Autonomix Medical expects cash to last only into Q2 2027
The company estimates current resources will fund operations into but not beyond the second calendar quarter of 2027.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Filing Summary
Autonomix Medical, Inc. reported a $3.1 million net loss for the three months ended September 30, 2026, compared with $7.5 million a year earlier, and no revenue in either period. Six-month net loss was $5.9 million versus $10.8 million; operating cash used was $6.2 million versus $6.4 million.
Cash was $7.7 million at September 30, 2026. The company estimates current resources, including updated ATM proceeds, will fund operations into but not beyond the second calendar quarter of 2027. It says these factors raise substantial doubt about its ability to continue as a going concern within one year after the financial statements are issued. In October 2026, it sold 85,255 shares under the updated ATM for net proceeds of approximately $0.3 million.
The development-stage medical-device company is prioritizing a standalone sensing system, targeting potential U.S. 510(k) clearance approximately 15 months after its September 2026 announcement and initial commercialization in 2028. After a September FDA pre-submission meeting, it said a Class II 510(k) pathway may be available; the feedback is not clearance or approval. Technology optimization is expected to take approximately 12 months, subject to additional financing.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Positive
- Moderate pointQuarterly loss narrowed to $3.1 million from $7.5 million in 2025.
Negative
- Major pointSubstantial going-concern doubt; estimated runway into but not beyond Q2 2027.
Filing Explained
Warrant exercises completed by September 30 increased common shares outstanding to 1,959,938 from 542,312 at March 31, diluting existing holders’ percentage ownership.
During the six months ended
The company raised its at-the-market (ATM) sales ceiling to
Key Figures
Key Terms
510(k) regulatory
substantial doubt financial
At The Market Issuances Sales Agreement financial
beneficial ownership limitation regulatory
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What was AMIX's net loss for the quarter ended September 30, 2026?
How long does AMIX expect its cash to fund operations?
Will AMIX's initial 510(k) strategy cover renal denervation guidance?
AI-generated analysis. How Rhea-AI works. Not financial advice.
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from ________ to__________
Commission file number
Autonomix Medical, Inc.
(Exact Name of Registrant as Specified in Its Charter)
(State or Other Jurisdiction of | (I.R.S. Employer Identification No.) |
Incorporation or Organization) |
|
(Address of Principal Executive Offices) (Zip Code)
Registrant’s Telephone Number, including Area Code:
(
(Former Name, Former Address and Former Fiscal Year, if Changed Since Last Report)
Securities registered pursuant to Section 12(b) of the Exchange Act:
Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
The |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter periods as the registrant was required to file such reports) and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated Filer ☐ | Accelerated Filer ☐ |
Smaller reporting company | |
| Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes
The number of shares of the Company's outstanding common stock as of November 6, 2026 was
1
Table of Contents
Autonomix Medical, Inc.
Index to Unaudited Condensed Financial Statements
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PART I FINANCIAL INFORMATION |
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Item 1. |
Condensed Financial Statements |
3 |
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Unaudited Condensed Balance Sheets as of September 30, 2026 and March 31, 2026 |
3 |
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Unaudited Condensed Statements of Operations for the three and six months ended September 30, 2026 and 2025 |
4 |
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Unaudited Condensed Statements of Stockholders’ Equity for the three and six months ended September 30, 2026 and 2025 |
5 |
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Unaudited Condensed Statements of Cash Flows for the six months ended September 30, 2026 and 2025 |
6 |
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Notes to the Unaudited Condensed Financial Statements |
7 |
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
23 |
Item 3. |
Quantitative and Qualitative Disclosures About Market Risk |
29 |
Item 4. |
Controls and Procedures |
29 |
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PART II OTHER INFORMATION |
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Item 1. |
Legal Proceedings |
31 |
Item 1A. |
Risk Factors |
31 |
Item 2. |
Unregistered Sales of Equity Securities and Use of Proceeds |
31 |
Item 3. |
Defaults Upon Senior Securities |
31 |
Item 4. |
Mine Safety Disclosures |
32 |
Item 5. |
Other Information |
32 |
Item 6. |
Exhibits |
32 |
Signatures |
33 |
|
2
Table of Contents
PART I - FINANCIAL INFORMATION
Item 1. Condensed Financial Statements
Autonomix Medical, Inc.
Condensed Balance Sheets
(Unaudited)
(in thousands, except par value and share data) |
| As of |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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Other current assets |
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Total current assets |
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Noncurrent assets: |
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Property and equipment, net |
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Total noncurrent assets |
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Total Assets |
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Liabilities and Stockholders' Equity |
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Current liabilities: |
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Accounts payable |
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Accrued expenses |
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Total current liabilities |
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Total Liabilities |
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Commitments and contingencies (Note 4) |
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Stockholders' equity: |
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Preferred stock, $ par value, shares authorized, shares issued and outstanding as of September 30, 2026 and March 31, 2026 |
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Common stock, $ par value, shares authorized, and shares issued and outstanding as of September 30, 2026 and March 31, 2026 |
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Additional paid-in capital |
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Accumulated deficit |
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Total Stockholders' Equity |
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Total Liabilities and Stockholders' Equity |
| $ |
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| $ |
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See accompanying notes to the unaudited condensed financial statements.
3
Table of Contents
Autonomix Medical, Inc.
Condensed Statements of Operations
(Unaudited)
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| Three Months Ended |
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| Six Months Ended |
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| September 30, |
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| September 30, |
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(in thousands, except share and per share data) |
| 2026 |
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| 2025 |
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| 2025 |
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Operating expenses: |
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Research and development |
| $ |
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General and administrative |
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Total operating expenses |
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Loss from operations |
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Other income: |
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Interest income |
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Total other income |
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Loss before income taxes |
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Income taxes |
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Net loss |
| $ | ( | ) |
| $ | ( | ) |
| $ | ( | ) |
| $ | ( | ) |
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Loss per share - basic and diluted (2025 is "as revised") |
| $ | ( | ) |
| $ | ( | ) |
| $ | ( | ) |
| $ | ( | ) |
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Weighted average shares outstanding - basic and diluted (2025 is "as revised") |
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See accompanying notes to the unaudited condensed financial statements.
4
Table of Contents
Autonomix Medical, Inc.
Condensed Statements of Stockholders' Equity
(Unaudited)
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| Additional |
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| Common Stock |
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| Paid-in |
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| Total |
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| Shares |
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| Amount |
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| Capital |
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| Accumulated |
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| Stockholders' |
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(in thousands) |
| (as revised) |
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| (as revised) |
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| (as revised) |
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| Deficit |
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| Equity |
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Balance March 31, 2025 |
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| $ |
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| $ |
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| $ | ( | ) |
| $ |
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Net loss |
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| - |
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| ( | ) |
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Stock-based compensation |
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| - |
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Issuance of common stock, net of offering costs |
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Issuance of common stock - warrants exercised |
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Balance June 30, 2025 |
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| ( | ) |
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Net loss |
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| - |
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| ( | ) |
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| ( | ) | ||
Stock-based compensation |
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| - |
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Stock option cancellations, unamortized stock-based compensation |
|
| - |
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Issuance of common stock - warrants exercised, net of costs |
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Issuance of common stock, net of costs |
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Issuance of common stock for equity line of credit commitment fee |
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Balance September 30, 2025 |
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| ( | ) |
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Balance March 31, 2026 |
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| ( | ) |
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| |
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Net loss |
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| - |
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| ( | ) |
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| ( | ) | ||
Stock-based compensation |
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| - |
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Fractional share buyback in connection with reverse stock split |
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| - |
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| ( | ) |
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| ( | ) | ||
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Balance June 30, 2026 |
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| ( | ) |
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Net loss |
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| - |
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| ( | ) |
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| ( | ) | ||
Stock-based compensation |
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| - |
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Issuance of common stock - warrants exercised, net of costs |
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Issuance of restricted stock awards |
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Settlement of restricted stock awards for statutory tax withholding |
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| ( | ) |
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| ( | ) |
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| ( | ) | ||
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| |
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| |
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| |
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| |
Balance September 30, 2026 |
|
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| $ |
|
| $ |
|
| $ | ( | ) |
| $ |
| ||||
See accompanying notes to the unaudited condensed financial statements.
5
Table of Contents
Autonomix Medical, Inc.
Condensed Statements of Cash Flows
(Unaudited)
|
| Six Months Ended September 30, |
| |||||
(in thousands) |
| 2026 |
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| 2025 |
| ||
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Cash Flows from Operating Activities: |
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Net loss |
| $ | ( | ) |
| $ | ( | ) |
Adjustments to reconcile net loss to net cash used in operating activities: |
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Stock-based compensation |
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Stock option cancellations, unamortized stock-based compensation |
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Issuance of common stock for equity line of credit commitment fee |
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Depreciation expense |
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Changes in operating assets - decrease: |
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Other current assets |
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Changes in operating liabilities - (decrease)/increase: |
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Accounts payable |
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| ( | ) |
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Accrued expenses |
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| ( | ) |
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| ( | ) |
Net cash used in operating activities |
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| ( | ) |
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Cash Flows from Investing Activities: |
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Purchase of property and equipment |
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| ( | ) |
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Net cash used in investing activities |
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| ( | ) |
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Cash Flows from Financing Activities: |
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Gross proceeds from issuance of common stock |
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Direct financing costs for issuance of common stock |
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| ( | ) | |
Gross proceeds from exercise of warrants |
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Direct transaction costs for warrant exercises |
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| ( | ) |
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| ( | ) |
Fractional share buyback in connection with reverse stock split |
|
| ( | ) |
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| |
Settlement of restricted stock awards for statutory tax withholding |
|
| ( | ) |
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| |
Payment of issuance costs for registration statement |
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| ( | ) |
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Net cash provided by financing activities |
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Net increase (decrease) in cash and cash equivalents |
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| ( | ) | |
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Cash and cash equivalents, at beginning of period |
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Cash and cash equivalents, at end of period |
| $ |
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Supplemental cash flow disclosures: |
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Non-cash financing activities: |
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Direct financing costs included in accounts payable |
| $ |
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| $ |
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Issuance costs included in accounts payable |
| $ |
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| $ |
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Cashless exercise of warrants |
| $ |
|
| $ |
| ||
Recognition of deferred offering costs associated with issuance of common stock |
| $ |
|
| $ | ( | ) | |
See accompanying notes to the unaudited condensed financial statements.
