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Clearmind Medicine Inc.
Response Received
1 company response(s)
High - file number match
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Clearmind Medicine Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2024-04-01
Clearmind Medicine Inc.
Summary
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Clearmind Medicine Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2024-03-21
Clearmind Medicine Inc.
Summary
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Clearmind Medicine Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-02-28
Clearmind Medicine Inc.
Summary
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Company responded
2024-03-18
Clearmind Medicine Inc.
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Clearmind Medicine Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-02-14
Clearmind Medicine Inc.
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Company responded
2024-02-14
Clearmind Medicine Inc.
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Clearmind Medicine Inc.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2023-12-26
Clearmind Medicine Inc.
Summary
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Clearmind Medicine Inc.
Response Received
5 company response(s)
High - file number match
SEC wrote to company
2023-07-24
Clearmind Medicine Inc.
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2023-07-25
Clearmind Medicine Inc.
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2023-07-27
Clearmind Medicine Inc.
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2023-09-05
Clearmind Medicine Inc.
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2023-09-06
Clearmind Medicine Inc.
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2023-09-13
Clearmind Medicine Inc.
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Clearmind Medicine Inc.
Response Received
2 company response(s)
Medium - date proximity
SEC wrote to company
2023-03-06
Clearmind Medicine Inc.
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2023-03-27
Clearmind Medicine Inc.
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2023-03-28
Clearmind Medicine Inc.
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Clearmind Medicine Inc.
Response Received
10 company response(s)
High - file number match
SEC wrote to company
2022-07-07
Clearmind Medicine Inc.
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2022-08-18
Clearmind Medicine Inc.
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2022-09-20
Clearmind Medicine Inc.
References: August 18, 2022
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2022-10-06
Clearmind Medicine Inc.
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2022-10-20
Clearmind Medicine Inc.
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2022-10-26
Clearmind Medicine Inc.
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2022-11-01
Clearmind Medicine Inc.
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2022-11-03
Clearmind Medicine Inc.
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2022-11-09
Clearmind Medicine Inc.
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2022-11-09
Clearmind Medicine Inc.
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2022-11-09
Clearmind Medicine Inc.
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Clearmind Medicine Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2022-11-08
Clearmind Medicine Inc.
Summary
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Clearmind Medicine Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2022-11-02
Clearmind Medicine Inc.
Summary
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Clearmind Medicine Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2022-10-31
Clearmind Medicine Inc.
Summary
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Clearmind Medicine Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2022-10-25
Clearmind Medicine Inc.
Summary
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Clearmind Medicine Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2022-10-13
Clearmind Medicine Inc.
Summary
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Clearmind Medicine Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2022-09-29
Clearmind Medicine Inc.
Summary
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Clearmind Medicine Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2022-09-01
Clearmind Medicine Inc.
References: August 18, 2022
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Clearmind Medicine Inc.
Response Received
2 company response(s)
Medium - date proximity
SEC wrote to company
2022-06-21
Clearmind Medicine Inc.
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Company responded
2022-06-29
Clearmind Medicine Inc.
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2022-06-29
Clearmind Medicine Inc.
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Clearmind Medicine Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2022-05-24
Clearmind Medicine Inc.
Summary
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Clearmind Medicine Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2022-01-24
Clearmind Medicine Inc.
Summary
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-30 | Company Response | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2025-09-24 | SEC Comment Letter | Clearmind Medicine Inc. | Canada (Federal Level) | 333-290404 | Read Filing View |
| 2024-04-01 | SEC Comment Letter | Clearmind Medicine Inc. | Canada (Federal Level) | 001-41557 | Read Filing View |
| 2024-03-21 | SEC Comment Letter | Clearmind Medicine Inc. | Canada (Federal Level) | 001-41557 | Read Filing View |
| 2024-03-18 | Company Response | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2024-02-28 | SEC Comment Letter | Clearmind Medicine Inc. | Canada (Federal Level) | 001-41557 | Read Filing View |
| 2024-02-14 | SEC Comment Letter | Clearmind Medicine Inc. | Canada (Federal Level) | 333-276913 | Read Filing View |
| 2024-02-14 | Company Response | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2023-12-26 | Company Response | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2023-09-13 | Company Response | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2023-09-06 | Company Response | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2023-09-05 | Company Response | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2023-07-27 | Company Response | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2023-07-25 | Company Response | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2023-07-24 | SEC Comment Letter | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2023-03-28 | Company Response | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2023-03-27 | Company Response | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2023-03-06 | SEC Comment Letter | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2022-11-09 | Company Response | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2022-11-09 | Company Response | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2022-11-09 | Company Response | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2022-11-08 | SEC Comment Letter | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2022-11-03 | Company Response | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2022-11-02 | SEC Comment Letter | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2022-11-01 | Company Response | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2022-10-31 | SEC Comment Letter | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2022-10-26 | Company Response | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2022-10-25 | SEC Comment Letter | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2022-10-20 | Company Response | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2022-10-13 | SEC Comment Letter | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2022-10-06 | Company Response | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2022-09-29 | SEC Comment Letter | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2022-09-20 | Company Response | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2022-09-01 | SEC Comment Letter | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2022-08-18 | Company Response | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2022-07-07 | SEC Comment Letter | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2022-06-29 | Company Response | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2022-06-29 | Company Response | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2022-06-21 | SEC Comment Letter | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2022-05-24 | SEC Comment Letter | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2022-01-24 | SEC Comment Letter | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-24 | SEC Comment Letter | Clearmind Medicine Inc. | Canada (Federal Level) | 333-290404 | Read Filing View |
| 2024-04-01 | SEC Comment Letter | Clearmind Medicine Inc. | Canada (Federal Level) | 001-41557 | Read Filing View |
| 2024-03-21 | SEC Comment Letter | Clearmind Medicine Inc. | Canada (Federal Level) | 001-41557 | Read Filing View |
| 2024-02-28 | SEC Comment Letter | Clearmind Medicine Inc. | Canada (Federal Level) | 001-41557 | Read Filing View |
| 2024-02-14 | SEC Comment Letter | Clearmind Medicine Inc. | Canada (Federal Level) | 333-276913 | Read Filing View |
| 2023-07-24 | SEC Comment Letter | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2023-03-06 | SEC Comment Letter | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2022-11-08 | SEC Comment Letter | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2022-11-02 | SEC Comment Letter | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2022-10-31 | SEC Comment Letter | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2022-10-25 | SEC Comment Letter | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2022-10-13 | SEC Comment Letter | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2022-09-29 | SEC Comment Letter | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2022-09-01 | SEC Comment Letter | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2022-07-07 | SEC Comment Letter | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2022-06-21 | SEC Comment Letter | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2022-05-24 | SEC Comment Letter | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2022-01-24 | SEC Comment Letter | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-30 | Company Response | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2024-03-18 | Company Response | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2024-02-14 | Company Response | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2023-12-26 | Company Response | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2023-09-13 | Company Response | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2023-09-06 | Company Response | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2023-09-05 | Company Response | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2023-07-27 | Company Response | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2023-07-25 | Company Response | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2023-03-28 | Company Response | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2023-03-27 | Company Response | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2022-11-09 | Company Response | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2022-11-09 | Company Response | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2022-11-09 | Company Response | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2022-11-03 | Company Response | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2022-11-01 | Company Response | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2022-10-26 | Company Response | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2022-10-20 | Company Response | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2022-10-06 | Company Response | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2022-09-20 | Company Response | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2022-08-18 | Company Response | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2022-06-29 | Company Response | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
| 2022-06-29 | Company Response | Clearmind Medicine Inc. | Canada (Federal Level) | N/A | Read Filing View |
2025-09-30 - CORRESP - Clearmind Medicine Inc.
CORRESP 1 filename1.htm Clearmind Medicine Inc. 101 – 1220 West 6th Avenue Vancouver, British Columbia V6H1A5 September 30, 2025 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 RE: Clearmind Medicine Inc. (CIK 0001892500) Registration Statement No. 333-290404 on Form F-1 (the "Registration Statement") Ladies and Gentlemen: Clearmind Medicine Inc. (the " Registrant ") hereby requests acceleration of the effectiveness of the above-referenced Registration Statement pursuant to Rule 461 under the Securities Act of 1933, as amended (the " Securities Act "), so that it may become effective on September 30, 2025 at 4:30 p.m., Eastern Time, or as soon thereafter as is practicable. The undersigned respectfully requests that it be notified of the effectiveness of the Registration Statement by telephone call to our counsel, Greenberg Traurig, P.A., by calling David Huberman at +1 (312) 364-1633. The Company hereby authorizes Mr. Huberman to orally modify or withdraw this request for acceleration. Very truly yours, CLEARMIND MEDICINE INC. By: /s/ Dr. Adi Zuloff-Shani Dr. Adi Zuloff-Shani Chief Executive Officer
2025-09-24 - UPLOAD - Clearmind Medicine Inc. File: 333-290404
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> September 24, 2025 Adi Zuloff-Shani, Ph.D. Chief Executive Officer Clearmind Medicine Inc. 101 1220 West 6th Avenue Vancouver, British Columbia V6H1A5 Re: Clearmind Medicine Inc. Registration Statement on Form F-1 Filed September 19, 2025 File No. 333-290404 Dear Adi Zuloff-Shani Ph.D.: 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 Chris Edwards at 202-551-6761 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: David Huberman, Esq. </TEXT> </DOCUMENT>
2024-04-01 - UPLOAD - Clearmind Medicine Inc. File: 001-41557
United States securities and exchange commission logo
April 1, 2024
Alan Rootenberg
Chief Financial Officer
Clearmind Medicine Inc.
101 – 1220 West 6th Avenue
Vancouver, British Columbia
Re:Clearmind Medicine Inc.
