What changed in this filing

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Item 1. Business

2022-09-22 compared with 2021-09-16 · 267 added, 309 removed, 477 unchanged (55% of the section changed)

and its wholly owned subsidiary, GBS Operations Inc.

were formed on December 5, 2016 under the laws of the State of Delaware.

headquarters are located in New York, New York.

are a biosensor diagnostic technology company operating across the Asia-Pacific Region (“APAC”) and an interest in the USA

Region with the biosensor platform comprising of biochemistry, immunology, tumor markers, hormones, and nucleic acid diagnostic modalities,

and worldwide with our COV2 test.

objective is to introduce and launch initially the Saliva Glucose Biosensor (referred to as the “SGB”), the diagnostic test

that stems from the Biosensor Platform that we license from Life Science Biosensor Diagnostics Pty Ltd (“LSBD”or “Licensor”)

in our regions and the COV2 test globally.

This will be followed by developing the platform to its full capacity testing across the

diagnostic modalities of Immunology, Hormones, Chemistry, Tumor markers and Nucleic Acid tests.

We are a 42.6% (as of June 30, 2021)

owned (by voting rights) affiliate of LSBD, an Australian company that owns the worldwide intellectual property rights to

the biosensor platform.

were each formed on December 5, 2016 under the laws of the state of

Glucose Biosensor Systems (Greater China) Pty Ltd (“GBSPL”) 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.

These companies (collectively, “we,” “us,” “our,” or the

“Company,”) were formed to provide a non-invasive, pain free innovation to make it easier for people to manage diabetes

using 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”).

Our headquarters are in New York, New York.

are a biosensor diagnostic technology company operating across the Asia-Pacific region (the “APAC Region”) and an

interest in the North America region with the biosensor platform comprising of biochemistry, immunology, tumor markers, hormones,

and nucleic acid diagnostic modalities, and worldwide with our SARS-CoV-2 test.

objective is to introduce and launch initially the SGB, the diagnostic test that stems from the Biosensor Platform that we license from

Life Science Biosensor Diagnostics Pty Ltd (“LSBD” or the “Licensor”), in our regions and the SARS-CoV-2 test

This will be followed by developing the platform to its full capacity testing across the diagnostic modalities of immunology,

hormones, chemistry, tumor markers and nucleic acid tests.

of Achievements

major highlights of achievements since listing the Company on the NASDAQ Global Market in December 2020 are:

being awarded $4.7 million (excluding GST/VAT) in Medical Products Priority Grant funding by the Australian government to fund a high-tech

manufacturing facility, identified as one of six National Manufacturing Priorities

Longwood Campus Institutional Review Board approval to perform a clinical study with patient samples with the SARS-CoV-2 Antibody

of an option to acquire the North America license for Glucose Testing

major highlights of achievements for the fiscal year 2022:

Company and University of Newcastle have identified and selected an initial site to begin construction of a pilot manufacturing facility

Management along with university leadership and staff will commence the next phase of the commercial buildout that will

utilize the already delivered equipment, while the architectural design phase is finalized later this year.

The Company anticipates

construction to commence before end of calendar year 2022.

On June 16, 2022, the Company executed an exclusivity agreement (the “Exclusivity 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 (or a similar transaction).

In consideration for this exclusivity, on June 16, 2022, the Company entered into a Bridge Facility Agreement with IFP (the

“Bridge Facility Agreement”) through which the Company provided IFP with an unsecured term loan facility in the

amount of $500,000 (the “Loan”), which amount is payable 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 Bridge Facility Agreement, or December 31,

The Loan contains customary representations and warranties by IFP and bears interest at two percent per annum (or four percent per

annum in the event the Loan is not repaid in full when due) above the Sterling Barclays Bank Base Rate from time to time.

acquisition If consummated would potentially combine Intelligent Fingerprinting’s leadership position as a revolutionary point of

care fingerprint sweat-based drug screening technology with our saliva-based glucose biosensor platform and manufacturing expertise.

Company would be able to serve a wider spectrum of patients at point of care across global diagnostic markets.

This proposed acquisition,

if consummated, could provide the Company with a clear opportunity to build long-term shareholder value, accelerate revenue growth through

an expanded portfolio of tests, and allow the Company to further solidify its leadership as a developer of rapid non-invasive diagnostic

Completion of the proposed transaction contemplated by the Exclusivity Agreement is subject to the negotiation of a definitive

agreement providing for the transaction and satisfaction of any conditions negotiated therein.

Accordingly, there can be no assurance

that a definitive agreement will be entered into or that the proposed transaction will be consummated, or if a transaction is consummated,

as to its terms, structure, or timing.]

has obtained and 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

Nearly 1,400 samples of blood and oral fluids were collected and analyzed.

Analysis of the resulting data will explore

the degree of agreement among glucose levels in oral fluid and blood samples.

The full details of the analysis will is expected to

be announced in September 2022.

