GlucoTrack(GCTK) - 2025 Q1 - Quarterly Results

Corporate Highlights and Outlook 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][11] - Expects to receive Investigational Device Exemption (IDE) approval from the U.S. FDA for its novel CBGM technology in Q4 2025[1][11] - 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] - Successfully completed a first-in-human clinical study that met its primary endpoint with no serious adverse events, confirming sensor function and placement[3] - 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] - Received ISO 13485:2016 certification, demonstrating its ability to meet global standards for medical device design and manufacturing[4] Financial Results (Q1 2025) 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] - 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] Financial Statements 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 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 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 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] - 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] - The CBGM is currently an Investigational Device and is limited by U.S. federal law to investigational use only[12] - 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]