Core Points - Glucotrack, Inc. will hold a Special Meeting of Shareholders on October 31, 2025, to vote on an Equity Purchase Agreement with Sixth Borough Capital Fund [1] - Shareholders of record as of September 23, 2025, are eligible to vote, and the company encourages prompt voting [2] - The Board of Directors recommends that shareholders vote "FOR" all proposals to ensure their shares are represented [4] Voting Information - Shareholders can vote via telephone, online, or by returning a completed proxy card [2] - Those holding shares in multiple accounts will receive separate voting materials and must vote for each account [3] - Additional details regarding the proposals are available in the definitive proxy statement filed with the SEC on October 3, 2025 [5] Company Overview - Glucotrack, Inc. focuses on developing novel technologies for diabetes management, including a long-term implantable continuous blood glucose monitoring system [7] - The Glucotrack CBGM system is designed to measure blood glucose levels continuously with a sensor longevity of 3 years and minimal calibration [8]

As filed with the Securities and Exchange Commission on October 8, 2025 Registration Statement No. 333-290587 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Delaware 3841 98-0668934 (State or Other Jurisdiction of Incorporation or Organization) (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) 301 Rte. 17 North, Ste. 800, Rutherford, NJ 07070 (201) 842-7715 (Address, including zip code, and telephone number, including area code, of regi ...

As filed with the Securities and Exchange Commission on September 29, 2025 Registration Statement No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Glucotrack, Inc. (Exact name of registrant as specified in its charter) (State or Other Jurisdiction of Incorporation or Organization) Delaware 3841 98-0668934 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) 301 Rte. 17 ...

Summary of GlucoTrack Conference Call Company Overview - **Company**: GlucoTrack (NasdaqCM: GCTK) - **Industry**: Continuous Glucose Monitoring (CGM) Core Points and Arguments 1. **Product Development**: GlucoTrack is developing a fully implantable continuous blood glucose monitor that lasts for three years, eliminating the need for wearable devices [2][23] 2. **Market Size**: The CGM market reached $11.6 billion in revenues last year and is still growing at double-digit rates, with only about 50% penetration in the U.S. market [3][15] 3. **Clinical Trials**: GlucoTrack has completed a first-in-human study outside the U.S. and is starting another study in Australia, with plans for a U.S. Investigational Device Exemption (IDE) study [4][27] 4. **Team Expertise**: The company boasts a seasoned team with experience in continuous glucose sensing, cardiovascular, and implantable devices [5] 5. **Market Challenges**: Despite broad reimbursement, there are challenges in increasing CGM adoption due to the discomfort and management issues associated with current wearable devices [3][19] 6. **Unique Value Proposition**: The implantable device offers a "set it and forget it" solution, providing continuous glucose monitoring without the need for on-body wearables [2][23] 7. **Target Population**: The serviceable market is estimated to be around 3 million patients, with a total addressable market of 10.7 million patients needing insulin or at severe hypoglycemic risk [25][32] 8. **Regulatory Pathway**: The company is targeting FDA approval by the end of the year and plans to launch a pivotal trial by 2027 [4][27] Additional Important Information 1. **Patient Feedback**: Surveys indicate that patients desire improvements in CGM technology, particularly regarding the wearability and management of current devices [20][21] 2. **Technological Approach**: The device leverages established cardiovascular technologies to minimize risks associated with new materials and procedures [22][34] 3. **Financial Projections**: The estimated capital required for clinical trials and regulatory approval is projected to be between $20 million to $25 million annually, totaling around $60 million to $75 million for commercial approval [33][34] 4. **Market Penetration**: Current CGM products have a penetration rate of about 30% among the target population, indicating significant room for growth [25][32] This summary encapsulates the key points discussed during the GlucoTrack conference call, highlighting the company's innovative approach to diabetes management and the potential market opportunities ahead.

Core Viewpoint - GlucoTrack (GCTK.US) experienced a significant increase of over 123%, reaching $10.91, following the announcement of a deal to sell up to $20 million in common stock [1] Company Summary - GlucoTrack specializes in the development of implantable continuous glucose monitoring devices that directly measure blood glucose levels, eliminating lag time, making it suitable for diabetes patients [1] Financial Summary - The agreement with Sixth District Capital involves the sale of up to $20 million in common stock, which may provide additional capital for the company's operations and growth [1]

Core Insights - GlucoTrack (GCTK.US) experienced a significant increase of over 123%, reaching a price of $10.91 [1] - The company announced an agreement with Sixth District Capital to sell up to $20 million in common stock [1] - GlucoTrack specializes in developing implantable continuous glucose monitoring devices that directly measure blood glucose levels, eliminating lag time, and are suitable for diabetes patients [1]

Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential trading opportunities before the market opens [1] Premarket Gainers - Vestand Inc. (VSTD) is up 96% at $2.53 - GlucoTrack, Inc. (GCTK) is up 86% at $9.09 - HCW Biologics Inc. (HCWB) is up 71% at $5.68 - Millennium Group International Holdings Limited (MGIH) is up 31% at $2.87 - IBEX Limited (IBEX) is up 27% at $38.74 - BGSF, Inc. (BGSF) is up 27% at $8.19 - Apimeds Pharmaceuticals US, Inc (APUS) is up 23% at $2.40 - Asset Entities Inc. (ASST) is up 16% at $10.39 - HUB Cyber Security Ltd. (HUBC) is up 10% at $2.71 - BioNexus Gene Lab Corp. (BGLC) is up 9% at $4.70 [3] Premarket Losers - Rent the Runway, Inc. (RENT) is down 21% at $6.17 - XTI Aerospace, Inc. (XTIA) is down 19% at $1.64 - RH (RH) is down 9% at $206.00 - Frequency Electronics, Inc. (FEIM) is down 9% at $30.96 - Global Mofy AI Limited (GMM) is down 9% at $1.99 - Jeffs' Brands Ltd (JFBR) is down 8% at $4.33 - Kindly MD, Inc. (NAKA) is down 8% at $3.60 - Empro Group Inc. (EMPG) is down 7% at $12.38 - Rezolve AI PLC (RZLV) is down 6% at $6.32 - NLS Pharmaceutics AG (NLSP) is down 5% at $2.03 [4]

Core Insights - Glucotrack, Inc. is participating in the Q3 Virtual Investor Summit on September 16-17, 2025, where management will present and hold one-on-one meetings with investors [1][2]. Company Overview - Glucotrack, Inc. (NASDAQ: GCTK) focuses on the design, development, and commercialization of innovative technologies for diabetes management [2]. - The company is developing a long-term implantable continuous blood glucose monitoring system aimed at improving the lives of people with diabetes [2]. Product Details - The Glucotrack Continuous Blood Glucose Monitoring (CBGM) system is designed to measure blood glucose levels continuously, featuring a sensor longevity of 3 years, no on-body wearable component, and minimal calibration requirements [3]. - The CBGM is currently classified as an Investigational Device and is limited to investigational use under U.S. law [3].

