Glucotrack Reports Full Year 2024 Financial Results and Recent Corporate Highlights
Glucotrack (NASDAQ: GCTK) reported its full year 2024 financial results, marking a transformative year as the company advanced from preclinical to clinical stage. The company successfully completed its first human clinical study of the continuous blood glucose monitor (CBGM), which met its primary endpoint with no serious adverse events.
Key financial highlights include:
- R&D expenses increased to $9.5M (vs $4.7M in 2023)
- Marketing and administrative expenses rose to $5.1M (vs $2.4M in 2023)
- Net loss widened to $22.6M (vs $7.1M in 2023)
- Cash position of $5.6M as of December 31, 2024
- Secured $16.3M through multiple funding rounds from November 2024 through March 2025
The company expects FDA IDE approval for their CBGM technology in Q4 2025 and plans to commence a long-term multicenter feasibility study in Australia in Q2 2025. Their CBGM technology will be the first fully implantable system with a multi-year monitoring capability and real-time measuring features.
Glucotrack (NASDAQ: GCTK) ha riportato i risultati finanziari per l'intero anno 2024, segnando un anno di trasformazione mentre l'azienda è passata dalla fase preclinica a quella clinica. L'azienda ha completato con successo il suo primo studio clinico umano sul monitoraggio continuo della glicemia (CBGM), che ha raggiunto il suo obiettivo primario senza eventi avversi gravi.
Le principali evidenze finanziarie includono:
- Le spese per R&S sono aumentate a 9,5 milioni di dollari (rispetto ai 4,7 milioni di dollari nel 2023)
- Le spese di marketing e amministrative sono salite a 5,1 milioni di dollari (rispetto ai 2,4 milioni di dollari nel 2023)
- La perdita netta è aumentata a 22,6 milioni di dollari (rispetto ai 7,1 milioni di dollari nel 2023)
- Posizione di cassa di 5,6 milioni di dollari al 31 dicembre 2024
- Assicurati 16,3 milioni di dollari attraverso più turni di finanziamento da novembre 2024 a marzo 2025
L'azienda si aspetta l'approvazione IDE della FDA per la propria tecnologia CBGM nel quarto trimestre del 2025 e prevede di avviare uno studio di fattibilità multicentrico a lungo termine in Australia nel secondo trimestre del 2025. La loro tecnologia CBGM sarà il primo sistema completamente impiantabile con capacità di monitoraggio pluriennale e caratteristiche di misurazione in tempo reale.
Glucotrack (NASDAQ: GCTK) informó sus resultados financieros del año completo 2024, marcando un año transformador mientras la empresa avanzó de la etapa preclínica a la etapa clínica. La compañía completó con éxito su primer estudio clínico humano del monitor de glucosa en sangre continuo (CBGM), que cumplió con su objetivo primario sin eventos adversos graves.
Los aspectos financieros clave incluyen:
- Los gastos de I+D aumentaron a 9,5 millones de dólares (frente a 4,7 millones de dólares en 2023)
- Los gastos de marketing y administrativos aumentaron a 5,1 millones de dólares (frente a 2,4 millones de dólares en 2023)
- La pérdida neta se amplió a 22,6 millones de dólares (frente a 7,1 millones de dólares en 2023)
- Posición de efectivo de 5,6 millones de dólares al 31 de diciembre de 2024
- Aseguró 16,3 millones de dólares a través de múltiples rondas de financiamiento desde noviembre de 2024 hasta marzo de 2025
La empresa espera la aprobación IDE de la FDA para su tecnología CBGM en el cuarto trimestre de 2025 y planea comenzar un estudio de viabilidad multicéntrico a largo plazo en Australia en el segundo trimestre de 2025. Su tecnología CBGM será el primer sistema completamente implantable con capacidad de monitoreo a varios años y características de medición en tiempo real.
글루코트랙 (NASDAQ: GCTK)은 2024년 전체 연도 재무 결과를 보고하며, 회사가 전임상 단계에서 임상 단계로 발전한 변혁의 해를 기념합니다. 회사는 지속적인 혈당 모니터(CBGM)의 첫 번째 인간 임상 연구를 성공적으로 완료했으며, 주요 목표를 달성하고 심각한 부작용 없이 진행되었습니다.
