Quarterly Report for Quarter Ending September 30, 2026 (Form 10-Q)

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

References in this Form 10-Q to "we," "us," "its," "our" or the "Company" are to Autonomix Medical, Inc. ("Autonomix"), as appropriate to the context.

You should read the following discussion and analysis of our financial condition and results of operations in conjunction with the financial statements and the related notes appearing elsewhere in this Form 10-Q. This discussion contains forward-looking statements reflecting our current expectations that involve risks and uncertainties. See the section titled "Risk Factors" as found in our Annual Report on Form 10-K filed with the SEC on May 27, 2026, which is available on the SEC's EDGAR website at www.sec.gov, and any updates or amendments to those risk factors subsequently filed with the SEC, for a discussion of the uncertainties, risks and assumptions associated with these statements. Actual results and the timing of events could differ materially from those discussed in our forward-looking statements as a result of many factors, including those set forth under "Risk Factors" and elsewhere in this Form 10-Q.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

We make forward-looking statements under the "Management's Discussion and Analysis of Financial Condition and Results of Operations" and in other sections of this Form 10-Q. In some cases, you can identify these statements by forward-looking words such as "may," "might," "should," "would," "could," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "potential" or "continue," and the negative of these terms and other comparable terminology. These forward-looking statements, which are subject to known and unknown risks, uncertainties and assumptions about us, may include projections of our future financial performance based on our growth strategies and anticipated trends in our business. These statements are only predictions based on our current expectations and projections about future events. There are important factors that could cause our actual results, level of activity, performance or achievements to differ materially from the results, level of activity, performance or achievements expressed or implied by the forward-looking statements. In particular, you should consider the numerous risks and uncertainties described under "Risk Factors" as discussed in our Annual Report on Form 10-K filed with the SEC on May 27, 2026, and in other filings made by us from time to time with the SEC.

While we believe we have identified material risks, these risks and uncertainties are not exhaustive. Other sections of this Form 10-Q may describe additional factors that could adversely impact our business and financial performance. Moreover, we operate in a very competitive and rapidly changing environment. New risks and uncertainties emerge from time to time, and it is not possible to predict all risks and uncertainties, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.

Although we believe the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, level of activity, performance or achievements. Moreover, neither we nor any other person assumes responsibility for the accuracy or completeness of any of these forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. We are under no duty to update any of these forward-looking statements after the date of this Form 10-Q to conform our prior statements to actual results or revised expectations, and we do not intend to do so.

Forward-looking statements include, but are not limited to, statements about:

	•	the success of our ongoing and future clinical trials;
	•	competition from existing products or new products that may emerge;
	•	potential product liability claims;
	•	our dependency on third-party manufacturers to supply or manufacture our future products;
	•	our ability to obtain all parts required to manufacture our devices;
	•	our ability to establish or maintain collaborations, licensing or other arrangements;
	•	our ability and third parties' abilities to protect intellectual property rights;
	•	liquidity and going concern;
	•	our ability to raise additional capital to adequately support future growth;
	•	our ability to attract and retain key personnel to manage our business effectively;
	•	risks associated with our identification of material weaknesses in our control over financial reporting;
	•	natural disasters affecting us, our primary manufacturer or our suppliers;

	•	our ability to establish relationships with health care professionals and organizations;
	•	general economic uncertainty that adversely affects spending on medical procedures;
	•	our ability to maintain the listing of our common stock on the Nasdaq Capital Market;
	•	volatility in the market price of our stock; and
	•	potential dilution to current stockholders from the issuance of equity awards and from future capital raising activities.

We caution you not to place undue reliance on the forward-looking statements, which speak only as of the date of this Form 10-Q in the case of forward-looking statements contained in this Form 10-Q.

Overview

We are a development-stage medical device company developing a technology platform for nerve-targeted procedures. Our platform combines a catheter-based sensing antenna array and microchip, designed to acquire low-amplitude biological electrical signals that travel through blood vessel walls and amplify them near the point of detection, with signal-processing capabilities. Over time, this design is intended to support interpretation of the recorded signals and the guidance and verification of nerve-targeted treatment.

