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What changed in INTELLIGENT BIO SOLUTIONS INC.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of INTELLIGENT BIO SOLUTIONS INC.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+346 added−430 removedSource: 10-K (2025-08-15) vs 10-K (2024-09-18)

Top changes in INTELLIGENT BIO SOLUTIONS INC.'s 2025 10-K

346 paragraphs added · 430 removed · 236 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

51 edited+44 added−58 removed43 unchanged
Biggest changeEven 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.
Biggest changeEven 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. 7 Point of Care / Rapid Diagnostics Market According 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) of 10.7%.
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.
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.
Competition 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.
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.
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.
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.
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.
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.
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. 16 The issuance of a patent does not ensure that it is valid or enforceable.
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. The issuance of a patent does not ensure that it is valid or enforceable.
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.
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.
UK (GB 2570945) Europe (EP 19707069.1) (Pending) 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 2570945) Europe (EP 19707069.1) 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.
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. 10 Competition IFP has developed a Point of Care (POC) drug screening test system and a drug laboratory-based confirmation testing service.
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. 9 Competition IFP has developed a Point of Care (POC) drug screening test system and a drug laboratory-based confirmation testing service.
The below table compares the IFP System to other drug testing systems: 11 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.
The table below compares the IFP System to other drug testing systems: 10 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.
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 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.
Expanding into the Middle East and Africa (“MEA”): The Company’s Vice President of Global Sales and the dedicated European representative will initially manage MEA operations. Depending on market opportunities and sales volume, the Company may appoint a dedicated distribution leader for MEA operations at a later stage.
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.
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 15/328799) (Pending) 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.
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.
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. The 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.
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. 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.
Our subsidiary, IFP, has 37 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 subsidiary, IFP, has 37 full time and 2 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.
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.
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.
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: The Company utilizes a third-party sales agency under the direction of the Global Vice President of Sales.
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 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. 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 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.
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 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.
Our reference to the URL for our website is intended to be an inactive textual reference only. 18
Our reference to the URL for our website is intended to be an inactive textual reference only. 14
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) The COV2 Products only include products that are supplied by an authorized supplier.
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).
The Company has quality and regulatory oversight of sub-contracted reference laboratories, where its methodology is accredited by the United Kingdom Accreditation Service (UKAS), ensuring that the laboratory operates according to the ISO 17025 standard.
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.
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.
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 Company further intends to utilize distributor partnerships to cover regions such as Western Australia, South Australia, and more remote areas. 7 United States: 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.
We also intend to utilize distributor partnerships to cover regions such as Western Australia, South Australia, and more remote areas. 6 United States: 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.
The Company plans to focus on identifying distributors and partners already operating within the U.S. drug screening market. European Expansion: The Company plans to appoint a dedicated European representative to identify, negotiate, and sign distributor agreements and maximize sales in targeted territories.
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.
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. Available Information Our website is at www.ibs.inc .
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.
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.
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. 13 Human Capital As of August 14, 2025, we have 14 full-time employees in Australia and 2 in the United States.
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, the Company may license additional technologies from the Licensor or third parties.
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.
UK (GB 2592432) Australia (AU 2021225394) (Pending) European Unitary (EP 4111173) UK (via Europe (EP 4111173) US (US 17/904887) (Pending) The lateral flow test strip reader family - is directed to the DSR-Plus reader used in the commercial product This family was filed in 2020 and is estimated to expire in 2040-2041. 9 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.
UK (GB 2592432) Australia (AU 2021225394) (Pending) European Unitary (EP 4111173) UK (via Europe (EP 4111173) US (US 17/904887) (Pending) The lateral flow test strip reader family - is directed to the DSR-Plus reader used in the commercial product This family was filed in 2020 and is estimated to expire in 2040-2041.
The Company’s current product portfolio includes: ● Intelligent Fingerprinting Platform: A proprietary portable platform that analyzes fingerprint sweat using a one-time cartridge and portable handheld reader.
Our 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.
Biosensor Platform Technology 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 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.
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.
Distribution and Sales The Company serves over 400 active customer accounts, primarily in the United Kingdom, with additional customers across various global locations. The 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.
Distribution and Sales We 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.
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. 17 Human Capital As of September 16, we have 11 full-time employees in Australia and 2 in the United States.
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.
IFP continues to manufacture the cartridges for the Fingerprinting Drug Screening System in its factory in Cambridge, England. Research and Development The Company’s research and development (R&D) team collaborates with external specialist organizations across jurisdictions to conduct comprehensive R&D initiatives. These collaborative efforts are currently driven by the following primary objectives: 1.
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.
Manufacturing The 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.
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 are in place at our manufacturing facility in Cambridge, UK, which is used for fabrication and quality control.
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. 5 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.
The Company further announced that it received its first order under this agreement, from a Chile-based electrical distribution company. Intelligent Fingerprinting Drug Screening System The 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.
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 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.
Our overall competitive position depends upon several factors, including product performance and reliability, connectivity, manufacturing cost, and customer support. 11 Technology License Agreements We had entered into following technology license agreements with LSBD, which is now in 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.
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 Intelligent Fingerprinting DSR-Plus Reader and Cartridge system, which has been predominantly sold in the United Kingdom, mainland Europe and the Middle East.
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 IFP System in its factory in Cambridge, England.
Intelligent 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.
Intelligent Fingerprinting Drug Screening System Functionality 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.
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’s R&D, manufacturing facilities and operations for drug screening products adhere to stringent quality criteria, complying with ISO 13485 for In Vitro Diagnostic Devices and Medical Devices, as well as ISO 9001.
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.
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. 12 Technology 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.
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.
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.
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.
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.
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.
The Recreational Drug Industry There are four principal categories of recreational drugs - analgesics, depressants, stimulants, and hallucinogens. Analgesics include narcotics like heroin, morphine, fentanyl, and codeine. Depressants include alcohol, barbiturates, tranquilizers, and nicotine. Stimulants include cocaine, methamphetamine, and ecstasy (MDMA).
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).
A similar device with no dielectric layer. Further devices including a porous wicking layer to facilitate onset of device function.
A similar device with no dielectric layer. Further devices including a porous wicking layer to facilitate onset of device function. 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.
No assurance can be given that there will not be significant direct competition for our products in the APAC Region following the expiration of patent protection. 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.
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. 12 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.
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.
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.
The 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.
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. We intend to vigorously protect our intellectual property rights for any technologies owned through patents and copyrights, both in the United States and internationally.
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. Intellectual Property The following patents are owned by IFP. Patent Families Primary Patent Families - technologies that are either used in the commercial products or closely related to the commercial products.
Primary Patent Families - technologies that are either used in the commercial products or closely related to the commercial products.
Customers include safety-critical industries such as construction, transportation and logistics, manufacturing, engineering, drug treatment organizations in the rehabilitation sector, and judicial organizations. ● The 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”).
Customers include safety-critical industries such as construction, transportation and logistics, mining, manufacturing, engineering, drug treatment organizations in the rehabilitation sector, and judicial organizations.
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A timeline for these discussions has not yet been established. 3 Highlights of Achievements and Developments Our major highlights of achievements for the fiscal year 2024: ● As 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 securities. ● On 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”) .
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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; ● 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; and ● developing a strategic network of distributors with established customer bases throughout the APAC Region, Europe and North America to distribute the IFP Products.
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The Company expects to complete the full PK study in the third calendar quarter of 2024. ● On 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.
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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”.
Removed
Initiating the clinical studies plan represented a critical milestone for the Company. ● 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.
Added
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.
Removed
This accreditation serves as an independent benchmark for technical validation, demonstrating the Company’s commitment to product quality, safety, and reliability for its customers. 4 ● During 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.
Added
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.
Removed
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.
Added
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.
Removed
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. ● On 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.
Added
Business - Technology License Agreements.” Reportable Segments 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.
Removed
Expansion into New Zealand demonstrates the Company’s ability to introduce its product in new markets.
Added
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 licensor.
Removed
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. ● On 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.
Added
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. Our new reportable segments are: (i) United Kingdom; (ii) Asia Pacific (APAC); (iii) Americas; and (iv) Rest of World.
Removed
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. ● On 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.
Added
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.
Removed
The recertification took effect on October 14, 2023, and is valid for three years.
Added
Historical 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.
Removed
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. ● On 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. ● On 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.
Added
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. 3 Highlights of Achievements and Developments Our major highlights of achievements for the fiscal year 2025: ● 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.
Removed
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.
Added
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.
Removed
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. ● On 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. ● On 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.
Added
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.
Removed
Australia: 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 customers.
Added
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.
Removed
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. 6 United States of America: In February 2024, the Company entered into a partnership with Cliantha Research to conduct the pharmacokinetic (PK) study.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

133 edited+30 added−99 removed180 unchanged
Biggest changeIf available, financing terms may lead to significant dilution of our stockholders’ equity. ● Our independent registered public accounting firm has included an explanatory paragraph relating to our ability to continue as a going concern in its report on our audited financial statements included in our Annual Report on Form 10-K for the Fiscal year ended June 30, 2024. ● Neither we nor the Licensor have yet launched the BPT and the ability to do so will depend on the acceptance of the BPT in the global healthcare market. ● We have incurred significant losses since inception and continue to incur losses, and we may not be able to achieve significant revenues or profitability. ● We rely on third parties to perform certain confirmatory tests for our IFP Drug Screening System. ● We depend on a limited number of single-source suppliers to manufacture certain components of IFP Drug Screening System, which makes us vulnerable to supply shortages and price fluctuations that could negatively affect our business, financial condition and results of operations. ● Our results may be impacted by changes in foreign currency exchange rates. ● If we fail to retain marketing and sales personnel, or if we fail to increase our marketing and sales capabilities as we grow, or if we fail to develop broad awareness of our product in a cost-effective manner, we may not be able to generate revenue growth. ● The license agreement with the Licensor, which covers the license of the core technology used in our Biosensor Platform products, contains significant risks that may have a material adverse effect on us and our business, assets and prospects ● If the BPT fails to satisfy current or future customer requirements, we may be required to make significant expenditures to redesign the product candidate, and we may have insufficient resources to do so. ● We are yet to finalize the manufacturing plan for the production of the BPT on a mass market commercial scale, and may be dependent upon third-party manufacturers and suppliers, making us vulnerable to contractual relationships and market forces, supply problems and price fluctuations, which could harm our business. ● We expect to rely in part on third-party distributors to effectively distribute our products, if our distributors fail to effectively market and sell the BPT and IFP products in full compliance with applicable laws, our operating results and business may suffer. ● As we intend to conduct business internationally, we are susceptible to risks associated with international relationships, which could adversely impact our results of operations and financial condition. ● If third-party payors do not provide coverage and reimbursement for the use of the BPT and IFP products, our business and prospects may be negatively impacted. ● Non-United States governments often impose price controls, which may adversely affect our profitability. ● The BPT and IFP Drug Screening System may contain undetected errors, which could limit our ability to provide our products and services and diminish the attractiveness of our service offerings. ● We will rely on the proper function, security and availability of our information technology systems and data to operate our business, and a breach, cyber-attack or other disruption to these systems or data could materially and adversely affect our business, results of operations, financial condition, cash flows, reputation or competitive position. ● If we are not able to attract and retain highly skilled managerial, scientific and technical personnel, we may not be able to implement our business model successfully. ● If we or our manufacturers fail to comply with applicable regulations, our proposed operations could be interrupted, and our operating results may be negatively impacted. ● We may be subject to healthcare laws and regulations which, if violated, could subject us to substantial penalties. ● Product liability suits, whether or not meritorious, could be brought against us due to an alleged defective product or for the misuse of the BPT and IFP Drug Screening System. 19 ● If we are found to have violated laws protecting the confidentiality of patient health information, we could be subject to penalties, which could increase our liabilities and harm our reputation or our business. ● The regulatory clearance/approval process which we may be required to navigate may be expensive, time-consuming, and uncertain and may prevent us from obtaining clearance for any product launch by the Company of the BPT and IFP products in certain jurisdiction or our any future product. ● Clinical data obtained subsequent to the implementation of the clinical evidence module may not meet the required objectives, which could delay, limit or prevent additional regulatory clearance or approval. ● We may be unable to complete required clinical evaluations, or we may experience significant delays in completing such clinical evaluations, which could prevent or significantly delay our targeted product launch timeframe and impair our business plan. ● We are subject to the risk of reliance on third parties to conduct our clinical evaluation work, their inability to comply with good clinical practice and relevant regulation could adversely affect the clinical development of our product candidates and harm our business. ● Our success will depend on our ability to obtain, maintain and protect our intellectual property rights. ● We are subject to risk related to the possibility of modifications to our rights to, or the Company’s ability to use, the Licensed Products in relation to the Biosensor Platform due to liquidation of the Licensor, which could materially and adversely affect the Company’s planned business, financial condition, and operating results. ● We depend on intellectual property licensed from the Licensor for our BPT related products, and any absence of legal effect of the license or dispute over the license would significantly harm our BPT related business. ● We will depend primarily on the Licensor to file, prosecute, maintain, defend and enforce intellectual property that we license from it and that is material to our business. ● We and the Licensor may be unable to protect or enforce the intellectual property rights licensed to us, which could impair our competitive position. ● We and where applicable, the Licensor of our products have limited foreign intellectual property rights and may not be able to protect those intellectual property rights, which means that we and/or Licensor may not be able to prevent third parties from practicing our inventions or from selling or importing products made using those inventions. ● We and the Licensor may be subject to claims challenging the invention of the intellectual property we license. ● Our products and operations are subject to extensive government regulation.
