Autonomix Medical (AMIX) risk factors, FY2025 10-K

Risks Related to Our Overall Business

1. 01Factors raise substantial doubt about our ability to continue as a going concern
2. 02We have no approved products, and we cannot assure you that we will generate revenue or become profitable in the future
3. 03We believe our existing capital resources, will be sufficient to fund our operations into the first calendar quarter of 2026 without additional capital infusion
4. 04We intend to utilize a single manufacturer for the manufacture of our lead product candidate and expect to continue to do so for commercial products. Risks associated with the manufacturing of our products could reduce our gross margins and negatively affect our operating results
5. 05potential damage to or destruction of our manufacturers' equipment or facilities
6. 06We are a developmental stage company and have not yet had a history of generating revenue
7. 07Our business may be adversely affected by the state of the global economy, uncertainties in global financial markets, and possible trade tariffs and trade restrictions
8. 08We have limited experience in assembling and testing our products and may encounter problems or delays in the assembly of our products or fail to meet certain regulatory requirements which could result in an adverse effect on our business and financial results
9. 09complying with state, federal and foreign regulations
10. 10Rapidly changing technology in life sciences could make the products we are developing obsolete
11. 11termination of cash management arrangements and/or delays in accessing or actual loss of funds subject to cash management arrangements
12. 12We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights
13. 13Catastrophic events and disaster recovery may disrupt business continuity
14. 14We may fail to meet the Sarbanes-Oxley regulations and may lack the financial controls and safeguards required of public companies
15. 15While our Company’s management is working to improve our internal controls and procedures, at present management has determined that our internal controls were deemed to be inadequate, which could cause our financial reporting to be unreliable and lead to misinformation being disseminated to the public
16. 16provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the Company’s assets that could have a material effect on the financial statements

Risks Related to Government Regulation and Product Approvals

1. 17Changes to United States federal and state regulatory agencies may cause disruptions and delays in approval of the government approval processes and regulation relating to our products
2. 18There is no guarantee that the FDA will grant 510(k) or de novo clearance or a premarket approval application (“PMA”) of our future products and failure to obtain necessary clearances or approvals for our future products would adversely affect our ability to grow our business
3. 19If we fail to obtain and maintain regulatory approvals and clearances, or are unable to obtain, or experience significant delays in obtaining, FDA clearances or approvals for our device, our future products or product enhancements, our ability to commercially distribute and market these products could suffer
4. 20Our product development for our sensing and ablation technologies may not meet the necessary validation requirements to achieve regulatory approvals, or our internal specifications for commercial viability
5. 21Modifications to our future products may require new regulatory clearances or approvals or may require us to recall or cease marketing our products until clearances or approvals are obtained
6. 22The results of our future clinical trials may not support our product candidate claims or may result in the discovery of adverse side effects
7. 23Our clinical studies could be delayed or otherwise adversely affected by many factors, including difficulties in enrolling patients
8. 24the risk that patients enrolled in clinical studies will choose to withdraw from or otherwise not be able to complete a clinical study
9. 25We may have limitations in generating statistically significant long-term clinical data and gaining extended-duration indications from clinical studies involving terminal patients
10. 26Even if our products are cleared or approved by the FDA, if we or our suppliers fail to comply with ongoing FDA requirements, or if we experience unanticipated problems with our products, these products could be subject to restrictions or withdrawal from the market
11. 27Our products may in the future be subject to product recalls that could harm our reputation, business and financial results
12. 28If our products cause or contribute to a death or a serious injury, or malfunction in certain ways, we will be subject to medical device reporting regulations, which can result in voluntary corrective actions or agency enforcement actions
13. 29Certain parts used in the manufacturing of our equipment may experience shortages in global supply, which could impact our ability to manufacture our device for customers or maintain research and development timelines
14. 30U.S. legislative or FDA regulatory reforms may make it more difficult and costly for us to obtain regulatory approval of our product candidates and to manufacture, market and distribute our products after approval is obtained
15. 31Failure to secure and maintain adequate coverage and reimbursement from third-party payers could adversely affect acceptance of our products, if approved, and reduce our revenues
16. 32We may not be successful in securing and maintaining reimbursement codes necessary to facilitate accurate and timely billing for our products or physician services attendant to our products
17. 33If we are unable to establish good relationships with physicians, our business could be negatively affected
18. 34There is no assurance that Medicare or the Medicare Administrative Contractors will provide coverage or adequate payment rates for our products

Risks Related to Intellectual Property

1. 35If third parties claim that our products infringe their intellectual property rights, we may be forced to expend significant financial resources and management time defending against such actions and our financial condition and our results of operations could suffer
2. 36If we are unable to protect the intellectual property used in our products, others may be able to copy our innovations which may impair our ability to compete effectively in our markets
3. 37We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers
4. 38If we are unable to protect the confidentiality of our proprietary information and know-how, the value of our technology and products could be adversely affected
5. 39We may not be able to protect our intellectual property rights throughout the world

Risks Related to Information Technology

1. 40Our business and operations would suffer in the event of third-party computer system failures, cyberattacks on third-party systems or deficiency in our cybersecurity
2. 41Artificial intelligence presents risks and challenges that can impact our business, including by posing security risks to our confidential information, proprietary information and personal data
3. 42Cybersecurity risks and cyber incidents could adversely affect our business and disrupt operations

Risks Related to our Common Stock

1. 43Concentration of ownership of our common stock among our existing executive officers and directors may prevent new investors from influencing significant corporate decisions
2. 44We do not intend to pay cash dividends on our common stock in the foreseeable future
3. 45If our stock price fluctuates, you could lose a significant part of your investment
4. 46Techniques employed by short sellers may in the future drive down the market price of our common stock
5. 47If securities or industry analysts do not publish research or reports about us, or if they adversely change their recommendations regarding our common stock, then our stock price and trading volume could decline
6. 48The market price of our stock may be highly volatile, and you could lose all or part of your investment
7. 49Your ownership may be diluted if additional capital stock is issued to raise capital, to finance acquisitions or in connection with strategic transactions
8. 50We may be required to issue up to 271,846 shares of common stock in connection with the reverse stock split we completed on October 24, 2024, and we may be subject to potential liability if it is determined that we are required to issue such shares and we fail to issue such shares on a timely basis
9. 51If 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 sell your shares
10. 52Provisions of the Series A Warrants we issued in our offering could discourage an acquisition of us by a third party

General Risks

1. 53Shareholder activism could cause material disruption to our business
2. 54As an “emerging growth company” under the Jumpstart Our Business Startups Act, or JOBS Act, we are permitted to, and intend to, rely on exemptions from certain disclosure requirements
3. 55the date on which we are deemed a “large accelerated issuer” as defined under the federal securities laws
4. 56We intend to take advantage of all of these reduced reporting requirements and exemptions
5. 57Our Certificate of Incorporation includes a forum selection provision, which could result in less favorable outcomes to the plaintiff(s) in any action against us
6. 58The requirements of being a public company may strain our resources, divert management’s attention and affect our ability to attract and retain qualified board members
7. 59We may be at an increased risk of securities class action litigation