[PART I - FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) This section presents the company's unaudited condensed consolidated financial statements and related disclosures [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements.) This section presents the unaudited condensed consolidated financial statements for GlucoTrack Inc., including the Balance Sheets, Statements of Operations and Comprehensive Loss, Statement of Changes in Stockholders' Equity, and Statements of Cash Flows, along with their accompanying notes. The financial statements reflect the company's ongoing development phase, characterized by operating losses, negative cash flows, and a reliance on external financing, leading to a going concern uncertainty. [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section presents the company's financial position, including assets, liabilities, and equity, at specific dates | Metric (in thousands of US dollars) | June 30, 2025 (Unaudited) | December 31, 2024 | | :--------------------------------- | :------------------------ | :---------------- | | Cash and cash equivalents | $9,555 | $5,617 | | Total current assets | $10,077 | $5,768 | | Total assets | $10,210 | $5,932 | | Total current liabilities | $3,085 | $1,275 | | Derivative financial liabilities | $5 | $17,421 | | Total liabilities | $3,330 | $18,932 | | Total stockholders' equity (deficit)| $6,880 | $(13,000) | - The company's cash and cash equivalents increased significantly from **$5,617 thousand** at December 31, 2024, to **$9,555 thousand** at June 30, 2025[14](index=14&type=chunk) - Total stockholders' equity shifted from a deficit of **$(13,000) thousand** at December 31, 2024, to a positive equity of **$6,880 thousand** at June 30, 2025, primarily due to equity issuances[14](index=14&type=chunk) - Derivative financial liabilities decreased substantially from **$17,421 thousand** to **$5 thousand**, indicating a significant reduction in these obligations[14](index=14&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section details the company's revenues, expenses, and net loss over specific reporting periods | Metric (in thousands of US dollars) | Six-month period ended June 30, 2025 | Six-month period ended June 30, 2024 | Three-month period ended June 30, 2025 | Three-month period ended June 30, 2024 | | :--------------------------------- | :----------------------------------- | :----------------------------------- | :------------------------------------- | :------------------------------------- | | Research and development expenses | $5,021 | $5,737 | $3,150 | $3,589 | | General and administrative expenses| $2,963 | $1,535 | $1,464 | $802 | | Marketing expenses | $310 | $170 | $182 | $100 | | Total operating expenses | $8,294 | $7,442 | $4,796 | $4,491 | | Operating loss | $8,294 | $7,442 | $4,796 | $4,491 | | Change in fair value of derivative Liabilities | $3,269 | $- | $(107) | $- | | Net Loss | $11,589 | $7,416 | $4,756 | $4,489 | | Basic and diluted net loss per common stock ($) | $34.81 | $1,700 | $9.62 | $984 | - Net loss for the six months ended June 30, 2025, increased to **$11.589 million** from **$7.416 million** in the prior-year period, primarily due to a **$3.269 million** change in fair value of derivative liabilities[16](index=16&type=chunk)[125](index=125&type=chunk) - General and administrative expenses significantly increased by **93%** for the six-month period and **82%** for the three-month period, driven by higher legal, professional fees, and personnel costs[16](index=16&type=chunk)[112](index=112&type=chunk)[119](index=119&type=chunk) - Research and development expenses decreased by **12.5%** for the six-month period and **12.2%** for the three-month period, attributed to a reduction in product and manufacturing costs[16](index=16&type=chunk)[113](index=113&type=chunk)[120](index=120&type=chunk) [Condensed Consolidated Statement of Changes in Stockholders' Equity](index=7&type=section&id=Condensed%20Consolidated%20Statement%20of%20Changes%20in%20Stockholders'%20Equity) This section outlines changes in the company's equity due to operations, financing, and other transactions - Total stockholders' equity shifted from a deficit of **$(13,000) thousand** at December 31, 2024, to a positive equity of **$6,880 thousand** at June 30, 2025[18](index=18&type=chunk) - The company issued **665,052** common shares from public offerings, resulting in **$10.715 million** in additional paid-in capital during the six months ended June 30, 2025[18](index=18&type=chunk) - Cashless exchange of warrants into common shares contributed **$20.625 million** to additional paid-in capital, involving **162,063** shares[18](index=18&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section reports the cash inflows and outflows from operating, investing, and financing activities | Metric (in thousands of US dollars) | Six-month period ended June 30, 2025 | Six-month period ended June 30, 2024 | | :--------------------------------- | :----------------------------------- | :----------------------------------- | | Loss for the period | $(11,589) | $(7,416) | | Net cash used in operating activities | $(6,683) | $(4,849) | | Net cash used in investing activities | $(9) | $(71) | | Net cash provided by financing activities | $10,555 | $580 | | Change in cash and cash equivalents, and restricted cash | $3,928 | $(4,334) | | Cash and cash equivalents, and restricted cash, end of period | $9,555 | $168 | - Net cash used in operating activities increased to **$6.683 million** for the six months ended June 30, 2025, from **$4.849 million** in the prior-year period[22](index=22&type=chunk) - Net cash provided by financing activities significantly increased to **$10.555 million** in 2025, primarily from **$10.715 million** in net proceeds from public offerings, compared to **$0.580 million** in 2024[22](index=22&type=chunk) - The company's cash and cash equivalents, and restricted cash balance at the end of the period increased substantially to **$9.555 million** from **$0.168 million** year-over-year[22](index=22&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and additional information supporting the financial statements [NOTE 1 – GENERAL](index=10&type=section&id=NOTE%201%20%E2%80%93%20GENERAL) This note provides an overview of GlucoTrack Inc.'s business, focusing on the development of its implantable continuous blood glucose monitor (CBGM). It details the product's features, target patient population, and recent clinical study results. The note also addresses the company's liquidity challenges and going concern uncertainty, along with recent corporate actions like reverse stock splits and an increase in authorized common stock. [A. Company Overview & Product Development](index=10&type=section&id=A.