Biggest changeIf available, financing terms may lead to significant dilution of our stockholders’ equity. ● Our independent registered public accounting firm has included an explanatory paragraph relating to our ability to continue as a going concern in its report on our audited financial statements included in our Annual Report on Form 10-K for the Fiscal year ended June 30, 2025. ● We have incurred significant losses since inception and continue to incur losses, and we may not be able to achieve significant revenues or profitability. ● We rely on third parties to perform certain confirmatory tests for our IFP System. ● We depend on a limited number of single-source suppliers to manufacture certain components of IFP System, which makes us vulnerable to supply shortages and price fluctuations. ● Our results may be impacted by changes in foreign currency exchange rates. ● If we fail to retain marketing and sales personnel, or if we fail to increase our marketing and sales capabilities as we grow, or if we fail to develop broad awareness of our products in a cost-effective manner, we may not be able to generate revenue growth. ● Our ability to achieve profitability depends in part on maintaining or increasing our gross margins on product sales which we may not be able to achieve. ● We expect to rely in part on third-party distributors to effectively distribute our products, if our distributors fail to effectively market and sell the IFP products in full compliance with applicable laws, our operating results and business may suffer. ● If third-party payors do not provide coverage and reimbursement for the use of the IFP products, our business and prospects may be negatively impacted. ● Non-United States governments often impose strict price controls, which may adversely affect our future profitability. ● The IFP System, including its software and systems, may contain undetected errors, which could limit our ability to provide our products and services and diminish the attractiveness of our service offerings. ● If we are not able to attract and retain highly skilled managerial, scientific and technical personnel, we may not be able to implement our business model successfully. ● If we or our manufacturers fail to comply with applicable regulatory quality system regulations or any applicable equivalent regulations, our proposed operations could be interrupted, and our operating results may be negatively impacted. ● We may be subject to healthcare laws and regulations which, if violated, could subject us to substantial penalties. ● Product liability suits, whether or not meritorious, could be brought against us due to an alleged defective product or for the misuse of the IFP System. ● If we are found to have violated laws protecting the confidentiality of patient health information, we could be subject to civil or criminal penalties, which could increase our liabilities and harm our reputation or our business. ● Changes to U.S. tax laws under the One Big Beautiful Bill Act and potential changes to tariff policies could adversely affect our business, financial condition, and results of operations. ● The regulatory clearance/approval process which we may be required to navigate may be expensive, time-consuming, and uncertain and may prevent us from obtaining clearance for any product launch by the Company of the IFP products in certain jurisdiction or our any future product. ● Clinical data obtained subsequent to the implementation of the clinical evidence module may not meet the required objectives, which could delay, limit or prevent additional regulatory clearance or approval. ● We may be unable to complete required clinical evaluations, or we may experience significant delays in completing such clinical evaluations, which could prevent or significantly delay our targeted product launch timeframe and impair our business plan. ● We are subject to the risk of reliance on third parties to conduct our clinical evaluation work, their inability to comply with good clinical practice and relevant regulation could adversely affect the clinical development of our product candidates and harm our business. ● Our success will depend on our ability to obtain, maintain and protect our intellectual property rights. ● We may be unable to protect or enforce our intellectual property rights, including those licensed to us, which could impair our competitive position. ● We have limited foreign intellectual property rights and may not be able to protect those intellectual property rights, which means that we may not be able to prevent third parties from practicing our inventions or from selling or importing products made using those inventions. ● We may be subject to claims challenging the invention of the intellectual property that we use. ● Our products and operations are subject to extensive government regulation and oversight both in the United States and abroad.
If we are unsuccessful in attracting new capital, we may not be able to continue operations or may be forced to sell assets to do so. Alternatively, capital may not be available to us on favorable terms, or at all. If available, financing terms may lead to significant dilution of our stockholders’ equity.
If we are unsuccessful in attracting new capital, we may not be able to continue operations or may be forced to sell assets to do so. Alternatively, capital may not be available to us on favorable terms, or if at all. If available, financing terms may lead to significant dilution of our stockholders’ equity.
If we seek additional financing to fund our business activities in the future and there remains substantial doubt about our ability to continue as a going concern, investors or other financing sources may be unwilling to provide additional funding to us on commercially reasonable terms or at all.
If we seek additional financing to fund our business activities in the future and there remains substantial doubt about our ability to continue as a going concern, investors or other financing sources may be unwilling to provide additional funding to us on commercially reasonable terms or if at all.
In addition, if we experience a significant increase in demand, additional supplies of raw materials or additional manufacturing capacity may not be available when required on terms that are acceptable to us, or at all, or suppliers may not be able to allocate sufficient capacity in order to meet our increased requirements, which will negatively affect our business, financial condition and results of operations.
In addition, if we experience a significant increase in demand, additional supplies of raw materials or additional manufacturing capacity may not be available when required on terms that are acceptable to us, or at all, or suppliers or may not be able to allocate sufficient capacity in order to meet our increased requirements, which will negatively affect our business, financial condition and results of operations.
Although we believe that we and the Licensor take reasonable steps to protect our intellectual property, including the use of agreements relating to the non-disclosure of confidential information to third parties, as well as agreements that purport to require the disclosure and assignment to us of the rights to the ideas, developments, discoveries and inventions of our employees and consultants while we or the Licensor employ them, the agreements can be difficult and costly to enforce.
Although we believe that we take reasonable steps to protect our intellectual property, including the use of agreements relating to the non-disclosure of confidential information to third parties, as well as agreements that purport to require the disclosure and assignment to us of the rights to the ideas, developments, discoveries and inventions of our employees and consultants while we or the Licensor employ them, the agreements can be difficult and costly to enforce.
Furthermore, even if we are granted regulatory clearances or approvals, they may include significant limitations on the indicated uses for the product, which may limit the market for the product.
Furthermore, even if we are granted regulatory clearances or approvals, they may include significant limitations on the indicated uses for the product, which may limit the market for product.
Our products may also contain hazardous substances, and they are subject to laws and regulations relating to labelling requirements 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.
Our products may also contain hazardous substances, and they are subject laws and regulations relating to labelling requirements and to their sale, collection, recycling, treatment, storage and disposal. Compliance with these laws and regulations may be expensive and noncompliance could result in substantial fines and penalties.
If we fail to comply with present or future regulatory requirements that are applicable to us, we may be subject to enforcement action by regulatory agencies, which may include, among others, any of the following sanctions: ● untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties; ● customer notification, or orders for repair, replacement or refunds; ● voluntary or mandatory recall or seizure of our current or future products; ● imposing operating restrictions, suspension or shutdown of production; ● refusing our requests for clearance or pre-market approval of new products, new intended uses or modifications to the BPT, IFP products or future products; ● rescinding clearance or suspending or withdrawing pre-market approvals that have already been granted; and ● criminal prosecution.
If we fail to comply with present or future regulatory requirements that are applicable to us, we may be subject to enforcement action by regulatory agencies, which may include, among others, any of the following sanctions: ● untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties; ● customer notification, or orders for repair, replacement or refunds; ● voluntary or mandatory recall or seizure of our current or future products; ● imposing operating restrictions, suspension or shutdown of production; ● refusing our requests for clearance or pre-market approval of new products, new intended uses or modifications to the IFP products or future products; ● rescinding clearance or suspending or withdrawing pre-market approvals that have already been granted; and ● criminal prosecution.
If our remediation of the material weaknesses is not effective, or if we experience additional material weaknesses in the future or otherwise fail to maintain an effective system of internal controls in the future, we may not be able to accurately or timely report our financial condition or results of operations, which may adversely affect investor confidence in us and, as a result, the value of our common stock. ● We are obligated to maintain a system of effective internal control over financial reporting.
If our remediation of the material weaknesses is not effective, or if we experience additional material weaknesses in the future or otherwise fail to maintain an effective system of internal controls in the future, we may not be able to accurately or timely report our financial condition or results of operations, which may adversely affect investor confidence in us and, as a result, the value of our common stock. ● We are obligated to develop and maintain a system of effective internal control over financial reporting.
If our information technology systems, products or services or sensitive data are compromised, patients or employees could be exposed to financial or medical identity theft or suffer a loss of product functionality, and we could lose existing customers, have difficulty attracting new customers, have difficulty preventing, detecting, and controlling fraud, be exposed to the loss or misuse of confidential information, have disputes with customers, physicians, and other health care professionals, suffer regulatory sanctions or penalties, experience increases in operating expenses or an impairment in our ability to conduct our operations, incur expenses or lose revenues as a result of a data privacy breach, product failure, information technology outages or disruptions, or suffer other adverse consequences including lawsuits or other legal action and damage to our reputation. 30 Our future performance will depend on the continued engagement of key members of our management team, and the loss of one or more of the key members of our management team could have a negative impact on our business.
If our information technology systems, products or services or sensitive data are compromised, patients or employees could be exposed to financial or medical identity theft or suffer a loss of product functionality, and we could lose existing customers, have difficulty attracting new customers, have difficulty preventing, detecting, and controlling fraud, be exposed to the loss or misuse of confidential information, have disputes with customers, physicians, and other health care professionals, suffer regulatory sanctions or penalties, experience increases in operating expenses or an impairment in our ability to conduct our operations, incur expenses or lose revenues as a result of a data privacy breach, product failure, information technology outages or disruptions, or suffer other adverse consequences including lawsuits or other legal action and damage to our reputation. 22 Our future performance will depend on the continued engagement of key members of our management team, and the loss of one or more of the key members of our management team could have a negative impact on our business.
Government regulations specific to medical devices are wide ranging and govern, among other things: ● Product design, development, manufacture, and release; ● Laboratory, pre-clinical and clinical testing, labeling, packaging, storage and distribution; ● Product safety and efficacy; ● Premarketing clearance or approval; ● Service operations; ● Record keeping; ● Product marketing, promotion and advertising, sales and distribution; ● Post-marketing surveillance, including reporting of deaths or serious injuries and recalls and correction and removals; ● Post-market approval studies; and ● Product import and export. 39 If we fail to remain in compliance with applicable European laws and directives, we would be unable to continue to affix the CE mark to our products, which would prevent us from selling them within the European Economic Area (“EEA”).
Government regulations specific to medical devices are wide ranging and govern, among other things: ● Product design, development, manufacture, and release; ● Laboratory, pre-clinical and clinical testing, labeling, packaging, storage and distribution; ● Product safety and efficacy; ● Premarketing clearance or approval; ● Service operations; ● Record keeping; ● Product marketing, promotion and advertising, sales and distribution; ● Post-marketing surveillance, including reporting of deaths or serious injuries and recalls and correction and removals; ● Post-market approval studies; and ● Product import and export. 30 If we fail to remain in compliance with applicable European laws and directives, we would be unable to continue to affix the CE mark to our products, which would prevent us from selling them within the European Economic Area (“EEA”).
Furthermore, our key component suppliers may not currently be or may not continue to be in compliance with applicable regulatory requirements, which may result in manufacturing delays for our product and cause our revenue to decline. We can provide no assurance that we will continue to remain in compliance with the UKAS, QSR and European Union Notified Bodies.
Furthermore, our key component suppliers may not currently be or may not continue to be in compliance with applicable regulatory requirements, which may result in manufacturing delays for our product and cause our revenue to decline. 32 We can provide no assurance that we will continue to remain in compliance with the UKAS, QSR and European Union Notified Bodies.
If we are unable to raise additional funding to meet our operational needs, we will be forced to limit or cease our operations. 46 In addition to our current capital needs, we regularly consider fundraising opportunities and may decide, from time to time, to raise capital based on various factors, including market conditions and our plans of operation.
