Glucotrack, Inc. (GCTK) — 10-K

Filed 2026-03-30 · Period ending 2025-12-31 · 63,577 words · SEC EDGAR

← GCTK Profile · GCTK JSON API

# Glucotrack, Inc. (GCTK) — 10-K

**Filed:** 2026-03-30
**Period ending:** 2025-12-31
**Accession:** 0001493152-26-013656
**Source:** [SEC EDGAR](https://www.sec.gov/Archives/edgar/data/1506983/000149315226013656/)
**Origin leaf:** 1c9b4cbc4cb96377ee1e5168ed2f8805561e621e75d53abcb6eab19c6d9ad3a6
**Words:** 63,577



---

**
UNITED
STATES**
**SECURITIES
AND EXCHANGE COMMISSION**
**Washington,
D.C. 20549**
**FORM
10-K**
****
**(Mark
One)**
| 
| 
ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |
**For
the fiscal year ended December 31, 2025**
**OR**
****
| 
| 
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |
**For
the transition period from _______ to ______**
**Commission
file number 001-41141**
**GLUCOTRACK,
INC.**
**(Exact
name of registrant as specified in its charter)**
| 
Delaware | 
| 
98-0668934 | |
| 
(State
or other jurisdiction of incorporation or organization) | 
| 
(I.R.S.
Employer Identification No.) | |
| 
| 
| 
| |
| 
301
Route 17 North, Suite 800
Rutherford,
NJ | 
| 
07070 | |
| 
(Address
of Principal Executive Offices) | 
| 
(Zip
Code) | |
**(201)
842-7715**
Registrants
telephone number, including area code
Securities
registered pursuant to Section 12(b) of the Act:
| 
Title
of each class | 
| 
Trading
Symbol(s) | 
| 
Name
of each exchange on which registered | |
| 
Common
Stock, par value $0.001 per share | 
| 
GCTK | 
| 
The
Nasdaq Stock Market LLC | |
Securities
registered pursuant to section 12(g) of the Act: None
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes No 
Indicate
by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes No 
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes No 
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes No 
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of large accelerated filer, accelerated filer,
smaller reporting company and emerging growth company in Rule 12b-2 of the Exchange Act.
| 
Large
accelerated filer | 
| 
| 
Accelerated
filer | 
| |
| 
Non-accelerated
filer | 
| 
| 
Smaller
reporting company | 
| |
| 
| 
| 
| 
Emerging
growth company | 
| |
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. 
Indicate
by check mark whether the registrant has filed a report on and attestation to its managements assessment of the effectiveness
of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered
public accounting firm that prepared or issued its audit report. 
If
securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant
included in the filing reflect the correction of an error to previously issued financial statements. 
Indicate
by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation
received by any of the registrants executive officers during the relevant recovery period pursuant to 240.10D-1(b). 
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes No 
As
of June 30, 2025, the last business day of the registrants last completed second quarter, the aggregate market value of the common
stock held by non-affiliates of the registrant was approximately $5.4 million based on the closing price per share of the registrants
common stock, par value $0.001 per share (the Common Stock), on June 30, 2025, as reported by the Nasdaq Stock Market.
For the purposes of this disclosure, shares of Common Stock held by each executive officer, director and affiliate based on public filings
and other information known to the registrant have been excluded since such persons may be deemed affiliates. This determination of affiliate
status is not necessarily a conclusive determination for other purposes.
As
of March 30, 2026, there were 1,944,279 shares of Common Stock, par value $0.001 per share, of the registrant issued and outstanding.
**DOCUMENTS
INCORPORATED BY REFERENCE**
None.
| | | |
****
**Table
of Contents**
| 
| 
Page | |
| 
PART
I | 
| |
| 
Item
1. Business | 
4 | |
| 
Item
1A. Risk Factors | 
15 | |
| 
Item
1B. Unresolved Staff Comments | 
32 | |
| 
Item
1C. Cybersecurity | 
32 | |
| 
Item
2. Properties | 
33 | |
| 
Item
3. Legal Proceedings | 
33 | |
| 
Item
4. Mine Safety Disclosures | 
33 | |
| 
| 
| |
| 
PART
II | 
| |
| 
Item
5. Market for Registrants Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | 
34 | |
| 
Item
6. [Reserved] | 
35 | |
| 
Item
7. Managements Discussion and Analysis of Financial Condition and Results of Operations | 
35 | |
| 
Item
7A. Quantitative and Qualitative Disclosures About Market Risk | 
43 | |
| 
Item
8. Financial Statements and Supplementary Data | 
43 | |
| 
Item
9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure | 
43 | |
| 
Item
9A. Controls and Procedures | 
43 | |
| 
Item
9B. Other Information | 
44 | |
| 
Item
9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections | 
44 | |
| 
| 
| |
| 
PART
III | 
| |
| 
Item
10. Directors, Executive Officers and Corporate Governance | 
45 | |
| 
Item
11 Executive Compensation | 
48 | |
| 
Item
12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | 
51 | |
| 
Item
13. Certain Relationships and Related Transactions, and Director Independence | 
57 | |
| 
Item
14. Principal Accountant Fees and Services | 
60 | |
| 
| 
| |
| 
PART
IV | 
| |
| 
Item
15. Exhibits and Financial Statement Schedules | 
61 | |
| 
Item
16. Form 10-K Summary | 
62 | |
| 
Signatures | 
63 | |
| 2 | |
**Cautionary
Note Regarding Forward-Looking Statements**
This
Annual Report on Form 10-K (the Annual Report) includes statements that express our opinions, expectations, beliefs, plans,
objectives, assumptions or projections regarding future events or future results and therefore are, or may be deemed to be, forward-looking
statements. All statements other than statements of historical facts contained in this Annual Report may be forward-looking statements.
These forward-looking statements can generally be identified by the use of forward-looking terminology, including the terms believes,
estimates, continues, anticipates, expects, seeks, projects,
intends, plans, may, will, would or should or, in
each case, their negative or other variations or comparable terminology. They appear in a number of places throughout this Annual Report,
and include statements regarding our intentions, beliefs or current expectations concerning, among other things, our results of operations,
financial condition, liquidity, prospects, growth, strategies, future acquisitions and the industry in which we operate.
By
their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that
may or may not occur in the future. We believe that these risks and uncertainties include, but are not limited to, those described in
the *Risk Factors* section of this Annual Report, which include, but are not limited to, risks related to the following:
| 
| 
| 
our
ability to manufacture, market and sell our products; | |
| 
| 
| 
our
ability to launch and penetrate markets; | |
| 
| 
| 
our
dependency upon effective operation with operating systems, devices, networks and standards that we do not control and on our continued
relationships with mobile operating system providers, device manufacturers and mobile software application stores on commercially
reasonable terms or at all; | |
| 
| 
| 
our
ability to hire and retain key personnel; | |
| 
| 
| 
the
possibility of security and privacy breaches in our systems and in the third-party software and/or systems that we use, damaging
client relations and inhibiting our ability to grow; | |
| 
| 
| 
our
ability to internally develop new inventions and intellectual property; | |
| 
| 
| 
the
existence of undetected software defects in our products and our failure to resolve detected defects in a timely manner; | |
| 
| 
| 
our
ability to remain a going concern; | |
| 
| 
| 
our
ability to raise additional capital and the risk of such capital not being available to us at commercially reasonable terms or at
all; | |
| 
| 
| 
our
ability to be profitable; | |
| 
| 
| 
interpretations
of current laws and the passages of future laws; | |
| 
| 
| 
acceptance
of our business model by investors; | |
| 
| 
| 
intense
competition in our industry and the markets in which we operate, and our ability to successfully compete; | |
| 
| 
| 
the
risks inherent with international operations; | |
| 
| 
| 
the
impact of evolving information security and data privacy laws on our business and industry; | |
| 
| 
| 
the
impact of governmental regulations on our business and industry; | |
| 
| 
| 
our
ability to protect our intellectual property and our ability to operate our business without infringing on the rights of others; | |
| 
| 
| 
the
risk of being delisted from Nasdaq Capital Market (Nasdaq) if we fail to meet any of its applicable listing requirements; | |
| 
| 
| 
the
difficulty of predicting our revenues and operating results and the chance of such revenues and results falling below analyst or
investor expectations, which could cause the price of our Common Stock to fall | |
| 
| 
| 
the
other factors described in the Risk Factors section of this Annual Report. | |
These
factors should not be construed as exhaustive and should be read with the other cautionary statements in this Annual Report.
Readers
are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date this report is filed with
the Securities and Exchange Commission (SEC). We cannot guarantee the accuracy of any such forward-looking statements contained
in this Annual Report, and we do not intend to publicly update or revise any forward-looking statements, whether as a result of new information,
future events, or otherwise. For further information regarding risks and uncertainties associated with our business, and important factors
that could cause our actual results to vary materially from those expressed or implied in such forward-looking statements, please refer
to the factors listed and described in this Annual Report and in our other SEC filings.
| 3 | |
**PART
I**
**Item
1. Business**
****
*Unless
the context otherwise requires, the terms we, our, ours us, Company
and Glucotrack refer to Glucotrack, Inc., a Delaware corporation.*
**Overview**
The
Company was incorporated on May 18, 2010 under the laws of the State of Delaware. We are a medical device company focused on the development
of an implantable continuous blood glucose monitor (CBGM) for persons with Type 1 diabetes and Type 2 diabetes using insulin
or at risk for hypoglycemia (the Glucotrack CBGM).
The
Company was founded with a mission to develop Glucotrack, a non-invasive glucose monitoring device designed to help people with
diabetes and pre-diabetics obtain glucose level readings without the pain, inconvenience, cost and difficulty of conventional (invasive)
spot finger stick devices. The first generation Glucotrack, which successfully received CE Mark approval, obtained glucose measurements
via a small sensor clipped onto ones earlobe. A limited release beta test in Europe and the Middle East demonstrated the need
for an updated product with improved accuracy and human factors. As the glucose monitoring landscape has since rapidly moved away from
point-in-time measurement to continuous measurement, the Company determined in 2023 that it would focus its efforts on developing the
Glucotrack CBGM. As such, the Company withdrew the CE Mark for Glucotrack and are no longer pursuing commercialization of this product
or development of any further iterations.
On
October 7, 2022, the Company acquired certain intellectual property related to the Glucotrack CBGM from Paul V. Goode, the Companys
Chief Executive Officer and intends to develop the technology to address the growing Type 1 and Type 2 diabetes market.
The
Company is currently developing the Glucotrack CBGM for use by Type 1 diabetes patients as well as Type 2 diabetes using insulin or at
risk for hypoglycemia.. Implant longevity is key to the success of such a device. We have continued to evolve our sensor chemistry following
our successful in-vitro feasibility study demonstrating that a minimum two-year implant life is highly probable with the current sensor
design. Subsequently we announced that a 3-year longevity is feasible leveraging both in-vitro and in-silico test results. We have also
completed multiple animal studies with initial prototype systems which demonstrated a simple implant procedure with good safety and functionality.
The results of both were presented in poster form at the 2024 American Diabetes Association annual conference. We believe our technology,
if successful, has the potential to be more accurate, more convenient and have a longer duration than other implantable glucose monitors
that are either in the market or currently under development.
Further
to the above progress on the Glucotrack CBGM, we have also successfully demonstrated continuous glucose sensing in the epidural space.
This latter approach is of importance for patients with diabetes already contemplating spinal cord stimulation therapy for their condition.
The Company believes this approach may enable integrated chronic disease management with one system that provides dual benefits of pain
relief and glucose monitoring.
The
Company completed a first in human study in 2025. This study was an acute study intended to demonstrate device performance and safety,
as well as safety of the implant and removal procedures. The study used the planned commercial version of the implantable sensor connected
to an externalized prototype electronics device. Patients were monitored in hospital for 4 days. Results of the study were positive,
meeting the endpoints of no serious safety events while demonstrating similar performance and accuracy as observed in longer-term animal
studies. Initial results were presented in poster form at the 2025 Advanced Technologies & Treatments for Diabetes annual meeting
and final results were presented in poster form at the 2025 American Diabetes Association annual conference.
The
Company initiated a long-term, multicenter feasibility study in Australia to evaluate the CBGM product performance and safety. The
first phase of the clinical study provided early product learnings about how the complexity of certain health conditions may impact
study eligibility as well as identified certain product improvements. Following a reassessment of the study in light of planned
product updates and anticipated protocol modifications,the Company determined that continuation of the study in its current
form was no longer practical and elected to close the study.
Consequently, the Company is expediting discussions with the U.S. Food and Drug Administration
(FDA) regarding our planned United States (U.S.) clinical trial program that we expect to launch in the second
half of 2026, subject to FDA approval of our Investigational Device Exemption (IDE) submission expected to be filed in the second quarter of 2026.
The
Company initially obtained ISO13485 certification in 2024 and successfully passed the 2025 annual audit, both efforts without any
major nonconformities. ISO 13485 is an internationally agreed-upon standard of quality system requirements for the design, production,
distribution, and sale of medical devices. Certification of compliance to the standard is recognized and accepted by the FDA, the European
Medicines Agency (EMA), and many other regulatory authorities worldwide.
| 4 | |
Our
executive management team consists of our Chief Executive Officer and President, Paul V. Goode PhD, an experienced executive with a 25+
year career developing innovative medical technologies, including at Dexcom, Inc. (Dexcom) and MiniMed (now Medtronic Diabetes)
and Chief Financial Officer, Peter C. Wulff, who has 40 years of experience as a chief financial officer and chief operating officer
in both public and private entities. Our senior management team consists of: Mark Tapsak PhD, Chief Scientific Officer, a medical research
scientist who brings over 25 years of experience in the diabetes industry, including previous senior roles at Dexcom and Medtronic; Vincent
Wong, Chief Operating Officer, a medical device professional with over 15 years of experience in operations and quality systems for implantable
medical device manufacturing with senior roles at Cirtec Medical and TOMZ Corporation (TOMZ); James P. Thrower PhD, Vice
President of Advanced Technologies, a seasoned engineering executive with 20 years experience formerly of Sterling Medical Devices,
Mindray DS USA and Dexcom.; Drinda Benjamin, Vice President of Marketing, a medical device professional with over 20 years of experience
in the medical device and diabetes industry with senior roles at Intuity Medical, Senseonics, Incorporated, Abbott Diabetes, and Medtronic
Diabetes; Sandie Martha, Vice President Clinical Operations, a medical device professional with over 20 years of experience in the medical
device and diabetes industry with senior roles at Dexcom and GlySens Incorporated (GlySens); and Ted Williams, Vice President
Regulatory, a medical device professional with over 20 years of experience in the biotech and diabetes industry with a senior role at
GlySens.
Our
Board of Directors (the Board or Board of Directors) includes the Chairman Luis J. Malav, formerly
of Insulet Corp, Medtronic and MiniMed (now Medtronic Diabetes); Andy Balo, formerly of Dexcom and St Jude Medical (now Abbott), Erin
Carter, formerly of Medtronic and Boston Scientific; and Victoria Carr-Brendel, formerly of Dexcom, Boston Scientific, JenaValve Technology,
and Advanced Bionics.
**Market
Opportunity**
**Diabetes**
Diabetes
is a chronic, life-threatening disease for which there is no known cure. Diabetes is caused by the bodys inability to produce
or effectively utilize the hormone insulin. This inability prevents the body from adequately regulating blood glucose levels. Glucose,
the primary source of energy for cells, must be maintained at certain concentrations in the blood in order to permit optimal cell function
and health. Normally, the pancreas provides control of blood glucose levels by secreting the hormone insulin to decrease blood glucose
levels when concentrations are too high. In people with diabetes, blood glucose levels fluctuate between very high levels, a condition
known as hyperglycemia, and very low levels, a condition known as hypoglycemia. Hyperglycemia can lead to serious long-term complications,
such as blindness, kidney disease, nervous system disease, amputations, stroke and cardiovascular disease. Hypoglycemia can lead to confusion,
loss of consciousness or death.
Diabetes
is typically classified into two major groups: Type 1 and Type 2. Type 1 diabetes is characterized by the bodys inability to produce
insulin, resulting from destruction of the insulin producing cells of the pancreas. Individuals with Type 1 diabetes must rely on frequent
insulin injections in order to regulate and maintain blood glucose levels. Type 1 diabetes is frequently diagnosed during childhood or
adolescence, although disease onset can occur at any age. Type 2 diabetes, the more common form of diabetes, is a metabolic disorder
that is characterized by the bodys inability to either properly utilize insulin or produce enough insulin. Type 2 diabetes is
associated with older age, obesity, family history of diabetes, history of gestational diabetes, impaired glucose metabolism, physical
inactivity and race or ethnicity. Depending on the severity of Type 2 diabetes, individuals may require diet and nutrition management,
exercise, oral medications or insulin injections to regulate blood glucose levels.
According
to the Diabetes Atlas (Eleventh Edition) published by the International Diabetes Federation in 2025, approximately 589 million adults
worldwide, between the ages of 20 and 79, or approximately 10% of the worlds adult population, were estimated to suffer from diabetes
in 2025 (not including those persons who suffer from impaired glucose tolerance or gestational diabetes, diabetic conditions first arising
during pregnancy). The International Diabetes Federation estimates that this number will grow to approximately 853 million adults worldwide
by 2045. The Centers for Disease Control and Prevention in its 2025 National Diabetes Statistics Report provided crude estimates for
2021 that there are approximately 40.1 million people with diabetes in the U.S., of which 29.1 million have diagnosed diabetes. Among
US adults ages 18 years or older, there were 1.5 million new cases of diabetes diagnosed in 2023.
| 5 | |
****
**Glucose
Monitoring**
Blood
glucose levels can be affected by many factors, including the carbohydrate and fat content of meals, exercise, stress, illness or impending
illness, hormonal releases, medications, variability in insulin absorption and changes in the effects of insulin in the body. Given the
many factors that affect blood glucose levels, maintaining glucose within a normal range can be difficult. People with diabetes generally
manage their blood glucose levels by administering insulin or ingesting carbohydrates throughout the day to maintain blood glucose within
normal ranges. Normal ranges vary from person to person. In order to maintain blood glucose levels within normal ranges, people with
diabetes must first measure their blood glucose levels so that they can make the proper therapeutic adjustments. As adjustments are made,
additional blood glucose measurements may be necessary to gauge the individuals response to the adjustments. More frequent testing
of blood glucose levels provides these individuals with information that can be used to better understand and manage their diabetes.
Testing of blood glucose levels should be performed (at a minimum) before meals, after meals and before going to sleep. People with diabetes
who take insulin usually need to test more often than those who do not take insulin.
Until
recently, spot finger stick devices known as blood glucose monitors (BGM) have been the most prevalent devices for blood
glucose monitoring. These devices require users to insert a strip into a glucose meter, take a blood sample with a finger stick and place
a drop of blood on a test strip that yields a single point in time blood glucose measurement. Despite continued developments in the field
of BGMs, the routine measurement of glucose levels remains invasive, painful, inconvenient, difficult and costly. Moreover, the American
Diabetes Association updated guidelines (released 2023) indicated there is no clinical evidence of benefit for non-insulin using Type
2 diabetes patients; and recommended CGM as the standard of care for those patients.
Continuous
glucose monitor (CGM) systems involve the insertion of sensors into the body to measure glucose levels in the interstitial
fluid throughout the day and night, providing real-time data that shows trends in glucose measurements. Many published clinical studies
demonstrate that CGMs improve glycemic control in people with Type 1 diabetes or people with insulin-requiring Type 2 diabetes. As a
result, CGM use is rapidly increasing and has become the clinically recommended standard of care for these patients.
Despite
the benefits in glycemic control and significant insurance coverage, almost half of the people with diabetes still have not adopted CGM.
We believe that a significant market opportunity exists for an innovative CGM device that addresses the remaining barriers to adoption.
According to a 2017 Diabetes Care study, these barriers include the inconvenience of wearing devices all the time, discomfort and inconvenience
of bi-weekly device replacement, dislike for having diabetes devices on the body, and dislike for how diabetes devices look on the body.
Additionally, the study reported that reasons that people discontinued using a CGM included the device being uncomfortable or painful
and the belief that the device is not accurate. The Company believes that improved CGM devices that address these barriers could provide
significant benefits to patients, healthcare providers and payors, thereby increasing overall CGM adoption and ongoing satisfaction.
The Company conducted its own market research studies in 2024 and 2025 to validate its belief that these findings are still relevant.
The results on over 1,500 patients demonstrated that patients with diabetes still have the same issues as expressed in 2017 and that interest
in a long-term, fully implantable CBGM is high. The Company is developing a long-term CBGM that will allow continuous monitoring of blood
glucose levels, which the Company believes is a significant improvement in quality compared to spot finger stick devices and CGM.
| 6 | |
**Our
Product**
The
Company is currently developing a long-term implantable CBGM with no requirement for an additional wearable component with minimal calibration
(the Glucotrack CBGM). The Glucotrack CBGM utilizes an intravascular approach, in which the device is implanted subcutaneously
and connected to a lead that is placed directly into a blood vessel. This facilitates continuous blood glucose measurements with effectively
zero lag time. In comparison, commercially-available CGM systems measure glucose in the interstitial fluid, which lags behind blood glucose.
Our approach is based on design elements, implant techniques, and implant tools commonly used for active implantable devices in the cardiovascular
space. As a result, it employs a recognized, established, and widely utilized implant procedure and device form factor.
In
2023, we completed the laboratory-based feasibility study demonstrating that the CBGM sensor is capable of measuring glucose for at least
two years post-implant. By the end of 2023 we completed our initial preclinical in vivo animal study. This initial preclinical study
produced very strong results, demonstrating at least three months of well-sustained sensor life while also demonstrating that the sensor
is safe for animals. The study also indicated the CBGM is capable of a high level of measurement accuracy as compared with conventional
CGM technologies on the market. Since 2023, we have completed three additional preclinical animal studies for our CBGM sensor, demonstrating
performance and accuracy up to six months.
By
the end of 2023, we initiated a human clinical device/system design and development program. The program outsourced development and manufacturing
to respective contract design and contract manufacturing organizations. Since then, we have developed a dual supply source for both implantable
system components (the electronics assembly and the sensor lead), both of which are ISO 13485 certified with dedicated experience in
manufacturing active implantable medical devices. Both organizations have since manufactured products used in various Glucotrack pre-clinical
bench and animal studies, as well products used in both our human clinical trials.
Also
in 2024, we worked with The Technology Partnership, or TTP (Cambridge, UK) to demonstrate a sensor longevity of 3 years.
Using in silico modeling to iterate membrane parameter design changes, and further validated by in vitro bench testing, we were able
to improve our projected sensor longevity from 2 years to 3 years. Since then, we have worked with TTP to migrate sensor chemistry into
a production environment under ISO 13485 certification.
In
2024, we announced that the Glucotrack CBGM successfully completed a 60-day long-term preclinical study on measuring glucose in the epidural
space. The Glucotrack CBGM sensor, implanted in the epidural space of animals, closely tracked both blood glucose and a commercially
available subcutaneous CGM throughout the 60-day period. The implantation procedure took approximately 20 minutes, and the animals recovered
without complications. No abnormal clinical signs were observed throughout the study period, and no abnormal findings were observed in
the spinal cord or surrounding tissues during post-explant analysis. The study also confirmed that the implanted sensor did not cause
any delayed latent effects over the long-term period, which is particularly important as a complete healing process in animal studies
with implanted devices may take several weeks. With the completion of this study, the durability of the epidural approach for continuous
glucose monitoring has now been confirmed over the 60-day period. The Company is currently working with a renowned neuromodulation physician
to evaluate a clinical development program to further advance the medical application of this technology.
In
late 2024, we initiated an acute (5 day) FIH study for a prototype version of our CBGM in Sao Paulo, Brazil. The clinical trial
evaluated the CBGM sensor technology in a cohort of 8 in-hospital patients. The goals of the study were to prove the implant and
removal procedures were safe and reasonable, the device was safe and functional, and the overall experience was well-tolerated. The
study was completed in early 2025 and successfully met all objectives.
In
late 2025, the Company initiated a clinical study outside the United States to evaluate the CBGM product performance and safety. The
first phase of the clinical study provided early learnings about how the complexity of certain health conditions may impact study eligibility
as well as identified certain product improvements. Based on these findings, the Company plans to continue its clinical program with
protocol amendments. These learnings have been incorporated into the Companys ongoing discussions with the FDA regarding the U.S. clinical study program. In the first half of 2026, the Company intends to advance these discussions
and reprioritize its clinical activities to place greater emphasis on the U.S. clinical study program.
Since
second quarter 2025, the Company has been in discussions with the FDA through the presub process and preparing for an Investigational
Device Exemption (IDE) submission in the second quarter of 2026. The presub discussions pertain to the protocol study design and
related requirements to secure IDE approval for the initial Feasibility Study and future long-term human clinical trials in the United
States. In anticipation of the IDE approval for the Feasibility Study, the Company has identified and is collaborating with a respected
physician investigator and medical institution well known for conducting CGM studies.
In
early 2025, we received ISO 13485:2016 certification from the British Standards Institute (BSI). This verified the Company
has established, and is maintaining, a quality management system that meets all requirements of the ISO 13485:2016 standard for design
and development of our products. The Company had the annual compliance audit in late 2025 and was found to be in compliance with no major
findings.
| 7 | |
**Research
and Development**
See
*Item 7 Managements Discussion and Analysis of Financial Condition and Results of Operation Results of
Operation* below for a discussion of the research and development expenses for the fiscal years ended December 31, 2025 and
2024.
**Regulatory
Considerations**
Healthcare
is heavily regulated by federal, state and local governments in the United States, and by similar authorities in other countries. Any
product that we develop must receive all relevant regulatory approvals or clearances, as the case may be, before it may be marketed in
a particular country. The laws and regulations affecting healthcare change regularly, thereby increasing the uncertainty and risk associated
with any healthcare related venture. The United States government has in the past considered, is currently considering and may in the
future consider healthcare policies and proposals intended to curb rising healthcare costs, including those that could significantly
and adversely affect reimbursement for healthcare products such as our devices. These policies have included and may in the future include:
basing reimbursement policies and rates on clinical outcomes, the comparative effectiveness and costs of different treatment technologies
and modalities; imposing price controls and taxes on medical device providers; and other measures. Future significant changes in the
healthcare systems in any jurisdiction in which our devices may be cleared for sale could also have a negative impact on the demand
for our devices. These include changes that may reduce reimbursement or payment rates for such products.
In
the United States, the federal government regulates healthcare through various agencies, including but not limited to the following:
(i) the FDA, which administers the Food, Drug, and Cosmetic Act (the FDCA) as well as other relevant laws; (ii) the Centers
for Medicare & Medicaid Services (CMS), which administers the Medicare and Medicaid programs; (iii) the Office of Inspector
General, which enforces various laws aimed at curtailing fraudulent or abusive practices including, by way of example, the Anti-Kickback
Law, the Anti-Physician Referral Law, commonly referred to as the Stark Law, the Anti-Inducement Law, the Civil Money Penalty Law, and
the laws that authorize the Office of Inspector General to exclude health care providers and others from participating in federal healthcare
programs; and (iv) the Office of Civil Rights which administers the privacy and security aspects of the Health Insurance Portability
and Accountability Act of 1996 (HIPAA). All of the aforementioned are agencies within the Department of Health and Human
Services. Healthcare is also provided or regulated, as the case may be, by the Department of Defense through its TriCare program, the
Department of Veterans Affairs under, among other laws, the Veterans Health Care Act of 1992, the Public Health Service within the Department
of Health and Human Services under the Public Health Service Act, the Department of Justice through the federal False Claims Act (the
FCA) and various criminal statutes, and state governments under the Medicaid program and their internal laws regulating
all healthcare activities. If and when we receive FDA approval to market our devices in the United States, we will be subject to regulation
by some or all of the foregoing agencies.
The
applicable regulatory schemes in the EU are significantly more diverse than those in the United States and do not lend themselves to
similar summary. Although the CE Mark system and the Medical Device Regulation (MDR) require a minimum level of harmonization
in the EU, each EU member country may impose additional regulatory requirements. Because there are numerous EU member countries with
distinct legal systems, the scope of potential regulatory requirements in each of the EU countries (additional to the harmonized EU requirements)
is difficult to summarize or predict.
**Regulation
of the Design, Manufacture and Distribution of Medical Devices**
Any
product that we develop must receive all relevant regulatory clearances or approvals, as the case may be, before it may be marketed in
a particular country.
Sales
of medical devices outside the United States are subject to foreign regulatory requirements that vary widely from country to country.
These laws and regulations range from simple product registration requirements in some countries to complex clearance and production
controls in others. As a result, the processes and time periods required to obtain foreign marketing approval may be longer or shorter
than those necessary to obtain FDA approval (as described below). These differences may affect the efficiency and timeliness of international
market introduction of our devices. For countries in the EU, medical devices must display a CE Mark before they may be imported or sold
and must comply with the requirements of the MDR. However, although the MDR is applicable throughout the EU, in practice it does not
ensure uniform regulation throughout the EU. Rather, the MDR requires only a minimum level of harmonization in the EU. Accordingly, member
countries may apply and enforce the MDRs terms differently, and certain EU member countries may request or require performance
and/or safety data in addition to the MDRs requirements from time to time, on a case-by-case basis. The CE Mark also permits the
sale in countries that have an MDR Mutual Recognition Agreement with the EU.
| 8 | |
In
the United States, under Section 201(h) of the FDCA, a medical device is an article which, among other things, is intended for use in
the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease in man or other animals.
We believe that our devices will be classified as medical devices and subject to regulation by numerous agencies and legislative bodies,
including the FDA and its foreign counterparts. Devices are subject to varying levels of regulatory control, the most comprehensive of
which requires that a clinical evaluation be conducted before a device receives approval for commercial distribution. The FDA classifies
medical devices into one of three classes. Class I devices are relatively simple and can be manufactured and distributed with general
controls. Class II devices are somewhat more complex and require greater scrutiny. Class III devices are new and frequently help sustain
life.
In
the United States, a company generally can obtain permission to distribute a new device in two ways through a so-called 510(k)
premarket notification application or through a Section 515 premarket approval (PMA) application. The 510(k) submission
applies to any device that is substantially equivalent to a device first marketed prior to May 28, 1976 or to another device marketed
after that date, but which was substantially equivalent to a pre-May 28, 1976 device. These devices are either Class I or Class II devices.
Under the 510(k) submission process, the FDA will issue an order finding substantial equivalence to a predicate device (pre-May 28, 1976
or post-May 28, 1976 device that was substantially equivalent to a pre- May 28, 1976 device) and permitting commercial distribution of
that device for its intended use. A 510(k) submission must provide information supporting its claim of substantial equivalence to the
predicate device. The FDA permits certain low risk medical devices to be marketed without requiring the manufacturer to submit a premarket
notification. In other instances, the FDA may require that a premarket notification not only be submitted, but also be accompanied by
clinical data. If clinical data from human experiments are required to support the 510(k) submissions, these data must be gathered in
compliance with investigational device exemption regulations for investigations performed in the United States. The FDA review process
for premarket notifications submitted pursuant to section 510(k) should take about 90 days, but it can take substantially longer if the
FDA has concerns, and there is no guarantee that the FDA will clear the device for marketing, in which case the device cannot be lawfully
distributed in the United States. If the FDA finds that the device subject to the premarket notification is substantially equivalent
to a proper predicate device, then the FDA may clear that device for marketing. These devices are not approved
by the FDA. It is very unlikely, however, that the FDA will deem our Glucotrack CBGM subject to the 510(k) process, as opposed to the
more time-consuming, resource intensive and problematic PMA application process described below.
The
more comprehensive PMA process applies to a new device that either is not substantially equivalent to a pre-May 28, 1976 product or is
to be used in supporting or sustaining life or preventing impairment. These devices are normally Class III devices and can only be marketed
following approval of a PMA application. For example, most implantable devices are subject to the PMA approval process. Two steps of
FDA approval generally are required before a company can market a product in the U.S. that is subject to Section 515 PMA approval, as
compared to a Section 510(k) clearance. First, a company must comply with investigational device exemption regulations in connection
with any human clinical investigation of the device; however, those regulations permit a company to undertake a clinical study of a non-significant
risk device without formal FDA approval. Prior express FDA approval is required if the device is a significant risk device. If
there is any doubt as to whether a device is a non-significant risk device, companies normally seek prior approval from
the FDA. Normally, clinical studies of new diagnostic products are conducted in tandem with a cleared or approved device and treatment
decisions are based on the results from the existing diagnostic device. In such a setting, the FDA may consider the clinical trial as
one not posing a significant risk. However, FDA action is always uncertain and dependent on the contours of the design of the clinical
trial and the device and there is no assurance that the FDA would consider any proposed clinical trial as one posing a non-significant
risk. Moreover, before undertaking any clinical trial, the company sponsoring the trial and the investigator conducting the trial are
required by federal law to seek and obtain the approval of institutional review boards (IRB). An IRB weighs the risks and
benefits of a proposed trial to ensure that the human subjects are not exposed to unnecessary risk and reviews the informed consent form
to ensure that it meets federal requirements and accurately describes the risks and benefits, if any, of the clinical trial. IRB review
occurs annually, and annual re-approval is required. University medical centers as well as other entities maintain and operate IRB. Second,
the FDA must review a companys PMA, which contains, among other things, clinical information acquired under the investigational
device exemption. The FDA will approve the PMA if it finds there is reasonable assurance that the device is safe and effective for its
intended use. The premarket approval process takes substantially longer than the 510(k) process.
| 9 | |
The
Glucotrack CBGM is still under development and has not yet been approved for commercial sale in or outside the United States. Given
the implantable nature of our CBGM, it is most likely that the device will be assigned a Class III designation which commonly
requires the PMA process for regulatory approval. However, in discussions with the FDA, the Company believes it can file under a De
Novo 510k process provided it meets interoperable Continuous Glucose Monitor (iCGM) requirements. The clinical trial rigor necessary to meet this is the same as that for a PMA,
but the benefits of a 510k classification are impactful post-clearance.
Even
when a clinical study has been approved or cleared by the FDA or a notified body or deemed approved, the study is subject to factors
beyond a manufacturers control, including, but not limited to the fact that the IRB at a given clinical site might not approve
the study, might decline to renew approval which is required annually, or might suspend or terminate the study before the study has been
completed. Also, the interim results of a study may not be satisfactory, in which case the sponsor may terminate or suspend the study
on its own initiative or the FDA or a notified body may terminate or suspend the study. There is no assurance that a clinical study at
any given site will progress as anticipated; there may be an insufficient number of patients who qualify for the study or who agree to
participate in the study, or the investigator at the site may have priorities other than the study. Also, there can be no assurance that
the clinical study will provide sufficient evidence to assure the FDA or a notified body that the product is safe and effective, a prerequisite
for FDA approval of a PMA. Even if the FDA or a notified body approves or clears a device, it may limit its intended uses in such a way
that manufacturing and distributing the device may not be commercially feasible.
After
approval to market is given, the FDA and foreign regulatory agencies, upon the occurrence of certain events, are authorized under various
circumstances to withdraw the clearance or approval or require changes to a device, its manufacturing process or its labeling or additional
proof that regulatory requirements have been met.
A
manufacturer of a device approved through the PMA process is not permitted to make changes to the device which affects its safety or
effectiveness without first submitting a supplement application to its PMA and obtaining FDA approval for that supplement. In some instances,
the FDA may require clinical trials to support a supplement application. Any change in the intended uses of a PMA device or a 510(k)
device requires an approval supplement. Exported devices are subject to the regulatory requirements of each country to which the device
is exported, as well as certain FDA export requirements.
The
Company plans to leverage the De Novo clinical trial data, if successful, along with the associated development and manufacturing information,
for CE Mark certification. The Company will choose a notified body and submit via the MDR regulations to obtain this necessary clearance
for marketing in EU member states. Upon approval, if granted, the Company may consider alternative markets that can leverage both the
FDA and CE Mark approvals.
| 10 | |
**Reimbursement
Considerations**
In
the U.S. market, coverage and reimbursement from Medicare, Medicaid or other governmental healthcare programs or systems, and private
third-party healthcare payors is critical to the success of a medical device company. CGM systems have been broadly accepted by Medicare
and commercial third-party payors. Currently, Medicare covers CGM systems, which includes supplies necessary for the use of the device
under the Durable Medical Equipment (DME), benefit category. Previously, Medicare coverage for CGM was only available to Medicare patients
who take at least three doses of insulin a day. The Local Coverage Determination (LCD), that the Medicare Administrative Contractors
(MACs) released in April 2023 extended Medicare CGM coverage to all patients using insulin. The LCD also allows coverage for patients
not taking insulin if the patient has a history of problematic hypoglycemia.
There
is currently one commercially available implantable CGM product and the current reimbursement landscape includes coverage for the product
itself, coverage for the implantation process and coverage for the removal and reinsertion process. Additionally, an LCD was recently
released (NGS ICGM LCD - Effective 4/1/2024) allowing for expanded access of this product to include all people with diabetes using insulin,
removing the previous requirement for at least three doses of insulin a day. Like non-implantable CGM, the LCD also allows coverage for
patients not taking insulin if the patient has a history of problematic hypoglycemia.
Even
though CGM coverage is broad, we anticipate that sales volumes and prices of the Glucotrack CBGM will depend in large part on the availability
of adequate reimbursement from Medicare and third-party payors. Medicare reimburses medical devices in a variety of ways depending on
where and how the device is used. However, Medicare only provides reimbursement if CMS determines that the device should be covered and
that the use of the device is consistent with the coverage criteria. A coverage determination can be made at the national level by CMS
or at the local level by the Medicare administrative contractor (formerly called carriers and fiscal intermediaries) or a private contractor
that processes and pays claims on behalf of CMS for the geographic area where the services were rendered. Obtaining a coverage determination,
whether local or national, is a time-consuming, expensive and highly uncertain proposition, especially for a new technology, and inconsistent
local determinations are possible. Our inability to obtain a favorable coverage determination for our CBGM product may adversely affect
our ability to market the product and thus, the commercial viability of the product.
Additionally,
we believe that the overall escalating cost of medical products and services has led to and will continue to lead to increased pressures
on the healthcare industry to reduce the costs of products and services. There can be no assurance that third-party reimbursement and
coverage will be available or adequate, or that future legislation, regulation, or reimbursement policies of third-party payors will
not adversely affect the demand for our products or our ability to sell these products on a profitable basis. The unavailability or inadequacy
of third-party payor coverage or reimbursement could have a material adverse effect on our business, operating results, and financial
condition. Until adequate reimbursement or insurance coverage is established, patients may have to bear the financial cost of our products.
To
mitigate these risks, we are starting our reimbursement planning process early, well in advance of obtaining regulatory approval. We
have engaged a leading reimbursement consultant to complete an initial analysis of the current landscape for CGM technologies. Additionally,
since our product is an implantable device and very similar in form factor and procedure to commercially available cardiovascular devices,
we are also assessing the current reimbursement landscape for those technologies. This will enable us to craft a reimbursement strategy
that is best suited to our Glucotrack CBGM and reflects the different healthcare providers that may be involved in utilizing the product.
Our
reimbursement strategy also incorporates coverage for the product, the implantation procedure, and the removal and reinsertion procedures.
While we are proactively preparing our reimbursement strategy, some activities such as coding applications, if needed, may not be executed
until FDA approval is obtained.