%20The%20Company%20was%20incorporated%20on%20May%2018,%202010%20under%20the%20laws%20of%20the%20State%20of%20Delaware.) This section provides an overview of the company's business, product development, and clinical study progress - GlucoTrack Inc. is developing an implantable continuous blood glucose monitor (CBGM) designed for a **three-year** sensor life, direct blood glucose measurement, no on-body wearable component, and minimal calibration[23](index=23&type=chunk)[28](index=28&type=chunk) - A first-in-human (FIH) short-term clinical study completed in **Q1 2025** met all primary and secondary endpoints, demonstrating excellent accuracy with a Mean Absolute Relative Difference (MARD) of **7.7%** and no serious adverse events[25](index=25&type=chunk) - The company obtained regulatory approval in **Q2 2025** for a long-term clinical study outside the U.S., with patient enrollment expected to begin in **Q3 2025**[26](index=26&type=chunk) - Discussions with the FDA for a pre-investigational device exemption (IDE) submission began in **Q2 2025**, with the IDE submission expected in **Q4 2025** for future U.S. clinical trials[27](index=27&type=chunk) [B. Liquidity and Going Concern](index=10&type=section&id=B.%20Liquidity%20and%20Going%20Concern) This section discusses the company's financial liquidity, accumulated deficit, and ability to continue as a going concern - As of June 30, 2025, the company had an accumulated deficit of **$144.039 million** and has generated operating losses and negative cash flow from operations since inception[29](index=29&type=chunk) - The company's cash and cash equivalents amounted to **$9.555 million** as of June 30, 2025[29](index=29&type=chunk) - Management has determined that these conditions raise substantial doubt about the company's ability to continue as a going concern[31](index=31&type=chunk) - During the six months ended June 30, 2025, the company raised **$10.7 million** through the sale of common stock to finance operations[30](index=30&type=chunk) [C. 2025 Reverse Stock Splits and Increase in Authorized Common Stock](index=11&type=section&id=C.%202025%20Reverse%20Stock%20Splits%20and%20Increase%20in%20Authorized%20Common%20Stock) This section details the company's reverse stock splits and the increase in authorized common stock during 2025 - The company implemented a **1-for-20** reverse stock split effective February 3, 2025, and a **1-for-60** reverse stock split effective June 13, 2025[32](index=32&type=chunk)[34](index=34&type=chunk) - Authorized shares of Common Stock were increased from **100 million** to **250 million** on January 3, 2025, and approved by stockholders on February 3, 2025[33](index=33&type=chunk) - All shares, options, warrants, and loss per share amounts have been retroactively adjusted for these reverse stock splits[35](index=35&type=chunk) [NOTE 2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES](index=12&type=section&id=NOTE%202%20%E2%80%93%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) This note outlines the significant accounting policies applied in preparing the condensed consolidated financial statements, including the basis of presentation, use of estimates, principles of consolidation, and definitions of cash equivalents. It also details the accounting treatment for warrants, distinguishing between equity-classified and derivative liabilities, and explains the fair value hierarchy for financial instruments. The company operates as a single reportable segment focused on the Glucotrack CBGM Product. [A. Basis of Presentation](index=12&type=section&id=A.%20Basis%20of%20Presentation) This section describes the basis for preparing the unaudited condensed interim consolidated financial statements - The unaudited condensed interim consolidated financial statements are prepared in accordance with SEC rules for interim financial statements, condensing certain information and footnote disclosures[36](index=36&type=chunk) - Management believes all necessary adjustments have been made to fairly present the financial position and operating results, and all such adjustments are of a normal recurring nature[36](index=36&type=chunk) [B. Use of Estimates in the Preparation of Financial Statements](index=12&type=section&id=B.%20Use%20of%20Estimates%20in%20the%20Preparation%20of%20Financial%20Statements) This section explains the role of management's estimates and assumptions in financial statement preparation - Preparation of financial statements requires management to make estimates and assumptions, particularly regarding going concern, classification of financial instruments, and fair value of derivative liabilities[38](index=38&type=chunk) [C. Principles of Consolidation](index=12&type=section&id=C.%20Principles%20of%20Consolidation) This section outlines the principles used for consolidating the accounts of the company and its subsidiary - The condensed interim consolidated financial statements include the accounts of the Company and its subsidiary, with significant intercompany balances and transactions eliminated[39](index=39&type=chunk) [D. Cash and Cash Equivalents](index=12&type=section&id=D.%20Cash%20and%20Cash%20Equivalents) This section defines cash equivalents and reports the company's holdings as of the balance sheet dates - Cash equivalents are short-term, highly liquid investments with maturities of **three months or less** from the date acquired, and the company held no cash equivalents as of June 30, 2025, and December 31, 2024[40](index=40&type=chunk) [E. Warrants](index=12&type=section&id=E.%20Warrants) This section details the accounting classification of warrants as either equity instruments or derivative liabilities - Warrants are classified as equity instruments if they are freestanding, do not obligate the company to repurchase shares, and permit holders to receive a fixed number of shares for a fixed price[41](index=41&type=chunk) - Series A and Series B Warrants issued in November 2024 are classified as derivative liabilities at fair value, with changes recorded in profit or loss, because their settlement amount might not be based on a fixed number of shares for a fixed consideration[42](index=42&type=chunk) [F. Fair value of financial instruments](index=14&type=section&id=F.%20Fair%20value%20of%20financial%20instruments) This section describes valuation methods and fair value hierarchy for financial instruments, especially derivative liabilities - The company uses **Level 3** inputs for valuing derivative liabilities, which are adjusted to reflect estimated fair value at each period end, with changes recorded in other income or expense[44](index=44&type=chunk) | Metric (in thousands of US dollars) | Warrant Liability | | :--------------------------------- | :---------------- | | Balance – November 14, 2024 | $16,626 | | Fair value adjustments | $795 | | Balance – December 31, 2024 | $17,421 | | Fair value adjustments | $3,376 | | Cashless exchange of warrants | $(20,620) | | Balance – March 31, 2025 | $177 | | Fair value adjustments | $(107) | | Series A Warrant repurchase | $(65) | | Balance – June 30, 2025 | $5 | [G. Segment reporting](index=14&type=section&id=G.