6
Table of Contents
Autonomix Medical, Inc.
Notes to the Unaudited Condensed Financial Statements
Note 1 – Description of the Business, Basis of Presentation and Summary of Significant Accounting Policies
Description of the Business
Autonomix Medical, Inc. (“we,” “us,” “our,” or the “Company”) is a Delaware corporation organized on June 10, 2014. The Company is a development-stage medical device company focused on advancing catheter-based technologies for acquiring low-amplitude biological electrical signals from within blood vessels and developing potential applications for sensing and treating disorders of the nervous system. The Company’s sensing technology incorporates a proprietary microchip-enabled architecture that places signal amplification and digitization at or near the point of detection. This architecture is intended to reduce signal degradation and support the acquisition of low-amplitude electrical activity. The Company is evaluating the source and clinical significance of recorded signals and the potential for its technology to support future neural-interpretation, procedural-guidance and treatment-verification applications.
The Company’s development programs include sensing technology and therapeutic radiofrequency (“RF”) ablation. Its broader platform concept contemplates a “sense, treat, verify” approach intended to improve the precision and consistency of nerve-targeted therapies. These capabilities remain subject to further development and validation. Although bench tests and animal studies have produced promising findings, recorded signal characteristics and responses following intervention have varied across studies, anatomical locations and time points. Physiological changes, catheter position, electrode contact and acquisition conditions may affect recorded activity and complicate attribution of observed changes to neural activity or treatment effect. A reduction in recorded electrical activity alone does not establish the completeness or durability of denervation.
The Company is continuing to refine its sensing technology and processing methods and to evaluate performance under intended conditions of use. We are also engaging with the U.S. Food and Drug Administration (“FDA”) regarding our proposed development and regulatory approach. FDA pre-submission feedback does not constitute clearance or approval or assurance that the FDA will accept our proposed pathway or supporting evidence. Any initial sensing 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.
The Company’s therapeutic development efforts have focused initially on pain associated with pancreatic cancer. In connection with these efforts, 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. These clinical activities are distinct from validation of our proprietary sensing technology. We are also evaluating potential future applications in other visceral pain conditions, hypertension, cardiovascular disease and other nerve-related disorders. These applications would require additional development, validation and applicable regulatory authorizations.
The Company’s technologies remain investigational. Continued development and commercialization depend on successful testing and validation, manufacturing readiness, sufficient financing and receipt of necessary regulatory authorizations. There can be no assurance that we will establish the evidence required for our proposed indications or achieve regulatory authorization or commercialization within anticipated time frames, if at all.
On January 14, 2026, the Company received a deficiency letter from the Listing Qualifications Department (the “Staff”) of the Nasdaq Stock Market (“Nasdaq”) notifying the Company that for the last 30 consecutive business days the closing bid price for the Company’s common stock had closed below the minimum $1.00 per share requirement for continued inclusion on the Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Rule”).
On July 9, 2026, the Company received a letter from the Staff notifying the Company that it had regained compliance with the Bid Price Rule as a result of the closing bid price of the Company’s 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 the Company is in compliance with the Bid Price Rule and the matter is closed.
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Reverse Stock Split
The Company held its annual meeting of stockholders (the "Annual Meeting") on October 30, 2025. In that Annual Meeting, stockholders of the Company approved an amendment to the Company’s amended and restated certificate of incorporation (the "Amendment”) to effect the reverse stock split at a ratio in the range of 1-for-
Pursuant to such authority granted by the Company’s stockholders, the Company’s board of directors approved a one-for- (1:21) reverse stock split (the "Reverse Stock Split”) of the Company’s common stock and the filing of the Amendment to effectuate the Reverse Stock Split. The Amendment was filed with the Secretary of State of the State of Delaware and the Reverse Stock Split became effective in accordance with the terms of the Amendment at 12:01 a.m. Eastern Time on June 24, 2026 (the "Effective Time”), and the Company’s common stock opened for trading on The Nasdaq Capital Market on June 24, 2026 on a post-split basis, under the existing ticker symbol "AMIX” but with a new CUSIP number 05330T304. The Amendment provides that, at the Effective Time, every twenty-one shares of the Company’s issued and outstanding common stock were automatically combined into one issued and outstanding share of common stock, without any change in par value per share, which continues to remain at $
The number of authorized shares of common stock remained at
No fractional shares were issued as a result of the Reverse Stock Split, and instead, stockholders who would have been entitled to receive fractional shares received cash in lieu thereof. The Company paid cash (without interest) equal to such fraction multiplied by the average of the closing sales prices of the common stock during the regular trading hours for the five consecutive trading days immediately preceding the Reverse Stock Split. The total amount paid in July 2026 for cash in lieu thereof was approximately $
The Reverse Stock Split has been retroactively adjusted throughout these interim financial statements and footnotes for all periods presented, including exercise prices and share data. These retroactive adjustments have been captioned with "as revised". As a result of the Reverse Stock Split, the Company approximately $
Liquidity and Going Concern
The Company's condensed financial statements are prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. The Company is an early-stage company that is subject to all the risks associated with early-stage and emerging growth companies and has incurred losses since inception.
For the three months ended September 30, 2026 and 2025 and the six months ended September 30, 2026 and 2025, the Company had net losses of $
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The Company estimates its current cash resources, including the proceeds from the updated ATM in Note 6, are sufficient to fund its operations into but not beyond the second calendar quarter of 2027. The Company recognizes it will need to raise additional capital to continue to execute its business plan, including obtaining regulatory clearance for its 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 the Company. A failure to raise sufficient capital, generate sufficient product revenues, control expenditures and regulatory matters, among other factors, will adversely impact the Company’s ability to meet its financial obligations as they become due and payable and to achieve its intended business objectives. If the Company is unable to raise sufficient additional funds, it will have to scale back its operations.
These factors raise substantial doubt about the Company's ability to continue as a going concern within one year after the date the financial statements are issued. The accompanying condensed financial statements have been prepared on a going concern basis and do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.
Basis of Presentation
The accompanying condensed interim financial statements are unaudited. These unaudited condensed interim financial statements have been prepared in accordance with the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) for interim financial information. Accordingly, they do not include all the information and notes required by generally accepted accounting principles in the United States of America (“GAAP”) for complete financial statements. The Company’s fiscal year end is March 31st. These unaudited condensed interim financial statements should be read in conjunction with the audited financial statements and accompanying notes for the year ended March 31, 2026 as found in the Company's Annual Report on Form 10-K filed with the SEC on May 27, 2026. In the opinion of management, the unaudited condensed interim financial statements reflect all the adjustments (consisting of normal recurring adjustments) necessary to state fairly the Company’s financial position, results of operations and cash flows for the quarterly and year-to-date periods, as applicable. The interim results of operations are not necessarily indicative of the results that may occur for the full fiscal year. The March 31, 2026 condensed balance sheet included herein was derived from the audited financial statements, but does not include all disclosures, including notes, required by GAAP for complete financial statements.
Use of Estimates in Financial Statement Presentation
The preparation of these unaudited condensed interim financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. The Company's significant estimates and assumptions include work performed but not yet billed by contract manufacturers, engineers and research organizations and the valuation of equity related instruments. Although the Company believes that its estimates and assumptions are reasonable, they are based upon information available at the time the estimates and assumptions were made. Some of these judgments can be subjective and complex, and, consequently, actual results could differ from those estimates.
Cash and Cash Equivalents
The Company considers all highly liquid investments with original maturities of three months or less at the date of acquisition to be cash equivalents. Periodically, the Company may carry cash balances at financial institutions in excess of the federally insured limit of $250 thousand. The Company has not experienced losses on these accounts and management believes, based upon the quality of the financial institutions, that the credit risk with regard to these deposits is not significant.
Other Current Assets
Other current assets consisted of the following (in thousands):
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| As of September 30, |
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| As of March 31, |
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| 2026 |
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| 2026 |
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Prepaid insurance |
| $ |
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| $ |
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Other current assets and prepaid expenses |
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Total other current assets |
| $ |
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| $ |
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Offering and Financing Costs
Offering costs consist of professional costs incurred through the balance sheet date that are direct and incremental related to the Company’s equity financing activities. The Company includes offering costs in additional paid-in capital, to the extent there are sufficient cash proceeds, upon completion of the sale of equity. Costs associated with salaries and other period costs are expensed as incurred.
