New data in human cancer cell lines provides confirmation of pan-KRAS mutation inhibition with inhibition of G12D, G12V, G12R, G12C, G13C, G12A, Q61H, and G13D mutations Company Reports first evidence of gastric cancer activity expands potential therapeutic reach of SIL204 GRAND CAYMAN, Cayman Islands, Sept. 30, 2025 (GLOBE NEWSWIRE) -- Silexion Therapeutics Corp. (NASDAQ: SLXN) ("Silexion" or the "Company"), a clinical-stage biotechnology company pioneering RNA interference (RNAi) therapies for KRAS-driven ...

Company Successfully Meets Both Minimum Bid Price and Shareholders' Equity Requirements, Securing Continued Listing on the Nasdaq Capital MarketGRAND CAYMAN, Cayman Islands, Sept. 25, 2025 (GLOBE NEWSWIRE) -- Silexion Therapeutics Corp. (NASDAQ: SLXN) ("Silexion" or the "Company"), a clinical-stage biotechnology company pioneering RNA interference (RNAi) therapies for KRAS-driven cancers, today announced that it has received written notification from The Nasdaq Stock Market LLC ("Nasdaq") confirming that th ...

Silexion Therapeutics Corp. SLXN stock is trading higher on Thursday, with a session volume of 16.87 million compared to the average volume of 74.2 thousand as per data from Benzinga Pro.The company released new preclinical data demonstrating that subcutaneously administered SIL204 successfully reaches all primary sites of pancreatic cancer metastasis and shows anti-tumor activity.The study evaluated SIL204’s biodistribution and therapeutic activity following subcutaneous administration in a metastatic panc ...

Core Viewpoint - Silexion Therapeutics Corp. has announced a public offering of 1,500,000 ordinary shares and accompanying warrants at a price of $4.00 per share, aiming to raise approximately $6.0 million to advance its pre-clinical studies and for general corporate purposes [1][2]. Group 1: Offering Details - The public offering includes 1,500,000 ordinary shares, series A warrants, and series B warrants, all priced at $4.00 per share [1]. - Series A warrants will have an exercise price of $4.00, exercisable immediately, and will expire five years from issuance [1]. - Series B warrants will also have an exercise price of $4.00, exercisable immediately, but will expire twelve months from issuance [1]. - The offering is expected to close on or about September 12, 2025, pending customary closing conditions [1]. Group 2: Financial Aspects - The gross proceeds from the offering are expected to be $6.0 million before deducting fees and expenses [2]. - The net proceeds will be utilized to advance pre-clinical studies and for general corporate purposes [2]. Group 3: Company Background - Silexion Therapeutics is focused on developing RNA interference therapies for KRAS-driven cancers, particularly targeting solid tumors with mutated KRAS oncogenes [5]. - The company has conducted a Phase 2a clinical trial for its first-generation product, showing a positive trend compared to chemotherapy alone [5]. - Silexion is committed to advancing therapeutic options in oncology, specifically for locally advanced pancreatic cancer [5].

New Positive Preclinical Data Shows Succesful Drug Distribution to Liver, Peritoneum, and Lung with Measurable Reductions in Tumor Burden at Clinically Relevant Doses Results Provide Further Validation of the Systemic Component of a Dual-Route Administration Strategy Enabeling Potential Targeting of Both Primary Tumors and Metastatic Disease Silexion Remains on Track for Phase 2/3 Trial Initiation in H1 2026 Following Planned Q4 2025 and Q1 2026 Regulatory Submissions GRAND CAYMAN, Cayman Islands, Sept. 1 ...

Core Insights - Silexion Therapeutics Corp has selected AMS Advanced Medical Services GmbH as its contract research organization (CRO) to support upcoming Phase 2/3 clinical trials for SIL204, a next-generation siRNA candidate targeting KRAS-driven solid tumor cancers [1][2][3] - The partnership is expected to enhance Silexion's regulatory submissions to the Israel Ministry of Health in Q4 2025 and to the European Union in Q1 2026, with trials commencing in the first half of 2026 [2][3] - SIL204 has demonstrated up to 97% inhibition rates in preclinical studies across various cancer models, including pancreatic, colorectal, and lung cancers [3][5] Company Overview - Silexion Therapeutics is a clinical-stage biotechnology company focused on developing RNA interference therapies for cancers driven by the mutated KRAS oncogene, which is prevalent in human cancers [6] - The company aims to advance its lead product candidate for locally advanced pancreatic cancer, building on positive trends observed in previous clinical trials [7] Clinical Development Strategy - The upcoming Phase 2/3 trial will evaluate SIL204's dual-route administration strategy, which combines intratumoral delivery to target primary tumors and systemic administration for metastatic disease [5] - Preclinical data supports the efficacy of SIL204 in significantly reducing both primary tumor growth and metastatic spread in relevant pancreatic cancer models [5] CRO Partnership - AMS brings over 28 years of experience in oncology clinical development and regulatory affairs, which is crucial for executing Silexion's clinical program effectively [2][4] - The collaboration will cover regulatory strategy, clinical trial design, site selection and management, and data analysis for the planned Phase 2/3 study [4]

Core Insights - Silexion Therapeutics Corp. is a clinical-stage biotechnology company focused on RNA interference therapies for KRAS-driven cancers [1][3] - The company will present at the 27th Annual H.C. Wainwright Global Investment Conference on September 10, 2025 [1][2] - Silexion's lead product candidate targets locally advanced pancreatic cancer and has shown positive trends in a Phase 2a clinical trial compared to chemotherapy alone [3] Company Presentation Details - The presentation is scheduled for September 10, 2025, at 2:00 PM ET [2] - An updated company presentation is available on Silexion's investor website [2] - Management will be available for one-on-one investor meetings during the conference [2] Company Background - Silexion Therapeutics is dedicated to developing innovative treatments for solid tumor cancers with mutated KRAS oncogenes, which are prevalent in human cancers [3] - The company aims to advance therapeutic options in oncology, particularly for patients with unsatisfactorily treated cancers [3]

[CERTAIN TERMS](index=3&type=section&id=CERTAIN%20TERMS) The company, Silexion Therapeutics Corp, completed a business combination on August 15, 2024, and defines key financial instruments and agreements - The company, Silexion Therapeutics Corp (formerly Biomotion Sciences), is a Cayman Islands exempted company, with its securities trading on Nasdaq following the August 15, 2024 Business Combination where Moringa and Silexion became wholly-owned subsidiaries of New Silexion[8](index=8&type=chunk) - Key agreements include the A&R Sponsor Promissory Note for **$3,433,000**, the ELOC Agreement with White Lion Capital, LLC, and the Marketing Agreement with EarlyBirdCapital, Inc[8](index=8&type=chunk) - Financial instruments include ordinary shares (**$0.0135 par value**), private warrants, public warrants, and general warrants[11](index=11&type=chunk) [SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS](index=4&type=section&id=SPECIAL%20NOTE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) This section highlights the presence of forward-looking statements concerning the company's future financial position, operations, and strategic objectives - The report contains forward-looking statements about the Company's financial position, business strategy, and future operations, identifiable by terms such as 'expect,' 'believe,' and 'anticipate'[10](index=10&type=chunk) - Forward-looking statements encompass expectations regarding Nasdaq listing, pre-clinical and clinical studies, regulatory approvals, market opportunity, and future capital requirements[11](index=11&type=chunk)[14](index=14&type=chunk) - Actual results may differ materially due to risks including limited operating history, absence of product sales revenue, the need for substantial additional funding, and the unproven nature of RNAi therapeutics for oncology[12](index=12&type=chunk)[14](index=14&type=chunk) [PART I - FINANCIAL INFORMATION](index=6&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) This section presents the company's unaudited condensed consolidated financial statements and management's discussion and analysis of financial condition and results of operations - Financial statements for comparative periods, such as June 30, 2024, reflect Silexion Therapeutics Ltd. as the accounting acquirer and predecessor entity before the August 15, 2024 Business Combination, and New Silexion subsequently[16](index=16&type=chunk) [Item 1. Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) This section provides the unaudited condensed consolidated financial statements for Silexion Therapeutics Corp, including balance sheets, statements of operations, statements of changes in equity, and cash flow statements, along with comprehensive notes explaining the accounting policies and specific financial details [Condensed Consolidated Balance Sheets (unaudited)](index=9&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20%28unaudited%29) This table presents the company's unaudited condensed consolidated balance sheets, detailing assets, liabilities, and shareholders' equity as of June 30, 2025, and December 31, 2024 Condensed Consolidated Balance Sheets (U.S. dollars in thousands) | Metric | June 30, 2025 | December 31, 2024 | Change (2025 vs 2024) | | :-------------------------------- | :-------------- | :---------------- | :-------------------- | | **Assets** | | | | | Cash and cash equivalents | $3,466 | $1,187 | +$2,279 | | Total Current Assets | $5,237 | $2,250 | +$2,987 | | Total Non-Current Assets | $560 | $613 | -$53 | | **TOTAL ASSETS** | **$5,797** | **$2,863** | **+$2,934** | | **Liabilities** | | | | | Total Current Liabilities | $2,150 | $3,523 | -$1,373 | | Total Non-Current Liabilities | $3,527 | $3,329 | +$198 | | **TOTAL LIABILITIES** | **$5,677** | **$6,852** | **-$1,175** | | **Shareholders' Equity (Capital Deficiency)** | | | | | Total Shareholders' Equity (Capital Deficiency) | $120 | $(3,989) | +$4,109 | [Condensed Consolidated Statements of Operations (unaudited)](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20%28unaudited%29) This table presents the company's unaudited condensed consolidated statements of operations, detailing revenues, expenses, and net loss for the six and three months ended June 30, 2025 and 2024 Condensed Consolidated Statements of Operations (U.S. dollars in thousands) | Metric | Six months ended June 30, 2025 | Six months ended June 30, 2024 | Three months ended June 30, 2025 | Three months ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | :------------------------------- | :------------------------------- | | Research and development | $1,608 | $1,727 | $1,018 | $766 | | General and administrative | $2,326 | $908 | $1,266 | $619 | | **TOTAL OPERATING EXPENSES** | **$3,934** | **$2,635** | **$2,284** | **$1,385** | | **OPERATING LOSS** | **$3,934** | **$2,635** | **$2,284** | **$1,385** | | Financial expenses, net | $301 | $270 | $216 | $102 | | **LOSS BEFORE INCOME TAX** | **$4,235** | **$2,905** | **$2,500** | **$1,487** | | Income tax | $3 | $7 | $3 | $2 | | **NET LOSS** | **$4,238** | **$2,912** | **$2,503** | **$1,489** | | LOSS PER SHARE, BASIC AND DILUTED | $8.21 | $381.09 | $4.32 | $197.80 | | WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES OUTSTANDING | 516,110 | 7,466 | 579,523 | 7,442 | [Condensed Consolidated Statements of Changes in Redeemable Convertible Preferred Shares and Shareholders' Equity (Capital Deficiency) (unaudited)](index=12&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Redeemable%20Convertible%20Preferred%20Shares%20and%20Shareholders%27%20Equity%20%28Capital%20Deficiency%29%20%28unaudited%29) This section outlines the changes in the company's redeemable convertible preferred shares and shareholders' equity (or capital deficiency) for the six months ended June 30, 2025 Changes in Shareholders' Equity (Capital Deficiency) (U.S. dollars in thousands) | Metric | Balance at Jan 1, 2025 | Issuance of ordinary shares and warrants | Exercise of warrants | Issuance of ordinary shares and warrants upon inducement | Share-based compensation | Conversion of EarlyBird Promissory Note | Net loss | Balance at June 30, 2025 | | :-------------------------------- | :--------------------- | :------------------------------------- | :------------------- | :------------------------------------------------ | :----------------------- | :------------------------------------ | :------- | :----------------------- | | Ordinary shares | $2 | $3 | $3 | $2 | $* | $* | - | $8 | | Additional paid-in capital | $39,263 | $4,252 | $863 | $2,812 | $58 | $356 | - | $47,604 | | Accumulated deficit | $(43,254) | - | - | - | - | - | $(4,238) | $(47,492) | | **TOTAL SHAREHOLDERS' EQUITY (CAPITAL DEFICIENCY)** | **$(3,989)** | **$4,255** | **$864** | **$2,814** | **$58** | **$356** | **$(4,238)** | **$120** | - Total shareholders' equity improved from a **$(3,989) thousand deficiency** at January 1, 2025, to a **positive $120 thousand** at June 30, 2025, primarily due to public offerings, warrant exercises, and inducement transactions[30](index=30&type=chunk) [Condensed Consolidated Statements of Cash Flows (unaudited)](index=14&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20%28unaudited%29) This table presents the company's unaudited condensed consolidated statements of cash flows, categorizing cash activities for the six and three months ended June 30, 2025 and 2024 Condensed Consolidated Statements of Cash Flows (U.S. dollars in thousands) | Cash Flow Activity | Six months ended June 30, 2025 | Six months ended June 30, 2024 | Three months ended June 30, 2025 | Three months ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | :------------------------------- | :------------------------------- | | Net cash used in operating activities | $(4,960) | $(2,817) | $(2,507) | $(1,065) | | Net cash used in investing activities | $(7) | $(6) | $(1) | $0 | | Net cash provided by (used in) financing activities | $7,237 | $* | $(195) | $0 | | **INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS AND RESTRICTED CASH** | **$2,270** | **$(2,823)** | **$(2,703)** | **$(1,065)** | | Balance at beginning of period | $1,270 | $4,645 | $6,233 | $2,831 | | **BALANCE AT END OF PERIOD** | **$3,544** | **$1,747** | **$3,544** | **$1,747** | - Cash and cash equivalents and restricted cash increased by **$2,270 thousand** for the six months ended June 30, 2025, primarily from **$7,237 thousand in financing activities**, offsetting **$4,960 thousand in operating cash outflows**[37](index=37&type=chunk)[175](index=175&type=chunk) [Notes to Condensed Consolidated Financial Statements (unaudited)](index=16&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements%20%28unaudited%29) This section provides detailed explanations and disclosures for the unaudited condensed consolidated financial statements, covering accounting policies, specific transactions, and financial instrument valuations [NOTE 1 - GENERAL](index=16&type=section&id=NOTE%201%20-%20GENERAL) This note provides general information about Silexion Therapeutics Corp, including its formation, Nasdaq listing, and going concern considerations - Silexion Therapeutics Corp (New Silexion) was formed for the Business Combination on August 15, 2024, operating as a publicly-traded holding company for Silexion Therapeutics Ltd., the accounting acquirer[44](index=44&type=chunk) - The company's ordinary shares and warrants are listed on the Nasdaq Global Market under the symbols 'SLXN' and 'SLXNW'[44](index=44&type=chunk) - The company incurred **losses of $4,238 thousand** for the six months ended June 30, 2025, and **$16,519 thousand** for the year ended December 31, 2024, alongside **negative operating cash flows of $4,960 thousand** for the six months ended June 30, 2025[47](index=47&type=chunk) - Management has concluded there is substantial doubt about the Company's ability to continue as a going concern for at least 12 months from the financial statements' issuance date, owing to ongoing losses and negative cash flows[49](index=49&type=chunk) [NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES](index=17&type=section&id=NOTE%202%20-%20SIGNIFICANT%20ACCOUNTING%20POLICIES) This note details the significant accounting policies used in preparing the unaudited interim condensed consolidated financial statements, including fair value measurements and recent accounting pronouncement adoptions - The unaudited interim condensed consolidated financial statements adhere to U.S. GAAP for interim reporting and SEC requirements, omitting some information typically found in annual statements[50](index=50&type=chunk) - Fair value measurements are classified into a three-level hierarchy, distinguishing between quoted prices (Level 1), observable prices (Level 2), and unobservable inputs (Level 3), to ensure consistency and comparability[57](index=57&type=chunk)[58](index=58&type=chunk) - The company adopted ASU 2022-03 'Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions' on January 1, 2025, without material impact on its consolidated financial statements[61](index=61&type=chunk) [NOTE 3 - SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION](index=20&type=section&id=NOTE%203%20-%20SUPPLEMENTARY%20FINANCIAL%20STATEMENT%20INFORMATION) This note provides detailed breakdowns of research and development expenses, general and administrative expenses, and financial expenses, net, for the reported periods Research and Development Expenses (U.S. dollars in thousands) | Expense Category | Six months ended June 30, 2025 | Six months ended June 30, 2024 | Three months ended June 30, 2025 | Three months ended June 30, 2024 | | :----------------------------- | :----------------------------- | :----------------------------- | :------------------------------- | :------------------------------- | | Payroll and related expenses | $854 | $476 | $485 | $216 | | Share-based compensation | $0 | $38 | $0 | $19 | | Subcontractors and consultants | $598 | $1,128 | $442 | $497 | | Rent and maintenance | $95 | $49 | $55 | $18 | | Other | $61 | $36 | $36 | $16 | | **Total R&D Expenses** | **$1,608** | **$1,727** | **$1,018** | **$766** | General and Administrative Expenses (U.S. dollars in thousands) | Expense Category | Six months ended June 30, 2025 | Six months ended June 30, 2024 | Three months ended June 30, 2025 | Three months ended June 30, 2024 | | :----------------------------- | :----------------------------- | :----------------------------- | :------------------------------- | :------------------------------- | | Payroll and related expenses | $739 | $280 | $407 | $151 | | Share-based compensation | $58 | $26 | $37 | $13 | | Professional services | $1,111 | $448 | $586 | $369 | | Depreciation | $7 | $15 | $3 | $7 | | Rent and maintenance | $85 | $72 | $55 | $46 | | Patent registration | $51 | $25 | $47 | $16 | | Travel expenses | $91 | $16 | $37 | $7 | | Other | $184 | $26 | $94 | $10 | | **Total G&A Expenses** | **$2,326** | **$908** | **$1,266** | **$619** | Financial Expenses, Net (U.S. dollars in thousands) | Expense Category | Six months ended June 30, 2025 | Six months ended June 30, 2024 | Three months ended June 30, 2025 | Three months ended June 30, 2024 | | :--------------------------------------------- | :----------------------------- | :----------------------------- | :------------------------------- | :------------------------------- | | Change in fair value of financial liabilities | $277 | $145 | $198 | $64 | | Interest income, net | $(34) | $(25) | $(43) | $(6) | | Foreign currency exchange loss, net | $55 | $148 | $61 | $42 | | Other | $3 | $2 | $0 | $2 | | **Total Financial Expense (Income), Net** | **$301** | **$270** | **$216** | **$102** | [NOTE 4 - WARRANTS TO PURCHASE PREFERRED SHARES](index=20&type=section&id=NOTE%204%20-%20WARRANTS%20TO%20PURCHASE%20PREFERRED%20SHARES) This note details the company's warrant transactions, including public offerings, pre-funded warrants, and induced warrant exercises, along with their financial impact - In January 2025, the Company completed a public offering, selling **143,067 ordinary shares** and **143,067 ordinary warrants**, plus **103,847 pre-funded warrants** and **103,847 ordinary warrants**, generating approximately **$5,000 thousand in gross proceeds**[65](index=65&type=chunk) - Pre-funded warrants were immediately exercisable at **$0.0015 per share**, while ordinary warrants were exercisable at **$20.25 per share** for a five-year term[66](index=66&type=chunk) - As of June 30, 2025, **42,683 investor warrants** and all **103,847 pre-funded warrants** were exercised, yielding **$864 thousand in proceeds**[70](index=70&type=chunk) - An induced warrant exercise on January 29, 2025, resulted in holders exercising **148,102 ordinary warrants** at **$20.25 per share**, generating approximately **$3,276 thousand in gross proceeds**, and receiving new ordinary warrants[71](index=71&type=chunk) [NOTE 5 - UNDERWRITERS PROMISSORY NOTE](index=21&type=section&id=NOTE%205%20-%20UNDERWRITERS%20PROMISSORY%20NOTE) This note describes the repayment and extinguishment of the Underwriters Promissory Note and the EarlyBird Convertible Promissory Note - During January 2025, the Company repaid **$158 thousand** of the Underwriters Promissory Note principal[74](index=74&type=chunk) - On March 13, 2025, the Company agreed with EarlyBird to extinguish the remaining **$880 thousand** outstanding principal and accrued interest of the Convertible Promissory Note for a **$551 thousand cash payment** and **18,519 Ordinary Shares**[74](index=74&type=chunk) [NOTE 6 - SHARE-BASED COMPENSATION](index=22&type=section&id=NOTE%206%20-%20SHARE-BASED%20COMPENSATION) This note details the company's share-based compensation expenses, available shares for grant, and activity related to stock options and restricted stock units - Share-based compensation expenses amounted to **$58 thousand** for the six months ended June 30, 2025, a decrease from **$64 thousand** in the corresponding period of 2024[76](index=76&type=chunk) - As of June 30, 2025, **1,778 shares** were available for grant under the 2024 Incentive Option Plans, with an additional **84,791 shares** approved on July 14, 2025, bringing the total to **86,568 shares**[76](index=76&type=chunk)[77](index=77&type=chunk) Summary of Share-Based Compensation Activity (Six months ended June 30, 2025) | Metric | Number of options | Weighted average exercise price (U.S. dollars) | | :-------------------------- | :---------------- | :--------------------------------------------- | | Outstanding at January 1, 2025 | 1,608 | $897.47 | | Granted | 4,680 | $18.90 | | Expired | (20) | $907.57 | | **Outstanding at June 30, 2025** | **6,268** | **$241.40** | | Exercisable at June 30, 2025 | 1,588 | $897.34 | - In the six months ended June 30, 2025, Silexion granted **3,994 RSUs** to directors and service providers, including **3,966 RSUs** approved for directors on February 9, 2025[79](index=79&type=chunk) [NOTE 7 - FAIR VALUE MEASUREMENTS](index=23&type=section&id=NOTE%207%20-%20FAIR%20VALUE%20MEASUREMENTS) This note outlines the fair value measurements for financial liabilities, specifically private warrants and promissory notes, using Level 3 inputs and valuation models Financial Liabilities Measured at Fair Value (Level 3, U.S. dollars in thousands) | Financial Liabilities | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :-------------- | :---------------- | | Private Warrants to ordinary shares | $* | $2 | | Promissory Notes | $3,190 | $3,965 | - The fair value of Promissory Notes is determined using a discount rate of **11.85%-13.39%** (including a credit spread of **6.67%-7.56%**) and the Company's forecasts for conversion/repayment timing[80](index=80&type=chunk) - Warrants' fair value is calculated using a Black-Scholes-Merton model with Level 3 inputs, incorporating volatility (**90.34% in 2025**, **74.82% in 2024**), term (**4.13 years in 2025**, **5.13 years in 2024**), and a zero dividend yield[82](index=82&type=chunk)[83](index=83&type=chunk) [NOTE 8 - NET LOSS PER SHARE](index=24&type=section&id=NOTE%208%20-%20NET%20LOSS%20PER%20SHARE) This note presents the calculation of basic and diluted net loss per share, along with the weighted-average number of ordinary shares outstanding for the reported periods Net Loss Per Share (U.S. dollars in thousands, except per share data) | Metric | Six months ended June 30, 2025 | Six months ended June 30, 2024 | Three months ended June 30, 2025 | Three months ended June 30, 2024 | | :------------------------------------------------------------------------------------------------ | :----------------------------- | :----------------------------- | :------------------------------- | :------------------------------- | | Net loss attributable to ordinary shareholders | $4,238 | $2,845 | $2,503 | $1,472 | | Weighted-average shares outstanding | 516,110 | 7,466 | 579,523 | 7,442 | | **Net loss per share, basic and diluted** | **$8.21** | **$381.09** | **$4.32** | **$197.80** | - Diluted net loss per share equals basic net loss per share for all periods, as potential ordinary share equivalents would be anti-dilutive if included[86](index=86&type=chunk) - Anti-dilutive instruments excluded from diluted EPS calculations include warrants to purchase ordinary shares, share-based compensation, promissory notes, and redeemable convertible preferred shares and their associated