If we are unable to raise additional funding to meet our operational needs, we will be forced to limit or cease our operations. In addition to our current capital needs, we regularly consider fundraising opportunities and may decide, from time to time, to raise capital based on various factors, including market conditions and our plans of operation.
This summary is qualified by reference to the full set of risk factors set forth in this Item. ● We may need to raise additional capital to fund our operations in the future. If we are unsuccessful in attracting new capital, we may not be able to continue operations or may be forced to sell assets to do so.
This summary is qualified by reference to the full set of risk factors set forth in this Item. ● We will need to raise additional capital to fund our operations in the future. If we are unsuccessful in attracting new capital, we may not be able to continue operations or may be forced to sell assets to do so.
If sufficient coverage and reimbursement is not available for our current or future products, in any country where our license operates, the demand for our products and our revenues will be adversely affected. Non-United States governments often impose strict price controls, which may adversely affect our future profitability.
If sufficient coverage and reimbursement is not available for our current or future products, in any country where our license operates, the demand for our products and our revenues will be adversely affected. 21 Non-United States governments often impose strict price controls, which may adversely affect our future profitability.
Price controls may reduce prices to levels significantly below those that would prevail in less regulated markets or limit the volume of products which may be sold, either of which may have a material and adverse effect on potential revenues from sales of the BPT and IFP products.
Price controls may reduce prices to levels significantly below those that would prevail in less regulated markets or limit the volume of products which may be sold, either of which may have a material and adverse effect on potential revenues from sales of the IFP products.
Although we and the Licensor seek to enter into these types of agreements with contractors, consultants, advisors and research collaborators, to the extent that employees and consultants utilize or independently develop intellectual property in connection with any of our projects, disputes may arise as to the intellectual property rights associated with our technology.
Although we seek to enter into these types of agreements with contractors, consultants, advisors and research collaborators, to the extent that employees and consultants utilize or independently develop intellectual property in connection with any of our projects, disputes may arise as to the intellectual property rights associated with our technology.
We expect to rely in part on third-party distributors to effectively distribute our products, if our distributors fail to effectively market and sell the BPT and IFP products in full compliance with applicable laws, our operating results and business may suffer. We will depend in part on qualified distributors for the marketing and selling of our products.
We expect to rely in part on third-party distributors to effectively distribute our products, if our distributors fail to effectively market and sell the IFP products in full compliance with applicable laws, our operating results and business may suffer. We will depend in part on qualified distributors for the marketing and selling of our products.
If we or our suppliers fail to comply The United Kingdom Accreditation Services (UKAS), FDA’s Quality System Regulation (QSR) and CE (European Conformity) markings and other relevant regulations regulation, our manufacturing or distribution operations could be delayed or shut down and our revenue could suffer.
If we or our suppliers fail to comply with The United Kingdom Accreditation Services (UKAS), FDA’s Quality System Regulation (QSR) and CE (European Conformity) Markings and other relevant regulations regulation, our manufacturing or distribution operations could be delayed or shut down and our revenue could suffer.
If we fail to retain marketing and sales personnel, or if we fail to increase our marketing and sales capabilities as we grow, or if we fail to develop broad awareness of our product in a cost-effective manner, we may not be able to generate revenue growth. We have limited experience marketing and selling our products.
If we fail to retain marketing and sales personnel, or if we fail to increase our marketing and sales capabilities as we grow, or if we fail to develop broad awareness of our products in a cost-effective manner, we may not be able to generate revenue growth. We have limited experience marketing and selling our products.
Some of the factors that may cause the market price of our common stock to fluctuate include: ● any delay in or the results of our clinical evaluations; ● any delay in manufacturing of our products; ● any delay with the approval for reimbursement for the patients from their insurance companies; ● our failure to comply with regulatory requirements; ● the announcements of clinical evaluation data, and the investment community’s perception of and reaction to those data; ● the results of clinical evaluations conducted by others on products that would compete with ours; ● any delay or failure to receive clearance or approval from regulatory agencies or bodies; ● our inability to commercially launch products or market and generate sales of our products, including the BPT; ● failure of the BPT or any other products, even if approved for marketing, to achieve any level of commercial success; 47 ● our failure to obtain intellectual property protection for any of our technologies and products (including those related to the BPT) or the issuance of third-party intellectual property that cover our proposed technologies or products; ● developments or disputes concerning our product’s intellectual property rights; ● our or our competitors’ technological innovations; ● general and industry-specific economic conditions that may affect our expenditures; ● changes in market valuations of similar companies; ● announcements by us or our competitors of significant contracts, acquisitions, strategic partnerships, joint ventures, capital commitments, new technologies, or intellectual property; ● failure to adequately manufacture the BPT or any other products through third parties; ● future sales of our common stock or other securities, including shares issuable upon the exercise of outstanding warrants or otherwise issued pursuant to certain contractual rights; ● period-to-period fluctuations in our financial results; and ● low or high trading volume of our common stock due to many factors, including the terms of our financing arrangements.
Some of the factors that may cause the market price of our common stock to fluctuate include: ● any delay in or the results of our clinical evaluations; ● any delay in manufacturing of our products; ● any delay with the approval for reimbursement for the patients from their insurance companies; ● our failure to comply with regulatory requirements; ● the announcements of clinical evaluation data, and the investment community’s perception of and reaction to those data; ● the results of clinical evaluations conducted by others on products that would compete with ours; ● any delay or failure to receive clearance or approval from regulatory agencies or bodies; ● our inability to commercially launch products or market and generate sales of our products, ● failure our products, even if approved for marketing, to achieve any level of commercial success; ● our failure to obtain intellectual property protection for any of our technologies and products or the issuance of third-party intellectual property that cover our proposed technologies or products; ● developments or disputes concerning our product’s intellectual property rights; ● our or our competitors’ technological innovations; ● general and industry-specific economic conditions that may affect our expenditures; ● changes in market valuations of similar companies; 37 ● announcements by us or our competitors of significant contracts, acquisitions, strategic partnerships, joint ventures, capital commitments, new technologies, or intellectual property; ● failure to adequately manufacture our other products through third parties; ● future sales of our common stock or other securities, including shares issuable upon the exercise of outstanding warrants or otherwise issued pursuant to certain contractual rights; ● period-to-period fluctuations in our financial results; and ● low or high trading volume of our common stock due to many factors, including the terms of our financing arrangements.
There can be no assurance that the current operating plan will be achieved in the time frame anticipated by us, or that our cash resources will fund our operating plan for the period anticipated by the Company or that additional funding will be available on terms acceptable to us, or at all.
There can be no assurance that the current operating plan will be achieved in the time frame anticipated by us, or that our cash resources will fund our operating plan for the period anticipated by the Company or that additional funding will be available on terms acceptable to us, or if at all.
If third-party payors do not provide coverage and reimbursement for the use of the BPT and IFP products, our business and prospects may be negatively impacted. Third-party payors, whether governmental or commercial, are developing increasingly sophisticated methods of controlling healthcare costs.
If third-party payors do not provide coverage and reimbursement for the use of the IFP products, our business and prospects may be negatively impacted. Third-party payors, whether governmental or commercial, are developing increasingly sophisticated methods of controlling healthcare costs.
These risks and uncertainties include: ● different regulatory requirements for medical product approvals in foreign countries; ● different standards of care in various countries that could complicate the evaluation of our product candidates; ● different medical product import and export rules; ● different labor laws; ● reduced protection for intellectual property rights in certain countries; ● unexpected changes in tariffs, trade barriers and regulatory requirements; ● different reimbursement systems and different competitive medical products indicated for glucose testing; 28 ● localization of products and services, including translation of foreign languages; ● delivery, logistics and storage costs; ● longer accounts receivable payment cycles and difficulties in collecting accounts receivable; ● difficulties providing customer services; ● economic weakness, including inflation, or political instability in particular foreign economies and markets; ● compliance with tax, employment, immigration and labor laws for employees living or traveling abroad; ● compliance with the Foreign Corrupt Practices Act, or the “FCPA,” and other anti-corruption and anti-bribery laws; ● foreign taxes, including withholding of payroll taxes; ● foreign currency fluctuations, which could result in increased operating expenses and reduced revenues, and other obligations incident to doing business in another country; ● restrictions on the repatriation of earnings; ● workforce uncertainty in countries where labor unrest is more common than in the United States; ● potential liability resulting from development work conducted by third-party foreign distributors; and ● business interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters, management, communication, and integration problems resulting from cultural differences and geographic dispersion.
These risks and uncertainties include: ● different regulatory requirements for medical product approvals in foreign countries; 20 ● different standards of care in various countries that could complicate the evaluation of our product candidates; ● different medical product import and export rules; ● different labor laws; ● reduced protection for intellectual property rights in certain countries; ● unexpected changes in tariffs, trade barriers and regulatory requirements; ● different reimbursement systems and different competitive medical products; ● localization of products and services, including translation of foreign languages; ● delivery, logistics and storage costs; ● longer accounts receivable payment cycles and difficulties in collecting accounts receivable; ● difficulties providing customer services; ● economic weakness, including inflation, or political instability in particular foreign economies and markets; ● compliance with tax, employment, immigration and labor laws for employees living or traveling abroad; ● compliance with the Foreign Corrupt Practices Act, or the “FCPA,” and other anti-corruption and anti-bribery laws; ● foreign taxes, including withholding of payroll taxes; ● foreign currency fluctuations, which could result in increased operating expenses and reduced revenues, and other obligations incident to doing business in another country; ● restrictions on the repatriation of earnings; ● workforce uncertainty in countries where labor unrest is more common than in the United States; ● potential liability resulting from development work conducted by third-party foreign distributors; and ● business interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters, management, communication and integration problems resulting from cultural differences and geographic dispersion.
However, there can be no assurance that when the Company requires additional financing, such financing will be available on terms which are favorable to the Company, or at all.
However, there can be no assurance that when the Company requires additional financing, such financing will be available on terms which are favorable to the Company, or if at all.
Failure to take adequate corrective action in response to an adverse regulatory inspection could result in, among other things, a shutdown of our manufacturing or product distribution operations, significant fines, suspension of marketing clearances and approvals, seizures or recalls of our device, operating restrictions and criminal prosecutions, any of which would negatively affect our business, financial condition and results of operations.
Failure to take adequate corrective action in response to an adverse regulatory inspection could result in, among other things, a shutdown of our manufacturing or product distribution operations, significant fines, suspension of marketing clearances and approvals, seizures or recalls of our devices, operating restrictions and criminal prosecutions, any of which would negatively affect our business, financial condition and results of operations.
In the event that another party has intellectual property protection relating to an invention or technologies licensed by us from the Licensor, we and/or the Licensor may be required to participate in an interference proceeding declared by the regulatory authorities to determine priority of invention, which could result in substantial uncertainties and costs for us, even if the eventual outcome was favorable to us.
In the event that another party has intellectual property protection relating to an invention or technologies licensed by us, we may be required to participate in an interference proceeding declared by the regulatory authorities to determine priority of invention, which could result in substantial uncertainties and costs for us, even if the eventual outcome was favorable to us.
A third-party may claim that we and/or the Licensor are using inventions claimed by their intellectual property and may go to court to stop us and/or the Licensor from engaging in our normal operations and activities, such as research, development and the sale of any future products. Such lawsuits are expensive and would consume significant time and other resources.
A third-party may claim that we are using inventions claimed by their intellectual property and may go to court to stop us from engaging in our normal operations and activities, such as research, development and the sale of any future products. Such lawsuits are expensive and would consume significant time and other resources.
Any of these factors could harm our operating results. Our independent registered public accounting firm has included an explanatory paragraph relating to our ability to continue as a going concern in its report on our audited financial statements included in our Annual Report on Form 10-K for the Fiscal year ended June 30, 2024.
Any of these factors could harm our operating results. Our independent registered public accounting firm has included an explanatory paragraph relating to our ability to continue as a going concern in its report on our audited financial statements included in our Annual Report on Form 10-K for the Fiscal year ended June 30, 2025.
The facilities could be harmed or rendered inoperable by natural or man-made disasters, including, but not limited to, earthquakes, flooding, fire and power outages, which may render it difficult or impossible for us to perform our research, development and commercialization activities for some period of time for IFP Drug Screening System.
The facilities could be harmed or rendered inoperable by natural or man-made disasters, including, but not limited to, earthquakes, flooding, fire and power outages, which may render it difficult or impossible for us to perform our research, development and commercialization activities for some period of time for the IFP System.
Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees. As a result, it is unclear whether and, if so, to what extent employees of ours and the Licensor may be able to claim compensation with respect to our future revenue.
Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees. As a result, it is unclear whether and, if so, to what extent employees of ours may be able to claim compensation with respect to our future revenue.
If our facilities become damaged or inoperable, we will be unable to continue to research, develop and supply our product which could negatively affect our business, financial condition and results of operations until we are able to secure a new facility and rebuild our inventory. We do not have redundant facilities.
If our facilities become damaged or inoperable, we will be unable to continue to research, develop and supply our products which could negatively affect our business, financial condition and results of operations until we are able to secure a new facility and rebuild our inventory. We do not have redundant facilities.
We do not know whether or when we will become profitable. 22 Our ability to generate higher revenue and achieve profitability depends upon our ability, alone or with others, to complete the development process of our products, including regulatory approvals, and achieve substantial acceptance in the marketplace for our existing IFP products.
We do not know whether or when we will become profitable. Our ability to generate revenue and achieve profitability depends upon our ability, alone or with others, to complete the development process of our products, including regulatory approvals, and achieve substantial acceptance in the marketplace for our existing IFP products.
Despite the protective measures we employ, we and the Licensor still face the risk that: ● these agreements may be breached; ● these agreements may not provide adequate remedies for the applicable type of breach; ● our proprietary know-how will otherwise become known; or ● our competitors will independently develop similar technology or proprietary information.
Despite the protective measures we employ, we still face the risk that: ● these agreements may be breached; ● these agreements may not provide adequate remedies for the applicable type of breach; ● our proprietary know-how will otherwise become known; or ● our competitors will independently develop similar technology or proprietary information.
We are not profitable and have had negative cash flow from operations since our inception. To fund our operations and to develop and commercialize our products (including the BPT and planned applications of IFP Drug Screening System), we have relied primarily on equity and some debt financing and government support income.
We are not profitable and have had negative cash flow from operations since our inception. To fund our operations and to develop and commercialize our products (including the BPT and planned applications of IFP System), we have relied primarily on equity and some debt financing and government support income.
Our ability to increase our customer base and achieve broader market acceptance of our product will depend to a significant extent on our ability to expand our marketing efforts. We plan to dedicate significant resources to our marketing programs, as we plan to further expand our geographical reach especially in the APAC Region and the North America region.
Our ability to increase our customer base and achieve broader market acceptance of our products will depend to a significant extent on our ability to expand our marketing efforts. We plan to dedicate significant resources to our marketing programs, as we plan to further plan to expand our geographical reach especially in the APAC Region and the North America region.
In addition, the laws of some foreign countries do not protect intellectual property to the same extent as laws in the United States. Consequently, we and/or the Licensor may not be able to prevent third parties from practicing our inventions or from selling or importing products made using our inventions.
In addition, the laws of some foreign countries do not protect intellectual property to the same extent as laws in the United States. Consequently, we may not be able to prevent third parties from practicing our inventions or from selling or importing products made using our inventions.
The intellectual property laws and other statutory and contractual arrangements in the United States and other jurisdictions we depend upon may not provide sufficient protection in the future to prevent the infringement, use, violation or misappropriation of our trademarks, data, technology and other intellectual property and services, and may not provide an adequate remedy if our intellectual property rights are infringed, misappropriated or otherwise violated. 34 We rely, in part, on our ability to obtain, maintain, expand, enforce, and defend the scope of our intellectual property portfolio or other proprietary rights, including the amount and timing of any payments we may be required to make in connection to the filing, defence and enforcement of any patents or other intellectual property rights.
The intellectual property laws and other statutory and contractual arrangements in the United States and other jurisdictions we depend upon may not provide sufficient protection in the future to prevent the infringement, use, violation or misappropriation of our trademarks, data, technology and other intellectual property and services, and may not provide an adequate remedy if our intellectual property rights are infringed, misappropriated or otherwise violated. 26 We rely, in part, on our ability to obtain, maintain, expand, enforce, and defend the scope of our intellectual property portfolio or other proprietary rights, including the amount and timing of any payments we may be required to make in connection the filing, defense and enforcement of any patents or other intellectual property rights.
There is a risk that a court will decide that we and/or the Licensor are infringing the third-party’s intellectual property and will order us to stop the activities claimed by the intellectual property. In addition, there is a risk that a court will order us and/or the Licensor to pay the other party damages for having infringed their intellectual property.
There is a risk that a court will decide that we are infringing the third-party’s intellectual property and will order us to stop the activities claimed by the intellectual property. In addition, there is a risk that a court will order us to pay the other party damages for having infringed their intellectual property.
For example, we and the Licensor may have inventorship disputes arising from conflicting obligations of consultants or others who are involved in developing our product candidates. Litigation may be necessary to defend against these and other claims challenging inventorship.
For example, we may have inventorship disputes arising from conflicting obligations of consultants or others who are involved in developing our product candidates. Litigation may be necessary to defend against these and other claims challenging inventorship.
As a result, fluctuations in exchange rates may have a material adverse effect on your investment. 42 We are subject to laws and regulations governing business conduct, which will require us to develop and implement costly compliance programs.
As a result, fluctuations in exchange rates may have a material adverse effect on your investment. 33 We are subject to laws and regulations governing business conduct, which will require us to develop and implement costly compliance programs.
We may not complete our analysis of our internal control over financial reporting in a timely manner, or these internal controls may not be determined to be effective, which may harm investor confidence in our company and the value of our common stock.
We may not complete our analysis of our internal control over financial reporting in a timely manner, or these internal controls may not be determined to be effective, which may harm investor confidence in our company and, as a result, the value of our common stock.
While we believe that our efforts will enhance our internal control, remediation of the material weaknesses will require further validation and testing of the design and operating effectiveness of internal controls over a sustained period of financial reporting cycles, and we cannot assure you that we have identified all, or that we will not in the future have additional, material weaknesses. 45 We are obligated to maintain a system of effective internal control over financial reporting.
While we believe that our efforts will enhance our internal control, remediation of the material weaknesses will require further validation and testing of the design and operating effectiveness of internal controls over a sustained period of financial reporting cycles, and we cannot assure you that we have identified all, or that we will not in the future have additional, material weaknesses. 35 We are obligated to develop and maintain a system of effective internal control over financial reporting.
In those countries, we and/or the Licensor may have limited remedies if our intellectual property is infringed or if we and/or the Licensor are compelled to grant a license to a third-party, which could materially diminish the value of that intellectual property.
In those countries, we may have limited remedies if our intellectual property is infringed or if we are compelled to grant a license to a third-party, which could materially diminish the value of that intellectual property.
In order to compete, we and the Licensor (where relevant) need to adjust, develop, license or acquire new technology on a schedule that keeps pace with technological and other developments and the requirements for products addressing a broad spectrum of needs. Fluctuation in the value of foreign currencies may have a material adverse effect on your investment.
In order to compete, we need to adjust, develop, license or acquire new technology on a schedule that keeps pace with technological and other developments and the requirements for products addressing a broad spectrum of needs. Fluctuation in the value of foreign currencies may have a material adverse effect on your investment.
We rely on single-source suppliers for certain components of our IFP Drug Screening System and materials for our other current products. These components and materials are critical and there are no or relatively few alternative sources of supply.
We rely on single-source suppliers for certain components of our IFP System and materials for our other current products. These components and materials are critical and there are no or relatively few alternative sources of supply.
Alternatively, capital may not be available to us on favorable terms, or at all.
Alternatively, capital may not be available to us on favorable terms, or if at all.
Failure in our conventional, online and digital marketing efforts could impact our ability to generate sales. We intend to engage in conventional marketing strategies and also may utilize online and digital marketing in order to create awareness to the BPT and the IFP products.
Failure in our conventional, online and digital marketing efforts could impact our ability to generate sales. We intend to engage in conventional marketing strategies and also may utilize online and digital marketing in order to create awareness of the IFP products.
There can be no assurance that we will successfully complete any clinical evaluations necessary to receive regulatory clearance or approvals. The preliminary results that are indicative of the potential performance of the BPT, data already obtained, or to be obtained in future, from clinical studies do not necessarily predict the results that will be obtained from later clinical evaluations.
There can be no assurance that we will successfully complete any clinical evaluations necessary to receive regulatory clearance or approvals. The preliminary results that are indicative of the potential performance of the IFP products, data already obtained, or to be obtained in future, from clinical studies do not necessarily predict the results that will be obtained from later clinical evaluations.
We have commenced the required regulatory approval process with FDA in the United States, which may be an expensive, lengthy and unpredictable process. We may not be able to obtain any necessary clearances or approval or may be unduly delayed in doing so, which will negatively affect our business, financial condition and results of operations.
The regulatory approval process with FDA in the United States may be an expensive, lengthy and unpredictable process. We may not be able to obtain any necessary clearances or approval or may be unduly delayed in doing so, which will negatively affect our business, financial condition and results of operations.
These conditions raise substantial doubt about the Company’s ability to continue as a going concern for a period of at least one year from the date these financial statements were issued. Accordingly, the Company may be required to raise additional funds during the next 12 months.
These conditions raise substantial doubt about the Company’s ability to continue as a going concern for a period of at least one year from the date these consolidated financial statements were issued. Accordingly, the Company will be required to raise additional funds during the next 12 months.
We cannot guarantee that we will be able to establish alternative relationships on similar terms, without delay or at all. We depend on a limited number of single-source suppliers to manufacture certain components of IFP Drug Screening System, which makes us vulnerable to supply shortages and price fluctuations that could negatively affect our business, financial condition and results of operations.
We cannot guarantee that we will be able to establish alternative relationships on similar terms, without delay or if at all. 17 We depend on a limited number of single-source suppliers to manufacture certain components of IFP System, which makes us vulnerable to supply shortages and price fluctuations that could negatively affect our business, financial condition and results of operations.
If we and the Licensor fail in defending any such claims, in addition to paying monetary damages, we and the Licensor may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, valuable intellectual property. Such an outcome could have a material adverse effect on our business.
If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, valuable intellectual property. Such an outcome could have a material adverse effect on our business.
Our proprietary IFP Drug Screening System is subject to extensive regulation in the United States and abroad, including the European Union, our largest market for the IFP Drug Screening System.
Our proprietary IFP System is subject to extensive regulation in the United States and abroad, including the European Union, our largest market for the IFP System.
There are numerous U.S. federal and state, as well as foreign, laws pertaining to healthcare fraud and abuse, including anti-kickback, false claims and transparency laws. Many international healthcare laws and regulations apply to the BPT businesses and medical devices. We will be subject to certain regulations regarding commercial practices false claims.
There are numerous U.S. federal and state, as well as foreign, laws pertaining to healthcare fraud and abuse, including anti-kickback, false claims and transparency laws. Many international healthcare laws and regulations apply to the medical testing and medical device businesses. We will be subject to certain regulations regarding commercial practices false claims.
The report from our independent registered public accounting firm for the year ended June 30, 2024, includes an explanatory paragraph stating that our losses from operations and required additional funding to finance our operations raise substantial doubt about our ability to continue as a going concern for a period of one year after the date the financial statements are issued.
The report from our independent registered public accounting firm for the year ended June 30, 2025, includes an explanatory paragraph stating that our losses from operations and required additional funding to finance our operations raise substantial doubt about our ability to continue as a going concern for a period of one year after the date the audited financial statements were issued.
All of these penalties could adversely affect our ability to operate our business and our financial results. 31 Product liability suits, whether or not meritorious, could be brought against us due to an alleged defective product or for the misuse of the BPT and IFP Drug Screening System.
All of these penalties could adversely affect our ability to operate our business and our financial results. Product liability suits, whether or not meritorious, could be brought against us due to an alleged defective product or for the misuse of the IFP System.
We market IFP products as a screening device. The clinical studies undertaken to date may not meet the requirements of certain regulatory bodies for us to market in those jurisdictions.
We market IFP products as screening devices. The clinical studies undertaken to date may not meet the requirements of certain regulatory bodies for us to market in those jurisdictions.
We are subject to the risks associated with new businesses generally. We were formed in December 2016 as a new business with a plan to commercialize our licensed technology.
We are subject to the risks associated with new businesses generally. We were formed in December 2016 as a new business with a plan to commercialize our licensed technology related to the Biosensor Platform.
We also will be subject to numerous post-marketing regulatory requirements, which may include labelling regulations and medical device reporting regulations, which may require us to report to different regulatory agencies if our device causes or contributes to a death or serious injury, or malfunctions in a way that would likely cause or contribute to a death or serious injury.