Outside
the United States, availability of reimbursement from third parties varies widely from country to country. Within the EU member countries,
healthcare reimbursement, coverage regulations, and systems differ significantly. An EU reimbursement analysis and strategy may begin
if and when we decide to enter the EU market.
| 11 | |
**Anti-Fraud
and Abuse Rule**
There
are extensive United States federal and state laws and regulations prohibiting fraud and abuse in the healthcare industry that can result
in significant criminal and civil penalties that can materially affect us, if and when we receive FDA approval to market our products
in the United States. These federal laws include, by way of example, the following:
| 
| 
The
anti-kickback statute (Section 1128B(b) of the Social Security Act), which prohibits certain business practices and relationships
that might affect the provision and cost of healthcare services reimbursable under Medicare, Medicaid and other federal healthcare
programs, including the payment or receipt of remuneration for the referral of patients whose care will be paid by Medicare or other
governmental programs; | |
| 
| 
| |
| 
| 
The
physician self-referral prohibition (Ethics in Patient Referral Act of 1989, as amended, commonly referred to as the Stark Law, Section
1877 of the Social Security Act), which prohibits referrals by physicians of Medicare or Medicaid patients to providers of a broad
range of designated healthcare services in which the physicians (or their immediate family members) have ownership interests or with
which they have certain other financial arrangements; | |
| 
| 
| |
| 
| 
The
anti-inducement provisions of the Civil Monetary Penalties Law (Section 1128A(a)(5) of the Social Security Act), which prohibit providers
from offering anything to a Medicare or Medicaid beneficiary to induce that beneficiary to use items or services covered by either
program; | |
| 
| 
| |
| 
| 
The
FCA (31 U.S.C. 3729 et seq.), which prohibits any person from knowingly presenting or causing to be presented false or fraudulent
claims for payment to the federal government (including the Medicare and Medicaid programs); and | |
| 
| 
| |
| 
| 
The
Civil Monetary Penalties Law (Section 1128A of the Social Security Act), which authorizes the United States Department of Health
and Human Services to impose civil penalties administratively for fraudulent or abusive acts. | |
Sanctions
for violating these federal laws include criminal and civil penalties that range from punitive sanctions, damage assessments, monetary
penalties, imprisonment and/or denial of Medicare and Medicaid payments or exclusion from the Medicare and Medicaid programs, or both.
These laws also impose an affirmative duty on those receiving Medicare or Medicaid funding to ensure that they do not employ or contract
with persons excluded from the Medicare and other government programs.
Many
states have adopted or are considering legislative proposals similar to the federal fraud and abuse laws, some of which extend beyond
the Medicare and Medicaid programs, to prohibit the payment or receipt of remuneration for the referral of patients and physician self-referrals
regardless of whether the service was reimbursed by Medicare or Medicaid. Many states have also adopted or are considering legislative
proposals to increase patient protections, such as limiting the use and disclosure of patient specific health information. These state
laws also impose criminal and civil penalties similar to the federal laws.
Similarly,
the EU and EU member countries may have similar fraud and abuse laws which would regulate our business in those jurisdictions. However,
given the diversity of legal systems within the EU, it is difficult to predict with specificity what anti-fraud legislation and regulations
may be implemented and the penalties that they impose.
In
the ordinary course of their business, medical device manufacturers and suppliers have been and are subject regularly to inquiries, investigations
and audits by federal and state agencies that oversee these laws and regulations. Recent federal and state legislation has greatly increased
funding for investigations and enforcement actions, which have increased dramatically over the past several years. This trend is expected
to continue. Private enforcement of healthcare fraud also has increased due in large part to amendments to the civil FCA that were designed
to encourage private persons to sue on behalf of the government. These whistleblower suits by private persons, known as qui tam relators,
may be filed by almost anyone, including present and former patients or nurses and other employees, as well as competitors. HIPAA, in
addition to its privacy provisions, created a series of new healthcare-related crimes.
As
federal and state budget pressures continue, federal and state administrative agencies may also continue to escalate investigation and
enforcement efforts to root out waste and to control fraud and abuse in governmental healthcare programs. A violation of any of these
federal and state fraud and abuse laws and regulations could have a material adverse effect on a suppliers liquidity and financial
condition. An investigation into the use of a device by physicians may dissuade physicians from recommending that their patients use
the device. This could have a material adverse effect on our ability to commercialize our products.
| 12 | |
**The
Privacy Provisions of HIPAA**
In
the United States, HIPAA, among other things, protects the privacy and security of individually identifiable health information by limiting
its use and disclosure. HIPAA directly regulates covered entities, such as healthcare providers, insurers and clearinghouses,
and regulates business associates, with respect to the privacy of patients medical information. All entities that
receive and process protected health information are required to adopt certain procedures to safeguard the security of that information.
It is uncertain whether we would be deemed to be a covered entity under HIPAA and, owing to changes in the law, it is uncertain, based
on our current business model, whether we would be a business associate. Nevertheless, we will likely be contractually required to physically
safeguard the integrity and security of any patient information that we receive, store, create or transmit in the United States. If we
fail to adhere to our contractual commitments, then our physician, hospital or insurance customers may be subject to civil monetary penalties,
which could adversely affect our ability to market our devices. Changes in the law wrought by the provisions of Health Information Technology
for Economic and Clinical Health (HITECH) Act, enacted as part of the American Recovery and Reinvestment Act of 2009 (ARRA),
increase the duties of business associates and covered entities with respect to protected health information that thereby subject them
to direct government regulation, increasing its compliance costs and exposure to civil monetary penalties and other government sanctions.
While HITECH does not alter the definition of a business associate, it makes it more likely that covered entities with whom we are likely
to do business in the United States, if and when we receive FDA approval to market the Glucotrack CBGM in the United States, will require
us to enter into business associate agreements.
**Intellectual
Property**
We
are pursuing a proactive intellectual property strategy, which includes patent filings in multiple jurisdictions, including the United
States and other commercially significant markets. We understand the importance of obtaining patent and trade secret protection for new
technologies, products and processes. Our success will depend in large part on our ability to file for and obtain patent protection of
our principal products and procedures, to defend existing or future patents, to maintain trade secrets and to operate without infringing
upon the proprietary rights of others.
As
of December 31, 2025, the Company has strengthened its patent portfolio with the issuance of three U.S. patents:
U.S.
Patent No. 12,453,494, Methods and Systems for Measuring Glucose Having Improved Decay Rates and Lag Times (issued October 28, 2025).
This patent covers methods and system architectures for implantable glucose sensing that address signal decay and response lag over time.
The claims relate to sensor configurations, control strategies, and data-processing approaches intended to improve temporal response
characteristics and signal stability during long-term glucose monitoring.
U.S.
Patent No. 12,458,257, Implantable Glucose Sensors and Methods of Glucose Measurement Configured for Minimal Sensor Surface Obstruction
(issued November 4, 2025). This patent covers implantable glucose sensor designs and related measurement methods that reduce functional
impairment caused by surface obstruction or fouling. The claims focus on structural, material, and interface features intended to preserve
sensor performance in vivo by mitigating the effects of tissue interaction and biological accumulation at the sensor surface.
U.S.
Patent No. 12,458,258, Low Power Implantable Glucose Sensors and Methods of Glucose Measurement (issued November 4, 2025). This patent
covers implantable glucose sensing systems and operational methods designed to reduce power consumption while maintaining measurement
functionality. The claims relate to low-power sensor architectures, measurement strategies, and system-level approaches intended to support
extended operational lifetimes in implantable glucose monitoring applications.
The
three U.S. patents described above resulted from the prosecution of previously filed and previously disclosed patent applications that
were converted to issued patents in 2025. In addition to these issued patents, the Company filed one U.S. utility patent application,
one U.S. continuation application and one U.S. provisional application. The Company may evaluate additional patent filings from time
to time as its technology development progresses.
| 13 | |
In
2025, one related international patent application has been published:
WO
2025/193719 A1, Systems and Methods for Integrated Spinal Cord Stimulation and Glucose Monitoring (published September 18, 2025).
We
have trademark registrations for Glucotrack in the U.S. and Europe and various other jurisdictions.
We
believe that our intellectual property and products do not and will not infringe patents or violate proprietary rights of others, although
it is possible that our existing patent rights may not be valid or that infringement of existing or future patents or proprietary rights
may occur. Litigation may be necessary to defend or enforce our patent rights or to determine the scope and validity of the proprietary
rights of others. Defense and enforcement of patent claims can be expensive and time consuming, even in those instances in which the
outcome is favorable and could result in the diversion of substantial resources and management time and attention from our other activities.
An adverse outcome could subject us to significant liability to third parties, require us to obtain licenses from third parties, require
us to alter our products or processes, or require that we cease altogether any related research and development activities or product
sales.
Patent
protection is highly uncertain and involves complex legal and factual questions and issues. The patent application and issuance process
can be expected to take several years and entails considerable expense. There can be no assurance that patents will be issued as a result
of any applications or that any patents resulting from such applications, or our existing patents will be sufficiently broad to afford
protection against competitors with similar or competing technology. Patents that we obtain may be challenged, invalidated or circumvented,
or the rights granted under such patents may not provide us with any competitive advantages.
**Competition**
The
market for CGM devices is intensely competitive, subject to rapid change and significantly affected by new product introductions. Three
companies, Abbott Laboratories (Abbott), DexCom and Medtronic currently account for substantially all of the worldwide
sales of CGM systems. These products are all transcutaneous systems with sensor longevities of 7-15 days. These systems have a sensor
that is worn on the back of the upper arm or the abdomen, depending on the system. The sensor measures glucose in the interstitial fluid,
which lags glucose in the blood, so the CGM readings may lag about 15-20 minutes behind blood glucose readings. Depending on the system,
the sensor provides glucose readings every one to five minutes and streams directly to the users compatible smartphone. Following
the insertion of a new Abbott FreeStyle Libre 3 or DexCom G7 sensor, there is a warm-up period of 30-60 minutes, depending on the system,
during which time no readings are available. After that period, both systems are factory-calibrated, which means that no fingersticks
(blood glucose measurements using a glucometer) are required for calibration. For the Medtronic Guardian 4 system, there is a 2-hour
warm-up period; after that period, no fingersticks are required for calibration when using as a part of the MiniMed 780G insulin pump
system.
There
is currently one implantable CGM that is commercially available in the US and Europe: Senseonics Holdings, Inc. The sensor is inserted
by a doctor under the skin of the upper arm and lasts up to 365 days. The wearable smart transmitter provides on-body vibe alerts and
is worn over the sensor using a daily adhesive. There is a 24-hour warm up period with this system and, after that period, fingersticks
are required for calibration twice a day for the 1st 21 days and then once daily. Similar to the transcutaneous systems, this system
also measures glucose in the interstitial fluid. All four competitors are either publicly traded or are divisions of publicly traded
companies, and they enjoy several competitive advantages, including:
| 
| 
| 
significantly
greater name recognition; | |
| 
| 
| 
| |
| 
| 
| 
established
relations with healthcare professionals, customers and third-party payors; | |
| 
| 
| 
| |
| 
| 
| 
established
distribution networks; | |
| 
| 
| 
| |
| 
| 
| 
additional
lines of products, and the ability to offer rebates or bundle products to offer higher discounts or incentives to gain a competitive
advantage; | |
| 
| 
| 
| |
| 
| 
| 
greater
experience in conducting research and development, manufacturing, clinical trials, obtaining regulatory approval for products and
marketing approved products; and | |
| 
| 
| 
| |
| 
| 
| 
greater
financial and human resources for product development, sales and marketing, and patent litigation. | |
| 14 | |
As
a result, we cannot ensure that we will be able to compete effectively against these companies or their products.
There
are several new and smaller players that have obtained clearance to market in EU or Asia. Their systems are transcutaneous systems with
similar form factors and longevity as the Abbott, DexCom and Medtronic systems. None of these companies has yet achieved a significant
user base.
Additionally,
Medtronic and other companies have developed or are developing, insulin pumps integrated with CGM systems that provide, among other things,
the ability to suspend insulin administration while the users glucose levels are low and to automate basal or bolus insulin dosing.
Both Abbott and DexCom have received FDA clearance to integrate certain versions of their sensors into automated insulin delivery systems.
Although
we face potential competition from many different sources, we believe that our technology, experience and scientific knowledge provide
us with competitive advantages of accuracy, longevity, discretion and usability, though our technology is not in any way integrated with
an automatic insulin delivery system.
**Corporate
Information**
Our
principal offices are located at 301 17 North, Suite 800, Rutherford NJ 07070, and our telephone number is 201-842-7715. Our website
address is http://www.glucotrack.com; the reference to such website address does not constitute incorporation by reference of the information
contained on the website and such information should not be considered part of this Annual Report.
**Board
and Committees**
We
have five members on our Board, four of whom are independent members. The Board has an audit committee (the Audit Committee),
a compensation committee and a nominating and corporate governance committee. Each of our committees consists solely of independent directors.
**Employees**
As
of December 31, 2025, we had fifteen full-time employees. None of our employees are represented by a collective bargaining agreement.
**Item
1A. Risk Factors**
****
*An
investment in our Common Stock involves a high degree of risk. You should carefully consider the following risks and all of the other
information contained in this Annual Report before deciding whether to invest in our Common Stock. If any of the following risks are
realized, our business, financial condition and results of operations could be materially and adversely affected. In that event, the
trading price of our Common Stock could decline, and you could lose all or part of your investment in our Common Stock. Additional risks
of which we are not presently aware or that we currently believe are immaterial may also harm our business and results of operations.
Some statements in this Annual Report, including such statements in the following risk factors, constitute forward-looking statements.
See the section entitled Cautionary Note Regarding Forward-Looking Statements.*
**Risks
Related to our Business and Industry**
**We
have a history of operating losses, and there is no assurance that we will generate material revenues or become profitable in the near
future.**
We
are a medical device company with a limited operating history. We are not profitable and have incurred losses since our inception.
To date we have not generated material revenue from the sale of products, and we do not anticipate that we will report operating
income in the foreseeable future. Our first product was removed from international markets as the Company withdrew its CE Mark by
2023. As of 2023, all commercialization and development efforts ceased of the first product. Our second and novel new product,
Glucotrack CBGM, has not been approved for marketing in the United States or internationally and is currently under preclinical
development. Our net losses for the years ended December 31, 2025 and 2024 were approximately $19.4 million and $22.6 million,
respectively, and we had an accumulated deficit of approximately $151.8 million as of December 31, 2025. We expect to continue to
incur losses for the foreseeable future, and these losses will likely increase as we develop and prepare to commercialize Glucotrack
CBGM. If we are not successful in developing, manufacturing and distributing Glucotrack CBGM, or if Glucotrack CBGM does not achieve
market acceptance, we may never become profitable. Even if we achieve profitability in the future, we may not be able to sustain
profitability in subsequent periods.
| 15 | |
**When
we evolve from a company primarily involved in development to a company also involved in commercialization, we may encounter
difficulties in managing our growth and expanding our operations successfully.**
We
anticipate that, as our operations expand and, assuming that our development, testing, pre-clinical studies and human clinical trials
are successful, we will need to build and develop our marketing and sales capabilities. Maintaining and managing our future growth will
impose significant added responsibilities on members of our management team. We must be able to manage our development efforts effectively;
manage our clinical trials effectively; hire, train and integrate additional management, development, administrative and sales and marketing
personnel; improve managerial, development, operational and finance systems; and expand our facilities, all of which may impose a strain
on our administrative and operational infrastructure.
**We
may have future capital needs and may not be able to obtain additional financing on acceptable terms.**
Economic
and credit market conditions, the performance of our industry and our financial performance, as well as other factors, may constrain
our financing abilities. Our ability to secure additional financing, if available, and to satisfy our financial obligations under indebtedness
outstanding from time to time will depend upon our future operating performance, the availability of credit, economic conditions and
financial, business and other factors, many of which are beyond our control.
We
may require additional financing to fund our operations and growth. The failure to secure additional financing could have an adverse
effect on our continued development or growth. None of our officers, directors or stockholders is required to provide any financing to
us.
**Raising
additional capital may cause dilution to our existing stockholders and investors, restrict our operations, or require us to relinquish
rights to our products and/or product candidates on unfavorable terms to us.**
We
will seek additional capital through a variety of means, including through private and public equity offerings and debt financings, collaborations,
strategic alliances and marketing, distribution or licensing arrangements. To the extent that we raise additional capital through the
sale of equity or convertible debt securities, or through the issuance of shares under other types of contracts, or upon the exercise
or conversion of outstanding options, warrants, convertible debt or other similar securities, the ownership interests of our stockholders
will be diluted, and the terms of such financings may include liquidation or other preferences, anti-dilution rights, conversion and
exercise price adjustments and other provisions that adversely affect the rights of our stockholders, including rights, preferences and
privileges that are senior to those of our holders of Common Stock in terms of the payment of dividends or in the event of a liquidation.
In addition, debt financing, if available, could include covenants limiting or restricting our ability to take certain actions, such
as incurring additional debt, making capital expenditures, entering into licensing arrangements or declaring dividends and may require
us to grant security interests in our assets. If we raise additional funds through collaborations, strategic alliances or marketing,
distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue
streams, product or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional
funds through equity or debt financing when needed, we may need to curtail or cease our operations.
| 16 | |
****
**Our
independent registered public accounting firms report contains an explanatory paragraph that expresses substantial doubt about
our ability to continue as a going concern.**
We
may not have sufficient liquidity to meet our anticipated obligations over the next year from the issuance of the financial statements
contained in this Annual Report. We have incurred net losses and negative cash flows from our operations and comprehensive loss since
our inception and as of December 31, 2025, we had an accumulated deficit of $151.8 million. As of December 31, 2025, we had cash and
cash equivalents of $7.4 million. There are no assurances that we will be able to raise additional capital or do so on terms favorable
to us. Our recurring losses from operations and projected future cash flow requirements raise substantial doubt about our ability to
continue as a going concern without sufficient capital resources and we have included explanatory information in the notes to our financial
statements for the year ended December 31, 2025, with respect to this uncertainty, and the report of our independent registered public
accounting firm with respect to our audited financial statements for the year ended December 31, 2025 included an emphasis
of matter for this as well. Our consolidated financial statements do not include any adjustments that might result from the outcome of
this going concern uncertainty and have been prepared under the assumption that we will continue to operate as a going concern, which
contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.
Our
ability to continue as a going concern is dependent on our available cash, how well we manage that cash, and our operating requirements.
If we are unable to raise additional capital when needed, we could be forced to curtail operations or take other actions such as implementing
additional restructuring and cost reductions, disposing of one or more product lines and/or, selling or licensing intellectual property.
If we are unable to continue as a going concern, we may be forced to liquidate our assets, which would have an adverse impact on our
business and developmental activities. In such a scenario, the values we receive for our assets in liquidation or dissolution could be
significantly lower than the values reflected in our financial statements.
**Economic
crises and market instability may materially and adversely affect the demand for our products, as well as our ability to obtain credit
or secure funds through sales of our stock, which may materially and adversely affect our business, financial condition and ability to
fund our operations.**
Economic
crises may reduce the demand for new and innovative medical devices, resulting in delayed market acceptance of our products, if and when
they are approved. Such a delay could have a material adverse impact on our business, expected cash flows, results of operations and
financial condition. Additionally, we have funded our operations to date primarily through public and private sales of securities, including
Common Stock and other securities convertible into or exercisable for shares of our Common Stock. Economic turmoil and instability in
the worlds equity and credit markets may materially adversely affect our ability to sell additional securities and/or borrow cash.
There can be no assurance that we will be able to raise additional working capital on acceptable terms or at all, and any failure to
do so may materially adversely affect our ability to continue operations.
**Glucotrack
CBGM is not approved for sale in the United States or other jurisdictions.**
We
will likely be required to undertake significant clinical trials to demonstrate to the FDA that Glucotrack CBGM is safe and effective
for its intended use (refer to *Business* *Regulatory Considerations*). We may also be required to undertake
similar clinical trials by non-U.S. regulatory agencies, particularly for the European Union (CE Mark). Clinical trials for implantable
medical devices are expensive and uncertain processes that take years to complete. Failure can occur at any point in the process and
early positive results do not ensure that the entire clinical trial will be successful. Product candidates in clinical trials may fail
to show desired efficacy and safety traits despite early promising results. A number of companies in the medical device industry have
suffered significant setbacks in advanced clinical trials, even after their product candidates demonstrated promising results at earlier
points.
Positive
results from the limited safety and performance pre-clinical trials and first-in-human acute clinical studies that we have conducted
should not be relied upon as evidence that early-stage or large-scale clinical trials will succeed. Despite efforts to choose the proper
animal model reflecting our intended use, our pre-clinical animal trials and first-in-human acute clinical studies cannot be a guarantee
of clinical trial success because human physiology and anatomy are different. Because of the sample size, possible variation in methodology
or differences in physiology, the results of these pre-clinical trials may not be indicative of future results. We will be required to
demonstrate through multiple well-controlled clinical trials that Glucotrack CBGM or future product candidates, if any, are safe and
effective for their intended uses.
| 17 | |
Further,
the Glucotrack CBGM or our future product candidates, if any, may not be cleared or approved, as the case may be, even if the clinical
data are satisfactory and support, in our view, its or their clearance or approval. The FDA or other non-U.S. regulatory authorities
may disagree with our trial design or interpretation of the clinical data. In addition, any of these regulatory authorities may change
requirements for the clearance or approval of a product candidate even after reviewing and providing comment on a protocol for a pivotal
clinical trial that has the potential to result in FDA approval. In addition, any of these regulatory authorities may also clear or approve
a product candidate for fewer or more limited patient populations than we request or may grant clearance or approval contingent on the
performance of costly post-marketing clinical trials. In addition, the FDA or other non-regulatory authorities may not approve the labeling
claims necessary or desirable for the successful commercialization of Glucotrack CBGM or our future product candidates, if any.
**We
are highly dependent on the success of our primary product candidate, Glucotrack CBGM, and cannot give any assurance that it will receive
regulatory approval or clearance or be successfully commercialized.**
We
are highly dependent on the success of our primary product candidate, Glucotrack CBGM. We cannot give any assurance that the FDA will
permit us to clinically test the device, nor can we give any assurance that the clinical trials will be successful or that Glucotrack
CBGM will receive regulatory clearance or approval or be successfully commercialized, for a number of reasons, including, without limitation,
the potential introduction by our competitors of more clinically-effective or cost-effective alternatives, failure in our sales and marketing
efforts, or the failure to obtain positive coverage determinations or reimbursement. Any failure to obtain approval to conduct clinical
trials, favorable clinical data, clearance or approval of or to successfully commercialize Glucotrack CBGM would have a material adverse
effect on our business.
**If
our competitors develop and market products that are more effective, safer or less expensive than Glucotrack CBGM or our future product
candidates, if any, our commercial opportunities will be adversely affected.**
The
life sciences industry is highly competitive, and we face significant competition from many medical device companies that are researching
and marketing products designed to address the needs of people suffering from diabetes. We are currently developing medical devices that
will compete with other medical devices that currently exist or are being developed. Some of our competitors have significantly greater
financial, manufacturing, marketing and product development resources than we do. Large medical device companies, in particular, have
extensive experience in clinical testing and in obtaining regulatory clearances or approvals for medical devices. These companies also
have significantly greater research and marketing capabilities than us. Some of the medical device companies that we expect to compete
with include Abbott Laboratories, DexCom, Medtronic, and Senseonics. In addition, many universities and private and public research institutions
are or may become active in research involving blood glucose measurement devices.
We
believe that our ability to successfully compete will depend on, among other things:
| 
| 
| 
our
ability to have partners manufacture and sell commercial quantities of any approved products to the market; | |
| 
| 
| 
| |
| 
| 
| 
acceptance
of product candidates by physicians and other health care providers; | |
| 
| 
| 
| |
| 
| 
| 
the
results of our clinical trials; | |
| 
| 
| 
| |
| 
| 
| 
our
ability to recruit and enroll patients for our clinical trials; | |
| 
| 
| 
| |
| 
| 
| 
the
efficacy, safety, performance and reliability of our product candidates; | |
| 
| 
| 
| |
| 
| 
| 
the
speed at which we develop product candidates or required iterations thereon; | |
| 
| 
| 
| |
| 
| 
| 
our
ability to obtain prompt and favorable FDA review and approval of an IDE to conduct our clinical trials; | |
| 
| 
| 
| |
| 
| 
| 
our
ability to obtain prompt and favorable IRB review and approval at each of our clinical sites; | |
| 
| 
| 
| |
| 
| 
| 
our
ability to commercialize and market any of our product candidates that may receive regulatory clearance or approval; | |
| 
| 
| 
| |
| 
| 
| 
our
ability to design and successfully execute appropriate clinical trials; | |
| 18 | |
| 
| 
| 
the
timing and scope of regulatory clearances or approvals; | |
| 
| 
| 
| |
| 
| 
| 
appropriate
coverage and adequate levels of reimbursement under private and governmental health insurance plans, including Medicare; and | |
| 
| 
| 
| |
| 
| 
| 
our
ability to protect intellectual property rights related to our products. | |
If
our competitors market products that are more effective, safer, easier to use or less expensive than Glucotrack CBGM or our future product
candidates, if any, or that reach the market sooner than Glucotrack CBGM or our future product candidates, if any, we may not achieve
commercial success. In addition, the medical device industry is characterized by rapid technological change. It may be difficult for
us to stay abreast of the rapid changes in each technology. If we fail to stay at the forefront of technological change, we may be unable
to compete effectively. Technological advances or products developed by our competitors may render our technologies or product candidates
obsolete or less competitive.
A
number of medical device companies, medical researchers and pharmaceutical companies are also pursuing new delivery technologies, procedures,
drugs and other therapies for the monitoring, treatment and prevention of diabetes. If successful, these technologies could render glucose
monitoring devices, like the Glucotrack CBGM, obsolete. Technological breakthroughs in diabetes treatment or prevention could reduce
the potential market for Glucotrack CBGM, making it less competitive or obsolete altogether.
The
diabetes market is currently seeing increasing use of GLP-1 drugs for the treatment of obesity and Type 2 diabetes. While GLP-1s have
been used as a companion product in conjunction with CGM systems, such drugs could potentially compete with the Glucotrack CBGM and impact
successful commercialization particularly as it applies to patients with Type 2 diabetes not dependent on insulin as well as those with
pre-diabetes conditions.
**Our
product development activities could be delayed or stopped.**
We
do not know whether our future clinical trials will begin on time, or at all, and whether ongoing and/or future clinical trials will
be completed on schedule, or at all.
The
commencement of future clinical trials could be substantially delayed or prevented by several factors, including:
| 
| 
| 
the
failure to obtain sufficient funding to pay for all necessary clinical trials; | |
| 
| 
| 
| |
| 
| 
| 
limited
number of, and competition for, suitable patients that meet the protocols inclusion criteria and do not meet any of the exclusion
criteria; | |
| 
| 
| 
| |
| 
| 
| 
limited
number of, and competition for, suitable sites to conduct the clinical trials, and delay or failure to obtain FDA approval, if necessary,
to commence a clinical trial; | |
| 
| 
| 
| |
| 
| 
| 
delay
or failure to obtain sufficient supplies of the product candidate for clinical trials; | |
| 
| 
| 
| |
| 
| 
| 
requirements
to provide the medical device required in clinical trials at cost, which may require significant expenditures that we are unable
or unwilling to make; | |
| 
| 
| 
| |
| 
| 
| 
delay
or failure to reach agreement on acceptable clinical trial agreement terms or clinical trial protocols with prospective sites or
investigators; and | |
| 
| 
| 
| |
| 
| 
| 
delay
or failure to obtain IRB approval or renewal of such approval to conduct a clinical trial at a prospective or accruing site, respectively. | |
| 19 | |
The
completion of clinical trials in connection with our application for FDA approval could also be substantially delayed or prevented by
several factors, including:
| 
| 
| 
delay
or failure to obtain FDA IDE approval or renewal of such approval to conduct a clinical trial; | |
| 
| 
| 
| |
| 
| 
| 
slower
than expected rates of patient recruitment and enrollment; | |
| 
| 
| 
| |
| 
| 
| 
failure
of patients to complete the clinical trial; | |
| 
| 
| 
| |
| 
| 
| 
unforeseen
safety issues; | |
| 
| 
| 
| |
| 
| 
| 
lack
of efficacy evidenced during clinical trials; | |
| 
| 
| 
| |
| 
| 
| 
termination
of clinical trials by one or more clinical trial sites; | |
| 
| 
| 
| |
| 
| 
| 
inability
or unwillingness of patients or medical investigators to follow clinical trial protocols; | |
| 
| 
| 
| |
| 
| 
| 
inability
to monitor patients adequately during or after the clinical study period; and, | |
| 
| 
| 
| |
| 
| 
| 
inability
to meet safety and efficacy endpoints required by the FDA for market clearance. | |
Our
clinical trials may be suspended or terminated at any time by the FDA, other regulatory authorities, and/or the IRB for any given site
or us. Any failure or significant delay in completing clinical trials for the Glucotrack CBGM or future product candidates, if any, could
materially harm our financial results and the commercial prospects for our product candidates.
**The
regulatory approval process is expensive, time-consuming and uncertain and may prevent us from obtaining approvals for the commercialization
of Glucotrack CBGM or our future product candidates, if any.**
The
research, testing, manufacturing, labeling, approval, selling, marketing and distribution of medical devices are subject to extensive
regulation by the FDA and other non-U.S. regulatory authorities, with regulations that differ from country to country. We are not permitted
to market our product candidates in the United States until we receive a clearance letter under Section 515 premarket approval from the
FDA. We have not submitted an application or premarket notification for or received marketing clearance or approval for our current product
candidate. Obtaining approval of any premarket approval can be a lengthy, expensive and uncertain process, particularly for Class III
devices under which our product candidate falls. In lieu of acting on a premarket notification, the FDA may seek additional information
or additional data which would further delay our ability to market the product candidate. In addition, failure to comply with FDA, non-U.S.
regulatory authorities or other applicable U.S. and non-U.S. regulatory requirements may, either before or after product clearance or
approval, if any, subject us to administrative or judicially imposed sanctions, including:
| 
| 
| 
restrictions
on the products, manufacturers or manufacturing process; | |
| 
| 
| 
| |
| 
| 
| 
adverse
inspectional observations (Form 483), warning letters or non-warning letters incorporating inspectional observations, i.e., so-called
untitled letter; | |
| 
| 
| 
| |
| 
| 
| 
civil
and criminal penalties; | |
| 
| 
| 
| |
| 
| 
| 
injunctions; | |
| 
| 
| 
| |
| 
| 
| 
suspension
or withdrawal of regulatory clearances or approvals; | |
| 
| 
| 
| |
| 
| 
| 
product
seizures, detentions or import bans; | |
| 
| 
| 
| |
| 
| 
| 
voluntary
or mandatory product recalls and publicity requirements; | |
| 
| 
| 
| |
| 
| 
| 
total
or partial suspension of production; | |
| 
| 
| 
| |
| 
| 
| 
imposition
of restrictions on operations, including costly new manufacturing requirements; and | |
| 
| 
| 
| |
| 
| 
| 
refusal
to clear or approve pending applications or premarket notifications. | |
| 20 | |
Regulatory
approval of a Class III medical device is not guaranteed, and the approval will take several years when factoring in clinical trial timelines.
The FDA also has substantial discretion in the medical device clearance or approval processes. Despite the time and expense exerted,
failure can occur at any stage, and we could encounter problems that cause us to abandon clinical trials or to repeat or perform additional
pre-clinical studies and clinical trials. The number of pre-clinical studies and clinical trials that will be required for FDA clearance
or approval varies depending on the medical device candidate, the disease or condition that the medical device candidate is designed
to address and the regulations applicable to any particular medical device candidate. The FDA can delay, limit or deny clearance or approval
of a medical device candidate for many reasons, including:
| 
| 
| 
a medical
device candidate may not be deemed safe or effective; | |
| 
| 
| 
| |
| 
| 
| 
FDA
officials may not find the data from the clinical trials sufficient; | |
| 
| 
| 
| |
| 
| 
| 
the
FDA might not approve our third-party manufacturers processes or facilities; or | |
| 
| 
| 
| |
| 
| 
| 
the
FDA may change its clearance or approval policies or adopt new regulations. | |
**Failure
to recruit and enroll patients for clinical trials may cause the development of our product candidates to be delayed.**
We
may encounter delays if we are unable to recruit, enroll and retain enough patients to complete clinical trials. Patient enrollment depends
on many factors, including the size of the patient population, the nature of the protocol, the proximity of patients to clinical sites
and the eligibility criteria for the trial. Delays in patient enrollment are not unusual. Any such delays in planned patient enrollment
may result in increased costs, which could harm our ability to develop products.
**The
terms of clearances or approvals and ongoing regulation of our products may limit how we manufacture and market our product candidates,
which could materially impair our ability to generate anticipated revenues.**
Once
regulatory clearance or approval has been granted, the cleared or approved product and its manufacturer are subject to continual review.
Any cleared or approved product may only be promoted for its indicated uses. In addition, if the FDA or other non-U.S. regulatory authorities
clear or approve Glucotrack CBGM or our future product candidates, if any, the labeling, packaging, adverse event reporting, storage,
advertising and promotion for the product will be subject to extensive regulatory requirements. We, and the manufacturers of our products
also will be required to comply with the FDAs Quality System Regulation, which includes requirements relating to quality control
and quality assurance, as well as the corresponding maintenance of records and documentation. Moreover, device manufacturers are required
to report adverse events by filing Medical Device Reports with the FDA, which are publicly available. Further, regulatory agencies must
approve our manufacturing facilities before they can be used to manufacture products, and these facilities are subject to ongoing regulatory
inspection. If we fail to comply with the regulatory requirements of the FDA and other non-U.S. regulatory authorities, or if previously
unknown problems with our products, manufacturers or manufacturing processes are discovered, we could be subject to administrative or
judicially imposed sanctions, including:
| 
| 
| 
restrictions
on the products, manufacturers or manufacturing process; | |
| 
| 
| 
| |
| 
| 
| 
adverse
inspectional observations (Form 483), warning letters, or non-warning letters incorporating inspectional observations; | |
| 
| 
| 
| |
| 
| 
| 
civil
or criminal penalties or fines; | |
| 
| 
| 
| |
| 
| 
| 
injunctions; | |
| 21 | |
| 
| 
| 
product
seizures, detentions or import bans; | |
| 
| 
| 
| |
| 
| 
| 
voluntary
or mandatory product recalls and publicity requirements; | |
| 
| 
| 
| |
| 
| 
| 
suspension
or withdrawal of regulatory clearances or approvals; | |
| 
| 
| 
| |
| 
| 
| 
total
or partial suspension of production; | |
| 
| 
| 
| |
| 
| 
| 
imposition
of restrictions on operations, including costly new manufacturing requirements; and | |
| 
| 
| 
| |
| 
| 
| 
refusal
to clear or approve pending applications or premarket notifications. | |
In
addition, the FDA and other non-U.S. regulatory authorities, including the EU and each of the EU member countries individually, may change
their policies and enact additional regulations that could prevent or delay regulatory clearance or approval of our product candidates.
We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative
action, either in the United States or abroad. If we are not able to maintain regulatory compliance, we will likely not be permitted
to market future product candidates and may not achieve or sustain profitability.
**Even
if we receive regulatory clearance or approval to market Glucotrack CBGM or our future product candidates, if any, the market may not
be receptive to our products.**
Even
if Glucotrack CBGM or our future product candidates, if any, obtain regulatory clearance or approval, resulting products may not gain
market acceptance among physicians, patients, health care payors or the medical community. We believe that the degree of market acceptance
will depend on a number of factors, including:
| 
| 
| 
timing
of market introduction of competitive products; | |
| 
| 
| 
| |
| 
| 
| 
safety
and efficacy of our product; | |
| 
| 
| 
| |
| 
| 
| 
prevalence
and severity of any side effects; | |
| 
| 
| 
| |
| 
| 
| 
potential
advantages or disadvantages over alternative treatments; | |
| 
| 
| 
| |
| 
| 
| 
strength
of marketing, sales, and distribution support; | |
| 
| 
| 
| |
| 
| 
| 
price
of our product candidates, both in absolute terms and relative to alternative treatments; and | |
| 
| 
| 
| |
| 
| 
| 
availability
of coverage and reimbursement from government and other third-party payors. | |
**If
the Glucotrack CBGM or our future product candidates, if any, fail to achieve sufficient reimbursement and coverage, we may not be able
to generate significant revenue or achieve or sustain profitability.**
The
reimbursement status and coverage of newly cleared or approved medical devices is uncertain, and failure to obtain adequate coverage
and adequate reimbursement could limit our ability to market Glucotrack CBGM or future product candidates, if any, and may inhibit our
ability to generate revenue from Glucotrack CBGM or our future product candidates, if any, that may be cleared or approved.
The commercial success
of Glucotrack CBGM or our future product candidates, if any, in both domestic and international markets will depend in part on the availability
of coverage and adequate reimbursement from third-party payors, including government payors, such as the Medicare and Medicaid programs,
managed care organizations and other third-party payors. Government and other third-party payors are increasingly attempting to contain
health care costs by limiting both coverage and the level of reimbursement for new products and, as a result, they may not cover or provide
adequate payment for Glucotrack CBGM or our future product candidates, if any. These payors may conclude that our products are not as
safe or effective as existing devices or that the overall cost of using one of our devices exceeds the overall cost of the competing
device, and third-party payors may not approve Glucotrack CBGM or our future product candidates, if any, for coverage and adequate reimbursement.
Furthermore, deficit reduction and austerity measures in the United States and abroad may put further pressure on governments to limit
coverage of, and reimbursement for, our products. The failure to obtain coverage and adequate reimbursement for Glucotrack CBGM or our
future product candidates, if any, or health care cost containment initiatives that limit or restrict reimbursement for such products,
may reduce any future product revenue.
| 22 | |
****
**We
may not obtain insurance coverage to adequately cover all significant risk exposures.**
We
will be exposed to liabilities that are unique to the products we provide. We currently maintain commercial general liability and property
insurance, but there can be no assurance that we will acquire or maintain insurance for certain risks, that the amount of our insurance
coverage will be adequate to cover all claims or liabilities or that we will not be forced to bear substantial costs resulting from risks
and uncertainties of business. It is also not possible to obtain insurance to protect against all operational risks and liabilities.
The failure to obtain adequate insurance coverage on terms favorable to us, or at all, could have a material adverse effect on our business,
financial condition and results of operations.
**If
product liability lawsuits are brought against us, we may incur substantial liabilities.**
We
face a potential risk of product liability as a result of any of the products that we offer for sale. For example, we may be sued if
any product we sell allegedly causes injury or is found to be otherwise unsuitable during product testing, manufacturing, marketing or
sale. Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of
dangers inherent in the product, negligence, strict liability and a breach of warranties. Claims could also be asserted under state or
federal consumer protection laws or regulations. If we cannot successfully defend ourselves against product liability claims, we may
incur substantial liabilities. Even successful defense would require significant financial and managerial resources. Regardless of the
merits or eventual outcome, liability claims may result in:
| 
| 
| 
decreased
demand for products that we may offer for sale; | |
| 
| 
| 
| |
| 
| 
| 
injury
to our reputation; | |
| 
| 
| 
| |
| 
| 
| 
costs
to defend the related litigation; | |
| 
| 
| 
| |
| 
| 
| 
a
diversion of managements time and our resources; | |
| 
| 
| 
| |
| 
| 
| 
substantial
monetary awards to trial participants or patients; | |
| 
| 
| 
| |
| 
| 
| 
product
recalls, withdrawals or labeling, marketing or promotional restrictions; and | |
| 
| 
| 
| |
| 
| 
| 
a
decline in our stock price. | |
Our
inability to obtain and retain sufficient product liability insurance at an acceptable cost to protect against potential product
liability claims could prevent or inhibit the commercialization of products we develop. We currently do not maintain product
liability insurance in the United States and maintain product liability insurance in Australia up to $10.0 Million AUS Dollars per
claim and in the aggregate. Regardless of whether we maintain product liability insurance coverage in any jurisdiction, including
Australia or in the future the United States, we may be required to pay amounts awarded by a court or negotiated in a settlement that
exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient
capital to pay such amounts.
| 23 | |
****
**If
we fail to attract and retain key management and scientific personnel, we may be unable to successfully develop or commercialize Glucotrack
CBGM or our future product candidates, if any.**
We
will need to expand and effectively manage our managerial, operational, financial, development and other resources in order to successfully
pursue our research, development and commercialization efforts for Glucotrack CBGM or our future product candidates, if any. Our success
depends on our continued ability to attract, retain and motivate highly qualified management and pre-clinical and clinical personnel.