We describe our staged strategy as "sense, treat and verify." Having obtained proof-of-concept toward our ability to successfully treat targeted nerves with a commercial RF ablation system through human clinical studies in pancreatic cancer pain, we have turned our attention toward regulatory approval of our standalone sensing system, for which we are targeting an initial U.S. 510(k) clearance with the U.S. Food and Drug Administration ("FDA"). In parallel, we are advancing our understanding of recorded signals and developing processing methods that we believe may provide physicians with additional physiological information before, during and after an intervention. We believe this approach positions our platform for future cardiovascular applications, including renal denervation, as well as pain management and other conditions involving the peripheral nervous system.

Development Priorities and Strategic Rationale

We have prioritized a standalone transvascular sensing system as our initial U.S. regulatory and commercialization opportunity. The proposed initial device is intended to serve as a general acquisition tool for biological electrical signals in the heart and peripheral vessels, providing information for clinician review as part of clinical decision-making. The decision to prioritize a standalone transvascular sensing system was based on several reasons, including, without limitation:

i) An earlier path to market. The potential regulatory pathway for a standalone acquisition device may provide an earlier and less capital-intensive route to initial U.S. commercialization versus pursuing clearance of a combined sensing and ablation therapy ("Dual Therapy") for pancreatic cancer pain first. This dual therapy required a de novo clearance supported by pivotal clinical trials, while pursuing our standalone sensing device allows us to target a 510(k) path, which is typically a faster and less capital extensive route to clearance;

ii). One foundation for many applications. The applications we are pursuing share a common core capability: reliably acquiring low-amplitude biological electrical signals. Establishing the sensing, manufacturing and quality-system foundation, and then extending it, is intended to reduce risk and cost across our pipeline and support further investment in additional clinical applications; and

iii) A growing foundation of experimental data. Each study adds to our understanding of recorded signals, the conditions that influence them and the effects of changes to our technology. Concentrating resources on signal acquisition and processing is intended to improve measurement quality, inform technology optimization and help us determine which clinical applications to advance next.

Renal denervation and other cardiovascular applications are our primary near-term development focus, given the market opportunity and level of strategic activity described below. Pancreatic cancer pain remains our next priority indication. We have deferred our U.S. clinical milestones while prioritizing the standalone sensing system, and we believe our sensing and technology optimization work currently underway may strengthen that program as it advances.

Renal Denervation Opportunity and Strategic Activity

Hypertension is among the most prevalent chronic diseases worldwide and represents a substantial unmet medical need. The World Health Organization estimates that approximately 1.4 billion adults aged 30 to 79 had hypertension in 2024 and that approximately 23% had it under control. In the United States, the Centers for Disease Control and Prevention reports that approximately 119.9 million adults, or 48.1%, have high blood pressure, and that approximately 22.5% of those adults have it under control. These estimates use different population definitions and diagnostic criteria, but both show the substantial burden of inadequately controlled hypertension. (Sources: World Health Organization, Hypertension fact sheet; Centers for Disease Control and Prevention, High Blood Pressure Facts.)

Renal denervation has emerged as a treatment option for selected patients with uncontrolled hypertension. In November 2023, the FDA approved the Paradise ultrasound and Symplicity Spyral radiofrequency renal denervation systems. In October 2025, the Centers for Medicare & Medicaid Services established national coverage for renal denervation, under specified conditions, through coverage with evidence development. These developments are important steps in the clinical and reimbursement environment for renal denervation, although they do not currently establish coverage for our sensing system.

We see an opportunity to complement these therapies with information about electrical activity at the treatment site. Physicians currently have limited access to direct intraprocedural measurements of neural activity that could inform treatment delivery and assessment of treatment effect. Our platform is being developed for potential use alongside different ablation technologies, which we believe could support collaboration with multiple therapy developers and, over time, extend to other cardiovascular and nerve-targeted applications.

The prevalence of hypertension illustrates the underlying clinical need, rather than the addressable market, for our initial device. Our initial 510(k) strategy does not include renal denervation guidance or treatment-verification claims, which would require additional supporting evidence and regulatory authorization, that we consider to be important to successful commercialization of the technology.

