SLXN 8-K
Silexion Therapeutics Corp (SLXN)
8-K
2025-11-12
For: 2025-11-12
View Original
Added on
April 06, 2026
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant
to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of report (Date of earliest event reported):
(Exact name of registrant as specified in its charter)
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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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(Address of principal executive offices)
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(Zip Code)
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-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
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Trading Symbol(s)
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Name of each exchange on which registered
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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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On November 12, 2025, Silexion Therapeutics Corp issued a press release announcing its financial results for the
third quarter ended September 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.
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Item 9.01
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Financial Statements and Exhibits
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(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.
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SILEXION THERAPEUTICS CORP
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Date: November 12, 2025
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By:
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/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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Exhibit 99.1
Silexion Therapeutics Reports Third Quarter 2025 Financial Results and Provides Business
Update
Continued advancement toward Phase 2/3 clinical trial initiation, on track for the first half of
2026
New preclinical data demonstrated SIL204’s exceptional efficacy across multiple human cancer
cell lines, highlighting potential effectiveness against five KRAS-driven cancer types
Successfully raised over $9 million during the third quarter, significantly strengthening the
Company’s balance sheet
GRAND CAYMAN, Cayman Islands, November 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 third quarter ended September 30, 2025, and provided an update on recent business developments.
Recent Milestones & Business Highlights:
Clinical Trial Preparation On Track:
Silexion continues to advance operational readiness for its planned Phase 2/3 clinical trials of SIL204, with toxicology studies progressing as planned. Regulatory submissions are expected to be filed with the Israel Ministry of Health in Q4 2025
and in Germany and in the European Union in Q1 2026, with clinical trial initiation anticipated in the first half of 2026.
Strong Preclinical Results Across
Multiple Cancer Types: The Company continues to accumulate positive efficacy preclinical data in various KRAS-driven cancers, further supporting the
potential of SIL204 as a platform technology for these oncogene-driven cancers. Silexion announced that SIL204 successfully killed cancer cells across five different cancer types with very high effectiveness. The drug worked against eight different
cancer-causing mutations, including the most common ones found in pancreatic, lung, and colorectal cancers. Importantly, this included the first evidence that SIL204 works in gastric (stomach) cancer. These results demonstrate SIL204's potential to
treat a wide range of KRAS-driven cancers with a single therapy.
CRO Partnership to Support the Phase 2/3
Trials: In September 2025, Silexion announced that it had selected AMS Advanced Medical Services GmbH
as its contract research organization (CRO) to support the upcoming Phase 2/3 clinical trials for SIL204. AMS brings over 28 years of oncology clinical development and regulatory experience, including management of Phase 3 trials in
pancreatic cancer. This partnership covers regulatory strategy, clinical trial design, and data management to advance Silexion’s dual-route administration approach combining intratumoral and systemic delivery methods.
Capital Raises Significantly Strengthen
Balance Sheet: During the third quarter, Silexion completed a public offering and received additional proceeds from warrant exercises, raising approximately $9.5 million in gross proceeds. These transactions, together with cost discipline and balance-sheet optimization, increased cash and cash equivalents to $9.2 million as of September 30, 2025, up from $3.5 million at June 30, 2025. In light of the foregoing transactions, together with a partial promissory note conversion, the Company’s shareholders’ equity rose to $7.0 million, a substantial improvement from a capital deficiency of $4.0 million at year-end 2024.
Regaining Nasdaq Listing Compliance:
Following the Nasdaq hearings panel decision in July 2025, Silexion successfully demonstrated compliance with Nasdaq’s minimum bid price and shareholders’ equity requirements. On September 23, 2025, Nasdaq confirmed that the Company had regained
full compliance with Listing Rules 5550(a)(2) and 5550(b)(1), securing continued listing on the Nasdaq Capital Market.
Ilan Hadar, Chairman and Chief Executive
Officer of Silexion, commented: “The third quarter marked a period of strong scientific progress and continued operational momentum for Silexion. With new preclinical data demonstrating SIL204’s exceptional efficacy across a broad range
of KRAS mutations and multiple cancer types, we are entering the next phase of development with great confidence. The selection of a CRO partner and the successful completion of additional financing further strengthen our readiness to initiate
Phase 2/3 clinical trials in the first half of 2026. Our focus now is on completing regulatory submissions in Israel and the EU and advancing toward the clinic with the same precision and discipline that have defined our progress to date.”
