What changed in this filing

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Item 1. Business

2025-08-15 compared with 2024-09-18 · 452 added, 465 removed, 174 unchanged (84% of the section changed)

Bio Solutions Inc.

and its wholly owned Delaware subsidiary, GBS Operations Inc., were each formed on December

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

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.

Intelligent Bio Solutions Inc.

and its wholly

owned Delaware subsidiary, GBS Operations Inc., were each formed on December 5, 2016, under the laws of the state of Delaware.

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 Company’s headquarters are in New York, New York.

Bio Solutions Inc.

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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.

Testing Platforms

Intelligent Fingerprinting Platform:

The Company’s current active product is the Intelligent Fingerprinting Platform, which consists of the 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 IFP 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, mining,

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

We plan to bring the IFP System to new markets and grow within existing markets concentrating on:

increasing market share across the United Kingdom and mainland

commencing sales and distribution throughout Australia, New

Zealand and other countries in the Asia Pacific Region (“APAC Region”), and establishing the infrastructure and satisfying

the regulatory requirements needed to do so;

continue to work on 510(k) pre-market notification submitted

on December 2024 for expansion into United States markets that require FDA clearance, followed by the planned initial launch of our opiate

test system for codeine and then for additional drugs following such additional FDA clearance as may be required;

initiating research aimed at broadening the capabilities of

the IFP System to test for additional drugs and indications, facilitating the expansion of the platform into point-of-care medical testing;

expanding the IFP System into new customer segments, including

major sporting organizations, law enforcement, and commercial airlines;

developing a strategic network of distributors with established

customer bases throughout the APAC Region, Europe and North America to distribute the IFP Products.

Biosensor Platform :

Under the terms

of an Amended and Restated License Agreement dated September 12, 2019 (the “BPT License Agreement”), between the Company

and Life Science Biosensor Diagnostics Pty Ltd (“LSBD” or “Licensor”), the Company held an exclusive license

in the Asia Pacific Region (“APAC Region”) to the Licensor’s proprietary rights to the biosensor technology (the

“Biosensor IP”) used in the biosensor platform we refer to as the Biosensor Platform Technology (“BPT”), or

simply the “Biosensor Platform”.

This platform consists of a small, printable modified organic thin-film transistor

strip designed to detect multiple biological analytes by substituting the top enzyme layer of the biosensor to suit each analyte.

refer to products that use the BPT as the “Licensed Products”.

This platform technology has the potential to develop a

range of Point of Care Tests.

We understand that following the appointment of a liquidator to LSBD on July 21, 2023, the Biosensor

IP we licensed from LSBD has reverted back to the University of Newcastle.

Following our ongoing discussions with the University, it

is the Company’s understanding that the University of Newcastle cannot finalize licensing of the Biosensor IP until the

liquidation of LSBD is complete.

As the timeline for the completion of LSBD’s liquidation is unknown, the Company does not

expect any updates or finalization of any license terms until this occurs.

As a result, further development of the BPT has been

postponed until we are able to finalize licensing arrangements related to the BPT.

For more information regarding our licensing

agreements with LSBD, see “Item 1.

Business - Technology License Agreements.”

The businesses discussed in this Annual Report

on Form 10-K reflect the reportable segments that existed through the fiscal year ended June 30, 2025.

Effective June 30, 2025, we revised

our reportable segments to a region-focused structure, aligning with changes in our business and organizational structure.

This transition

was driven by several key developments, including the end of a project for the construction of a manufacturing facility in Australia during

the fourth fiscal quarter and decision by management to not pursue the BPT any further on until the liquidation of the LSBD is complete

following the reversion of intellectual property rights (BPT related) to the University of Newcastle after the liquidation of the former

These events prompted a reassessment of the Company’s operating model and strategic priorities, resulting in the adoption

of a region-based segment reporting structure that better aligns with the geographic focus of the business and how management evaluates

performance and allocates resources.

new reportable segments are:

(i) United Kingdom;

(ii) Asia Pacific (APAC);

(iii) Americas;

and (iv) Rest of World.