warrants[88](index=88&type=chunk)[89](index=89&type=chunk) [NOTE 9 - TRANSACTIONS AND BALANCES WITH RELATED PARTIES](index=25&type=section&id=NOTE%209%20-%20TRANSACTIONS%20AND%20BALANCES%20WITH%20RELATED%20PARTIES) This note provides a summary of transactions and balances with related parties, including share-based compensation, financial expenses, and promissory notes Transactions with Related Parties (U.S. dollars in thousands) | Transaction Type | Six months ended June 30, 2025 | Six months ended June 30, 2024 | Three months ended June 30, 2025 | Three months ended June 30, 2024 | | :--------------------------------------------- | :----------------------------- | :----------------------------- | :------------------------------- | :------------------------------- | | Share-based compensation (R&D) | $0 | $34 | $0 | $17 | | Share-based compensation (G&A) | $58 | $24 | $37 | $12 | | Financial expenses | $229 | $135 | $197 | $60 | Balances with Related Parties (U.S. dollars in thousands) | Balance Type | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :-------------- | :---------------- | | Private warrants to purchase ordinary shares (Current) | $* | $1 | | Sponsor Promissory Note (Non-Current) | $3,190 | $2,961 | [NOTE 10 - SEGMENT INFORMATION](index=26&type=section&id=NOTE%2010%20-%20SEGMENT%20INFORMATION) This note clarifies that the company operates as a single operating segment focused on R&D of siRNA-based treatments, with performance reviewed on a consolidated basis - The Company operates as a single operating segment, concentrating on the research and development of siRNA-based treatments for pancreatic cancer[90](index=90&type=chunk) - The CEO, acting as the Chief Operating Decision Maker (CODM), reviews performance on a consolidated basis, aligning segment loss, assets, and liabilities with the consolidated net loss, assets, and liabilities[90](index=90&type=chunk)[92](index=92&type=chunk) Key Segment Expenses and Financials (U.S. dollars in thousands) | Metric | Six months ended June 30, 2025 | Six months ended June 30, 2024 | Three months ended June 30, 2025 | Three months ended June 30, 2024 | | :---------------------------------------------------- | :----------------------------- | :----------------------------- | :------------------------------- | :------------------------------- | | Clinical trials and other R&D service providers | $598 | $1,131 | $442 | $497 | | R&D payroll and related expenses (excl. share-based) | $854 | $476 | $485 | $216 | | G&A Professional services | $1,111 | $448 | $586 | $369 | | Operating loss | $3,934 | $2,635 | $2,284 | $1,385 | | Net loss | $4,238 | $2,912 | $2,503 | $1,489 | | Segment assets | $5,797 | $2,315 | $5,797 | $2,315 | | Segment liabilities | $5,677 | $2,372 | $5,677 | $2,372 | [NOTE 11 - SUBSEQUENT EVENTS](index=27&type=section&id=NOTE%2011%20-%20SUBSEQUENT%20EVENTS) This note discloses significant events occurring after the reporting period, including an increase in the equity incentive plan, a reverse share split, and an induced warrant exercise transaction - On July 14, 2025, shareholders approved an increase of **84,791 ordinary shares** to the 2024 Equity Incentive Plan, bringing the total to **86,568 shares**[96](index=96&type=chunk) - On July 28, 2025, the Company executed a **1-for-15 reverse share split** to regain compliance with Nasdaq Listing Rule 5550(a)(2) and maintain its Nasdaq Capital Market listing[97](index=97&type=chunk)[98](index=98&type=chunk) - On July 31, 2025, an induced warrant exercise resulted in holders exercising **152,106 existing ordinary warrants** for cash at **$11.57 per share**, generating approximately **$1,800 thousand in gross proceeds**, and receiving new ordinary warrants to purchase **304,212 shares**[99](index=99&type=chunk)[100](index=100&type=chunk)[101](index=101&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and results of operations, discussing its business overview, recent corporate actions like reverse share splits and Nasdaq listing efforts, detailed analysis of operating expenses and financial results, liquidity and capital resources, critical accounting policies, and regulatory status - Silexion Therapeutics Corp operates through its subsidiary Silexion, a clinical-stage oncology biotechnology company developing proprietary treatments for KRAS-driven cancers, with its lead product candidate **SIL204**, a second-generation siRNA[107](index=107&type=chunk) - The company has incurred significant operating losses, with **net losses of $4.2 million** and **$2.5 million** for the six and three months ended June 30, 2025, respectively, and an **accumulated deficit of $47.5 million** as of June 30, 2025[112](index=112&type=chunk) - The company anticipates continued significant expenses from R&D, clinical trials, potential new pipeline products, and increased costs associated with public company operations[113](index=113&type=chunk)[114](index=114&type=chunk) [Overview](index=28&type=section&id=Overview) This section provides a high-level overview of Silexion Therapeutics Corp, its focus on developing treatments for KRAS-driven cancers, its technology, funding sources, and financial performance - Silexion Therapeutics Corp (New Silexion) is a publicly-traded holding company for Silexion, a clinical-stage oncology biotechnology company developing treatments for KRAS-driven cancers, with **SIL204** as its lead product candidate[106](index=106&type=chunk)[107](index=107&type=chunk) - The company's technology utilizes small interfering RNA (siRNA) to silence the KRAS oncogene, preventing mutated KRAS protein production, and employs an Integrated Treatment Regimen (direct tumor injection and systemic administration) with standard chemotherapy[107](index=107&type=chunk) - Funding sources include private offerings, **$5.8 million** in Israeli Innovation Authority grants, **$2.0 million PIPE financing**, a **$15.0 million ELOC** (with **$3.1 million utilized**), a **$5.0 million gross January 2025 public offering**, and induced warrant exercises totaling **$3.3 million** and **$1.8 million gross** in January and August 2025, respectively[109](index=109&type=chunk)[110](index=110&type=chunk)[111](index=111&type=chunk) - Net losses were **$4.2 million** for the six months ended June 30, 2025, and **$2.5 million** for the three months ended June 30, 2025, resulting in an **accumulated deficit of $47.5 million** as of June 30, 2025, with no revenue generated to date[112](index=112&type=chunk) [Reverse Share Splits](index=30&type=section&id=Reverse%20Share%20Splits) This section details the company's implementation of two reverse share splits and their retroactive adjustment across all historical share data in the report - The company implemented two reverse share splits: **1-for-9** on November 27, 2024, and **1-for-15** on July 28, 2025, with market effective dates of November 29, 2024, and July 29, 2025, respectively[115](index=115&type=chunk) - All historical share, per share, and related option/warrant data in the report have been retroactively adjusted to reflect these reverse share splits[115](index=115&type=chunk) [Continued Nasdaq Listing](index=30&type=section&id=Continued%20Nasdaq%20Listing) This section discusses the company's efforts to maintain its Nasdaq listing, including addressing delisting notices and implementing a reverse share split to meet compliance requirements - On May 22, 2025, Nasdaq issued a delisting notice due to the company's failure to maintain minimum Market Value of Listed Securities (**$50 million**) and Market Value of Publicly Held Shares (**$15 million**)[117](index=117&type=chunk) - A Nasdaq hearings panel granted the company's request to remain listed on July 7, 2025, leading to a transfer from the Nasdaq Global Market to the Nasdaq Capital Market[117](index=117&type=chunk) - Continued listing is contingent upon demonstrating at least **$2.5 million in shareholders' equity** by September 19, 2025, and adhering to all Nasdaq listing rules[118](index=118&type=chunk)[119](index=119&type=chunk) - The company executed a **1-for-15 reverse share split** on July 28, 2025, to address a bid price deficiency and maintain the minimum number of publicly held shares[118](index=118&type=chunk) [Components of our Results of Operations](index=31&type=section&id=Components%20of%20our%20Results%20of%20Operations) This section describes the key components of the company's results of operations, including research and development expenses, general and administrative expenses, and financial expenses, net - Research and development expenses, encompassing payroll, share-based