Form 8-K

8-K — Silexion Therapeutics Corp

Accession: 0001178913-26-004666

Filed: 2026-09-30

Period: 2026-09-30

CIK: 0002022416

SIC: 2836 (BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES))

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

8-K — zk2636171.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (exhibit_99-1.htm)

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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):

September 30, 2026

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 $0.135 per share

SLXN

The Nasdaq Stock Market LLC

Warrants exercisable for Ordinary Shares at an exercise price of $15,525.00 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 September 30, 2026, Silexion Therapeutics

Corp issued a press release entitled “Silexion Therapeutics Announces First Patient Successfully Dosed in Phase 2/3 Clinical

Trial of SIL204 in Locally Advanced Pancreatic Cancer”. A copy of the press release is furnished as Exhibit 99.1 to this Current

Report on Form 8-K (this “Form 8-K”) and is incorporated herein by reference.

The information in this Item 7.01 of Form 8-K,

including the information in the press release furnished pursuant to this Item 7.01, 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 this Item 7.01, 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 September 30, 2026

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: September 30, 2026

/s/ Ilan Hadar

Name:

Ilan Hadar

Title:

Chief Executive Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: exhibit_99-1.htm · Sequence: 2

Exhibit 99.1

Silexion Therapeutics

Announces First Patient Successfully Dosed in

Phase 2/3 Clinical

Trial of SIL204 in Locally Advanced Pancreatic Cancer

Global Phase 2/3 trial evaluates SIL204 in combination

with standard chemotherapy in patients with

locally advanced pancreatic cancer

Integrated regimen combines direct EUS-guided

intratumoral delivery to penetrate tumor stroma with

subcutaneous dosing; first patient treated at Tel Aviv Sourasky Medical Center (Ichilov)

Grand Cayman, Cayman Islands and Ramat Gan, Israel, September 30, 2026

-- 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 that the first patient worldwide has been successfully

dosed in its Phase 2/3 clinical trial evaluating the Company's lead candidate, SIL204, in patients with locally advanced pancreatic cancer

(LAPC). The treatment was administered at Tel Aviv Sourasky Medical Center ("TASMC" or "Ichilov") in Israel, marking

a defining transition into active clinical execution for the Company's global therapeutics program.

The trial is a prospective, randomized, controlled, multinational,

Phase 2/3, open-label study evaluating the efficacy and safety of SIL204 administered as an integrated therapeutic regimen in combination

with standard-of-care chemotherapy, versus chemotherapy alone, in patients with LAPC. The study is structured with an initial safety run-in

cohort of approximately 18 patients, followed by global expansion to enroll a randomized cohort of approximately 166 patients. The trial

enrolls newly diagnosed, treatment-naïve adult patients with unresectable Stage 3 LAPC without distant metastases whose tumors harbor

a confirmed KRAS mutation. SIL204 is administered as a first-line regimen alongside standard chemotherapy, with the choice of chemotherapy

at the treating physician's discretion.

In this trial, SIL204 is administered via an innovative dual-route

delivery strategy designed to address the anatomical and biological barriers of pancreatic tumors. Treatment combines direct intratumoral

administration via an endoscopic ultrasound (EUS)-guided procedure, targeting the primary pancreatic lesion to bypass dense tumor stroma,

with subcutaneous abdominal injections designed to provide systemic exposure and address potential micro-metastases.

"Successfully dosing the first patient in our Phase 2/3 clinical

trial of SIL204 is a defining operational and clinical milestone for Silexion, transitioning our lead RNAi program into active patient

treatment," said Ilan Hadar, Chairman and Chief Executive Officer of Silexion Therapeutics. "Locally advanced pancreatic cancer

is one of the most aggressive and lethal solid tumors, with patients facing a persistent lack of new therapeutic options. By combining

direct local tumor penetration with systemic coverage, our integrated regimen is engineered to overcome the critical delivery barriers

that have historically limited pancreatic cancer treatments. We are thrilled to initiate dosing at Tel Aviv Sourasky Medical Center and

look forward to advancing additional clinical trial sites across Israel and Germany, as we work toward preliminary clinical readouts in

the near term to evaluate SIL204's potential to improve response rates and survival outcomes for patients with locally advanced pancreatic

cancer."

Tel Aviv Sourasky Medical Center serves as the anchor clinical center

for the trial in Israel following receipt of institutional ethics approval and authorization from the Israeli Ministry of Health. Additional

Israeli oncology centers, alongside leading academic medical institutions in Germany approved under the European Union Clinical Trials

Regulation (EU CTR) framework by the Federal Institute for Drugs and Medical Devices (BfArM), are progressing through site activation

and are expected to join the Phase 2/3 program in the coming months.

About Silexion Therapeutics

Silexion Therapeutics is a pioneering clinical-stage, oncology-focused

biotechnology company dedicated to the development of innovative treatments for unsatisfactorily treated solid tumor cancers that 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 candidate, which showed a positive trend in comparison to the control of chemotherapy

alone, and is now advancing its lead, second-generation, product candidate, SIL204, a small interfering RNA (siRNA), through Phase 2/3

clinical evaluation. 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: 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 the clinical development, timing, enrollment, protocol execution, and anticipated outcomes of the Phase 2/3 clinical trial of

SIL204 in locally advanced pancreatic cancer; the timing, availability, and potential clinical significance of anticipated preliminary

clinical readouts in the near term; the potential of SIL204 to improve response rates, survival outcomes, or other clinical metrics; the

therapeutic potential, biological mechanism, and clinical utility of SIL204 and the Company’s integrated treatment regimen; the

anticipated activation and onboarding of additional clinical trial sites in Israel and Germany; Silexion's transition into active clinical

execution; and the Company's future strategy, operations, and milestones, are forward-looking statements. These forward-looking statements

are generally identified by terminology such as "may", "should", "could", "might", "plan",

"possible", "expect", "intend", "will", "estimate", "anticipate", "believe",

"predict", "prospective", or "potential", 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) the ability of Silexion and its participating clinical trial centers to successfully enroll, treat, and evaluate patients

in accordance with the study protocol, including the initial safety run-in cohort of approximately 18 patients and the randomized expansion

cohort of approximately 166 patients; (ii) the risk that preliminary clinical safety, tolerability, response rate, or survival data may

not be achieved, confirmed, or replicated as the trial advances, that early observations may not be predictive of final trial results,

or that SIL204 may not demonstrate statistically significant improvements in clinical efficacy compared to chemotherapy alone; (iii) the

ability of Silexion to complete standard site activation procedures at additional medical centers in Israel and Germany on anticipated

timelines; (iv) Silexion's strategy, future operations, financial position, projected costs, prospects, and plans; (v) the impact of the

regulatory environment and compliance complexities, including site-level approvals, conditions, and clearances required prior to study

commencement in each jurisdiction; (vi) expectations regarding future clinical, academic, or commercial partnerships; (vii) Silexion's

future capital requirements and sources and uses of cash, including its ability to obtain additional financing to fund clinical trials;

(viii) Silexion's ability to maintain its Nasdaq listing; and (ix) 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, 2025, filed with the SEC on March

17, 2026, and the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, filed with the SEC on August 14, 2026.

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

info@silexion.com

Investor Relations Contact

Arx Investor Relations

North American Equities Desk

silexion@arxhq.com

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