UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
☒
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended March 31, 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: 000-54785
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 May 13, 2022, 15,461,757 shares of the Company’s common stock, par value $0.001
per share, were outstanding.
GLUCOTRACK
INC. (FORMERLY: INTEGRITY APPLICATIONS, 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.
11
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
16
Item 4. Controls and Procedures.
16
PART II - OTHER INFORMATION
17
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
17
Item 6. Exhibits.
17
EXHIBIT INDEX
17
SIGNATURES
18
2
GLUCOTRACK
INC. (FORMERLY: INTEGRITY APPLICATIONS, INC.)
PART
I - FINANCIAL INFORMATION
Item
1. Financial Statements
GLUCOTRACK
INC. (FORMERLY: INTEGRITY APPLICATIONS, INC.)
CONDENSED
CONSOLIDATED BALANCE SHEETS
March 31,
2022
December 31,
2021
In thousands of US dollars
(except share data)
March 31,
2022
December 31,
2021
(Unaudited)
Current Assets
Cash and cash equivalents
4,789
6,062
Other current assets
442
43
Total current assets
5,231
6,105
Operating lease right-of-use assets, net
18
40
Property and equipment, net
60
69
Restricted Cash
50
51
TOTAL ASSETS
5,359
6,265
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities
Accounts payable
590
631
Operating lease liabilities, current
12
23
Other current liabilities
314
229
Total Current Liabilities
916
883
Non-current Liabilities
Loans from stockholders
206
210
Operating lease liabilities, non-current
6
17
Total non-current liabilities
212
227
Total liabilities
1,128
1,110
Stockholders’ Equity
Common Stock of $ 0.001 par value (“Common Stock”):
500,000,000 shares authorized; 15,452,285 shares issued and outstanding as of March 31, 2022 and December 31, 2021
15
15
Common Stock Value
15
15
Additional paid-in capital
102,763
102,612
Accumulated other comprehensive income (loss)
1
( 6 )
Receipts on account of shares
11
-
Accumulated deficit
( 98,559 )
( 97,466 )
Total Stockholders’ equity
4,231
5,155
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
5,359
6,265
The
accompanying notes are an integral part of these condensed consolidated financial statements.
3
GLUCOTRACK
INC. (FORMERLY: INTEGRITY APPLICATIONS, INC.)
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
2022
2021
In thousands of US dollars
(except share data)
Three-month period ended March 31,
2022
2021
(Unaudited)
Research and development expenses
460
309
Marketing expenses
-
23
General and administrative expenses
633
564
Total operating expenses
1,093
896
Operating loss
1,093
896
Financing expense, net
-
8
Loss for the period
1,093
904
Other comprehensive income:
Foreign currency translation income
( 7 )
( 22 )
Comprehensive loss for the period
1,086
882
Loss per share (Basic and Diluted)
( 0.07 )
( 0.06 )
Weighted average number of common stock outstanding used in computing basic and diluted net loss per share
15,461,757
15,444,697
The
accompanying notes are an integral part of these condensed consolidated financial statements.
4
GLUCOTRACK
INC. (FORMERLY: INTEGRITY APPLICATIONS, INC.)
CONDENSED
CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY
In
thousands of US dollars (except share data)
(unaudited)
Common
Stock
Additional
Accumulated
other
Total
Number
of shares
Amount
paid
in
capital
comprehensive
income
Accumulated
deficit
Stockholders’
Equity
Balance
as of January 1, 2021
15,444,697
15
102,351 -
15
( 93,399 )
8,982
Loss
for the period of three months
-
( 904 )
( 904 )
Other
comprehensive income
-
-
-
22
-
22
Stock-based
compensation
-
-
49
-
-
49
Balance
as of March 31, 2021
1,5444,697
15
102,400 -
37
( 94,303 )
8,149
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
income (loss)
Accumulated
Deficit
Stockholders’
Equity
Balance
at January 1, 2022
15,452,285
15
102,612
-
( 6 )
( 97,466 )
5,155
Loss
for the period of three months
-
-
-
-
-
( 1,093 )
( 1,093 )
Other
comprehensive income
-
-
-
-
7
-
7
Stock-based
compensation
-
-
151
-
-
-
151
Issuance
of restricted
shares
as compensation towards directors (*)
(*)
-
-
-
11
-
-
11
Balance
as of March 31, 2022
15,452,285
15
102,763
11
1
( 98,559 )
4,231
(*) 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. (FORMERLY: INTEGRITY APPLICATIONS, INC.)
