What changed in this filing

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Item 1. Business

2024-09-18 compared with 2023-08-23 · 372 added, 906 removed, 267 unchanged (83% of the section changed)

Bio Solutions Inc.

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

were each formed on December

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.

The Company’s Australian subsidiary, Intelligent Bio Solutions (APAC) 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”).

The Company’s headquarters are in

New York, New York.

Bio Solutions Inc.

is a medical technology company focused on developing and delivering intelligent, rapid, non-invasive testing and

screening solutions.

The Company operates globally with the objective of providing innovative and accessible solutions that improve the

quality of life.

Company’s current product portfolio includes:

Fingerprinting Platform:

A proprietary portable platform that analyzes fingerprint sweat using a one-time cartridge and portable

handheld reader.

The 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, fingerprint sweat-based diagnostic testing products designed to detect drugs of abuse

including opiates, 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 a confirmatory kit can also be sent to a

third-party laboratory service provider for confirmation testing.

Customers include safety-critical industries such as construction,

transportation and logistics, manufacturing, engineering, drug treatment organizations in the rehabilitation sector, and judicial

organizations.

Biosensor Platform – A biosensor platform we refer to as the Biosensor Platform Technology (“BPT”), or simply the “Biosensor

Platform,” consists of a small, printable modified organic

thin-film transistor strip that we license across the Asia Pacific Region (“APAC Region”) from Life Science Biosensor Diagnostics

Pty Ltd (“LSBD” or “Licensor”).

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

the top enzyme layer of the biosensor to suit each analyte.

This platform technology has the potential to develop a range of Point of

Care Tests (“POCT”), including the modalities of clinical chemistry, immunology, tumor markers, allergens, and endocrinology.

We understand that following the appointment of a liquidator to LSBD, the intellectual property rights licensed by us from the Licensor

(LSBD) have reverted to the University of Newcastle.

The Company is in early-stage discussions regarding the potential restructuring of

future licensing of BPT and products with the University of Newcastle.

A timeline for these discussions has not yet been established.

of Achievements and Developments

major highlights of achievements for the fiscal year 2024:

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.

The study design was intended to support the clinical

development of its next-generation Saliva Glucose Biosensor.

A total of 40 adult subjects with type 2 diabetes were recruited for

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

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

of June 30, 2024, the Company had a cash balance of approximately $6.30 million after raising approximately $14.56 million

throughout the fiscal year (after deducting fees, discounts, closing costs, and other expenses payable by the Company), through an

underwritten public offering, a warrant inducement transaction, and a private placement of the Company’s

June 28, 2024, the Company announced the successful completion of the in-clinic portion of its Pharmacokinetic

(PK) study, a core component of the Company’s

clinical study plan for its 510(k) pathway for clearance by the United States Food and

Drug Administration (“FDA”) .

The Company expects to

complete the full PK study in the third calendar quarter of 2024.

April 11, 2024, the Company announced that its wholly owned subsidiary, Intelligent Fingerprinting Limited, had been granted a new

European patent with unitary effect for its DSR-Plus Cartridge Reader, bringing the patent into effect in 17 European countries.

On February 28, 2024, the Company announced its partnership with Cliantha Research to perform a pharmacokinetic (PK)

study as part of its FDA 510(k) clinical study plan.

Initiating the clinical studies plan represented a critical milestone for the Company.

December 2023, the National Association of Testing Authorities (NATA) accredited the Company’s laboratory partner, Racing Analytical

Services Limited (RASL), to perform its fingerprint confirmatory drug testing procedure.

This accreditation serves as an independent

benchmark for technical validation, demonstrating the Company’s commitment to product quality, safety, and reliability for

its customers.

the year, the Company announced new partnerships with Robinson Brothers, DGP Plc and James Jones & Sons, VKVP Haulage, State

Road Constructions, Titan Cranes and Rigging Pty Ltd.

and P&O Ferries.