$1,003,904 in Australian government support as a Research and Development (R&D) incentives for the development of the technology

of global voice of customer survey of more than 300 patients living with diabetes verified

an overall 90% desirability for the Saliva Glucose Biosensor

7 out of 10 patients “seriously interested in purchasing the product upon its release

3 out of 10 wanting to be placed on the waiting list ahead of release

Consulting agreement to identify suitable partnership opportunities for sales and distribution in the APAC region

during the fiscal year 2022.

Saliva Glucose Biosensor

SGB uses saliva to measure glucose non-invasively.

When the SGB interacts with saliva, an electrochemical reaction is initiated that

produces 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 by a software app on a smart device or a dedicated smart reader for those that do not possess

a compliant and compatible smart device.

The reading may then be stored in our proprietary cloud-based digital information system.

APAC Region includes over 164 million people living with diabetes, which accounts for 38% of the world’s diabetic population.

urbanization, unhealthy diets and increasingly sedentary lifestyles have resulted in ever increasing rates of obesity and diabetes across

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scientific research and has been extensively referenced in scientific literature.

SGB is an organic transistor, which in its structure embeds the glucose oxidase enzyme (referred to as “

GOX ”).

the single-use SGB interacts with saliva it initiates an electrochemical reaction, 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.

patent protected SGB is able to detect glucose in saliva at concentrations between 8 and 200 µM and exhibits linear glucose sensing

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.

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.

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This will be achieved by directly transferring the SGB reading from the smart device or dedicated

reader to our proprietary digital information system, which is cloud-based to enable every patient the option to create their own medical

record where the SGB results will be uploaded.

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

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.

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.

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to leverage our digital information system to decrease cost and improve outcomes and convenience.

the SGB we aim to drive economic value beyond the revenue stemming from the sale of the SGB units –

it also allows for monetization

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:

The usage of the data, and the analysis and interpretation of the data, to improve patients’

conditions and leveraging

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.

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These services may include, but will not limited to:

Generation of Patient Reported Outcomes, or “PROs”.

– Generation of Patient Reported Outcomes, or “PROs”.

– Market insights, clinical trial recruitment for third parties, e.g., pharmaceutical companies or clinical research organizations.

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to support regulatory approval / market access for platform tests under development.

SGB has been under continuous development for over six years, first by the University of Newcastle, Australia, then by the Licensor and

The SGB development program is currently at the validation stage, which is Phase 5 of development of the SGB, this includes the stages

of design & process development to enable 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.

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 01, 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, where China has the highest number of people with diabetes.

We will first seek regulatory approval with the

NMPA of China.

SGB has been under continuous development for over seven years, first by the University of Newcastle, Australia, then by the Licensor

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.

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.

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

However, we intend to apply for regulatory approval in each jurisdiction across the APAC Region.

Recently, we entered

into non-binding memoranda of understanding with two large distributors in China, which express our intent to enter into definitive agreements

to collaborate on the manufacture, regulatory approval, and distribution and sale of, and the medical affairs, marketing, and identification

of strategic opportunities for, the SGB in China.

SGB is manufactured using modified reel-to-reel printing technology that was developed at the Australian National Fabrication Facility.

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helping prevent or delay diabetes complications and ultimately personalizing diabetes management.

COV2 Biosensor

SARS-CoV-2 Biosensor

COVID-19 pandemic will not simply go away, and we believe it will remain with us for many years.

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risk management decision-making about social distancing, treatments, and vaccination (once the latter two become available).

can support measurements of both the presence of SARS-CoV-2 RNA26-28 as well as antibodies against SARS-CoV-2, this sample type could

provide an important opportunity to monitor individual and population-level SARS-CoV-2 transmission, infection, and immunity dynamics

over place and time.

anticipate there to be 3 different applications for the near future:

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.

Precise knowledge of population immunity could allow government bodies to make informed decisions about

how and when to relax stay-at-home directives and to reopen the economy.

The COV2 Biosensor test can be used as a complement to the (RNA) virus detection tests for patients presenting late after

symptoms onset to healthcare facilities and where virus detection tests are negative despite strong indications of infection.

addition, they can potentially be used for informing the decision on discharge of patients who recovered from SARS-CoV-2 infection

but remain RNA-positive by RT-PCR for a long time after symptoms have subsided.

The degree of protective immunity conferred by or

correlated with the antibodies detected in subjects with past SARS-CoV-2 infection is still under investigation.

Once this is clarified,

the COV 2 antibody tests could be, together with the (RNA) direct virus detection, an essential tool in de-escalation strategies.

can support measurements of both the presence of SARS-CoV-2 as well as antibodies against SARS-CoV-2, this sample type could provide

an important opportunity to monitor individual and population-level SARS-CoV-2 transmission, infection, and immunity dynamics over place

We anticipate there to be 3 different applications

for the near future:

Screening – SARS-CoV-2 antibody testing is urgently needed to estimate the incidence and prevalence of COVID-19 at the general

population level.

