Intelligent Bio Solutions (INBS) risk factors, FY2025 10-K

Other

1. 01If 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 securitiesNew

Risks Related to Our Business

1. 02Our 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
2. 03We are subject to the risks associated with new businesses generally50% rewritten
3. 04We have incurred significant losses since inception and continue to incur losses, and we may not be able to achieve significant revenues or profitability58% rewritten
4. 05We rely on third parties to perform certain confirmatory tests for our IFP System
5. 06We 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
6. 07Our results may be impacted by changes in foreign currency exchange rates
7. 08If 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
8. 09Our results of operations will be materially harmed if we are unable to accurately forecast customer demand for our products and manage our inventory
9. 10If 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
10. 11Our 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
11. 12We 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 forecast40% rewritten
12. 13We 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
13. 14Failure in our conventional, online and digital marketing efforts could impact our ability to generate sales22% rewritten
14. 15As 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
15. 16If third-party payors do not provide coverage and reimbursement for the use of the IFP products, our business and prospects may be negatively impacted
16. 17Non-United States governments often impose strict price controls, which may adversely affect our future profitability23% rewritten
17. 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
18. 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
19. 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
20. 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
21. 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
22. 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 rates
23. 24If 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
24. 25We could be party to litigation or other legal proceedings that could adversely affect our business, results of operations and reputation
25. 26Changes to U.S. tax laws under the One Big Beautiful Bill Act and potential changes to tariff policies could adversely affect our financial condition and results of operationsNew

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 product33% rewritten
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 plan25% rewritten
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 unsuccessful72% rewritten
6. 36We may be unable to protect or enforce our intellectual property rights, including those licensed to us, which could impair our competitive position77% rewritten
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 inventionsNew
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 us25% rewritten
9. 39We may be subject to claims challenging the invention of the intellectual property that we use27% rewritten

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 obsolete35% rewritten
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 timeNew
2. 49We are an emerging growth company and currently have limited accounting personnel and other supervisory resources. This can result in a lack of necessary resources to adequately execute our accounting processes and address our internal controls over financial reporting requirements
3. 50Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or products36% rewritten
4. 51The market price of our common stock may be significantly volatile
5. 52We 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 businessNew
6. 53We may have difficulties integrating acquired businesses and as a result, our business, results of operations and/or financial condition may be materially adversely affected