compensation, subcontractor costs, and clinical trial costs, are projected to increase with further **SIL204** development and additional hiring[122](index=122&type=chunk)[123](index=123&type=chunk) - General and administrative expenses, covering personnel costs, patent fees, professional services, and travel, are anticipated to rise due to business growth and public company operating costs[124](index=124&type=chunk)[125](index=125&type=chunk) - Financial expenses, net, primarily comprise changes in the fair value of financial liabilities, interest expenses, and foreign currency exchange differences[126](index=126&type=chunk) [Results of Operations](index=31&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance, detailing changes in operating expenses, financial expenses, and net loss for the six and three-month periods ended June 30, 2025 and 2024 - Net loss increased by **44.8%** to **$4.2 million** for the six months ended June 30, 2025, compared to **$2.9 million** in 2024, mainly due to higher general and administrative expenses associated with public company status[134](index=134&type=chunk) - Net loss increased by **66.7%** to **$2.5 million** for the three months ended June 30, 2025, compared to **$1.5 million** in 2024, primarily driven by increased general and administrative and research and development expenses[139](index=139&type=chunk) [Comparison of six-month periods ended June 30, 2025 and 2024](index=32&type=section&id=Comparison%20of%20six-month%20periods%20ended%20June%2030%2C%202025%20and%202024) This section compares the company's operating expenses and net loss for the six-month periods ended June 30, 2025, and 2024, highlighting key drivers of change Operating Expenses (Six-month period ended June 30, U.S. dollars in thousands) | Expense Category | 2025 | 2024 | Change ($) | Change (%) | | :------------------------- | :--- | :--- | :--------- | :--------- | | Research and development | $1,608 | $1,727 | $(119) | -6.9% | | General and administrative | $2,326 | $908 | $1,418 | +156.2% | | **Total operating expenses** | **$3,934** | **$2,635** | **$1,299** | **+49.3%** | | Operating loss | $3,934 | $2,635 | $1,299 | +49.3% | | Financial expenses, net | $301 | $270 | $31 | +11.5% | | Net loss | $4,238 | $2,912 | $1,326 | +45.5% | - R&D expenses decreased by **$0.1 million (5.9%)** to **$1.6 million**, primarily due to a **$0.5 million reduction** in subcontractors/consultants as the development program shifted from API development to manufacturing, partially offset by a **$0.4 million increase** in payroll from headcount and salary increases[130](index=130&type=chunk) - G&A expenses rose by **$1.4 million (155.6%)** to **$2.3 million**, driven by a **$0.5 million increase** in payroll and a **$0.7 million increase** in professional services related to public company operations[132](index=132&type=chunk) [Comparison of three-month periods ended June 30, 2025 and 2024](index=33&type=section&id=Comparison%20of%20three-month%20periods%20ended%20June%2030%2C%202025%20and%202024) This section compares the company's operating expenses and net loss for the three-month periods ended June 30, 2025, and 2024, detailing the factors contributing to changes Operating Expenses (Three-month period ended June 30, U.S. dollars in thousands) | Expense Category | 2025 | 2024 | Change ($) | Change (%) | | :------------------------- | :--- | :--- | :--------- | :--------- | | Research and development | $1,018 | $766 | $252 | +32.9% | | General and administrative | $1,266 | $619 | $647 | +104.5% | | **Total operating expenses** | **$2,284** | **$1,385** | **$899** | **+64.9%** | | Operating loss | $2,284 | $1,385 | $899 | +64.9% | | Financial expenses, net | $216 | $102 | $114 | +111.8% | | Net loss for the quarter | $2,503 | $1,489 | $1,014 | +68.1% | - R&D expenses increased by **$0.2 million (25.0%)** to **$1.0 million**, primarily due to higher payroll and related expenses from additional headcount, salary increases, and bonus accruals post-Business Combination[136](index=136&type=chunk) - G&A expenses increased by **$0.7 million (116.7%)** to **$1.3 million**, fueled by a **$0.3 million increase** in payroll and a **$0.2 million increase** in professional services for public company financing activities[137](index=137&type=chunk) - Financial expenses, net, increased by **$0.1 million (100.0%)** to **$0.2 million**, mainly due to higher revaluation expenses of financial instruments[138](index=138&type=chunk) [Liquidity and Capital Resources](index=35&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's liquidity position, capital resources, funding requirements, and various financing activities undertaken to support operations and development - As of June 30, 2025, cash and cash equivalents totaled **$3.5 million**, with net losses of **$4.2 million** and **$2.5 million** for the six and three months ended June 30, 2025, respectively[140](index=140&type=chunk) - Current cash and anticipated cash flow are insufficient for the next 12 months, raising substantial doubt about the company's ability to continue as a going concern without additional capital[142](index=142&type=chunk)[143](index=143&type=chunk) - Primary liquidity sources include private offerings, IIA grants, **$2.0 million PIPE financing**, **$3.1 million utilized ELOC**, a **$5.0 million gross January 2025 public offering**, and induced warrant exercises totaling **$3.3 million** and **$1.8 million gross**[141](index=141&type=chunk) - Future capital requirements depend on R&D, clinical trials, new product candidates, and public company operating costs; financing will likely involve public/private equity offerings, debt, strategic alliances, and licensing arrangements[179](index=179&type=chunk)[181](index=181&type=chunk)[182](index=182&type=chunk)[187](index=187&type=chunk) [Public Offering via H.C. Wainwright](index=35&type=section&id=Public%20Offering%20via%20H.C.%20Wainwright) This section details the company's January 2025 public offering, including the securities sold, gross proceeds, warrant terms, and associated placement agent fees - On January 15 and 17, 2025, the company completed a public offering (HCW Offering) of **143,067 ordinary shares**, **103,847 pre-funded warrants**, and **246,914 ordinary warrants**, raising approximately **$5.0 million in gross proceeds**[146](index=146&type=chunk) - Pre-funded warrants were exercisable at **$0.0015 per share**, and ordinary warrants at **$20.25 per share**, both with a five-year term[148](index=148&type=chunk) - The company paid H.C. Wainwright a **7.0% cash placement agent fee** and a **1.0% management fee**, and issued **17,284 placement agent warrants** (7.0% of shares/pre-funded warrants sold) with an exercise price of **$25.3125**[151](index=151&type=chunk) - Net proceeds from the HCW Offering were approximately **$4.26 million**, designated for advancing pre-clinical clinical studies and general corporate purposes[152](index=152&type=chunk) [Induced Warrant Exercise Transactions](index=36&type=section&id=Induced%20Warrant%20Exercise%20Transactions) This section describes the induced warrant exercise transactions in January and July 2025, detailing the number of warrants exercised, gross proceeds generated, and new warrants issued - On January 29, 2025, and July 31, 2025, induced warrant exercise transactions involved holders exercising **148,102** and **152,106 existing ordinary warrants**, respectively, for cash[153](index=153&type=chunk) - These exercises generated gross proceeds of approximately **$3.3 million** (January 2025) and **$1.8 million** (August 2025), prior to deducting placement agent fees and other offering expenses[153](index=153&type=chunk) - In consideration, new ordinary warrants were issued to purchase **148,102** and **304,212 ordinary shares**, respectively, alongside placement agent warrants for **10,368** and **10,647 shares**, respectively[153](index=153&type=chunk)[154](index=154&type=chunk) - The company engaged H.C. Wainwright as the exclusive placement agent, paying cash fees (**7.0% placement**, **1.0% management**) and issuing placement agent warrants[154](index=154&type=chunk) [ELOC Financing](index=37&type=section&id=ELOC%20Financing) This section outlines the Equity Line of Credit (ELOC) Agreement with White Lion Capital, LLC, including the credit limit, commitment shares, and aggregate proceeds generated - The ELOC Agreement, effective August 15, 2024, provides an equity line of credit of up to **$15.0 million** from White Lion Capital, LLC, valid until December 31, 2025[158](index=158&type=chunk) - As consideration, the