The loss of the services of any of our executive and senior management could delay or prevent the development or commercialization of
Glucotrack CBGM or our future product candidates, if any. At present, we do not have executive insurance policies with respect to any
of our employees. We will need to hire additional personnel as we continue to expand our research and development activities and build
a sales and marketing function.
We
may not be able to attract or retain qualified management and scientific personnel in the future due to the intense competition for qualified
personnel among medical device and other businesses. If we are not able to attract and retain the necessary personnel to accomplish our
business objectives, we may experience constraints that will significantly impede the achievement of our research and development objectives,
our ability to raise additional capital and our ability to implement our business strategy. In particular, if we lose any members of
our executive or senior management teams, we may not be able to find suitable replacements in a timely fashion or at all and our business
may be harmed as a result.
**We
rely on third parties to manufacture and supply our product.**
We
do not own or operate manufacturing facilities for clinical or commercial production of Glucotrack CBGM, other than a research and prototyping
lab. We, therefore, lack the internal capability to manufacture the Glucotrack CBGM on a commercial scale.
If
our manufacturing partners are unable to produce our products in the amounts, timing or pricing that we require, we may not be able to
establish a contract and obtain a sufficient alternative supply from another supplier on a timely basis and in the quantities or pricing
we require. We expect to depend on third-party contract manufacturers for the foreseeable future.
Glucotrack
CBGM does, and our future product candidates, if any, likely will require precise, high quality manufacturing. Any of our contract manufacturers
will be subject to ongoing periodic unannounced inspections by the FDA and other non-U.S. regulatory authorities to ensure strict compliance
with quality system regulations, including current good manufacturing practices and other applicable government regulations and corresponding
standards. If our contract manufacturers fail to achieve and maintain high manufacturing standards in compliance with quality system
regulations, we may experience manufacturing errors resulting in patient injury or death, product recalls or withdrawals, delays or interruptions
of production or failures in product testing or delivery, delay or prevention of filing or approval of marketing applications for our
products, cost overruns or other problems that could seriously harm our business.
Any
performance failure on the part of our third-party manufacturers could delay clinical development or regulatory clearance or approval
of our product candidates or commercialization of our future product candidates, if any, depriving us of potential product revenue and
resulting in additional losses. In addition, our dependence on a third-party for manufacturing may adversely affect our future profit
margins. Our ability to replace an existing manufacturer may be difficult because the number of potential manufacturers is limited and
the FDA must approve any replacement manufacturer before it can begin manufacturing our product candidates. Such approval would require
additional non-clinical testing and compliance inspections. It may be difficult or impossible for us to identify and engage a replacement
manufacturer on acceptable terms in a timely manner, or at all.
**Independent
clinical investigators and contract research organizations that we may engage to conduct our clinical trials may not be diligent, careful
or timely.**
We
will depend on independent clinical investigators to conduct our clinical trials. Contract research organizations may also assist us
in the collection and analysis of data. These investigators and contract research organizations will not be our employees and we will
not be able to control, other than by contract, the amount of resources spent on our endeavors, including time that they devote to products
that we develop. If independent investigators fail to devote sufficient resources to the clinical trials, or if their performance is
substandard, it will delay the approval or clearance and commercialization of any products that we develop. Further, the FDA requires
that we comply with standards, commonly referred to as good clinical practice, for conducting, recording and reporting clinical trials
to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial subjects
are protected. If our independent clinical investigators and contract research organizations fail to comply with good clinical practice,
the results of our clinical trials could be called into question and the clinical development of our product candidates could be delayed.
Failure of clinical investigators or contract research organizations to meet their obligations to us or comply with federal regulations
could adversely affect the clinical development of our product candidates and harm our business.
| 24 | |
**Our
business may become subject to economic, political, regulatory and other risks associated with international operations, which could
harm our business.**
Our
business is subject to risks associated with conducting business internationally. Accordingly, our future results could be harmed by
a variety of factors, including:
| 
| 
| 
difficulties
in compliance with non-U.S. laws and regulations; | |
| 
| 
| 
| |
| 
| 
| 
changes
in non-U.S. regulations and customs; | |
| 
| 
| 
| |
| 
| 
| 
changes
in non-U.S. currency exchange rates and currency controls; | |
| 
| 
| 
| |
| 
| 
| 
changes
in a specific country or regions political or economic environment; | |
| 
| 
| 
| |
| 
| 
| 
trade
protection measures, import or export licensing requirements or other restrictive actions by U.S. or non-U.S. governments; | |
| 
| 
| 
| |
| 
| 
| 
negative
consequences from changes in tax laws; and | |
| 
| 
| 
| |
| 
| 
| 
difficulties
associated with staffing and managing foreign operations, including differing labor relations. | |
**The
funding that we received through the Israeli Innovation Authority (IIA) for research and development activities restricts
our ability to manufacture products or to transfer technology outside of Israel of its first product which we have taken off the market
and no longer have available for sale.**
In
2023, the Company abandoned pursuit of its Israeli originated first generation product development programs, including the
abandonment of any associated intellectual property and intangible assets. The Company is solely focused on its second product,
which is uniquely designed and patented, under product and clinical development efforts in the United States. The Companys Israeli subsidiary is in the process of dissolution and does not conduct any operating activities.
On
March 4, 2004, the IIA agreed to provide us with a grant of 420,000 New Israeli Shekels (NIS), or approximately $93 thousand
at an exchange rate of 4.502 NIS/dollar (the exchange rate in effect on such date), for our plan to develop a non-invasive blood glucose
monitor (the development plan). This grant constituted 60% of our research and development budget for the development plan
at that time. Due to our acceptance of this grant, we are subject to the provisions of the Israeli Law for the Encouragement of Industrial
Research and Development, 1984 (the R&D Law). Among other things, the R&D Law restricts the ability to sell or
transfer rights in technology or know-how developed with IIA funding or transfer any Means of Control (as defined in the R&D Law)
of us to non-Israeli entities. The Industrial Research and Development Committee at the IIA (the research committee) may,
under special circumstances, approve the transfer outside of Israel of rights in technology or know-how developed with IIA funding subject
to certain conditions, including the condition that certain payments be made to the IIA. Additionally, products developed with IIA funding
outside of Israel cannot be manufactured without the approval of a research committee. The restrictions regarding the sale or transfer
of technology or manufacturing rights out of Israel could have a material adverse effect on the ability to enter into strategic alliances
or enter into merger or acquisition transactions in the future that provide for the sale or transfer of technology or manufacturing rights.
| 25 | |
**Our
results of operations could be adversely affected by general conditions in the global economy and in the global financial markets.**
****
Factors
such as geopolitical events (including the ongoing wars in Iran, Ukraine and Israel and the risk of increased tensions between China
and Taiwan), inflationary pressures, public health crises, and U.S. election cycles, and changes in government administration and policies
have caused extreme volatility and disruptions in the capital and credit markets in recent years. Uncertainty or unfavorable global economic
conditions could result in a variety of impacts to our business, including adversely impacting our ability to raise additional capital
when needed on acceptable terms, if at all.
**Risks
Related to Owning our Common Stock**
**We
have never declared or paid any cash dividends on our Common Stock and do not anticipate paying any dividends on our Common Stock in
the foreseeable future.**
We
have never declared or paid any cash dividends on our Common Stock and do not anticipate paying any dividends on our Common Stock in
the foreseeable future. Any cash that might be available for payment of dividends will be used to expand our business. Payments of any
cash dividends in the future will depend on our financial condition, results of operation and capital requirements, as well as other
factors deemed relevant to our Board of Directors.
**If
we are unable to continue to satisfy the applicable continued listing requirements of Nasdaq, our Common Stock could be delisted, and
we and our stockholders could face significant material adverse consequences. In addition, Nasdaq has recently proposed a new $5 million market value of listed securities requirement that we may not satisfy and therefore
could cause our Common Stock to be delisted by Nasdaq on an imminent basis, if approved by the SEC.**
In
order to remain listed on Nasdaq, we must satisfy minimum financial and other continued listing requirements and standards, including
those regarding director independence and independent committee requirements, minimum stockholders equity, minimum share price,
and certain corporate governance requirements (the Nasdaq Listing Rules).
For
example, Nasdaq Listing Rule 5550(b)(1) requires companies listed on Nasdaq to maintain a minimum of $2,500,000 in stockholders
equity for continued listing (the Minimum Stockholders Equity Requirement). On May 21, 2024, the Nasdaq Qualifications
Listing Staff (the Staff) notified us that our Form 10-Q for the period ended March 31, 2024, indicated that we no longer
met the Minimum Stockholders Equity Requirement. Failure to meet the Minimum Stockholders Equity Requirement is a basis
for delisting our Common Stock.
Because
we were not in compliance with the requirement to maintain a minimum bid price of $1.00 per share for continued listing on Nasdaq as
set forth in Nasdaq Listing Rule 5550(a)(2) (the Bid Price Rule), at the time we were notified about the non-compliance
with the Minimum Stockholders Equity Requirement, we were not eligible to submit a plan to regain compliance with the Staff. However,
we timely requested a hearing before the Nasdaq hearings panel and paid the fee, which resulted in a stay of any suspension or delisting
action pending the hearing. The hearing took place on July 9, 2024, and on August 5, 2024, we received the decision of the panel, and
they granted us an extension until November 18, 2024 to regain compliance with the Minimum Stockholders Equity Requirement.
On
November 19, 2024, the Company received a compliance letter (the Compliance Letter) from Nasdaq, informing the Company
that it had regained compliance with the Minimum Stockholders Equity Requirement. The Compliance Letter noted, that because the
Companys bid price had closed below the minimum required by the Bid Price Rule following the November Offering (defined blow),
the Panel had determined to impose on the Company a Discretionary Panel Monitor, pursuant to Listing Rule 5815(d)(4)(B), for a period
of one year from the date of the Compliance Letter, to ensure that the Company maintained long-term compliance with the Minimum Stockholders
Equity Requirement, the Bid Price Rule, and all other Nasdaq Listing Rules.
On
December 31, 2024, Nasdaq notified us that for at least the last 30 consecutive business days, the bid price for our Common Stock had
closed below the minimum $1.00 per share requirement for continued inclusion on the Nasdaq Capital Market pursuant to the Bid Price Rule.
In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we had a compliance period of 180 calendar days, or until June 30, 2025, to regain
compliance with the Bid Price Rule. On February 3, 2025, the Company implemented a reverse stock split at a ratio of 1-for-20 to regain
compliance with the Bid Price Rule. On April 2, 2025, we received a letter from Nasdaq notifying us that as a result of non-compliance
with the Bid Price Rule, Nasdaq Staff had determined to delist our securities. We timely submitted a hearing request to the hearings
panel on April 9, 2025, and paid the fee, which resulted in a stay of any suspension or delisting action pending the hearing. The hearing
took place on May 13, 2025, and on June 2, 2025, we received the decision of the panel granting us an extension until July 3, 2025, to
regain compliance with the Bid Price Rule. On June 13, 2025, the Company implemented a reverse stock split at a ratio of 1-for-60 to
regain compliance with the Bid Price Rule.
On
July 18, 2025, we received notice from Nasdaq that we had regained compliance with the Bid Price Rule. The Panel retained jurisdiction
over the Company through September 29, 2025. On November 5, 2025, the Company was notified by Nasdaq Staff that the Company was in compliance
with all Nasdaq Listing Rules.
In
addition to the foregoing requirements, Nasdaq has recently proposed a new listing requirement that would require each Nasdaq listed
issuer to maintain a minimum market value of listed securities of at least $5 million. Under this proposal, if the value of an issuers
listed securities, as measured by each applicable trading days closing price, continues to be less than $5 million for a period
of 30 consecutive trading days, the issuers securities would immediately be delisted, with no compliance or cure period. The proposed
rule would also preclude an issuers ability to seek stay of delisting during any appeals process, and would preclude Nasdaq hearings
panels from reversing the delisting determination to situations where there was an error and the company never actually failed to satisfy
the requirement. The panel would also not be able to consider any facts indicating that issuer subsequently regained compliance with
the requirement or grant an issuer any additional time to regain compliance. The proposed rule is subject to review and approval by the
SEC, and it is unknown whether the SEC will approve the proposal. If approved by the SEC, the rule could become effective on an imminent
basis. Our Common Stock currently trades at levels that are below the $5 million aggregate market value threshold proposed by Nasdaq.
As such, if this proposal is approved by the SEC, our Common Stock could be imminently delisted by Nasdaq on this basis.
We
may be required to monitor our market value of listed securities closely and, if necessary, take actions such as issuing additional securities,
raising additional capital or undertaking other corporate actions to seek to maintain compliance, any of which could dilute our existing
shareholders, increase our costs, or divert managements attention. The risk of a rapid loss of Nasdaq listing, or an actual delisting,
could adversely affect investor confidence, the liquidity and trading price of our Common Stock, and our ability to access the capital
markets, and could have a material adverse effect on our business, financial condition and results of operations.
There
can be no assurance that we will be able to continue to maintain compliance with the Nasdaq Listing Rules. If we are not able to comply
with applicable Nasdaq Listing Rules, our shares of Common Stock will be subject to delisting.
| 26 | |
If
Nasdaq delists our Common Stock from trading on its exchange for failure to meet comply with the Bid Price Rule, or any other Nasdaq
Listing Rules, we and our stockholders could face significant material adverse consequences including, but not limited to:
| 
| 
| 
a
limited availability of market quotations for our securities; | |
| 
| 
| 
| |
| 
| 
| 
a
reduction in liquidity and market price of our Common Stock; | |
| 
| 
| 
| |
| 
| 
| 
a
reduction in the number of investors willing to hold or acquire our Common Stock, which could negatively impact our ability to raise
equity financing; | |
| 
| 
| 
| |
| 
| 
| 
a
determination that our Common Stock is a penny stock, which will require brokers trading in our Common Stock to adhere
to more stringent rules, possibly resulting in a reduced level of trading activity in the secondary trading market for our Common
Stock; | |
| 
| 
| 
| |
| 
| 
| 
a
limited amount of analyst coverage; and | |
| 
| 
| 
| |
| 
| 
| 
a
decreased ability to issue additional securities or obtain additional financing in the future. | |
**We
had identified a material weakness in our internal control over financial reporting, and we may not be able to successfully implement
remedial measures.**
We
identified material weaknesses related to our internal control over financial reporting as of December 31, 2024 and concluded that internal
control over financial reporting as at December 31, 2025 were not effective. The ineffectiveness of the Companys internal control
over financial reporting was due to identification of material weaknesses related to lack of sufficient internal accounting personnel,
segregation of duties, and lack of sufficient internal controls (including IT general controls) that encompass the Company as a whole
with respect to entity and transaction level controls in order to ensure complete documentation of complex and non-routine transactions
and adequate financial reporting.
During the fiscal year ended December 31, 2025, management identified and began implementing corrective actions to remediate these material
weaknesses. These actions include implementing enhanced IT system access controls and data backup procedures, hiring additional accounting
personnel to improve segregation of duties, engaging thirdparty valuation and technical accounting experts, and initiating the
implementation of an enterprise resource planning system designed to automate user roles, permissions, and approval workflows. Management
intends to continue these remediation efforts during fiscal year 2026; however, these initiatives may not fully remediate all material
weaknesses in our internal control over financial reporting.
Further,
there can be no assurance that we will not suffer from other material weaknesses or significant deficiencies in the future. If we fail
to remediate these material weaknesses or fail to otherwise maintain effective internal controls over financial reporting in the future,
such failure could result in a material misstatement of our annual or quarterly financial statements that would not be prevented or detected
on a timely basis and which could cause investors and other users to lose confidence in our financial statements, limit our ability to
raise capital and have a negative effect on the trading price of our Common Stock. Additionally, failure to remediate the material weakness
or otherwise maintain effective internal controls over financial reporting may also negatively impact our operating results and financial
condition, impair our ability to timely file our periodic and other reports with the SEC, subject us to additional litigation and regulatory
actions and cause us to incur substantial additional costs in future periods relating to the implementation of remedial measures.
**The
market price and trading volume of our Common Stock has been volatile and may continue to be volatile due to numerous circumstances beyond
our control, and stockholders could lose all or part of their investment.**
The
market price and trading volume of our Common Stock has been and may continue to be highly volatile. Our stock price and trading volume
could be subject to wide fluctuations in response to a variety of factors, including, without limitation:
| 
| 
| 
results
of trials or studies; | |
| 
| 
| 
| |
| 
| 
| 
the
announcement of new products or product enhancements by us or our competitors; | |
| 
| 
| 
| |
| 
| 
| 
developments
concerning intellectual property rights and regulatory approvals; | |
| 
| 
| 
| |
| 
| 
| 
variations
in our and our competitors results of operations; | |
| 27 | |
| 
| 
| 
changes
in earnings estimates or recommendations by securities analysts, if the Common Stock is covered by analysts; | |
| 
| 
| 
| |
| 
| 
| 
developments
in the medical device industry; | |
| 
| 
| 
| |
| 
| 
| 
the
results of product liability or intellectual property lawsuits; | |
| 
| 
| 
| |
| 
| 
| 
sales,
or the perception that future sales may occur, of equity securities or issuance of debt; | |
| 
| 
| 
| |
| 
| 
| 
future
issuances of Common Stock or other securities; | |
| 
| 
| 
| |
| 
| 
| 
the
addition or departure of key personnel; | |
| 
| 
| 
| |
| 
| 
| 
changes
in state, provincial, or federal regulations affecting us and our industry; | |
| 
| 
| 
| |
| 
| 
| 
economic,
political, and other external factors; | |
| 
| 
| 
| |
| 
| 
| 
announcements
by us or our competitors of acquisitions, investments or strategic alliances; and | |
| 
| 
| 
| |
| 
| 
| 
general
market conditions and other factors, including factors unrelated to our operating performance. | |
In
addition, the stock market in general, and the market for medical device companies in particular, have experienced extreme price and
volume fluctuations. Continued or renewed market fluctuations could result in extreme volatility in the price of our Common Stock, which
could cause a decline in the value of the Common Stock.
****
**We
have a substantial number of convertible securities outstanding and the exercise of our outstanding warrants could have a dilutive
effect on our Common Stock.**
We have a substantial number of convertible securities outstanding, including warrants exercisable for shares of our Common Stock. The
issuance of shares upon the exercise of these warrants would result in dilution to our existing stockholders and could adversely affect
the market price of our Common Stock. The trading price of our Common Stock fluctuates and may not be sufficient to induce warrant holders
to exercise their warrants. If the warrants are out of the money, meaning the exercise price exceeds the market price of
our Common Stock, warrant holders are unlikely to exercise their warrants
**Our
charter documents, Delaware law, and our commercial contracts may contain provisions that may discourage an acquisition of us by others
and may prevent attempts by our stockholders to replace or remove our current management.**
Provisions
in our charter documents, as well as provisions of the Delaware General Corporation Law (DGCL), could have an impact on
the trading price of our Common Stock by making it more difficult for a third party to acquire us at a price favorable to our stockholders.
For example, our charter documents include provisions prohibiting the use of cumulative voting for the election of directors; authorizing
the issuance of blank check preferred stock, the terms of which may be established and shares of which may be issued by
our board of directors without stockholder approval to defend against a takeover attempt; and establishing advance notice requirements
for nominations for election to our Board or for proposing matters that can be acted upon at stockholder meetings.
In
addition, these provisions may frustrate or prevent any attempts by our stockholders to replace or remove our Board or current management.
We are subject to Section 203 of the DGCL, which generally prohibits a Delaware corporation from engaging in any of a broad range of
business combinations with an interested stockholder for a period of three years following the date on which the stockholder became an
interested stockholder, unless such transactions are approved by our Board. This provision could have the effect of delaying or preventing
a change of control, whether or not it is desired by or beneficial to our stockholders, which could also affect the price that some investors
are willing to pay for our Common Stock.
Finally,
commercial contracts that we enter into with our vendors and customers in the course of our business operations may contain provisions
with respect to changes in control that could provide for termination rights or otherwise have a negative impact on our business or results
of operations if a stockholder were to acquire a significant percentage of our outstanding stock.
| 28 | |
**Risks
Related to Intellectual Property**
**If
we are unable to obtain and enforce patent protection for our products, our business could be materially harmed.**
Our
success depends, among other things, on our ability to protect proprietary methods and technologies that we develop under the patent
and other intellectual property laws of the United States and other countries, so that we can prevent others from unlawfully using our
inventions and proprietary information. However, we may not hold proprietary rights to some patents required for us to commercialize
proposed products. For this and other reasons, we may be unable to secure desired patent rights, thereby losing desired exclusivity.
Although we do not believe that we need any licenses for Glucotrack CBGM, we may need to obtain licenses in the future for other products
or in certain circumstances, such as if one of our patents were declared invalid in the future. If such licenses are not available to
us on acceptable terms, we will not be able to market the affected products or conduct the desired activities, unless we successfully
challenge the validity, enforceability or infringement of the third-party patent or otherwise circumvent the third-party patent.
Our
strategy depends on our ability to rapidly identify and seek patent protection for our discoveries. The process of obtaining patent protection
is expensive and time-consuming. Despite our efforts to protect our proprietary rights, unauthorized parties may be able to obtain and
use information that we regard as proprietary.
The
issuance of a patent does not guarantee that it is valid or enforceable. Any patents we have obtained, or which we may obtain in the
future, may be challenged, invalidated, unenforceable or circumvented. Moreover, the United States Patent and Trademark Office (the USPTO)
may commence interference proceedings involving our patents or patent applications. Any challenge to, finding of unenforceability or
invalidation or circumvention of our patents or patent applications would be costly, would require significant time and attention of
our management and could have a material adverse effect on our business. In addition, court decisions may introduce uncertainty in the
enforceability or scope of patents owned by medical device companies.
Our
pending patent applications may not result in issued patents. The patent position of medical device companies, including us, is generally
uncertain and involves complex legal and factual considerations. The standards that the USPTO and its foreign counterparts use to grant
patents are not always applied predictably or uniformly and can change. There is also no uniform, worldwide policy regarding the subject
matter and scope of claims granted or allowable in medical device patents. Accordingly, we do not know the degree of future protection
for our proprietary rights or the breadth of claims that will be allowed in any patents issued to us or to others. The legal systems
of certain countries do not favor the aggressive enforcement of patents, and the laws of foreign countries may not protect our rights
to the same extent as the laws of the United States. Therefore, the enforceability or scope of our patents in the United States or in
foreign countries cannot be predicted with certainty, and, as a result, any patents that we own may not provide sufficient protection
against competitors. We may not be able to obtain or maintain patent protection for our pending patent applications or those we may file
in the future.
While
the Company has obtained issued patents, we cannot assure you that any patents that will issue, that may issue or that may be licensed
to us will be enforceable or valid or will not expire prior to the commercialization of our product candidates, thus allowing others
to more effectively compete with us. Therefore, any patents that we own may not adequately protect our product candidates or our future
products.
| 29 | |
**If
we are unable to protect the confidentiality of our proprietary information and know-how, the value of our technology and products could
be adversely affected.**
In
addition to patent protection, we also rely on other proprietary rights, including protection of trade secrets, know-how and confidential
and proprietary information. To maintain the confidentiality of trade secrets and proprietary information, we will seek to enter into
confidentiality and non-disclosure agreements with our employees, consultants and collaborators upon the commencement of their relationships
with us. These agreements generally require that all confidential information developed by the individual or made known to the individual
by us during the course of the individuals relationship with us be kept confidential and not disclosed to third parties. Our agreements
with employees also generally provide and will generally provide that any inventions conceived by the individual in the course of rendering
services to us shall be our exclusive property. However, we may not obtain these agreements in all circumstances, and individuals with
whom we have these agreements may not comply with their terms. In the event of unauthorized use or disclosure of our trade secrets or
proprietary information, these agreements, even if obtained, may not provide meaningful protection, particularly for trade secrets or
other confidential information. To the extent that our employees, consultants or contractors use technology or know-how owned by third
parties in their work for us, disputes may arise between us and those third parties as to the rights in related inventions.
Adequate
remedies may not exist in the event of unauthorized use or disclosure of our confidential information. The disclosure of trade secrets
would impair our competitive position and may materially harm our business, financial condition and results of operations.
**Our
commercial success depends significantly on our ability to operate without infringing the patents and other proprietary rights of third
parties.**
Other
entities may have or obtain patents or proprietary rights that could limit our ability to manufacture, use, sell, offer for sale or import
products or impair our competitive position. In addition, to the extent that a third party develops new technology that covers our products,
we may be required to obtain licenses to that technology, which licenses may not be available on commercially reasonable terms, if at
all. If licenses are not available on acceptable terms, we will not be able to market the affected products or conduct the desired activities
unless we successfully challenge the validity, enforceability or infringement of the third-party patent or circumvent the third-party
patent, which would be costly and would require significant time and attention of our management. Third parties may have or obtain valid
and enforceable patents or proprietary rights that could block us from developing products using our technology. Our failure to obtain
a license to any technology that we require may materially harm our business, financial condition and results of operations.
**If
we become involved in patent litigation or other proceedings related to a determination of rights, we could incur substantial costs and
expenses, substantial liability for damages or be required to stop our product development and commercialization efforts.**
Third
parties may sue us for infringing their patent rights. Likewise, we may need to resort to litigation to enforce a patent issued or licensed
to us or to determine the scope and validity of proprietary rights of others. In addition, a third party may claim that we have improperly
obtained or used our confidential or proprietary information. The cost to us of any litigation or other proceeding relating to intellectual
property rights, even if resolved in our favor, could be substantial, and the litigation would divert managements efforts. Some
of our competitors may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially
greater resources. Uncertainties resulting from the initiation and continuation of any litigation could limit our ability to continue
our operations.
If
any parties successfully claim that our creation or use of proprietary technologies infringes upon their intellectual property rights,
we might be forced to pay damages, potentially including treble damages, if we are found to have willfully infringed on such parties
patent rights. In addition to any damages we might have to pay, a court could require us to stop the infringing activity or obtain a
license. Any license required under any patent may not be made available on commercially acceptable terms, if at all. In addition, such
licenses are likely to be non-exclusive and, therefore, our competitors may have access to the same technology. If we fail to obtain
a required license and are unable to design technology that does not infringe upon a patent belonging to a third party, we may be unable
to effectively market some of our technology and products, which could limit our ability to generate revenues or achieve profitability
and possibly prevent us from generating revenue sufficient to sustain operations.
| 30 | |
**Security
threats to our information technology infrastructure could expose us to liability and damage our reputation and business.**
It
is essential to our business strategy that our technology and network infrastructure remain secure and are perceived by our customers
and corporate partners to be secure. Despite security measures, however, any network infrastructure may be vulnerable to cyber-attacks
by hackers and other security threats. We may face cyber-attacks that attempt to penetrate our network security, sabotage or otherwise
disable our research, products and services, misappropriate our or our customers and partners proprietary information,
which may include personally identifiable information, or cause interruptions of our internal systems and services.
Additionally,
there are a number of state, federal and international laws protecting the privacy and security of health information and personal data.
For example, HIPAA imposes limitations on the use and disclosure of an individuals healthcare information by healthcare providers,
healthcare clearinghouses and health insurance plans, or, collectively, covered entities, and also grants individuals rights with respect
to their health information. HIPAA also imposes compliance obligations and corresponding penalties for non-compliance on individuals
and entities that provide services to healthcare providers and other covered entities. As part of the ARRA, the privacy and security
provisions of HIPAA were amended. ARRA also made significant increases in the penalties for improper use or disclosure of an individuals
health information under HIPAA and extended enforcement authority to state attorneys general. As amended by ARRA and subsequently by
the final omnibus rule adopted in 2013, HIPAA also imposes notification requirements on covered entities in the event that certain health
information has been inappropriately accessed or disclosed as well as notification requirements to individuals, federal regulators and
in some cases, notification to local and national media. Notification is not required under HIPAA if the health information that is improperly
used or disclosed is deemed secured in accordance with encryption or other standards developed by the U.S. Department of Health and Human
Services. Most states have laws requiring notification of affected individuals and/or state regulators in the event of a breach of personal
information, which is a broader class of information than the health information protected by HIPAA. Many state laws impose significant
data security requirements, such as encryption or mandatory contractual terms, to ensure ongoing protection of personal information.
Activities outside of the United States implicate local and national data protection standards, impose additional compliance requirements,
and generate additional risks of enforcement for non-compliance. We may be required to expend significant capital and other resources
to ensure ongoing compliance with applicable privacy and data security laws, to protect against security breaches and hackers or to alleviate
problems caused by such breaches.
**If
we are not able to adequately prevent disclosure of trade secrets and other proprietary information, the value of our technology and
product could be significantly diminished.**
We
also rely on trade secrets to protect our proprietary technologies, especially where we do not believe patent protection is appropriate
or obtainable. However, trade secrets are difficult to protect. We rely in part on confidentiality agreements with our employees, consultants,
outside scientific collaborators, sponsored researchers and other advisors to protect our trade secrets and other proprietary information.
These agreements may not effectively prevent disclosure of confidential information and may not provide an adequate remedy in the event
of unauthorized disclosure of confidential information. In addition, others may independently discover our trade secrets and proprietary
information. For example, the FDA, as part of its transparency initiative, is currently considering whether to make additional information
publicly available on a routine basis, including information that we may consider to be trade secrets or other proprietary information,
and it is not clear at the present time how the FDAs disclosure policies may change in the future, if at all. Costly and time-consuming
litigation could be necessary to enforce and determine the scope of our proprietary rights, and failure to obtain or maintain trade secret
protection could adversely affect our competitive business position.
**We
may be subject to claims that our employees or consultants have wrongfully used or disclosed alleged trade secrets.**
As
is common in the biotechnology and pharmaceutical industries, we employ individuals who were previously employed at other biotechnology
or pharmaceutical companies, including our competitors or potential competitors. Although we try to ensure that our employees and consultants
do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that we or our employees
or consultants have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of their former employers.
Litigation may be necessary to defend against these claims. If we fail to defend any such claims, in addition to paying monetary damages,
we could lose valuable intellectual property rights or personnel, which could adversely impact our business. Even if we are successful
in defending against these claims, litigation could result in substantial costs and be a distraction to management.
| 31 | |
**Item
1B. Unresolved Staff Comments**
None.
**Item
1C. Cybersecurity**
**Risk
Management and Strategy**
We
recognize the critical importance of developing, implementing, and maintaining robust cybersecurity measures to safeguard our information
systems and protect the confidentiality, integrity, and availability of our data. The Company considers its primary cybersecurity risks
to be theft of intellectual property, theft of other business data, fraud or extortion, lack of access to its information systems, harm
to employees, harm to business partners, violation of privacy laws, potential reputational risk, and litigation or other legal risk if
a cybersecurity incident were to occur. It is difficult to assign a monetary materiality assessment to these risks or to the impact if
the Company were to sustain a breach of its systems. The Companys approach to cybersecurity is based on the premise that any cybersecurity
incident could result in material harm to the Company. We have a cybersecurity and risk management processes in place to oversee risks
associated with cybersecurity and respond to emerging threats in a timely and effective manner. We monitor our systems to assess cybersecurity
risks and threats.
*Managing
Material Risks & Integrated Overall Risk Management*
We
have integrated cybersecurity risk management into our broader risk management framework. This integration ensures that cybersecurity
considerations are an integral part of our decision-making process. We conduct annual risk assessments and quarterly vulnerability scans
of risks posed by cybersecurity threats in conjunction with our insurance renewal cycles. As a result of these assessments, we have implemented
technical, administrative, and, where appropriate, physical controls and practices to proactively monitor our systems and user accounts
including, but not limited to, deploying solutions to constantly monitor users accessing systems, implementation of two factor authentication
for logins, and improved rules for password maintenance.
Like
many companies, we make use of cloud-based solutions provided by several large service providers for critical information technology
infrastructure such as email and file storage. We do not maintain stand-alone servers for our email, file storage or other business applications.
In the normal course of our relationships with the providers of these services, we regularly monitor their message boards and other formal
and informal communications channels for signs of breaches of their systems. We also survey available public information for indications
that they have suffered a breach of their systems.
*Engage
Third Parties on Risk Management*
Our
Audit Committee has been designated with oversight responsibility for cybersecurity risks and our Chief Financial Officer is responsible
for managing our efforts in this area. Neither the Chief Financial Officer nor any member of the Audit Committee has relevant expertise
in cybersecurity. Recognizing the complexity and evolving nature of cybersecurity threats, the Company has retained a third-party technical
expert to support its information technology systems including addressing cybersecurity risks. This relationship enables us to leverage
specialized knowledge and insights, to ensure our cybersecurity strategies and processes are aligned with industry best practices.
*Oversee
Third Party Risk*
We
utilize various third-party software applications in the functioning of our core business. We conduct assessments of all third-party
providers and maintain ongoing reviews to ensure compliance with our cybersecurity standards. Our assessment of risks associated with
the use of third-party providers is part of our overall cybersecurity framework. In addition, some of our business partners also maintain
data related to our trials and ongoing product development on servers they maintain. We require these partners to comply with all HIPAA
standards for maintaining security of their systems where this data resides.
| 32 | |
*Risks
from Cybersecurity Threats*
We
face risk from cybersecurity threats that could have a material adverse effect on our business, financial condition, results of operations,
cash flows or reputation. For more information about the cybersecurity risks we face, see the risk factor entitled *Security
threats to our information technology infrastructure could expose us to liability and damage our reputation and business*.
in *Item 1A., Risk Factors*.
**Governance**
Our
Board of Directors is aware of the critical nature of managing risks associated with cybersecurity threats, and recognizes the significance
of these threats to our operational integrity and stockholder confidence.
*Risk
Management Personnel*
We
utilize an out-sourced information technology (IT) network and cybersecurity compliance service provider, Windstar Technologies, Inc.
(Windstar) Windstar, under the supervision of our Chief Financial Officer, is responsible for developing and implementing
our information security program. Windstar provides managed IT network and cloud services, network, cyber and web security services,
cyber risk audits and compliance and penetration testing assessments.
*Board
of Directors Oversight*
Our
Board is aware of the critical nature of managing risks associated with cybersecurity threats, and recognizes the significance of these
threats to our operational integrity and stockholder confidence. The Audit Committee is central to the Boards oversight of cybersecurity
risks and bears the primary responsibility for this domain.
*Managements
Role Managing Risk and Reporting to the Board*
We
do not currently have an employee who has significant and demonstrated professional IT management experience. Presently, our Chief Financial
Officer with assistance from our third-party IT services provider, Windstar, are primarily responsible for informing the Audit Committee
regarding cybersecurity risks. They provide briefings to the Audit Committee on a regular basis, with a minimum frequency of once per
year.
In
addition to scheduled meetings, the Audit Committee and the Chief Financial Officer maintain an ongoing dialogue regarding emerging or
potential cybersecurity risks. Together, they receive updates on any significant developments in the cybersecurity domain, ensuring the
Boards oversight is proactive and responsive. This involvement ensures that cybersecurity considerations are integrated into the
Companys broader strategic objectives and helps in identify areas for improvement, ensuring the alignment of cybersecurity efforts
with the overall risk management framework.
To
date, we have not experienced any previous cybersecurity incidents that have materially affected or are reasonably likely to materially
affect our business strategy, results of operations, or financial condition.
**Item
2. Properties**
The
following table describes our principal property leased as of the date of this Annual Report. We believe the facility described below
is adequate for our current needs.
| 
Purpose | 
| 
Location | 
| 
Square
Footage | |
| 
Office
and Research Laboratory(1) | 
| 
Front
Royal, Virginia | 
| 
2,700 | |
| 
(1) | 
Monthly
rental payments of $2,500 per month on a month-to-month basis. The lease expires on March 31, 2027. | |
**Item
3. Legal Proceedings**
We
are not presently a party to any material litigation. From time to time, we may however, become involved in litigation matters
arising in the ordinary course of our business.
**Item
4. Mine Safety Disclosures**
Not
applicable.
| 33 | |
**PART
II**
**Item
5. Market for Registrants Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities**
**Market
Information**
Our
Common Stock is listed on the Nasdaq Capital Market under the symbol GCTK.
**Holders**
As
of March 30, 2026, there were 318 holders of record of our Common Stock. A substantially greater number of holders are street
name or beneficial holders, whose shares of record are held by banks, brokers, and other financial institutions.
**Dividends**
Since
our inception, we have not paid any dividends on our Common Stock, and we currently expect that, for the foreseeable future, all earnings,
if any, will be retained for use in the development and operation of our business. In the future, our Board may decide, at its discretion,
whether dividends may be declared and paid to holders of our Common Stock.
**Securities
Authorized for Issuance under Equity Compensation Plans**
The
information required by Item 5 of Form 10-K regarding equity compensation plans is incorporated herein by reference to Item 12 of Part
III of this Annual Report.
**Unregistered
Sales of Equity Securities**
None.
| 34 | |
**Item
6. [Reserved]**
**Item
7. Managements Discussion and Analysis of Financial Condition and Results of Operations**
*The
discussion in this section contains forward-looking statements. These statements relate to future events, our future operations or our
future financial performance. We have attempted to identify forward-looking statements by terminology such as anticipate,
believe, can, continue, could, estimate, expect,
intend, may, plan, potential, predict, should, would
or will or the negative of these terms or other comparable terminology, but their absence does not mean that a statement
is not forward-looking. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, which
could cause our actual results to differ from those projected in any forward-looking statements we make. Several risks and uncertainties
we face are discussed in more detail under Risk Factors in Part I, Item 1A of this Annual Report or in the discussion and
analysis below. You should, however, understand that it is not possible to predict or identify all risks and uncertainties and you should
not consider the risks and uncertainties identified by us to be a complete set of all potential risks or uncertainties that could materially
affect us. You should not place undue reliance on the forward-looking statements we make herein because some or all of them may turn
out to be wrong. We undertake no obligation to update any of the forward-looking statements contained herein to reflect future events
and developments, except as required by law. The following discussion should be read in conjunction with the consolidated financial statements
and the notes to those statements included elsewhere in this Annual Report.*
*Unless
otherwise noted, all information in this Item 7 regarding share amounts of our Common Stock and prices per share of our Common Stock
has been adjusted to reflect the application of the one-for-five reverse stock split of our Common Stock that we effected on May 27,
2024, the one-for-twenty reverse stock split of our Common Stock that we effected on February 3, 2025, and the one-for-sixty reverse
stock split of our Common Stock that we effected on June 13, 2025, as further described below, on a retroactive basis.*
**Overview**
****
The
Company was incorporated on May 18, 2010 under the laws of the State of Delaware. We are a medical device company focused on the development
of an implantable continuous blood glucose monitor (CBGM) for persons with Type 1 diabetes and Type 2 diabetes using insulin
or at risk for hypoglycemia (the Glucotrack CBGM).
