[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)

Core Insights - Glucotrack, Inc. is progressing towards the initiation of a long-term multicenter feasibility study for its fully implantable continuous blood glucose monitor (CBGM) system in Australia, expected to begin in Q3 2025 [1][6] - The company anticipates receiving Investigational Device Exemption (IDE) approval from the FDA for its novel CBGM technology in Q4 2025 [1][6] - The CEO expressed confidence in the clinical study's potential to enhance the body of evidence supporting the CBGM system, while also focusing on strengthening the company's capital structure [2] Product and Clinical Development - The company received ethical approval in Australia to start a long-term clinical study involving participants with type 1 and type 2 diabetes [6] - Glucotrack is participating in the FORGETDIABETES initiative, which aims to develop an artificial pancreas for type 1 diabetes, utilizing its CBGM technology for real-time glucose data [6] - A collaboration with OneTwo Analytics has been established to apply AI and machine learning to clinical study data, aiming to gain deeper insights into the technology's performance [6] - A first-in-human clinical study of the CBGM was successfully completed, meeting its primary endpoint with no serious adverse events reported [6] Financial Results - Research and development expenses for Q1 2025 were $1.9 million, a decrease from $2.1 million in Q1 2024, primarily due to timing in product development activities [7] - Marketing, general, and administrative expenses increased to $1.6 million in Q1 2025 from $0.8 million in Q1 2024, mainly due to higher legal and professional fees [8] - The net loss for Q1 2025 was $6.8 million, compared to a net loss of $2.9 million in Q1 2024, largely due to a non-cash change in fair value of derivative liabilities [9] Cash Position - As of March 31, 2025, cash and cash equivalents were $9.1 million, up from $5.6 million at the end of 2024, attributed to $6.4 million from financing activities [10] - The company believes its existing cash will be sufficient to fund its 2025 operating plan, including the initiation of human clinical trials [11] Milestones and Future Plans - The company plans to implant the first patients in the long-term multicenter feasibility study of the CBGM system in Australia in Q3 2025 [6] - IDE approval from the FDA for a long-term multicenter pilot study of the CBGM system is anticipated in Q4 2025 [6]

Core Insights - Glucotrack, Inc. has received ethical approval for a long-term clinical study of its continuous blood glucose monitor (CBGM) for type 1 and type 2 diabetes patients [1][2] - The study will enroll up to 30 participants and evaluate the device's performance and safety over an initial period of 1 year, with potential extension to 3 years [2][4] - The CBGM is designed to provide real-time blood glucose measurements directly from blood, offering advantages over traditional systems that measure interstitial fluid [3][4] Company Overview - Glucotrack, Inc. focuses on the design, development, and commercialization of innovative technologies for diabetes management [6] - The CBGM is a long-term implantable system with a sensor longevity of up to 3 years and minimal calibration required [7] Clinical Study Details - The study will be led by Professor David O'Neal and will take place at St. Vincent's Hospital Melbourne [2][3] - The first patient implants are expected to occur by July 2025 [2] - The study aims to address key challenges faced by diabetes patients, including the need for extended sensor life and the elimination of on-body wearables [4]

Core Insights - Glucotrack, Inc. is participating in the FORGETDIABETES initiative to develop a long-term automated insulin delivery system for optimal glucose control without patient intervention [1][2] - The FORGETDIABETES initiative is funded by the European Union's Horizon 2020 program, which has a budget of €75 billion for various research and innovation projects [2] - The initiative aims to create a bionic pancreas that alleviates the daily management burden of type 1 diabetes, transforming it into a more manageable lifestyle condition [3][4] Company Overview - Glucotrack focuses on designing, developing, and commercializing novel technologies for diabetes management, including a Continuous Blood Glucose Monitor (CBGM) [6][7] - The CBGM is a long-term implantable system with a sensor longevity of 3 years, requiring minimal calibration and no on-body wearable component [7] Initiative Details - The FORGETDIABETES initiative includes various participants, such as the University of Padova, BioRobotics Institute, and several health institutions across Europe [4] - The initiative aims to integrate Glucotrack's CBGM into automated insulin delivery systems, enhancing diabetes management [4]

Core Insights - Glucotrack, Inc. has entered into a collaboration with OneTwo Analytics AB to enhance the clinical study data analysis of its Continuous Blood Glucose Monitor (CBGM) using AI and machine learning technologies [1][3] - The CBGM is designed to provide real-time blood glucose readings directly from blood, offering a more accurate and less intrusive monitoring solution compared to traditional continuous glucose monitors [2][6] - The partnership aims to create a comprehensive ecosystem for diabetes management, integrating blood glucose insights, risk stratification data, and patient engagement tools [3][7] Company Overview - Glucotrack, Inc. focuses on developing innovative technologies for diabetes management, specifically a long-term implantable continuous blood glucose monitoring system [5][6] - OneTwo Analytics specializes in AI-driven healthcare solutions, particularly in diabetes data analysis and technology stack development [7][8] Product Features - The CBGM is a long-term implantable device with a sensor longevity of three years, requiring minimal calibration and having no external components [2][6] - This device aims to provide continuous and accurate blood glucose monitoring, enhancing the convenience for users [2][6] Strategic Goals - The collaboration with OneTwo Analytics is expected to leverage their analytics expertise to quantify the long-term benefits of the CBGM technology [3] - Both companies aim to revolutionize diabetes management by delivering an end-to-end solution for healthcare providers and patients [3][7]

