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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-29 | Company Response | Autonomix Medical, Inc. | DE | N/A | Read Filing View |
| 2025-09-29 | SEC Comment Letter | Autonomix Medical, Inc. | DE | 333-290472 | Read Filing View |
| 2025-09-04 | Company Response | Autonomix Medical, Inc. | DE | N/A | Read Filing View |
| 2025-08-28 | SEC Comment Letter | Autonomix Medical, Inc. | DE | 333-289741 | Read Filing View |
| 2025-03-10 | Company Response | Autonomix Medical, Inc. | DE | N/A | Read Filing View |
| 2025-03-07 | SEC Comment Letter | Autonomix Medical, Inc. | DE | 333-285464 | Read Filing View |
| 2024-11-19 | Company Response | Autonomix Medical, Inc. | DE | N/A | Read Filing View |
| 2024-11-19 | Company Response | Autonomix Medical, Inc. | DE | N/A | Read Filing View |
| 2024-08-02 | SEC Comment Letter | Autonomix Medical, Inc. | DE | 377-07354 | Read Filing View |
| 2023-09-15 | Company Response | Autonomix Medical, Inc. | DE | N/A | Read Filing View |
| 2023-09-06 | SEC Comment Letter | Autonomix Medical, Inc. | DE | N/A | Read Filing View |
| 2023-08-21 | Company Response | Autonomix Medical, Inc. | DE | N/A | Read Filing View |
| 2023-08-03 | SEC Comment Letter | Autonomix Medical, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-29 | SEC Comment Letter | Autonomix Medical, Inc. | DE | 333-290472 | Read Filing View |
| 2025-08-28 | SEC Comment Letter | Autonomix Medical, Inc. | DE | 333-289741 | Read Filing View |
| 2025-03-07 | SEC Comment Letter | Autonomix Medical, Inc. | DE | 333-285464 | Read Filing View |
| 2024-08-02 | SEC Comment Letter | Autonomix Medical, Inc. | DE | 377-07354 | Read Filing View |
| 2023-09-06 | SEC Comment Letter | Autonomix Medical, Inc. | DE | N/A | Read Filing View |
| 2023-08-03 | SEC Comment Letter | Autonomix Medical, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-29 | Company Response | Autonomix Medical, Inc. | DE | N/A | Read Filing View |
| 2025-09-04 | Company Response | Autonomix Medical, Inc. | DE | N/A | Read Filing View |
| 2025-03-10 | Company Response | Autonomix Medical, Inc. | DE | N/A | Read Filing View |
| 2024-11-19 | Company Response | Autonomix Medical, Inc. | DE | N/A | Read Filing View |
| 2024-11-19 | Company Response | Autonomix Medical, Inc. | DE | N/A | Read Filing View |
| 2023-09-15 | Company Response | Autonomix Medical, Inc. | DE | N/A | Read Filing View |
| 2023-08-21 | Company Response | Autonomix Medical, Inc. | DE | N/A | Read Filing View |
2025-09-29 - CORRESP - Autonomix Medical, Inc.
CORRESP 1 filename1.htm amix20250929_corresp.htm Autonomix Medical, Inc. 21 Waterway Avenue, Suite 300 The Woodlands, Texas 77380 September 29, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporate Finance Washington, DC 20549 Re: Autonomix Medical, Inc. Registration Statement on Form S-1 Registration No. 333-290472 Ladies and Gentlemen: Pursuant to Rule 461 of the Securities Act of 1933, as amended, Autonomix Medical, Inc., a Delaware corporation (the “Company”), hereby respectfully requests that the effective date for the Registration Statement referred to above be accelerated so that it will be declared effective at 4:00 P.M. (Eastern Time) on September 30, 2025, or as soon thereafter as possible on such date. Very truly yours, Autonomix Medical, Inc. By: /s/ Trent Smith Name: Trent Smith Title: Chief Financial Officer
2025-09-29 - UPLOAD - Autonomix Medical, Inc. File: 333-290472
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> September 29, 2025 Brad Hauser Chief Executive Officer and President Autonomix Medical, Inc. 21 Waterway Avenue, Suite 300 The Woodlands, TX 77380 Re: Autonomix Medical, Inc. Registration Statement on Form S-1 Filed September 23, 2025 File No. 333-290472 Dear Brad Hauser: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Margaret Sawicki at 202-551-7153 with any questions. Sincerely, Division of Corporation Finance Office of Industrial Applications and Services cc: Cavas S. Pavri, Esq. </TEXT> </DOCUMENT>
2025-09-04 - CORRESP - Autonomix Medical, Inc.
CORRESP 1 filename1.htm amix20250904_corresp.htm Autonomix Medical, Inc. 21 Waterway Avenue, Suite 300 The Woodlands, Texas 77380 September 4, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporate Finance Washington, DC 20549 Re: Autonomix Medical, Inc. Registration Statement on Form S-1 Registration No. 333-289741 Ladies and Gentlemen: Pursuant to Rule 461 of the Securities Act of 1933, as amended, Autonomix Medical, Inc., a Delaware corporation (the “Company”), hereby respectfully requests that the effective date for the Registration Statement referred to above be accelerated so that it will be declared effective at 4:00 P.M. (Eastern Time) on September 8, 2025, or as soon thereafter as possible on such date. Very truly yours, Autonomix Medical, Inc. By: /s/ Trent Smith Name: Trent Smith Title: Chief Financial Officer
2025-08-28 - UPLOAD - Autonomix Medical, Inc. File: 333-289741
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> August 28, 2025 Brad Hauser Chief Executive Officer Autonomix Medical, Inc. 21 Waterway Avenue, Suite 300 The Woodlands, TX 77380 Re: Autonomix Medical, Inc. Registration Statement on Form S-1 Filed August 20, 2025 File No. 333-289741 Dear Brad Hauser: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Juan Grana at 202-551-6034 with any questions. Sincerely, Division of Corporation Finance Office of Industrial Applications and Services cc: Cavas S. Pavri </TEXT> </DOCUMENT>
2025-03-10 - CORRESP - Autonomix Medical, Inc.
