NASDAQ: INBS
INTELLIGENT BIO SOLUTIONS INC.CIK 0001725430 · SIC 3841 · Surgical & Medical Instruments
In this Annual Report on Form 10-K, unless the context otherwise requires, the terms “we,” “us,” “our,” “Company,” or “INBS” refer to Intelligent Bio Solutions Inc. together with its wholly owned subsidiaries. About this business →
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Latest financial statements
From 10-K filed Aug 19, 2026 (period ending Jun 30, 2026). SEC XBRL (companyfacts) — not generated by the model.
Consolidated Statements of Operations
| Description | Year ended Jun 30, 2026 | Year ended Jun 30, 2025 | Year ended Jun 30, 2024 |
|---|---|---|---|
| Revenue: | |||
| Total revenue / net sales | 4.2 | 3.1 | 3.1 |
| Cost of revenue / cost of sales | 2.2 | 1.8 | 1.7 |
| Gross profit | 2.0 | 1.2 | 1.4 |
| Operating expenses: | |||
| General and administrative | 10.5 | 8.9 | 9.3 |
| Selling, general and administrative | 10.5 | 8.9 | |
| Depreciation and amortization | 1.2 | 1.2 | 1.2 |
| Total operating expenses | 15.3 | 12.7 | 12.1 |
| Operating income | (12.6) | (10.7) | (10.3) |
| Interest expense | 0.01 | 0.03 | 0.2 |
| Other income/(expense), net | 0.1 | 0.07 | 0.09 |
| Net income | (12.4) | (10.6) | (10.2) |
| Basic earnings per share | (8.44) | (20.04) | (6.38) |
| Diluted earnings per share | (8.44) | (20.04) | (6.38) |
Consolidated Balance Sheets
| Description | Jun 30, 2026 | Jun 30, 2025 |
|---|---|---|
| Current assets: | ||
| Cash and equivalents | 4.0 | 1.0 |
| Accounts receivable, net | 0.8 | 0.6 |
| Other receivables, net | — | 0.09 |
| Inventories | 0.4 | 0.6 |
| Prepaid expenses and other current assets | 1.0 | 0.8 |
| Assets held for sale | 0.3 | |
| Other current assets | 0.8 | 0.6 |
| Total current assets | 7.1 | 4.1 |
| Property, plant and equipment, net | 0.3 | 0.3 |
| Operating lease right-of-use assets, net | 1.8 | 0.07 |
| Finite-lived intangible assets, net | 2.7 | 3.7 |
| Identifiable intangible assets, net | 2.8 | 3.8 |
| Other long-term assets | (2.7) | (3.7) |
| TOTAL ASSETS | 11.9 | 8.2 |
| Current liabilities: | ||
| Notes payable, current | 0.2 | |
| Accounts payable | 0.7 | 0.9 |
| Current portion of operating lease liabilities | 0.1 | 0.08 |
| Accrued liabilities | 1.2 | |
| Income taxes payable | 0.2 | 0.08 |
| Other current liabilities | 3.9 | 2.9 |
| Total current liabilities | 4.9 | 5.4 |
| Operating lease liabilities | 1.7 | |
| Total liabilities | 6.7 | 5.4 |
| Shareholders' equity: | ||
| Common stock | 0.03 | 0.01 |
| Capital in excess of stated value | 81.0 | 65.8 |
| Accumulated other comprehensive income (loss) | (0.5) | (0.3) |
| Retained earnings (deficit) | (75.0) | (62.5) |
| Treasury stock | — | — |
| Total shareholders' equity | 5.5 | 3.0 |
| TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | 11.9 | 8.2 |
Consolidated Statements of Cash Flows
| Description | Year ended Jun 30, 2026 | Year ended Jun 30, 2025 |
|---|---|---|
| Operating Activities: | ||
| Net cash from operating activities | (11.9) | (9.7) |
| Investing Activities: | ||
| Net cash from investing activities | (0.09) | (0.2) |
| Financing Activities: | ||
| Net cash from financing activities | 15.0 | 4.6 |
| Net increase/(decrease) in cash | 3.0 | (5.3) |
Amounts in millions USD; EPS as reported. Line labels are presentation-friendly mappings of filer XBRL tags — not a re-audit of the full statements. Use EDGAR for interactive notes and detail. Interactive statements & notes on EDGAR ↗
About INTELLIGENT BIO SOLUTIONS INC.