We also will be subject to numerous post-marketing regulatory requirements, which may include labelling regulations and medical device reporting regulations, which may require us to report to different regulatory agencies if our devices cause or contribute to a death or serious injury, or malfunction in a way that would likely cause or contribute to a death or serious injury.
As a result, we may be unable to further develop, obtain regulatory approval for, manufacture, market, sell and derive revenues from the BPT and the other products in our pipeline based on the Biosensor Platform, and our inability to do so would materially and adversely impact our business.
As a result, we may be unable to further develop, obtain regulatory approval for, manufacture, market, sell and derive revenues from the other products in our pipeline, and our inability to do so would materially and adversely impact our business.
If the BPT and IFP Drug Screening System or any future diagnostic test based on the Biosensor Platform or IFP Drug Screening System is defectively designed or manufactured, contains defective components or is misused, or if someone claims any of the foregoing, whether or not meritorious, we may become subject to substantial and costly litigation.
If the IFP System or any future diagnostic test based on the IFP System is defectively designed or manufactured, contains defective components or is misused, or if someone claims any of the foregoing, whether or not meritorious, we may become subject to substantial and costly litigation.
The completion of any future clinical evaluations for the BPT and IFP products, or other studies that we may be required to undertake in the future for the BPT and IFP Drug Screening System could be delayed, suspended or terminated for several reasons, including: ● we may fail to or be unable to conduct the clinical evaluation in accordance with regulatory requirements; ● sites participating in the trial may drop out of the trial, which may require us to engage new sites for an expansion of the number of sites that are permitted to be involved in the trial; ● patients may not enroll in, remain in or complete, the clinical evaluation at the rates we expect; and ● clinical investigators may not perform our clinical evaluation on our anticipated schedule or consistent with the clinical evaluation protocol and good clinical practices. 33 If our clinical evaluations are delayed it will take us longer to ultimately launch the BPT, IFP and other products in the relevant markets requiring regulatory approval and generate revenues.
The completion of any future clinical evaluations for the IFP products, or other studies that we may be required to undertake in the future for the IFP or other products based on the IFP System could be delayed, suspended or terminated for several reasons, including: ● we may fail to or be unable to conduct the clinical evaluation in accordance with regulatory requirements; ● sites participating in the trial may drop out of the trial, which may require us to engage new sites for an expansion of the number of sites that are permitted to be involved in the trial; ● patients may not enroll in, remain in or complete, the clinical evaluation at the rates we expect; and ● clinical investigators may not perform our clinical evaluation on our anticipated schedule or consistent with the clinical evaluation protocol and good clinical practices. 25 If our clinical evaluations are delayed it will take us longer to ultimately launch the IFP in certain jurisdictions and generate revenues.
We and the Licensor may be subject to claims challenging the invention of the intellectual property we license. We and the Licensor may be subject to claims that former employees, collaborators or other third parties have an interest in intellectual property as an inventor or co-inventor.
We may be subject to claims challenging the invention of the intellectual property that we use. We may be subject to claims that former employees, collaborators or other third parties have an interest in intellectual property as an inventor or co-inventor.
We intend to seek approval to market the BPT across the APAC Region and expand IFP products offerings in the APAC region. If we obtain approval for BPT in one or more of the jurisdictions within our License Agreement, we will be subject to rules and regulations in those jurisdictions relating to our products.
We intend to seek approval to market and expand the IFP products offerings in the APAC region. If we obtain approval for IFP products in one or more of the jurisdictions, we will be subject to rules and regulations in those jurisdictions relating to our products.
If we or the Licensor (where relevant) are unable to respond to these developments, we may lose competitive position, and our other products may become uncompetitive or obsolete, causing our business and prospects to suffer.
If we are unable to respond to these developments, we may lose competitive position, and our other products may become uncompetitive or obsolete, causing our business and prospects to suffer.
We may receive less revenue from future products if any of employees of the Licensor or us successfully claim compensation for their work in developing our intellectual property, which in turn could impact our future profitability. Risks Related to Our Industry Our products and operations are subject to extensive government regulation.
We may receive less revenue from future products if any of our employees successfully claim compensation for their work in developing our intellectual property, which in turn could impact our future profitability. Risks Related to Our Industry Our products and operations are subject to extensive government regulation and oversight both in the United States and abroad.
A number of factors may adversely impact our gross margins on product sales and services, including: ● lower than expected manufacturing yields of high-cost components leading to increased manufacturing costs; ● shortages of electric components resulting in higher prices or an inability to supply key parts; ● low production volume which will result in high levels of overhead cost per unit of production; ● the timing of revenue recognition and revenue deferrals; ● increased material or labor costs; ● increased service or warranty costs or the failure to reduce service or warranty costs; ● increased price competition; ● variation in the margins across products in a particular period; and ● how well we execute on our strategic and operating plans.
A number of factors may adversely impact our gross margins on product sales and services, including: ● lower than expected manufacturing yields of high-cost components leading to increased manufacturing costs; ● shortages of electric components resulting in higher prices or an inability to supply key parts; ● low production volume which will result in high levels of overhead cost per unit of production; ● the timing of revenue recognition and revenue deferrals; ● increased material or labor costs; ● increased service or warranty costs or the failure to reduce service or warranty costs; ● increased price competition; ● variation in the margins across products in a particular period; and ● how well we execute on our strategic and operating plans. 19 If we are unable to maintain or increase our gross margins on product sales, our results of operations could be adversely impacted, we may not achieve profitability and our stock price could decline.
Our failure to comply with applicable regulatory requirements could result in enforcement action by any such agency, which may include any of the following sanctions: ● Adverse publicity, warning letters, fines, injunctions, consent decrees and civil penalties; ● Repair, replacement, refunds, recall or seizure of our products; ● Operating restrictions, partial suspension or total shutdown of production; ● Denial of our requests for regulatory clearance or premarket approval of new products or services, new intended uses or modifications to existing products or services; ● Withdrawal of regulatory clearance or premarket approvals that have already been granted; or ● Criminal prosecution.
Our failure to comply with applicable regulatory requirements could result in enforcement action by any such agency, which may include any of the following sanctions: ● Adverse publicity, warning letters, fines, injunctions, consent decrees and civil penalties; ● Repair, replacement, refunds, recall or seizure of our products; ● Operating restrictions, partial suspension or total shutdown of production; ● Denial of our requests for regulatory clearance or premarket approval of new products or services, new intended uses or modifications to existing products or services; ● Withdrawal of regulatory clearance or premarket approvals that have already been granted; or ● Criminal prosecution. 31 If any of these events were to occur, it will negatively affect our business, financial condition and results of operations.
If we or our manufacturers fail to comply with applicable regulations, our proposed operations could be interrupted, and our operating results may be negatively impacted.
If we or our manufacturers fail to comply with applicable regulatory quality system regulations or any applicable equivalent regulations, our proposed operations could be interrupted, and our operating results may be negatively impacted.
In connection with the preparation of our financial statements for the fiscal year ended June 30, 2024, we identified material weaknesses in our internal control over financial reporting.
In connection with the preparation of our financial statements for the years ended June 30, 2024 and June 30, 2025, we identified material weaknesses in our internal control over financial reporting.
We may be unable to achieve any or all of these goals. We rely on third parties to perform certain confirmatory tests for our IFP Drug Screening System. We rely on third-party service providers to analyze samples collected from our confirmatory kit of the IFP Drug Screening System.
We may be unable to achieve any or all of these goals. We rely on third parties to perform certain confirmatory tests for our IFP System. We rely on third-party service providers to analyze samples collected from our confirmatory kit of the IFP System. We contract with third-party laboratory service provider to perform confirmation testing on the samples collected.
We and the Licensor have determined that filing, prosecuting and defending intellectual property rights in all countries globally would be prohibitively expensive, and intellectual property rights in some countries can be less extensive than those in the United States.
Our intellectual property rights include intellectual property rights related to the IFP products. We have determined that filing, prosecuting and defending intellectual property rights in all countries globally would be prohibitively expensive, and intellectual property rights in some countries can be less extensive than those in the United States.
We also could be required to seek funds through arrangements with partners or others that may require us to relinquish rights or jointly own some aspects of our technologies or products that we would otherwise pursue on our own.
We also could be required to seek funds through arrangements with partners or others that may require us to relinquish rights or jointly own some aspects of our technologies or products that we would otherwise pursue on our own. 36 The market price of our common stock may be significantly volatile.
The Company believes there is material risk that its cash and cash equivalents as of June 30, 2024, of $6,304,098 may be insufficient to allow the Company to fund its current operating plan through at least the next twelve months from the issuance of its audited financial statements for the year ended June 30, 2024.
The Company believes there is material risk that its cash and cash equivalents as of June 30, 2025, of $1,019,909 may be insufficient to allow the Company to fund its current operating plan through at least the next twelve months from the issuance of its consolidated financial statements for the year ended June 30, 2025.
A significant proportion of our sales are outside of the United States, and a majority of those are denominated in foreign currencies, which exposes us to foreign currency risks, including changes in currency exchange rates. We do not currently engage in any hedging transactions.
Except for limited Forensic Use Only sales, all of our sales are outside of the United States, and a majority of those are denominated in foreign currencies, which exposes us to foreign currency risks, including changes in currency exchange rates. We do not currently engage in any hedging transactions.
We contract with third-party laboratory service providers to perform confirmation testing on the samples collected. This service is critical and there are relatively few alternatives. These third-party service providers may be unwilling or unable to provide the necessary services reliably and at the levels we anticipate or that are required by the market.
This service is critical and there are relatively few alternatives. These third-party service providers may be unwilling or unable to provide the necessary services reliably and at the levels we anticipate or that are required by the market.
Further, many international markets have government-managed healthcare systems that control reimbursement for new devices and procedures. For example, no government in the areas where we hold our license has approved reimbursement of the BPT or the IFP Drug Screening System.
Further, many international markets have government-managed healthcare systems that control reimbursement for new devices and procedures. For example, no government in the areas where we market the IFP System has approved reimbursement of the IFP System.
Any failure by us or our partners to maintain compliance with applicable laws and regulations or obtain and maintain required licenses and permits may result in the suspension or termination of our business activities in certain countries and territories in the APAC Region or in the region as a whole. 40 Compliance with environmental laws and regulations could be expensive, and the failure to comply with these laws and regulations could subject us to significant liability.
Any failure by us or our partners to maintain compliance with applicable laws and regulations or obtain and maintain required licenses and permits may result in the suspension or termination of our business activities in certain countries and territories in the APAC Region or in the region as a whole.
Our management believes that using a wide variety of marketing strategies, including online advertisement and a variety of other pay-for-performance methods may be effective for marketing and generating sales of the BPT and the IFP products, as opposed to relying exclusively on traditional, expensive retail channels.
Our management believes that using a wide variety of marketing strategies, including online advertisement and a variety of other pay-for-performance methods may be effective for marketing and generating sales of the IFP products, as opposed to relying exclusively on traditional, expensive retail channels. In any event, there is a risk that any or all of our marketing strategies could fail.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeAs many of our applications are developed and managed by third parties, we are dependent on these providers for many functions including disaster recovery during a disaster or cyber incident. Our goal is to only utilize the most secure and trusted providers for our IT needs.
Biggest changeAll employees received cybersecurity training and other education regarding their use of computers, information technology, and sensitive data including specifically how to recognize common attack strategies. As many of our applications are developed and managed by third parties, we are dependent on these providers for many functions including disaster recovery during a disaster or cyber incident.
Our Chief Financial Officer and Chief Executive Officer are the members of management responsible for managing and assessing our cybersecurity practices and have recently (subsequent to June 30, 2024) commenced reporting on such practices and risks. The plan for the future is that they will continue to report to the Board on cybersecurity at least quarterly.
Governance The Board of Directors is responsible for oversight of cybersecurity risk. Our Chief Financial Officer and Chief Executive Officer are the members of management responsible for managing and assessing our cybersecurity practices and have commenced reporting on such practices and risks .
Our current cybersecurity management strategy consists of utilizing a combination of employee education, preventative controls, detective controls, and periodic cybersecurity testing. Our process and cybersecurity posture will continue to be refined based on the results of periodic cybersecurity assessments conducted internally and with our IT consultants and service providers, as needed.
Our process and cybersecurity posture will continue to be refined based on the results of periodic cybersecurity assessments conducted internally and with our IT consultants and service providers, as needed. We have recently begun reporting on cybersecurity in reports to the Board of Directors and will continue to do so.
To this end, we are currently reviewing the security credentials and certifications of our key application providers. Our business continuity plans are evaluated against evolving security and service level standards, which includes evaluating those cybersecurity threats associated with our use of key third party service providers.