Precise knowledge of population immunity could allow government bodies to make informed decisions about how and

when to relax stay-at-home directives and to reopen the economy.

– The SARS-CoV-2 Biosensor test can be used as a complement to the (RNA) virus detection tests for patients presenting

late after symptoms onset to healthcare facilities and where virus detection tests are negative despite strong indications of infection.

In addition, they can potentially be used for informing the decision on discharge of patients who recovered from COVID-19 but remain

RNA-positive by RT-PCR for a long time after symptoms have subsided.

The degree of protective immunity conferred by or correlated

with the antibodies detected in subjects with past SARS-CoV-2 infection is still under investigation.

Once this is clarified, the

SARS-CoV-2 antibody tests could be, together with the (RNA) direct virus detection, an essential tool in de-escalation strategies.

Currently antibody tests are used for sero-epidemiological surveys and studies.

vaccination screening - To assess the degree of the elicited potent antigen-specific antibody responses, to COV2 vaccines when

developed and administered to humans.

believe our COVID test will have significant advantages and we anticipate it will be a ground-breaking development in the management

vaccination screening – To assess the degree of the elicited potent antigen-specific antibody responses, to COVID-19 vaccines

when developed and administered to humans.

believe our SARS-CoV-2 test will have significant advantages and we anticipate it will be a ground-breaking development in the

management of COVID-19.

on a recent paper publicly available and authored by the team at Johns Hopkins Department of Environmental Health and Engineering, Bloomberg

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A saliva-based approach could serve as a non-invasive approach for accurate and large-scale SARS-CoV-2

“sero”-surveillance.

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

“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.

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or approximately two weeks post-presumed infection.

utilizing the biosensor platform for detecting COV2 we expect to have lower detection limits, improve on sensitivity and specificity

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

characteristics of current diagnostic methods, be able to provide real time results at the point of care and provide quantitative results

as opposed to negative or positive which is how other POCT report the results.

as opposed to negative or positive which is how other point of care testing (“POCT”) report the results.

and scalable point-of-care (POC) tests for the diagnosis of COVID-19 would increase the scope for diagnosis to be made in the community

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Platform Technology

Biosensor Platform ”

on which the SGB is based is a modified Organic Thin Film Transistor, or “

OTFT ,”

architecture.

The basis OTFT structure consists of a source and drain electrode, a semiconducting layer, a gate electrode, an optional

separation (or dielectric) layer, all printed on a substrate material and superimposed by a polyelectrolyte membrane/enzyme layer onto

which the analyte is placed.

The layered biosensor architecture and fabrication allows the recognition element within the biosensor to

be exchanged.

The sensing principle for the COV2 Test is the same as the Salivary Glucose Test, amperometric:

target biomolecules generate

an electrical current that is detected by the transistor.

The major difference is that only the GOX layer is substituted with an alternative

layer containing a different recognition element, in this case the COV2 Protein that enables the detection of COV2 antibodies.

The underlying

layers of the Organic Thin Film Transistor (OTFT) remain unchanged.

Hence this significantly simplifies our development effort to make

a blood and saliva based COV2 diagnostic test.

the glucose oxidase (“GOX”) element of the biosensor used to detect glucose in the case of the SGB can be substituted with

antibodies specific to cancer biomarkers, immunological tests, hormones and other biomarkers.

Saliva Glucose Test

“ Biosensor Platform ” on which the SGB is based is a modified Organic Thin Film Transistor (OTFT).

The OTFT structure

consists of a source and drain electrode, a semiconducting layer, a gate electrode, an optional separation (or dielectric) layer, all

printed on a substrate material and superimposed by a polyelectrolyte membrane/enzyme layer onto which the analyte is placed.

biosensor architecture and fabrication allows the recognition element within the biosensor to be exchanged.

The sensing principle for

the SARS-CoV-2 Test is similar to the Saliva Glucose Test:

an enzymatic reaction causes changes at the OTFT surface that lead to a measurable

change in electrical current that is detected by the transistor.

The major difference is that a binding reaction between immunoglobulin

to SARS-CoV-2 in the sample amplifies the transistor signal by bringing and enzyme conjugate into close proximity with the transistor

The underlying layers of the OTFT remain unchanged.

This significantly simplifies our development effort to make a blood- or

saliva-based SARS-CoV-2 diagnostic test.

Saliva Glucose Test (SGT)

SGT consists of:

a single use disposable saliva biosensor, and

SGB – a single use disposable saliva biosensor, and

app on a smart device or a dedicated reader that interfaces the SGB with our digital information system.

Saliva Glucose Biosensor (SGB)

SGB was invented at the COE at the University of Newcastle, Australia.

Patents for the SGB technology have been granted in the United

States (9,766,199) and China (ZL201380022888.2).