Source: Item 1 (Business) from the 10-K filed August 19, 2026. Description as filed by the company with the SEC.
ITEM 1. BUSINESS.
In this Annual Report on Form 10-K, unless the
context otherwise requires, the terms “we,” “us,” “our,” “Company,” or “INBS”
refer to Intelligent Bio Solutions Inc. together with its wholly owned subsidiaries.
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. On October 4, 2022, INBS acquired Intelligent Fingerprinting Limited (“IFP”), a company registered in England
and Wales. Our headquarters are in New York City.
Intelligent
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.
On December 12, 2025, the Company filed a certificate of amendment
to its amended and restated certificate of incorporation to effect, as of 11:59 p.m. December 15, 2025, a 1-for-10 reverse stock
split of the Company’s common stock (the “2025 Reverse Stock Split”). The Company’s common stock began trading
on a reverse stock split-adjusted basis on The Nasdaq Capital Market on December 16, 2025. Unless otherwise indicated, all issued and
outstanding shares of common stock, per share amounts and outstanding equity instruments and awards exercisable into common stock have
been retroactively adjusted to reflect the 2025 Reverse Stock Split for all prior periods presented.
Read full description ↓
Our
Testing Platforms
Intelligent
Fingerprinting Platform: The Company’s current active product is the Intelligent Fingerprinting Platform, a proprietary portable
system that analyzes fingerprint sweat using a single-use cartridge and a 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”). The IFP System is a non-invasive, fingerprint sweat-based diagnostic screening
product designed to detect drugs of abuse, including opiates, cocaine, methamphetamine, 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
one minute, and a portable Intelligent Fingerprinting DSR-Plus analysis unit (the “IFP Reader”) that provides on-screen
results in under ten minutes. Samples collected with a confirmatory kit may also be sent to a third-party laboratory service provider
for confirmation testing. Customers include organizations in safety-critical industries such as construction, transportation and logistics,
mining, manufacturing, and engineering, as well as 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 Europe;
●
expanding
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;
●
continuing to work to gather additional supporting data to strengthen
the Company’s new 510(k) submission to the United States Food and Drug Administration (“FDA”);
●
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; and
●
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 certain of the Licensor’s proprietary intellectual
property rights (the “LSBD IP”), which includes the Licensor’s 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. We 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
commencement of the liquidation of LSBD on July 21, 2023, the LSBD IP we licensed from LSBD, which includes the Biosensor IP, has reverted
back to the University of Newcastle. Following our discussions with the University of Newcastle, it is our understanding that the University
of Newcastle cannot finalize licensing of the Biosensor IP until the liquidation, by virtue of the status of LSBD being under external
administration, is completed. As of the date of this Annual Report on Form 10-K the ASIC database maintained by the Australian Securities
and Investments Commission (ASIC) indicates that LSBD (Australian Company Number 613 279 771) is under the status of a company being
under external administration. We do not know the timeline for when LSBD’s liquidation will be complete or when LSBD’s status
will change, and accordingly, we do 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 appropriate licensing arrangements related to the BPT. The Company’s
licensing of intellectual property from LSBD related to the COV2 Products described below, which includes a biosensor strip for antibodies
against SARS-CoV-2, is subject to similar uncertainties and constraints related to the liquidation of LSBD. For more information regarding
our licensing agreements with LSBD, see “Item 1. Business - Technology License Agreements.” We do not believe the Biosensor
Platform licenses have a material impact on the Company.