CORRESP 1 filename1.htm amix20250310_corresp.htm Autonomix Medical, Inc. 21 Waterway Avenue, Suite 300 The Woodlands, Texas 77380 March 10, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporate Finance Washington, DC 20549 Attention: Juan Grana Re: Autonomix Medical, Inc. Registration Statement on Form S-3 Filed February 28, 2025 Registration No. 333-285464 Ladies and Gentlemen: Pursuant to Rule 461 of the Securities Act of 1933, as amended, Autonomix Medical, Inc., a Delaware corporation (the “Company”), hereby respectfully requests that the effective date for the Registration Statement referred to above be accelerated so that it will be declared effective at 4:30 P.M. (Eastern Time) on March 11, 2025, or as soon thereafter as possible on such date. Please direct any questions or comments concerning this request to Cavas Pavri of Arent Fox LLP at (202) 724-6847. Also, please notify Mr. Pavri when this request for acceleration has been granted. Very truly yours, Autonomix Medical, Inc. By: /s/ Trent Smith Name: Trent Smith Title: Chief Financial Officer
2025-03-07 - UPLOAD - Autonomix Medical, Inc. File: 333-285464
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> March 7, 2025 Brad Hauser Chief Executive Officer Autonomix Medical, Inc. 21 Waterway Avenue, Suite 300 The Woodlands, TX 77380 Re: Autonomix Medical, Inc. Registration Statement on Form S-3 Filed February 28, 2025 File No. 333-285464 Dear Brad Hauser: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Juan Grana at 202-551-6034 with any questions. Sincerely, Division of Corporation Finance Office of Industrial Applications and Services cc: Cavas S. Pavri, Esq. </TEXT> </DOCUMENT>
2024-11-19 - CORRESP - Autonomix Medical, Inc.
CORRESP 1 filename1.htm amix20241119_corresp.htm Autonomix Medical, Inc. 21 Waterway Avenue, Suite 300 The Woodlands, TX 77380 November 19, 2024 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporate Finance Washington, DC 20549 Re: Autonomix Medical, Inc. Registration Statement on Form S-1 File No. 333-282940 Ladies and Gentlemen: Pursuant to Rule 461 of the Securities Act of 1933, as amended, Autonomix Medical, Inc., a Delaware corporation (the “Company”), hereby respectfully requests that the effective date for the Registration Statement referred to above be accelerated so that it will be declared effective at 5:30 P.M. (Eastern Time) on November 21, 2024, or as soon thereafter as possible on such date. Very truly yours, Autonomix Medical, Inc. By: /s/ Trent Smith Name: Trent Smith Title: Chief Financial Officer
2024-11-19 - CORRESP - Autonomix Medical, Inc.
CORRESP 1 filename1.htm amix20241119c_corresp.htm Ladenburg Thalmann & Co. Inc. 640 Fifth Avenue, 4th Floor New York, New York 10019 November 19, 2024 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Re: Autonomix Medical, Inc. Registration Statement on Form S-1, as amended File No: 333-282940 Ladies and Gentlemen: Pursuant to Rule 461 of the General Rules and Regulations of the U.S. Securities and Exchange Commission (the “Commission”) under the Securities Act of 1933, as amended (the “Securities Act”), Ladenburg Thalmann & Co. Inc., as representative of the underwriters for the proposed offering, hereby joins the request of Autonomix Medical, Inc. (the “Company”) that the effective date of the above-referenced Registration Statement be accelerated so that it will become effective at 5:30 p.m. Eastern Time on Thursday, November 21, 2024, or as soon thereafter as practicable. Pursuant to Rule 460 of the General Rules and Regulations of the Commission under the Securities Act, please be advised that there will be distributed to each underwriter, dealer or agent, who is reasonably anticipated to participate in the distribution of the securities in this offering, as many copies of the preliminary prospectus as appears to be reasonable to secure adequate distribution of the preliminary prospectus. The undersigned is aware of its obligations under the provisions of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended, including the delivery requirements contained in such Rule, in connection with the above-referenced issue. Very truly yours, Ladenburg Thalmann & Co. Inc. By: /s/ Nicholas Stergis Name: Nicholas Stergis Title: Managing Director, Head of Investment Banking cc: Leslie Marlow, Esq., Blank Rome LLP Patrick J. Egan, Esq., Blank Rome LLP
2024-08-02 - UPLOAD - Autonomix Medical, Inc. File: 377-07354
August 2, 2024
Brad Hauser
Chief Executive Officer and President
Autonomix Medical, Inc.
21 Waterway Avenue
Suite 300
The Woodlands, Texas 77380
Re:Autonomix Medical, Inc.
Drafted Registration Statement on Form S-1
Submitted July 26, 2024
CIK No. 0001617867
Dear Brad Hauser:
This is to advise you that we do not intend to review your registration statement.
We request that you publicly file your registration statement no later than 48 hours prior to
the requested effective date and time. Please refer to Rules 460 and 461 regarding requests for
acceleration. We remind you that the company and its management are responsible for the
accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or
absence of action by the staff.
Please contact Robert Augustin at 202-551-8483 with any questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
2023-09-15 - CORRESP - Autonomix Medical, Inc.
