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): March 18, 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: March 18, 2025
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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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Merger Completion: On August 15, 2024, Silexion completed its
business combination with Moringa Acquisition Corp, becoming a publicly traded company on Nasdaq under the ticker “SLXN.” This strategic milestone provides Silexion with greater access to capital to advance its clinical pipeline
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Clinical Program Progress: The Company's first-generation
candidate, LODER™, has previously demonstrated promise in clinical settings for non-resectable pancreatic cancer. As previously reported on September 24, 2024, the Phase 2 trial of LODER showed a 56% objective response rate (ORR) in
patients with KRAS G12D/V mutations, with tumor resectability improving to 67% for some non-resectable cases. The trial data underscore LODER’s potential to improve surgical outcomes and overall survival for patients with locally advanced
pancreatic cancer (LAPC).
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Significant Preclinical Advancements for SIL204: As previously
reported, SIL204 exhibited a marked reduction in tumor growth following systemic administration in preclinical pancreatic cancer models. The latest SIL204-microparticle optimized extended-release formulation was shown to inhibit tumor
growth and induce necrosis of the human pancreatic cell line bearing the KRAS G12D mutation xenotransplanted into mice. Since then, Silexion has continued to make significant preclinical advancements. In January 2025, data confirmed that a
single systemic dose of SIL-204 maintained effective drug levels for over 56 days, supporting its potential for long-term therapeutic exposure. Building on this progress, February 2025 marked the completion of Silexion’s first study in
orthotopic pancreatic cancer models, which better simulate human disease progression. March 2025 results confirmed that systemically administered SIL-204 significantly reduced both primary tumor burden and metastatic spread to secondary
organs, including the liver, intestine, spleen, and stomach.
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Advancing Toward SIL204 Clinical Trials: As previously reported
on October 1, 2024, Silexion is preparing SIL204 for toxicology studies, with plans to initiate Phase 2/3 clinical trials by the first half of 2026, targeting LAPC.
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Exploring Colorectal Cancer Applications: In parallel, the
Company plans to initiate preclinical studies for SIL204 in colorectal cancer models, expanding its potential applications across additional KRAS-driven cancers, as previously reported on October 1, 2024.
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Board Appointments: In December 2024, Prof. Amnon Peled was
appointed to the Board of Directors. Prof. Peled is a renowned expert in cancer therapeutics and a globally recognized scientific authority who has been involved in multiple successful publicly traded bio-pharma companies.
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Strengthened Financial Position: During 2024, the Company
utilized its Equity Line of Credit (ELOC), raising approximately $3.1 million in net proceeds to support its development and growth. Notably, after the reporting date, Silexion successfully received further funding through a previously
announced priced offering, a warrant inducement transaction, and warrant exercises, together totaling approximately $9.1 million in gross proceeds (approximately $7.9 million net of transaction costs), extending the Company's operational
runway.
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Cash Position: Cash and cash equivalents as of December 31,
2024, were $1.2 million, compared to $4.6 million as of December 31, 2023. The decrease reflects ongoing operational expenses and strategic investments in clinical development. Since the reporting date, the Company has successfully received
further funding through a previously announced priced offering, warrant inducement transaction, and warrant exercises, together totaling approximately $9.1 million in gross proceeds (approximately $7.9 million net of transaction costs).
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Operating Expenses: Total operating expenses for 2024 were $12.6 million, compared to $4.7 million in 2023. This increase includes significant one-time expenses related to the business combination and becoming a
public company, including, among others, $5.8 million in share-based compensation associated with the business combination. Research and development expenses increased by $2.1 million to $5.8 million (compared to $3.7 million in 2023),
primarily due to $2.3 million in one-time non-cash share-based compensation expenses related to employee grants issued at the time of the business combination in August 2024, and a $0.3 million increase in payroll expenses, partially offset
by a $0.6 million decrease in subcontractors and consultants expenses. General and administrative expenses increased by $5.8 million to $6.8 million (compared to $1.0 million in 2023), with $3.4 million attributable to one-time non-cash
share-based compensation, $1.2 million in one-time professional services costs for legal, accounting, and other expenses directly associated with becoming a public company, and $0.9 million in increased payroll expenses. Additionally, in
March 2025, the Company entered into an agreement to retire a promissory note through a combination of cash and share issuances, and completed the retirement of the promissory note on March 18, 2025.
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Financial Expenses: Financial expenses, net for 2024 were $3.9
million, compared to $0.4 million in 2023, an increase of $3.5 million. This increase was primarily driven by a one-time loss of $4.8 million upon entering the business combination , partially offset by a $1.2 million increase in
revaluation income from financial instruments (warrants, promissory notes and ELOC).
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Net Loss: Net loss for 2024 was $16.5 million, compared to $5.1
million in 2023. This increase was primarily driven by higher general and administrative expenses (including a significant increase in non-cash share-based compensation in the amount of $5.7 million), increased research and development
investments, and one-time financial expenses of $4.8 million related to the Company's business combination and transition to a public entity.
