[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)

Core Viewpoint - Glucotrack, Inc. is making significant advancements in the development of its fully implantable continuous blood glucose monitor (CBGM) system, with plans to initiate clinical studies in Australia and submit an Investigational Device Exemption (IDE) to the FDA by the end of 2025, while also strengthening its corporate structure and expanding its advisory boards [1][2][11]. Corporate Highlights - The company is on track to implant the first patients in a long-term, multicenter feasibility study of the CBGM system in Australia in Q3 2025 [1]. - An IDE submission to the FDA for the novel CBGM technology is anticipated in Q4 2025 [1]. - The Board of Directors has been strengthened with the appointment of Dr. David S. Hirsh as Medical Director - Cardiology and Dr. Victoria E. Carr-Brendel to the Board [2][5]. - A Patient Advisory Board has been established to incorporate patient perspectives into the development of the CBGM technology [2][5]. Financial Overview - Cash and cash equivalents as of June 30, 2025, were $9.6 million, an increase from $5.6 million as of December 31, 2024, primarily due to $10.7 million in net proceeds from public equity financings [12]. - Research and development expenses for the six months ended June 30, 2025, were $5.0 million, down from $5.7 million in the prior-year period [8]. - Marketing, general, and administrative expenses increased to $3.3 million for the six months ended June 30, 2025, compared to $1.7 million in the prior-year period [9]. - The net loss for the six months ended June 30, 2025, was $11.6 million, compared to a net loss of $7.4 million for the same period in the previous year [10]. Clinical Development - Positive results were reported from a first-in-human study for the CBGM, achieving a Mean Absolute Relative Difference (MARD) of 7.7% across 122 matched pairs, with a 99% data capture rate [11]. - The company received ethical approval in Australia to initiate a long-term clinical study of the CBGM in participants with type 1 and type 2 diabetes [11]. - Glucotrack is participating in the FORGETDIABETES initiative, which aims to develop an artificial pancreas for type 1 diabetes, utilizing the CBGM technology for real-time glucose data [11].

Company Overview - Glucotrack, Inc. is a medical device company focused on the design, development, and commercialization of novel technologies for people with diabetes [5] - The company is developing a long-term implantable continuous blood glucose monitoring system [5][6] Product Details - Glucotrack's Continuous Blood Glucose Monitor (CBGM) is designed to measure blood glucose levels directly from the blood, without the need for on-body wearables, and has a sensor longevity of up to three years [3][6] - The CBGM aims to minimize daily disruptions for diabetes patients by addressing limitations of traditional continuous glucose monitors (CGM), such as frequent sensor changes and challenges associated with on-body wearables [3] Upcoming Events - Glucotrack will participate in the 2025 Association of Diabetes Care and Education Specialists (ADCES) Annual Meeting from August 8-11, 2025, in Phoenix, AZ [1] - The company will showcase its CBGM at Booth 1724 and present a poster on physician perspectives regarding continuous blood glucose monitoring technology [2][3]

Core Insights - Glucotrack, Inc. has successfully repurchased over 90% of its outstanding Series A Warrants as part of its capital formation strategy, reflecting confidence in its product development [1][2][4] - The repurchase involved approximately 49,700 Series A Warrants, leaving around 4,300 outstanding, with expectations for further repurchases [3] - The Series A and Series B Warrants were originally issued in connection with a $10 million public offering completed in November 2024 [2] Company Overview - Glucotrack, Inc. focuses on the design, development, and commercialization of innovative technologies for diabetes management [4][5] - The company is developing a long-term implantable continuous blood glucose monitoring system, which features a sensor longevity of 3 years and minimal calibration requirements [5] Financial Strategy - The warrant repurchase is seen as a significant step towards strengthening the company's capital structure and delivering value to shareholders [4] - The repurchase was funded using existing cash on hand, indicating a solid financial position [3]