4
Highlights
of Achievements and Developments
Our highlights of achievements for the fiscal
year 2026:
● On June 16, 2026, the Company announced the initiation of an
Interference Study to support its FDA 510(k) submission for U.S. market clearance of its IFP System for detection of the opiate codeine.
The Company again partnered with CenExel Clinical Research, Inc. to complete the clinical study. The Interference Study assessed
how potentially interfering substances may impact the IFP System’s accuracy and reliability.
● On June 2, 2026, the Company announced the initiation of a multi-site
Method Comparison Study to support its FDA 510(k) submission for U.S. market clearance of its IFP System for the opiate codeine. The
Company partnered with CenExel Clinical Research, Inc., to perform the study, which was designed to evaluate the accuracy of the IFP
System when operated by intended end-users across multiple clinical sites.
● On April 20, 2026, the Company announced the launch of a validation
study aimed at significantly reducing the analysis time of its IFP System.
● On April 17, 2026, the Company announced the successful completion
of penetration testing as part of its upcoming FDA 510(k) submission. The testing identified no major vulnerabilities, verified the robustness
of the Company’s existing security infrastructure, and strengthened its regulatory submission to the FDA.
● On April 2, 2026, the Company announced the successful completion
of its initial clinical Cut-off Study supporting the Company’s FDA 510(k) submission for U.S. market clearance of its IFP System
for detection of the opiate codeine. The clinical Cut-off Study evaluated codeine detection cut-off levels in 40 adults.
● On March 26, 2026, the Company announced it had received European
Patent EP3752831, related to contextualizing fingerprint chemical analysis with fingerprint deposition volume. The grant marked the Company’s
eighth European patent, further enhancing intellectual property rights around its fingerprint sweat drug testing technology.
● On February 25, 2026, the Company announced the successful receipt
and deployment of the first shipment of IFP Readers manufactured under its new strategic manufacturing
partnership with Syrma Johari MedTech Ltd. (“Syrma Johari”). The shipment marked a significant step in scaling the Company’s
production capacity and validated the operational and financial benefits of the collaboration announced in December 2025.
● On February 24, 2026, the Company announced a partnership with
Bouygues UK, a subsidiary of Bouygues Construction, a multi-billion-dollar global construction firm with 35,600 employees, for the deployment
of INBS’s fingerprint drug screening technology across its UK operations.
● On January 28, 2026, the Company announced the commencement
of its clinical study program to support its new FDA 510(k) submission for U.S. market clearance of its IFP System for detection of the
opiate codeine. The Company again partnered with Cliantha Research.
● On January 2, 2026, the Company announced the closing of its previously announced private placement
with two healthcare focused institutional investors priced at-the-market under Nasdaq rules of 2,298,850 shares of common stock (or
pre-funded warrants in lieu thereof), Series K-1 warrants to purchase up to an aggregate of 2,298,850 shares of common stock and
Series K-2 warrants to purchase up to an aggregate of 2,298,850 shares of common stock, at a combined purchase price of $4.35 per
share of common stock (or pre-funded warrant) and associated Series K-1 warrants and Series K-2 warrants, for expected gross
proceeds to INBS of approximately $10.0 million, before deducting placement agent fees and other offering expenses payable by the
Company.
● On December 31, 2025, the Company announced a new strategic
manufacturing partnership with Syrma Johari MedTech Ltd. (“Syrma Johari”), a globally recognized medical device engineering
and manufacturing organization with over 45 years of experience, to support and scale the production of its IFP Reader. The collaboration
is also expected to support long-term margin improvement.
● On December 18, 2025, the Company announced it has entered
into a non-exclusive strategic alliance and collaboration agreement with Vlepis Pty Ltd (“Vlepis”),
an Australian medical and wellbeing technology company specializing in advanced sensing and wearable patch technologies, which better
positions the Company to enter the consumer health monitoring market. Vlepis’ wearable and software-based technologies complement
the Company’s existing portfolio.
