What changed in this filing

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Item 2. Management’s Discussion and Analysis

2022-05-16 compared with 2022-02-11 · 67 added, 92 removed, 222 unchanged (42% of the section changed)

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should read the following discussion in conjunction with our audited historical consolidated financial statements, which are included

in the 2021 Form 10-K and our unaudited condensed consolidated financial statements for the fiscal quarter ended December 31, 2021 included

in the 2021 Form 10-K and our unaudited condensed consolidated financial statements for the fiscal quarter ended March 31, 2022 included

elsewhere in this Quarterly Report on Form 10-Q.

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testing in the hands of patients and their primary health practitioners at point of care.

are 18.5% (as of December 31, 2021) owned by LSBD, an Australian company that owns the worldwide intellectual property rights to the

biosensor platform acquired from University of Newcastle, Australia.

LSBD has licensed to us that technology to introduce and launch

the platform in the APAC Region, the world license for the SARS-CoV-2 Antibody Sensor, and furthermore we own 50% of BiosensX (North

America) Inc which has the North American license to the biosensor platform.

an Australian company that owns the worldwide intellectual property rights to the biosensor platform acquired from University of Newcastle,

Australia has licensed to us that technology to introduce and launch the platform in the APAC Region, the world license for the SARS-CoV-2

Antibody Sensor, and furthermore we own 50% of BiosensX (North America) Inc which has the North American license to the biosensor platform.

We were incorporated under the laws of Delaware on December 5, 2016.

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Saliva Glucose Biosensor, and

the SARS-CoV-2 Antibody

SARS-CoV-2 Antibody Biosensor

Saliva Glucose Biosensor (“SGB”), together with the software app that interfaces the SGB with the Company’s Digital

Information System (“SGT”), the SGT aims to provide a non-invasive and pain free way to make it easier for people to manage

innovative technology aims to free people living with diabetes from having to use painful and invasive blood monitoring devices to

innovative technology will aim to free people living with diabetes from having to use painful and invasive blook monitoring devices to

manage their condition, giving them a better quality of life.

SGB is being developed as a small, printable organic strip designed to put the power of accurate, timely diagnosis in the hands of

patients and their primary health practitioners.

SGB is manufactured using modified reel-to-reel printing technology which allows

mass volume printing at a low cost.

SGB is being developed as a small, printable organic strip designed to put the power of accurate, timely diagnosis in the hands of patients

and their primary health practitioners.

SGB is manufactured using modified reel-to-reel printing technology which allows mass volume

printing at a low cost.

Development Plan

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team has submitted the correlation clinical trial protocol for IRB approval to the Mills-Peninsula Medical Center (MPMC) in California

( which will be responsible for executing this initial clinical trial enrolling 40 subjects.) The objectives will be:

Explore the relationship

between salivary glucose and plasma glucose as well as the time course between the two testing modalities using Glucose Tolerance

Testing in 40 subjects

Generation of time course

date from these studies to determine salivary glucose characteristics

(which will be responsible for executing this initial clinical trial enrolling 40 subjects).

The objectives will be:

the relationship between salivary glucose and plasma glucose as well as the time course between the two testing modalities using

Glucose Tolerance Testing in 40 subjects.

of time course date from these studies to determine salivary glucose characteristics.

is anticipated that the first stage of this Clinical Plan to be completed by July 2022.

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of efficiency to progress development of the biosensor and at the same time commission this equipment in preparation for the facility.

The initial batch of the equipment is expected to be ordered in April and finalized in June 2022.

Discussions are underway between the University of Newcastle and GBS Inc for the location, buildout, and commissioning of the new high-tech

manufacturing facility.

response to the Australian government’s announcement of the Medical Research Commercialization Initiative, GBS is in the

process of evaluating and preparing expressions of interests towards further Australian Government funding, as we believe that GBS

firmly fits into the objectives of this initiative.

