What changed in this filing

/stocks — the workspaceLOADING

Item 1. Business

2023-08-23 compared with 2022-09-22 · 1065 added, 636 removed, 108 unchanged (94% of the section changed)

and its wholly owned subsidiary, GBS Operations Inc.

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

Bio Solutions Inc.

(formerly known as GBS Inc.), and its wholly owned Delaware subsidiary, GBS Operations Inc.

were each formed on December

5, 2016, under the laws of the state of Delaware.

Our Australian subsidiary Intelligent Bio Solutions (APAC) Pty Ltd (formerly known

as 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 Intelligent Bio Solutions (APAC) Pty Ltd on January 6, 2023.

On October 4, 2022, INBS acquired Intelligent Fingerprinting

Limited (“IFP”), a company registered in England and Wales (the “IFP Acquisition”).

Our headquarters are in New

York, New York.

are a medical technology company focused on developing and delivering non-invasive, rapid and pain free innovative testing and screening

We operate globally with the objective of providing intelligent, pain-free, and accessible solutions that improve the quality

current product portfolio includes:

Fingerprinting Platform - Our proprietary portable platform analyzes fingerprint sweat using a one-time (recyclable) cartridge

and portable handheld reader.

Our flagship product from this platform, which is commercially available in certain countries outside

of the United States, is the Intelligent Fingerprinting Drug Screening System (the “IFP System” or “IFP Products”),

a two-part system that consists of non-invasive, sweat-based fingerprint diagnostic testing products designed to detect drugs of

abuse including opioids, cocaine, methamphetamines, benzodiazepines, cannabis, methadone, and buprenorphine.

The system comprises

a small, tamper-evident drug screening cartridge onto which ten fingerprint sweat samples are collected in under a minute, before

the portable analysis unit provides an on-screen result in under ten minutes.

Samples collected with our confirmatory kits can also

be sent to a third-party laboratory service provider to perform confirmation testing.

Customers include safety-critical industries

such as construction, transportation and logistics firms, manufacturing, engineering, drug treatment organizations in the rehabilitation

sector, and judicial organizations.

Biosensor Platform – Our “Biosensor Platform” consists of a small, printable modified organic thin-film transistor

strip that we license across the Asia Pacific Region from Life Science Biosensor Diagnostics Pty Ltd (“LSBD” or “Licensor”).

The Biosensor Platform, which is designed to detect multiple biological analytes by substituting the Glucose Oxidase (“GOX”)

enzyme with a suitable alternative for each analyte, is currently in the development stage.

Our flagship product candidate based

on the Biosensor Platform technology is the Saliva Glucose Biosensor (“SGB” and, together with a software app that interfaces

the SGB with the Company’s digital information system, the Saliva Glucose Test or “SGT”), a Point of Care Test

(POCT) expected to complement the finger pricking invasive blood glucose monitoring test for diabetic patients.

Our products based

on the SGT are referred to herein as the “SGT products.”

platform technologies have the potential to develop a range of POCT including the modalities of clinical chemistry, immunology, tumor

markers, allergens, and endocrinology.

of Achievements and Developments

major highlights of achievements for the fiscal year 2023:

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

June 28, 2023, the Company announced it had received guidance from the United States Food and Drug Administration (the “FDA”)

regarding the regulatory classification of its Intelligent Fingerprinting Drug Screening Cartridge.

The FDA provisionally determined

that the cartridge falls within 21 CFR 862.3650, Opiate Test System, a Class II type device that requires the submission of a pre-market

notification 510(k) and the FDA’s clearance prior to marketing.

The preliminary assessment, in response to the Company’s

March 2023 513(g) request for product classification, provides a clear regulatory pathway for INBS as part of the Company’s

expansion strategy into the United States.

The Company intends to submit a 510(k) pre-market notification for its proprietary Intelligent

Fingerprinting Drug Screening Cartridge.

June 2023, the Company concluded its study on the Correlation of Glucose and Cortisol between Oral Fluid and Blood Compartments.

The study aimed to determine the degree of correlation between saliva and blood glucose and cortisol levels in subjects with and

without diabetes.

The results of the study indicate that saliva sampling and analysis has potential use in various applications,

including as an aid in screening for diabetes in unhygienic environments where blood sampling is risky, and in point-of-care or at-home

cortisol tests where characterizing early morning levels and daily variation is important.

The Company intends to compile a white

paper summarizing the findings as it determines the next phase of development.

On May 2, 2023, the Company announced the recruitment of its Australian sales force and the addition of a new distribution

hub and office facility to manage sales and operations, significantly expanding its ability to service customers throughout the Asia Pacific

March 15, 2023, the Company announced that it has selected Human and Supplement Testing Australia (“HASTA”), Australia’s

largest independent sports drug testing laboratory, as its preferred drug testing specialist in Australia to complete lab-based confirmation

February 16, 2023, the Company announced that it has filed a 513(g) submission with the United States Food and Drug Administration

(FDA) for its Intelligent Fingerprinting Drug Screening Cartridge.

The submission will allow Intelligent Bio Solutions to determine

the most suitable FDA regulatory pathway as part of the Company’s strategy for expansion into the U.S.

January 23, 2023, the Company published the results of Milestone 7, a phase of its biosensor platform development at the University

of Newcastle, Australia, that included testing time-to-result (TTR), sensitivity, and reproducibility.

The results showed a record

4x improvement in TTR, enabling the biosensor to return test results in under one minute.

the year, the Company continued to expand its customer base by entering into sales contracts with Haulier, Eastern Airways, Hozelock, Boughey

Distribution, A&F Sprinklers and Dodman Limited.

Company completed the acquisition of Intelligent Fingerprinting Limited (IFP), a company registered in England and

Wales and on October 4, 2022 (the IFP Acquisition).

IFP owns a portfolio of intellectual property for diagnostic tests

and associated technologies including drug testing through the analysis of fingerprint sweat.

The acquisition of IFP has expanded

the Company’s platform of rapid, non-invasive diagnostic testing technologies.

The IFP Acquisition is described in more detail below.

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.

3 unchanged sentences

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

during the fiscal year 2022.

Saliva Glucose Biosensor

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

blood glucose monitors were introduced to the market in the 1970s and, since then, the method of glucose self-monitoring has not meaningfully

The industry remains dominated by invasive methods that ultimately use blood or interstitial fluid to measure glucose.

the methodology of the SGB 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.

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.

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.

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.

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

this insight to improve patient care.

data sharing.

The provision of data sharing services between users/patients, authorized care givers and authorized medical practitioners.

The collection of anonymized data, its aggregation with other data from multiple sources and multiple health devices

and its combination with non-health data.

plan to leverage this usage, safe sharing and collection of data in the following four revenue-generating channels:

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:

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.

party coverage, other industry/retail players pay fee for their own customers.

sharing/profit sharing, success-based payment models.

third party ads tailored to demographic data leveraging characteristics unique to channel.

value of GBS brand loyalty.

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:

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

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

– e-commerce platform, third party customer care, advertising.

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

payment model with insurance subsidy.

for outcomes model.

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:

access to customers for better experience in customer care.

learning and support to decrease customer care resource commitment.

market and customer insights (including better understanding of customer journey).

customer data for targeted marketing & marketing impact monitoring.

cost effective, digital marketing channel enabling agile marketing approach.

data to support unique marketing claims.

engagement, customer loyalty and customer lifetime value.

driven innovation and customer involvement in development.

in testing & refining to develop demand-oriented products rapidly.

and fast clinical evaluation recruitment.

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

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.

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.

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.

SARS-CoV-2 Biosensor

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

Development of an improved antibody

assays to detect prior infection with SARS-CoV-2 has been identified as one of the top unmet needs in the ongoing COVID-19 pandemic response.

Precise knowledge of SARS-CoV-2 infection at the individual level can potentially inform clinical decision-making, whereas at the population

level, precise knowledge of prior infection, immunity, and attack rates (particularly asymptomatic infection) is needed to prioritize

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 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 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

School of Public Health, results indicate it is feasible to accurately measure the salivary IgG response to identify individuals with

a prior SARS-CoV-2 infection.

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

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 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 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

and outside the laboratory setting They would have the potential to reduce the time to obtaining an actionable result, could support

early identification of those with COVID-19 and could also support appropriate use of isolation resources, infection control measures,

and recruitment into clinical trials of treatments.

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.

Our major developments for the fiscal year 2023:

IFP Acquisition – Issuance of Series C Preferred Stock

On October 4, 2022,

in connection with the IFP Acquisition, the Company entered into a Share Exchange Agreement with IFP (the “Share Exchange Agreement”),

the holders of all of the issued shares in the capital of IFP (collectively, the “IFP Sellers”) and the IFP Sellers’

representatives named therein.

the terms of the Share Exchange Agreement, the Company, among other things, acquired from the IFP Sellers all of the issued shares

in the capital of IFP, and as consideration therefor the Company issued to the IFP Sellers upon the closing of the IFP Acquisition

(the “IFP Closing”) an aggregate of (i) 148,155 shares (148,183 shares after taking into effect of rounding due to

Reverse Stock Split) of the Company’s common stock (the “Common Stock Consideration”), and (ii) 2,363,003 shares

of the Company’s Series C Convertible Preferred Stock, par value $0.01 per share (the “Series C Preferred

An additional 1,649,273

shares of Series C Preferred Stock were reserved for potential future issuance by the Company, consisting of (i) 500,000 shares of Series

C Preferred Stock, that are being held back from the IFP Sellers for one year after the IFP Closing to secure potential indemnification

claims by the Company against the IFP Sellers (the “Closing Holdback Shares”) and

(ii) 1,149,273 shares of Series C Preferred Stock (the “Lender Preferred Shares”) underlying convertible debt (referred to

herein as the “Convertible Debt” and “convertible notes”) payable to certain lenders to IFP (the “IFP Lenders”).

When initially issued

in connection with the IFP Acquisition and prior to the Reverse Stock Split (defined below), each share of Series C Preferred Stock was

convertible into three shares of common stock, subject to adjustment upon the occurrence of specified events (such as Reverse Stock Split)

and contingent upon approval by the Company’s stockholders.

As a result of the Reverse Stock Split, each share of Series C Preferred

Stock is currently convertible into 0.15 shares of common stock (subject to adjustment upon the occurrence of specified events).

The full conversion

of the Series C Preferred Stock was approved by the Company’s stockholders at the special meeting of the Company’s stockholders

on May 8, 2023 (the “Special Meeting”).