CORRESP
1
filename1.htm
September 15, 2023
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
Office of Industrial Applications and Services
100 F Street, NE
Washington, DC 20549
Attention: Benjamin Richie
Re:
Autonomix Medical, Inc.
Amendment No. 1 to Offering Statement on Form 1-A
Filed August 22, 2023
File No. 024-12296
Ladies and Gentlemen:
This letter is being submitted
on behalf of Autonomix Medical, Inc. (the “Company”) in response to the comment letter, dated September 6, 2023, of
the staff of the Division of Corporation Finance (the “Staff”) of the Securities and Exchange Commission (the “Commission”)
with respect to the Amended Offering Statement on Form 1-A filed on August 3, 2023. The Company’s Amendment No. 2 to the Offering
Statement (the “Amended Offering Statement”) has been filed with the Commission.
Amendment No. 1 to Offering Statement
on Form 1-A
Summary, page 4
1. We
note that, in response to comment 2, you revised your disclosure to state that the platform "appears to detect and differentiate
neural signals with up to 3,000 times greater sensitivity" (emphasis added). Please revise this statement, here and on pages 35,
37, and 39, as this statement implies that your product candidate is effective. We do not object to the objective data set forth in your
Business section on page 37.
RESPONSE: The references in the above comment have been revised in the Amended Offering Statement to address the
Staff’s comment.
Risk Factors
Concentration of ownership of our common
stock . . ., page 23
2. We
note your revised disclosure and response to comment 5 that you do not believe you will be considered a "controlled company"
as defined by the Nasdaq Stock Market. We also note, however, in your table of beneficial ownership on page 65, that following a $5M offering,
the Company's officers and directors as a group will own more than 50% of the outstanding common stock. Please revise your disclosure
to include a risk factor that discusses the potential to be a "controlled company" and the effect, risks and uncertainties of
such a designation. In addition, please amend your disclosure to state, as you do in your response, that to the extent the company were
to be a "controlled company," it does not intend to rely on any exemptions granted to such companies.
RESPONSE: The Amended Offering Statement has been amended to address the Staff’s comment.
Liquidity
and Capital Resources, page 36
3. We
note your response to comment 7, including your revised disclosure that "[t]he amount invested was convertible into equity instruments
that were issued upon the closing of a subsequent equity financing or a corporate transaction . . . of at least $2 million with a pre-
money valuation of not more than $35,000,000," and "[i]n March 2022, the SAFE instrument converted into 200,000 shares of our
common stock at $2 per share." Please briefly describe the subsequent equity financing or corporate transaction that triggered the
conversion of the SAFE into equity instruments.
RESPONSE: The above referenced paragraph in the Amended Offering Statement has been amended to include the following
disclosure (emphasis added):
“In December 2021, we entered into
a SAFE and received total proceeds of $400,000. The amount invested was convertible into equity instruments that were issued upon the
closing of a subsequent equity financing or a corporate transaction (such as change of control, merger, initial public offering, or sale
of substantially all our assets) of at least $2 million with a pre-money valuation of not more than $35,000,000. The SAFE did not have
a stated interest rate. In March 2022, we completed a common stock offering, in which we sold 1,000,000 shares of common stock for
gross proceeds of $2,000,000, which offering satisfied the conversion feature of the SAFE instrument, and, as such, I in March 2022 the
SAFE instrument converted into 200,000 shares of our common stock at $2 per share. In connection with the initial investment,
the SAFE investor also received a warrant with a 7-year exercise period and an exercise price $0.01 per share. The number of warrant shares
were variable based upon a formula in the award. In connection with the conversion of the SAFE, the investor’s warrants were modified
that resulted in a fixed number of shares. The investor received 6,460,000 warrants to purchase common stock at an exercise price of $0.01
per share, which remain outstanding.”
The Autonomix Solution, page 39
4. We
note your revised disclosure in response to comment 10. Please revise to further explain the details of the device and the functions of
each of the antenna, chipset, amplifier, converter, and multiplexer, as they work to detect signals within the catheter wires. For example,
please explain what the proprietary chipset does and how it replaces the machine depicted in the image on page 39.
RESPONSE: The Amended Offering Statement has been revised to address the Staff’s comment.
Regulatory Pathway, page 44
5. We
note your additional disclosure regarding your proof of concept trials in Poland in response to comment 12. Please include risk factor
disclosure indicating that the FDA may require you to conduct additional trials if it does not accept data from your international trials
or believes that additional data is necessary to supplement your trial data. This disclosure should include a statement that additional
trials may be costly and time-consuming.
RESPONSE: The Amended Offering Statement has been revised to address the Staff’s comment. The Company supplementally
advises the Staff that the Amended Offering Statement no longer discusses conducting trials in Poland, but discloses the intent to conduct
the trials in a foreign jurisdiction. The Company has not finalized its decision in location for the trial and has revised the Amended
Offering Statement accordingly.
License Agreement, page 53
6. We
note your response to comment 15 and reissue in part. Please amend your filing to disclose any fees paid by the licensee to the company
and any revenue generated under the license agreement to date. Also, please amend your risk factors to disclose any risks related to dilution
from the issuance of the shares in lieu of a termination fee. Finally, please file the license agreement and related termination agreement
as exhibits to your offering statement, or tell us why you believe you are not required to do so.
RESPONSE:
The Amended Offering Statement has been revised to address
the Staff’s comment. The license agreement and related termination agreement have been filed as exhibits to the offering statement.
* * *
* * *
2
Should you have any questions regarding the foregoing,
please do not hesitate to contact Cavas Pavri at (202) 724-6847.
