Glucotrack Reports Second Quarter 2025 Financial Results and Recent Corporate Highlights
Glucotrack (NASDAQ:GCTK), a medical technology company developing novel diabetes technologies, reported significant progress in Q2 2025. The company is preparing to launch a multicenter feasibility study of its fully implantable continuous blood glucose monitor (CBGM) system in Australia in Q3 2025, followed by an FDA IDE submission in Q4 2025.
Key developments include strengthening the leadership team with Dr. David Hirsh as Medical Director-Cardiology and Dr. Victoria Carr-Brendel joining the Board. Clinical data presented at the ADA conference showed excellent accuracy with a MARD of 7.7% and 99% data capture rate. The company reported $9.6 million in cash as of June 30, 2025, sufficient to fund operations through 2025.
Financial results showed R&D expenses of $5.0 million and net loss of $11.6 million for H1 2025. The company strengthened its capital structure by repurchasing Series A Warrants to eliminate warrant liability and dilution concerns.
Glucotrack (NASDAQ:GCTK), società di tecnologia medica che sviluppa nuove soluzioni per il diabete, ha comunicato progressi significativi nel secondo trimestre 2025. L'azienda si prepara a lanciare uno studio di fattibilità multicentrico del suo sistema completamente impiantabile per il monitoraggio continuo del glucosio ematico (CBGM) in Australia nel terzo trimestre 2025, seguito da una sottomissione IDE alla FDA nel quarto trimestre 2025.
Tra gli sviluppi principali, il rafforzamento del team direttivo con la nomina del dott. David Hirsh come Medical Director-Cardiology e l'ingresso di dott.ssa Victoria Carr-Brendel nel Consiglio di Amministrazione. I dati clinici presentati all'ADA hanno mostrato un'ottima accuratezza con un MARD del 7,7% e un tasso di acquisizione dati del 99%. Al 30 giugno 2025 la società aveva $9,6 milioni di liquidità, sufficienti per finanziare le operazioni fino al 2025.
I risultati finanziari hanno evidenziato costi per R&S pari a $5,0 milioni e una perdita netta di $11,6 milioni per il primo semestre 2025. La società ha inoltre rafforzato la struttura patrimoniale riacquistando le Warrant di Serie A per eliminare la passività legata alle warrant e le preoccupazioni di diluizione.
Glucotrack (NASDAQ:GCTK), una empresa de tecnología médica que desarrolla nuevas soluciones para la diabetes, informó avances significativos en el segundo trimestre de 2025. La compañía se está preparando para lanzar en el tercer trimestre de 2025 un estudio multicéntrico de viabilidad de su sistema totalmente implantable de monitor continuo de glucosa en sangre (CBGM) en Australia, seguido de la presentación de un IDE a la FDA en el cuarto trimestre de 2025.
Entre los hitos clave se incluye el fortalecimiento del equipo directivo con el nombramiento del Dr. David Hirsh como Medical Director-Cardiology y la incorporación de la Dra. Victoria Carr-Brendel al consejo. Los datos clínicos presentados en la ADA mostraron una excelente precisión con un MARD del 7,7% y una tasa de captura de datos del 99%. La compañía informó de $9,6 millones en efectivo a 30 de junio de 2025, suficiente para financiar las operaciones durante 2025.
En cuanto a las finanzas, los gastos de I+D fueron de $5,0 millones y la pérdida neta de $11,6 millones en el primer semestre de 2025. La empresa además mejoró su estructura de capital recomprando las Warrants de la Serie A para eliminar la pasividad por warrants y las preocupaciones sobre la dilución.
Glucotrack (NASDAQ:GCTK)는 혁신적인 당뇨병 기술을 개발하는 의료기기 회사로 2025년 2분기에 괄목할 만한 성과를 보고했습니다. 회사는 2025년 3분기에 호주에서 완전 이식형 연속 혈당모니터(CBGM) 시스템의 다기관 타당성 연구를 개시할 예정이며, 이어 2025년 4분기에 FDA에 IDE를 제출할 계획입니다.
주요 진전 사항으로는 Dr. David Hirsh를 Medical Director-Cardiology로 영입하고 Dr. Victoria Carr-Brendel을 이사회에 합류시키며 리더십을 강화한 점이 있습니다. ADA 학회에서 발표된 임상 데이터는 MARD 7.7%와 데이터 캡처율 99%로 우수한 정확도를 보였습니다. 회사는 2025년 6월 30일 기준 $9.6M의 현금을 보유하고 있어 2025년 내 운영 자금은 충분한 것으로 보고했습니다.
