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 September 30, 2022
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.)
8
Ariel Sharon Street
P.O.
Box 6037607
Or
Yehuda , Israel
L3
7760049
(Address
of principal executive offices)
(Zip
Code)
972
(8) 675-7878
(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
NASDAQ
Capital Market
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 November 14, 2022, 15,476,665 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
3
Item 1. Financial Statements.
3
Condensed Consolidated Balance Sheets
3
Condensed Consolidated Statements of Operations and Comprehensive Loss
4
Condensed Consolidated Statement of Changes in Stockholders’ Equity
5
Condensed Consolidated Statements of Cash Flows
6
Notes to Condensed Consolidated Financial Statements
7
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
10
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
15
Item 4. Controls and Procedures.
15
PART II - OTHER INFORMATION
16
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
16
Item 6. Exhibits.
16
EXHIBIT INDEX
16
SIGNATURES
17
2
GLUCOTRACK
INC.
PART
I - FINANCIAL INFORMATION
Item
1. Financial Statements
GLUCOTRACK
INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
September 30,
2022
December 31,
2021
In thousands of US dollars
(except share data)
September 30,
2022
December 31,
2021
(Unaudited)
Current Assets
Cash and cash equivalents
3,241
6,062
Other current assets
187
43
Total current assets
3,428
6,105
Operating lease right-of-use assets, net
-
40
Property and equipment, net
44
69
Restricted Cash
39
51
TOTAL ASSETS
3,511
6,265
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities
Accounts payable
713
631
Operating lease liabilities, current
-
23
Other current liabilities
252
229
Total Current Liabilities
965
883
Non-current Liabilities
Loans from Stockholders
191
210
Operating lease liabilities, non-current
-
17
Total Non-current liabilities
191
227
Total Liabilities
1,156
1,110
Stockholders’ Equity
Common Stock of $ 0.001 par value (“Common Stock”): 500,000,000
shares authorized; 15,476,665
and 15,452,285
shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively
15
15
Additional paid-in capital
102,906
102,612
Accumulated other comprehensive income (loss)
30
( 6 )
Receipts on account of shares
18
-
Accumulated deficit
( 100,614 )
( 97,466 )
Total Stockholders’ equity
2,355
5,155
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
3,511
6,265
The
accompanying notes are an integral part of these condensed consolidated financial statements.
3
GLUCOTRACK
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
2022
2021
2022
2021
In thousands of US dollars (except share data)
Nine-month
period ended September 30,
Three-month
period ended September 30,
(Unaudited)
(Unaudited)
2022
2021
2022
2021
Research and development
1,363
1,077
434
447
Marketing expenses
-
136
-
113
General and administrative
1,782
1,323
495
207
Total operating expenses
3,145
2,536
929
767
Operating Loss
( 3,145 )
( 2,536 )
( 929 )
( 767 )
Other expenses
( 1 )
( 46 )
( 1 )
( 46 )
Finance Income (Expenses), net
( 2 )
21
2
9
Net Loss
( 3,148 )
( 2,561 )
( 928 )
( 804 )
Other comprehensive income (expenses):
Foreign currency translation adjustment
36
( 11 )
( 1 )
( 4 )
Comprehensive loss for the period
( 3,112 )
( 2,572 )
( 929 )
( 808 )
Net Loss per Common Stock
Basic
( 0.20 )
( 0.17 )
( 0.06 )
( 0.05 )
Diluted
( 0.20 )
( 0.17 )
( 0.06 )
( 0.05 )
Average number of Common Stock used in computing basic and diluted loss per share
15,468,279
15,448,923
15,473,521
15,451,726
The
accompanying notes are an integral part of these condensed consolidated financial statements.
4
GLUCOTRACK
INC.