The core innovative characteristic of the SGB is the sensitivity of the glucose biosensor

that enables it to detect glucose in saliva at concentrations between 8-200 µM and exhibits linear glucose sensing characteristics

at these concentrations, sensing glucose at levels 100 times lower than in blood.

SGB interacts with the glucose in the saliva and initiates an electrochemical reaction, 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

software app installed on a smart device or a dedicated smart reader.

The data may then be transferred to our digital information system

coupled with an artificial intelligence system, which will provide the patient with personalized healthcare advice enabling a practical

understanding of lifestyle factors that may affect their glucose levels.

SGB utilizes the GOX enzyme for signal generation.

The enzyme acts on glucose, triggering a series of reactions that yields two protons

(i.e., electrical current) for each interaction with a substrate molecule.

The biosensor therefore produces an electrical current (i.e.,

signal) that is proportional to the concentration of glucose in the sample.

The GOX enzyme is well-suited for monitoring glucose levels

and it has been used extensively in commercially available products.

Its mode of action, including the direct signal correlation with

the amount of glucose, has been reviewed in numerous scientific journal articles, including in Biosensors and Bioelectronics, International

Journal of Biochemistry & Cell Biology and Journal of Diabetes Science and Technology .

Additional scientific journal articles

in Applied Physics Letters have described the biophysical characterization of the SGB and further support the claim that its signal

directly correlates with the glucose concentration in the sample.

direct correlation between glucose concentration and sensor signal is independent of the type of sample under examination (i.e., blood

The use of saliva as a meaningful proxy for estimating blood glucose level is supported by extensive scientific literature

that has investigated the physiological glucose concentration in both biological fluids and overwhelmingly reported a strong correlation,

including in articles published in independent journals such as the Journal of Obesity , the Journal of International Oral Health ,

the Journal of Clinical and Experimental Dentistry , the Journal of Oral Biology and Craniofacial Research, Diabetes & Metabolic

Syndrome , the Journal of Biological Regulators and Homeostatic Agents and Diabetologia , among others.

However, a few isolated

articles have reported finding no significant correlation, including articles in the Journal of Clinical and Diagnostic Research

and the Journal of Oral Science .

Overall, we believe there is abundant clinical evidence in independently reviewed scientific

literature that saliva can be utilized as a non-invasive alternative to blood to monitor glycemic status in diabetic patients.

SGB was invented at the Centre for Organic Electronics (COE) at the University of Newcastle, Australia.

Patents for the SGB technology

have been granted in the United States (9,766,199) and China (ZL201380022888.2).

The core innovative characteristic of the SGB is the

sensitivity of the glucose biosensor that enables it to detect glucose in saliva at concentrations between 8-200 µM and exhibits

linear glucose sensing characteristics at these concentrations, sensing glucose at levels 100 times lower than in blood.

to the patent disclosures, details of the SGB design have been published in Applied Physical Letters, a peer-reviewed physics journal.

The Licensor owns patents in Australia, China and the United States protecting the following technological claims of the SGB:

the architecture

of a biofunctional organic thin film transistor device comprising a gate electrode, a dielectric layer, a partially-organic semiconducting

layer, a source electrode, a drain electrode, a substrate and an enzyme;

the method for producing the organic thin film transistor device;

and the method for determining the concentration of a compound in a sample by interpreting the amperometric signals generated by the

The Chinese and the United States patent belong to the same patent family, originating from the Australian patent.

of the patents relate to identical technology claims.

basic OTFT structure consists of a source and drain electrode on a semiconducting material which is itself separated from a third gate

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structure, and in the case of the SGB, the recognition element is GOX.

SGB interacts with the glucose in the saliva and initiates an enzymatic reaction whereby GOX enzyme produces hydrogen peroxide from glucose,

which modifies the properties of the OTFT gate material, 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 software app installed

on a smart device or a dedicated smart reader.

The data may then be transferred to our digital information system coupled with an artificial

intelligence system, which will provide the patient with personalized healthcare advice enabling a practical understanding of lifestyle

factors that may affect their glucose levels.

quality OTFTs have been routinely fabricated at the materials node of the Australian National Fabrication Facility.

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A possible route to achieve

this technical aim is to leverage near-field-communication, or “

tags, available off the shelf and routinely

this technical aim is to leverage near-field-communication, or “ NFC ,” tags, available off the shelf and routinely

used in consumer electronics, to power the SGB and implement the communication protocol.

NFC tags are compatible with flexible electronics

and widely used in “internet of things”

applications in view of their low cost.

and widely used in “internet of things” applications in view of their low cost.

We believe that NFC tags suitable for integration

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cost of suitable NFC tags will be viable and less than $0.04.