These new reportable

segments reflect how the Company is currently managed and correspond to the manner in which financial information is reviewed by our

Chief Operating Decision Maker (CODM) for resource allocation and performance assessment.

segment reporting, which was based on products—(i) Commercially Available Intelligent Fingerprinting Products (“IFPG”

or “IFPG segment”), and (ii) Development-Stage Biosensor Platform Technology (“BPT segment”)—has been recast

in this filing to reflect the new structure.

Note 4, “Segment Reporting”, in the

Notes to Consolidated Financial Statements included in Item 8 of this report provides information on revenue, government support income,

net income (loss), long-lived assets, and inventory by our revised segments.

of Achievements and Developments

major highlights of achievements for the fiscal year 2025:

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.

As of June 30, 2025, the Company had a cash balance of approximately

$1.02 million after raising approximately $4.60 million throughout the fiscal year (after deducting fees, discounts, closing costs, and

other expenses payable by the Company) through an underwritten public offering and an At-the-Market (ATM) offering in accordance with

an effective shelf registration on Form S-3.

On May 06, 2025, the Company announced the launch of three

new localized websites in Arabic, Italian, and Spanish.

This rollout supports the Company’s global growth plans and international

sales expansion by opening digital and commercial access to some of the world’s fastest-growing, high-demand regions for workplace

safety and compliance solutions.

On April 22, 2025, the Company announced the integration of Latin American

Spanish into its IFP System.

The enhancement allows users to operate the IFP System in English, Arabic, and Latin American Spanish, extending

the platform’s usability across diverse international settings.

On March 31, 2025, the Company announced the integration of Arabic

as the second international language to its IFP System as part of the Company’s multilingual upgrade.

On March 26, 2025, the Company announced it had been granted

a patent in the United States (U.S.) relating to its Intelligent Fingerprinting Drug Screening Cartridge.

This is the Company’s

sixth active patent to be granted in the U.S., strengthening the protection of its unique and proprietary drug screening technology.

On January 31, 2025, the Company announced plans for a major upgrade

to its IFP System.

The system upgrade will support multiple languages spoken across North and South America, Europe, Asia Pacific, and

the Middle East.

On December 18, 2024, the Company announced the submission of its 510(k)

premarket notification to the U.S.

Food and Drug Administration (FDA) for clearance following FDA review of its IFP System.

On November 26, 2024, the Company announced the successful completion

of its method comparison study on its IFP System.

The method comparison study confirmed the sensitivity, specificity, accuracy, and usability

of the System, validating its potential for use in workplace drug testing and other applications.

The method comparison study demonstrated

82.2% sensitivity, 100% specificity, and 94.1% accuracy for the IFP System.

On November 13, 2024, the Company announced strong initial

results from its Pharmacokinetic (PK) study required for its FDA 510(k) submission.

The data from the PK study showed that fingerprint

sweat mimics the rate and extent of codeine in blood and saliva.

The study successfully demonstrated that fingerprint sweat provides

a reliable sample matrix for drug detection, showing quantitative PK data closely aligned to blood, based on statistical comparisons

made at the 95% confidence level.

On October 9, 2024, the Company announced a new distribution

partnership with Spirit Group, an Australian, Indigenous-owned marketing and consulting agency, with prominent clients across a wide

range of industries, including mining, transportation, and construction.

On August 21, 2024, the Company announced the installation

of over 1,000 Intelligent Fingerprinting Drug Screening Readers with customers as of June 30, 2024, a significant milestone for the Company,

underscoring the growing demand for its advanced drug screening technology.

On July 24, 2024, the Company announced a new distribution

partnership with QabasTech as its exclusive distributor in Saudi Arabia.

On July 18, 2024, the Company announced the successful completion of

biocompatibility testing of its IFP System, a pivotal phase in the clinical study plan required for FDA 510(k) regulatory clearance.