Property and Equipment
Property and equipment (comprised of computer and information technology equipment) are stated at historical cost and depreciated on a straight-line basis over their estimated useful lives, generally years. Upon disposition of the assets, the costs and related accumulated depreciation are removed from the accounts and any resulting gain or loss is included in the results of operations.
Accrued Expenses
Accrued expenses consisted of the following (in thousands):
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| As of September 30, |
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| As of March 31, |
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| 2026 |
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| 2026 |
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Accrued compensation |
| $ |
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| $ |
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Accrued clinical research costs |
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Accrued product development costs |
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Accrued professional fees |
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Other miscellaneous accrued expenses |
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Total accrued expenses |
| $ |
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| $ |
| ||
Fair Value of Financial Instruments
Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value maximize the use of observable inputs and minimize the use of unobservable inputs. The Company utilizes a three-level valuation hierarchy for disclosures of fair value measurements, defined as follows:
Level 1 – inputs to the valuation methodology are quoted prices (unadjusted) for identical assets or liabilities in active markets.
Level 2 – inputs to the valuation methodology include quoted prices for similar assets and liabilities in active markets, and inputs that are observable for the asset or liability, either directly or indirectly, for substantially the full term of the financial instrument.
Level 3 – inputs to the valuation methodology are unobservable and significant to the fair value and require significant judgment and estimation.
Financial assets and financial liabilities are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. While the Company believes that its valuation methods are appropriate, the Company recognizes that the use of different methodologies or assumptions to determine the fair value could result in a different estimate of fair value at the reporting date. The primary assumptions that would significantly affect the fair values are the probability weighting of the different settlement outcomes used.
The Company did have any assets or liabilities measured at fair value as of September 30, 2026 and March 31, 2026.
The carrying value of short-term instruments, including cash, accounts payable and accrued expenses, approximate fair value due to the relatively short period to maturity for these instruments.
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Related Parties
The Company follows Accounting Standards Codification ("ASC") 850, Related Party Disclosures, for the identification of related parties and disclosure of related party transactions. See further discussion in Note 5 below on this matter.
Income Taxes
The Company uses the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on the differences between the financial reporting and the tax basis of reported assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company must then assess the likelihood that the resulting deferred tax assets will be realized. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. As of September 30, 2026 and March 31, 2026, the Company determined a full valuation allowance was required to offset its deferred tax assets as a result of recurring operating losses.
The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740-10 which prescribes a recognition threshold and measurement attribute for financial statement disclosure of tax positions taken, or expected to be taken, on its tax return. The Company evaluates and records any uncertain tax positions based on the amount that management deems is more likely than not to be sustained upon examination and ultimate settlement with the tax authorities in the tax jurisdictions in which it operates. As of September 30, 2026 and March 31, 2026, the Company had no uncertain tax positions.
The Company does not expect to pay any significant federal, state, or foreign income taxes in its fiscal year 2027 (ending March 31, 2027) as a result of the losses recorded during the six months ended September 30, 2026 and the additional losses expected for the remainder of its fiscal year 2027 and cumulative net operating loss carryforwards. Accounting standards require the consideration of a valuation allowance for deferred tax assets if it is “more likely than not” that some component or all of the benefits of deferred tax assets will not be realized.
The Company recorded
Stock-based Compensation
Employee and non-employee share-based compensation is measured at the grant date, based on the fair value of the award, and is recognized as an expense over the requisite service period. For awards with a performance condition, compensation expense is recognized over the requisite service period if it is probable that the performance condition will be satisfied. For awards to non-employees, the Company recognizes compensation expense in the same manner as if the Company had paid cash for the goods or services. The Company estimates the fair value of options and equity classified warrants granted using an options pricing model. Expense is recognized within general and administrative and research and development expenses and forfeitures are recognized as they are incurred.
Restricted Stock Awards
The Company may grant restricted shares of common stock ("Restricted Stock Awards" or "RSAs") to employees, non-employee directors and consultants pursuant to its equity incentive plans. RSAs generally represent shares of the Company's common stock that are issued subject to specified service-based or performance-based vesting requirements and are subject to forfeiture if the applicable vesting conditions are not satisfied.
The fair value of equity-classified RSAs is generally determined based on the closing market price of the Company's common stock on the grant date, adjusted when necessary for applicable award-specific terms. Compensation expense associated with service-based RSAs is generally recognized on a straight-line basis over the requisite service period for awards with graded vesting provisions for which that recognition method is permitted and elected. For awards with cliff vesting provisions, compensation expense is generally recognized ratably over the requisite service period.
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RSAs are subject to forfeiture until the applicable vesting conditions have been satisfied. The Company recognizes the effects of forfeitures in the period in which they occur and reverses previously recognized compensation expense related to forfeited awards, as applicable.
The Company evaluates the terms of its RSAs to determine their appropriate classification as equity or liabilities and accounts for any modifications in accordance with ASC Topic 718.
The Company evaluates the impact of RSAs on basic and diluted earnings per share in accordance with ASC Topic 260, Earnings Per Share, including the treatment of unvested shares that are subject to forfeiture and any applicable nonforfeitable dividend or dividend-equivalent rights.
Additional information regarding RSA activity, stock-based compensation expense and unrecognized compensation cost is included in Note 3 — Equity.
Warrants
The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in Financial Accounting Standards Board ("FASB") ASC 480, Distinguishing Liabilities from Equity (“ASC 480”) and ASC 815, Derivatives and Hedging (“ASC 815”). The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the Company’s own ordinary shares and whether the warrant holders could potentially require “net cash settlement” in a circumstance outside of the Company’s control, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent quarterly period end date while the warrants are outstanding.
For issued or modified warrants that meet all of the criteria for equity classification, the warrants are required to be recorded as a component of additional paid-in capital at the time of issuance. For issued or modified warrants that do not meet all the criteria for equity classification, the warrants are required to be recorded at their initial fair value on the date of issuance, and each balance sheet date thereafter. Changes in the estimated fair value of the warrants are recognized as a non-cash gain or loss on the statements of operations. The fair value of the warrants is estimated using a Black-Scholes pricing model or a Monte Carlo simulation.
Loss Per Common Share
Basic loss per common share is computed by dividing net loss by the weighted-average number of common shares outstanding during the period, which includes shares issuable for little to no consideration upon the exercise of certain equity-classified warrants and shares held in abeyance as a result of the beneficial ownership limitation included in the warrants, for which the exercise price has been paid in full. The
Generally, the Company's warrants issued to holders in connection with capital transactions are participating securities as the holders receive the right to participate pro rata in distributions, but they are not obligated to fund losses. In periods of loss, since no income is allocated to these securities, the Company's use of the "treasury stock method" derives the same result. The dilutive effect of convertible securities is calculated using the “if-converted method.” Under the if-converted method, securities are assumed to be converted at the beginning of the period, and the resulting common shares are included in the denominator of the diluted calculation for the entire period being presented.
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For the six months ended September 30, 2026 and 2025, dilutive securities that were not included in the calculations of the loss per common share because they would be anti-dilutive included the following:
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| September 30, |
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| 2025 |
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| 2026 |
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Equity based warrants to purchase common shares |
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Bridge financing warrants |
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Stock options granted under Company's incentive plan |
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Restricted stock awards |
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Series A warrants |
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Series B warrants |
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Series E-1 warrants |
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Series E-2 warrants |
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Representative warrants |
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Total potentially dilutive securities |
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Research and Development Costs
Research and development costs are expensed as incurred.
Advertising
It is the Company's policy to expense advertising costs as incurred. Advertising expenses would be included within general and administrative expenses within the statement of operations. For the three and six months ended September 30, 2026 and 2025, the Company recorded advertising expenses.
JOBS Act Accounting Election
The Company qualifies as an emerging growth company (“EGC”), as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). The JOBS Act exempts emerging growth companies from being required to comply with new or revised financial accounting standards until private companies are required to comply with the new or revised financial accounting standards. The JOBS Act provides that a company can elect to opt out of the extended transition period and comply with the requirements that apply to non-emerging growth companies but any such election to opt out is irrevocable. The Company has elected not to opt out of such extended transition period which means that when a standard is issued or revised and it has different application dates for public or private companies, the Company, as an emerging growth company, can adopt the new or revised standard at the time private companies adopt the new or revised standard. This may make comparison of the Company’s financial statements with another public company which is neither an early-stage company nor an emerging growth company which has opted out of using the extended transition period difficult or impossible because of the potential differences in accounting standards used.
Segments
Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker ("CODM"), or decision-making group, in deciding how to allocate resources in assessing performance. Management has determined that the Company operates in reportable segment, which is advancing the development of innovative technologies for sensing and treating disorders relating to the nervous system. The Company is initially focused on developing the technology for patients with pancreatic cancer, however, the Company believes the technology constitutes a platform with the potential to address several indications, including chronic pain management, hypertension, cardiovascular disease and a wide range of other nerve-related disorders. The Company's CODM is its Chief Executive Officer.
The accounting policies of the segment are the same as those described in the summary of significant accounting policies. The CODM assesses performance based on net loss, which is reported on the Statements of Operations. The measure of segment assets is reported on the balance sheet as total assets.
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To date, the Company has not generated any product revenue. The Company expects to continue to incur significant expenses and operating losses for the foreseeable future as it advances its technology through all stages of development and clinical trials and, ultimately, seeks regulatory approval.