Form 20-F for the fiscal year ended October 31, 2023
Filed January 29, 2024
File No. 001-41557
Dear Alan Rootenberg:
We have completed our review of your filing. 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.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2024-03-21 - UPLOAD - Clearmind Medicine Inc. File: 001-41557
United States securities and exchange commission logo
March 21, 2024
Alan Rootenberg
Chief Financial Officer
Clearmind Medicine Inc.
101 – 1220 West 6th Avenue
Vancouver, British Columbia
Re:Clearmind Medicine Inc.
Form 20-F for the fiscal year ended October 31, 2023
Filed January 29, 2024
File No. 001-41557
Dear Alan Rootenberg:
We have reviewed your March 18, 2024 response to our comment letter and have the
following comment.
Please respond to this letter within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe
our comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to this letter, we may have additional comments. Unless
we note otherwise, any references to prior comments are to comments in our February 28,
2024 letter.
Amendment No.1 to Form 20-F for the fiscal year ended October 31, 2023
Item 19. Exhibits, page 2
1.We note you did not include the certification pursuant to Securities Exchange Act of
1934 Rule 13a-14(b) and Rule 15d-14(b) signed by each of your principal executive
officer and principal financial officer for this amendment. Please amend your filing to
include updated certifications that reference the amendment. Refer to question 161.01 of
the Compliance and Disclosure Interpretations for Exchange Act Rules.
Please contact Jenn Do at 202-551-3743 or Vanessa Robertson at 202-551-3649 if you
have questions regarding comments on the financial statements and related matters.
FirstName LastNameAlan Rootenberg
Comapany NameClearmind Medicine Inc.
March 21, 2024 Page 2
FirstName LastName
Alan Rootenberg
Clearmind Medicine Inc.
March 21, 2024
Page 2
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2024-03-18 - CORRESP - Clearmind Medicine Inc.
CORRESP
1
filename1.htm
March 18, 2024
VIA EDGAR AND EMAIL
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn:
Jenn Do
Vanessa Robertson
Re:
Clearmind Medicine Inc.
Form 20-F for the fiscal year ended October 31, 2023
Filed January 29, 2024
File No. 001-41557
Dear Ms. Do:
On behalf of Clearmind Medicine Inc. (the “Company”),
we are writing to submit the Company’s responses to the comment of the staff (the “Staff”) of the Division of
Corporation Finance Office of Life Sciences of the Securities and Exchange Commission (the “Commission”) dated February
28, 2024, relating to the above referenced Annual Report on Form 20-F (File No. 001-41557) filed by the Company on January 29, 2024 (the
“Form 20-F”)
Concurrent with the submission of this letter,
the Company is filing via EDGAR Amendment No. 1 to the Form 20-F (“Amendment No. 1”), which reflects the Company’s
response to the comment received by the Staff and certain updated information.
For ease of review, we have set forth below the
comment of your letter and the Company’s response thereto. Capitalized terms used herein but not defined herein have the meanings
given to such terms in the Form 20-F.
Form 20-F for the fiscal year ended October 31, 2023
Independent Auditor’s Report, page F-4
1.
We note that the opinion of your predecessor auditor, Saturna Group, is dated March 8, 2022, except as to Notes 1(c) and 1(d) which is as of January 26, 2024. We further note, however, that Saturna Group’s registration with the PCAOB was withdrawn effective May 31, 2023. In accordance with PCAOB Rule 2107(b)(1), a firm that was once registered and then later withdrew their registration from the PCAOB may reissue or give consent to the use of a prior report that it issued while registered. However, the firm cannot update or dual-date a previously issued report after the firm is no longer registered, as that involves additional audit work. As such, tell us how you considered having your current independent accountants audit the adjustments made to the October 31, 2021 financial statements discussed in Notes 1(c) and 1(d) or re-audit the October 31, 2021 financial statements. Please amend your Form 20-F accordingly.
Response: In response to the Staff’s comment, the Company
has filed Amendment No. 1 and respectfully notes that the Company’s current independent accountant has audited the adjustments made
to the October 31, 2021 financial statements discussed in Notes 1(c) and 1(d). The audit reports of both Saturna Group and Brightman Almagor
Zohar & Co., a Firm in the Deloitte Global Network, have been revised accordingly.
Please contact me at (312) 364-1633 if you have
any questions or require any additional information in connection with this letter or the Company’s filing of Amendment No. 1.
Sincerely,
/s/ David Huberman, Esq.
cc: Alan Rootenberg, Chief Financial Officer
2024-02-28 - UPLOAD - Clearmind Medicine Inc. File: 001-41557
United States securities and exchange commission logo
February 28, 2024
Alan Rootenberg
Chief Financial Officer
Clearmind Medicine Inc.
101 – 1220 West 6th Avenue
Vancouver, British Columbia
Re:Clearmind Medicine Inc.
Form 20-F for the fiscal year ended October 31, 2023
Filed January 29, 2024
File No. 001-41557
Dear Alan Rootenberg:
We have limited our review of your filing to the financial statements and related
disclosures and have the following comment.
Please respond to this letter within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe
our comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to this letter, we may have additional comments.
Form 20-F for the fiscal year ended October 31, 2023
Independent Auditor's Report, page F-4
1.We note that the opinion of your predecessor auditor, Saturna Group, is dated March 8,
2022, except as to Notes 1(c) and 1(d) which is as of January 26, 2024. We further note,
however, that Saturna Group’s registration with the PCAOB was withdrawn effective
May 31, 2023. In accordance with PCAOB Rule 2107(b)(1), a firm that was once
registered and then later withdrew their registration from the PCAOB may reissue or give
consent to the use of a prior report that it issued while registered. However, the firm
cannot update or dual-date a previously issued report after the firm is no longer registered,
as that involves additional audit work. As such, tell us how you considered having your
current independent accountants audit the adjustments made to the October 31, 2021
financial statements discussed in Notes 1(c) and 1(d) or re-audit the October 31, 2021
financial statements. Please amend your Form 20-F accordingly.
FirstName LastNameAlan Rootenberg
Comapany NameClearmind Medicine Inc.
February 28, 2024 Page 2
FirstName LastName
Alan Rootenberg
Clearmind Medicine Inc.
February 28, 2024
Page 2
In closing, 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 Jenn Do at 202-551-3743 or Vanessa Robertson at 202-551-3649 with any
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2024-02-14 - UPLOAD - Clearmind Medicine Inc. File: 333-276913
United States securities and exchange commission logo
February 14, 2024
Dr. Adi Zuloff-Shani
Chief Executive Officer
Clearmind Medicine Inc.
101 – 1220 West 6th Avenue
Vancouver, British Columbia V6H1A5
Re:Clearmind Medicine Inc.
Registration Statement on Form F-1
Filed February 7, 2024
File No. 333-276913
Dear Dr. Adi Zuloff-Shani:
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 Cindy Polynice at 202-551-8707 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: David Huberman, Esq.
2024-02-14 - CORRESP - Clearmind Medicine Inc.
CORRESP
1
filename1.htm
Clearmind Medicine Inc.
101 – 1220 West 6th Avenue
Vancouver, British Columbia V6H1A5
February 14, 2024
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
RE:
Clearmind Medicine Inc. (CIK 0001892500)
Registration Statement No. 333-276913 on Form F-1 (the “Registration Statement”)
Ladies and Gentlemen:
Clearmind Medicine Inc. (the “Registrant”)
hereby requests acceleration of the effectiveness of the above-referenced Registration Statement pursuant to Rule 461 under the Securities
Act of 1933, as amended (the “Securities Act”), so that it may become effective on February 16, 2024 at 4:00 p.m.,
Eastern Time, or as soon thereafter as is practicable.
The undersigned respectfully requests
that it be notified of the effectiveness of the Registration Statement by telephone call to our counsel, Greenberg Traurig, P.A., by calling
David Huberman at +1 312.364.1633. The Company hereby authorizes Mr. Huberman to orally modify or withdraw this request for acceleration.
Very truly yours,
CLEARMIND MEDICINE INC.
By:
/s/ Dr. Adi Zuloff-Shani
Dr. Adi Zuloff-Shani
Chief Executive Officer
2023-12-26 - CORRESP - Clearmind Medicine Inc.
CORRESP
1
filename1.htm
Clearmind Medicine Inc.
101 – 1220 West 6th Avenue
Vancouver, British Columbia V6H1A5
December 26, 2023
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
RE:
Clearmind Medicine Inc. (CIK 0001892500)
Registration Statement No. 333-275991 on Form F-3 (the “Registration Statement”)
Ladies and Gentlemen:
Clearmind Medicine Inc. (the
“Registrant”) hereby requests acceleration of the effectiveness of the above-referenced Registration Statement pursuant
to Rule 461 under the Securities Act of 1933, as amended (the “Securities Act”), so that it may become effective on
December 26, 2023 at 4:00 p.m., Eastern Time, or as soon thereafter as is practicable.
The undersigned respectfully
requests that it be notified of the effectiveness of the Registration Statement by telephone call to our counsel, Greenberg Traurig, P.A.,
by calling David Huberman at +1 312.364.1633. The Company hereby authorizes Mr. Huberman to orally modify or withdraw this request for
acceleration.
Very truly yours,
CLEARMIND MEDICINE INC.
By:
/s/ Dr. Adi Zuloff-Shani
Dr. Adi Zuloff-Shani
Chief Executive Officer
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Clearmind Medicine Inc.
101 – 1220 West 6th Avenue
Vancouver, British Columbia V6H1A5
September 13, 2023
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
RE:
Clearmind Medicine Inc. (CIK: 0001892500)
Registration Statement No. 333-273293 on Form F-1 (the “Registration Statement”)
Ladies and Gentlemen:
Clearmind Medicine Inc. (the “Registrant”)
hereby requests acceleration of the effectiveness of the above-referenced Registration Statement pursuant to Rule 461 under the Securities
Act of 1933, as amended (the “Securities Act”), so that it may become effective on September 14, 2023 at 9:00 a.m.,
Eastern Time, or as soon thereafter as is practicable.
