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 June 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.)
301 Rte 17N , Suite 800
Rutherford ,
NJ
07070
(Address of principal executive
offices)
(Zip Code)
972
(8) 675-7878
(Registrant’s
telephone number, including area code)
8 Ariel Sharon Street
P.O. Box 6037607
Or Yehuda, Israel
L3 7760049
(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 August 15, 2022, 15,473,262
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
June 30, 2022
December 31, 2021
In thousands of US dollars
(except share data)
June 30, 2022
December 31, 2021
(Unaudited)
Current Assets
Cash and cash equivalents
3,854
6,062
Other current assets
370
43
Total current assets
4,224
6,105
Operating lease right-of-use assets, net
-
40
Property and equipment, net
49
69
Restricted Cash
44
51
TOTAL ASSETS
4,317
6,265
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities
Accounts payable
617
631
Operating lease liabilities, current
-
23
Other current liabilities
318
229
Total Current Liabilities
935
883
Non-current Liabilities
Loans from Stockholders
192
210
Operating lease liabilities, non-current
-
17
Total Non-current liabilities
192
227
Total Liabilities
1,127
1,110
Stockholders’ Equity
Common Stock of $ 0.001 par value (“Common Stock”):
500,000,000 shares authorized; 15,473,262 and 15,452,285 shares issued and outstanding as of June 30, 2022 and December 31, 2021, respectively
15
15
Common stock value
15
15
Additional paid-in capital
102,821
102,612
Accumulated other comprehensive income (loss)
31
( 6 )
Receipts on account of shares
9
-
Accumulated deficit
( 99,686 )
( 97,466 )
Total Stockholders’ equity
3,190
5,155
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
4,317
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
US dollars (except share data)
US dollars (except share data)
Six-month
period
ended June 30,
Three-month
period
ended June 30,
(Unaudited)
(Unaudited)
2022
2021
2022
2021
Research and development
929
630
469
321
Selling and marketing expenses
-
23
-
-
General and administrative
1,287
1,116
654
552
Total operating expenses
2,216
1,769
1,123
873
Operating Loss
( 2,216 )
( 1,769 )
( 1,123 )
( 873 )
Finance Income (Expenses), net
( 4 )
12
( 4 )
20
Net Loss
( 2,220 )
( 1,757 )
( 1,127 )
( 853 )
Other comprehensive income (expenses):
Foreign currency translation adjustment
37
( 7 )
30
( 29 )
Comprehensive loss for the period
( 2,183 )
( 1,764 )
( 1,097 )
( 882 )
Net Loss per Common Share
Basic
( 0.14 )
( 0.11 )
( 0.07 )
( 0.06 )
Diluted
( 0.14 )
( 0.11 )
( 0.07 )
( 0.06 )
Average number of common shares used in computing basic and diluted loss per share
15,465,692
15,447,490
15,473,813
15,448,212
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
of shares
Comprehensive
Loss
Accumulated
Deficit
Equity
(Deficit)
US Dollars (except share data)
(Unaudited)
Common Stock
Additional
Receipts
on
account
Accumulated
Other
Total
Stockholders’
Numbers
of Shares
Amount
Paid-in
Capital
of shares
Comprehensive
Loss
Accumulated
Deficit
Equity
(Deficit)
Balance at January 1, 2021
15,444,697
15
102,351
-
15
( 93,399 )
8,982
Loss for the period
-
-
-
-
-
( 1,757 )
( 1,757 )
Other comprehensive loss
-
-
-
-
( 7 )
-
( 7 )
Issuance of restricted shares as compensation towards directors (*)
-
-
-
10
-
-
10
Stock-based compensation
-
-
58
-
-
-
58
Balance at June 30, 2021
15,444,697
15
102,409
10
8
( 95,156 )
7,286
Balance at April 1, 2021
15,444,697
15
102,400
-
37
( 94,303 )
8,149
Loss for the period
-
-
-
-
-
( 853 )
( 853 )
Other comprehensive loss
-
-
-
-
( 29 )
-
( 29 )
Stock-based compensation
-
-
9
-
-
-
9
Issuance of restricted shares as compensation towards directors (*)
-
-
-
10
-
-
10
Balance at June 30, 2021
15,444,697
15
102,409
10
8
( 95,156 )
7,286
Balance at January 1, 2022
15,452,285
15
102,612
-
( 6 )
( 97,466 )
5,155
Loss for the period
( 2,220 )
( 2,220 )
Other comprehensive income
-
-
-
-
37
-
37
Issuance of restricted shares as compensation towards directors (*)
7,872
-
11
9
-
-
20
Stock-based compensation
13,105
-
198
-
-
-
198
Balance at June 30, 2022
15,473,262
15
102,821
9
31
( 99,686 )
3,190
Balance at April 1, 2022
15,452,285
15
102,763
11
1
( 98,559 )
4,231
Loss for the period
-
-
-
-
-
( 1,127 )
( 1,127 )
Other comprehensive income
-
-
-
-
30
-
30
Issuance of restricted shares as compensation towards directors (*)
7,872
-
11
( 2 )
-
-
9
Issuance of restricted shares as compensation towards directors
7,872
-
11
( 2 )
-
-
9
Stock-based compensation
13,105
-
47
-
-
-
47
Balance at June 30, 2022
15,473,262
15
102,821
9
31
( 99,686 )
3,190
(*)
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
US Dollars
Six-month period ended June 30.
