Autonomix Medical, Inc.
For the period ended Sep 30, 2026. Filed Nov 10, 2026.
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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, 2026 · Filed Nov 10, 2026
AMIX$1.85+8.8%Stored close · as of Nov 10, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-13.
0001437749-26-027429
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-10.
0001437749-26-036033
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 47 previous paragraphs and 79 current paragraphs.
29 unchanged; 9 reworded; 40 added; 9 removed; 0 previous and 1 current paragraphs rearranged.
Tables are not compared: 4 previous and 5 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 (40)
Current report
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.
Current report
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.
Current report
Development Priorities and Strategic Rationale
Current report
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:
Current report
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;
Current report
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
Current report
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.
Current report
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.
Current report
Renal Denervation Opportunity and Strategic Activity
Current report
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.)
Current report
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.
Current report
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.
Current report
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.
Current report
Preclinical Progress and Technology Optimization
Current report
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.
Current report
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.
Current report
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.
Current report
Signal Processing and Interpretation
Current report
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.
Current report
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.
Current report
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.
Current report
FDA Pre-Submission Feedback and Commercialization Plan
Current report
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.
Current report
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.
Current report
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.
Current report
Pancreatic Cancer Pain Program
Current report
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.
Current report
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.
Current report
Development Considerations and Risks
Current report
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.
Current report
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.
Current report
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.
Current report
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.
Current report
In October 2026, we sold 85,255 shares pursuant to the updated ATM for net proceeds of approximately $0.3 million.
Current report
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.
Current report
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.
Current report
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.
Current report
Net cash used in investing activities was $7 thousand for the six months ended September 30, 2026.
Current report
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.
Current report
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.
Removed paragraphs (9)
Previous report
We are a development-stage medical device company focused on advancing technologies for sensing and treating disorders of the nervous system. Our platform is designed to integrate high-sensitivity neural signal detection with targeted radiofrequency (“RF”) ablation, enabling a “sense, treat, verify” approach intended to improve the precision and consistency of nerve-targeted therapies.
Previous report
The technology we have developed consists of a catheter-based system incorporating a proprietary microchip-enabled sensing architecture designed to detect low-amplitude neural signals from within the vascular system. By placing signal amplification and digitization at or near the point of detection, this approach is intended to reduce signal degradation and improve detection of neural activity compared to conventional systems. We believe this may enable more precise localization of target nerves and support targeted therapeutic intervention.
Previous report
Our development efforts are focused on two core components: diagnostic sensing and therapeutic RF ablation. In preclinical studies, our sensing technology has demonstrated the ability to detect signals from specific nerve bundles prior to ablation and confirm signal termination following treatment. We are currently refining the design of our catheter to meet requirements for human use in the United States.
Previous report
In parallel with development of our sensing system, we have conducted an early clinical proof-of-concept study evaluating the safety and feasibility of transvascular nerve ablation using commercially available RF ablation technologies. Following positive initial findings, we initiated an expansion study to evaluate a broader patient population. As the study progressed, we observed variability in early clinical outcomes, which we believe may be related to differences in vascular access and anatomical targeting. Enrollment was subsequently paused to allow for further evaluation and refinement of our clinical and procedural approach.
Previous report
We are initially developing our technology for the treatment of pain associated with pancreatic cancer, a disease where existing therapies, including opioid pharmacotherapy and neurolytic injections, may provide inconsistent relief and are associated with meaningful risks and undesirable side effects. We believe our platform may also have the potential to support additional applications, including other visceral pain conditions, hypertension, cardiovascular disease, and other nerve-related disorders. These potential applications remain under evaluation and will require further development and clinical validation.
Previous report
On July 9, 2026, we received a letter from the Listing Qualifications Department of the Nasdaq Stock Market notifying us that we had regained compliance with the Bid Price Rule as a result of the closing bid price of our common stock being at or above $1.00 per share for the 10 consecutive business days from June 24, 2026 through July 8, 2026. Accordingly, the letter indicated we were in compliance with the Bid Price Rule and the matter was closed.