Additionally, the Company reported the successful completion

of 25,000 Intelligent Fingerprinting tests by its existing customer, Auctus Management Group.

Continued customer account growth demonstrates

the strength of the Company’s proprietary fingerprint sweat-based technology in the market.

The Company looks to continue this

momentum and expand into new customer segments and geographical regions throughout the APAC Region, Europe, South America and the

United Arab Emirates.

October 24, 2023, the Company announced its expansion into the New Zealand market, expanding its global footprint and extending the

reach of its drug screening product.

Expansion into New Zealand demonstrates the Company’s ability to introduce its product

in new markets.

The Company aims to continue growth in new markets, offering an alternative and innovative solution that places a

strong emphasis on operational efficiency, fitness for duty, employee privacy and dignity.

October 4, 2023, the Company raised approximately $4.38 million, prior to deducting underwriting discounts, commissions and offering

expenses, via a registered underwritten public offering of the Company’s securities.

Net proceeds to the Company, after deducting

the underwriting discounts and commissions and estimated offering expenses payable by the Company, were approximately $3.79 million.

September 27, 2023, the Company announced that its Intelligent Fingerprinting Drug Screening business had obtained recertification

for the latest ISO 13485:

2016 harmonized quality management system standard for the medical device industry.

The recertification

took effect on October 14, 2023, and is valid for three years.

ISO 13485:2016 is the international standard for medical devices quality

management system certification and is a requirement for medical device manufacturers operating across key regions, including the

USA, Canada, Europe, Japan, Singapore, Malaysia and Saudi Arabia.

September 21, 2023, the Company announced the successful debut of its Intelligent Fingerprinting Drug Screening System at the 2023 Workplace Health & Safety Show in Sydney, Australia.

September 8, 2023, the Company announced the successful completion of a key development milestone in its plans to add ketamine and

tramadol to its Intelligent Fingerprinting Drug Screening System.

New assays for testing both drugs have passed the Company’s

initial design phase and are ready for scale-up and transfer to manufacture in preparation for potential clinical trials.

After completing

these activities and successful clinical trials, the assays can be added to the panel of substances detected by the Company’s

proprietary drug screening system.

August 1, 2023, the Company announced that it had secured 8 new customers across various locations throughout Australia, which collectively

employ over 10,000 individuals, within just two months of launching its Intelligent Fingerprinting Drug Screening System in Australia.

July 6, 2023, the Company announced that it has signed a distribution agreement with Chile-based company TSCOM SPA for its Intelligent

Fingerprinting Drug Screening System, increasing the product’s availability across South America.

The Company further announced

that it received its first order under this agreement, from a Chile-based electrical distribution company.

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.

Company’s wholly owned subsidiary, Intelligent Fingerprinting Limited (IFP), is the developer and owner of a 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 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,

3 unchanged sentences

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

The 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 Cartridge is inserted

into a reader, and within 10 minutes, the results are displayed, with options to print and save anonymized data for further use.

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

employee medical records or for general statistical analysis.

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and Development

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

R&D initiatives.

Company’s 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:

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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.

of the existing lateral flow assay technology on which the Intelligent Fingerprinting Platform has been developed.

By expanding the

capabilities of this platform, the Company will be better equipped to address diverse diagnostic needs and contribute to improved patient outcomes.

Company’s 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.

The Company has quality and regulatory oversight

of sub-contracted reference laboratories, where its methodology is accredited by the United Kingdom Accreditation Service (UKAS), ensuring

that the laboratory operates according to the ISO 17025 standard.

In December 2023, the National Association of Testing Authorities (NATA) accredited the Company’s laboratory partner, Racing

Analytical Services Limited (RASL), to perform its fingerprint confirmatory drug testing procedure.

This accreditation serves as an independent

benchmark for technical validation, demonstrating the Company’s commitment to product quality, safety, and reliability for its

This achievement positions INBS as a trusted and reliable partner, catering to the evolving compliance and safety needs of

organizations across Asia-Pacific and beyond.

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.

