Autonomix Medical, Inc.

In addition to the other information set forth in this report, you should carefully consider the factors discussed in the section entitled “Risk Factors” as found in our Annual Report on Form 10-K filed with the SEC on May 27, 2026.

The risks described in our Form 10-K are not the only risks facing us. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition and/or operating results. Except as set forth below, there have been no material changes to our risk factors from those set forth in our Form 10-K filed with the SEC on May 27, 2026.

If Nasdaq’s minimum Market Value of Listed Securities requirement of $5 million takes effect, it could result in the suspension and delisting of our common stock from Nasdaq.

On July 22, 2026, the SEC approved a new Nasdaq rule requiring companies listed on Nasdaq to maintain a minimum Market Value of Listed Securities (“MVLS”) of at least $5.0 million. Under the new rule, if a company’s MVLS remains below $5 million for 30 consecutive business days, Nasdaq will issue a Staff Delisting Determination, and trading in the company’s securities will be immediately suspended without any cure or compliance period. Furthermore, a request for a hearing before a Nasdaq Hearings Panel will not stay the suspension. On July 29, 2026, the MVLS rule was automatically stayed pending review by the SEC and, as of the date of this Form 10-Q, the stay remains in effect. It is not certain whether or when the MVLS rule will retake effect.

A delisting under this rule would have adverse consequences on our common stock, including reduced liquidity, limited market quotations, diminished analyst coverage, and impaired ability to raise capital. In addition, a delisting from Nasdaq could cause our common stock to be classified as a “penny stock,” which would subject broker-dealers trading in our common stock to additional sales practice requirements and further reduce the liquidity and market price of our common stock. We can provide no assurance that we will be able to maintain compliance with this new MVLS requirement or that any actions we may take to increase our MVLS, such as additional capital raising, will be successful or will not have other adverse effects on our stockholders.

Feedback received from the FDA through the pre-submission process does not assure acceptance of our proposed regulatory pathway, a determination of substantial equivalence, or authorization to market our products.

We are subject to extensive regulation by the U.S. Food and Drug Administration (“FDA”), including requirements governing the development, testing, clearance, approval and commercialization of our medical devices. As part of our regulatory strategy, we may engage with the FDA through its pre-submission program to obtain feedback regarding our proposed regulatory pathway, device classification, testing protocols, clinical evidence requirements and other matters relevant to a future marketing submission. Although we believe such interactions may provide valuable guidance in developing our regulatory strategy, feedback received through the pre-submission process is generally nonbinding and does not constitute a determination by the FDA that our proposed regulatory pathway is appropriate, that our devices are substantially equivalent to legally marketed predicate devices, or that our devices will ultimately receive marketing authorization.

The FDA may determine, upon review of a subsequent marketing submission, that additional nonclinical testing, clinical data, design modifications or other information is required, or that a different regulatory pathway, including a De Novo classification request or premarket approval application, is necessary. In particular, if we pursue clearance through the Section 510(k) premarket notification process, there can be no assurance that the FDA will agree with our identification of an appropriate predicate device or determine that our device is substantially equivalent to such predicate device. The FDA may also modify or reconsider feedback previously provided based on additional information, changes in the proposed device, evolving scientific or regulatory considerations, or other factors identified during its review.

Any such determination could require us to conduct additional studies, incur substantial costs, modify our products or regulatory strategy, or experience significant delays in obtaining marketing authorization. Furthermore, even if the FDA provides favorable feedback during the pre-submission process, there can be no assurance that we will successfully complete the necessary testing or clinical studies, satisfy applicable regulatory requirements, or obtain FDA clearance, approval or other marketing authorization within our anticipated timeframe, if at all.

Our failure to obtain marketing authorization for our products, or any material delay or additional expense associated with the regulatory review process, could adversely affect our development and commercialization plans, increase our capital requirements, limit our ability to generate revenue and materially adversely affect our business, financial condition, results of operations and prospects.