As a result of the stockholder approval, all then-outstanding shares of Series C Preferred

Stock (other than the Lender Preferred Shares and shares held by the two shareholders referred to herein as the “RFA Sellers”)

were automatically converted into common stock effective May 10, 2023.

The IFP Lenders and RFA Sellers subsequently elected to convert

the Lender Preferred Shares and all other shares Series C Preferred Stock they held into common stock effective May 10, 2023.

of this report, “RFA Seller” means The Ma-Ran Foundation and The Gary W.

Rollins Foundation.

Concurrently with the

IFP Acquisition, the Company and the IFP Sellers entered into two registration rights agreements (the “IFP Registration Rights Agreements”)

granting the IFP Sellers customary registration rights with respect to the shares of common stock and the common stock underlying the

Series C Preferred Stock issued to the IFP Sellers by the Company in connection with the IFP Acquisition.

On June 6, 2023, the Company

filed a registration statement on Form S-1, which was subsequently amended on June 21, 2023 (File No.

333-272463) (the “June Resale

Registration Statement”), in connection with fulfilling its obligations under the IFP Registration Rights Agreements.

The June Resale

Registration Statement was declared effective on June 27, 2023.

December Private Placement – Issuance of Series D Preferred Stock

On December 21, 2022,

the Company entered into a Securities Purchase Agreement (the “December Purchase Agreement”) with 14 investors (the “Series

D Investors”), pursuant to which the Company agreed to issue and sell to the Series D Investors in a Regulation S private placement

(the “December Private Placement”):

(i) 176,462 shares of the Company’s Series D Convertible Preferred Stock, par value

$0.01 per share (the “Series D Preferred Stock”), and (ii) 529,386 warrants to purchase common stock (the “D Warrants”).

The Series D Preferred Stock and D Warrants were sold together as a unit (“Unit”), with each Unit consisting of one share

of Series D Preferred Stock and three D Warrants.

An additional 26,469 warrants (the “Winx Warrants”) were issued to Winx

Capital Pty Ltd., the placement agent for the December Private Placement.

The Company received aggregate gross proceeds from the December

Private Placement of $220,585 before deducting the placement agent’s fees and the Company’s transaction expenses.

Private Placement closed on December 22, 2022.

The purchase price

for the Units was $1.25 per Unit.

The Unit offering price and the D Warrants exercise price were priced above the Nasdaq “Minimum

Price” as that term is defined in Nasdaq Rule 5635(d)(1).

When initially issued

in connection with the December Private Placement and prior to the Reverse Stock Split, the 176,462 outstanding shares of Series D Preferred

Stock were convertible into 529,386 shares of common stock.

As a result of the Reverse Stock Split, the 176,462 outstanding shares of

Series D Preferred Stock were, at the time of conversion, convertible into an aggregate of 26,464 shares of common stock.

The Company’s

stockholders approved the full conversion of the Series D Preferred Stock at the Special Meeting on May 8, 2023, and the conversion of

the Series D Preferred Stock was effective as of May 10, 2023.

As a result of the

Reverse Stock Split, (i) each share of Series D Preferred Stock was convertible into 0.15 shares of common stock at the time of conversion

(initially three shares of common stock pre-Reverse Stock Split, subject to adjustment upon the occurrence of specified events);

each D Warrant currently represents the right to purchase 0.05 shares of common stock with an exercise price of $5.80 per share (initially

exercisable for one share of common stock with an exercise price of $0.29 per share pre-Reverse Stock Split);

and (iii) each Winx Warrant

currently represents the right to purchase 0.05 shares of common stock, with an exercise price of $10.40 per share (initially exercisable

for one share of common stock with an exercise price of $0.52 per share pre-Reverse Stock Split).

The D Warrants expire June 22, 2028

and the Winx Warrants expire five years following the effective date of a registration statement covering the resale of common stock underlying

the Series D Preferred Stock acquired by the Series D Investors.

Concurrent with entry

into the December Purchase Agreement, the Company and the Series D Investors entered into a Registration Rights Agreement (the “December

Registration Rights Agreement”) granting the Series D Investors customary registration rights with respect to the shares of common

stock underlying the Series D Preferred Stock and the D Warrants acquired by the Series D Investors in the December Private Placement.

The June Resale Registration Statement, which was declared effective on June 27, 2023, was filed in connection with fulfilling the Company’s

obligations under the December Registration Rights Agreements.

March 2023 Offering

On March 8, 2023, the

Company entered into an underwriting agreement (the “Underwriting Agreement”) with Ladenburg Thalmann & Co.

Inc., as representative

(the “Representative”) of the underwriters named therein (collectively, the “Underwriters”), relating to an underwritten

public offering of 569,560 shares (the “March Shares”) of the Company’s common stock and warrants (the “March

Warrants”) to purchase 170,868 shares of common stock (collectively, the “March 2023 Offering”).

Each of the March Shares

was sold in combination with an accompanying one-third Warrant.

The combined purchase price for each March Share and accompanying March

Warrant was $3.90 and the Underwriters agreed to purchase 569,560 March Shares and 170,868 March Warrants.

The Company granted

the Underwriters a 45-day option to purchase an additional 85,430 shares and/or warrants to purchase up to 25,629 shares of common stock,

in any combination, at the public offering price less the underwriting discounts and commissions.

On March 9, 2023, the Representative

fully exercised the over-allotment option to purchase an additional 85,430 March Shares and additional March Warrants to purchase 25,629

shares of common stock.

The March 2023 Offering closed on March 10, 2023.

As a result of the Representative exercising the over-allotment

option in full, the gross proceeds, before deducting underwriting discounts and commissions and other March 2023 Offering expenses, was

approximately $2.55 million.

The March Warrants

have, (i) an exercise price of $3.90 per share of common stock, (ii) a cashless exercise option for a net number of shares of common stock

determined according to the formula set forth in the March Warrant or (iii) an alternate cashless exercise option (beginning on or after

the initial exercise date), to receive an aggregate number of shares of common stock equal to the product of (x) the aggregate number

of shares of common stock that would be issuable upon a cash exercise and (y)1.00.

Each whole March Warrant entitles the holder thereof

to purchase 1 share of common stock.

The March Warrants are exercisable upon issuance and will expire on March 10, 2028.

price and the number of shares of common stock issuable upon exercise of the March Warrants is subject to appropriate adjustments in the

event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the

common stock.

The March 2023 Offering

was made pursuant to an effective shelf registration statement on Form S-3, which was filed with the Securities and Exchange Commission

(the “SEC”) on April 8, 2022 and subsequently declared effective on April 20, 2022 (File No.

333-264218), and the base prospectus

contained therein.

A prospectus supplement relating to the March 2023 Offering was filed with the SEC on March 9, 2023.

Under the terms of

the Underwriting Agreement, the Company also agreed to issue to the Representative unregistered warrants (the “March Representative’s

Warrants”) to purchase 32,750 shares of common stock, which warrants have an exercise price of $4.875 per share (125% of the public

offering price per Share and accompanying Warrant) and will terminate on March 8, 2028.

The shares of common stock underlying the March

Representative’s Warrants were subsequently registered under the June Resale Registration Statement, which was declared effective

on June 27, 2023.

Conversion of Convertible Debt and Preferred Stock

At the Special Meeting

of the Company’s stockholders held on May 8, 2023, the stockholders of the Company approved, among other things, (a) the full conversion

of the Series C Preferred Stock issued by the Company pursuant to the Share Exchange Agreement and the issuance of shares of common stock

in connection with such conversion (the “Series C Conversion Approval”), and (b) the full conversion of the Series D Preferred

Stock issued by the Company pursuant to the Securities Purchase Agreement and the issuance of shares of common stock in connection with

such conversion (the “Series D Conversion Approval”).

A result of the Series

C Conversion Approval, and in accordance with the terms of the Share Exchange Agreement, convertible debt for which IFP is the borrower

and the Company is a guarantor (the “Convertible Debt”), became eligible for conversion into shares of IFP that were then

to be immediately transferred to the Company in exchange for shares of Series C Preferred Stock.

As of May 8, 2023, all eight holders

of the Convertible Debt (the IFP Lenders) committed to, or otherwise indicated that they were committed to, the above-described conversion

and exchange of the Convertible Debt (the “Loan Conversion”), which, in the aggregate, had an outstanding balance of £1,360,761

in principal and accrued interest as of May 8, 2023.

On May 12, 2023, the

Company entered into Convertible Loan Conversion Agreements (the “Conversion Agreements”) with the eight IFP Lenders relating

to the Convertible Debt in order to effect the above-described conversion and exchange of the Convertible Debt.

Each of the Conversion

Agreements is dated and is effective as of May 9, 2023.

Upon the conversion

and exchange of the Convertible Debt in accordance with their respective terms and the terms of the Share Exchange Agreement and the Conversion

Agreements, the IFP Lenders received an aggregate of 1,149,273 shares of Series C Preferred Stock.

The conversion and exchange of the

Convertible Debt into Series C Preferred Stock is deemed to be effective as of May 9, 2023.

Effective as of May 10, 2023, the 1,149,273

shares of Series C Preferred Stock issued to the IFP Lenders pursuant to the Conversion Agreements were converted into an aggregate of

172,386 shares of common stock.

Effective as of May

10, 2023, all 3,512,277 shares of Series C Preferred Stock issued and outstanding on that date, including the 1,149,273 shares of Series

C Preferred Stock issued to the IFP Lenders, were converted into an aggregate of 526,818 shares of common stock.

Such conversion of the

Series C Preferred Stock into common stock was effected in accordance with the Series C Conversion Approval, the terms of the Share Exchange

Agreement and the Certificate of Designation of Preferences, Rights and Limitations of Series C Convertible Preferred Stock.

This conversion

of Series C Preferred Stock into common stock was deemed effective as of May 10, 2023.

As of May 10, 2023,

the holders of all 176,462 shares of the Company’s Series D Preferred Stock issued and outstanding on that date elected to convert

those shares of Series D Preferred Stock into shares of common stock, and the 176,462 shares of the Company’s Series D Preferred

Stock were then converted into an aggregate of 26,464 shares of common stock effective as of that date.

The conversion of the Series D

Preferred Stock was effected in accordance with the Series D Conversion Approval, the terms of the Securities Purchase Agreement and the

Certificate of Designation of Preferences, Rights and Limitations of Series D Convertible Preferred Stock.