In February 2024, the Company entered into a partnership with Cliantha Research to conduct the pharmacokinetic

In addition, the Company entered into agreement with CenExel in August 2024 to perform a method comparison clinical study.

Both of these clinical studies form part of the Company’s FDA 510(k) clinical study plan and pathway for clearance by the FDA.

Initiating the clinical studies plan represents a critical milestone and the Company believes it remains on track for planned submission

by the end of 2024 and planned entry into the United States market in 2025.

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

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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,

equipment and facilities required to produce the Intelligent Fingerprinting Drug Screening Cartridge and DSR-Plus Reader are in place

at the Company’s 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;

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.

Company serves over 400 active customer accounts, primarily in the United Kingdom, with additional customers across various global locations.

Company intends to expand its account base by strengthening its presence in existing markets and, subject to receiving necessary

regulatory approvals and clearances, venture into new regions.

The Company plans to tailor its 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.

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.

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

These distributors can be

exclusive or non-exclusive, depending on the agreed arrangement.

The Company plans to focus on distributors with existing customer networks

in the drug screening segment and a proven track record in their territories.

The Company also plans 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 and a National Sales Manager under the direction of the

Global Vice President of Sales.

The team utilizes telemarketing leads and a variety of other inbound lead-generation tactics to

connect with new businesses and schedule on-site and virtual product demonstrations.

The UK team includes a Customer Experience Team

that manages account relationships, product support, training and sales administration.

New customer accounts are assigned to sales

representatives based on geographic territories.

The Company utilizes a third-party sales agency under the direction of the Global Vice President of Sales.

The agency’s primary

area of focus is the east coast of Australia, comprising approximately 72% of the country’s population.

The agency’s team

utilizes their extensive network of existing contacts and relationships to introduce the IFP products through in-person demonstrations.

The Company further intends to utilize distributor partnerships to cover regions such as Western Australia, South Australia, and more

remote areas.

During the Company’s 510(k) premarket submission and subject to receiving appropriate approvals/ clearance from the FDA, the Company

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

The Company plans to focus on 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.

The Company plans to 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.

The Company’s Vice President of Global Sales and the dedicated European representative

will initially manage MEA operations.

Depending on market opportunities and sales volume, the Company may appoint a dedicated distribution

leader for MEA 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.

drug screening market encompasses various sectors, including workplaces, drug rehabilitation, drug testing labs, criminal justice,

law enforcement, schools and colleges, pain management centers, the military, medical examiners, individual users, and sporting

organizations.

We intend to aggressively market IFP Products to different geographical regions outside the UK, with a focus on the

industries and segments noted above.

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

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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

workplace challenges persist relating to impairment, drug dependency and associated criminal activity, which increase the need for testing.

Recreational Drug Industry

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

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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.

According to the World Drug Report 2023 (“WDR”) published by the United Nations Office on Drugs &

Crime, around 296 million people used drugs worldwide in 2021, a 23% increase over the previous decade.

The WDR states that cannabis remains

the world’s most-used drug, with 219 million users in 2021, representing 4% of the global population.

The WDR also reports that

opioids remain the most lethal group of drugs, accounting for two-thirds of drug-related deaths, with 60 million users in 2021.

Additionally,

according to the WDR, there were 36 million users of amphetamines, 22 million users of cocaine, and 20 million users of ecstasy in 2021.

The WDR also reported that there were 39.5 million people with drug use disorders in 2021, an increase of 45% over the past ten years.

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.

to the MarketsandMarkets 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 study, this market growth is expected to be driven by several factors, including the increasing prevalence of infectious

diseases, supportive government policies, the rising demand for over the counter (OTC) and home-based POCT testing products, and

technological advancements in diagnostic devices.

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.

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

methodologies.

following patents are owned by IFP.