The
Company was founded with a mission to develop Glucotrack, a non-invasive glucose monitoring device designed to help people with
diabetes and pre-diabetics obtain glucose level readings without the pain, inconvenience, cost and difficulty of conventional (invasive)
spot finger stick devices. The first generation Glucotrack, which successfully received CE Mark approval, obtained glucose measurements
via a small sensor clipped onto ones earlobe. A limited release beta test in Europe and the Middle East demonstrated the need
for an updated product with improved accuracy and human factors. As the glucose monitoring landscape has since rapidly moved away from
point-in-time measurement to continuous measurement, the Company determined in 2023 that it would focus its efforts on developing the
Glucotrack CBGM. As such, the Company withdrew the CE Mark for Glucotrack and are no longer pursuing commercialization of this product
or development of any further iterations.
| 35 | |
On
October 7, 2022, the Company acquired certain intellectual property related to the Glucotrack CBGM from Paul V. Goode, the Companys
Chief Executive Officer and intends to develop the technology to address the growing Type 1 and Type 2 diabetes market.
The
Company is currently developing the Glucotrack CBGM for use by Type 1 diabetes patients as well as Type 2 diabetes using insulin or at
risk for hypoglycemia. Implant longevity is key to the success of such a device. We have continued to evolve our sensor chemistry following
our successful in-vitro feasibility study demonstrating that a minimum two-year implant life is highly probable with the current sensor
design. Subsequently we announced that a 3-year longevity is feasible leveraging both in-vitro and in-silico test results. We have also
completed multiple animal studies with initial prototype systems which demonstrated a simple implant procedure with good safety and functionality.
The results of both were presented in poster form at the 2024 American Diabetes Association annual conference. We believe our technology,
if successful, has the potential to be more accurate, more convenient and have a longer duration than other implantable glucose monitors
that are either in the market or currently under development.
Further
to the above progress on the Glucotrack CBGM, we have also successfully demonstrated continuous glucose sensing in the epidural space.
This latter approach is of importance for patients with diabetes already contemplating spinal cord stimulation therapy for their condition.
The Company believes this approach may enable integrated chronic disease management with one system that provides dual benefits of pain
relief and glucose monitoring.
The
Company completed a first in human study in 2025. This study was an acute study intended to demonstrate device performance and safety,
as well as safety of the implant and removal procedures. The study used the planned commercial version of the implantable sensor connected
to an externalized prototype electronics device. Patients were monitored in hospital for 4 days. Results of the study were positive,
meeting the endpoints of no serious safety events while demonstrating similar performance and accuracy as observed in longer-term animal
studies. Initial results were presented in poster form at the 2025 Advanced Technologies & Treatments for Diabetes annual meeting
and final results were presented in poster form at the 2025 American Diabetes Association annual conference.
The
Company initiated a long-term, multicenter feasibility study in Australia to evaluate the CBGM product performance and safety. The first
phase of the clinical study provided early product learnings about how the complexity of certain health conditions may impact study eligibility
as well as identified certain product improvements. Following a reassessment of the study in light of planned product updates
and anticipated protocol modifications,the Company determined that continuation of the study in its current form was no longer
practical and elected to close the study.
Consequently, the Company is expediting discussions with the U.S. Food and Drug Administration
(FDA) regarding our planned United States (U.S.) clinical trial program that we expect to launch in the 2nd
half of 2026, subject to FDA approval of our Investigational Device Exemption (IDE) submission expected to be filed in the second quarter of 2026.
The
Company initially obtained ISO13485 certification in 2024 and successfully passed the 2025 annual audit, both efforts without any
major nonconformities. ISO 13485 is an internationally agreed-upon standard of quality system requirements for the design, production,
distribution, and sale of medical devices. Certification of compliance to the standard is recognized and accepted by the FDA, the European
Medicines Agency (EMA), and many other regulatory authorities worldwide.
| 36 | |
**Recent
Developments**
**Corporate
and Regulatory**
*Nasdaq
Listing Status*
Nasdaq
Listing Rule 5550(b)(1) requires companies listed on Nasdaq to maintain a minimum of $2,500,000 in stockholders equity for continued
listing. On May 21, 2024, Nasdaq notified us that our Quarterly Report on Form 10-Q for the period ended March 31, 2024, indicated that
we no longer met the Minimum Stockholders Equity Requirement. Failure to meet the Minimum Stockholders Equity Requirement
was a basis for delisting our Common Stock.
Because
we were not in compliance with the Bid Price Rule at the time we were notified about the non-compliance with the Minimum Stockholders
Equity Requirement, we were not eligible to submit a plan to regain compliance with the Staff. However, we timely requested a hearing
before the Nasdaq Hearings Panel and paid the fee, which resulted in a stay of any suspension or delisting action pending the hearing.
The hearing took place on July 9, 2024, and on August 5, 2024, we received the decision of the Panel, and they granted us an extension
until November 18, 2024 to regain compliance with the Minimum Stockholders Equity Requirement.
On
November 19, 2024, the Company received a Compliance Letter from Nasdaq, informing the Company that it had regained compliance with the
Minimum Stockholders Equity Requirement. The Compliance Letter noted, that because the Companys bid price has closed below
the minimum required by the Bid Price Rule following the 2024 November Offering (defined below), the Panel had determined to impose on
the Company a Discretionary Panel Monitor, pursuant to Listing Rule 5815(d)(4)(B), for a period of one year from the date of the Compliance
Letter, to ensure that the Company maintains long-term compliance with the Minimum Stockholders Equity Requirement, the Bid Price
Rule, and all of Nasdaqs continued listing requirements.
On
December 31, 2024, Nasdaq notified us that for at least the last 30 consecutive business days, the bid price for our Common Stock had
closed below the minimum $1.00 per share requirement for continued inclusion on the Nasdaq Capital Market pursuant to the Bid Price Rule.
In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we had a compliance period of 180 calendar days, or until June 30, 2025, to regain
compliance with the Bid Price Rule. On February 3, 2025, the Company implemented a reverse stock split at a ratio of 1-for-20 to regain
compliance with the Bid Price Rule. On April 2, 2025, we received a letter from Nasdaq notifying us that as a result of non-compliance
with the Bid Price Rule, Nasdaq Staff had determined to delist our securities. We timely submitted a hearing request to the hearings
panel on April 9, 2025, and paid the fee, which resulted in a stay of any suspension or delisting action pending the hearing. The hearing
took place on May 13, 2025, and on June 2, 2025, we received the decision of the panel granting us an extension until July 3, 2025, to
regain compliance with the Bid Price Rule. On June 13, 2025, the Company implemented a reverse stock split at a ratio of 1-for-60 to
regain compliance with the Bid Price Rule.
On
July 18, 2025, we received notice from Nasdaq that we had regained compliance with the Bid Price Rule. The Panel retained jurisdiction
over the Company through September 29, 2025. On November 5, 2025, the Company was notified by Nasdaq Staff that the Company was in compliance
with all Nasdaq Listing Rules.
There
can be no assurance that we will be able to continue to maintain compliance with Nasdaqs continued listing requirements, the Bid
Price Rule, or other Nasdaq listing requirements. See *Risk Factors Our failure to maintain compliance with Nasdaqs
continued listing requirements could result in the delisting of our Common Stock*.
| 37 | |
**Reverse
Stock Splits**
2024
Reverse Stock Split
We
filed with the Delaware Secretary of State a Certificate of Amendment to our Certificate of Incorporation which became effective at 4:30
p.m. on May 17, 2024, to implement a reverse stock split at a ratio of 1-for-5 (the 2024 Reverse Stock Split) of the shares
of our Common Stock. The 2024 Reverse Stock Split was approved by our stockholders at the 2024 annual meeting of the stockholders on
April 26, 2024.
As
a result of the 2024 Reverse Stock Split, every five (5) shares of issued and outstanding Common Stock were automatically combined into
one (1) issued and outstanding share of Common Stock, without any change in the par value per share. No fractional shares were issued
as a result of the 2024 Reverse Stock Split, and any person who would otherwise be entitled to a fractional share of Common Stock as
a result of the 2024 Reverse Stock Split was entitled to receive a cash payment equal to the fraction of a share of Common Stock to which
such holder would otherwise be entitled, multiplied by the closing price per share of the Common Stock on Nasdaq at the close of business
on the date prior to the First Effective Time.
Following
the 2024 Reverse Stock Split, the number of shares of Common Stock outstanding was proportionally reduced. The shares of Common Stock
underlying the outstanding stock options and warrants were similarly adjusted along with corresponding adjustments to their exercise
prices. The 2024 Reverse Stock Split also proportionally reduced the total number of authorized shares of Common Stock from 500,000,000
shares to 100,000,000 shares.
2025
Reverse Stock Splits and Increase in Authorized Common Stock
*February
2025 1-for-20 Reverse Stock Split*
We
filed with the Delaware Secretary of State a Certificate of Amendment to our Certificate of Incorporation which became effective at 4:30
p.m. on February 3, 2025, to implement a reverse stock split at a ratio of 1-for-20 (the February 2025 Reverse Stock Split)
of the shares of our Common Stock. The February 2025 Reverse Stock Split was approved by our stockholders at the special meeting of stockholders
held on January 3, 2025 (the Special Meeting).
On
January 3, 2025, we filed an amendment to our Certificate of Incorporation to increase the Companys authorized shares of Common
Stock from 100,000,000 to 250,000,000. On February 3, 2025, the stockholders approved at the Special Meeting the increase in our authorized
shares of Common Stock from 100,000,000 to 250,000,000, as well as the full issuance of shares of Common Stock issuable by us upon the
exercise of Series A Warrants and Series B Warrants (defined herein).
*June
2025 1-for-60 Reverse Stock Split*
We
filed with the Delaware Secretary of State a Certificate of Amendment to our Certificate of Incorporation which became effective at 4:30
p.m. on June 13, 2025, to implement a reverse stock split at a ratio of 1-for-60 (the June 2025 Reverse Stock Split) of
the shares of its Common Stock. The June 2025 Reverse Stock Split was approved by the Companys stockholders at the 2025 annual
meeting of the stockholders held on May 22, 2025.
All
shares, options and warrants to purchase shares of Common Stock and loss per share amounts have been adjusted to give retroactive effect
to the February and June 2025 reverse share splits, (the Reverse Stock Splits) for all periods presented in these interim
consolidated financial statements. Any fractional shares resulting from the Reverse Stock Splits were rounded up to the nearest whole
share.
**Financing
Activity**
****
All
information below is stated in thousands of US dollars (except share data).
****
*ATM
Sales Agreement*
On
December 17, 2024, we entered into an ATM sales agreement (the Sales Agreement) with Dawson James Securities, Inc. (Dawson
James), pursuant to which we agreed to issue and sell shares of Common Stock, having an aggregate offering price of up to $8,230,
from time to time, through an at-the-market equity offering program (the ATM Program) under which Dawson
James will act as sales agent (the Agent).
| 38 | |
On
March 21, 2025, we sold 206,300 shares of Common Stock at an average offering price of $18.24 per share pursuant to the Sales Agreement,
for net proceeds of $3,593, after deducting fees owed to the Agent from such sale.
During
the three months ended June 30, 2025, we sold 414,784 shares of Common Stock at an average offering price of $10.74 per share pursuant
to the Sales Agreement for net proceeds of $4,320, after deducting fees owed to the Agent from such sale. As of September 30, 2025, there
was no remaining capacity available under the ATM Program.
The
shares of Common Stock sold in conformance to the Sales Agreement were offered by us pursuant to a prospectus supplement dated December
17, 2024, and accompanying prospectus dated October 3, 2024, which forms a part of our registration statement on Form S-3 (Registration
No. 333-282297) (the S-3 Registration Statement), which was declared effective by the Securities and Exchange Commission,
on October 3, 2024.
*Registered
Direct Offering*
On
February 4, 2025, we entered into a securities purchase agreement with certain institutional investors, relating to the registered direct
offering and sale of an aggregate of 43,968 shares of Common Stock at an offering price of $69.00 per share (the February 2025
Offering). The net proceeds to us from the February 2025 Offering were approximately $2,752, after deducting fees owed to placement
agent and other offering expenses. The February 2025 Offering closed on February 5, 2025.
The
shares of Common Stock from the February 2025 Offering were offered by us pursuant to a prospectus supplement dated February 4, 2025,
and accompanying prospectus dated October 3, 2024, which forms a part of our S-3 Registration Statement. Dawson James acted as the placement
agent for the offerings pursuant to a placement agency agreement, dated February 4, 2025, by and between us and Dawson James.
*Private
Placement December 2025*
**
On
December 29, 2025, we entered into a Securities Purchase Agreement with Armistice Capital Master Fund Ltd. for a private placement
of securities (the Private Placement). The closing of the Private Placement occurred on December 31, 2025 (the
Closing). At the Closing, we issued (i) 1,033,591 pre-funded warrants to purchase 1,033,591 shares of Common Stock (the Pre-Funded Warrants),
and (ii) 2,067,182 warrants to purchase shares of Common Stock (the Common Warrants). Each Pre-Funded Warrant was sold with two Common Warrants at
a combined purchase price of $3.869, which is equal to the Nasdaq Official Closing Price (as reflected on Nasdaq.com) of the Common
Stock on December 29, 2025, minus the exercise price of the Pre-Funded Warrant of $0.001 per share.
In
connection with the Private Placement, on December 29, 2025, we entered into a Placement Agency Agreement with Curvature Securities,
LLC (the Placement Agent). As part of its compensation for acting as Placement Agent for the Private Placement, we paid
the Placement Agent a cash fee of 7.0% of the aggregate gross proceeds and issued to the Placement Agent warrants to purchase 124,030
shares of Common Stock at an exercise price of $4.257 per share, which are exercisable at any time on or after the date that is one hundred
eighty (180) days from the date of the commencement of sales in connection with the Private Placement, and expire on the five year anniversary
of the commencement date (the Placement Agent Warrants).
We
received aggregate net proceeds from the Private Placement of approximately $3,544, after deducting estimated placement agent commissions
and expenses in connection with the Private Placement, which were payable by us.
*Promissory
Note*
On
September 12, 2025, we entered into a Note Purchase Agreement, with an investor, pursuant to which we issued a Promissory Note to the
investor in the principal amount of $3,600 for a purchase price of $3,000.
| 39 | |
*Warrant
Exchange*
Beginning
on January 6, 2025, through March 15, 2025, we received exchange notices from certain holders of the Series B Warrants, with respect
to an aggregate of 54,021 of the Series B Warrants, requiring the delivery of 162,603 shares of Common Stock according to the alternative
cashless exercise provision of the Series B Warrants sold in the November 2024 registered direct offering. The remaining 11 Series B
Warrants are exchangeable for 11 shares of Common Stock (subject to adjustment in the event of any stock dividend and split, reverse
stock split, recapitalization, reorganization or similar transaction).
*Warrant
Repurchase*
During
the fiscal year ended December 31, 2025, we repurchased 51,529 of its Series A Warrants from existing warrant holders for $166. The fair
value of the Series A Warrants on the date of exercise was $67, resulting in a loss on repurchase of $99.
**Financial
Overview**
**Operating
Expenses**
*Research
and Development*
Research
and development expenses consist primarily of salaries and other personnel-related expenses, including stock-based compensation
expenses, materials, travel expenses, clinical trials and other expenses. We expect research and development expenses to increase in
2026 and beyond, primarily due to expanding clinical trial activities, hiring additional personnel, as well the development of
Glucotrack CBGM; however, we may adjust or allocate the level of our research and development expenses based on available financial
resources and based on our commercial needs, including the FDA registration process, specific requirements from customers,
development of new Glucotrack CBGM models and other product candidates.
*General
and Administrative*
General
and administrative expenses consist primarily of professional services, salaries, travel expenses and other related expenses for executive,
finance and administrative personnel, including stock-based compensation expenses. Other general and administrative costs and expenses
include facility-related costs not otherwise included in research and development costs and expenses, and professional fees for legal,
accounting, media, and public and investor relation services.
*Other
(Income) Expense*
Other
income expense, consist primarily of the change in fair value of derivatives liabilities, loss on the issuance of equity, loss on settlement
of debt to equity and finance income.
**Results
of Operations Comparison of the Years Ended December 31, 2025 and 2024**
All
information below is stated in thousands of US dollars.
The
following discussion of our operating results explains material changes in our results of operations for the years ended December 31,
2025 and December 31, 2024. The discussion should be read in conjunction with the financial statements and related notes included elsewhere
in this Annual Report.
**Research
and Development Expense**
Research
and development expenses were $9,813 for the year ended December 31, 2025, as compared to $9,499 for the prior-year period. The increase
of $314 was primarily attributable to increased expenses related to product design, development and manufacturing activities and pre-clinical
animal studies.
**General
and Administrative Expense**
General
and administrative expenses were $6,277 for the year ended December 31, 2025, as compared to $5,048 for the prior-year
period. The increase of $1,229 is primarily attributable to increased professional fees, personnel costs and placement
agent fees.
| 40 | |
Share-based
compensation expense included in research and development and selling, general and administrative expense, for the fiscal years ended
December 31, 2025 and 2024, was comprised as follows:
| 
| | 
December
31, 2025 | | | 
December
31, 2024 | | |
| 
| | 
| | | 
| | |
| 
Research and development | | 
| 124 | | | 
| 307 | | |
| 
General and administrative | | 
| 87 | | | 
| 364 | | |
| 
| | 
| 211 | | | 
| 671 | | |
The
decrease in share-based compensation expense is primarily attributable to a reduction in the fair value of shares issued for Board compensation
and shares issued under IP agreements.
**Other
(Income) Expense, net**
Other
expense was $3,298 for the year ended December 31, 2025, as compared to other income $8,050 for the prior-year period. The decrease in
other expense is primarily attributed to reductions in recognized losses on the settlement of debt and reduced losses from the issuance
of equity. These reductions were offset by the current year fair value change in derivative liabilities.
**Net
Loss**
Net
loss was $19,388 for the year ended December 31, 2025, as compared to a net loss of $22,579 for the prior-year period. The decrease in
net loss is attributable primarily to the reduction in other expense discussed above.
**Liquidity
and Going Concern**
****
As
of December 31, 2025, we had $7,383 in cash and cash equivalents compared with $5,627 in cash, cash equivalents and restricted cash as
of December 31, 2024. The net increase in cash and cash equivalents was attributable to the $17,043 of net proceeds received from financing
activities offset by cash used in operating and investing activities of $15,336.
We
have a history of recurring losses, and as of December 31, 2025, we have an accumulated deficit of $151,838. During the fiscal year ended
December 31, 2025, we recorded a net loss of $19,388. Our primary requirements for liquidity have been to fund product and clinical development
activities and to satisfy our general corporate and working capital needs.
Based
on our operating plans, we do not expect that our current cash and cash equivalents as of December 31, 2025, will be sufficient to fund
our operating cash flow needs for at least the next twelve months, assuming our programs advance as currently contemplated. Based upon this review and our current financial
condition, we have concluded that substantial doubt exists as to our ability to continue as a going concern. We have raised and believe
we will continue to be able to raise additional capital through debt financings, private or public equity financings, license agreements,
collaborative agreements or other arrangements with other companies, or other sources of financing. However, there can be no assurances
that such financing will be available or will be at terms acceptable to us, or at all. If we are unable to raise capital when needed
or on attractive terms, we would be forced to delay, reduce, or eliminate our clinical trials or other operations. If any of these events
occur, our ability to achieve our operational goals would be adversely affected. Our future capital requirements and the adequacy of
available funds will depend on many factors, including those described in the section titled *Risk Factors*. Depending
on the severity and direct impact of these factors on us, we may be unable to secure additional financing to meet our operating requirements
on commercially acceptable terms favorable to us, or at all.
| 41 | |
**Critical
Accounting Policies and Estimates**
The
discussion and analysis of our financial condition and results of operations are based on our audited consolidated financial statements,
which have been prepared in accordance with accounting principles generally accepted in the United States, or GAAP. The preparation of
these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues,
expenses, and related disclosures. We evaluate our estimates on an ongoing basis. We base our estimates on historical experience and
on other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments
about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from
these estimates under different assumptions or conditions.
We
believe the following accounting policies and estimates are critical to aid you in understanding and evaluating our reported financial
results.
**Share-Based
Compensation**
We
grant equity-based awards under share-based compensation plans. We estimate the fair value of share-based payment awards using the Black-Scholes
option valuation model. This fair value is then amortized over the requisite service periods of the awards. The Black-Scholes option
valuation model requires the input of subjective assumptions, including price volatility of the underlying stock, risk-free interest
rate, dividend yield, and expected life of the option. Share-based compensation expense is based on awards ultimately expected to vest
and therefore is reduced by expected forfeitures. Changes in assumptions used under the Black-Scholes option valuation model could materially
affect our net loss and net loss per share.
**Derivative
Financial Instruments**
We
review the terms of the Common Stock, warrants and convertible debt we issue to determine whether there are derivative instruments, including
embedded conversion options that are required to be bifurcated and accounted for separately as derivative financial instruments. In circumstances
where the host instrument contains more than one embedded derivative instrument, including a conversion option, that is required to be
bifurcated, the bifurcated derivative instruments are accounted for as a single, compound derivative instrument.
Derivatives
are initially recorded at fair value and are then revalued at each reporting date with changes in the fair value reported as non-operating
income or expense. When the equity or convertible debt instruments contain embedded derivative instruments that are to be bifurcated
and accounted for as liabilities, the total proceeds received are first allocated to the fair value of all the bifurcated derivative
instruments. The remaining proceeds, if any, are then allocated to the host instruments themselves, usually resulting in those instruments
being recorded at a discount from their face value.
**Recent
Accounting Pronouncements**
Information
regarding recent accounting pronouncements is contained in Note 2 to the Consolidated Financial Statements, included elsewhere in this
report, and is incorporated by reference.
**Off
Balance Sheet Arrangements**
We
do not have any off-balance sheet arrangements.
| 42 | |
****
**Item
7A. Quantitative and Qualitative Disclosure About Market Risk**
As
a smaller reporting company, we have elected not to provide the disclosure required by this item.
**Item
8. Financial Statements and Supplementary Data**
Reference
is made to pages F-1 through F-25 comprising a portion of this Annual Report on Form 10-K, which are incorporated by reference under
this Item.
**Item
9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure**
None.
**Item
9A. Controls and Procedures**
**Evaluation
of Disclosure Controls and Procedures**
Management,
under the supervision and with the participation of the Chief Executive Officer and Chief Financial Officer, have conducted an evaluation
of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e)
under the Exchange Act). Disclosure controls and procedures are designed to ensure that information required to be disclosed by a company
in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods
specified in the SECs rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures
designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange
Act is accumulated and communicated to our management, including our principal executive and principal financial officers, as appropriate
to allow timely decisions regarding required disclosure. Based on that evaluation, our Chief Executive Officer and our Chief Financial
Officer, concluded that as of the end of the period covered by this Annual Report, (i) the Companys disclosure controls and procedures
were not effective to ensure that material information relating to the Company is recorded, processed, summarized, and reported within
the time periods specified in the rules and forms of the SEC, and (ii) the Companys controls and procedures have not been designed
to ensure that information required to be disclosed by the Company in the reports that it files or submits under the Exchange Act, is
accumulated and communicated to the Companys management, including its principal executive and principal financial officers, or
persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.
**Managements
Report on Internal Controls Over Financial Reporting**
Management
is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Exchange
Act Rules 13a-15(f) and 15d-15(f). Under the supervision and with the participation of management including our Chief Executive Officer
and our Chief Financial Officer, the Company conducted an evaluation of the effectiveness of its internal control over financial reporting
based principally on the framework and criteria established in Internal Control - Integrated Framework (2013) issued by the Committee
of Sponsoring Organizations of the Treadway Commission as of the end of the period covered by this Annual Report. Based on the foregoing
evaluation, management concluded that the Companys internal controls over financial reporting were not effective because of the
material weaknesses discussed below.
This
Annual Report does not include an attestation report of the Companys registered public accounting firm regarding internal control
over financial reporting because the attestation report requirement has been removed for smaller reporting companies under
the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010.
| 43 | |
The
Company has identified material weaknesses in its internal control over financial reporting. As defined in Regulation 12b-2 under
the Exchange Act, a material weakness is a deficiency, or combination of deficiencies, in internal control over
financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial
statements will not be prevented, or detected on a timely basis. During the fiscal year ended December 31, 2025, the
Company identified material weaknesses in its internal controls in the following areas: general IT controls; lack of sufficient
accounting personnel and inadequate segregation of duties consistent with control objectives.
**Managements
Remediation Measures**
During
the fiscal year ended December 31, 2025, management has identified corrective actions to remediate such material weaknesses, which includes
the implementation of proper IT system access controls and the proper backup of the Companys IT architecture. Additionally, the
Company has hired accounting personnel to improve segregation of duties over financial reporting, engaged third-party experts for valuation
and technical accounting services, and initiated the implementation of Oracle NetSuite as its enterprise resource planning (ERP) system.
The implementation of Oracle NetSuite is designed to automate user roles, permissions, and approval workflows, thereby strengthening
internal controls over financial reporting. Management intends to continue the implementation of procedures to remediate such material
weaknesses during the fiscal year 2026; however, the implementation of these initiatives may not fully address any material weaknesses
that we may have in our internal control over financial reporting.
The
Company will continue to review and improve its internal controls over financial reporting to address the underlying causes of the material
weaknesses and control deficiencies. Such material weaknesses and control deficiencies will not be remediated until the Companys
remediation plan has been fully implemented, and it has concluded that its internal controls are operating effectively for a sufficient
period of time.
**Changes
in Internal Control over Financial Reporting**
Except
for the material weaknesses and the remediation efforts described above, no other change in our internal control over financial
reporting (as defined by Rules 13a-15(f) and 15d-15(f) under the Exchange Act) occurred during the quarter ended December 31, 2025,
that has materially affected, or is reasonably likely to materially affect, the Companys internal control over financial
reporting.
**Item
9B. Other Information**
| 
| 
(a) | 
None. | |
| 
| 
| 
| |
| 
| 
(b) | 
None of our directors or officers, as defined in Rule 16a-1(f) under the Exchange Act adopted or terminated a Rule 10b5-1 trading
arrangement or a non-Rule 10b5-1 trading arrangement (in each case as defined in Item 408 of Regulation S-K) during
the fiscal quarter ended December 31, 2025. | |
**Item
9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections**
Not
applicable.
| 44 | |
****
**PART
III**
**Item
10. Directors, Executive Officers and Corporate Governance**
**Information
Regarding Directors and Executive Officers**
The
following table sets forth information regarding our executive officers and non-employee directors.
| 
Name | 
| 
Age | 
| 
Position | |
| 
Paul
V. Goode | 
| 
58 | 
| 
Chief
Executive Officer, President, and Director | |
| 
Peter
C. Wulff | 
| 
66 | 
| 
Chief
Financial Officer | |
| 
Luis
Malave | 
| 
64 | 
| 
Director | |
| 
Erin
Carter | 
| 
56 | 
| 
Director | |
| 
Andrew
K. Balo | 
| 
78 | 
| 
Director | |
| 
Victoria
Carr-Brendel | 
| 
61 | 
| 
Director | |
**Paul
V. Goode, PhD Chief Executive Officer, President and Director**
Dr. Goode has served as the Companys Chief Executive Officer
since November 2021 and has served on our Board since 2024. He most recently served as Vice President of Product Development at Orchestra
Biomed where he oversaw development of its implantable cardiac stimulator system for hypertension. Prior to Orchestra, from 2010 until
July 2019 Dr. Goode served in several executive roles at EndoStim, including Senior Vice President of R&D, Chief Technology Officer,
and Interim Chief Executive Officer. Dr. Goode currently serves as a Senior Advisor and Board Member of EndoStim. From 2006 through 2010
he served as Vice President of Research and Development at Metacure and from 2004 through 2006 Dr. Goode served as Director of Engineering
at Impulse Dynamics. Prior to that, Dr. Goode was employed as Director of Engineering at DexCom and as Senior Engineer at MiniMed. Dr.
Goode received his BS, MS and PhD degrees from North Carolina State University. Dr. Goodes extensive experience in the medical
device space qualifies him to serve on our Board of Directors.
**Peter
C. Wulff Chief Financial Officer, Treasurer and Corporate Secretary**
Mr.
Wulff has served as the Companys Chief Financial Officer since January 2025. Mr. Wulff has over 40 years experience in
financial and operating management in the emerging growth life sciences industry, having served most recently as Chief Financial Officer
of Biological Dynamics, Inc., a life science research organization focused on early cancer detection, from January 2023 to June 2024.
Prior to his time at Biological Dynamics, Inc., he served as the Chief Financial Officer at JenaValve Technology, Inc., a heart valve
technology medical device company, from August 2015 to April 2022. Mr. Wulff has served as the executive financial officer of various
other medical technology companies, including PURE Bioscience, Inc. from November 2012 to July 2015, Alphatec Spine Holdings from June
2008 to April 2011, Artes Medical Inc. from January 2005 to May 2008, and CryoCor, Inc. from May 2001 to May 2004. In these roles, he
directed and managed accounting and finance and investor relations. Mr. Wulff earned his MBA in Finance and his bachelors degree
in Economics and Germanic Languages from Indiana University.
**Luis
Malav Director**
Mr.
Malav has served as a director of the Company since June 22, 2021 and serves on our Audit Committee and Nominating, Governance
and Compensation Committee. Mr. Malav brings more than 30 years of leadership experience in the MedTech industry, primarily in
diabetes management, spanning all company stages, from private startups to large-cap publicly listed companies. He has extensive expertise
in product development, operations, marketing, strategic partnerships, and US FDA regulatory strategy. Since October 2017, Mr. Malav
has served as President of EOFLOW CO. Ltd., a company listed on the Korea Stock Exchange that has developed a wearable disposable insulin
pump. From October 2014 to June 2016, he was COO of Mikroscan Technologies. Prior to that, Mr. Malav was the President and CEO
of Palyon Medical, maker of an implantable drug-delivery system that spun out from German medical-technology giant Fresenius SE. Prior
to Palyon, he spent nearly a decade at insulin pump maker Insulet Corp., including as its Senior Vice President of Research, Development
and Engineering, and as Chief Operating Officer. He also held various senior positions at Medtronic and MiniMed, overseeing product development
of various diabetes management devices. Mr. Malav earned his Bachelors degree in Mathematics and Computer Science from
the University of Minnesota, a Masters degree in Software Engineering from the University of St. Thomas, and an MBA from the University
of Maryland. Mr. Malavs extensive experience in the medical device space and public company experience qualify him to
serve on our Board of Directors.
| 45 | |
**Erin
Carter Director**
Ms.
Carter has served as a director of the Company since August 25, 2023, and is the Chair of its Audit Committee. Ms. Carter brings 30 years
of executive level finance experience in the medical device industry. Ms. Carter (since November 2025) currently serves as the SVP of Corporate Development and Strategic Finance for Masimo
Corporation. At Masimo, she leads the companys inorganic growth strategy through mergers and acquisitions, strategic partnerships,
and post-merger integrations. She also provides strategic financial leadership across major initiatives, including long-range planning.
From 2023 to 2025, she served as the Chief Financial Officer for the Mayo Collaborative Services, at the Mayo Clinic. Mayo Collaborative Services facilitates access to the Mayo Clinic diagnostic
expertise and services with revenues exceeding $1B. From 2012 until March of 2023, she held various senior roles with Medtronic, most
recently serving as Chief Financial Officer and Vice President of Finance for their $9B Neuroscience division. In addition, during her
tenure at Medtronic she grew the Gastrointestinal Solutions division from early tech start-up acquisition of $36M to revenue of $450M
in 5 years through organic growth and multiple acquisitions. Prior to Medtronic, Ms. Carter served as Director of Finance at Boston Scientific
and as VP of Accounting and Reporting at UnitedHealth Group. Prior to that, she served as Assistant Controller for Arterial Vascular
Engineering, where she was instrumental in guiding the rapid growth of the company from 200 employees to over 4,000 in under five years.
During this time, she managed the integration of two acquisitions and subsequently that companys sale to Medtronic. Ms. Carter
holds a B.S. in Business Administration from California Polytech State University and is a Certified Public Accountant (inactive) in
the State of California. Ms. Carters extensive executive finance experience, including leadership roles in the medical device
space, makes her qualified to serve on our Board of Directors.
**Andrew
K. Balo Director**
Mr.
Balo has served as a director of the Company since June 2024. Mr. Balo joined DexCom International, Ltd. as part of the original executive
team in 2002 and played a critical role in shaping the companys future. During his tenure, he was responsible for numerous glucose
monitoring regulatory submissions and clinical trials worldwide and coordinated quality activities across multiple manufacturing facilities.
From February 2022 until his retirement on March 24, 2024, Mr. Balo served as Executive Vice President of Clinical, Global Access, and
Medical Affairs. Prior to joining Dexcom, Mr. Balo held several leadership positions at St. Jude Medical, including Corporate Vice President
of Regulatory, Clinical, and Quality, and also served in executive roles at Baxter, Pacesetter and Endocardial Solutions. Mr. Balos
extensive leadership experience in clinical and regulatory affairs makes him qualified to serve on the Board of Directors.
**Victoria
Carr-Brendel Director**
Dr.
Carr-Brendel has served as a member of the board of directors of Vicarious Surgical Inc. (NYSE: RBOT) since January 2023 and is a member
of both the audit and compensation committee. Dr. Carr-Brendel served as Group Vice Present of Cochlear Implants at Sonova Group from
December 2018 to July 2024, where she doubled the revenue of the division in 5 years and took on meaningful market share gain with international
expansion and product launches. Prior to that, she served as Chief Executive Officer of JenaValve Technology, Inc., a medical device
company focused on developing minimally invasive transcatheter aortic valve repair systems to treat patients suffering from severe aortic
valve disease. From 2004 through 2015, Dr. Carr-Brendel held various roles at Boston Scientific, with her last position overseeing the
acquisition of Bayers interventional radiology division in 2014. She started her career as a scientist in R&D at Baxter Healthcare,
focused on the artificial pancreas, and spent 4 years at Dexcom developing the G1 and G2 sensors. She has amassed over forty patents
and took on increasingly larger business and management roles. She holds a B.A. in biology from Monmouth College, an M.S. in microbiology
from Iowa State University, and a Ph.D. in microbiology and immunology from the University of Illinois at Chicago. Dr. Carr-Brendels
qualifications to serve on our Board include over thirty years of medical device development leadership and proven expertise in R&D
oversight, continuous glucose sensor development, new product development, business development, commercial execution, and intellectual
property portfolio management.
| 46 | |
**Compliance
with Section 16(a) of the Exchange Act**
Section
16(a) of the Securities Exchange Act of 1934, as amended (the Exchange Act) requires our directors, executive officers
and persons who own more than 10% of our common stock to file with the SEC initial reports of ownership and reports of changes in
ownership of common stock and other of our equity securities.
Based
solely upon a review of those reports and written representations provided to us by all of our directors and executive officers, we
believe that during the year ended December 31, 2025, our directors, executive officers and greater than 10% stockholders did not
report the following transactions on a timely basis: a Form 3 filing for Luis Malave that was due on June 22, 2021, which was filed
on March 28, 2025; a Form 3 filing for Andrew Balo that was due on June 24, 2024, which was filed on March 28, 2025; a Form 3 filing
for the John A. Ballantyne Revocable Trust 08/01/2017 (the Ballantyne Trust) that was due on August 9, 2024, which was
filed on March 28, 2025; Forms 4 for Allen Danzig reporting the acquisition of Common Stock on each of October 4, 2022 and April 8,
2024, both of which were not filed (both of the aforementioned acquisitions by Allen Danzig were subsequently reported on a Form 4
filed on March 28, 2025); Forms 4 for Robert Fischell reporting the acquisition of Common Stock on each of August 24, 2021 and April
8, 2024, each of which were not filed (both of the aforementioned acquisitions by Robert Fischell were subsequently reported on a
Form 4 filed on March 28, 2025); a Form 4 for Paul Goode disclosing an option grant that was made on June 14, 2024, was not filed; a
Form 4 for Paul Goode disclosing the purchase of a warrant on July 1, 2024, was not filed; a Form 4 for Paul Goode reporting the
purchase of a convertible promissory note on July 18, 2024, was not filed; a Form 4 for Paul Goode reporting the conversion of a
promissory note on November 14, 2024, was not filed; a Form 4 for Paul Goode reporting the acquisition of Series A Common Warrants
and Series B Common Warrants on November 14, 2024, was not filed; a Form 4 for Paul Goode reporting the acquisition of Common Stock
pursuant to the IP Purchase Agreement, was not filed (each of the aforementioned transactions by Paul Goode were subsequently
reported on a Form 4 filed on March 28, 2025); Forms 4 for Erin Carter reporting the acquisition of Common Stock on each of December
31, 2023 and April 8, 2024, both of which were not filed; a Form 4 for Erin Carter reporting the purchase of a convertible
promissory note on July 18, 2024, was not filed; a Form 4 for Erin Carter reporting the conversion of a promissory note on November
14, 2024, was not filed; a Form 4 for Erin Carter reporting the acquisition of Series A Common Warrants and Series B Common Warrants
on November 14, 2024, was not filed (each of the aforementioned transactions by Erin Carter were subsequently reported on a Form 4
filed on March 28, 2025); a Form 4 for John Ballantyne reporting the purchase of three warrants on July 30, 2024, was not filed; a
Form 4 for John Ballantyne reporting the conversion of a promissory note on November 14, 2024, was not filed; a Form 4 for John
Ballantyne reporting the acquisition of Series A Common Warrants and Series B Common Warrants on November 14, 2024, was not filed;
(each of the aforementioned transactions by John Ballantyne were subsequently reported on a Form 4 filed on March 31, 2025); a Form
4 for the Ballantyne Trust reporting the purchase of three warrants on July 30, 2024, was not filed; a Form 4 for the Ballantyne
Trust reporting the conversion of a promissory note on November 14, 2024, was not filed; a Form 4 for the Ballantyne Trust reporting
the acquisition of Series A Common Warrants and Series B Common Warrants on November 14, 2024, was not filed (each of the
aforementioned transactions by the Ballantyne Trust were subsequently reported on a Form 4 filed on March 31, 2025); Forms 4 for
Luis Malave reporting the acquisition of Common Stock on each of September 30, 2021, December 31, 2021, March 31, 2022, June 30, 2022,
October 4, 2022, January 9, 2023, April 20, 2023, December 31, 2023 and April 8, 2024, each of which were not filed; a Form 4 for
Luis Malave reporting the purchase of a convertible promissory note on July 18, 2024, was not filed; a Form 4 for Luis Malave
reporting the conversion of a promissory note on November 14, 2024, was not filed; and a Form 4 for Luis Malave reporting the
acquisition of Series A Common Warrants and Series B Common Warrants on November 14, 2024, was not filed; (each of the
aforementioned transactions by Luis Malave were subsequently reported on a Form 4 filed on March 31, 2025); a Form 4 for Paul Goode reporting the acquisition of Common Stock pursuant to the IP Purchase Agreement that was due on March 27, 2025,
which was filed on October 7, 2025; Forms 4 for Erin Carter reporting the acquisition of Common Stock on each of March 25, 2025 and July
11, 2025, both of which were not filed (each of the aforementioned transactions by Erin Carter were subsequently reported on a Form 4
filed on October 7, 2025); Forms 4 for Luis Malave reporting the acquisition of Common Stock on each of March 25, 2025 and July 11, 2025,
both of which were not filed (each of the aforementioned transactions by Luis Malave were subsequently reported on a Form 4 filed on October
7, 2025); Forms 4 for Andrew Balo reporting the acquisition of Common Stock on each of March 25, 2025 and July 11, 2025, both of which
were not filed (each of the aforementioned transactions by Andrew Balo were subsequently reported on a Form 4 filed on October 7, 2025);
and a Form 3 for Victoria Carr-Brendel that was due on June 2, 2025, which was filed on October 7, 2025.
