UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
| QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |
| For
the quarterly period ended |
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:
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) | |
| (Address of principal executive offices) | (Zip Code) |
(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 | ||
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.
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).
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 ☐ | ||
| 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 August 14, 2025, shares of the Company’s common stock, par value $ per share, were outstanding.
GLUCOTRACK INC.
TABLE OF CONTENTS
| 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, 2024, 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
(in thousands of US dollars except share data)
In thousands of US dollars (except stock data) | ||||||||
| June 30, 2025 | December 31, 2024 | |||||||
| Unaudited | ||||||||
| Current Assets | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Other current assets | ||||||||
| Total current assets | ||||||||
| Operating lease right-of-use asset, net | ||||||||
| Property and equipment, net | ||||||||
| Restricted cash | ||||||||
| TOTAL ASSETS | $ | $ | ||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | ||||||||
| Current Liabilities | ||||||||
| Accounts payable | $ | $ | ||||||
| Operating lease liability, current | ||||||||
| Convertible promissory notes | ||||||||
| Other current liabilities | ||||||||
| Total current liabilities | ||||||||
| Non-Current Liabilities | ||||||||
| Derivative financial liabilities (Note 2F and Note 3B) | ||||||||
| Operating lease liability, non-current | ||||||||
| Loans from stockholders | ||||||||
| Total liabilities | $ | $ | ||||||
| Commitments and contingent liabilities (Note 4) | ||||||||
| Stockholders’ Equity (Deficit) | ||||||||
| Common Stock of $ par value (“Common Stock”): | ||||||||
| and shares authorized as of June 30, 2025 and December 31, 2024, respectively; and shares issued and outstanding as of June 30, 2025 and December 31, 2024, respectively | (*) | |||||||
| Additional paid-in capital | ||||||||
| Receipts on account of shares | ||||||||
| Accumulated other comprehensive income | ( | ) | ||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Total stockholders’ equity (deficit) | ( | ) | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | $ | $ | ||||||
| (*) |
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)
| Six-month period ended June 30, | Three-month period ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Operating expenses | ||||||||||||||||
| Research and development expenses | $ | $ | $ | $ | ||||||||||||
| General and administrative expenses | ||||||||||||||||
| Marketing expenses | ||||||||||||||||
| Total operating expenses | ||||||||||||||||
| Operating loss | ||||||||||||||||
| Other (income) expense | ||||||||||||||||
| Change in fair value of derivative Liabilities | ( | ) | ||||||||||||||
| Other (income) expense, net | ||||||||||||||||
| Finance income, net | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Net Loss | ||||||||||||||||
| Other comprehensive income: | ||||||||||||||||
| Foreign currency translation adjustment | ( | ) | ( | ) | ( | ) | ||||||||||
| Comprehensive loss for the period | $ | $ | $ | $ | ||||||||||||
| Basic and diluted net loss per common stock | $ | $ | $ | $ | ||||||||||||
| Weighted average number of common stock used in computing basic and diluted loss per common stock | ||||||||||||||||
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
(in thousands of US Dollars except share data) (unaudited)
| In thousands of US Dollars (except share data) | ||||||||||||||||||||||||||||
| Common Stock |
| Accumulated | ||||||||||||||||||||||||||
| Numbers of Shares | Amount | Additional Paid-in | Receipts on account
|
Other Comprehensive
| Accumulated Deficit | Total Stockholders’ | ||||||||||||||||||||||
| Balance as of December 31, 2024 (Audited) | $ | (*) | $ | $ | | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||||||||||||
| Loss for the period | - | ( | ) | ( | ) | |||||||||||||||||||||||
| Other comprehensive income | - | |||||||||||||||||||||||||||
| Stock-based compensation | - | |||||||||||||||||||||||||||
| Issuance of common stock upon the completion of public offerings, net of offering expenses of $ | ||||||||||||||||||||||||||||
| Stock split adjustment | (*) | |||||||||||||||||||||||||||
| Cashless exchange of warrants into common shares | (*) | |||||||||||||||||||||||||||
| Balance as of June 30, 2025 (Unaudited) | $ | $ | $ | $ | $ | ( | ) | $ | ||||||||||||||||||||
| Balance as of December 31, 2023 (Audited) | $ | (*) | $ | $ | $ | $ | ( | ) | $ | |||||||||||||||||||
| Loss for the period | - | ( | ) | ( | ) | |||||||||||||||||||||||
| Other comprehensive income | - | |||||||||||||||||||||||||||
| Stock-based compensation | - | |||||||||||||||||||||||||||
| Issuance of restricted shares as compensation towards directors | (*) | ( | ) | |||||||||||||||||||||||||
