UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
☒
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended March 31, 2026
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
(Registrant’s
telephone number, including area code)
N/A
(Former
name, former address and former fiscal year, if changed since last report)
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
GCTK
The
Nasdaq Stock Market LLC
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 and posted on its corporate Web site, if any, every Interactive Data
File required to be submitted and posted 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 and post such files). Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, 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 is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As
of May 14, 2026, 6,259,279 shares of the Company’s common stock, par value $ 0.001 per share, were outstanding.
GLUCOTRACK
INC.
TABLE
OF CONTENTS
Page
PART I - FINANCIAL INFORMATION
4
Item 1. Financial Statements.
4
Condensed Consolidated Balance Sheets
4
Condensed Consolidated Statements of Operations and Comprehensive Loss
5
Condensed Consolidated Statement of Changes in Stockholders’ Equity
6
Condensed Consolidated Statements of Cash Flows
7
Notes to Condensed Consolidated Financial Statements
8
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
18
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
22
Item 4. Controls and Procedures.
22
PART II - OTHER INFORMATION
23
Item 1. Legal Proceedings
23
Item 1A Risk Factors
23
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
24
Item 3. Defaults Upon Senior Securities
24
Item 4. Mine Safety Disclosures
24
Item 5. Other Information
24
Item 6. Exhibits.
25
EXHIBIT INDEX
25
SIGNATURES
26
2
CAUTIONARY
NOTE REGARDING FORWARD LOOKING STATEMENTS
This
Quarterly Report on Form 10-Q includes forward-looking statements. These forward-looking statements include statements about our expectations,
beliefs or intentions regarding our product development efforts, business, financial condition, results of operations, strategies or
prospects. All statements other than statements of historical fact included in this Quarterly Report on Form 10-Q, including statements
regarding our future activities, events or developments, including such things as future revenues, product development, clinical trials,
regulatory approval, market acceptance, responses from competitors, capital expenditures (including the amount and nature thereof), business
strategy and measures to implement strategy, competitive strengths, goals, expansion and growth of our business and operations, plans,
references to future success, projected performance and trends, and other such matters, are forward-looking statements. The words “believe,”
“expect,” “intend,” “anticipate,” “estimate,” “plan,” “may,”
“will,” “could,” “would,” “should” and other similar words and phrases or the negative
of such terms, are intended to identify forward-looking statements. The forward-looking statements made in this Quarterly Report on Form
10-Q are based on certain historical trends, current conditions and expected future developments, as well as other factors we believe
are appropriate in the circumstances. These statements relate only to events as of the date on which the statements are made and we undertake
no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise,
except as required by law. All of the forward-looking statements made in this Quarterly Report on Form 10-Q are qualified by these cautionary
statements and there can be no assurance that the actual results anticipated by us will be realized or, even if substantially realized,
that they will have the expected consequences to or effects on us or our business or operations. Whether actual results will conform
to our expectations and predictions is subject to a number of risks and uncertainties that may cause actual results to differ materially.
Risks and uncertainties, the occurrence of which could adversely affect our business, include the risks identified in our Annual Report
on Form 10-K for year ended December 31, 2025, under the caption “Risk Factors.” We undertake no obligation to publicly update
or revise any forward-looking statements to reflect events or circumstances that may arise after the date of this report unless required
by law.
3
GLUCOTRACK
INC.
PART
I - FINANCIAL INFORMATION
Item
1. Financial Statements
GLUCOTRACK
INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(i n
thousands of US dollars except share data)
March 31,
2026
December 31,
2025
In thousands of US dollars
(except stock data)
March 31,
2026
December 31,
2025
Unaudited
Current Assets
Cash and cash equivalents
$ 3,929
$ 7,383
Other current assets
285
284
Total current assets
4,214
7,667
Operating lease right-of-use asset, net
26
33
Property and equipment, net
116
138
TOTAL ASSETS
$ 4,356
$ 7,838
LIABILITIES AND STOCKHOLDERS’ (DEFICIT) EQUITY
Current Liabilities
Accounts payable
$ 1,299
$ 1,317
Operating lease liability, current
26
28
Promissory notes
3,330
3,182
Other current liabilities
320
246
Total current liabilities
4,975
4,773
Non-Current Liabilities
Derivative financial liabilities
-
1
Operating lease liability, non-current
-
5
Loans from stockholders
232
231
Total liabilities
5,207
5,010
Commitments and contingent liabilities (Note 4)
-
-
Stockholders’ Equity (Deficit)
Common Stock of $ 0.001 par value (“Common Stock”):
250,000,000 shares authorized as of March 31, 2026 and as of December 31, 2025; 2,524,279 and 910,688 shares issued and outstanding as of March 31, 2026 and December 31, 2025, respectively
3
1
Common
Stock of $0.001
par value 250,000,000 shares authorized as of March 31, 2026 and as of December 31, 2025; 2,524,279
and 910,688
shares issued and outstanding as of March 31, 2026 and December 31, 2025, respectively
3
1
Additional paid-in capital
155,274
151,080
Receipts on account of shares
-
3,544
Accumulated other comprehensive income
44
41
Accumulated deficit
( 156,172 )
( 151,838 )
Total stockholders’ equity (deficit)
( 851 )
2,828
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
$ 4,356
$ 7,838
The
accompanying notes are an integral part of these condensed interim consolidated financial statements.