5
● On October 23, 2025, the Company announced it has secured a
major new contract with one of the United Kingdom’s largest industrial service providers. The multinational company, a global
leader operating across the energy, defense, nuclear, and industrial sectors, employs more than 30,000 people worldwide and services
complex, safety-critical projects across Europe, the Middle East, and Asia-Pacific.
● On September 26, 2025, the Company provided an update on the
timeline for anticipated FDA 510(k) clearance for the use of its IFP System for the opiate codeine. Following feedback from the
U.S. Food and Drug Administration (FDA), the Company established a pathway to gather additional supporting data to strengthen its new
510(k) submission to the FDA.
● On September 17, 2025, the Company provided an update on its FDA 510(k) clearance process for its
IFP System. In December 2024, the Company submitted its 510(k) premarket notification to the FDA for review and clearance of
its IFP System. The FDA reviewed and responded with questions by issuing an Additional Information (AI) request in February 2025.
This AI request consisted of over 70 items to be addressed by the Company. With the support of specialized FDA consultants and
expert third-party partners, the Company responded to the FDA’s questions and submitted additional information in August 2025.
The FDA appeared to be satisfied with the majority of responses to the items and responded with a request for new additional
information that required the Company to resubmit a new 510(k) notification.
● On August 19, 2025, the Company announced its highest-ever monthly
cartridge sales for July 2025, with a record 519 boxes shipped, representing over 12,500 cartridges and a 60% increase year-on-year.
● On August 6, 2025, the Company announced the submission of its
Additional Information (“AI”) response to the FDA as part of its ongoing 510(k) clearance process for its IFP System. The
response included new positive data that strengthened the Company’s 510(k) submission and further validated the security and performance
of its innovative fingerprint sweat-based drug screening technology.
● On July 30, 2025, the Company announced it had secured a major
contract with one of London’s largest public transport operators, spanning 14 operational sites in greater London and employing
over 4,400 staff.
● On July 25, 2025, the Company announced an agreement between
the Company and several current warrant holders to exercise (or prepay the exercise price) certain existing warrants to purchase up to
2,023,228 shares of common stock (the “Existing Warrants”) at a reduced exercise price of $1.90 per share. The gross proceeds
to the Company from the exercise (or prepayment of the exercise price) of the Existing Warrants were approximately $3.8 million prior
to deducting placement agent fees and estimated offering expenses.
● On July 23, 2025, the Company announced the successful collection
of new data that further reinforces the security and performance of its IFP System, strengthening its FDA 510(k) submission. The
Company completed rigorous cybersecurity testing, including penetration testing and electromagnetic compatibility testing, to validate
the resilience of its system.
● On July 16, 2025, the Company announced a new global distribution
agreement with SMARTOX®, a Texas-based leader in drug and alcohol screening services, to bring its SmarTest Patch drug
detection product to international markets outside of the United States (“U.S”) and Canada. This partnership builds
on the long-standing relationship between INBS and SMARTOX, the U.S. distributor of the Company’s Intelligent Fingerprinting
Drug Testing Solution in the Forensic Use Only market.
● On July 15, 2025, the Company announced the addition of the SmarTest®
Patch to its portfolio of non-invasive drug testing solutions. The SmarTest Patch is an innovative wearable device, developed by SMARTOX®,
that enables continuous drug detection through sweat over a 7 to 10-day period. The SmarTest Patch complements the Company’s flagship
product, the Intelligent Fingerprinting Drug Testing Solution, strengthening its product portfolio of sweat-based, non-invasive
testing technologies.
Our
Products
Intelligent
Fingerprinting Drug Screening System
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. This system eliminates the need for invasive and unpleasant urine, saliva, or blood collection
to test for substance abuse. The ten samples are collected in under a minute before the portable analysis unit provides an on-screen
result in under ten minutes. The IFP System is currently designed to detect opiates, 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.
