GlucoTrack(GCTK) - 2025 Q2 - Quarterly Report

PART I - FINANCIAL INFORMATION This section presents the company's unaudited condensed consolidated financial statements and related disclosures Item 1. Financial Statements 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 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] - 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] - Derivative financial liabilities decreased substantially from $17,421 thousand to $5 thousand, indicating a significant reduction in these obligations[14] Condensed Consolidated Statements of Operations and Comprehensive Loss 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][125] - 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][112][119] - 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][113][120] Condensed Consolidated Statement of Changes in Stockholders' Equity 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] - 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] - Cashless exchange of warrants into common shares contributed $20.625 million to additional paid-in capital, involving 162,063 shares[18] Condensed Consolidated Statements of Cash Flows 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] - 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] - 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] Notes to Condensed Consolidated Financial Statements This section provides detailed explanations and additional information supporting the financial statements NOTE 1 – GENERAL 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 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][28] - 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] - 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] - 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] B. Liquidity and Going Concern 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] - The company's cash and cash equivalents amounted to $9.555 million as of June 30, 2025[29] - Management has determined that these conditions raise substantial doubt about the company's ability to continue as a going concern[31] - During the six months ended June 30, 2025, the company raised $10.7 million through the sale of common stock to finance operations[30] C. 2025 Reverse Stock Splits and Increase in Authorized Common Stock 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][34] - 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] - All shares, options, warrants, and loss per share amounts have been retroactively adjusted for these reverse stock splits[35] NOTE 2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES 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 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] - 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] B. Use of Estimates in the Preparation of Financial Statements 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] C. Principles of Consolidation 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] D. Cash and Cash Equivalents 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] E. Warrants 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] - 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] F. Fair value of financial instruments 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] | 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 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][49] - The Chief Executive Officer acts as the Chief Operating Decision Maker (CODM), reviewing consolidated results for resource allocation and performance assessment[46][49] H. Basic and diluted loss per share 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] | 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 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 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][54] - A Registered Direct Offering in February 2025 raised approximately $2.752 million net proceeds from the sale of 43,968 shares[55] - 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][59] B. Warrant Net Share Exchange into Common Stock and Warrant Repurchase 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] - 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] - 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] C. Note and Warrant Purchase Agreements 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] - 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] - As of June 30, 2025, all notes have been settled by the company[71] NOTE 4 – COMMITMENTS AND CONTINGENT LIABILITIES 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] - 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] - 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] - 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][78] - The third milestone was met on March 26, 2025, earning an additional 42 shares and recognizing $0.6 thousand in stock-based compensation[80] NOTE 5. SUBSEQUENT EVENTS 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] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations 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 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][91] - 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] - 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] - 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][91] Recent Events 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][93][94] - 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][98] - A Registered Direct Offering in February 2025 generated approximately $2.752 million in net proceeds from the sale of 43,968 shares[100] - 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] - Peter C. Wulff was appointed Chief Financial Officer on January 28, 2025[105] Financial Overview 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] - 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] - Other (income) expense primarily includes changes in the fair value of derivative liabilities and finance income/expense[109] Results of Operations 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 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] - 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] - 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][118] - Change in derivative liability resulted in a $0.107 million decrease (income) for Q2 2025, reflecting fair value adjustments of remaining warrants[115] Consolidated Results of Operations for the Six Months ended June 30, 2025 and 2024 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] - 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] - 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][125] - 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] Liquidity and Going Concern 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] - The company has a history of recurring losses and an accumulated deficit of $144.039 million as of June 30, 2025[127] - 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] - Substantial doubt exists about the company's ability to continue as a going concern, necessitating additional capital through debt, equity, or other arrangements[128] Critical Accounting Policies 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] - 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] Off Balance Sheet Arrangements 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] Item 3. Quantitative and Qualitative Disclosures About Market Risk 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] Item 4. Controls and Procedures 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 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] - 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] - Remediation actions include implementing proper IT system access controls, backing up IT architecture, outsourcing certain accounting functions, and hiring additional accounting personnel[135] Changes in Internal Control over Financial Reporting 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] PART II - OTHER INFORMATION This section covers legal proceedings, risk factors, equity sales, and other miscellaneous disclosures Item 1. Legal Proceedings 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] Item 1A. Risk Factors 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] - Additional risks and uncertainties not currently known or deemed immaterial may also adversely affect the business[140] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 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][142][143] Item 3. Defaults Upon Senior Securities The company reported no defaults upon senior securities for the period. - There were no defaults upon senior securities[144] Item 4. Mine Safety Disclosures This item is not applicable to GlucoTrack Inc. - Mine Safety Disclosures are not applicable to the company[144] Item 5. Other Information The company reported no other information requiring disclosure under this item. - No other information was reported under this item[145] Item 6. Exhibits 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] - 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] - Inline XBRL documents (Instance, Schema, Calculation, Label, Presentation, Definition Linkbase) are included for interactive data filing[147] 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][151]