UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-Q
(Mark
One)
☒
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended September 30, 2022
or
☐
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from _____ to _____
Commission
File Number 001-39825
Intelligent Bio Solutions Inc.
(Exact
name of Registrant as specified in its Charter)
Delaware
82-1512711
(State
or other jurisdiction of
incorporation
or organization)
(I.R.S.
Employer
Identification
No.)
Intelligent Bio Solutions Inc .,
142
West, 57 th Street , 11 th
Floor , New York , NY
10019
(Address
of principal executive offices)
(Zip
Code)
Registrant’s
telephone number, including area code: (646) 828-8258
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, par value $0.01 per share
INBS
The Nasdaq
Stock Market LLC
Securities
registered pursuant to Section 12(g) of the Act: None
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 every Interactive Data File required to be submitted 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 such files). YES ☒ NO ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a 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 Act). YES ☐ NO ☒
As
of November 10, 2022, there were 18,352,995 of the registrant’s Common Stock issued and outstanding.
Table
of Contents
Page
PART
I.
FINANCIAL
INFORMATION
Item
1.
Financial
Statements (unaudited)
3
Condensed
Consolidated Balance Sheets
3
Condensed
Consolidated Statements of Operations and Other Comprehensive Loss
4
Condensed
Consolidated Statements of Changes in Shareholders’ 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.
17
Item
3.
Quantitative
and Qualitative Disclosures About Market Risk.
24
Item
4.
Controls
and Procedures.
24
PART
II.
OTHER
INFORMATION
Item
1.
Legal
Proceedings.
26
Item
1A.
Risk
Factors.
26
Item
2.
Unregistered
Sales of Equity Securities and Use of Proceeds.
27
Item
3.
Defaults
Upon Senior Securities.
27
Item
4.
Mine
Safety Disclosures.
27
Item
5.
Other
Information.
27
Item
6.
Exhibits.
28
Signatures
29
2
PART
I. FINANCIAL INFORMATION
ITEM
1. FINANCIAL STATEMENTS
Intelligent
Bio Solutions Inc.
Condensed
Consolidated Balance Sheets
September
30, 2022 (Unaudited)
June 30, 2022
ASSETS
Current assets:
Cash and cash equivalents
$ 5,742,626
$ 8,238,301
Deferred charges
300,000
-
Grant receivable, current portion
1,443,939
1,529,882
Research and development tax incentive receivable
571,860
353,048
Other current assets
148,927
746,761
Total current assets
8,207,352
10,867,992
Long-term grant receivable
1,031,384
1,092,773
Construction in progress
416,029
391,408
Other non-current assets
504,938
-
TOTAL ASSETS
$ 10,159,703
$ 12,352,173
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current liabilities:
Accounts payable and accrued expenses
$ 1,038,545
$ 1,625,089
Current portion of deferred grant income
1,018,918
2,836,582
Current employee benefit liabilities
299,686
201,332
Total current liabilities
2,357,149
4,663,003
Employee benefit liabilities
20,791
50,626
Long-term deferred grant income
2,585,629
1,092,773
Total liabilities
4,963,569
5,806,402
Commitments and contingencies (Note 11)
-
-
Shareholders’ equity:
Common stock, $ 0.01 par value, 100,000,000 shares authorized, 14,889,904 shares issued and outstanding at September 30, 2022 and June 30, 2022, respectively
148,899
148,899
Additional paid-in capital
38,440,011
38,440,011
Accumulated deficit
( 32,384,146 )
( 31,175,853 )
Accumulated other comprehensive loss
( 923,694 )
( 788,135 )
Total consolidated Intelligent Bio Solutions Inc. equity
5,281,070
6,624,922
Non-controlling interest
( 84,936 )
( 79,151 )
Total shareholders’ equity
5,196,134
6,545,771
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY
$ 10,159,703
$ 12,352,173
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
3
Intelligent
Bio Solutions Inc.
Condensed
Consolidated Statements of Operations and Other Comprehensive Loss
(Unaudited)
2022
2021
Three Months Ended September 30,
2022
2021
Revenue:
-
-
Other income:
Government support income
$ 311,320
$ -
Total revenue and other income
311,320
-
Operating expenses:
General and administrative expenses
1,450,418
1,332,520
Development and regulatory approval expenses
79,274
106,799
Total operating expenses
1,529,692
1,439,319
Loss from operations
( 1,218,372 )
( 1,439,319 )
Other income (expense):
Interest expense
( 1,065 )
-
Realized foreign exchange loss
( 2,247 )
( 3,118 )
Interest income
7,606
4,597
Total other income (expense)
4,294
1,479
Net loss
( 1,214,078 )
( 1,437,840 )
Net loss attributable to non-controlling interest
( 5,785 )
( 5,188 )
Net loss attributable to Intelligent Bio Solutions Inc.
$ ( 1,208,293 )
$ ( 1,432,652 )
Other comprehensive loss, net of tax:
Foreign currency translation loss
$ ( 135,559 )
$ ( 67,482 )
Total other comprehensive loss
( 135,559 )
( 67,482 )
Comprehensive loss
( 1,349,637 )
( 1,505,322 )
Comprehensive loss attributable to non-controlling interest
( 5,785 )
( 5,188 )
Comprehensive loss attributable to Intelligent Bio Solutions Inc.
$ ( 1,343,852 )
$ ( 1,500,134 )
Net loss per share, basic and diluted
$ ( 0.08 )
$ ( 0.10 )
Weighted average shares outstanding, basic and diluted
14,889,904
14,006,127
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
4
Intelligent Bio Solutions Inc.
Condensed
Consolidated Statements of Changes in Shareholders’ Equity
(Unaudited)
Shares
Amount
Shares
Amount
capital
deficit
loss
interest
(deficit)
Total
Preferred stock
Common stock
Additional
paid in
Accumulated
Other
comprehensive
Non-
controlling
shareholders’
equity
Shares
Amount
Shares
Amount
capital
deficit
loss
interest
(deficit)
Balance, June 30, 2022
-
$ -
14,889,904
$ 148,899
$ 38,440,011
$ ( 31,175,853 )
$ ( 788,135 )
$ ( 79,151 )
$ 6,545,771
Foreign currency translation loss
-
-
-
-
-
-
( 135,559 )
-
( 135,559 )
Net loss
-
-
-
-
-
( 1,208,293 )
-
( 5,785 )
( 1,214,078 )
Balance, September 30, 2022
-
$ -
14,889,904
$ 148,899
$ 38,440,011
$ ( 32,384,146 )
$ ( 923,694 )
$ ( 84,936 )
$ 5,196,134
Balance, June 30, 2021
1,300,000
$ 13,000
13,582,122
$ 135,821
$ 38,440,089
$ ( 22,869,803 )
$ ( 661,260 )
$ ( 51,226 )
$ 15,006,621
Balance
1,300,000
$ 13,000
13,582,122
$ 135,821
$ 38,440,089
$ ( 22,869,803 )
$ ( 661,260 )
$ ( 51,226 )
$ 15,006,621
Series B warrants exercised to purchase common shares
-
-
400
4
( 4 )
-
-
-
-
Conversion of convertible preferred shares into common shares
( 1,300,000 )
( 13,000 )
1,300,000
13,000
-
-
-
-
-
Foreign currency translation loss
-
-
-
-
-
-
( 67,482 )
-
( 67,482 )
Net loss
-
-
-
-
-
( 1,432,652 )
-
( 5,188 )
( 1,437,840 )
Balance, September 30, 2021
-
$ -
14,882,522
$ 148,825
$ 38,440,085
$ ( 24,302,455 )
$ ( 728,742 )
$ ( 56,414 )
$ 13,501,299
Balance
-
$ -
14,882,522
$ 148,825
$ 38,440,085
$ ( 24,302,455 )
$ ( 728,742 )
$ ( 56,414 )
$ 13,501,299
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
5
Intelligent
Bio Solutions Inc.
Condensed
Consolidated Statements of Cash Flows
(Unaudited)
2022
2021
Three Months Ended September
30,
2022
2021
Cash flows from operating activities:
Net loss
$ ( 1,214,078 )
$ ( 1,437,840 )
Adjustments to reconcile net loss to net cash used in operating activities:
Loss/ (gain) on foreign currency translation, net
2,247
3,118
Non-cash refund of R&D expenditure claims
( 60,413 )
-
Non-cash other operating activities
25,035
20,136
Changes in assets and liabilities:
Grant receivable, current and non-current
147,332
2,503,875
Research and development tax incentive receivable, current
( 218,812 )
-
Deferred charges
( 300,000 )
-
Other assets, current and non-current
92,896
240,246
Accounts and other payables
( 13,299 )
( 635,568 )
Accounts payable - related party
-
55,485
Deferred grant income, current and non-current
( 324,808 )
( 674,984 )
Other long-term liabilities
( 29,835 )
8,494
Net cash (used in) provided by operating activities
( 1,893,735 )
82,962
Cash flows from investing activities:
Amount invested on construction in progress
( 474,891 )
-
Net cash used in investing activities
( 474,891 )
-
Effect of foreign exchange rates on cash and cash equivalents
( 127,049 )
( 48,179 )
(Decrease) increase in cash and cash equivalents
( 2,495,675 )
34,783
Cash and cash equivalents, beginning of period
8,238,301
12,573,685
Cash and cash equivalents, end of period
$ 5,742,626
$ 12,608,468
Non-cash investing and financing activities
Conversion of preferred shares into common shares
$ -
$ 13,000
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
6
Intelligent
Bio Solutions Inc.
Notes
to the Condensed Consolidated Financial Statements
(Unaudited)
NOTE
1. ORGANIZATION AND DESCRIPTION OF THE BUSINESS
Intelligent
Bio Solutions Inc. (formerly, GBS Inc.) (“INBS”) and its wholly owned subsidiary, GBS Operations Inc. were each formed
on December 5, 2016, under the laws of the state of Delaware. Glucose Biosensor Systems (Greater China) Pty Ltd was formed on August
4, 2016, under the laws of New South Wales, Australia and was renamed to GBS (APAC) Pty Ltd on October 14, 2020. Glucose Biosensor
Systems (Japan) Pty Ltd and Glucose Biosensor Systems (APAC) Pty Ltd were formed under the laws of New South Wales, Australia on
February 22, 2017 and February 23, 2017 respectively. On October 26, 2022, the Company changed its corporate name (the “Name
Change”) from “GBS Inc.” to “Intelligent Bio Solutions Inc.” For purpose of the Quarterly Report on
Form 10-Q, the terms “Company”, “we,” “us” and “our” refer to INBS and its
consolidated subsidiaries unless context indicates otherwise.
