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): May 13, 2025
Silexion Therapeutics Corp
(Exact name of registrant as specified in its charter)
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Cayman Islands
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001-42253
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N/A |
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(State or other jurisdiction
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(Commission File Number)
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(I.R.S. Employer
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of incorporation)
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Identification No.)
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12 Abba Hillel Road Ramat-Gan, Israel |
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5250606
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(Address of principal executive offices)
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(Zip Code)
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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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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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
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Trading Symbol(s)
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Name of each exchange on which registered
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Ordinary Shares, par value $0.0009 per share
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SLXN |
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The Nasdaq Stock Market LLC
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Warrants exercisable for Ordinary Shares at an exercise price of $103.50 per share
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SLXNW
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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 2.02
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Results of Operations and Financial Condition.
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Item 9.01
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Financial Statements and Exhibits
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SILEXION THERAPEUTICS CORP
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| Date: May 13, 2025 | By: | /s/ Ilan Hadar |
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Name:
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Ilan Hadar
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Title:
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Chief Executive Officer
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Breakthrough Anti-Tumor and Anti-Metastatic Activity in Orthotopic
Models: On March 5, 2025, Silexion announced positive data from orthotopic pancreatic cancer models demonstrating that subcutaneously administered SIL204 effectively reduces both primary tumor growth and metastatic spread. These
findings showed a ~70% reduction in tumor cell numbers in the AsPC-1 (KRAS G12D) model and ~80% reduction in the BxPC-3 model by day 28, along with a substantial reduction in metastases to secondary organs.
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Extended Therapeutic Exposure and Chemotherapy Synergy Data: Earlier
in the quarter, on January 28, 2025, the Company reported that a single systemic dose of SIL204 maintained effective drug levels for over 56 days in preclinical models, highlighting its potential for long-term therapeutic exposure.
Additionally, on January 15, 2025, Silexion announced data demonstrating synergistic activity of SIL204 with first-line chemotherapy agents used in treating pancreatic cancer.
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Expanded Development Strategy: On March 28, 2025, the Company
unveiled an expanded dual-route development plan for SIL204, integrating both systemic administration to target metastatic progression and intratumoral administration to focus on primary tumors. This comprehensive approach aims to address the
complex nature of KRAS-driven cancers, with clinical trials planned to be initiated in the first half of 2026.
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Strategic Collaboration: Following the quarter end, on April 23,
2025, Silexion announced a strategic collaboration with Catalent, a global leader in advanced delivery technologies, to conduct formulation development and clinical manufacturing activities for SIL204 at Catalent’s state-of-the-art facility
in Limoges, France.
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Strengthened Financial Position: During Q1 2025, the
Companycompleted a public offering of ordinary shares, pre-funded warrants, and ordinary warrants, raising gross proceeds of approximately $5.0 million. An additional $0.9 million of proceeds was received from the exercise of certain of
those warrants. In late January, Silexion completed a warrant exercise inducement transaction, generating additional gross proceeds of approximately $3.3 million. Additionally, in March 2025, the Company entered into an agreement to retire
a promissory note in a principal amount of $1.25 million, through a combination of cash payments and share issuances, and completed the retirement of the promissory note on March 18, 2025.
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Cash Position: Cash and cash equivalents were $6.2 million as of
March 31, 2025, compared to $1.2 million as of December 31, 2024. The increase primarily reflects successful financing activities during the quarter, partially offset by operating expenses supporting clinical and preclinical development.
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Operating Expenses: Total operating expenses for Q1 2025 were
$1.7 million, compared to $1.3 million in the same period of 2024. Research and development expenses decreased to $0.6 million for Q1 2025, compared to $1.0 million for Q1 2024, primarily due to decreased subcontractors and consultants
expenses, as the comparative quarter from 2024 included development activities related to the Company’s Application Programming Interface. General and administrative expenses increased to $1.1 million for Q1 2025, compared to $0.3 million for
Q1 2024, primarily due to increased payroll expenses due to headcount growth and an increase in salaries following the closing of the Business Combination in August 2024, and higher professional services costs related to financing activities
as a public company.