Preclinical Progress and Technology Optimization

During 2026, we expanded our bench testing and animal studies to evaluate signal acquisition, repeatability, and changes in recorded electrical activity under different physiological conditions, including before and after ablation. Bench testing and several animal evaluations have produced repeatable measurements under the controlled conditions tested. In certain animal studies, we observed higher electrical activity before ablation and lower activity after treatment, consistent with the anticipated direction of response. We believe these findings support continued development of our sensing platform and investigation of its potential role in assessing treatment-related changes.

Each study is also improving our understanding of the technical and physiological factors that influence recorded signals. Those insights inform a technology optimization initiative designed to improve signal fidelity, measurement consistency and overall system performance. The program includes modifications to the sensing antenna design, a revised iteration of our application-specific integrated circuit ("ASIC"), and continued firmware and software development.

We expect to complete the planned optimization work over approximately the 12 months following the date of this report, subject to the receipt of additional financing. The initiative is directed toward the commercial configuration and future capabilities of our platform. Our initial clearance strategy remains focused on the current configuration and its proposed general signal-acquisition function.

Signal Processing and Interpretation

The nervous system is an unsolved system within the body that has lacked the tools to acquire and understand nerve signal meaning. Coupled with system complexity, transvascular recordings are low in amplitude and may contain overlapping contributions from neural activity, cardiac and respiratory activity, catheter position and the recording environment. Understanding these contributions is an important step between acquiring a signal and determining its biological and clinical significance.

Our signal-processing development is intended to improve the consistency of recorded measurements and support evaluation of signal features across studies. By comparing recordings with documented physiological conditions, interventions and device settings, we seek to identify reproducible patterns and better understand the factors that affect them.

We believe this work can help us evaluate antenna, electronics and processing modifications, prioritize subsequent experiments and develop the evidence needed for future signal-interpretation capabilities. Our growing body of recordings may also support investigation of relationships between electrical activity and responses to treatment. These efforts remain developmental and their potential clinical applications will depend on further validation.

FDA Pre-Submission Feedback and Commercialization Plan

In September 2026, we completed a pre-submission meeting with the FDA regarding the standalone sensing system. Based on the feedback received, we believe a Class II pathway through a premarket notification under Section 510(k) may be available, using a substantial-equivalence strategy involving a previously cleared device.

As announced in September 2026, we are targeting potential U.S. clearance of the current configuration approximately 15 months from that announcement and initial commercialization of the standalone sensing system in 2028. Our commercialization readiness plan incorporates technology optimization, verification and validation, manufacturing preparation and any FDA review required for the commercial configuration. Based on our current development plan, we do not expect the technology optimization initiative to change either target.

We continue to refine our regulatory strategy for subsequent configurations, and potential expanded indications, and we plan to discuss that strategy with the FDA through an additional pre-submission interaction. The nature and timing of any subsequent submissions will depend on the proposed modifications, intended uses, supporting evidence and FDA feedback.

Pancreatic Cancer Pain Program

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Pancreatic cancer pain remains our next priority indication, reflecting the significant unmet need among these patients and the encouraging clinical experience generated to date. We completed our initial first-in-human proof-of-concept study evaluating a commercial transvascular radiofrequency ablation system for pancreatic cancer pain, which did not use our sensing array, in the second calendar quarter ending June 30, 2025. We believe future development of this application may benefit from the sensing foundation and technology improvements we are now prioritizing.

This prioritization changes the timing of the program's next milestones. We no longer expect to initiate the previously contemplated U.S. clinical studies for pancreatic cancer pain in early 2027 and we have not established a revised start date for a U.S. pivotal study. Timing will depend on progress in our sensing technology development, regulatory discussions, clinical study planning and available resources. Under this revised sequence, we no longer anticipate FDA marketing authorization for the pancreatic cancer pain indication in 2028.

Development Considerations and Risks

Acquiring low-amplitude biological electrical signals within blood vessels, and determining their source and clinical significance, present substantial technical challenges. Although multiple bench tests and animal studies have produced promising findings, signal amplitude, spectral characteristics and responses following intervention have varied across studies, anatomical locations and time points. Physiological changes associated with an intervention, catheter position, electrode contact and acquisition conditions are all variables that may affect recorded activity and complicate attribution of changes to neural activity or treatment effect.