We
are a medical technology company operating across the Asia-Pacific region (the “APAC Region”) with an objective to
introduce and deliver intelligent pain free diagnostic tests. We also have an interest in the North America region. Our goal is to
expand the global footprint of our drug screening tests following our recent acquisition of Intelligent Fingerprinting Limited,
while continuing to develop our Biosensor Platform that we license from Life Science Biosensor Diagnostics Pty Ltd
(“LSBD” or the “Licensor”). This will be followed by developing both of our platforms to their
full capacity across multiple diagnostic modalities of immunology, hormones, chemistry, tumor markers and nucleic acid
tests.
NOTE
2. LIQUIDITY
The
Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 205-40, Presentation
of Financial Statements - Going Concern (ASC 205-40) requires management to assess an entity’s ability to continue as a going
concern within one year of the date of the financial statements are issued. In each reporting period, including interim periods, an entity
is required to assess conditions known and reasonably knowable as of the financial statement issuance date to determine whether it is
probable an entity will not meet its financial obligations within one year from the financial statement issuance date. Substantial doubt
about an entity’s ability to continue as a going concern exists when conditions and events, considered in the aggregate, indicate
it is probable the entity will be unable to meet its financial obligations as they become due within one year after the date the financial
statements are issued.
The
Company is an emerging growth company and has not generated any revenues to date. As such, the Company is subject to all of the risks
associated with emerging growth companies. Since inception, the Company has incurred losses and negative cash flows from operating activities.
The Company does not expect to generate positive cash flows from operating activities in the near future until such time, if at all,
the Company completes the development process of its products, including regulatory approvals, and thereafter, begins to commercialize
and achieve substantial acceptance in the marketplace for the first of a series of products in its medical device portfolio.
The
Company incurred a net loss of $ 1,208,293 for the three months ended September 30, 2022 (net loss of $ 1,432,652 for the three months
ended September 30, 2021). At September 30, 2022, the Company has shareholders’ equity of $ 5,196,134 , working capital of $ 5,850,203 ,
and an accumulated deficit of $ 32,384,146 .
In
the near future, the Company anticipates incurring operating losses and does not expect to experience positive cash flows from operating
activities and may continue to incur operating losses until it completes the development of its products and seeks regulatory approvals
to market such products.
The
Company has evaluated whether there are conditions and events, considered in the aggregate, that raise a substantial doubt about its
ability to continue as going concern within one year after the date of release of the condensed consolidated financial statements.
The Company expects that its cash and cash equivalents as of September 30, 2022, of $ 5,742,626 ,
may be insufficient to allow the Company to fund its current operating plan through at least the next twelve months from the
issuance of these financial statements, taking into account the acquisition of Intelligent Fingerprinting
Limited. Should revenue not be generated during this period to cover expenses, then these conditions may raise substantial doubt
about the Company’s ability to continue as a going concern for a period of at least one year from the date these financial
statements are issued. Accordingly, it appears that the Company will be required to raise additional funds during the next 12 months.
The Company is currently evaluating potentially raising additional funds through private placements and/or public equity financing.
However, there can be no assurance that, in the event that the Company requires additional financing, such financing will be
available on terms which are favorable to the Company, or at all. If the Company is unable to raise additional funding to meet its
working capital needs in the future, it will be forced to delay or reduce the scope of its research programs and/or limit or cease
its operations. Accordingly, these factors raise substantial doubt about the Company’s ability to continue as a going concern
unless it can successfully raise additional capital.
7
The
Company’s unaudited condensed consolidated financial statements have been prepared on a going concern basis which contemplates
the realization of assets and satisfaction of liabilities and commitments in the normal course of business. The unaudited condensed
consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset
amounts or the amounts and classification of liabilities should the Company be unable to continue as a going concern.
NOTE
3. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis
of presentation
The
unaudited condensed consolidated financial statements of the Company have been prepared in accordance with accounting principles
generally accepted in the United States of America (“GAAP”) for interim financial information and the instructions to
Form 10-Q and Article 10 of Regulation S-X. Accordingly, our unaudited condensed consolidated financial statements do not include
all the information and footnotes required by GAAP for complete financial statements. Normal and recurring adjustments considered
necessary for a fair statement of the results for the interim periods, in the opinion of the Company’s management, have been
included. Operating results for the three months ended September 30, 2022, are not necessarily indicative of the results that may be
expected for the year ending June 30, 2023. The accompanying unaudited condensed consolidated financial statements and related
footnote disclosures should be read in conjunction with the consolidated financial statements and notes thereto included in our Form
10-K and 10-K/A for the year ended June 30, 2022, which was filed with the U.S. Securities and Exchange Commission (the
“SEC”) on September 22, 2022 and amended on Form 10-K/A filed with the SEC on October 7, 2022 (as amended, the
“2022 Form 10-K”).
Principles
of consolidation
These unaudited condensed consolidated financial statements include the accounts of the Company, all wholly owned and majority-owned
subsidiaries in which the Company has a controlling voting interest and, when applicable, variable interest entities in which the Company
has a controlling financial interest or is the primary beneficiary. Investments in affiliates where the Company does not exert a controlling
financial interest are not consolidated .
All
significant intercompany transactions and balances have been eliminated upon consolidation.
Equity
offering costs
The
Company complies with the requirements of ASC 340, Other Assets and Deferred Costs , with regards to offering costs. Prior to the
completion of an offering, offering costs are capitalized as deferred offering costs on the consolidated balance sheets. The deferred
offering costs will be charged to shareholders’ equity upon the completion of the related offering.
Use
of estimates
The
preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect
the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial
statements, and the reported amounts of revenue and expenses during the reporting period. Actual results could materially differ from
those estimates.
8
Revenue
recognition
Revenue
from contracts with customers is recognized when, or as, the Company satisfies its performance obligations by delivering the promised
goods or service deliverables to the customers. A good or service deliverable is transferred to a customer when, or as, the customer
obtains control of that good or service deliverable.
Deferred
grant income
On
June 30, 2021, the Company executed a definitive grant agreement with the Australian Government to assist with building a manufacturing
facility. The grant has a total value of up to $ 4.7 million upon the achievement of certain milestones until March 28, 2024. Proceeds
from the grant will be used primarily to reimburse the Company for costs incurred in the construction of the manufacturing facility.
Accounting
for the grant does not fall under ASC 606, Revenue from Contracts with Customers , as the Australian Government will not benefit
directly from our manufacturing facility. As there is no authoritative guidance under U.S. GAAP on accounting for grants to for-profit
business entities, we applied International Accounting Standards 20 (“IAS 20”), Accounting for Government Grants and Disclosure
of Government Assistance by analogy when accounting for the Australian Government grant to the Company.
The
Australian Government grant proceeds, which will be used to reimburse construction costs incurred, meet the definition of grants related
to assets as the primary purpose for the payments is to fund the construction of a capital asset. Under IAS 20, government grants related
to assets are presented in the statement of financial position either by setting up the grant as deferred income that is recognized in
the statement of operation on a systematic basis over the useful life of the asset or by deducting the grant in arriving at the carrying
amount of the asset. Either of these two methods of presentation of grants related to assets in financial statements are regarded as
acceptable alternatives under IAS 20. The Company has elected to record the grants received initially as deferred income and deducting
the grant proceeds received from the gross costs of the assets or construction in progress (“CIP”) and the deferred grant
income liability.
Under
IAS 20, government grants are initially recognized when there is reasonable assurance the conditions of the grant will be met and
the grant will be received. As of June 30, 2021, management concluded that there was reasonable assurance the grant conditions will
be met and all milestone payment received. The total grant value of $ 4.7
million was recognized as both a grant receivable and deferred grant income on the grant effective date. The grant receivable was
reduced by $ 2.1
million for payments received during the twelve months ended June 30, 2022 ( no
payments were received during the three months ended September 30, 2022) and $ 2.5
million remains in grant receivable on the Condensed Consolidated Balance Sheets for the period ended September 30, 2022. The
receivable balance at September 30, 2022 is arrived at after considering the forex impact on the grant receivable by foreign
subsidiary.
After
initial recognition, under IAS 20, government grants are recognized in earnings on a systematic basis in a manner that mirrors the manner
in which the Company recognizes the underlying costs for which the grant is intended to compensate. Further, IAS 20 permits for recognition
in earnings either separately under a general heading such as other income, or as a reduction of the cost of the asset. The Company has
elected to recognize government grant income separately within other income for operating expenditures. Similarly, for capital expenditures,
the carrying amount of assets purchased or constructed out of the grant funds are presented net by deducting the grant proceeds received
from the gross costs of the assets or CIP and deferred grant income liability. A total of $ 60,413 deferred grant income was recognized
within other income during the current period.
Development
and regulatory approval costs
Expenditures
relating to research and development (“R&D”) are expensed as incurred and recorded in development and regulatory approval
in the Condensed Consolidated Statements of Operations and Other Comprehensive Loss. R&D expenses include external expenses incurred
under arrangements with third parties; salaries and personnel-related costs; license fees to acquire in-process technology and other
expenses. The Company recognizes the benefit of refundable R&D tax refunds as a R&D tax refund income when there is reasonable
assurance that the amount claimed will be recovered (refer to the R&D tax refund discussion below).
9
Intellectual
property acquired for a particular research and development project and that have no alternative future uses (in other research and development
projects or otherwise) are expensed in research and development costs at the time the costs are incurred.
In
certain circumstances, the Company may be required to make advance payments to vendors for goods or services that will be received in
the future for use in R&D activities. In such circumstances, the non-refundable advance payments are deferred and capitalized, even
when there is no alternative future use for the R&D, until the related goods or services are provided. In circumstances where amounts
have been paid in excess of costs incurred, the Company records a prepaid expense.
R&D
tax refund
The
Company measures the R&D grant income and receivable by considering the time spent by employees on eligible R&D activities and
R&D costs incurred to external service providers. The R&D tax refund receivable is recognized as the Company believes that it
is probable that the amount will be recovered in full through a future claim. A total of $ 250,907 and $ nil of R&D tax refund income
was recognized in other income during the three months ended September 30, 2022, and 2021, respectively.
Foreign
currency translation
Assets
and liabilities of foreign subsidiaries are translated from local (functional) currency to reporting currency (U.S. dollar) at the
rate of exchange in effect on the consolidated balance sheets date; income and expenses are translated at the average rate of
exchange prevailing during the year. The functional currency of INBS is the United States dollar. Foreign currency movements
resulted in a loss of $ 135,559
and $ 67,482
for the three months ended September 30, 2022, and 2021, respectively.
