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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): August 12, 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)

+972-3-7564999
(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 $0.0135 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 2.02
Results of Operations and Financial Condition.
 
On August 12, 2025, Silexion Therapeutics Corp issued a press release announcing its financial results for the second quarter ended June 30, 2025. A copy of the press release is furnished as Exhibit 99.1 hereto and is incorporated by reference into this Item 2.02.
 
The information contained in this Item 2.02 and Exhibit 99.1 hereto shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of such section, nor will such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or under the Exchange Act, except as may be expressly set forth by specific reference in such filing.
 
Item 9.01
Financial Statements and Exhibits
 
(d) Exhibits

 



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: August 12, 2025
By:
/s/ Ilan Hadar
 
Name:
Ilan Hadar
 
Title:
Chief Executive Officer
 

EX-99.1 2 exhibit_99-1.htm EXHIBIT 99.1

Exhibit 99.1


Silexion Therapeutics Reports Second Quarter 2025 Financial
Results and Provides Business Update
 
Continued advancement of SIL204 preclinical program with strong efficacy data
across multiple KRAS-driven cancer types; company strengthened financial
position and maintains progress toward clinical trials
 
GRAND CAYMAN, Cayman Islands, August 12, 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 reported its financial results for the second quarter ended June 30, 2025, and provided an update on recent business developments.
 
Recent Milestones & Business Highlights:
 
Groundbreaking Preclinical Data Across Multiple Cancer Types: Following the completion of studies evaluating the Company’s second-generation drug candidate SIL204 in orthotopic pancreatic cancer models in February 2025, the Company announced a significant expansion of its preclinical program. In May 2025, Silexion announced preclinical studies exploring SIL204's potential impact on colorectal and lung cancer, with results demonstrating strong efficacy across multiple KRAS-driven cancer types:
 

Pancreatic Cancer: SIL204 demonstrated up to 94% inhibition in cancer cells harboring KRAS G12D mutations
 

Colorectal Cancer: Achieved approximately 90% inhibition rate in GP2D colorectal cancer cells with KRAS G12D mutations
 

Lung Cancer: Showed significant dose-dependent inhibition in human lung cancer cell lines harboring KRAS G12D mutations
 

New KRAS Mutation Coverage: In July 2025, the Company reported first evidence of SIL204's efficacy against the clinically significant KRAS Q61H mutation, with up to 97% inhibition in pancreatic cancer cells
 
Strategic Formulation Partnership: In April 2025, Silexion announced a strategic collaboration with Catalent, a global leader in advanced delivery technologies, for formulation development and clinical manufacturing activities for SIL204 at Catalent's facility in Limoges, France. This partnership supports the Company's dual-route development strategy targeting both the primary tumor and resulting metastases.


 
Regulatory and Clinical Timeline: The Company remains on track to initiate Phase 2/3 clinical trials for SIL204 in the first half of 2026, focusing initially on locally advanced pancreatic cancer.
 
Silexion is currently conducting the toxicology studies to initiate the clinical trial, and those are progressing as planned. Silexion plans for regulatory submission to initiate the Phase 2/3 trial  to the Israel Ministry of Health in the fourth quarter of 2025 and the European Union in the first quarter of 2026.
 
Nasdaq Listing Maintained: In July 2025, the Company received a favorable decision from a Nasdaq hearings panel, allowing it to maintain its listing on the Nasdaq Capital Market. As part of maintaining compliance, Silexion effected a 1-for-15 reverse share split on July 29, 2025, and continues to work toward achieving the required $2.5 million shareholders' equity threshold.
 
Recent Financing Activities: Subsequent to the quarter end, on July 31, 2025, the Company entered into a warrant exercise inducement transaction generating approximately $1.8 million in gross proceeds from the exercise of 152,106 existing warrants.
 
Ilan Hadar, Chairman and CEO of Silexion commented: "The second quarter of 2025 marked a transformative period for Silexion as we significantly expanded the potential therapeutic applications of SIL204 beyond pancreatic cancer. Our preclinical data now demonstrates SIL204's impressive efficacy across pancreatic, colorectal, and lung cancers - three of the most challenging KRAS-driven malignancies. With high inhibition rates and coverage of multiple KRAS mutations including the newly validated Q61H and G13D variants, SIL204 is positioned as a potentially transformative pan-KRAS therapeutic."
 