%20Segment%20reporting) This section clarifies that the company operates as a single reportable segment focused on the Glucotrack CBGM Product - The company operates as a single reportable segment, the Glucotrack CBGM Product Segment, as all research and development activities are related to this product[47](index=47&type=chunk)[49](index=49&type=chunk) - The Chief Executive Officer acts as the Chief Operating Decision Maker (CODM), reviewing consolidated results for resource allocation and performance assessment[46](index=46&type=chunk)[49](index=49&type=chunk) [H. Basic and diluted loss per share](index=15&type=section&id=H.%20Basic%20and%20diluted%20loss%20per%20share) This section explains the calculation of basic and diluted loss per share, noting the anti-dilutive effect of certain securities - Basic and diluted net loss per common share are the same due to net losses, making potentially dilutive securities anti-dilutive[50](index=50&type=chunk) | Potentially Dilutive Securities (Number of Shares) | June 30, 2025 | June 30, 2024 | | :--------------------------------- | :------------ | :------------ | | Common stock options | 274 | 250 | | Shares issuable from warrants | 8,961 | 155 | | Total | 9,235 | 405 | [NOTE 3 - SIGNIFICANT TRANSACTIONS](index=16&type=section&id=NOTE%203%20-%20SIGNIFICANT%20TRANSACTIONS) This note details significant financial transactions, including equity issuances through ATM sales and a registered direct offering in 2025, as well as prior year private and public equity offerings. It also covers warrant-related activities such as cashless exchanges and repurchases, and the settlement of note and warrant purchase agreements. [A. Equity Issuances](index=16&type=section&id=A.%20Equity%20Issuances) This section details the company's equity financing activities, including ATM sales and registered direct offerings - Under an ATM Sales Agreement, the company sold **206,300** shares for **$3.643 million** net proceeds in **Q1 2025** and **414,785** shares for **$4.320 million** net proceeds in **Q2 2025**[53](index=53&type=chunk)[54](index=54&type=chunk) - A Registered Direct Offering in **February 2025** raised approximately **$2.752 million** net proceeds from the sale of **43,968** shares[55](index=55&type=chunk) - In **November 2024**, a public offering and concurrent private offering generated **$10.0 million** gross proceeds and converted **$4.093 million** of debt into common stock and warrants[58](index=58&type=chunk)[59](index=59&type=chunk) [B. Warrant Net Share Exchange into Common Stock and Warrant Repurchase](index=17&type=section&id=B.%20Warrant%20Net%20Share%20Exchange%20into%20Common%20Stock%20and%20Warrant%20Repurchase) This section describes transactions involving the cashless exchange of warrants into common stock and warrant repurchases - From **January to March 2025**, **54,021** Series B Warrants were cashless exchanged for **162,063** shares of Common Stock, resulting in **$20.625 million** classified to equity[65](index=65&type=chunk) - On **June 30, 2025**, the company repurchased **49,668** Series A Warrants for **$0.160 million**, incurring a loss on repurchase of **$0.095 million**[66](index=66&type=chunk) - As of **June 30, 2025**, **11** Series B Warrants and **4,368** Series A Warrants remained outstanding, with a combined value of **$5 thousand**[67](index=67&type=chunk) [C. Note and Warrant Purchase Agreements](index=17&type=section&id=C.%20Note%20and%20Warrant%20Purchase%20Agreements) This section outlines agreements for unsecured promissory notes and warrants, and their subsequent settlement - In **June 2024**, the company entered into agreements for private placement of **$0.100 million** in unsecured promissory notes and warrants to purchase up to **5,000** shares[68](index=68&type=chunk) - The notes bore **3%** simple interest and were due on the earlier of **twelve months** or when the company raised **$1.0 million** in third-party equity capital[69](index=69&type=chunk) - As of **June 30, 2025**, all notes have been settled by the company[71](index=71&type=chunk) [NOTE 4 – COMMITMENTS AND CONTINGENT LIABILITIES](index=19&type=section&id=NOTE%204%20%E2%80%93%20COMMITMENTS%20AND%20CONTINGENT%20LIABILITIES) This note outlines the company's commitments and contingent liabilities, including royalty obligations to the Israeli Innovation Authority (IIA) and contingent consideration related to an Intellectual Property Purchase Agreement. It details the achievement of performance milestones for the IP acquisition, leading to the issuance of restricted shares and recognition of stock-based compensation expenses. - The company has a contingent liability to the Israeli Innovation Authority (IIA) for royalties on future sales, totaling approximately **$0.093 million** (excluding interest) as of June 30, 2025[79](index=79&type=chunk) - Under an Intellectual Property Purchase Agreement, the company is obligated to issue up to **10,000** shares of Common Stock based on specified performance milestones[73](index=73&type=chunk) - The first performance milestone was achieved in **June 2023**, resulting in the commitment to issue **17** restricted shares and recording **$0.131 million** in stock-based compensation[76](index=76&type=chunk) - The second performance milestone was achieved in **May 2024**, committing the company to issue **25** restricted shares and recording **$0.192 million** in stock-based compensation[77](index=77&type=chunk)[78](index=78&type=chunk) - The third milestone was met on **March 26, 2025**, earning an additional **42** shares and recognizing **$0.6 thousand** in stock-based compensation[80](index=80&type=chunk) [NOTE 5. SUBSEQUENT EVENTS](index=20&type=section&id=NOTE%205.