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]

Core Viewpoint - Glucotrack, Inc. will implement a 1-for-60 reverse stock split effective June 16, 2025, to comply with Nasdaq's minimum bid price requirement and attract institutional investors [1][3]. Group 1: Reverse Stock Split Details - The reverse stock split will reduce the total outstanding shares from 32,541,327 to approximately 542,356 shares [8]. - Each stockholder's ownership percentage will remain unchanged, except for fractional shares, which will be rounded up to the next whole share [8]. - The new CUSIP number for the Common Stock post-split will be 45824Q804 [2]. Group 2: Compliance and Strategic Intent - The reverse stock split aims to bring Glucotrack into compliance with the $1.00 minimum bid price requirement for Nasdaq listing [3]. - The company may face delisting if it becomes deficient with any Nasdaq Listing Rule before September 29, 2025 [3]. Group 3: Company Overview - Glucotrack focuses on developing novel technologies for diabetes management, including a long-term implantable continuous blood glucose monitoring system [7][9].

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]

Core Insights - Glucotrack, Inc. has established a Patient Advisory Board (PAB) to incorporate patient perspectives into the development of its long-term implantable Continuous Blood Glucose Monitor (CBGM) technology [1][2][3] - The PAB consists of individuals with diabetes who will provide insights on the challenges of diabetes management, influencing all stages of the CBGM's development from clinical trials to commercialization [2][3] - The CBGM is designed to offer continuous, accurate blood glucose monitoring for up to three years without a wearable component, measuring glucose directly from blood rather than interstitial fluid [4][7] Company Overview - Glucotrack, Inc. focuses on the design, development, and commercialization of innovative technologies for diabetes management [6] - The company is currently developing a long-term implantable continuous blood glucose monitoring system aimed at improving the convenience and accuracy of glucose monitoring for individuals with diabetes [6][7] Product Details - The CBGM system is characterized by its long-term implantable nature, sensor longevity of three years, and minimal calibration requirements [4][7] - Unlike traditional systems, the CBGM provides real-time glucose readings without the lag associated with interstitial fluid measurements, enhancing the user experience [4]

Financial Performance - The company reported a net loss of approximately $6.833 million for the three-month period ended March 31, 2025, compared to a net loss of approximately $2.927 million for the same period in 2024, reflecting an increase in general and administrative expenses and changes in derivative liabilities [95]. - General and administrative expenses increased to approximately $1.499 million for the three-month period ended March 31, 2025, from approximately $733,000 in the prior-year period, primarily due to higher legal and professional fees [90]. - Research and development expenses decreased to approximately $1.871 million for the three-month period ended March 31, 2025, compared to approximately $2.148 million in the prior-year period, attributed to reduced product and manufacturing fees related to the Glucotrack CBGM [91]. - The company has an accumulated deficit of $139.283 million as of March 31, 2025, and has not yet commercialized the Glucotrack CBGM [100]. Cash Position and Funding Needs - The company had cash and cash equivalents of $9.1 million as of March 31, 2025, up from $5.617 million as of December 31, 2024, due to financing activities [96]. - The company estimates it will require approximately $15.0 million in cash to fund operations over the next twelve months, raising substantial doubt about its ability to continue as a going concern [99]. - The company entered into an ATM sales agreement to issue and sell shares of Common Stock with an aggregate offering price of up to $8.23 million [79]. - The company sold 12,377,967 shares of Common Stock at an average offering price of $0.304 per share, resulting in net proceeds of $3.6 million [80]. Regulatory and Clinical Developments - A regulatory submission has been made for a first-in-human study outside the United States, with a long-term clinical trial expected to begin in the second quarter of 2025 [75]. - The company successfully demonstrated continuous glucose sensing in the epidural space, which is significant for diabetes patients considering spinal cord stimulation therapy [74]. Accounting and Reporting - No material changes to critical accounting policies and estimates as filed in the Annual Report on Form 10-K for the year ended December 31, 2024 [103]. - Company does not have any off balance sheet agreements [104]. - As a smaller reporting company, the company is not required to provide certain market risk disclosures [106].

