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, 2023
or
☐
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from ________________ to ________________
Commission
File Number: 001-41141
GLUCOTRACK,
INC.
(Exact
name of registrant as specified in its charter)
Delaware
98-0668934
(State
or other jurisdiction of
incorporation
or organization)
(I.R.S.
Employer
Identification
No.)
301
Route 17 North , Suite 800
Rutherford ,
NJ
07070
(Address
of principal executive offices)
(Zip
Code)
(201)
842-7715
(Registrant’s
telephone number, including area code)
N/A
(Former
name, former address and former fiscal year, if changed since last report)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class
Trading
Symbol(s)
Name
of each exchange on which registered
Common
Stock
GCTK
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 11, 2023, 20,892,193 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.
14
Item 4. Controls and Procedures.
14
PART II - OTHER INFORMATION
15
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
15
Item 6. Exhibits.
15
EXHIBIT INDEX
15
SIGNATURES
16
2
GLUCOTRACK
INC.
PART
I - FINANCIAL INFORMATION
Item
1. Financial Statements
GLUCOTRACK
INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
June 30,
2023
December 31,
2022
In thousands of US dollars
(except share data)
June 30,
2023
December 31,
2022
(Unaudited)
Current Assets
Cash and cash equivalents
$ 8,774
$ 2,312
Other current assets
171
67
Total current assets
8,945
2,379
Property and equipment, net
27
40
Restricted Cash
10
19
TOTAL ASSETS
8,982
2,438
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities
Accounts payable
832
672
Other current liabilities
218
341
Total Current Liabilities
$ 1,050
$ 1,013
Non-current Liabilities
Loans from Stockholders
189
195
Total Non-current liabilities
189
195
Total Liabilities
1,239
1,208
Stockholders’ Equity
Common Stock of $ 0.001 par value (“Common Stock”):
500,000,000 shares authorized as of June 30, 2023 and December 31, 2022; 20,892,193 and 15,500,730 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively
20
15
Common Stock of $ 0.001 par value (“Common Stock”) : 500,000,000 shares authorized as of
June 30, 2023 and December 31, 2022; 20,892,193 and 15,500,730 shares issued and outstanding as of June 30, 2023 and December 31,
2022, respectively
20
15
Additional paid-in capital
112,918
103,095
Accumulated other comprehensive income
28
17
Receipts on account of shares
-
4
Accumulated deficit
( 105,218 )
( 101,901 )
Total Stockholders’ equity
7,743
1,230
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
$ 8,982
$ 2,438
The
accompanying notes are an integral part of these condensed consolidated financial statements.
3
GLUCOTRACK
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
2023
2022
2023
2022
US dollars (except share data)
US dollars (except share data)
Six-month
period ended June 30,
Three-month
period ended June 30,
(Unaudited)
(Unaudited)
2023
2022
2023
2022
Research and development
$ 1,269
$ 929
$ 627
$ 469
General and administrative
1,194
1,287
552
654
Total operating expenses
2,463
2,216
1,179
1,123
Operating Loss
2,463
2,216
1,179
1,123
Finance Income (Expenses), net
( 1 )
4
( 3 )
4
Net Loss
2,462
2,220
1,176
1,127
Other comprehensive income:
Foreign currency translation adjustment
( 11 )
( 37 )
( 6 )
( 30 )
Comprehensive loss for the period
$ 2,451
$ ( 2,183 )
$ 1,170
$ ( 1,097 )
Basic net loss per common stock
$ ( 0.18 )
$ ( 0.14 )
$ ( 0.09 )
$ ( 0.07 )
Diluted net loss per common stock
$ ( 0.18 )
$ ( 0.14 )
$ ( 0.09 )
$ ( 0.07 )
Weighted average number of common shares used in computing basic and diluted loss per common stock
18,532,553
15,465,692
21,561,473
15,473,813
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
Income (Loss)
Accumulated
Deficit
Stockholders’
Equity
In thousands of US Dollars (except share data)
(Unaudited)
Common Stock
Additional
Receipts
on
account
Accumulated
Other
Total
Numbers
of Shares
Amount
Paid-in
Capital
of shares
Comprehensive
Income (Loss)
Accumulated
Deficit
Stockholders’
Equity
Balance at January 1, 2023
15,550,730
$ 15
$ 103,095
$ 4
$ 17