**Code
of Ethics and Business Conduct**
In
accordance with the information required by this Item 10 relating to the code of ethics required by Item 406 of Regulation S-K, the Company
has a Code of Ethics and Business Ethics (the Code of Ethics), which applies to its directors, officers, and employees,
including its principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing
similar functions (collectively, the Covered Persons and each a Covered Person). The full text of the Code
of Ethics is available on the Investors section of our website, which is located at *www.glucotrack.com*. We will provide to any person without charge, upon request, a copy of the
Code. Such requests should be made in writing to the following address: c/o Glucotrack, Inc., 301 Route 17 North, Ste. 800, Rutherford,
New Jersey 07070. The Company
intends to satisfy the SECs requirements regarding amendments to, or waivers from, the Code of Ethics by posting such information
on its website or by filing a Current Report on Form 8-K to disclose such information.
**Procedures
for Stockholders to Recommend Director Nominees**
There
have been no material changes to the procedures by which security holders may recommend nominees to our Board.
| 47 | |
**Audit
Committee Information** 
The
Companys Board has a standing Audit Committee. Our Audit Committee is chaired by Erin Carter and its other members are Luis Malave, and Victoria Carr-Brendel . Our Board has determined that each of these directors is independent as defined
by the rules of the SEC and the Nasdaq Listing Rules. The Board has determined that Ms. Carter is an audit committee financial
expert as that term is defined in Item 407(d)(5)(ii) of Regulation S-K.
**Insider
Trading Policy**
The
Company has an insider trading policy (the Insider Trading Policy) which prohibits Covered Persons from buying or selling
the Companys securities while the Covered Person is aware of material nonpublic information about the Company. The Company believes
that its Insider Trading Policy is reasonably designed to promote compliance with insider trading laws, rules and regulations, and any
applicable listing standards. A copy of the Insider Trading Policy is filed as Exhibit 19.1 to this Annual Report.
**Item
11. Executive Compensation**
The
following discussion contains forward-looking statements that are based on our current plans, considerations, expectations and determinations
regarding future compensation programs. The actual amount and form of compensation and the compensation policies and practices that we
adopt in the future may differ materially from currently planned programs as summarized in this discussion.
We
are currently considered a smaller reporting company within the meaning of the Securities Act for purposes of the SECs
executive compensation disclosure rules. Accordingly, we are required to provide a Summary Compensation Table, as well as limited narrative
disclosures regarding executive compensation for our last two completed fiscal years and an Outstanding Equity Awards at Fiscal Year
End Table for our last completed fiscal year. These reporting obligations extend only to named executive officers. Individuals
we refer to as our named executive officers include (i) all individuals serving as our Chief Executive Officer during the
fiscal year ended December 31, 2025 and (ii) our two most highly compensated executive officers, as defined in Exchange Act Rule 3b-7,
other than our Chief Executive Officer, who were serving as executive officers at the end of the fiscal year ended December 31, 2025,
whose salary and bonus for services rendered in all capacities exceeded $100,000 during the fiscal year ended December 31, 2025.
This
section discusses material components of the executive compensation programs for the Companys named executive officers
who are named in the Summary Compensation Table below. In 2025, the Companys named executive officers
were Paul V. Goode, the Companys Chief Executive Officer and Peter C. Wulff, the Companys Chief Financial Officer. Mr.
Wulff was appointed Chief Financial Officer of the Company in January 2025. In 2024, the Companys named executive officer
was Paul V. Goode, the Companys Chief Executive Officer. No other executive officer of the Company received total compensation
during the fiscal year ended December 31, 2025 and 2024 in excess of $100,000, and thus disclosure is not required for any other person.
**Summary
Compensation Table**
The
following table sets forth total compensation paid to our named executive officers for the years ended December 31, 2025, and 2024.
| 
Name
and Position | | 
Year | | | 
Salary
($)(1) | | | 
Bonus
($)(2) | | | 
Stock
Awards
($) | | | 
Option
Awards
($)
(3) | | | 
Non-Equity
Incentive Plan
Compensation
($) | | | 
Non-qualified
Deferred
Compensation
Earnings 
($) | | | 
All
Other
Compensation
($) | | | 
Total
($) | | |
| 
Paul
V Goode | | 
2025 | | | 
| 350,000 | | | 
| 44,100 | | | 
| | | | 
| 
| | | 
| | | | 
| | | | 
| | | | 
| 394,100 | | |
| 
Chief
Executive Officer | | 
2024 | | | 
| 350,000 | | | 
| | | | 
| | | | 
| 2,096 | | | 
| | | | 
| | | | 
| | | | 
| 352,096 | | |
| 
Peter
C. Wulff | | 
2025 | | | 
| 300,000 | | | 
| | | 
| | | | 
| | | | 
| 200,000 | (4) | | 
| | | | 
| | | | 
| 500,000 | | |
| 
Chief
Financial Officer(5) | | 
| | | 
| | | | 
| | | | 
| | | | 
| | | | 
| | | | 
| | | | 
| | | | 
| | | |
| 
(1) | 
Amounts
reflect salary earned during the respective fiscal years. | |
| 
| 
| |
| 
(2) | 
Represents
bonus paid to Mr. Goode during fiscal 2025 for milestones met in fiscal 2024. | |
| 
| 
| |
| 
(3) | 
Amounts
for the years ended December 31, 2024 reflect the grant date fair value for financial statement reporting purposes with respect to
stock options granted during the respective fiscal year, calculated in accordance with authoritative guidance. | |
| 
| 
| |
| 
(4) | 
Represents
compensation paid to Mr. Wulff in fiscal 2025 for financing milestones met in the current year, pursuant to Mr. Wulffs employment
agreement. | |
| 
| 
| |
| 
(5) | 
Executive compensation information for the fiscal year ended December 31,
2024 is not provided, as the individual was not a named executive officer for that period. | |
| 48 | |
**Narrative
to the Summary Compensation Table**
**Annual
Base Salary**
We
pay our named executive officers a base salary to compensate them for services rendered to our Company. The base salary payable to our
named executive officers is intended to provide a fixed component of compensation reflecting the executives skill set, experience,
role and responsibilities.
**Annual
Bonus**
For
2025, our named executive officers earned a cash bonus under the Companys annual bonus program based upon achievement of both
corporate and individual goals determined by the Board based on a target percentage of annual base salary and certain milestones.
**Equity
Compensation**
We
have granted stock options to our employees, including our named executive officers, in order to attract and retain them, as well as
to align their interests with the interests of our shareholders. In order to provide a long-term incentive, stock options typically vest
over three years subject to continued service.
**Executive
Compensation Arrangements**
**Employment
Agreements**
Set forth below is a summary of the material terms of the employment
agreements of our current named executive officers.
*Paul
V. Goode*
On
October 19, 2021, Paul V. Goode was appointed as President and Chief Operating Officer of the Company, effective November 1, 2021 (the
Goode Effective Date) and currently serves as the Chief Executive Officer. In connection with his appointment as Chief
Executive Officer, the Company entered into an employment agreement with Dr. Goode (the Goode Employment Agreement), on
October 19, 2021.
In
this role, Dr. Goode leads the Companys operations, overseeing strategy, design, manufacturing, business and product development
and helps to build the U.S. infrastructure in preparation for the U.S. clinical trials of the Company. He devotes such time as necessary
to perform his duties but is able to pursue other professional opportunities at the same time. His current annual base salary is $350,000
per year (the Base Salary), and he is entitled to a cash bonus of up to 20% of his Base Salary as determined by the Companys
Compensation Committee. Pursuant to the Goode Employment Agreement, Dr. Goode was granted options to purchase up to one-and-a-half percent
(1.5%) of the fully diluted Common Stock as of the Goode Effective Date, with a per share exercise price equal to $2,940.00 per share,
which vests in equal monthly installments over a three-year period following the Goode Effective Date.
Upon
termination of employment for any reason, Dr. Goode is entitled to: (A) all Base Salary earned through the date of termination, (B) any
Annual Bonuses (as defined in the Goode Employment Agreement), pro-rated, to be paid in accordance with the terms of the Goode Employment
Agreement; (C) all accrued but unused vacation time; and (D) reimbursement of all reasonable expenses.
The
bonus and equity incentives are subject to clawback rights if there is a misstatement of financials which changes any metrics upon which
a bonus or incentives are based and the clawback will be pro rata based upon the changes in the financials with respect to the effect
on any underlying metrics.
*Peter
C. Wulff*
In connection with his
appointment as Chief Financial Officer, the Company entered into an employment agreement with Mr. Wulff (the Employment
Agreement), on January 29, 2025. The Employment Agreement provides for at-will employment that may be terminated by the
Company with or without cause or in the event of the executives disability, and by the executive with or without good reason,
or in the event of the executives death.
The Employment Agreement
provides for a base salary of $300,000 per annum for 2025, and for fiscal year 2026 and thereafter, a base salary of $450,000 per annum
(the Base Salary). Mr. Wulff is eligible for bonus payments during the 2025 fiscal year, contingent upon the Company meeting
specific financing milestones. These include: (i) a bonus of $75,000 upon the successful closing of one or more transactions totaling
$6 million, (ii) an additional $125,000 upon the closing of one or more transactions with a cumulative value of $12 million, and (iii)
an additional $62,500 upon the closing of one or more transactions with a cumulative value of $18 million, each payable at the end of
the month of achievement or as soon as administratively practical thereafter. Pursuant to the Employment Agreement, during the 2026 fiscal
year, and fiscal years thereafter, Mr. Wulff is also eligible for an annual performance bonus in cash of up to 15% of the Base Salary,
contingent upon the determination that relevant targets, if any, have been met. The Employment Agreement also provides for initial grants
under the Companys 2024 Equity Incentive Plan of options to purchase a number of shares of Company common stock equal to 1.25%
of the Companys outstanding common stock as of the effective date of the Employment Agreement. Provided that Mr. Wulff is still
employed on December 31, 2025, and subject to Board approval and the achievement of financial transaction goals by the Company, Mr. Wulff
will be eligible for an additional option grant to offset any dilution of the initial grant resulting from dilutive events, the amount
and terms of which are to be determined in the discretion of the Board on or before December 31, 2025.
Upon termination of employment
for any reason, Mr. Wulff is entitled to: (A) all Base Salary and accrued but unused vacation time earned through the date of termination,
if and only if Mr. Wulff is still employed with the Company six months after the Effective Date (as defined in the Employment Agreement),
(B) any Annual Bonuses (as defined in the Employment Agreement), pro-rated, to be paid in accordance with the terms of the Employment
Agreement; and (C) reimbursement of all reasonable expenses. Subject to Board approval, for fiscal years 2026 and 2027, Mr. Wulff is entitled
to receive no less than 6 months of severance benefits, which are in line with market norms for a similarly situated executive at a similar
employer.
On
March 27, 2026, the Company entered into a Separation Agreement and Release (the Separation Agreement) with Peter C. Wulff.
Mr. Wulff tendered his resignation on March 27, 2026, and his employment with the Company will end effective March 31, 2026.
Pursuant
to the Separation Agreement, Mr. Wulff is entitled to receive severance payments in an aggregate amount of $112,500, representing three
months of his base salary, payable in two equal installments on April 15, 2026 and April 30, 2026, subject to his continued compliance
with the terms of the Separation Agreement. Mr. Wulff is also required to assist with the orderly transition of his duties during the
severance period.
In
connection with the Separation Agreement, Mr. Wulff agreed to a broad release of claims against the Company and its affiliates, subject
to customary exceptions, and waived any rights to outstanding equity awards, including both vested and unvested stock options previously
granted to him. The Separation Agreement also provides that Mr. Wulff is not eligible for a 2026 annual bonus.
The
Separation Agreement includes customary confidentiality, non-disparagement, non-solicitation, cooperation, and return-of-property provisions.
| 49 | |
**Outstanding
Equity Awards as of December 31, 2025**
The
following table sets forth for the Companys named executive officer certain information regarding unexercised options as of December
31, 2025:
| 
| 
| 
Number
of
Securities
Underlying
Unexercised
Options | 
| 
| 
Number
of
Securities
Underlying
Unexercised
Options | 
| 
| 
Option
Exercise | 
| 
| 
Option
Expiration | 
| |
| 
Name | 
| 
(#)
Exercisable | 
| 
| 
(#)
Unexercisable | 
| 
| 
Price | 
| 
| 
Date | 
| |
| 
Paul
V. Goode | 
| 
| 
55 | 
| 
| 
| 
28 | 
| 
| 
$ | 
2,940.00 | 
| 
| 
| 
6/14/2034 | 
| |
**Director
Compensation**
Decisions
regarding the compensation to be paid to the members of our Board of Directors, if any, are determined and/or ratified by the Board with
recommendations given by the Compensation Committee. Non-employee directors are compensated with a combination of cash and shares. Additionally,
we provide reimbursement to our non-employee directors for their reasonable expenses incurred in attending meetings of our Board of Directors
and its committees. Directors may also receive equity awards from time to time. The directors who also serve as an employee of the Company
do not receive additional compensation for their service as a director.
The
following table sets forth compensation earned in the fiscal year ended December 31, 2025 by each of our non-employee directors:
| 
Name | 
| | 
Fees
Earned
in
Cash | | | 
Stock
Awards
($)(1) | | | 
Options Awards
($)(2) | | | 
All
Other
Compensation
($) | | | 
Total | | |
| 
Luis Malave | 
(3) | | 
$ | 87,000 | | | 
$ | 18,000 | | | 
$ | 29,000 | | | 
$ | | | | 
$ | 134,000 | | |
| 
Erin Carter | 
(4) | | 
$ | 70,000 | | | 
$ | 15,000 | | | 
$ | 29,000 | | | 
$ | | | | 
$ | 114,000 | | |
| 
Andrew Balo | 
(5) | | 
$ | 35,000 | | | 
$ | 50,000 | | | 
$ | 29,000 | | | 
$ | | | | 
$ | 149,000 | | |
| 
Victoria Carr-Brendel | 
(6) | | 
$ | 42,583 | | | 
$ | 3,250 | | | 
$ | 29,000 | | | 
$ | | | | 
$ | 74,833 | | |
| 
Allen
Danzig | 
(7) | 
| 
$ | 
| 
| 
| 
$ | 
| 
| 
| 
$ | 
| 
| 
| 
$ | 
| 
| 
| 
$ | 
| 
| |
| 
Dr.
Robert Fischell | 
(7) | 
| 
$ | 
| 
| 
| 
$ | 
| 
| 
| 
$ | 
| 
| 
| 
$ | 
| 
| 
| 
$ | 
| 
| |
| 
John
Ballantyne | 
(7) | 
| 
$ | 
| 
| 
| 
$ | 
| 
| 
| 
$ | 
| 
| 
| 
$ | 
| 
| 
| 
$ | 
| 
| |
| 
(1) | 
Amounts
for the year ended December 31, 2025 reflect the fair value of restricted shares issued as compensation for Board service, calculated
in accordance with ASC Topic 718. | |
| 
| 
| |
| 
(2) | 
Amounts
for the year ended December 31, 2025 reflect the grant date fair value for financial statement reporting purposes with respect to
stock options granted during the fiscal year, calculated in accordance with ASC Topic 718. | |
| 
(3) | 
Mr.
Malave received equity compensation for his service as a member of the Board of Directors, consisting of (i) 1,200 shares of Common
Stock earned on July 11, 2025, with an aggregate grant-date fair value of $9,000, and 463 shares of Common Stock earned on October
3, 2025, with an aggregate grant-date fair value of $9,000 (collectively, $18,000), and (ii) 4,055 stock options granted on October
3, 2025, with a grant-date fair value of $29,000. As of December 31, 2025, Mr. Malave held 4,058 shares of Common Stock and 4,055
stock options granted as compensation for his Board service. | |
| 
| 
| |
| 
(4) | 
Ms.
Carter received equity compensation for her service as a member of the Board of Directors, consisting of (i) 1,000 shares of Common
Stock earned on July 11, 2025, with an aggregate grant-date fair value of $7,500, and 386 shares of Common Stock earned on October
3, 2025, with an aggregate grant-date fair value of $7,500 (collectively, $15,000), and (ii) 4,055 stock options granted on October
3, 2025, with a grant-date fair value of $29,000. As of December 31, 2025, Ms. Carter held 2,148 shares of Common Stock and 4,055
stock options granted as compensation for her Board service. | |
| 
| 
| |
| 
(5) | 
Mr.
Balo received equity compensation for his service as a member of the Board of Directors, consisting of (i) 3,332 shares of Common
Stock earned on July 11, 2025, with an aggregate grant-date fair value of $25,000, and 1,285 shares of Common Stock earned on October
3, 2025, with an aggregate grant-date fair value of $25,000 (collectively, $50,000), and (ii) 4,055 stock options granted on October
3, 2025, with a grant-date fair value of $29,000. As of December 31, 2025, Mr. Balo held 4,692 shares of Common Stock and 4,055 stock
options granted as compensation for his Board service. | |
| 
| 
| |
| 
(6) | 
Ms.
Carr-Brendel received equity compensation for her service as a member of the Board of Directors, consisting of 434 shares of Common
Stock earned on October 3, 2025, with an aggregate grant-date fair value of $3,250, and (ii) 4,055 stock options granted on October
3, 2025, with a grant-date fair value of $29,000. As of December 31, 2025, Ms. Carr-Brendel held 167 shares of Common Stock and 4,055
stock options granted as compensation for her Board service. | |
| 
| 
| |
| 
(7) | 
Mr. Danzig, Dr. Fischell and Mr. Ballantyne were not nominated for re-election
at the 2025 annual meeting, and their respective terms on the Board and any committees of the Board expired on May 22, 2025. | |
| 50 | |
**Item
12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters**
**Securities
Authorized for Issuance under Share-Based Compensation Plans**
**Equity
Compensation Plan Information**
The
following table sets forth, as of December 31, 2025, information regarding awards previously granted and outstanding, and securities
authorized for future issuance, under the Companys equity compensation plans.
| 
Plan Category | | 
Number
of
Securities
to be
Issued
Upon
Exercise
of
Outstanding
Options,
Warrants
or
Rights | | | 
Weighted-Average
Exercise
Price
of
Outstanding
Options,
Warrants
or
Rights | | | 
Number
of
Securities
Remaining
Available
for
Future
Issuance
Under
Equity
Compensation
Plans
(Excluding
Outstanding
Options,
Warrants,
or
Rights) | | |
| 
Equity compensation plans approved
by shareholders | | 
| 16,499 | | | 
$ | 57.75 | | | 
| 97,544 | | |
| 
Equity compensation plans not approved by shareholders | | 
| - | | | 
| - | | | 
| - | | |
**2024
Equity Incentive Plan**
The
Companys shareholders approved the 2024 Equity Incentive Plan (the 2024 Plan) in April 2024. The 2024 Plan initially
provided for a reserve of 2,675,636 shares of Common Stock, which was subsequently reduced to 535,127 shares in connection with the Companys
one-for-five (1:5) reverse stock split, effective May 17, 2025, and such shares were registered on a Form S-8 filed with the SEC in August
2024. The share reserve was subsequently reduced to 26,757 shares in connection with the Companys one-for-twenty (1:20) reverse
stock split, effective February 3, 2025.
In
May 2025, the Companys shareholders approved an amendment (the Amendment) to the 2024 Plan that increased the maximum
aggregate number of shares that could be issued under the 2024 Plan to 7,500,000 shares. The maximum aggregate number of shares that
could be issued under the 2024 Plan was subsequently reduced to 125,000 shares in connection with the Companys one-for-sixty (1:60)
reverse stock split, effective June 13, 2025. The additional 124,555 shares added by the Amendment were registered on a Form S-8 filed
with the SEC in September 2025. The 2024 Plan provides for the grant of incentive stock options, nonqualified stock options, and other
share-based awards to employees, directors, consultants, and advisors. These awards have contractual terms of up to ten years and are
subject to vesting conditions determined by the Compensation Committee of the Board of Directors. As of December 31, 2025, 97,544 shares
remained available for issuance under the 2024 Plan.
**Summary
of Material Terms of the 2024 Equity Incentive Plan**
The
following is a summary of the material features of the Glucotrack, Inc. 2024 Equity Incentive Plan. This summary is qualified in its
entirety by the full text of the 2024 Plan, a copy of which is filed as an exhibit to this Annual Report.
*Purpose*
The
purpose of the 2024 Plan is to provide employees, directors, and consultants with opportunities to acquire the Companys shares,
or to receive monetary payments based on the value of such shares. Equity awards and equity-linked compensatory opportunities are intended
to assist in further aligning the interests of directors, employees, and consultants with those of our stockholders.
| 51 | |
*Eligibility*
Persons
eligible to participate in the 2024 Plan will be employees, directors, and consultants of the Company and its subsidiaries as selected
from time to time by the plan administrator in its discretion, including prospective officers, employees, non-employee directors and
consultants. Any awards granted to such a prospect before the individuals start date may not become vested or exercisable, and
no shares may be issued to such individual, before the date the individual first commences performance of services with the Company.
As of the date of this Annual Report, approximately 15 individuals are eligible to participate in the 2024 Plan.
*Administration*
The
2024 Plan will be administered by the Compensation Committee of our Board of Directors, our Board of Directors, or such other similar
committee pursuant to the terms of the 2024 Plan. The plan administrator, which initially will be the Compensation Committee of our Board
of Directors, will have full power to select, from among the individuals eligible for awards, the individuals to whom awards will be
granted, to make any combination of awards to participants, and to determine the specific terms and conditions of each award, subject
to the provisions of the 2024 Plan. The plan administrator may delegate to one or more officers of the Company, the authority to grant
awards to individuals who are not subject to the reporting and other provisions of Section 16 of the Exchange Act.
*Share
Reserve*
Up
to 125,000 shares of our Common Stock may be issued under the 2024 Plan. Following stockholder approval of the 2024 Plan, no new awards
will be made under the 2010 Plan. As of December 31, 2025, 97,544 shares remained available for issuance under the 2024 Plan.
Shares
issuable under the 2024 Plan may be authorized, but unissued, or reacquired shares of Common Stock. Shares underlying any awards under
the 2024 Plan that are forfeited, cancelled, held back upon exercise of an option or settlement of an award to cover the exercise price
or tax withholding satisfied without the issuance of stock or otherwise terminated (other than by exercise) will be added back to the
shares available for issuance under the 2024 Plan, although shares shall not again become available for issuance as incentive stock options.
*Annual
Limitation on Awards to Non-Employee Directors*
The
2024 Plan contains a limitation whereby the value of all awards under the 2024 Plan and all other cash compensation paid by the Company
to any non-employee director may not exceed $750,000 for the first calendar year a non-employee director is initially appointed to the
Companys Board of Directors, and $500,000 in any other calendar year.
*Types
of Awards*
The
2024 Plan provides for the grant of stock options, stock appreciation rights, restricted stock, restricted stock units, and other stock-based
awards (collectively, awards). Unless otherwise set forth in an individual award agreement, each award shall vest over
a three (3) year period, with one-third (1/3) of the award vesting on the first annual anniversary of the date of grant and the remaining
portion of the award vesting monthly thereafter.
Stock
Options.
The
2024 Plan permits the granting of both options intended to qualify as incentive stock options under Section 422 of the Internal Revenue
Code of 1986, as amended (the Code) and options that do not so qualify. Options granted under the 2024 Plan will be nonqualified
options if they fail to qualify as incentive stock options or exceed the annual limit on incentive stock options. Incentive stock options
may only be granted to employees of the Company and its subsidiaries. Nonqualified options may be granted to any persons eligible to
receive awards under the 2024 Plan.
The
exercise price of each option will be determined by the plan administrator, but such exercise price may not be less than 100% of the
fair market value of one share of Common Stock on the date of grant or, in the case of an incentive stock option granted to a 10% or
greater stockholder, 110% of such shares fair market value. The term of each option will be fixed by the plan administrator and
may not exceed ten (10) years from the date of grant (or five years for an incentive stock option granted to a 10% or greater stockholder).
The plan administrator will determine at what time or times each option may be exercised, including the ability to accelerate the vesting
of such options.
| 52 | |
Upon
exercise of an option, the exercise price must be paid in full either in cash, check or, with approval of the plan administrator, by
delivery (or attestation to the ownership) of the shares of Company Common Stock that are beneficially owned by the optionee free of
restrictions or were purchased in the open market. Subject to applicable law and approval of the plan administrator, the exercise price
may also be made by means of a broker-assisted cashless exercise. In addition, the plan administrator may permit nonqualified options
to be exercised using a net exercise arrangement that reduces the number of shares issued to the optionee by the largest
whole number of shares with fair market value that does not exceed the aggregate exercise price.
Stock
Appreciation Rights. 
The
plan administrator may award stock appreciation rights subject to such conditions and restrictions as it may determine. Stock appreciation
rights entitle the recipient to shares of Common Stock or cash, equal to the value of the appreciation in the Companys stock price
over the exercise price, as set by the plan administrator. The term of each stock appreciation right will be set by the plan administrator
and may not exceed ten years from the date of grant. The plan administrator will determine at what time or times each stock appreciation
right may be exercised, including the ability to accelerate the vesting of such stock appreciation rights.
Restricted
Stock. 
A
restricted stock award is an award of shares of Common Stock that vests in accordance with the terms and conditions established by the
plan administrator. The plan administrator will determine the persons to whom grants of restricted stock awards are made, the number
of restricted shares to be awarded, the price (if any) to be paid for the restricted shares, the time or times within which awards of
restricted stock may be subject to forfeiture, the vesting schedule and rights to acceleration thereof, and all other terms and conditions
of restricted stock awards. Unless otherwise provided in the applicable award agreement, a participant generally will have the rights
and privileges of a stockholder as to such restricted shares, including without limitation the right to vote such restricted shares and
the right to receive dividends, if applicable.
Restricted
Stock Units.
Restricted
stock units are the right to receive shares of Common Stock at a future date in accordance with the terms of such grant upon the attainment
of certain conditions specified by the plan administrator. Restrictions or conditions could include, but are not limited to, the attainment
of performance goals, continuous service with the Company or its subsidiaries, the passage of time or other restrictions or conditions.
The plan administrator determines the persons to whom grants of restricted stock units are made, the number of restricted stock units
to be awarded, the time or times within which awards of restricted stock units may be subject to forfeiture, the vesting schedule, and
rights to acceleration thereof, and all other terms and conditions of the restricted stock unit awards. The value of the restricted stock
units may be paid in shares of Common Stock, cash, other securities, other property, or a combination of the foregoing, as determined
by the plan administrator.
The
holders of restricted stock units will have no voting rights. Prior to settlement or forfeiture, restricted stock units awarded under
the 2024 Plan may, at the plan administrators discretion, provide for a right to dividend equivalents. Such right entitles the
holder to be credited with an amount equal to all dividends paid on one share of Common Stock while each restricted stock unit is outstanding.
Dividend equivalents may be converted into additional restricted stock units. Settlement of dividend equivalents may be made in the form
of cash, shares of Common Stock, other securities, other property, or a combination of the foregoing. Prior to distribution, any dividend
equivalents shall be subject to the same conditions and restrictions as the restricted stock units to which they are payable.
| 53 | |
Other
Stock-Based Awards.
Other
stock-based awards may be granted either alone, in addition to, or in tandem with, other awards granted under the 2024 Plan and/or cash
awards made outside of the 2024 Plan. The plan administrator shall have authority to determine the persons to whom and the time or times
at which other stock-based awards will be made, the amount of such other stock-based awards, and all other conditions, including any
dividend and/or voting rights.
*Repricing*
The
2024 Plan authorizes the plan administrator to take the following repricing actions without stockholder approval: (i) modify the purchase
price or the exercise price of any outstanding award or (ii) cancel any award in exchange for cash or another award.
*Tax
Withholding*
Participants
in the 2024 Plan are responsible for the payment of any federal, state, or local taxes that the Company or its subsidiaries are required
by law to withhold upon the exercise of options or stock appreciation rights or vesting of other awards. The plan administrator may cause
any tax withholding obligation of the Company or its subsidiaries to be satisfied, in whole or in part, by the applicable entity withholding
from the shares of Common Stock to be issued pursuant to an award a number of shares with an aggregate fair market value that would satisfy
the withholding amount due. The plan administrator may also require any tax withholding obligation of the Company or its subsidiaries
to be satisfied, in whole or in part, by an arrangement whereby a certain number of shares issued pursuant to any award are immediately
sold and proceeds from such sale are remitted to the Company or its subsidiaries in an amount that would satisfy the withholding amount
due.
*Equitable
Adjustments*
In
the event of a merger, consolidation, recapitalization, stock split, reverse stock split, reorganization, split-up, spin-off, combination,
repurchase or other change in corporate structure affecting shares of Common Stock, the maximum number and kind of shares reserved for
issuance or with respect to which awards may be granted under the 2024 Plan will be adjusted to reflect such event, and the plan administrator
will make such adjustments as it deems appropriate and equitable in the number, kind, and exercise price of shares of Common Stock covered
by outstanding awards made under the 2024 Plan.
*Change
in Control*
In
the event of any proposed change in control (as defined in the 2024 Plan), the plan administrator will take any action as it deems appropriate,
which action may include, without limitation, the following: (i) the continuation of any award, if the Company is the surviving corporation;
(ii) the assumption of any award by the surviving corporation or its parent or subsidiary; (iii) the substitution by the surviving corporation
or its parent or subsidiary of equivalent awards; (iv) accelerated vesting of the award, with all performance objectives and other vesting
criteria deemed achieved at targeted levels, and a limited period during which to exercise the award prior to closing of the change in
control, or (v) settlement of any award for the change in control price (less, to the extent applicable, the per share exercise price).
Unless determined otherwise by the plan administrator, in the event that the successor corporation refuses to assume or substitute for
the award, a participant shall fully vest in and have the right to exercise the award as to all shares of Common Stock, including those
that would not otherwise be vested or exercisable, all applicable restrictions will lapse, and all performance objectives and other vesting
criteria will be deemed achieved at targeted levels.
*Transferability
of Awards*
Unless
determined otherwise by the plan administrator, an award may not be sold, pledged, assigned, hypothecated, transferred, or disposed of
in any manner, except to a participants estate or legal representative, and may be exercised, during the lifetime of the participant,
only by the participant. If the plan administrator makes an award transferable, such award will contain such additional terms and conditions
as the plan administrator deems appropriate.
| 54 | |
*Term*
The
2024 Plan became effective when approved by our shareholders, and, unless terminated earlier, the 2024 Plan will continue in effect for
a term of ten (10) years.
*Amendment
and Termination*
Our
Board may amend or terminate the 2024 Plan at any time. Any such termination will not affect outstanding awards. No amendment or termination
of the 2024 Plan will materially impair the rights of any participant, unless mutually agreed otherwise between the participant and the
Company. Approval of the stockholders shall be required for any amendment, where required by applicable law, as well as (i) to increase
the number of shares available for issuance under the 2024 Plan and (ii) to change the persons or class of persons eligible to receive
awards under the 2024 Plan.
*Recoupment
Policy*
All
awards granted under the 2024 Plan, all amounts paid under the 2024 Plan, and all shares of Common Stock issued under the 2024 Plan shall
be subject to reduction, recoupment, clawback, or recovery by the Company in accordance with applicable laws and with Company policy.
*Form
S-8*
During
September 2025, the Company filed with the SEC a registration statement on Form S-8 covering the shares of Common Stock issuable under
the 2024 Plan.
*Material
United States Federal Income Tax Considerations*
The
following is a general summary under current law of the material U.S. federal income tax considerations related to awards and certain
transactions under the 2024 Plan, based upon the current provisions of the Code and regulations promulgated thereunder. This summary
deals with the general federal income tax principles that apply and is provided only for general information. It does not describe all
federal tax consequences under the 2024 Plan, nor does it describe state, local, or foreign income tax consequences or federal employment
tax consequences. The rules governing the tax treatment of such awards are quite technical, so the following discussion of tax consequences
is necessarily general in nature and is not complete. In addition, statutory provisions are subject to change, as are their interpretations,
and their application may vary in individual circumstances. This summary is not intended as tax advice to participants, who should consult
their own tax advisors.
The
2024 Plan is not qualified under the provisions of Section 401(a) of the Code and is not subject to any of the provisions of the Employee
Retirement Income Security Act of 1974, as amended. The Companys ability to realize the benefit of any tax deductions described
below depends on the Companys generation of taxable income as well as the requirement of reasonableness and the satisfaction of
the Companys tax reporting obligations.
Incentive
Stock Options.
No
taxable income is generally realized by the optionee upon the grant or exercise of an incentive stock option. If shares of Common Stock
issued to an optionee pursuant to the exercise of an incentive stock option are sold or transferred after two years from the date of
grant and after one year from the date of exercise, then generally (i) upon sale of such shares, any amount realized in excess of the
option exercise price (the amount paid for the shares) will be taxed to the optionee as a long-term capital gain, and any loss sustained
will be a long-term capital loss, and (ii) neither the Company nor its subsidiaries will be entitled to any deduction for federal income
tax purposes; provided that such incentive stock option otherwise meets all of the technical requirements of an incentive stock option.
The exercise of an incentive stock option will give rise to an item of tax preference that may result in alternative minimum tax liability
for the optionee.
| 55 | |
If
the shares of Common Stock acquired upon the exercise of an incentive stock option are disposed of prior to the expiration of the two-year
and one-year holding periods described above (a disqualifying disposition), generally (i) the optionee will realize ordinary
income in the year of disposition in an amount equal to the excess (if any) of the fair market value of the shares of Common Stock at
exercise (or, if less, the amount realized on a sale of such shares of Common Stock) over the option exercise price thereof, and (ii)
the Company or its subsidiaries will be entitled to deduct such amount. Special rules will apply where all or a portion of the exercise
price of the incentive stock option is paid by tendering shares of Common Stock.
If
an incentive stock option is exercised at a time when it no longer qualifies for the tax treatment described above, the option is treated
as a nonqualified option. Generally, an incentive stock option will not be eligible for the tax treatment described above if it is exercised
more than three months following termination of employment (or one year in the case of termination of employment by reason of disability).
In the case of termination of employment by reason of death, the three-month rule does not apply.
Nonqualified
Options.
No
income is generally realized by the optionee at the time a nonqualified option is granted. Generally, (i) at exercise, ordinary income
is realized by the optionee in an amount equal to the difference between the option exercise price and the fair market value of the shares
of Common Stock issued on the date of exercise, and the Company or its subsidiaries receive a tax deduction for the same amount, and
(ii) at disposition, appreciation or depreciation after the date of exercise is treated as either short-term or long-term capital gain
or loss depending on how long the shares of Common Stock have been held. Special rules will apply where all or a portion of the exercise
price of the nonqualified option is paid by tendering shares of Common Stock. Upon exercise, the optionee will also be subject to Social
Security taxes on the excess of the fair market value of the shares of Common Stock over the exercise price of the option.
Stock
Appreciation Rights, Restricted Stock, Restricted Stock Units, and Other Stock-Based Awards.
The
current federal income tax consequences of other awards authorized under the 2024 Plan generally follow certain basic patterns: (i) stock
appreciation rights are taxed and deductible in substantially the same manner as nonqualified options; (ii) nontransferable restricted
stock subject to a substantial risk of forfeiture results in income recognition equal to the excess of the fair market value of the shares
of Common Stock over the price paid, if any, only at the time the restrictions lapse (unless the recipient elects to accelerate recognition
as of the date of grant through a Section 83(b) election); and (iii) restricted stock units, dividend equivalents, and other stock or
cash based awards are generally subject to tax at the time of payment. The Company or its subsidiaries generally should be entitled to
a federal income tax deduction in an amount equal to the ordinary income recognized by the participant at the time the participant recognizes
such income.
The
participants basis for the determination of gain or loss upon the subsequent disposition of shares of Common Stock acquired from
a stock appreciation right, restricted stock, restricted stock unit, or other stock-based award will be the amount paid for such shares
plus any ordinary income recognized when the shares were originally delivered, and the participants capital gain holding period
for those shares will begin on the day after they are transferred to the participant.
Parachute
Payments.
The
vesting of any portion of an award that is accelerated due to the occurrence of a change in control (such as a sale event) may cause
all or a portion of the payments with respect to such accelerated awards to be treated as parachute payments as defined
in the Code. Any such parachute payments may be non-deductible to either the Company or its subsidiaries, in whole or in part, and may
subject the recipient to a non-deductible 20% federal excise tax on all or a portion of such payment (in addition to other taxes ordinarily
payable).
| 56 | |
Section
409A.
The
foregoing description assumes that Section 409A of the Code does not apply to an award under the 2024 Plan. In general, stock options
and stock appreciation rights are exempt from Section 409A if the exercise price per share is at least equal to the fair market value
per share of the underlying stock at the time the option or stock appreciation right was granted. Restricted stock awards are not generally
subject to Section 409A. Restricted stock units are subject to Section 409A unless they are settled within two and one-half months after
the end of the later of (1) the end of the Companys fiscal year in which vesting occurs or (2) the end of the calendar year in
which vesting occurs. If an award is subject to Section 409A and the provisions for the exercise or settlement of that award do not comply
with Section 409A, then the participant would be required to recognize ordinary income whenever a portion of the award vested (regardless
of whether it had been exercised or settled). This amount would also be subject to a 20% federal tax and premium interest in addition
to the federal income tax at the participants usual marginal rate for ordinary income.
**Security
Ownership of Certain Beneficial Owners and Management**
The
following table provides information regarding the beneficial ownership of our common stock as of March 30, 2026, or the Evaluation
Date, by: (i) each of our current directors, (ii) each of our named executive officers as set forth in Item 11 of this Annual
Report, (iii) all such directors and executive officers as a group and (iv) our five percent or greater stockholders. The table is
based upon information supplied by our officers, directors and principal stockholders and a review of Schedules 13D and 13G, if any,
filed with the SEC. Unless otherwise indicated in the footnotes to the table and subject to community property laws where
applicable, we believe that each of the stockholders named in the table has sole voting and investment power with respect to the
shares indicated as beneficially owned.