Our business continuity plans are evaluated against evolving security and service level standards, which includes evaluating those cybersecurity threats associated with our use of key third party service providers. 39 Our current cybersecurity management strategy consists of utilizing a combination of employee education, preventative controls, detective controls, and periodic cybersecurity testing.
Removed
All employees have recently (subsequent to June 30, 2024) begun receiving cybersecurity training and other education regarding their use of computers, information technology, and sensitive data including specifically how to recognize common attack strategies.
Added
Our goal is to only utilize the most secure and trusted providers for our IT needs. To this end, we are currently reviewing the security credentials and certifications of our key application providers.
Removed
We have recently begun reporting on cybersecurity in reports to the Board of Directors and will continue to do so. Governance The Board of Directors is responsible for oversight of cybersecurity risk.
Added
The plan for the future is that they will continue to report to the Board on cybersecurity at least quarterly.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeThird, the location functions as a distribution hub for expanding sales across the Asia-Pacific market, optimizing our logistics and reach in the region. Cambridge, England: We rent a multifunctional facility in the UK consisting of approximately 11,500 Sq foot, which is integral to our global operations falling under our IFPG segment.
Biggest changeSecond, the facility houses our new Australian sales and marketing team, offering them both office and warehouse space. Third, the location functions as a distribution hub for expanding sales across the Asia-Pacific market, optimizing our logistics and reach in the region.
We have no immediate plans to upgrade or expand our facilities, given that they are currently adequately meeting our needs. However, we are open to establishing permanent offices for regional heads as required in the future, ensuring that we are well positioned to adapt and grow as our business evolves. 49
However, we are open to establishing permanent offices for regional heads as required in the future, ensuring that we are well-positioned to adapt and grow as our business evolves.
ITEM 2. PROPERTIES. Our company currently operates out of three strategically located facilities, which cater to different aspects of our business: Sydney, Australia: We rent an office/warehouse space of approximately 2,080 Sq foot. Our office/warehouse facility serves three fundamental purposes and is used in connection with operations falling under both our IFPG and BPT segments.
ITEM 2. PROPERTIES. Our company currently operates out of three strategically located facilities, which cater to different aspects of our business: Sydney, Australia: We rent an office/warehouse space of approximately 2,080 sq. ft. Our office/warehouse facility serves three fundamental purposes. First, it provides a dedicated office space for our administrative staff, who are responsible for managing and overseeing INBS operations.
It houses office space, a warehouse, research and development (R&D), and manufacturing capabilities, catering to the UK market and our global supply needs. Currently, our manufacturing facility can produce up to 90,000 cartridges per month. Our production rate stands at approximately 12,000 cartridges per month, providing ample room for growth in the coming years.
Cambridge, England: We rent a multifunctional facility in the UK consisting of approximately 11,500 sq. ft, which is integral to our global operations. It houses office space, a warehouse, research and development (R&D), and manufacturing capabilities, catering to the UK market and our global supply needs. Currently, our manufacturing facility can produce up to 90,000 cartridges per month.
New York City, United States: We have a small, shared office space in New York that accommodates our two US employees, fostering closer collaboration and communication. This location provides a focal point for all our global operations and solidifies our presence and commitment to the US market.
Our production rate stands at approximately 12,000 cartridges per month, providing ample room for growth in the coming years. New York City, United States: We have a small, shared office space in New York that accommodates our two US employees, fostering closer collaboration and communication.
Removed
First, it provides dedicated office space for our administrative staff, who are responsible for managing and overseeing the Company’s operations. Second, the facility houses our new Australian sales and marketing team, offering them both office and warehouse space.
Added
This location provides a focal point for our global operations and solidifies our presence and commitment to the US market. We have no immediate plans to upgrade or expand our facilities, given that they are currently adequately meeting our needs.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeITEM 3. LEGAL PROCEEDINGS. From time to time, we may be subject to legal proceedings and claims arising in the ordinary course of business. We are not currently engaged in any material legal proceedings. ITEM 4. MINE SAFETY DISCLOSURES. Not applicable. PART II
Biggest changeITEM 3. LEGAL PROCEEDINGS. From time to time, we may be subject to legal proceedings and claims arising in the ordinary course of business. We are not currently engaged in any material legal proceedings. ITEM 4. MINE SAFETY DISCLOSURES. Not applicable. 40 PART II

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeSecurities Authorized for Issuance Under Equity Compensation Plans See Item 12. “ Security Ownership of Certain Beneficial Owners and Management Related Stockholders Matters ” for information with respect to our compensation plans under which equity securities are authorized for issuance. 50 ITEM 6. RESERVED
Biggest changeSecurities Authorized for Issuance Under Equity Compensation Plans See “Item 11. Executive Compensation ” for information with respect to our compensation plans under which equity securities are authorized for issuance. 41 ITEM 6. RESERVED
Recent Sales of Unregistered Securities Other than any sales previously reported in the Company’s Current Reports on Form 8-K or Quarterly Reports on Form 10-Q, the Company did not sell any unregistered securities during the period covered by this report. Purchases of Equity Securities by the Issuer and Affiliated Purchasers None.
Recent Sales of Unregistered Securities Other than any sales or arrangements previously reported in the Company’s Current Reports on Form 8-K or Quarterly Reports on Form 10-Q, the Company did not sell any unregistered securities during the period covered by this report. Purchases of Equity Securities by the Issuer and Affiliated Purchasers None.
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED SHAREHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES. Market Information Our common stock is traded on The Nasdaq Capital Market under the symbol “INBS”. Holders As of September 16, 2024, there are approximately 534 holders of record of our common stock.
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED SHAREHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES. Market Information Our common stock is traded on The Nasdaq Capital Market under the symbol “INBS”. Holders As of August 12, 2025, there are approximately 485 holders of record of our common stock.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeComparison of the Years Ended June 30, 2024 and 2023 Year ended June 30, 2024 2023 Revenue $ 3,111,781 $ 1,256,872 Cost of revenue (exclusive of amortization shown separately below) (1,686,155 ) (930,204 ) Gross profit 1,425,626 326,668 Other income: Government support income 424,776 737,628 Operating expenses: Selling, general and administrative expenses (9,258,496 ) (8,026,703 ) Development and regulatory approval expenses (1,673,806 ) (507,424 ) Depreciation and amortization (1,201,274 ) (966,732 ) Goodwill impairment - (4,158,670 ) Total operating expenses (12,133,576 ) (13,659,529 ) Loss from operations (10,283,174 ) (12,595,233 ) Other income (expense), net: Interest expense (167,140 ) (223,534 ) Realized foreign exchange loss (1,178 ) (9,829 ) Fair value gain on revaluation of financial instrument 175,738 2,154,365 Interest income 84,822 9,676 Total other income, net 92,242 1,930,678 Net loss (10,190,932 ) (10,664,555 ) Net loss attributable to non-controlling interest (34,173 ) (32,835 ) Net loss attributable to Intelligent Bio Solutions Inc. $ (10,156,759 ) $ (10,631,720 ) Other comprehensive income (loss), net of tax: Foreign currency translation gain/ (loss) (137,118 ) 212,639 Total other comprehensive income (loss) (137,118 ) 212,639 Comprehensive loss (10,328,050 ) (10,451,916 ) Comprehensive loss attributable to non-controlling interest (34,173 ) (32,835 ) Comprehensive loss attributable to Intelligent Bio Solutions Inc.
Biggest changeAs a result, further development of the BPT has been postponed until we are able to finalize licensing arrangements related to the BPT. 43 Results of Operations Comparison of the Years Ended June 30, 2025 and 2024 Year Ended June 30, 2025 2024 Revenue $ 3,052,532 $ 3,111,781 Cost of revenue (exclusive of amortization shown separately below) (1,805,673 ) (1,686,155 ) Gross profit 1,246,859 1,425,626 Other income Government support income 816,901 424,776 Operating expenses Selling, general and administrative expenses (8,883,917 ) (9,258,496 ) Development and regulatory approval expenses (2,396,513 ) (1,673,806 ) Depreciation and amortization (1,207,875 ) (1,201,274 ) Impairment of long-lived assets (220,062 ) - Total operating expenses (12,708,367 ) (12,133,576 ) Loss from operations (10,644,607 ) (10,283,174 ) Other income (expense), net Interest expense (60,890 ) (167,140 ) Realized foreign exchange loss (911 ) (1,178 ) Fair value gain on revaluation of financial instrument - 175,738 Interest income 101,522 84,822 Total other income, net 39,721 92,242 Net loss (10,604,886 ) (10,190,932 ) Net loss attributable to non-controlling interest (36,153 ) (34,173 ) Net loss attributable to Intelligent Bio Solutions Inc. $ (10,568,733 ) $ (10,156,759 ) Other comprehensive income (loss), net of tax Foreign currency translation gain (loss) 384,670 (137,118 ) Total other comprehensive income (loss) 384,670 (137,118 ) Comprehensive loss (10,220,216 ) (10,328,050 ) Comprehensive loss attributable to non-controlling interest (36,153 ) (34,173 ) Comprehensive loss attributable to Intelligent Bio Solutions Inc.
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.
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.
Recently issued Accounting Pronouncements For the impact of recently issued accounting pronouncements on the Company’s consolidated financial statements, see Note 3 to the consolidated financial statements included in Part II, Item 8 of this Annual Report on Form 10-K and incorporated herein by reference.
Recently issued Accounting Pronouncements For the impact of recently issued accounting pronouncements on the Company’s consolidated financial statements, see Note 3 to the consolidated financial statements included in Part II, Item 8 of this Annual Report on Form 10-K and incorporated herein by reference. 51
As there is no authoritative guidance under US GAAP on accounting for grants to for-profit business entities, we applied International Accounting Standards 20 (“IAS 20”), Accounting for Government Grants and Disclosure of Government Assistance by analogy when accounting for the Australian Government grant to the Company. 57 The Australian Government grant proceeds, which will be used to reimburse construction costs incurred, meet the definition of grants related to assets as the primary purpose for the payments is to fund the construction of a capital asset.
As there is no authoritative guidance under US GAAP on accounting for grants to for-profit business entities, we applied International Accounting Standards 20 (“IAS 20”), Accounting for Government Grants and Disclosure of Government Assistance by analogy when accounting for the Australian Government grant to the Company. 49 The Australian Government grant proceeds, which will be used to reimburse construction costs incurred, meet the definition of grants related to assets as the primary purpose for the payments is to fund the construction of a capital asset.
To supplement our consolidated financial statements, which are prepared and presented in accordance with US GAAP, we present contribution margin and contribution margin %, which are non-GAAP financial measures. Contribution margin and contribution margin % are presented in the section titled “Contribution Margin (non-GAAP)”.
Non-GAAP Financial Measures To supplement our consolidated financial statements, which are prepared and presented in accordance with US GAAP, we present “contribution margin” and “contribution margin %”, which are non-GAAP financial measures. Contribution margin and contribution margin % are presented in the section titled “Contribution Margin (non-GAAP)”.
Off-Balance Sheet Arrangements As of June 30, 2024, we did not have any off-balance sheet arrangements. Critical Accounting Estimates The preparation of our consolidated financial statements in conformity with US GAAP requires management to make judgments, estimates and assumptions that impact the amounts reported in our consolidated financial statements and accompanying notes that are not readily apparent from other sources.
Off-Balance Sheet Arrangements As of June 30, 2025, we did not have any off-balance sheet arrangements. Critical Accounting Estimates The preparation of our consolidated financial statements in conformity with US GAAP requires management to make judgments, estimates and assumptions that impact the amounts reported in our consolidated financial statements and accompanying notes that are not readily apparent from other sources.
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 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.
Failure to generate sufficient revenues or raise additional capital through debt or equity financings, or through collaboration agreements, strategic alliances or marketing and distribution arrangements, could have a material adverse effect on our ability to meet our long-term liquidity needs and achieve our intended long-term business plan.
Failure to generate sufficient revenues or raise additional capital through debt or equity financing, or through collaboration agreements, strategic alliances or marketing and distribution arrangements, could have a material adverse effect on our ability to meet our long-term liquidity needs and achieve our intended long-term business plan.
As the Company’s operating activities increase, we expect its general and administrative costs will include additional costs in overhead contribution, consultancy, as well as an increase in employee-related costs associated with a higher headcount.
As the Company’s operating activities increase, we expect its selling, general and administrative expenses will include additional costs in overhead contribution, consultancy, as well as an increase in employee-related costs associated with a higher headcount.