As such, the CODM primarily evaluates performance of the Company using various financial metrics, including net loss from operations, also shown on the Statements of Operations, forecasted cash expenditures and existing and forecasted cash balances. These financial metrics are used by the CODM to make key operating decisions, such as the assessment of segment performance and allocation of resources. All of the Company's assets are located in the United States. The significant expense categories within net loss from operations that the CODM regularly reviews are expenses related to research and development and general and administrative. The significant expense categories and subcategories are reported on the Statements of Operations. Other expenses included in the Company’s net loss include other income (expense), interest income, net, and any additional non-operating expenses that are reported in the Statements of Operations.
Recent Accounting Pronouncements
In December 2025, the FASB issued ASU 2025-12 Codification Improvements: The amendments in this update are effective for all entities for annual reporting periods beginning after December 15, 2026, and interim reporting periods within those annual reporting periods. Early adoption is permitted in both interim and annual reporting periods in which financial statements have not yet been issued or made available for issuance. If an entity adopts the amendments in this update in an interim period, it must adopt them as of the beginning of the annual reporting period that includes that interim reporting period. An entity may elect to early adopt the amendments on an issue-by-issue basis. An entity should apply the amendments in this update (except for the amendments to Topic 260, Earnings Per Share) using one of the following transition methods: 1. Prospectively to all transactions recognized on or after the date that the entity first applies the amendments 2. Retrospectively to the beginning of the earliest comparative period presented. An entity should adjust the opening balance of retained earnings (or other appropriate components of equity or net assets in the statement of financial position) as of the beginning of the earliest comparative period presented. An entity may elect the transition method on an issue-by-issue basis. For the amendments in this update to Topic 260, an entity should apply the amendments retrospectively to each prior reporting period presented in the period of adoption. There are no current impacts on the Company's earnings per share as the Company has no liability-based instruments.
In December 2025, the FASB issued ASU 2025-11 Interim Reporting (Topic 270): Narrow-Scope Improvements: The amendments in this update are effective for interim reporting periods within annual reporting periods beginning after December 15, 2027, for public business entities and for interim reporting periods within annual reporting periods beginning after December 15, 2028, for entities other than public business entities. Early adoption is permitted for all entities. The amendments in this update can be applied either (1) prospectively or (2) retrospectively to any or all prior periods presented in the financial statements. The Company is currently evaluating the new guidance to determine the impact it may have on its financial statements and related disclosures.
In November 2024 and January 2025, the FASB issued ASU 2024-03 and ASU 2025-01, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, which requires disclosure in the notes to the financial statements of specified information about certain costs and expenses. The amendments to the standards are effective for fiscal years beginning after December 15, 2026, and for interim periods within fiscal years beginning after December 15, 2027. Early adoption is permitted. The amendments should be applied either prospectively to financial statements issued for reporting periods after the effective date of this ASU or retrospectively to any or all prior periods presented in the financial statements. The Company is currently evaluating the new guidance to determine the impact it may have on its financial statements and related disclosures.
There are no other effective pronouncements, or pronouncements issued but not yet effective, if adopted, that management believes would have a material effect on the accompanying financial statements.
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Reverse Stock Split
A summary of the impact of the Company’s Reverse Stock Split reflecting the prior period impact to the Company’s Statement of Operations and earnings per share is shown below:
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| Three Months Ended September 30, 2025 |
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Net Loss (in thousands) |
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Loss per share - basic and diluted |
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Weighted average shares outstanding - basic and diluted |
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Net Loss (in thousands) |
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Loss per share - basic and diluted |
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Weighted average shares outstanding - basic and diluted |
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Note 2 – Convertible Notes Payable Warrants
On September 9, 2023, the Company's Board authorized an offering of up to $
The Bridge Financing Warrants can be exercised from the date of Notes issuance through the five-year anniversary of the issuance of the Notes. The Note holders were not permitted to convert their Notes when the holders or any of their affiliates would beneficially own in excess of
Warrants - Convertible Promissory Notes
The following table presents a summary of activity for the Bridge Financing Warrants issued in connection with the Notes:
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Outstanding and exercisable, March 31, 2026 |
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Outstanding and exercisable, September 30, 2026 |
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Note 3 – Equity
On November 29, 2023, and as amended, the Company’s Board and applicable shareholders approved an amendment to the Company’s certificate of incorporation that increased the authorized shares to
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Table of Contents
Preferred Stock
As of September 30, 2026, the Company had
Restricted Stock
On September 3, 2026, the Company granted
A summary of unvested restricted stock activity for the three and six months ended September 30, 2026 is as follows:
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Issued and outstanding at September 30, 2026 |
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The Company recognized $
Common Stock
On February 28, 2025, the Company entered into an At The Market Issuances Sales Agreement (the "ATM Agreement") with Ladenburg Thalmann & Co. Inc. (the "Agent"). Pursuant to the terms of the ATM Agreement, the Company was initially able to sell from time to time through the Agent, as sales agent or principal, shares of its common stock with an initial aggregate sales price of up to $
On September 11, 2026, the Company increased the aggregate sales price of shares of its common stock that may be sold pursuant to the updated ATM Agreement to $
On August 25, 2025, the Company entered into a purchase agreement (the “Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”), under which, subject to specified terms and conditions, the Company may sell up to $
As of September 30, 2026, the Company has sold
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Table of Contents
Stock Plan and Stock Options
In June 2023, the Company adopted, and the Company’s shareholders approved, the Autonomix Medical, Inc. 2023 Stock Plan (the “Plan”). The Plan is a stock-based compensation plan that provides for discretionary grants of stock options, stock awards and stock unit awards to key employees, non-employee directors, and consultants, subject to certain individual threshold limitations. The Plan initially provided for up to
In August 2023, the Plan was amended to allow for an automatic increase of the available shares for issuance, whereby on the first of each fiscal year, beginning on April 1, 2024 and ending on (and including) April 1, 2033, the number of shares available for issuance increases in an amount equal to five percent (
In July 2025, the Company entered into stock option cancellation agreements with certain employees to cancel an aggregate of
In October 2025, the Company adopted, and the Company's shareholders approved, the Plan, as amended and restated. Pursuant to this amendment and restatement, the Plan was increased by
The following table summarizes the stock option activity for the six months ended September 30, 2026:
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Outstanding, March 31, 2026 |
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Forfeited |
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Outstanding, September 30, 2026 |
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| $ |
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Exercisable, September 30, 2026 |
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| $ |
| ||
The Company’s stock option awards did not automatically adjust for the Reverse Stock Split. However, the Company chose to exercise its rights under the Plan to adjust the exercise price and number of shares exercisable or issuable upon vesting for the Reverse Stock Split.
Based on the Company's modification accounting analysis, there was no incremental stock-based compensation expense associated with the Reverse Stock Split.
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All options issued and outstanding are being amortized over their respective vesting periods. The unrecognized compensation expense at September 30, 2026 was less than $
Equity-Based Stock Warrants
August 2026 Warrant Inducement Agreement
On August 24, 2026, the Company entered into a warrant inducement offer letter (the “Inducement Letter”) with the holder of Series D- warrants and Series D-2 warrants issued on July 15, 2026 (see definition below under July 2026 Warrant Inducement Agreement), to purchase up to
Pursuant to the Inducement Letter, the holder agreed to exercise the Existing Warrants to purchase an aggregate of
The resale of the shares of Company common stock issuable upon exercise of the Existing Warrants has been registered for resale pursuant to an effective registration statement on Form S-3 (File No. 333-298774). The Company received aggregate gross proceeds of approximately $
The Series E Warrants are immediately exercisable and have an exercise price of $
At issuance the Series E Warrants had a fair value of $
The Company accounted for the Inducement Letter as a capital transaction for the cash proceeds received, net of issuance costs. As a result of the application of ASC Sub-topic 815-40, the Company considered the modification of the Existing Warrants and the issuance of the Series E Warrants to represent a cost of the capital transaction.
Maxim Group LLC (“Maxim”) acted as financial advisor in connection with the transaction, and the Company paid Maxim a cash fee equal to
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July 2026 Warrant Inducement Agreement
On July 13, 2026, the Company entered into a warrant inducement offer letter (the “July 2026 Inducement Letter”) with the holder of certain existing Series C Warrants issued on November 19, 2025, to purchase up to
Pursuant to the July 2026 Inducement Letter, the Company reduced the exercise price of the Series C Warrants to $
The Company received aggregate gross proceeds of approximately $
The Series D Warrants are immediately exercisable and have an exercise price of $
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 Series D-1 Warrant calculated pursuant to a formula set forth therein, payable in cash if the fundamental transaction is within the Company’s control or, if the fundamental transaction is not within the Company’s 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 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.
At issuance the Series D Warrants had a fair value of $
The Company accounted for the July 2026 Inducement Letter as a capital transaction for the cash proceeds received, net of issuance costs. As a result of the application of ASC Sub-topic 815-40, the Company considered the modification of the Series C Warrants and the issuance of the Series D Warrants to represent a cost of the capital transaction.
The Company filed a registration statement providing for the resale of the Series D Warrant Shares issuable upon the exercise of the Series D Warrants and has agreed to keep the resale registration statement effective at all times until no holder of the Series D Warrants owns any Series D Warrants or Series D Warrant Shares. All of the Series D Warrants were exercised in August 2026 in connection with the Inducement Letter.