Sincerely,
ARENTFOX SCHIFF LLP
/s/ Cavas Pavri
By: Cavas Pavri
Enclosures
cc: Lori Bisson, CEO, Autonomix Medical, Inc.
3
2023-09-06 - UPLOAD - Autonomix Medical, Inc.
United States securities and exchange commission logo
September 6, 2023
Lori Bisson
Chief Executive Officer
Autonomix Medical, Inc.
21 Waterway Avenue, Suite 300
The Woodlands, TX 77380
Re:Autonomix Medical, Inc.
Amendment No. 1 to Offering Statement on Form 1-A
Filed August 22, 2023
File No. 024-12296
Dear Lori Bisson:
We have reviewed your amended offering statement and have the following
comments. In some of our comments, we may ask you to provide us with information so we
may better understand your disclosure.
Please respond to this letter by amending your offering statement and providing the
requested information. If you do not believe our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your offering statement and the information you
provide in response to these comments, we may have additional comments. Unless we note
otherwise, our references to prior comments are to comments in our August 3, 2023 letter.
Amendment No. 1 to Offering Statement on Form 1 A
Summary, page 4
1.We note that, in response to comment 2, you revised your disclosure to state that the
platform "appears to detect and differentiate neural signals with up to 3,000 times greater
sensitivity" (emphasis added). Please revise this statement, here and on pages 35, 37, and
39, as this statement implies that your product candidate is effective. We do not object to
the objective data set forth in your Business section on page 37.
Risk Factors
Concentration of ownership of our common stock . . ., page 23
2.We note your revised disclosure and response to comment 5 that you do not believe you
FirstName LastNameLori Bisson
Comapany NameAutonomix Medical, Inc.
September 6, 2023 Page 2
FirstName LastNameLori Bisson
Autonomix Medical, Inc.
September 6, 2023
Page 2
will be considered a "controlled company" as defined by the Nasdaq Stock Market. We
also note, however, in your table of beneficial ownership on page 65, that following a
$5M offering, the Company's officers and directors as a group will own more than 50% of
the outstanding common stock. Please revise your disclosure to include a risk factor that
discusses the potential to be a "controlled company" and the effect, risks and uncertainties
of such a designation. In addition, please amend your disclosure to state, as you do in
your response, that to the extent the company were to be a "controlled company," it does
not intend to rely on any exemptions granted to such companies.
Liquidity and Capital Resources, page 36
3.We note your response to comment 7, including your revised disclosure that "[t]he amount
invested was convertible into equity instruments that were issued upon the closing of a
subsequent equity financing or a corporate transaction . . . of at least $2 million with a pre-
money valuation of not more than $35,000,000," and "[i]n March 2022, the SAFE
instrument converted into 200,000 shares of our common stock at $2 per share." Please
briefly describe the subsequent equity financing or corporate transaction that triggered the
conversion of the SAFE into equity instruments.
The Autonomix Solution, page 39
4.We note your revised disclosure in response to comment 10. Please revise to further
explain the details of the device and the functions of each of the antenna, chipset,
amplifier, converter, and multiplexer, as they work to detect signals within the catheter
wires. For example, please explain what the proprietary chipset does and how it replaces
the machine depicted in the image on page 39.
Regulatory Pathway, page 44
5.We note your additional disclosure regarding your proof of concept trials in Poland in
response to comment 12. Please include risk factor disclosure indicating that the FDA
may require you to conduct additional trials if it does not accept data from your
international trials or believes that additional data is necessary to supplement your trial
data. This disclosure should include a statement that additional trials may be costly and
time-consuming.
License Agreement, page 53
6.We note your response to comment 15 and reissue in part. Please amend your filing to
disclose any fees paid by the licensee to the company and any revenue generated under the
license agreement to date. Also, please amend your risk factors to disclose any risks
related to dilution from the issuance of the shares in lieu of a termination fee. Finally,
please file the license agreement and related termination agreement as exhibits to your
offering statement, or tell us why you believe you are not required to do so.
FirstName LastNameLori Bisson
Comapany NameAutonomix Medical, Inc.
September 6, 2023 Page 3
FirstName LastName
Lori Bisson
Autonomix Medical, Inc.
September 6, 2023
Page 3
You may contact Christie Wong at 202-551-3684 or Terence O'Brien at 202-551-3355 if
you have questions regarding comments on the financial statements and related matters. Please
contact Benjamin Richie at 202-551-7857 or Katherine Bagley at 202-551-2545 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc: Cavas S. Pavri
2023-08-21 - CORRESP - Autonomix Medical, Inc.
CORRESP
1
filename1.htm
August 21, 2023
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
Office of Industrial Applications and Services
100 F Street, NE
Washington, DC 20549
Attention: Benjamin Richie
Re: Autonomix Medical, Inc.
Offering Statement on Form 1-A
Filed July 7, 2023
File No. 024-12296
Ladies and Gentlemen:
This letter is being submitted
on behalf of Autonomix Medical, Inc. (the “Company”) in response to the comment letter, dated August 3, 2023, of the
staff of the Division of Corporation Finance (the “Staff”) of the Securities and Exchange Commission (the “Commission”)
with respect to the Offering Statement on Form 1-A filed on July 7, 2023 (the “Draft Offering Statement”). The Company’s
amended Offering Statement (the “Amended Offering Statement”) has been filed with the Commission.