CONDENSED
CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY
Numbers
of Shares
Amount
Paid-in
Capital
account
of shares
Comprehensive
Loss
Accumulated
Deficit
Stockholders’
Equity
In thousands of US Dollars (except share data)
(Unaudited)
Common Stock
Additional
Receipts
on
Accumulated
Other
Total
Numbers
of Shares
Amount
Paid-in
Capital
account
of shares
Comprehensive
Loss
Accumulated
Deficit
Stockholders’
Equity
Balance at January 1, 2021
15,444,697
15
102,351
-
15
( 93,399 )
8,982
Loss for the period
-
-
-
-
-
( 2,561 )
( 2,561 )
Other comprehensive loss
-
-
-
-
( 11 )
-
( 11 )
Issuance of restricted shares as compensation towards directors ( * )
-
-
-
25
-
-
25
Stock-based compensation
-
-
66
-
-
-
66
Balance at September 30, 2021
15,444,697
15
102,417
25
4
( 95,960 )
6,501
Balance at July 1, 2021
15,444,697
15
102,409
10
8
( 95,156 )
7,286
Loss for the period
-
-
-
-
-
( 804 )
( 804 )
Other comprehensive loss
-
-
-
-
( 4 )
-
( 4 )
Stock-based compensation
-
-
8
-
-
-
8
Issuance of restricted shares as compensation towards directors ( * )
-
-
-
15
-
-
15
Balance at September 30, 2021
15,444,697
15
102,417
25
4
( 95,960 )
6,501
Balance at January 1, 2022
15,452,285
15
102,612
-
( 6 )
( 97,466 )
5,155
Loss for the period
( 3,148 )
( 3,148 )
Other comprehensive income
-
-
-
-
36
-
36
Issuance of restricted shares as compensation towards directors
11,275
-
20
-
-
-
20
Restricted shares to be issued as compensation towards directors ( * )
-
-
-
18
-
-
18
Stock-based compensation
13,105
-
274
-
-
-
274
Balance at September 30, 2022
15,476,665
15
102,906
18
30
( 100,614 )
2,355
Balance at July 1, 2022
15,473,262
15
102,821
9
31
( 99,686 )
3,190
Beginning balance, value
15,473,262
15
102,821
9
31
( 99,686 )
3,190
Loss for the period
-
-
-
-
-
( 928 )
( 928 )
Other comprehensive income (expenses)
-
-
-
-
( 1 )
-
( 1 )
Issuance of restricted shares as compensation towards directors ( * )
3,403
-
9
( 9 )
-
-
-
Issuance of restricted shares as compensation towards directors
3,403
-
9
( 9 )
-
-
-
Restricted shares to be issued as compensation towards directors ( * )
-
-
-
18
-
-
18
Restricted shares to be issued as compensation towards directors
-
-
-
18
-
-
18
Stock-based compensation
-
76
-
-
-
76
Balance at September 30, 2022
15,476,665
15
102,906
18
30
( 100,614 )
2,355
Ending balance, value
15,476,665
15
102,906
18
30
( 100,614 )
2,355
(*)
Actual
issuance occurred subsequent to the balance sheet date.
The
accompanying notes are an integral part of these condensed consolidated financial statements.
5
GLUCOTRACK
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
2022
2021
In thousands of US Dollars
Nine-month period ended
September 30.
2022
2021
(Unaudited)
CASH FLOWS FROM OPERATING ACTIVITIES
Loss for the period
$ ( 3,148 )
$ ( 2,561 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation
19
33
Capital loss on sale of property and equipment
-
41
Stock-based compensation
274
66
Issuance of restricted shares as compensation towards directors ( * )
38
-
Issuance of restricted shares as compensation towards directors
38
-
Linkage difference on principal of loans from stockholders
8
5
Changes in assets and liabilities:
Increase in inventory
-
( 6 )
Increase in other current assets
( 148 )
( 9 )
Increase (Decrease) in accounts payable
117
( 223 )
Increase (Decrease) in other current liabilities
51
( 142 )
Net cash used in operating activities
( 2,789 )
( 2,796 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Proceeds from sale of property and equipment
-
4
Purchase of property and equipment
( 4 )
( 1 )
Net cash provided by (used in) investing activities
( 4 )
3
Effect of exchange rate changes on cash and cash equivalents, and restricted cash
( 40 )
( 14 )
Decrease in cash, cash equivalents, and restricted cash
( 2,833 )
( 2,807 )
Cash, cash equivalents, and restricted cash at beginning of the period
6,113
9,885
Cash, cash equivalents, and restricted cash, end of period
$ 3,280
$ 7,078
(*)
Actual
issuance occurred subsequent to the balance sheet date.
The
accompanying notes are an integral part of these condensed consolidated financial statements.