Maxim served as warrant solicitation agent in connection with the solicitation of the exercise of the Series C Warrants, and the Company paid Maxim a cash fee equal to
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November 2025 Securities Purchase Agreement
On November 18, 2025, the Company entered into a Securities Purchase Agreement (the "Agreement") with an institutional investor, pursuant to which the investor purchased in a private placement: (i) pre-funded warrants to purchase
At issuance, the Common Warrants had a fair value of $
The Company accounted for the November 2025 Offering as a capital transaction for the cash proceeds received, net of issuance costs. As a result of the application of ASC Sub-topic 815-40, it was determined that the November 2025 Pre-Funded Warrants and Common Warrants both met the requirements for equity classification. The proceeds from the Agreement were recorded in additional paid-in capital, net of the costs incurred.
In connection with the above November 2025 Offering, on November 18, 2025, the Company entered into a placement agency agreement with Maxim Group LLC (the “Placement Agent”) (the “Placement Agreement”), pursuant to which the Company agreed to pay the Placement Agent an aggregate fee equal to up to
July 2025 Warrant Inducement Agreement
On July 21, 2025, the Company entered into warrant exercise inducement offer letters (each, a "July 2025 Inducement Letter") with the holders ( "November 2024 Holders") of certain existing warrants issued in the November 2024 Offering to purchase up to
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At issuance, the July 2025 Inducement Warrants and the placement agent warrants had a fair value of $
The Company accounted for the July 2025 Inducement Letter as a capital transaction for the cash proceeds received, net of issuance costs. As a result of the application of ASC Sub-topic 815-40, the Company considered the modification of the November 2024 Existing Warrants and the issuance of the July 2025 Inducement Warrants to represent a cost of the capital transaction.
The Company may not effect the exercise of certain July 2025 Inducement Warrants, which upon giving effect to such exercise, would cause the aggregate number of shares of common stock beneficially owned by the November 2024 Holder (together with its affiliates) to exceed
Subsequent to the July 2025 Inducement Letter,
The Company will periodically grant warrants to holders in connection with equity financing or to third-party service providers in exchange for services rendered. The following table summarizes the stock warrant activity for the six months ended September 30, 2026:
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| Weighted-Average |
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| Exercise Price |
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| Warrants |
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| Per Share |
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Outstanding, March 31, 2026 (as revised) |
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Granted |
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Exercised |
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| ( | ) |
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Forfeited |
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| ( | ) |
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Outstanding and exercisable, September 30, 2026* |
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* | Amount includes |
Note 4 – Commitments and Contingencies
Legal Proceedings
From time to time, the Company may be involved in claims that arise during the ordinary course of business. Although the results of litigation and claims cannot be predicted with certainty, the Company does not currently have any pending litigation to which it is a party or to which its property is subject that we believe to be material. There are legal matters for which a reasonably estimated range of losses can be determined. Regardless of the outcome, litigation can be costly and time consuming, and it can divert management’s attention from important business matters and initiatives, negatively impacting our overall operations.
Employment Agreements
The Company has 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 $
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Fractional Shares
On November 1, 2024, the Company received notice from the Depository Trust and Clearing Corporation ("DTCC") on behalf of the brokerage firms that hold the shares of Company common stock held in “street name” that, in connection with the rounding of fractional shares in connection with the Company's October 2024 reverse stock split, the Company would need to issue
On October 24, 2024, the Company completed a one-for- reverse stock split of its common stock.
In connection with the approval of the reverse stock split, the Company agreed that no fractional shares will be issued in connection with the reverse stock split and that it would issue one full share of the post-reverse stock split common stock to any shareholder who would have been entitled to receive a fractional share as a result of the process. The Company does not believe the number of Shares being requested is correct based on the historical number of shareholders of its common stock and is aware of similar anomalies in recent months for other companies completing a Reverse Stock Split. As such, the Company has begun an inquiry into the calculations set forth in the request. During the pendency of this inquiry, the Company does not intend to issue any shares in connection with the fractional shares being requested and has concluded that an obligation should not be recorded in its financial statements. The Company is not currently subject to any pending litigation as a result of the fractional roundup shares.
Note 5 – Related Party Transactions
On December 21, 2021, the Company entered into a license agreement with a company controlled by a significant stockholder of the Company (“Licensee”). On July 7, 2023, the Company and the Licensee entered into an Exclusive License Termination Agreement (the “Termination Agreement”) in exchange for the issuance, upon the closing of the Company’s initial public offering within one year of the agreement’s execution, of a warrant to purchase shares of the Company for a variable number of shares. The variable number of shares issued was based upon a fixed value of $
On January 29, 2024, the Company issued a warrant to purchase
Note 6 – Subsequent Events
In October 2026, the Company sold
On October 29, 2026, the Company held its Annual Meeting. In that Annual Meeting, among other items, the Company's stockholders approved i) an amendment to the Company's amended and restated certificate of incorporation (the "Amendment”) to effect the reverse stock split at a ratio in the range of 1-for-
As approved in its Annual Meeting, the number of shares in the Company's Plan was increased to
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| Item 2. | MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
|
References in this Form 10-Q to “we," “us," "its," “our” or the “Company” are to Autonomix Medical, Inc. (“Autonomix”), as appropriate to the context.
You should read the following discussion and analysis of our financial condition and results of operations in conjunction with the financial statements and the related notes appearing elsewhere in this Form 10-Q. This discussion contains forward-looking statements reflecting our current expectations that involve risks and uncertainties. See the section titled “Risk Factors” as found in our Annual Report on Form 10-K filed with the SEC on May 27, 2026, which is available on the SEC’s EDGAR website at www.sec.gov, and any updates or amendments to those risk factors subsequently filed with the SEC, for a discussion of the uncertainties, risks and assumptions associated with these statements. Actual results and the timing of events could differ materially from those discussed in our forward-looking statements as a result of many factors, including those set forth under “Risk Factors” and elsewhere in this Form 10-Q.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
We make forward-looking statements under the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and in other sections of this Form 10-Q. In some cases, you can identify these statements by forward-looking words such as “may,” “might,” “should,” “would,” “could,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “potential” or “continue,” and the negative of these terms and other comparable terminology. These forward-looking statements, which are subject to known and unknown risks, uncertainties and assumptions about us, may include projections of our future financial performance based on our growth strategies and anticipated trends in our business. These statements are only predictions based on our current expectations and projections about future events. There are important factors that could cause our actual results, level of activity, performance or achievements to differ materially from the results, level of activity, performance or achievements expressed or implied by the forward-looking statements. In particular, you should consider the numerous risks and uncertainties described under “Risk Factors” as discussed in our Annual Report on Form 10-K filed with the SEC on May 27, 2026, and in other filings made by us from time to time with the SEC.
While we believe we have identified material risks, these risks and uncertainties are not exhaustive. Other sections of this Form 10-Q may describe additional factors that could adversely impact our business and financial performance. Moreover, we operate in a very competitive and rapidly changing environment. New risks and uncertainties emerge from time to time, and it is not possible to predict all risks and uncertainties, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.
Although we believe the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, level of activity, performance or achievements. Moreover, neither we nor any other person assumes responsibility for the accuracy or completeness of any of these forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. We are under no duty to update any of these forward-looking statements after the date of this Form 10-Q to conform our prior statements to actual results or revised expectations, and we do not intend to do so.
Forward-looking statements include, but are not limited to, statements about:
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• |
the success of our ongoing and future clinical trials; |
|
• |
competition from existing products or new products that may emerge; |
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• |
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; |
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• |
our ability to establish or maintain collaborations, licensing or other arrangements; |
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• |
our ability and third parties’ abilities to protect intellectual property rights; |
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• | 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; |
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|
• |
our ability to establish relationships with health care professionals and organizations; |
|
• |
general economic uncertainty that adversely affects spending on medical procedures; |
|
• | our ability to maintain the listing of our common stock on the Nasdaq Capital Market; |
|
• |
volatility in the market price of our stock; and |
|
• |
potential dilution to current stockholders from the issuance of equity awards and from future capital raising activities. |
We caution you not to place undue reliance on the forward-looking statements, which speak only as of the date of this Form 10-Q in the case of forward-looking statements contained in this Form 10-Q.
Overview
We are a development-stage medical device company developing a technology platform for nerve-targeted procedures. Our platform combines a catheter-based sensing antenna array and microchip, designed to acquire low-amplitude biological electrical signals that travel through blood vessel walls and amplify them near the point of detection, with signal-processing capabilities. Over time, this design is intended to support interpretation of the recorded signals and the guidance and verification of nerve-targeted treatment.
We describe our staged strategy as “sense, treat and verify.” Having obtained proof-of-concept toward our ability to successfully treat targeted nerves with a commercial RF ablation system through human clinical studies in pancreatic cancer pain, we have turned our attention toward regulatory approval of our standalone sensing system, for which we are targeting an initial U.S. 510(k) clearance with the U.S. Food and Drug Administration ("FDA"). In parallel, we are advancing our understanding of recorded signals and developing processing methods that we believe may provide physicians with additional physiological information before, during and after an intervention. We believe this approach positions our platform for future cardiovascular applications, including renal denervation, as well as pain management and other conditions involving the peripheral nervous system.