The initial batch of the equipment has been ordered and is expected to be finalized in June 2022.

are underway between the University of Newcastle and GBS Inc for the location, buildout, and commissioning of the new high-tech manufacturing

response to the Australian’s government’s announcement of the Medical Research Commercialization Initiative, GBS is in

the process of evaluating and preparing expressions of interests towards further Australian Government funding, as we believe that

GBS firmly fits into the objectives of this initiative.

The initiative will focus on Early-Stage Translation and Commercialization

Support, which funds support for early stage medical research and medical innovation projects with commercial potential.

Research Future Fund will have available in total approximately $225 million (USD) of project funding over the next 10 years

for companies that meets the criteria.

Research Future Fund will have available in total approximately $225 million (USD) of project funding over the next 10 years for

companies that meets the criteria.

Assurance and Regulatory Affairs

regulatory affairs plan is underway to address the Asian Pacific (APAC) region requirements.

team is working closely with LSBD on its FDA submissions and the clinical development plan

Implementation

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of key suppliers in progress.

clinical validation study was conducted at the Wyss Institute for Biologically Inspired Engineering at Harvard University.

The objective

of this study was to develop an electrochemical assay to detect SARS-CoV-2 IgG in human plasma.

The statistical design of the study was

powered in accordance with this study objective.

Preliminary findings were:

SARS-CoV-2 Antibody biosensor assay was 100% sensitive and 100% specific using positive and negative SARS-CoV-2 human plasma samples.

time in obtaining results was less than 10 minutes.

study is a key milestone towards validating a rapid point-of-care diagnostic test intended to quantify the measurement of antibodies

against SARS-CoV-2 in saliva and will assist in the preparation for clinical trials.

Potential Applications

We anticipate there to be 3 different applications for the foreseeable future:

Population Screening SARS-CoV-2 antibody testing is urgently needed to estimate the incidence and prevalence of SARS-CoV-2 infection at the general population level.

relation to the potential application of the biosensor towards validating a rapid point-of-care diagnostic test intended to qualify the

measurement of antibodies against SARS-CoV-2, we anticipate there to be 3 potential applications for the foreseeable future of population

Screening SARS-CoV-2 antibody testing needed to estimate the incidence and prevalence of SARS-CoV-2 infection at the general population

vaccination screening - To assess the degree of the elicited potent antigen-specific antibody responses, to SARS-CoV-2 vaccines and

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“sero”-surveillance.

saliva antibody test can greatly increase the scale of testing—particularly among susceptible populations—compared to blood

and could clarify population immunity and susceptibility to SARS-CoV-2.

The team at John Hopkins further demonstrated in the laboratory

that when saliva was collected ≥10 days post symptom onset, the anti-SARS-CoV-2 IgG assay detects SARS-CoV-2 infection with 100% sensitivity

and 99% specificity.

In addition, the team demonstrated that the temporal kinetics of SARS-CoV-2-specific IgG responses in saliva are

consistent with those observed in serum and indicate that most individuals seroconvert approximately 10 days after COVID-19 symptom onset

or approximately two weeks post-presumed infection.

utilizing the Saliva Glucose Test for detecting SARS-CoV-2 we expect to have lower detection limits, improve on sensitivity and specificity

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of Operations:

of the Three and Six Months Ended December 31, 2021 and 2020

of the Three and Nine Months Ended March 31, 2022 and 2021

support income

support income decreased by $105,246 to $177,791 from $283,037 for the quarter ended December 31, 2021 compared to same period in 2020.

support income increased by $158,210 to $192,500 from $34,290 for the quarter ended March 31, 2022 compared to same period in 2021.

increase was primarily attributable to GBS Inc.’s subsidiary companies recognizing R&D tax refund as the company believes that

it is probable that the certain amount will be recovered in full through a future claim (see note 3 on R&D tax refund).

support income decreased by $2,463 to $370,291 from $372,754 for the nine months ended March 31, 2022 compared to same period in 2021.