Financial Performance - Glucotrack reported a net loss of $22.6 million for the full year 2024, compared to a net loss of $7.1 million in 2023, reflecting an increase in operating expenses and non-cash losses [8]. - Research and development expenses rose to $9.5 million in 2024, up from $4.7 million in 2023, primarily due to increased product design and pre-clinical study activities [6]. - Cash and cash equivalents increased to $5.6 million as of December 31, 2024, compared to $4.5 million at the end of 2023, with a pro forma cash position of $11.9 million after accounting for first quarter 2025 financing [9][10]. Funding and Development - The company secured $16.3 million in funding from multiple rounds between November 2024 and March 2025, providing necessary runway for product and clinical development milestones in 2025 [4]. Clinical Studies and Approvals - The first human clinical study of the continuous blood glucose monitor (CBGM) was successfully completed, meeting its primary endpoint with no serious adverse events reported [3]. - Anticipated FDA approval for Investigational Device Exemption (IDE) for the CBGM technology is expected in Q4 2025 [1]. - The company plans to commence a long-term multicenter feasibility study of the fully implantable CBGM system in Australia in Q2 2025 [5]. Compliance and Certification - The company received ISO 13485:2016 certification, demonstrating compliance with global standards for medical device design and manufacturing [5]. Leadership and Team Development - Glucotrack appointed several key executives to strengthen its leadership team, including a new Chief Financial Officer and Vice President of Regulatory Affairs [5]. Product Innovation - Glucotrack's CBGM technology aims to provide a fully implantable system with a sensor longevity of 3 years, enhancing convenience and accuracy for diabetes management [21].

Core Insights - Glucotrack, Inc. has successfully transitioned from a preclinical to a clinical stage company, focusing on the development of its continuous blood glucose monitoring (CBGM) technology [2][3] - The company anticipates FDA approval for its CBGM technology's Investigational Device Exemption (IDE) in Q4 2025, which is expected to enhance patient outcomes for those living with diabetes [1][2] Financial Performance - For the year ended December 31, 2024, research and development expenses increased to $9.5 million from $4.7 million in 2023, primarily due to heightened product design and development activities [7] - Marketing, general, and administrative expenses rose to $5.1 million in 2024 from $2.4 million in 2023, driven by increased legal and professional fees [8] - The net loss for 2024 was $22.6 million, compared to a net loss of $7.1 million in 2023, attributed to higher operating expenses and non-cash losses related to debt settlements [9] Cash Position - As of December 31, 2024, cash and cash equivalents were $5.6 million, up from $4.5 million in 2023, with a net increase due to financing activities [10] - Pro forma cash and cash equivalents, adjusted for early 2025 financing activities, were $11.9 million, indicating sufficient funds to support the 2025 operating plan [11][22] Clinical Development - The first human clinical study of the CBGM was successfully completed, meeting its primary endpoint without serious adverse events, confirming the technology's reliability and accuracy [4] - The company received ISO 13485:2016 certification, demonstrating its commitment to high-quality medical device standards [4] Leadership and Advisory Board - Glucotrack has strengthened its leadership team with key appointments, including a new Chief Financial Officer and Vice Presidents for Regulatory Affairs and Clinical Operations, enhancing its capacity for clinical development [12][12] Future Milestones - The company plans to commence a long-term multicenter feasibility study of the fully implantable CBGM system in Australia in Q2 2025 and aims to secure IDE approval for a pilot study [12][12]

Core Insights - Glucotrack, Inc. is set to present safety and performance data from its first-in-human trial of a long-term continuous blood glucose monitoring (CBGM) system at the 2025 International Conference on Advanced Technologies & Treatment for Diabetes (ATTD) in Amsterdam from March 19 to 22, 2025 [1][2] - The CBGM technology allows for real-time glucose monitoring directly from blood, potentially offering greater accuracy without the need for on-body wearables, marking a significant advancement in diabetes management [2][3] Company Overview - Glucotrack, Inc. focuses on the design, development, and commercialization of innovative technologies for diabetes care, currently developing a long-term implantable continuous blood glucose monitoring system [5][6] - The CBGM is designed to be a long-term implantable device with a sensor longevity of three years, providing continuous and accurate blood glucose monitoring without external components [3][6]

Core Insights - Glucotrack, Inc. announced the presentation of safety and performance data from its first-in-human trial of a long-term continuous blood glucose monitoring (CBGM) system at the 2025 International Conference on Advanced Technologies & Treatment for Diabetes (ATTD) [1][2] - The CBGM system is designed to measure glucose directly from the blood, offering real-time monitoring with potentially greater accuracy and without the need for on-body wearables, marking a significant advancement in diabetes management [2][3] - The device is an implantable system with a sensor longevity of three years, providing a more convenient and less intrusive glucose monitoring solution compared to traditional continuous glucose monitors [3][6] Company Overview - Glucotrack, Inc. focuses on the design, development, and commercialization of innovative technologies for diabetes care, currently developing a long-term implantable continuous blood glucose monitoring system [5][6] - The company aims to advance its clinical program with an upcoming chronic implant study following the presentation of findings at the ATTD conference [2][3]

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 currently developing a long-term implantable continuous blood glucose monitoring (CBGM) system [5][6] Key Appointment - Dr. Guillermo Umpierrez has been appointed as a new member of Glucotrack's Medical Advisory Board, effective immediately [1] - Dr. Umpierrez is a Professor of Medicine at Emory University and has extensive experience in diabetes care and clinical research [2] Technology Development - Glucotrack's CBGM system is designed to directly measure blood glucose levels without the lag time associated with traditional continuous glucose monitoring systems [3] - The CBGM system features a sensor life of 3 years, no wearable component, and aims to improve real-time accuracy, longevity, comfort, and supply management [3][6] Clinical Development - Dr. Umpierrez's expertise will be instrumental as Glucotrack advances its CBGM technology through clinical development and into human clinical trials [2] - The company aims to make glucose monitoring less burdensome for individuals living with diabetes [2]