$ ( 101,901 )
$ 1,230
Loss for the period
-
-
-
-
-
( 2,462 )
( 2,462 )
Other comprehensive income
-
-
-
-
11
-
11
Deemed dividend resulted from trigger of down round protection feature of certain warrants granted
-
-
855
-
-
( 855 )
-
Issuance of Ordinary Shares upon completion of public offering, net of offering expenses
5,376,472
5
8,725
-
-
-
8,730
Issuance of restricted shares as compensation towards directors and officer
14,991
- (*)
9
( 4 )
-
-
5
Stock-based compensation
-
-
229
-
-
-
229
Balance at June 30, 2023
20,892,193
$ 20
$ 112,913
$ -
$ 28
$ ( 105,218 )
$ 7,743
Balance at April 1, 2023
15,503,632
$ 15
$ 103,156
$ 5
$ 22
$ ( 103,187 )
$ 11
Loss for the period
-
-
-
-
-
( 1,176 )
( 1,176 )
Other comprehensive income
-
-
-
-
6
-
6
Deemed dividend resulted from trigger of down round protection feature of certain warrants granted
-
-
855
-
-
( 855 )
-
Issuance of Ordinary Shares upon completion of public offering, net of offering expenses
5,376,472
5
8,725
-
-
-
8,730
Issuance of restricted shares as compensation towards directors and officer
12,089
- (*)
5
( 5 )
-
-
-
Stock-based compensation
-
-
172
-
-
-
172
Balance at June 30, 2023
20,892,193
$ 20
$ 112,913
$ -
$ 28
$ ( 105,218 )
$ 7,743
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
Beginning balance
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
Stock-based compensation
13,105
- (*)
47
-
-
-
47
Balance at June 30, 2022
15,473,262
$ 15
$ 102,821
$ 9
$ 31
$ ( 99,686 )
$ 3,190
Ending balance
15,473,262
$ 15
$ 102,821
$ 9
$ 31
$ ( 99,686 )
$ 3,190
(*)
Represents
amount lower than $1.
(**)
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
2023
2022
US Dollars
Six-month period ended June 30.
2023
2022
(Unaudited)
CASH FLOWS FROM OPERATING ACTIVITIES
Loss for the period
$ ( 2,462 )
$ ( 2,220 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation
7
14
Stock-based compensation
229
198
Issuance of restricted shares as compensation towards directors
5
20 (*)
Linkage difference on principal of loans from stockholders
6
6
Changes in assets and liabilities:
Increase in other current assets
( 104 )
( 331 )
Increase in accounts payable
173
18
Increase (Decrease) in other current liabilities
( 121 )
114
Net cash used in operating activities
( 2,267 )
( 2,181 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of property and equipment
-
( 4 )
Net cash used in investing activities
-
( 4 )
CASH FLOWS FROM FINANCING ACTIVITIES:
Net proceeds received from underwritten U.S. public offering
8,730
-
Net cash provided by financing activities
8,730
-
Effect of exchange rate changes on cash and cash equivalents, and restricted cash
( 10 )
( 30 )
Change in cash, cash equivalents, and restricted cash
6,453
( 2,215 )
Cash, cash equivalents, and restricted cash at beginning of the period
2,331
6,113
Cash, cash equivalents, and restricted cash, end of period
$ 8,784
$ 3,898
Non-cash financing activities
Deemed dividend upon trigger of down round protection
$ 855
$ -
(*)
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. The Company is a medical
device company, focused on the design, development and commercialization of novel technologies for use by people with diabetes and
prediabetes. The Company is currently developing two products; a non-invasive glucose monitor for use by persons with Type 2 diabetes
and prediabetes, and an implantable continuous glucose monitor for persons with Type 1 diabetes and insulin-dependent Type 2 diabetes.
B.
Liquidity
and Going Concern Uncertainty
To
date, the Company has not yet generated significant revenues from selling of GlucoTrack 1.0 product, a product that has been
discontinued. In addition, development and commercialization of both GlucoTrack 2.0 product and the implantable continuous glucose
monitor is expected to require substantial expenditures;therefore, the Company is dependent upon external sources for financing its
operations. As of June 30, 2023, the Company has incurred accumulated deficit of $ 105,218
thousand. Furthermore, the Company has generated operating losses and negative operating cash flow for all reported
periods.