The Registrant understands that
the Securities and Exchange Commission will consider this request for acceleration of the effective date of the Registration Statement
as a confirmation of the fact that the Registrant is aware of its responsibilities under the Securities Act as they relate to the proposed
public offering of the securities specified in the Registration Statement.
The Registrant respectfully requests
that it be notified of such effectiveness by a telephone call to David Huberman, Esq. of Greenberg Traurig, P.A. at (312) 364-1633 and
that such effectiveness also be confirmed in writing.
Very truly yours,
Clearmind Medicine Inc.
By:
/s/ Dr. Adi Zuloff-Shani
Dr. Adi Zuloff-Shani
Chief Executive Officer
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Clearmind Medicine Inc.
101 – 1220 West 6th Avenue
Vancouver, British Columbia V6H1A5
September 6, 2023
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
RE:
Clearmind Medicine Inc. (CIK: 0001892500)
Registration Statement No. 333-273293 on Form F-1 (the “Registration Statement”)
Ladies and Gentlemen:
Reference is made to our
letter, filed as correspondence via EDGAR on September 5, 2023, in which we requested acceleration of the effective date of the above
referenced Registration Statement to 5:00 p.m., Eastern Time, on September 6, 2023, or as soon as possible thereafter, in accordance with
Rule 461 under the Securities Act of 1933, as amended. We are no longer requesting that such Registration Statement be declared effective
at such time and we hereby withdraw our request for acceleration of the effective date until further notice from the Company.
The Registrant respectfully requests
that it be notified of acceptance of this notice of withdrawal by a telephone call to David Huberman, Esq. of Greenberg Traurig, P.A.
at (312) 364-1633.
Very truly yours,
Clearmind Medicine Inc.
By:
/s/ Dr. Adi Zuloff-Shani
Dr. Adi Zuloff-Shani
Chief Executive Officer
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Clearmind Medicine Inc.
101 – 1220 West 6th Avenue
Vancouver, British Columbia V6H1A5
September 5, 2023
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
RE:
Clearmind Medicine Inc. (CIK: 0001892500)
Registration Statement No. 333-273293 on Form F-1 (the “Registration Statement”)
Ladies and Gentlemen:
Clearmind Medicine Inc. (the
“Registrant”) hereby requests acceleration of the effectiveness of the above-referenced Registration Statement pursuant
to Rule 461 under the Securities Act of 1933, as amended (the “Securities Act”), so that it may become effective on
September 6, 2023 at 5:00 p.m., Eastern Time, or as soon thereafter as is practicable.
The Registrant understands
that the Securities and Exchange Commission will consider this request for acceleration of the effective date of the Registration Statement
as a confirmation of the fact that the Registrant is aware of its responsibilities under the Securities Act as they relate to the proposed
public offering of the securities specified in the Registration Statement.
The Registrant respectfully
requests that it be notified of such effectiveness by a telephone call to David Huberman, Esq. of Greenberg Traurig, P.A. at (312) 364-1633
and that such effectiveness also be confirmed in writing.
Very truly yours,
Clearmind Medicine Inc.
By:
/s/ Dr. Adi Zuloff-Shani
Dr. Adi Zuloff-Shani
Chief Executive Officer
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Clearmind Medicine Inc.
101 – 1220 West 6th Avenue
Vancouver, British Columbia V6H1A5
July 27, 2023
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
RE:
Clearmind Medicine Inc. (CIK: 0001892500)
Registration Statement No. 333-273293 on Form F-1 (the “Registration Statement”)
Ladies and Gentlemen:
Reference is made to our
letter, filed as correspondence via EDGAR on July 25, 2023, in which we requested acceleration of the effective date of the above referenced
Registration Statement to 5:00 p.m., Eastern Time, on July 27, 2023, or as soon as possible thereafter, in accordance with Rule 461 under
the Securities Act of 1933, as amended. We are no longer requesting that such Registration Statement be declared effective at such time
and we hereby withdraw our request for acceleration of the effective date until further notice from the Company.
The Registrant respectfully requests
that it be notified of acceptance of this notice of withdrawal by a telephone call to David Huberman, Esq. of Greenberg Traurig, P.A.
at (312) 364-1633.
Very truly yours,
Clearmind Medicine Inc.
By:
/s/ Dr. Adi Zuloff-Shani
Dr. Adi Zuloff-Shani
Chief Executive Officer
2023-07-25 - CORRESP - Clearmind Medicine Inc.
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Clearmind Medicine Inc.
101 – 1220 West 6th Avenue
Vancouver, British Columbia V6H1A5
July 25, 2023
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
RE:
Clearmind Medicine Inc. (CIK: 0001892500)
Registration Statement No. 333-273293 on Form F-1 (the “Registration Statement”)
Ladies and Gentlemen:
Clearmind Medicine Inc. (the
“Registrant”) hereby requests acceleration of the effectiveness of the above-referenced Registration Statement pursuant
to Rule 461 under the Securities Act of 1933, as amended (the “Securities Act”), so that it may become effective on
July 27, 2023 at 5:00 p.m., Eastern Time, or as soon thereafter as is practicable.
The Registrant understands
that the Securities and Exchange Commission will consider this request for acceleration of the effective date of the Registration Statement
as a confirmation of the fact that the Registrant is aware of its responsibilities under the Securities Act as they relate to the proposed
public offering of the securities specified in the Registration Statement.
The Registrant respectfully
requests that it be notified of such effectiveness by a telephone call to David Huberman, Esq. of Greenberg Traurig, P.A. at (312) 364-1633
and that such effectiveness also be confirmed in writing.
Very truly yours,
Clearmind Medicine Inc.
By:
/s/ Dr. Adi Zuloff-Shani
Dr. Adi Zuloff-Shani
Chief Executive Officer
2023-07-24 - UPLOAD - Clearmind Medicine Inc.
United States securities and exchange commission logo
July 24, 2023
Adi Zuloff-Shani, Ph.D.
Chief Executive Officer
Clearmind Medicine Inc.
101 – 1220 West 6th Avenue
Vancouver, British Columbia V6H1A5
Re:Clearmind Medicine Inc.
Registration Statement on Form F-1
Filed July 17, 2023
File No. 333-273293
Dear Adi Zuloff-Shani:
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 Jason Drory at 202-551-8342 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: David A. Huberman
2023-03-28 - CORRESP - Clearmind Medicine Inc.
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Clearmind Medicine Inc.
101 – 1220 West 6th Avenue
Vancouver, British Columbia V6H1A5
March 28, 2023
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
RE:
Clearmind Medicine Inc. (CIK: 0001892500)
Registration Statement No. 333-270859 on Form F-1 (the “Registration Statement”)
Ladies and Gentlemen:
Clearmind Medicine Inc. (the “Registrant”)
hereby requests acceleration of the effectiveness of the above-referenced Registration Statement pursuant to Rule 461 under the Securities
Act of 1933, as amended (the “Securities Act”), so that it may become effective on March 30, 2023 at 5:00 p.m., Eastern
Time, or as soon thereafter as is practicable.
The Registrant understands that
the Securities and Exchange Commission will consider this request for acceleration of the effective date of the Registration Statement
as a confirmation of the fact that the Registrant is aware of its responsibilities under the Securities Act as they relate to the proposed
public offering of the securities specified in the Registration Statement.
The Registrant respectfully requests
that it be notified of such effectiveness by a telephone call to David Huberman, Esq. of Greenberg Traurig, P.A. at (312) 364-1633 and
that such effectiveness also be confirmed in writing.
Very truly yours,
Clearmind Medicine Inc.
By:
/s/ Dr. Adi Zuloff-Shani
Dr. Adi Zuloff-Shani
Chief Executive Officer
2023-03-27 - CORRESP - Clearmind Medicine Inc.
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March 27, 2023
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549
Attention:
Joshua
Gorsky
Joe
McCann
Re:
Clearmind Medicine Inc.
Draft Registration Statement on Form F-1
Submitted on February 21, 2023
Filed February 3, 2023
CIK No. 0001892500
Ladies and Gentlemen
On behalf of Clearmind Medicine Inc. (the “Company”),
we are writing to submit the Company’s responses to the comments of the staff (the “Staff”) of the Division of Corporation
Finance of the Securities and Exchange Commission (the “Commission”) dated March 6, 2023, relating to the above referenced
Registration Statement on Form F-1 (CIK No. 0001892500) submitted by the Company on February 21, 2023 (the “Draft Registration
Statement”).
Concurrent with the submission
of this letter, the Company is filing via EDGAR a revised Registration Statement on Form F-1 (the “Registration Statement”),
which reflects the Company’s responses to the comments received by the Staff and certain updated information.
For ease of review, we have
set forth below each of the numbered comments of your letter and the Company’s responses thereto. Capitalized terms used herein
but not defined herein have the meanings given to such terms in the Registration Statement.
Draft Registration Statement on Form F-1, submitted on February
21, 2023
Cover Page
1.
Please revise your disclosure
to include all of the information that is required by Item 501(b)(8)(iii) of Regulation S-K, including the date that the offering
will end. Additionally, we note your disclosure that the placement agent expects to deliver the Common Shares on or about a certain
date. Please disclose whether this offering will end in a single closing.