company issued **$337,500 worth of ELOC Commitment Shares** (**2,707 ordinary shares**) to the ELOC Investor on September 18, 2024[160](index=160&type=chunk) - Through the reporting date, the company has issued **50,915 ordinary shares** to the ELOC Investor under the ELOC Agreement, generating aggregate proceeds of approximately **$3.1 million**[161](index=161&type=chunk) [Settlement of Amounts Due Under Marketing Agreement with EarlyBird](index=37&type=section&id=Settlement%20of%20Amounts%20Due%20Under%20Marketing%20Agreement%20with%20EarlyBird) This section details the settlement of amounts due under the Marketing Agreement with EarlyBird, including cash payments, conversion of a promissory note into shares, and the note's retirement - Moringa and EarlyBird agreed to reduce the Marketing Agreement fee to **$1.6 million**, with **$350,000 paid in cash** at closing and a **$1.25 million EarlyBird Convertible Note** issued[162](index=162&type=chunk) - Through January 31, 2025, **$407,556** was paid on the EarlyBird Convertible Note[162](index=162&type=chunk) - On March 13, 2025, a letter agreement resulted in a **$400,000 cash payment** (plus **$15,000 legal expenses**), conversion of the remaining **$880,202 outstanding principal and interest** into **18,519 ordinary shares**, and a final cash payment of **$135,998**[163](index=163&type=chunk)[164](index=164&type=chunk) - The EarlyBird Convertible Note was fully retired on March 18, 2025[164](index=164&type=chunk) [Issuance of A&R Sponsor Promissory Note](index=38&type=section&id=Issuance%20of%20A%26R%20Sponsor%20Promissory%20Note) This section describes the issuance of the A&R Sponsor Promissory Note, its principal amount, maturity date, and conversion terms into ordinary shares - The A&R Sponsor Promissory Note for **$3,433,000** was issued to the Moringa sponsor at the Business Combination closing, superseding all prior promissory notes[165](index=165&type=chunk) - The note matures on February 15, 2027, with amounts repayable via conversion into ordinary shares (Note Shares)[165](index=165&type=chunk) - Conversion terms permit conversion at the price of subsequent equity financings (up to **30% of shares issued**) or at the sponsor's election after 24 months at the 20-day VWAP[165](index=165&type=chunk) - As of the reporting date, no amounts under the A&R Sponsor Promissory Note have been converted into ordinary shares[165](index=165&type=chunk) [Government Grants](index=38&type=section&id=Government%20Grants) This section details the royalty-bearing grants received from the Israeli Innovation Authority (IIA) for R&D efforts and the associated royalty payment obligations - The company has received approximately **$5.8 million** in royalty-bearing grants from the Israeli Innovation Authority (IIA) for R&D efforts as of June 30, 2025[166](index=166&type=chunk) - The company is committed to paying royalties to the IIA at a rate of **3.0% to 5.0%** on sales of products developed with IIA-funded know-how, up to the total grant amount plus interest[167](index=167&type=chunk) - The total royalty amount potentially payable by the company as of June 30, 2025, is approximately **$5.8 million** (**$6.6 million including interest**)[171](index=171&type=chunk) [Cash flows for the six-month periods ended June 30, 2025 and 2024](index=39&type=section&id=Cash%20flows%20for%20the%20six-month%20periods%20ended%20June%2030%2C%202025%20and%202024) This section analyzes the company's cash flow activities for the six-month periods ended June 30, 2025, and 2024, detailing changes in operating, investing, and financing cash flows Cash Flows (Six-month period ended June 30, U.S. dollars in thousands) | Cash Flow Activity | 2025 | 2024 | Change ($) | Change (%) | | :-------------------------------- | :--- | :--- | :--------- | :--------- | | Net cash used in operating activities | $(4,960) | $(2,817) | $(2,143) | +76.1% | | Net cash used in investing activities | $(7) | $(6) | $(1) | +16.7% | | Net cash provided by financing activities | $7,237 | $0 | $7,237 | N/A | | **Net increase (decrease) in cash and cash equivalents and restricted cash** | **$2,270** | **$(2,823)** | **$5,093** | N/A | - Net cash used in operating activities increased by **$2.2 million (78.6%)** to **$5.0 million**, primarily due to a **$1.3 million increase** in net loss and a **$0.9 million increase** in net working capital[174](index=174&type=chunk) - Net cash provided by financing activities increased by **$7.2 million** to **$7.2 million**, primarily from **$5.0 million** (net of **$0.7 million costs**) from the HCW Offering, **$0.9 million** from warrant exercises, and **$3.3 million** (net of **$0.5 million costs**) from the January 2025 warrant inducement transaction, partially offset by **$0.7 million** in EarlyBird Convertible Note payments[175](index=175&type=chunk) [Cash flows for the quarters ended June 30, 2025 and 2024](index=39&type=section&id=Cash%20flows%20for%20the%20quarters%20ended%20June%2030%2C%202025%20and%202024) This section analyzes the company's cash flow activities for the three-month periods ended June 30, 2025, and 2024, detailing changes in operating, investing, and financing cash flows Cash Flows (Three-month period ended June 30, U.S. dollars in thousands) | Cash Flow Activity | 2025 | 2024 | Change ($) | Change (%) | | :-------------------------------- | :--- | :--- | :--------- | :--------- | | Net cash used in operating activities | $(2,507) | $(1,065) | $(1,442) | +135.4% | | Net cash used in investing activities | $(1) | $0 | $(1) | N/A | | Net cash used in financing activities | $(195) | $0 | $(195) | N/A | | **Net increase (decrease) in cash and cash equivalents and restricted cash** | **$(2,703)** | **$(1,065)** | **$(1,638)** | +153.8% | - Net cash used in operating activities increased by **$1.4 million (127.3%)** to **$2.5 million**, primarily due to a **$1.0 million increase** in net loss and a **$0.6 million increase** in net working capital[177](index=177&type=chunk) - Net cash used in financing activities decreased by **$0.2 million** to **$0.2 million**, primarily due to cash issuance costs from the public offering paid in the three-month period ended June 30, 2025[178](index=178&type=chunk) [Funding Requirements](index=40&type=section&id=Funding%20Requirements) This section outlines the company's anticipated funding needs for ongoing and planned activities, particularly R&D and clinical trials, and addresses the going concern uncertainty - The company anticipates substantial financial resources will be allocated to ongoing and planned activities, especially the development of **SIL204** and pre-clinical/clinical trials[179](index=179&type=chunk) - As of June 30, 2025, existing cash and cash equivalents (**$3.5 million**) are projected to fund operations only into the first quarter of 2026[182](index=182&type=chunk)[185](index=185&type=chunk) - Management has concluded there is substantial doubt about the company's ability to continue as a going concern for 12 months without additional financing, owing to operating losses and negative cash flows[182](index=182&type=chunk)[183](index=183&type=chunk) - Future funding will likely originate from public/private equity offerings, debt, strategic alliances, and licensing arrangements, potentially causing significant dilution to current shareholders[187](index=187&type=chunk)[188](index=188&type=chunk) [Critical Accounting Policies and Estimates](index=41&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) This section identifies the company's critical accounting estimates, specifically focusing on the fair value measurement of promissory notes - Critical accounting estimates include the valuation of promissory notes, which are measured at fair value[190](index=190&type=chunk)[191](index=191&type=chunk) - The fair value of promissory notes is determined using a discount rate of **11.85%-13.39%** (including a credit spread of **7.56%**) and management's forecasts for conversion/redemption timing[191](index=191&type=chunk) [Recent Accounting Pronouncements](index=42&type=section&id=Recent%20Accounting%20Pronouncements) This section directs readers to Note 2 of the financial statements for details on recent accounting pronouncements relevant to the company's financial reporting - Refer to Note 2 of the financial statements for details on recent accounting pronouncements applicable to the current and prior year financial statements[192](index=192&type=chunk) [Smaller Reporting Company Status](index=42&type=section&id=Smaller%20Reporting%20Company%20Status) This section explains the company's status