Income
taxes
In
accordance with the provisions of FASB ASC 740, Income Taxes , tax positions initially need to be recognized in the consolidated
financial statements when it is more likely than not that the positions will be sustained upon examination by taxing authorities. It
also provides guidance for de-recognition, classification, interest and penalties, accounting in interim periods, disclosure, and transition.
As
of September 30, 2022, the Company had no uncertain tax positions that qualified for either recognition or disclosure in the consolidated
financial statements. Additionally, the Company had no interest and penalties related to income taxes.
Licensing
rights
During
the first quarter of the fiscal year ended June 30, 2020, the Company purchased the license right procurement assets from LSBD for
an amount of $ 976,308
in relation to the development and approval process for the Glucose Biosensor Technology in the APAC region. The Company recorded the license at the
historical carrying value in the books of LSBD which was $nil and recorded the amount paid as a deemed dividend. The Company has
agreed to pay royalties of sales & milestones payments as defined.
On
September 12, 2019, the Company entered into an amended and restated license agreement for Saliva Biosensor Technology. On June 23, 2020,
the Company entered into a license agreement with LSBD for the worldwide rights to SARS-CoV-2 application of the Saliva Glucose Biosensor.
In
relation to these licenses, there is no set expiration date for the license. However, the exclusivity of the license granted under the
license agreement runs until the expiration of the patent portfolio covered by the agreement which is currently until 2033. No royalties
have been incurred through to September 30, 2022.
On
March 31, 2021, the Company entered into an agreement with LSBD to provide the Company an option to acquire an exclusive license to
use LSBD’s intellectual property in the Saliva Glucose Biosensor in North America (the “Option Agreement”). The
Option Agreement has a term of two
years ending March 31, 2023 and the exercise price for the option is $ 5,000,000 .
The fee of $ 500,000
incurred for the option was expensed in the period incurred.
10
Trade,
note and other receivables
Trade,
note and other receivables are recorded net of allowances for uncollectible accounts. The Company evaluates the collectability of its
accounts receivable based on various factors including historical experience, the length of time the receivables are past due and the
financial health of the customer. The Company reserves specific receivables if collectability is no longer reasonably assured. Based
upon the assessment of these factors, the Company did not record an allowance for uncollectible accounts as of September 30, 2022, or
2021.
Net
loss per share attributable to common shareholders (“EPS”)
The
Company calculates earnings per share attributable to common shareholders in accordance with ASC 260, Earning Per Share . Basic
net loss per share attributable to common shareholders is calculated by dividing net loss attributable to common shareholders by the
weighted average number of common shares outstanding during the period. Diluted net loss per common share is calculated by dividing net
loss attributable to common shareholders by weighted average common shares outstanding during the period plus potentially dilutive common
shares, such as share warrants.
Potentially
dilutive common shares shall be calculated in accordance with the treasury share method, which assumes that proceeds from the exercise
of all warrants are used to repurchase common share at market value. The number of shares remaining after the proceeds are exhausted
represents the potentially dilutive effect of the securities.
As
the Company has incurred net losses in all periods, certain potentially dilutive securities, including convertible preferred stock, warrants
to acquire common stock, and convertible notes payable have been excluded in the computation of diluted loss per share as the effects
are antidilutive.
Property,
Plant and Equipment (PPE) & Construction in Progress (CIP)
In
accordance with the ASC 360, Property, Plant, and Equipment , the Company’s PPE, except land, is stated at cost net of accumulated
depreciation and impairment losses, if any. Land is stated at cost less any impairment losses. Costs incurred to acquire, construct,
or install PPE, before the assets is ready for use, are capitalized in CIP at historical cost. The carrying amount of assets purchased
or constructed out of the grant funds are presented net by deducting the grant proceeds received from the gross costs of the assets or
CIP. CIP is not depreciated until such time when the asset is substantially completed and ready for its intended use.
Recently
issued accounting pronouncements
As
the Company is an emerging growth company, we have elected to defer the adoption of new accounting pronouncements until they would apply
to private companies.
Adopted:
In
August 2020, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No.
2020-06, Debt – Debt with Conversion and Other Options (“ASU 2020-06”), which simplifies the guidance on the
issuer’s accounting for convertible debt instruments by removing the separation models for (1) convertible debt with a cash conversion
feature and (2) convertible instruments with a beneficial conversion feature. As a result, entities will not separately present in equity
an embedded conversion feature in such debt and will account for a convertible debt instrument wholly as debt, unless certain other conditions
are met. The elimination of these models will reduce reported interest expense and increase reported net income for entities that have
issued a convertible instrument that is within the scope of ASU 2020-06. Also, ASU 2020-06 requires the application of the if-converted
method for calculating diluted earnings per share and treasury stock method will be no longer available. The Company adopted ASU 2020-06
as of July 1, 2022. Adoption did not have a material impact on the Company’s financial statements.
11
Pending
adoption:
In
November 2021, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No.
2021-10, Government Assistance (“ASU 2021-10”). This update requires annual disclosures about transaction with a government
that are accounted for by applying a grant or contribution accounting model by analogy. Required disclosures include (1) information
about the nature of the transactions and the related accounting policy used to account for the transactions, (2) the line items on the
balance sheet and income statement that are affected by the transactions, and the amounts applicable to each financial statement line
item, and (3) significant terms and conditions of the transactions, including commitments and contingencies. ASU 2021-10 is applicable
for fiscal years beginning after December 15, 2021, with early adoption permitted. The Company is planning to complete the required ASU
2021-10 disclosures with the filing of its Annual Report on Form 10-K for the year ending on June 30, 2023. Based on the management’s
assessment of ASU2021-10, this standard is not expected to have a material impact on the Company’s financial statements.
In
October 2021, the FASB issued ASU No. 2021-08, Business Combinations (Topic 805) – Accounting for Contract Assets and Contract
Liabilities from Contracts with Customers (“ASU 2021-08”). ASU 2021-08 requires that an acquirer recognize and measure
contract assets and contract liabilities acquired in a business combination in accordance with Topic 606, as if it had originated the
contracts. Prior to this ASU, an acquirer generally recognized contract assets acquired and contract liabilities assumed that arose from
contracts with customers at fair value on the acquisition date. The ASU is effective for fiscal years beginning after December 15, 2023,
with early adoption permitted. The ASU is to be applied prospectively to business combinations occurring on or after the effective date
of the amendment. The Company has not early adopted and continues to evaluate the impact of the provisions of ASU 2021-08 on its consolidated
financial statements.
In
June 2016, the FASB issued ASU No. 2016-13 (Topic 326), Financial Instruments – Credit Losses (“ASU 2016-13”).
This update (i) significantly changes the impairment model for most financial assets that are measured at amortized cost and certain
other instruments from an incurred loss model to an expected loss model which will be based on an estimate of current expected credit
loss (“CECL”) (ASC 326-20); and (ii) provides for recording credit losses on available-for-sale (“AFS”) debt
securities through an allowance account (ASC 326-30). The standard also requires certain incremental disclosures. Subsequently, the FASB
issued several ASUs to clarify, improve, or defer the adoption of ASU 2016-13. ASU 2016-13, as amended by ASU 2019-10, is applicable
for Smaller Reporting Companies (“SRCs”) for fiscal years beginning after December 15, 2022, with early adoption permitted.
The Company has not early adopted the standard and continues to evaluate the impact.
In
February 2016, the FASB issued ASU No. 2016-02, Leases (“ASU 2016-02”). This update requires all leases with a term
greater than 12 months to be recognized on the balance sheet through a right-of-use asset and a lease liability and the disclosure of
key information pertaining to leasing arrangements. This new guidance is effective for fiscal years beginning after December 15, 2021,
and interim period within fiscal years beginning after December 15, 2022, as amended by ASU 2020-05 with early adoption permitted. The
Company has not early adopted the standard and continues to evaluate the impact.
Concentration
of credit risk
The
Company places its cash and cash equivalents, which may at times be in excess of the Australia Financial Claims Scheme or the United
States’ Federal Deposit Insurance Corporation insurance limits, with high credit quality financial institutions and attempts to
limit the amount of credit exposure with any one institution.
Fair
value of financial instruments
The
accounting guidance defines fair value, establishes a consistent framework for measuring fair value and expands disclosure for each major
asset and liability category measured at fair value on either a recurring or non-recurring basis. Fair value is defined as an exit price,
representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market
participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants
would use in pricing an asset or liability. As a basis for considering such assumptions, the accounting guidance establishes a three-tier
fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows:
Level
1 -Quoted prices in active markets for identical assets or liabilities.
Level
2 -Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities, quoted prices in markets
that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full
term of the assets or liabilities.
Level
3 -Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets
or liabilities.
12
Assets
and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the
fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its
entirety requires management to make judgments and consider factors specific to the asset or liability.
The
carrying amounts of cash equivalents, prepaid and other assets, accounts payable and accrued liabilities are representative of their
respective fair values because of the short-term nature of those instruments.
NOTE
4. OTHER CURRENT ASSETS
Other
current assets consist of the following:
SCHEDULE OF OTHER CURRENT ASSETS
September 30, 2022
June 30, 2022
Intelligent Fingerprinting Limited note receivable
$ —
$ 500,445
Prepayments
41,532
116,525
Goods and services tax receivable
55,852
57,746
Deposits
44,493
46,602
Other receivables
7,050
25,443
Total
$ 148,927
$ 746,761
NOTE 5. OTHER NON-CURRENT ASSETS
Other non-current assets consist of the following :
SCHEDULE OF OTHER NON-CURRENT ASSETS
September 30, 2022
June 30, 2022
Intelligent Fingerprinting Limited note receivable
$ 504,938
$ —
Total
$ 504,938
$ —
On June 16, 2022, the Company entered into an agreement
with Intelligent Fingerprinting Limited (“IFP”), providing the Company with the exclusive right, until December 31, 2022,
to evaluate and negotiate a transaction to acquire IFP or its assets. In consideration for this exclusivity, on June 16, 2022, the Company
provided IFP with an unsecured term loan facility in the amount of $ 500,000 , which was payable by IFP on the earliest of the consummation
of an acquisition, 30 days following the termination of exclusivity under the exclusivity agreement, an event of default under the term
loan facility agreement, or December 31, 2022. This $ 500,000 term note receivable bears an interest rate of 2 % per annum above the Sterling
Barclays Bank Base Rate from time to time. The Company subsequently completed the acquisition of IFP, and in connection therewith amended
the terms of the term loan facility, in October 2022. See note 14.