| Restricted shares to be issued as compensation towards directors | - | |||||||||||||||||||||||||||
| Issuance of Common Stock upon private placement transaction | (*) | |||||||||||||||||||||||||||
| Issuance of restricted shares as payment for a previous achievement of milestone pursuant to purchase agreement | (*) | |||||||||||||||||||||||||||
| Exercise of prefunded warrants into shares | (*) | |||||||||||||||||||||||||||
| Exchange of warrants into shares | (*) | |||||||||||||||||||||||||||
| Issuance of warrants through private placement transaction | - | |||||||||||||||||||||||||||
| Balance as of June 30, 2024 (Unaudited) | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||||||||
| Balance as of March 31, 2025 (Unaudited) | $ | (*) | $ | $ | $ | $ | ( | ) | $ | |||||||||||||||||||
| Loss for the period | - | ( | ) | ( | ) | |||||||||||||||||||||||
| Other comprehensive income | - | |||||||||||||||||||||||||||
| Stock-based compensation | - | |||||||||||||||||||||||||||
| Issuance of common stock upon the completion of public offerings, net of offering expenses | (*) | |||||||||||||||||||||||||||
| Stock split adjustment | (*) | |||||||||||||||||||||||||||
| Balance as of June 30, 2025 (Unaudited) | $ | $ | $ | $ | $ | ( | ) | $ | ||||||||||||||||||||
| Balance as of March 31, 2024 (Unaudited) | $ | (*) | $ | $ | $ | $ | ( | ) | $ | |||||||||||||||||||
| Loss for the period | - | ( | ) | ( | ) | |||||||||||||||||||||||
| Issuance of restricted shares as compensation towards directors | (*) | ( | ) | |||||||||||||||||||||||||
| Stock-based compensation | - | |||||||||||||||||||||||||||
| Issuance of common stock upon private placement transaction | (*) | |||||||||||||||||||||||||||
| Restricted shares to be issued as compensation towards directors | - | |||||||||||||||||||||||||||
| Issuance of warrants through private placement transaction | - | |||||||||||||||||||||||||||
| Balance as of June 30, 2024 (Unaudited) | $ | $ | $ | $ | | $ | ( | ) | $ | ( | ) | |||||||||||||||||
| (*) |
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)
Six-month period ended June 30, | ||||||||
| 2025 | 2024 | |||||||
| (Unaudited) | ||||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
| Loss for the period | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation and amortization | ||||||||
| Stock-based compensation | ||||||||
| Issuance of restricted shares as compensation towards directors | ||||||||
| Linkage difference on principal of loans from stockholders | ( | ) | ||||||
| Change in fair value of derivative liability | ||||||||
| Amortization of debt discount and interest expense related to promissory notes | ||||||||
| Loss on warrant repurchase | ||||||||
| Changes in assets and liabilities: | ||||||||
| Other current assets | ( | ) | ||||||
| Accounts payable | ||||||||
| Other current liabilities | ||||||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| CASH FLOWS FROM INVESTING ACTIVITIES: | ||||||||
| Purchase of property and equipment | ( | ) | ( | ) | ||||
| Net cash used in investing activities | ( | ) | ( | ) | ||||
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
| Net proceeds from underwritten U.S. public offerings (Note 3A) | ||||||||
| Series A warrant repurchase | ( | ) | ||||||
| Issuance of notes and warrants through private placement transaction | ||||||||
| Net proceeds from private placement transaction | ||||||||
| Net cash provided by financing activities | ||||||||
| Effect of exchange rate changes on cash and cash equivalents, and restricted cash | ||||||||
| Change in cash and cash equivalents, and restricted cash | ( | ) | ||||||
| Cash and cash equivalents, and restricted cash at beginning of the period | ||||||||
| Cash and cash equivalents, and restricted cash, end of period | $ | $ | ||||||
Six-month period ended June 30, | ||||||||
| 2025 | 2024 | |||||||
| (Unaudited) | ||||||||
| Supplemental disclosure of cash flow activities: | ||||||||
| (a) Net cash paid during the quarter for: | ||||||||
| Interest | $ | $ | ||||||
| (b) Non-cash activities: | ||||||||
| Recognition of right for usage asset against a lease liability | $ | $ | ||||||
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)
NOTE 1 – GENERAL
| A. | The Company was incorporated on May 18, 2010 under the laws of the State of Delaware. The Company is currently developing an implantable continuous blood glucose monitor (“CBGM”). The Glucotrack CBGM is a long-term fully implantable continuous glucose monitor (CGM), consisting of a sensor lead implanted into the subclavian vein and connected to subcutaneous electronics that communicate with a mobile application. It measures glucose directly from the blood, eliminating the lag time associated with interstitial fluid glucose monitors. Designed for a three-year sensor life with continuous, accurate blood glucose monitoring, the system offers a more convenient and less burdensome solution for people with diabetes, with no on-body wearable component and minimal calibration requirements.
