Autonomix Medical, Inc.
For the period ended Sep 30, 2025. Filed Nov 12, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 12, 2025
AMIX$1.520.0%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-13.
0001437749-25-026564
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-12.
0001437749-25-034517
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 55 previous paragraphs and 57 current paragraphs.
33 unchanged; 14 reworded; 10 added; 8 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 4 previous and 4 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (10)
Current report
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.
Current report
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.
Current report
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.
Current report
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.
Current report
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.
Current report
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.
Current report
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.
Current report
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 inour 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.
Current report
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.
Current report
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.
Removed paragraphs (8)
Previous report
In April 2025, we announced the completion of enrollment in our PoC 1, which evaluated the safety and feasibility of the Autonomix Elpis System in patients with late-stage pancreatic cancer experiencing severe pain. Preliminary results demonstrated statistically significant reductions in pain, with responding patients reporting improvement within 24 hours of the procedure and sustained responses observed at 4 to 6 weeks. Among responders, the mean pain reduction reached 59.2%, and 73% and the responders remained opioid-free during follow-up. No device-related serious adverse events were reported. These data supported the clinical potential of our platform and informed the next phase of development.
Previous report
In May 2025, we received Ethics Committee approval to expand our proof-of-concept study into PoC 2, broadening the clinical focus to include patients with earlier-stage pancreatic cancer as well as those with other visceral cancers, such as gallbladder, bile duct, and liver cancers. This expansion is expected to double the potential addressable market for the platform.
Previous report
We treated the first patient in the PoC 2 study in June 2025, marking the initiation of this market expansion phase. The study is designed to further evaluate the safety and feasibility of our system across a broader population and generate data to support both regulatory submissions and future commercial adoption.
Previous report
In parallel, we held a formal pre-submission meeting with the U.S. Food and Drug Administration ("FDA") in May 2025 under the Q-Submission Program to discuss the regulatory requirements for initiating a U.S. clinical study under an Investigational Device Exemption ("IDE"). Based on FDA guidance, we have finalized our Good Laboratory Practices ("GLP") preclinical study, including 90-day and 180-day safety endpoints. The FDA indicated that favorable 90-day data may support the initiation of an Early Feasibility Study ("EFS") in the United States, with the 180-day cohort supporting a future marketing application. Feedback was also provided on pivotal trial design, including recommendations regarding appropriate control arms, concurrent therapy tracking, and anatomical safety assessment. We have incorporated this guidance into our development plan and are targeting potential De Novo approval in 2028, following completion of the EFS and subsequent pivotal study. We anticipate submitting our 90-day GLP data by the end of 2025 and initiating the EFS in the first half of 2026.
Previous report
We also made continued progress on product development. Engineering refinements to the ablation catheter during the quarter focused on improving steerability, vessel wall contact, and energy delivery precision, particularly in the complex anatomy of the celiac region. In parallel, development continued on our sensing catheter, with design modifications underway to support future activation of its sensing capabilities for targeted nerve localization. These enhancements are being guided by physician feedback and preclinical learnings and will be incorporated into our clinical-stage configurations.
Previous report
Additionally, we strengthened our intellectual property portfolio with the issuance of two new U.S. patents during the quarter. U.S. Patent No. 12,257,071 relates to controlled sympathectomy and micro-ablation systems and methods, while U.S. Patent No. 12,279,889 B2 covers technologies for mapping, evaluating, and modifying neurological activity. These patents support our long-term strategy to protect our innovations and expand into adjacent indications within interventional neuromodulation.
Previous report
In July 2025, we entered into stock option cancellation agreements with certain employees to cancel an aggregate of 57,331 stock options. Employees that elected to cancel their stock options were granted severance agreements for three, six or nine months of their base salary (under certain conditions). On August 11, 2025, we entered into stock option cancellation agreements with Board members and certain officers of the Company to cancel an aggregate of 177,652 stock options. Our Board members included Mr. Walter Klemp, Chairman of the Board; Ms. Lori Bisson, Executive Chair of the Board; and Mr. Chris Capelli, Director, respectively, and included amounts of 8,773; 65,542; and 3,750, respectively. Our officers included Mr. Brad Hauser, Chief Executive Officer and President; Mr. Landy Toth, Chief Technology Officer; Mr. Robert Schwartz, Chief Medical Officer; and Mr. Trent Smith, Chief Financial Officer, respectively, and included amounts of 45,000; 8,773; 13,159; and 32,655, respectively. Mr. Hauser was granted three months of his base salary, in addition to the twelve months of his base salary per his July 17, 2024 employment agreement. Mr. Toth and Mr. Schwartz were granted severance agreements that amounted to nine months of their base salary. Mr. Smith was granted three months of his base salary, in addition to the nine months of his base salary per his July 24, 2023 employment agreement.