Licensor owns patents in Australia, China and the United States protecting the following technological claims of the SGB:

the architecture

of a biofunctional organic thin film transistor device comprising a gate electrode, a dielectric layer, a partially-organic semiconducting

layer, a source electrode, a drain electrode, a substrate and an enzyme;

the method for producing the organic thin film transistor device;

and the method for determining the concentration of a compound in a sample by interpreting the amperometric signals generated by the

The Chinese and the United States patent belong to the same patent family, originating from the Australian patent.

of the patents relate to identical technology claims.

use of saliva as a meaningful proxy for estimating blood glucose level has been reported in scientific literature, including articles

published in independent journals such as the Journal of Obesity , the Journal of International Oral Health , the Journal

of Clinical and Experimental Dentistry , the Journal of Oral Biology and Craniofacial Research, Diabetes & Metabolic Syndrome ,

the Journal of Biological Regulators and Homeostatic Agents and Diabetologia , among others.

However, a few articles have reported

finding little or no significant correlation, including articles in the Journal of Clinical and Diagnostic Research and the Journal

of Oral Science .

Consequently, GBS is performing clinical research to determine if saliva can be utilized as a non-invasive alternative

to blood to monitor glycemic status in diabetes patients.

this time, GBS has concluded the in-clinic portion of a clinical study to measure glucose in oral fluids and blood.

The study consented

40 subjects with type 2 diabetes, and collected saliva, gingival crevicular fluid, venous blood and fingerstick capillary blood over

the course of a two-hour oral glucose tolerance test.

GBS is in the process of analyzing the data from this study.

and Background of the Saliva Glucose Biosensor

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It has been demonstrated that the SGB exhibits linear glucose sensing

at concentrations of 8-200 µM (micro molar) offering a saliva-based test for diabetic monitoring and diagnosis.

at concentrations of 8-200 µM (micro molar) offering a saliva-based test for diabetes diagnosis and monitoring.

of the biosensor technology have been well-characterized and have deep scientific foundations.

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have dominated the mainstream microelectronics industry.

Field Effect Transistors, or “

FETs ,”

are a class of transistor

Field Effect Transistors, or “ FETs ,” are a class of transistor

in which the current between a pair of source and drain electrodes separated by a semiconductor is controlled by a voltage applied to

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discussed above, the architecture of the Biosensor Platform allows the recognition element of the biosensor to be exchanged.

the GOX element used to detect glucose in the case of the SGB can be substituted with antibodies specific to SARS-CoV-2, cancer biomarkers,

immunological tests, hormones and other biomarkers.

The substitute recognition element will generate an electrical current signal that

is detected in a manner identical to the SGB.

Given the underlying sensing mechanism is unaltered, we believe the technical risk associated

with the development of other tests for biomarkers other than glucose is considered to be relatively low.

the GOX element used to detect glucose in the case of the SGB can be substituted for a different enzyme, or with antibodies specific

to SARS-CoV-2, cancer biomarkers, immunological tests, hormones and other biomarkers.

The substitute recognition element will catalyze

a reaction leading to a signal that is proportional to the amount of analyte, or participate in a binding reaction of labelled antibodies

that will lead to a signal proportional to the amount of analyte of interest.

Given the underlying sensing mechanism is unaltered, we

believe the technical risk associated with the development and manufacturing scale-up of other tests for biomarkers other than glucose

is considered to be relatively low.

Testing, Current State of Development and Next Steps

Analytical Performance Testing

Approval COV2 Test (“COV2T”)

the COV2T we intend to use the section 564 of the Federal Food, Drug and Cosmetic (FD&C) Act, that there is a public health emergency

that has a significant potential to affect national security or the health and security of United States citizens living abroad, and

that involves a novel (new) coronavirus (nCoV) first detected in Wuhan City, Hubei Province, China in 2019 (2019-nCoV).

now named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which causes the disease COVID-19.

Approval SARS-CoV-2 Test

the SARS-CoV-2 Test we intend to use the section 564 of the Federal Food, Drug and Cosmetic (FD&C) Act, that there is a public health

emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad,

and that involves a novel (new) coronavirus (nCoV) first detected in Wuhan City, Hubei Province, China in 2019 (2019-nCoV).

is now named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which causes the disease COVID-19.

the basis of this determination, the Secretary of HHS has subsequently declared that circumstances exist justifying the Emergency Use

Authorization (“EUA”) of in vitro diagnostics for the detection and/or diagnosis of COVID-19 (February 4, 2020), personal

respiratory protective devices (March 2, 2020), and other medical devices, including alternative products used as medical devices (March

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or life-threatening disease

of effectiveness the “may be effective”

standard for EUAs provides for a lower level of evidence than the “effectiveness”

of effectiveness the “may be effective” standard for EUAs provides for a lower level of evidence than the “effectiveness”

standard that FDA uses for product approvals.

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Commercialization

is the company’s intent to introduce and launch the test globally, through assignment of a sublicense and or distributors agreements.

is the Company’s intent to introduce and launch the test globally, through assignment of a sublicense and or distributors agreements.