Response: In response to the
Staff’s comment, the Company has revised the cover page to include all of the information that is required by Item
501(b)(8)(iii) of Regulation S-K, including the date that the offering will end. The Company respectfully notes that the offering
will terminate on the first date that the Company enters into a placement agent agreement to sell the securities being registered
under the Registration Statement and that the securities are expected to be issued in a single closing. The Company further notes
that it expects that the offering will close on April 6, 2023 but the offering will be terminated by May 7, 2023, provided that the
closing of the offering has not occurred by such date, and may not be extended.
2.
Please revise the heading
to reflect that you are also offering 4,054,100 Common Shares underlying the Common Warrants.
Response: In response to the Staff’s comment, the Company
has revised the cover page to reflect that the Company is also offering the Common Shares underlying each of the Common Warrants and
Pre-Funded Warrants. Such number has been amended from up to 4,054,100 Common Shares underlying each of the Common Warrants and Pre-Funded
Warrants to 4,225,400 Common Shares underlying each of the Common Warrants and Pre-Funded Warrants.
Please contact me at (312) 364-1633 if you have
any questions or require any additional information in connection with this letter or the Company’s submission of its draft Registration
Statement on Form F-1.
Sincerely,
/s/
David Huberman
cc: Adi Zuloff-Shani, Chief
Executive Officer
2023-03-06 - UPLOAD - Clearmind Medicine Inc.
United States securities and exchange commission logo
March 6, 2023
Dr. Adi Zuloff-Shani
Chief Executive Officer
Clearmind Medicine Inc.
101 – 1220 West 6th Avenue
Vancouver, British Columbia V6H1A5
Re:Clearmind Medicine Inc.
Draft Registration Statement on Form F-1
Submitted on February 21, 2023
CIK No. 0001892500
Dear Dr. Adi Zuloff-Shani:
We have conducted a limited review of your draft registration statement. 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 providing any requested information and by publicly
filing your registration statement and non-public draft submission on EDGAR. 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 the information you provide in response to these comments and your
filed registration statement, we may have additional comments.
Draft Registration Statement on Form F-1, submitted on February 21, 2023
Cover Page
1.Please revise your disclosure to include all of the information that is required by Item
501(b)(8)(iii) of Regulation S-K, including the date that the offering will end.
Additionally, we note your disclosure that the placement agent expects to deliver the
Common Shares on or about a certain date. Please disclose whether this offering will end
in a single closing.
2.Please revise the heading to reflect that you are also offering 4,054,100 Common Shares
underlying the Common Warrants.
FirstName LastNameDr. Adi Zuloff-Shani
Comapany NameClearmind Medicine Inc.
March 6, 2023 Page 2
FirstName LastName
Dr. Adi Zuloff-Shani
Clearmind Medicine Inc.
March 6, 2023
Page 2
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 your registration statement must be on file no later than 48 hours
prior to the requested effective date and time. Refer to Rules 460 and 461 regarding requests for
acceleration. Please allow adequate time for us to review any amendment prior to the requested
effective date of the registration statement.
Please contact Joshua Gorsky at 202-551-7836 or Joe McCann on 202-551-6262 with any
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: David A. Huberman
2022-11-09 - CORRESP - Clearmind Medicine Inc.
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November 9, 2022
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
RE:
Clearmind Medicine, Inc. (CIK: 0001892500)
Registration Statement on Form F-1 (the “Registration Statement”)
Reg. No. 333-265900
Ladies and Gentlemen:
Pursuant to Rule 461 of the General Rules and Regulations of the U.S. Securities
and Exchange Commission under the Securities Act of 1933, as amended (the “Securities Act”), Aegis Capital Corp.
hereby requests acceleration of the effective date of the above-referenced Registration Statement so that it will become effective at
4:30 p.m. Eastern Time, on November 10, 2022, or as soon thereafter as practicable.
Pursuant to Rule 460 under the Securities Act, please be advised that we
will distribute as many electronic copies of the proposed form of preliminary prospectus as appears to be reasonable to secure adequate
distribution.
By:
AEGIS CAPITAL CORP.
By:
/s/ Griffin Cassagne
Name: Griffin Cassagne
Title: Executive Vice President
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Clearmind Medicine Inc
101 – 1220 West 6th Avenue
Vancouver, British Columbia V6H1A5
November 9, 2022
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
RE:
Clearmind Medicine Inc. (CIK 0001892500)
Registration Statement No. 333-265900 on Form F-1 (the “Registration Statement”)
Ladies and Gentlemen:
Clearmind Medicine Inc. (the “Registrant”)
hereby requests acceleration of the effectiveness of the above-referenced Registration Statement pursuant to Rule 461 under the Securities
Act of 1933, as amended (the “Securities Act”), so that it may become effective on November 10, 2022 at 4:30 p.m.,
Eastern Time, or as soon thereafter as is practicable.
The undersigned respectfully requests
that it be notified of the effectiveness of the Registration Statement by telephone call to our counsel, Greenberg Traurig LLP, by calling
David Huberman at (212) 801-9221. The Company hereby authorizes Mr. Huberman to orally modify or withdraw this request for acceleration.
Very truly yours,
CLEARMIND MEDICINE
INC.
By:
/s/ Dr. Adi Zuloff-Shani
Dr. Adi Zuloff-Shani
Chief Executive Officer
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November 9, 2022
VIA EDGAR AND EMAIL
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn:
Margaret Schwartz
Joe McCann
Christie Wong
Mary Mast
Re:
Clearmind Medicine Inc.
Amendment No. 7 to Registration Statement on Form F-1
Filed November 4, 2022
File No. 333-265900
Dear Ms. Schwartz:
On behalf of Clearmind Medicine Inc. (the “Company”),
we are writing to submit the Company’s responses to the comments of the staff (the “Staff”) of the Division of
Corporation Finance of the Securities and Exchange Commission (the “Commission”) dated November 8, 2022, relating to
the above referenced Amendment No. 7 to Registration Statement on Form F-1 (File No. 333-265900) filed by the Company on November 2, 2022.
Concurrent with the submission of this letter,
the Company is filing via EDGAR Amendment No. 8 to the F-1 (“Amendment No. 8”), which reflects the Company’s
responses to the comments received by the Staff and certain updated information.
For ease of review, we have set forth below each
of the numbered comments of your letter and the Company’s responses thereto. Capitalized terms used herein but not defined herein
have the meanings given to such terms in Registration Statement.
Amendment No. 7 to Form F-1 filed on November 4, 2022
Cover page
1.
Please revise to clarify whether your offering is contingent
upon final approval of your NASDAQ listing. Please ensure the disclosure is consistent with your underwriting agreement.
Response: In response to the Staff’s comment the Company has
revised its disclosure on the cover page to further clarify that it is a condition to the closing of the offering that the Company’s
common shares shall have been approved for listing on The Nasdaq Capital Market, which is consistent with the underwriting agreement.
Risk Factors, page 13
2.
We note recent instances of extreme stock
price run-ups followed by rapid price declines and stock price volatility seemingly unrelated to company performance following a
number of recent initial public offerings, particularly among companies with relatively smaller public floats. Revise to include
a separate risk factor addressing the potential for rapid and substantial price volatility and any known factors particular to your
offering that may add to this risk and discuss the risks to investors when investing in stock where the price is changing rapidly.
Clearly state that such volatility, including any stock-run up, may be unrelated to your actual or expected operating performance
and financial condition or prospects, making it difficult for prospective investors to assess the rapidly changing value of your
stock.
Response: In response to the Staff’s comment the Company has
added the additional risk factor disclosure on page 7 and page 63.
Dilution, page 73
3.
Please revise to exclude intangible assets from your historical
and adjusted net tangible book value and per share information.
Response: In response to the Staff’s comment the Company
has revised its disclosures on page 73 and page 74.
Please contact me at (212) 801-9221 if
you have any questions or require any additional information in connection with this letter or the Company’s submission of its draft
Registration Statement on Form F-1.
Sincerely,
/s/ David Huberman
cc: Adi-Zuloff Shani, Chief Executive Officer
2022-11-08 - UPLOAD - Clearmind Medicine Inc.
United States securities and exchange commission logo
November 8, 2022
Adi Zuloff-Shani
Chief Executive Officer
Clearmind Medicine Inc.
101 – 1220 West 6th Avenue
Vancouver, British Columbia V6H1A5
Re:Clearmind Medicine Inc.
Amendment No. 7 to Registration Statement on Form F-1
Filed November 4, 2022
File No. 333-265900
Dear Adi Zuloff-Shani:
We have reviewed your amended registration 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 registration 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 registration 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 November 2, 2022 letter.
Amendment No. 7 to Form F-1 filed on November 4, 2022
Cover page
1.Please revise to clarify whether your offering is contingent upon final approval of your
NASDAQ listing. Please ensure the disclosure is consistent with your underwriting
agreement.
Risk Factors, page 13
2.We note recent instances of extreme stock price run-ups followed by rapid price declines
and stock price volatility seemingly unrelated to company performance following a
number of recent initial public offerings, particularly among companies with relatively
smaller public floats. Revise to include a separate risk factor addressing the potential for
FirstName LastNameAdi Zuloff-Shani
Comapany NameClearmind Medicine Inc.
November 8, 2022 Page 2
FirstName LastName
Adi Zuloff-Shani
Clearmind Medicine Inc.
November 8, 2022
Page 2
rapid and substantial price volatility and any known factors particular to your offering that
may add to this risk and discuss the risks to investors when investing in stock where the
price is changing rapidly. Clearly state that such volatility, including any stock-run up,
may be unrelated to your actual or expected operating performance and financial
condition or prospects, making it difficult for prospective investors to assess the rapidly
changing value of your stock.
Dilution, page 73
3.Please revise to exclude intangible assets from your historical and adjusted net tangible
book value and per share information.