Management
has considered the significance of such conditions in relation to the Company’s ability to meet its current obligations and
to achieve its business targets and determined that these conditions do not raise substantial doubt about the Company’s ability
to continue as a going concern, taking into consideration the net proceeds received in total amount of $ 8,730 thousand upon closing
of a public offering through prospectus supplement on Form S-3 on April 17 2023 (see also Note 3 below). Based on its assessment,
management believe that such funds are sufficient for the Company to realize its business plans for the twelve months subsequent
to the reporting period.
NOTE
2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
A.
Basic of Presentation
1.
Accounting
Principles
The
accompanying unaudited condensed consolidated interim financial statements and related notes should be read in conjunction with the
consolidated financial statements and related notes contained in the Annual Report on Form 10-K for the fiscal year ended December
31, 2022, filed with the Securities and Exchange Commission (“SEC”) on March 31, 2023. 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 period of six months ended June 30, 2023 are not necessarily indicative of the results to be expected for the year
ending December 31, 2023 or for any other interim period or for any future period.
2.
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.
7
GLUCOTRACK
INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
NOTE
2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (CONT.)
A.
Basic of Presentation
3.
Net
Loss Per Common Stock
Basic
net loss per Common Stock is computed by dividing the loss for the period applicable for holders of Common Stock and pre-funded
warrants by the weighted average number of shares of Common Stock and pre-funded warrants outstanding during the period. Diluted
loss per share gives effect to all potentially dilutive common shares outstanding during the period using the treasury stock method
with respect to stock options and certain stock warrants. In computing diluted loss per Common Stock, 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
to be issued upon exercise of all stock options and stock warrants have been excluded from the calculation of the diluted net loss
per Common Stock for all the reported periods for which net loss was reported because the effect of the Common Stock issuable upon
exercise of these instruments was anti-dilutive.
The
net loss and the weighted average number of shares of Common Stock used in computing basic and diluted net loss per Common Stock
for the period of six and three months ended June 30, 2023 and 2022, is as follows:
SCHEDULE
OF ANTIDILUTIVE NET LOSS AND WEIGHTED AVERAGE
2023
2022
2023
2022
US dollars (except share data)
US dollars (except share data)
Six-month period ended June 30,
Three-month period ended June 30,
(Unaudited)
(Unaudited)
2023
2022
2023
2022
Numerator:
Net loss
$ 2,462
$ 2,220
$ 1,176
$ 1,127
Deemed dividend related to trigger of down round protection feature (see Note 3A below)
855
-
855
-
Net loss attributable to common stockholders
$ 3,317
$ 2,220
$ 2,031
$ 1,127
Denominator:
Ordinary shares used in computing basic and diluted net loss per common stock
(*) 18,532,553
15,465,692
(*) 21,561,473
15,473,813
Basic and diluted net loss per common stock
$ ( 0.19 )
$ ( 0.14 )
$ ( 0.10 )
$ ( 0.07 )
(*) Including pre-funded
warrants issued upon completion of underwritten U.S. public offering.
8
GLUCOTRACK
INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) (CONT.)
NOTE
3 - SIGNIFICANT TRANSACTIONS
A.
Completion
of underwritten U.S. public offering
On
April 13, 2023, the Company completed an underwritten public offering under which the Company received gross proceeds of approximately
$ 10,000 thousand for issuance of (i) 5,376,472 shares of common stock and (ii) 1,976,470 pre-funded warrants at a price to the public
of $ 1.36 per share. The pre-funded warrants are exercisable for the same number of shares of common stock and may be exercised at
any time until exercised in full at an exercise price of $ 0.001 .
Upon
satisfaction of customary closing conditions, the closing date of the above underwritten public offering was April 17, 2023 (the
“Closing Date”).
The Company received substantially all the pre-funded warrant’s proceeds upfront (without any conditions) as part of the pre-funded
warrant’s purchase price and in return the Company is obligated to issue fixed number of shares of common stock to the holders.
Thus, pre-funded warrants were accounted for and were classified as additional paid-in capital as part of the Company’s stockholders’
equity.
Total
incremental and direct issuance costs amounted to $ 1,270 thousand. These expenses were deducted from additional paid-in capital as
they were allocated to shares of Common Stock and pre-funded warrants.