재무 실적은 2025년 상반기 연구개발 비용이 $5.0M, 순손실이 $11.6M임을 보여줍니다. 또한 회사는 Series A 워런트를 환매하여 워런트 부채와 희석 우려를 해소함으로써 자본 구조를 강화했습니다.
Glucotrack (NASDAQ:GCTK), une société de technologies médicales développant de nouvelles solutions pour le diabète, a annoncé des progrès significatifs au 2e trimestre 2025. L'entreprise se prépare à lancer au 3e trimestre 2025 une étude de faisabilité multicentrique de son système de moniteur glycémique sanguin continu entièrement implantable (CBGM) en Australie, suivie d'un dépôt IDE auprès de la FDA au 4e trimestre 2025.
Parmi les avancées clés figurent le renforcement de l'équipe dirigeante avec le Dr David Hirsh en tant que Medical Director-Cardiology et l'arrivée de la Dr Victoria Carr-Brendel au conseil d'administration. Les données cliniques présentées lors de l'ADA ont montré une excellente précision avec un MARD de 7,7 % et un taux de capture des données de 99 %. Au 30 juin 2025, la société disposait de 9,6 M$ en trésorerie, suffisant pour financer ses opérations pendant 2025.
Les résultats financiers montrent des dépenses R&D de 5,0 M$ et une perte nette de 11,6 M$ pour le premier semestre 2025. La société a par ailleurs renforcé sa structure de capital en rachetant les warrants de série A afin d'éliminer le passif lié aux warrants et les risques de dilution.
Glucotrack (NASDAQ:GCTK), ein Medizintechnologie-Unternehmen, das neuartige Diabetes-Technologien entwickelt, meldete deutliche Fortschritte im zweiten Quartal 2025. Das Unternehmen bereitet für das dritte Quartal 2025 den Start einer multizentrischen Machbarkeitsstudie seines vollständig implantierbaren kontinuierlichen Blutglukosemesssystems (CBGM) in Australien vor, gefolgt von einer IDE-Einreichung bei der FDA im vierten Quartal 2025.
Zu den wichtigsten Entwicklungen zählt die Verstärkung der Führungsebene mit Dr. David Hirsh als Medical Director-Cardiology sowie dem Eintritt von Dr. Victoria Carr-Brendel in den Verwaltungsrat. Klinische Daten, die auf der ADA vorgestellt wurden, zeigten eine hervorragende Genauigkeit mit einem MARD von 7,7 % und einer Daten-Erfassungsrate von 99 %. Zum 30. Juni 2025 wies das Unternehmen $9,6 Millionen an Zahlungsmitteln auf, ausreichend zur Finanzierung der Geschäftstätigkeit bis Ende 2025.
Finanziell ergaben sich F&E-Aufwendungen von $5,0 Millionen und ein Nettoverlust von $11,6 Millionen für das erste Halbjahr 2025. Zudem stärkte das Unternehmen seine Kapitalstruktur durch den Rückkauf der Series-A-Warrants, um die Verbindlichkeit aus Warrants und Verwässerungsbedenken zu beseitigen.
- Clinical trial results demonstrated excellent accuracy with 7.7% MARD and 99% data capture rate
- 73% of surveyed endocrinologists expressed willingness to prescribe CBGM at 3-year sensor life
- Cash position increased to $9.6 million from $5.6 million in December 2024
- Strengthened capital structure through Series A Warrants repurchase, eliminating dilution overhang
- R&D expenses decreased by $0.7 million compared to prior year period
- Net loss increased to $11.6 million from $7.4 million in prior year period
- Marketing, General and Administrative expenses increased by $1.6 million year-over-year
- Required additional $10.7 million from public equity financings to maintain operations
Insights
Glucotrack's implantable glucose monitor advances to clinical trials with FDA submission planned, amid strengthened leadership and improved financial position.
Glucotrack's Q2 update reveals significant progress toward commercialization of their potentially disruptive continuous blood glucose monitoring (CBGM) technology. The company has secured ethical approval in Australia and is on track to implant first patients in Q3 2025, representing a critical validation milestone. The planned FDA Investigational Device Exemption submission in Q4 2025 further accelerates their regulatory pathway.