4
GLUCOTRACK
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in
thousands of US dollars except share data) (unaudited)
2026
2025
Three-month period ended
March 31,
2026
2025
Operating expenses:
Research and development
$ 2,132
$ 1,871
General and administrative
2,071
1,627
Total operating expenses
4,203
3,498
Loss from operations
4,203
3,498
Other (income) expense:
Change in fair value of derivative liabilities
( 1 )
3,376
Other (income) expense, net
132
( 4 )
Finance expenses (income), net
-
( 37 )
Total other (income) expense
131
3,335
Net Loss
4,334
6,833
Other comprehensive income:
Foreign currency translation adjustment
( 3 )
( 36 )
Comprehensive loss for the period
$ 4,331
$ 6,797
Basic and diluted loss per share
$ 2.65
$ 40.14
Weighted average number of Common Stock outstanding used in computing basic and diluted loss per share
1,638,128
169,345
The
accompanying notes are an integral part of these condensed interim consolidated financial statements.
5
GLUCOTRACK
INC.
CONDENSED
CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)
(in
thousands of US Dollars except share data) (unaudited)
Numbers of
Shares
Amount
Additional
Paid-in
Capital
on
account of
shares
Other
Comprehensive
Income
Accumulated
Deficit
Total
Stockholders’
Equity
In thousands of US Dollars (except share data)
Common Stock
Receipts
Accumulated
Numbers of
Shares
Amount
Additional
Paid-in
Capital
on
account of
shares
Other
Comprehensive
Income
Accumulated
Deficit
Total
Stockholders’
Equity
Balance as of December 31, 2025
910,688
$ 1
$ 151,080
$ 3,544
$ 41
$ ( 151,838 )
$ 2,828
Loss for the period
-
-
-
-
-
( 4,334 )
( 4,334 )
Other comprehensive income
-
-
-
-
3
-
3
Stock-based compensation
-
-
61
-
-
-
61
Issuance of common stock upon exercise of pre-funded warrants
1,033,591
1
3,544
( 3,544 )
-
-
1
Issuance of common stock upon completion of ELOC financing, net of offering expenses
580,000
1
589
-
-
-
590
Balance as of March 31, 2026 (Unaudited)
2,524,279
$ 3
$ 155,274
$ -
$ 44
$ ( 156,172 )
$ ( 851 )
In thousands of US Dollars (except share data)
Common Stock
Receipts
Accumulated
Numbers of
Shares
Amount
Additional
Paid-in
Capital
on
account of
shares
Other
Comprehensive
Income
Accumulated
Deficit
Total
Stockholders’
Equity
Balance as of December 31, 2024
13,193
$ - *
$ 119,230
$ 228
$ ( 8 )
$ ( 132,450 )
$ ( 13,000 )
Balance
13,193
$ -
$ 119,230
$ 228
$ ( 8 )
$ ( 132,450 )
$ ( 13,000 )
Loss for the period
-
-
-
-
-
( 6,833 )
( 6,833 )
Other comprehensive income
-
-
-
-
36
-
36
Stock-based compensation
-
-
40
-
-
-
40
Issuance of common stock upon completion of public offering, net of offering expenses
250,267
- *
6,394
-
-
6,394
Cashless exercise of warrants into common stock
162,062
- *
20,621
-
-
-
20,621
Stock split adjustment
909
- *
- *
-
-
-
Balance as of March 31, 2025 (Unaudited)
426,431
$ - *
$ 146,285
$ 228
$ 28
$ ( 139,283 )
$ 7,258
Balance
426,431
$ -
$ 146,285
$ 228
$ 28
$ ( 139,283 )
$ 7,258
(*)
Represents
amount lower than $1.
The
accompanying notes are an integral part of these condensed interim consolidated financial statements.