Upon
closing of underwritten U.S. public offering, a
down round protection feature of certain warrants granted in previous years to service providers was triggered by the way of reduction
of their exercise price from a price in a range of $ 3.35 -$ 70.20 to a price of $ 1.36 which represented the above public offering price.
Such reduction was accounted for as deemed dividend estimated at total amount of $ 855 thousand which was recorded as part of the
additional paid-in capital versus increase of accumulated deficit. Regarding the effect of the loss per share, see also Note 2.A.3.
above.
B.
Intellectual
Property Purchase Agreement
In
the middle of June 2023, the Company achieved the first performance milestone out of the five performance milestones outlined in
the Intellectual Property Purchase Agreement (the “Agreement”) executed between the Company and Paul Goode, which is
the Company’s Chief Executive Officer (the “Seller”) as October 7, 2022 (the “Closing Date”). As result,
the Company is committed to issue 100,000 restricted shares to the Seller. During the periods of three and six months ended June
30, 2023, the Company recorded stock-based compensation expenses amounted to $ 131 thousand which representing the quoted price of
its Common Stock at the Closing Date, after taking into consideration a discount for lack of marketability in a rate of 30.4 % over
a restriction period of 1-year. As of June 30, 2023, achievement of all other performance milestones was not considered probable
and thus no stock-based compensation expenses were recorded with respect to thereof.
C.
Notice
of Delisting or Failure to Satisfy a Continued Listing Rule or Standard
On
May 26, 2023, the Company received a letter from Nasdaq that it no longer complies with Rule 5550(a)(2) of Nasdaq’s Listing
Rules (the “Rules”) which require listed securities to maintain a minimum bid price of $ 1 per share. However, the Rules
provide the Company a compliance period of 180-days to regain compliance under which if at any time during 180-days period the closing
bid price of the Company’s security is at least $ 1 for a minimum of ten consecutive business days, Nasdaq will provide the
Company written confirmation of compliance and this matter will be closed. In the event the Company does not regain compliance by
the 180th day, the Company may be eligible for additional time to regain compliance or may face delisting.
NOTE
4 - SUBSEQUENT EVENTS
The
Company evaluated subsequent events and transactions that occurred after the balance sheet date up to the date that the condensed interim
consolidated financial statements were issued (August 14, 2023). Based upon this review, the Company did not identify
any other subsequent events that would have required adjustment or disclosure in the 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, 2022. 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
are a medical device company focused on the design, development and commercialization of novel technologies for use by people with diabetes
and prediabetes. We are currently developing two products; a non-invasive glucose monitor for use by those with Type 2 diabetes and prediabetes,
and an implantable continuous glucose monitor for those with Type 1 diabetes and insulin-dependent Type 2 diabetes.
The
Company was founded with a mission to develop GlucoTrack®, a noninvasive glucose monitoring device designed to help people with diabetes
and pre-diabetics obtain glucose level readings without the pain, inconvenience, cost and difficulty of conventional (invasive) spot
finger stick devices. The first generation GlucoTrack (“GlucoTrack 1.0”), which successfully received CE Mark approval and
ISO certifications, utilized a combination of ultrasound, electromagnetic and thermal technologies to obtain 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 or interstitial fluid. After a limited release beta test in Europe and the Middle East, the Company determined
that it would focus its efforts on developing its next generation non-invasive monitor (“GlucoTrack 2.0”), and we have since
withdrawn our CE Mark and ISO certifications for GlucoTrack 1.0 and are no longer pursuing commercialization of this product.
I nstead, we are currently developing GlucoTrack
2.0. The current clinical prototype utilizes ultrasound-only sensor technology, reduces the overall cost and complexity of the device,
and reduces the measurement time from approximately sixty seconds to less than two seconds. Initial testing has produced promising results,
suggesting measurement accuracies could be relatively comparable with those of conventional, already in-the-market CGM technologies. Internal
development efforts continue toward a robust measurement technique that consistently achieves significant measurement accuracy in normal
use applications. A first-in-human (FIH) clinical study will begin once this metric has been achieved.. Collecting data for sensor characterization
and algorithm development will be the primary goals of the FIH study. The results of this study will also drive the development of the
commercial version of the device, which is expected to commence early 2024. Once
the development of the commercial device version is complete, we intend to conduct a scaled down version of the FDA pivotal trial to resolve
any lingering device performance or human factors issues prior to executing the larger pivotal trial for FDA submission.