This decrease was primarily attributable to GBS Inc.’s subsidiary companies receiving COVID-19 related government support in the

previous financial year which was discontinued in April 2021.

support income decreased by $160,673 to $177,791 from $338,464 for the six months ended December 31, 2021 compared to same period in

This decrease was primarily attributable to GBS Inc.’s subsidiary companies receiving COVID-19 related government support

in the previous financial year which was discontinued in April 2021.

previous financial year which was discontinued in April 2021 offset by the unwinding of deferred income as government support income

during the nine months ended March 21, 2022

and administrative expenses

and administrative expenses increased by $331,794 to $1,003,244 from $671,450 for the quarter ended December 31, 2021 compared to the

and administrative expenses increased by $108,615 to $1,122,004 from $1,013,389 for the quarter ended March 31, 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

and administrative expenses increased by $1,143,311 to $2,335,764 from $1,192,453 for the six months ended December 31, 2021 compared

to the same period in 2020.

and administrative expenses increased by $1,251,926 to $3,457,768 from $2,205,842 for the nine months ended March 31, 2022 compared to

the same period in 2021.

This increase was primarily driven by an increase in operational activities following completion of the IPO

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contribution, consultancy, as well as an increase in employee related costs associated with a higher headcount.

and regulatory expenses

and regulatory expenses increased by $2,299,362 to $2,641,182 from $341,820 for the quarter ended December 31, 2021 compared to the same

period in 2020.

This increase is primarily driven by funding availability since completion of the IPO in December 2020 that has allowed

the Company to progress on its milestones as well as expensing of the prepaid R&D contribution of $ 2,600,000.

and regulatory expenses increased by $2,375,223 to $2,747,981 from $372,758 for the six months ended December 31, 2021 compared to the

same period in 2020.

This increase is primarily driven by funding availability since completion of the IPO in December 2020 that has

allowed the Company to progress on its milestones as well as expensing of the prepaid R&D contribution of $ $2,600,000.

and regulatory approval expenses

and regulatory approval expenses decreased by $1,742,991 to $413,325 from $2,156,316 for the quarter ended March 31, 2022 compared to

the same period in 2021.

This decrease is primarily driven by delay in the timing of receipt of invoices from University of Newcastle.

and regulatory approval expenses increased by $632,232 to $3,161,306 from $2,529,074 for the nine months ended March 31, 2022 compared

to the same period in 2021.

This increase is primarily driven by funding availability since completion of the IPO in December 2020 that

has allowed the Company to progress on its milestones as well as expensing of the prepaid R&D contribution of $2,600,000.

the Company’s operating activities increase, we expect its development and regulatory expenses to increase in future periods.

and capital raising expenses

and capital raising expenses decreased by $187,093 to zero from $187,093 for the quarter ended December 31, 2021 compared to the same

period in 2020.

and capital raising expenses decreased by $5,100 to zero from $5,100 for the quarter ended March 31, 2022 compared to the same period

This decrease was attributable to final expenditures required by us in the first half of the last financial year to successfully

complete our IPO in December 2020.

and capital raising expenses decreased by $353,574 to zero from $353,574 for the six months ended December 31, 2021 compared to the same

and capital raising expenses decreased by $358,674 to zero from $358,674 for the nine months ended March 31, 2022 compared to the same

period in 2021.

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income and expenses

expense decreased by $986,185 to $675 from $986,860 for the quarter ended December 31, 2021 as compared to the same period in 2020.

expense decreased by $14,344 to $4,217 from $18,561 for the quarter ended March 31, 2022 as compared to the same period in 2021.

decrease was attributable to the conversion of convertible notes into common shares after the completion of the IPO in December 2020.

expense decreased by $1,072,013 to $675 from $1,072,688 for the six months ended December 31, 2021 as compared to the same period in

expense decreased by $1,086,357 to $4,892 from $1,091,249 for the nine months ended March 31, 2022 as compared to the same period in

This decrease was attributable to the conversion of convertible notes into common shares after the completion of the IPO in December

foreign exchange gain (loss)

foreign exchange gain (loss) increased by $86,651 to a gain of $14 from a loss of $86,637 for the quarter ended December 31, 2021 compared

foreign exchange gain decreased by $8,764 to a gain of $10 from a gain of $8,774 for the quarter ended March 31, 2022 compared to the

same period in 2021.