6
GLUCOTRACK
INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited)
NOTE
1 – GENERAL
A.
GlucoTrack
Inc (the “Company”) was incorporated on May 18, 2010 under the laws of the State of Delaware. On July 15, 2010, GlucoTrack
Acquisition Corp. Ltd. (hereinafter: “Integrity Acquisition”), a wholly owned Israeli subsidiary of the Company, which
was established on May 23, 2010, completed a merger with A.D. Integrity Applications Ltd. (hereinafter: “Integrity Israel”),
an Israeli corporation that was previously held by the stockholders of the Company. Pursuant to the merger, all equity holders of
Integrity Israel received the same proportional ownership in the Company as they had in Integrity Israel prior to the merger. Following
the merger, Integrity Israel remained a wholly owned subsidiary of the Company. As the merger transaction constituted a structural
reorganization, the merger has been accounted for at historical cost in a manner similar to a pooling of interests. Integrity Israel
was incorporated in 2001 and commenced its operations in 2002.
The
Company and Integrity Israel are referred as the “Group”.
On
December 8, 2021, the Company announced that its shares of Common Stock were approved for listing on the Nasdaq Capital Market (“NASDAQ”).
Trading on NASDAQ commenced on December 10, 2021 under its existing trading symbol, IGAP.
On
March 14, 2022, the Company announced that it has completed its corporate name and ticker symbol change on the Nasdaq Capital Market
(from IGAP to GCTK), to be effective at the commencement of trading on March 14, 2022.
In
connection with its application to list its shares on Nasdaq Capital Market (“NASDAQ”), as detailed above, on August
13, 2021, the Company effected a reverse split of its Common Stock in a ratio of 1 for 13 (the “Reverse Share Split”).
For accounting purposes, all Shares, options and warrants to purchase Common Stock and loss per share amounts have been adjusted
to give retroactive effect to this Reverse Share Split for all periods presented in these interim consolidated financial statements.
Any fractional shares resulting from the Reverse Share Split were rounded up to the nearest whole share.
B.
Going
concern uncertainty
Since
its incorporation, the Company did not conduct any material operations other than the design, development and commercialization of
the first generation of non-invasive glucose monitoring devices for use by people with diabetes. The development and commercialization
of the second generation of the product is expected to require substantial expenditures. The Company and Integrity Israel have not
yet generated significant revenues from operations, and therefore they are dependent upon external sources for financing their operations.
As of September 30, 2022, the Group has accumulated
deficit of $ 100,614 thousand, and incurred losses and generated negative cash flow from operating activity for the nine-months period.
As of September 30, 2022, the Company had $ 3,241 thousand in cash. Management has considered the significance of such condition 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
Company plans to finance its operations through the sale of equity and/or debt securities (including shelf registration statement
on Form S-3 that was declared effective on September 27, 2021 by the Securities and Exchange Commission (SEC) and which allows the
Company to register up to $ 100,000 thousand of certain equity and/or debt securities of the Company through prospectus supplement).
There can be no assurance that the Company will succeed in obtaining the necessary financing or generating sufficient revenues from
product sales to continue its operations as a going concern. The consolidated financial statements do not include any adjustments
that might result from the outcome of this uncertainty.
7
GLUCOTRACK
INC
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited) (cont.)
NOTE
2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
A.
Basis
of presentation
Accounting
Principles
The
accompanying unaudited condensed consolidated interim financial statements and related notes should be read in conjunction with our
consolidated financial statements and related notes contained in our Annual Report on Form 10-K for the fiscal year ended December
31, 2021, filed with the Securities and Exchange Commission (“SEC”) on March 31, 2022. The unaudited condensed 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. 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 nine months ended September 30, 2022 are not necessarily indicative of the results to be expected for the year ending
December 31, 2022 or for any other interim period or for any future period.
Principles
of Consolidation
The
consolidated financial statements include the accounts of the Company and its subsidiary. Significant intercompany balances and transactions
have been eliminated in consolidation
Net
Loss Per Share
Basic
loss per share is computed by dividing the loss for the period applicable for holders of our Common Stock by the weighted average
number of shares of Common Stock outstanding during the period.