10
Following the acquisition of certain IP in the fourth quarter of 2022,
we are also developing an implantable continuous glucose monitor for use by Type 1 diabetes patients as well as insulin-dependent Type
2 patients. Implant longevity is key to the success of such a device, and we have recently completed our feasibility study successfully
demonstrating that a minimum two-year implant life is highly probable with the current sensor design. We believe our technology, if successful,
has the potential to be more accurate, more convenient and have a longer duration than other implantable glucose monitors that are either
in the market or currently under development.
We
are currently developing our own companion applications and a cloud-based solutions to offer an effective platform to provide real time,
data driven personalized tools to effectively help a user manage their diabetes, which will be utilized during the clinical trials. In
addition to being a critical and effective management tool for the end user, we believe that third parties such as insurers, pharmaceutical
companies and advertisers would be willing to pay for the de-identified data that we will obtain through our platform, and that this
is an opportunity for us to develop an additional revenue source.
Our
Senior Management team includes; CEO and President, Paul V. Goode PhD, who has a decorated career developing innovative medical technologies,
including at DexCom and MiniMed, CFO and General Counsel, Jolie Kahn, Esq., who has a multidecade career as a well respected securities
attorney and finance professional, James P. Thrower PhD, Vice President of Engineering, a seasoned executive formerly of Sterling Medical
Devices, Mindray DS USA and DexCom, Inc., and Mark Tapsak PhD, Vice President of Sensor Technology, a medical research scientist who
brings over 25 years of experience in the diabetes industry, including previous senior roles at DexCom and Medtronic. 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 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
March 14, 2022, we changed our name to GlucoTrack, Inc. 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, assumed Mr. Shushan’s responsibilities.
In
connection with the Company’s previously announced plans to migrate certain aspects of the product development 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.
11
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.
On
November 22, 2022, Nasdaq provided notice that pursuant to Nasdaq Listing Rule 5550(b)(1), the Company did not meet the alternatives
of market value of listed securities or net income from continuing operations.
On
January 4, 2023, Nasdaq provided notice that since the Company had not held an annual meeting of shareholders within twelve months of
the end of the Company’s fiscal year end ended December 31, 2021, it no longer complied with Listing Rules for continued listing.
On
February 7, 2023, Nasdaq issued a letter to the Company granting an extension until May 22, 2023 to obtain compliance with the Listing
Rule 5550(b).
On
March 31, 2023, GlucoTrack, Inc. held its 2022 Annual Meeting of Shareholders. The results of the voting with respect to this Annual
Meeting are as set forth below.
Directors Information
Dir #
Votes
For
Votes Withheld
Broker Non-Vote
% Votes
For
Dr. Robert Fischell
2,881,036.00
5,250,502.00
488,583.00
18.58
Luis Malave
2,880,918.00
5,250,620.00
488,583.00
18.58
Andrew Sycoff
2,945,847.00
5,185,691.00
488,583.00
19.00
Shimon Rapps
2,882,073.00
5,249,465.00
488,583.00
18.59
Allen Danzig
2,880,916.00
5,250,622.00
488,583.00
18.58
Proposals Information
Prop #
Votes
For
Votes Against
Votes Abstain
Broker Non-Vote
% Votes For
Ratify Auditor
8,612,584.00
7,481.00
56.00
0.00
55.55
Nonbinding Say on Pay
2,844,095.00
5,205,181.00
82,262.00
488,583.00
18.34
On
April 17, 2023, the Company announced the closing of a firm commitment underwritten public offering of shares of its common stock with
gross proceeds to the Company of approximately $10 million, before deducting underwriting discounts and other estimated expenses. The
offering consisted of 5,376,472 shares of common stock and 1,976,470 pre-funded warrants to purchase shares of common stock at a price
to the public of $1.36 per share (less $0.001 in exercise price per pre-funded warrant). The Company entered into an underwriting agreement
with Aegis Capital Corp. on April 13, 2023. The Company intends to use the net proceeds from this offering primarily for working capital
and general corporate purposes, which may include, without limitation, engaging in acquisitions or other business combinations or investments,
sales and marketing activities, general and administrative matters and capital expenditures.