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December 31
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2023
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Assets
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CURRENT ASSETS:
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Cash and cash equivalents
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$
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1,187
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$
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4,595
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Restricted cash
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35
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25
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Prepaid expenses
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966
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335
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Other current assets
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62
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24
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TOTAL CURRENT ASSETS
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2,250
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4,979
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NON-CURRENT ASSETS:
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Restricted cash
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48
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25
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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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30
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49
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Operating lease right-of-use asset
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530
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198
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TOTAL NON-CURRENT ASSETS
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613
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277
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TOTAL ASSETS
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$
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2,863
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$
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5,256
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December 31
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2024
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2023
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Liabilities and redeemable convertible preferred shares, net of capital deficiency
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CURRENT LIABILITIES:
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Trade payables
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$
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929
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$
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319
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Current maturities of operating lease liability
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158
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112
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Warrants to preferred shares (including $0 and $186 due to related party, as of
December 31, 2024 and December 31, 2023, respectively)
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-
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200
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Employee related obligations
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642
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207
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Accrued expenses and other accounts payable
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788
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1,358
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Private warrants to purchase ordinary shares (including $1 and $0 due to related
party, as of December 31, 2024 and December 31, 2023, respectively)
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2
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-
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Underwriters Promissory Note
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1,004
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-
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TOTAL CURRENT LIABILITIES
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3,523
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2,196
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NON-CURRENT LIABILITIES:
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Long-term operating lease liability
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368
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59
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Related Party Promissory Note
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2,961
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-
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TOTAL NON-CURRENT LIABILITIES
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$
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3,329
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$
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59
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TOTAL LIABILITIES
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$
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6,852
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$
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2,255
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COMMITMENTS AND CONTINGENT LIABILITIES
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REDEEMABLE CONVERTIBLE PREFERRED SHARES AND NON-CONTROLLING
INTERESTS:
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Convertible Series A Preferred Shares (NIS 0.09 par value, 0 and 56,667 shares
authorized as of December 31, 2024 and 2023, 0 and 43,121 shares issued and outstanding as of December 31, 2024 and 2023);
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Convertible Series A-1 Preferred Shares (NIS 0.09 par value per share, 0 and 13,334
shares authorized as of December 31, 2024 and 2023, 0 and 10,136 shares issued and outstanding as of December 31, 2024 and 2023);
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Convertible Series A-2 Preferred Shares (NIS 0.09 par value per share, 0 and 22,223
shares authorized as of December 31, 2024 and 2023, 0 and 5,051 shares issued and outstanding as of December 31, 2024 and 2023);
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Convertible Series A-3 Preferred Shares (NIS 0.09 par value per share, 0 and 8,889
shares authorized as of December 31, 2024 and 2023, 0 and 7,037 shares issued and outstanding as of December 31, 2024 and 2023);
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Convertible Series A-4 Preferred Shares (NIS 0.09 par value per share 0 and 90,556 and
shares authorized as of December 31, 2024 and 2023, respectively 0 and 2,413** shares issued and outstanding as of December 31, 2024 and 2023, respectively);
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TOTAL REDEEMABLE CONVERTIBLE PREFERRED SHARES
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15,057
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CONTINGENTLY REDEEMABLE NON-CONTROLLING INTERESTS
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3,420
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TOTAL REDEEMABLE CONVERTIBLE PREFERRED SHARES AND CONTINGENTLY
REDEEMABLE NON-CONTROLLING INTERESTS
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$
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-
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$
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18,477
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CAPITAL DEFICIENCY:
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Ordinary shares ($0.0009 par value per share, 22,222,222 shares authorized as of
December 31, 2024 and 2023; 1,848,711*** and 97,120 shares issued and outstanding as of December 31, 2024 and 2023, respectively)
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2
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*
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Additional paid-in capital
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39,263
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11,335
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Accumulated deficit
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(43,254
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)
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(26,811
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)
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TOTAL CAPITAL DEFICIENCY
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$
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(3,989
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)
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$
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(15,476
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)
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TOTAL REDEEMABLE CONVERTIBLE PREFERRED SHARES AND CONTINGENTLY REDEEMABLE NON-CONTROLLING INTERESTS, NET OF
CAPITAL DEFICIENCY
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$
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(3,989
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)
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$
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3,001
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TOTAL LIABILITIES, REDEEMABLE CONVERTIBLE PREFERRED SHARES AND NON-CONTROLLING INTEREST, NET
OF CAPITAL DEFICIENCY
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$
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2,863
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$
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5,256
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Year ended December 31
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OPERATING EXPENSES:
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Research and development (including $1,796 and $69 from related party, for the year
ended December 31, 2024 and December 31, 2023, respectively)
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$
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5,815
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$
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3,708
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General and administrative (including $2,972 and $48 from related party, for the year
ended December 31, 2024 and December 31, 2023, respectively)
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6,756
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973
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TOTAL OPERATING EXPENSES
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12,571
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4,681
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OPERATING LOSS
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12,571
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4,681
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Financial expenses (income), net (including $(1,249) and $83 from related party, for the year ended December 31, 2024 and
December 31, 2023, respectively)
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3,938
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395
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LOSS BEFORE INCOME TAX
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$
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16,509
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$
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5,076
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INCOME TAX
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10
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32
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NET LOSS FOR THE YEAR
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$
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16,519
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$
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5,108
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Attributable to:
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Equity holders of the Company
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16,443
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4,942
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Non-controlling interests
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76
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166
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$
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16,519
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$
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5,108
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LOSS PER ORDINARY SHARE, BASIC AND DILUTED*
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$
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26.36
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$
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44.23
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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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623,846
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111,726
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