Previous report
Net cash provided by financing activities was $2.1 million for the three months ended June 30, 2025. On February 28, 2025, we entered into an At Market Issuances Sales Agreement (the “Agreement”) with Ladenburg Thalmann & Co. Inc. (the “Agent”). Pursuant to the terms of the Agreement, we were able to sell $2.1 million of our common stock, before deducting Agent commissions and other estimated expenses payable by the Company. During the three months ended June 30, 2025, we also paid less than $0.1 million in issuance costs related to the Agreement.
Reworded paragraphs (14)
Previous wording
On July 21, 2025, we entered into a warrant exercise inducement offer letter (the "Inducement Letter") with the holders ("Holders") of certain existing warrants issued in the Offering from November 2024 to purchase up to 1,477,596 shares of our common stock (the "Existing Warrants"). 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; 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 us further reducing the exercise price of such Existing Warrants to purchase 622,596 shares of our common stock to $0.001 per share with an exercise term of 5.5 years. In consideration of the foregoing, we agreed to issue the Holders new 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 (the “Inducement Warrants” and the shares of our common stock underlying the Inducement Warrants, the “Inducement Warrant Shares”) at $1.723 per share with an exercise term of 5.5 years from the initial exercise date. In addition, we issued 88,656 Representative's Warrants at $2.6707 per share with an exercise term of 5 years. We received total gross proceeds of approximately $2.6 million, less expenses paid to the Placement Agent of approximately $0.3 million.
Current wording
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.
Previous wording
Results of Operations for the Three Months Ended June 30, 2025 Compared to the Three Months Ended June 30, 2024
Current wording
Results of Operations for the Three and Six Months Ended September 30, 2025 Compared to the Three and Six Months Ended September 30, 2024
Previous wording
Research and development expense was $1.6 million for the three months ended June 30, 2025 compared to $1.0 million for the same period in 2024. The increase in research and development expenses during the current year was mainly attributed to 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 trial and product development costs.
Current wording
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.
Previous wording
General and administrative expense was $1.8 million for the three months ended June 30, 2025 compared to $1.8 million for the same period in 2024. This was driven primarily by an increase in legal and professional fees of $0.1 million, offset by a decrease in officer and employee compensation and benefits of $0.1 million.
Current wording
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.
Previous wording
For the three months ended June 30, 2025 and 2024, we had interest expense of $0 and less than $0.1 million, respectively, related to the amortization of debt discount.
Current wording
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.
Previous wording
For the three months ended June 30, 2025 and 2024, we had interest income of less than $0.1 million, respectively.
Current wording
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.
Previous wording
On June 30, 2025, we had cash of $8.6 million, and working capital of $7.0 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 second calendar quarter of 2026.
Current wording
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.
Previous wording
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 $32 to $40 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.
Current wording
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.
Previous wording
Net cash used in operating activities was $2.6 million during the three months ended June 30, 2025, consisting of a net loss of $3.3 million, a decrease in operating assets of $0.1 million and an increase in operating liabilities of $0.2 million. The change in operating assets and liabilities included sources of cash from a decrease in other current assets of $0.1 million and a net increase in accounts payable and accrued expenses of $0.2 million. The increase in accounts payable and accrued expenses was driven primarily by increases in research and development expenses. Non-cash items primarily consisted of stock-based compensation of $0.4 million.
Current wording
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.
Previous wording
Net cash used in investing activities was $0 for the three months ended June 30, 2025.
Current wording
Net cash used in investing activities was $0 for the six months ended September 30, 2025.
Previous wording
Net cash used in investing activities was $5 thousand for the three months ended June 30, 2024 related to the purchase of computer hardware and software.
Current wording
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.
Previous wording
Net cash provided by financing activities was $0 for the three months ended June 30, 2024.
Current wording
Net cash provided by financing activities was $0 for the six months ended September 30, 2024.
Previous wording
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 key members of executive management to provide certain benefits, including salary and other wage-related benefits, in the event of termination. In total, these benefits would amount to a range of $1.2 million to $1.7 million using the rate of compensation in effect at June 30, 2025.
Current wording
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.
Previous wording
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, warrant liability 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.
Current wording
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.