%20SUBSEQUENT%20EVENTS) Management evaluated subsequent events and transactions after the balance sheet date up to the issuance date of the condensed interim consolidated financial statements and identified no other significant subsequent events requiring adjustment or disclosure. - No other significant subsequent events requiring adjustment or disclosure were identified by management after the balance sheet date up to the date the financial statements were issued[82](index=82&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) This section provides management's perspective on the company's financial condition and operational results for the three and six months ended June 30, 2025, compared to the prior year. It covers the company's business overview, recent corporate and product development events, a detailed analysis of operating expenses, and a discussion of liquidity and going concern issues. The analysis highlights increased net losses, significant financing activities, and ongoing clinical trial progress for the Glucotrack CBGM. [Overview](index=21&type=section&id=Overview) This section provides a general overview of the company's business, product development, and clinical study progress - The company is developing the Glucotrack CBGM, a long-term fully implantable continuous glucose monitor designed for a **three-year** sensor life, direct blood glucose measurement, and minimal calibration[85](index=85&type=chunk)[91](index=91&type=chunk) - A first-in-human (FIH) clinical study completed in **Q1 2025** met all primary and secondary endpoints, showing excellent accuracy (MARD of **7.7%**) and no device-related serious adverse events[88](index=88&type=chunk) - Regulatory approval for a long-term clinical study outside the U.S. was obtained in **Q2 2025**, with patient enrollment expected in **Q3 2025**[89](index=89&type=chunk) - Discussions with the FDA for a pre-IDE submission began in **Q2 2025**, with the IDE submission anticipated in **Q4 2025** for future U.S. clinical trials[90](index=90&type=chunk)[91](index=91&type=chunk) [Recent Events](index=23&type=section&id=Recent%20Events) This section summarizes significant corporate and financial events, including stock splits, equity offerings, and personnel changes - The company executed two reverse stock splits in **2025**: a **1-for-20** split in February and a **1-for-60** split in June, along with an increase in authorized common stock to **250 million** shares[92](index=92&type=chunk)[93](index=93&type=chunk)[94](index=94&type=chunk) - Through an ATM Sales Agreement, the company sold **206,300** shares for **$3.643 million** net proceeds in **Q1 2025** and **414,785** shares for **$4.320 million** net proceeds in **Q2 2025**[97](index=97&type=chunk)[98](index=98&type=chunk) - A Registered Direct Offering in **February 2025** generated approximately **$2.752 million** in net proceeds from the sale of **43,968** shares[100](index=100&type=chunk) - Cashless exchanges of **54,021** Series B Warrants resulted in the issuance of **162,603** shares of Common Stock between **January and March 2025**[102](index=102&type=chunk) - Peter C. Wulff was appointed Chief Financial Officer on **January 28, 2025**[105](index=105&type=chunk) [Financial Overview](index=25&type=section&id=Financial%20Overview) This section overviews operating expenses, categorizing them into G&A, R&D, and Marketing, and other income/expense items - General and administrative expenses include professional services, salaries, travel, and stock-based compensation for executive, finance, and administrative personnel[106](index=106&type=chunk) - Research and development expenses primarily consist of personnel costs, materials, travel, and clinical trials, and are expected to increase in **2025** and beyond due to expanding clinical activities[107](index=107&type=chunk) - Other (income) expense primarily includes changes in the fair value of derivative liabilities and finance income/expense[109](index=109&type=chunk) [Results of Operations](index=25&type=section&id=Results%20of%20Operations) This section details changes in operating results for Q2 and H1 2025 vs. 2024, including expenses and derivative impacts [Consolidated Results of Operations for the Three Months ended June 30, 2025 and 2024](index=25&type=section&id=Consolidated%20Results%20of%20Operations%20for%20the%20Three%20Months%20ended%20June%2030,%202025%20and%202024) This section analyzes the company's operating results for the three-month periods ended June 30, 2025 and 2024 - General and administrative expenses increased by **82%** to **$1.464 million** in **Q2 2025** from **$0.802 million** in **Q2 2024**, driven by higher legal, professional fees, and personnel costs[112](index=112&type=chunk) - Research and development expenses decreased by **12.2%** to **$3.150 million** in **Q2 2025** from **$3.589 million** in **Q2 2024**, due to reduced product and manufacturing costs[113](index=113&type=chunk) - Net loss for **Q2 2025** was **$4.756 million**, an increase from **$4.489 million** in **Q2 2024**, primarily due to increased G&A expenses and a **$0.095 million** loss from Series A Warrant repurchase[116](index=116&type=chunk)[118](index=118&type=chunk) - Change in derivative liability resulted in a **$0.107 million** decrease (income) for **Q2 2025**, reflecting fair value adjustments of remaining warrants[115](index=115&type=chunk) [Consolidated Results of Operations for the Six Months ended June 30, 2025 and 2024](index=26&type=section&id=Consolidated%20Results%20of%20Operations%20for%20the%20Six%20Months%20ended%20June%2030,%202025%20and%202024) This section analyzes the company's operating results for the six-month periods ended June 30, 2025 and 2024 - General and administrative expenses increased by **93%** to **$2.963 million** for the six months ended June 30, 2025, from **$1.535 million** in the prior-year period, due to higher legal, professional fees, and personnel costs[119](index=119&type=chunk) - Research and development expenses decreased by **12.5%** to **$5.021 million** for the six months ended June 30, 2025, from **$5.737 million** in the prior-year period, due to reduced product and manufacturing costs[120](index=120&type=chunk) - Net loss for the six months ended June 30, 2025, was **$11.589 million**, an increase from **$7.416 million** in the prior-year period, primarily attributed to increased G&A expenses and a **$3.269 million** change in fair value of derivative liabilities[122](index=122&type=chunk)[125](index=125&type=chunk) - Marketing expenses increased by **82%** to **$0.310 million** for the six months ended June 30, 2025, from **$0.170 million** in the prior-year period, due to increased market research fees and personnel costs[121](index=121&type=chunk) [Liquidity and Going Concern](index=27&type=section&id=Liquidity%20and%20Going%20Concern) This section discusses the company's cash position, historical losses, future funding needs, and going concern assessment - As of **June 30, 2025**, cash and cash equivalents were **$9.555 million**, an increase from **$5.627 million** at December 31, 2024, primarily due to **$10.555 million** from financing activities[126](index=126&type=chunk) - The company has a history of recurring losses and an accumulated deficit of **$144.039 million** as of June 30, 2025[127](index=127&type=chunk) - Current cash and cash equivalents are not expected to be sufficient to fund operating cash flow needs for the next **twelve months**, with an estimated requirement of **$15.0 million**[128](index=128&type=chunk) - Substantial