In
computing, diluted loss per share, basic earnings per share are adjusted to reflect the potential dilution that could occur upon
the exercise of options or warrants issued or granted using the “treasury stock method”, if the effect of each of such
financial instruments is dilutive.
In
computing diluted loss per share, the average stock price for the period is used in determining the number of Common Stock assumed
to be purchased from the exercise of stock options or stock warrants.
Shares
that will be issued upon exercise of all stock options and stock warrants, have been excluded from the calculation of the diluted
net loss per share for all the reported periods for which net loss was reported because the effect of the Common Stock issuable as
a result of the exercise or conversion of these instruments was anti-dilutive.
Total
weighted average number of 6,562,279 and 6,356,344
outstanding stock options and stock warrants have been excluded from the calculation of the diluted net
loss per share for the period of nine months ended September 30, 2022 and 2021, respectively, because the effect of the Common stock
issuable as a result of the exercise or conversion of these instruments was determined to be anti-dilutive.
8
GLUCOTRACK
INC
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (cont.)
NOTE
2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (cont.)
B.
Use
of estimates in the preparation of financial statements
The
preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States
(“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 consolidated financial statements, and the reported amounts
of revenues and expenses during the reporting periods. Actual results could differ from those estimates. As applicable to these consolidated
interim condensed financial statements, the most significant estimates and assumptions relate to the going concern assumptions.
NOTE
3 – CASH AND CASH EQUIVALENTS
SCHEDULE OF CASH AND CASH EQUIVALENTS
US dollars
September 30,
December 31,
2022
2021
US Dollar
3,226
6,028
Other
15
34
3,241
6,062
NOTE
4 – SUBSEQUENT EVENTS
The
Company has evaluated all subsequent events through the date when these financial statements were issued to determine if these must be
reported. The Company determined that there were no reportable subsequent events to disclose in these financial statements.
9
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, 2021. 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
We
were incorporated in Delaware in May 2010. On July 15, 2010, we completed a reverse triangular merger with Integrity Israel and Integrity
Acquisition Corp. Ltd., an Israeli corporation and a wholly owned subsidiary of ours, pursuant to which Integrity Acquisition Corp. Ltd.
merged with and into Integrity Israel and all of the stockholders and option holders of Integrity Israel became entitled to receive shares
and options in us in exchange for their shares and options in Integrity Israel (the “Reorganization”). Following the Reorganization,
the former equity holders of Integrity Israel were entitled to the same proportional ownership in us as they had in Integrity Israel
prior to the Reorganization. As a result of the Reorganization, Integrity Israel became a wholly owned subsidiary of ours. We operate
primarily through Integrity Israel.
10
We
are a medical device company focused on the design, development and commercialization of innovative technologies for use by people with
diabetes and prediabetes. Our first product focus is GlucoTrack®, a non-invasive blood glucose monitor designed to help people with
diabetes obtain spot blood glucose level readings without the pain, inconvenience, cost and difficulty of conventional (invasive) spot
finger stick devices. Our first-generation device, GlucoTrack® 1.0 utilized a patented combination of ultrasound, electromagnetic
and thermal technologies to obtain blood glucose measurements in approximately one minute via a small sensor that is clipped onto one’s
earlobe and connected to a small, handheld control and display unit, all without drawing blood. GlucoTrack® 1.0, which received CE
Mark approval, underwent a limited release beta test in Europe and the Middle East. The Company is now focused on the development of
its next generation non-invasive glucose monitor, GlucoTrack® 2.0. In addition, following the recent acquisition of certain related
IP, the Company has commenced an R&D program to develop a long-term implantable glucose management technology to address the growing
Type 1 and insulin dependent Type 2 diabetes market.
GlucoTrack®
2.0 utilizes a different and significantly simplified and less costly sensor technology than our 1.0 technology. We are designing a form
factor that will shed the wired handheld unit from the GlucoTrack 1.0 design to be a completely wireless clip with Bluetooth connectivity
for pairing directly with the user’s own mobile device (smartphone and/or tablet). The device will be pocket-sized and rechargeable,
facilitating easy and convenient portability. Eliminating the cabled main unit hardware is also expected to significantly lower our manufacturing
costs. This will enable an attractive end-user price point while maintaining healthy margins for the company. In addition, we believe
that the new sensor technology will lead to a substantially faster measurement than our 1.0 version.