Development Priorities and Strategic Rationale
We have prioritized a standalone transvascular sensing system as our initial U.S. regulatory and commercialization opportunity. The proposed initial device is intended to serve as a general acquisition tool for biological electrical signals in the heart and peripheral vessels, providing information for clinician review as part of clinical decision-making. The decision to prioritize a standalone transvascular sensing system was based on several reasons, including, without limitation:
i) An earlier path to market. The potential regulatory pathway for a standalone acquisition device may provide an earlier and less capital-intensive route to initial U.S. commercialization versus pursuing clearance of a combined sensing and ablation therapy ("Dual Therapy”) for pancreatic cancer pain first. This dual therapy required a de novo clearance supported by pivotal clinical trials, while pursuing our standalone sensing device allows us to target a 510(k) path, which is typically a faster and less capital extensive route to clearance;
ii). One foundation for many applications. The applications we are pursuing share a common core capability: reliably acquiring low-amplitude biological electrical signals. Establishing the sensing, manufacturing and quality-system foundation, and then extending it, is intended to reduce risk and cost across our pipeline and support further investment in additional clinical applications; and
iii) A growing foundation of experimental data. Each study adds to our understanding of recorded signals, the conditions that influence them and the effects of changes to our technology. Concentrating resources on signal acquisition and processing is intended to improve measurement quality, inform technology optimization and help us determine which clinical applications to advance next.
Renal denervation and other cardiovascular applications are our primary near-term development focus, given the market opportunity and level of strategic activity described below. Pancreatic cancer pain remains our next priority indication. We have deferred our U.S. clinical milestones while prioritizing the standalone sensing system, and we believe our sensing and technology optimization work currently underway may strengthen that program as it advances.
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Renal Denervation Opportunity and Strategic Activity
Hypertension is among the most prevalent chronic diseases worldwide and represents a substantial unmet medical need. The World Health Organization estimates that approximately 1.4 billion adults aged 30 to 79 had hypertension in 2024 and that approximately 23% had it under control. In the United States, the Centers for Disease Control and Prevention reports that approximately 119.9 million adults, or 48.1%, have high blood pressure, and that approximately 22.5% of those adults have it under control. These estimates use different population definitions and diagnostic criteria, but both show the substantial burden of inadequately controlled hypertension. (Sources: World Health Organization, Hypertension fact sheet; Centers for Disease Control and Prevention, High Blood Pressure Facts.)
Renal denervation has emerged as a treatment option for selected patients with uncontrolled hypertension. In November 2023, the FDA approved the Paradise ultrasound and Symplicity Spyral radiofrequency renal denervation systems. In October 2025, the Centers for Medicare & Medicaid Services established national coverage for renal denervation, under specified conditions, through coverage with evidence development. These developments are important steps in the clinical and reimbursement environment for renal denervation, although they do not currently establish coverage for our sensing system.
We see an opportunity to complement these therapies with information about electrical activity at the treatment site. Physicians currently have limited access to direct intraprocedural measurements of neural activity that could inform treatment delivery and assessment of treatment effect. Our platform is being developed for potential use alongside different ablation technologies, which we believe could support collaboration with multiple therapy developers and, over time, extend to other cardiovascular and nerve-targeted applications.
The prevalence of hypertension illustrates the underlying clinical need, rather than the addressable market, for our initial device. Our initial 510(k) strategy does not include renal denervation guidance or treatment-verification claims, which would require additional supporting evidence and regulatory authorization, that we consider to be important to successful commercialization of the technology.
Preclinical Progress and Technology Optimization
During 2026, we expanded our bench testing and animal studies to evaluate signal acquisition, repeatability, and changes in recorded electrical activity under different physiological conditions, including before and after ablation. Bench testing and several animal evaluations have produced repeatable measurements under the controlled conditions tested. In certain animal studies, we observed higher electrical activity before ablation and lower activity after treatment, consistent with the anticipated direction of response. We believe these findings support continued development of our sensing platform and investigation of its potential role in assessing treatment-related changes.
Each study is also improving our understanding of the technical and physiological factors that influence recorded signals. Those insights inform a technology optimization initiative designed to improve signal fidelity, measurement consistency and overall system performance. The program includes modifications to the sensing antenna design, a revised iteration of our application-specific integrated circuit (“ASIC”), and continued firmware and software development.
We expect to complete the planned optimization work over approximately the 12 months following the date of this report, subject to the receipt of additional financing. The initiative is directed toward the commercial configuration and future capabilities of our platform. Our initial clearance strategy remains focused on the current configuration and its proposed general signal-acquisition function.
Signal Processing and Interpretation
The nervous system is an unsolved system within the body that has lacked the tools to acquire and understand nerve signal meaning. Coupled with system complexity, transvascular recordings are low in amplitude and may contain overlapping contributions from neural activity, cardiac and respiratory activity, catheter position and the recording environment. Understanding these contributions is an important step between acquiring a signal and determining its biological and clinical significance.
Our signal-processing development is intended to improve the consistency of recorded measurements and support evaluation of signal features across studies. By comparing recordings with documented physiological conditions, interventions and device settings, we seek to identify reproducible patterns and better understand the factors that affect them.
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We believe this work can help us evaluate antenna, electronics and processing modifications, prioritize subsequent experiments and develop the evidence needed for future signal-interpretation capabilities. Our growing body of recordings may also support investigation of relationships between electrical activity and responses to treatment. These efforts remain developmental and their potential clinical applications will depend on further validation.
FDA Pre-Submission Feedback and Commercialization Plan
In September 2026, we completed a pre-submission meeting with the FDA regarding the standalone sensing system. Based on the feedback received, we believe a Class II pathway through a premarket notification under Section 510(k) may be available, using a substantial-equivalence strategy involving a previously cleared device.
As announced in September 2026, we are targeting potential U.S. clearance of the current configuration approximately 15 months from that announcement and initial commercialization of the standalone sensing system in 2028. Our commercialization readiness plan incorporates technology optimization, verification and validation, manufacturing preparation and any FDA review required for the commercial configuration. Based on our current development plan, we do not expect the technology optimization initiative to change either target.
We continue to refine our regulatory strategy for subsequent configurations, and potential expanded indications, and we plan to discuss that strategy with the FDA through an additional pre-submission interaction. The nature and timing of any subsequent submissions will depend on the proposed modifications, intended uses, supporting evidence and FDA feedback.
Pancreatic Cancer Pain Program
`
Pancreatic cancer pain remains our next priority indication, reflecting the significant unmet need among these patients and the encouraging clinical experience generated to date. We completed our initial first-in-human proof-of-concept study evaluating a commercial transvascular radiofrequency ablation system for pancreatic cancer pain, which did not use our sensing array, in the second calendar quarter ending June 30, 2025. We believe future development of this application may benefit from the sensing foundation and technology improvements we are now prioritizing.
This prioritization changes the timing of the program’s next milestones. We no longer expect to initiate the previously contemplated U.S. clinical studies for pancreatic cancer pain in early 2027 and we have not established a revised start date for a U.S. pivotal study. Timing will depend on progress in our sensing technology development, regulatory discussions, clinical study planning and available resources. Under this revised sequence, we no longer anticipate FDA marketing authorization for the pancreatic cancer pain indication in 2028.
Development Considerations and Risks
Acquiring low-amplitude biological electrical signals within blood vessels, and determining their source and clinical significance, present substantial technical challenges. Although multiple bench tests and animal studies have produced promising findings, signal amplitude, spectral characteristics and responses following intervention have varied across studies, anatomical locations and time points. Physiological changes associated with an intervention, catheter position, electrode contact and acquisition conditions are all variables that may affect recorded activity and complicate attribution of changes to neural activity or treatment effect.
Further work is needed to establish performance across the intended conditions of use and to support future claims concerning neural interpretation, procedural guidance or treatment verification. A reduction in recorded electrical activity alone does not establish the completeness or durability of denervation. The degree to which our planned technology modifications and processing methods will improve performance remains subject to testing and validation.
FDA pre-submission feedback does not constitute clearance of our device or assurance that the FDA will accept our proposed pathway or determine substantial equivalence. Any clearance would be limited to the authorized indications for use and would not, by itself, authorize therapeutic ablation or future neural-interpretation, procedural-guidance or treatment-verification claims.
Our development and commercialization targets depend on successful testing and validation, manufacturing readiness, sufficient financing and receipt of the necessary regulatory authorizations. Additional technical findings or regulatory requirements could increase costs or delay planned milestones. Our technology remains investigational, and there can be no assurance that our programs will produce the evidence necessary for the proposed indications or that we will obtain clearance or approval or achieve commercialization within the anticipated time frames.
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Recent Developments
In October 2026, we sold 85,255 shares pursuant to the updated ATM for net proceeds of approximately $0.3 million.
On October 29, 2026, we held our Annual Stockholder Meeting ("Annual Meeting"). In that Annual Meeting, among other items, our stockholders approved i) an amendment to our amended and restated certificate of incorporation (the “Amendment”) to effect the reverse stock split at a ratio in the range of 1-for-2 to 1-for-25, with such ratio to be determined in the discretion of our board of directors and with such reverse stock split to be effected at such time and date, if at all, as determined by our board of directors in its sole discretion prior to the one-year anniversary of the Annual Meeting; and ii) an amendment to our amended and restated 2023 Stock Plan (the “Plan”) to increase the number of shares of common stock available for issuance under the Plan.