doubt exists about the company's ability to continue as a going concern, necessitating additional capital through debt, equity, or other arrangements[128](index=128&type=chunk) [Critical Accounting Policies](index=27&type=section&id=Critical%20Accounting%20Policies) This section highlights the significant accounting policies and estimates used in preparing the financial statements - The company's financial statements are prepared in accordance with U.S. GAAP, requiring management to make assumptions and estimates about future events[129](index=129&type=chunk) - There have been no material changes to the critical accounting policies and estimates as filed in the Annual Report on Form 10-K for the year ended December 31, 2024[130](index=130&type=chunk) [Off Balance Sheet Arrangements](index=27&type=section&id=Off%20Balance%20Sheet%20Arrangements) This section confirms the absence of any off-balance sheet arrangements for the company - The company does not have any off-balance sheet arrangements[131](index=131&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=27&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk.) As a smaller reporting company, GlucoTrack Inc. is not required to provide quantitative and qualitative disclosures about market risk in this report. - As a smaller reporting company, GlucoTrack Inc. is exempt from providing quantitative and qualitative disclosures about market risk[132](index=132&type=chunk) [Item 4. Controls and Procedures](index=28&type=section&id=Item%204.%20Controls%20and%20Procedures.) This section addresses the effectiveness of the company's disclosure controls and procedures and internal control over financial reporting. It identifies material weaknesses in internal controls as of June 30, 2025, and outlines ongoing remediation efforts. [Evaluation of Disclosure Controls and Procedures](index=28&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) This section evaluates the effectiveness of the company's disclosure controls and procedures and identifies material weaknesses - As of **June 30, 2025**, the company's disclosure controls and procedures were deemed ineffective in timely recording, processing, summarizing, and reporting required information[133](index=133&type=chunk) - Material weaknesses in internal control over financial reporting were identified in general IT controls, lack of sufficient accounting personnel, and inadequate segregation of duties[134](index=134&type=chunk) - Remediation actions include implementing proper IT system access controls, backing up IT architecture, outsourcing certain accounting functions, and hiring additional accounting personnel[135](index=135&type=chunk) [Changes in Internal Control over Financial Reporting](index=28&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) This section reports on any material changes in internal control over financial reporting during the period - Except for the material weaknesses and remediation efforts described, no other material changes in internal control over financial reporting occurred during the quarter ended **March 31, 2025**[137](index=137&type=chunk) [PART II - OTHER INFORMATION](index=29&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) This section covers legal proceedings, risk factors, equity sales, and other miscellaneous disclosures [Item 1. Legal Proceedings](index=29&type=section&id=Item%201.%20Legal%20Proceedings) As of June 30, 2025, GlucoTrack Inc. did not have any pending legal claims, charges, or litigation that were expected to have a material adverse impact on its financial position, results of operations, or cash flows. - As of **June 30, 2025**, the company had no pending legal proceedings expected to materially adversely impact its financial position, results of operations, or cash flows[139](index=139&type=chunk) [Item 1A. Risk Factors](index=29&type=section&id=Item%201A%20Risk%20Factors) This section refers readers to the comprehensive discussion of risk factors in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, noting that there have been no material changes to these risks. - There have been no material changes to the risk factors previously disclosed in the Annual Report on Form 10-K for the year ended **December 31, 2024**[140](index=140&type=chunk) - Additional risks and uncertainties not currently known or deemed immaterial may also adversely affect the business[140](index=140&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=29&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section indicates that there were no unregistered sales of equity securities or use of proceeds to report for the period. - There were no unregistered sales of equity securities or use of proceeds to report[141](index=141&type=chunk)[142](index=142&type=chunk)[143](index=143&type=chunk) [Item 3. Defaults Upon Senior Securities](index=29&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities for the period. - There were no defaults upon senior securities[144](index=144&type=chunk) [Item 4. Mine Safety Disclosures](index=29&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to GlucoTrack Inc. - Mine Safety Disclosures are not applicable to the company[144](index=144&type=chunk) [Item 5. Other Information](index=29&type=section&id=Item%205.%20Other%20Information) The company reported no other information requiring disclosure under this item. - No other information was reported under this item[145](index=145&type=chunk) [Item 6. Exhibits](index=30&type=section&id=Item%206.%20Exhibits.) This section lists all exhibits filed as part of the Form 10-Q, including various certificates of incorporation, bylaws, and certifications required by the Sarbanes-Oxley Act, along with Inline XBRL documents. - The exhibits include various amendments to the Certificate of Incorporation and Bylaws, reflecting corporate governance changes[147](index=147&type=chunk) - Certifications from the Principal Executive Officer and Principal Financial Officer, pursuant to Sections **302** and **906** of the Sarbanes-Oxley Act of **2002**, are filed[147](index=147&type=chunk) - Inline XBRL documents (Instance, Schema, Calculation, Label, Presentation, Definition Linkbase) are included for interactive data filing[147](index=147&type=chunk) [SIGNATURES](index=31&type=section&id=SIGNATURES) The report is duly signed on behalf of GlucoTrack Inc. by Peter C. Wulff, Chief Financial Officer, on August 14, 2025. - The report was signed by **Peter C. Wulff**, Chief Financial Officer, on **August 14, 2025**[150](index=150&type=chunk)[151](index=151&type=chunk)