In
Q2 of this year, the Company completed lab testing of its 2.0 clinical prototype system. This process included testing of multiple iterations
of electronics, ear clip, and mobile app with cloud-based software. In addition, human factors testing of the mobile app has been completed
through simulated use in focus groups and by conducting a rigorous external design review for system architecture, stability, and cybersecurity.
The completion of bench testing and analyses of the clinical prototype system was followed by simulated use testing. During this in-house
testing of multiple iterations, the Company achieved better than expected accuracy and performance. Initial data collected indicates
that the Gen 2 system may achieve an accuracy comparable to invasive Continuous Glucose Monitors (CGM’s) currently available in
the market when conducting the upcoming first in-human clinical study. Further to that, the testing validated a dramatically faster speed
of measurement is possible, which will significantly improve the patient use experience. The in-house testing also exposed some clip-based
human factors considerations that appear to impact consistent device performance. Further improvements are being investigated to improve
device performance consistency prior to launching the first-in-human clinical study, which is expected to be conducted at the Rabin
Medical Center in Israel. The initial results from this study will drive a follow-up multi-center study in the United States, led by
Dr. Klonoff, Chair of the Company’s Scientific Advisory Board and Medical Director of the Diabetes Research Institute of Mills-Peninsula
Medical Center. The U.S. study is intended to be a precursor to the eventual pivotal trial for FDA clearance.
We
are also developing a wireless mobile platform that will support capturing anonymized data that can leverage novel machine learning
(AI) and data analytic techniques to facilitate device iterations and glucose sensing accuracy improvements. In addition, mobile
device pairing to this platform will facilitate data transfer to electronic medical records (EMRs) used by managing physicians to
effectively treat their patients. Moreover, this data can provide a potential revenue stream for valuable T2DM and pre-T2DM
de-identified patient data that can be used by third-party organizations such as pharma, insurance, and others.
While
historically the Company has operated out of its Israel location, the Company has transitioned all operations and development to the
United States as of the end of Q3. Remaining activities in Israel include accounting and as-needed contract resources to support the
first-in-human clinical trial.
A
number of high-quality individuals have joined the Company, each of whom bring extensive experience in their respective fields.
Paul, V. Goode PhD, who has a decorated career developing innovative medical technologies, including at DexCom and MiniMed and was a
member of the Board of Directors of the Company, has been appointed as President and Chief Executive Officer. In addition, James P.
Thrower PhD, a seasoned executive formerly of Sterling Medical Devices, Mindray DS USA and DexCom, Inc. joined as Vice President of
Engineering. Mark Tapsak PhD, a medical research scientist, joined as Vice President of Sensor Technology, bringing over 25 years of
experience in the diabetes industry, including previous senior roles at DexCom and Medtronic, Inc. Luis J. Malavé, formerly
of Insulet Corp, Medtronic and MiniMed has joined as an independent board member. Several highly talented and accomplished
executives joined the Company as senior advisors to the Board. These include Yair Briman, the former CEO of Philips Healthcare
Informatics, Daniel McCaffrey MBA MA, a world-renowned behavioral scientist and digital health expert currently VP of Digital Health
and Software at OMRON Healthcare, Inc. and formerly at Samsung Health and Dexcom, Inc., Dr. Alexander Raykhman PhD, a measurement
and artificial intelligence expert and Dr. David C. Klonoff, world renowned endocrinologist and diabetes technology thought leader.
We intend to continue to invest in our talent and to expand and strengthen all areas within the Company.
Recent
Events
On
October 19, 2021, Paul V. Goode was appointed as President and Chief Operating Officer of the Company, effective November 1, 2021
(“Effective Date”). He has served as a member of Integrity’s Board of Directors since December 17, 2020.
Concurrent with his new appointment, Mr. Goode stepped down from the Board. As of the filing of this Quarterly Report, Mr. Goode has
been appointed Chief Executive Officer.
11
In
connection with our application to list our shares of common stock on Nasdaq Capital Market (“NASDAQ”), on August 13, 2021,
we effected a reverse split of our common stock in a ratio of 1 for 13 (the “Reverse Share Split”).