6
GLUCOTRACK
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in
thousands of US Dollars)
2026
2025
Three-month period ended
March 31,
2026
2025
(Unaudited)
CASH FLOWS FROM OPERATING ACTIVITIES:
Loss for the period
$ ( 4,334 )
$ ( 6,833 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
22
8
Stock-based compensation
61
40
Amortization of original issue discount related to promissory note
148
-
Change in fair value of derivative liability
( 1 )
3,376
Amortization of debt discount and interest expense related to promissory notes
-
3
Changes in assets and liabilities:
Increase in other current assets
( 1 )
( 204 )
(Decrease) increase in accounts payable
( 18 )
620
Increase in other current liabilities
75
51
Net cash used in operating activities
( 4,048 )
( 2,939 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of property and equipment
-
( 9 )
Net cash used in investing activities
-
( 9 )
CASH FLOWS FROM FINANCING ACTIVITIES:
Net proceeds from exercise of pre-funded warrants
1
-
Net proceeds from ELOC financing
590
-
Net proceeds from underwritten U.S. public offerings
-
6,395
Net cash provided by financing activities
591
6,395
Effect of exchange rate changes on cash and cash equivalents
3
36
Change in cash and cash equivalents
( 3,454 )
3,483
Cash and cash equivalents, at beginning of the period
7,383
5,627
Cash and cash equivalents, end of period
$ 3,929
$ 9,110
2026
2025
Three-month period ended
March 31,
2026
2025
(Unaudited)
Supplemental disclosure of cash flow activities:
(a) Net cash paid during the quarter for:
Interest
$ -
$ 28
(b) Non-cash activities:
Recognition of right for usage asset against a lease liability
$ -
$ 79
The
accompanying notes are an integral part of these condensed interim consolidated financial statements.
7
GLUCOTRACK
INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
(in
thousands of US Dollars)
1.
Organization and Business
The
Company
The
Company was incorporated on May 18, 2010 under the laws of the State of Delaware. The Company is 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 one’s 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 is 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 patients using insulin
or at risk for hypoglycemia. Implant longevity is key to the success of such a device. The Company has demonstrated 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. During the period, two peer-reviewed scientific articles
were published related to the CBGM technology. One article, published in the IEEE Sensors Journal, characterized the long-term in-vitro
stability of electrochemical glucose sensors of the type used in the CBGM system, including the first year-long measurements of glucose
oxidase enzyme decay reported in the literature. A second peer-reviewed article, published in The Journal of Diabetes Research, evaluated
the long-term accuracy and stability of the CBGM system in an in-vivo ovine model, providing externally validated evidence supporting
the long-term performance of the technology. 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.
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.
8
Subsequent
to March 31, 2026, the Company submitted an Investigational Device Exemption (“IDE”) application to the U.S. Food and Drug
Administration (“FDA”) to initiate a U.S. clinical study of its CBGM technology. The IDE submission represents an important
milestone for the Company and reflects progress in its preclinical development and underlying technical foundation. The Company has also
engaged a clinical research organization and identified trial sites in preparation for study commencement.
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 March
31, 2026, the Company has incurred an accumulated deficit of $ 156,172 . In addition, the Company has generated operating losses and negative
cash flow from operations since inception. As of March 31, 2026, the balance of cash and cash equivalents amounted to $ 3,929 .
During the quarter ended March 31, 2026, the Company raised $ 591 through the sale of shares of its common stock, par value $ 0.001 per
share (the “Common Stock”). 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 Company’s ability to meet its current obligations and to
achieve its business targets and determined that these conditions raise substantial doubt about the Company’s ability to continue
as a going concern.
The
condensed 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 Company’s stockholders at the special
meeting of stockholders held on January 3, 2025 (the “Special Meeting”).
On
January 3, 2025, the stockholders approved at the Special Meeting the increase in the Company’s 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 3C. On February 3, 2025, the
Company filed an amendment to the Company’s Certificate of Incorporation to increase the Company’s authorized shares of Common
Stock from 100,000,000 to 250,000,000 .
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 Company’s 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 condensed
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 2025 financial statements to conform to the 2026 presentation. Specifically, prior-year marketing
expenses, as presented in the Condensed 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 unaudited condensed interim consolidated financial statements and related notes should be read in conjunction with the Company’s
consolidated financial statements and related notes included in the Company’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2025, filed with the SEC on March 30, 2026 (the “Annual Report”). The unaudited condensed interim consolidated
financial statements have been prepared in accordance with the rules and regulations of the SEC related to interim financial statements.
As permitted under those rules, certain information and footnote disclosures normally required or included in financial statements prepared
in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”), have been condensed
or omitted. The financial information contained herein is unaudited; however, management believes all adjustments have been made that
are considered necessary to present fairly the results of the Company’s financial position and operating results for the interim
periods. All such adjustments are of a normal recurring nature.
The
results for the three months’ period ended March 31, 2026 are not necessarily indicative of the results to be expected for the
year ending December 31, 2026 or for any other interim period or for any future period.
Use
of Estimates
The
preparation of the condensed consolidated financial statements in conformity with U.S. 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 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 quarter. Gains or losses resulting from translation adjustments
are reflected in stockholders’ equity, under “Accumulated other comprehensive income.”