You may contact Christie Wong at 202-551-3684 or Mary Mast at 202-551-3613 if you
have questions regarding comments on the financial statements and related matters. Please
contact Margaret Schwartz at 202-551-7153 or Joe McCann at 202-551-6262 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: David Huberman, Esq.
2022-11-03 - CORRESP - Clearmind Medicine Inc.
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November 3, 2022
VIA EDGAR AND EMAIL
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn:
Margaret Schwartz
Joe McCann
Christie Wong
Mary Mast
Re:
Clearmind Medicine Inc.
Registration Statement on Form F-1
Filed November 2, 2022
File No. 333-265900
Dear Ms. Schwartz:
On behalf of Clearmind Medicine Inc. (the “Company”),
we are writing to submit the Company’s responses to the comments of the staff (the “Staff”) of the Division of
Corporation Finance of the Securities and Exchange Commission (the “Commission”) dated November 2, 2022, relating to
the above referenced Registration Statement on Form F-1 (File No. 333-265900) filed by the Company on November 2, 2022.
Concurrent with the submission of this letter, the Company
is filing via EDGAR Amendment No. 7 to the F-1 (“Amendment No. 7”), which reflects the Company’s responses to
the comments received by the Staff and certain updated information.
For ease of review, we have set forth below each of
the numbered comments of your letter and the Company’s responses thereto. Capitalized terms used herein but not defined herein have
the meanings given to such terms in Registration Statement.
Amendment No. 6 to Form F-1 filed on November 2, 2022
Capitalization, page 72
1.
Refer to your response to comment 1. Please revise the Capitalization table and throughout the filing, as necessary, to be consistent with the reclassification from Share Capital to Warrant Reserve in Shareholders’ Equity.
Response: In response to the Staff’s comment the Company has
revised its disclosure on page 72.
Please contact me at +972 (0)
3.636.6000 if you have any questions or require any additional information in connection with this letter or the Company’s
Registration Statement on Form F-1.
Sincerely,
/s/ David Huberman
cc: Adi-Zuloff Shani, Chief Executive Officer
2022-11-02 - UPLOAD - Clearmind Medicine Inc.
United States securities and exchange commission logo
November 2, 2022
Adi Zuloff-Shani
Chief Executive Officer
Clearmind Medicine Inc.
101 – 1220 West 6th Avenue
Vancouver, British Columbia V6H1A5
Re:Clearmind Medicine Inc.
Amendment No. 6 to Registration Statement on Form F-1
Filed November 2, 2022
File No. 333-265900
Dear Adi Zuloff-Shani:
We have reviewed your amended registration 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 registration 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 registration 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 October 31, 2022 letter.
Amendment No. 6 to Form F-1 filed on November 2, 2022
Capitalization, page 72
1.Refer to your response to comment 1. Please revise the Capitalization table and
throughout the filing, as necessary, to be consistent with the reclassification from Share
Capital to Warrant Reserve in Shareholders' Equity.
FirstName LastNameAdi Zuloff-Shani
Comapany NameClearmind Medicine Inc.
November 2, 2022 Page 2
FirstName LastName
Adi Zuloff-Shani
Clearmind Medicine Inc.
November 2, 2022
Page 2
You may contact Christie Wong at 202-551-3684 or Mary Mast at 202-551-3613 if you
have questions regarding comments on the financial statements and related matters. Please
contact Margaret Schwartz at 202-551-7153 or Joe McCann at 202-551-6262 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: David Huberman, Esq.
2022-11-01 - CORRESP - Clearmind Medicine Inc.
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November 1, 2022
VIA EDGAR AND EMAIL
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn:
Margaret Schwartz
Joe McCann
Christie Wong
Mary Mast
Re:
Clearmind Medicine Inc.
Registration Statement on Form F-1
Filed October 26, 2022
File No. 333-265900
Dear Ms. Schwartz:
On behalf of Clearmind Medicine Inc. (the “Company”),
we are writing to submit the Company’s responses to the comments of the staff (the “Staff”) of the Division of
Corporation Finance of the Securities and Exchange Commission (the “Commission”) dated October 31, 2022, relating to
the above referenced Registration Statement on Form F-1 (File No. 333-265900) filed by the Company on October 26, 2022.
Concurrent with the submission of this letter,
the Company is filing via EDGAR Amendment No. 6 to the F-1 (“Amendment No. 6”), which reflects the Company’s
responses to the comments received by the Staff and certain updated information.
For ease of review, we have set forth below each
of the numbered comments of your letter and the Company’s responses thereto. Capitalized terms used herein but not defined herein
have the meanings given to such terms in Registration Statement.
Amendment No. 5 to Form F-1 filed on October 26, 2022
Condensed interim Statements of Changes in Shareholders' Equity,
page F-29
1. We
note your response to our comment 1. In the Note 9(c) on page F-36, you indicated that you issued 39,747 units for proceeds of $953,925
with $190,785 allocated to warrants reserve. As previously requested, please tell us why the entire $953,925 is included in the
share capital.
Response: In response to the Staff’s comment the Company has revised its
disclosure on pages F-27 and F-29.
Exhibits
2. We
acknowledge your response to our prior comment number 1. Please confirm the other issuances in Item 7 appropriately reflect the stock
split as previously requested.
Response: The Company hereby advises the Staff that all
issuances in Item 7 appropriately reflect the stock split.
Please contact me at +972 (0) 3.636.6000 if
you have any questions or require any additional information in connection with this letter or the Company’s submission of its draft
Registration Statement on Form F-1.
Sincerely,
/s/ David Huberman
cc: Adi-Zuloff Shani, Chief Executive Officer
2022-10-31 - UPLOAD - Clearmind Medicine Inc.
United States securities and exchange commission logo
October 31, 2022
Adi Zuloff-Shani
Chief Executive Officer
Clearmind Medicine Inc.
101 – 1220 West 6th Avenue
Vancouver, British Columbia V6H1A5
Re:Clearmind Medicine Inc.
Amendment No. 5 to Registration Statement on Form F-1
Filed October 26, 2022
File No. 333-265900
Dear Adi Zuloff-Shani:
We have reviewed your amended registration 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 registration 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 registration 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 October 25, 2022 letter.
Amendment No. 5 to Registration Statement on Form F-1, filed October 26, 2022
Condensed Interim Statements of Changes in Shareholders' Equity, page F-29
1.We note your response to our comment 1. In the Note 9(c) on page F-36, you indicated
that you issued 39,747 units for proceeds of $953,925 with $190,785 allocated to warrants
reserve. As previously requested, please tell us why the entire $953,925 is included in the
share capital.
2.We acknowledge your response to our prior comment number 1. Please confirm the other
issuances in Item 7 appropriately reflect the stock split as previously requested.
FirstName LastNameAdi Zuloff-Shani
Comapany NameClearmind Medicine Inc.
October 31, 2022 Page 2
FirstName LastName
Adi Zuloff-Shani
Clearmind Medicine Inc.
October 31, 2022
Page 2
You may contact Christie Wong at 202-551-3684 or Mary Mast at 202-551-3613 if you
have questions regarding comments on the financial statements and related matters. Please
contact Margaret Schwartz at 202-551-7153 or Joe McCann at 202-551-6262 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: David Huberman, Esq.
2022-10-26 - CORRESP - Clearmind Medicine Inc.
CORRESP
1
filename1.htm
October 26, 2022
VIA EDGAR AND EMAIL
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn:
Margaret Schwartz
Jeffrey Gabor
Christie Wong
Mary Mast
Re:
Clearmind Medicine Inc.
Registration Statement on Form F-1
Filed October 20, 2022
File No. 333-265900
Dear Ms. Schwartz:
On behalf of Clearmind Medicine Inc. (the “Company”),
we are writing to submit the Company’s responses to the comments of the staff (the “Staff”) of the Division of
Corporation Finance of the Securities and Exchange Commission (the “Commission”) dated October 25, 2022, relating to
the above referenced Registration Statement on Form F-1 (File No. 333-265900) filed by the Company on October 20, 2022.
Concurrent with the submission of this letter,
the Company is filing via EDGAR Amendment No. 5 to the F-1 (“Amendment No. 5”), which reflects the Company’s
responses to the comments received by the Staff and certain updated information.
For ease of review, we have set forth below each
of the numbered comments of your letter and the Company’s responses thereto. Capitalized terms used herein but not defined herein
have the meanings given to such terms in Registration Statement.
Amendment No. 4 to Form F-1 filed on October 20, 2022
Condensed interim Statements of Changes in Shareholders' Equity,
page F-29
1. You state in Note 9c on page F-36 that you issued 39,747
units at $0.80 per unit for proceeds of $953,925 with $190,785 allocated to warrants reserve. Please address the following:
· Reconcile
the disclosure in Note 9c with the disclosure on the Statements of Changes in Shareholders' Equity. In this regard, it appears that the
per unit amount may not reflect the stock split and it is unclear why the entire $953,925 is included in the Statements of Changes in
Shareholders' Equity.
· Update
your disclosure in Item 7. Recent Sales of Unregistered Securities, as necessary, for the issuances to Medigus to reflect the stock split.
Also confirm the other issuances in Item 7 appropriately reflect the stock split.
Response: In response to the Staff’s comment, the
Company has revised its disclosure on pages F-25 and F-36 of Amendment No. 5 to correct the per unit amount to reflect the stock split.
In addition, the Company has revised its disclosure on page II-1 of Amendment No. 5 to reflect the stock split with respect to the private
placement with Medigus Ltd.
Exhibits
2.
We refer to Exhibit 23.1. Please have your auditor revise the consent to reflect the dual date of the auditor's report.
Response: In response to the Staff’s comment, the Company
has filed a revised Exhibit 23.1 to reflect the dual date of the auditor’s report.
Please contact me at +1 312 372 2000 if
you have any questions or require any additional information in connection with this letter or the Company’s submission of its draft
Registration Statement on Form S-1.