as a "smaller reporting company" and the associated reduced disclosure requirements - The company is a 'smaller reporting company' with a market value of ordinary shares held by non-affiliates less than **$700 million** and annual revenue less than **$100 million**[193](index=193&type=chunk) - This status permits the presentation of only the two most recent fiscal years of audited financial statements and reduced executive compensation disclosure[193](index=193&type=chunk) [Emerging Growth Company Status](index=42&type=section&id=Emerging%20Growth%20Company%20Status) This section describes the company's "emerging growth company" status, its election for an extended transition period for accounting standards, and the conditions for retaining this status - The company is an 'emerging growth company' and has opted for the extended transition period for new or revised financial accounting standards under the JOBS Act[195](index=195&type=chunk) - This status may affect the comparability of its financial results with other public companies[195](index=195&type=chunk) - The company will retain its emerging growth company status until specific thresholds are met (e.g., market value exceeding **$700 million**, revenue exceeding **$1.235 billion**, debt exceeding **$1.0 billion**) or December 31, 2029[195](index=195&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=43&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, Silexion is exempt from detailed disclosures under this item, noting its funds are in demand-deposit interest-bearing bank accounts and no material impact from interest rate fluctuations is anticipated - As a 'smaller reporting company,' Silexion is exempt from detailed market risk disclosures[196](index=196&type=chunk) - Funds are invested in demand-deposit interest-bearing bank accounts, with no material impact from interest rate fluctuations anticipated[196](index=196&type=chunk) [Item 4. Control and Procedures](index=43&type=section&id=Item%204.%20Control%20and%20Procedures) Management, with the participation of the CEO and CFO, evaluated the effectiveness of the company's disclosure controls and procedures as of June 30, 2025, and concluded they were effective, with no material changes in internal control over financial reporting during the quarter - Management, including the CEO and CFO, concluded that disclosure controls and procedures were effective as of June 30, 2025[199](index=199&type=chunk) - No material changes in internal control over financial reporting occurred during the fiscal quarter ended June 30, 2025[200](index=200&type=chunk) [PART II - OTHER INFORMATION](index=43&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) This section covers other required disclosures, including legal proceedings, risk factors, unregistered sales of equity securities, defaults upon senior securities, mine safety disclosures, and a list of exhibits [Item 1. Legal Proceedings](index=43&type=section&id=Item%201.%20Legal%20Proceedings) The company reported no legal proceedings - The company has no legal proceedings to report[202](index=202&type=chunk) [Item 1A. Risk Factors](index=43&type=section&id=Item%201A.%20Risk%20Factors) This section refers readers to the 'Risk Factors' section of the 2024 Annual Report for factors that could materially affect actual results, noting no material changes to those risk factors as of the date of this Quarterly Report - Refer to 'Part I, Item 1.A Risk Factors' of the 2024 Annual Report for factors that could materially affect actual results[203](index=203&type=chunk) - As of the date of this Quarterly Report, no material changes to previously disclosed risk factors have occurred[203](index=203&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=43&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section incorporates by reference disclosures from 'Management's Discussion and Analysis of Financial Condition and Results of Operations' regarding unregistered sales of equity securities, specifically induced warrant exercise transactions and the settlement of amounts due under the Marketing Agreement with EarlyBird, all made in reliance on Section 4(a)(2) of the Securities Act and/or Rule 506 of Regulation D - Disclosures regarding unregistered sales of equity securities, including induced warrant exercise transactions and settlement with EarlyBird, are incorporated by reference from Item 2 of Part I[204](index=204&type=chunk) - These sales were conducted in reliance on Section 4(a)(2) of the Securities Act and/or Rule 506 of Regulation D[204](index=204&type=chunk) - No disclosure is required for the use of proceeds from the initial registration statement on Form S-4 related to the Business Combination, as it qualified as a business combination under Rule 145(a)[205](index=205&type=chunk) [Item 3. Defaults Upon Senior Securities](index=44&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - The company reported no defaults upon senior securities[207](index=207&type=chunk) [Item 4. Mine Safety Disclosures](index=44&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Mine Safety Disclosures are not applicable to the company[208](index=208&type=chunk) [Item 5. Other Information](index=44&type=section&id=Item%205.%20Other%20Information) The company reported no other information - The company reported no other information[209](index=209&type=chunk) [Item 6. Exhibits](index=44&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed as part of, or incorporated by reference into, the Quarterly Report on Form 10-Q, including certifications and XBRL documents - The report includes certifications from the Principal Executive Officer and Principal Financial Officer (Exhibits 31.1, 31.2, 32.1, 32.2)[211](index=211&type=chunk) - Inline XBRL documents (Instance, Schema, Calculation, Definition, Label, Presentation Linkbase Documents) and the Cover Page Interactive Data File are filed as exhibits[211](index=211&type=chunk) [SIGNATURES](index=45&type=section&id=SIGNATURES) This section contains the signatures of the company's Chairman and Chief Executive Officer and Chief Financial Officer, certifying the report on August 12, 2025 - The report is signed by Ilan Hadar, Chairman and Chief Executive Officer, and Mirit Horenshtein-Hadar, Chief Financial Officer, on August 12, 2025[215](index=215&type=chunk)

Executive Summary Silexion Therapeutics, a clinical-stage biotech, advanced its RNAi therapy for KRAS-driven cancers, secured a key partnership, and strengthened its financial position [Company Overview](index=1&type=section&id=company_overview) Silexion Therapeutics Corp. is a clinical-stage biotechnology company focused on developing RNA interference (RNAi) therapies specifically for KRAS-driven cancers - Silexion Therapeutics Corp. is a clinical-stage biotechnology company developing RNA interference (RNAi) therapies for KRAS-driven cancers[2](index=2&type=chunk) [Q2 2025 Business Highlights](index=1&type=section&id=q2_2025_business_highlights) Silexion Therapeutics reported strong preclinical efficacy data for SIL204 across multiple KRAS-driven cancer types, secured a strategic formulation partnership, maintained its Nasdaq listing, and strengthened its financial position, remaining on track for Phase 2/3 clinical trials in H1 2026 - Continued advancement of SIL204 preclinical program with strong efficacy data across multiple KRAS-driven cancer types[1](index=1&type=chunk) - Company strengthened financial position and maintains progress toward clinical trials[1](index=1&type=chunk) - Preclinical data demonstrates SIL204's impressive efficacy across pancreatic, colorectal, and lung cancers, with **high inhibition rates** and coverage of multiple KRAS mutations including Q61H and G13D variants[9](index=9&type=chunk) Business Developments Silexion advanced its SIL204 preclinical program, secured a strategic partnership, achieved corporate milestones, and progressed towards clinical trials [Preclinical Program Advancement (SIL204)](index=1&type=section&id=preclinical_program_advancement_sil204) Silexion significantly expanded its preclinical program for SIL204, demonstrating strong efficacy in inhibiting KRAS G12D mutations across pancreatic, colorectal, and lung cancer models, and reported initial evidence of SIL204's efficacy against the clinically significant KRAS Q61H mutation - Significant expansion of preclinical program for SIL204, exploring its potential impact on colorectal and lung cancer[3](index=3&type=chunk) - Results demonstrated strong efficacy across multiple KRAS-driven cancer types[3](index=3&type=chunk) [Efficacy Across Multiple Cancer Types](index=1&type=section&id=efficacy_across_multiple_cancer_types) SIL204 showed high inhibition rates in preclinical studies for pancreatic, colorectal, and lung cancers, specifically targeting KRAS G12D mutations SIL204 Efficacy in KRAS G12D Mutations | Cancer Type | KRAS Mutation | Inhibition Rate | | :---------- | :------------ | :-------------- | | Pancreatic Cancer | KRAS G12D | Up to 94% | | Colorectal Cancer | KRAS G12D | Approx. 