Upon effectiveness

of the above-described conversion of Series C Preferred Stock and Series D Preferred Stock into common stock, the Company had approximately

2,285,849 shares of common stock issued and outstanding, subject to adjustment for rounding of fractional shares, if any.

Reverse Stock Split

At the annual meeting

of the Company’s stockholders held on February 8, 2023 (the “Annual Meeting”), the stockholders of the Company approved

an amendment (the “Amendment”) to the Company’s Amended and Restated Certificate of Incorporation (the “Certificate

of Incorporation”) to effect a reverse stock split at a ratio of not less than 1-for-2 and not more than 1-for-35 at any time within

12 months following the date of stockholder approval, with the exact ratio to be set within this range by the Company’s Board of

Directors (the “Board”) at its sole discretion without further approval or authorization of our stockholders.

such authority granted by the Company’s stockholders, the Board approved a 1-for-20 reverse stock split (the “Reverse Stock

Split”) of the Company’s common stock and the filing of the Amendment to effectuate the Reverse Stock Split.

On February 9, 2023,

the Company filed the Amendment in order to effect 1-for-20 reverse stock split of the Company’s common stock.

The Reverse Stock

Split was effective at 4:05 p.m., Eastern Time, on February 9, 2023, at which time every twenty shares of the Company’s issued and

outstanding common stock were automatically combined into one issued and outstanding share of common stock.

No fractional shares were

issued as a result of the Reverse Stock Split.

The par value of the

Company’s common stock and the number of authorized shares of the common stock were not affected by the Reverse Stock Split.

As a result of the

Reverse Stock Split, the number of shares of common stock outstanding was reduced from approximately 18,325,289 shares (excluding treasury

shares) as of February 8, 2023, to approximately 916,265 shares (excluding treasury shares, and subject to the rounding up of fractional

shares), and the number of authorized shares of common stock remained 100 million shares.

In order reflect the

Reverse Stock Split, proportionate adjustments were made to the number of shares of common stock issuable upon conversion of preferred

stock and the exercise of the warrants, as applicable;

as well as to any applicable conversion and exercise prices, which were also adjusted

in proportion to the reverse stock split ratio of the Reverse Stock Split (subject to adjustment for fractional interests).

Unless otherwise indicated,

all authorized, issued, and outstanding stock and per share amounts reflected herein have been adjusted to reflect the 1-for-20 Reverse

Fingerprinting Drug Screening System

wholly owned subsidiary, Intelligent Fingerprinting Limited (IFP), is the developer and owner of our proprietary and commercially available

portable drug screening system designed to detect common drugs of abuse through fingerprint sweat.

The Intelligent Fingerprinting Drug

Screening System consists of a small, tamper-evident drug screening cartridge that collects ten fingerprint sweat samples, which are

then analyzed in a portable handheld reader for precise on-screen results in minutes.

This system eliminates the need for invasive and

unpleasant urine, saliva, or blood collection to test for substance abuse.

The ten samples are collected in under a minute before the

portable analysis unit provides an on-screen result in under ten minutes.

The system is currently designed to detect opioids, cocaine,

methamphetamines, benzodiazepines, cannabis, methadone, and buprenorphine.

In addition, samples collected via confirmatory kits can be

sent to a third-party laboratory service provider for confirmation testing.

Fingerprinting Drug Screening System Functionality

Intelligent Fingerprinting Drug Screening System consists of single-use, tamper-evident Intelligent Fingerprinting Cartridges (for sample

collection) and the portable Intelligent Fingerprinting DSR-Plus portable analysis unit.

The process of collecting and analyzing samples

is as follows:

fingerprint sweat samples (one from each finger) are collected onto the Drug Screening Cartridge sample application pad (five seconds

sample collection, the tester slides the Cartridge’s tamper-evident protective cover across the pad, which locks into place

to protect against tampering or contamination.

Cartridge is then activated by depressing the buffer clip.

This releases buffer solution into the Cartridge, which contains antibodies

that have been configured to detect the presence of drugs (and/or their metabolites) within the collected fingerprint sweat sample.

The fingerprints are dissolved during this process and destroyed.

Cartridge is inserted into the DSR-Plus Reader.

tester follows the simple touch-screen instructions, and analysis begins.

10 minutes, the test results are displayed on the DSR-Plus touch-screen, providing a negative or non-negative indicator for each

drug group in the screening panel.

screening results can be printed using a separate portable label printer (available as an accessory) to provide a permanent record.

Anonymized details of the sample donor are entered into the DSR-Plus as part of the analysis procedure, and this information, along

with the time and date, is recorded on the results print-out, which is important where evidence continuity is required.

can also be downloaded to a computer for and be used for, among other things, and to the extent legally permissible, integration with

employee medical records or for general statistical analysis.

and Background of the Intelligent Fingerprinting Drug Screening System

in 2007, IFP is a spin-out company from the University of East Anglia (UEA) and is based in Cambridge, England.

IFP developed and commercialized

the patented Intelligent Fingerprinting DSR-Plus Reader and Cartridge system, which has been predominantly sold in the United Kingdom,

mainland Europe and the Middle East.

IFP continues to manufacture the cartridges for the Fingerprinting Drug Screening System in its

factory in Cambridge, England.

and Development

research and development (R&D) team collaborates with external specialist organizations across jurisdictions to conduct comprehensive

R&D initiatives.

These collaborative efforts are currently driven by the following primary objectives:

This involves integrating wireless connectivity, data collection capabilities, and important system architecture

improvements such as miniaturization, extended battery life, and a refined touch-screen interface for a seamless user experience.

testing capabilities:

The focus is on enabling the current cartridges to detect highly relevant substances in today’s pharmaceutical

landscape, such as fentanyl and oxycodone.

new tests in the medical point of care domain:

This initiative aims to explore potential new tests within the medical point of

care domain, resulting in a broader range of diagnostic tools for healthcare providers.

facilitate the expansion of point-of-care testing into additional areas of interest, such as tumor markers, hormones, and allergies,

the core team will collaborate with external research specialists.

This joint exploration aims to unlock the untapped potential applications

of our existing lateral flow assay technology on which the Intelligent Fingerprinting Platform has been developed and the organic thin

film transistor on which the Biosensor Platform has been developed.

By expanding the capabilities of these platforms, we will be better

equipped to address diverse diagnostic needs and contribute to improved patient outcomes.

R&D, manufacturing facilities and operations for drug screening products adhere to stringent quality criteria, complying with ISO

13485 for In Vitro Diagnostic Devices and Medical Devices, as well as ISO 9001.

We have quality and regulatory oversight of our sub-contracted

reference laboratories, where our methodology is accredited by the United Kingdom Accreditation Service (UKAS), ensuring that the laboratory

operates according to the ISO 17025 standard.

While we are already permitted to sell the Intelligent Fingerprinting Drug Screening System as a drug screening device in Australia,

we are in the process of obtaining accreditation from NATA (National Association of Testing Authorities, Australia).

have partnered with Racing Analytical Services Limited (RASL), one of Australia’s largest independent drug testing laboratories,

to provide confirmation tests for our drug screening solutions and assist in obtaining NATA accreditation.

States of America:

We are currently navigating our regulatory pathway in the United States as we seek approval to sell the Intelligent

Fingerprinting Drug Screening System in the United States.

We have completed a 513(g) submission and received a response from the United

States Food and Drug Administration (“FDA”) that allows us to pursue the submission of a 510(k) premarket notification.

Additionally,

we must identify potential laboratory partners for further certifications and studies that may be necessary.

We anticipate that obtaining

FDA approval will benefit entry into other regions of the world.

Distributors in other countries and jurisdictions will be responsible for obtaining all necessary approvals within their

respective territories.

Manufacturing

facilities required to produce the Intelligent Fingerprinting Drug Screening Cartridge and DSR-Pus Reader are in place at our manufacturing

facility in Cambridge, UK, which is used for fabrication and quality control.

The facility operates a Quality Management System that

complies with the requirements of ISO 13486 for the design, development, manufacture, distribution, servicing and supply of devices and

readers designed to screen for drugs of abuse using fingerprint diagnostic technology;

design, development, manufacture, distribution,

servicing and supply of devices for collection of fingerprint samples used to detect drugs of abuse;

and the design, development, manufacture,

distribution, servicing and supply of in vitro diagnostic kits for the detection of viral infection antigens in human saliva and anterior

nares samples.

The facility further operates a quality management system that complies with the requirements of ISO 9001 for the design,

development, manufacture, distribution, servicing and supply of devices and readers designed to screen for drugs of abuse using fingerprint

diagnostic technology and the design, development, manufacture, distribution, servicing, and supply of devices for collection of fingerprint

samples used to detect drugs of abuse.

currently serve over 350 small to medium-sized businesses, primarily located throughout the United Kingdom, with additional customers

coming from various global locations.

We intend to expand our customer base by strengthening our presence in existing markets and, subject

to receiving necessary regulatory approvals and clearances, venture into new regions.

We will tailor our strategy to the targeted region,

establishing direct sales and marketing teams or utilizing distribution networks.

In some cases, a combination of these strategies may

be appropriate.

Distributors:

Through the use of buy-sell agreements, distributors will purchase the IFP Products and resell them to customers.

These distributors

can be exclusive or non-exclusive, depending on our arrangements.

We focus on distributors with existing customer networks in the drug

screening segment and who have a proven track record in their respective territories.

We also plan to utilize exclusive distributors who

will be the sole providers within certain defined territories and will need to satisfy certain minimum quarterly purchase requirements.

Our direct sales team consists of four sales representatives, one sales leader and one National Sales Manager.

utilizes telemarketing leads to schedule on-site demonstrations.

The team manages customer relationships and oversees the sales cycle.

Customers are assigned to sales representatives based on geographic territories.

Our direct sales team consists of four sales representatives and the vice president of sales.

Their primary area of focus is the

east coast of Australia, which comprises approximately 72% of the country’s population.

The team utilizes their extensive network

of existing contacts and relationships to introduce the IFP product through in-person demonstrations.

We also intend to utilize distributor

partnerships to supplement our direct team and cover regions such as Western Australia, South Australia and more remote areas.

During our 510(k) premarket submission and subject to receiving appropriate approvals from the FDA, we plan to appoint a

dedicated distribution leader to spearhead market entry strategies by identifying and selecting distributors and partners.

will be identifying distributors and partners already operating within the U.S.

drug screening market.

