Autonomix Medical Inc.

02/11/2026 | Press release | Distributed by Public on 02/11/2026 16:01

Quarterly Report for Quarter Ending December 31, 2025 (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 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, 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;

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

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

On October 9 and December 30, 2025, we announced the issuance of a new U.S. patent and a new European patent, respectively, covering key aspects of our platform technology for precision nerve-targeted therapies in cardiology. U.S. Patent No. 12,369,852 and European Patent No. EP4230133, both titled "Controlled and Precise Treatment of Cardiac Tissues," further strengthens our intellectual property position and supports the development of catheter-based neuromodulation approaches across multiple cardiology applications. These patents enhance our ability to pursue precision nerve-targeted therapies in large and growing areas of cardiology, including renal denervation for hypertension, arrhythmia management, heart failure, and refractory angina.

During the quarter ended December 31, 2025, we continued to advance development of our catheter-based sensing and ablation system. We completed key verification and validation activities for our ablation catheter in preparation for human use. We also continued enrollment in our second proof-of-concept (PoC 2) human clinical study evaluating our technology in patients with other visceral cancers and earlier-stage pancreatic cancer.

During the quarter ended December 31, 2025, we were selected for two podium presentations at the Transcatheter Cardiovascular Therapeutics 2025 Annual Scientific Conference in San Francisco. These presentations, delivered as part of the Innovation Session and Hypertension and Renal Denervation Session, highlighted early clinical findings from our first-in-human proof-of-concept clinical study. The data demonstrated the feasibility and safety of transvascular energy delivery to target and modulate problematic nerves, with early data supporting clinical benefit in mitigating severe pancreatic cancer-related pain.

On November 18, 2025, we entered into a Securities Purchase Agreement with an institutional investor, pursuant to which the investor purchased in a private placement: (i) Pre-Funded Warrants to purchase 4,501,666 shares of the our common stock; and (ii) Common Warrants to purchase up to an aggregate of 9,003,332 shares of our common stock. The combined purchase price of one Pre-Funded Warrant and accompanying Common Warrants was $1.1097. The gross proceeds to us from the November 2025 Offering was approximately $5.0 million, before deducting the Placement Agent's fees of $450 thousand and other offering expenses of $36 thousand.

On October 30, 2025, we held our annual meeting of stockholders (the "Annual Meeting"). In that Annual Meeting, among other items, our stockholders approvedi) 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.

Results of Operations for the Three and Nine Months Ended December 31, 2025 Compared to the Three and Nine Months Ended December 31, 2024

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

Three Months Ended December 31,

Change

Change

2025

2024

( $ )

( % )

Operating expenses:

Research and development

$ 1,724 $ 1,044 $ 680 65 %

General and administrative

1,619 1,703 (84 ) (5 )%

Total operating expenses

$ 3,343 $ 2,747 $ 596 22 %

Nine Months Ended December 31,

Change

Change

2025

2024

( $ )

( % )

Operating expenses:

Research and development

$ 5,684 $ 3,172 $ 2,512 79 %

General and administrative

8,613 5,164 3,449 67 %

Total operating expenses

$ 14,297 $ 8,336 $ 5,961 72 %

Research and Development Expense

Research and development expense was $1.7 million for the three months ended December 31, 2025 compared to $1.0 million for the same period in 2024. This $0.7 million increase was driven primarily by an increase in our clinical trialsand product development costs. We expect to incur increased research and development costs in the future as we continue with our clinical trialsand product development costs.

Research and development expense was $5.7 million for the nine months ended December 31, 2025 compared to $3.2 million for the same period in 2024. This $2.5 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 $2.0 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 $1.6 million for the three months ended December 31, 2025 compared to $1.7 million for the same period in 2024. This $0.1 million decrease was driven primarily by a decrease in stock-based compensation - option expense of $0.4 million, due to the stock option cancellation agreements, offset by an increase in legal and professional fees of $0.3 million.

General and administrative expense was $8.6 million for the nine months ended December 31, 2025 compared to $5.2 million for the same period in 2024. This $3.4 million increase was driven primarily by an increase in stock-based compensation - option expense of $2.5 million, mainly due to the stock option cancellation agreements, and an increase in legal and professional fees of $1.1 million, offset by a decrease in compensation and benefits of $0.1 million and a decrease in other expenses of $0.1 million.

Interest expense

For the three and nine months ended December 31, 2025, we had no interest expense.

For the three and nine months ended December 31, 2024, we had interest expense of less than $0.1 million and $0.1 million, respectively, related to the amortization of debt discount.

Interest income

For the three and nine months ended December 31, 2025, we had interest income of less than $0.1 million and $0.2 million, respectively.

For the three and nine months ended December 31, 2024, we had interest income of less than $0.1 million and $0.2 million, respectively.

Liquidity and Capital Resources

On December 31, 2025, we had cash of $9.9 million and working capital of $8.5 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 $9.4 million during the nine months ended December 31, 2025, consisting of a net loss of $14.0 million and a decrease in operating assets and liabilities of $0.2 million and $0.1 million, respectively. 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.

Net cash used in operating activities was $5.7 million during the nine months ended December 31, 2024, consisting of a net loss of $8.2 million, a decrease in operating assets of $0.7 million and an increase in operating liabilities of $0.3 million. The change in operating assets and liabilities included sources of cash from a decrease in other current assets of $0.7 million and a net increase in accounts payable and accrued expenses of $0.3 million. The decrease in other current assets was driven primarily by the receipt of funds from our marketing partner that were a holdback from our IPO and the amortization of prepaid insurance costs. The net increase in accounts payable and accrued expenses was driven primarily by increases in research and development expenses. Non-cash items consisted of stock-based compensation of $1.2 million, depreciation and amortization of $0.1 million and issuance of common stock, net of discount for lack of marketability of $0.1 million.

Cash used in investing activities

Net cash used in investing activities was $7 thousand for the nine months ended December 31, 2025 related to the purchase of computer hardware and software.

Net cash used in investing activities was $10 thousand for the nine months ended December 31, 2024 related to the purchase of computer hardware and software.

Cash provided by financing activities

Net cash provided by financing activities was $10.2 million for the nine months ended December 31, 2025. During the nine months ended December 31, 2025, we had gross proceeds from the issuance of common stock of $3.5 million, gross proceeds from warrant inducements of $2.6 million and gross proceeds from issuance of pre-funded warrants and Series C warrants of $5.0 million. During the nine months ended December 31, 2025, we also paid $0.1 million in direct financing costs for the issuance of common stock, $0.3 million in direct financing costs for warrant inducements and $0.5 million in direct issuance costs for issuance of pre-funded warrants and Series C warrants.

Net cash provided by financing activities was $9.0 million for the nine months ended December 31, 2024. During the nine months ended December 31, 2024, we had gross proceeds from a financing event of $10.0 million, before deducting underwriting discounts and other estimated expenses payable by the Company. We also paid $1.1 million in issuance costs related to this financing event.

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 December 31, 2025.

Off-balance Sheet Arrangements

As of December 31, 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.

Autonomix Medical Inc. published this content on February 11, 2026, and is solely responsible for the information contained herein. Distributed via EDGAR on February 11, 2026 at 22:01 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]