Sincerely,
/s/ David Huberman
cc: Adi-Zuloff Shani, Chief Executive Officer
2022-10-25 - UPLOAD - Clearmind Medicine Inc.
United States securities and exchange commission logo
October 25, 2022
Adi Zuloff-Shani
Chief Executive Officer
Clearmind Medicine Inc.
101 – 1220 West 6th Avenue
Vancouver, British Columbia V6H1A5
Re:Clearmind Medicine Inc.
Amendment No. 4 to Registration Statement on Form F-1
Filed October 20, 2022
File No. 333-265900
Dear Adi Zuloff-Shani:
We have reviewed your amended registration 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 registration 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 registration statement and the information you
provide in response to these comments, we may have additional comments.
Amendment No. 4 to Registration Statement on Form F-1, filed October 20, 2022
Condensed interim Statements of Changes in Shareholders' Equity, page F-29
1.You state in Note 9c on page F-36 that you issued 39,747 units at $0.80 per unit for
proceeds of $953,925 with $190,785 allocated to warrants reserve. Please address the
following:
•Reconcile the disclosure in Note 9c with the disclosure on the Statements of Changes
in Shareholders' Equity. In this regard, it appears that the per unit amount may not
reflect the stock split and it is unclear why the entire $953,925 is included in the
Statements of Changes in Shareholders' Equity.
•Update your disclosure in Item 7. Recent Sales of Unregistered Securities, as
necessary, for the issuances to Medigus to reflect the stock split. Also confirm the
other issuances in Item 7 appropriately reflect the stock split.
FirstName LastNameAdi Zuloff-Shani
Comapany NameClearmind Medicine Inc.
October 25, 2022 Page 2
FirstName LastName
Adi Zuloff-Shani
Clearmind Medicine Inc.
October 25, 2022
Page 2
Exhibits
2.We refer to Exhibit 23.1. Please have your auditor revise the consent to reflect the dual
date of the auditor's report.
You may contact Christie Wong at 202-551-3684 or Mary Mast at 202-551-3613 if you
have questions regarding comments on the financial statements and related matters. Please
contact Margaret Schwartz at 202-551-7153 or Joe McCann at 202-551-6262 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: David Huberman, Esq.
2022-10-20 - CORRESP - Clearmind Medicine Inc.
CORRESP
1
filename1.htm
October 20, 2022
VIA EDGAR AND EMAIL
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn:
Margaret Schwartz
Jeffrey Gabor
Christie Wong
Mary Mast
Re:
Clearmind Medicine Inc.
Registration Statement on Form F-1
Filed October 6, 2022
File No. 333-265900
Ladies and Gentlemen:
On behalf of Clearmind Medicine Inc. (the “Company”),
we are writing to submit the Company’s responses to the comments of the staff (the “Staff”) of the Division of
Corporation Finance of the Securities and Exchange Commission dated October 13, 2022, relating to the above referenced Registration Statement
on Form F-1 (File No. 333-265900) filed by the Company on October 6, 2022.
Concurrent with the submission of this letter,
the Company is filing via EDGAR Amendment No. 3 to the F-1 (“Amendment No. 4”), which reflects the Company’s
responses to the comments received by the Staff and certain updated information.
For ease of review, we have set forth below each
of the numbered comments of your letter and the Company’s responses thereto. Capitalized terms used herein but not defined herein
have the meanings given to such terms in Registration Statement.
Amendment No. 3 to Form F-1 filed on October 6, 2022
Capitalization, page 72
1.
You indicated on page 10 that the midpoint of the Company's IPO price range is $7 per share. We further note you disclosed in the capitalization table and the dilution table on page 72 and page 74, respectively, that $6 per share is the midpoint of the price range. Please revise to reconcile the discrepancies.
Response: In response to the Staff’s comment, the
Company has revised its disclosure on pages 72 and 74 to clarify that the midpoint of the price range is $7.00.
Dilution, page 73
2.
Please exclude the intangible assets from your historical net tangible book value and per share calculation.
Response: In response to the Staff’s comment, the Company
has revised its disclosure on page 73 to exclude intangible assets from its historical net tangible book value and per share calculation.
Description of Share Capital, page 125
3.
As previously requested, please explain to us the reasons for any difference between recent valuation of your common shares leading up to the planned initial public offering and the mid-point of your estimated offering price range. This information will help facilitate our review of your accounting for equity issuance including stock compensation.
Response: The Company
respectfully acknowledges the Staff’s comment. An analysis explaining the reasons for the differences between recent valuations
of the Company’s Common Shares leading up to the proposed IPO and the estimated offering price per share is provided below. All
share and per share amounts have been presented giving effect to a stock split effected by the Company, at a ratio of 1 to 30.
The Company and Aegis Capital Corp. (“Aegis”),
as sole underwriter for the Company’s proposed initial public offering (“IPO”), currently estimate a pre−money
equity valuation for the Company at the time of IPO (the “Valuation Range”) that corresponds to a range per common
share of $6 to $8 (the “Preliminary IPO Price Range”). The mid−point of the Preliminary IPO Price Range is $7 per share.
The Valuation Range was determined based, in part, upon the Company’s business and financial prospects, prospects for the Company’s
industry more broadly, the general condition of the securities markets, and the recent market prices of, and the demand for, publicly
traded shares of generally comparable companies. The Company notes that, as is typical in IPOs, the Preliminary IPO Price Range was not
derived using a formal determination of fair value, but was determined by discussions among the Company and Aegis based on their collective
assessment of the foregoing factors
2
In 2021 and 2022, the Company
undertook to grant options to purchase Ordinary Shares, to certain directors, officers, employees and consultants, as follows:
Option Grant Date
Number of Option Shares
Exercise Price (CAD)
May 26, 2021
20,000
$ 22.50
May 26, 2021
2,000
$ 22.50
May 26, 2021
2,000
$ 22.50
May 26, 2021
2,000
$ 22.50
July 2, 2021
20,000
$ 25.20
September 19, 2021
4,000
$ 24.90
October 22, 2021
2,000
$ 23.40
December 8, 2021
12,667
$ 20.40
February 1, 2022
10,000
$ 16.80
February 1, 2022
2,000
$ 16.80
February 1, 2022
6,667
$ 16.80
February 1, 2022
2,000
$ 16.80
February 1, 2022
31,333
$ 24.00
May 26, 2021
2,000
$ 22.50
May 26, 2021
2,000
$ 22.50
May 26, 2021
3,000
$ 22.50
May 26, 2021
16,000
$ 5.55
May 26, 2021
2,000
$ 22.50
October 22, 2021
1,000
$ 23.40
October 22, 2021
3,000
$ 23.40
December 7, 2021
3,333
$ 30.00
February 1, 2022
3,000
$ 16.80
February 1, 2022
2,000
$ 16.80
February 1, 2022
3,667
$ 16.80
The exercise prices were determined based on the closing price of the
Company’s Common Shares on the Canadian Stock Exchange (the “CSE”) on the day before the grant, as required for
companies listed on the CSE.
In addition, the Company notes that all but one option grant made in
2021 and 2022 were issued at an exercise price well above the Preliminary IPO Price Range.
3
Consolidated Financial Statements, page F-4
4.
As previously requested, please reflect the 1:30 reverse stock split retroactively as of and for your fiscal year ended October 31, 2021.
Response: In response to the Staff’s comment, the Company
has revised its disclosure throughout its consolidated financial statements to reflect the 1:30 reverse stock split retroactively as of
and for its fiscal year ended October 31, 2021.
Notes to the Condensed Interim Consolidated Financial Statements
Lease Liabilities, page F-35
5.
We note you entered into a lease agreement in the third quarter of fiscal year 2021, but there was no right of use asset or related lease liability recognized as of October 31, 2021. Please clarify and tell us when you adopted ASC 842, Leases.
Response: The Company hereby advises the Staff that it reports
under International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board. As of October 31,
2021 the Company did not believe that the adoption of IFRS 16 “Leases” would have had a material effect on the financial statements,
and therefore, it only recorded the right of use assets and related lease liability in its financial statements for the nine month period
ended July 31, 2022.
Please contact me at +1 312 372 2000 if
you have any questions or require any additional information in connection with this letter or the Company’s submission of its draft
Registration Statement on Form S-1.
Sincerely,
/s/ David Huberman
cc: Adi-Zuloff Shani, Chief Executive Officer
4
2022-10-13 - UPLOAD - Clearmind Medicine Inc.
United States securities and exchange commission logo
October 13, 2022
Adi Zuloff-Shani
Chief Executive Officer
Clearmind Medicine Inc.
101 – 1220 West 6th Avenue
Vancouver, British Columbia V6H1A5
Re:Clearmind Medicine Inc.
Amendment No. 3 to Registration Statement on Form F-1
Filed October 6, 2022
File No. 333-265900
Dear Adi Zuloff-Shani:
We have reviewed your amended registration 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 registration 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 registration 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 September 28, 2022 letter.
Amendment No. 3 to Form F-1 filed on October 6, 2022
Capitalization, page 72
1.You indicated on page 10 that the midpoint of the Company's IPO price range is $7 per
share. We further note you disclosed in the capitalization table and the dilution table on
page 72 and page 74, respectively, that $6 per share is the midpoint of the price range.
Please revise to reconcile the discrepancies.
Dilution, page 73
2.Please exclude the intangible assets from your historical net tangible book value and per
share calculation.
FirstName LastNameAdi Zuloff-Shani
Comapany NameClearmind Medicine Inc.
October 13, 2022 Page 2
FirstName LastName
Adi Zuloff-Shani
Clearmind Medicine Inc.
