# EDGAR Filing Document

**Accession Number:** 0002022416
**File Stem:** 0001178913-25-003949
**Filing Date:** 2025-11
**Character Count:** 12376
**Document Hash:** 67aec0e293d0ba88842a634e42b7864a
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001178913-25-003949.hdr.sgml**: 20251125

**ACCESSION NUMBER**: 0001178913-25-003949

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 15

**CONFORMED PERIOD OF REPORT**: 20251125

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20251125

**DATE AS OF CHANGE**: 20251125

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Silexion Therapeutics Corp
- **CENTRAL INDEX KEY:** 0002022416
- **STANDARD INDUSTRIAL CLASSIFICATION:** BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 000000000
- **STATE OF INCORPORATION:** E9
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-42253
- **FILM NUMBER:** 251515515

**BUSINESS ADDRESS:**
- **STREET 1:** 12 ABBA HILLEL ROAD
- **CITY:** RAMAT GAN
- **STATE:** L3
- **ZIP:** 5250606
- **BUSINESS PHONE:** 972-8-6286005

**MAIL ADDRESS:**
- **STREET 1:** 12 ABBA HILLEL ROAD
- **CITY:** RAMAT GAN
- **STATE:** L3
- **ZIP:** 5250606

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Biomotion Sciences
- **DATE OF NAME CHANGE:** 20240506

?xml version='1.0' encoding='ASCII'?

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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): **November 25, 2025** 

**Silexion Therapeutics Corp**

(Exact name of registrant as specified in its charter)

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| | | |
|:---|:---|:---|
| **Cayman Islands**<br>| **001-42253**<br>| **N/A** |
| (State or other jurisdiction | (Commission File Number) | (I.R.S. Employer |
| of incorporation) |  | Identification No.) <br>|

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| | |
|:---|:---|
| **12 Abba Hillel Road**<br>**Ramat-Gan, Israel**<br>| **5250606**<br>|
| (Address of principal executive offices) | (Zip Code) <br>|

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**+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:

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| | | |
|:---|:---|:---|
| 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**  |

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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. ☐

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**Item 7.01 Regulation FD Disclosure.**

On November 25, 2025, Silexion Therapeutics Corp issued a press release entitled "Silexion Therapeutics Successfully Completes Toxicology Studies for SIL204, Next-Generation RNA Silencing Therapy, Ahead 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**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) Exhibits

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| | |
|:---|:---|
| [99.1](exhibit_99-1.htm) | [Press Release dated November 25, 2025](exhibit_99-1.htm) |
| 104 | Cover Page Interactive Data File (formatted in Inline XBRL) |

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#### 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.

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| | | |
|:---|:---|:---|
|  | **SILEXION THERAPEUTICS CORP** | **SILEXION THERAPEUTICS CORP** |
| Date: November 25, 2025 | /s/ Ilan Hadar | /s/ Ilan Hadar |
|  | Name: | Ilan Hadar |
|  | Title: | Chief Executive Officer |

---

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## Exhibit 99.1

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**<u>Exhibit 99.1</u>**

![](image0.jpg)

#### Silexion Therapeutics Successfully Completes Toxicology Studies for SIL204, Next-Generation

#### RNA Silencing Therapy, Ahead of Phase 2/3 Clinical Trial in Pancreatic Cancer
*Successful completion of two-species toxicology studies confirms no systemic organ toxicity,* 

*advancing the Company towards its planned regulatory submissions to Israel and Germany*

*Company remains on track to initiate Phase 2/3 clinical trial in locally advanced pancreatic* 

*cancer in Q2 2026*

**Grand Cayman, Cayman Islands, November 25, 2025** -- Silexion Therapeutics Corp. (NASDAQ: SLXN) ("Silexion" or the "Company"), a clinical-stage biotechnology company developing RNA interference (RNAi) therapies for KRAS-driven cancers, today announced the successful completion of toxicology studies for SIL204, the Company's next-generation RNA silencing (siRNA) therapy targeting mutated KRAS oncogenes, ahead of its planned Phase 2/3 clinical trial in locally advanced pancreatic cancer (LAPC).

SIL204 was engineered as a next-generation siRNA therapy targeting mutant KRAS oncogenes to abolish expression of mutated KRAS proteins, which drive aggressive cancers. Designed for enhanced cellular delivery, stability, and broad antitumor activity, SIL204 has shown positive preclinical data demonstrating significant inhibition of cancer cell growth in vitro across a broad range of KRAS mutated cell lines and has shown positive anti-tumor activity in pancreatic cancer sites following systemic administration. The compelling positive preclinical evidence supporting SIL204's potential efficacy in treating aggressive cancers is now further strengthened by the recently completed toxicology study package. Conducted in two species, these toxicology studies confirmed that administration of SIL204 does not lead to systemic organ toxicity, advancing Silexion's plans to initiate clinical trial sites for a Phase 2/3 trial in LAPC.

**Ilan Hadar, Chairman and Chief Executive Officer of Silexion, commented:** "Results from the toxicology studies have cleared us to maintain our planned timelines to initiate SIL204's Phase 2/3 clinical trial in pancreatic cancer. We have recently secured our CRO partner for the trial and continue to prepare regulatory submissions to both Israel's Ministry of Health and Germany's Health Authority (BfArM). SIL204's preclinical package has shown remarkable potential as a cancer treatment, offering an innovative modality - stopping mutated, cancer-driving proteins before they are expressed. We are eager to prove this potential in the clinic and bring SIL204 to patients who could benefit from this treatment. We remain on track to initiate the first stage of SIL204's advanced clinical development in the second quarter of 2026."

**Dr. Mitchell Shirvan, Chief Scientific and Development Officer of Silexion, added:** "We are highly encouraged by the favorable safety results, which support our unique integrated treatment regimen approach to treating this disease that currently has no solution for its extremely high mortality rate. We believe our integrated approach which combines administering both intratumorally and systemically, combined with our innovative platform for disrupting communication between the KRAS oncogene and tumor cells, holds great promise for improving survival in these patients with a reasonable quality of life."

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**About Silexion Therapeutics:**<br> Silexion Therapeutics is a pioneering clinical stage, oncology-focused biotechnology company dedicated to the development of innovative treatments for unsatisfactorily treated solid tumor cancers which have the mutated KRAS oncogene, generally considered to be the most common oncogenic gene driver in human cancers. The Company conducted a Phase 2a clinical trial in its first-generation product which showed a positive trend in comparison to the control of chemotherapy alone. Silexion is committed to pushing the boundaries of therapeutic advancements in the field of oncology, and further developing its lead product candidate for locally advanced pancreatic cancer. For more information please visit: <u>https://silexion.com</u>

#### Cautionary Note 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, the implications of the completed toxicology studies for SIL204, the timing of the planned initiation of a Phase 2/3 clinical trial, SIL204's potential efficacy and safety profile, and the overall therapeutic potential of SIL204 for treating locally advanced pancreatic cancer, 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; (vi) Silexion's ability to maintain its Nasdaq listing; and (vii) other risks and uncertainties set forth in the documents filed by the Company with the SEC, including the Company's Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 18, 2025. 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:**<br> Silexion Therapeutics Corp<br> Ms. Mirit Horenshtein Hadar, CFO<br> mirit@silexion.com

**Investor Contact:**<br> Arx Investor Relations<br> North American Equities Desk<br> silexion@arxhq.com

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