Company confirmed that all materials used in its system, including the Drug Screening Cartridge, Confirmatory Cartridge, and the DSR-Plus

Reader, are safe for use in medical devices.

The Company added 115 new

customer accounts throughout the fiscal year 2025.

Fingerprinting Drug Screening System

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,

methamphetamines, benzodiazepines, cannabis, methadone, and buprenorphine.

In addition, samples collected via confirmatory kits can be

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

Our 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 IFP 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.

eliminates the need for invasive and unpleasant urine, saliva, or blood collection to test for substance abuse.

The ten samples are collected

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

The IFP System is currently designed

to detect opioids, cocaine, methamphetamines, benzodiazepines, cannabis, methadone, and buprenorphine.

In addition, samples collected

via confirmatory kits can be sent to a third-party laboratory service provider for confirmation testing.

Fingerprinting Drug Screening System Functionality

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.

The IFP 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.

Results 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.

Results 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.

and Background of the Intelligent Fingerprinting Drug Screening System

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

IFP developed and commercialized

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

mainland Europe and the Middle East.

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

factory in Cambridge, England.

Founded in 2007, IFP is a spin-out company from

the University of East Anglia (UEA) and is based in Cambridge, England.

IFP developed and commercialized the patented Intelligent Fingerprinting

DSR-Plus Reader and Cartridge system, which has been predominantly sold in the United Kingdom, mainland Europe and the Middle East.

continues to manufacture the cartridges for the IFP System in its factory in Cambridge, England.

and Development

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

comprehensive R&D initiatives.

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

R&D initiatives.

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

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

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

testing capabilities:

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

landscape, such as fentanyl and oxycodone.

Enhancing the Reader:

This involves integrating wireless connectivity, data collection capabilities, and important system architecture improvements such as miniaturization, extended battery life, and a refined touch-screen interface for a seamless user experience.

Expanding testing capabilities:

The focus is on enabling the current cartridges to detect highly relevant substances in today’s pharmaceutical landscape, such as fentanyl and oxycodone.

new tests in the medical point of care domain:

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

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

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

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

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

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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

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 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,

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

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

approving and issuing

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

approving the establishment of enterprises

for pharmaceutical manufacture and distribution;

formulating administrative rules and policies concerning the supervision and administration

of food, cosmetics and pharmaceuticals;

and handling significant accidents involving these products.

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.

R&D, manufacturing facilities and operations for drug screening products must also 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

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.

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:

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.

are already permitted to sell the IFP System as a drug screening device in Australia, we have obtained 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.

United States of America:

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

We completed a 510(k) submission in December 2024, and remain focused on securing FDA 510(k) clearance for the IFP System’s opiate

test system for codeine in the U.S., which will enable broader use beyond current Forensic Use Only settings.

Additionally, we must identify

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

In fiscal 2025, the Company advanced its regulatory

strategy through increased engagement with regulatory consultants, refined clinical study design, and the generation of new scientific

and clinical data to support its submission.

We anticipate that obtaining FDA clearance will benefit entry into other regions of the world.

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

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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.

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 450 small to medium-sized businesses, primarily located in the United Kingdom, with additional customers across

various global locations.

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

necessary regulatory approvals and clearances, venture into new regions.

We will tailor our strategy to the targeted region, establishing

direct sales and marketing teams or utilizing distribution networks.

In some cases, a combination of these strategies may be appropriate.

Distributors:

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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.

We plan to focus on distributors with existing customer networks in

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

We utilize a third-party sales agency under the direction of the Vice President of Global 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.

intend to utilize distributor partnerships to cover regions such as Western Australia, South Australia, and more remote areas.

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

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

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

drug screening market.

The Company plans to appoint a dedicated European representative to identify, negotiate, and sign distributor agreements and

maximize sales in targeted territories.

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

sales in target territories.

into the Middle East and Africa (“MEA”):

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

Our Vice President of Global Sales and the dedicated European representative

will initially manage MEA operations.

