Form 8-K

8-K — Silexion Therapeutics Corp

Accession: 0001178913-26-004628

Filed: 2026-09-28

Period: 2026-09-28

CIK: 0002022416

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

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

8-K — zk2636165.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 28, 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)

+972-3-7564999

(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 28, 2026, Silexion Therapeutics

Corp issued a press release entitled “Silexion Therapeutics Reports Positive Preclinical Findings for SIL204, Demonstrating Key

Mechanism for Endogenous Systemic Uptake in KRAS-Driven Cancers”. 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 28, 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 28, 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 Reports Positive Preclinical Findings for SIL204,

Demonstrating Key Mechanism for Endogenous Systemic Uptake in KRAS-Driven

Cancers

Translational

research demonstrates that SIL204 utilizes native serum lipids to facilitate intracellular

delivery and robust KRAS oncogene knockdown

Findings

validate that physiological lipoprotein levels are sufficient for cellular entry without requiring

artificial nanoparticles, supporting

systemic administration in the Company's Phase 2/3 clinical program

Grand

Cayman, Cayman Islands, September 28, 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 positive

new findings from an ongoing translational study evaluating the cellular uptake and gene-silencing mechanism of its lead candidate, SIL204.

The study, part of the Company's translational research program supporting its Phase 2/3 clinical development, demonstrates that SIL204

effectively harnesses naturally occurring circulating lipoproteins to achieve cellular internalization and drive potent, dose-dependent

knockdown of mutant KRAS oncogene expression in cancer cells.

Extending

oligonucleotide delivery beyond the liver represents a major frontier in RNAi therapeutics.1 The newly reported findings demonstrate

that SIL204 is designed to utilize native lipid transport pathways to achieve intracellular delivery in tumor cells. In the study, conducted

in a carrier-free, non-transfection assay without synthetic transfection reagents, human KRAS-driven cancer cells treated with SIL204

exhibited robust, dose-dependent gene silencing in the presence of standard physiological serum lipids. In contrast, depletion of serum

lipids resulted in a statistically significant reduction in gene-knockdown efficiency (P < 0.001), confirming that circulating lipoproteins

play a direct, functional role in mediating SIL204 cellular uptake and oncogenic silencing.2

Importantly,

the addition of exogenous human low-density lipoprotein (LDL) did not alter gene-silencing potency compared to complete serum alone.

This observation indicates that endogenous levels of circulating lipoproteins present under normal physiological conditions are already

sufficient to support efficient cellular uptake and target knockdown, eliminating the need for external lipid supplementation or artificial

carrier vehicles.

"These

findings represent an essential mechanistic milestone in our translational characterization of SIL204," said Dr. Mitchell Shirvan,

Chief Scientific and Development Officer of Silexion Therapeutics. "One of the central design objectives of SIL204 was to engineer

an oligonucleotide construct capable of entering target cancer cells efficiently while maintaining biological integrity. By demonstrating

that SIL204 engages native lipoprotein pathways for cellular entry without requiring synthetic transfection reagents, we have demonstrated

a fundamental biological mechanism that underpins its intracellular delivery. These results establish that standard physiological lipid

levels are sufficient to enable potent target silencing, providing crucial mechanistic support as we advance our ongoing pharmacokinetic

and biodistribution evaluations. Because the LDL receptor has been shown in vivo to be upregulated in cancer cells compared to healthy

cells3, this represents an endogenous targeted delivery mechanism that is envisioned to improve the side effect profile in

a clinically meaningful way."

"Demonstrating

this natural uptake mechanism reinforces our broader clinical development strategy and our Integrated Treatment Regimen for SIL204,"

said Ilan Hadar, Chairman and Chief Executive Officer of Silexion Therapeutics. "While our Phase 2/3 clinical program in locally

advanced pancreatic cancer targets the primary tumor, our vision has always encompassed systemic administration to address micro-metastases

and distant disease spread. Confirming that SIL204 can leverage the body's own lipid transport network for cellular entry provides a

strong mechanistic foundation for systemic subcutaneous delivery. As we continue active site initiation and patient screening in our

clinical program, these translational insights further validate the unique therapeutic potential of our next-generation RNAi platform."

The

findings emerge as Silexion continues translational characterization of SIL204 alongside clinical trial site initiation at Tel Aviv Sourasky

Medical Center and regulatory clearances in Germany. Additional preclinical evaluations, including in vivo pharmacokinetic (PK), cellular

uptake kinetics, and tissue biodistribution studies, are currently underway to further characterize the correlation between lipoprotein

association, LDLR pathway engagement, systemic exposure, and anti-tumor activity in vivo.

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 potential therapeutic benefits and future clinical

development of SIL204, the Company's ongoing and planned preclinical and clinical studies, including pharmacokinetic and biodistribution

studies, and the potential future use of SIL204 for systemic administration, 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", 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 inherent

uncertainties associated with translational and preclinical research and drug development, including the risk that preliminary in vitro

findings regarding cellular uptake, lipoprotein association, and gene silencing may not translate to in vivo pharmacokinetic models or

clinical outcomes; (ii) Silexion's ability to successfully complete additional preclinical and pharmacokinetic studies and initiate and

conduct clinical trials, including the Phase 2/3 trial of SIL204 in locally advanced pancreatic cancer; (iii) Silexion's strategy, future

operations, financial position, projected costs, prospects, and plans; (iv) the impact of the regulatory environment and compliance complexities,

including site-level approvals, conditions, and clearances required prior to study commencement at clinical sites in Israel, Germany,

and other jurisdictions; (v) expectations regarding future partnerships or other relationships with third parties; (vi) Silexion's future

capital requirements and sources and uses of cash, including its ability to obtain additional capital; (vii) Silexion's ability to maintain

its Nasdaq listing; and (viii) 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

____________________

Roberts TC, Langer R, Wood MJA. Advances in oligonucleotide drug delivery. Nature Reviews Drug Discovery 19, 673-694 (2020). DOI:

https://doi.org/10.1038/s41573-020-0075-7

Wolfrum C, Shi S, Jayaprakash KN, et al. Mechanisms and optimization of in vivo delivery of lipophilic siRNAs. Nature Biotechnology

25, 1149-1157 (2007). DOI: https://doi.org/10.1038/nbt1339

Guillaumond F, Bidaut G, Ouaissi M, et al. Cholesterol uptake disruption, in association with chemotherapy, is a promising combined

metabolic therapy for pancreatic adenocarcinoma. Proceedings of the National Academy of Sciences (PNAS) 112 (8), 2473-2478 (2015). DOI:

https://doi.org/10.1073/pnas.1421601112

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