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Financial Expenses: Financial expenses, net for Q1 2025 were $0.1
million, compared to $0.2 million in Q1 2024. This decrease was mainly due to reduced foreign exchange losses.
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Net Loss: Net loss for the first quarter of 2025 was $1.7
million, compared to $1.4 million for the first quarter of 2024. The increase was mainly due to higher general and administrative expenses related to being a public company, partially offset by decreased research and development expenses.
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March 31,
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December 31
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2025
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2024
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U.S. dollars in thousands
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Assets
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CURRENT ASSETS:
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Cash and cash equivalents
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$
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6,152
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$
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1,187
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Restricted cash
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34
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35
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Prepaid expenses
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1,478
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966
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Other current assets
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58
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62
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TOTAL CURRENT ASSETS
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7,722
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2,250
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NON-CURRENT ASSETS:
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Restricted cash
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47
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48
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Long-term deposit
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5
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5
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Property and equipment, net
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32
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30
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Operating lease right-of-use asset
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502
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530
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TOTAL NON-CURRENT ASSETS
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586
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613
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TOTAL ASSETS
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$
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8,308
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$
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2,863
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March 31,
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December 31
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2025
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2024
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U.S. dollars in thousands
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Liabilities and shareholders’ equity (capital deficiency)
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CURRENT LIABILITIES:
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Trade payables
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$
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722
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$
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929
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Current maturities of operating lease liability
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155
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158
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Employee related obligations
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624
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642
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Accrued expenses and other account payable
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893
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788
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Private warrants to purchase ordinary shares (including $1 and $1 due to related party,
as of March 31, 2025 and December 31, 2024, respectively)
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1
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2
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Underwriters Promissory Note
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-
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1,004
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TOTAL CURRENT LIABILITIES
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2,395
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3,523
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NON-CURRENT LIABILITIES:
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Long-term operating lease liability
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334
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368
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Related Party Promissory Note
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2,993
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2,961
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TOTAL NON-CURRENT LIABILITIES
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$
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3,327
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$
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3,329
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TOTAL LIABILITIES
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$
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5,722
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$
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6,852
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SHAREHOLDERS' EQUITY (CAPITAL DEFICIENCY):
Ordinary shares ($0.0009 par value per share, 22,222,222 shares authorized as of March
31, 2025 and December 31, 2024; 8,691,971* and 1,848,711* shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively)
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8
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2
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Additional paid-in capital
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47,567
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39,263
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Accumulated deficit
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(44,989
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)
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(43,254
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)
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TOTAL SHAREHOLDERS' EQUITY (CAPITAL DEFICIENCY)
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$
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2,586
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$
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(3,989
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)
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TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY (CAPITAL DEFICIENCY)
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$
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8,308
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$
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2,863
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Three months ended
March 31
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2025
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2024
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U.S. dollars in thousands
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OPERATING EXPENSES:
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Research and development (including $0 and $17 from related parties for the three
months period ended March 31, 2025 and 2024, respectively)
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$
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590
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$
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961
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General and administrative (including $21 and $12 from related parties for the three
months period ended March 31, 2025 and 2024, respectively)
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1,060
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289
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TOTAL OPERATING EXPENSES
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1,650
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1,250
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OPERATING LOSS
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Financial expenses, net (including $32 and $75 from related parties for the three months period ended March 31, 2025 and 2024,
respectively)
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85
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168
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LOSS BEFORE INCOME TAX
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$
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1,735
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$
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1,418
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INCOME TAX
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*
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5
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NET LOSS
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$
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1,735
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$
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1,423
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Attributable to:
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Equity holders of the Company
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1,735
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1,373
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Non-controlling interests
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-
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50
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$
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1,735
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$
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1,423
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LOSS PER SHARE, BASIC AND DILUTED
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$
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0.26
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$
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12.29**
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WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES OUTSTANDING USED IN
COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE
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6,779,205
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111,726**
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