The Glucotrack CBGM is being developed for use by diabetes patients who are dependent on daily glucose monitoring to manage their disease. These include patients who have the following conditions: Type 1 diabetes, Type 2 insulin-dependent diabetes, Type 2 diabetes using basal insulin and Type 2 diabetes at risk for hypoglycemia.
The Company has continued to evolve its sensor chemistry following the results of an initial in-vitro feasibility study. In 2024, 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 that implant accuracy and longevity is key to the success for long term use.
The Company initiated a first-in-human (“FIH”) short-term clinical study outside of the United States in fourth quarter of 2024 and completed the study in first quarter of 2025. The Company recently presented results at the 2025 American Diabetes Association annual conference at the Innovation Hub podium as well as a poster. The ADA presentation reported that the FIH clinical study met all primary and secondary endpoints with no procedure or device related serious adverse events reported from implant through seven days post-removal of the CBGM sensor lead. The system also demonstrated excellent accuracy with a Mean Absolute Relative Difference (MARD) of 7.7% across 122 matched pairs, a 99% data capture rate, and no procedure or device-related serious adverse events. These findings validate the safety and performance of the system which measures glucose from blood rather than interstitial fluid, eliminating the typical lag time associated with traditional continuous glucose monitoring systems. The MARD value demonstrates very high accuracy and compares favorably to commercially available CGM systems. The FIH study also confirmed the function of the CBGM sensor lead in the subclavian vein. Placement and removal procedures were successfully performed by interventional cardiologists.
The Company is preparing for a long-term clinical study outside the United States to evaluate the device’s performance and safety over an initial period of 1 year. The Company obtained regulatory approval during the second quarter 2025 and patient enrollment is expected to begin in the third quarter of 2025.
During the second quarter 2025, the Company initiated discussions with the Food & Drug Administration (“FDA”) in preparations for a pre-investigational device exemption (“IDE”) submission. The discussions pertain to the protocol study design and related requirements to secure IDE approval for future long-term human clinical trials in the United States. The Company expects to file the IDE submission to the FDA during the fourth quarter of 2025.
The Company believes its technology, if successful, has the potential to be a long-term, implantable system that continually measures blood glucose levels with a sensor longevity of 3 years, no on-body wearable component and with minimal calibration. |
| B. | 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 June 30, 2025, the Company has incurred an accumulated deficit of $ | |
| During
the six months ended June 30, 2025, the Company raised $ | |
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. | |
| C. | 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
On January 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 to . On February 3, 2025, the stockholders approved at the Special Meeting the increase in the Company’s authorized shares of Common Stock from to , 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.
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
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. |
| 8 |
GLUCOTRACK INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
(in thousands of US Dollars)
NOTE 2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
A. 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, 2024, as was filed with the Securities Exchange Commission, (the “SEC”) on March 31, 2025. 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 U.S. Generally Accepted Accounting Principles, (or “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 and six month periods ended June 30, 2025 are not necessarily indicative of the results to be expected for the year ending December 31, 2025 or for any other interim period or for any future period. |
B. Use of Estimates in the Preparation of Financial Statements
| 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. |
C. Principles of Consolidation
| The condensed interim consolidated financial statements include the accounts of the Company and its subsidiary. Significant intercompany balances and transactions have been eliminated in consolidation. |
D. Cash and Cash Equivalents
| Cash
equivalents are short-term highly liquid investments which include short term bank deposits (up to three months from the date of
deposit), that are not restricted as to withdrawals or use that are readily convertible to cash with maturities of three months or
less as of the date acquired. As June 30, 2025 and December 31, 2024, the Company held |
E. 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.
Warrants classified as derivative liabilities
Upon initial recognition of Series A Warrants and 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. |
| 9 |
GLUCOTRACK INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
(in thousands of US Dollars)
NOTE 2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (CONT.)