We will appoint a dedicated European representative to identify, negotiate, and sign distributor agreements and maximize

sales in targeted territories.

into the Middle East and Africa (MEA):

A representative from our European operations will initially manage M.E.A operations.

on market opportunities and sales volume, we may appoint a dedicated distribution leader for M.E.A.

operations at a later stage.

Analysis and Opportunity

Drug Screening Market

drug screening market encompasses various sectors, including workplaces, drug testing labs, criminal justice, law enforcement, schools

and colleges, pain management centers, the military, medical examiners, individual users, and sporting organizations.

misuse is a global concern, and while the approach to this problem varies depending on the legal and regulatory landscape of each country,

what remains constant is the need for regular testing, particularly in areas and industries of concern.

Even in regions where certain

drugs, such as cannabis, have been decriminalized (such as in various states across the United States, Canada, and Europe), social and

workplace challenges persist relating to impairment, drug dependency and associated criminal activity, which in turn will increase the

need for testing.

market can be separated into four segments:

Drug testing to support companies with workplace policies to address drug misuse – and assess the potential impairment

effects of drug misuse on employees with safety-critical roles.

Rehabilitation:

Testing to support health service providers and charities involved in providing drug addiction treatment programs.

Institutional

Drug testing to support policies to address drug misuse in national institutions such as prisons, probation, and the

Testing in support of the police and their agencies to investigate drug-related crimes and activities

is an increasing demand to introduce more effective drug monitoring systems in the above segments.

We intend to aggressively market IFP

Products to different geographical regions outside the U.K., with a focus on the following industries and workplaces:

airports, transportation

& logistics, mining, construction, drug testing labs, criminal justice, law enforcement, education facilities, pain management centers,

drug rehabilitation centers, military, medical examiners, individual users and sporting organizations.

Recreational Drug Monitoring Industry

are four principal categories of recreational drugs - analgesics, depressants, stimulants, and hallucinogens.

Analgesics include narcotics

like heroin, morphine, fentanyl, and codeine.

Depressants include alcohol, barbiturates, tranquilizers, and nicotine.

Stimulants include

cocaine, methamphetamine, and ecstasy (MDMA).

to the World Drug Report 2022 published by the United Nations Office on Drugs & Crime, around 284 million people aged 15-64

years old used drugs worldwide in 2020, a 26% increase over the previous decade.

Cannabis remains the world’s most used drug,

with 209 million past-year users in 2020, a 23% increase on the previous decade.

Opioid use remains a major concern due to

potentially severe health consequences, with 61 million past-year users for non-medical reasons in 2020.

Additionally, according to

such report, there were 34 million past-year users of amphetamines and 21 million past-year users of cocaine or similar substances

Young people are using more drugs, with use levels today in many countries higher than with the previous

In Africa and Latin America, people under 35 represent the majority of people being treated for drug use disorders.

the United States and Canada, overdose deaths, predominantly driven by an epidemic of the non-medical use of fentanyl, continue to

break records.

to the White House’s 2022 National Drug Control Strategy, the 2020 National Survey on Drug Use and Health, published October 2021

by the Substance Abuse and Mental Health Services Administration, showed that among the 41.1 million people who needed treatment for

substance abuse, only 2.7 million (6.5%) received treatment at a specialty treatment facility in the past year.

of Care/Rapid Diagnostics Market

According to the MarketsandMarkets, Inc.’s

study, Point of Care/Rapid Diagnostics Market by Product, Platform, Purchase, Sample, User - Global Forecast to 2027, published in December

2022, the global market for Point of Care medical diagnostics was estimated to be $45.36bn in 2022, rising to $75.46bn in 2027 with a

compounded annual growth rate (CAGR) of 10.7% from 2022 to 2027.

The Company intends to develop pathways into areas of medical diagnostics

utilizing existing technology and techniques to exploit a competitive advantage against traditional testing methodologies.

following patents are owned by IFP.

Patent Families - technologies that are either used in the commercial products or closely related to the commercial products.

Numbers and Geographical Coverage

(via Europe) (DE 602015039916.1)

(via Europe) (EP(FR) 3172566)

(via Europe) (EP(GB) 3172566)

(via Europe) (EP(NL) 3172566)

(AU 2015293652)

(US 15/328799) (Pending)

lateral flow – broad concept – is directed to a lateral flow strip that are being used in the commercial product

family was filed in 2014 and is estimated to expire in 2034-2035.

(via Europe) (DE 602016018952.6)

(via Europe) (EP(FR) 3262413)

(via Europe) (EP(GB) 3262413)

(via Europe) (EP(NL) 3262413)

(AU 2016225217)

(CN ZL201680012388.4)

(US 11150243)

lateral flow cartridge family- is directed to the lateral flow-based fingerprint cartridge used in the commercial product

family was filed in 2015 and is estimated to expire in 2035-2036.

(AU 2018247080) (Pending)

(EP 18716321.7) (Pending)

(US 11227140)

confirmation cartridge family - is directed to the confirmation cartridge used in the commercial product

family was filed in 2017 and is estimated to expire in 2037-2038.

(AU 2021225394) (Pending)

(EP 21709774.0) (Pending)

(US 17/904887) (Pending)

lateral flow test strip reader family - is directed to the DSR-Plus reader used in the commercial product

family was filed in 2020 and is estimated to expire in 2040-2041.

/ Tertiary Patent Families

(AU 2014313919)

(US 10617397)

first cartridge family - is directed to a sample cartridge that is no longer being sold or used.

family was filed in 2013 and is estimated to expire in 2033-2034.

(via Europe) (EP(DE) 3065640)

(via Europe) (EP(FR) 3065640)

(via Europe) (EP(GB) 3065640)

(via Europe) (EP(NL) 3065640)

(AU 2014345356)

(US 10254277)

microfluidics family - is directed to a reagent cartridge component that is not used in the commercial product.

family was filed in 2006 and is estimated to expire in 2026-2027.

(via Europe) (DE 602015039053.9)

(via Europe) (EP(FR) 3171847)

(via Europe) (EP(GB) 3171847)

(via Europe) (EP(NL) 3171847)

(AU 2015293654)

(US 10675222)

medication dispenser family - is directed to a reagent cartridge that is not used in the commercial product.

family was filed in 2014 and is estimated to expire in 2034-2035.

(EP 17752467.5) (Pending)

project ridgeway family is directed to a waveguide device that is not used in the commercial product.

family was filed in 2016 and is estimated to expire in 2036-2037.

(EP 19707068.3) (Pending)

ecosystem family is directed to a method for chemical analysis that is not used in the commercial product

family was filed in 2019 and is estimated to expire in 2039.

(EP 19707069.1) (Pending)

project ridgeway with calibration family is directed to an improved waveguide device that is not used in the commercial product

family was filed in 2018 and is estimated to expire in 2038-2039.

project matchbox family is directed to a method for quantifying a skinprint that is not used in the commercial product.

family was filed in 2018 and is estimated to expire in 2038.

patents listed above cover virtually all aspects of fingerprint diagnostics including:

chemistry, screening cartridge technology, collection

cartridge technology, fingerprint quantitation, fingerprint controlled medication dispenser, lab testing of fingerprints, accessories,

and lateral flow test strip reader.

has developed a Point of Care (POC) drug screening test system and a drug laboratory-based confirmation testing service.

Both of these

involve the collection of fingerprint sweat samples for analysis.

For many years, competitor POC and confirmation tests have needed to

rely on collecting either urine or oral fluid (saliva) body fluid samples.

There are several competitive advantages of analyzing fingerprint

sweat over urine and oral fluid drug testing:

sample collection :

Fingerprint sweat can be collected within seconds from any location without needing trained specialists, gender-specific

collectors or prepared collection areas.

The sweat from the fingerprints is collected simply by pressing each finger onto a disposable

sample collection cartridge for five seconds.

In contrast, the collection of urine and oral fluid samples can take several hours

and requires trained collectors.

Collection areas must be specially prepared, and sample collection should be observed directly to

avoid cheating tests.

This is highly invasive and undignified, particularly in the case of urine.

and non-biohazardous :

Fingerprint sweat samples are non-biohazardous, so the screening and collection kit material can be disposed

of in routine waste or recycled.

Kits used to collect urine and saliva are a potential biohazard and must be treated as such –

either incinerated or into landfill.

The results of conventional urine and oral fluid POC drug screening tests require reading the test results by interpreting

the presence or absence of colored test lines using the naked eye.

Often these test lines are weak and difficult to see, leading

to inaccuracy in reading the test result.

In contrast, the results of the IFP screening test are provided automatically by the DSR-Plus

reader unit, providing an unambiguous test result that does not require any user interpretation, increasing the accuracy of the test.

combination of these benefits shows that fingerprint drug testing provides a more cost-effective, less invasive and more dignified method

when compared to urine and oral fluid-based tests.

The recyclability of IFP Product test kits is of specific benefit to organizations

with environmental policies to reduce single-use plastics.

below table compares the IFP System to other drug testing systems:

IFP System eliminates the need for highly trained technicians or personal protective equipment, providing a non-invasive and objective

testing experience.

Its unique 16-hour detection window makes it ideal for assessing an individual’s fitness for work at the time

Based on research commissioned by the Company, the system has the ability to achieve sensitivity and accuracy levels as demonstrated

by the performance characteristics in the table below.

believe that the lateral flow assay technology used in IFP Products has the potential to also deliver significant benefits in other areas

of medical diagnostics.

For example, the potential exists use the technology to detect biomarkers of health and disease and provide non-invasive

monitoring of therapeutic drug levels via fingerprint analysis.

IFP is also researching a pipeline of development projects with the vision

that fingerprint-based diagnostic tests could provide rapid health/disease triage and wellness tests, meeting the requirements of a post-covid

medical diagnostics world.

The Company seeks to broaden development pathways into other areas of medical diagnostics utilizing existing

technology and techniques to exploit a competitive advantage against traditional testing methodologies.

Some examples of potential target

fentanyl and other opiate pain medications, epilepsy management medications, anti-psychotic medications, cortisol (stress

marker for wellbeing determination), protein targets, diabetes markers (c-peptide, fructosamine, insulin and proinsulin), infectious

diseases (methicillin-resistant staphylococcus aureus (mrsa), Lyme disease, dengue, measles and German measles) and food contamination

/ infection from animals (brucella, salmonella, proteus).

Platform Technology

“ 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.

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

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.

The Biosensor Platform is designed to detect multiple biological analytes by substituting the GOX enzyme

with a suitable alternative for each analyte.