"The strategic collaboration with Catalent and our continued progress toward clinical trials in 2026 reinforce our commitment to bringing this innovative RNAi therapy to patients with limited treatment options. As we advance our dual-route administration strategy and maintain our Nasdaq listing, we remain focused on executing our clinical development plan and delivering value to both patients and shareholders."
 
Second Quarter 2025 Financial Results:
 
Cash Position: Cash and cash equivalents were $3.5 million as of June 30, 2025, compared to $1.2 million as of December 31, 2024. The increase primarily reflects proceeds from financing activities completed in early 2025, partially offset by ongoing operational expenses supporting preclinical development activities.
 
Operating Expenses: Total operating expenses for the three-month period ended June 30, 2025 were $2.3 million, compared to $1.4 million for the three-month period ended June 30, 2024, an increase of 64.3%. Research and development expenses increased to $1.0 million for the three-month period ended June 30, 2025, compared to $0.8 million for the three-month period ended June 30, 2024, an increase of $0.2 million or 25.0%, primarily due to increased payroll and payroll-related expenses from additional headcount and salary increases following the business combination, as well as bonus accrual in the second quarter of 2025. General and administrative expenses increased to $1.3 million for the three-month period ended June 30, 2025, compared to $0.6 million for the three-month period ended June 30, 2024, an increase of $0.7 million or 116.7%, mainly due to increased payroll expenses and professional services costs associated with operating as a public company.


 
Financial Expenses: Financial expenses, net for the three-month period ended June 30, 2025 were $0.2 million, compared to $0.1 million for the three-month period ended June 30, 2024, an increase of $0.1 million or 100.0%, primarily due to an increase in revaluation expenses of financial instruments.
 
Net Loss: Net loss for the three-month period ended June 30, 2025 was $2.5 million, compared to $1.5 million for the three-month period ended June 30, 2024, an increase of $1.0 million or 66.7%. The increase was mainly due to an increase in our general and administrative expenses related to our status as a public company and research and development expenses.
 
Six-Month Results: For the six months ended June 30, 2025, net loss was $4.2 million compared to $2.9 million for the same period in 2024, primarily reflecting increased general and administrative expenses related to operating as a public company.
 
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 Silexion's business strategy, preclinical and clinical development plans, timeline for clinical trials, regulatory submissions, collaboration with Catalent, and expectations regarding SIL204's therapeutic potential, 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 or to be filed with the SEC by the Company, including the Company's Quarterly Report on Form 10-Q for the period ended June 30, 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:
Silexion Therapeutics Corp
Ms. Mirit Horenshtein Hadar, CFO
mirit@silexion.com
 
Capital Markets & IR Contact:
Arx Capital Markets
North American Equities Desk
silexion@arxadvisory.com
 


SILEXION THERAPEUTICS CORP
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS

   
June 30, 2025
   
December 31, 2024
 
   
U.S. dollars in thousands
 
Assets
           
CURRENT ASSETS:
           
Cash and cash equivalents
 
$
3,466
   
$
1,187
 
Restricted cash
   
25
     
35
 
Prepaid expenses
   
1,683
     
966
 
Other current assets
   
63
     
62
 
TOTAL CURRENT ASSETS
   
5,237
     
2,250
 
NON-CURRENT ASSETS:
               
Restricted cash
   
53
     
48
 
Long-term deposit
   
5
     
5
 
Property and equipment, net
   
30
     
30
 
Operating lease right-of-use asset
   
472
     
530
 
TOTAL NON-CURRENT ASSETS
   
560
     
613
 
TOTAL ASSETS
 
$
5,797
   
$
2,863
 
 


 
SILEXION THERAPEUTICS CORP
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS

   
June 30, 2025
   
December 31, 2024
 
   
U.S. dollars in thousands
 
Liabilities and shareholders’ equity (capital deficiency)
           
CURRENT LIABILITIES:
           
Trade payables
 
$
692
   
$
929
 
Current maturities of operating lease liability
   
171
     
158
 
Employee related obligations
   
628
     
642
 
Accrued expenses and other account payable
   
659
     
788
 
Private warrants to purchase ordinary shares (including $* and $1 due to related party, as of June 30, 2025 and December 31, 2024, respectively)
   