Effective contemporaneously with the closing of the
Company’s acquisition of IFP, the Company entered into an amendment to the bridge facility agreement between the Company and IFP,
dated as of June 16, 2022, the $ 500,000 loan from the Company to IFP pursuant thereto will remain outstanding until October 4, 2024.
NOTE
6. ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Accounts
payable and accrued expenses consist of the following:
SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES
September 30, 2022
June 30, 2022
Accounts and other payables
$ 379,912
$ 715,902
Accruals
658,633
909,187
Total
$ 1,038,545
$ 1,625,089
As
on September 30, 2022, the Company’s $ 658,633 of accruals include $ 415,350 related to legal and consulting fees, $ 135,615 related
to development and regulatory approval expenses, $ 80,363 related to audit and accounting service fees, and $ 27,305 related to other general
and administrative expenses.
NOTE
7. SHAREHOLDERS’ EQUITY
As
of September 30, 2022, 1,401,377 and 52,400 Series A and Series B warrants were held by certain shareholders, respectively. Each warrant
is convertible into 1 share of the Company’s common stock.
13
NOTE
8. RELATED PARTY TRANSACTIONS
Sales
to and purchases from related parties are made in arm’s length transactions both at normal market prices and on normal commercial
terms. The following transactions occurred with LSBD during the comparative period July 1, 2021, to September 30, 2021:
The
Company incurred a total of $ nil
during three months to September 2022 (September
2021: $ 119,652 )
towards overhead cost reimbursement which includes salaries, rents and other related overheads directly attributable to the Company which
are included in general and administration expenses.
During
the year ended June 30, 2021, the Company contributed a total of $ 2,600,000 towards budgeted development and commercialization costs
to be incurred by BiosensX (North America) Inc. relating to the development and preparation for submission of the Saliva Glucose Biosensor
connected with regulatory approval for the U.S. market by the U.S. Food & Drug Administration.
As
of September 30, 2022, $ 8,545 (September 30, 2021: $ 68,808 ) remains payable to LSBD in relation to overhead reimbursements detailed above.
NOTE
9. INVESTMENT IN AFFILIATE
On
May 29, 2020, LSBD, issued 14,000,000 common shares of BiosensX (North America) Inc. to the Company at par value of $ 0.001 per share.
This transaction provided the Company with a 50 % interest in BiosensX (North America) Inc., the holder of the technology license for
the North America region.
The
investment in BiosensX (North America) Inc. is accounted for by use of the equity method in accordance with ASC 323, Investments -
Equity Method and Joint Ventures .
At
the date of this transaction, LSBD was the parent of both the Company and BiosensX (North America) Inc., the transfer of BiosensX shares
to the Company was deemed to be a common control transaction. As a result of the share transfer, the Company has significant influence
over BiosensX (North America) Inc.
During
the year ended June 30, 2022, LSBD sold all its shares in INBS. The Company determined whether it has a controlling financial interest
in BiosensX (North America) Inc. by first evaluating whether the entity is a voting interest entity or a VIE under GAAP. Voting interest
entities are entities in which the total equity investment at risk is sufficient to enable the entity to finance itself independently
and provides the equity holders with the obligation to absorb losses, the right to receive residual returns and the right to make decisions
about the entity’s activities. The Company consolidates voting interest entities in which it has all, or at least a majority of,
the voting interests. As defined in applicable accounting standards, VIEs are entities that lack one or more of the characteristics of
a voting interest entity. A controlling financial interest in a VIE is present when an enterprise has both the power to direct the activities
of the VIE that most significantly impact the VIE’s economic performance and an obligation to absorb losses or the right to receive
benefits that could potentially be significant to the VIE. The enterprise with a controlling financial interest, known as the primary
beneficiary, consolidates the VIE. The Company concluded that it does not have a controlling financial interest in BiosensX (North America)
Inc., hence it continues to recognize its investments in BiosensX (North America) Inc. using the equity method.
The
carrying amount of investments in BiosensX (North America) Inc. was $ nil
as of September 30, 2022, and June 30, 2022.
NOTE
10. CONSTRUCTION IN PROGRESS
During
the three months ended September 30, 2022, the Company incurred costs of $ 49,242 towards the construction of R&D and manufacturing
facility at the University of Newcastle. The Australian government reimbursed the Company 50 % of the costs incurred towards building
of the facility. The carrying amounts of the Constructions in Progress (CIP) is calculated by deducting the reimbursement from total
cost incurred.
The
following table summarizes the amount of CIP recorded in the Condensed Consolidated Balance Sheets:
SUMMARY
OF AMOUNT RECORDED IN THE CONSOLIDATED BALANCE SHEETS
September 30, 2022
June 30, 2022
Investments in construction in progress
$ 832,058
$ 782,816
Less: 50 % contributed under government grant
( 416,029 )
( 391,408 )
Carrying amount
$ 416,029
$ 391,408
14
NOTE
11. COMMITMENTS AND CONTINGENCIES
During
February 2021 the Company signed a deed of confirmation and variation with the University of Newcastle for the research and development
of the Saliva Glucose Biosensor and the SARS-CoV-2 Antibody Biosensor. The Company agreed to pay the University of Newcastle $ 2,054,880
of which $ 135,615 remains payable as of September 30, 2022.
The
Company has no material future minimum lease commitments or purchase commitments.
From
time to time, the Company may become a party to various legal proceedings arising in the ordinary course of business. Based on information
currently available, the Company is not involved in any pending or threatened legal proceedings that it believes could reasonably be
expected to have a material adverse effect on its financial condition, results of operations or liquidity. However, legal matters are
inherently uncertain, and the Company cannot guarantee that the outcome of any potential legal matter will be favorable to the Company.
NOTE
12. INCOME TAX
The
Company shall file its income tax returns with the Internal Revenue Service and Australian Taxation Office. The Company has operating
losses carried forward of $ 28,443,205 which are derived from its operations in Australia and the US and are available to reduce future
taxable income. Such loss carry forwards may be carried forward indefinitely, subject to compliance with tests of continuity and additional
rules.
The
net operating loss carried forward gives rise to a deferred tax asset of approximately $ 6,325,630 . However, the Company has determined
that a valuation allowance of $ 6,325,630 against such deferred tax asset is necessary, as it cannot be determined that the carry forwards
will be utilized.
NOTE
13. LOSS PER SHARE
Basic
loss per common share is computed by dividing net loss allocable to common shareholders by the weighted average number of shares of common
stock or common stock equivalents outstanding. Diluted loss per common share is computed similar to basic loss per common share except
that it reflects the potential dilution that could occur if dilutive securities or other obligations to issue common stock were exercised
or converted into common stock.
SCHEDULE OF BASIC LOSS PER COMMON SHARE POTENTIAL DILUTIVE SECURITIES
2022
2021
Three Months Ended September
30,
2022
2021
Net loss attributable to Intelligent Bio Solutions Inc.
$ ( 1,208,293 )
$ ( 1,432,652 )
Basic and diluted net loss per share attributed to common shareholders
$ ( 0.08 )
$ ( 0.10 )
Weighted-average number of shares outstanding
14,889,904
14,006,127
15
The
following outstanding warrants, options and preferred shares were excluded from the computation of diluted net loss per share for the
periods presented because their effect would have been anti-dilutive:
SCHEDULE OF ANTI-DILUTIVE WARRANTS
Three Months Ended September
30,
2022
2021
Warrants - Series A
1,401,377
1,401,377
Warrants - Series B
52,400
59,782
Warrants issued to underwriters
63,529
63,529
Pre IPO warrants
2,736,675
2,736,675
Warrants issued to the licensor
3,000,000
3,000,000
NOTE
14. SUBSEQUENT EVENTS
On August 5, 2022, the Company filed a registration statement on Form S-8 with the SEC to register 500,000 shares of the Company’s
common stock issuable pursuant to the Company’s 2019 Long Term Incentive Plan (the “2019 Plan”). On October 6, 2022,
the Company issued 500,000 common shares to its employees under the 2019 Plan. These shares vested immediately upon issuance, and the
respective holders thereof had the immediate right to receive all shares of common stock issued under the 2019 Plan.
On
October 4, 2022, the Company acquired Intelligent Fingerprinting Limited (“IFP”), a company registered in England and
Wales, through a share exchange agreement with the shareholders of IFP (the “Sellers”). The Company purchased 100 %
of the issued shares of IFP by issuing 2,963,091
shares of the Company’s common stock and 2,363,003
shares of the Company’s series C convertible preferred stock (“preferred stock”) to the Sellers. Up to an
additional 1,649,273
shares of preferred stock have been reserved for potential future issuance by the Company, consisting of (i) 500,000
shares of preferred stock held back from the Sellers for one year after the closing of the acquisition to secure potential
indemnification claims by the Company against the Sellers and (ii) 1,149,273
shares of preferred stock for Sellers who are also the IFP convertible loan holders and, at each loan holder’s respective
option, convert such the outstanding convertible loans to IFP into shares of Company preferred stock, contingent upon approval of
the Company’s stockholders of the conversion of the preferred stock into common stock. Each preferred share will be
convertible into three shares of Company common stock, contingent upon approval by the Company’s stockholders. In addition,
the Company is obligated to pay the cash bonuses of approximately $ 350,150
(consisting of £ 239,707
and $ 83,043 )
to certain current and former IFP employees and directors in two equal installments. The first payment was made immediately
following the closing of the acquisition, and the second payment is required to be made on the six-month anniversary of closing date
of the acquisition. The acquisition of IFP will expand the Company’s platform of rapid, non-invasive diagnostic testing
technologies.
In
conjunction with the IFP acquisition, the Company has agreed to make a Company’s stock option plan available to IFP
employees for up to 1,000,000 shares common stock following the closing of the acquisition. An equal number of stock options will be
granted to the Company’s employees, for an aggregate amount of 2,000,000 Company stock options.
Due
to the limited time between the transaction date and the Company’s filing of this Quarterly Report on Form 10-Q for the quarter
ended September 30, 2022, initial accounting for the business combination is incomplete and the Company is not yet able to disclose the
provisional amounts to be recognized as of the acquisition date for assets acquired and liabilities assumed, and the pro forma revenues
for the combined entity. Management is evaluating the transaction costs and the fair value of consideration transferred, assets acquired,
and liabilities assumed. The Company expects to provide the preliminary purchase price allocation information in the Quarterly Report
on Form 10-Q for the quarter ending December 31, 2022.