October 13, 2022
Page 2
Description of Share Capital, page 125
3.As previously requested, please explain to us the reasons for any difference between
recent valuation of your common shares leading up to the planned initial public offering
and the mid-point of your estimated offering price range. This information will help
facilitate our review of your accounting for equity issuance including stock
compensation.
Consolidated Financial Statements, page F-4
4.As previously requested, please reflect the 1:30 reverse stock split retroactively as of and
for your fiscal year ended October 31, 2021.
Notes to the Condensed Interim Consolidated Financial Statements
8. Lease Liabilities, page F-35
5.We note you entered into a lease agreement in the third quarter of fiscal year 2021, but
there was no right of use asset or related lease liability recognized as of October 31, 2021.
Please clarify and tell us when you adopted ASC 842, Leases.
You may contact Christie Wong at (202) 551-3684 or Mary Mast at (202) 551-3613
if you have questions regarding comments on the financial statements and related
matters. Please contact Margaret Schwartz at (202) 551-7153 or Joe McCann at (202) 551-
6262 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: David Huberman, Esq.
2022-10-06 - CORRESP - Clearmind Medicine Inc.
CORRESP
1
filename1.htm
October 6, 2022
VIA EDGAR AND EMAIL
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn:
Margaret Schwartz
Jeffrey Gabor
Christie Wong
Mary Mast
Re:
Clearmind Medicine Inc.
Registration Statement on Form F-1
Filed September 20, 2022
File No. 333-265900
Dear Ms. Schwartz:
On behalf of Clearmind Medicine Inc. (the “Company”),
we are writing to submit the Company’s responses to the comments of the staff (the “Staff”) of the Division of
Corporation Finance of the Securities and Exchange Commission (the “Commission”) dated September 29, 2022, relating
to the above referenced Registration Statement on Form F-1 (File No. 333-265900) filed by the Company on September 20, 2022.
Concurrent with the submission of this letter,
the Company is filing via EDGAR Amendment No. 3 to the F-1 (“Amendment No. 3”), which reflects the Company’s
responses to the comments received by the Staff and certain updated information.
For ease of review, we have set forth below each
of the numbered comments of your letter and the Company’s responses thereto. Capitalized terms used herein but not defined herein
have the meanings given to such terms in Registration Statement.
Registration Statement on Form F-1,
Filed September 20, 2022
Cover Page
1.
We note your revised disclosure indicating that your share price on the CSE “may not be indicative of the actual offering price” and that the offering price “may be at a discount to the current market price.” Accordingly, please revise the cover page of the preliminary prospectus to include a bona fide price range of the offered securities or, alternatively, an expected range of deviation from the home market trading price. For additional guidance, refer to Item 501(b)(3) of Regulation S-K.
Response: In response to the Staff’s comment the Company
has revised its disclosure on the cover page and throughout Amendment No. 3 to provide a bona fide price range of the offered securities.
2.
We note that you reference your share price on the TASE, though elsewhere you refer to being listed on the CSE, not the TASE. Please revise to instead refer to the CSE or advise.
Response: In response to the Staff’s comment, the Company
has revised its disclosure on the cover page of Amendment No. 3 to remove reference to the TASE.
Prospectus Summary, page 1
3.
On page 3 and elsewhere you state that Medigus will be entitled to receive 40,471 Common Shares upon the successful completion of your initial public offering pursuant to an anti-dilution mechanism in the Medigus Amendment. On page 11 you state that the offering information presented assumes 1,041,666 Common Shares will be issued pursuant to an anti-dilution provision included in the Medigus Amendment. Please reconcile these figures or advise.
Response: In response to the Staff’s comment, the Company
has reconciled the disclosure on page 11 of Amendment No. 3 to match the disclosure on page 3 of Amendment No. 3 with reference to the
number of Common Shares to be issued to Medigus through the anti-dilution mechanism in the Medigus Amendment.
Dilution, page 73
4.
Please also present the net tangible book value and the per share information in CAD$, to be consistent with the financial statements on page F-25.
Response: In response to the Staff’s comment, the Company
has revised its disclosure on page 73 of Amendment No. 3 to present the net tangible book value and the per share information in CAD$,
to be consistent with the financial statements on page F-25.
Management’s Discussion and Analysis
Components of Operating Results
Year Ended October 31, 2021 Compared to Year Ended October 31, 2020
Net loss, page 77
5.
Please revise the net loss disclosure to agree to the Statement of Operations.
Response: In response to the Staff’s comment, the Company
has revised its disclosure on page 77 of Amendment No. 3 to discuss net loss and comprehensive loss, such that it is now consistent and
agrees with the disclosure in the Statement of Operations.
Consolidated Financial Statements, page F-4
6.
Please reflect the 1:30 reverse stock split retroactively for all periods presented pursuant to SAB Topic 4.C.
Response: In response to the Staff’s comment the Company
has revised its disclosure throughout the consolidated financial statements to reflect the 1:30 reverse stock split retroactively for
all periods presented pursuant to SAB Topic 4.C.
2
Exhibits
7.
Please have counsel revise its opinion, filed as Exhibit 5.1, to revise the limitation on reliance in the last two sentences of the opinion. Refer to Staff Legal Bulletin No. 19, Section II.B.3.d. Please also tell us whether the opinion covers the common shares underlying the 59,896 underwriter’s warrants, which are referenced on page 10. Finally, please revise to remove the following assumption “[T]o the extent the Officer’s Certificate and any other certificate or document referenced herein, is based on any assumption, given in reliance on any other certificate or document, understanding or other criteria or is made subject to any limitation, qualification or exception, our opinions are also based on such assumption, given in reliance on such other certificate, document, understanding or other criteria and are made subject to such limitation, qualification or exception.”
Response: In response to the Staff’s comment the Company
has re-filed Exhibit 5.1 to remove the limitation on reliance in the last two sentences of the opinion. In addition, the Company
has revised Exhibit 5.1 to clarify that the opinion covers the common shares underlying the 66,700 underwriter’s warrants
issued as part of the offering, reflecting the updated deal size. Finally, the Company revised Exhibit 5.1 to remove the aforementioned
assumption.
Please contact me at +1 312 372 2000 if
you have any questions or require any additional information in connection with this letter or the Company’s submission of its draft
Registration Statement on Form S-1.
Sincerely,
/s/ David Huberman
cc: Adi-Zuloff Shani, Chief Executive Officer
3
2022-09-29 - UPLOAD - Clearmind Medicine Inc.
United States securities and exchange commission logo
September 28, 2022
Adi Zuloff-Shani
Chief Executive Officer
Clearmind Medicine Inc.
101 – 1220 West 6th Avenue
Vancouver, British Columbia V6H1A5
Re:Clearmind Medicine Inc.
Amendment No. 2 to Registration Statement on Form F-1
Filed September 20, 2022
File No. 333-265900
Dear Dr. Zuloff-Shani:
We have reviewed your amended registration 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 registration 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 registration 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 September 1, 2022 letter.
Amendment No. 2 to Registration Statement on Form F-1, Filed September 20
Cover Page
1.We note your revised disclosure indicating that your share price on the CSE "may not be
indicative of the actual offering price" and that the offering price "may be at a discount to
the current market price." Accordingly, please revise the cover page of the preliminary
prospectus to include a bona fide price range of the offered securities or, alternatively, an
expected range of deviation from the home market trading price. For additional guidance,
refer to Item 501(b)(3) of Regulation S-K.
2.We note that you reference your share price on the TASE, though elsewhere you refer to
being listed on the CSE, not the TASE. Please revise to instead refer to the CSE or advise.
FirstName LastNameAdi Zuloff-Shani
Comapany NameClearmind Medicine Inc.
September 28, 2022 Page 2
FirstName LastName
Adi Zuloff-Shani
Clearmind Medicine Inc.
September 28, 2022
Page 2
Prospectus Summary, page 1
3.On page 3 and elsewhere you state that Medigus will be entitled to receive 40,471
Common Shares upon the successful completion of your initial public offering pursuant
to an anti-dilution mechanism in the Medigus Amendment. On page 11 you state that the
offering information presented assumes 1,041,666 Common Shares will be issued
pursuant to an anti-dilution provision included in the Medigus Amendment. Please
reconcile these figures or advise.
Dilution, page 73
4.Please also present the net tangible book value and the per share information in CAD$, to
be consistent with the financial statements on page F-25.
Management's Discussion and Analysis
Components of Operating Results
Year Ended October 31, 2021 Compared to Year Ended October 31, 2020
Net loss, page 77
5.Please revise the net loss disclosure to agree to the Statement of Operations.
Consolidated Financial Statements , page F-4
6.Please reflect the 1:30 reverse stock split retroactively for all periods presented pursuant to
SAB Topic 4.C
Exhibits
7.Please have counsel revise its opinion, filed as Exhibit 5.1, to revise the limitation on
reliance in the last two sentences of the opinion. Refer to Staff Legal Bulletin No. 19,
Section II.B.3.d. Please also tell us whether the opinion covers the common shares
underlying the 59,896 underwriter's warrants, which are referenced on page 10. Finally,
please revise to remove the following assumption "[T]o the extent the Officer’s Certificate
and any other certificate or document referenced herein, is based on any assumption,
given in reliance on any other certificate or document, understanding or other criteria or is
made subject to any limitation, qualification or exception, our opinions are also based on
such assumption, given in reliance on such other certificate, document, understanding or
other criteria and are made subject to such limitation, qualification or exception."
FirstName LastNameAdi Zuloff-Shani
Comapany NameClearmind Medicine Inc.
September 28, 2022 Page 3
FirstName LastName
Adi Zuloff-Shani
Clearmind Medicine Inc.