Offering Statement on Form 1-A filed
July 7, 2023
Cover Page
1. We
note your disclosure that "We will pay a cash commission of 7.0% to Digital Offering on sales of the shares of common stock from
investors introduced to us by Digital Offering and issue a warrant to Digital Offering to purchase that number of shares of Common Stock
equal to 7.0% of the total number of shares sold in this offering, exercisable for five years at $6.25 per share." Please amend your
cover page, including your table, to include the warrants and underlying common shares in the total volume of securities you are seeking
to qualify in this offering, and the total dollar amount of securities you are seeking to qualify on this offering statement. In this
regard, we note your disclosure that your filing "also registers the issuance of the shares of our common stock issuable upon exercise
of such Selling Agent’s warrants," but it does not appear that these additional shares or the warrants are included in the
total volume of securities on your cover page.
RESPONSE: The cover page of the offering circular in the Amended Offering Statement has been revised to include
the warrants issuable to Digital Offering.
Summary, page 4
2. We
note certain statements eluding to or stating efficacy determinations throughout your offering circular. For example, you state that your
"technology platform includes a catheter-based microchip-enabled sensing array that can detect and differentiate neural signals with
up to 1,000 times greater sensitivity than currently available transvascular technologies," your sensing catheter is able to "demonstrate
efficacy in animal models," and that "there was a statistically significant reduction in tumor progression" in your Pilot
Mouse Study. Please revise, throughout the offering circular, disclosure that states or implies that your device in development is effective,
as these determinations are solely within the authority of the FDA and comparable regulatory bodies. We do not object to the presentation
of objective data resulting from your trials without conclusions related to efficacy. Make conforming changes throughout your filing,
including the description of your business.
RESPONSE: The Amended Offering Statement has been amended to address the Staff’s comment.
1
United States Securities and Exchange Commission
August 21, 2023
Page 2
3. Please
amend your summary to disclose, as you do on page 10, that as of March 31, 2023, you had an accumulated deficit of $23,543,465, negative
cash flows from operating activities of $1,854,398 and working capital of $644,028, which raises substantial doubt about your ability
to continue as a going concern.
RESPONSE: The “Summary” section of the Amended Offering Statement has been amended to include the following
disclosure:
“As of March 31, 2023, we had an
accumulated deficit of $23,543,465, negative cash flows from operating activities of $1,854,398 and working capital of $644,028, which
raises substantial doubt about our ability to continue as a going concern. Further, we have incurred and expect to continue to incur significant
costs in pursuit of our business plans. We cannot assure you that our plans to raise sufficient capital through this offering will be
successful. These factors, among others, raise substantial doubt about our ability to continue as a going concern. The financial statements
contained elsewhere in this offering circular do not include any adjustments that might result from our inability to consummate this offering
or our inability to continue as a going concern.”
4. As
a related matter, please amend your disclosure in this section to clearly disclose, if true, that you have not yet assembled or tested
your device. In this regard, we note your risk factor disclosure on page 15 that "[w]e have no experience in assembling and testing
our planned device, and no experience in doing so on a commercial scale." Alternatively, please revise your disclosure in the risk
factor section for consistency, or advise.
RESPONSE: The “Summary” section of the Amended Offering Statement has been amended to include the following
disclosure:
“We believe one of the most demanding
aspects of our commercialization plan will be scaling up from our existing sensing prototype to a robust commercial version. Today, our
sensing device is hand built and includes a combination of hand-crafted and 3D printed parts. We have not yet assembled or tested what
will be the commercial version of our proposed device. Even if our proposed device is cleared for commercial use, there is no assurance
that we will be able to successfully build such device on a commercial scale.”
Risk Factors
Concentration of ownership of our common
stock . . ., page 23
5. We note your disclosure that "[yo]ur executive officers and directors, and their affiliates, in the aggregate, beneficially
own approximately 55.0% of [y]our outstanding common stock as of the date hereof." Please tell us whether you will be deemed a "controlled
company" as defined by the market on which you intend to list your securities and, if so, whether you intend to rely on any exemptions
as a controlled company. If applicable, please disclose on the prospectus cover page and in the prospectus summary that you are a controlled
company, and include a risk factor that discusses the effect, risks and uncertainties of being designated a controlled company.
RESPONSE: The Company respectfully advises the Staff that it does not believe it will be a “controlled company”
as defined by the Nasdaq Stock Market upon the closing of the offering. Furthermore, to the extent the Company were to be a “controlled
company” it does not intend to rely on any exemptions granted to such companies.
United States Securities and Exchange Commission
August 21, 2023
Page 3
Management's Discussion and Analysis of
Financial Condition and Results of Operations Research and Development, page 37
6. We note the significant increase in your research and development expenses in fiscal 2023. Please revise future filings to provide
more details about your research and development expenses for each period presented, including but not limited to by product/program as
well as by the nature of the expenses. To the extent that you do not track expenses by product candidate, please disclose as such.
RESPONSE: The Amended Offering Statement has been revised to address the
Staff’s comment.
Liquidity and Capital Resources, page 38
7. We note your disclosure in Results of Operations that "[t]he change in [general and administrative expense] is attributable
primarily to the warrant expense of $12,866,911 incurred during the year ended March 31, 2022 related to our SAFE instrument." We
also note your disclosure in the notes to the financial statements describing the "SAFE Financing." In your "Liquidity
and Capital Resources" section, please provide additional detail describing the SAFE financing, including what the SAFE instrument
is, the date of issuance, and any relevant, material terms of the issuance and the instrument.
RESPONSE: The “Liquidity and Capital Resources” section of the Amended Offering Statement has been amended
to include the following disclosure:
“In December 2021, we entered into a Simple Agreement
for Future Equity (“SAFE”) and received total proceeds of $400,000. The amount invested was convertible into equity instruments
that were issued upon the closing of a subsequent equity financing or a corporate transaction (such as change of control, merger, initial
public offering, or sale of substantially all our assets) of at least $2 million with a pre-money valuation of not more than $35,000,000.