On
July 25, 2023, the Company announced the completion and positive results of its feasibility study for its implantable continuous
glucose monitor technology for patients with Type 1 and Type 2 insulin-dependent diabetes. The primary goal of the feasibility study
was to demonstrate that the CGM sensor design could reliably report glucose measurements for two years post-implant. Laboratory
bench testing confirmed that a minimum two-year implant longevity is highly probable with the current sensor design. The implant
longevity was independently verified by a third-party using sensor parameters to simulate sensor performance over time. Given the
positive results of the study, the Company is now preparing for long-term animal studies, which are expected to begin later this
year.
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 2022 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.
12
Critical
Accounting Policies
This
Management’s Discussion and Analysis of Financial Condition and Results of Operations discuss our financial statements, which have
been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”).
In connection with the preparation of our financial statements, we are required to make assumptions and estimates about future events
and apply judgments that affect the reported amounts of assets, liabilities, expenses and the related disclosures. We base our assumptions,
estimates and judgments on historical experience, current trends and other factors that management believes to be relevant at the time
our 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.
Results
of Operations
The
following discussion of our operating results explains material changes in our results of operations for the six month period ended June
30, 2023 compared with the same period ended June 30, 2022. The discussion should be read in conjunction with the financial statements
and related notes included elsewhere in this report.
Six
Months ended June 30, 2023 compared to Six Months ended June 30, 2022
Research
and development expenses
Research
and development expenses were $1,269 thousand for the six-month period ended June 30, 2023, as compared to $929 thousand for the prior-year
period. The increase is attributable to professional fees we accrued during the period.
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 2023 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 $1,194 thousand for the six-month period ended June 30, 2023, as compared to $1,287 thousand for the
prior-year period. The decrease is attributable to professional fees we accrued during the period.
General
and administrative expenses consist primarily of professional services, salaries, consulting fees, 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
expenses, net was approximately $1 thousand for the six-month period ended June 30, 2023, as compared to financing income of $4 thousand
for the prior-year period. The change is immaterial.
Net
Loss
Net
loss was $2,462 thousand for the six-month period ended June 30, 2023, as compared to $2,220 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
Going
Concern Uncertainty
The
development and commercialization of GlucoTrack 2.0 product 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. However, in April 2023, we completed an underwriting U.S. public offering under
which net proceeds of $8,730 thousand has been raised. As of June 30, 2023, our cash on hand is sufficient to continue our operations
for a period of twelve-months subsequent to the reporting period.
Net
Cash Used in Operating Activities for the Six-Month Periods Ended June 30, 2023 and June 30, 2022
Net
cash used in operating activities was $2,269 thousand and $2,181 thousand for the six-month periods ended June 31, 2023 and 2022, respectively.
Net cash used in operating activities primarily reflects the net loss for those periods of $2,462 thousand and $2,220 thousand, respectively.
Net
Cash Used in Investing Activities for the Six-Month Periods Ended June 30, 2023 and June 30, 2022
Net
cash used in investing activities was $0 thousand and $4 thousand for the six-month periods ended June 30, 2023 and 2022, respectively.
Net cash used in investing activities primarily reflects the purchasing of fixed assets.
Net
Cash Used in Financing Activities for the Six-Month Periods Ended June 30, 2023 and June 30, 2022
Net
cash provided by financing activities was $8,730 thousand and $0 thousand for the six-month periods ended June 30, 2023 and 2022, respectively.
Net cash provided by financing activities primarily reflects the net proceeds received from public offering, net of offering expenses.
Off-Balance
Sheet Arrangements
As
of June 30, 2023, 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,
2023, 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 related to lack of sufficient internal accounting personnel, segregation of duties, and lack of sufficient internal
controls (including IT general controls) that encompass the Company as a whole with respect to entity and transactions level controls
in order to ensure complete documentation of complex and non-routine transactions and adequate financial reporting.
Management has identified corrective actions to remediate such material weaknesses, which includes hiring additional
employees. Management intends to implement procedures to remediate such material weaknesses during the fiscal year 2023; however, the
implementation of these initiatives may not fully address any material weaknesses that we may have in our 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.
14
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)
15
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned thereunto duly authorized.
Dated:
August 14, 2023
GLUCOTRACK, INC.
By:
/s/
Jolie Kahn
Name:
Jolie
Kahn
Title
Chief
Financial Officer
(Principal
Financial Officer)
16
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.