GlucoTrack(GCTK) - 2025 Q2 - Quarterly Results

Executive Summary This section provides an overview of Glucotrack's Q2 2025 performance, strategic developments, and future outlook Overview of Q2 2025 Performance and Outlook 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][2] - Investigational Device Exemption (IDE) submission to FDA of novel CBGM technology anticipated in Q4 2025, enabling a U.S. Pilot Study in 2026[1][2] - Strengthened Board of Directors, expanded clinical advisory board, and established a Patient Advisory Board[1][2] - Improved capital structure by removing warrant liability and share dilution overhang, with cash and cash equivalents expected to fund operations through 2025[1][2] Second Quarter 2025 & Recent Highlights This section details Glucotrack's corporate achievements and advancements in product and clinical development during Q2 2025 Corporate Highlights 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] - Appointed David S. Hirsh, M.D., as Medical Director – Cardiology, expanding the clinical advisory team[5] - Elected Victoria E. Carr-Brendel, Ph.D., a seasoned medical device executive, to the Company's Board of Directors[5] - Established a Patient Advisory Board (PAB) to inform the development of the Company's CBGM technology, ensuring patient insights are at the forefront[5] Advanced Product and Clinical Development 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] - 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] - 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] Anticipated Milestones in 2025 This section outlines Glucotrack's key upcoming milestones for CBGM development and clinical trials in 2025 Key Milestones for CBGM Development and Clinical Trials 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] - Anticipated implantation of first patients in the long-term, multicenter feasibility study of the fully implantable CBGM system in Australia in Q3 2025[12] - 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] - Announced participation in FORGETDIABETES, a European research initiative, where Glucotrack's CBGM technology will provide real-time glucose data for an artificial pancreas[12] Financial Results for the year-to-date six months ended June 30, 2025 This section presents Glucotrack's H1 2025 financial performance, detailing changes in expenses, net loss, and cash position Research and Development Expenses 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] Marketing, General and Administrative Expenses 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] Net Loss 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] Cash Position 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] - 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] About Glucotrack, Inc. This section provides an overview of Glucotrack, Inc., detailing its mission and implantable CBGM system features Company Overview and Product Focus 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] - The Company is currently developing a long-term implantable continuous blood glucose monitoring (CBGM) system[13] - The CBGM system features a sensor longevity of 3 years, no on-body wearable component, and minimal calibration[14] - The Glucotrack CBGM is an Investigational Device and is limited by federal law to investigational use[14] Forward-Looking Statements This section outlines inherent risks and uncertainties of forward-looking statements, emphasizing potential deviations Disclaimer and Risk Factors 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] - 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] - 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] Contacts This section provides essential contact information for investor relations and media inquiries Investor and Media Relations This section provides contact information for investor relations and media inquiries - Investor Relations contact: investors@glucotrack.com[17] - Media contact: GlucotrackPR@icrinc.com[17] Financial Statements This section presents Glucotrack's condensed consolidated financial statements, including balance sheets and operations Condensed Consolidated Balance Sheets 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] - The company transitioned from a total stockholders' deficit of $(13,000) thousand to a positive total stockholders' equity of $6,880 thousand[19] Condensed Consolidated Statements of Operations and Comprehensive Loss 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] - 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]