The SAFE did not have a stated interest rate. In March 2022, the SAFE instrument converted into 200,000 shares of our common stock at
$2 per share. In connection with the initial investment, the SAFE investor also received a warrant with a 7-year exercise period and an
exercise price $0.01 per share. The number of warrant shares were variable based upon a formula in the award. In connection with the conversion
of the SAFE, the investor’s warrants were modified that resulted in a fixed number of shares. The investor received 6,460,000 warrants
to purchase common stock at an exercise price of $0.01 per share.”
Business, page 39
8. Please provide support for the following disclosure, or characterize the statements as management's opinions or beliefs:
· "very few tools currently
exist for the sensing and targeting of individual nerve fibers within the peripheral nervous system;"
· "Although this vascular
superhighway has long been utilized for certain catheter- based evaluation and intervention, its use throughout the body has been limited
by the lack of adequate sophistication of catheter systems;"
· "This is a relatively
quick, very common and safe method of access that should significantly reduce the potential for complications as compared with NCPB.
With the benefit of our sensing technology, we have the potential to identify and target the nerves that are responsible for the pain
signal and with the ability to focus the ablative energy on that target, we should have a much greater degree of accuracy, control and
reliability as compared with NCPB;"
· "When comparing to the
use of opioids, the potential benefits are even more obvious;" and
· the pain management market
is a "$70 billion" market, and the hypertension market is a "$20 billion" market.
In addition, we note your statement that
"All told, we believe the Autonomix platform has the potential to address more than $100 billion in market opportunities." Please
clarify how you calculated that the potential addressable market for the Autonomix platform is $100 billion.
RESPONSE: The Amended Offering Statement has been revised to address the
Staff’s comment.
United States Securities and Exchange Commission
August 21, 2023
Page 4
The Sensing Problem, page 40
9. Where you make a claim that is supported by industry literature or state the findings of such literature, please provide a citation
to and, at each source's first instance, include language summarizing the material conclusions of such literature. This includes, but
is not limited to, the American Cancer Society's "Key Statistics for Pancreatic Cancer" and "[a] market analysis published
by Precedence Research" on page 44. As a related matter, please provide a citation to the "published survey" you reference
in the section "Significant Unmet Need," and the "[s]tudies in animals" referenced on page 44.
RESPONSE: The Amended Offering Statement has been revised to address the
Staff’s comment.
The Autonomix Solution, page 41
10. We note that you analogize the equipment used in a catheter lab to a "mountain" and show an image of a "typical
catheter room." However, we also note that the object your microchip replaces, based on the disclosure's description and the graphic's
circle designating the replacement, does not appear to take up a large percentage of the room. Please revise to balance your disclosure
and ensure that your description of your device and its ability remains objective, and clearly disclose, as appropriate throughout, that
your device and its abilities are still in development. In addition, please clarify whether the "proprietary chipset" shown
in your diagram has been developed, or is a rendering of your intended device. In this regard, we note your disclosure elsewhere that
your device has yet to be assembled or tested.
RESPONSE: The Amended Offering Statement has been revised to address the
Staff’s comment.
Beneficial Clinical Trial Dynamics/Expedited
Regulatory Process, page 43
11. We note that you "believe regulatory authorities are willing to consider lower preclinical hurdles and smaller and simpler
trial designs to help encourage trial sponsors to seek improved treatment options." Please revise your disclosure to state that these
decisions are under the exclusive control of regulatory authorities and there is no guarantee that certain trial designs will be approved.
Further, when discussing trials, such as the reference to a "pivotal clinical trial" on pages 4 and 39, please revise to state
that there is no guarantee that the results of the trials will produce positive results or that the results will support the Company's
claims.
RESPONSE: The Amended Offering Statement has been revised to address the
Staff’s comment.
Regulatory Pathway, page 46
12. Here and throughout your offering circular, such as on page 48, when discussing regulatory approvals and projected timelines, please
revise to state that any such approvals or time frames are not guaranteed. Please also describe the logistics related to establishing
a Proof of Concept in Europe with the intention to focus your approval process on the United States.
RESPONSE: The Amended Offering Statement has been revised to address the
Staff’s comment.
4
United States Securities and Exchange Commission
August 21, 2023
Page 5
Technology Development, page 47
13. We note that you plan to use an existing "off label" RF system in a PoC trial attempting to demonstrate that transvascular
ablation of certain nerves will reduce pain. Please provide more detail regarding this trial and material steps necessary to complete
prior to initiation of this trial.
RESPONSE: The Amended Offering Statement has been revised to address the
Staff’s comment.
Intellectual Property, page 49
14. Please revise to identify, for each material patent and provisional patent application, the identification number, type of patent
protection, jurisdiction in which the protection is held, and expiration dates. Please also update your discussion to include the timeline
of your specific trademarks, whether they are currently in active use, and whether they must be in continued use or will be maintained
until a third-party challenge. In this regard, a tabular format may be useful.
RESPONSE: The Amended Offering Statement has been revised to address the
Staff’s comment.
15. We note your disclosure that "[i]n December 2021, we granted a company affiliated with certain early investors in the Company
a license to our technology for use in the field of cardiology. The license provides the Company with an option to terminate in exchange
for a termination fee of $14 million, which amount is payable in shares of common stock of the Company following Offering and which option
the Company intends to exercise." Please amend your disclosure to provide additional detail regarding this license agreement, including
any fees paid by the licensee to the company and any revenue generated under this agreement to date. Also, disclose the number of shares
of common stock the company may issue in lieu of the termination fee, and amend your risk factors to disclose any risks related to dilution
from the issuance of these shares.