The substitute enzyme will generate an electrical current signal that is detected in a

manner similar to the SGB.

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

development of other tests for biomarkers other than glucose is low.

Development efforts for biomarkers other than glucose, including

the development of the Prostate Specific Antigen test, the Peanut Kernel Allergen test and the Luteinizing Hormone test are currently

in the early stages of development.

and Background of the Biosensor Platform

Biosensor was invented at the Priority Research Centre for Organic Electronics at The University of Newcastle, Australia.

for Organic Electronics is the first of its kind in Australia.

It is an exciting new initiative focusing on the development of new electronic

devices at the intersection between semiconductors and plastics.

The Centre focuses on the scientific challenges in the development of

organic electronics, with massive potential for the next generation of environmentally friendly energy sources, photonics and biosensors.

Saliva Glucose Test (SGT)

SGT consists of:

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.

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 through a dedicated reader and a software application installed on a smart device.

would then be stored in a proprietary cloud-based digital information system.

SGT consists of (i) the SGB, which is a single use disposable saliva biosensor, (ii) a dedicated reader that will display the result

once the biosensor has been inserted, and (iii) a software application for smart devices that interfaces with the dedicated reader.

Saliva Glucose Biosensor (SGB)

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;

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

Patents for the SGB technology have

been granted in the United States (9,766,199) and China (104412101).

The core innovative characteristic of the SGB is the sensitivity

of the glucose biosensor that is designed 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.

In addition to the patent disclosures,

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

The Licensor (LSBD) owns

patents in 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

electrode by a thin insulating layer.

The COE has pioneered the fabrication of these novel biosensors based on integrating biomolecules,

such as enzymes, directly into the architecture of organic transistors;

producing electronic devices with both high sensitivity and high

specificity for the target analyte.

In these biosensors, a molecular recognition element can simply be integrated directly into the device

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

and the method

for determining the concentration of a compound in a sample by interpreting the amperometric signals generated by the device.

and the United States patent belong to the same patent family.

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

by a thin insulating layer.

The Centre for Organic Electronics has pioneered the fabrication of these novel biosensors based on integrating

biomolecules, such as enzymes, directly into the architecture of organic transistors;

producing electronic devices with both high sensitivity

and high specificity for the target analyte.

In these biosensors, a molecular recognition element can simply be integrated directly into

the device 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,

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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.

This measurement is then converted into a real-time saliva glucose reading through a dedicated reader and software

application that can be installed on a smart device.

The data has the potential to be transferable to a digital information system, which

can potentially provide the patient with personalized healthcare advice enabling a practical understanding of lifestyle factors that

may affect their glucose levels.

The SGB, along with the above-described software and analysis capabilities, are still currently in the

planning phase.

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

The COE has pioneered

the fabrication of novel biosensors based on integrating biomolecules, such as enzymes, directly into the architecture of organic transistors,

producing electronic devices with both high sensitivity and high specificity for the target analyte and in this case, glucose.

development of an intermediate device that communicates to the smart device has been completed.

The intermediate device emulates a glucometer,

providing the mechanical and electrical interfaces to receive and power the SGB as well as the required circuitry for accurately reading

the amperometric signals.

We intend to transfer the responsibilities of the intermediate device to the SGB.

A possible route to achieve

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.

We believe that NFC tags suitable for integration

with the SGB can be purchased for approximately $0.10 per tag, even at low volumes.

The cost of electronic components is well known to

significantly reduce as volume increases.

Due to the large, expected volumes of the SGB, we believe it is reasonable to assume that the

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

The Centre for Organic

Electronics has pioneered the fabrication of novel biosensors based on integrating biomolecules, such as enzymes, directly into the architecture

of organic transistors, producing electronic devices with both high sensitivity and high specificity for the target analyte and in this

case, glucose.

development of a dedicated reader that communicates to the smart device is in prototype phase and needs to be validated after clinical

trials of the SGB.

The dedicated reader emulates a glucometer, providing the mechanical and electrical interfaces to receive and power

the SGB as well as the required circuitry for accurately reading the amperometric signals.

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.

published in independent journals such as the International Journal of Environmental Research and Public Health 1 , the Journal

of Oral and Maxillofacial Pathology 2 , and the Journal of Diabetes and Metabolism 3 , among others.

few articles have reported finding little or no significant correlation, such as articles in Heliyon 4 and the Journal of

the Royal Society of Medicine 5 .

Consequently, The Company is performing clinical research to collect and provide the data

necessary to support that saliva can be utilized as a non-invasive alternative to blood to monitor glycemic status in diabetes patients.

and Background of the Saliva Glucose Biosensor

SGB leverages the decades of history of all-polymer printed OTFTs.

Through the research conducted at COE, this OTFT technology has been

transformed into a medical device and expected to conform to the highest medical device standards globally.

The SGB is based on a modified

OTFT architecture incorporating GOX as the recognition element.

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 diabetes diagnosis and monitoring.

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

Since their invention in 1947, transistors

have dominated the mainstream microelectronics industry.

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

a third electrode known as the gate.

The gate electrode is separated from the source-drain region by a thin (~100 nm) insulating dielectric

region and thus is coupled to the semiconductor.

By altering the bias voltage applied to the gate region, the source-drain region can

be altered from conducting to insulating and thus the device can be turned on or off.

Importantly, the presence of a relatively small

number of charges on the gate electrode alters the flow of a great many charges between the source and drain electrodes.

the FET acts as a switch as well as an amplifier.

SGB integrates another scientific discovery known as organic electronic polymers.

This work, which was conducted in the 1970s, focused

on the development of doped polyacetylene.

Historically conductive polymers can also be traced back to the early 1960s.

Conductive polymers

have several advantages over other organic conductors with regard to their processability and hence their use is becoming increasingly

The polymers that show the most promise in this area are based on the polythiophene structure.

The flexible nature of these

polymers allows them to be processed into almost any desired shape or form, making them attractive for the low-cost production of flexible

electronic circuits, such as FETs.

first demonstrated combination of FETs and organic electronic polymers was in the solid-state OTFT developed in 1986 using polythiophene

(an organic electronic polymer) as the semi-conducting layer, with a similar device being reported in 1988.

The performance of OTFTs

in comparison with conventional silicon-based transistors has been considered encouraging and they have already been used in applications

in logic circuits or as the driving elements in active matrix displays.

Biosensor fabrication based on organic electronics is also well-established,

primarily driven by the appealing features offered by these materials such as flexible and adjustable chemical properties, and room temperature

of the most attractive features of organic electronics is the potential for flexible low-cost fabrication.

A common feature of early

OTFTs was the use of silicon as the substrate material, and thus since these hybrid devices are not truly all-polymer-based they do not

offer all the advantages with respect to fabrication.

In the world of sensors, the vast majority of previous scientific research and

subsequent technological implementation of organic sensors has involved electrochemically grown films exhibiting performance levels that

are, in most cases, inadequate for real applications.

Solution-processed polymers, on the other hand, offer the greatest potential for

the fabrication of low-cost electronics since they can be easily processed as liquids, unlike the organic crystals and short chain oligomers

which are typically vapor deposited.

Combining these unique material properties with low-cost techniques, such as ink-jet or reel-to-reel

printing, offers the ability to rapidly produce disposable printed electronic circuits.

SGB is based on a modified OTFT architecture incorporating GOX as the recognition element.

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 diabetes diagnosis and monitoring.

their invention in 1947, transistors have dominated the mainstream microelectronics industry.

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 a third electrode known as the gate.

The gate electrode is separated from the source-drain region by a thin (~100

nm) insulating dielectric region and thus is coupled to the semiconductor.

By altering the bias voltage applied to the gate region, the

source-drain region can be altered from conducting to insulating and therefore;

the device can be turned on or off.

Importantly, the

presence of a relatively small number of charges on the gate electrode alters the flow of a great many charges between the source and

drain electrodes.

Accordingly, the FET acts as a switch as well as an amplifier.

SGB integrates another scientific discovery known as organic conductive polymers.

Organic conductive polymers have several advantages

over other conductors with regard to their cost and processability.

The polymers that show the most promise in this area are based on

the polythiophene structure.

The flexible nature of these polymers allows them to be processed into almost any desired shape or form,

making them attractive for the low-cost production of flexible electronic circuits, such as FETs.

first all-polymer printed OTFT was reported in 1994.

OTFTs are an exciting class of devices within the organic electronics field.

prospect of low cost organic electronic modules incorporating OTFTs fabricated at low temperatures using low energy techniques is very

Low temperature solution-based processes, such as ink-jet printing, allow for compatibility with flexible substrates, upon

which it would be impossible to fabricate conventional electronics.

In addition, conducting polymers can be synthesized in a laboratory

without using rare or expensive materials.

OTFTs can be fabricated at low temperatures using low-energy techniques.

Low-temperature

solution-based processes, such as ink-jet printing, allow for compatibility with flexible substrates, upon which it would be impossible

to fabricate conventional electronics.

In addition, conducting polymers can be synthesized in a laboratory without using rare or expensive

Y., Zhang, H., Zhu, J., Liao, Z., Wang, S., Liu, W.

(2022)’Correlations of salivary and blood glucose levels among six saliva collection

methods’, International Journal of Environmental Research and Public Health , 19(7), p.

Gupta, S., Nayak, M., Sunitha, JD., Dawar, G., Sinha, N., Rallan, N.S.

(2017) ‘Correlation of salivary glucose level with

blood glucose level in diabetes mellitus’, Journal of Oral and Maxillofacial Pathology , 21(3), p.

M.M., Ahmed Ibrahim, A.S., Gamal, A.M.

(2018) ‘Salivary glucose monitoring versus interstitial glucose monitoring in patients

with type 1 diabetes mellitus’, Journal of Diabetes & Metabolism , 09(08).

Ephraim, R., Anto, E.O., Acheampong, E., Fondjo, L.A., Barnie, R.B., Sakyi S.A., Asare, A.

(2019) ‘Fasting salivary glucose

levels is not a better measure for identifying diabetes mellitus than serum or capillary blood glucose levels:

Comparison in a Ghanaian

population’, Heliyon , 5(3).

5 Forbat, L.N., Collins, R.E., Maskell,

G.K., Sönksen, P.H.

(1981) ‘Glucose concentrations in parotid fluid and venous blood of patients attending a diabetic clinic1’,

Journal of the Royal Society of Medicine , 74(10), pp.

Tests Based on the Biosensor Platform

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 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.