Intelligent
Fingerprinting Drug Screening System Functionality
The
IFP System consists of single-use, tamper-evident Intelligent Fingerprinting Cartridges for sample collection and the portable IFP Reader 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.
6
History
and Background of the Intelligent Fingerprinting Drug Screening System
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 IFP 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 IFP System in its factory in Cambridge, England.
Research
and Development
Our
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:
1.
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.
2.
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.
3.
Exploring 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.
To
facilitate the expansion of point-of-care testing into additional areas of interest, such as tumor markers, hormones, and allergies,
the core team will collaborate with external research specialists. This joint exploration aims to unlock the untapped potential applications
of 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.
Regulatory
Matters
The
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. Their
primary responsibilities include evaluating, registering and approving new drugs, generic drugs and imported drugs; approving and issuing
permits for the manufacture, export and import of pharmaceutical products and medical appliances; approving the establishment of enterprises
for pharmaceutical manufacture and distribution; formulating administrative rules and policies concerning the supervision and administration
of food, cosmetics and pharmaceuticals; and handling significant accidents involving these products.
The
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.
The
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.
Our 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. Additionally, 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 operations meet the ISO 17025 standard.
Australia: We are permitted
to sell the IFP System as a drug screening device in Australia and have obtained accreditation from NATA (National Association of Testing
Authorities, Australia).
We 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. RASL laboratory operations meet the ISO 17025 standard.
7
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 are focused on securing FDA 510(k) clearance for the IFP System’s opiate test 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 2026, 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.
Other
Regions: Distributors in other countries and jurisdictions will be responsible for obtaining all necessary approvals within their
respective territories.
Manufacturing
The
equipment and facilities required to produce the Intelligent Fingerprinting Drug Screening Cartridge and DSR-Plus Reader (IFP
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 13485 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; 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.
Furthermore,
we have also outsourced the manufacturing of IFP Reader via strategic manufacturing partnership
to third parties. We ensure that our manufacturing partners adhere to stringent quality criteria including ISO 13485, MDSAP, FDA,
TUV SUD, and GMP standards, ensuring world-class compliance and quality in medical device manufacturing.
The
U.S. Food and Drug Administration (FDA) finalized the Quality Management System Regulation (QMSR) to harmonize its medical
device quality system requirements with ISO 13485:2016. The QMSR became effective on February 2, 2026, replacing the previous Quality
System Regulation (QSR) framework in 21 CFR Part 820. Rather than maintaining a standalone set of FDA quality system requirements,
the QMSR incorporates ISO 13485:2016 by reference while preserving certain FDA-specific statutory and regulatory requirements,
such as provisions related to records, complaint handling, labeling, and other obligations under the Federal Food, Drug, and Cosmetic
Act. Intelligent Fingerprinting Ltd has the framework for medical device manufacture which enables it to comply with QMSR set out by
the FDA. IFP are also FDA site registered.
Distribution
and Sales
We
currently serve over 502 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:
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. 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.
United Kingdom: Our direct sales team consists
of five sales representatives and a National Sales Manager under the direction of the Vice President of Global 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.
Australia: 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. We also intend to utilize distributor partnerships to cover
regions such as Western Australia, South Australia, and other remote areas.
8
United States: Upon our
planned 510(k) 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.
European
Expansion: We will appoint a dedicated European representative to identify, negotiate, and sign distributor agreements and maximize
sales in target territories.
Expanding
into the Middle East and Africa (“MEA”): Our 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.
Market
Analysis and Opportunity
The
Drug Screening Market
The
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
misuse is a global concern, and while the approach to this problem varies depending on the legal and regulatory landscape of each country,
what remains constant is the need for regular testing, particularly in areas and industries of concern. Even in regions where certain
drugs, such as cannabis, have been decriminalized (such as in various states across the United States, Canada, and Europe), social and
workplace challenges persist relating to impairment, drug dependency and associated criminal activity, which increase the need for testing.