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

(AU 2018247080) (Pending)

(EP 18716321.7) (Pending)

(AU 2018247080)

Unitary (EP 3600034)

(via Europe) (EP 3600034)

(US 11227140)

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(AU 2021225394) (Pending)

(EP 21709774.0) (Pending)

Unitary (EP 4111173)

(via Europe (EP 4111173)

(US 17/904887) (Pending)

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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

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,

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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:

For many years, competitor POC and confirmation tests relied on collecting

either urine or oral fluid (saliva) samples.

There are several competitive advantages of analyzing fingerprint sweat over urine and oral

fluid drug testing:

sample collection :

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avoid cheating tests.

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

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

and non-biohazardous :

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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:

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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).

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.

Company believes that the lateral flow assay technology used in the IFP Products has the potential to also deliver significant benefits

in other areas of medical diagnostics.

For example, the potential exists to 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 assays are 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 “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)

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 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 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,

which modifies the properties of the OTFT gate material, producing an electrical signal directly correlated to the amount of glucose

present in the saliva.

This measurement is then converted into a real-time saliva glucose reading through 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 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 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 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 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 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

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

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.

The research team at the University of Newcastle, in order to benchmark the performance of the biosensor prototype

systems, compared it with the partial requirements of the ISO standard ISO 15197:2013.

This standard dictates the analytical standards

and performance evaluation of a blood-glucose monitoring system for self-testing in managing diabetes mellitus.

The standard dictates

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.

However, at this stage of

product development, we wanted to assess the dynamic range of the biosensor to 20-fold of the upper physiological range (9.01 mg/dL)3.

The concentration range of greater than 9.01-180.2 mg/dL is not clinically relevant criteria for glucose in saliva.

The results of the

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 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 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 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.

We will work with these distributors

to market our products.

These distributors typically would sell a variety of other, non-competing products and will be expected to devote

certain resources to selling the SGB.

We expect to devote suitable time and effort to recruiting and retaining qualified third-party

distributors and training them in our technology and product offering.

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

and sales efforts.

Biosensor Platform Technology (BPT), or simply the “Biosensor Platform,” consists of a small, printable modified organic

thin-film transistor strip that we license across the APAC Region from LSBD.

The Biosensor Platform is designed to detect multiple biological

analytes by substituting the top enzyme layer of the biosensor to suit each analyte.

This platform technology has the potential to develop

a range of Point of Care Tests (POCTs), including the modalities of clinical chemistry, immunology, tumor markers, allergens, and endocrinology.

License Agreements

We understand that following the appointment of a liquidator to Life Science Biosensor Diagnostics Pty Ltd, (LSBD),

the intellectual property rights licensed by us from the Licensor have reverted to the University of Newcastle.

The Company is in early-stage

discussions regarding the potential restructuring of future licensing of BPT and products with the University of Newcastle.

for these discussions has not yet been established.

As the liquidation of LSBD has not been finalized, and the post-liquidation status

of our licensing arrangements with LSBD has not been determined as of the date of this report, below is a description of our existing

licensing arrangements with LSBD prior to the liquidation of LSBD.

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

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

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.

addition to the above, we have a 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

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

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

with LSBD amending and restating all the previous BPT license agreements with LSBD.

The BPT 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, 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.

We do not currently intend to manufacture the Licensed Products in-house.

to the BPT 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:

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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,

BPT 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.

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 BPT License Agreement.

is no set expiration date for the BPT License Agreement.

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

runs until the expiration of the patent portfolio covered by the BPT 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 BPT 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 BPT 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

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

The BPT License Agreement also may be terminated by us after July 3, 2029 upon 180 days’ prior written notice.

The BPT 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 BPT License Agreement, we may continue to market and sell the Licensed Products.

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

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

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

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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 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

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

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);

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.

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.

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.

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

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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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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).

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

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).

A second 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

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of the patent claims varies between countries.

patents protect the following technological claims of the SGB:

patents protect the following technological claims of the BPT:

the architecture of a biofunctional organic thin film transistor device

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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

through registration in the United States and internationally.

We also will rely upon trade secrets, know-how, and continuing technological

innovation to develop and maintain our competitive position.