16
ITEM
2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
You
should read the following discussion in conjunction with our audited historical consolidated financial statements, which are included
in the 2022 Form 10-K and our unaudited condensed consolidated financial statements for the fiscal quarter ended September 30, 2022 included
elsewhere in this Quarterly Report on Form 10-Q. This Management’s Discussion and Analysis of Financial Condition and Results of
Operations contains statements that are forward-looking. These statements are based on current expectations and assumptions that are
subject to risks, uncertainties and other factors. Actual results could differ materially because of the factors discussed below or elsewhere
in this Quarterly Report on Form 10-Q. See Part II, Item 1A. “Risk Factors” of this Quarterly Report on Form 10-Q and Part
I, Item 1A. “Risk Factors” of the 2022 Form 10-K.
Forward-Looking
Information
All
statements other than statements of historical fact or relating to present facts or current conditions included in this Quarterly
Report on Form 10-Q are forward-looking statements. Forward-looking statements include, but are not limited to, statements regarding
expectations, hopes, beliefs, intentions or strategies regarding the future. In addition, any statements that refer to projections,
forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking
statements. These statements may include words such as “anticipate,” “estimate,” “expect,” “project,”
“plan,” “intend,” “believe,” “may,” “should,” “can have,”
“likely” and the negative of such words and other words and terms of similar meaning, but the absence of these words
does not mean that a statement is not forward-looking.
The
forward-looking statements contained in this Quarterly Report on Form 10-Q are based on our current expectations and beliefs concerning
future developments and their potential effects on us. These forward-looking statements are subject to a number of risks, uncertainties
and assumptions, including those described in “Item 1A — Risk Factors” of this Quarterly Report on Form 10-Q and
in our 2022 Form 10-K. Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to
time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or
the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in
any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the future events and trends
discussed in this Quarterly Report on Form 10-Q may not occur and actual results could differ materially and adversely from those
anticipated or implied in the forward-looking statements.
You
should not rely upon forward-looking statements as predictions of future events. The events and circumstances reflected in the forward-looking
statements may not be achieved or occur. Although we believe that the expectations reflected in the forward-looking statements are
reasonable, we cannot guarantee future results, levels of activity, performance, or achievements. Except as required by the federal
securities laws, we are under no duty to update any of these forward-looking statements after the date of this Quarterly Report on
Form 10-Q or to conform these statements to actual results or revised expectations.
Overview
Intelligent
Bio Solutions Inc. (formerly, GBS Inc.) (“INBS”) and its wholly owned subsidiary, GBS Operations Inc. were each formed on
December 5, 2016, under the laws of the state of Delaware. Glucose Biosensor Systems (Greater China) Pty Ltd was formed on August 4,
2016, under the laws of New South Wales, Australia and was renamed to GBS (APAC) Pty Ltd on October 14, 2020. Glucose Biosensor Systems
(Japan) Pty Ltd and Glucose Biosensor Systems (APAC) Pty Ltd were formed under the laws of New South Wales, Australia on February 22,
2017 and February 23, 2017 respectively. On October 26, 2022, the Company changed its corporate name (the “Name Change”)
from “GBS Inc.” to “Intelligent Bio Solutions Inc.” For purpose of the Quarterly Report on Form 10-Q, the terms
“Company”, “we,” “us” and “our” refer to INBS and its consolidated subsidiaries unless
context indicates otherwise.
We
are a medical technology company operating across the Asia-Pacific region (the “APAC Region”) with an objective to introduce
and deliver intelligent pain free diagnostic tests. We also have an interest in the North America region. Our goal is to expand the global
footprint of our drug screening tests following our recent acquisition of Intelligent Fingerprinting Limited, while continuing to develop
our Biosensor Platform that we license from Life Science Biosensor Diagnostics Pty Ltd (“LSBD” or the “Licensor”).
This will be followed by developing both of our platforms to their full capacity across multiple diagnostic modalities of immunology,
hormones, chemistry, tumor markers and nucleic acid tests.
Highlights
of Achievements during the Quarter
Highlights
of our major achievements for the quarter ended September 30, 2022 are:
● During the quarter ended September 30, 2022 the Company
negotiated the acquisition of Intelligent Fingerprinting Limited (“IFP”), a company registered in England and Wales and
on October 4, 2022 the Company closed on the acquisition of IFP (the “Acquisition”).
In
connection with the Acquisition, on October 4, 2022, the Company entered into a Share Exchange Agreement (the “Share Exchange Agreement”)
with IFP, the holders of all of the issued shares in the capital of IFP (collectively, the “Sellers”) and the “Sellers’
Representatives” named therein (the “Sellers’ Representatives”).
17
Pursuant
to the Share Exchange Agreement, among other things, the Company acquired from the Sellers all of the issued shares in the capital of
IFP, and as consideration therefor the Company issued and sold to the Sellers upon the closing of the Acquisition (the “Closing”)
an aggregate number of (i) 2,963,091 shares of the Company’s common stock,
and (ii) 2,363,003 shares of the Company’s series C convertible preferred stock, par value $0.01 per share (the “Preferred
Stock”). Up to an additional 1,649,273 shares of Preferred Stock have been reserved for potential future issuance by the Company,
consisting of (i) 500,000 shares of Preferred Stock, representing approximately 10% of the total Acquisition consideration, that are
being held back from the Sellers for one year after the Closing to secure potential indemnification claims by the Company against the
Sellers and (ii) 1,149,273 shares of Preferred Stock to certain lenders to IFP (the “Lenders”) who may, at each such Lender’s
respective option, convert such Lender’s respective loans to IFP into shares of Preferred Stock, contingent upon approval of the
Company’s stockholders of the conversion of Preferred Stock into Common Stock, as described below (the “Lender Preferred
Shares”). Each Preferred Share would be convertible into three shares of Common Stock, contingent upon approval by the Company’s
stockholders.
Also
pursuant to the Share Exchange Agreement, the Company has an obligation to provide IFP with cash in an amount such that IFP is able to
pay cash payments to certain current and former United Kingdom and United States-based employees and directors (the “IFP Bonus
Recipients”), in aggregate amounts of £239,707 and $83,043, respectively (the “Cash Bonuses”), plus any applicable
employer’s National Insurance contributions. The Cash Bonuses are being paid to the IFP Bonus Recipients in two equal instalments,
with the first payment made immediately following the Closing and the second payment to be made on the six-month anniversary of such
date.
Also
pursuant to the Share Exchange Agreement, the Company has agreed to make available to the employees of IFP (the “IFP Employees”)
a Company stock option plan in form and substance satisfactory to the Company in relation to up to 1,000,000 shares Common Stock following
the Closing on the basis that an equal number of Company stock options will be granted to the IFP Employees and Company employees up
to an aggregate amount of 2,000,000 Company stock options.
Each
of the Company, IFP and the Sellers made certain customary representations and warranties and agreed to certain covenants in the Share
Exchange Agreement.
● On
July 13, 2022, INBS completed Institutional Review Board (IRB) approved clinical studies at the
Diabetes Research Institute of Sutter Health’s Mills-Peninsula Medical Center (MPMC)
in San Mateo, California. The study design was intended to support the clinical development
of its next-generation Saliva Glucose Biosensor. A total of 40 adult subjects with type 2
diabetes were recruited for the study. Nearly 1,400 samples of blood and oral fluids were
collected and analyzed. The subsequent statistical analysis of the correlation of glucose
levels among these sample types will act as foundation for building a robust portfolio of
prospective clinical evidence, forming the backbone for future regulatory submissions. The
Company anticipates further clinical studies in the fourth quarter of this calendar year
and will utilize Saliva Glucose Biosensors fabricated at the Centre for Organic Electronics
in New South Wales, Australia
● We
are continuing to develop our R&D and manufacturing facility at University of Newcastle, Australia.
During the quarter, we commenced the design of the facility and constructions of the facility
is expected to start in second quarter of calendar year 2023.
● During
the quarter, we received and commenced installation of new lab equipment including the Mass
Spectrometer and GPC systems, which allows to improve the specificity, sensitivity, and reproducibility
of our Biosensor technology.
18
The
Saliva Glucose Biosensor
The
APAC Region includes over 164 million people living with diabetes, which accounts for approximately 38% of the world’s
diabetic population. Rapid urbanization, unhealthy diets and increasingly sedentary lifestyles have resulted in ever increasing
rates of obesity and diabetes across the region.
Self-testing
blood glucose monitors were introduced to the market in the 1970s and, since then, the method of glucose self-monitoring has not meaningfully
changed. The industry remains dominated by invasive methods that ultimately use blood or interstitial fluid to measure glucose. We believe
the methodology of the Company’s Saliva Glucose Biosensor (“SGB” and, together
with the software app that interfaces the SGB with the Company’s digital information system, the “SGT”) represents a breakthrough in glucose monitoring as it represents the only non-invasive, painless, and cost-effective
saliva-based method of measuring glucose levels. The biosensor technology has been developed over several decades of university-based
scientific research and has been extensively referenced in scientific literature.
The
SGB is an organic, thin-film transistor, which in its structure embeds the glucose oxidase enzyme (referred to as “ GOX ”).
When the single-use SGB interacts with saliva it initiates a sequence of enzymatic and electrochemical reactions, producing an electrical
signal directly correlated to the amount of glucose present in the saliva. This measurement is then converted into a real-time saliva
glucose reading, through the biosensor app installed on a smart device or a dedicated reader. The reading may then be stored in a cloud-based
digital information system.
The
patent protected SGB is able to detect glucose in saliva at concentrations between 8 and 200 µM and exhibits linear glucose sensing
characteristics at these concentrations, sensing glucose at levels 100 times lower than blood.
In
our development of the SGT, we aim to go beyond the innovation of changing the sampling medium from blood to saliva, and further create
value for the patient and the payers by decreasing the cost of managing diabetes, improving the outcomes of the disease and providing
convenience in testing methodology. This will be achieved by directly transferring the SGB reading from the smart device or dedicated
reader to a cloud-based digital information system to enable all patients the option to create their own medical records where the SGB
results will be uploaded.
Our
digital information system is intended to be interfaced to an artificial intelligence system and will be able to, at the patient’s
or authorized care giver’s direction, disseminate patient data to a remote caregiver, a service for consultation or to any other
individual with whom the patient chooses to share his or her glucose level measurements. We believe patients and payers will be able
to leverage our digital information system to decrease cost and improve outcomes and convenience.
With
the SGB we aim to drive economic value beyond the revenue stemming from the sale of the SGB units – it also allows for monetization
and the creation of separate revenue streams from the patient network and other data that resides within our digital information system,
by way of the following:
● Data
usage. The usage of the data, and the analysis and interpretation of the data, to improve
patients’ conditions and leveraging this insight to improve patient care.