10
Principles
of Consolidation
The
condensed consolidated financial statements include the accounts of the Company and its subsidiary. All intercompany balances and transactions
have been eliminated in consolidation.
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 March 31, 2026, and December 31, 2025, the Company held 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.
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.
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 Company’s 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.
11
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 Entity’s 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 Company’s 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 warrant 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. During the three months ended March 31, 2026, the Company recognized a reduction to the change in fair
value of derivative liabilities of $ 1 . During the three months ended March 31, 2025, the Company recognized $ 3,376 to the change in fair
value of derivative liabilities.
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 shares of Common Shares outstanding
for the period. The Company’s diluted net loss per share of Common Stock is the same as its basic net loss per 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 March 31, 2026 and 2025, stock options and shares issuable upon
the conversion of warrants of 2,214,800 and 3,535,505 , respectively, have been excluded from the computation of diluted shares outstanding.
Schedule of Anti Dilutive Securities
2026
2025
March 31,
2026
2025
Common stock options
16,499
16,436
Shares issuable upon the conversion of warrants
2,198,301
3,519,069
Total
2,214,800
3,535,505
12
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.
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 Company’s 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 Company’s 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 its 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.
3.
Significant Transactions
A
– Promissory Note
On
September 12, 2025 (the “Issue Date”), the Company entered into a Note Purchase Agreement (the “Note Purchase Agreement”),
with an investor (the “Note 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 Company’s 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.
During
the three months ended March 31, 2026, the Company amortized $ 148 of the original issue discount to interest expense. As of March 31,
2026, the unamortized discount was $ 270 , and the carrying amount of the Note was $ 3,330 .
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 Company’s Common Stock (the “Purchase Shares”), subject to the terms and conditions
set forth therein. Pursuant to the Note Purchase Agreement, the Company was 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 the Company obtained stockholder approval
(the “Stockholder Approval”) to issue Purchase Shares in excess of the “Exchange Cap,” as defined in the ELOC.
The Company obtained Stockholder Approval on March 12, 2026. 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.
13
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”).
B
– Equity and Common Issuances
Current
Year
ELOC
Financing
On
March 27, 2026, the Company sold 580,000 shares of Common Stock at an average offering price of $ 1.03 per share pursuant to the ELOC
for net proceeds of $ 590 , after deducting fees from such sale.
Exercise
of Pre-Funded Warrants
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.
During
the three months ended March 31, 2026, the Company received $ 1 from the exercise of 1,033,591 Pre-Funded Warrants.
Prior
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 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 $ 3,642 , after deducting fees owed to the Agent from such sale.
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 43,967 shares of Common Stock at an offering price of $ 69.00 per share for net proceeds of
$ 2,752 , after deducting fees owed to the placement agent and other offering expenses.
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.
14
C
– Warrant Net Share Exchange into Common Stock
Prior
Year
As
previously disclosed, on November 12, 2024, the Company commenced a best efforts public offering, and concurrent with the offering entered
into a private placement, collectively (the “2024 November Offerings”) where the Company issued an aggregate of (i) 8,359
Series A Warrants (the “Series A Warrants”) and (ii) 8,359 Series B Warrants (the “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 $ 6.17 . The Series B warrant assumptions used in the Monte Carlo simulations are an expected
term of 2.5 years, an exercise price of $ 36.20 , company historical volatility of 378.6 %, risk-free interest rate of 4.30 % and share price
of $ 370.20 .
During
the three months’ period ended March 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 162,062 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 exercise of the
Series B Warrants, the fair value of the warrants exercised as of the settlement dates of $ 20,621 was classified to equity under additional
paid-in capital.
In
addition, the remaining 11 Series B Warrants and 54,032 Series A Warrants were revalued as of March 31, 2025, resulting in a reduction
to the warrant liability of $ 2,370 .
4.
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 Company’s 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 March 31, 2026, the remaining contingent liability with respect to royalty payment on future sales
equals approximately $ 93 excluding interest. Such contingent obligation has no expiration date.
15
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 Company’s 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. As of March 31, 2026, the remaining milestones were not considered probable, and no additional compensation
expense had been recorded.
5.
Subsequent Events
Subsequent
to March 31, 2026, the Company repaid the Note Investor 50 % of the net proceeds received from equity sales completed
under the ELOC during the three months ended March 31, 2026.
During
April 2026, the Company raised approximately $ 115 in gross proceeds from the issuance of 180,000 shares of Common Stock pursuant to the
ELOC facility. Net proceeds, after fees and the 50 % repayment to the Note Investor, was approximately $ 56 .
During
May 2026, the Company raised approximately $ 987 in gross proceeds from the issuance of 1,300,000 shares of Common Stock pursuant to the
ELOC facility. Net proceeds, after fees, was approximately $ 972 , as the Note Investor waived the 50 % note repayment fee.