주요 재무 하이라이트는 다음과 같습니다:
- 연구 개발 비용이 950만 달러로 증가했습니다(2023년 470만 달러 대비)
- 마케팅 및 관리 비용이 510만 달러로 증가했습니다(2023년 240만 달러 대비)
- 순손실이 2260만 달러로 확대되었습니다(2023년 710만 달러 대비)
- 2024년 12월 31일 기준 현금 보유액이 560만 달러입니다
- 2024년 11월부터 2025년 3월까지 여러 자금 조달 라운드를 통해 1630만 달러를 확보했습니다
회사는 2025년 4분기에 CBGM 기술에 대한 FDA IDE 승인을 기대하고 있으며, 2025년 2분기에 호주에서 장기 다기관 타당성 연구를 시작할 계획입니다. 그들의 CBGM 기술은 다년간 모니터링 기능과 실시간 측정 기능을 갖춘 최초의 완전 이식형 시스템이 될 것입니다.
Glucotrack (NASDAQ: GCTK) a annoncé ses résultats financiers pour l'année complète 2024, marquant une année transformative alors que l'entreprise est passée de la phase préclinique à la phase clinique. L'entreprise a réussi à compléter sa première étude clinique humaine sur le moniteur de glucose sanguin continu (CBGM), qui a atteint son objectif principal sans événements indésirables graves.
Les points financiers clés incluent :
- Les dépenses de R&D ont augmenté à 9,5 millions de dollars (contre 4,7 millions de dollars en 2023)
- Les dépenses de marketing et administratives ont augmenté à 5,1 millions de dollars (contre 2,4 millions de dollars en 2023)
- La perte nette s'est élargie à 22,6 millions de dollars (contre 7,1 millions de dollars en 2023)
- Position de trésorerie de 5,6 millions de dollars au 31 décembre 2024
- 16,3 millions de dollars sécurisés grâce à plusieurs tours de financement de novembre 2024 à mars 2025
L'entreprise attend l'approbation IDE de la FDA pour sa technologie CBGM au quatrième trimestre 2025 et prévoit de commencer une étude de faisabilité multicentrique à long terme en Australie au deuxième trimestre 2025. Leur technologie CBGM sera le premier système entièrement implantable avec une capacité de surveillance pluriannuelle et des fonctionnalités de mesure en temps réel.
Glucotrack (NASDAQ: GCTK) hat seine Finanzzahlen für das Gesamtjahr 2024 veröffentlicht und damit ein transformierendes Jahr markiert, da das Unternehmen von der präklinischen zur klinischen Phase übergegangen ist. Das Unternehmen hat erfolgreich seine erste klinische Studie mit Menschen zum kontinuierlichen Blutzuckermonitor (CBGM) abgeschlossen, die ihr primäres Ziel ohne schwerwiegende Nebenwirkungen erreicht hat.
Wichtige finanzielle Höhepunkte sind:
- F&E-Ausgaben stiegen auf 9,5 Millionen Dollar (im Vergleich zu 4,7 Millionen Dollar im Jahr 2023)
- Marketing- und Verwaltungskosten stiegen auf 5,1 Millionen Dollar (im Vergleich zu 2,4 Millionen Dollar im Jahr 2023)
- Der Nettoverlust erweiterte sich auf 22,6 Millionen Dollar (im Vergleich zu 7,1 Millionen Dollar im Jahr 2023)
- Liquidität von 5,6 Millionen Dollar zum 31. Dezember 2024
- 16,3 Millionen Dollar durch mehrere Finanzierungsrunden von November 2024 bis März 2025 gesichert
Das Unternehmen erwartet die FDA IDE-Zulassung für seine CBGM-Technologie im vierten Quartal 2025 und plant, im zweiten Quartal 2025 eine langfristige multizentrische Machbarkeitsstudie in Australien zu beginnen. Ihre CBGM-Technologie wird das erste vollständig implantierbare System mit mehrjährigen Überwachungsmöglichkeiten und Echtzeitmessfunktionen sein.