F. 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. ASC Topic 825-10, establishes the following fair value hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value: |
| ● | 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.
There were no Level 3 assets or liabilities for the six months ended June 30, 2024. 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 three and six months ended June 30, 2025:
Fair Value of Significant Unobservable Inputs (Level 3)
| Warrant | ||||
| Liability | ||||
| Balance – November 14, 2024 – Warrant issuance date | $ | |||
| Fair value adjustments – Derivative financial liability | ||||
| Balance – December 31, 2024 | $ | |||
| Fair value adjustments – Derivative financial liability | ||||
| Cashless exchange of warrants into common shares | ( | ) | ||
| Balance – March 31, 2025 | $ | |||
| Fair value adjustments – Derivative financial liability | ( | ) | ||
| Series A Warrant repurchase | ( | ) | ||
| Balance – June 30, 2025 | $ | |||
G. 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 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.
The Company adheres to the provisions of ASC 280, Segment Reporting, which establishes standards for the way public business enterprises report information about operating segments in annual financial statements and requires that those enterprises report selected information about operating segments in financial statements issued to shareholders. As the Company is currently involved in the development of one product, the Platform, the Company has determined that it operates in a single reportable segment. The Company’s Chief Operating Decision Maker (CODM), its Chief Executive Officer (CEO), reviews the consolidated results of operations when making decisions about allocating resources and assessing the performance of the Company as a whole and, hence, the Company has only one reportable segment. The Company’s assets are located in the United States of America. |
| Basic net loss per common share is computed as net loss divided by the weighted average number of common shares outstanding for the period. The Company’s 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 June 30, 2025 and 2024, stock options and shares issuable upon the conversion of warrants of and , respectively, have been excluded from the computation of diluted shares outstanding. |
| June 30, | ||||||||
| 2025 | 2024 | |||||||
| Common stock options | ||||||||
| Shares issuable upon the conversion of warrants | ||||||||
| Total | ||||||||
| 10 |
GLUCOTRACK INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)(CONT.)
(in thousands of US Dollars)
NOTE 3 - 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 $
On
March 21, 2025, the Company sold shares of Common Stock at an average offering price of $ per share pursuant to the
Sales Agreement for net proceeds of $
During
the three months ended June 30, 2025, the Company sold shares of Common Stock at an average offering price of $ per
share pursuant to the Sales Agreement for net proceeds of $
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 shares of Common Stock at an offering price of $ per share for
gross proceeds of $
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.
Prior Year
April 2024 Private Equity Offering
On
April 22, 2024, the Company entered into a private placement agreement under which the Company issued shares of its common stock
at a price of $ per share for aggregate gross proceeds of $
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 gross proceeds of $
In a private placement offering completed concurrently
with the Equity Offering (the “Concurrent Private Offering”), the Company converted approximately $
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 $ | |
| B. | Warrant Net Share Exchange into Common Stock and Warrant Repurchase |
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”) whereas the Company issued an aggregate of (i) Series A Warrants and (ii) 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 shares to shares, respectively.
The
Company accounted for the
During
the three months’ period ended March 31, 2025, there were cashless exchanges of an aggregate
On
June 30, 2025, the Company repurchased of its Series A Warrants form existing warrant holders for $
During
the three and six month period ending June 30, 2025, the Company recognized a change in fair value of derivative liabilities of $
As
of June 30, 2025, |
| C. | Note and Warrant Purchase Agreements |
On
June 27, 2024, the Board of Directors approved the Company to enter into note and warrant
purchase agreements with certain officers, directors and existing investors, providing for
the private placement of unsecured promissory notes in the aggregate principal amount of
$
Each
Warrant has an exercise price of $
At
the initial date, the total proceeds received of $ |
Fair value at Closing Date | ||||
| Notes (1) | $ | |||
| Warrants (2) | ||||
| $ | ||||
As of June 30, 2025, all Notes have been settled by the Company.
| 11 |
GLUCOTRACK INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)(CONT.)