On
April 13, 2026, the Company entered into an Exchange Agreement (the “First Exchange Agreement”) with the Note Investor relating
to the existing promissory Note (the “Original Note”) previously issued to the Note Investor in the principal amount of $ 3,600 .
Pursuant
to the First Exchange Agreement, the Company and the Note Investor partitioned a new promissory note in the original principal amount
of $ 600 (the “First Partitioned Note”) from the Original Note. Following such partition, the outstanding balance of the
Original Note was reduced by an amount equal to the initial outstanding balance of the First Partitioned Note, and the Original Note
otherwise remains in full force and effect in accordance with its terms.
16
Under
the Exchange Agreement, the Company and the Note Investor further agreed to exchange the Partitioned Note for an aggregate of 895,000
shares of the Company’s Common Stock (the “Exchange Shares”). The exchange consisted solely of the surrender and cancellation
of the First Partitioned Note in exchange for the issuance of the Exchange Shares, with no cash or other consideration paid by the Investor.
On
April 29, 2026, the Company entered into a Second Exchange Agreement (the “Second Exchange Agreement” and together with the
First Exchange Agreement, the “Exchange Agreements”) with the Note Investor relating to the Original Note (such note previously
issued to the Investor in the principal amount of $ 3,600 , with such principal subsequently reduced by $ 600 pursuant to the First
Exchange Agreement).
Pursuant
to the Second Exchange Agreement, the Company and the Note Investor partitioned a new promissory note in the original principal amount
of $ 988 (the “Second Partitioned Note” and together with the First Partitioned Note, the “Partitioned Notes”)
from the Original Note. Following such partition, the outstanding balance of the Original Note was reduced by an amount equal to the
initial outstanding balance of the Second Partitioned Note, and the Original Note otherwise remains in full force and effect in accordance
with its terms.
Under
the Exchange Agreement, the Company and the Investor further agreed to exchange the Second Partitioned Note for an aggregate of 1,300,000
Exchange Shares. The exchange consisted solely of the surrender and cancellation of the Second Partitioned Note in exchange for the issuance
of the Exchange Shares, with no cash or other consideration paid by the Note Investor.
The
issuance of the Exchange Shares from the April 13 th and April 29 th Exchange Agreements is subject to a beneficial
ownership limitation, which generally restricts the Company from issuing shares to the Note Investor to the extent that such issuance
would cause the Note Investor and its affiliates to beneficially own more than 19.9% of the Company’s outstanding Common Stock,
calculated in accordance with Section 13(d) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). To the
extent the limitation applies, the Exchange Shares may be issued in one or more tranches, and any portion of a Partitioned Note not exchanged
as a result of the limitation will remain outstanding and exchangeable in accordance with the terms of the applicable Exchange Agreement.
The
Partitioned Notes were issued in a private placement to the Note 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”). The Exchange
Shares were issued pursuant to the exemption from the registration requirements of the Securities Act provided by Section 3(a)(9) of
the Securities Act, on the basis that (a) the Exchange Shares were issued in exchange for other outstanding securities of the Company;
(b) there was no additional consideration delivered by the Note Investor in connection with the exchange; and (c) there were no commissions
or other remuneration paid by the Company in connection with the exchanges.
In
addition, subsequent to March 31, 2026, pre-funded warrants to purchase 60,000 shares of Common Stock previously issued to the ELOC investor
as a commitment fee, were exercised, resulting in the issuance of 60,000 shares of Common Stock.
Nasdaq
Listing Status
On
May 11, 2026, the Company received a Staff Determination letter (the “Staff Determination”) from the Listing Qualifications
Department of Nasdaq notifying the Company that Nasdaq staff (the “Nasdaq Staff”) has determined to delist its Common Stock
from The Nasdaq Capital Market.
The
Staff Determination stated that the bid price of the Common Stock had closed at less than $ 1.00 per share over the previous 30 consecutive
business days, from March 27, 2026 through May 8, 2026, and that, as a result, the Company is not in compliance with Nasdaq Listing Rule
5550(a)(2), which requires listed securities to maintain a minimum bid price of $ 1.00 per share (the “Bid Price Rule”).
The
Staff Determination further stated that, although companies are typically afforded a 180-calendar day period to regain compliance with
the Bid Price Rule, the Company is not eligible for any such compliance period pursuant to Nasdaq Listing Rule 5810(c)(3)(A)(iv). Nasdaq
Staff cited the fact that t he Company has effected a reverse stock split over the prior one-year period and have effected one or more
reverse stock splits over the prior two-year period with a cumulative ratio of 250 shares or more to one. Accordingly, unless the
Company requests an appeal by May 18, 2026, its Common Stock will be scheduled for delisting and suspended at the opening of business
on May 20, 2026.