9
Point
of Care / Rapid Diagnostics Market
According
to the Point of Care/Rapid Diagnostics Market report by MarketsandMarkets1, 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)
of 10.7%. 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.
Within
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 20302. 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 20303.
These
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.
There
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, benzodiazepines, and nicotine. Stimulants include
cocaine, methamphetamine, and ecstasy (MDMA). Hallucinogens include LSD, psilocybin and ketamine.
According
to the 2024 World Drug Report published by the United Nations Office on Drugs and Crime, the emergence of new synthetic opiates 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. Cannabis
remains the world’s most used drug, with 228 million users. Opiate 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 opiates
which can be even more potent than fentanyl, have recently emerged in several high-income countries, resulting in an increase in overdose
deaths. Though an estimated 64 million people worldwide suffer from drug use disorders, only one in 11 is in treatment4.
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 2022. Of those, only 13.1 million received any form of treatment5. 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 services6.
1
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.
2
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.
3
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.
4
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.
5
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.
6
Executive Office of the President, Office of National Drug Control Policy (ONDCP) 2024, National Drug Control Strategy: Performance
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.
10
Intellectual
Property
The
following patents are owned by IFP.
Primary
Patent Families - technologies that are either used in the commercial products or closely related to the commercial products.
Patent
Numbers and Geographical Coverage
Description
Expiry
UK
(GB 2528657)
Germany
(via Europe) (DE 602015039916.1)
France
(via Europe) (EP(FR) 3172566)
UK
(via Europe) (EP(GB) 3172566)
Netherlands
(via Europe) (EP(NL) 3172566)
Australia
(AU 2015293652)
Canada
(CA 2956026)
Japan
(JP 6621462)
US
(US 12259385)
The
lateral flow – broad concept – is directed to a lateral flow strip that are being used in the commercial product
This
family was filed in 2014 and is estimated to expire in 2034-2035.
Germany
(via Europe) (DE 602016018952.6)
France
(via Europe) (EP(FR) 3262413)
UK
(via Europe) (EP(GB) 3262413)
Netherlands
(via Europe) (EP(NL) 3262413)
Australia
(AU 2016225217)
Canada
(CA 2977891)
China
(CN ZL201680012388.4)
Japan
(JP 6694892)
US
(US 11150243)
The
lateral flow cartridge family- is directed to the lateral flow-based fingerprint cartridge used in the commercial product
This
family was filed in 2015 and is estimated to expire in 2035-2036.
UK
(GB 2561165)
Australia
(AU 2018247080)
European
Unitary (EP 3600034)
UK
(via Europe) (EP 3600034)
US
(US 11227140)
The
confirmation cartridge family - is directed to the confirmation cartridge used in the commercial product
This
family was filed in 2017 and is estimated to expire in 2037-2038.
UK
(GB 2592432)
Australia (AU2021225394) (Pending)
Australia
(AU 2021225394)
European
Unitary (EP 4111173)
UK
(via Europe (EP(GB) 4111173)
US
(US 17/904887)
The
lateral flow test strip reader family - is directed to the DSR-Plus reader (IFP Reader) used in the commercial
product
This
family was filed in 2020 and is estimated to expire in 2040-2041.
Secondary
/ Tertiary Patent Families
UK
(GB 2517737)
Australia
(AU 2014313919)
US
(US 10617397)
The
first cartridge family - is directed to a sample cartridge that is no longer being sold or used.
This
family was filed in 2013 and is estimated to expire in 2033-2034.
UK
(GB 2520063)
Germany
(via Europe) (EP(DE) 3065640)
France
(via Europe) (EP(FR) 3065640)
UK
(via Europe) (EP(GB) 3065640)
Netherlands
(via Europe) (EP(NL) 3065640)
Australia
(AU 2014345356)
Japan
(JP 6568063)
US
(US 10254277)
The
microfluidics family - is directed to a reagent cartridge component that is not used in the commercial product.