*
     
2
 
Underwriters Promissory Note
   
-
     
1,004
 
TOTAL CURRENT LIABILITIES
   
2,150
     
3,523
 
NON-CURRENT LIABILITIES:
               
Long-term operating lease liability
   
337
     
368
 
Related Party Promissory Note
   
3,190
     
2,961
 
TOTAL NON-CURRENT LIABILITIES
 
$
3,527
   
$
3,329
 
TOTAL LIABILITIES
 
$
5,677
   
$
6,852
 
SHAREHOLDERS' EQUITY (CAPITAL DEFICIENCY):
               
Ordinary shares ($0.0135 par value per share, 1,481,482 shares authorized as of June 30, 2025 and
December 31, 2024; 579,536 and 123,290** shares issued and outstanding as of June 30, 2025
and December 31, 2024, respectively)
   
8
     
2
 
Additional paid-in capital
   
47,604
     
39,263
 
Accumulated deficit
   
(47,492
)
   
(43,254
)
TOTAL SHAREHOLDERS' EQUITY (CAPITAL DEFICIENCY)
 
$
120
   
$
(3,989
)
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY (CAPITAL DEFICIENCY)
 
$
5,797
   
$
2,863
 
 
All share amounts have been retroactively adjusted to reflect a 1-for-15 reverse share split as discussed in Note 11(b) to the Company’s
condensed consolidated financial statements included in the Company’s quarterly report on Form 10-Q for the quarter ended June 30, 2025

* Represents an amount less than $1
 
** Net of 28 treasury shares held by the Company as of December 31, 2024
 

 
SILEXION THERAPEUTICS CORP
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
 
   
Six months ended June 30
   
Three months ended June 30
 
   
2025
   
2024
   
2025
   
2024
 
   
U.S. dollars in thousands
   
U.S. dollars in thousands
 
OPERATING EXPENSES:
                       
Research and development
(including $0 and $34 from related party for the six months period ended June 30, 2025
and 2024, respectively, and including $0 and $17 from related party for the three
months period ended June 30, 2025 and 2024, respectively)
 
$
1,608
   
$
1,727
   
$
1,018
   
$
766
 
General and administrative
(including $58 and $24 from related party for the six months period ended June 30, 2025
and 2024, respectively, and including $37 and $12 from related party for the three
months period ended June 30, 2025 and 2024, respectively)
   
2,326
     
908
     
1,266
     
619
 
TOTAL OPERATING EXPENSES
   
3,934
     
2,635
     
2,284
     
1,385
 
OPERATING LOSS
   
3,934
     
2,635
     
2,284
     
1,385
 
Financial expenses, net
(including $229 and $135 from related party for the six months period ended June 30, 2025
and 2024, respectively, and including $197 and $60 from related party for the
three months period ended June 30, 2025 and 2024, respectively)
   
301
     
270
     
216
     
102
 
LOSS BEFORE INCOME TAX
 
$
4,235
   
$
2,905
   
$
2,500
   
$
1,487
 
INCOME TAX
   
3
     
7
     
3
     
2
 
NET LOSS
 
$
4,238
   
$
2,912
   
$
2,503
   
$
1,489
 
                                 
Attributable to:
                               
Equity holders of the Company
   
4,238
     
2,845
     
2,503
     
1,472
 
Non-controlling interests
   
-
     
67
     
-
     
17
 
Total
 
$
4,238
   
$
2,912
   
$
2,503
   
$
1,489
 
                                 
LOSS PER SHARE, BASIC AND DILUTED
 
$
8.21
   
$
381.09
   
$
4.32
   
$
197.80
 
                                 
WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE
   
516,110
     
7,466
     
579,523
     
7,442
 

All share and per share amounts have been adjusted (for any period preceding the relevant reverse share split, on a retroactive basis)
to reflect 1-for-9 and 1-for-15 reverse share splits, as discussed in Notes 1(g) and 11(b) to the Company’s condensed
consolidated financial statements included in the Company’s quarterly report on Form 10-Q for the quarter ended June 30, 2025