● Safe
data sharing. The provision of data sharing services between users/patients, authorized care
givers and authorized medical practitioners.
● Data
collection. The collection of anonymized data, its aggregation with other data from multiple
sources and multiple health devices and its combination with non-health data.
We
plan to leverage this usage, safe sharing and collection of data in the following four revenue-generating channels:
Direct
Monetization Channel . This channel focuses on the development of revenue based on commercial relationships for the use of anonymized
and compliant information derived from data generation. These services may include, but will not be limited to:
● Fee for service, per performed action by pharma, or other commercial partners.
● Subscription, regular recurring payments for continued access to service.
● Prescription,
value acknowledged by payer reimbursement per active user.
● Third
party coverage, other industry/retail players pay fee for their own customers.
● Risk
sharing/profit sharing, success-based payment models.
● Advertising,
third party ads tailored to demographic data leveraging characteristics unique to channel.
● Added
value of INBS brand loyalty.
19
Commercial
Adjacencies Channel . This channel focuses on the development of revenue from data generated through patient engagement and market
insights from a clinical and medical perspective. These services may include, but will not limited to:
● Medical – Generation of Patient Reported Outcomes, or “PROs”.
●
Data – Market insights, clinical trial recruitment for third parties, e.g., pharmaceutical
companies or clinical research organizations.
●
Consumer – e-commerce platform, third party customer care, advertising.
Product
and Service Bundles Channel . This channel focuses on ancillary revenue generated through bespoke service opportunities across the
industry, for example, by working with insurers to develop products that integrate the usage of testing as part of their service offering.
These services may include, but will not be limited to:
●
Over-the-counter model.
●
Bundle payment model with insurance subsidy.
●
Pay for outcomes model.
Core
Operations Synergy Channel . Through combining the data generation with the use of artificial intelligence, we expect to have a deep
insight into our customer base, providing an elevated level of customer insight. It is expected that this insight will drive high customer
retention levels and generate a considerable number of broader revenue opportunities through direct and specific interaction with our
customer base. These opportunities may include, but will not be limited to:
● Direct access to customers for better experience in customer care.
●
Peer learning and support to decrease customer care resource commitment.
●
Direct market and customer insights (including better understanding of customer journey).
●
More customer data for targeted marketing & marketing impact monitoring.
●
New cost effective, digital marketing channel enabling agile marketing approach.
●
PRO data to support unique marketing claims.
●
Higher engagement, customer loyalty and customer lifetime value.
●
Consumer driven innovation and customer involvement in development.
●
Involvement in testing & refining to develop demand-oriented products rapidly.
●
Easy and fast clinical evaluation recruitment.
●
PRO to support regulatory approval / market access for platform tests under development.
The
SGB has been under continuous development for over seven years, first by the University of Newcastle, Australia, then by the Licensor
and us. The SGB development program is currently at the design and manufacturing process development stage, which includes the testing
needed to verify and validate the final product. This stage involves implementation of the clinical evidence module, which incorporates
the commercial production of the investigative biosensor devices to commence the clinical evaluation of analytical performance of the
device and generate the clinical evidence necessary to gain regulatory approval.
On
May 1, 2020, the Licensor filed a submission with the FDA for the Saliva Glucose Biosensor Diagnostic Test, currently in development
as a point-of-care test intended to replace blood glucose testing for diabetes management. Following the 513(g) submission to the FDA
(Submitted May 1, 2020), it was determined that the Company could seek the De Novo application pathway for the Saliva Glucose Biosensor
Diagnostic Test, we were appointed an expert contact person, Acting Branch Chief from the Diabetes Diagnostic Devices Branch. We have
further commenced planning discussions with the FDA Office of In Vitro Diagnostics and Radiological Health and the Office of Product
Evaluation and Quality pertaining to the clinical development and study plan of the Saliva Glucose Biosensor. We expect to leverage synergies
from the planned approval process with the FDA within the Asia Pacific region, We will first seek regulatory approval with the Therapeutic
Goods Administration (TGA) in Australia. However, we intend to apply for regulatory approval in each jurisdiction across the APAC Region.
20
The
SGB is manufactured using modified reel-to-reel printing technology that was developed at the Australian National Fabrication Facility.
This technology allows mass volume printing at a low cost. Previous research published in the journal Solar Energy Materials and Solar
Cells has shown that the cost of manufacture of printed organic electronic devices (like the SGB) using mass volume printing is $7.85
per square meter, with an uncertainty of 30%. The size of the printed biosensors is approximately one square centimeter, resulting in
a manufacturing cost per biosensor of approximately $0.01.
We
anticipate that the non-invasive nature of saliva-based glucose testing will make patients more amenable to glucose monitoring, with
the expected result of increasing the number of times a patient tests per day. The data generated by the SGB, combined with the interface
of the smart device or dedicated reader with our digital information system and the artificial intelligence feedback, will allow the
patient to achieve better glucose control through a practical understanding of lifestyle factors that affect glucose levels, thereby
helping prevent or delay diabetes complications and ultimately personalizing diabetes management.
Initial
public offering & share structure
On
December 28, 2020, the Company closed its initial public offering (“IPO”) and sold 1,270,589 units, consisting of (a) one
share of the Company’s common stock (or, at the purchaser’s election, one share of Series B Convertible Preferred Stock),
(b) one Series A warrant (the “Series A Warrants”) to purchase one share of the Company’s common stock at an exercise
price equal to $8.50 per share, exercisable until the fifth anniversary of the issuance date, and (c) one Series B warrant (the “Series
B Warrants”) to purchase one share of the Company’s common stock at an exercise price equal to $17.00 per share, exercisable
until the fifth anniversary of the issuance date and subject to certain adjustment and cashless exercise provisions. The public offering
price of the shares sold in the IPO was $17.00 per unit. In aggregate, the units issued in the offering generated $17,732,448 in net
proceeds, which amount is net of $1,714,001 in underwriters’ discount and commissions, and $2,153,564 in offering costs. The Company
also issued to the underwriter an option, exercisable one or more times in whole or in part, to purchase up to 190,588 additional shares
of common stock and/or Series A Warrants to purchase up to an aggregate of 190,588 shares of common stock and/or Series B Warrants to
purchase up to an aggregate of 190,588 shares of common stock, in any combinations thereof, from us at the public offering price per
security, less the underwriting discounts and commissions, for 45 days after the date of the IPO to cover over-allotments, if any (the
“Over-Allotment Option”).
Upon
the closing of the IPO, all shares of preferred stock then outstanding were automatically converted into 2,810,190 shares of common stock,
and all convertible notes then outstanding were automatically converted into 710,548 shares of common stock.
Certain
preferred shareholders were issued warrants that, following the Company’s completed IPO, allow the holder to acquire 2,736,675
shares of common stock at the IPO price during years two through three following the IPO. At the exercise date, the shareholder must
hold for each warrant to be exercised, one underlying common share to exercise the option. The warrants are not transferable and apply
to the number of shares that were subscribed for.
The
share structure as of November 10, 2022 was as follows:
●
18,352,995
of Issued Common Stock
●
1,401,377
of Series A warrants exercisable at $8.50
●
59,782
of Series B warrants exercisable at $0 (subject to a cashless exercise provision)
●
2,363,003 of Series C Convertible Preferred Stock
●
63,529
of Warrants issued to the underwriter exercisable at $18.70
●
2,736,675
of the Pre-IPO Warrants exercisable at $8.50 (during year two through year three after the IPO)
●
3,000,000
Warrants issued to LSBD exercisable at $17.00
Nasdaq
Minimum Bid Price Requirement
On
March 17, 2022, the Company received a letter (the “Notice”) from the Listing Qualifications Department of The Nasdaq Stock
Market LLC (“Nasdaq”) notifying the Company that the minimum closing bid price per share for its common stock was below $1.00
for 30 consecutive business days preceding the date of the Notice, and that the Company did not meet the $1.00 per share minimum bid
price requirement set forth in Nasdaq Listing Rule 5450(a)(1).
The
Notice has no immediate effect on the listing or trading of the Company’s common stock on the Nasdaq Capital Market.
Pursuant
to Nasdaq Listing Rule 5810(c)(3)(A), the Company had a compliance period of 180 calendar days, or until September 13, 2022 (the “Compliance
Period”), to regain compliance with Nasdaq’s minimum bid price requirement. If at any time during the Compliance Period,
the closing bid price per share of the Company’s common stock is at least $1.00 for a minimum of 10 consecutive business days,
Nasdaq will provide the Company a written confirmation of compliance and the matter will be closed. On September 8, 2022, the Company
filed a request for a second 180-day period within which to evidence compliance with the $1.00 bid price requirement following the expiration
of the current compliance period on September 13, 2022. No further communication has been received from by Nasdaq as at the date of this
Quarterly Report on Form 10-Q.
As
part of its review process, Nasdaq will make a determination of whether it believes the Company will be able to cure the deficiency.
If Nasdaq concludes that the Company will not be able to cure the deficiency, or if the Company determine not to submit a transfer application
or make the required representation, Nasdaq will provide notice that the Company’s securities will be subject to delisting. If
the Company chooses to implement a reverse stock split, it must complete the split no later than ten business days prior to the expiration
of the second compliance period.
Results
of Operations:
Comparison
of the Three Months Ended September 30, 2022 and 2021
Revenue
Government
support income
Government
support income increased from $0 to $311,320 for the quarter ended September 30, 2022, compared to same period in 2021. The income
is comprised of $250,907 as R&D tax refund and $60,413 as unwinding of deferred grant income for which the grant is intended to
compensate. This increase was primarily attributable to INBS’s subsidiary companies recognizing $250,907 as R&D tax refund
on qualifying research and development expenditures during the three months ended September 30, 2022 as the Company believes that it
is probable that the certain amount will be recovered in full through a future claim (see the R&D tax refund section of Note 3
to the unaudited condensed consolidated financial statements included in “Part I, Item 1 — Financial Statements”
of this Quarterly Report on Form 10-Q and incorporated herein by reference).
21
Operating
expenses
General
and administrative expenses
General
and administrative expenses increased by $117,898 to $1,450,418 from $1,332,520 for the quarter year ended September 30, 2022, compared
to the same period in 2021. This increase was primarily driven by an increase in operational activities following completion of the IPO
in December 2020.
As
the Company’s operating activities increase, we expect its general and administrative costs will include additional costs in overhead
contribution, consultancy, as well as an increase in employee related costs associated with a higher headcount.