The
Company intends to timely request a hearing before a Nasdaq Hearings Panel (the “Panel”) to appeal Nasdaq Staff’s
determination. A timely hearing request will stay any further delisting actions through the hearing process. At the hearing,
the Company expects to present its plan to regain compliance with the Bid Price Rule. The Company intends to continue to monitor the
closing bid price of its Common Stock and will consider available options to regain compliance with the Bid Price Rule, including
potentially implementing a reverse stock split (if approved by the Company’s stockholders). There can be no assurance that the
Company will be successful in its appeal, that the Panel will grant the Company’s request for continued listing, or that the
Company will be able to regain compliance with the Bid Price Rule or maintain compliance with other applicable Nasdaq listing
requirements. Please refer to “ Risk Factors — 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 Part II, Item 1A of this Quarterly Report for more
information.
17
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Cautionary
Note Regarding Forward-Looking Statements
This
Quarterly Report on Form 10-Q (the “Quarterly Report”) contains forward-looking statements. These forward-looking statements
include statements about our expectations, beliefs or intentions regarding our product development efforts, business, financial condition,
results of operations, strategies and prospects. All statements other than statements of historical fact included in this Quarterly Report,
including statements regarding our future activities, events or developments, including such things as future revenues, capital raising
and financing, product development, clinical trials, regulatory approval, market acceptance, responses from competitors, capital expenditures
(including the amount and nature thereof), business strategy and measures to implement strategy, competitive strengths, goals, expansion
and growth of our business and operations, plans, references to future success, projected performance and trends, and other such matters,
are forward-looking statements. The words “believe,” “expect,” “anticipate,” “intend,”
“estimate,” “plan,” “may,” “will,” “could,” “would,” “should”
and other similar words and phrases, are intended to identify forward-looking statements. The forward-looking statements made in this
Quarterly Report are based on certain historical trends, current conditions and expected future developments as well as other factors
we believe are appropriate in the circumstances. These statements relate only to events as of the date on which the statements are made
and we undertake no obligation to update publicly any forward-looking statements, whether as a result of new information, future events
or otherwise, except as required by law. All of the forward-looking statements made in this Quarterly Report are qualified by these cautionary
statements and there can be no assurance that the actual results anticipated by us will be realized or, even if substantially realized,
that they will have the expected consequences to or effects on us or our business or operations. Whether actual results will conform
to our expectations and predictions is subject to a number of risks and uncertainties that may cause actual results to differ materially.
Risks and uncertainties, the occurrence of which could adversely affect our business, include the risks identified under the caption
“Risk Factors” included in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the U.S. Securities
and Exchange Commission (the “SEC”) on March 30, 2026 (the “Annual Report”). The following discussion should
be read in conjunction with the condensed consolidated financial statements and the notes thereto included in Item 1 of this Quarterly
Report.
Overview
The
Company was incorporated on May 18, 2010 under the laws of the State of Delaware. The Company is 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 one’s 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 is 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 Company’s
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 patients using insulin
or at risk for hypoglycemia. Implant longevity is key to the success of such a device. The Company has demonstrated 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. During the period, two peer-reviewed scientific articles
were published related to the CBGM technology. One article, published in the IEEE Sensors Journal, characterized the long-term in-vitro
stability of electrochemical glucose sensors of the type used in the CBGM system, including the first year-long measurements of glucose
oxidase enzyme decay reported in the literature. A second peer-reviewed article, published in The Journal of Diabetes Research, evaluated
the long-term accuracy and stability of the CBGM system in an in-vivo ovine model, providing externally validated evidence supporting
the long-term performance of the technology. 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.
18
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.
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.
Subsequent
to March 31, 2026, the Company submitted an Investigational Device Exemption (“IDE”) application to the U.S. Food and Drug
Administration (“FDA”) to initiate a U.S. clinical study of its CBGM technology. The IDE submission represents an important
milestone for the Company and reflects progress in its preclinical development and underlying technical foundation. The Company has also
engaged a clinical research organization and identified trial sites in preparation for study commencement.
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.
Recent
Events
2025
Reverse Stock Split and Increase in Authorized Common Stock
We
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 “2025 Reverse Stock Split”) of the
shares of our Common Stock. The 2025 Reverse Stock Split was approved by our stockholders at the special meeting of stockholders held
on January 3, 2025 (the “Special Meeting”). All shares and per share numbers in the consolidated financial statements have
been retroactively adjusted and are reflected on a post-reverse share split basis.
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). On January 3, 2025, we filed an amendment to our Certificate of Incorporation, as to increase the Company’s
authorized shares of Common Stock from 100,000,000 to 250,000,000.
19
ELOC
Financing
On
March 12, 2026, the Company received stockholder approval to issue Purchase Shares in excess of the “Exchange Cap,” as defined
in the ELOC. On March 27, 2026, the Company sold 580,000 shares of Common Stock at an average offering price of $1.03 per share pursuant
to the ELOC for net proceeds of $590, after deducting fees from such sale.