[Corporate Highlights and Outlook](index=1&type=section&id=Corporate%20Highlights%20and%20Outlook) Glucotrack achieved key milestones in Q1 2025, including ethical approval for its CBGM study in Australia and successful first-in-human trials - The company is on track to implant the first patients in its long-term, multicenter feasibility study of the fully implantable CBGM system in Australia in **Q3 2025**[1](index=1&type=chunk)[11](index=11&type=chunk) - Expects to receive Investigational Device Exemption (IDE) approval from the U.S. FDA for its novel CBGM technology in **Q4 2025**[1](index=1&type=chunk)[11](index=11&type=chunk) - Received ethical approval in Australia to initiate a long-term clinical study of the CBGM in participants with type 1 and type 2 diabetes[3](index=3&type=chunk) - Successfully completed a first-in-human clinical study that met its primary endpoint with no serious adverse events, confirming sensor function and placement[3](index=3&type=chunk) - Collaborating with OneTwo Analytics to apply advanced AI and machine learning to its clinical study data to gain deeper insights into the technology's performance[3](index=3&type=chunk) - Received **ISO 13485:2016 certification**, demonstrating its ability to meet global standards for medical device design and manufacturing[4](index=4&type=chunk) [Financial Results (Q1 2025)](index=2&type=section&id=Financial%20Results%20for%20the%20Quarter%20ended%20March%2031%2C%202025) Q1 2025 saw a net loss of $6.8 million, driven by a non-cash charge, while cash reserves increased to $9.1 million Q1 2025 vs Q1 2024 Financial Performance (in millions) | Metric | Q1 2025 | Q1 2024 | Change | Primary Reason | | :--- | :--- | :--- | :--- | :--- | | Research & Development | $1.9 million | $2.1 million | -$0.2 million | Timing in product development activities | | Marketing, General & Admin | $1.6 million | $0.8 million | +$0.8 million | Increased legal, professional, and personnel costs | | **Net Loss** | **$6.8 million** | **$2.9 million** | **+$3.9 million** | **$3.4 million non-cash change in fair value of derivative liabilities** | Cash Position | Date | Cash and Cash Equivalents | | :--- | :--- | | **March 31, 2025** | **$9.1 million** | | December 31, 2024 | $5.6 million | - The increase in cash was primarily due to **$6.4 million** received from financing activities, offset by **$2.9 million** used in operating and investing activities[9](index=9&type=chunk) - The company believes its existing cash and cash equivalents are sufficient to fund its **2025 operating plan**, including the initiation of human clinical trials[10](index=10&type=chunk) [Financial Statements](index=4&type=section&id=Financial%20Statements) The financial statements reflect a strengthened balance sheet with positive equity and a net loss of $6.8 million for Q1 2025 [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets reached $9.6 million, liabilities significantly decreased, and stockholders' equity turned positive to $7.3 million Condensed Consolidated Balance Sheets (in thousands of US dollars) | | March 31, 2025 (Unaudited) | December 31, 2024 | | :--- | :--- | :--- | | **Total current assets** | **$9,455** | **$5,768** | | Cash and cash equivalents | $9,100 | $5,617 | | **TOTAL ASSETS** | **$9,612** | **$5,932** | | **Total current liabilities** | **$1,950** | **$1,275** | | Derivative financial liabilities | $177 | $17,421 | | **Total liabilities** | **$2,354** | **$18,932** | | **Total stockholders' equity (deficit)** | **$7,258** | **($13,000)** | | **TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)** | **$9,612** | **$5,932** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Q1 2025 operating loss was $3.5 million, with a net loss of $6.8 million primarily due to derivative liability changes Condensed Consolidated Statements of Operations (in thousands of US dollars) | | Three-month period ended March 31, | | | :--- | :--- | :--- | | | **2025** | **2024** | | Research and development | $1,871 | $2,148 | | General and administrative | $1,499 | $733 | | **Total operating expenses** | **$3,498** | **$2,951** | | **Operating loss** | **($3,498)** | **($2,951)** | | Change in fair value of derivative liabilities | $3,376 | - | | **Net Loss** | **($6,833)** | **($2,927)** | | **Basic and diluted net loss per common stock** | **($0.67)** | **($11.73)** | [Company Information and Disclosures](index=3&type=section&id=Company%20Information%20and%20Disclosures) Glucotrack develops a 3-year implantable CBGM system, with disclosures highlighting forward-looking statements and associated risks - The company is focused on the design, development, and commercialization of a long-term implantable continuous blood glucose monitoring system for people with diabetes[13](index=13&type=chunk) - Glucotrack's CBGM is designed to be a long-term implantable system with a sensor longevity of **3 years**, no on-body wearable component, and minimal calibration[14](index=14&type=chunk) - The CBGM is currently an Investigational Device and is limited by U.S. federal law to investigational use only[12](index=12&type=chunk) - The report contains forward-looking statements and warns of risks related to raising capital, regulatory approvals, clinical trial enrollment, and other factors described in SEC filings[15](index=15&type=chunk)