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Drug Screening Market

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.

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

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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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.

of Care / Rapid Diagnostics Market

to the Point of Care/Rapid Diagnostics Market report by MarketsandMarkets 1 , the global Point of Care (POC) diagnostics

market was valued at $45.36 billion in 2022 and is projected to reach $75.46 billion by 2027, at a compound annual growth rate (CAGR)

Growth is largely driven by increasing decentralization in healthcare, demand for faster diagnostic turnaround, and rising adoption

of lateral flow assays, particularly in home care and workplace environments.

Notably, the lateral flow assays segment accounted for the

largest share of the market in 2021 and is projected to grow from $28.76 billion in 2022 to $47.37 billion by 2027, at a CAGR of 10.5%.

This technology continues to dominate due to its speed, ease of use, and portability.

this broader landscape, drug screening has emerged as a high-growth category.

Our fingerprint sweat-based drug screening technology leverages

lateral flow technology, aligning it directly with this high-growth segment.

A 2024 MarketsandMarkets report estimates the global drug

screening market will reach $19.5 billion by 2029, growing at a CAGR of 16.6% 1 .

In the employer and workplace drug testing

segment, Grand View Research estimates the global market size at $5.90 billion in 2023, with an expected CAGR of 4.5% from 2024 to 2030,

reaching approximately $7.96 billion by 2030 2 .

Specifically, in the United States, the employer and workplace drug testing

market was valued at $2.47 billion in 2023 and is projected to grow at a CAGR of 5.1% from 2024 to 2030 3 .

trends support our mission to provide reliable, scalable, and dignified fingerprint sweat-based drug testing solutions offering a strategic

fit with growing demand for on-site, non-invasive screening in safety-critical industries.

We also intend to expand into adjacent areas

of medical diagnostics by leveraging its core lateral flow platform technology and technical capabilities.

This strategic focus aims

to unlock broader healthcare applications and deliver a differentiated alternative to conventional testing methodologies, offering greater

speed, accessibility, and efficiency.

are four primary categories of recreational drugs:

analgesics, depressants, stimulants, and hallucinogens.

Analgesics include narcotics

like heroin, morphine, fentanyl, and codeine.

Depressants include alcohol, barbiturates, tranquilizers, and nicotine.

Depressants include alcohol, barbiturates, benzodiazepines, and nicotine.

Stimulants include

cocaine, methamphetamine, and ecstasy (MDMA).

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

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.

Hallucinogens include LSD, psilocybin and ketamine.

to the 2024 World Drug Report published by the United Nations Office on Drugs and Crime, the emergence of new synthetic opioids and a

record supply and demand of other drugs has compounded the impacts of the world drug problem, leading to a rise in drug use disorders

and environmental harms.

Approximately 292 million people used drugs worldwide in 2022, a 20% increase over the previous decade.

remains the world’s most used drug, with 228 million users.

Opioid use remains a major concern, with 60 million users, followed

by amphetamines (30 million users), cocaine (23.5 million users), and ecstasy (20 million users).

Nitazenes, a group of synthetic opioids

which can be even more potent than fentanyl, have recently emerged in several high-income countries, resulting in an increase in overdose

Though an estimated 64 million people worldwide suffer from drug use disorders, only one in 11 is in treatment 4 .

According to the 2022 National

Survey on Drug Use and Health (NSDUH), approximately 54.6 million people aged 12 or older in the U.S.

needed substance use treatment in

Of those, only 13.1 million received any form of treatment 5 .

To address this treatment gap, the White House’s 2024

National Drug Control Strategy Performance Review highlights more than $82 billion in federal investments in treatment and harm reduction

MarketsandMarkets 2024, Drug & Alcohol Screening Market by Product, Sample Type, End User & Region – Global Forecast

to 2029 , available at:

https://www.marketsandmarkets.com/Market-Reports/drug-alcohol-screening-market-162987773.html.