[Executive Summary](index=1&type=section&id=Executive%20Summary) This section provides an overview of Glucotrack's Q2 2025 performance, strategic developments, and future outlook [Overview of Q2 2025 Performance and Outlook](index=1&type=section&id=Overview%20of%20Q2%202025%20Performance%20and%20Outlook) Glucotrack reported Q2 2025 financial results and corporate highlights, emphasizing significant progress in clinical development, strengthening capital structure, and upcoming milestones for its fully implantable continuous blood glucose monitor (CBGM) system. The company is on track to initiate clinical studies in Australia and submit an IDE to the FDA - On track to implant first patients in long-term, multicenter feasibility study of the fully implantable continuous blood glucose monitor (CBGM) system in Australia in Q3 2025[1](index=1&type=chunk)[2](index=2&type=chunk) - Investigational Device Exemption (IDE) submission to FDA of novel CBGM technology anticipated in Q4 2025, enabling a U.S. Pilot Study in 2026[1](index=1&type=chunk)[2](index=2&type=chunk) - Strengthened Board of Directors, expanded clinical advisory board, and established a Patient Advisory Board[1](index=1&type=chunk)[2](index=2&type=chunk) - Improved capital structure by removing warrant liability and share dilution overhang, with cash and cash equivalents expected to fund operations through **2025**[1](index=1&type=chunk)[2](index=2&type=chunk) [Second Quarter 2025 & Recent Highlights](index=2&type=section&id=Second%20Quarter%202025%20%26%20Recent%20Highlights) This section details Glucotrack's corporate achievements and advancements in product and clinical development during Q2 2025 [Corporate Highlights](index=2&type=section&id=Corporate%20Highlights) Glucotrack strengthened its capital structure by repurchasing Series A Warrants, appointed new medical and executive leadership, and established a Patient Advisory Board to integrate patient perspectives into CBGM development - Strengthened capital structure through the repurchase of Series A Warrants, eliminating warrant liability accounting and share dilution overhang[5](index=5&type=chunk) - Appointed David S. Hirsh, M.D., as Medical Director – Cardiology, expanding the clinical advisory team[5](index=5&type=chunk) - Elected Victoria E. Carr-Brendel, Ph.D., a seasoned medical device executive, to the Company's Board of Directors[5](index=5&type=chunk) - Established a Patient Advisory Board (PAB) to inform the development of the Company's CBGM technology, ensuring patient insights are at the forefront[5](index=5&type=chunk) [Advanced Product and Clinical Development](index=2&type=section&id=Advanced%20Product%20and%20Clinical%20Development) The company presented positive first-in-human study results for its CBGM, demonstrating excellent accuracy (MARD of 7.7%) and safety, and reported strong endocrinologist interest in the implantable device due to its extended sensor life and potential for greater accuracy - Presented a poster at the ADCES Annual Conference demonstrating strong endocrinologist interest in the CBGM concept, with **73% of 100 surveyed endocrinologists** willing to prescribe it for a **3-year sensor life**[5](index=5&type=chunk) - Reported positive final results of the first-in-human study for continuous blood glucose monitoring at the ADA 85th Scientific Sessions, meeting all primary and secondary endpoints[5](index=5&type=chunk) - The first-in-human study demonstrated excellent accuracy with a Mean Absolute Relative Difference (MARD) of **7.7%** across **122 matched pairs**, a **99% data capture rate**, and no procedure or device-related serious adverse events[5](index=5&type=chunk) [Anticipated Milestones in 2025](index=3&type=section&id=Anticipated%20Milestones%20in%202025) This section outlines Glucotrack's key upcoming milestones for CBGM development and clinical trials in 2025 [Key Milestones for CBGM Development and Clinical Trials](index=3&type=section&id=Key%20Milestones%20for%20CBGM%20Development%20and%20Clinical%20Trials) Glucotrack expects to initiate its long-term clinical study in Australia in Q3 2025, submit an Investigational Device Exemption (IDE) to the FDA in Q4 2025 for a U.S. Pilot Study, and continue expanding its advisory boards and presenting clinical data - Received ethical approval in Australia to initiate a long-term clinical study of the Company's CBGM in participants with type 1 and type 2 diabetes[12](index=12&type=chunk) - Anticipated implantation of first patients in the long-term, multicenter feasibility study of the fully implantable CBGM system in Australia in **Q3 2025**[12](index=12&type=chunk) - Planned submission of the Company's Investigational Device Exemption (IDE) to the U.S. Food and Drug Administration in **Q4 2025**, to initiate a U.S. long-term, multicenter Pilot Study[12](index=12&type=chunk) - Announced participation in FORGETDIABETES, a European research initiative, where Glucotrack's CBGM technology will provide real-time glucose data for an artificial pancreas[12](index=12&type=chunk) [Financial Results for the year-to-date six months ended June 30, 2025](index=3&type=section&id=Financial%20Results%20for%20the%20year-to-date%20six%20months%20ended%20June%2030%2C%202025) This section presents Glucotrack's H1 2025 financial performance, detailing changes in expenses, net loss, and cash position [Research and Development Expenses](index=3&type=section&id=Research%20and%20Development%20Expenses) Research and development expenses decreased by $0.7 million for the six months ended June 30, 2025, primarily due to timing in product and manufacturing development activities | Period | Amount (in millions) | | :--- | :--- | | 2025 | $5.0 | | 2024 | $5.7 | | **Change** | **-$0.7 (Decrease)** | - The decrease was primarily due to timing in product and manufacturing development activities[7](index=7&type=chunk) [Marketing, General and Administrative Expenses](index=3&type=section&id=Marketing%2C%20General%20and%20Administrative%20Expenses) Marketing, General and Administrative expenses increased by $1.6 million for the six months ended June 30, 2025, mainly attributable to increased legal and professional fees and personnel costs | Period | Amount (in millions) | | :--- | :--- | | 2025 | $3.3 | | 2024 | $1.7 | | **Change** | **+$1.6 (Increase)** | - The increase was primarily attributable to increased legal and professional fees and personnel costs[8](index=8&type=chunk) [Net Loss](index=3&type=section&id=Net%20Loss) Net loss for the six months ended June 30, 2025, increased to $11.6 million compared to $7.4 million in the prior-year period, primarily due to a non-cash change in fair value of derivative liabilities and increased operating expenses | Period | Amount (in millions) | | :--- | :--- | | 2025 | $11.6 | | 2024 | $7.4 | | **Change** | **+$4.2 (Increase)** | - The increase in net loss is attributable primarily to a non-cash **$3.3 million** change in fair value of derivative liabilities and an increase of **$0.9 million** in operating expenses[9](index=9&type=chunk) [Cash