Their technology's differentiated value proposition is becoming increasingly clear: a fully implantable, real-time, multi-year CBGM system that eliminates the need for external devices. Early clinical data is promising, with their first-in-human study demonstrating excellent accuracy (MARD of 7.7%) across 122 matched pairs, 99% data capture rate, and no serious adverse events. For context, a MARD below 10% is considered strong performance in glucose monitoring, putting Glucotrack's system in a competitive position.
Market validation data appears encouraging, with 73% of surveyed endocrinologists expressing willingness to prescribe a CBGM with 3-year sensor life. The company's participation in the FORGETDIABETES artificial pancreas initiative further validates their technology's potential integration into broader diabetes management systems.
Financially, the $9.6M cash position represents improvement from $5.6M at end-2024, with management stating it's sufficient to fund operations through 2025, including overseas clinical trials. The strategic warrant repurchase eliminates dilution concerns and improves their capital structure for future fundraising. R&D expenses decreased slightly to $5M for the six-month period, while G&A expenses increased to $3.3M, reflecting organizational growth. The net loss widened to $11.6M, largely due to non-cash derivative liability adjustments.
The strengthened leadership, including Dr. Carr-Brendel's board appointment and Dr. Hirsh joining as Medical Director-Cardiology, brings valuable implantable device expertise at a critical juncture when implantation protocols need refinement. The formation of a Patient Advisory Board demonstrates commitment to user-centered design in a competitive diabetes market.
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
Investigational Device Exemption submission to FDA of novel CBGM technology in Q4 2025
Strengthened Board of Directors, expands clinical advisory board, and established a Patient Advisory Board
Improved capital structure, cash and cash equivalents expected to fund operations through 2025, including initiation of OUS clinical trials and achievement of related milestones
Rutherford, NJ, Aug. 14, 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 reported financial results and recent corporate highlights for the six months ended June 30, 2025.
“This quarter, we made meaningful progress across the business, including the expansion of our clinical advisory team with the appointment of Dr. Hirsh, an expert in implantation protocols, as Medical Director - Cardiology, and the election of Dr. Carr-Brendel, a seasoned medical device executive, to our Board of Directors. We also established a Patient Advisory Board to ensure patient perspectives remain central as we continue to refine and advance our CBGM technology. We are also encouraged by the growing momentum and strong interest in our technology, particularly among key opinion leaders, as demonstrated by the standing-room-only audience at our presentation during the ADA conference in June,” said Paul V. Goode, PhD, President and Chief Executive Officer of Glucotrack. “At the same time, we strengthened our capital structure, removing the warrant liability and share dilution overhang which, we believe, creates attractive opportunities for new investors to join in our mission to bring our potentially life-improving technology to the millions of diabetes patients who need it most.”
Dr. Goode continued, “Looking ahead, we are on track to initiate our clinical study in Australia in the third quarter and to continue building our robust body of clinical evidence supporting the use of our well-differentiated, fully implantable, real-time, multi-year CBGM system. We also anticipate submitting our IDE to the FDA in the fourth quarter, enabling in 2026 the launch of our long-term, multicenter Pilot Study in the US.”
Second Quarter 2025 & Recent Highlights
Corporate Highlights
- Strengthened capital structure through the repurchase of Series A Warrants. The transaction eliminated the warrant liability accounting and share dilution overhang, preserving shareholder value and providing optionality for potential investors.
- Appointed David S. Hirsh, M.D., as Medical Director – Cardiology, expanding the clinical advisory team. Dr. Hirsh brings extensive cardiology and electrophysiology experience to Glucotrack, and his procedural expertise will be invaluable in optimizing the Company’s implantation protocols and ensuring patient safety.
- Elected Victoria E. Carr-Brendel, Ph.D., to the Company’s Board of Directors. Dr. Carr-Brendel brings extensive leadership experience as a medical device executive, with particular expertise in implantable technologies.
- Established a Patient Advisory Board (PAB) to inform the development of the Company’s CBGM technology. The PAB comprises leading patient voices and advocates within the diabetes community with firsthand experiences and understanding of the impact diabetes management has on daily living. The PAB was established to keep patients’ insights at the forefront of Glucotrack’s development plans for its CBGM.