(in thousands of US Dollars)
NOTE 4 – COMMITMENTS AND CONTINGENT LIABILITIES
| A. | On
March 4, 2004, the Israeli Innovation Authority (the “IIA”) provided Integrity Israel with a grant of approximately $ | |
| B. | On October 7, 2022 (“the Closing Date”), the Company entered into Intellectual Property Purchase Agreement (the “Agreement”) with Paul Goode, which is the Company’s Chief Executive Officer (the “Seller”), under which it was agreed that on and subject to the terms and conditions of the Agreement, at the Closing Date, Seller sold and assigned to the Company, all of Seller’s right, title and interest in and to the following assets, properties and rights (collectively, the “Purchased Assets”): (i) all rights, title, interests in all current and future intellectual property, including, but not limited to patents, trademarks, trade secrets, industry know-how and other IP rights relating to an implantable continuous glucose sensor (collectively, the “Conveyed Intellectual Property”); and (ii) all the goodwill relating to the Purchased Assets. |
In
consideration for the sale of the Purchased Assets to the Company, at the Closing Date, the
Company paid to Seller cash in the amount of one dollar and obligated to issue up to
shares of Common Stock to be issued based upon specified performance milestones as set forth
in the Agreement (the “Purchase Price”). In addition, if upon the final issuance,
the aggregate shares represent less than
When the Company acquires net assets that do not constitute a business, as defined under ASU 2017-01 Business Combinations (Topic 805) Clarifying the Definition of a Business (such when there is no substantive process in the acquired entity) the transaction is accounted for as asset acquisition and no goodwill is recognized. The acquired In-Process Research and Development intangible asset (“IPR&D”) to be used in research and development projects which have been determined not to have alternative future use at the acquisition date, is expensed immediately.
At the Closing Date, it was determined that the asset acquisition represents the purchase of IPR&D with no alternative future use. However, the achievement of each of the performance milestones is considered as a contingent event outside the Company’s control and thus the contingent consideration which is equal to the fair value of the Purchase Price as measured at the Closing Date will be recognized when and if it becomes probable that each target will be achieved within the reasonable period. Such additional contingent consideration will be recognized in subsequent periods if and when the contingency (the achievement of targets) is resolved.
In
June 2023, the Seller achieved the first performance milestone out of the five performance milestones outlined in the Agreement executed
between the Company and the Seller as of the Closing Date. As a result, upon the date of the fulfilment of the first performance
milestone the Company was committed to issue 17 restricted shares to the Seller. Accordingly, the Company recorded an amount of $
In May 2024, the second performance milestone was achieved out of the five performance milestones outlined in the Agreement executed between the Company and the Seller as of the Closing Date.
As
result, the Company was committed to issue restricted shares to the Seller. Accordingly, the Company recorded stock-based compensation
expenses amounted to $ which represents the quoted price of its Common Stock at the Closing Date, after taking into consideration
a discount for lack of marketability in a rate of
On March 26, 2025, the Board determined that the third milestone was met and that an additional shares of Common Stock have been earned under the terms of the IP Purchase Agreement. As a result, an amount of $ was recognized to stock-based compensation. The shares were issued in reliance on the exemption from registration requirements thereof provided by Section 4(a)(2) of the Securities Act.
As of June 30, 2025, the achievement of all other remaining performance milestones was not considered probable and thus no stock-based compensation expenses were recorded with respect to thereof. |
NOTE 5. SUBSEQUENT EVENTS
| Management evaluated subsequent events and transactions that occurred after the balance sheet date up to the date that the condensed interim consolidated financial statements were available to be issued. Based upon this review, the Company did not identify any other significant subsequent events that would have required adjustment or disclosure in the financial statements, |
| 12 |
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 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 on Form 10-Q, 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 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 under the caption “Risk Factors” included in our Annual Report on Form 10-K for the year ended December 31, 2024. 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 on Form 10-Q.
Overview
The Company was incorporated on May 18, 2010 under the laws of the State of Delaware. We are currently developing an implantable continuous blood glucose monitor (“CBGM”). The Glucotrack CBGM is a long-term fully implantable continuous glucose monitor (CGM), consisting of a sensor lead implanted into the subclavian vein and connected to subcutaneous electronics that communicate with a mobile application. It measures glucose directly from the blood, eliminating the lag time associated with interstitial fluid glucose monitors. Designed for a three-year sensor life with continuous, accurate blood glucose monitoring, the system offers a more convenient and less burdensome solution for people with diabetes, with no on-body wearable component and minimal calibration requirements.