90% | | Lung Cancer | KRAS G12D | Significant dose-dependent inhibition | [New KRAS Mutation Coverage](index=1&type=section&id=new_kras_mutation_coverage) In July 2025, Silexion reported the first evidence of SIL204's efficacy against the clinically significant KRAS Q61H mutation, achieving up to 97% inhibition in pancreatic cancer cells - First evidence of SIL204's efficacy against the clinically significant KRAS Q61H mutation[5](index=5&type=chunk) - Achieved up to **97% inhibition** in pancreatic cancer cells with KRAS Q61H mutation[5](index=5&type=chunk) [Strategic Formulation Partnership](index=1&type=section&id=strategic_formulation_partnership) In April 2025, Silexion partnered with Catalent, a global leader in advanced delivery technologies, for formulation development and clinical manufacturing of SIL204, supporting a dual-route development strategy for primary tumors and metastases - Strategic collaboration with Catalent for formulation development and clinical manufacturing activities for SIL204[4](index=4&type=chunk) - Partnership supports the Company's dual-route development strategy targeting both the primary tumor and resulting metastases[4](index=4&type=chunk) [Regulatory and Clinical Timeline](index=2&type=section&id=regulatory_and_clinical_timeline) Silexion remains on track to initiate Phase 2/3 clinical trials for SIL204 in the first half of 2026, initially focusing on locally advanced pancreatic cancer, with regulatory submissions planned for Israel in Q4 2025 and the EU in Q1 2026 - Company remains on track to initiate Phase 2/3 clinical trials for SIL204 in the **first half of 2026**[6](index=6&type=chunk) - Initial focus on locally advanced pancreatic cancer[6](index=6&type=chunk) - Regulatory submission plans: Israel Ministry of Health in **Q4 2025** and European Union in **Q1 2026**[6](index=6&type=chunk) [Corporate Milestones](index=2&type=section&id=corporate_milestones) Silexion successfully maintained its Nasdaq listing following a favorable decision and completed a 1-for-15 reverse share split, also generating approximately $1.8 million in gross proceeds from a warrant exercise inducement transaction [Nasdaq Listing Status](index=2&type=section&id=nasdaq_listing_status) Silexion received a favorable decision from a Nasdaq hearings panel in July 2025, allowing it to maintain its listing, and effected a 1-for-15 reverse share split on July 29, 2025, as part of compliance efforts - Received a favorable decision from a Nasdaq hearings panel in **July 2025**, allowing maintenance of Nasdaq Capital Market listing[7](index=7&type=chunk) - Effected a **1-for-15 reverse share split** on **July 29, 2025**, to maintain compliance[7](index=7&type=chunk) [Recent Financing Activities](index=2&type=section&id=recent_financing_activities) Subsequent to the quarter end, on July 31, 2025, Silexion generated approximately $1.8 million in gross proceeds from the exercise of 152,106 existing warrants through an inducement transaction - Entered into a warrant exercise inducement transaction on **July 31, 2025**[8](index=8&type=chunk) - Generated approximately **$1.8 million** in gross proceeds from the exercise of **152,106 existing warrants**[8](index=8&type=chunk) Second Quarter 2025 Financial Performance Silexion Therapeutics reported a significant increase in cash position, higher operating expenses driven by R&D and G&A, increased net financial expenses, and a larger net loss for Q2 and the six months ended June 30, 2025 [Cash Position](index=2&type=section&id=cash_position) Cash and cash equivalents increased significantly to $3.5 million as of June 30, 2025, up from $1.2 million at December 31, 2024, primarily due to financing activities completed in early 2025 Cash and Cash Equivalents | Metric | June 30, 2025 | December 31, 2024 | Change | | :----- | :------------ | :---------------- | :----- | | Cash and cash equivalents | $3.5 million | $1.2 million | +$2.3 million | - Increase primarily reflects proceeds from financing activities completed in early 2025, partially offset by ongoing operational expenses[10](index=10&type=chunk) [Operating Expenses](index=2&type=section&id=operating_expenses) Total operating expenses for Q2 2025 increased by 64.9% year-over-year to $2.3 million, driven by increases in both research and development (32.9% increase) and general and administrative expenses (104.5% increase) due to increased headcount, salary adjustments, bonus accruals, and public company costs Operating Expenses (Three Months Ended June 30, in thousands) | Expense Category | Q2 2025 | Q2 2024 | Change (YoY) | % Change (YoY) | | :--------------- | :------ | :------ | :----------- | :------------- | | Research and development | $1,018 | $766 | +$252 | +32.9% | | General and administrative | $1,266 | $619 | +$647 | +104.5% | | **Total Operating Expenses** | **$2,284** | **$1,385** | **+$899** | **+64.9%** | - R&D increase primarily due to increased payroll and payroll-related expenses from additional headcount and salary increases following the business combination, as well as bonus accrual[11](index=11&type=chunk) - G&A increase mainly due to increased payroll expenses and professional services costs associated with operating as a public company[11](index=11&type=chunk) [Financial Expenses, Net](index=3&type=section&id=financial_expenses_net) Net financial expenses for Q2 2025 increased by 111.8% to $0.2 million from $0.1 million in Q2 2024, primarily due to an increase in revaluation expenses of financial instruments Financial Expenses, Net (Three Months Ended June 30, in thousands) | Metric | Q2 2025 | Q2 2024 | Change (YoY) | % Change (YoY) | | :----- | :------ | :------ | :----------- | :------------- | | Financial expenses, net | $216 | $102 | +$114 | +111.8% | - Increase primarily due to an increase in revaluation expenses of financial instruments[12](index=12&type=chunk) [Net Loss](index=3&type=section&id=net_loss) The net loss for Q2 2025 increased by 68.1% year-over-year to $2.5 million, primarily driven by higher general and administrative expenses related to public company status and increased research and development expenses, with the six-month net loss reaching $4.2 million Net Loss (Three and Six Months Ended June 30, in thousands) | Metric | Q2 2025 | Q2 2024 | Change (YoY) | % Change (YoY) | | :----- | :------ | :------ | :----------- | :------------- | | Net Loss (3 months) | $2,503 | $1,489 | +$1,014 | +68.1% | | Net Loss (6 months) | $4,238 | $2,912 | +$1,326 | +45.5% | - Increase in net loss mainly due to increased general and administrative expenses related to public company status and research and development expenses[13](index=

Core Insights - Silexion Therapeutics Corp. has made significant advancements in its preclinical program for SIL204, demonstrating strong efficacy across multiple KRAS-driven cancer types, including pancreatic, colorectal, and lung cancers [1][2][7] - The company has strengthened its financial position and is on track to initiate Phase 2/3 clinical trials for SIL204 in the first half of 2026 [1][4][5] Recent Milestones & Business Highlights - The preclinical data for SIL204 shows up to 94% inhibition in pancreatic cancer cells with KRAS G12D mutations, approximately 90% inhibition in colorectal cancer cells, and significant dose-dependent inhibition in lung cancer cell lines [9] - A strategic partnership with Catalent was established for formulation development and clinical manufacturing of SIL204, supporting a dual-route development strategy [3] Regulatory and Clinical Timeline - Silexion plans to submit regulatory applications to initiate Phase 2/3 trials to the Israel Ministry of Health in Q4 2025 and to the European Union in Q1 2026 [4] Financial Overview - As of June 30, 2025, cash and cash equivalents increased to $3.5 million from $1.2 million at the end of 2024, reflecting successful financing activities [10] - Total operating expenses for Q2 2025 were $2.3 million, a 64.3% increase from Q2 2024, with R&D expenses rising to $1.0 million [11] - The net loss for Q2 2025 was $2.5 million, compared to $1.5 million in Q2 2024, primarily due to increased general and administrative expenses [13]