Advanced Product and Clinical Development
- Presented a poster at the Association of Diabetes Care & Education Specialists (ADCES) Annual Conference held August 8-10, 2025, titled “Endocrinologists’ Perspectives on an Implantable Continuous Blood Glucose Monitor,” demonstrating strong endocrinologist interest in the continuous blood glucose monitoring concept due to its extended sensor life, freedom from wearables, and the potential for greater accuracy from blood-based readings. At a sensor life of 3 years,
73% of the 100 endocrinologists surveyed expressed a willingness to prescribe the CBGM. - Presented compelling data at the American Diabetes Association’s (ADA) 85th Scientific Sessions held June 20-23, 2025:
- In a poster presentation titled, “Early Feasibility Study to Evaluate an Intravascular Continuous Blood Glucose Monitor in Adults with Diabetes Mellitus,” Glucotrack reported positive final results of their first-in-human study for continuous blood glucose monitoring. The Company leveraged OneTwo Analytics’ advanced artificial intelligence and machine learning platform to generate deeper insights into the performance and clinical impact of the Company’s technology. The study met all primary and secondary endpoints, demonstrating excellent accuracy with a Mean Absolute Relative Difference (MARD) of
7.7% across 122 matched pairs, a99% data capture rate, and no procedure or device-related serious adverse events. These findings begin to validate the safety and performance of the Company’s long-term, implantable CBGM. - In an oral presentation titled “Re-Imagining the Future of Continuous Glucose Monitoring with CBGM,” Glucotrack discussed the future of continuous glucose monitoring and the Company’s CBGM technology.
- In a poster presentation titled, “Early Feasibility Study to Evaluate an Intravascular Continuous Blood Glucose Monitor in Adults with Diabetes Mellitus,” Glucotrack reported positive final results of their first-in-human study for continuous blood glucose monitoring. The Company leveraged OneTwo Analytics’ advanced artificial intelligence and machine learning platform to generate deeper insights into the performance and clinical impact of the Company’s technology. The study met all primary and secondary endpoints, demonstrating excellent accuracy with a Mean Absolute Relative Difference (MARD) of
- Received ethical approval in Australia to initiate long-term clinical study of the Company’s CBGM in participants with type 1 and type 2 diabetes.
- Announced participation in FORGETDIABETES, a prominent European research initiative dedicated to developing an immuno-optimized, fully-implantable, fully-automated, artificial pancreas for people with type 1 diabetes. Glucotrack’s CBGM technology will provide real-time glucose data to guide insulin dosing decisions within the artificial pancreas.
Anticipated Milestones in 2025
- Implanting first patients in long-term, multicenter feasibility study of the fully implantable CBGM system in Australia, anticipated in third quarter of 2025.
- Submitting the Company’s Investigational Device Exemption (IDE) to the U.S. Food and Drug Administration in the fourth quarter of 2025, to initiate a U.S. long-term, multicenter Pilot Study of the CBGM system, subject to current agency response timelines.
- Presenting clinical data demonstrating the safety and accuracy of the CBGM at additional industry conferences.
- Further expanding Advisory Boards with world-renowned experts in endocrinology and cardiology and others essential to the diabetes community.
Financial Results for the year-to-date six months ended June 30, 2025
Research and Development Expenses: Research and development expenses were
Marketing, General and Administrative Expenses: Marketing, General and Administrative expenses were
Net Loss: Net loss for the six months ended June 30, 2025, was
Cash Position: Cash and cash equivalents as of June 30, 2025, were
Based on current plans and assumptions, the Company believes that its existing cash and cash equivalents will be sufficient to fund its 2025 operating plan to initiate human clinical trials and related milestones.
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About Glucotrack, Inc.
Glucotrack, Inc. (Nasdaq: GCTK) is focused on the design, development, and commercialization of novel technologies for people with diabetes. The Company is currently developing a long-term implantable continuous blood glucose monitoring system for people living with diabetes.
Glucotrack’s Continuous Blood Glucose Monitor (CBGM) is a long-term, implantable system that continually measures blood glucose levels with a sensor longevity of 3 years, no on-body wearable component and with minimal calibration. The Glucotrack CBGM is an Investigational Device and is limited by federal (or United States) law to investigational use.
For more information, please visit http://www.glucotrack.com. Information on the Company’s website does not constitute a part of and is not incorporated by reference into this press release.