The Glucotrack CBGM is being developed for use by diabetes patients who are dependent on daily glucose monitoring to manage their disease. These include patients who have the following conditions: Type 1 diabetes, Type 2 insulin-dependent diabetes, Type 2 diabetes using basal insulin and Type 2 diabetes at risk for hypoglycemia.
We have continued to evolve our sensor chemistry following the results of an initial in-vitro feasibility study. In 2024, 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 that implant accuracy and longevity is key to the success for long term use.
We initiated a first-in-human (“FIH”) short-term clinical study outside of the United States in fourth quarter of 2024 and completed the study in first quarter of 2025. We recently presented results at the 2025 American Diabetes Association annual conference at the Innovation Hub podium as well as a poster. The ADA presentation reported that the FIH clinical study met all primary and secondary endpoints with no procedure or device related serious adverse events reported from implant through seven days post-removal of the CBGM sensor lead. The system also demonstrated excellent accuracy with a Mean Absolute Relative Difference (MARD) of 7.7% across 122 matched pairs, a 99% data capture rate, and no procedure or device-related serious adverse events. These findings validate the safety and performance of the system which measures glucose from blood rather than interstitial fluid, eliminating the typical lag time associated with traditional continuous glucose monitoring systems. The MARD value demonstrates very high accuracy and compares favorably to commercially available CGM systems. The FIH study also confirmed the function of the CBGM sensor lead in the subclavian vein. Placement and removal procedures were successfully performed by interventional cardiologists.
We are preparing for a long-term clinical study outside the United States to evaluate the device’s performance and safety over an initial period of 1 year. We obtained regulatory approval during the second quarter 2025 and patient enrollment is expected to begin in the third quarter of 2025.
During the second quarter 2025, we initiated discussions with the Food & Drug Administration (“FDA”) in preparations for a pre-investigational device exemption (“IDE”) submission. The discussions pertain to the protocol study design and related requirements to secure IDE approval for future long-term human clinical trials in the United States. We expects to file the IDE submission to the FDA during the fourth quarter of 2025.
We believe our technology, if successful, has the potential to be a long-term, implantable system that continually measures blood glucose levels with a sensor longevity of 3 years, no on-body wearable component and with minimal calibration.
| 13 |
Recent Events
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 Company’s 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 Company’s 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.
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”).
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 $3,643, after deducting fees owed to the Agent from such sale.
During the three months ended June 30, 2025, we sold 414,785 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 June 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.
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
On June 30, 2025, we repurchased 49,668 Series A Warrants from existing warrant holders for $160. The fair value of the Series A Warrants on the date of exercise was $65, resulting in a loss on repurchase of $95.
Appointment of Peter C. Wulff as Chief Financial Officer
Mr. Cardwell’s resigned as Chief Financial Officer of the Company, and on January 28, 2025, our board of directors (the “Board”) appointed Peter C. Wulff as Chief Financial Officer of the Company.
| 14 |
Financial Overview
Operating Expenses
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 and accounting services.
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 2025 and beyond, primarily due to expanding clinical trial activities, hiring additional personnel, as well the development of the 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, development of new Glucotrack CBGM models and other product candidates.
Marketing
Marketing expenses consist primarily of personnel-related expenses and professional service costs.
Other (Income) Expense
Other income expense, consist primarily of the change in fair value of derivative liabilities, finance (income) expense and other (income) expense.
Results of Operations
The following discussion of our operating results explains material changes in our results of operations for the three and six months ended June 30, 2025 compared with the same periods ended June 30, 2024. 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 June 30, 2025 and 2024
All information below is stated in thousands of U.S. dollars.
General and administrative expenses
General and administrative expenses were approximately $1,464 for the three-month period ended June 30, 2025, as compared to approximately $802, for the prior-year period. The increase is primarily attributable to increased legal and professional fees, and personnel costs.
Research and development expenses
Research and development expenses were approximately $3,150 for the three-month period ended June 30, 2025, as compared to approximately $3,589 for the prior-year period. The decrease is attributable to a reduction in product and manufacturing costs we accrued during the period related to the development of the Glucotrack CBGM model.
Marketing expenses
Marketing expenses were approximately $182 for the three-month period ended June 30, 2025, as compared to $100 for the prior-year period. This increase is primarily attributable to increased market research fees.
