial application for SIL204.

How did Silexion Therapeutics disclose the SIL204 clinical trial application?

The company disclosed the submission in a press release titled “Silexion Therapeutics Announces Submission of Phase 2/3 Clinical Trial Application to Israel for SIL204 in Locally Advanced Pancreatic Cancer,” furnished as Exhibit 99.1.

Is the SIL204 press release considered filed for liability purposes under the Exchange Act?

No. The company stated that information in Item 7.01, including the press release, is furnished, not filed, and is not subject to Section 18 liabilities or automatically incorporated into Securities Act filings.

What SEC item did Silexion use to share the SIL204 trial application update?

The update was provided under Item 7.01, Regulation FD Disclosure, which is used to share information broadly with the market.