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

the GOX element designed to detect glucose in the case of the SGB can, we believe, potentially be substituted for a different enzyme,

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 relatively low.

Testing, Current State of Development and Next Steps

Analytical Performance Testing

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

24, 2020), for use during the COVID-19 outbreak pursuant to section 564 of the Act and subject to the terms of any authorization issued

under that section.

criteria for issuance of EUA are the following:

or life-threatening disease

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.

FDA intends to assess the potential effectiveness of a possible EUA product on a case-by-case

basis using a risk-benefit analysis, If, based on the totality of the scientific evidence available, it is reasonable to believe

that the product may be effective for the specified use, FDA may authorize its emergency use, provided that other statutory criteria

for issuing an EUA also are met.

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

The SGB is currently in the advanced stages of development.

2022, the Company concluded the in-clinic portion of a clinical study collecting coincident samples of oral fluids and blood to evaluate

the time-course of glucose in those samples.

The study consisted of 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.

January 2023, the Company’s research partner, the Centre for Organic Electronics at the University of Newcastle, which focuses

on the development of new electronic devices, completed a key milestone, Milestone 7, a phase of the Company’s biosensor platform

development at the University of Newcastle, Australia that included testing time-to-result (TTR), sensitivity, and reproducibility.

inks and device architectures have been developed and show improved performance.

These new inks will significantly reduce manufacturing

time when printing on the biosensor.

biosensor time to result (TTR) has been reduced from 120 seconds to 30 seconds showing a significant improvement.

biosensor limit of detection (LOD) has been reduced from 0.05mM to 0.02 mM.

These results met and/or exceeded the target for this

milestone (0.02 - 0.03 mM).

relation to the error grid target, significant improvements are only expected following the implementation of the new printing and quality

control equipment currently being procured.

June 2023, the Company concluded its study on the Correlation of Glucose and Cortisol between Oral Fluid and Blood Compartments.

study aimed to determine the degree of correlation between saliva and blood glucose and cortisol levels in subjects with and without

Additionally, the research aimed to evaluate whether salivary glucose can potentially be used as a tool to discriminate between

populations with and without diabetes.

One hundred adult subjects were recruited and consented for the study, including 40 with Type

2 diabetes (“T2D”).

Saliva specimens were collected following two rinses with bottled water, while whole blood specimens

were collected through venipuncture and fingerstick methods.

The glucose and cortisol levels in saliva were measured using isotope liquid

chromatography/mass spectrometry (LC-MS) by Johns Hopkins Hospital and Quest.

correlations were analyzed among 6 parameters, with 6 correlations determined to be statistically significant, particularly for glucose

and cortisol levels between saliva and blood.

The correlation between salivary glucose and hemoglobin A1c was also statistically significant.

Specifically, the correlation analysis between salivary cortisol and free cortisol shows a Pearson correlation coefficient of 0.75, and

between salivary glucose and blood glucose a Pearson correlation coefficient of 0.48.

The mean salivary cortisol is approximately 30%

of that of free cortisol in blood.

Furthermore, the data showed a statistically significant difference in the median salivary glucose

for the T2D cohort relative to the control group:

2.92 versus 1.38 mg/dL.

Receiver operating characteristic (ROC) curve analysis yielded

an area-under-curve of 0.71 for the use of salivary glucose as a tool to screen for T2D.

results of the study indicate that saliva sampling and analysis has potential use in various applications, including as an aid in screening

for diabetes in unhygienic environments where blood sampling is risky, and in point-of-care or at-home cortisol tests where characterizing

early morning levels and daily variation is important.

The Company intends to compile a white paper summarizing the findings as it determines

the next phase of development.

Commercialization

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.

The Saliva Glucose Biosensor

has been designed and developed to meet the ISO 15197:2013 standard and we intend to seek regulatory approval under the specifications

Company intends to introduce and launch the SGB within its licensed regions by assigning a sublicense and/or distributor agreements.

The SGB has been designed and developed to meet the ISO 15197:2013 standard, and we intend to seek regulatory approval under the specifications

of this standard.

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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.

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,

that at least 95 % of results for a given system must 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.

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The results of the

116 prototype biosensors that were assessed for precision and accuracy by implementing the ISO standard.

In conclusion, from the 116

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).

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

116 prototype biosensors were assessed for precision and accuracy by implementing the ISO standard.

In conclusion, from the 116 devices

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

95 % of the measured

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

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

manual printing process of the biosensors rather than a biosensor technology deficiency.

Currently the biosensor is in the process of

transferring to a quality-controlled pilot production phase , standardizing the automated processes, and characterization procedures

which will eliminate such manufacturing deviations in the released biosensor product format.

Regardless, 110 prototype sensors in this

test performed at a level to allow compliance with the ISO standard.

It is important to note that the ISO standard references blood glucose

monitors rather than salivary glucose monitors so a direct application of the standard here is not entirely practical.

Currently, the biosensor is transferring to

a quality-controlled pilot production phase, standardizing the automated processes and characterization procedures to eliminate such

manufacturing deviations in the released biosensor product format.

Regardless, 110 prototype sensors in this test performed at a level

to allow compliance with the ISO standard.

It is important to note that the ISO standard references blood glucose monitors rather than

salivary glucose monitors, so a direct application of the standard here is not entirely practical.

Manufacturing

facilities required for the fabrication of these OTFT devices are all in place at the Australian National Fabrication Facility, which

we have used for fabrication and testing.

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

facilities required for the fabrication of the OTFT devices are in place at the Australian National Fabrication Facility, which we have

used for fabrication and testing.

We anticipate that these facilities, which we have used extensively, will continue to 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.

to enter into arrangements with distributors to market and sell the SGB.

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.

recently 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.

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

scope of commercial partners.

received approval for $4.7 million in Medical Products Priority Grant funding from the Australian Government in June 2021 as contributions

towards establishing a high-tech manufacturing facility in Australia.

Amounts under this grant are paid to the Company upon the Company

achieving certain deliverables and are subject to certain other conditions.

As of the end of June 2023, the Company has received $3.25

million of this grant.

The Company has requested an extension (from March 2024 to March 2025) to deliver certain of the deliverables

the completion of development and receipt of all required regulatory approvals, we intend to market and distribute the SGT in the APAC

We propose to enter into arrangements with distributors to market and sell the SGB.

We plan to enter into an agreement with a

medical affairs commercialization company to drive pre-launch activity with the scope to create awareness and build a reputation with

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

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.

5 unchanged sentences

distributors and training them in our technology and product offering.

We plan to adopt a multiple channel strategy to balance the marketing

We plan to adopt a multi-channel strategy to balance the marketing

and sales efforts.

Glucose Monitoring Industry

Self-Monitoring of Blood Glucose

Self-Monitoring

of blood glucose is the main approach for glucose monitoring and has been used for over 40 years.

Currently, self-monitoring of blood

glucose is conducted periodically by the patient using a blood glucose measuring device.

Blood glucometers require pricking a finger

with a lancet and applying a drop of blood on the test strip.

The test strip is then inserted into the device which provides a reading

of glucose level in blood.

Test strips are supplied by the glucometer manufacturer and are generally device-specific, although generic

test strips are also available.

There are more than 100 types of blood glucometers currently are commercially available and they differentiate

based on size and weight, cost, data storage capacity, test accuracy, blood sample size and screen visibility (users with poor eyesight

may prefer larger screens).

Glucose Monitoring

glucose monitoring is not an alternative to finger prick self-monitoring of blood glucose.

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.

The procedure is invasive

and involves the insertion of a glucose biosensor into the subcutaneous tissue layer or the hypodermis.

The biosensor, which measures

glucose levels in interstitial fluid, is attached to a transmitter that sends signals to either an insulin pump or a portable meter.

These devices are generally worn for about one week and require regular calibration through conventional blood glucose detection, about

While the accuracy of these devices has been an issue, it has improved in recent years.

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.

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

are changing rapidly.

Subcutaneous glucose levels have a time lag compared to blood glucose measurements, and measurements may not always

match blood glucose.

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.

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

part of a closed-loop.

CSII is generally restricted to Type 1 diabetics, where the need for ongoing insulin infusion is highest.

glucose monitoring is mainly used in a limited proportion of diabetics, particularly those concerned about severe, nocturnal hypoglycemia,

pregnant women who require meticulous glucose control or those who may not be able to easily administer a self-monitoring test (e.g.,

those living in remote or hostile environments).

However, continuous glucose monitoring is more expensive than traditional self-monitoring

of blood glucose and in many cases is not eligible for reimbursement.

of Glucose Monitoring

of the main aims of diabetes monitoring and management is to maintain blood glucose levels within a specified target range.

Self-monitoring

of blood glucose should be part of a regular management plan for patients with diabetes to enable this.

Self-monitoring provides information

regarding an individual’s dynamic blood glucose profile.

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

and medication.

It is also required for understanding of the timing of blood glucose variations.

Lack of regular self-monitoring predicts

hospitalization for diabetes-related complications.

Self-monitoring of blood glucose is an essential tool for people with diabetes who

are taking insulin or for those who experience fluctuations in their blood glucose levels, especially hypoglycemia.

For patients taking

insulin and adjusting their dose, self-monitoring is needed for self-management.

For others receiving oral medication, profiling glucose

trends and the confirmation of high or low blood glucose can be a useful addendum to successful management.

Self-monitoring

of blood glucose aids the management of diabetes by:

the development of an individualized blood glucose profile, which can then guide health care professionals in treatment planning

for an individualized diabetic regimen;

people with diabetes and their families the ability to make appropriate day-to-day treatment choices in diet and physical activity

as well as administration of insulin or other agents;

patients’ recognition of hypoglycemia or severe hyperglycemia;

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

role of blood glucose control in preventing the development and progression of complications has been proven in both type 1 and type

2 diabetes, with an especially strong relationship between intensive blood glucose control and complications such as neuropathy (affecting

limbs) and diabetic retinopathy (leading to blindness).

time, glucose measurements are expected to provide the patient and their health care professionals with the information and insights

required to determine the best management strategy for diabetes, potentially minimizing the fluctuations in their glucose levels and

resulting in better health outcomes.

role of blood glucose monitoring and control in preventing the development and progression of diabetes complications has been well established.

Studies show that those who properly monitored blood glucose levels had better health outcomes (such as reduced complications of diabetes)

compared to those who did not.

a person with diabetes, however, this daily process is not only painful but can be exhausting, disruptive, frustrating, frightening and

consuming, which often leads to poor compliance and poor health outcomes.