The grant support income is primarily attributable to INBS’s subsidiary companies recognizing an R&D tax refund as the Company believes that it is probable that the certain amount will be recovered in full through a future claim (see Note 3 to our consolidated financial statements appearing elsewhere in our Annual Report on Form 10-K for further information and disclosures relating R&D tax refund).
The grant support income is primarily attributable to INBS’s subsidiary companies recognizing an R&D tax refund as the Company believes there is a reasonable assurance that the certain amount will be recovered in full through future claims (see Note 3 to our consolidated financial statements appearing elsewhere in our Annual Report on Form 10-K for further information and disclosures relating R&D tax refund).
The Company’s current product portfolio includes: ● Intelligent Fingerprinting Platform: A proprietary portable platform that analyzes fingerprint sweat using a one-time cartridge and portable handheld reader.
The Company’s current product portfolio includes: ● 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 research and development tax refund receivable is recognized as the Company believes that it is probable that the amount will be recovered in full through a future claim.
The research and development tax refund receivable is recognized as the Company believes that there is a reasonable assurance the amount will be recovered in full through future claims.
These conditions raise substantial doubt about the Company’s ability to continue as a going concern for a period of at least one year from the date these financial statements are issued.
These conditions raise substantial doubt about the Company’s ability to continue as a going concern for a period of at least one year from the date these consolidated financial statements are issued. Accordingly, the Company will be required to raise additional funds during the next 12 months.
As of June 30, 2024, we had $6,304,098 in cash and cash equivalents and working capital of $3,083,510. The Company expects that its cash and cash equivalents as of June 30, 2024, may be insufficient to allow the Company to fund its current operating plan through at least the next twelve months from the issuance of these financial statements.
The Company expects that its cash and cash equivalents as of June 30, 2025, may be insufficient to allow the Company to fund its current operating plan through at least the next twelve months from the issuance of these consolidated financial statements.
Interest income Interest income increased by $75,146 to $84,822 from $9,676 for the year ended June 30, 2024, as compared to the same period in 2023.
Interest income Interest income increased by $16,700 to $101,522 from $84,822 for the year ended June 30, 2025, as compared to the same period in 2024.
R&D Tax Refund The Company measures the research and development grant income and receivable by calculating the time spent by employees and costs incurred to external service providers on eligible research and development activities.
There was no impairment loss recognized during the fiscal year ended June 30, 2024. 50 R&D Tax Refund The Company measures the research and development grant income and receivable by calculating the time spent by employees and costs incurred to external service providers on eligible research and development activities.
We aim to ensure that our cost efficiency is increased over the same period whilst we streamline the business, delivering increased value for investors. 54 Development and regulatory approval expenses Development and regulatory approval expenses increased by $1,166,382 to $1,673,806 from $507,424 for the year ended June 30, 2024, compared to the same period in 2023.
We aim to increase our cost efficiency as we streamline the business and implement changes, delivering increased value for investors. 46 Development and regulatory approval expenses Development and regulatory approval expenses increased by $722,707 to $2,396,513 from $1,673,806 for the year ended June 30, 2025, compared to the same period in 2024.
This information is intended to provide investors with information about our liquidity. Other companies in our industry may calculate this measure differently than we do, limiting its usefulness as a comparative measure. Since our inception, our operations have primarily been financed through the issuance of our common stock, redeemable convertible preferred stock, and the incurrence of debt.
This information is intended to provide investors with information about our liquidity. Other companies in our industry may calculate this measure differently than we do, limiting its usefulness as a comparative measure.
Revenue from the IFPG segment relates to the sale of readers, cartridges and accessories and is summarized as follows: Year Ended June 30, 2024 2023 Sales of goods - cartridges $ 1,549,409 $ 724,304 Sales of goods - readers 938,897 335,863 Other sales 623,475 196,705 Total revenue $ 3,111,781 $ 1,256,872 Cost of revenue Cost of revenue increased by $755,951 to $1,686,155 from $930,204 for the year ended June 30, 2024, compared to same period in 2023.
Revenue from IFP Products relates to the sale of readers, cartridges and accessories and is summarized as follows: Year Ended June 30, 2025 2024 Sales of goods - cartridges $ 1,762,153 $ 1,549,409 Sales of goods - readers 711,737 938,897 Other sales 578,642 623,475 Total revenue $ 3,052,532 $ 3,111,781 Cost of revenue Cost of revenue increased by $119,518 to $1,805,673 from $1,686,155 for the year ended June 30, 2025, compared to same period in 2024.
Intellectual property acquired for a particular research and development project and that have no alternative future uses (in other research and development projects or otherwise) are expensed in research and development costs at the time the costs are incurred. 59 In certain circumstances, the Company may be required to make advance payments to vendors for goods or services that will be received in the future for use in R&D activities.
Intellectual property acquired for a particular research and development project and that have no alternative future uses (in other research and development projects or otherwise) are expensed in research and development costs at the time the costs are incurred.
This decrease is due to the revaluation gains on the convertible notes and contingent consideration for holdback Series C Preferred Stock resulting from the acquisition of IFP. The convertible notes and holdback Series C Preferred Stock shares were converted into common stock in May 2023 and October 2023, respectively.
This decrease is due to the revaluation gain on contingent consideration for holdback Series C Preferred Stock resulting from the acquisition of IFP. The holdback Series C Preferred Stock shares were converted into common stock in October 2023. There was no fair value revaluation gain or loss on financial instruments for the year ended June 30, 2025.
These non-GAAP financial measures are not intended to be considered in isolation or as a substitute for, or superior to, financial information prepared and presented in accordance with US GAAP. These measures may be different from non—GAAP financial measures used by other companies, limiting their usefulness for comparison purposes.
We have also included reconciliations of these non-GAAP financial measures to their most directly comparable GAAP financial measures. These non-GAAP financial measures are not intended to be considered in isolation or as a substitute for, or superior to, financial information prepared and presented in accordance with US GAAP.
Realized foreign exchange loss Realized foreign exchange loss decreased by $8,651 to $1,178 from $9,829 for the year ended June 30, 2024, compared to the same period in 2023. This decrease was largely attributable to favorable exchange rates while settling transactions in currencies other than its functional currencies.
This decrease was largely attributable to favorable exchange rates while settling transactions in currencies other than its functional currencies. Fair value gain on revaluation of financial instruments The fair value gain decreased by $175,738 to $0 from $175,738 for the year ended June 30, 2025, as compared to the same period in 2024.
Our failure to obtain such funding when needed could create a negative impact on our stock price or could potentially lead to a reduction in our operations or the failure of our Company. Accordingly, these factors raise substantial doubt about the Company’s ability to continue as a going concern unless it can successfully raise additional capital.
Our failure to obtain such funding when needed could create a negative impact on our stock price or could potentially lead to a reduction in our operations or the failure of our Company.
This increase was attributable to the higher bank balance during the current period due to capital raising of approximately $14.56 million, net of costs during fiscal year ended June 30, 2024. 55 Income tax (expense) benefit There was no income tax expense for the years ended June 30, 2024, and 2023, respectively, as the Company has established a full valuation allowance for all its deferred tax assets.
This increase was attributable to funds received from capital raising activities, which contributed to the balance on which interest was earned. 47 Income tax (expense) benefit There was no income tax expense for the years ended June 30, 2025, and 2024, respectively, as the Company has established a full valuation allowance for all its deferred tax assets.
In such circumstances, the non-refundable advance payments are deferred and capitalized, even when there is no alternative future use for the R&D, until the related goods or services are provided. In circumstances where amounts have been paid in excess of costs incurred, the Company records a prepaid expense.
In certain circumstances, the Company may be required to make advance payments to vendors for goods or services that will be received in the future for use in R&D activities. In such circumstances, the non-refundable advance payments are deferred and capitalized, even when there is no alternative future use for the R&D, until the related goods or services are provided.
Other comprehensive income Foreign currency translation gain/(loss) Unrealized foreign currency translation gain decreased by $349,757 to a loss of $137,118 from a gain of $212,639 for the year ended June 30, 2024, compared to the same period in 2023.
The Company is currently assessing the future implications of these tax law changes. Other comprehensive income (loss) Foreign currency translation gain (loss) Unrealized foreign currency translation gain increased by $521,788 to a gain of $384,670 from a loss of $137,118 for the year ended June 30, 2025, compared to the same period in 2024.
Cost of revenue Year Ended June 30, 2024 2023 Direct material cost 1,017,218 369,217 Direct labor cost 646,246 533,618 Direct overhead cost 22,691 27,369 Total cost of revenue $ 1,686,155 $ 930,204 Gross profit Year Ended June 30, 2024 2023 Revenue $ 3,111,781 $ 1,256,872 Direct material cost (1,017,218 ) (369,217 ) Direct labor cost (646,246 ) (533,618 ) Direct overhead cost (22,691 ) (27,369 ) Cost of revenue (1,686,155 ) (930,204 ) Gross profit 1,425,626 326,668 Gross profit margin 45.81 % 25.99 % Gross profit increased by $1,098,958 to $1,425,626 from $326,668 for the year ended June 30, 2024, compared to same period in 2023.
Cost of revenue Year Ended June 30, 2025 2024 Direct material cost $ 923,251 $ 1,017,218 Direct labor cost 834,231 646,246 Direct overhead cost 48,191 22,691 Total cost of revenue (exclusive of amortization) $ 1,805,673 $ 1,686,155 Gross profit Year Ended June 30, 2025 2024 Revenue $ 3,052,532 $ 3,111,781 Direct material cost (923,251 ) (1,017,218 ) Direct labor cost (834,231 ) (646,246 ) Direct overhead cost (48,191 ) (22,691 ) Cost of revenue (1,805,673 ) (1,686,155 ) Gross profit $ 1,246,859 $ 1,425,626 Gross profit margin 40.85 % 45.81 % Gross profit decreased by $178,767 to $1,246,859 from $1,425,626 for the year ended June 30, 2025, compared to same period in 2024.
See Note 13, Shareholders’ Equity, for further details. 56 Extended Transition Period for “Emerging Growth Companies” We have elected to use the extended transition period for complying with new or revised accounting standards under Section 102(b)(1) of the JOBS Act.
Accordingly, these factors raise substantial doubt about the Company’s ability to continue as a going concern unless it can successfully raise additional capital. 48 Extended Transition Period for “Emerging Growth Companies” We have elected to use the extended transition period for complying with new or revised accounting standards under Section 102(b)(1) of the JOBS Act.
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.
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.
Contribution margin (non-GAAP) Year Ended June 30, 2024 2023 Revenue $ 3,111,781 $ 1,256,872 Direct material cost (1,017,218 ) (369,217 ) Contribution margin (non-GAAP) 2,094,563 887,655 Contribution margin % (non-GAAP) 67.31 % 70.62 % Contribution margin, which is a non-GAAP measure of our financial performance, increased by $1,206,908 to $2,094,563 from $887,655 for the year ended June 30, 2024, compared to same period in 2023.
The gross profit margin decreased by 4.96% due to an increase in direct labor costs due to additional head counts, increase in minimum wages of factory staff by 8.90% year-on-year and direct overhead costs. 45 Contribution margin (non-GAAP) Year Ended June 30, 2025 2024 Revenue $ 3,052,532 $ 3,111,781 Direct material cost (923,251 ) (1,017,218 ) Contribution margin (non-GAAP) $ 2,129,281 $ 2,094,563 Contribution margin % (non-GAAP) 69.75 % 67.31 % Contribution margin (non-GAAP) Contribution margin, which is a non-GAAP measure of our financial performance, increased by $34,718 to $2,129,281 from $2,094,563 for the year ended June 30, 2025, compared to same period in 2024.
There can be no assurance that, in the event that the Company requires additional financing, such financing may be available on terms which are favorable to us, or at all. In the event we require additional capital, there can be no assurances that we will be able to raise such capital on acceptable terms, or at all.
Risk Factors - The Company may not be able to repay the grant it received from the Australian Government on time.” However, there can be no assurances that we will be able to raise such capital on acceptable terms, or at all.
Operating expenses Selling, general and administrative expenses Selling, general and administrative expenses increased by $1,231,793 to $9,258,496 from $8,026,703 for the year ended June 30, 2024, compared to the same period in 2023.
Operating expenses Selling, general and administrative expenses Selling, general and administrative expenses decreased by $374,579 to $8,883,917 from $9,258,496 for the year ended June 30, 2025, compared to the same period in 2024. This decrease is primarily due to a decrease in legal, insurance, and general overhead costs offset by an increase in advertising, marketing and travel costs.
Moreover, presentation of contribution and contribution margin is provided for year-over-year comparison purposes.