Further work is needed to establish performance across the intended conditions of use and to support future claims concerning neural interpretation, procedural guidance or treatment verification. A reduction in recorded electrical activity alone does not establish the completeness or durability of denervation. The degree to which our planned technology modifications and processing methods will improve performance remains subject to testing and validation.

FDA pre-submission feedback does not constitute clearance of our device or assurance that the FDA will accept our proposed pathway or determine substantial equivalence. Any clearance would be limited to the authorized indications for use and would not, by itself, authorize therapeutic ablation or future neural-interpretation, procedural-guidance or treatment-verification claims.

Our development and commercialization targets depend on successful testing and validation, manufacturing readiness, sufficient financing and receipt of the necessary regulatory authorizations. Additional technical findings or regulatory requirements could increase costs or delay planned milestones. Our technology remains investigational, and there can be no assurance that our programs will produce the evidence necessary for the proposed indications or that we will obtain clearance or approval or achieve commercialization within the anticipated time frames.

Recent Developments

In October 2026, we sold 85,255 shares pursuant to the updated ATM for net proceeds of approximately $0.3 million.

On October 29, 2026, we held our Annual Stockholder Meeting ("Annual Meeting"). In that Annual Meeting, among other items, our stockholders approved i) an amendment to our amended and restated certificate of incorporation (the "Amendment") to effect the reverse stock split at a ratio in the range of 1-for-2 to 1-for-25, with such ratio to be determined in the discretion of our board of directors and with such reverse stock split to be effected at such time and date, if at all, as determined by our board of directors in its sole discretion prior to the one-year anniversary of the Annual Meeting; and ii) an amendment to our amended and restated 2023 Stock Plan (the "Plan") to increase the number of shares of common stock available for issuance under the Plan.

Results of Operations for the Three and Six Months Ended September 30, 2026 Compared to the Three and Six Months Ended September 30, 2025

Below is a summary of the results of operations (in thousands):

		Three Months Ended September 30,
										Change				Change
		2026				2025				( $ )				( % )
Operating expenses:
Research and development		$	1,584			$	2,367			$	(783	)			(33	)%
General and administrative			1,593				5,167				(3,574	)			(69	)%
Total operating expenses		$	3,177			$	7,534			$	(4,357	)			(58	)%

		Six Months Ended September 30,
				​				​		Change				Change
		2026				2025				( $ )				( % )
Operating expenses:				​				​				​				​
Research and development		$	3,098			$	3,960			$	(862	)			(22	)%
General and administrative			2,849				6,995				(4,146	)			(59	)%
Total operating expenses		$	5,947			$	10,955			$	(5,008	)			(46	)%

Research and Development Expense

Research and development expense was $1.6 million for the three months ended September 30, 2026 compared to $2.4 million for the same period in 2025. This $0.8 million decrease was primarily due to a decrease in stock-based compensation - option expense of $0.6 million, due to the stock option cancellation agreements.

Research and development expense was $3.1 million for the six months ended September 30, 2026 compared to $4.0 million for the same period in 2025. This $0.9 million decrease was primarily due to a decrease in stock-based compensation - option expense of $0.6 million, due to the stock option cancellation agreements.

General and Administrative Expense

General and administrative expense was $1.6 million for the three months ended September 30, 2026 compared to $5.2 million for the same period in 2025. This $3.6 million decrease was driven primarily by a decrease in stock-based compensation - option expense of $3.3 million, due to the stock option cancellation agreements, a decrease in legal and professional fees of $0.4 million offset by an increase in employee compensation and benefits of $0.1 million.

General and administrative expense was $2.8 million for the six months ended September 30, 2026 compared to $7.0 million for the same period in 2025. This $4.1 million decrease was driven primarily by a decrease in stock-based compensation - option expense of $3.6 million, due to the stock option cancellation agreements and a decrease in legal and professional fees of $0.5 million.

Interest Income

For the three and six months ended September 30, 2026, we had interest income of less than $0.1 million.

For the three and six months ended September 30, 2025, we had interest income of less than $0.1 million and $0.2 million, respectively.