This
family was filed in 2006 and is estimated to expire in 2026-2027.
UK
(GB 2528654)
Germany
(via Europe) (DE 602015039053.9)
France
(via Europe) (EP(FR) 3171847)
UK
(via Europe) (EP(GB) 3171847)
Netherlands
(via Europe) (EP(NL) 3171847)
Australia
(AU 2015293654)
US
(US 10675222)
The
medication dispenser family - is directed to a reagent cartridge that is not used in the commercial product.
This
family was filed in 2014 and is estimated to expire in 2034-2035.
UK
(GB 2552823)
Europe
(EP 17752467.5) (Pending)
The
project ridgeway family is directed to a waveguide device that is not used in the commercial product.
This
family was filed in 2016 and is estimated to expire in 2036-2037.
UK
(GB 2570944)
Europe
(EP 3752831)
The
ecosystem family is directed to a method for chemical analysis that is not used in the commercial product
This
family was filed in 2019 and is estimated to expire in 2039.
UK
(GB 2570945)
Europe
(EP 3752954)
The
project ridgeway with calibration family is directed to an improved waveguide device that is not used in the commercial product
This
family was filed in 2018 and is estimated to expire in 2038-2039.
UK
(GB 2577237)
The
project matchbox family is directed to a method for quantifying a skinprint that is not used in the commercial product.
This
family was filed in 2018 and is estimated to expire in 2038.
The
patents listed above cover virtually all aspects of fingerprint diagnostics including: chemistry, screening cartridge technology, collection
cartridge technology, fingerprint quantitation, fingerprint controlled medication dispenser, lab testing of fingerprints, accessories,
and lateral flow test strip reader.
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Technology
License Agreements
We
had entered into following technology license agreements with Life Science Biosensor Diagnostics Pty Ltd (incorporated in New South Wales,
Australia (LSBD), which subsequently went into liquidation:
1)
The 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.
2)
The technology license agreement dated June 23, 2020 (the “COV2 License Agreement”), for COV2 diagnostic test globally.
In
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.
We
do not believe the above Biosensor Platform licenses or interests have a material impact on the Company.
For
a discussion of the commencement of the liquidation of LSBD, the reversion of the intellectual property we have licensed from LSBD (including
the Biosensor IP and COV2 IP) to the University of Newcastle, the status of LSBD’s external administration, and the resulting postponement
of further development of the BPT pending finalization of appropriate licensing arrangements, see “Item 1. Business - Our Testing
Platforms - Biosensor Platform.”
BPT
License Agreement
Under
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 commencement of the liquidation of LSBD on July 21, 2023, the LSBD IP we licensed from LSBD, which includes
the Biosensor IP, has reverted back to the University of Newcastle. Following our discussions with the University of Newcastle, it is
our understanding that the University of Newcastle cannot finalize licensing of the Biosensor IP until the liquidation, by virtue of
the status of LSBD being under external administration, is completed. As of the date of this Annual Report on Form 10-K the ASIC database
maintained by the Australian Securities and Investments Commission (ASIC) indicates that LSBD (Australian Company Number 613 279 771)
is under the status of a company being under external administration. We do not know the timeline for when LSBD’s liquidation will
be complete or when LSBD’s status will change, and accordingly, we do 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 appropriate licensing
arrangements related to the BPT.
COV2
License Agreement
On
June 23, 2020, we entered into a COV2 License Agreement, with LSBD. The COV2 License Agreement sets forth our contractual rights and
responsibilities relating to the COV2 Products. The “COV2 Products” include: (i) a biosensor strip for antibodies against
SARS-CoV-2; (ii) a proprietary smartphone application for the purpose reading, storing, analyzing and providing patient support programs
for any one or more of the indicators for the purpose of measuring the amount or concentration of immunoglobulins (IgG, IgM, IgA) specific
to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2); 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). 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 commencement of the liquidation of LSBD on July 21, 2023, the LSBD IP we licensed from LSBD, which includes
the Biosensor IP, has reverted back to the University of Newcastle. Following our discussions with the University of Newcastle, it is
our understanding that the University of Newcastle cannot finalize licensing of the COV2 IP until the liquidation, by virtue of
the status of LSBD being under external administration, is completed. As of the date of this Annual Report on Form 10-K the ASIC database
maintained by the Australian Securities and Investments Commission (ASIC) indicates that LSBD (Australian Company Number 613 279 771)
is under the status of a company being under external administration. We do not know the timeline for when LSBD’s liquidation will
be complete or when LSBD’s status will change, and accordingly, we do not expect any updates or finalization of any license terms
until this occurs. As a result, further development of the COV2 Products has been postponed until we are able to finalize appropriate licensing
arrangements related to the COV2 Products.
Intellectual
Property Protection
We
vigorously protect our intellectual property rights for any technologies owned through patents and copyrights, both in the United States
and internationally. Additionally, we leverage trade secrets, know-how, and continuing technological innovation to develop and maintain
our competitive position. We protect 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 our proprietary information. We generally require employees to assign patents and other intellectual property to the Company 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. 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.
12
The
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. 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.
Competition
IFP
has developed a Point of Care (POC) drug screening test system and a drug laboratory-based confirmation testing service. Both of these
involve the collection of fingerprint sweat samples for analysis. For many years, competitor POC and confirmation tests 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:
1.
Non-Invasive
sample collection: Fingerprint sweat can be collected within seconds from any location without needing trained specialists, gender-specific
collectors or prepared collection areas. The sweat from the fingerprints is collected simply by pressing each finger onto a disposable
sample collection cartridge for five seconds. In contrast, the collection of urine and oral fluid samples can take several hours
and requires trained collectors. Collection areas must be specially prepared, and sample collection should be observed directly to
avoid cheating tests. This is highly invasive, particularly in the case of urine.
2.
Hygienic
and non-biohazardous: Fingerprint sweat samples are non-biohazardous, so the screening and collection kit material can be disposed
of in routine waste or recycled. Kits used to collect urine and saliva are a potential biohazard and must be treated as such –
either incinerated or into landfill.
3.
Accurate
Results: The results of conventional urine and oral fluid POC drug screening tests require reading the test results by interpreting
the presence or absence of colored test lines using the naked eye. Often these test lines are weak and difficult to see, leading
to inaccuracy in reading the test result. In contrast, the results of the IFP screening test are provided automatically by the IFP
Reader unit, providing an unambiguous test result that does not require any user interpretation, increasing the accuracy of the test.
The
combination of these benefits shows that fingerprint drug testing provides a more cost-effective, less invasive and more dignified method
when compared to urine and oral fluid-based tests.
The
table below compares the IFP System to other drug testing systems:
The
IFP System eliminates the need for highly trained technicians or personal protective equipment, providing a non-invasive and objective
testing experience. Its unique 16-hour detection window makes it ideal for assessing an individual’s fitness for work at the time
of testing. 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.
13
We
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 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).
The
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
resources. Our overall competitive position depends upon several factors, including product performance and reliability, connectivity,
manufacturing cost, and customer support.
Human
Capital
As of
June 30, 2026, we have 13 full-time employees in Australia and 2 in the United States. Our subsidiary, IFP, has 44 full time
and 1 part time employees in the United Kingdom.
Our
team, including our employees, contractors, and collaborators, comprises multiple cross-functional units, including strategy, project
management, technical engineering, manufacturing and supply chain, quality assurance, legal and compliance, regulatory affairs, clinical
affairs, product management, marketing, systems engineering, human resources, IT, investor relations, and finance. Our team collectively
possesses the experience and capabilities to build a robust medical technology company that develops next-generation non-invasive medical
devices and solutions.
Legal
Proceedings
We
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.
Available
Information
Our
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.
14