The development path will follow the geographical regulatory path, beginning by the North American markets.

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The standard dictates

that at least 95 % of results for a given system have to be within ±

15 mg/dL at glucose concentrations less than 100 mg/dL and

within ±

15 % at glucose concentrations greater than or equal to 100 mg/dL.

that at least 95 % of results for a given system have to be within ± 15 mg/dL at glucose concentrations less than 100 mg/dL and

within ± 15 % at glucose concentrations greater than or equal to 100 mg/dL.

Artificial saliva was prepared based on the most widely

used Fusayama Meyer solution consisting of 11 different glucose concentrations of 0, 0.18, 0.36, 0.9, 1.8, 3.6, 9.01, 18.02, 36.04, 90.1,

Only the first seven concentrations are clinically relevant in saliva (0 –

9.01 mg/dL)3.

Only the first seven concentrations are clinically relevant in saliva (0 – 9.01 mg/dL)3.

However, at this stage of

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devices assessed 110 devices (94.8 %) met the blood glucose ISO standard in relation to the adapted system accuracy (i.e.

measured results must fall within ±

15 mg/dL at glucose concentrations less than 100 mg/dL).

measured results must fall within ± 15 mg/dL at glucose concentrations less than 100 mg/dL).

believe the deficiency of the 6 prototype devices that failed to meet the ISO standard is attributable to the previously non-validated

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we have used for fabrication and testing.

These facilities are being extensively used, and we anticipate they can also be used for

initial manufacturing and charged under a cost recovery basis.

We have received approval for $4.7 million

(excluding GST/VAT) million Medical Products Priority Grant funding by the Australian Government as contributions towards the

establishment of a high-tech manufacturing facility in Australia.

Amounts will be paid under this grant upon GBS in achieving

certain deliverables.

These facilities are being extensively used, and we anticipate they can also be used for initial

manufacturing and charged under a cost recovery basis.

received approval for $4.7 million (excluding GST/VAT) Medical Products Priority Grant funding by the Australian Government in June 2021

as contributions towards the establishment of a high-tech manufacturing facility in Australia.

Amounts will be paid under this grant

upon GBS in achieving certain deliverables.

in the manufacturing process is a separate calibration process that is batch dependent and ensures analytical performance quality control.

Further to this an authenticity validation process verifies that the biosensor is authentic or otherwise flags a device.

Company and University of Newcastle have identified and selected an initial site to begin operations on campus.

Management along with

university leadership and staff will commence this next phase of the commercial buildout that will utilize the already delivered equipment,

while the architectural design phase is finalized later this year and the primary manufacturing and construction begins on this second

site location.

The Company anticipates construction to commence before end of calendar year 2022.

intend, assuming the completion of development and regulatory approval, to market and distribute the SGT in the APAC Region.

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We have entered into an agreement in principle with a medical

affairs commercialization company to drive prelaunch activity with the scope to create awareness and build “share of voice”

with local referring physicians, diabetes educators, patient associations, government organizations and general practitioners.

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marketing, and identification of strategic opportunities for, the SGB in China.

We have engaged L.E.K Consulting to assist in

expanding the scope of commercial partners.

We engaged L.E.K Consulting to assist in expanding the

scope of commercial partners.

strategy will depend in part on finding qualified distributors for the marketing and sale of our products.

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Only one system to date has been deemed of

equivalent use “as an aid to monitor the effectiveness of diabetes control”

or non-adjunctive use.

equivalent use “as an aid to monitor the effectiveness of diabetes control” or non-adjunctive use.

The procedure is invasive

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Continuous glucose monitoring can

track a patients’

glucose throughout the day and night, notifying the patient of highs and lows so the person can act.

track a patients’ glucose throughout the day and night, notifying the patient of highs and lows so the person can act.

glucose levels change more slowly than plasma glucose, which can be a restriction to their effectiveness, particularly if glucose levels

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Continuous glucose monitoring is commonly used in conjunction with continuous subcutaneous insulin infusion, or

CSII ,”

which involves a patient wearing an insulin pump and infusion set that infuses insulin into the body.

“ CSII ,” which involves a patient wearing an insulin pump and infusion set that infuses insulin into the body.

pumps are currently manually controlled by the patient, continuous glucose monitoring combined with CSII could potentially be used as

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Self-monitoring provides information

regarding an individual’s dynamic blood glucose profile.

This information can help with the appropriate scheduling of food, activity,

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as well as administration of insulin or other agents;

patients’

recognition of hypoglycemia or severe hyperglycemia;

patients’ recognition of hypoglycemia or severe hyperglycemia;

patient education and patient empowerment regarding the effects of lifestyle and pharmaceutical intervention on glycemic control.

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License Agreement

June 23, 2020, we entered into a certain Technology License Agreement, or the “License Agreement,”

with Life Science Biosensor

Diagnostics Pty Ltd, (“LSBD”

or “Licensor”).