Development
and regulatory expenses
Development
and regulatory expenses decreased by $27,525 to $79,274 from $106,799 for the quarter September 30, 2022, compared to the same period
in 2021. This decrease is primarily driven by timing of invoicing for milestones/ research and development activities carried on at the
University of Newcastle and other research partners.
As
the Company’s operating activities increase, we expect its development and regulatory expenses to increase in future periods.
Other
income and expenses
Interest
expense
Interest
expense increased from $0 to $1,065 for the quarter ended September 30, 2022, as compared to the same period in 2021. This increase was
attributable to the payment arrangement for directors and officers insurance policy.
Realized
foreign exchange loss
Realized
foreign exchange loss decreased by $871 to $2,247 from $3,118 for the quarter ended September 30, 2022, compared to the same period in
2021. This decrease in loss was largely attributable to the favorable exchange rates while settling transactions in currencies other
than its functional currencies.
Income
tax (expense) benefit
There
was no income tax expense for the three months period ended September 30, 2022, and 2021, respectively, as the Company has established
a full valuation allowance for all its deferred tax assets.
Other
comprehensive income
Foreign
currency translation gain/(loss)
Unrealized
foreign currency translation loss increased by $68,077 to a loss of $135,559 from a loss of $67,482 for the quarter ended September 30,
2022, compared to the same period in 2021. It is calculated based on the Company’s unsettled transactions in currencies other than
its functional currency.
Net
loss
Net
loss attributable to INBS decreased by $224,359 to $1,208,293 from $1,432,652 for the quarter ended September 30, 2022, compared to the
same period in 2021. This decrease in loss is primarily due to recognition of government support income in the current quarter due to
expenditure incurred on qualifying research and development activities.
Liquidity
and Capital Resources
We
use working capital and cash measures to evaluate the performance of our operations and our ability to meet our financial obligations.
We define Working Capital as current assets less current liabilities. This measure should not be considered in isolation or as a substitute
for any standardized measure under GAAP. This information is intended to provide investors with information about our liquidity. Other
companies in our industry may calculate this measure differently than we do, limiting its usefulness as a comparative measure.
Since
our inception, our operations have primarily been financed through the issuance of our common stock, redeemable convertible preferred
stock and the incurrence of debt. As of September 30, 2022, we had $5,742,626 in cash and cash equivalents and $5,850,203 in working
capital.
See
“Initial public offering & share structure” herein for details about our IPO.
22
The
Company expects that its cash and cash equivalents as of September 30, 2022, may be insufficient to allow the Company to fund its
current operating plan through at least the next twelve months from the issuance of these financial statements, taking into account
the acquisition of Intelligent Fingerprinting Limited. Should revenue not be generated during this period to
cover expenses, then these conditions may raise substantial doubt about the Company’s ability to continue as a going concern
for a period of at least one year from the date these financial statements are issued. It appears that the Company will be required
to raise additional funds during the next 12 months. The Company is currently evaluating potential raising additional funds through
private placements and or public equity financing. However, there can be no assurance that, in the event that the Company requires
additional financing, such financing will be available on terms which are favorable to us, or at all. Accordingly, these factors raise substantial doubt about the Company’s ability to continue as a going concern.
We
do not anticipate generating any revenue in the near future, until such time, if at all, the Company completes the development process
of its products, including regulatory approvals, and thereafter, begins to commercialize and achieve substantial acceptance in the marketplace
for the first of a series of products in its medical device portfolio. In addition, available resources may be consumed more rapidly
than currently anticipated, and there can be no assurance that we will be successful in developing the SGT and generating sufficient
revenue in the timeframe set forth above, or at all. We may be unable to meet our targets for regulatory approval and market launch,
or we may be unable to generate anticipated amounts of revenue from sales of the system. We may also need additional funding for developing
new products and services and for additional sales, marketing and promotional activities. Should this occur, we may need to seek additional
capital earlier than anticipated.
In
the event we require additional capital, there can be no assurances that we will be able to raise such capital on acceptable terms,
or at all. Failure to generate sufficient revenues or raise additional capital through debt or equity financings, or through
collaboration agreements, strategic alliances or marketing and distribution arrangements, could have a material adverse effect on
our ability to meet our long-term liquidity needs and achieve our intended long-term business plan. Our failure to obtain such
funding when needed could create a negative impact on our stock price or could potentially lead to a reduction in our operations or
the failure of our company. Accordingly, these factors raise substantial doubt about the Company’s ability to continue as a going concern.
Extended
Transition Period for “Emerging Growth Companies”
We
have elected to use the extended transition period for complying with new or revised accounting standards under Section 102(b)(1) of
the JOBS Act. This election allows us to delay the adoption of new or revised accounting standards that have different effective dates
for public and private companies until those standards apply to private companies. As a result of this election, our financial statements
may not be comparable to companies that comply with public company effective dates. Because our financial statements may not be comparable
to companies that comply with public company effective dates, investors may have difficulty evaluating or comparing our business, performance
or prospects in comparison to other public companies, which may have a negative impact on the value and liquidity of our common stock.
Critical
Accounting Estimates
The
preparation of our consolidated financial statements in conformity with GAAP requires management to make judgments, estimates and assumptions
that impact the amounts reported in our consolidated financial statements and accompanying notes that are not readily apparent from other
sources. The estimates and associated assumptions are based on historical experience and other factors that are considered relevant.
Actual results may differ from these estimates.
Our
critical accounting policies are described in our Annual Report on Form 10-K filed with the SEC on September 22, 2022, and the notes
to the unaudited condensed consolidated financial statements included in “Part I, Item 1 — Financial Statements” of
this Quarterly Report on Form 10-Q.
During
the three months ended September 30, 2022, there were no material changes to our critical accounting policies from those in our June
30, 2022, Annual Report on Form 10-K filed with the SEC on September 22, 2022.
Recently
issued Accounting Pronouncements
For
the impact of recently issued accounting pronouncements on the Company’s consolidated financial statements, see Note 3 to the unaudited
condensed consolidated financial statements included in “Part I, Item 1 — Financial Statements” of this Quarterly Report
on Form 10-Q and incorporated herein by reference.
23
ITEM
3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
We
are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information otherwise
required under this item.
ITEM
4. CONTROLS AND PROCEDURES
Evaluation
of Disclosure and Control Procedures
Our
management, with the participation of our Principal Executive Officer and Principal Financial and Accounting Officer, evaluated the effectiveness
of the design and operations of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange
Act) as of the end of the period covered by this Quarterly Report on Form 10-Q, and have concluded that, based on such evaluation, our
disclosure controls and procedures were not effective due to the material weaknesses in our internal control over financial reporting as
of September 30, 2022 as described below.
A
material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is
a reasonable possibility that a material misstatement of a company’s annual or interim consolidated financial statements will not
be prevented or detected on a timely basis.
Notwithstanding
the conclusion that our disclosure controls and procedures were not effective as of the end of the period covered by this report, we
believe that our unaudited condensed financial statements and other information contained in this Quarterly Report on Form 10-Q present
fairly, in all material respects, our business, financial condition and results of operations for the interim periods presented.
24
Material
Weaknesses
As
a result of the assessment, management concluded that the Company’s internal control over financial reporting was ineffective as
of the evaluation date due to the following material weaknesses in control environment, risk assessment, control activities, information
and communication and monitoring.
The material weaknesses identified relate to the
fact that the Company has not yet designed and maintained an effective control environment commensurate with its financial reporting
requirements, including a) has not yet completed the formally documented policies and procedures with respect to the review, supervision
and monitoring of the Company’s accounting and reporting functions, b) lack of evidence to support the performance of controls
and the adequacy of review procedures, including the completeness and accuracy of information used in the performance of controls and
c) as an emerging growth company we currently have limited accounting personnel and other supervisory resources necessary to adequately
execute the Company’s accounting processes and address its internal controls over financial reporting.
Remediation
Plan
Management
is committed to continuing with the steps necessary to remediate the control deficiencies that constituted the above material weaknesses.
Since the IPO, we made the following enhancements to our control environment:
●
We
added accounting and finance personnel to provide additional individuals to allow for segregation of duties in the preparation and
review of schedules, calculations, and journal entries that support financial reporting, to provide oversight, structure and reporting
lines, and to provide additional review over our disclosures;
●
We
enhanced our controls to improve the preparation and review over complex accounting measurements, and the application of GAAP to
significant accounts and transactions, and our financial statement disclosures;
●
We
plan to engage independent experts when complex transactions are entered;
●
We
plan to recruit additional financial reporting and accounting personnel with adequate knowledge of US GAAP and SEC rules; and
●
We
are in the process of engaging outside consultants to assist us in our evaluation of the design, implementation, and documentation
of internal controls that address the relevant risks, and that provide for appropriate evidence of performance of our internal controls
(including completeness and accuracy procedures).
Under
the direction of the audit committee of our board of directors, management will continue to take measures to remediate the material weakness
in the fiscal year 2023. As such, we will continue to enhance corporate oversight over process-level controls and structures to ensure
that there is appropriate assignment of authority, responsibility, and accountability to enable remediation of our material weakness.
As
we continue to evaluate, and work to improve, our internal control over financial reporting, management may determine that additional
measures to address control deficiencies or modifications to the remediation plan are necessary.
Changes
in Internal Control Over Financial Reporting
Other
than the ongoing remediation effort, described above, there have been no changes to the Company’s internal controls over financial
reporting (as defined in Rules 13a-15(f) and 15d 15(f) under the Exchange Act) during the most recent fiscal quarter that have materially
affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Inherent
Limitation on the Effectiveness of Internal Controls
The
effectiveness of any system of internal control over financial reporting, including ours, is subject to inherent limitations, including
the exercise of judgment in designing, implementing, operating, and evaluating the controls and procedures, and the inability to eliminate
misconduct completely. Accordingly, in designing and evaluating the disclosure controls and procedures, management recognizes that any
system of internal control over financial reporting, including ours, no matter how well designed and operated, can only provide reasonable,
not absolute assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures must
reflect the fact that there are resource constraints, and that management is required to apply its judgment in evaluating the benefits
of possible controls and procedures relative to their costs. Moreover, projections of any evaluation of effectiveness to future periods
are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the
policies or procedures may deteriorate. We intend to continue to monitor and upgrade our internal controls as necessary or appropriate
for our business but cannot assure you that such improvements will be sufficient to provide us with effective internal control over financial
reporting.
25
PART
II. OTHER INFORMATION
ITEM
1. LEGAL PROCEEDINGS.
From
time to time, we may be subject to legal proceedings and claims arising in the ordinary course of business. We are not currently engaged
in any material legal proceedings.
ITEM
1A. RISK FACTORS.