People with diabetes have reported that stigma is a significant

concern to them.

This causes tension and anxiety and, because the procedure is perceived as inconvenient and difficult, leads to suboptimal

monitoring and poor adherence.

Many people with diabetes do not test as often as clinically recommended, increasing the risk of complications.

License Agreements

are party to following technology license agreements.

Amended and Restated License Agreement dated September 12, 2019, which amends and restates all previous license agreements (the “SGT

License Agreement”) is limited to the APAC Region.

technology license agreement dated June 23, 2020 (the “COV2 License Agreement”), for COV2 diagnostic test globally.

addition to above, we have 50% equity interest in BiosensX (North America) Inc., which has a separate technology license agreement with

the Licensor covering glucose/diabetes management field in the North America Territory.

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”).

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;

(ii) a proprietary smartphone application for the purpose reading,

storing, analyzing and providing patient support programs for any one or more of the Indicators for the purpose of measuring the amount

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

(iii) a dedicated sensor strip reading device for any one or more of the Indicators for the purpose of measuring the amount or concentration

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

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:

September 12, 2019, we entered into an Amended and Restated Technology License Agreement, or the “SGT License Agreement,”

with the Life Science Biosensor Diagnostic Pty Ltd, amending and restating all the previous SGT license agreements with LSBD.

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

The “Licensed

Products” are products consisting of a biosensor strip and smart device application or dedicated reader device that use the biosensor

technology owned by the Licensor relating to measuring, or otherwise determining, the amount or concentration of glucose, and the existence

of biological markers of cancer, allergy/immunology and hormones, in a bodily fluid.

The Licensed Products only include products that

are supplied by an “Authorized Supplier,” meaning, by 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.

We do not currently intend to manufacture the Licensed Products

to the SGT 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, solely in the APAC Region and solely to:

as the authorized party for the purpose of prosecuting the application of, and obtaining any, regulatory approval for the Licensed

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data acquired from the Licensed Products

are required to collect and anonymize demographic information about the end users of the Licensed Products and data acquired from the

Licensed Products.

While the anonymized data will be owned by the Licensor, we will own during the term of the License Agreement the

personally identifiable data, including health data, collected by us.

In addition, the Licensor will provide us with certain of the data

acquired from the Licensed Products.

The demographic information and personally identifiable information will be used, following patient

consent, as a disease management tool to offer patients value-added services, i.e., personalized education services for lifestyle, diet

and glucose management.

These services will be in accordance with the applicable local medical codes and regulatory environment.

use of such consensual information will be in accordance with privacy laws of the relevant countries and territories.

license is non-transferable, non-assignable and non-sublicensable, except that the Licensor will in good faith consider any request by

us for any sublicense.

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.

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

The projected net sales will be an

amount mutually agreed between us and the Licensor for the first such year.

For each ensuing year after the first year, the projected

net sales will be the number of Licensed Products sold in such jurisdiction in the prior year, as adjusted for the mutually agreed expected

market growth.

In addition to the expected market growth, there will be an additional growth rate percentage of 7% for each year through

the tenth year.

In the event of a dispute between us and the Licensor regarding the determination of the expected market growth or the

additional growth percentage, the License Agreement provides for resolution by an independent third party.

At the end of each quarter,

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

Royalty and the Actual Royalty.

The royalty fee rate will be reduced from 13% to 3% upon the expiration of the patent portfolio covered

by the License Agreement.

We may not exploit or seek to exploit any rights in respect of the Licensed Product outside of the APAC Region

through any means, including digitally or online where the end user is not physically resident in the APAC Region.

We must do all things

necessary in turn to ensure that any distributors of Licensed Products in the APAC Region do not exploit or seek to exploit any rights

in respect of the Licensed Product outside of the distributor’s territorial boundary.

The SGT License Agreement requires,

among other material provisions, that commencing after the receipt of regulatory approval in a jurisdiction, we will pay the Licensor

a minimum royalty with respect to such jurisdiction for each year, in four equal quarterly instalments.

The minimum royalty will be 13%

of the projected net sales in such jurisdiction for each such year.

The projected net sales will be an amount mutually agreed between

us and the Licensor for the first such year.

For each ensuing year after the first year, the projected net sales will be the number of

certain licensed products sold in the prior year, as adjusted for the expected market growth and, for each year through the tenth year,

as increased by up to an additional 7%.

At the end of each quarter, if the quarterly instalment of the minimum royalty is less than the

actual royalty (13% of the actual net sales of the licensed products for such quarter) in such jurisdiction, we will pay Licensor the

difference between the quarterly instalment of the minimum royalty and the actual royalty.

The royalty fee rate will be reduced from 13%

to 3% upon the expiration of the patent portfolio covered by the SGT License Agreement.

There is no set expiration date for the SGT License Agreement.

the exclusivity of the license granted under the SGT License Agreement runs until the expiration of the patent portfolio covered by the

SGT License Agreement, which is currently until 2033.

We expect that the patent portfolio will be extended as new patents are created

throughout product development, thereby extending the exclusivity of the SGT License Agreement.

For instance, we expect to seek additional

patents in connection with the development of the Prostate Specific Antigen test, the Peanut Kernel Allergen test and the Luteinizing

Hormone test.

The SGT License Agreement may be terminated by us in the event of a material breach by the Licensor, if the Licensor does

not cure the breach within 30 days after receiving notice of the breach;

or in the event the Licensor discontinues its business operations

or in the case of certain events related to insolvency or bankruptcy.

The SGT License Agreement also may be terminated by us after July

3, 2029 upon 180 days’ prior written notice.

The SGT License Agreement may not be terminated by the Licensor unless we permanently

discontinue our business operations in relation to the Licensed Products, or if we dissolve or cease to exist.

the expiration of the exclusivity period under the SGT License Agreement, we may continue to market and sell the Licensed Products.

believe the non-invasive nature of our product will establish us as a significant participant in the glucose testing market in the APAC

Region and, therefore, by the time the patents expire, and by the time the exclusivity period under the SGT License Agreement expires,

we expect to hold a meaningful share in the market, and brand awareness that will ensure we continue to operate successfully.

can be given that there will not be significant direct competition for our products in the APAC Region following the expiration of patent

License Agreement

June 23, 2020, we entered into a COV2 License Agreement with LSBD.

The COV2 License Agreement sets forth our contractual rights and

responsibilities relating to the COV2 Products.

The “COV2 Products” include:

(i) a biosensor strip for antibodies against

(ii) a proprietary smartphone application for the purpose reading, storing, analyzing and providing patient support programs

for any one or more of the indicators for the purpose of measuring the amount or concentration of immunoglobulins (IgG, IgM, IgA) specific

to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2);

and/or (iii) a dedicated sensor strip reading device for any one or

more of the indicators for the purpose of measuring the amount or concentration of immunoglobulins (IgG, IgM, IgA) specific to severe

acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

The COV2 Products only include products that are supplied by an “Authorized

Supplier,” meaning, by 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 COV2 Products to us.

to the COV2 License Agreement, the Licensor granted to us an exclusive license to the Licensor’s proprietary rights to the biosensor

technology used in the COV2 Products, worldwide and solely to:

as the authorized party for the purpose of prosecuting the application of, and obtaining any, regulatory approval for the COV2 Products,

including being authorized to prosecute the approval for an investigational device required for the purpose of carrying out clinical

promote, market, import, offer, sell and distribute the COV2 Products;

reasonable customer support services on the use of the COV2 Products to end users of, and health care practitioners referring end

users to, the COV2 Products;

the COV2 Products only for the purposes identified and permitted pursuant to regulatory approval;

data acquired from the COV2 Products.

license is non-transferable, non-assignable and non-sublicensable, except that the Licensor will in good faith consider any request by

us for any sublicense.

the COV2 License Agreement, commencing 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 “COV2 Minimum Royalty,”

in four equal quarterly installments.

The COV2 Minimum Royalty will be 13% of the projected net sales in such jurisdiction for each such

The projected net sales will be an amount mutually agreed between us and the Licensor for the first such year.

For each ensuing

year after the first year, the projected net sales will be the number of COV2 Products sold in such jurisdiction in the prior year, as

adjusted for the mutually agreed expected market growth.

In addition to the expected market growth, there will be an additional growth

rate percentage of 7% for each year through the tenth year.

In the event of a dispute between us and the Licensor regarding the determination

of the expected market growth or the additional growth percentage, the COV2 License Agreement provides for resolution by an independent

At the end of each quarter, if the quarterly installment of the COV2 Minimum Royalty is less than 13% of the actual net

sales of COV2 Products in such jurisdiction for such quarter, or the “COV2 Actual Royalty,” we will pay Licensor the difference

between the quarterly installment of the COV2 Minimum Royalty and the COV2 Actual Royalty.

The royalty fee rate will be reduced from

13% to 3% upon the expiration of the patent portfolio covered by the COV2 License Agreement.

a result of the significant global progress made in mitigating the severity of the COVID-19 pandemic and the significantly diminished

demand for COVID-19 testing products, we have redirected our resources and efforts away from developing products related to COVID testing

to instead acquire and develop drug testing and screening systems, notwithstanding the license held by us under the COV2 License Agreement.

between us and the Licensor, the Licensor solely owns all right, title and interest to, among other items of intellectual property, the

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any of the foregoing intellectual property and proprietary rights.

is no set expiration date for the License Agreement.

However, the exclusivity of the license granted under the License Agreement runs

until the expiration of the patent portfolio covered by the License Agreement, which is currently until 2033.

We expect that the patent

portfolio will be extended as new patents are created throughout product development, thereby extending the exclusivity of the License

For instance, we expect to seek additional patents in connection with the development of the Prostate Specific Antigen test,

the Peanut Kernel Allergen test and the Luteinizing Hormone test.

The License Agreement may be terminated by us in the event of a material

breach by the Licensor, if the Licensor does not cure the breach within 30 days after receiving notice of the breach;

or in the event

the Licensor discontinues its business operations or in the case of certain events related to insolvency or bankruptcy.

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.

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

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.

The Licensor has secured and continues to

pursue intellectual property rights related to this technology in China, the United States and other countries.

The original patent application,

which claims a priority date of March 2012, has been granted in the United States (9,766,199) and China (ZL201380022888.2).

international patent application (PCT/AU2016/050555) claiming iterations to the device design has been filed with a priority date of

June 2016 and will soon enter national phase in certain jurisdictions, and further patent applications are in preparation.

protect 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

is no set expiration date for the COV2 License Agreement.