Grand View Research 2024, Employer and Workplace Drug Testing Market Size, Share & Trends Analysis Report By Services, By

Sample Type, By End-use, By Region, And Segment Forecasts, 2024 - 2030 , available at:

https://www.grandviewresearch.com/industry-analysis/employer-workplace-drug-testing-market-report.

Grand View Research 2024, U.S.

Employer and Workplace Drug Testing Market Size, Share & Trends Analysis Report By Services, By

Sample Type, By End-use, By Region, And Segment Forecasts, 2024 - 2030 , available at:

https://www.grandviewresearch.com/industry-analysis/us-employer-workplace-drug-testing-market-report.

United Nations Office on Drugs and Crime (UNODC) 2024, UNODC World Drug Report 2024:

Harms of world drug problem continue to mount

amid expansions in drug use and markets , available at:

https://www.unodc.org/unodc/en/press/releases/2024/June/unodc-world-drug-report-2024_-harms-of-world-drug-problem-continue-to-mount-amid-expansions-in-drug-use-and-markets.html.

Substance Abuse and Mental Health Services Administration (SAMHSA) 2023, 2022 National Survey on Drug Use and Health (NSDUH) National

Report , U.S.

Department of Health and Human Services, Center for Behavioral Health Statistics and Quality, available at:

https://www.samhsa.gov/data/sites/default/files/reports/rpt42731/2022-nsduh-nnr.pdf.

Executive Office of the President, Office of National Drug Control Policy (ONDCP) 2024, National Drug Control Strategy:

Review System Report , December 2024, The White House, Washington, D.C., available at:

https://www.whitehouse.gov/wp-content/uploads/2024/04/ONDCP_NDCS-2024-Performance-Review-System-Report_Final.pdf.

following patents are owned by IFP.

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(AU 2015293652)

(US 15/328799) (Pending)

(US 12259385)

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

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

(EP 19707069.1) (Pending)

(EP 19707069.1)

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

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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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when compared to urine and oral fluid-based tests.

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

The table below compares the IFP System to other

drug testing systems:

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

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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.

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 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.

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).

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

activities of industry participants.

We face potential competition from major medical device companies worldwide, many of which have

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

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

manufacturing cost, and customer support.

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.

We had entered into following

technology license agreements with LSBD, which is now in liquidation:

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

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

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.

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 “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:

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

Product, including being authorized to prosecute the approval for an investigational device required for the purpose of carrying

out clinical studies;

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

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

end users to, the Licensed Products;

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

data acquired from the Licensed Products.

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

us for any sublicense.

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

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

We must do all things

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

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

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.

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

the terms of the BPT License Agreement we held an exclusive license in the APAC Region to the LSBD’s proprietary rights to the

biosensor technology used in the biosensor platform we refer to as the Biosensor Platform Technology (BPT), or simply the “Biosensor

Platform.” This platform consists of a small, printable modified organic thin-film transistor strip 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.

We understand that following the appointment of

a liquidator to LSBD on July 21, 2023, the intellectual property (IP) rights we licensed from LSBD have reverted back to the University

of Newcastle.

Following our ongoing discussions with the University of Newcastle, it is the Company’s understanding that the University

of Newcastle cannot finalize licensing of the proprietary rights related to the BPT until the liquidation of LSBD is complete.

timeline for the completion of LSBD’s liquidation is unknown, the Company does not expect any updates or finalization of any license

terms until this occurs.

License Agreement

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

The COV2 License Agreement sets forth our contractual rights and responsibilities

relating to the COV2 Products.

The COV2 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 SARS-CoV-2;

a proprietary smartphone application for the purpose reading, storing, analyzing and providing patient support programs for any one or

(i) a biosensor strip for antibodies against

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

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

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

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

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

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

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

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

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

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

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

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

users to, the COV2 Products;

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

data acquired from the COV2 Products.

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

us for any sublicense.

the COV2 License Agreement, commencing after the receipt of regulatory approval in a jurisdiction, and the earning of revenue we will

be required to pay the Licensor a minimum royalty fee with respect to such jurisdiction for each year, or the “COV2 Minimum Royalty,”

in four equal quarterly installments.