We intend to protect any of our proprietary rights through a variety of

methods, including confidentiality agreements and/or proprietary information agreements with suppliers, employees, consultants, independent

contractors and other entities who may have access to proprietary information.

We will generally require employees to assign patents

and other intellectual property to us as a condition of employment with us.

All of our consulting agreements will pre-emptively assign

to us all new and improved intellectual property that arise during the term of the agreement.

In addition, we may license additional

technologies from the Licensor or third parties.

Prior to any further acquisition or licensing of technology from a third party, we will

evaluate the existing proprietary rights, our ability to obtain and protect these rights, and the likelihood or possibility of infringement

upon competing rights of others.

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.

Company intends to vigorously protect its intellectual property rights for any technologies owned through patents and copyrights,

both in the United States and internationally.

Additionally, the Company plans to leverage trade secrets, know-how, and continuing

technological innovation to develop and maintain its competitive position.

The Company intends to protect its proprietary rights

through a variety of methods, including confidentiality agreements and/or proprietary information agreements with suppliers,

employees, consultants, independent contractors and other entities who may have access to proprietary information.

The Company will

generally require employees to assign patents and other intellectual property to it as a condition of employment.

All consulting

agreements will pre-emptively assign all new and improved intellectual property that arise during the term of the agreement to the

In addition, the Company may license additional technologies from the Licensor or third parties.

Prior to any further

acquisition or licensing of technology from a third party, the Company will evaluate the existing proprietary rights, its ability to

obtain and protect these rights, and the likelihood or possibility of infringement upon competing rights of others.

issuance of a patent does not ensure that it is valid or enforceable.

The term of individual patents depends upon the legal term of the

patents in the countries in which they are obtained.

In most countries in which we file, the patent term is 20 years from the earliest

date of filing a non-provisional patent application.

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

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

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

granting a patent.

The term of individual patents depends upon the legal term of

the patents in the countries where they are obtained.

In most countries where the Company files patents, the patent term is 20 years from

the earliest date of filing a non-provisional patent application.

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

patent is terminally disclaimed over another patent or as a result of delays in patent prosecution by the patentee, and a

patent’s term may be lengthened by patent term adjustment, which compensates a patentee for administrative delays by the

United States Patent and Trademark Office in granting a patent.

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

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manufacturing cost, and customer support.

operate in a highly regulated industry.

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.

Company operates in a highly regulated industry.

Its current and future business has been and will continue to be subject to a variety

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

commercial sales, and distribution of our products.

Internationally,

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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

injury or malfunctions in a way that would likely cause or contribute to a death or serious injury.

We may be subject to further regulations

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 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.

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

reporting regulations, and which may require it to report to different regulatory agencies if its device causes or contributes to a death

or serious injury or malfunctions in a way that would likely cause or contribute to a death or serious injury.

The Company may be subject

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

These regulatory

requirements may change in the future.

Company’s research, development and manufacturing operations, including its product assembly line in Cambridge, UK, involve the

use of hazardous substances, and consequently, it is subject to a variety of foreign environmental laws and regulations relating to the

storage, use, handling, generation, manufacture, treatment, discharge and disposal of hazardous substances.

The Company’s products

may also contain hazardous substances and they are subject to laws and regulations relating to labelling and to their sale, collection, recycling, treatment,

storage, and disposal.

Compliance 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.

Human Capital

of September 16, we have 11 full-time employees in Australia and 2 in the United States.

Our subsidiary, IFP, has 37 employees in

the United Kingdom.

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

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devices and solutions.

to Information

Available Information

website is at www.ibs.inc .

3 unchanged sentences

electronically filed with the SEC.

The SEC maintains an internet site that contains

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

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

Our reference

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

The SEC maintains an internet site that contains reports, proxy and information statements and other

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

Information contained on our website does

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

Our reference to the URL for our website is intended

to be an inactive textual reference only.

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

What changed 10-K

Item 1. Business