Liquidity and Capital Resources

On September 30, 2026, we had cash of $7.7 million and working capital of $6.9 million. We have historically funded our operations from proceeds from debt and equity sales. Including approximately $0.3 million of net proceeds received under the ATM program in October 2026, we estimate our current cash resources are sufficient to fund our operations into but not beyond the second calendar quarter of 2027.

We will need to raise additional capital to meet our obligations and execute our business plan. We estimate that we will require additional financing of approximately $22 million to $27 million to fund our operations to commercialization of our first indication. The timing and costs of clinical trials are difficult to predict and trial plans may change in response to evolving circumstances and as such the foregoing estimates may prove to be inaccurate. If we are unable to raise sufficient funds, we will be required to develop and implement an alternative plan to further extend payables, reduce overhead or scale back our business plan until sufficient additional capital is raised to support further operations. There can be no assurance that such a plan will be successful. We recognize the need to raise additional capital to continue to execute our business plan, including obtaining regulatory clearance for our products currently under development and commercializing and generating revenues from products under development. There is no assurance that additional financing will be available when needed or that management will be able to obtain financing on terms acceptable to us. A failure to raise sufficient capital, generate sufficient product revenues, control expenditures and regulatory matters, among other factors, will adversely impact our ability to meet our financial obligations as they become due and payable and to achieve our intended business objectives. If we are unable to raise sufficient additional funds, we will have to scale back our operations.

Summary of Cash Flows

Cash used in operating activities

Net cash used in operating activities was $6.2 million during the six months ended September 30, 2026, consisting of a net loss of $5.9 million and a decrease in operating assets and liabilities of $0.4 million. Non-cash items consisted of stock-based compensation of $0.1 million.

Net cash used in operating activities was $6.4 million during the six months ended September 30, 2025, consisting of a net loss of $10.8 million and a decrease in operating assets and liabilities of $0.2 million. Non-cash items consisted of stock-based compensation of $4.3 million and the issuance of common stock for equity line of credit commitment fee of $0.3 million.

Cash used in investing activities

Net cash used in investing activities was $7 thousand for the six months ended September 30, 2026.

Net cash used in investing activities was $0 for the six months ended September 30, 2025.

Cash provided by financing activities

Net cash provided by financing activities was $6.9 million for the six months ended September 30, 2026. We had gross proceeds from warrant inducements of $7.5 million. We also paid $0.6 million in direct financing costs for the warrant inducements.

Net cash provided by financing activities was $4.8 million for the six months ended September 30, 2025. We had gross proceeds from the issuance of common stock of $2.6 million and gross proceeds from warrant inducements of $2.5 million. We also paid $0.1 million in direct financing costs for the issuance of common stock and $0.3 million in direct financing costs for warrant inducements.

Contractual Obligations and Commitments

None other than described below.

Employment Arrangements

We have agreements with key employees to provide certain benefits, including salary and other wage-related benefits, in the event of termination. In addition, the Company has adopted a severance policy for certain employees and officers in the event of termination. In total, these benefits would amount to a range of $1.9 million to $2.5 million using the rate of compensation in effect at September 30, 2026.

Off-balance Sheet Arrangements

As of September 30, 2026 and March 31, 2026, we did not have any relationships with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance or special purpose entities, established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes.

Critical Accounting Policies and Significant Judgments and Estimates

The financial statements in this quarterly report have been prepared in accordance with generally accepted accounting principles in the United States of America ("GAAP"). The preparation of financial statements in conformity with GAAP requires management to make estimates, assumptions and judgments that affect the amounts reported in the financial statements, including the notes thereto. We consider critical accounting policies to be those that require more significant judgments and estimates in the preparation of our financial statements, including the following: work performed but not yet billed by contract manufacturers, engineers and research organizations and the valuation of equity-related instruments. Management relies on historical experience and other assumptions believed to be reasonable in making its judgments and estimates. Actual results could differ materially from those estimates.

Management believes its application of accounting policies, and the estimates inherently required therein, are reasonable. These accounting policies and estimates are periodically reevaluated, and adjustments are made when facts and circumstances dictate a change.

Our accounting policies are more fully described under the heading "Description of the Business, Basis of Presentation and Summary of Significant Accounting Policies" in Note 1 of our Annual Report on Form 10-K filed with the SEC on May 27, 2026.