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
2022
2021
In Thousands of US dollars
Three-month period ended March 31,
2022
2021
(unaudited)
Cash flows from operating activities:
Loss for the period
( 1,093 )
( 904 )
Adjustments to reconcile loss for the period to net cash used in operating activities:
Depreciation
9
12
Stock-based compensation
151
49
Issuance of restricted shares as compensation towards directors (*) (*)
11
-
Linkage difference on principal of loans from stockholders
2
2
Changes in assets and liabilities:
Increase in accounts receivable
-
( 5 )
Increase in inventory
-
( 6 )
Increase (Decrease) in other current assets
( 400 )
10
Decrease in accounts payable
( 35 )
( 155 )
Increase in other current liabilities
90
64
Net cash used in operating activities
( 1,265 )
( 933 )
Effect of exchange rate changes on cash, cash equivalents and restricted cash
( 9 )
1
Change in cash, cash equivalents, and restricted cash
( 1,274 )
( 932 )
Cash, cash equivalents, and restricted cash at beginning of the period
6,113
9,885
Cash, cash equivalents, and restricted cash at end of the period
4,839
8,953
(*) 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. (FORMERLY: INTEGRITY APPLICATIONS, 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
those carried out by Integrity Israel a medical device company, which focuses on the design,
development and commercialization of non-invasive glucose monitoring devices for use by people
with diabetes. The development and commercialization of Integrity Israel’s 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 March 31, 2022, the Group
has accumulated deficit of $ 98,559 thousand, and incurred losses and generated negative cash
flow from operating activity for the three-months period. As of March 31, 2022, the Company
had $ 4,789 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. (FORMERLY: INTEGRITY APPLICATIONS, 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 three months ended March 31, 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 6,452,510
and 6,481,598
outstanding stock options and stock warrants
have been excluded from the calculation of the diluted net loss per share for the period of three months ended March 31, 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. (FORMERLY: INTEGRITY APPLICATIONS, 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.
C.
Reclassified
Amounts
Certain
prior year amounts have been reclassified for consistency with the current year presentation. These reclassifications did not have
material effect on the reported results of operations, shareholder’s equity or cash flows .
9
GLUCOTRACK
INC. (FORMERLY: INTEGRITY APPLICATIONS, INC.)
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited) (cont.)
NOTE
3 – Cash and cash equivalents
SCHEDULE
OF CASH AND CASH EQUIVALENTS
2022
2021
US dollars
March 31,
December 31,
2022
2021
US Dollar
4,776
6,028
Other
13
34
Total
4,789
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.
10
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
Incorporated
in Delaware in May 2010, we are a medical device company focused on the design, development and commercialization of non-invasive glucose
monitoring devices for use by people with diabetes and pre-diabetics. 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.
11
We
are a medical device company focused on the design, development and commercialization of non-invasive glucose monitoring devices for
use by people with diabetes. Integrity Israel was founded in 2001 with a mission to develop, produce and market non-invasive glucose
monitors for home use by diabetics. We have developed a non-invasive blood glucose monitor, GlucoTrack®, which is designed to help
people with diabetes obtain blood glucose level readings without the pain, inconvenience, cost and difficulty of conventional (invasive)
spot finger stick devices. Our first generation product, GlucoTrack® 1.0 utilizes 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. Our next generation product, GlucoTrack®
2.0 which is currently under development, utilizes substantially identical underlying sensor technology, and is expected to be a completely
wireless sensor to be clipped on the earlobe. GlucoTrack eliminates the handheld unit and will transmit results directly to a user’s
smartphone.
Talent
development, recruiting and organizational health have been a critical focus of the Company. 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,
was appointed as President and Chief Operating 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.
Recently,
the Company performed a top-down analysis of the GlucoTrack 1.0 model to identify areas of potential enhancement, as it relates to the
platform, integrations, sensor technologies, accuracy as well as manufacturing costs. The result of this comprehensive review is an accelerated
development plan for GlucoTrack 2.0. GlucoTrack 2.0 will be a completely wireless and rechargeable earclip to be paired with a smartphone,
with more capabilities and features, increased accuracy, significantly greater margins for the Company and lower cost to the end-user
as compared to GlucoTrack 1.0.
As
previously reported, the Company made significant progress towards receiving insurance reimbursement in the Netherlands. With the new
accelerated development plan for GlucoTrack 2.0, and all of the expected advantages over GlucoTrack 1.0, it became clear to the Company
that introducing GlucoTrack 2.0 rather than the GlucoTrack 1.0 would serve the diabetes market and the Company more effectively. We are
currently working with our European partners on the roadmap for distribution of GlucoTrack 2.0 when completed and ready to market.
In addition to the European markets, the Company is now focused on the U.S. market as well, including building
out its U.S. go-to-market strategy and planning the required FDA clinical trials and field testing to support its entrance into the market.
The Company is currently in the process of identifying clinical sites in the U.S., interviewing Contract Research Organizations (CRO’s),
and forming its Scientific and Medical Advisory Boards. We intend to build out a team to support the U.S. activities while continuing
our technology development in our R&D facility located in Israel.
Recent Events
On
June 22, 2021, Luis J. Malavé has been appointed to the Company’s Board of Directors. Mr. Malavé brings more than
30 years of leadership experience in the MedTech industry, primarily in diabetes management, spanning all company stages, from private
startups to large-cap publicly listed companies. He has extensive expertise in product development, operations, marketing, strategic
partnerships, and US FDA regulatory strategy.