As
of the date of this Quarterly Report on Form 10-Q, there have been no material changes to the risk factors disclosed in our Annual Report
on Form 10-K filed with the SEC on September 22, 2022 except for the risks described below. Any of those risk factors could result in a significant or material adverse
effect on our results of operations or financial condition. Additional risk factors not presently known to us or that we currently deem
immaterial may also impair our business or results of operations. We may disclose changes to such factors or disclose additional factors
from time to time in our future filings with the SEC.
We
may not be able to satisfy the continued listing requirements of the Nasdaq Capital Market in order to maintain the listing of our common
stock.
On
March 17, 2022, the Company received a letter (the “Notice”) from the Listing
Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that the minimum closing bid price
per share for its common stock was below $1.00 for 30 consecutive business days preceding the date of the Notice, and that the Company
did not meet the $1.00 per share minimum bid price requirement set forth in Nasdaq Listing Rule 5450(a)(1).
The
Notice has no immediate effect on the listing or trading of the Company’s common stock on the Nasdaq Capital Market.
Pursuant
to Nasdaq Listing Rule 5810(c)(3)(A), the Company had a compliance period of 180 calendar days, or until September 13, 2022 (the “Compliance
Period”), to regain compliance with Nasdaq’s minimum bid price requirement. If at any time during the Compliance Period,
the closing bid price per share of the Company’s common stock is at least $1.00 for a minimum of 10 consecutive business days,
Nasdaq will provide the Company a written confirmation of compliance and the matter will be closed.
On
September 8, 2022, the Company filed a request for a second 180-day period within which to evidence compliance with the $1.00 bid
price requirement following the expiration of the current compliance period on September 13, 2022. No further communication has been
received from by Nasdaq as at the date of this Quarterly Report on Form 10-Q.
26
As
part of its review process, Nasdaq will make a determination of whether it believes the Company will be able to cure the deficiency.
If Nasdaq concludes that the Company will not be able to cure the deficiency, or if the Company determine not to submit a transfer application
or make the required representation, Nasdaq will provide notice that the Company’s securities will be subject to delisting. If
the Company chooses to implement a reverse stock split, it must complete the split no later than ten business days prior to the expiration
of the second compliance period.
Our
Licensor is undergoing equity recapitalization the outcome with which could materially and adversely affect our business, financial condition
and operating results.
We
are party to a Technology License Agreement (the “Technology License Agreement”) with Life Science Biosensor Diagnostics
Pty Ltd. (“LSBD”), pursuant to which, among other things, the Company licenses certain products from LSBD (the “Licensed
Products”), and an option agreement with LSBD and BiosensX (North America) Inc., pursuant to which, among other things, LSBD granted
to the Company an exclusive option (the “Option”) to purchase an exclusive license to use, make, sell and offer to sell products
under the intellectual property rights in connection with the Biosensor technology the glucose/diabetes management field in the United
States, Mexico and Canada. See exhibits 10.2, exhibits 10.3, exhibits 9, 5– Technology License Agreements of the 10-K filed on
September 22, 2022 for a description of the Technology License Agreement, the Licensed Products, and the Option. According to the Australian
Securities and Investment Commission’s (ASIC’s), Companies and Organizations Register, on May 10, 2022, LSBD filed a Notice
of Appointment of External Administrator, followed by a filing of a Deed of Company Arrangement on the August 2, 2022. Pursuant this
filing we understand that LSBD is proposing to undergo a recapitalization of its equity structure on or before December 5, 2022. We understand,
the Deed Administrators granted a further extension from October 2, 2022 to December 5, 2022 to the Deed Proponents to complete their
due diligence. The terms of such recapitalization or other outcome of such administration of LSBD could result in, among other things,
change in control of the Licensor or more parties other than LSBD becoming the owner of the Intellectual Property (IP) rights. Accordingly,
this has an inherent risk of the possibility of modifications to, or the Company’s ability to use, the Licensed Products, which
could materially and adversely affect the Company’s business, financial condition and operating results.
ITEM
2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.
Other than any sales previously reported in the Company’s Current
Reports on Form 8-K, the Company did not sell any unregistered securities during the period covered by this report.
ITEM
3. DEFAULTS UPON SENIOR SECURITIES.
None.
ITEM
4. MINE SAFETY DISCLOSURES.
Not
applicable.
ITEM
5. OTHER INFORMATION.
None.
27
ITEM
6. EXHIBITS
Exhibit
No.
Description
2.1
Share Exchange Agreement, dated as of October 4, 2022, by and among GBS INC., Intelligent Fingerprinting Limited, the Sellers Listed on Schedule I thereto, Jason Isenberg (as the RFA Sellers’ Representative), and Philip Hand (as the other Sellers’ Representative) (incorporated by reference to Exhibit 2.1 to the Company’s Current Report on Form 8-K filed with the Commission on October 11, 2022).
3.1
Certificate of Certificate of Designation of Preferences, Rights and Limitations of Series C Convertible Preferred Stock, par value $0.01 per share, of the Company, dated October 4, 2022, filed with the Secretary of State of Delaware on October 4, 2022 (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed with the Commission on October 11, 2022).
3.2
Certificate of Amendment to the Amended and Restated Certificate of Incorporation of GBS Inc. (now known as Intelligent Bio Solutions Inc.), as filed with the Secretary of State of Delaware on October 26, 2022 (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed with the Commission on October 27, 2022).
3.3
Amended and Restated Bylaws of Intelligent Bio Solutions Inc., as amended as of October 26, 2022 (incorporated by reference to Exhibit 3.2 to the Company’s Current Report on Form 8-K filed with the Commission on October 27, 2022)
10.1
Employment Agreement between the Glucose Biosensor Systems (Greater China) Pty Ltd and Spiro Sakiris (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the Commission on September 15, 2022)
10.2
Employment Agreement between the Glucose Biosensor Systems (Greater China) Pty Ltd and Harry Simeonidis (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed with the Commission on September 15, 2022)
10.3
Employment Agreement between the GBS (APAC) Pty Ltd and Steven Boyages (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the Commission on September 30, 2022).
10.4
Investors’ Rights Agreement, dated as of October 4, 2022, by and among the Company, The Ma-Ran Foundation, The Gary W. Rollins Foundation and Jason Isenberg, as the RFA Sellers’ Representative (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the Commission on October 11, 2022).
10.5
Registration Rights Agreement, dated as of October 4, 2022, by and among the Company and the stockholders of the Company named therein (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed with the Commission on October 11, 2022).
10.6
Registration Rights Agreement, dated as of October 4, 2022, by and among the Company and the stockholders of the Company named therein (incorporated by reference to Exhibit 10.3 to the Company’s Current Report on Form 8-K filed with the Commission on October 11, 2022).
10.7
Voting Agreement, dated as of October 4, 2022, by and among the Company and the stockholders of the Company named therein (incorporated by reference to Exhibit 10.4 to the Company’s Current Report on Form 8-K filed with the Commission on October 11, 2022).
10.8
Form of Voting Agreement, dated as of October 4, 2022, by and among the Company, the Sellers’ Representatives’ named therein and each of Spiro Sakiris, Harry Simeonides and Christopher Towers (incorporated by reference to Exhibit 10.5 to the Company’s Current Report on Form 8-K filed with the Commission on October 11, 2022).
10.9
Extension Agreement, dated as of October 4, 2022, to Bridge Facility Agreement, dated as of June 16, 2022, between the Company and Intelligent Fingerprinting Limited (incorporated by reference to Exhibit 10.6 to the Company’s Current Report on Form 8-K filed with the Commission on October 11, 2022).
10.10
Deed of Amendment and Restatement, dated October 4, 2022, between Intelligent Fingerprinting Limited, Karin Briden and the Company (incorporated by reference to Exhibit 10.7 to the Company’s Current Report on Form 8-K filed with the Commission on October 11, 2022).
10.11
Deed of Amendment and Restatement, dated October 4, 2022, between Intelligent Fingerprinting Limited, Debra Coffey and the Company (incorporated by reference to Exhibit 10.8 to the Company’s Current Report on Form 8-K filed with the Commission on October 11, 2022).
10.12
Deed of Amendment and Restatement, dated October 4, 2022, between Intelligent Fingerprinting Limited, Thomas Johnson and the Company (incorporated by reference to Exhibit 10.9 to the Company’s Current Report on Form 8-K filed with the Commission on October 11, 2022).
10.13
Deed of Amendment and Restatement, dated October 4, 2022, between Intelligent Fingerprinting Limited, The Ma-Ran Foundation, The Gary W. Rollins Foundation and the Company (incorporated by reference to Exhibit 10.10 to the Company’s Current Report on Form 8-K filed with the Commission on October 11, 2022).
10.14
Deed of Amendment and Restatement, dated October 4, 2022, between Intelligent Fingerprinting Limited, John Polden and the Company (incorporated by reference to Exhibit 10.11 to the Company’s Current Report on Form 8-K filed with the Commission on October 11, 2022).
10.15
Deed of Amendment and Restatement, dated October 4, 2022, between Intelligent Fingerprinting Limited, Sennett Kirk III and the Company (incorporated by reference to Exhibit 10.12 to the Company’s Current Report on Form 8-K filed with the Commission on October 11, 2022).
10.16
Deed of Amendment and Restatement, dated October 4, 2022, between Intelligent Fingerprinting Limited, Sennett Kirk III Exempt Trust and the Company (incorporated by reference to Exhibit 10.13 to the Company’s Current Report on Form 8-K filed with the Commission on October 11, 2022).
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 the Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2#
Certification of the Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.INS#
Inline
XBRL Instance Document.
101.SCH#
Inline
XBRL Taxonomy Extension Schema Document.
101.CAL#
Inline
XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF#
Inline
XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB#
Inline
XBRL Taxonomy Extension Label Linkbase Document.
101.PRE#
Inline
XBRL Taxonomy Extension Presentation Linkbase Document.
104#
Cover
Page Interactive Data File (formatted in XBRL and included in Exhibit 101).
#
Filed herewith.
28
SIGNATURES
Pursuant
to the requirements of the Exchange Act of 1934, the registrant caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
Intelligent
Bio Solutions Inc.
Date:
November 10, 2022
By:
/s/
Harry Simeonidis
HARRY
SIMEONIDIS
CHIEF
EXECUTIVE OFFICER AND PRESIDENT
(Principal
Executive Officer)
Date:
November 10, 2022
By:
/s/
Spiro Sakiris
SPIRO
SAKIRIS
CHIEF
FINANCIAL OFFICER
(Principal
Financial Officer)
29
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.