- Successful completion of first human clinical study with positive safety results
- Secured $16.3M in funding through multiple rounds
- Received ISO 13485:2016 certification for medical device quality standards
- Strengthened leadership team with key industry veterans
- Cash position sufficient to fund 2025 operating plan
- Net loss increased significantly to $22.6M from $7.1M in 2023
- R&D expenses doubled to $9.5M from $4.7M in 2023
- Marketing and administrative expenses more than doubled to $5.1M
- Additional financing needed for future operations beyond 2025
Insights
Glucotrack's year-end results reveal a classic biotech transition story as the company shifts from preclinical to clinical stage development. The $22.6 million net loss (up significantly from $7.1 million in 2023) reflects the expected higher burn rate associated with this transition, evident in the $9.5 million R&D expenses (up from $4.7 million).
The company's financing activities demonstrate substantial investor confidence, securing $16.3 million through multiple funding rounds from November 2024 through March 2025. This strengthens their pro forma cash position to $11.9 million when incorporating Q1 2025 activities, which management indicates should fund the 2025 operating plan and key milestones.
Their successful first human clinical study represents a crucial de-risking event, confirming both safety and functionality in a real-world setting. The parallel expansion of their leadership team with experienced industry executives in finance, regulatory affairs, and clinical operations aligns well with their development stage needs.
While the path to commercialization remains lengthy with IDE approval targeted for Q4 2025, Glucotrack has positioned itself with appropriate runway to reach these next inflection points. The long-term implantable continuous glucose monitoring market represents a substantial opportunity if they can successfully navigate the regulatory pathway with their differentiated technology.
Glucotrack's continuous blood glucose monitor (CBGM) technology offers several potential competitive advantages in the diabetes management space. Most significantly, their system features a multi-year sensor longevity (3 years), requires no on-body wearable component, and needs minimal calibration – addressing key limitations of current CGM technologies.
The successful completion of their first human clinical study provides early validation of the technology's core functionality. The study achieved three critical objectives: demonstrating safety with no serious adverse events, confirming proper sensor lead placement in the subclavian vein using standard cardiac pacemaker lead placement techniques, and verifying reliable Bluetooth performance with accuracy comparable to preclinical studies.
Their ISO 13485:2016 certification from BSI represents an important quality management milestone that will support future regulatory submissions. The planned Australian feasibility study (Q2 2025) and anticipated FDA IDE approval (Q4 2025) establish a clear regulatory pathway.
The company's novel research into glucose monitoring in the epidural space creates additional strategic opportunities in integrated chronic disease management beyond their core diabetes focus. This technical differentiation, combined with the strengthened clinical and regulatory team, positions Glucotrack well for the next phase of development in an increasingly competitive glucose monitoring market that demands meaningful innovation over incremental improvements.
Transformational 2024: successfully advanced from preclinical to clinical stage company
Strengthened leadership team to drive growth and advance clinical development
Investigational Device Exemption (IDE) approval for continuous blood glucose monitoring (CBGM) technology from FDA expected in Q4 2025
Rutherford, NJ, March 31, 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 fourth quarter and full year ended December 31, 2024.
“2024 was transformative for Glucotrack as we advanced the development of our CBGM technology and successfully transitioned from a preclinical to a clinical stage company. As we move into the next phase of growth, we have also strengthened our leadership team with key additions to our senior leadership, clinical and regulatory management team as well as our Medical Advisory Board,” said Paul V. Goode, PhD, President and Chief Executive Officer of Glucotrack. “We are confident that our differentiated technology for blood glucose monitoring will change the lives of those living with diabetes and improve patient outcomes. This will be the first fully implantable CBGM technology with a multi-year monitoring system and real-time measuring capabilities, offering differentiated benefits of accuracy, convenience and independence for patients.”
Dr. Goode continued, “As we look to 2025, I am pleased with the progress we are making to advance our technology. Moving towards these goals, we will continue to look for ways to strengthen our capital structure. We recently secured multiple funding rounds, demonstrating investors’ continued support of our mission, vision, and strategy. We are committed to pursuing additional financing strategies that align with our mission, create value for our shareholders, and provide additional runway to enable us to continue executing on our strategic priorities. We are optimistic about 2025 and look forward to updating you on our progress periodically.”
Fourth Quarter 2024 & Recent Highlights
Advanced Product and Clinical Development
- Successfully completed the first human clinical study of the continuous blood glucose monitor (CBGM) clearly demonstrating the promise and performance of the technology:
- The study met its primary endpoint with no procedure- or device-related serious adverse events reported from placement, use and through removal.