On
September 27, 2021, our shelf registration statement on Form S-3 (file no. 333-259664) was declared effective by the SEC. The shelf registration
statement permits us to register up to $100,000,000 of certain equity and debt securities of the Company via prospectus supplement.
On
December 8, 2021, we announced that our shares of common stock were approved for listing on the NASDAQ. Trading on NASDAQ commenced on
December 10, 2021, under its existing trading symbol, IGAP.
On
March 14, 2022, we changed our name to GlucoTrack, Inc. with Nasdaq and our trading symbol to GCTK.
On
March 22, 2022, Shalom Shushan, Chief Technology Officer, provided notice of his resignation from the Company, effective May 22, 2022,
for personal reasons. In connection with the Company’s previously announced plans to migrate certain aspects of product development
to the United States, James P. Thrower PhD, Vice President of Engineering, will be assuming Mr. Shushan’s responsibilities.
In
connection with the Company’s previously announced plans to migrate certain aspects of the product development of GT 2.0 to the
United States, as well as in preparation for U.S. clinical trials, Erez Ben-Zvi, VP of Product in Israel, resigned from the Company,
effective June 12, 2022.
On
October 10, 2022, the Company announced that it has acquired certain IP related to a long-term implantable continuous glucose monitor
and that it intends to develop the technology to address the growing Type 1 and insulin dependent Type 2 diabetes market.
On
October 14, 2022, the Company announced the hiring of Dr. Mark Tapsak as Vice President of Sensor Technology.
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 fiscal 2021 Form 10-K. 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.
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, revenue, 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 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. As applicable to the consolidated financial statements included elsewhere in this report, the
most significant estimates and assumptions relate to the going concern assumptions.
12
Results
of Operations
The
following discussion of our operating results explains material changes in our results of operations for the three and nine months period
ended September 30, 2022 compared with the same period ended September 30, 2021. The discussion should be read in conjunction with the
financial statements and related notes included elsewhere in this report.
Three
Months ended September 30, 2022 compared to Three Months ended September 30, 2021
Research
and development expenses
Research
and development expenses were $434 thousand for the three-month period ended September 30, 2022, as compared to $447 thousand for the
prior-year period. The Decrease is immaterial.
Research
and development expenses consist primarily of salaries and other personnel-related expenses, materials, clinical trials, and other expenses.
We expect research and development expenses to increase in 2022 and beyond, primarily due to hiring additional personnel and developing
and validating our next generation product line, 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® models and others.
Marketing
expenses
Marketing
expenses were $0 thousand for the three-month period ended September 30, 2022, as compared to $113 thousand for the prior-year period.
The decrease is primarily attributable to the Company’s decision to reduce/stop its marketing
expenses until the completion of the development of the GlucoTrack® 2.0.
Marketing
expenses during the three-month period ended September 30, 2021, consisted in primarily of professional services, salaries, travel expenses
and other related expenses.
General
and administrative expenses
General
and administrative expenses were $495 thousand for the three-month period ended September 30, 2022, as compared to $207 thousand for
the prior-year period. The increase is primarily attributable to the additional expenses that the company accrued due to its listing
on the Nasdaq Capital Market (“NASDAQ”).
General
and administrative expenses consist primarily of professional services, salaries, insurance, 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.
Financing
income, net
Financing
income, net was approximately $2 thousand for the three-month period ended September 30, 2022, as compared to financing income of $9
thousand for the prior-year period. The decrease in the financing income is mainly attributed to
the decrease in interest income resulting from the reduction in the company’s cash balance over the year.
Net
Loss
Net
loss was $928 thousand for the three-month period ended September 30, 2022, as compared to $804 thousand for the prior-year period. The
increase in net loss is attributable primarily to the increase in our operating expenses, as described above.
13
Nine
Months ended September 30, 2022 compared to Nine Months ended September 30, 2021
Research
and development expenses
Research
and development expenses were $1,363 thousand for the nine-month period ended September 30, 2022, as compared to $1,077 thousand for
the prior-year period. The increase is primarily attributable to developing and validating our next generation product line.
Research
and development expenses consist primarily of salaries and other personnel-related expenses, materials, clinical trials, and other expenses.
We expect research and development expenses to increase in 2022 and beyond, primarily due to hiring additional personnel and developing
and validating our next generation product line, 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® models and others.