The Licensor owns 42.6% of our outstanding common

stock (by voting rights) as of June 30, 2021.

June 23, 2020, we entered into a certain Technology License Agreement, or the “License Agreement,” with Life Science Biosensor

Diagnostics Pty Ltd, (“LSBD” or “Licensor”).

License Agreement sets forth our contractual rights and responsibilities relating to the Licensed Products.

The “Licensed Products”

(i) a biosensor strip for antibodies against SARS-CoV-2;

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of immunoglobulins (IgG, IgM, IgA) specific to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

“Authorized Supplier”

includes us, the Licensor, any of our affiliates or any affiliates of the Licensor, or any third party

“Authorized Supplier” includes us, the Licensor, any of our affiliates or any affiliates of the Licensor, or any third party

manufacturer and/or reseller that the Licensor has expressly identified or approved in advance in writing for the purpose of quality

control for the supply of Licensed Products to us.

to the License Agreement, the Licensor granted to us an exclusive license to the Licensor’s proprietary rights to the biosensor

technology used in the Licensed Products, worldwide and solely to:

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after the receipt of regulatory approval in a jurisdiction, and the earning of revenue we will be required to pay the Licensor a minimum

royalty fee with respect to such jurisdiction for each year, or the “Minimum Royalty,”

in four equal quarterly installments.

royalty fee with respect to such jurisdiction for each year, or the “Minimum Royalty,” in four equal quarterly installments.

The Minimum Royalty will be 13% of the projected net sales in such jurisdiction for each such year.

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if the quarterly installment of the Minimum Royalty is less than 13% of the actual net sales of Licensed Products in such jurisdiction

for such quarter, or the “Actual Royalty,”

we will pay Licensor the difference between the quarterly installment of the Minimum

for such quarter, or the “Actual Royalty,” we will pay Licensor the difference between the quarterly installment of the Minimum

Royalty and the Actual Royalty.

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The License Agreement

also may be terminated by us at any time after the tenth anniversary of the License Agreement upon 180 days’

prior written notice.

also may be terminated by us at any time after the tenth anniversary of the License Agreement upon 180 days’ prior written notice.

March 31, 2021, the Company, entered into an Option Agreement with LSBD and BiosensX (North America) Inc.

(“BIOX”).

Under the terms of this

Option Agreement, 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 (the “NA Territory”).

The Company is entitled to exercise this Option

at any time during the 2-year term from the effective date of the Option Agreement by paying the option fee in the amount of $5 million

to LSBD at the time of the option exercise.

Upon such exercise, (i) LSBD and BIOX will promptly terminate their respective agreement

with respect to the NA Territory, and (ii) LSBD and the Company will promptly enter into a license agreement pursuant to which LSBD will

grant an exclusive license (with the right to sublicense) to the Company, substantially on the same set of terms as the LSBD-BIOX license

agreement currently in place, provided that the license agreement between LSBD and the Company will also contain a commercialization

milestone payment to the LSBD for the equivalent of 5 years’

of royalties based upon agreed maintainable sales due 90 days from

the end of the first royalty year.

The terms and provisions of the foregoing transaction have been reviewed and approved by the Company’s

Board of Directors and the Audit Committee of the Board.

the terms of this Option Agreement, 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 (the “NA Territory”).

The Company is entitled

to exercise this Option at any time during the 2-year term from the effective date of the Option Agreement by paying the option fee in

the amount of $5 million to LSBD at the time of the option exercise.

Upon such exercise, (i) LSBD and BIOX will promptly terminate their

respective agreement with respect to the NA Territory, and (ii) LSBD and the Company will promptly enter into a license agreement pursuant

to which LSBD will grant an exclusive license (with the right to sublicense) to the Company, substantially on the same set of terms as

the LSBD-BIOX license agreement currently in place, provided that the license agreement between LSBD and the Company will also contain

a commercialization milestone payment to the LSBD for the equivalent of 5 years’ of royalties based upon agreed maintainable sales

due 90 days from the end of the first royalty year.

The terms and provisions of the foregoing transaction have been reviewed and approved

by the Company’s Board of Directors and the Audit Committee of the Board.

business depends on the proprietary biosensor technologies licensed by us from the Licensor.

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date of filing a non-provisional patent application.

In the United States, a patent’s term may be shortened if a patent is terminally

disclaimed over another patent or as a result of delays in patent prosecution by the patentee, and a patent’s term may be lengthened

In the United States, a patent’s term may be shortened if a patent is terminally

disclaimed over another patent or as a result of delays in patent prosecution by the patentee, and a patent’s term may be lengthened

by patent term adjustment, which compensates a patentee for administrative delays by the United States Patent and Trademark Office in

granting a patent.

conduct our business using the licensed trademark “Glucose Biosensor”

and our logo, as well as domain names incorporating

conduct our business using the licensed trademark “Glucose Biosensor” and our logo, as well as domain names incorporating

either or both of these trademarks.