This decrease was largely attributable to the favorable foreign exchange translations on capital raisings from AUD

to USD during the same period in 2021.

foreign exchange loss decreased by $267,239 to a loss of $3,094 from a loss of $270,333 for the nine months ended March 31, 2022 compared

to the same period in 2021.

This increase was largely attributable to the favorable foreign exchange translations on capital raisings

This decrease was largely attributable to the unfavorable foreign exchange translations on capital raisings

from AUD to USD during the same period in 2021.

foreign exchange loss deceased by $276,003 to a loss of $3,104 from a loss of $279,107 for the six months ended December 31, 2021 compared

to the same period in 2020.

This increase was largely attributable to the unfavorable foreign exchange translations on capital

raisings from AUD to USD during the same period in 2020.

tax (expense) benefit

was no income tax expense for the three and six months ended December 31, 2021 and 2020, respectively, and the Company has established

was no income tax expense for the three and nine months ended March 31, 2022 and 2021, respectively, and the Company has established

a full valuation allowance for all of its deferred tax assets.

comprehensive income

currency translation gain (loss)

foreign currency translation gain (loss) decreased by $26,501 to a $7,355 gain from a $33,856 gain for the quarter ended December 31,

2021 as compared to the same period in 2020.

It is calculated based on the Company’s unsettled transactions in currencies other

than its functional currency.

foreign currency translation loss increased by $43,415 to a loss of $60,127 from a loss of $16,712 for the six months ended December

comprehensive loss

currency translation loss

foreign currency translation loss decreased by $264,825 to a $2,793 gain from a $262,032 loss for the quarter ended March 31, 2022 as

compared to the same period in 2021.

It is calculated based on the Company’s unsettled transactions in currencies other than its

functional currency.

foreign currency translation loss decreased by $221,410 to a loss of $57,334 from a loss of $278,744 for the nine months ended March

31, 2022 as compared to the same period in 2021.

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than its functional currency.

loss increased by $1,473,434 to $3,463,832 from $1,990,389 for the quarter ended December 31, 2021 compared to the same period in 2020.

This increase is primarily driven by the expansion of the Company’s operational activities in order to progress on its regulatory

and development milestones.

loss increased by $1,834,359 to $4,901,663 from $3,067,304 for the six months ended December 31, 2021 compared to the same period in

loss decreased by $1,792,567 to $1,335,246 from $3,127,813 for the quarter ended March 31, 2022 compared to the same period in 2021.

This decrease is primarily driven by higher expenditure incurred on research and development activities in the same period in 2021.

loss increased by $43,609 to $6,227,896 from $6,184,287 for the nine months ended March 31, 2022 compared to the same period in 2021.

This increase is primarily driven by the expansion of the Company’s operational activities in order to progress on its regulatory

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the incurrence of debt.

As of December 31, 2021, we had $11,190,622 in cash and cash equivalents and $10,075,538 in working capital.

As of March 31, 2022, we had $10,756,089 in cash and cash equivalents and $8,433,248 in working capital.

to our management’s estimates, based on our budget and proposed schedules of development, approvals and organization, we believe,

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Sheet Arrangements

of December 31, 2021, we do not have any off-balance-sheet arrangements that have, or are reasonably likely to have, a material current

of March 31, 2022, we do not have any off-balance-sheet arrangements that have, or are reasonably likely to have, a material current

or future effect on our results of operations or financial condition, revenues, expenses, results of operations, liquidity, cash requirements

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included in “Part I, Item 1 — Financial Statements” of this Quarterly Report on Form 10-Q and incorporated herein by

the three and six months ended December 31, 2021, there were no material changes to our critical accounting policies from those in the

the three and nine months ended March 31, 2022, there were no material changes to our critical accounting policies from those in the

2021 Form 10-K.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis