Glucotrack Reports First Quarter 2025 Financial Results and Recent Corporate Highlights
- Received ethical approval in Australia for long-term clinical study of CBGM
- Successfully completed first-in-human clinical study with no serious adverse events
- Cash position improved to $9.1M from $5.6M in December 2024
- Obtained ISO 13485:2016 certification demonstrating quality standards compliance
- Strategic partnerships established with FORGETDIABETES initiative and OneTwo Analytics
- Net loss increased significantly to $6.8M from $2.9M year-over-year
- Marketing, General and Administrative expenses doubled to $1.6M from $0.8M
- Product still in investigational phase with no immediate revenue generation
Insights
Glucotrack's CBGM advances toward Q3 clinical trials with solid progress, though widening losses may pressure its $9.1M cash position.
Glucotrack is making methodical progress on its fully implantable continuous blood glucose monitor (CBGM), which represents a potentially disruptive advancement in diabetes management technology. The company has secured ethical approval in Australia for a long-term clinical study and is on track to implant first patients in Q3 2025, following a successful first-in-human study that met its primary safety endpoint. The CBGM system's multi-year implantable design offers a significant differentiation from current CGM technologies that typically require weekly or bi-weekly sensor replacements.
The company's ISO 13485:2016 certification is particularly noteworthy as it validates their quality management system meets international standards for medical device manufacturing, an essential regulatory milestone. Their expected IDE approval from the FDA in Q4 2025 would mark another critical regulatory advancement, opening the path to U.S. clinical trials.
The company's collaborations are strategically sound - particularly their involvement in the European FORGETDIABETES artificial pancreas initiative and partnership with OneTwo Analytics to apply AI to their clinical data. These relationships could accelerate development and potentially enhance the system's capabilities.
However, investors should note the widening net loss of $6.8 million compared to $2.9 million in Q1 2024, with $3.4 million attributed to non-cash changes in derivative liabilities. While their cash position improved to $9.1 million from $5.6 million at year-end 2024 (due to $6.4 million from financing activities), their current burn rate suggests potential capital constraints as clinical trials advance. The company believes its cash will fund the 2025 operating plan through initial human clinical trials, but expansion beyond this timeframe will likely require additional funding.
Glucotrack shows promising clinical progress but faces concerning financial trends with widening losses and potentially inadequate cash runway.
Glucotrack's Q1 2025 financials reveal concerning trends that temper optimism about their clinical progress. The company's net loss more than doubled year-over-year to $6.8 million compared to $2.9 million in Q1 2024. While $3.4 million of this increase stems from non-cash derivative liability valuation changes, the remaining $0.5 million represents a real increase in operating expenses, particularly in SG&A which rose 100% year-over-year from $0.8 million to $1.6 million.
Cash position improved to $9.1 million from $5.6 million at 2024 year-end, but this increase came primarily from financing activities that contributed $6.4 million, masking the $2.9 million consumed by operations and investments. This quarterly burn rate projects to approximately $11.6 million annually, suggesting the current cash position provides less than a one-year runway at current spending levels.
The company's assertion that existing funds will sustain operations through 2025 operating plan and clinical trial initiation appears plausible, but barely. The impending Australian clinical trial in Q3 and potential U.S. IDE approval in Q4 will likely accelerate expenses, potentially straining financial resources further.
R&D expenses decreased slightly by $0.2 million, which the company attributes to timing of development activities rather than any strategic reduction in innovation efforts. However, the substantial increase in SG&A expenses merits scrutiny as it appears disproportionate for a pre-revenue company focused on clinical development. With no product revenues to offset these growing expenses, Glucotrack will almost certainly require additional capital raises in 2026, which could lead to further shareholder dilution if equity financing is pursued.
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 (IDE) approval for novel CBGM technology from FDA expected in Q4 2025
Rutherford, NJ, May 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 first quarter ended March 31, 2025.
“I am pleased with the progress we made during the quarter and look forward to commencing our clinical study in Australia, where we expect to continue growing our body of clinical evidence to support the use of our well-differentiated, fully implantable, real-time, multi-year continuous blood glucose monitoring system,” said Paul V. Goode, PhD, President and Chief Executive Officer of Glucotrack. “At the same time, we remain focused on strengthening our capital structure and ensuring that we have the runway to bring our potentially life-improving technology to the millions of diabetes patients who need it most.”
First Quarter 2025 & Recent Highlights
Advanced Product and Clinical Development
- Received ethical approval in Australia to initiate long-term clinical study of the Company’s continuous blood glucose monitor (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.
- Announced collaboration with OneTwo Analytics to apply advanced artificial intelligence and machine learning analytics to clinical study data from the Company’s CBGM. The partnership aims to generate deeper insights into the performance and clinical impact of the Company’s technology.
- Successfully completed a first-in-human clinical study of the CBGM that met its primary endpoint with no procedure- or device-related serious adverse events reported. The study confirmed successful function and placement of the sensor lead in the subclavian vein, and demonstrated solid Bluetooth performance with accuracy comparable to animal studies. These data were presented at the 2025 International Conference on Advanced Technologies & Treatment for Diabetes (ATTD).
- 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.
Anticipated Milestones in 2025
- 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.
- Implanting first patients in long-term, multicenter feasibility study of the fully implantable CBGM system in Australia, anticipated in Q3 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 Quarter ended March 31, 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 first quarter of 2025 was
Cash Position: Cash and cash equivalents as of March 31, 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.
The Glucotrack Continuous Blood Glucose Monitor is an Investigational Device and is limited by federal (or United States) law to investigational use.
For more information about Glucotrack’s CBGM, visit glucotrack.com. Information on the Company’s website does not constitute a part of and is not incorporated by reference into this press release.
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 “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) | ||||||||
| March 31, 2025 | December 31, 2024 | |||||||
| Unaudited | ||||||||
| Current Assets | ||||||||
| Cash and cash equivalents | 9,100 | 5,617 | ||||||
| Other current assets | 355 | 151 | ||||||
| Total current assets | 9,455 | 5,768 | ||||||
| Operating lease right-of-use asset, net | 53 | 59 | ||||||
| Property and equipment, net | 94 | 95 | ||||||
| Restricted cash | 10 | 10 | ||||||
| TOTAL ASSETS | 9,612 | 5,932 | ||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | ||||||||
| Current Liabilities | ||||||||
| Accounts payable | 1,612 | 992 | ||||||
| Operating lease liability, current | 26 | 26 | ||||||
| Convertible promissory notes | 9 | 5 | ||||||
| Other current liabilities | 303 | 252 | ||||||
| Total current liabilities | 1,950 | 1,275 | ||||||
| Non-Current Liabilities | ||||||||
| Derivative financial liabilities (Note 2F and Note 3B) | 177 | 17,421 | ||||||
| Operating lease liability, non-current | 26 | 33 | ||||||
| Loans from stockholders | 201 | 203 | ||||||
| Total liabilities | 2,354 | 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 March 31, 2025 and December 31, 2024, respectively; 25,585,853 and 791,609 shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively | 26 | 1 | ||||||
| Additional paid-in capital | 146,259 | 119,229 | ||||||
| Receipts on account of shares | 228 | 228 | ||||||
| Accumulated other comprehensive income | 28 | (8 | ) | |||||
| Accumulated deficit | (139,283 | ) | (132,450 | ) | ||||
| Total stockholders’ equity (deficit) | 7,258 | (13,000 | ) | |||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | 9,612 | 5,932 | ||||||
GLUCOTRACK INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands of US dollars except share data) (unaudited)
| Three-month period ended March 31, | ||||||||
| 2025 | 2024 | |||||||
| Operating expenses | ||||||||
| Research and development | $ | 1,871 | $ | 2,148 | ||||
| General and administrative | 1,499 | 733 | ||||||
| Selling and marketing expenses | 128 | 70 | ||||||
| Total operating expenses | 3,498 | 2,951 | ||||||
| Operating loss | 3,498 | 2,951 | ||||||
| Other (income) expense | ||||||||
| Change in fair value of derivative liabilities | 3,376 | - | ||||||
| Other (income) expense, net | (4 | ) | - | |||||
| Finance expenses (income), net | (37 | ) | (24 | ) | ||||
| Net Loss | 6,833 | 2,927 | ||||||
| Other comprehensive income: | ||||||||
| Foreign currency translation adjustment | (36 | ) | (6 | ) | ||||
| Comprehensive loss for the period | $ | 6,797 | $ | 2,921 | ||||
| Basic and diluted net loss per common stock | $ | (0.67 | ) | $ | (11.73 | ) | ||
| Weighted average number of common stock used in computing basic and diluted loss per common stock | 10,160,725 | 249,598 | ||||||
FAQ
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