Change in derivative liability
Change in derivative liability for the three months ended June 30, 2025, was a decrease of $107. The change is primarily due to adjustments of the estimated fair value of the remaining 4,368 Series A and Series B Warrants.
| 15 |
Other (income) expense, net
Other expense was $96 for the three-month period ended June 30, 2025. The increase was due to the $95 loss from the Series A Warrant repurchase.
Financing income (expenses), net
Financing income, net was approximately $29 for the three-month period ended June 30, 2025, as compared to financing income of approximately $2 for the prior-year period. The increase is attributable to interest income received during the period.
Net Loss
Net loss was $4,756 for the three-month period ended June 30, 2025, as compared to $4,489 for the prior-year period. The increase in net loss is primarily attributed to the increase in general and administrative expenses and the loss from the Series A Warrant repurchase, as described above.
Consolidated Results of Operations for the Six Months ended June 30, 2025 and 2024
General and administrative expenses
General and administrative expenses were approximately $2,963 for the six-month period ended June 30, 2025, as compared to approximately $1,535, for the prior-year period. The increase is primarily attributable to increased legal and professional fees, personnel costs.
Research and development expenses
Research and development expenses were approximately $5,021 for the six-month period ended June 30, 2025, as compared to approximately $5,737 for the prior-year period. The decrease is attributable to a reduction in product and manufacturing costs we accrued during the period related to the development of the Glucotrack CBGM model.
Marketing expenses
Marketing expenses were approximately $310 for the six-month period ended June 30, 2025, as compared to $170 for the prior-year period. This increase is primarily attributable to increased market research fees and personnel costs.
Change in derivative liability
Change in derivative liability for the six months ended June 30, 2025, was a decrease of $3,269. The change is primarily due to adjustments of the estimated fair value of the remaining 4,368 Series A and Series B Warrants.
Other (income) expense, net
Other expense was $92 for the six-month period ended June 30, 2025. The increase was primarily due to the $95 loss from the Series A Warrant repurchase.
Financing income (expenses), net
Financing income, net was $66 for the six-month period ended June 30, 2025, as compared to financing income of $29 for the prior-year period. The increase is attributable to interest income received during the period.
Net Loss
Net loss was $11,589 for the six-month period ended June 30, 2025, as compared to $7,416 for the prior-year period. The increase in net loss is primarily attributed to the increase in general and administrative expenses and the fair value change of the derivative liability, as described above.
| 16 |
Liquidity and Going Concern
As of June 30, 2025, we had $9,555 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 $10,555 of net proceeds received from financing activities offset by cash used in operating and investing activities of $6,693.
We have a history of recurring losses, and as of June 30, 2025, we have an accumulated deficit of $144,039. During the six months ended June 30, 2025, we recorded a net loss of $11,589. 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 June 30, 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. The Company estimates it will require approximately $15.0 million in cash to fund operations over this period. Based upon this review and our current financial condition, the Company has 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 financing, 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.
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 on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 31, 2025. 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.
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.
| 17 |
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
Our principal executive officer and principal financial officer have 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 June 30, 2025 (the “Evaluation Date”). Based on such evaluation, those officers have concluded that, as of the Evaluation Date, our disclosure controls and procedures are ineffective 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 and financial officers, 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 annual or interim Consolidated Financial Statements for the periods ended June 30, 2025 and December 31, 2024.
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. In addition, the Company has outsourced certain accounting functions to ensure proper segregation of duties over financial reporting and hired additional accounting personnel. Management intends to continue the implementation of procedures to remediate such material weaknesses during the fiscal year 2025; 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, 2025, that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting.
| 18 |
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 June 30, 2025, 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 for the fiscal year ended December 31, 2024, which could materially affect our business, financial position, or future results of operations. There have been no material changes from the risk factors previously disclosed under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024. The risks described in our Annual Report for the fiscal year ended December 31, 2024, 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.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
(a) None.
(b) Not applicable.
(c) None.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
None.
| 19 |
Item 6. Exhibits.
| * | Filed or furnished herewith. |
| 20 |
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: August 14, 2025
| GLUCOTRACK, INC. | ||
| By: | /s/ Peter C. Wulff | |
| Name: | Peter C. Wulff | |
| Title | Chief Financial Officer | |
| (Principal Financial Officer) | ||
| 21 |