Core Insights - Glucotrack's Continuous Blood Glucose Monitor (CBGM) technology has demonstrated safety and accuracy with a Mean Absolute Relative Difference (MARD) of 7.7% in a first-in-human clinical study [1][2][5] Study Results - The clinical study met all primary and secondary endpoints, achieving a 99% data capture rate and no serious adverse events related to the procedure or device [2][4] - Analysis showed that 92% of CBGM measurement values were in the green zone according to the Diabetes Technology Society Error Grid, indicating high clinical accuracy [3] Technology Overview - The CBGM is a fully implantable system that measures glucose directly from blood, eliminating lag time associated with traditional interstitial fluid monitors [6] - Designed for a three-year sensor life, the system requires minimal calibration and has no on-body wearable component, offering a less intrusive solution for diabetes management [6][11] Future Plans - Glucotrack plans to initiate a long-term early feasibility study in Q3 2025 to further evaluate the safety and performance of the CBGM technology [5]

1-for-60 reverse stock split to become effective as of the opening of trading on June 16, 2025 Rutherford, NJ, June 12, 2025 (GLOBE NEWSWIRE) -- Glucotrack, Inc. (Nasdaq: GCTK) (“Glucotrack” or the “Company”), a medical technology company focused on the design, development, and commercialization of novel technologies for people with diabetes, today announced that it will effect a 1-for-60 reverse stock split (the “Reverse Stock Split”) of its issued and outstanding common stock par value $0.001 per share (t ...

Core Insights - Glucotrack, Inc. is set to present safety and performance data from its first-in-human trial of an implantable continuous blood glucose monitoring (CBGM) system at the American Diabetes Association's 85th Scientific Sessions in June 2025 [1][4] - The CBGM system is designed to measure glucose directly from the blood, offering real-time, accurate readings without the need for wearable devices, and has a sensor longevity of up to three years [5][8] Company Overview - Glucotrack, Inc. focuses on the design, development, and commercialization of innovative technologies for diabetes management [7] - The company aims to redefine diabetes management through its long-term CBGM system, which minimizes daily disruptions for users [4][5] Event Details - The American Diabetes Association's 85th Scientific Sessions will take place in Chicago from June 20 to June 23, 2025, where Glucotrack will participate in the Innovation Hub program [2] - Mark Tapsak, the Chief Scientific Officer of Glucotrack, will deliver a live presentation on the future of continuous glucose monitoring [2][7] Technology Highlights - Glucotrack's CBGM system is an investigational device that operates from within the body, measuring blood glucose levels directly, unlike traditional monitors that measure interstitial fluid [5][8] - The system is designed for minimal calibration and aims to provide a more convenient solution for diabetes management [8]

Company Overview - Glucotrack, Inc. is focused on the design, development, and commercialization of novel technologies for people with diabetes [5] - The company is currently developing a long-term implantable continuous blood glucose monitoring (CBGM) system [5][6] Leadership Addition - Victoria E. Carr-Brendel, PhD, has been elected to Glucotrack's Board of Directors effective May 22, 2025 [1] - Dr. Carr-Brendel brings extensive experience in medical devices and implantable technologies, having held leadership roles at various companies including Vicarious Surgical Inc. and Sonova Group [2][3] Technology Development - Glucotrack's CBGM is designed as a long-term implantable system that provides continuous blood glucose monitoring for up to three years [3][6] - The system measures glucose directly from blood, offering real-time readings without the lag time associated with traditional continuous glucose monitoring systems [3] Strategic Importance - Dr. Carr-Brendel expressed her commitment to contributing to Glucotrack's strategic and clinical milestones, emphasizing the potential of the CBGM to address unmet needs for diabetes management [3]

About Glucotrack, Inc. Patients get a seat at the table in development of long-term implantable continuous blood glucose monitoring technology RUTHERFORD, N.J., May 20, 2025 (GLOBE NEWSWIRE) -- Glucotrack, Inc. (Nasdaq: GCTK), a medical device company focused on the design, development, and commercialization of novel technologies for people with diabetes, today announced the formation of a Patient Advisory Board (PAB) comprised of leading patient voices and advocates within the diabetes community. Following ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________________ to ________________ Commission File Number: 001-41141 GLUCOTRACK, INC. (Exact name of registrant as specified in its charter) Delaware 98-0668934 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 301 Route 17 North, Suite 800 Rutherford, ...