Position](index=3&type=section&id=Cash%20Position) Cash and cash equivalents increased to $9.6 million as of June 30, 2025, from $5.6 million at December 31, 2024, primarily due to $10.7 million in net proceeds from public equity financings, offsetting cash used in operations and investing activities. The company believes existing cash will fund operations through 2025 | Date | Amount (in millions) | | :--- | :--- | | June 30, 2025 | $9.6 | | December 31, 2024 | $5.6 | | **Net Increase** | **+$4.0** | - The net increase in cash and cash equivalents was attributable to **$10.7 million** net proceeds from public equity financings, offset by cash used in operating and investing activities of **$6.7 million**[10](index=10&type=chunk) - Based on current plans, the Company believes its existing cash and cash equivalents will be sufficient to fund its **2025** operating plan, including initiation of human clinical trials and related milestones[11](index=11&type=chunk) [About Glucotrack, Inc.](index=4&type=section&id=About%20Glucotrack%2C%20Inc.) This section provides an overview of Glucotrack, Inc., detailing its mission and implantable CBGM system features [Company Overview and Product Focus](index=4&type=section&id=Company%20Overview%20and%20Product%20Focus) Glucotrack, Inc. is a medical technology company focused on designing, developing, and commercializing novel technologies for people with diabetes, specifically a long-term implantable continuous blood glucose monitoring (CBGM) system with a 3-year sensor longevity and no on-body wearable component - Glucotrack, Inc. (Nasdaq: GCTK) is a medical technology company focused on novel technologies for people with diabetes[13](index=13&type=chunk) - The Company is currently developing a long-term implantable continuous blood glucose monitoring (CBGM) system[13](index=13&type=chunk) - The CBGM system features a sensor longevity of **3 years**, no on-body wearable component, and minimal calibration[14](index=14&type=chunk) - The Glucotrack CBGM is an Investigational Device and is limited by federal law to investigational use[14](index=14&type=chunk) [Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) This section outlines inherent risks and uncertainties of forward-looking statements, emphasizing potential deviations [Disclaimer and Risk Factors](index=4&type=section&id=Disclaimer%20and%20Risk%20Factors) This section contains cautionary statements regarding forward-looking information, emphasizing that actual results may differ materially due to various factors, including the ability to raise additional capital, regulatory approvals, clinical trial risks, and other risks detailed in SEC filings - This news release contains forward-looking statements subject to risks and uncertainties, and Glucotrack undertakes no obligation to publicly update them[16](index=16&type=chunk) - Factors that may affect actual results include the ability to raise additional capital, risks relating to regulatory approvals (including FDA), risks relating to patient enrollment and conduct of clinical trials, and future distribution agreements[16](index=16&type=chunk) - Additional risk factors are described in Glucotrack's filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2024[16](index=16&type=chunk) [Contacts](index=4&type=section&id=Contacts) This section provides essential contact information for investor relations and media inquiries [Investor and Media Relations](index=4&type=section&id=Investor%20and%20Media%20Relations) This section provides contact information for investor relations and media inquiries - Investor Relations contact: investors@glucotrack.com[17](index=17&type=chunk) - Media contact: GlucotrackPR@icrinc.com[17](index=17&type=chunk) [Financial Statements](index=5&type=section&id=Financial%20Statements) This section presents Glucotrack's condensed consolidated financial statements, including balance sheets and operations [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, Glucotrack's total assets increased significantly to $10.2 million from $5.9 million at December 31, 2024, driven by an increase in cash and cash equivalents. Total liabilities decreased substantially due to the reduction in derivative financial liabilities, leading to a positive stockholders' equity **Condensed Consolidated Balance Sheets (in thousands of US dollars):** | Item | June 30, 2025 | December 31, 2024 | Change | | :--- | :--- | :--- | :--- | | Cash and cash equivalents | $9,555 | $5,617 | +$3,938 | | Total current assets | $10,077 | $5,768 | +$4,309 | | TOTAL ASSETS | $10,210 | $5,932 | +$4,278 | | Derivative financial liabilities | $5 | $17,421 | -$17,416 | | Total liabilities | $3,330 | $18,932 | -$15,602 | | Total stockholders' equity (deficit) | $6,880 | $(13,000) | +$19,880 | - A significant decrease in derivative financial liabilities from **$17,421 thousand** as of December 31, 2024, to **$5 thousand** as of June 30, 2025[19](index=19&type=chunk) - The company transitioned from a total stockholders' deficit of **$(13,000) thousand** to a positive total stockholders' equity of **$6,880 thousand**[19](index=19&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For the six months ended June 30, 2025, Glucotrack reported an increased net loss of $11.6 million compared to $7.4 million in the prior year, primarily due to a $3.3 million change in fair value of derivative liabilities. Operating expenses saw a slight increase, with R&D decreasing and G&A/Marketing increasing **Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands of US dollars):** | Item | Six-month period ended June 30, 2025 | Six-month period ended June 30, 2024 | Three-month period ended June 30, 2025 | Three-month period ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development expenses | $5,021 | $5,737 | $3,150 | $3,589 | | General and administrative expenses | $2,963 | $1,535 | $1,464 | $802 | | Marketing expenses | $310 | $170 | $182 | $100 | | Total operating expenses | $8,294 | $7,442 | $4,796 | $4,491 | | Operating loss | $8,294 | $7,442 | $4,796 | $4,491 | | Change in fair value of derivative Liabilities | $3,269 | $0 | $(107) | $0 | | Net Loss | $11,589 | $7,416 | $4,756 | $4,489 | | Basic and diluted net loss per common stock | $34.81 | $1,700 | $9.62 | $984 | | Weighted average number of common stock | 332,931 | 4,363 | 494,504 | 4,564 | - Net loss for the six-month period increased by **$4,173 thousand** year-over-year, primarily driven by a **$3,269 thousand** change in fair value of derivative liabilities in 2025[20](index=20&type=chunk) - Basic and diluted net loss per common stock for the six months ended June 30, 2025, was **$34.81**, significantly lower than **$1,700** in the prior year, reflecting a substantial increase in weighted average shares outstanding[20](index=20&type=chunk)