However, the exclusivity of the license granted under the COV2 License Agreement

runs until the expiration of the patent portfolio covered by the COV2 License Agreement, which is currently until 2033.

We expect that

the patent portfolio will be extended as new patents are created throughout product development, thereby extending the exclusivity of

the COV2 License Agreement.

The COV2 License Agreement may be terminated by us in the event of a material breach by the Licensor, if

the Licensor does not cure the breach within 30 days after receiving notice of the breach;

or in the event the Licensor discontinues

its business operations or in the case of certain events related to insolvency or bankruptcy.

The COV2 License Agreement also may be

terminated by us at any time after the tenth anniversary of the COV2 License Agreement upon 180 days’ prior written notice.

Analysis and Opportunity

According to Diabetes Atlas Factsheet 2021, in 2021 there were 206 million people living with diabetes in the Western Pacific, which accounts for 38% of the world’s diabetic

Rapid urbanization, unhealthy diets and increasingly sedentary lifestyles have resulted in ever increasing

rates of obesity and diabetes across the APAC Region.

The countries and territories constituting the APAC Region, where we will introduce,

market and launch the biosensor, are:

Australia, New Zealand, Japan, Singapore, Malaysia, South Korea, Indonesia, the Philippines, Bangladesh,

Taiwan, China, Hong Kong, Thailand, Vietnam and an additional 18 countries and territories comprising the South Pacific Region.

to IDF Diabetes Atlas, 10 th edition, 2021, there were 463 million individuals in the 20-79 year age group living with diabetes worldwide in 2019.

number increased to 537 million in 2021.

By 2030, the number of diabetics is expected to reach 643 million, and by 2045, 783 million.

The rising prevalence of diabetes is driving the growth of the self-monitoring blood glucose devices market.

Glucose Monitoring Industry

Self-Monitoring of Blood Glucose

Self-Monitoring

of blood glucose is the primary approach for glucose monitoring and has been used for over 40 years.

Currently, self-monitoring of blood

glucose is conducted periodically by the patient using a blood glucose measuring device.

Blood glucometers require pricking a finger

with a lancet and applying a drop of blood on the test strip.

The test strip is then inserted into the device, which provides a reading

of the glucose levels in the blood.

Test strips are supplied by the glucometer manufacturer and are generally device-specific, although

generic test strips are also available.

There are currently more than 100 types of blood glucometers commercially available, and they

differentiate based on size and weight, cost, data storage capacity, test accuracy, blood sample size and screen visibility (users with

poor eyesight may prefer larger screens).

Glucose Monitoring

glucose monitoring is invasive and involves the insertion of a glucose biosensor into the subcutaneous tissue layer or the hypodermis.

The biosensor, which measures glucose levels in interstitial fluid, is attached to a transmitter that sends signals to either an insulin

pump or a portable meter.

These devices are generally worn for about two weeks and some require regular calibration through conventional

blood glucose detection about twice a day.

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.

Subcutaneous glucose levels change more slowly than plasma glucose, which

can be a restriction to their effectiveness, particularly if glucose levels are changing rapidly.

Subcutaneous glucose levels have a

time lag compared to blood glucose measurements, and measurements may not always match blood glucose.

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.

Although pumps are currently manually controlled by the patient,

continuous glucose monitoring combined with CSII could potentially be used as part of a closed-loop.

CSII is generally restricted to

Type 1 diabetics, where the need for ongoing insulin infusion is highest.

Continuous glucose monitoring is mainly used in a limited proportion

of diabetics, particularly those concerned about severe, nocturnal hypoglycemia, pregnant women who require meticulous glucose control

or those who may not be able to easily administer a self-monitoring test (e.g., those living in remote or hostile environments).

continuous glucose monitoring is more expensive than traditional self-monitoring of blood glucose and in many cases is not eligible for

reimbursement.

Digital Healthcare Industry

the APAC Region, many countries and territories are experiencing an aging population combined with healthcare infrastructures that have

struggled to keep up with the pace of socioeconomic change.

This creates a significant opportunity to enhance efficiency through digital

broad scope of digital health includes categories such as mobile health (mHealth), health information technology, wearable devices, telehealth

and telemedicine, and personalized healthcare.

Providers and other stakeholders are using digital health in their efforts to reduce inefficiencies,

improve access, reduce cost, increase quality, and make medicine more personalized for patients.

growth in digital healthcare is expected to be driven in large part by solutions to address current inefficiencies and unmet needs in

the APAC Region healthcare systems for diabetes sufferers.

The promise of digital health – also termed “connected health”

– in this context is to allow for remote diagnosis and monitoring;

facilitate self-managed care;

deliver care outside traditional

settings, with better access at lower cost;

and assist chronic disease management to improve population health outcomes.

biosensor business is dependent on the proprietary biosensor technology we license from LSBD.

LSBD continues to pursue intellectual

property rights related to this technology in China, the United States and other countries.

The original patent application, which

claims a priority date of March 2012, has been granted in the United States (9,766,199) and China (ZL201380022888.2).

patent application for a different iteration of the device design has been filed with a priority date of June 2016 and is granted in

the United States (10,978,653) and Australia (2016412541).

A third patent application for a further iteration of the device has been

filed with a priority date of 15 May 2018.

Further patents may yet be issued based on all three applications.

Chinese and the United States patents belong to the same patent family and relate to the same invention.

The United States and Australian

patents originating with the second application are similarly of the same patent family and relate to the same invention.

The exact wording

of the patent claims varies between countries.

patents protect 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 device.

The Chinese and the United States patent belong to the

same patent family, originating from the Australian patent.

As such, all of the patents relate to identical technology claims.

believe that the Licensor intends to aggressively prosecute these patent applications and file further applications, as appropriate,

to protect the proprietary biosensor technologies, including improvements thereon, in the United States as well as in the APAC Region,

and to take any necessary action to maintain and enforce its patent and other intellectual property rights.

There can be no assurance,

however, that the Licensor will take such actions, and under the License Agreement, we have no right to compel them to do so.

Licensor elects not to protect or enforce its intellectual property rights, we would be permitted take action to protect or enforce these

rights in the APAC Region, but any such action would be at our cost and expense.

and methods of using the device to detect glucose levels.

A similar device with no dielectric layer.

Further devices including a porous wicking layer to facilitate onset of device function.

is responsible for prosecuting these patent applications and file further applications, as appropriate, to protect the proprietary biosensor

technologies, including improvements thereon, in the United States as well as in the APAC Region, and to take any necessary action to

maintain and enforce its patent and other intellectual property rights.

There can be no assurance, however, that the Licensor will take

such actions, and under the License Agreement, we have no right to compel them to do so.

If the Licensor elects not to protect or enforce

its intellectual property rights, we would be permitted to take action to protect or enforce these rights in the APAC Region, but any such

action would be at our cost and expense.

intend to vigorously protect our intellectual property rights in any technologies owned by us through patents and copyrights, as available

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granting a patent.

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

either or both of these trademarks.

Our trademarks are not registered.

We own the domain name glucosebiosensor.com .

medical device industry is highly competitive, subject to rapid change, and significantly affected by new product introductions and other

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longer, more established operating histories and significantly greater financial, technical, marketing, sales, distribution, and other

Our overall competitive position is dependent upon a number of factors, including product performance and reliability, connectivity,

Our overall competitive position depends upon several factors, including product performance and reliability, connectivity,

manufacturing cost, and customer support.

glucose monitoring industry currently is dominated by blood glucometers that require pricking a finger with a lancet and applying a drop

of blood on a test strip.

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

Government Regulation

operate in a highly regulated industry.

Our present and future business has been, and will continue to be, subject to a variety of laws

Our current and future business has been and will continue to be, subject to a variety of laws

globally regarding quality, safety and efficacy, and governing, among other things, clinical evaluations, marketing authorization, commercial

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;

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

Internationally,

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

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.

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

regulations, and which may require us to report to different regulatory agencies if our device causes or contributes to a death or serious

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We may be subject to further regulations

in the areas of import and export restrictions and tariff regulations, duties and tax requirements.

In addition, these regulatory requirements

may change in the future.

regarding import and export restrictions, tariff regulations, and duties and tax requirements.

These regulatory requirements may change

in the future.

research, development and manufacturing operations including product assembly line at Cambridge, UK involve the use of hazardous substances,

and we are subject to a variety foreign environmental laws and regulations relating to the storage, use, handling, generation, manufacture,

treatment, discharge and disposal of hazardous substances.

Our products may also contain hazardous substances, and they are subject laws

and regulations relating to labelling requirements and to their sale, collection, recycling, treatment, storage and disposal.

with these laws and regulations may be expensive and noncompliance could result in substantial fines and penalties.

Environmental laws

and regulations also impose liability for the remediation of releases of hazardous substances into the environment and for personal injuries

resulting from exposure to hazardous substances, and they can give rise to substantial remediation costs and to third-party claims, including

for property damage and personal injury.

Liability under environmental laws and regulations can be joint and several and without regard

to fault or negligence, and they tend to become more stringent over time, imposing greater compliance costs and increased risks and penalties

associated with violations.

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 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.

obligations other than particular shared corporate overheads as required in connection with this utilization.

We have reimbursed the

Licensor for any costs the Licensor incurs on our behalf.

currently have 15 full-time employees in Australia and 2 in the United States.

Our subsidiary, IFP, has 34 employees in the United Kingdom.

We further rely on the services of our scientific advisory board, contractors, collaborators, consultants, and personnel at the University

of Newcastle (through a collaboration with the institution), to execute our mission to deliver pain-free, accessible medical devices

and solutions that drive transformative change and improve the quality of life.

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

management, technical engineering, manufacturing and supply chain, and quality assurance, legal and compliance, regulatory affairs, clinical

management, technical engineering, manufacturing and supply chain, quality assurance, legal and compliance, regulatory affairs, clinical

affairs, product management & marketing, systems engineering, human resources, IT, investor relations, and finance.

We believe our

team collectively possesses industry leading capabilities and positions us to build a strong life science company focused on developing

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

Our team collectively

possesses the experience and capabilities to build a robust medical technology company that develops next-generation non-invasive medical

devices and solutions.

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

website is at www.ibs.inc .

We make available, free of charge, on our corporate website, our annual reports 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”).

electronically filed with the SEC.

The SEC maintains an internet site that contains

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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-K

Item 1. Business