Mirit Horenshtein Hadar, Chief Financial
Officer of Silexion, added: “Our financial results for the third quarter reflect meaningful improvement in both our balance sheet and operating efficiency. The successful $9.5 million of financings completed during the quarter
significantly increased our cash position and shareholders’ equity, contributing to maintaining our Nasdaq listing. We believe our strengthened capital structure and financial discipline provide a solid foundation to support us as we advance
towards our upcoming regulatory and clinical milestones.”
Financial Results for the Three Months Ended September 30, 2025:
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Research and Development (R&D) Expenses for the three months ended September 30, 2025, were $2.2 million, compared to $3.2 million for the same period in 2024, a decrease of 31.3%, primarily due to the absence in the current year
period of $2.4 million in non-cash share-based compensation expenses recorded in the prior-year period (associated with grants issued during the August
2024 Business Combination), partially offset by increased subcontractor costs of approximately $1.3 million related to API manufacturing activities and formulation development as the development program advances.
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General and
Administrative (G&A) Expenses for the three months ended September 30, 2025, were $1.1 million,
compared to $4.8 million for the same period in 2024, a decrease of 77.1%, mainly attributable to the absence of $3.4 million in non-cash share-based compensation expenses
recognized in the prior-year period in connection with grants issued during the August 2024 Business Combination.
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Net loss for the three months ended September 30, 2025, was $3.3
million, or ($2.88) per share, compared to a net loss of $11.9 million,
or ($274.25) per share, for the same period in 2024, representing a decrease of approximately 72.3%. The improvement was mainly attributable to the absence of significant one-time costs and expenses related to the August 2024 Business Combination and the Company’s transition to a public company,
including share-based compensation, transaction, and financial expenses.
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Financial Results for the Nine Months Ended September 30, 2025:
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Research and
Development (R&D) Expenses for the nine months ended September 30, 2025, were $3.8 million,
compared to $4.9 million for the same period in 2024, a decrease of 22.4%,
primarily due to the absence of non-cash share-based compensation expenses recognized in the prior-year period in connection with grants issued during the August 2024 Business Combination partially offset by higher subcontractor costs
related to API manufacturing activities and formulation development as the development program advanced.
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General and
Administrative (G&A) Expenses for the nine months ended September 30, 2025, were $3.5 million,
compared to $5.7 million for the same period in 2024, a decrease of 38.6%, mainly reflecting the absence of non-cash share-based compensation expenses and transaction costs recognized in the prior-year period in connection with grants issued during the August 2024
Business Combination. This decrease was partially offset by higher professional services costs including director compensation, legal and other expenses associated with the transition to a public company subsequent to the
Closing of the Business Combination, and more.
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Net loss for the nine months ended September 30, 2025, was $7.5 million,
or ($10.36) per share, compared to a net loss of $14.8 million, or ($754.85) per share, for the same period in 2024, representing a decrease of 49.3%.
The reduction was mainly due to lower share-based compensation expenses and the absence of significant one-time costs and expenses related to the August 2024 Business Combination, including transaction and financial expenses.
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Balance Sheet Highlights:
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As of September 30, 2025, Silexion had cash and cash equivalents of
$9.2 million, compared to $1.2 million as of December 31, 2024. This significant increase reflects the successful completion of public offerings and
warrant exercises during 2025, which substantially strengthened the Company’s balance sheet and support its continued advancement toward regulatory submissions and Phase 2/3 clinical trial initiation.
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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 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: https://silexion.com
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: 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 Silexion’s business strategy, preclinical study results and development plans for SIL204, its anticipated mutation coverage and therapeutic potential across multiple cancer types, the expected timing of regulatory submissions to the Israel Ministry of Health and the European Union, the planned initiation of Phase 2/3 clinical trials in the first half of 2026, future capital-raising and operational readiness activities, and the overall potential of SIL204 as a pan-KRAS RNAi therapeutic candidate, 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 with the SEC by the Company, 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.
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 study results and development plans for SIL204, its anticipated mutation coverage and therapeutic potential across multiple cancer types, the expected timing of regulatory submissions to the Israel Ministry of Health and the European Union, the planned initiation of Phase 2/3 clinical trials in the first half of 2026, future capital-raising and operational readiness activities, and the overall potential of SIL204 as a pan-KRAS RNAi therapeutic candidate, 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 with the SEC by the Company, 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.