Results of Operations for the Three and Six Months Ended September 30, 2026 Compared to the Three and Six Months Ended September 30, 2025
Below is a summary of the results of operations (in thousands):
|
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Three Months Ended September 30, |
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Change |
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Change |
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2026 |
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2025 |
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( $ ) |
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( % ) |
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Operating expenses: |
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ | 1,584 |
|
|
$ | 2,367 |
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|
$ | (783 | ) |
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|
(33 | )% |
General and administrative |
|
|
1,593 |
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|
|
5,167 |
|
|
|
(3,574 | ) |
|
|
(69 | )% |
Total operating expenses |
|
$ | 3,177 |
|
|
$ | 7,534 |
|
|
$ | (4,357 | ) |
|
|
(58 | )% |
|
|
Six Months Ended September 30, |
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Change |
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Change |
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||
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|
2026 |
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2025 |
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( $ ) |
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|
( % ) |
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||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ | 3,098 |
|
|
$ | 3,960 |
|
|
$ | (862 |
) |
|
|
(22 |
)% |
General and administrative |
|
|
2,849 |
|
|
|
6,995 |
|
|
|
(4,146 |
) |
|
|
(59 |
)% |
Total operating expenses |
|
$ | 5,947 |
|
|
$ | 10,955 |
|
|
$ | (5,008 |
) |
|
|
(46 |
)% |
Research and Development Expense
Research and development expense was $1.6 million for the three months ended September 30, 2026 compared to $2.4 million for the same period in 2025. This $0.8 million decrease was primarily due to a decrease in stock-based compensation - option expense of $0.6 million, due to the stock option cancellation agreements.
Research and development expense was $3.1 million for the six months ended September 30, 2026 compared to $4.0 million for the same period in 2025. This $0.9 million decrease was primarily due to a decrease in stock-based compensation - option expense of $0.6 million, due to the stock option cancellation agreements.
General and Administrative Expense
General and administrative expense was $1.6 million for the three months ended September 30, 2026 compared to $5.2 million for the same period in 2025. This $3.6 million decrease was driven primarily by a decrease in stock-based compensation - option expense of $3.3 million, due to the stock option cancellation agreements, a decrease in legal and professional fees of $0.4 million offset by an increase in employee compensation and benefits of $0.1 million.
General and administrative expense was $2.8 million for the six months ended September 30, 2026 compared to $7.0 million for the same period in 2025. This $4.1 million decrease was driven primarily by a decrease in stock-based compensation - option expense of $3.6 million, due to the stock option cancellation agreements and a decrease in legal and professional fees of $0.5 million.
Interest Income
For the three and six months ended September 30, 2026, we had interest income of less than $0.1 million.
For the three and six months ended September 30, 2025, we had interest income of less than $0.1 million and $0.2 million, respectively.
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Liquidity and Capital Resources
On September 30, 2026, we had cash of $7.7 million and working capital of $6.9 million. We have historically funded our operations from proceeds from debt and equity sales. Including approximately $0.3 million of net proceeds received under the ATM program in October 2026, we estimate our current cash resources are sufficient to fund our operations into but not beyond the second calendar quarter of 2027.
We will need to raise additional capital to meet our obligations and execute our business plan. We estimate that we will require additional financing of approximately $22 million to $27 million to fund our operations to commercialization of our first indication. The timing and costs of clinical trials are difficult to predict and trial plans may change in response to evolving circumstances and as such the foregoing estimates may prove to be inaccurate. If we are unable to raise sufficient funds, we will be required to develop and implement an alternative plan to further extend payables, reduce overhead or scale back our business plan until sufficient additional capital is raised to support further operations. There can be no assurance that such a plan will be successful. We recognize the need to raise additional capital to continue to execute our business plan, including obtaining regulatory clearance for our products currently under development and commercializing and generating revenues from products under development. There is no assurance that additional financing will be available when needed or that management will be able to obtain financing on terms acceptable to us. A failure to raise sufficient capital, generate sufficient product revenues, control expenditures and regulatory matters, among other factors, will adversely impact our ability to meet our financial obligations as they become due and payable and to achieve our intended business objectives. If we are unable to raise sufficient additional funds, we will have to scale back our operations.
Summary of Cash Flows
Cash used in operating activities
Net cash used in operating activities was $6.2 million during the six months ended September 30, 2026, consisting of a net loss of $5.9 million and a decrease in operating assets and liabilities of $0.4 million. Non-cash items consisted of stock-based compensation of $0.1 million.
Net cash used in operating activities was $6.4 million during the six months ended September 30, 2025, consisting of a net loss of $10.8 million and a decrease in operating assets and liabilities of $0.2 million. Non-cash items consisted of stock-based compensation of $4.3 million and the issuance of common stock for equity line of credit commitment fee of $0.3 million.
Cash used in investing activities
Net cash used in investing activities was $7 thousand for the six months ended September 30, 2026.
Net cash used in investing activities was $0 for the six months ended September 30, 2025.
Cash provided by financing activities
Net cash provided by financing activities was $6.9 million for the six months ended September 30, 2026. We had gross proceeds from warrant inducements of $7.5 million. We also paid $0.6 million in direct financing costs for the warrant inducements.
Net cash provided by financing activities was $4.8 million for the six months ended September 30, 2025. We had gross proceeds from the issuance of common stock of $2.6 million and gross proceeds from warrant inducements of $2.5 million. We also paid $0.1 million in direct financing costs for the issuance of common stock and $0.3 million in direct financing costs for warrant inducements.
Contractual Obligations and Commitments
None other than described below.
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Employment Arrangements
We have agreements with key employees to provide certain benefits, including salary and other wage-related benefits, in the event of termination. In addition, the Company has adopted a severance policy for certain employees and officers in the event of termination. In total, these benefits would amount to a range of $1.9 million to $2.5 million using the rate of compensation in effect at September 30, 2026.
Off-balance Sheet Arrangements
As of September 30, 2026 and March 31, 2026, we did not have any relationships with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance or special purpose entities, established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes.
Critical Accounting Policies and Significant Judgments and Estimates
The financial statements in this quarterly report have been prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”). The preparation of financial statements in conformity with GAAP requires management to make estimates, assumptions and judgments that affect the amounts reported in the financial statements, including the notes thereto. We consider critical accounting policies to be those that require more significant judgments and estimates in the preparation of our financial statements, including the following: work performed but not yet billed by contract manufacturers, engineers and research organizations and the valuation of equity-related instruments. Management relies on historical experience and other assumptions believed to be reasonable in making its judgments and estimates. Actual results could differ materially from those estimates.
Management believes its application of accounting policies, and the estimates inherently required therein, are reasonable. These accounting policies and estimates are periodically reevaluated, and adjustments are made when facts and circumstances dictate a change.
Our accounting policies are more fully described under the heading “Description of the Business, Basis of Presentation and Summary of Significant Accounting Policies” in Note 1 of our Annual Report on Form 10-K filed with the SEC on May 27, 2026.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
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.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
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 financial officer and 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, 2026, 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, 2026, our disclosure controls and procedures were not effective.
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A material weakness is a control deficiency, or combination of control deficiencies, that results in a reasonable possibility 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 27, 2026, our management concluded that our internal control over financial reporting was, and continues to be, ineffective as of September 30, 2026 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 ended March 31, 2026, 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
Other than as described above, there has been no change in our internal control over financial reporting during our most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
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PART II - OTHER INFORMATION
Item 1. Legal Proceedings
From time to time, in the ordinary course of our business, we may be involved in legal proceedings, the outcomes of which may not be determinable. The results of litigation are inherently unpredictable. Any claims against us, whether meritorious or not, could be time consuming, result in costly litigation, require significant amounts of management time and result in diversion of significant resources. We have insurance policies covering potential losses where such coverage is cost effective.
Item 1A. Risk Factors
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 our Annual Report on Form 10-K filed with the SEC on May 27, 2026.
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. Except as set forth below, 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 27, 2026.
If Nasdaq’s minimum Market Value of Listed Securities requirement of $5 million takes effect, it could result in the suspension and delisting of our common stock from Nasdaq.
On July 22, 2026, the SEC approved a new Nasdaq rule requiring companies listed on Nasdaq to maintain a minimum Market Value of Listed Securities (“MVLS”) of at least $5.0 million. Under the new rule, if a company’s MVLS remains below $5 million for 30 consecutive business days, Nasdaq will issue a Staff Delisting Determination, and trading in the company’s securities will be immediately suspended without any cure or compliance period. Furthermore, a request for a hearing before a Nasdaq Hearings Panel will not stay the suspension. On July 29, 2026, the MVLS rule was automatically stayed pending review by the SEC and, as of the date of this Form 10-Q, the stay remains in effect. It is not certain whether or when the MVLS rule will retake effect.
A delisting under this rule would have adverse consequences on our common stock, including reduced liquidity, limited market quotations, diminished analyst coverage, and impaired ability to raise capital. In addition, a delisting from Nasdaq could cause our common stock to be classified as a “penny stock,” which would subject broker-dealers trading in our common stock to additional sales practice requirements and further reduce the liquidity and market price of our common stock. We can provide no assurance that we will be able to maintain compliance with this new MVLS requirement or that any actions we may take to increase our MVLS, such as additional capital raising, will be successful or will not have other adverse effects on our stockholders.
Feedback received from the FDA through the pre-submission process does not assure acceptance of our proposed regulatory pathway, a determination of substantial equivalence, or authorization to market our products.