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Our major competitors for glucose testing solutions include Bayer, Abbott, and Roche.

Government Regulation

operate in a highly regulated industry.

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sales and distribution of our products.

Internationally,

various regulatory bodies monitor and supervise the administration of pharmaceutical products, as well as medical devices and equipment.

Their primary responsibilities include evaluating, registering and approving new drugs, generic drugs and imported drugs;

approving and

issuing permits for the manufacture, export and import of pharmaceutical products and medical appliances;

approving the establishment

of enterprises for pharmaceutical manufacture and distribution;

formulating administrative rules and policies concerning the supervision

and administration of food, cosmetics and pharmaceuticals;

and handling significant accidents involving these products.

Internationally, various regulatory bodies monitor and supervise the administration of

pharmaceutical products, as well as medical devices and equipment.

Their primary responsibilities include evaluating, registering and

approving new drugs, generic drugs and imported drugs;

approving and issuing permits for the manufacture, export and import of pharmaceutical

products and medical appliances;

approving the establishment of enterprises for pharmaceutical manufacture and distribution;

administrative rules and policies concerning the supervision and administration of food, cosmetics and pharmaceuticals;

significant accidents involving these products.

also will be subject to numerous post-marketing regulatory requirements, which may include labeling regulations and medical device reporting

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may change in the future.

the past, we have utilized for our benefit certain employees of the Licensor, our largest stockholder.

We have not incurred or

accrued any financial or other obligations other than certain shared corporate overhead as required in connection with this utilization.

We have reimbursed the Licensor for any costs the Licensor incurs on our behalf.

the past, we have utilized for our benefit certain employees of the Licensor.

We have not incurred or accrued any financial or other

obligations other than certain shared corporate overhead as required in connection with this utilization.

We have reimbursed the Licensor

for any costs the Licensor incurs on our behalf.

in anticipation of product commercialization, we have expanded our team.

We currently have seven full time employees and two part-time

We also rely on the services of contractors, collaborators and consultants.

We have assembled an outstanding team of 14 people,

including our 9 employees, our scientific advisory board and personnel at the University of Newcastle through a collaboration with the

institution, to execute on our mission to create next generation non-invasive diagnostic tools to help patients suffering with diabetes.

From time to time, we also contract for various administrative and other services from our largest stockholder.

the Licensor,

Our employees, including our management, have extensive experience in the research, development and commercialization of

life science assets and are leaders in their respective fields.

We currently have 12 full time employees.

We also rely on

the services of contractors, collaborators and consultants.

We have assembled an outstanding team of 17 people, including our 12 employees,

our scientific advisory board and personnel at the University of Newcastle through a collaboration with the institution, to execute on

our mission to create next generation non-invasive diagnostic tools to help patients suffering with diabetes.

Our employees, including

our management, have extensive experience in the research, development and commercialization of life science assets and are leaders in

their respective fields.

team, including our employees, contractors, and collaborators, comprises multiple cross-functional units, including strategy, project

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next generation non-invasive diagnostic tools for the tens of millions of diabetes patients worldwide.

public offering

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.

costs include underwriters’

warrants to acquire up to 63,529 shares with an exercise price of $18.70 per share, exercisable until

the fifth anniversary of the issuance date.

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”).

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.

preferred shareholders were issued warrants following the Company’s completed IPO, that allow the holders to acquire 2,736,675

shares of common stock at the IPO price during year two through to year three following the completion of the IPO.

At exercise date,

the shareholder must hold, for each warrant to be exercised, the underlying common share to exercise the warrant.

The warrants are not

transferable and apply to the number of shares that were subscribed for.

to Information

website is at www.gbs.inc we make available, free of charge, on our corporate website, our annual report on Form 10-K, quarterly reports

on Form 10-Q, current reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the

Securities Exchange Act of 1934, as amended (the “Exchange Act”), as soon as reasonably practicable after they are electronically

filed with the Securities and Exchange Commission (“SEC”).

The SEC maintains an internet site that contains reports, proxy

and information statements and other information regarding issuers that file electronically with the SEC at www.sec.gov.

contained on our website does not, and shall not be deemed to, constitute part of this Annual Report on Form 10-K.

Our reference to the

URL for our website is intended to be an inactive textual reference only.

website is at www.gbs.inc.

We make available, free of charge, on our corporate website, our annual report on Form 10-K, quarterly

reports on Form 10-Q, current reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d)

of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), as soon as reasonably practicable after they are

electronically filed with the Securities and Exchange Commission (“SEC”).

The SEC maintains an internet site that contains

reports, proxy and information statements and other information regarding issuers that file electronically with the SEC at www.sec.gov .

Information contained on our website does not, and shall not be deemed to, constitute part of this Annual Report on Form 10-K.

Our reference

to the URL for our website is intended to be an inactive textual reference only.

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-K

Item 1. Business