These measures may be different from non-GAAP financial measures used by other companies, limiting their usefulness for comparison purposes. Moreover, presentation of contribution and contribution margin is provided for year-over-year comparison purposes.
(10,293,877 ) (10,419,081 ) Net loss per share, basic and diluted* $ (6.38 ) $ (127.00 ) Weighted average units outstanding, basic and diluted * 1,592,746 83,717 The accompanying notes are an integral part of these consolidated financial statements. * Common Stock and per share amounts have been retroactively adjusted to reflect the decreased number of shares resulting from the 1-for-12 reverse stock split effected on January 26, 2024, throughout the consolidated financial statement unless otherwise stated. 52 Results of Operations: Comparison of the Years Ended June 30, 2024, and 2023 Revenue Sales of goods Revenue from sales of goods increased by $1,854,909 to $3,111,781 from $1,256,872 for the year ended June 30, 2024, compared to same period in 2023.
(10,184,063 ) (10,293,877 ) Net loss per share, basic and diluted $ (2.00 ) $ (6.38 ) Weighted average shares outstanding, basic and diluted 5,273,643 1,592,746 44 Results of Operations: Comparison of the Years Ended June 30, 2025, and 2024 Revenue Sales of goods Revenue from sales of goods decreased by $59,249 to $3,052,532 from $3,111,781 for the year ended June 30, 2025, compared to same period in 2024.
It is calculated based on the Company’s unsettled transactions in currencies other than its functional currency and translation of assets and liabilities of foreign subsidiaries in reporting currency. Net loss attributable to INBS Net loss attributable to INBS decreased by $474,961 to $10,156,759 from $10,631,720 for the year ended June 30, 2024, compared to the same period in 2023.
This is due to the favorable exchange rate calculated based on the Company’s unsettled transactions in currencies other than its functional currency and translation of assets and liabilities of foreign subsidiaries in reporting currency.
Depreciation and amortization Depreciation and amortization increased by $234,542 to $1,201,274 from $966,732 for the year ended June 30, 2024, compared to same period in 2023.
We expect development and regulatory expenses to increase in future periods, as the Company aims to conduct future studies for additional drugs of abuse. Depreciation and amortization Depreciation and amortization increased by $6,601 to $1,207,875 from $1,201,274 for the year ended June 30, 2025, compared to same period in 2024.
Other income and expenses Interest expense Interest expense decreased by $56,394 to $167,140 from $223,534 for the year ended June 30, 2024, as compared to the same period in 2023. This decrease was attributable to the conversion of the convertible notes into common stock of the Company in May 2023.
The increase is mainly due to the impairment of construction in progress (CIP) assets. Refer to Note 7 of financial reports for details. Other income and expenses Interest expense Interest expense decreased by $106,250 to $60,890 from $167,140 for the year ended June 30, 2025, as compared to the same period in 2024.
Cost of revenue relates to the direct labor, direct material costs and direct overhead costs incurred in the production of the goods. This is in line with expectations, as the business expands into new markets. The following table shows the composition of cost of revenue.
The increase in cost of revenue is mainly due to an increase in direct labor cost due to annual salary revision for direct manufacturing labor during the fourth quarter of fiscal 2025 and direct overhead costs. The following table shows the composition of cost of revenue.
Removed
Unless otherwise indicated, all share and per share information in this report gives effect to the reverse stock split of our outstanding common stock, which was effected at a ratio of 1-for-12 as of 5:00 p.m. Eastern Time on January 26, 2024.
Added
Customers include safety-critical industries such as construction, transportation and logistics, manufacturing, engineering, drug treatment organizations in the rehabilitation sector, and judicial organizations. 42 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; ● 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; 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 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”.
Removed
Customers include safety-critical industries such as construction, transportation and logistics, manufacturing, engineering, drug treatment organizations in the rehabilitation sector, and judicial organizations. ● The 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”).
Added
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.
Removed
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.
Added
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.
Removed
A timeline for these discussions has not yet been established. 51 Results of Operations: Key Financial Performance Year Ended June 30, 2024 Year Ended June 30, 2023 % Change Revenue $ 3,111,781 $ 1,256,872 +147.58 % Gross Profit $ 1,425,626 $ 326,668 +336.41 % Gross Profit % 45.81 % 25.99 % +19.82 % The Company continues to meet its objectives of strong market penetration and improved margins achieved through economies of scale with enough volume to achieve growth of 147.58% in sales revenue and 336.41% growth in gross profit for the fiscal year ended June 30, 2024, compared to the same period in fiscal 2023.
Added
This decrease is mainly due to instability in the construction sector in our primary market, the UK which has resulted in the lower number of readers being sold during the period.
Removed
Furthermore, the Company is set to compound this growth with the numbers of readers reaching 1,037 on customer sites, as of June 2024.
Added
The contribution margin improved by approximately 2.44% due to improved production efficiency and sales mix, as the sales of high margin cartridges continue to increase as a proportion of the total revenue.
Removed
This is due to the expansion of the customer base, both in the pre-existing markets and expansion into new regions. We expect this trend to continue as we expand into new markets in the future.
Added
Reconciliation of contribution margin (non-GAAP) Year Ended June 30, 2025 2024 Revenue (GAAP) $ 3,052,532 $ 3,111,781 Less: Cost of revenue (exclusive of amortization) (GAAP) (1,805,673 ) (1,686,155 ) Gross Profit (GAAP) $ 1,246,859 $ 1,425,628 Add: Direct labor cost 834,231 646,246 Add: Direct overhead cost 48,191 22,691 Contribution margin (non-GAAP) $ 2,129,281 $ 2,094,565 Contribution margin % (non-GAAP) 69.75 % 67.31 % Government support income Government support income in the United Kingdom and Australia geographic segments increased by $392,125 to $816,901 from $424,776 for the year ended June 30, 2025, compared to same period in 2024.
Removed
This has been driven by increased revenue from acquiring new customers. 53 The gross profit is primarily attributable to the IFPG segment.
Added
This increase was primarily attributable to the Company’s investment in qualifying research and development expenditures for research and development government subsidies and unwinding of the grant income in the fourth fiscal quarter of FY 2024-25 upon the completion of the grant acquittal audit.
Removed
This has been driven by increased revenue from acquiring new customers. Government support income Government support income in the IFPG and BPT segments decreased by $312,852 to $424,776 from $737,628 for the year ended June 30, 2024, compared to same period in 2023.
Added
This increase is primarily driven by the increased expenditure on R&D activities as the Company undertook multiple clinical trials and filed for FDA 510 (k) clearance. During the year ended June 30, 2025, the Company partnered with CenExel Research, a third party Clinical Research Organization (CRO), and completed a method comparison clinical study on its IFP System.
Removed
This decrease was primarily attributable to an adjustment for a potential refund of the Australian Government grant if we are unable to complete the project on time.
Added
This increase is mainly due to the fluctuation in the foreign exchange rate for conversion of the account balances. Impairment of long-lived assets The Impairment of long-lived assets increased by $220,062 to $220,062 from $0 for the year ended June 30, 2025, compared to the same period in 2024.
Removed
This increase is primarily due to engagement of consultants for marketing, media and investor relationship management, capital raising, professional fees for legal and compliance as the Company continues to expand its business and conduct clinical study as it progresses along its 510(k) pathway for FDA clearance.
Added
This decrease was attributable to the reduction of the interest recorded for leased assets and notes payable as the leases are nearing its termination date. Realized foreign exchange loss Realized foreign exchange loss decreased by $267 to $911 from $1,178 for the year ended June 30, 2025, compared to the same period in 2024.
Removed
This increase is primarily driven by amounts spent on in-house R&D staff and timing of R&D work performed by the research partners engaged by the Company. As the Company continues its FDA 501(k) clinical study plan, we expect development and regulatory expenses to increase in future periods, as demonstrated by the results above.
Added
The One Big Beautiful Bill Act (the “OBBBA”), signed into law on July 4, 2025, introduces amendments to U.S. tax laws with various effective dates. Key tax-related provisions of the OBBBA include changes to bonus depreciation, research and development expenditures, interest expense deductibility, and revisions to international tax regimes.
Removed
This is mainly due to inclusion of amortization of intangible assets for twelve months to June 30, 2024 results as compared to approximately nine months to June 30, 2023 upon the acquisition of IFP in October 2022 offset by the revaluation of the useful life of technology assets from 5 years to 7 years on April 1, 2023.
Added
Net loss attributable to INBS Net loss attributable to INBS increased by $411,974 to $10,568,733 from $10,156,759 for the year ended June 30, 2025, compared to the same period in 2024.
Removed
Goodwill Impairment The goodwill impairment expenses decreased by $4,158,670 to $0 from $4,158,670 for the year ended June 30, 2024, compared to the same period in 2023. Refer to note 3 of our consolidated financial statements appearing elsewhere in our Annual Report on Form 10-K.
Added
This increase is primarily driven by increase in development and regulatory approval expenses as the Company ran multiple clinical trials for submission to the FDA and impairment of the available for sale assets during the year.
Removed
Fair value gain on revaluation of financial instruments The fair value gain decreased by $1,978,627 to $175,738 from $2,154,365 for the year ended June 30, 2024, as compared to the same period in 2023.
Added
Since our inception, we have financed our operations primarily though proceeds from public offerings and private placements of equity securities, existing trade and shareholder financing arrangements, and the incurrence of debt. As of June 30, 2025, we had $1,019,909 in cash and cash equivalents and working capital deficit of $1,212,419.
Removed
This decrease is primarily driven by goodwill impairment charges of $4,158,670 and combined results of operations after the acquisition of IFP offset by a recognition of fair value gain on revaluation of convertible notes and holdback Series C Preferred Stock of $2,062,878 during the same period in 2023.
Added
At the Market (ATM) Offering - On September 18, 2024, the Company entered into an At The Market Offering Agreement (the “ATM Agreement”) with Ladenburg Thalmann & Co. Inc. (“Ladenburg”).
Removed
Cash Provided by Financing Activities On October 4, 2023, the Company raised approximately $4.38 million, prior to deducting underwriting discounts and 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.
Added
Pursuant to the terms of the ATM Agreement, the Company may sell from time to time through Ladenburg, as sales agent and/or principal, shares of the Company’s common stock, with an aggregate sales price of up to $3.0 million.
Removed
See Note 13, Shareholders’ Equity, for further details. On February 7, 2024, the Company raised approximately $1.77 million, prior to deducting closing costs and placement agent fees, via a warrant inducement transaction with holders of the Company’s Series E Warrants issued on October 4, 2023.
Added
On March 11, 2025, the Company filed a prospectus supplement (the “2025 ATM Supplement”) to the ATM Prospectus (defined below) in connection with the offer, sale, and issuance of additional shares.
Removed
Net proceeds to the Company, after deducting closing costs, placement agent fees, and other estimated expenses payable by the Company, was approximately $1.58 million. See Note 13, Shareholders’ Equity, for further details.
Added
During the period between September 18, 2024, through to June 30, 2025, the Company raised approximately $2,251,540 (net of commissions of approximately $69,637 paid to Ladenburg) through the sale and issuance of 1,434,659 shares of Company common stock pursuant to the ATM Agreement.
Removed
On March 12, 2024, the Company raised approximately $10.10 million, prior to deducting placement agent’s fees and other offering expenses via a private placement of common stock and warrants priced at-the-market under Nasdaq rules. Net proceeds to the Company, after deducting placement agent’s fees and other estimated offering expenses payable by the Company, were approximately $9.12 million.
Added
During the three months ended June 30, 2025, the Company raised approximately $765,201 (net of commissions of approximately $23,666 paid to Ladenburg) through the sale and issuance of 514,296 shares of Company common stock pursuant to the ATM Agreement.
Removed
The project has been delayed due to global shortages of semiconductors that are used in manufacturing equipment and global supply chain disruption due to Covid-19 pandemic in the preceding year. As of June 30, 2024, the Company has only completed 4 of the 8 milestones in the grant agreement.
Added
Any sale of shares pursuant to the ATM Agreement are made under the Company’s effective “shelf” registration statement on Form S-3 (File No. 333-264218), which became effective on April 20, 2022, and included base prospectus, and under the related prospectus supplement (the “ATM Prospectus”) filed with the SEC, dated September 18, 2024, as supplemented by the 2025 ATM Supplement filed with the SEC on March 11, 2025.
Removed
On April 16, 2024, the Company entered into a Deed of Variation with Australian Government, Department of Industry, Science and Resources, extending the project completion date to March 28, 2025. The deed of variation also made certain modifications to the project costs.

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