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

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

For each ensuing

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

adjusted for the mutually agreed expected market growth.

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

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

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

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

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

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

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

The royalty fee rate will be reduced from

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

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

biosensor technology (including any improvements made to the biosensor technology by us), the anonymized data collected by us and any

other technology of the Licensor, and all derivations based on, and all proprietary rights in, the foregoing.

The Licensor will have

the right to decide whether to protect or enforce, and the right to control any action relating to the protection and enforcement of,

any of the foregoing intellectual property and proprietary rights.

is no set expiration date for the COV2 License Agreement.

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

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

We expect that

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

the COV2 License Agreement.

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

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

or in the event the Licensor discontinues

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

The COV2 License Agreement also may be

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

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

filed with a priority date of May 15, 2018.

Under the COV2 License Agreement, the Licensor granted to us an exclusive worldwide

license to Licensor’s proprietary rights to the biosensor technology used in the COV2 Products.

We understand that following the appointment of

a liquidator to LSBD on July 21, 2023, the intellectual property (IP) rights we licensed from LSBD have reverted back to the University

of Newcastle.

Following our ongoing discussions with the University of Newcastle, it is the Company’s understanding that the University

of Newcastle cannot finalize licensing of the proprietary rights related to COV2 Products until the liquidation of LSBD is complete.

the timeline for the completion of LSBD’s liquidation is unknown, the Company does not expect any updates or finalization of any

license terms until this occurs.

biosensor business is dependent on the proprietary biosensor technology we licensed 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 filed with

a priority date of May 15, 2018.

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

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

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

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

maintain and enforce its patent and other intellectual property rights.

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

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

If the Licensor elects not to protect or enforce

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

such action would be at our cost and expense.

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.

We understand that following the appointment of

a liquidator to LSBD on July 21, 2023, the intellectual property (IP) rights we licensed from LSBD have reverted back to the University

of Newcastle.

Following our ongoing discussions with the University of Newcastle, it is the Company’s understanding that the University

of Newcastle cannot finalize licensing of the proprietary rights related to the BPT until the liquidation of LSBD is complete.

timeline for the completion of LSBD’s liquidation is unknown, the Company does not expect any updates or finalization of any license

terms until this occurs.

intend to vigorously protect our intellectual property rights for any technologies owned through patents and copyrights, both in the

United States and internationally.

Additionally, we plan to leverage trade secrets, know-how, and continuing technological innovation

to develop and maintain its competitive position.

We intend 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.

We 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 Company.

In addition, we may license additional technologies from third parties.

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 where they are obtained.

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

activities of industry participants.

We face potential competition from major medical device companies worldwide, many of which have

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

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

manufacturing cost, and customer support.

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,

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

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

approving and issuing

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

approving the establishment of enterprises

for pharmaceutical manufacture and distribution;

formulating administrative rules and policies concerning the supervision and administration

of food, cosmetics and pharmaceuticals;

and handling significant accidents involving these products.

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

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.

As of August 14, 2025, we

have 14 full-time employees in Australia and 2 in the United States.

Our subsidiary, IFP, has 37 full time and 2 part time employees in

the United Kingdom.

5 unchanged sentences

devices and solutions.

Available Information

website is at www.ibs.inc .

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

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

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

electronically filed with the 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.

are currently not a party to any pending legal proceeding, nor is our property the subject of a pending legal proceeding that we believe

is not ordinary routine litigation incidental to our business or otherwise material to the financial condition of our business.

website is www.ibs.inc.

We make available, free of charge, on our investor website, https://investors.ibs.inc, our annual report on Form

10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section

13(a) or 15(d) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), as soon as reasonably practicable

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

The SEC maintains an internet site

that contains reports, proxy and information statements and other information regarding issuers that file electronically with the SEC

at www.sec.gov.

Information 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