- The study confirmed the function and placement of the CBGM sensor lead in the subclavian vein and verified no additional tools or skillset beyond typical cardiac pacemaker lead placement are needed.
- The study confirmed reliable Bluetooth performance and demonstrated similar accuracy as seen in animal studies.
- Received ISO 13485:2016 certification from the British Standards Institute (BSI) demonstrating our commitment and ability to meet rigorous global standards for design and manufacturing of high-quality medical devices.
- Presented preclinical data at the Diabetes Technology Meeting in October 2024, highlighting the robust early performance of our CBGM.
- Successfully completed the first-ever long-term preclinical study of glucose monitoring in the epidural space, creating a pathway for strategic opportunities in integrated chronic disease management.
Strengthened Financial Position
- Secured
$16.3 million in proceeds through multiple rounds of funding from November 2024 through March 2025. The proceeds provide runway for the Company to achieve near-term product and clinical development milestones in 2025.
Strengthened Leadership and Board to Drive Clinical Development
- Appointed Guillermo Umpierrez, MD, CDCES, FACE, MACP to the Medical Advisory Board. As a former president of the American Diabetes Association for Medicine and Science, Dr. Umpierrez has extensive experience leading and participating in clinical research that has significantly advanced the understanding and treatment of diabetes.
- Appointed Peter Wulff as Chief Financial Officer. Mr. Wulff is an industry veteran with over 35 years of financial management experience in both public and privately held companies in the emerging growth life sciences sector.
- Appointed Ted Williams as Vice President of Regulatory Affairs. Mr. Williams is a seasoned executive with a proven track record of successfully guiding highly complex Class III medical devices through various regulatory pathways.
- Appointed Sandra Martha as Vice President Clinical Operations. Ms. Martha brings over 20 years of clinical research experience in both medical technology and drug development, leading all aspects of clinical trials and successful delivery of clinical trials to quickly advance products through the clinical lifecycle.
Anticipated Milestones in 2025
- Presenting clinical data demonstrating the safety and accuracy of the CBGM at major medical conferences
- Early Feasibility Study to Evaluate an Intravascular Continuous Blood Glucose Monitor in Adults with Diabetes Mellitus Poster Presentation at the recent 18th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD 2025), March 19-22, 2025, Amsterdam, The Netherlands.
- Further expanding our Advisory Board with world-renowned experts in endocrinology and cardiology.
- Commencing a long-term, multicenter feasibility study of the fully implantable CBGM system in Australia, anticipated in Q2 2025.
- Securing IDE approval from the U.S. Food and Drug Administration for a long-term, multicenter Pilot Study of the CBGM system, anticipated in Q4 2025, subject to current agency response timelines.
Financial Results for the Year Ended December 31, 2024
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 full year 2024 was
Cash Position: Cash and cash equivalents as of December 31, 2024, were
On a pro forma basis, cash and cash equivalents as of December 31, 2024 was
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.
GLUCOTRACK INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
In thousands of US dollars (except stock and per stock amounts) | ||||||||
2024 | 2023 | |||||||
Research and development expenses (Note 9) | 9,499 | 4,704 | ||||||
Marketing expenses | 393 | 122 | ||||||
General and administrative expenses (Note 10) | 4,655 | 2,278 | ||||||
Total operating expenses | 14,547 | 7,104 | ||||||
Operating loss | 14,547 | 7,104 | ||||||
Other (income) expense | (14 | ) | - | |||||
Change in fair value of derivative liability | 798 | - | ||||||
Loss on equity issuance | 1,925 | - | ||||||
Loss on settlement of liabilities | 4,758 | - | ||||||
Finance expense (income), net (Note 7) | 583 | (7 | ) | |||||
Loss for the year | 22,597 | 7,097 | ||||||
Other comprehensive loss: | ||||||||
Foreign currency translation adjustment | (24 | ) | 1 | |||||
Comprehensive loss for the year | 22,573 | 7,098 | ||||||
Basic and diluted loss per share (Note 2O) | 68.44 | 34.18 | ||||||
Weighted average number of Common Stock outstanding used in computing basic and diluted net loss per share | 330,171 | 207,603 |
GLUCOTRACK INC.