RESPONSE: The Amended Offering Statement has been revised to address the
2023-08-03 - UPLOAD - Autonomix Medical, Inc.
United States securities and exchange commission logo
August 3, 2023
Lori Bisson
Chief Executive Officer
Autonomix Medical, Inc.
21 Waterway Avenue, Suite 300
The Woodlands, TX 77380
Re:Autonomix Medical, Inc.
Offering Statement on Form 1-A
Filed July 7, 2023
File No. 024-12296
Dear Lori Bisson:
We have reviewed your offering statement and have the following comments. In some of
our comments, we may ask you to provide us with information so we may better understand your
disclosure.
Please respond to this letter by amending your offering statement and providing the
requested information. If you do not believe our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response. After reviewing any amendment to your offering statement and the information you
provide in response to these comments, we may have additional comments.
Offering Statement on Form 1-A filed July 7, 2023
Cover Page
1.We note your disclosure that "We will pay a cash commission of 7.0% to Digital Offering
on sales of the shares of common stock from investors introduced to us by Digital
Offering and issue a warrant to Digital Offering to purchase that number of shares of
Common Stock equal to 7.0% of the total number of shares sold in this offering,
exercisable for five years at $6.25 per share." Please amend your cover page, including
your table, to include the warrants and underlying common shares in the total volume of
securities you are seeking to qualify in this offering, and the total dollar amount of
securities you are seeking to qualify on this offering statement. In this regard, we note
your disclosure that your filing "also registers the issuance of the shares of our common
stock issuable upon exercise of such Selling Agent’s warrants," but it does not appear that
these additional shares or the warrants are included in the total volume of securities on
your cover page.
FirstName LastNameLori Bisson
Comapany NameAutonomix Medical, Inc.
August 3, 2023 Page 2
FirstName LastNameLori Bisson
Autonomix Medical, Inc.
August 3, 2023
Page 2
Summary, page 4
2.We note certain statements eluding to or stating efficacy determinations throughout your
offering circular. For example, you state that your "technology platform includes a
catheter-based microchip-enabled sensing array that can detect and differentiate neural
signals with up to 1,000 times greater sensitivity than currently available transvascular
technologies," your sensing catheter is able to "demonstrate efficacy in animal models,"
and that "there was a statistically significant reduction in tumor progression" in your Pilot
Mouse Study. Please revise, throughout the offering circular, disclosure that states or
implies that your device in development is effective, as these determinations are solely
within the authority of the FDA and comparable regulatory bodies. We do not object to
the presentation of objective data resulting from your trials without conclusions related to
efficacy. Make conforming changes throughout your filing, including the description of
your business.
3.Please amend your summary to disclose, as you do on page 10, that as of March 31, 2023,
you had an accumulated deficit of $23,543,465, negative cash flows from operating
activities of $1,854,398 and working capital of $644,028, which raises substantial doubt
about your ability to continue as a going concern.
4.As a related matter, please amend your disclosure in this section to clearly disclose, if
true, that you have not yet assembled or tested your device. In this regard, we note your
risk factor disclosure on page 15 that "[w]e have no experience in assembling and testing
our planned device, and no experience in doing so on a commercial scale." Alternatively,
please revise your disclosure in the risk factor section for consistency, or advise.
Risk Factors
Concentration of ownership of our common stock . . ., page 23
5.We note your disclosure that "[yo]ur executive officers and directors, and their affiliates,
in the aggregate, beneficially own approximately 55.0% of [y]our outstanding common
stock as of the date hereof." Please tell us whether you will be deemed a
"controlled company" as defined by the market on which you intend to list your securities
and, if so, whether you intend to rely on any exemptions as a controlled company. If
applicable, please disclose on the prospectus cover page and in the prospectus summary
that you are a controlled company, and include a risk factor that discusses the effect, risks
and uncertainties of being designated a controlled company.
Management's Discussion and Analysis of Financial Condition and Results of Operations
Research and Development, page 37
6.We note the significant increase in your research and development expenses in fiscal
2023. Please revise future filings to provide more details about your research and
development expenses for each period presented, including but not limited to by
product/program as well as by the nature of the expenses. To the extent that you do not
FirstName LastNameLori Bisson
Comapany NameAutonomix Medical, Inc.
August 3, 2023 Page 3
FirstName LastNameLori Bisson
Autonomix Medical, Inc.
August 3, 2023
Page 3
track expenses by product candidate, please disclose as such.
Liquidity and Capital Resources, page 38
7.We note your disclosure in Results of Operations that "[t]he change in [general and
administrative expense] is attributable primarily to the warrant expense of $12,866,911
incurred during the year ended March 31, 2022 related to our SAFE instrument." We also
note your disclosure in the notes to the financial statements describing the "SAFE
Financing." In your "Liquidity and Capital Resources" section, please provide additional
detail describing the SAFE financing, including what the SAFE instrument is, the date of
issuance, and any relevant, material terms of the issuance and the instrument.
Business, page 39
8.Please provide support for the following disclosure, or characterize the statements as
management's opinions or beliefs:
•"very few tools currently exist for the sensing and targeting of individual nerve fibers
within the peripheral nervous system;"
•"Although this vascular superhighway has long been utilized for certain catheter-
based evaluation and intervention, its use throughout the body has been limited by the
lack of adequate sophistication of catheter systems;"
•"This is a relatively quick, very common and safe method of access that should
significantly reduce the potential for complications as compared with NCPB. With
the benefit of our sensing technology, we have the potential to identify and target the
nerves that are responsible for the pain signal and with the ability to focus the
ablative energy on that target, we should have a much greater degree of accuracy,
control and reliability as compared with NCPB;"
•"When comparing to the use of opioids, the potential benefits are even more
obvious;" and
•the pain management market is a "$70 billion" market, and the hypertension market
is a "$20 billion" market.