Applicable
percentages are based on 1,944,279 shares outstanding as of the Evaluation Date, adjusted as required by rules promulgated by the
SEC. These rules generally attribute beneficial ownership of securities to persons who possess sole or shared voting power or
investment power with respect to those securities. In addition, the rules include shares of our common stock issuable pursuant to
the exercise of stock options or warrants or settlement of shares issued for services that are either immediately exercisable or
exercisable within 60 days of the Evaluation Date. These shares are deemed to be outstanding and beneficially owned by the person
holding those securities for the purpose of computing the percentage ownership of that person, but they are not treated as
outstanding for the purpose of computing the percentage ownership of any other person. Unless otherwise indicated, the business
address for each listed stockholder is c/o Glucotrack, Inc., 301 Rte. 17 North, Ste. 800, Rutherford, NJ 07070.
| 
Name of Beneficial
Owner | | 
Number
of Shares Beneficially Owned | | | 
Percent
of Common Stock | | |
| 
Named
Executive Officers and Directors | | 
| | | | 
| | | |
| 
Paul V. Goode | | 
| 402 | (1) | | 
| * | | |
| 
Peter C. Wulff | | 
| - | | | 
| * | | |
| 
Luis Malav | | 
| 7,438 | (2) | | 
| * | | |
| 
Erin Carter | | 
| 5,528 | (3) | | 
| * | | |
| 
Victoria Carr-Brendel | | 
| 3,814 | (4) | | 
| * | | |
| 
Andrew K. Balo | | 
| 8,072 | (5) | | 
| * | | |
| 
All of our executive officers
and directors as a group (6 individuals) | | 
| 25,254 | | | 
| 1.30 | % | |
| 
| 
| 
| 
| 
| 
| 
| 
| 
| |
| 
5%
or Greater Stockholders | 
| 
| 
| 
| 
| 
| 
| 
| |
| 
None | 
| 
| 
| 
| 
| 
| 
| 
| |
| 
* | 
Indicates
less than one percent of the outstanding shares of the Companys Common Stock. | |
| 
| 
| |
| 
(1) | 
Includes
(i) 28 shares of Common Stock subject to options currently exercisable or exercisable within 60 days of the Evaluation Date, (ii) 35
warrants currently exercisable and (iii) 339 shares of Common Stock held directly by Mr. Goode. | |
| 
| 
| |
| 
(2) | 
Includes
(i) 3,380 shares of Common Stock subject to options currently exercisable or exercisable within 60 days of the Evaluation Date, and
(ii) 4,058 shares of Common Stock held directly by Mr. Malav. | |
| 
| 
| |
| 
(3) | 
Includes
(i) 3,380 shares of Common Stock subject to options currently exercisable or exercisable within 60 days of the Evaluation Date, and
(ii) 2,148 shares of Common Stock held directly by Ms. Carter. | |
| 
| |
| 
(4) | 
Includes
(i) 3,380 shares of Common Stock subject to options currently exercisable or exercisable within 60 days of the Evaluation Date, and
(ii) 434 shares of Common Stock held directly by Ms. Carr-Brendel. | |
| 
| 
| |
| 
(5) | 
Includes
(i) 3,380 shares of Common Stock subject to options currently exercisable or exercisable within 60 days of the Evaluation Date, and
(ii) 4,692 shares of Common Stock held directly by Mr. Balo. | |
**Changes
in Control**
Management
of the Company knows of no arrangements, including any pledge by any person or securities of the Company, the operation of which may
at a subsequent date result in a change in control of the registrant.
**Item
13. Certain Relationships and Related Transactions, and Director Independence**
Other
than as listed below, during 2025 and 2024, we were not a participant in any transaction or series of transactions in which the amount
involved did exceed or may exceed the lesser of $120,000 or 1% of the average of our total assets at year-end for 2025 and 2024 in which
any directors, director nominees, executive officers, greater than 5% beneficial owners and their respective immediate family members
(each, a Related Person) had or will have a direct or indirect material interest, other than the compensation arrangements
(including with respect to equity compensation) described in *Executive Compensation* beginning on page 48 and *Director
Compensation* on page 50.
We
intend to ensure that in accordance with the Audit Committee charter, that the Audit Committee shall conduct reasonable prior review
and oversight of all related party transaction for potential conflicts of interest, except for transactions involving the compensation
of executive officers or directors, which shall be overseen by the compensation committee.
| 57 | |
*Issuance
Under IP Purchase Agreement*
On
October 7, 2022, the Company entered into the IP Purchase Agreement with Paul Goode, which is the Companys Chief Executive Officer,
pursuant to which Dr. Goode sold, assigned, transferred, conveyed and delivered to the Company the Purchased Assets: (a) the Conveyed
Intellectual Property and (b) all the goodwill relating to the Purchased Assets.
In
consideration for the sale by Dr. Goode of the Purchased Assets to the Company, the Company paid to Dr. Goode cash in the amount of one
dollar and became obligated to issue up to 167 shares of Common Stock based upon specified performance milestones as set forth in
the IP Purchase Agreement. In addition, if upon the final issuance of Common Stock under the IP Purchase Agreement, the aggregate 167
shares represent less than 1.5% of the then outstanding Common Stock of the Company, the final issuance will include such number of additional
shares so that the total aggregate issuance equals 1.5% of the outstanding shares (the True-Up Shares) of Common Stock
of the Company. All shares of Common Stock to be issued under the IP Purchase Agreement shall be (i) restricted over a limited period
as defined in the IP Purchase Agreement and issued in transactions exempt from registration under Section 4(a)(2) of the Securities Act
of 1933, as amended and (ii) subject to the lockup provisions.
On
December 29, 2023, 17 shares of Common Stock were earned under the terms of the IP Purchase Agreement and were issued to Dr. Goode on
February 6, 2024. On May 1, 2024, 25 shares of Common Stock were earned under the terms of the IP Purchase Agreement. On March 26, 2025,
the Board determined that the third milestone was met and that an additional 42 shares of Common Stock have been earned under the terms
of the IP Purchase Agreement.
*April
Private Placement*
On
April 22, 2024, the Company entered into a private placement agreement under which the Company issued 3,969 shares of its Common Stock
at a price of $126.00 per share for aggregate gross proceeds of $500. The Offering included participation of certain members of the Companys
executive management, Board of Directors and existing shareholders.
*June
27 Private Placement*
On
June 27, 2024, the Company entered into note and warrant purchase agreements with certain officers, directors, and existing investors
(the June 27 Investors), providing for the private placement of unsecured promissory notes in the aggregate principal amount
of $100 (the June 27 Notes) and warrants (the June 27 Warrants) to purchase up to an aggregate of 250
shares of Common Stock. The closing of the private placement occurred on June 27, 2024.
The
June 27 Notes bore simple interest at the rate of three percent (3%) per annum and were due and payable in cash on the earlier of: (a)
twelve (12) months from the date of the June 27 Note; or (b) the date the Company raised third-party equity capital in an amount equal
to or in excess of $1,000 (the June 27 Maturity Date). The Company could prepay the June 27 Notes at any time prior
to the June 27 Maturity Date without penalty.
Each
June 27 Warrant has an exercise price of $5,490.00 per share. The June 27 Warrants are immediately exercisable and have a five-year term.
*July
18 Private Placement*
On
July 18, 2024, the Company entered into a series of convertible promissory notes with the July 18 Investors, providing for the private
placement of unsecured convertible promissory notes in the aggregate principal amount of $360.
The
July 18 Notes bore simple interest at the rate of eight percent (8%) per annum and were due and payable in cash on the earlier of: (a)
the twelve (12) month anniversary of the July 18 Note, or (b) the date of closing of a Qualified Financing (defined below) (the July
18 Maturity Date).
| 58 | |
Except
with regard to conversion of the July 18 Notes as discussed below, the Company could not prepay the July 18 Notes without the written
consent of the holder. If not sooner repaid, all outstanding principal and accrued but unpaid interest on the July 18 Notes (the Note
Balance), as of the close of business on the day immediately preceding the date of the closing of the next issuance and sale of
capital stock of the Company, in a single transaction or series of related transactions, to investors resulting in gross proceeds to
the Company of at least $500 (excluding indebtedness converted in such financing) (a Qualified Financing), would automatically
be converted into that number of shares of equity securities of the Company sold in the Qualified Financing equal to the number of shares
calculated by dividing (X) the Note Balance by (Y) an amount equal to the price per share or other unit of equity securities issued in
such Qualified Financing, and otherwise on the same terms as the security issued in the Qualified Financing, provided that the conversion
price per share shall not be lower than $1,872.00 (the Floor Price).
*July
30 Private Placement*
On
July 30, 2024, the Company entered into the July 30 Notes and the July 30 Warrants with the July 30 Holder, providing for the private
placement of a secured convertible promissory note in the aggregate principal amount of $4,000. The July 30 Note was not convertible
until and Stockholder Approval was obtained, which occurred on September 26, 2024. The July 30 Note bore simple interest at the rate
of eight percent (8%) per annum and was due and payable in cash on the July 30 Maturity Date. The July 30 Note was secured by a first-priority
security interest on all Company assets.
Except
with regard to conversion of the July 30 Note or a Sale Transaction as discussed below, the Company could not prepay the July 30 Notes
without the written consent of the July 30 Holder. The July 30 Note (i) was convertible at the discretion of the July 30 Holder at a
price equal to the closing price of the Common Stock on the date of conversion and, (ii) if the closing price of the Common Stock exceeds
$6,000.00 per share for a period of five (5) consecutive trading days, would automatically convert at a price equal to the five-day (5)
VWAP (subject to adjustment for any stock split, stock dividend, reverse stock split, combination or similar transaction). VWAP
means the daily volume weighted average price of the Common Stock.
In
the event of a Sale Transaction on or prior to the Maturity Date, the Company would repay the July 30 Holder, at the July 30 Holders
election, as follows: (a) cash equal to 200% of the Note balance, or (b) transaction consideration in the amount to be received by the
July 30 Holder in such Sale Transaction if the July 30 Note was converted pursuant to an optional conversion. Sale Transaction
means a merger or consolidation of the Company with or into any other entity, or a sale of all or substantially all of the assets of
the Company, or any other transaction or series of related transactions in which the Companys stockholders immediately prior to
such transaction(s) receive cash, securities or other property in exchange for their shares and, immediately after such transaction(s),
own less than 50% of the equity securities of the surviving corporation or its parent.
Each
July 30 Warrant becomes exercisable 12 months after its issuance and has term of 10 years. The July 30 Warrants are exercisable for
cash only and have no price-based antidilution. The first July 30 Warrant is for 1,778 shares at $2,250.00 per share. The second July
30 Warrant is for 1,270 shares at $3,150.00 per share. The third July 30 Warrant is for 988 shares at $4,050.00 per share.
*Concurrent
Private Offering*
In
the Concurrent Private Offering, the July 30 Holder, which is an existing investor controlled by a director of the Company,
converted the July 30 Note Debt, equaling approximately $4,093 of debt, which represented the then outstanding principal and accrued
interest under the July 30 Note. The July 30 Note Debt was converted to Common Stock and Common Warrants on substantially the same
terms as the November 2024 Offering, resulting in the issuance of 2,201 shares of Common Stock, 2,201 accompanying Series A Common
Warrants, and 2,201 accompanying Series B Common Warrants, based on a conversion price of $1,860.00 per share, which is equal to the
consolidated closing bid price of the Common Stock on the Nasdaq Capital Market on November 12, 2024.
| 59 | |
*July
18 Note Conversion*
In
addition, concurrently with the November 2024 Offering, the Company converted on substantially the same terms as the November Offering,
the three outstanding July 18 Notes, with an aggregate outstanding principal and accrued interest in the amount of $304. As previously
disclosed in the Form 8-K filed by the Company with the SEC on July 22, 2024, that disclosed the entry into the July 18 Notes, the July
18 Notes were to automatically convert upon a Qualified Financing, into a number of equity securities of the Company sold in the Qualified
Financing, equal to a number of shares calculated by dividing (X) the Note Balance by (Y) an amount equal to the price per share or other
unit of equity securities issued in such Qualified Financing, and otherwise on the same terms as the security issued in the Qualified
Financing, provided that the conversion price per share shall not be lower than the Floor Price. The three outstanding July 18 Notes
automatically converted in connection with the closing of the November 2024 Offering at a conversion price of $1,872.00, which is equal
to the Floor Price as defined in the July 18 Notes, for an aggregate of 163 shares of Common Stock, 163 Series A Common Warrants,
and 163 Series B Common Warrants (the July 18 Note Conversion).
*Warrant Exchange*
**
On March 11, 2025, the Company
received exchange notices from the July 30 Holder and the holders of the July 18 Notes with respect to an aggregate of 54,021 Series B
Warrants (the Exchanged Warrants), requiring the delivery of 162,063 shares of Common Stock. The Exchanged Warrants represent
all Series B Warrants held by the July 30 Holder and the holders of the July 18 Notes.
The Series B Warrants contained
an alternative cashless exercise feature, pursuant to which the holder of a Series B Warrant could exchange such Series B Warrant to acquire,
on a cashless basis, additional shares of Common Stock, pursuant to a formula set forth in the Series B Warrants that provided for the
acquisition of up to 300% of the number of shares that could otherwise be purchased under such Series B Warrant pursuant to a cash exercise
of such Series B Warrant.
**Item
14. Principal Accountant Fees and Services**
****
On July 18, 2025, the Company, with the prior approval of the Audit Committee, dismissed Fahn Kanne & Co. Grant Thornton Israel (Grant
Thornton) as the Companys independent registered public accounting firm. In connection with the dismissal of Grant Thornton,
with the prior approval of the Audit Committee, on July 18, 2025, the Company engaged CBIZ CPAs P.C. (CBIZ) as the Companys
independent registered public accounting firm for the fiscal year ending December 31, 2025.
The
following tables presents the aggregate fees billed by CBIZ and Grant Thornton for services performed during the fiscal years ended December
31, 2025 and 2024. These fees are categorized as audit fees, audit-related fees, tax fees and all other fees. The nature of the services
provided in each category is described following the tables.
**Fees
Paid to Independent Registered Public Accounting Firm**
****
The
following table provides information regarding the fees billed by CBIZ for the fiscal year ended December 31, 2025.
| 
| | 
2025 | | |
| 
| | 
| | |
| 
Audit Fees (1) | | 
$ | 146,550 | | |
| 
Audit-Related Fees (2) | | 
| - | | |
| 
Tax Fees (3) | | 
| | | |
| 
All Other Fees (4) | | 
$ | 8,007 | | |
**Fees
Paid to Prior Independent Registered Public Accounting Firm**
****
The
following table provides information regarding the fees billed by the Companys previous independent registered public accounting
firm, Grant Thornton, for the fiscal years ended December 31, 2025 and 2024.
| 
| | 
2025 | | | 
2024 | | |
| 
| | 
| | | 
| | |
| 
Audit Fees (1) | | 
$ | 127,000 | | | 
| 113,152 | | |
| 
Audit-Related Fees (2) | | 
| 64,000 | | | 
| 71,000 | | |
| 
Tax Fees (3) | | 
| 11,630 | | | 
| - | | |
| 
All Other Fees (4) | | 
$ | 9,928 | | | 
| - | | |
| 
(1) | Audit
Fees. Audit fees consist of fees billed for professional services rendered for the audit
of our year-end financial statements and services that are normally provided by our independent
registered public accounting firm in connection with statutory and regulatory filings. | |
| 
(2) | Audit-Related
Fees. Audit-related fees consist of fees billed for assurance and related services that
are reasonably related to performance of the audit or review of our year-end financial statements
and are not reported under Audit Fees. These services include attest services
that are not required by statute or regulation and consultation concerning financial accounting
and reporting standards. | |
| 
(3) | Tax
Fees. Tax fees consist of fees billed for professional services relating to tax compliance,
tax planning and tax advice. | |
| 
(4) | All
Other Fees. All other fees consist of fees billed for all other services. | |
**Policy on Pre-Approval
of Audit and Permissible Non-Audit Services of Independent Auditors**
Under
its charter, the Companys Audit Committee must review and pre-approve both audit and permitted non-audit services provided by
the Companys independent registered public accounting firm and shall not engage the independent registered public accounting
firm to perform any non-audit services prohibited by law or regulation. The independent registered public accounting firms
retention to audit the Companys financial statements, including the associated fee, is subject to approval each year by the
Audit Committee. The Audit Committee does not regularly evaluate potential engagements of the independent registered public
accounting firm and approve or reject such potential engagements. At each Audit Committee meeting, the Audit Committee receives
updates on the services actually provided by the independent registered public accounting firm, and management may present
additional services for pre-approval. The Audit Committee approved all of the fees paid to CBIZ and Grant Thornton during the years ended December 31, 2025 and 2024.
| 60 | |
**PART
IV**
**Item
15. Exhibits and Financial Statement Schedules**
****
(a)
Documents filed as part of this Annual Report
(1)
All financial statements
| 
Report
of Independent Registered Public Accounting Firm (PCAOB ID:199) | 
F-2 | |
| 
Report of Independent Registered Public Accounting Firm (PCAOB ID:1375) | 
F-3 | |
| 
Consolidated
Balance Sheets as of December 31, 2025 and 2024 | 
F-4 | |
| 
Consolidated
Statements of Operations for the Years Ended December 31, 2025 and 2024 | 
F-5 | |
| 
Consolidated
Statements of Changes in Stockholders Equity for the Years Ended December 31, 2025 and 2024 | 
F-6 | |
| 
Consolidated
Statements of Cash Flows for the Years Ended December 31, 2025 and 2024 | 
F-7 | |
| 
Notes
to Consolidated Financial Statements | 
F-8 | |
(2)
Financial Statement Schedules
All
financial statement schedules are omitted because they are either inapplicable or not required, or because the required information is
included in the Consolidated Financial Statements or notes thereto contained in this Annual Report.
(3)
Exhibits required by Item 601 of Regulation S-K
The
following documents are filed as exhibits to this registration statement:
| 
Exhibit
Number | 
| 
Description
of Exhibit | |
| 
3.1 | 
| 
Certificate
of Incorporation of Integrity Applications, Inc. (incorporated by reference to Exhibit 3.1 to the Registration Statement on Form
S-1 filed by Integrity Applications, Inc. on August 22, 2011) | |
| 
3.2 | 
| 
Certificate
of Amendment to Certificate of Incorporation of Integrity Applications, Inc. (incorporated by reference to Exhibit 3.2 to the Registration
Statement on Form S-1 filed by Integrity Applications, Inc. on August 22, 2011) | |
| 
3.3 | 
| 
Bylaws
of Integrity Applications, Inc. (incorporated by reference to Exhibit 3.3 to the Registration Statement on Form S-1 filed by Integrity
Applications, Inc. on August 22, 2011) | |
| 
3.4 | 
| 
Certificate
of Amendment to Certificate of Incorporation of Integrity Applications, Inc. (incorporated by reference to Exhibit 99.1 to the Current
Report on Form 8-K filed by Integrity Applications, Inc. on April 23, 2020) | |
| 
3.5 | 
| 
Amendments
to The Companys Certificate of Incorporation (incorporated by reference to Exhibit 3.5 to the Annual Report on Form 10-K filed
by Glucotrack, Inc. on March 28, 2024) | |
| 
3.6 | 
| 
First
Amendment to Bylaws dated June 14, 2024 (incorporated by reference to Exhibit 3.01 to the Current Report on Form 8-K filed by Glucotrack,
Inc. on June 20, 2024) | |
| 
3.7 | 
| 
Certificate
of Amendment to Amended and Restated Certificate of Incorporation, as filed with the Secretary of State of the State of Delaware
on May 17, 2024 (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed by Glucotrack, Inc. on May 20,
2024) | |
| 
3.8 | 
| 
Certificate
of Amendment of Certificate of Incorporation of Glucotrack, Inc., dated January 3, 2025 (incorporated by reference to Exhibit 3.1
to the Current Report on Form 8-K filed by Glucotrack, Inc. on January 7, 2025) | |
| 
3.9 | 
| 
Certificate
of Amendment to Certificate of Incorporation, as filed with the Secretary of State of the State of Delaware on February 3, 2025 (incorporated
by reference to Exhibit 3.1 to the Current Report on Form 8-K filed by Glucotrack, Inc. on February 4, 2025) | |
| 
3.10 | 
| 
Certificate of Amendment to Certificate of Incorporation, as filed with the Secretary of State of the State of Delaware on June 13, 2025 (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed by Glucotrack, Inc. on June 16, 2025) | |
| 
4.1* | 
| 
Description
of Registrants Securities | |
| 
4.2 | 
| 
Specimen
Certificate Evidencing Shares of Common Stock (incorporated by reference to Exhibit 4.1 to the Registration Statement on Form S-1
filed by Integrity Applications, Inc. on August 22, 2011) | |
| 
4.3 | 
| 
Form
of Warrant (incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K filed by Glucotrack, Inc. on July 1, 2024) | |
| 
4.4 | 
| 
Form
of Warrant (incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K filed by Glucotrack, Inc. on July 31, 2024) | |
| 
4.5 | 
| 
Form
of Pre-Funded Warrant (incorporated by reference to Exhibit 4.3 to the Current Report on Form 8-K filed by Glucotrack, Inc. on November
14, 2024) | |
| 
4.6 | 
| 
Form
of Series A Common Warrant (incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K filed by Glucotrack, Inc.
on November 14, 2024) | |
| 
4.7 | 
| 
Form
of Series B Common Warrant (incorporated by reference to Exhibit 4.2 to the Current Report on Form 8-K filed by Glucotrack, Inc.
on November 14, 2024) | |
| 
4.8 | 
| 
Form of Convertible Note, dated September 12, 2025 (incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K filed by Glucotrack, Inc. on September 12, 2025) | |
| 
4.9 | 
| 
Form of Amendment No. 1 to Convertible Promissory Note (incorporated by reference to Exhibit 4.2 to the Quarterly Report on Form 10-Q filed by Glucotrack, Inc. on November 13, 2025) | |
| 
4.10 | 
| 
Form of Pre-Funded Warrant, issued December 31, 2025 (incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K filed by Glucotrack, Inc. on December 31, 2025) | |
| 
4.11 | 
| 
Form of Common Warrant, issued December 31, 2025 (incorporated by reference to Exhibit 4.2 to the Current Report on Form 8-K filed by Glucotrack, Inc. on December 31, 2025) | |
| 
4.12 | 
| 
Form of Placement Agent Warrant, issued December 31, 2025 (incorporated by reference to Exhibit 4.3 to the Current Report on Form 8-K filed by Glucotrack, Inc. on December 31, 2025) | |
| 61 | |
| 
10.1+ | 
| 
Glucotrack,
Inc. 2024 Equity Incentive Plan (incorporated by reference to Appendix A of Glucotrack, Inc.s DEF 14A filed with the Commission
on April 1, 2024) | |
| 
10.2+ | 
| 
Amendment to Glucotrack, Inc. 2024 Equity Incentive Plan (incorporated by reference to Exhibit 99.1 to the Current Report on Form 8-K filed by Glucotrack, Inc. on May 23, 2025) | |
| 
10.3+ | 
| 
Employment
Agreement, dated October 19, 2021, by and between Integrity Applications, Inc. and Paul V. Goode (incorporated by reference to Exhibit
10.1 to the Current Report on Form 8-K filed by Integrity Applications, Inc. on October 25, 2021) | |
| 
10.4+ | 
| 
Employment
Agreement, dated January 29, 2025, by and between Glucotrack, Inc. and Peter Wulff (incorporated by reference to Exhibit 10.1 to
the Current Report on Form 8-K filed by Glucotrack, Inc. on January 29, 2025) | |
| 
10.5 | 
| 
At-the-Market
Sales Agreement, dated December 17, 2024, by and between Glucotrack, Inc. and Dawson James Securities, Inc. (incorporated by reference
to Exhibit 1.1 to the Current Report on Form 8-K filed by Glucotrack, Inc. on December 17, 2024) | |
| 
10.6 | 
| 
Form of Securities Purchase Agreement (incorporated by reference to Exhibit 10.1 to the Companys Current Report on Form 8-K filed with the SEC on February 5, 2025) | |
| 
10.7 | 
| 
Form of Placement Agent Agreement (incorporated by reference to Exhibit 10.2 to the Companys Current Report on Form 8-K filed with the SEC on February 5, 2025) | |
| 
10.8 | 
| 
Form of Lock-Up Agreement (incorporated by reference to Exhibit 10.3 to the Companys Current Report on Form 8-K filed with the SEC on February 5, 2025) | |
| 
10.9 | 
| 
Purchase Agreement, dated September 11, 2025, by and between Glucotrack, Inc. and Sixth Borough Capital Fund, LP (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed by Glucotrack, Inc. on September 11, 2025) | |
| 
10.10 | 
| 
Registration Rights Agreement, dated September 11, 2025, by and between Glucotrack, Inc. and Sixth Borough Capital Fund, LP (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed by Glucotrack, Inc. on September 11, 2025) | |
| 
10.11 | 
| 
Form of Note Purchase Agreement, dated September 12, 2025 (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed by Glucotrack, Inc. on September 12, 2025) | |
| 
10.12 | 
| 
Form of Securities Purchase Agreement, dated December 29, 2025 (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed by Glucotrack, Inc. on December 31, 2025) | |
| 
10.13 | 
| 
Form of Registration Rights Agreement, dated December 29, 2025 (incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K filed by Glucotrack, Inc. on December 31, 2025) | |
| 
10.14 | 
| 
Form of Lock-Up Agreement, dated December 29, 2025 (incorporated by reference to Exhibit 10.3 to the Current Report on Form 8-K filed by Glucotrack, Inc. on December 31, 2025) | |
| 
10.15 | 
| 
Placement Agency Agreement, dated December 29, 2025, by and between the Company and Curvature Securities, LLC (incorporated by reference to Exhibit 10.4 to the Current Report on Form 8-K filed by Glucotrack, Inc. on December 31, 2025) | |
| 
10.16 | 
| 
Letter of Approval, addressed to Integrity Applications Ltd. from the Ministry of Industry, Trade and Employment of the State of Israel (incorporated by reference to Exhibit 10.16 to the Registration Statement on Form S-1 filed by Integrity Applications, Inc. on November 10, 2011) | |
| 
10.17 | 
| 
Letter of Undertaking, addressed to the Ministry of Industry, Trade and Employment of the State of Israel - Office of the Chief Scientist from Integrity Applications Ltd. (incorporated by reference to Exhibit 10.17 to the Registration Statement on Form S-1 filed by Integrity Applications, Inc. on November 10, 2011) | |
| 
10.18* | 
| 
Separation Agreement and Release, dated March 27, 2026, by and between the Company and Peter C. Wulff | |
| 
19.1 | 
| 
Insider
Trading Policies and Procedures, adopted March 22, 2024 (incorporated by reference to Exhibit 19 to the Annual Report on Form 10-K
filed by Glucotrack, Inc. on March 28, 2024) | |
| 
21.1 | 
| 
Subsidiaries of the Registrant (incorporated by reference to Exhibit 21.1 to the Annual Report on Form 10-K filed by Glucotrack, Inc. on March 31, 2025) | |
| 
23.1* | 
| 
Consent of Independent Registered Public Accounting Firm (CBIZ CPAs P.C.) | |
| 
23.2* | 
| 
Consent of Independent Registered Public Accounting Firm (Fahn Kanne & Co. Grant Thornton Israel) | |
| 
97.1 | 
| 
Policy
Related to Recovery of Erroneously Awarded Compensation, adopted November 30, 2023 (incorporated by reference to Exhibit 97.1 to
the Annual Report on Form 10-K filed by Glucotrack, Inc. on March 28, 2024) | |
| 
31.1* | 
| 
Certification
of Principal Executive Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | |
| 
31.2* | 
| 
Certification
of Principal Financial Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | |
| 
32.1* | 
| 
Certification
of Principal Executive Officer, pursuant to 18 U.S.C. Section 1350, as created by Section 906 of the Sarbanes-Oxley Act of 2002 | |
| 
32.2* | 
| 
Certification
of Principal Financial Officer, pursuant to 18 U.S.C. Section 1350, as created by Section 906 of the Sarbanes-Oxley Act of 2002 | |
| 
99.1 | 
| 
Code of Ethics (incorporated by reference to Exhibit 99.1 to the Annual Report on Form 10-K filed by Glucotrack, Inc. on March 31, 2025) | |
| 
101.INS | 
| 
Inline
XBRL Instance Document - the instance document does not appear in the Interactive Data File because its Inline XBRL tags are embedded
within the Inline XBRL document | |
| 
101.SCH | 
| 
Inline
XBRL Taxonomy Extension Schema Document | |
| 
101.CAL | 
| 
Inline
XBRL Taxonomy Extension Calculation Linkbase Document | |
| 
101.DEF | 
| 
Inline
XBRL Taxonomy Extension Definition Linkbase Document | |
| 
101.LAB | 
| 
Inline
XBRL Taxonomy Extension Label Linkbase Document | |
| 
101.PRE | 
| 
Inline
XBRL Taxonomy Extension Presentation Linkbase Document | |
| 
104 | 
| 
Cover
Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101) | |
+
Denotes a management contract or compensatory plan or arrangement.
*
Filed or furnished herewith
Certain of the exhibits and schedules to this Exhibit have been omitted in accordance with Regulation S-K Item 601(a)(5). The Registrant
agrees to furnish a copy of all omitted exhibits and schedules to the SEC upon its request.
**Item
16. Form 10-K Summary**
None.
| 62 | |
**INDEX
TO CONSOLIDATED FINANCIAL STATEMENTS**
****
**Contents**
| 
Report of Independent Registered Public Accounting Firm (PCAOB ID:199) | 
F-2 | |
| 
Report of Independent Registered Public Accounting Firm (PCAOB ID: 1375) | 
F-3 | |
| 
Consolidated
Balance Sheets as of December 31, 2025 and 2024 | 
F-4 | |
| 
Consolidated
Statements of Operations for the Years Ended December 31, 2025 and 2024 | 
F-5 | |
| 
Consolidated
Statements of Changes in Stockholders Equity for the Years Ended December 31, 2025 and 2024 | 
F-6 | |
| 
Consolidated
Statements of Cash Flows for the Years Ended December 31, 2025 and 2024 | 
F-7 | |
| 
Notes
to Consolidated Financial Statements | 
F-8 | |
| F-1 | |
**REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM**
**To the Stockholders and Board of Directors of Glucotrack, Inc.**
**Opinion on the Financial Statements**
We have audited the accompanying consolidated
balance sheet of Glucotrack, Inc. (the Company) as of December 31, 2025, the related consolidated statements of operations
and comprehensive loss, stockholders (deficit) equity and cash flows for the year ended December 31, 2025, and the related notes
(collectively referred to as the financial statements). In our opinion, the financial statements present fairly, in all
material respects, the financial position of the Company as of December 31, 2025, and the results of its operations and its cash flows
for the year ended December 31, 2025, in conformity with accounting principles generally accepted in the United States of America.
**Explanatory Paragraph Going Concern**
The accompanying consolidated financial statements
have been prepared assuming that the Company will continue as a going concern. As more fully described in Note 1, the Company has a significant
working capital deficiency, has incurred significant losses and needs to raise additional funds to meet its obligations and sustain its
operations. These conditions raise substantial doubt about the Companys ability to continue as a going concern. Managements plans in
regard to these matters are also described in Note 1. The consolidated financial statements do not include any adjustments that might
result from the outcome of this uncertainty.
**Basis for Opinion**
These financial statements are the responsibility
of the Companys management. Our responsibility is to express an opinion on the Companys financial statements based on our audit. We
are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are
required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and
regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the
standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged
to perform, an audit of its internal control over financial reporting. As part of our audit we are required to obtain an understanding
of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Companys internal
control over financial reporting. Accordingly, we express no such opinion.
Our audit included performing procedures to assess
the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond
to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.
Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating
the overall presentation of the financial statements. We believe that our audit provides a reasonable basis for our opinion.
**Critical Audit Matters**
Critical audit matters are matters arising from
the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and
that: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging,
subjective, or complex judgments. We determined that there are no critical audit matters.
/s/ CBIZ CPAs P.C.
CBIZ CPAs P.C.
We have served as the Companys auditor
since 2025.
Costa Mesa, California
March 30, 2026
| F-2 | |
**REPORT OF INDEPENDENT REGISTERED PUBLIC
ACCOUNTING FIRM**
**Board of Directors and the Stockholders of
GLUCOTRACK, INC.**
**Opinion on the financial statements**
We
have audited, before the effects of the adjustments to retrospectively apply the Reverse stock split described in Note 1, the consolidated
balance sheet of Glucotrack Inc., a Delaware corporation (the Company) as of December 31, 2024, the related consolidated
statements of operations and comprehensive loss, changes in stockholders equity and cash flows for the year ended December 31,
2024 (the 2024 consolidated financial statements before the effects of the adjustments discussed in Note 1 are not presented herein),
and the related notes (collectively referred to as the consolidated financial statements). In our opinion, the consolidated
financial statements, which are before the effects of the adjustments to retrospectively apply the Reverse stock split described in Note
1, present fairly, in all material respects, the financial position of the Company as of December 31, 2024, and the results of its operations
and its cash flows for the year ended December 31, 2024, in conformity with accounting principles generally accepted in the United States
of America.
We
were not engaged to audit, review, or apply any procedures to the adjustments to retrospectively apply the Reverse stock split described
in Note 1, and accordingly, we do not express an opinion or any other form of assurance about whether such adjustments are appropriate
and have been properly applied. Those adjustments were audited by CBIZ CPAs P.C.
**Going Concern**
The accompanying consolidated financial statements
have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1B to the consolidated financial statements,
the Company has incurred operating losses and negative cash flows from its operations and comprehensive loss since its inception and as
of December 31, 2024, there is an accumulated deficit of $132,450. These conditions, along with other matters as set forth in Note 1B,
raise substantial doubt about the Companys ability to continue as a going concern. Managements plans regarding these matters
are also described in Note 1B. The consolidated financial statements do not include any adjustments that might result from the outcome
of this uncertainty.
**Basis for opinion**
These
consolidated financial statements are the responsibility of the Companys management. Our responsibility is to express an opinion
on the Companys consolidated financial statements based on our audit. We are a public accounting firm registered with the Public
Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company
in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission
and the PCAOB.
We
conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company
is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audit,
we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion
on the effectiveness of the Companys internal control over financial reporting. Accordingly, we express no such opinion.
Our
audit included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due
to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence
regarding the amounts and disclosures in the consolidated financial statements. Our audit also included evaluating the accounting principles
used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements.
We believe that our audit provides a reasonable basis for our opinion.
| 
/s/ FAHN KANNE & CO. GRANT THORNTON ISRAEL | |
| 
| |
| 
Certified Public Accountants (Isr.) | |
| 
We served as the Companys auditor from 2010 to 2025. | |
| 
| 
| |
| 
Tel-Aviv, Israel | 
| |
| 
March 31, 2025 | 
| |
| F-3 | |
**GLUCOTRACK
INC.**
**CONSOLIDATED
BALANCE SHEETS**
| 
| | 
December
31, 2025 | | | 
December
31, 2024 | | |
| 
| | 
In
thousands of US dollars (except
stock data) | | |
| 
| | 
December
31, 2025 | | | 
December
31, 2024 | | |
| 
| | 
| | | 
| | |
| 
Current Assets | | 
| | | | 
| | | |
| 
Cash and cash
equivalents | | 
$ | 7,383 | | $ | 5,617 | | |
| 
Other
current assets | | 
| 284 | | | 
| 151 | | |
| 
Total
current assets | | 
| 7,667 | | | 
| 5,768 | | |
| 
| | 
| | | | 
| | | |
| 
Operating lease right-of-use asset, net | | 
| 33 | | | 
| 59 | | |
| 
Property and equipment, net | | 
| 138 | | | 
| 95 | | |
| 
Restricted cash | | 
| - | | | 
| 10 | | |
| 
TOTAL
ASSETS | | 
$ | 7,838 | | | 
$ | 5,932 | | |
| 
| | 
| | | | 
| | | |
| 
LIABILITIES AND STOCKHOLDERS
(DEFICIT) EQUITY | | 
| | | | 
| | | |
| 
Current Liabilities | | 
| | | | 
| | | |
| 
Accounts payable | | 
$ | 1,317 | | | 
$ | 992 | | |
| 
Operating lease liability,
current | | 
| 28 | | | 
| 26 | | |
| 
Promissory notes | | 
| 3,182 | | | 
| - | | |
| 
Convertible promissory
notes | | 
| - | | | 
| 5 | | |
| 
Other
current liabilities | | 
| 246 | | | 
| 252 | | |
| 
Total current liabilities | | 
| 4,773 | | | 
| 1,275 | | |
| 
| | 
| | | | 
| | | |
| 
Non-Current Liabilities | | 
| | | | 
| | | |
| 
Derivative financial liabilities | | 
| 1 | | | 
| 17,421 | | |
| 
Operating lease liability,
non-current | | 
| 5 | | | 
| 33 | | |
| 
Loans
from stockholders | | 
| 231 | | | 
| 203 | | |
| 
Total liabilities | | 
| 5,010 | | | 
| 18,932 | | |
| 
| | 
| | | | 
| | | |
| 
Commitments and contingent liabilities (Note
5) | | 
| - | | | 
| - | | |
| 
| | 
| | | | 
| | | |
| 
Stockholders (Deficit) Equity | | 
| | | | 
| | | |
| 
Common Stock of $0.001 par value (Common
Stock): | | 
| | | | 
| | | |
| 
250,000,000
shares authorized as of December 31, 2025 and 100,000,000 shares authorized as of December 31, 2024; 910,688
and 13,409
shares issued and outstanding as of December 31, 2025 and 2024, respectively | | 
| 1 | | | 
| 1 | | |
| 
Common Stock of $0.001 par value (Common
Stock): 100,000,000 shares authorized as of December
31, 2025 and 2024; 910,688 and 13,409 shares issued and outstanding as of December 31, 2025 and 2024, respectively | | 
| 1 | | | 
| 1 | | |
| 
Additional paid-in capital | | 
| 151,080 | | | 
| 119,229 | | |
| 
Receipts on account of shares | | 
| 3,544 | | | 
| 228 | | |
| 
Accumulated other comprehensive
income | | 
| 41 | | | 
| (8 | ) | |
| 
Accumulated
deficit | | 
| (151,838 | ) | | 
| (132,450 | ) | |
| 
Total
stockholders (deficit) equity | | 
| 2,828 | | | 
| (13,000 | ) | |
| 
| | 
| | | | 
| | | |
| 
TOTAL LIABILITIES AND
STOCKHOLDERS (DEFICIT) EQUITY | | 
$ | 7,838 | | | 
$ | 5,932 | | |
The
accompanying notes are an integral part of these consolidated financial statements.
| F-4 | |
**GLUCOTRACK
INC.**
**CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS**
| 
| | 
2025 | | | 
2024 | | |
| 
| | 
In
thousands of US dollars (except
stock and per stock amounts) | | |
| 
| | 
2025 | | | 
2024 | | |
| 
Operating expenses: | | 
| | | | 
| | | |
| 
Research and development expenses | | 
$ | 9,813 | | | 
$ | 9,499 | | |
| 
General and administrative
expenses | | 
| 6,277 | | | 
| 5,048 | | |
| 
Total operating expenses | | 
| 16,090 | | | 
| 14,547 | | |
| 
Loss from operations | | 
| 16,090 | | | 
| 14,547 | | |
| 
Other income (expense): | | 
| | | | 
| | | |
| 
Other (income) expense | | 
| (26 | ) | | 
| (14 | ) | |
| 
Change in fair value of derivative liability | | 
| 3,267 | | | 
| 798 | | |
| 
Loss on equity
issuance | | 
| - | | | 
| 1,925 | | |
| 
Loss on settlement of liabilities | | 
| - | | | 
| 4,758 | | |
| 
Finance expense,
net | | 
| 57 | | | 
| 583 | | |
| 
Total other income | | 
| 3,298 | | | 
| 8,050 | | |
| 
Net loss | | 
| 19,388 | | | 
| 22,597 | | |
| 
Other comprehensive loss: | | 
| | | | 
| | | |
| 
Foreign currency translation
adjustment | | 
| (49 | ) | | 
| (24 | ) | |
| 
Comprehensive
loss | | 
$ | 19,339 | | | 
$ | 22,573 | | |
| 
Basic and diluted loss per share | | 
$ | 31.22 | | | 
$ | 4,106 | | |
| 
Weighted average number of Common Stock outstanding
used in computing basic and diluted net loss per share | | 
| 621,094 | | | 
| 5,503 | | |
The
accompanying notes are an integral part of the consolidated financial statements.