Marketing
expenses
Marketing
expenses were $0 thousand for the nine-month period ended September 30, 2022, as compared to $136 thousand for the prior-year period.
The decrease is primarily attributable to the Company’s decision to reduce/stop its Selling
and marketing expenses until the completion of the development of the GlucoTrack® 2.0.
Marketing
expenses consisted primarily of professional services, salaries, travel expenses and other related expenses.
General
and administrative expenses
General
and administrative expenses were $1,782 thousand for the nine-month period ended September 30, 2022, as compared to $1,323 thousand for
the prior-year period. The increase is primarily attributable to hiring of new and augmented personnel to move forward our business agenda,
and to additional expenses that the company accrued due to its listing on the Nasdaq Capital
Market (“NASDAQ”).
General
and administrative expenses consist primarily of professional services, salaries, insurance, 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.
Financing
income (expenses), net
Financing
income (expenses), net was approximately $(2) thousand for the nine-month period ended September 30, 2022, as compared to financing income
of $21 thousand for the prior-year period. The decrease in the financing income is attributed to
the decrease in interest income resulting from the reduction in the company’s cash balance over the year.
Net
Loss
Net
loss was $3,148 thousand for the nine-month period ended September 30, 2022, as compared to $2,561 thousand for the prior-year period.
The increase in net loss is attributable primarily to the increase in our operating expenses, as described above.
14
Going
Concern Uncertainty
As
of September 30, 2022, cash on hand was approximately $3.2 million. The development and commercialization of non-invasive glucose monitoring
devices for use by people, are expected to require substantial further expenditures. We remain dependent upon external sources for financing
our operations. Since inception, we have incurred substantial accumulated losses and negative operating cash flow and have a significant
accumulated deficit. These factors raise substantial doubt about our ability to continue as a going concern. The financial statements
do not include any adjustments that might result from the outcome of this uncertainty. We plan to finance our operations through the
sale of equity (including shelf registration statement on Form S-3 was declared effective on September 27, 2021 by the Securities and
Exchange Commission (SEC) which allows the Company to register up to $100,000 thousand of certain equity and/or debt securities of the
Company through prospectus supplement). There can be no assurance that we will succeed in obtaining the necessary financing to continue
our operations.
Net
Cash Used in Operating Activities for the Nine-Month Periods Ended September 30, 2022 and September 30, 2021
Net
cash used in operating activities was $2,789 thousand and $2,796 thousand for the nine-month periods ended September 30, 2022 and 2021,
respectively. Net cash used in operating activities primarily reflects the net loss for those periods of $3,148 thousand and $2,561 thousand,
respectively.
Net
Cash Used (provided ) in Investing Activities for the Nine-Month Periods Ended September 30, 2022 and September 30, 2021
Net
cash used (provided) in investing activities was $4 and $(3) thousand for the nine-month periods ended September 30, 2022 and 2021, respectively,
and was used (provided) mostly to purchase and sale of equipment.
Off-Balance
Sheet Arrangements
As
of September 30, 2022, we did not have any off-balance sheet arrangements as defined in Item 303(a)(4) of Regulation S-K .
Item
3. Quantitative and Qualitative Disclosures About Market Risk.
Not
required for smaller reporting companies.
Item
4. Controls and Procedures.
Evaluation
of Disclosure Controls and Procedures
Our
management, with the participation of our Principal Executive Officer and Chief 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 September
30, 2022, or 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,
due to the material weaknesses in internal control over financial reporting.
Changes
in Internal Control over Financial Reporting
There
were no changes in our internal control over financial reporting during our most recent fiscal quarter that have materially affected,
or are reasonably likely to materially affect, our internal control over financial reporting.
15
PART
II - OTHER INFORMATION
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds.
None
Item
3. Defaults Upon Senior Securities
None
Item
4. Mine Safety Disclosures
None
Item
6. Exhibits.
Exhibit
No.
Description
31.1
Certification of Principal Executive Officer and Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1
Certification of Principal Executive Officer and Financial Officer pursuant to 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)
16
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:
November 14, 2022
GLUCOTRACK,
INC.
By:
/s/
Jolie Kahn
Name:
Jolie
Kahn
Title
Chief
Financial Officer
(Principal
Executive and Financial Officer)
17
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.