Intelligent Bio Solutions (INBS) risk factors, FY2026 10-K

Other

1. 01We 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 operations100% rewritten
2. 02If third-party payors do not provide coverage and reimbursement for the use of the IFP products, our business and prospects may be negatively impacted100% rewritten
3. 03If 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 business99% rewritten

Risks Related to Our Business

1. 04Our 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, 2026
2. 05We are subject to the risks associated with new businesses generally
3. 06We have incurred significant losses since inception and continue to incur losses, and we may not be able to achieve significant revenues or profitability27% rewritten
4. 07We rely on third parties to perform certain confirmatory tests for our IFP System45% rewritten
5. 08Our results may be impacted by changes in foreign currency exchange rates
6. 09If 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
7. 10Our results of operations will be materially harmed if we are unable to accurately forecast customer demand for our products and manage our inventory
8. 11If 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
9. 12Our 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
10. 13We cannot accurately predict the volume or timing of any sales of any of our products, making the timing of any associated revenues uncertain and difficult to forecast
11. 14We 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
12. 15Failure in our conventional, online and digital marketing efforts could impact our ability to generate sales
13. 16As 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 condition44% rewritten
14. 17Non-United States governments often impose strict price controls, which may adversely affect our future profitability
15. 18The 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
16. 19Our 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
17. 20If 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
18. 21If 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
19. 22We may be subject to healthcare fraud and abuse laws and regulations which, if violated, could subject us to substantial penalties. Additionally, any challenge to or investigation into our practices under these laws could cause adverse publicity and be costly to respond to, and thus could harm our business
20. 23Product 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. These suits could result in expensive and time-consuming litigation, payment of substantial damages, and an increase in our insurance rates46% rewritten
21. 24We could be party to litigation or other legal proceedings that could adversely affect our business, results of operations and reputation
22. 25Changes to U.S. tax laws under the One Big Beautiful Bill Act and existing and future changes to tariff policies could adversely affect our financial condition and results of operations56% rewritten
23. 26Our use of artificial intelligence, or AI, and other emerging technologies could adversely impact our business and financial resultsNew

Risks Related to Product Development and Regulatory Approval or Clearance

1. 27The 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
2. 28Clinical 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
3. 29We 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
4. 30We 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

Risks Related to Our Intellectual Property

1. 31Our success will depend on our ability to obtain, maintain and protect our intellectual property rights
2. 32Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements
3. 33Patent terms may not be able to protect our competitive position for an adequate period of time with respect to our current or future technologies
4. 34Extensions of patent term may be available, but there is no guarantee that we would succeed in obtaining any particular extension and no guarantee any such extension would confer patent term for a sufficient period of time to exclude others from commercializing products similar or identical to ours
5. 35We may be subject to claims alleging the violation of the intellectual property rights of others, which could involve in lawsuits to protect or enforce our intellectual property rights, which could be expensive, time consuming and unsuccessful26% rewritten
6. 36We may be unable to protect or enforce our intellectual property rights, including those licensed to us, which could impair our competitive position
7. 37We 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
8. 38We rely on confidentiality agreements that could be breached and may be difficult to enforce, which could result in third parties using our intellectual property to compete against us
9. 39We may be subject to claims challenging the invention of the intellectual property that we use

Risks Related to Our Industry

1. 40If 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”)
2. 41If any of these events were to occur, it will negatively affect our business, financial condition and results of operations
3. 42Compliance with environmental laws and regulations could be expensive, and the failure to comply with these laws and regulations could subject us to significant liability
4. 43If 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
5. 44If we fail to respond quickly to technological or other developments, our products may become uncompetitive and obsolete
6. 45Fluctuation in the value of foreign currencies may have a material adverse effect on your investment
7. 46We are subject to laws and regulations governing business conduct, which will require us to develop and implement costly compliance programs
8. 47Changes in the economic, political or social conditions or government policies in our target markets could have a material adverse effect on our business and operations

Risks Related to the Ownership of Our Common Stock

1. 48The Company may not be able to repay the grant it received from the Australian Government on time95% rewritten
2. 49If we are unable to maintain compliance with the listing requirements of the Nasdaq Capital Market, our common stock may be delisted from the Nasdaq Capital Market which could have a material adverse effect on our financial condition and could make it more difficult for you to trade in our securities100% rewritten
3. 50In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we were provided with an initial period of 180 calendar days, or until June 15, 2026, to regain compliance with the Bid Price Rule. We effected the 2025 Reverse Stock Split in order to regain compliance with the Bid Price RuleNew
4. 51We are obligated to develop and maintain a system of effective internal control over financial reporting. Our 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 stockNew
5. 52The loss of our “emerging growth company” status will increase certain reporting and compliance obligations and any failure to meet these expanded requirements could expose us to regulatory scrutiny or sanctions and could harm our reputation and adversely affect our stock priceNew
6. 53Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or products
7. 54The market price of our common stock may be significantly volatile
8. 55We incur significantly increased costs and are subject to additional regulations and requirements as a result of becoming a public company, which could lower our profits or make it more difficult to run our business
9. 56We may have difficulties integrating acquired businesses and as a result, our business, results of operations and/or financial condition may be materially adversely affected
10. 57We are a “smaller reporting company”, and the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to investorsNew