Full Press Release Details
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, Nov. 12, 2025 (GLOBE NEWSWIRE) -- 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:
Financial Results for the Nine Months Ended September 30, 2025:
Balance Sheet Highlights:
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
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.
Company Contact:Silexion Therapeutics CorpMs. Mirit Horenshtein Hadar, CFOmirit@silexion.com
Investor Contact:Arx Investor RelationsNorth American Equities Desksilexion@arxhq.com
| SILEXION THERAPEUTICS CORPUNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS | ||
| September 30, 2025 | December 31, 2024 | |
| U.S. dollars in thousands | ||
| Assets | ||
| CURRENT ASSETS: | ||
| Cash and cash equivalents | $9,243 | $1,187 |
| Restricted cash | 26 | 35 |
| Prepaid expenses | 1,739 | 966 |
| Other current assets | 47 | 62 |
| TOTAL CURRENT ASSETS | 11,055 | 2,250 |
| NON-CURRENT ASSETS: | ||
| Restricted cash | 55 | 48 |
| Long-term deposit and other non-current assets | 36 | 5 |
| Property and equipment, net | 26 | 30 |
| Operating lease right-of-use asset | 442 | 530 |
| TOTAL NON-CURRENT ASSETS | 559 | 613 |
| TOTAL ASSETS | $11,614 | $2,863 |
| SILEXION THERAPEUTICS CORPUNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS | ||
| September 30, 2025 | December 31, 2024 | |
| U.S. dollars in thousands | ||
| Liabilities and shareholders’ equity (capital deficiency) | ||
| CURRENT LIABILITIES: | ||
| Trade payables | $946 | $929 |
| Current maturities of operating lease liability | 174 | 158 |
| Employee related obligations | 721 | 642 |
| Accrued expenses and other account payable | 945 | 788 |
| Private warrants to purchase ordinary shares (including $* and $1 due to related party, as of September 30, 2025 and December 31, 2024, respectively) | * | 2 |
| Underwriters Promissory Note | - | 1,004 |
| TOTAL CURRENT LIABILITIES | 2,786 | 3,523 |
| NON-CURRENT LIABILITIES: | ||
| Long-term operating lease liability | 311 | 368 |
| Related Party Promissory Note | 1,540 | 2,961 |
| TOTAL NON-CURRENT LIABILITIES | $1,851 | $3,329 |
| TOTAL LIABILITIES | $4,637 | $6,852 |
| SHAREHOLDERS' EQUITY (CAPITAL DEFICIENCY): | ||
| 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) | 42 | 2 |
| Additional paid-in capital | 57,689 | 39,263 |
| Accumulated deficit | (50,754) | (43,254) |
| TOTAL SHAREHOLDERS' EQUITY (CAPITAL DEFICIENCY) | $6,977 | $(3,989) |
| TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY (CAPITAL DEFICIENCY) | $11,614 | $2,863 |
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** Net of 28 treasury shares held by the Company as of December 31, 2024
SILEXION THERAPEUTICS CORPUNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
| Nine months ended September 30 | Three months ended September 30 | |||
| 2025 | 2024 | 2025 | 2024 | |
| U.S. dollars in thousands | U.S. dollars in thousands | |||
| OPERATING EXPENSES: | ||||
| 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) | $3,765 | $4,944 | $2,157 | $3,217 |
| 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) | 3,461 | 5,727 | 1,135 | 4,819 |
| TOTAL OPERATING EXPENSES | 7,226 | 10,671 | 3,292 | 8,036 |
| OPERATING LOSS | 7,226 | 10,671 | 3,292 | 8,036 |
| 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) | 271 | 4,092 | (30) | 3,822 |
| LOSS BEFORE INCOME TAX | $7,497 | $14,763 | $3,262 | $11,858 |
| INCOME TAX | 3 | 9 | - | 2 |
| NET LOSS | $7,500 | $14,772 | $3,262 | $11,860 |
| Attributable to: | ||||
| Equity holders of the Company | 7,500 | 14,696 | 3,262 | 11,851 |
| Non-controlling interests | - | 76 | - | 9 |
| Total | $7,500 | $14,772 | $3,262 | $11,860 |
| LOSS PER SHARE, BASIC AND DILUTED | $10.36 | $754.85 | $2.88 | $274.25 |
| WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE* | 723,886 | 19,469 | 1,132,658 | 43,213 |
* 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