2022
2021
(Unaudited)
CASH FLOWS FROM OPERATING ACTIVITIES
Loss for the period
$ ( 2,220 )
$ ( 1,757 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation
14
22
Capital loss on sale of property and equipment
-
5
Stock-based compensation
198
58
Issuance of restricted shares as compensation towards directors (*)
20
10
Linkage difference on principal of loans from stockholders
6
2
Changes in assets and liabilities:
Increase in accounts receivable
-
( 2 )
Increase in inventory
-
( 6 )
Increase in other current assets
( 331 )
( 13 )
Increase (Decrease) in accounts payable
18
( 131 )
Increase (Decrease) in other current liabilities
114
( 90 )
Net cash used in operating activities
( 2,181 )
( 1,902 )
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
( 30 )
( 16 )
Decrease in cash, cash equivalents, and restricted cash
( 2,215 )
( 1,915 )
Cash, cash equivalents, and restricted cash at beginning of the period
6,113
9,885
Cash, cash equivalents, and restricted cash, end of period
$ 3,898
$ 7,970
(*)
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 (Formerly:
Integrity Applications, 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 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 June 30,
2022, the Group has accumulated deficit of
$ 99,686 thousand,
and incurred losses and generated negative cash flow from operating activity for the six-months period. As of June 30, 2022, the
Company had $ 3,854 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 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 six
months ended June 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 shares issuable as a result of the
exercise or conversion of these instruments was anti-dilutive.
Total
weighted average number of 6,512,638 and 6,360,344 outstanding
stock options and stock warrants have been excluded from the calculation of the diluted net
loss per share for the period of six months ended June 30, 2022 and 2021, respectively, because the effect of the common shares 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
June 30,
December 31,
2022
2021
US Dollar
3,846
6,028
Other
8
34
3,854
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
and prediabetes obtain 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 less than 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.
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 earclip with Bluetooth connectivity
for pairing directly with the user’s own mobile device (smartphone and/or tablet). The earclip will be rechargeable and stored
in a small carrying case for storage and recharging when not in use, similar to wireless earbuds. This facilitates the smallest earclip
design by reducing battery size requirements. 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 this new sensor technology will lead to a substantially faster measurement than our 1.0 version.
In
early Q2 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, the Company achieved better than expected accuracy and performance. Initial data collected indicates that the GlucoTrack® 2.0 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.
The
Company has recently received Ethics Committee and clinical center approvals to conduct its first in-human study 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. The Company aims to begin its first
in-human study in Israel in Q3 and in U.S. centers in Q4.
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
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 is now transitioning all operations and development to
the United States.
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. 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.
Also
in connection with the Company’s previously announced plans to migrate certain aspects of product development to the United States,
as well as in preparation for U.S. clinical trials, on May 11, 2022 Erez Ben-Zvi, VP of Product in Israel, provided notice of his resignation
from the Company, to be effective June 12, 2022.
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 six months period
ended June 30, 2022 compared with the same period ended June 30, 2021. The discussion should be read in conjunction with the financial
statements and related notes included elsewhere in this report.
Three
Months ended June 30, 2022 compared to Three Months ended June 30, 2021
Research
and development expenses
Research
and development expenses were $469 thousand for the three-month period ended June 30, 2022, as compared to $321 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.
General
and administrative expenses
General
and administrative expenses were $654 thousand for the three-month period ended June 30, 2022, as compared to $552 thousand for the prior-year
period. The increase is primarily attributable to hiring of new and augmented personnel to move forward our business agenda.
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.
Financing
income (expenses), net
Financing
income (expenses), net was approximately $(4) thousand for the three-month period ended June 30, 2022, as compared to financing income
of $20 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 $1,127 thousand for the three-month period ended June 30, 2022, as compared to $853 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
Six
Months ended June 30, 2022 compared to Six Months ended June 30, 2021
Research
and development expenses
Research
and development expenses were $929 thousand for the six-month period ended June 30, 2022, as compared to $630 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.
Selling
and marketing expenses
Selling
and marketing expenses were $0 thousand for the six-month period ended June 30, 2022, as compared to $23 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.
Selling
and marketing expenses consisted primarily of professional services, salaries, travel expenses and other related expenses.
General
and administrative expenses
General
and administrative expenses were $1,287 thousand for the six-month period ended June 30, 2022, as compared to $1,116 thousand for the
prior-year period. The increase is primarily attributable to hiring of new and augmented personnel to move forward our business agenda.
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.
Financing
income (expenses), net
Financing
income (expenses), net was approximately $(4) thousand for the six-month period ended June 30, 2022, as compared to financing income
of $12 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 $2,220 thousand for the six-month period ended June 30, 2022, as compared to $1,757 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 June 30, 2022, cash on hand was approximately $3.8 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 Six-Month Periods Ended June 30, 2022 and June 30, 2021
Net
cash used in operating activities was $2,181 thousand and $1,902 thousand for the six-month periods ended June 30, 2022 and 2021, respectively.
Net cash used in operating activities primarily reflects the net loss for those periods of $2,220 thousand and $1,757 thousand, respectively.
Net
Cash Used (provided ) in Investing Activities for the Six-Month Periods Ended June 30, 2022 and June 30, 2021
Net
cash used (provided) in investing activities was $4 and $(3) thousand for the six-month periods ended June 30, 2022 and 2021, respectively,
and was used (provided) mostly to purchase and sale equipment.
Off-Balance
Sheet Arrangements
As
of June 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 June 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:
August 15, 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.