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SILEXION THERAPEUTICS CORP
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS |
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September 30, 2025
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December 31, 2024
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U.S. dollars in thousands
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||||||||
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Assets
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||||||||
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CURRENT ASSETS:
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Cash and cash equivalents
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$
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9,243
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$
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1,187
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Restricted cash
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26
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35
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Prepaid expenses
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1,739
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966
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Other current assets
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47
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62
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TOTAL CURRENT ASSETS
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11,055
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2,250
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NON-CURRENT ASSETS:
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Restricted cash
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55
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48
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Long-term deposit and other non-current assets
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36
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5
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Property and equipment, net
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26
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30
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Operating lease right-of-use asset
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442
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530
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TOTAL NON-CURRENT ASSETS
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559
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613
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TOTAL ASSETS
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$
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11,614
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$
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2,863
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SILEXION THERAPEUTICS CORP
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS |
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September 30, 2025
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December 31, 2024
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U.S. dollars in thousands
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||||||||
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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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946
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$
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929
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Current maturities of operating lease liability
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174
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158
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Employee related obligations
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721
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642
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Accrued expenses and other account payable
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945
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788
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Private warrants to purchase ordinary shares (including $* and $1 due to related party, as of September 30, 2025 and December 31,
2024, respectively)
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*
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2
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Underwriters Promissory Note
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-
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1,004
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TOTAL CURRENT LIABILITIES
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2,786
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3,523
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NON-CURRENT LIABILITIES:
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Long-term operating lease liability
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311
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368
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Related Party Promissory Note
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1,540
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2,961
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TOTAL NON-CURRENT LIABILITIES
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$
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1,851
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$
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3,329
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TOTAL LIABILITIES
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$
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4,637
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$
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6,852
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SHAREHOLDERS' EQUITY (CAPITAL DEFICIENCY):
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Ordinary shares ($0.0135 par value per share, 9,000,000 and 1,481,482 shares authorized as of September 30, 2025 and December 31,
2024, respectively; 3,126,642 and 123,290** shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively)
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42
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2
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Additional paid-in capital
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57,689
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39,263
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Accumulated deficit
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(50,754
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)
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(43,254
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)
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TOTAL SHAREHOLDERS' EQUITY (CAPITAL DEFICIENCY)
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$
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6,977
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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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11,614
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$
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2,863
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All share amounts have been retroactively adjusted to reflect a 1-for-15 reverse share split as
discussed in Note 1(g) to the Company’s condensed consolidated financial statements included in the Company’s quarterly report on Form 10-Q for the quarter ended September 30, 2025
* Represents an amount less than $1
* 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
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
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Nine months ended September 30
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Three months ended September 30
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|||||||||||||||
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2025
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2024
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2025
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2024
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U.S. dollars in thousands
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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 $1,796 from related party for the nine months period ended September 30, 2025 and
2024, respectively, and including $0 and $1,762 from related party for the three months period ended September 30, 2025 and 2024, respectively)
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$
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3,765
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$
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4,944
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$
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2,157
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$
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3,217
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General and administrative (including $96 and $2,972 from related party for the nine months period ended September 30, 2025 and
2024, respectively, and including $38 and $2,948 from related party for the three months period ended September 30, 2025 and 2024, respectively)
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3,461
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5,727
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1,135
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4,819
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TOTAL OPERATING EXPENSES
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7,226
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10,671
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3,292
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8,036
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OPERATING LOSS
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7,226
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10,671
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3,292
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8,036
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Financial expenses (income), net (including $203 and $(47) from related party for the nine months period ended September 30, 2025
and 2024, respectively, and including $)26( and $(182) from related party for the three months period ended September 30, 2025 and 2024, respectively)
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271
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4,092
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(30
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)
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3,822
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LOSS BEFORE INCOME TAX
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$
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7,497
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$
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14,763
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$
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3,262
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$
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11,858
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INCOME TAX
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3
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9
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-
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2
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||||||||||||
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NET LOSS
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$
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7,500
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$
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14,772
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$
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3,262
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$
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11,860
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Attributable to:
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||||||||||||||||
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Equity holders of the Company
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7,500
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14,696
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3,262
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11,851
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Non-controlling interests
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-
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76
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-
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9
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||||||||||||
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Total
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$
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7,500
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$
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14,772
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$
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3,262
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$
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11,860
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LOSS PER SHARE, BASIC AND DILUTED
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$
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10.36
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$
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754.85
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$
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2.88
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$
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274.25
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||||||||
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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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723,886
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19,469
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1,132,658
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43,213
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* All share amounts have been retroactively adjusted to reflect a 1-for-15 reverse share splits as discussed in
Note 1(g) to the Company’s condensed consolidated financial statements included in the Company’s quarterly report on Form 10-Q for the quarter ended September 30, 2025