CONSOLIDATED BALANCE SHEETS
In thousands of US dollars (except stock data) | ||||||||
December 31, 2024 | December 31, 2023 | |||||||
Current Assets | ||||||||
Cash and cash equivalents (Note 2D) | 5,617 | 4,492 | ||||||
Other current assets | 151 | 376 | ||||||
Total current assets | 5,768 | 4,868 | ||||||
Operating lease right-of-use asset, net (Note 6) | 59 | - | ||||||
Property and equipment, net | 95 | 27 | ||||||
Restricted cash (Note 2D) | 10 | 10 | ||||||
TOTAL ASSETS | 5,932 | 4,905 | ||||||
LIABILITIES AND STOCKHOLDERS’ (DEFICIT) EQUITY | ||||||||
Current Liabilities | ||||||||
Accounts payable | 992 | 839 | ||||||
Operating lease liability, current (Note 6) | 26 | - | ||||||
Convertible promissory notes (Note 4E) | 5 | - | ||||||
Other current liabilities | 252 | 673 | ||||||
Total current liabilities | 1,275 | 1,512 | ||||||
Non-Current Liabilities | ||||||||
Derivative financial liabilities (Note 4F, 4G and Note 4J) | 17,421 | - | ||||||
Operating lease liability, non-current (Note 6) | 33 | - | ||||||
Loans from stockholders (Note 3) | 203 | 196 | ||||||
Total liabilities | 18,932 | 1,708 | ||||||
Commitments and contingent liabilities (Note 5) | ||||||||
Stockholders’ (Deficit) Equity (Note 8) | ||||||||
Common Stock of | ||||||||
100,000,000 shares authorized as of December 31, 2024 and 2023; 791,609 and 208,914 shares issued and outstanding as of December 31, 2024 and 2023, respectively | 1 | - | ||||||
Additional paid-in capital | 119,229 | 112,986 | ||||||
Receipts on account of shares | 228 | 48 | ||||||
Accumulated other comprehensive income | (8 | ) | 16 | |||||
Accumulated deficit | (132,450 | ) | (109,853 | ) | ||||
Total stockholders’ (deficit) equity | (13,000 | ) | 3,197 | |||||
TOTAL LIABILITIES AND STOCKHOLDERS’ (DEFICIT) EQUITY | 5,932 | 4,905 |
GLUCOTRACK INC.
UNAUDITED PRO FORMA BALANCE SHEET
The unaudited pro forma information gives effect to the first quarter 2025 Offerings, the exchange of Series B Warrants to common stock, and the revaluation of Series A Warrants.
The unaudited pro forma financial information is presented for informational purposes only and does not purport to represent what the results of operations or financial position of the Company would have been had the transactions described above actually occurred on the dates indicated, nor do they purport to project the financial condition of the Company for any future period or as of any future date. The unaudited pro forma financial information should be read in conjunction with the Company’s financial statements and notes thereto included elsewhere in this Annual Report.
UNAUDITED PRO FORMA CONDENSED BALANCE SHEET
Year Ended December 31, 2024 | ||||||||||||||||||||
Adjustments | ||||||||||||||||||||
As Reported | Series B Warrant Exercise | 2025 Offerings | Revaluation of Series A Warrants | Pro Forma as Adjusted | ||||||||||||||||
Current Assets | ||||||||||||||||||||
Cash and cash equivalents | 5,617 | 6,300 | 11,917 | |||||||||||||||||
Total assets | 5,932 | 12,232 | ||||||||||||||||||
LIABILITIES AND STOCKHOLDERS’ (DEFICIT) EQUITY | ||||||||||||||||||||
Non-Current Liabilities | ||||||||||||||||||||
Derivative financial liabilities | 17,421 | (14,877 | ) | (2,452 | ) | 92 | ||||||||||||||
Total liabilities | 18,932 | 1,603 | ||||||||||||||||||
Stockholders’ (Deficit) Equity | ||||||||||||||||||||
Additional paid-in capital | 119,229 | 14,877 | 6,300 | 2,452 | 142,858 | |||||||||||||||
Total stockholders’ (deficit) equity | (13,000 | ) | 10,629 | |||||||||||||||||
TOTAL LIABILITIES AND STOCKHOLDERS’ (DEFICIT) EQUITY | 5,932 | 12,232 |
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 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. For more information, please visit http://www.glucotrack.com.
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 “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:
investors@glucotrack.com
Media:
GlucotrackPR@icrinc.com