Since
October 2017, Mr. Malavé has served as President of EOFLOW CO. Ltd., a company listed on the Korea Stock Exchange that has developed
a wearable disposable insulin pump. From October 2014 to June 2016, he was COO of Mikroscan Technologies. Prior to that, Mr. Malavé
was the President and CEO of Palyon Medical, maker of an implantable drug-delivery system that spun out from German medical-technology
giant Fresenius SE. Prior to Palyon, he spent nearly a decade at insulin pump maker Insulet Corp., including as its Senior Vice President
of Research, Development and Engineering, and as Chief Operating Officer. He also held various senior positions at Medtronic and MiniMed,
overseeing product development of various diabetes management devices. Mr. Malavé earned his Bachelor’s degree in Mathematics
and Computer Science from the University of Minnesota, a Master’s degree in Software Engineering from the University of St. Thomas,
and an MBA from the University of Maryland.
12
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 will be stepping down from the Board. In this role, Goode will lead the company’s operations, overseeing strategy, design,
manufacturing, business and product development and begin to build the U.S. infrastructure in preparation for the U.S. clinical trials
of GlucoTrack. He will devote such time as necessary to perform his duties but shall be able to pursue other professional opportunities
at the same time. His base salary shall be $175,000 per year, and he shall be entitled to a cash bonus of up to 20% of his annual base
salary as determined by the Company’s Compensation Committee and shall be granted options to purchase up to One and half Percent
(1.5%) of the fully diluted common stock, par value $0.001 per share, of the Company (“Common Stock”) as of the Effective
Date, with a per share exercise price equal to the greater of (A) $5.20 per share or (B) the closing price of a share of Common Stock
on the Effective Date, as reported by Bloomberg L.P., which shall vest in equal monthly installments over a three year period following
the Effective Date. The bonus and equity incentives shall be subject to clawback rights if there is a misstatement of financials which
changes any metrics upon which a bonus or incentives are based and the clawback will be pro rata based upon the changes in the financials
with respect to the effect on any underlying metrics.
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, on May 15, 2022 Erez Ben-Zvi, VP of Product in Israel, provided notice
of his resignation from the Company, to be effective June 26, 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.
13
Results
of Operations
The
following discussion of our operating results explains material changes in our results of operations for the three-month period ended
March 31, 2022 compared with the same period ended March 31, 2021. The discussion should be read in conjunction with the financial statements
and related notes included elsewhere in this report.
Three
Months ended March 31, 2022 compared to Three Months ended March 31, 2021
Revenues
During
the three-month period ended March 31, 2022 and 2021, we had no revenues.
Research
and development expenses
Research
and development expenses were $460 thousand for the three-month period ended March 31, 2022, as compared to $309 thousand for the comparative
period. The increase is primarily attributable to hiring of new and augmented personnel to move forward our business agenda.
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
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 March 31, 2022, as compared to $23 thousand for the comparative
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 during the
three-month period ended March 31, 2021, consisted in primarily of professional services, salaries, travel expenses and other related
expenses.
General and administrative expenses
General and administrative expenses
were $633 thousand for the three-month period ended March 31, 2022, as compared to $564 thousand for the comparative period.
The increase is primarily attributable to hiring of new and augmented personnel to move forward our business agenda.
14
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
expenses, net
Financing expenses, net were
approximately $0 thousand for the three-month period ended March 31, 2022, as compared to $8 thousand for the comparative
period. The change is immaterial.
Net Loss
Net loss was $1,093 thousand
for the three-month period ended March 31, 2022, as compared to $904 thousand for the comparative period. The Increase in net
loss is attributable primarily to hiring of new and augmented personnel to move forward our business agenda.
Going
Concern Uncertainty
As
of March 31, 2022, cash on hand was approximately $4.8 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 Three-Month Periods Ended March 31, 2022 and March 31, 2021
Net
cash used in operating activities was $1,265 thousand and $933 thousand for the three-month periods ended March 31, 2022 and 2021, respectively.
Net cash used in operating activities primarily reflects the net loss for those periods of $1,093 thousand and $904 thousand, respectively.
15
Off-Balance
Sheet Arrangements
As
of March 31, 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 March 31, 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.
16
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 pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2
Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1
Certification of Principal Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
32.2
Certification of Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101.INS
Inline XBRL
Instance Document (2)
101.SCH
Inline XBRL
Schema Document (2)
101.CAL
Inline XBRL
Calculation Linkbase Document (2)
101.LAB
Inline XBRL
Label Linkbase Document (2)
101.PRE
Inline XBRL
Presentation Linkbase Document (2)
101.DEF
Inline XBRL
Definition Linkbase Document (2)
104
Cover
Page Interactive Data File (embedded within the Inline XBRL document)
17
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned thereunto duly authorized.
Dated:
May 16, 2022
GLUCOTRACK
INC.
By:
/s/
Jolie Kahn
Name:
Jolie
Kahn
Title
Chief Financial Officer
(Principal
Financial Officer)
18
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.