| F-5 | |
**GLUCOTRACK
INC.**
**CONSOLIDATED
STATEMENTS OF CHANGES IN STOCKHOLDERS (DEFICIT) EQUITY**
| 
| | 
Numbers
of Shares | | | 
Amount | | | 
Paid-in
Capital | | | 
account
of
shares | | | 
Comprehensive
Income | | | 
Accumulated
Deficit | | | 
(Deficit)
Equity | | |
| 
| | 
In
thousands of US Dollars (except share data) | | |
| 
| | 
Common
Stock | | | 
Additional | | | 
Receipts
on | | | 
Accumulated
Other | | | 
| | | 
Total
Stockholders | | |
| 
| | 
Numbers
of Shares | | | 
Amount | | | 
Paid-in
Capital | | | 
account
of
shares | | | 
Comprehensive
Income | | | 
Accumulated
Deficit | | | 
(Deficit)
Equity | | |
| 
Balance
as of December 31, 2023 | | 
| 3,693 | | | 
$ | - | | | 
$ | 112,986 | | | 
$ | 48 | | | 
$ | 16 | | | 
$ | (109,853 | ) | | 
$ | 3,197 | | |
| 
| | 
| | | | 
| | | | 
| | | | 
| | | | 
| | | | 
| | | | 
| | | |
| 
Loss for the year | | 
| - | | | 
| - | | | 
| - | | | 
| - | | | 
| - | | | 
| (22,597 | ) | | 
| (22,597 | ) | |
| 
Other comprehensive loss | | 
| - | | | 
| - | | | 
| - | | | 
| - | | | 
| (24 | ) | | 
| - | | | 
| (24 | ) | |
| 
Stock-based compensation | | 
| - | | | 
| - | | | 
| 173 | | | 
| - | | | 
| - | | | 
| - | | | 
| 173 | | |
| 
Issuance of restricted shares as compensation
to directors | | 
| 73 | | | 
| -(*) | | | 
| 126 | | | 
| (48 | ) | | 
| - | | | 
| - | | | 
| 78 | | |
| 
Restricted shares to be issued as compensation
towards directors | | 
| - | | | 
| - | | | 
| - | | | 
| 228 | | | 
| - | | | 
| - | | | 
| 228 | | |
| 
Issuance of restricted shares as payment for
achievement of milestone pursuant to purchase agreement (Note 5B) | | 
| 42 | | | 
| -(*) | | | 
| 192 | | | 
| - | | | 
| - | | | 
| - | | | 
| 192 | | |
| 
Issuance of Common Stock upon private placement
transaction (Note 4C) | | 
| 67 | | | 
| -(*) | | | 
| 500 | | | 
| - | | | 
| - | | | 
| - | | | 
| 500 | | |
| 
Exercise of prefunded warrants into shares | | 
| 330 | | | 
| -(*) | | | 
| - | | | 
| - | | | 
| - | | | 
| - | | | 
| - | | |
| 
Issuance of Ordinary Shares upon completion
of public offering, net of offering expenses | | 
| 2,032 | | | 
| -(*) | | | 
| - | | | 
| - | | | 
| - | | | 
| - | | | 
| - | | |
| 
Issuance of detachable warrants through private
placement transactions | | 
| 3,965 | | | 
| -(*) | | | 
| - | | | 
| - | | | 
| - | | | 
| - | | | 
| - | | |
| 
Exchange of warrants into shares | | 
| 599 | | | 
| -(*) | | | 
| | | | 
| - | | | 
| - | | | 
| - | | | 
| - | | |
| 
Issuance of shares and warrants as settlement
of financial liabilities | | 
| 2,608 | | | 
| -(*) | | | 
| 2,618 | | | 
| - | | | 
| - | | | 
| - | | | 
| 2,618 | | |
| 
Issuance of detachable
warrants through private placement transactions | | 
| - | | | 
| - | | | 
| 2,635 | | | 
| - | | | 
| - | | | 
| - | | | 
| 2,635 | | |
| 
Balance as of December
31, 2024 | | 
| 13,409 | | | 
$ | -(*) | | | 
$ | 119,230 | | | 
$ | 228 | | | 
$ | (8 | ) | | 
$ | (132,450 | ) | | 
$ | (13,000 | ) | |
| 
| | 
| | | | 
| | | | 
| | | | 
| | | | 
| | | | 
| | | | 
| | | |
| 
Loss for year | | 
| - | | | 
| - | | | 
| - | | | 
| - | | | 
| - | | | 
| (19,388 | ) | | 
| (19,388 | ) | |
| 
Loss for the year | | 
| - | | | 
| - | | | 
| - | | | 
| - | | | 
| - | | | 
| (19,388 | ) | | 
| (19,388 | ) | |
| 
Other comprehensive income | | 
| - | | | 
| - | | | 
| - | | | 
| - | | | 
| 49 | | | 
| - | | | 
| 49 | | |
| 
Stock-based compensation | | 
| - | | | 
| - | | | 
| 211 | | | 
| - | | | 
| - | | | 
| - | | | 
| 211 | | |
| 
Issuance of common stock upon the completion
of public offerings, net of offering expenses of $539 | | 
| 665,052 | | | 
| 1 | | | 
| 10,664 | | | 
| - | | | 
| - | | | 
| - | | | 
| 10,665 | | |
| 
Stock split adjustment | | 
| 58,886 | | | 
| - | | | 
| - | | | 
| - | | | 
| - | | | 
| - | | | 
| - | | |
| 
Cashless exchange of warrants into common shares | | 
| 162,063 | | | 
| -(*) | | | 
| 20,625 | | | 
| | | | 
| - | | | 
| - | | | 
| 20,625 | | |
| 
Private placement December 2025 | | 
| - | | | 
| - | | | 
| - | | | 
| 3,544 | | | 
| - | | | 
| - | | | 
| 3,544 | | |
| 
Issuance of restricted shares as compensation
to directors | | 
| 11,236 | | | 
| -(*) | | | 
| 350 | | | 
| (228 | ) | | 
| - | | | 
| - | | | 
| 122 | | |
| 
Issuance of restricted
shares as payment for achievement of milestones | | 
| 42 | | | 
| -(*) | | | 
| - | | | 
| - | | | 
| - | | | 
| - | | | 
| - | | |
| 
Balance as of December
31, 2025 | | 
| 910,688 | | | 
$ | 1 | | | 
$ | 151,080 | | | 
$ | 3,544 | | | 
$ | 41 | | | 
$ | (151,838 | ) | | 
$ | 2,828 | | |
| 
| 
(*) | 
Less
than 1. | |
The
accompanying notes are an integral part of the consolidated financial statements.
| F-6 | |
**GLUCOTRACK
INC.**
**CONSOLIDATED
STATEMENTS OF CASH FLOWS**
| 
| | 
2025 | | | 
2024 | | |
| 
Cash flows from operating
activities: | | 
| | | | 
| | | |
| 
Loss for the
year | | 
$ | (19,388 | ) | | 
$ | (22,597 | ) | |
| 
| | 
| | | | 
| | | |
| 
Adjustments to reconcile
loss for the year to net cash used in operating activities: | | 
| | | | 
| | | |
| 
Depreciation | | 
| 42 | | | 
| 36 | | |
| 
Loss on fixed asset disposal | | 
| 16 | | | 
| - | | |
| 
Equity issuance costs | | 
| - | | | 
| 1,217 | | |
| 
Stock-based compensation | | 
| 211 | | | 
| 173 | | |
| 
Issuance of restricted
shares as compensation to directors | | 
| 122 | | | 
| 306 | | |
| 
Amortization of original
issue discount related to promissory note | | 
| 182 | | | 
| - | | |
| 
Shares issued to CEO for
achieving of IP Agreement milestones | | 
| - | | | 
| 192 | | |
| 
Loss on settlement
of liabilities | | 
| - | | | 
| 4,758 | | |
| 
Loss on equity issuance | | 
| - | | | 
| 1,925 | | |
| 
Change in fair value of
derivative liability | | 
| 3,267 | | | 
| 798 | | |
| 
Loss on Series A warrant
repurchase | | 
| 99 | | | 
| - | | |
| 
Discount amortization and
interest expenses related to promissory notes | | 
| - | | | 
| 628 | | |
| 
Linkage difference on principal
of loans from stockholders | | 
| - | | | 
| 7 | | |
| 
Changes
in assets and liabilities: | | 
| | | | 
| | | |
| 
Decrease (increase) in
other current assets | | 
| (133 | ) | | 
| 225 | | |
| 
Increase in accounts payable | | 
| 325 | | | 
| 263 | | |
| 
Increase
(decrease) in other current liabilities | | 
| 17 | | | 
| (421 | ) | |
| 
Net cash used in operating
activities | | 
| (15,240 | ) | | 
| (12,490 | ) | |
| 
| | 
| | | | 
| | | |
| 
Cash flows from investment
activities: | | 
| | | | 
| | | |
| 
Purchase
of property and equipment | | 
| (96 | ) | | 
| (104 | ) | |
| 
Net cash used in investment
activities | | 
| (96 | ) | | 
| (104 | ) | |
| 
| | 
| | | | 
| | | |
| 
Cash flows from financing
activities | | 
| | | | 
| | | |
| 
Net proceeds received from
underwritten U.S. public offering | | 
| 10,665 | | | 
| 8,783 | | |
| 
Proceeds from promissory
note, net of original issue discount of $600 | | 
| 3,000 | | | 
| - | | |
| 
Series A warrant repurchase | | 
| (166 | ) | | 
| - | | |
| 
Net proceeds from December
2025 private placement transaction | | 
| 3,544 | | | 
| | | |
| 
Issuance of promissory
notes and detachable warrants through private placement Transaction | | 
| - | | | 
| 100 | | |
| 
Issuance of convertible
promissory notes - related parties | | 
| - | | | 
| 4,000 | | |
| 
Issuance of convertible
promissory notes and bifurcated conversion feature through private placement transaction | | 
| - | | | 
| 360 | | |
| 
Net
proceeds received from underwritten U.S. public offering | | 
| - | | | 
| 500 | | |
| 
Net cash provided by financing
activities | | 
| 17,043 | | | 
| 13,743 | | |
| 
| | 
| | | | 
| | | |
| 
Effect of exchange rate
changes on cash and cash equivalents | | 
| 49 | | | 
| (24 | ) | |
| 
| | 
| | | | 
| | | |
| 
Change in cash, cash equivalents, and restricted
cash | | 
| 1,756 | | | 
| 1,125 | | |
| 
Cash, cash equivalents,
and restricted cash at beginning of the year | | 
| 5,627 | | | 
| 4,502 | | |
| 
Cash, cash equivalents,
and restricted cash at end of the year | | 
$ | 7,383 | | | 
$ | 5,627 | | |
| 
| | 
| | | | 
| | | |
| 
Supplemental
disclosure of cash flow activities: | | 
| | | | 
| | | |
| 
| | 
| | | | 
| | | |
| 
(a) Net cash (received) paid during the year
for: | | 
| | | | 
| | | |
| 
| | 
| | | | 
| | | |
| 
Interest | | 
$ | (52 | ) | | 
$ | (62 | ) | |
| 
| | 
| | | | 
| | | |
| 
(b) Non-cash investment and financing activities: | | 
| | | | 
| | | |
| 
| | 
| | | | 
| | | |
| 
Fair value of equity classified warrants issued in connection with December 2025 private placement | | 
$ | 8,090 | | | 
$ | - | | |
| 
Recognition of right
for use asset against a lease liability | | 
$ | - | | | 
$ | 79 | | |
| 
Settlement of liabilities
with equity | | 
$ | - | | | 
$ | 1,743 | | |
| 
Derivative liability | | 
$ | - | | | 
$ | 35 | | |
| 
Conversion of debt into
equity | | 
$ | - | | | 
$ | 2,284 | | |
The
accompanying notes are an integral part of the consolidated financial statements.
| F-7 | |
**GLUCOTRACK
INC.**
**NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS**
**1.
Organization and Business**
*The
Company*
**
The
Company was incorporated on May 18, 2010 under the laws of the State of Delaware. We are a medical device company focused on the development
of an implantable continuous blood glucose monitor (CBGM) for persons with Type 1 diabetes and Type 2 diabetes using insulin
or at risk for hypoglycemia (the Glucotrack CBGM).
The
Company was founded with a mission to develop Glucotrack, a non-invasive glucose monitoring device designed to help people with
diabetes and pre-diabetics obtain glucose level readings without the pain, inconvenience, cost and difficulty of conventional (invasive)
spot finger stick devices. The first generation Glucotrack, which successfully received CE Mark approval, obtained glucose measurements
via a small sensor clipped onto ones earlobe. A limited release beta test in Europe and the Middle East demonstrated the need
for an updated product with improved accuracy and human factors. As the glucose monitoring landscape has since rapidly moved away from
point-in-time measurement to continuous measurement, the Company determined in 2023 that it would focus its efforts on developing the
Glucotrack CBGM. As such, the Company withdrew the CE Mark for Glucotrack and are no longer pursuing commercialization of this product
or development of any further iterations.
The
Company is currently developing the Glucotrack CBGM for use by Type 1 diabetes patients as well as Type 2 diabetes using insulin or at
risk for hypoglycemia. Implant longevity is key to the success of such a device. The Company has continued to evolve its sensor chemistry
following the successful in-vitro feasibility study demonstrating that a minimum two-year implant life is highly probable with the current
sensor design. Subsequently the Company announced that a 3-year longevity is feasible leveraging both in-vitro and in-silico test results.
The Company has also completed multiple animal studies with initial prototype systems which demonstrated a simple implant procedure with
good safety and functionality. The results of both were presented in poster form at the 2024 American Diabetes Association annual conference.
The Company believes its technology, if successful, has the potential to be more accurate, more convenient and have a longer duration
than other implantable glucose monitors that are either in the market or currently under development.
****
Further
to the above progress on the Glucotrack CBGM, the Company has also successfully demonstrated continuous glucose sensing in the epidural
space. This latter approach is of importance for patients with diabetes already contemplating spinal cord stimulation therapy for their
condition. The Company believes this approach may enable integrated chronic disease management with one system that provides dual benefits
of pain relief and glucose monitoring.
The
Company completed a first in human study in 2025. This study was an acute study intended to demonstrate device performance and safety,
as well as safety of the implant and removal procedures. The study used the planned commercial version of the implantable sensor connected
to an externalized prototype electronics device. Patients were monitored in hospital for 4 days. Results of the study were positive,
meeting the endpoints of no serious safety events while demonstrating similar performance and accuracy as observed in longer-term animal
studies. Initial results were presented in poster form at the 2025 Advanced Technologies & Treatments for Diabetes annual meeting
and final results were presented in poster form at the 2025 American Diabetes Association annual conference.
| F-8 | |
The
Company initiated a long-term, multicenter feasibility study in Australia to evaluate the CBGM product performance and safety. The
first phase of the clinical study provided early product learnings about how the complexity of certain health conditions may impact
study eligibility as well as identified certain product improvements. Following a reassessment of the study in light of planned
product updates and anticipated protocol modifications,the Company determined that continuation of the study in its current
form was no longer practical and elected to close the study.
Consequently, the Company is expediting discussions with the U.S. Food
and Drug Administration (FDA) regarding our planned United States (U.S.) clinical trial program that we expect to launch
in the 2nd half of 2026, subject to FDA approval of our Investigational Device Exemption (IDE) submission expected
to be filed in the second quarter of 2026.
The
Company initially obtained ISO13485 certification in 2024 and successfully passed the 2025 annual audit, both efforts without any
major nonconformities. ISO 13485 is an internationally agreed-upon standard of quality system requirements for the design, production,
distribution, and sale of medical devices. Certification of compliance to the standard is recognized and accepted by the FDA, the European
Medicines Agency (EMA), and many other regulatory authorities worldwide.
*Liquidity
and Going Concern*
**
To
date, the Company has not yet commercialized the Glucotrack CBGM. Further development and commercialization efforts are expected to require
substantial additional expenditure. Therefore, the Company is dependent upon external sources for financing its operations. As of December
31, 2025, the Company has incurred an accumulated deficit of $151,838. In addition, the Company has generated operating losses and negative
cash flow from operations since inception. As of December 31, 2025, the balance of cash and cash equivalents amounted to $7,383.
During the year ended December 31, 2025, the Company raised $14,209 through the sale of shares of Common Stock, par value $0.001 per
share and $3,000 from the issuance of a promissory note. The Company plans to finance its operations through the sale of equity securities
(and/or debt securities). There can be no assurance that the Company will succeed in obtaining the necessary financing or generating
sufficient revenue from sale of its Glucotrack CBGM in order to continue its operations as a going concern.
Management
has considered the significance of such conditions in relation to the Companys ability to meet its current obligations and to
achieve its business targets and determined that these conditions raise substantial doubt about the Companys ability to continue
as a going concern.
The
consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
*2025
Reverse Stock Splits and Increase in Authorized Common Stock*
**
February
2025 1-for-20 Reverse Stock Split
The
Company filed with the Delaware Secretary of State a Certificate of Amendment to its Certificate of Incorporation which became effective
at 4:30 p.m. on February 3, 2025, to implement a reverse stock split at a ratio of 1-for-20 (the February 2025 Reverse Stock Split)
of the shares of its Common Stock. The February 2025 Reverse Stock Split was approved by the Companys stockholders at the special
meeting of stockholders held on January 3, 2025 (the Special Meeting).
On
February 3, 2025, the Company filed an amendment to the Companys Certificate of Incorporation to increase the Companys
authorized shares of Common Stock from 100,000,000
to 250,000,000.
On January 3, 2025, the stockholders approved at the Special Meeting the increase in the Companys authorized shares of
Common Stock from 100,000,000
to 250,000,000,
as well as the full issuance of shares of Common Stock issuable by the Company upon the exercise of Series A Warrants (defined
below) and the cashless exchange of Series B Warrants (defined below). See Note 3B.
| F-9 | |
June
2025 1-for-60 Reverse Stock Split
The
Company filed with the Delaware Secretary of State a Certificate of Amendment to its Certificate of Incorporation which became effective
at 4:30 p.m. on June 13, 2025, to implement a reverse stock split at a ratio of 1-for-60 (the June 2025 Reverse Stock Split)
of the shares of its Common Stock. The June 2025 Reverse Stock Split was approved by the Companys stockholders at the 2025 annual
meeting of the stockholders on May 22, 2025.
All
shares, options and warrants to purchase shares of Common Stock and loss per share amounts have been adjusted to give retroactive effect
to the February and June 2025 reverse share splits, (the Reverse Stock Splits) for all periods presented in these annual
consolidated financial statements. Any fractional shares resulting from the Reverse Stock Splits were rounded up to the nearest whole
share.
*Reclassifications*
**
Certain reclassifications have been made to the 2024
financial statements to conform to the 2025 presentation. Specifically, prior-year marketing expenses, as presented in the Consolidated
Statements of Operations and Comprehensive Loss, have been reclassified and combined within general and administrative expenses in the
current-year presentation. This reclassification had no effect on net earnings.
**2.
Summary of Significant Accounting Policies**
*Basis
of Presentation*
**
The
accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States
of America (GAAP).
*Use
of Estimates*
**
The
preparation of the consolidated financial statements in conformity with US GAAP requires management to make estimates and assumptions
that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the dates of the
financial statements, and the reported amounts of expenses during the reported periods. Actual results could differ from those estimates.
As applicable to these financial statements, the most significant estimates and assumptions relate to evaluation of going concern, the
classification of financial instruments as equity or liability, share based compensation and the determination of the fair value of derivative
liabilities.
*Functional
Currency*
**
The
functional currency of the Company is the US dollar, which is the currency of the primary economic environment in which it operates.
In accordance with ASC 830, Foreign Currency Matters (ASC 830), balances denominated in or linked to foreign currency are
stated on the basis of the exchange rates prevailing at the applicable balance sheet date. For foreign currency transactions included
in the statement of operations, the exchange rates applicable on the relevant transaction dates are used. Gains or losses arising from
changes in the exchange rates used in the translation of such transactions are carried as financing income or expenses. The functional
currency of the Israeli subsidiary is the New Israeli Shekel (NIS) and its financial statements are included in consolidation,
based on translation into US dollars. Accordingly, assets and liabilities were translated from NIS to US dollars using year-end exchange
rates, and expense items were translated at average exchange rates during the year. Gains or losses resulting from translation adjustments
are reflected in stockholders equity, under Accumulated other comprehensive income.
*Principles
of Consolidation*
**
The
consolidated financial statements include the accounts of the Company and its subsidiary. All intercompany balances and transactions
have been eliminated in consolidation.
| F-10 | |
*Cash
and Cash Equivalents and Restricted Cash*
**
The
Company considers all short-term investments, which are highly liquid investments with original maturities of three months or less at
the date of purchase, to be cash equivalents. As of December 31, 2025, the Company holds no restricted cash.
*Property
and Equipment, Net*
**
Property
and equipment are stated at cost, net of accumulated depreciation. Depreciation is calculated using the straight-line method over the
estimated useful lives of the assets. When an asset is retired or otherwise disposed of, the related carrying value and accumulated depreciation
are removed from the respective accounts and the net difference less any amount realized from disposition is reflected in the statements
of operations and comprehensive loss.
*Impairment
of Long-Lived Assets*
The
Companys long-lived assets are reviewed for impairment in accordance with ASC 360, Property, Plant and Equipment,
whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets
to be held and used is measured by a comparison of the carrying amount of an asset to the future undiscounted cash flows expected to
be generated by the asset. If such asset is considered to be impaired, the impairment to be recognized is measured by the amount by which
the carrying amount of the asset exceeds its fair value. To date, the Company did not incur any material impairment losses related to
long-lived assets.
*Software development costs*
Software development costs are expensed to research
and development. Our products include embedded software which is essential to the products functionality. Costs including charges
for consulting services and costs for Company personnel associated with programming, coding, and testing such software are expensed as
incurred.
*Convertible
Promissory Notes*
**
Upon
issuance of convertible promissory notes and similar instruments, the Company evaluates the embedded conversion features under ASC 470 and ASC 815
to determine whether they must be bifurcated from the host debt instrument.
If
the embedded conversion feature does not qualify for equity classification, it is bifurcated and recorded as a separate derivative liability
at fair value upon initial recognition and remeasured at fair value in subsequent periods. The remaining proceeds are allocated to the
host debt instrument, and any resulting discount is amortized to interest expense using the effective interest method over the term of
the note.
If
the embedded conversion feature qualifies for equity classification, it is not bifurcated. The Company then assesses whether the instrument
was issued at a significant premium. If a substantial premium exists, it is recorded in additional paid-in capital. Otherwise, no separate
accounting is required, and the note is accounted for at amortized cost using the effective interest method through maturity.
*Allocation
of Proceeds and Related Issuance Costs*
**
When
multiple instruments are issued in a single transaction (package issuance), the total gross proceeds from the transaction are allocated
among the individual freestanding instruments identified. The allocation occurs after identifying all freestanding instruments and the
subsequent measurement basis for those instruments.
Financial
instruments that are required to be subsequently measured at fair value (such as derivative liabilities) are measured at fair value and
the remaining consideration is allocated to other financial instruments that are not required to be subsequently measured at fair value
(such as liabilities measured at amortized cost, common shares and warrants eligible for equity classification), based on the relative
fair value basis for such instruments.
Issuance
costs allocated to financial instruments that are required to be subsequently measured at fair value are immediately expensed. Issuance
costs allocated to shares and warrants classified as equity components and are recorded as a reduction of additional paid-in capital.
Issuance costs allocated to financial liabilities measured at amortized cost are recorded as a discount and accreted over the contractual
term of the financial instrument using the effective interest method.
| F-11 | |
*Warrants*
**
Equity
classified warrants
Certain
warrants that were determined to be freestanding financial instruments that are legally detachable and separately exercisable, do
not embody an obligation for the Company to repurchase its own shares, and permit the holders to receive a fixed number of shares of
Common Stock upon exercise for a fixed exercise price and thus, are considered as indexed to the Companys own shares, were
classified as equity instruments. As such warrants were issued together with financial instruments that are not subsequently
measured at fair value, the warrants were measured based on allocation of the proceeds received by the Company in accordance with
the relative fair value basis. Direct issuance expenses that were allocated to such warrants were deducted from additional paid-in
capital.
Warrants
classified as derivative liabilities
Upon
initial recognition of Series A Warrants (the Series A Warrants) and Series B Warrants (the Series B Warrants)
that were issued in November 2024 as part of an equity issuance and debt conversions, management considered the provisions of ASC 815-40,
Derivatives and Hedging Contracts in Entitys Own Equity and determined that the settlement amount of Series A Warrants
and Series B Warrants might not be based on an exchange of a fixed number of shares for a fixed amount of consideration and thus such
warrants are not eligible to be considered as indexed to the Companys own shares. Accordingly, the Series A Warrants and Series
B Warrants were accounted for as warrant derivative liability at fair value and the changes in fair values are carried to profit or loss.
In accordance with ASC 210-10-20, the warrant derivative liability is presented as a noncurrent liability since its settlement will require
the issuance of shares and not the use of any resources that are properly classified as current assets.
*Fair
Value of Financial Instruments*
**
ASC
Topic 825-10, Financial Instruments defines financial instruments and requires disclosure of the fair value of financial
instruments held by the Company. The Company considers the carrying amount of cash and cash equivalents, restricted cash, accounts receivable,
other current assets, accounts payable and other current liabilities balances, to approximate their fair values due to the short-term
maturities of such financial instruments. In measuring fair value, the Company applies the fair value hierarchy established by ASC 820, Fair Value Measurement, which
prioritizes the inputs used in valuation techniques as follows:
| 
| Level
1 Quoted prices (unadjusted) in active markets that are accessible at the measurement
date for assets or liabilities. The fair value hierarchy gives the highest priority to Level
1 inputs. | |
| 
| | | |
| 
| Level
2 Observable prices that are based on inputs not quoted on active markets but corroborated
by market data. | |
| 
| | | |
| 
| Level
3 Unobservable inputs are used when little or no market data is available. Level
3 inputs are considered as the lowest priority under the fair value hierarchy. | |
The
Company did not estimate the fair value of the loans received from stockholders since their repayment schedule has not yet been determined.
The
Company used Level 3 inputs for the valuation methodology of the derivative liabilities. The derivative liabilities are adjusted to reflect
estimated fair value at each period end, with any decrease or increase in the estimated fair value being recorded in other income or
expense accordingly.
| F-12 | |
The
following table provides a reconciliation of the beginning and ending balances of the Series A Warrants and Series B Warrants classified
as derivative liabilities for the fiscal year ended December 31, 2025 and 2024, respectively.
**Fair
Value of Significant Unobservable Inputs (Level 3)**
Schedule of Derivative Liabilities Measured At Fair Value
| 
| | 
Warrant | | |
| 
| | 
Liability | | |
| 
Balance November 14, 2024 Warrant issuance date | | 
$ | 16,626 | | |
| 
Fair value adjustments Derivative financial liability | | 
| 795 | | |
| 
Balance December 31, 2024 | | 
| 17,421 | | |
| 
Fair value adjustments Derivative financial
liability | | 
| 3,267 | | |
| 
Cashless exchange of warrants into Common Stock | | 
| (20,620 | ) | |
| 
Series A Warrant repurchase | | 
| (166 | ) | |
| 
Loss on Series A Warrant repurchase | | 
| 99 | | |
| 
Balance December 31, 2025 | | 
$ | 1 | | |
*Income
Tax*
**
The
Company recognizes deferred tax assets and liabilities for temporary differences between the tax basis of assets and liabilities and
the amounts at which they are carried in the financial statements based upon the enacted tax rates in effect for the year in which the
differences are expected to reverse. A valuation allowance is established to reduce deferred tax assets to the amount expected to be
realized.
As of December 31, 2025 and 2024, the Company had
no unrecognized tax benefits and no positions which, in the opinion of management, would be reversed if challenged by a taxing authority.
In the event the Company is assessed interest or penalties, such amounts will be classified as income tax expense in the financial statements.
*Research
and Development Expenses*
**
Research
and development expenses are charged to operations and comprehensive loss, as incurred.
*Royalty-Bearing
Grants*
**
Royalty-bearing
grants from the Israeli Innovation Authority (IIA) to fund approved research and development projects are recognized at the time Integrity
Israel is entitled to such grants, on the basis of the costs incurred and reduce research and development costs. To date, the cumulative
research and development grants received by Integrity Israel from IIA amounted to $93.
*Basic
and Diluted Loss Per Share*
**
Basic
net loss per share of Common Stock is computed as net loss divided by the weighted average number of common shares outstanding for the
period. The Companys diluted net loss per common share is the same as our basic net loss per common share because it incurred
a net loss during each period presented, and the potentially dilutive securities from the assumed exercise of all outstanding stock options
and warrants would have an anti-dilutive effect. As of December 31, 2025 and 2024, stock options, shares issuable upon the conversion
of warrants and shares issuable upon the conversion of pre-funded warrants of 3,248,391 and 21,568, respectively, have been excluded
from the computation of diluted shares outstanding.
Schedule of Anti Dilutive Securities
| 
| | 
2025 | | | 
2024 | | |
| 
| | 
December
31, | | |
| 
| | 
2025 | | | 
2024 | | |
| 
Common stock options | | 
| 16,499 | | | 
| 279 | | |
| 
Shares issuable upon the conversion of warrants | | 
| 2,198,301 | | | 
| 21,289 | | |
| 
Share issuable upon the
conversion of pre-funded warrants | | 
| 1,033,591 | | | 
| - | | |
| 
Total | | 
| 3,248,391 | | | 
| 21,568 | | |
*Stock-Based
Compensation*
**
The
Company measures and recognizes the compensation expense for all equity-based payments to employees based on their estimated fair values
in accordance with ASC 718. Share-based payments including grants of stock options are recognized in the consolidated statement of operations
and comprehensive loss as an operating expense based on the fair value of the award at the date of grant. The fair value of stock options
granted is estimated using the Black-Scholes option-pricing model. The Company has expensed compensation costs, net of estimated forfeitures,
over the requisite service period or over the implicit service period when a performance condition affects the vesting, and it is considered
probable that the performance condition will be achieved. Share-based payments to non-employees are accounted for in accordance with
ASC 718.
| F-13 | |
*Segment
Reporting*
**
Operating
segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation
by the chief operating decision maker, or (CODM). The Company has identified its Chief Executive Officer, Paul V. Goode,
as the CODM who is responsible for making decisions regarding resource allocation and assessing performance. The Company views its operations
and manages its business as one operating segment. The Companys long-lived assets consist primarily of property and equipment,
net, which are all held in the United States.
ASC
280, Segment Reporting establishes standards for reporting information about operating segments on a basis consistent with
the Companys internal organization structure as well as information about services categories, business segments and major customers
in financial statements. The Company has only one reportable segment, the Glucotrack CBGM Product Segment, as all their research and
development activities are related the development of the Glucotrack CBGM Product. Since the Company operates in one operating segment,
all required financial segment information can be found in the consolidated financial statements.
*Concentrations
of Credit Risk*
**
Financial
instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents, and
restricted cash. Cash and cash equivalents and restricted cash are deposited with a major bank in the United States. Management believes
that such financial institutions are financially sound, accordingly, minimal credit risk exists with respect to these financial instruments.
The Company does not have any significant off-balance-sheet concentration of credit risk, such as foreign exchange contracts, option
contracts or other foreign hedging arrangements.
*Contingencies*
**
The
Company records accruals for loss contingencies arising from claims, litigation and other sources when it is probable that a liability
has been incurred and the amount can be reasonably estimated. These accruals are adjusted periodically as assessments change or additional
information becomes available. Legal costs incurred in connection with loss contingencies are expensed as incurred.
*Recent
Accounting Pronouncements*
**
In
November 2024, the Financial Accounting Standards Board, or (FASB) issued ASU 2024-03, Income StatementReporting
Comprehensive IncomeExpense Disaggregation Disclosures to require more detailed information about specified categories
of expenses (purchases of inventory, employee compensation, depreciation, amortization, and depletion) included in certain expense captions
presented on the face of the income statement. ASU 2024-03 is effective for fiscal years beginning after December 15, 2026 and for interim
periods within fiscal years beginning after December 15, 2027. Early adoption is permitted. The amendments may be applied either (1)
prospectively to financial statements issued for reporting periods after the effective date of this ASU or (2) retrospectively to all
prior periods presented in the financial statements. The Company is currently evaluating the impact of adopting this guidance on its
financial statements and related disclosures. The adoption of this pronouncement is not expected to have a material impact on the Companys
financial statements.
In
December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures related to improvements
to income tax disclosures. The amendments in this update require enhanced jurisdictional and other disaggregated disclosures for the
effective tax rate reconciliation and income taxes paid. The Company adopted this ASU on a prospective basis effective January 1, 2025. Refer to Note 10.Income Taxesfor
the inclusion of new disclosures required. 
**3.
Loans from Stockholders**
During
the years 2003-2004, Integrity Israel received loans from stockholders (four separate lenders) in a total amount of approximately $400.
However, following the repayment of the entire balance to certain lender in 2015, the remaining balance as of December 31, 2025 is approximately
$231. The loans are indexed to the Israeli consumer price index from their origination date and bear no interest.
| F-14 | |
The
Company will be required to pay the loans, in quarterly installments, commencing on the first quarter following the first fiscal year
in which the Company reports net profit in its annual report. At such time, the Company will be required to make quarterly payments equal
to 10% of its total sales for each quarter until the loans have been repaid in full. Notwithstanding the repayment mechanism, the Company
will not be required to repay the loans during any period in which such payment would cause a deficit in the Companys working
capital.
As
of December 31, 2025, the Company does not expect to make any material repayments during the following 12-month period, if any, and accordingly
the entire remaining balance of the loans from stockholders have been presented as non-current liability.
**4.
Significant Transactions**
**A
- Equity Issuances**
Current
Year
*ATM
Sales Agreement*
**
On
December 17, 2024, the Company entered into an ATM sales agreement (the Sales Agreement) with Dawson James Securities,
Inc. (Dawson James), pursuant to which the Company agreed to issue and sell shares of Common Stock, having an aggregate
offering price of up to $8,230, from time to time, through an at-the-market equity offering program (the ATM Program)
under which Dawson James will act as sales agent (the Agent).
On
March 21, 2025, the Company sold 206,300 shares of Common Stock at an average offering price of $18.24 per share pursuant to the Sales
Agreement for net proceeds of $3,593, after deducting fees owed to the Agent from such sale.
During
the three months ended June 30, 2025, the Company sold 414,784 shares of Common Stock at an average offering price of $10.74 per share
pursuant to the Sales Agreement for net proceeds of $4,320, after deducting fees owed to the Agent from such sale. As of December 31,
2025, there was no remaining capacity available under the ATM Program.
*Registered
Direct Offering*
**
On
February 4, 2025, the Company entered into a securities purchase agreement with certain institutional investors, relating to the registered
direct offering and sale of an aggregate of 43,968 shares of Common Stock at an offering price of $69.00 per share for gross proceeds
of $3,034. The net proceeds to the Company from the offering were approximately $2,752, after deducting fees owed to the placement agent
and other offering expenses. The February 2025 offering closed on February 5, 2025.
Dawson
James acted as the placement agent for the offerings pursuant to a placement agency agreement, dated February 4, 2025, by and between
the Company and Dawson James.
*Private
Placement December 2025*
**
On
December 29, 2025, we entered into a Securities Purchase Agreement (the Securities Purchase Agreement) with Armistice
Capital Master Fund Ltd. (also referred to herein as the Investor) for a private placement of securities (the
Private Placement). The closing of the Private Placement occurred on December 31, 2025 (the Closing). At
the Closing, the Company issued (i) 1,033,591
pre-funded warrants to purchase 1,033,591
shares of Common Stock (the Pre-Funded Warrants), and (ii) 2,067,182
warrants to purchase shares of Common Stock ( the Common Warrants). Each Pre-Funded Warrant was sold with two Common
Warrants at a combined purchase price of $3.869,
which is equal to the Nasdaq Official Closing Price (as reflected on Nasdaq.com) of the Common Stock on December 29, 2025 (the Minimum Price), minus
the exercise price of the Pre-Funded Warrant of $0.001
per share.
| F-15 | |
Pre-Funded
Warrants
The
exercise price of the Pre-Funded Warrants is $0.001 per share. The Pre-Funded Warrants are exercisable at any time after their original
issuance, and will not expire until exercised in full.
The
Pre-Funded Warrants provide that the Investor will not have the right to exercise any portion of its Pre-Funded Warrants if such exercise
would cause (i) the aggregate number of shares of Common Stock beneficially owned by the Investor (together with its affiliates) to exceed
9.99% of the number of shares of Common Stock outstanding immediately after giving effect to the exercise, or (ii) the combined voting
power of the Companys securities beneficially owned by the Investor (together with its affiliates) to exceed 9.99% of the combined
voting power of all of the Companys securities then outstanding immediately after giving effect to the exercise, as such percentage
ownership is determined in accordance with the terms of the Pre-Funded Warrants (the Pre-Funded Warrant Beneficial Ownership Limitation).
Common
Warrants
The
Common Warrants have an exercise price per share of Common Stock equal to $3.87 per share (which is equal to the Minimum Price). The Common Warrants are not exercisable, and the underlying Common Stock is not issuable
until the Company obtains stockholder approval for such exercise and issuance under applicable rules and regulations of Nasdaq (such
approval, Stockholder Approval and the date on which Stockholder Approval is received and deemed effective, the Stockholder
Approval Date). The Common Warrants will expire on the five year anniversary of the Stockholder Approval Date. The exercise price
and the number of shares of Common Stock issuable upon exercise of the Common Warrants is subject to appropriate adjustments in the event
of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the Common
Stock.
The
Common Warrants provide that the Investor will not have the right to exercise any portion of its Common Warrants if such exercise would
cause (i) the aggregate number of shares of Common Stock beneficially owned by the Investor (together with its affiliates) to exceed
4.99% (or, at the election of the purchaser, 9.99%) of the number of shares of Common Stock outstanding immediately after giving effect
to the exercise, or (ii) the combined voting power of the Companys securities beneficially owned by the Investor (together with
its affiliates) to exceed 4.99% (or, at the election of the purchaser, 9.99%) of the combined voting power of all of the Companys
securities then outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance
with the terms of the Common Warrants (the Common Warrant Beneficial Ownership Limitation and, together with the Pre-Funded
Warrant Beneficial Ownership Limitation, the Beneficial Ownership Limitations).
Placement
Agency Agreement
In
connection with the Private Placement, on December 29, 2025, the Company entered into a Placement Agency Agreement (the Placement
Agency Agreement) with Curvature Securities, LLC (the Placement Agent). As part of its compensation for acting as
Placement Agent for the Private Placement, the Company paid the Placement Agent a cash fee of 7.0% of the aggregate gross proceeds and
issued to the Placement Agent warrants to purchase 124,030 shares of Common Stock at an exercise price of $4.257 per share (the Placement
Agent Warrants), which are exercisable at any time on or after the date that is one hundred eighty (180) days from the date of
the commencement of sales in connection with the Private Placement (the Commencement Date), and expire on the five year
anniversary of the Commencement Date.
The
Company received aggregate net proceeds from the Private Placement of approximately $3,544, after deducting estimated placement agent
commissions and expenses in connection with the Private Placement, which were payable by the Company.
The
Company has assessed the Common Warrants and the Placement Agent Warrants, (the Combined Warrants), for appropriate equity
or liability classification and determined the Combined Warrants are freestanding instruments that are not included in the scope of ASC
480, Distinguishing Liabilities from Equity. In the event of a fundamental transaction warrant holders have the right to receive cash,
however, if a fundamental transaction is not within the Companys control, including that the transaction is not approved by the
Companys Board of Directors, the holders of the warrants shall only be entitled to receive from the Company the same type consideration
that is offered to the holders of the Companys Common Stock. In either case, in the event of fundamental transaction the value
of consideration is determined using Black Scholes model. The Combined Warrants are indexed to the Companys common stock and meet
all other conditions for equity classification under ASC 815-40, Contracts in Entitys Own Equity. Accordingly, the Combined
Warrants are classified as equity within the consolidated financial statements.
| F-16 | |
The
Combined Warrants were initially recognized at their relative fair value in the amount of $8,090 at the time
of issuance determined using Black-Scholes option-pricing model and will not be remeasured.