In addition, we note your statement that "All told, we believe the Autonomix platform has
the potential to address more than $100 billion in market opportunities." Please clarify
how you calculated that the potential addressable market for the Autonomix platform is
$100 billion.
The Sensing Problem, page 40
9.Where you make a claim that is supported by industry literature or state the findings of
such literature, please provide a citation to and, at each source's first instance, include
FirstName LastNameLori Bisson
Comapany NameAutonomix Medical, Inc.
August 3, 2023 Page 4
FirstName LastName
Lori Bisson
Autonomix Medical, Inc.
August 3, 2023
Page 4
language summarizing the material conclusions of such literature. This includes, but is
not limited to, the the American Cancer Society's "Key Statistics for Pancreatic Cancer"
and "[a] market analysis published by Precedence Research" on page 44. As a related
matter, please provide a citation to the "published survey" you reference in the section
"Significant Unmet Need," and the "[s]tudies in animals" referenced on page 44.
The Autonomix Solution, page 41
10.We note that you analogize the equipment used in a catheter lab to a "mountain" and show
an image of a "typical catheter room." However, we also note that the object your
microchip replaces, based on the disclosure's description and the graphic's circle
designating the replacement, does not appear to take up a large percentage of the room.
Please revise to balance your disclosure and ensure that your description of your device
and its ability remains objective, and clearly disclose, as appropriate throughout, that your
device and its abilities are still in development. In addition, please clarify whether the
"proprietary chipset" shown in your diagram has been developed, or is a rendering of your
intended device. In this regard, we note your disclosure elsewhere that your device has
yet to be assembled or tested.
Beneficial Clinical Trial Dynamics/Expedited Regulatory Process, page 43
11.We note that you "believe regulatory authorities are willing to consider lower preclinical
hurdles and smaller and simpler trial designs to help encourage trial sponsors to seek
improved treatment options." Please revise your disclosure to state that these decisions
are under the exclusive control of regulatory authorities and there is no guarantee that
certain trial designs will be approved. Further, when discussing trials, such as the
reference to a "pivotal clinical trial" on pages 4 and 39, please revise to state that there is
no guarantee that the results of the trials will produce positive results or that the results
will support the Company's claims.
Regulatory Pathway, page 46
12.Here and throughout your offering circular, such as on page 48, when
discussing regulatory approvals and projected timelines, please revise to state that any
such approvals or time frames are not guaranteed. Please also describe the logistics
related to establishing a Proof of Concept in Europe with the intention to focus your
approval process on the United States.
Technology Development, page 47
13.We note that you plan to use an existing "off label" RF system in a PoC trial attempting to
demonstrate that transvascular ablation of certain nerves will reduce pain. Please provide
more detail regarding this trial and material steps necessary to complete prior to initiation
of this trial.
FirstName LastNameLori Bisson
Comapany NameAutonomix Medical, Inc.
August 3, 2023 Page 5
FirstName LastName
Lori Bisson
Autonomix Medical, Inc.
August 3, 2023
Page 5
Intellectual Property, page 49
14.Please revise to identify, for each material patent and provisional patent application, the
identification number, type of patent protection, jurisdiction in which the protection is
held, and expiration dates. Please also update your discussion to include the timeline of
your specific trademarks, whether they are currently in active use, and whether they must
be in continued use or will be maintained until a third-party challenge. In this regard, a
tabular format may be useful.
15.We note your disclosure that "[i]n December 2021, we granted a company affiliated with
certain early investors in the Company a license to our technology for use in the field of
cardiology. The license provides the Company with an option to terminate in exchange for
a termination fee of $14 million, which amount is payable in shares of common stock of
the Company following Offering and which option the Company intends to exercise."
Please amend your disclosure to provide additional detail regarding this license
agreement, including any fees paid by the licensee to the company and any revenue
generated under this agreement to date. Also, disclose the number of shares of common
stock the company may issue in lieu of the termination fee, and amend your risk factors to
disclose any risks related to dilution from the issuance of these shares.
Exclusive Forum Provision, page 63
16.Please revise this section to disclose the risks that the exclusive forum provision may
result in increased costs for investors to bring a claim. Please make conforming changes
to your risk factor at the top of page 27. As a related matter, please amend your risk factor
disclosure to include the risks to investors related to the forum selection provision in your
subscription agreement described on page 75.
Exhibits
17.Please include all material exhibits in future filings. This includes, but may not be limited
to, the employment agreement with Lori Bisson and your 2023 Stock Plan.
We will consider qualifying your offering statement at your request. If a participant in
your offering is required to clear its compensation arrangements with FINRA, please have
FINRA advise us that it has no objections to the compensation arrangements prior to
qualification.
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff. We also remind you that, following qualification of your Form 1-A, Rule 257
of Regulation A requires you to file periodic and current reports, including a Form 1-K which
will be due within 120 calendar days after the end of the fiscal year covered by the report.
FirstName LastNameLori Bisson
Comapany NameAutonomix Medical, Inc.
August 3, 2023 Page 6
FirstName LastName
Lori Bisson
Autonomix Medical, Inc.
August 3, 2023
Page 6
You may contact Christie Wong at 202-551-3684 or Terence O'Brien at 202-551-3355 if
you have questions regarding comments on the financial statements and related matters. Please
contact Benjamin Richie at 202-551-7857 or Katherine Bagley at 202-551-2545 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc: Cavas S. Pavri