Autonomix Medical, Inc.: Form 10-Q for the period ended Sep 30, 2025

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 the Annual Report in our Form 10-K filed with the SEC on May 29, 2025, which is available on the SEC’s EDGAR website at www.sec.gov (http://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 the Annual Report in our Form 10-K filed with the SEC on May 29, 2025, 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;
• 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

Autonomix Medical, Inc. is a development-stage medical device company pioneering a first-in-class technology platform designed to sense and treat disorders of the nervous system. Our lead system in development is a catheter-based solution that combines diagnostic sensing and therapeutic radiofrequency ("RF") ablation. Initially developed to target intractable pain associated with pancreatic cancer, our platform is intended to provide minimally invasive access to deep neural structures and has the potential to address a wide range of clinical indications, including chronic pain, hypertension, cardiovascular disease, and other nerve-related disorders.

A key differentiator of our technology is its ability to detect neural signals with greater sensitivity than commercially available systems. This performance advantage stems from two core innovations. First, our proprietary antenna array is engineered to capture extremely low-amplitude neural signals that may not be detected by conventional devices. Second, and equally important, our system processes these signals at the point of detection using a proprietary microchip embedded within the catheter. This local signal processing minimizes degradation and noise that typically occur during transmission to external consoles, allowing for high-fidelity, real-time signal capture and interpretation. Together, these capabilities enable more precise identification and targeting of nerve activity and represent a fundamental advancement in transvascular neuromodulation.

Our product development strategy is centered around two integrated functions: diagnostic sensing to identify pathological nerve signals, and therapeutic RF ablation to treat the identified targets. In preclinical animal models, our system has demonstrated the ability to detect signals from specific nerve bundles before ablation and confirm signal termination after ablation. We are now refining the catheter design to meet regulatory and manufacturing standards for human use.

In parallel, we have advanced our clinical strategy. In the second quarter of 2025, we completed our initial first-in-human proof-of-concept study ("PoC 1") evaluating the safety and feasibility of transvascular RF ablation in patients with pancreatic cancer pain. Based on the positive clinical outcomes, we have initiated a follow-on study ("PoC 2") that expands the protocol to include patients with pain associated with additional visceral cancers such as gallbladder, liver, and bile duct, as well as earlier-stage pancreatic cancer patients experiencing moderate to severe pain. This expansion reflects our goal of broadening the platform’s utility across oncology, gastroenterology, and other applicable sectors.

As a development-stage company, our technology remains investigational, and there is no guarantee that our clinical trials will produce favorable outcomes or that our products will ultimately receive regulatory approval. One of the most challenging aspects of our commercialization plan will be scaling from our current prototype, which is built using hand-assembled and 3D-printed components, to a fully integrated commercial-grade device. While we have not yet assembled or tested the final commercial version, ongoing development efforts are focused on improving design robustness and manufacturability to support future clinical and commercial deployment.

Recent Developments

We held our annual meeting of stockholders (the "Annual Meeting") on October 30, 2025. 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; ii) our amended and restated 2023 Equity Incentive Plan; and iii) the issuance of more than 20% of our issued and outstanding common stock pursuant to the purchase agreement with Lincoln Park Capital Fund, LLC.

In October 2025, we announced the issuance of a new U.S. patent covering aspects of our platform technology enabling precision nerve-targeted therapies in cardiology, further strengthening our intellectual property position. Additionally, we strengthened our intellectual property portfolio with the issuance of two new patents during the quarter ended September 30, 2025. U.S. Patent No. 12,295,646 relates to a smart torquer device designed to enhance the manipulation of elongated intravascular devices during minimally invasive procedures, while integrating electronic components to facilitate both mechanical control and data communication, while European Patent No. 3,697,298 relates to use of its proprietary technology to collect and process sensing data for real-time physiological monitoring with broad application use that includes coronary artery/vagal nerve mapping, arterial/renal mapping, bladder/lower urinary tract applications, robotic prosthetics and implants, and central nervous system monitoring for neurotherapy.

During the quarter ended September 30, 2025, we also had multiple abstracts highlighting the technology and early PoC results was accepted for podium presentation at the 2025 Cardiovascular and Interventional Radiological Society of Europe (CIRSE) Annual Congress in Barcelona and at the Transcatheter Cardiovascular Therapeutics (TCT) 2025 Annual Scientific Conference in San Francisco.

In September 2025, we reported longer-term post-hoc data from the initial phase of our first-in-human PoC study in pancreatic cancer pain. Among responders, mean pain reduction was approximately 66% (mean 5.08-point improvement on the visual analog scale), and 100% of responders were opioid-free at three months post-procedure. Improvements were also observed across multiple quality-of-life measures, including sleep, energy, and daily activity levels.

In August 2025, we announced the completion of the final design review of our first-of-its-kind intravascular nerve-sensing catheter, an important step in preparation for U.S. clinical studies.

On August 25, 2025, we entered into a Purchase Agreement with Lincoln Park, under which, subject to specified terms and conditions, we may sell up to $15.0 million in shares of our common stock. The net proceeds we receive under the Purchase Agreement will depend on i) the frequency of sales; ii) the number of shares sold; and iii) the prices at which we sell shares to Lincoln Park. We also paid offering costs of less than $0.1 million and issued 261,932 Commitment Shares to Lincoln Park in consideration for its commitment to purchase shares of our common stock under the Purchase Agreement from time to time at our direction.

On August 25, 2025, we increased the aggregate sales price the Shares that may be sold pursuant to the February 28, 2025 Agreement with the Agent, by $1.4 million. As of September 30, 2025, the revised aggregate sales price of Shares that may be sold under the Agreement represents $3.5 million. As of September 30, 2025, we had sold 1,682,685 Shares for net proceeds of approximately $2.5 million, including $0.5 million for the three-month period ending September 30, 2025. As of September 30, 2025, we had sold 1,682,685 Shares, including 378,425 Shares during the three-month period ending September 30, 2025. We paid offering costs of less than $0.1 million. See Note 6 - Subsequent Events for additional information regarding events occurring after September 30, 2025.

On July 21, 2025, we entered into Inducement Letters with the Holders of certain Existing Warrants issued in the offering we completed in November 2024 to purchase up to 1,477,596 shares of common stock. The Existing Warrants had an exercise price of $6.54 per share. Pursuant to the Inducement Letter, we agreed to reduce the exercise price of the Existing Warrants to $1.723 per share and the Holders agreed: (i) to exercise Existing Warrants to purchase 855,000 shares of our common stock for $1.723 per share; and (ii) to prepay $1.722 per share of the reduced exercise price for Existing Warrants to purchase 622,596 shares of our common stock in consideration of our further reducing the exercise price of such Existing Warrants to purchase 622,596 shares of our common stock to $0.001 per share with a modified exercise term of 5.5 years. In consideration of the foregoing, we agreed to issue the Holders new Inducement Warrants to purchase up to a number of shares of our common stock equal to 100% of the number of shares of our common stock underlying the Existing Warrants, comprised of new Series B warrants to purchase up to 1,477,596 shares of our common stock at $1.723 per share with an exercise term of 5.5 years from the initial exercise date. In addition, we issued 88,656 Placement Agent Warrants at an exercise price of $2.671 per share with an exercise term of 5 years. We received total gross proceeds of approximately $2.5 million, less cash expenses paid to the Placement Agent and others of approximately $0.3 million.

Results of Operations for the Three and Six Months Ended September 30, 2025 Compared to the Three and Six Months Ended September 30, 2024

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

Research and Development Expense

Research and development expense was $2.4 million for the three months ended September 30, 2025 compared to $1.2 million for the same period in 2024. This $1.2 million increase was driven primarily by an increase in stock-based compensation - option expense of $0.5 million, due to the stock option cancellation agreements, and an increase in all other research and development expenses of $0.7 million, driven primarily by an increase in our clinical trials and product development costs. We expect to incur increased research and development costs in the future as we continue with our clinical trials and product development costs.

Research and development expense was $4.0 million for the six months ended September 30, 2025 compared to $2.1 million for the same period in 2024. This $1.9 million increase was driven primarily by an increase in stock-based compensation - option expense of $0.5 million, due to the stock option cancellation agreements, and an increase in all other research and development expenses of $1.4 million, driven primarily by an increase in our clinical trial and product development costs. We expect to incur increased research and development costs in the future as we continue with our clinical trials and product development costs.

General and Administrative Expense

General and administrative expense was $5.2 million for the three months ended September 30, 2025 compared to $1.7 million for the same period in 2024. This $3.5 million increase was driven primarily by an increase in stock-based compensation - option expense of $2.9 million, mainly due to the stock option cancellation agreements, and an increase in legal and professional fees of $0.6 million.

General and administrative expense was $7.0 million for the six months ended September 30, 2025 compared to $3.5 million for the same period in 2024. This $3.5 million increase was driven primarily by an increase in stock-based compensation - option expense of $2.9 million, mainly due to the stock option cancellation agreements, and an increase in legal and professional fees of $0.8 million, offset by a decrease in officer and employee compensation and benefits of $0.1 million and a decrease in other expenses of $0.1 million.

Interest expense

For the three and six months ended September 30, 2025 and 2024, we had interest expense of $0 and $0, respectively, and less than $0.1 million and less than $0.1 million, respectively, related to the amortization of debt discount.

Interest income

For the three and six months ended September 30, 2025 and 2024, we had interest income of less than $0.1 million and $0.2 million, respectively, and less than $0.1 million and $0.2 million, respectively.

Liquidity and Capital Resources

On September 30, 2025, we had cash of $7.5 million and working capital of $6.4 million. We have historically funded our operations from proceeds from debt and equity sales. We estimate our current cash resources are sufficient to fund our operations into but not beyond the third calendar quarter of 2026.

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 $30 to $36 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 $6.4 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 due to a decrease in operating liabilities of $0.2 million. The change in operating assets and liabilities included uses of cash from a net decrease in accounts payable and accrued expenses of $0.2 million. Non-cash items primarily 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 $0 for the six months ended September 30, 2025.

Net cash used in investing activities was $5 thousand for the six months ended September 30, 2024 related to the purchase of computer hardware and software.

Cash provided by financing activities

Net cash provided by financing activities was $4.8 million for the six months ended September 30, 2025. During 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 $2.6 million. During the six months ended September 30, 2025, 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.

Net cash provided by financing activities was $0 for the six months ended September 30, 2024.

Contractual Obligations and Commitments

None.

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, 2025.

Off-balance Sheet Arrangements

As of September 30, 2025 and March 31, 2025, 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 29, 2025.

We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required under this item.

Evaluation of Disclosure Controls and Procedures and Changes in Internal Control over Financial Reporting

We maintain a set of disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, designed to ensure that material information required to be disclosed in our filings under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and that material information is accumulated and communicated to our management, including our Chief Executive Officer (“CEO”), who serves as our principal executive officer, and Chief Financial Officer (“CFO”), who serves as our principal accounting officer, as appropriate, to allow timely decisions regarding required disclosures.

Under the supervision, and with the participation of our management, including our CEO and CFO, we conducted an evaluation of the effectiveness, as of September 30, 2025, of our disclosure controls and procedures. Based upon such evaluation and due to both the limited staffing of the Company at its early stage of development and the existence of the material weaknesses in our internal control over financial reporting described below, our CEO and CFO have concluded that, as of September 30, 2025, our disclosure controls and procedures were not effective.

A material weakness is a control deficiency, or combination of control deficiencies, that results in more than a remote likelihood that a material misstatement of the annual or interim financial statements will not be prevented or detected. As previously disclosed in our Form 10-K filed with the SEC on May 29, 2025, our management concluded that our internal control over financial reporting was, and continues to be, ineffective as of September 30, 2025 due to material weaknesses in our internal controls arising from a lack of segregation of duties; general technology controls; and financial statement reporting. It should be noted that any system of controls, however well designed and operated, can provide only reasonable and not absolute assurance that the objectives of the system are met. In addition, the design of any control system is based in part upon certain assumptions about the likelihood of certain events. Because of these and other inherent limitations of control systems, there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions, regardless of how remote.

Due to our size and the limited number of qualified personnel available, the segregation of certain duties, the proper review of complex accounting transactions and the availability of specific accounting expertise on critical and infrequent or unusual accounting matters may not always be possible and may not be economically feasible. However, to the extent possible, the initiation of daily transactions, the custody of assets and the recording, review and disclosure of complex and unusual accounting transactions should be performed by separate individuals, and where possible, with input from outside accounting subject matter experts. Management evaluated the impact of our failure to maintain effective segregation of duties on our assessment of our internal control over financial reporting and has concluded that the control deficiency represents a material weakness. As previously disclosed, in our Form 10-K for the fiscal year ending March 31, 2025, we hired new executive officers and management with significant financial and accounting experience in both private and public companies. We have added the use of additional consulting firms to assist with significant and complex accounting transactions and to assist with our segregation of duties and create a more structured financial statement reporting environment. Experienced personnel will be hired in the accounting and finance department and appropriate consultants will be upgraded as soon as it becomes economically feasible and sustainable. In addition, management has added additional mitigating controls with regards to cash disbursements; changes were made in our authorization processes to improve segregation of duties; and we performed additional analysis and other post-closing procedures to ensure our financial statements were prepared in accordance with generally accepted accounting principles. Accordingly, we believe that the financial statements included in this report fairly present, in all material respects, our financial condition, results of operations and cash flows for the periods presented.

Changes in Internal Control over Financial Reporting

We have not experienced any material impact to our internal controls over financial reporting despite the fact that our employees are working remotely. We are continually monitoring and assessing the situation on our internal controls to minimize the impact on their design and operating effectiveness.

Other than as described above, there has been no change in our internal control over financial reporting during our most recent calendar quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

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 the Annual Report in our Form 10-K filed with the SEC on May 29, 2025.

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. 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 29, 2025.