We are subject to extensive regulation by the U.S. Food and Drug Administration (“FDA”), including requirements governing the development, testing, clearance, approval and commercialization of our medical devices. As part of our regulatory strategy, we may engage with the FDA through its pre-submission program to obtain feedback regarding our proposed regulatory pathway, device classification, testing protocols, clinical evidence requirements and other matters relevant to a future marketing submission. Although we believe such interactions may provide valuable guidance in developing our regulatory strategy, feedback received through the pre-submission process is generally nonbinding and does not constitute a determination by the FDA that our proposed regulatory pathway is appropriate, that our devices are substantially equivalent to legally marketed predicate devices, or that our devices will ultimately receive marketing authorization.
The FDA may determine, upon review of a subsequent marketing submission, that additional nonclinical testing, clinical data, design modifications or other information is required, or that a different regulatory pathway, including a De Novo classification request or premarket approval application, is necessary. In particular, if we pursue clearance through the Section 510(k) premarket notification process, there can be no assurance that the FDA will agree with our identification of an appropriate predicate device or determine that our device is substantially equivalent to such predicate device. The FDA may also modify or reconsider feedback previously provided based on additional information, changes in the proposed device, evolving scientific or regulatory considerations, or other factors identified during its review.
Any such determination could require us to conduct additional studies, incur substantial costs, modify our products or regulatory strategy, or experience significant delays in obtaining marketing authorization. Furthermore, even if the FDA provides favorable feedback during the pre-submission process, there can be no assurance that we will successfully complete the necessary testing or clinical studies, satisfy applicable regulatory requirements, or obtain FDA clearance, approval or other marketing authorization within our anticipated timeframe, if at all.
Our failure to obtain marketing authorization for our products, or any material delay or additional expense associated with the regulatory review process, could adversely affect our development and commercialization plans, increase our capital requirements, limit our ability to generate revenue and materially adversely affect our business, financial condition, results of operations and prospects.
An initial FDA clearance for general sensing functionality may be limited to the specific indications for use authorized by the FDA and may not permit us to market our technology for therapeutic ablation, neural signal interpretation, procedural guidance or treatment verification.
We are developing medical device technologies intended to support the sensing and interpretation of neural signals and potentially facilitate the identification, targeting and treatment of neural tissue. Our regulatory strategy may involve pursuing an initial FDA marketing clearance for general sensing functionality, followed by additional regulatory submissions seeking authorization for expanded indications for use, therapeutic applications or other advanced capabilities. However, any initial FDA clearance would be limited to the specific intended use and indications for use authorized by the FDA and would not necessarily permit us to market, promote or commercialize our technology for additional diagnostic, therapeutic or procedural applications.
In particular, an initial clearance for general sensing functionality may not authorize the use of our technology for therapeutic ablation, the interpretation or characterization of neural signals for clinical decision-making, the identification or targeting of specific neural structures, procedural guidance, or the verification or assessment of treatment effectiveness. The FDA may determine that these additional functions or claims involve different intended uses, technological characteristics or risk profiles that require separate regulatory submissions, additional nonclinical or clinical evidence, or authorization through a different regulatory pathway, including the De Novo classification or premarket approval process.
There can be no assurance that we will successfully develop, validate or obtain FDA clearance, approval or other marketing authorization for any such expanded functionality or indications for use. The FDA may require additional testing, clinical studies, product modifications or other supporting evidence, which could result in substantial additional expenditures, delays in product development or commercialization, or limitations on the scope of our authorized product labeling and promotional claims. In addition, the FDA may impose restrictions or limitations on the indications for use or claims associated with any initial or subsequent marketing authorization, which could limit the clinical applications and commercial opportunities for our technology.
If we obtain an initial FDA clearance that does not encompass the full range of our intended therapeutic or advanced sensing applications, our ability to commercialize our technology, achieve market acceptance, generate revenue or realize the anticipated benefits of our development programs may be materially limited. Any inability to obtain subsequent regulatory authorizations for additional functionality or indications for use, or any significant delay or additional cost associated with obtaining such authorizations, could materially adversely affect our business, financial condition, results of operations and prospects.
Our product development for our sensing and ablation technologies may not meet the necessary validation requirements to achieve regulatory approvals, or our internal specifications for commercial viability.
We are developing proprietary sensing and ablation technologies that represent novel applications within the medical device space. As such, these technologies are subject to stringent validation and verification processes, both internally and by regulatory bodies such as the FDA. There is no assurance that our products will meet the safety, efficacy, and performance criteria required to obtain regulatory approvals. Acquiring low-amplitude biological electrical signals from within blood vessels and determining their source and clinical significance present substantial technical challenges. Physiological changes associated with an intervention, catheter position, electrode contact and acquisition conditions may affect recorded activity and complicate our ability to distinguish neural activity from other electrical activity or artifacts and to attribute observed changes to treatment effect. Our ability to record electrical activity does not, by itself, establish that the recorded activity can be reliably interpreted as neural activity or used to guide treatment or verify its effectiveness. In particular, a reduction in recorded electrical activity alone does not establish the completeness or durability of denervation. There can be no assurance that our planned technology modifications or processing methods will improve performance sufficiently to support these intended uses or claims. If we are unable to establish the reliability, reproducibility or clinical significance of our recordings, we may need to modify our technology, processing methods, study designs or proposed indications for use, or discontinue particular development programs. These developments could require additional financing, increase costs, delay regulatory submissions and commercialization, limit the capabilities or claims we are able to commercialize, or prevent commercialization of some or all of our proposed products. Additionally, even if our technologies are shown to be safe and effective in preclinical or early-stage clinical studies, they may not meet the technical, usability, cost, or performance benchmarks necessary for commercial viability. Any delays or failures in validation, or changes in FDA requirements or guidance, could significantly impact our development timelines, increase our costs, and delay or prevent our ability to bring our products to market.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
There have been no unregistered sales of securities by the Company during the period covered by this Report that have not been previously reported in a Current Report on Form 8-K.
Item 3. Defaults Upon Senior Securities
None.
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Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
During the period covered by this Quarterly Report, of our directors or officers have adopted or terminated a Rule - trading arrangement or a non-Rule -1 trading arrangement (each as defined in Item 408 of Regulation S-K under the Securities Exchange Act of 1934, as amended).
Item 6. Exhibits
INDEX TO EXHIBITS
Exhibit Number |
|
Description |
3.1 |
|
Amended and Restated Certificate of Incorporation of Autonomix Medical, Inc. (incorporated by reference from exhibit 2.1 of the Form 1-A POS, file number 024-12296, filed January 19, 2024) |
3.2 |
|
Amended and Restated Bylaws of Autonomix Medical, Inc. dated August 12, 2025 (incorporated by reference from exhibit 3.4 of the Form 10-Q, filed August 13, 2025) |
| 3.3 |
|
Certificate of Amendment to the Amended and Restated Certificate of Incorporation of Autonomix Medical, Inc., filed with the Secretary of State of the State of Delaware (incorporated by reference from exhibit 3.1 of the Form 8-K filed October 28, 2024) |
| 3.4 |
|
Certificate of Amendment to the Amended and Restated Certificate of Incorporation of Autonomix Medical, Inc., filed with the Secretary of State of the State of Delaware (incorporated by reference from exhibit 3.1 of the Form 8-K filed June 24, 2026) |
| 4.1 |
|
Form of Series D-1 Warrant (incorporated by reference from exhibit 4.1 of the Form 8-K filed July 15, 2026) |
| 4.2 |
|
Form of Series D-2 Warrant (incorporated by reference from exhibit 4.2 of the Form 8-K filed July 15, 2026) |
4.3 |
|
Form of Series E-1 Warrant (incorporated by reference from exhibit 4.1 of the Form 8-K filed August 26, 2026) |
4.4 |
|
Form of Series E-2 Warrant (incorporated by reference from exhibit 4.2 of the Form 8-K filed August 26, 2026) |
| 10.1 |
|
Form of Inducement Letter dated July 13, 2026 (incorporated by reference from exhibit 10.1 of the Form 8-K filed July 15, 2026) |
10.2 |
|
Form of Inducement Letter dated August 24, 2026 (incorporated by reference from exhibit 10.1 of the Form 8-K filed August 26, 2026) |
31.1* |
|
Certification of the Principal Executive Officer pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934. |
31.2* |
|
Certification of the Principal Financial Officer pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934. |
32.1*(1) |
|
Certification of the Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
32.2*(1) |
|
Certification of the Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
101.INS* |
|
Inline XBRL Instance Document |
101.SCH* |
|
Inline XBRL Taxonomy Extension Schema Document |
101.CAL* |
|
Inline XBRL Taxonomy Extension Calculation Linkbase Document |
101.DEF* |
|
Inline XBRL Taxonomy Extension Definition Linkbase Document |
101.LAB* |
|
Inline XBRL Taxonomy Extension Label Linkbase Document |
101.PRE* |
|
Inline XBRL Taxonomy Extension Presentation Linkbase Document |
| 104* |
|
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
|
* |
Filed herewith. |
|
(1) |
The certifications on Exhibit 32.1 and 32.2 hereto are deemed not “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liability of that Section. Such certifications will not be deemed incorporated by reference into any filing under the Securities Act or the Exchange Act. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
AUTONOMIX MEDICAL, INC.
SIGNATURE |
|
TITLE |
|
DATE |
|
|
|
|
|
/s/ Brad Hauser |
|
Chief Executive Officer and President |
|
November 10, 2026 |
Brad Hauser |
|
(principal executive officer) |
|
|
|
|
|
|
|
/s/ Trent Smith |
|
Chief Financial Officer and Executive Vice President |
|
November 10, 2026 |
Trent Smith |
|
(principal financial and accounting officer) |
|
|
33