An initial FDA clearance for general sensing functionality may be limited to the specific indications for use authorized by the FDA and may not permit us to market our technology for therapeutic ablation, neural signal interpretation, procedural guidance or treatment verification.

We are developing medical device technologies intended to support the sensing and interpretation of neural signals and potentially facilitate the identification, targeting and treatment of neural tissue. Our regulatory strategy may involve pursuing an initial FDA marketing clearance for general sensing functionality, followed by additional regulatory submissions seeking authorization for expanded indications for use, therapeutic applications or other advanced capabilities. However, any initial FDA clearance would be limited to the specific intended use and indications for use authorized by the FDA and would not necessarily permit us to market, promote or commercialize our technology for additional diagnostic, therapeutic or procedural applications.

In particular, an initial clearance for general sensing functionality may not authorize the use of our technology for therapeutic ablation, the interpretation or characterization of neural signals for clinical decision-making, the identification or targeting of specific neural structures, procedural guidance, or the verification or assessment of treatment effectiveness. The FDA may determine that these additional functions or claims involve different intended uses, technological characteristics or risk profiles that require separate regulatory submissions, additional nonclinical or clinical evidence, or authorization through a different regulatory pathway, including the De Novo classification or premarket approval process.

There can be no assurance that we will successfully develop, validate or obtain FDA clearance, approval or other marketing authorization for any such expanded functionality or indications for use. The FDA may require additional testing, clinical studies, product modifications or other supporting evidence, which could result in substantial additional expenditures, delays in product development or commercialization, or limitations on the scope of our authorized product labeling and promotional claims. In addition, the FDA may impose restrictions or limitations on the indications for use or claims associated with any initial or subsequent marketing authorization, which could limit the clinical applications and commercial opportunities for our technology.

If we obtain an initial FDA clearance that does not encompass the full range of our intended therapeutic or advanced sensing applications, our ability to commercialize our technology, achieve market acceptance, generate revenue or realize the anticipated benefits of our development programs may be materially limited. Any inability to obtain subsequent regulatory authorizations for additional functionality or indications for use, or any significant delay or additional cost associated with obtaining such authorizations, could materially adversely affect our business, financial condition, results of operations and prospects.

Our 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.

We are developing proprietary sensing and ablation technologies that represent novel applications within the medical device space. As such, these technologies are subject to stringent validation and verification processes, both internally and by regulatory bodies such as the FDA. There is no assurance that our products will meet the safety, efficacy, and performance criteria required to obtain regulatory approvals. Acquiring low-amplitude biological electrical signals from within blood vessels and determining their source and clinical significance present substantial technical challenges. Physiological changes associated with an intervention, catheter position, electrode contact and acquisition conditions may affect recorded activity and complicate our ability to distinguish neural activity from other electrical activity or artifacts and to attribute observed changes to treatment effect. Our ability to record electrical activity does not, by itself, establish that the recorded activity can be reliably interpreted as neural activity or used to guide treatment or verify its effectiveness. In particular, a reduction in recorded electrical activity alone does not establish the completeness or durability of denervation. There can be no assurance that our planned technology modifications or processing methods will improve performance sufficiently to support these intended uses or claims. If we are unable to establish the reliability, reproducibility or clinical significance of our recordings, we may need to modify our technology, processing methods, study designs or proposed indications for use, or discontinue particular development programs. These developments could require additional financing, increase costs, delay regulatory submissions and commercialization, limit the capabilities or claims we are able to commercialize, or prevent commercialization of some or all of our proposed products. Additionally, even if our technologies are shown to be safe and effective in preclinical or early-stage clinical studies, they may not meet the technical, usability, cost, or performance benchmarks necessary for commercial viability. Any delays or failures in validation, or changes in FDA requirements or guidance, could significantly impact our development timelines, increase our costs, and delay or prevent our ability to bring our products to market.