As
of December 31, 2025, the Pre Funded Warrants have yet to be exercised and no Combined Warrants have been exercised.
Prior
Year
*April
2024 Private Equity Offering*
**
On
April 22, 2024, the Company entered into a private placement agreement under which the Company issued 67 shares of its Common Stock at
a price of $7,560.00 per share for aggregate gross proceeds of $500. The offering included participation of certain members of the Companys
executive management, Board of Directors and existing shareholders.
*November
2024 Public Equity Offering and Concurrent Private Offering*
**
On
November 12, 2024, the Company completed a public offering (the Equity Offering) under which the Company received net proceeds
of $8,783 in exchange for issuance of an aggregate of (i) 2,032 shares (the Shares) of its Common Stock, (ii) 3,965 pre-funded
warrants (the Pre-Funded Warrants) to purchase up to an aggregate of 3,965 shares of Common Stock (the Pre-Funded
Warrant Shares) in lieu of Shares, (iii) Series A Warrants (the Series A Warrants) to purchase up to 5,996 shares
of Common Stock (the Series A Warrant Shares) and (iv) Series B Warrants (the Series B Warrants) and, together
with the Series A Warrants, the Common Warrants) to purchase up to 5,996 shares of Common Stock (the Series
B Warrant Shares together with the Series A Warrant Shares, the Warrant Shares). Each Share or Pre-Funded Warrant,
as applicable, was sold together with one Series A Warrant to purchase one share of Common Stock and one Series B Warrant to purchase
one share of Common Stock. The public offering price for each Share and accompanying Common Warrants was $1,668.00, and the public offering
price for each Pre-Funded Warrant and accompanying Common Warrants was $1,668.80.
In
a private placement offering completed concurrently with the Equity Offering (the Concurrent Private Offering and, together
with the Equity Offering, the 2024 November Offerings), the Company converted approximately $4,093 of debt, which represented
the then outstanding principal and accrued interest under a convertible promissory note dated July 30, 2024 (the July 30 Note
Debt). The July 30 Note Debt was converted to Common Stock and Series A Warrants and Series B Warrants on substantially the same
terms as the Equity Offering, resulting in the issuance of 2,201 shares of Common Stock, 2,201 accompanying Series A Warrants, and 2,201
accompanying Series B Warrants, based on a conversion price of $1,860.00 per share, which is equal to the consolidated closing bid price
of the Common Stock on the Nasdaq Capital Market on November 12, 2024.
In
addition, concurrently with the Equity Offering, the Company converted on substantially the same terms as the Equity Offering, three
outstanding July 18, 2024 Notes, with an aggregate outstanding principal and accrued interest in the amount of $305. The three outstanding
July 18, 2024 Notes automatically converted in connection with the closing of the Equity Offering at a conversion price of $1,872.00,
which is equal to the Floor Price as defined in the July 18, 2024 Notes, for an aggregate of 163 shares of Common Stock, 163 Series A
Warrants, and 163 Series B Warrants.
| F-17 | |
**B
Warrant Net Share Exchange into Common Stock and Warrant Repurchase**
In
connection with the Equity Offering, on November 12, 2024, the Company issued an aggregate of (i) 8,359 Series A Warrants and (ii) 8,359
Series B Warrants.
On
January 3, 2025, subject to shareholder approval the number of shares of Common Stock issuable upon exchange of the Series A Warrants
and Series B Warrants issued pursuant to the 2024 November Offerings was reset from 8,359 shares to 54,032 shares, respectively.
The
Company accounted for the 108,064 warrants issued in connection with the 2024 November Offerings in accordance with the accounting guidance
for derivatives. As further described in the annual financial statements for the year ended December 31, 2024, the Company analyzed the
terms of the Series A and Series B Warrants and determined that such warrants are not eligible for equity classification and thus would
be classified as derivative liabilities and recorded at fair value, with changes in fair value recorded through profit or loss. The Company
used the Monte Carlo Simulation method for determining the fair value of the warrants. The Series A warrant assumptions used in the Monte
Carlo simulations are an expected term of 4.62 years, an exercise price of $2,172, comparable company volatility of 113.5%, risk-free
interest rate of 3.95% and share price of $370.20. The Series B warrant assumptions used in the Monte Carlo simulations are an expected
term of 2.5 years, an exercise price of $2,172, company historical volatility of 378.6%, risk-free interest rate of 4.30% and share price
of $370.20.
During
the fiscal year ended December 31, 2025, there were cashless exchanges of an aggregate 54,021 Series B Warrants issued in connection
with the 2024 November Offerings, which resulted in the issuance of 162,063 shares of Common Stock. As these warrants were exchanged,
as permitted under the respective warrant agreements, the Company did not receive any cash proceeds. The warrants were measured at fair
value as of the settlement dates, and the change in fair value of $5,746, was recognized to net loss. Upon the exchange of the Series
B Warrants, the fair value of the warrants exchanged as of the settlement dates of $20,625 was classified to equity under additional
paid-in capital.
During
the fiscal year ended December 31, 2025, the Company repurchased 51,529 of its Series A Warrants form existing warrant holders for $166.
The fair value of the Series A Warrants on the date of exercise was $67, resulting in a loss on repurchase of $99.
During
the fiscal year ended December 31, 2025, the Company recognized a change in fair value of derivative liabilities of $3,267. As of December
31, 2025, 11 Series B Warrants and 2,507 Series A Warrants remain outstanding, for a combined value of $1.
**C
Promissory Note Current Year**
****
On
September 12, 2025 (the Issue Date), the Company entered into a Note Purchase Agreement (the Note Purchase Agreement),
with an investor (the Investor), pursuant to which the Company issued a Promissory Note (the Note) to the
Investor in the principal amount of $3,600 for a purchase price of $3,000. The Note was amended effective September 12, 2025, to remove
the convertible feature.
The
Note bears no interest, has an original issue discount of $600, is an unsecured obligation of the Company and will rank equal in right
of payment with the Companys existing and future unsecured indebtedness. The Note is due and payable on the twelve (12) month
anniversary of the Issue Date. The Company may prepay the Note at any time without the requirement for consent of the Investor.
Since
the Note bears no stated interest and was issued at a discount, the Company has recognized the original issue discount of $600 as imputed
interest expense over the term of the Note using the effective interest method, in accordance with the authoritative guidance. This imputed
interest is being amortized over the one-year term of the Note.
| F-18 | |
During
the fiscal year ended December 31, 2025, the Company amortized $182
of the original issue discount to interest expense. As of December
31, 2025, the unamortized discount was $418,
and the carrying amount of the Note was $3,182.
As
previously disclosed in the form 8-K filed by the Company with the SEC on September 11, 2025, the Company entered into a purchase agreement
with Sixth Borough Capital Fund, LP (Sixth Borough) establishing an equity line of credit (the ELOC). Under
the terms of the ELOC, the Company has the right, but not the obligation, to sell to Sixth Borough, and Sixth Borough is obligated to
purchase, up to $20.0 million of the Companys Common Stock (the Purchase Shares), subject to the terms and conditions
set forth therein. Pursuant to the Note Purchase Agreement, the Company is required to pay 100% of the net proceeds (after commission)
it receives from the sale of Purchase Shares under the ELOC towards repayment of the Note, until such time that the Company obtains stockholder
approval (the Stockholder Approval) to issue Purchase Shares in excess of the Exchange Cap, as defined in
the ELOC. Following Stockholder Approval, the Company is required to apply 50% of the net proceeds (after commissions) from any subsequent
sales of Purchase Shares under the ELOC to repay the Note.
The
Note contains certain specified events of default, the occurrence of which would entitle Investor to immediately demand repayment of
all outstanding principal on the Note such as certain events of bankruptcy and insolvency. The Note does not contain any affirmative
and restrictive covenants by the Company. The Purchase Agreement includes customary representations, warranties, and conditions precedent
of both parties.
The
Note was issued in a private placement to the Investor pursuant to an exemption for transactions by an issuer not involving a public
offering under Section 4(a)(2) of the Securities Act of 1933, as amended (the Securities Act).
As
of December 31, 2025, the Company has not received the necessary Stockholder Approval formally approving the ELOC.
**D
Note and Warrant Purchase Agreements Prior Year**
On
June 27, 2024, the Company entered into note and warrant purchase agreements with certain officers, directors, and existing investors
(the June 27 Investors), providing for the private placement of unsecured promissory notes in the aggregate principal amount
of $100 (the June 27 Notes) and warrants (the June 27 Warrants) to purchase up to an aggregate of 250 shares
of Common Stock. The closing of the private placement occurred on June 27, 2024.
The
June 27 Notes bore simple interest at the rate of three percent (3%) per annum and were due and payable in cash on the earlier of: (a)
twelve (12) months from the date of the June 27 Note; or (b) the date the Company raised third-party equity capital in an amount equal
to or in excess of $1,000 (the June 27 Maturity Date). The Company could prepay the June 27 Notes at any time prior
to the June 27 Maturity Date without penalty.
Each
June 27 Warrant has an exercise price of $5,940.00 per share. The June 27 Warrants are immediately exercisable and have a 5five-year term.
The
June 27 Notes and the June 27 Warrants were issued in reliance on the exemption from registration requirements thereof provided by Section
4(a)(2) of the Securities Act and Regulation D promulgated under the Securities Act. The Company relied on this exemption from registration
based in part on representations made by the June 27 Investors.
During
the fiscal year ended December 31, 2025, the Company repaid the remaining $5 outstanding as of December 31, 2024.
**E
Convertible Promissory Notes Prior Year**
On
July 18, 2024, the Company entered into a series of convertible promissory notes with three directors, and one member of the Companys
executive management (the July 18 Investors), providing for the private placement of unsecured convertible promissory notes
in the aggregate principal amount of $360 (the July 18 Notes and each a July 18 Note).
| F-19 | |
The
July 18 Notes bore simple interest at a rate of 8% per annum. Upon initial date, the management measured the fair value of the embedded
conversion feature which is accounted for as embedded derivative liability. The difference between the total gross cash proceeds received
and the fair value of the embedded conversion feature is allocated to the host component of the July 18 Notes that are measured at amortized
cost under which in subsequent periods the Company recognizes a discount expense over the economic life of the July 18 Notes based on
the effective interest rate method. However, the fair value of the embedded derivative liability related to the conversion feature was
determined by the management at an insignificant amount since upon closing of a Qualified Financing (as defined in the July 18 Notes),
the loan will convert based on market conditions (i.e. conversion price will be equal to the fair value of the share upon conversion)
and thus all proceeds received of $360 were allocated to the July 18 Notes.
On
September 5, 2024, the Company and one of July 18 Investors entered into a conversion agreement, under which the Company agreed to convert
his portion of the outstanding principal nominal amount plus any accrued but unpaid interest pursuant to the July 18 Note, totaling $101
into 83 shares of Common Stock at a conversion price of $1,224.00 per share.
In
November 2024, the Company and the remaining July 18 Investors entered into a conversion agreement under which the Company agreed to
convert their portion of the outstanding principal nominal amount plus any accrued but unpaid interest pursuant to the outstanding July
18 Notes, totaling $305 to Common Stock and warrants at a conversion price of $1,872.00 per share. The July 18 Investors received 163 shares
of Common Stock, 163 Series A Warrants and 163 Series B Warrants.
**F
Convertible Promissory Note and Warrant Agreement Prior Year**
****
On
July 30, 2024, the Company entered into a convertible promissory note and three warrant agreements (the July 30 Warrants)
with an existing investor (the July 30 Holder), providing for the private placement of a secured convertible promissory
note in the aggregate principal amount of $4,000 (the July 30 Note). The July 30 Note bore simple interest at a rate of
8% per annum and is due and payable in cash on earlier of: (i) 12 months anniversary of July 30 Note, or (ii) closing date of a Sale
Transaction (as defined in the July 30 Note) (the Maturity Date). The July 30 Note was secured by a first-priority security
interest on all Companys assets.
Each
July 30 Warrant becomes exercisable 12 months after its issuance and has term of 10 years. The July 30 Warrants are exercisable for cash
only and have no price-based antidilution. The first July 30 Warrant is for 1,778 shares at $2,250.00 per share. The second July 30 Warrant
is for 1,270 shares at $3,150.00 per share. The third July 30 Warrant is for 988 shares at $4,050.00 per share. Management has determined that
the warrants are eligible to be classified as a component of equity as their terms permit the holders to receive a fixed number of shares
of Common Stock upon exercise for a fixed exercise price.
At
the initial date, the Company has issued four freestanding instruments that include (i) a financial instrument that is considered as
host which comprised of July 30 Note and two embedded derivative financial instruments (i.e. an embedded conversion feature
and an embedded redemption feature to receive cash equals to 200% of July 30 Note balance upon the occurrence of a Sale Transaction)
and (ii) three series of detachable warrants. At the initial date, the Company is required to estimate the fair value of the freestanding
instruments and allocate the total gross proceeds received between them based on that relative fair value identified. The fair value
of the embedded derivative financial instruments (i.e. the conversion right and the redemption right) should be bifurcated from the host
instrument and remeasured on recurring basis at each reporting period under marked to market approach. The July 30 Note was accounted
for at amortized cost whereby discount and interest expenses are recorded over the economic life of the July 30 Note based on the effective
interest rate method and the July 30 Warrants are classified into equity without any further subsequent measurement.
Upon
initial recognition, the Company allocated the gross cash proceeds received based
on the relative fair value of the July 30 Note and the detachable July 30 Warrants in total amount of $1,450 and $2,550, respectively.
The fair value of the convertible note was determined by using hybrid method that includes conversion scenario and liquidation scenario
taking into account, inter alia, a debt discount rate of 28.65%. The fair value of the July 30 Warrants was determined by using Black-Scholes
pricing model taking into account, inter alia, expected stock price volatility of 122.8% and risk-free interest rate of 4.78%. The amount
allocated to July 30 Warrants was classified as a component of equity.
| F-20 | |
Furthermore,
it was determined that the embedded conversion feature and embedded redemption feature are required to be bifurcated from the host loan
instrument. The fair value of the bifurcated derivatives was determined by the management using the assistance of an external appraiser
in a total amount of $35 upon initial recognition and in subsequent periods as derivative liability at fair value through profit and
loss. The remaining amount of $1,415 was allocated to the host loan instrument which in subsequent periods was accounted for using the
effective interest method over the term of the loan, until its stated maturity.
On
September 24, 2024, the Company held a special meeting of its stockholders under which shares of Common Stock issuable by the Company
upon conversion of the July 30 Note and exercise of the July 30 Warrants was approved.
On
November 12, 2024, in connection with the Concurrent Private Offering, the Company and the July 30 Holder entered into an agreement for
the settlement of the July 30 Note plus any accrued but unpaid interest totaling $4,093 to Common Stock and warrants at a conversion
price of $1,860.00 per share. The July 30 Holder received 2,201 shares of Common Stock, 2,201 Series A Warrants and 2,201 Series B Warrants.
The fair value of the shares of Common Stock received was $813. The Series A and Series B Warrants are treated as derivative liabilities
and at grant date were valued at $609 and $3,768, respectively. As of the settlement date, the carrying amount of the July 30 Note under
the effective interest method was $1,978 and the fair value of the derivative liability relating to the conversion feature was $37. Upon
settlement, the total fair value of the warrant related derivatives of $4,377 and the equity received of $813 exceeded the net book value
of the July 30 Note of $1,978 and the value of the debt conversion derivative that was settled of $37. As a result, the Company recorded
a loss on extinguishment of debt in the amount of $3,175 in the Statement of Operations. Please see Note 4J for the terms and valuation
methodology of the Series A and Series B Warrants.
During
the period commencing the issuance date through December 31, 2025, none of the July 30 Warrants have been exercised.
**G
August and September 2024 Conversions Prior Year**
****
*August
2024 Conversion*
**
On
August 23, 2024 (the Commitment Date), the Company and two of June 27 Investors entered into conversion agreements, under
which the Company agreed to convert the principal nominal amount plus any accrued but unpaid interest pursuant to each of June 27 Notes,
with a face value of $20 each (the Debt), held by the Investors to Common Stock at a conversion price of $1,224.00 per share.
On October 15, 2024, the Company issued 17 shares of common stock for each of the two of the June 27 Investors in respect of each respective
Debt converted.
****
In
satisfaction of the Debt, the Company also issued to each of the two June 27 Investors three warrants (each an August 23 Warrant).
Each August 23 Warrant becomes exercisable on August 16, 2025 and has term of 10 years. The August 23 Warrants are exercisable for cash
only and have no price-based antidilution. The first August 23 Warrant is for 9 shares of Common Stock and is exercisable at $2,250.00
per share. The second August 23 Warrant is for 7 shares of Common Stock, exercisable at $3,150.00 per share. The third August 23 Warrant
is for 5 shares of Common Stock, exercisable at $4,050.00 per share.
The
above transaction was accounted for as a settlement of financial liabilities under which the instruments issued or to be issued to the
June 27 Investors (i.e. shares of common stock and August 23 Warrants) are eligible for equity classification and thus both have been
recorded as part of equity based on the total fair value of $238 at the Commitment Date. The difference between the fair value of these
equity instruments and the carrying amount of each of the respective Debt at the Commitment Date amounted to $11 was charged immediately
to the finance expenses. Due to the above settlement, the Company recorded a loss on the settlement on the amount
of $216.
During
the period commencing the issuance date through December 31, 2025, none of the August 23 Warrants have been exercised.
| F-21 | |
*September
2024 Conversion*
**
On
September 5, 2024 (the Commitment Date), the Company and one of June 27 Investors and July 18 Investors entered into a
conversion agreement, under which the Company agreed to convert outstanding board fees amounted $113 and the principal nominal amount
plus any accrued but unpaid interest pursuant to June 27 Note and July 18 Note, totaling $146 (referring together as a Debt),
held by the Investor to Common Stock at a conversion price of $1,224.00 per share. On October 15, 2024, the Company issued 212 shares
of common stock for the June 27 Investor in respect of the Debt converted.
In
satisfaction of the Debt, the Company also issued to June 27 Investor and July 18 Investor three warrants (each an September 5
Warrant). Each September 5 Warrant becomes exercisable on August 16, 2025 and has term of 10 years. The September 5 Warrants are
exercisable for cash only and have no price-based antidilution. The first September 5 Warrant is for 116 shares of Common Stock and is
exercisable at $2,250.00 per share. The second September 5 Warrant is for 83 shares of Common Stock, exercisable at $3,150.00 per share. The
third September 5 Warrant is for 65 shares of Common Stock, exercisable at $4,050.00 per share.
The
above transaction was accounted for as settlements of financial liabilities under which the instruments issued or to be issued to the
July 18 Investor (i.e. shares of common stock and September 5 Warrants) are eligible for equity classification and thus both have been
recorded as part of equity based on the total fair value of $1,505 at the Commitment Date. The carrying amount of the Debt at the Commitment
Date amounted to $227 and the difference was recorded as loss on settlement of debt in the Statement of Operations in the amount of $1,278.
During
the period commencing the issuance date through December 31, 2025, none of the September 5 Warrants have been exercised.
**5.
Commitments and Contingent Liabilities**
On
March 4, 2004, the Israeli Innovation Authority (the IIA) provided Integrity Israel with a grant of approximately $93 (NIS
420,000), for its plan to develop a non-invasive blood glucose monitor (the Development Plan). Integrity Israel is required
to pay royalties to the IIA at a rate ranging between 3-5% of the proceeds from the sale of the Companys products arising from
the Development Plan up to an amount equal to $93 plus interest at LIBOR from the date of grant. As to the replacement of the LIBOR benchmark
rate, even though the IIA has not declared the alternative benchmark rate to replace the LIBOR, the Company does not believe it will
have a significant impact. As of December 31, 2025, the remaining contingent liability with respect to royalty payment on future sales
equals approximately $93 excluding interest. Such contingent obligation has no expiration date.
*Intellectual
Property Purchase Agreement*
**
On
October 7, 2022, the Company entered into an Intellectual Property Purchase Agreement, (the IP Agreement) with its CEO, Paul V. Goode, under which he assigned
to the Company all rights, title, and interest in certain intellectual property related to an implantable continuous glucose sensor,
including patents, trademarks, trade secrets, know-how, and associated goodwill. In exchange, the Company paid one dollar in cash and
agreed to issue up to 167 shares of common stock upon achievement of specified performance milestones. If those shares represent less
than 1.5% of the Companys outstanding common stock at the time of final issuance, additional true-up shares will
be issued to reach that threshold. All shares issued under the agreement are subject to restrictions and lockup provisions.
**
Because
the acquired assets did not constitute a business under applicable accounting guidance, the transaction was treated as an asset acquisition,
with no goodwill recognized. The acquired in-process research and development (IPR&D) had no alternative future use and was expensed
immediately. Milestone-based share issuances are treated as contingent consideration and recognized as stock-based compensation when
achievement becomes probable. On December 29, 2023, 17 shares of Common Stock were earned under the terms of the IP Agreement and were
issued to Dr. Goode on February 6, 2024. On May 1, 2024, 25 shares of Common Stock were earned under the terms of the IP Agreement. On
March 26, 2025, the Board determined that the third milestone was met and that an additional 42 shares of Common Stock have been earned
under the terms of the IP Agreement. Stock-based compensation expense recognized during the fiscal year ended December 31, 2025 for the
third milestone was de minimus. As of December 31, 2025, the remaining milestones were not considered probable, and no additional compensation
expense had been recorded.
| F-22 | |
**6.
Lease Agreement**
On
February 19, 2024, the Company entered into a three-year lease agreement with Tapsak Enterprises LLC dba Virginia Analytical for premises
in the Front Royal, Virginia area, commencing March 1, 2024 and ending February 28, 2027, at a monthly rent of $2.5, with a $2.5 security
deposit refundable at the end of the initial term. The Company has the option to renew the lease for two additional three-year periods
at fair market rental rates, subject to advance notice, but only the initial lease term was considered for accounting purposes as renewal
was not deemed reasonably certain. In accordance with ASC 842, the Company recognized a right-of-use asset and corresponding lease liability
of $79 at commencement, with the lease liability measured as the present value of future lease payments discounted using the Companys
estimated incremental borrowing rate.
****
Operating
lease:
Schedule of Operating Lease
| 
| | 
December
31, 2025 | | | 
December
31, 2024 | | |
| 
| | 
| | | 
| | |
| 
Operating
right-of-use asset | | 
$ | 33 | | | 
$ | 59 | | |
| 
Current operating lease
liability | | 
$ | 28 | | | 
$ | 26 | | |
| 
Non-Current operating
lease liability | | 
$ | 5 | | | 
$ | 33 | | |
Maturity
analysis of the Companys lease liability:
Schedule of Maturity Analysis of Lease Liability
| 
| | 
December
31, 2025 | | | 
December
31, 2024 | | |
| 
| | 
| | | 
| | |
| 
Less than one year | | 
$ | 30 | | | 
$ | 30 | | |
| 
Between 1-2 years | | 
| 5 | | | 
| 30 | | |
| 
More than 2 years | | 
| - | | | 
| 5 | | |
| 
| | 
| | | | 
| | | |
| 
Total operating lease
payments | | 
$ | 35 | | | 
$ | 65 | | |
| 
Less: imputed interest | | 
$ | 2 | | | 
$ | 6 | | |
| 
| | 
| | | | 
| | | |
| 
Present value of lease liabilities | | 
$ | 33 | | | 
$ | 59 | | |
*Additional
information on lease*
**
The
following is a summary of the weighted average remaining lease terms and discount rate for the lease:
Schedule of Weighted Average Remaining Terms and Discount Rate
| 
| | 
December
31, 2025 | | | 
December
31, 2024 | | |
| 
Lease term (years) | | 
| 1.17 | | | 
| 2.17 | | |
| 
Weighted average discount rate | | 
| 9.03 | % | | 
| 9.03 | % | |
**7.
Share-Based Compensation**
*Stock
Option Plans*
**
2024
Equity Incentive Plan
The
Companys shareholders approved the 2024 Equity Incentive Plan (the 2024 Plan) in April 2024. The 2024 Plan initially
provided for a reserve of 2,675,636 shares of Common Stock, which was subsequently reduced to 535,127 shares in connection with the Companys
one-for-five (1:5) reverse stock split, effective May 17, 2025, and such shares were registered on a Form S-8 filed with the SEC in August
2024. The share reserve was subsequently reduced to 26,757 shares in connection with the Companys one-for-twenty (1:20) reverse
stock split, effective February 3, 2025.
| F-23 | |
In
May 2025, the Companys shareholders approved an amendment (the Amendment) to the 2024 Plan that increased the maximum
aggregate number of shares that could be issued under the 2024 Plan to 7,500,000 shares. The maximum aggregate number of shares that
could be issued under the 2024 Plan was subsequently reduced to 125,000 shares in connection with the Companys one-for-sixty (1:60)
reverse stock split, effective June 13, 2025. The additional 124,555 shares added by the Amendment were registered on a Form S-8 filed
with the SEC in September 2025. The 2024 Plan provides for the grant of incentive stock options, nonqualified stock options, and other
share-based awards to employees, directors, consultants, and advisors. These awards have contractual terms of up to ten years and are
subject to vesting conditions determined by the Compensation Committee of the Board of Directors. As of December 31, 2025, 97,544 shares
remained available for issuance under the 2024 Plan.
*Stock
Option Activity*
During
the fiscal year ended December 31, 2025, the Compensation Committee of the Board of Directors granted 16,220
stock options to the Companys directors with a fair value of $116 as
determined by the Black Scholes option pricing model. The options vest over a one year period and carry a ten-year term.
During
the fiscal year ended December 31, 2024, the Compensation Committee of the Board granted 109 stock options to the Companys employees
with a fair value of $325 as determined by the Black Scholes option pricing model. The vesting terms of the options vary between one
and two years and carry a ten-year term.
A
summary of the Companys stock option activity for the fiscal years ended December 31, 2025 and 2024 is as follows:
Schedule of Stock Option Activity
| 
| | 
Option
Shares | | | 
Weighted-
Average Exercise
Price | | | 
Weighted Average Remaining Contractual Life | | | 
Intrinsic Value | | |
| 
| | 
| | | 
| | | 
(years) | | | 
| | |
| 
| | 
| | | 
| | | 
| | | 
| | |
| 
Outstanding as of December 31, 2023 | | 
| 170 | | | 
$ | 2,940 | | | 
| 8.0 | | | 
$ | - | | |
| 
Granted | | 
| 109 | | | 
| 3,055 | | | 
| 9.37 | | | 
| - | | |
| 
Forfeited or expired | | 
| - | | | 
| - | | | 
| - | | | 
| - | | |
| 
Outstanding as of December 31, 2024 | | 
| 279 | | | 
| 2,985 | | | 
| 9.37 | | | 
| - | | |
| 
Granted | | 
| 16,220 | | | 
| 7.40 | | | 
| 9.76 | | | 
| - | | |
| 
Cancelled | | 
| - | | | 
| - | | | 
| - | | | 
| - | | |
| 
Forfeited or expired | | 
| - | | | 
| - | | | 
| - | | | 
| - | | |
| 
Outstanding as of December 31, 2025 | | 
| 16,499 | | | 
$ | 57.75 | | | 
| 9.74 | | | 
$ | - | | |
For
the fiscal year ended December 31, 2025 share-based compensation expense for stock options vesting during the period was $211. For the
fiscal year ended December 31, 2024 share-based compensation expense for stock options vesting during the period was $173.
At
December 31, 2025, options to purchase 8,236 shares of common stock were exercisable. These options had a weighted-average exercise price
of $83.47 and a weighted average remaining contractual term of 9.73 years. The total unrecognized compensation cost related to unvested
stock option grants as of December 31, 2025 was approximately $204, and the weighted average period over which these grants are expected
to vest is 1.00 years.
| F-24 | |
The
Company uses the Black-Scholes valuation model to calculate the fair value of stock options. Share-based compensation expense is recognized
over the vesting period using the straight-line method. The fair value of stock options was estimated at the grant date using the following
weighted average assumptions:
Schedule of Fair Value of Stock Options Weighted Average Assumptions
| 
| | 
2025 | | | 
2024 | | |
| 
| | 
For
the years ended December
31, | | |
| 
| | 
2025 | | | 
2024 | | |
| 
Volatility | | 
| 184 | % | | 
| 207-288 | % | |
| 
Risk-free interest rate | | 
| 4.13 | % | | 
| 3.51-4.64 | % | |
| 
Dividend yield | | 
| 0.0 | % | | 
| 0.0 | % | |
| 
Expected life | | 
| 5.15
years | | | 
| 3.00
years | | |
Volatility
is the measure by which the Companys stock price is expected to fluctuate during the expected term of an option. Volatility is
derived from the historical daily change in the market price of the Companys common stock, as it believe that historical volatility
is the best indicator of future volatility.
The
risk-free interest rates used in the Black-Scholes calculations are based on the prevailing U.S. Treasury yield as determined by the
U.S. Federal Reserve.
The
Company has never paid dividends on its common stock and does not anticipate paying dividends on its common stock in the foreseeable
future. Accordingly, it has assumed no dividend yield for purposes of estimating the fair value of its share-based compensation.
The
weighted average expected life of options was estimated using the average of the contractual term and the weighted average vesting term
of the options.
*Other
Common Stock Transactions*
**
During
the fiscal year ended December 31, 2025, the Company issued 10,959 shares of restricted common stock, with an aggregate grant-date fair
value of $122, as compensation to members of the Board of Directors.
In
addition, during fiscal 2025 the Company issued (i) 277 shares of restricted common stock to directors for services rendered and accrued
in the prior fiscal year and (ii) 42 shares of restricted common stock to its Chief Executive Officer, Paul V. Goode, in connection with
intellectual property milestones achieved during fiscal 2025. The fair value of the 42 shares issued to Dr. Goode was de minimus.
****
**8.
Related Parties**
*Lease
Agreement*
**
On
October 25, 2022, the Company entered into an agreement with Tapsak Enterprises LLC, doing business as Virginia Analytical, which is
wholly owned by Mark Tapsak, the Companys Chief Scientific Officer. Pursuant to the agreement, Tapsak Enterprises LLC dba Virginia
Analytical provides laboratory space, equipment, and materials to support the Companys research and development activities.
For
the years ended December 31, 2025 and 2024, the Company recorded $30 and $25, respectively, in research and development expenses related
to this arrangement.
For
additional information regarding the execution of the lease agreement with Tapsak Enterprises LLC dba Virginia Analytical, see Note 6
to the accompanying consolidated financial statements.
*Intellectual
Property Purchase Agreement*
**
For
additional information regarding the intellectual property purchase agreement with the Companys Chief Executive Officer, Paul
V. Goode, see Note 5 to the accompanying consolidated financial statements.
****
*Current
and Prior Year Equity and Debt Transactions*
**
For
additional information regarding related party equity and debt transactions that occurred during the current and prior fiscal year, see
Note 4 to the accompanying consolidated financial statements.
| F-25 | |
**9.
Segment Reporting**
Operating
segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation
by the chief operating decision maker, or (CODM). The Company has identified its Chief Executive Officer, Paul V. Goode,
as the CODM who is responsible for making decisions regarding resource allocation and assessing performance. The Company views its operations
and manages its business as one operating segment. The Companys long-lived assets consist primarily of property and equipment,
net, which are all held in the United States.
ASC
280, Segment Reporting establishes standards for reporting information about operating segments on a basis consistent with
the Companys internal organization structure as well as information about services categories, business segments and major customers
in financial statements. The Company has only one reportable segment, the Glucotrack CBGM Product Segment, as all their research and
development activities are related the development of the Glucotrack CBGM Product. Since the Company operates in one operating segment,
all required financial segment information can be found in the consolidated financial statements.
****
**10.
Income Taxes**
*Loss*
Pretax loss
for the years ended December 31, 2025 and 2024 consists of the following:
Schedule
of Pretax Loss for the Years
| 
| | 
2025 | | | 
2024 | | |
| 
| | 
December
31, | | |
| 
| | 
2025 | | | 
2024 | | |
| 
Domestic | | 
$ | 19,285 | | | 
$ | 22,502 | | |
| 
Foreign | | 
| 103 | | | 
| 95 | | |
| 
Pretax loss | | 
| 19,388 | | | 
| 22,597 | | |
*Income tax reconciliation*
Upon adoption of ASU 2023-09, Improvements to Income Tax Disclosures, the reconciliation of taxes at the federal
statutory rate to the Companys income tax expense (benefit) for the year ended December 31, 2025 is as follows:
Schedule of Effective Income Tax Rate
Reconciliation 
| 
| | 
| | | 
| | |
| 
| | 
December 31, 2025 | | |
| 
| | 
| | | 
| | |
| 
Tax at statutory federal rate | | 
$ | 4,071 | | | 
| 21 | % | |
| 
State income taxes | | 
| - | | | 
| - | | |
| 
Foreign | | 
| | | | 
| | | |
| 
Foreign income tax differential | | 
| 2 | | | 
| - | |
| 
Deferred tax adjustment- NOLs | | 
| (162 | ) | | 
| (1 | )% | |
| 
Change in valuation allowance | | 
| 136 | | 
| 1 | % | |
| 
Deferred tax adjustment Sec. 174 costs | | 
| (647 | ) | | 
| (3 | )% | |
| 
Change in valuation allowance | | 
| (2,505 | ) | | 
| (13 | )% | |
| 
Non-taxable/non-deductible items | | 
| | 
| |
| 
Change in fair value of derivative liabilities | | 
| (686 | ) | | 
| (4 | )% | |
| 
Other non-taxable/non-deductible items | | 
| (19 | ) | | 
| - | |
| 
Other adjustments | | 
| (190 | ) | | 
| (1 | )% | |
| 
Income tax expense (benefit) | | 
| - | | | 
| - | | |
| F-26 | |
Composition
of the change in the U.S. valuation allowance of deferred tax assets is as follows:
Schedule of Change in Valuation Allowance 
| 
| | 
| | | |
| 
Net loss in the U.S. | | 
| 3,471 | | |
| 
Deferred tax adjustment Sec. 174 costs | | 
| (647 | ) | |
| 
Research and experimental expense | | 
| (146 | ) | |
| 
Vacation accrual | | 
| (173 | ) | |
| 
Total | | 
| 2,505 | | |
The reconciliation of taxes at the federal statutory
rate to the Companys income tax expense (benefit) for the year ended December 31, 2024 in accordance with the guidance prior to
the adoption of ASU 2023-09 was as follows:
Schedule
of Income Tax Expense (Benefit)
| 
Composition
of deferred tax assets: | | 
2025 | | 
|
| 
| 
| | 
|
| 
Net
loss before tax | | 
$ | 22,597 | | 
|
| 
| | 
| | | |
| 
Tax
at statutory federal rate | | 
| 4,745 | | 
|
| 
Foreign
income tax differential | | 
| 2 | | 
|
| 
Change in valuation allowance | | 
| (4,542 | ) | 
|
| 
Non-deductible
expenses | | 
| (205 | ) | 
|
| 
Other
differences | | 
| - | | 
|
| 
Income
tax expense (benefit) | | 
| - | | 
|
*Composition of deferred tax assets*
Deferred taxes result principally from temporary differences
in the recognition of certain revenue and expense items for financial and income tax reporting purposes. Significant components of the
Companys future tax assets are as follows:
Schedule of Deferred Taxes Assets
| 
| | 
December 31, | | |
| 
| | 
2025 | | | 
2024 | | |
| 
Vacation accrual | | 
| 36 | | | 
| 208 | | |
| 
Research and development costs Sec. 174 | | 
| 2,482 | | | 
| 3,276 | | |
| 
Net operating losses carry forwards | | 
| 21,829 | | | 
| 16,981 | | |
| 
Net deferred tax asset before valuation allowance | | 
| 24,347 | | | 
| 20,465 | | |
| 
| | 
| | | | 
| | | |
| 
Valuation allowance | | 
| (24,347 | ) | | 
| (20,465 | ) | |
| 
Net deferred tax assets | | 
| - | | | 
| - | | |
Valuation allowance reflects uncertainty in the
Companys ability to generate taxable income and realization of deferred tax assets.
*Net Operating Losses (NOL) carryforward*
**
As of December 31, 2025, the Company had
cumulative Net Operating Losses (NOL) carry forwards for U.S. federal purposes of approximately $46.3
million to offset against future taxable income. Of the $46.3
million, $6.8
million will begin to expire in 2030 and the remainder can be carried forward for an indefinite period of time. Cumulative NOL carry
forwards for Israeli income tax purposes are approximately $52.6
million to offset against future taxable income for an indefinite period of time.
NOL carry forwards by U.S. federal and Israel at December
31, 2024 were $31.6 million and $38.5 million, respectively.
*Tax assessments*
**
For federal, state and local income tax purposes the
Company remains open for examination by the tax authorities for the tax years from 2022 through 2025 under the general statute of limitations.
Due to the Companys NOLs, all tax years beginning in 2010 are open for examination to the extent of NOLs. Israeli tax returns from
2022 through 2025 are open for examination.
As of December 31, 2025 and December 31, 2024, the
Company had no unrecognized tax benefits or position which, in the opinion of management, would be reversed if challenged by a taxing
authority. In the event the Company is assessed interest or penalties, such amounts would be classified as income tax expense.
**11.
Subsequent Events**
****
Subsequent to December 31, 2025, all 1,033,591 Pre-Funded Warrants from the December 2025 Private Placement were exercised into Common
Stock.
| F-27 | |
**SIGNATURE**
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned thereunto duly authorized.
| 
| 
GLUCOTRACK,
INC. | |
| 
| 
| 
| |
| 
Date: | 
March
30, 2026 | 
By: | 
/s/
Paul Goode | |
| 
| 
Name: | 
Paul
Goode | |
| 
| 
Title: | 
Chief
Executive Officer | |
| 
| 
| 
(Principal
Executive Officer) | |
| 
Date: | 
March
30, 2026 | 
By: | 
/s/
Peter Wulff | |
| 
| 
Name: | 
Peter
Wulff | |
| 
| 
Title: | 
Chief
Financial Officer | |
| 
| 
| 
(Principal
Financial and Accounting Officer) | |
Pursuant
to the requirements of the Securities Exchange Act of 1934, this Report has been signed below by the following persons on behalf of the
registrant and in the capacities and on the dates indicated.
| 
Signature | 
| 
Title | 
| 
Date | |
| 
| 
| 
| 
| 
| |
| 
/s/
Paul Goode | 
| 
Chief
Executive Officer and Director | 
| 
March 30, 2026 | |
| 
Paul
Goode | 
| 
(Principal
Executive Officer) | 
| 
| |
| 
| 
| 
| 
| 
| |
| 
/s/
Peter Wulff | 
| 
Chief
Financial Officer | 
| 
March 30, 2026 | |
| 
Peter
Wulff | 
| 
(Principal
Financial and Accounting Officer) | 
| 
| |
| 
| 
| 
| 
| 
| |
| 
/s/
Erin Carter | 
| 
Director | 
| 
March 30, 2026 | |
| 
Erin
Carter | 
| 
| 
| 
| |
| 
| 
| 
| 
| 
| |
| 
/s/
Luis Malave | 
| 
Director | 
| 
March 30, 2026 | |
| 
Luis
Malave | 
| 
| 
| 
| |
| 
| 
| 
| 
| 
| |
| 
/s/
Andrew Balo | 
| 
Director | 
| 
March 30, 2026 | |
| 
Andrew
Balo | 
| 
| 
| 
| |
| 
| 
| 
| 
| 
| |
| 
/s/
Victoria Carr-Brendel | 
| 
Director | 
| 
March 30, 2026 | |
| 
Victoria
Carr-Brendel | 
| 
| 
| 
| |
| 63 | |