Resignation
of Peter C. Wulff as Chief Financial Officer
Mr.
Wulff resigned as Chief Financial Officer of the Company on March 31, 2026.
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 as 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
The
following discussion of our operating results explains material changes in our results of operations for the three months ended March
31, 2026 compared with the same period ended March 31, 2025. The discussion should be read in conjunction with the financial statements
and related notes included elsewhere in this report.
Consolidated
Results of Operations for the Three Months Ended March 31, 2026 and 2025
All
information below is stated in thousands of U.S. dollars.
Research
and Development Expense
Research
and development expenses were $2,132 for the three months ended March 31, 2026, as compared to $1,871 for the prior-year period. The
increase of $261 was primarily attributable to increased expenses related to product design, development and manufacturing activities
and pre-clinical animal studies.
20
General
and Administrative Expense
General
and administrative expenses were $2,071 for the three months ended March 31, 2026, as compared to $1,627 for the prior-year period. The
increase of $444 is primarily attributable to increased professional fees and personnel costs.
Other
(Income) Expense, net
Other
expense was $131 for the three months ended March 31, 2026, as compared to $3,335 for the prior-year period. The decrease in other expense
is primarily attributed to the current year reduction in the change of derivative liabilities.
Net
Loss
Net
loss was $4,334 for the three months ended March 31, 2026, as compared to a net loss of $6,833 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 March 31, 2026, we had $3,929 in cash and cash equivalents compared with $7,383 in cash and cash equivalents as of December 31, 2025.
The net decrease in cash and cash equivalents was attributable to $4,048 of cash used in operating activities offset by net proceeds
received from financing activities of $591.
We
have a history of recurring losses, and as of March 31, 2026, we have an accumulated deficit of $156,172. During the three months ended
March 31, 2026, we recorded a net loss of $4,334. 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 March 31, 2026, 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 on 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.
Critical
Accounting Policies
This
Management’s Discussion and Analysis of Financial Condition and Results of Operations discuss our financial statements, which have
been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”).
In connection with the preparation of our financial statements, we are required to make assumptions and estimates about future events
and apply judgments that affect the reported amounts of assets, liabilities, expenses and the related disclosures. We base our assumptions,
estimates and judgments on historical experience, current trends and other factors that management believes to be relevant at the time
our condensed consolidated financial statements are prepared. On a regular basis, management reviews the accounting policies, assumptions,
estimates and judgments to ensure that our financial statements are presented fairly and in accordance with U.S. GAAP. However, because
future events and their effects cannot be determined with certainty, actual results could differ from our assumptions and estimates,
and such differences could be material.
The
summary of our significant accounting policies is included under Item 7 – Management’s Discussion and Analysis of Financial
Condition and Results of Operations of our Annual Report. An accounting policy is deemed to be critical if it requires an accounting
estimate to be made based on assumptions about matters that are highly uncertain at the time the estimate is made, if different estimates
reasonably could have been used, or if changes in the estimate that are reasonably possible could materially impact the financial statements.
There have been no material changes to the critical accounting policies and estimates as filed in such report.
21
Off
Balance Sheet Arrangements
We
do not have any off balance sheet agreements.
Item
3. Quantitative and Qualitative Disclosures About Market Risk.
As
a smaller reporting company, we are not required to provide the information required by this Item.
Item
4. Controls and Procedures.
Evaluation
of Disclosure Controls and Procedures
Our
principal executive and financial officer has evaluated the effectiveness of our disclosure controls and procedures (as such term is
defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of March 31, 2026 (the “Evaluation Date”). Based on such
evaluation, our principal executive and financial officer has concluded that, as of the Evaluation Date, our disclosure controls and
procedures are not effective in recording, processing, summarizing and reporting, on a timely basis, information required to be included
in periodic filings under the Exchange Act and that such information is not accumulated and communicated to management, including our
principal executive officer, in a manner sufficient to allow timely decisions regarding required disclosure.
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. 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. None of these
deficiencies resulted in a material misstatement to the Company’s interim and annual Consolidated Financial Statements for the
periods ended March 31, 2026 and 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 Company’s 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 Company’s
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 March 31, 2026, that has materially
affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting.
22
PART
II - OTHER INFORMATION
Item
1. Legal Proceedings.
From
time to time in the ordinary course of business, the Company may be subject to various claims, charges, and litigation. As of March 31,
2026, the Company did not have any pending claims, charges or litigation that were expected to have a material adverse impact on its
financial position, results of operations or cash flows.
Item
1A. Risk Factors.