Previous report
On July 13, 2026, we entered into a warrant inducement offer letter (the “July 2026 Inducement Letter”) with the holder (the “Investor") of certain existing Series C warrants issued on November 19, 2025, to purchase up to 428,731 shares of our common stock (the “Common Warrants”). Pursuant to the July 2026 Inducement Letter, we reduced the exercise price of the Common Warrants to $6.00 per warrant share, and the Investor exercised Common Warrants to purchase 428,731 shares of our common stock. In consideration of the foregoing, we issued the Investor (i) a new Series D-1 unregistered common stock purchase warrant to purchase up to 428,731 shares of our common stock (the “New Series D-1 Warrant”) and (ii) a new Series D-2 unregistered common stock purchase warrant to purchase up to 428,731 shares of our common stock (the “New Series D-2 Warrant” and, together with the New Series D-1 Warrant, the “New Series D Warrants,” and the shares of our common stock underlying the New Series D Warrants, the “New Series D Warrant Shares”), in each case pursuant to the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), with an exercise term of 5.5 years from issuance. We received aggregate gross proceeds of approximately $2.6 million from the exercise of the Common Warrants, before deducting financial advisory fees and estimated offering expenses. The New Series D Warrants are immediately exercisable and have an exercise price of $5.75 per share. The Investor of a New Series D Warrant may not exercise any such warrant to the extent that such exercise would result in the number of shares of common stock beneficially owned by such Investor and its affiliates exceeding 4.99% or 9.99% (at the election of the Investor) of the total number of shares of common stock outstanding immediately after giving effect to the exercise, which percentage may be increased or decreased at the Investor's election not to exceed 9.99% (the “Beneficial Ownership Limitation”). In the event of certain fundamental transactions, the holder of a New Series D-1 Warrant will have the right to receive the Black Scholes value of such New Series D-1 Warrant calculated pursuant to a formula set forth therein, payable in cash if the fundamental transaction is within our control or, if the fundamental transaction is not within our control, in the same type or form of consideration being offered and paid to the holders of common stock. In the event of a fundamental transaction, the holder of a New Series D-2 Warrant will have the right to receive the same type or form of consideration being offered and paid to the holders of common stock but shall not have a Black Scholes redemption right. Maxim Group LLC (“Maxim”) served as warrant solicitation agent in connection with the solicitation of the exercise of the Common Warrants, and the Company paid Maxim a cash fee equal to 7.0% of the total proceeds received by us from the exercis…
Excerpt shortened here; the source contains the full paragraph.
Previous report
None for the three months ended June 30, 2026.
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. We also paid less than $0.1 million in issuance costs related to the Agreement.
Reworded paragraphs (9)
Previous wording
Results of Operations for the Three Months Ended June 30, 2026 Compared to the Three Months Ended June 30, 2025
Current wording
Results of Operations for the Three and Six Months Ended September 30, 2026 Compared to the Three and Six Months Ended September 30, 2025
Previous wording
Research and development expense was $1.5 million for the three months ended June 30, 2026 compared to $1.6 million for the same period in 2025.
Current wording
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.
Previous wording
General and administrative expense was $1.3 million for the three months ended June 30, 2026 compared to $1.8 million for the same period in 2025. This $0.6 million decrease was driven primarily by a decrease in stock-based compensation - option expense of $0.3 million, due to the stock option cancellation agreements, a decrease in legal and professional fees of $0.1 million and a decrease in employee compensation and benefits of $0.1 million.
Current wording
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.
Previous wording
For the three months ended June 30, 2026 and 2025, we had interest income of less than $0.1 million.
Current wording
For the three and six months ended September 30, 2026, we had interest income of less than $0.1 million.
Previous wording
On June 30, 2026, we had cash of $3.5 million and working capital of $3.1 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 first calendar quarter of 2027.
Current wording
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.
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 $25 to $30 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 $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.
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 and a decrease in operating assets and liabilities of $0.3 million. Non-cash items consisted of stock-based compensation of $0.4 million.
Current wording
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.
Previous wording
Net cash used in operating activities was $3.5 million during the three months ended June 30, 2026, consisting of a net loss of $2.7 million and a decrease in operating assets and liabilities of $0.8 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. 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.
Previous wording
Net cash used in investing activities was $0 for the three months ended June 30, 2026 and 2025.
Current wording
Net cash used in investing activities was $0 for the six months ended September 30, 2025.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
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.