Forward-Looking Statements
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements contained in this news release that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “anticipate”, “believe”, “expect”, “plan” and “will” are intended to identify forward-looking statements. Such forward-looking statements are based on the beliefs of management, as well as assumptions made by, and information currently available to, management. These statements relate only to events as of the date on which the statements are made, and Glucotrack undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. All of the forward-looking statements made in this press release are qualified by these cautionary statements, and there can be no assurance that the actual results anticipated by Glucotrack will be realized or, even if substantially realized, that they will have the expected consequences to or effects on us or our business or operations. Readers are cautioned that certain important factors may affect Glucotrack’s actual results and could cause such results to differ materially from any forward-looking statements that may be made in this news release. Factors that may affect Glucotrack’s results include, but are not limited to, the ability of Glucotrack to raise additional capital to finance its operations (whether through public or private equity offerings, debt financings, strategic collaborations or otherwise); risks relating to the receipt (and timing) of regulatory approvals (including U.S. Food and Drug Administration approval); risks relating to enrollment of patients in, and the conduct of, clinical trials; risks relating to Glucotrack’s future distribution agreements; risks relating to its ability to hire and retain qualified personnel, including sales and distribution personnel; and the additional risk factors described in Glucotrack’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including its Annual Report on Form 10-K for the year ended December 31, 2024 as filed with the SEC on March 31, 2025.
Contacts:
| Investor Relations: | Media: |
| investors@glucotrack.com | GlucotrackPR@icrinc.com |
GLUCOTRACK INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands of US dollars except share data)
| In thousands of US dollars (except stock data) | ||||||||
| June 30, 2025 | December 31, 2024 | |||||||
| Unaudited | ||||||||
| Current Assets | ||||||||
| Cash and cash equivalents | $ | 9,555 | $ | 5,617 | ||||
| Other current assets | 522 | 151 | ||||||
| Total current assets | 10,077 | 5,768 | ||||||
| Operating lease right-of-use asset, net | 46 | 59 | ||||||
| Property and equipment, net | 87 | 95 | ||||||
| Restricted cash | - | 10 | ||||||
| TOTAL ASSETS | $ | 10,210 | $ | 5,932 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | ||||||||
| Current Liabilities | ||||||||
| Accounts payable | $ | 2,644 | $ | 992 | ||||
| Operating lease liability, current | 27 | 26 | ||||||
| Convertible promissory notes | - | 5 | ||||||
| Other current liabilities | 414 | 252 | ||||||
| Total current liabilities | 3,085 | 1,275 | ||||||
| Non-Current Liabilities | ||||||||
| Derivative financial liabilities (Note 2F and Note 3B) | 5 | 17,421 | ||||||
| Operating lease liability, non-current | 19 | 33 | ||||||
| Loans from stockholders | 221 | 203 | ||||||
| Total liabilities | $ | 3,330 | $ | 18,932 | ||||
| Commitments and contingent liabilities (Note 4) | ||||||||
| Stockholders’ Equity (Deficit) | ||||||||
| Common Stock of | ||||||||
| 250,000,000 and 100,000,000 shares authorized as of June 30, 2025 and December 31, 2024, respectively; 899,410 and 13,409 shares issued and outstanding as of June 30, 2025 and December 31, 2024, respectively | 1 | (*) | ||||||
| Additional paid-in capital | 150,649 | 119,230 | ||||||
| Receipts on account of shares | 228 | 228 | ||||||
| Accumulated other comprehensive income | 41 | (8 | ) | |||||
| Accumulated deficit | (144,039 | ) | (132,450 | ) | ||||
| Total stockholders’ equity (deficit) | 6,880 | (13,000 | ) | |||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | $ | 10,210 | $ | 5,932 | ||||
GLUCOTRACK INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands of US dollars except share data) (unaudited)
| Six-month period ended June 30, | Three-month period ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Operating expenses | ||||||||||||||||
| 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 | ||||||||||||
| Other (income) expense | ||||||||||||||||
| Change in fair value of derivative Liabilities | 3,269 | - | (107 | ) | - | |||||||||||
| Other (income) expense, net | 92 | 96 | ||||||||||||||
| Finance income, net | (66 | ) | (26 | ) | (29 | ) | (2 | ) | ||||||||
| Net Loss | 11,589 | 7,416 | 4,756 | 4,489 | ||||||||||||
| Other comprehensive income: | ||||||||||||||||
| Foreign currency translation adjustment | (65 | ) | (6 | ) | (29 | ) | - | |||||||||
| Comprehensive loss for the period | $ | 11,524 | $ | 7,410 | $ | 4,727 | $ | 4,489 | ||||||||
| Basic and diluted net loss per common stock | $ | 34.81 | $ | 1,700 | $ | 9.62 | $ | 984 | ||||||||
| Weighted average number of common stock used in computing basic and diluted loss per common stock | 332,931 | 4,363 | 494,504 | 4,564 | ||||||||||||
FAQ
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