You
should carefully consider the factors discussed in Part I, Item 1A., “Risk Factors” in our Annual Report, which could
materially affect our business, financial position, or future results of operations. Except as disclosed below, there have been no
material changes from the risk factors previously disclosed under the heading “Risk Factors” in our Annual Report. The
risks described in our Annual Report are not the only risks we face. Additional risks and uncertainties not currently known to us or
that we currently deem to be immaterial may also materially adversely affect our business, financial position, or future results of
operations. We may disclose changes to such factors or disclose additional factors from time to time in our future filings with the
SEC.
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”).
On
May 11, 2026, we received a Staff Determination letter (the “Staff Determination”) from the Listing Qualifications Department
of Nasdaq notifying us that Nasdaq staff (the “Nasdaq Staff”) has determined to delist our Common Stock from The Nasdaq Capital
Market.
The
Staff Determination stated that the bid price of the Common Stock had closed at less than $1.00 per share over the previous 30 consecutive
business days, from March 27, 2026 through May 8, 2026, and that, as a result, we are not in compliance with Nasdaq Listing Rule 5550(a)(2),
which requires listed securities to maintain a minimum bid price of $1.00 per share (the “Bid Price Rule”).
The
Staff Determination further stated that, although companies are typically afforded a 180-calendar day period to regain compliance with
the Bid Price Rule, the Company is not eligible for any such compliance period pursuant to Nasdaq Listing Rule 5810(c)(3)(A)(iv). Nasdaq
Staff cited the fact that we have effected a reverse stock split over the prior one-year period and have effected one or more reverse
stock splits over the prior two-year period with a cumulative ratio of 250 shares or more to one. Accordingly, unless we request
an appeal by May 18, 2026, our Common Stock will be scheduled for delisting and suspended at the opening of business on May 20, 2026.
We
intend to timely request a hearing before a Nasdaq Hearings Panel (the “Panel”) to appeal Nasdaq Staff’s
determination. A timely hearing request will stay any further delisting actions through the hearing process. At the hearing, we
expect to present our plan to regain compliance with the Bid Price Rule. We intend to continue to monitor the closing bid price of
our Common Stock and will consider available options to regain compliance with the Bid Price Rule, including potentially
implementing a reverse stock split (if approved by our stockholders). There can be no assurance that we will be successful in our
appeal, that the Panel will grant our request for continued listing, or that we will be able to regain compliance with the Bid Price
Rule or maintain compliance with other applicable Nasdaq listing requirements.
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 issuer’s
listed securities, as measured by each applicable trading day’s closing price, continues to be less than $5 million for a period
of 30 consecutive trading days, the issuer’s securities would immediately be delisted, with no compliance or cure period. The proposed
rule would also preclude an issuer’s 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 management’s 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 regain compliance with the Bid Price Rule or maintain compliance with the other 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.
23
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.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds.
(a)
During the quarter ended March 31, 2026, there were no unregistered sales of our securities that were not reported in a Current Report
on Form 8-K.
(b)
Not applicable.
(c)
None.
Item
3. Defaults Upon Senior Securities
None.
Item
4. Mine Safety Disclosures
Not
applicable.
Item
5. Other Information
None.
24
Item
6. Exhibits.
Exhibit
No.
Description
3.1
Certificate of Incorporation of Integrity Applications, Inc. (incorporated by reference to Exhibit 3.1 to the Company’s Registration Statement on Form S-1 filed with the SEC 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 Company’s Registration Statement on Form S-1 filed with the SEC on August 22, 2011)
3.3
Bylaws of Integrity Applications, Inc. (incorporated by reference to Exhibit 3.3 to the Company’s Registration Statement on Form S-1 filed with the SEC 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 Company’s Current Report on Form 8-K filed with the SEC on April 23, 2020)
3.5
Amendments to The Company’s Certificate of Incorporation (incorporated by reference to Exhibit 3.7 to the Company’s Annual Report on Form 10-K, filed with the SEC on March 31, 2022)
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)
10.1
Separation Agreement and Release, dated March 27, 2026, by and between the Company and Peter C. Wulff (incorporated by reference to Exhibit 10.18 to the Annual Report on Form 10-K filed by Glucotrack, Inc. on March 30, 2026)
31.1*
Certification of Principal Executive 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
101.INS*
Inline
XBRL Instance Document
101.SCH*
Inline
XBRL Schema Document
101.CAL*
Inline
XBRL Calculation Linkbase Document
101.LAB*
Inline
XBRL Label Linkbase Document
101.PRE*
Inline
XBRL Presentation Linkbase Document
101.DEF*
Inline
XBRL Definition Linkbase Document
104
Cover
Page Interactive Data File (embedded within the Inline XBRL document)
*
Filed
or furnished herewith.
25
SIGNATURES
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.
Dated:
May 14, 2026
GLUCOTRACK,
INC.
By:
/s/
Paul V. Goode
Name:
Paul
V. Goode
Title
Chief
Executive Officer
(Principal
Financial Officer)
26
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.