September 28, 2022
Page 3
You may contact Christie Wong at 202-551-3684 or Mary Mast at 202-551-3613 if you
have questions regarding comments on the financial statements and related matters. Please
contact Margaret Schwartz at 202-551-7153 or Joe McCann at 202-551-6262 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: David Huberman, Esq.
2022-09-20 - CORRESP - Clearmind Medicine Inc.
CORRESP
1
filename1.htm
September 20, 2022
VIA EDGAR AND EMAIL
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn:
Margaret Schwartz
Jeffrey Gabor
Christie Wong
Mary Mast
Re:
Clearmind Medicine Inc.
Registration Statement on Form F-1
Filed August 18, 2022
File No. 333-265900
Dear Ms. Schwartz:
On behalf of Clearmind Medicine Inc. (the “Company”),
we are writing to submit the Company’s responses to the comments of the staff (the “Staff”) of the Division of
Corporation Finance of the Securities and Exchange Commission (the “Commission”) dated September 1, 2022, relating
to the above referenced Registration Statement on Form F-1 (File No. 333-265900) filed by the Company on August 18, 2022.
Concurrent with the submission of this letter,
the Company is filing via EDGAR Amendment No. 2 to the F-1 (“Amendment No. 2”), which reflects the Company’s
responses to the comments received by the Staff and certain updated information.
For ease of review, we have set forth below each
of the numbered comments of your letter and the Company’s responses thereto. Capitalized terms used herein but not defined herein
have the meanings given to such terms in Registration Statement.
Registration Statement on Form F-1,
Filed August 18, 2022
Company Overview, page 1
1.
We note your response to our prior comment number 1. Please revise to specifically state how the FDA’s approval of your proposal would accelerate development.
Response: In response to the Staff’s comment, the Company
has revised its disclosure on pages 1 and 83 of Amendment No. 2 to clarify that If the FDA grants the Company the ability to use the
hybrid model that includes AUD patients, the Company’s timeline for the clinical development of MEAI could be accelerated as it
will potentially allow the Company to submit only one IND application, IRB application and one set of study reports for both Phase I
and Phase IIa of its clinical trial. Furthermore, this model allows the Company to reach its target population quicker, hence getting
more substantial safety data on its target population at an earlier stage.
Management’s Discussion and Analysis
Overview, page 76
2.
Please revise here, on pages 13 and 14, and throughout the filing to disclose the net losses for the years ended October 31, 2021 and 2020 in CAD$ that agree with your Statements of Operations on page F-5. In addition, please revise throughout the filing to consistently use CAD$ to denote when the amount is in the Canadian dollar. For example, you disclose net losses for the six months ended April 30, 2022 in CAD$ on page 76, however, your disclosure for the years ended October 31, 2021 and 2020 on the same page uses the $ to discuss your results of operations.
Response: In Response to the Staff's comment, the Company
revised its disclosure throughout Amendment No. 2 to consistently disclose the net losses for the years ended October 31, 2021 and
2020 in CAD$ such that they conform to the Company’s Statements of Operations on page F-5. The Company has also revised its
disclosure throughout Amendment No. 2 to consistently present U.S. dollars as “$” and Canadian dollars as “CAD$.”
Business
Pre-Clinical Studies
National Institute on Drug Abuse Study, page 91
3.
We note your response to our prior comment number 3. Please revise to remove any implication that your product candidate is safe as this determination is solely within the authority of the U.Ss. Food and Drug Administration and comparable regulatory bodies. In this regard, please revise to qualify your statements that your product candidate has “less of a tendency to be abused” and that is offers “a safer alternative to MDMA.” Also it appears premature to state that MEAI and MDMA can both be used for similar forms of pharmaceutical therapy to treat mental health disorders like PTSD and AUD. Additionally, please revise to disclose your assessment that MEAI and MDMA are chemically similar, as you do in your response letter dated August 18, 2022, and clarify more specifically why MEAI might have a lower likelihood of abuse than MDMA.
Response: In response to the Staff’s comment, the Company
has revised its disclosure on page 91 of Amendment No. 2 to clarify that it was the opinion of the authors of the study that MEAI has
less of a tendency to be abused than MDMA. In addition, the Company has removed references to MEAI providing a safer alternative to MDMA.
Further, the Company has clarified that MDMA has not been approved to treat any mental health disorders, and certain treatments containing
MDMA are currently under review by the FDA. Third, the Company has clarified that based on the findings of the authors of the study that
the mechanism of action in MEAI is similar to MDMA, the effects of MDMA and MEAI are similar, as opposed to their chemical composition.
Finally, the Company clarified that the authors of the study found that MEAI has a lower likelihood of abuse than MDMA because, based
on their research, MEAI was shown to release less dopamine and more serotonin when compared to MDMA, and dopamine releases have been shown
in drug abuse literature to create more abuse liability than serotonin releases.
Intellectual Property, page 94
4.
Please revise to clarify that certain pending patent applications were jointly filed with or otherwise involve SciSparc, as you state on page 125.
Response: In response to the Staff’s comment, the Company
has revised its disclosure on page 94 of Amendment No. 2 to clarify that it has filed patent applications jointly with SciSparc covering
(i) compositions comprising MEAI and n-acylethanolamines and uses thereof; and (ii) MEAI for the treatment of cocaine addiction.
1
Certain Relationships and Related Party Transactions
Cooperation Agreement with SciSparc Ltd., page 125
5.
Please file the Cooperation Agreement with SciSparc Ltd. as an exhibit pursuant to Item 601(b)(10) of Regulation S-K.
Response: In response to the Staff’s comment, the Company
has filed its Cooperation Agreement with SciSparc Ltd. as an exhibit to Amendment No. 2.
Please contact me at +1 312 372 2000 if
you have any questions or require any additional information in connection with this letter or the Company’s submission of its draft
Registration Statement on Form S-1.
Sincerely,
/s/ David Huberman
cc: Adi-Zuloff Shani, Chief Executive Officer
2
2022-09-01 - UPLOAD - Clearmind Medicine Inc.
United States securities and exchange commission logo
September 1, 2022
Adi Zuloff-Shani
Chief Executive Officer
Clearmind Medicine Inc.
101 – 1220 West 6th Avenue
Vancouver, British Columbia V6H1A5
Re:Clearmind Medicine Inc.
Amendment No. 1 to Registration Statement on Form F-1
Filed August 18, 2022
File No. 333-265900
Dear Dr. Zuloff-Shani:
We have reviewed your amended registration 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 registration 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 registration 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 July 7, 2022 letter.
Amendment No. 1 to Registration Statement on Form F-1, Filed August 18, 2022
Company Overview, page 1
1.We note your response to our prior comment number 1. Please revise to specifically state
how the FDA’s approval of your proposal would accelerate development.
Management's Discussion and Analysis
Overview, page 76
2.Please revise here, on pages 13 and 14, and throughout the filing to disclose the net losses
for the years ended October 31, 2021 and 2020 in CAD$ that agree with your Statements
of Operations on page F-5. In addition, please revise throughout the filing to consistently
use CAD$ to denote when the amount is in the Canadian dollar. For example, you disclose
FirstName LastNameAdi Zuloff-Shani
Comapany NameClearmind Medicine Inc.
September 1, 2022 Page 2
FirstName LastName
Adi Zuloff-Shani
Clearmind Medicine Inc.
September 1, 2022
Page 2
net losses for the six months ended April 30, 2022 in CAD$ on page 76, however, your
disclosure for the years ended October 31, 2021 and 2020 on the same page uses the $ to
discuss your results of operations.
Business
Pre-Clinical Studies
National Institute on Drug Abuse Study, page 91
3.We note your response to our prior comment number 3. Please revise to remove any
implication that your product candidate is safe as this determination is solely within the
authority of the U.S. Food and Drug Administration and comparable regulatory bodies.
In this regard, please revise to qualify your statements that your product candidate has
"less of a tendency to be abused" and that is offers "a safer alternative to MDMA." Also it
appears premature to state that MEAI and MDMA can both be used for similar forms of
pharmaceutical therapy to treat mental health disorders like PTSD and
AUD. Additionally, please revise to disclose your assessment that MEAI and MDMA are
chemically similar, as you do in your response letter dated August 18, 2022, and clarify
more specifically why MEAI might have a lower likelihood of abuse than MDMA.
Intellectual Property, page 94
4.Please revise to clarify that certain pending patent applications were jointly filed with or
otherwise involve SciSparc, as you state on page 125.
Certain Relationships and Related Party Transactions
Cooperation Agreement with SciSparc Ltd., page 125
5.Please file the Cooperation Agreement with SciSparc Ltd. as an exhibit pursuant to Item
601(b)(10) of Regulation S-K.
You may contact Christie Wong at 202-551-3684 or Mary Mast at 202-551-3613 if you
have questions regarding comments on the financial statements and related matters. Please
contact Margaret Schwartz at 202-551-7153 or Joe McCann at 202-551-6262 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: David Huberman, Esq.
2022-08-18 - CORRESP - Clearmind Medicine Inc.
CORRESP
1
filename1.htm
August
18, 2022
VIA
EDGAR AND EMAIL
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Attn:
Margaret
Schwartz
Jeffrey
Gabor
Christie
Wong
Mary
Mast
Re:
Clearmind Medicine Inc.
Registration Statement on Form F-1
Filed June 29, 2022
File No. 333-265900
Dear
Ms. Schwartz:
On
behalf of Clearmind Medicine Inc. (the “Company”), we are writing to submit the Company’s responses to the comments
of the staff (the “Staff”) of the Division of Corporation Finance of the Securities and Exchange Commission (the “Commission”)
dated July 7, 2022, relating to the above referenced Registration Statement on Form F-1 (File No. 333-265900) submitted by the Company
on June 29, 2022.
Concurrent
with the submission of this letter, the Company is filing via EDGAR Amendment No. 1 to the F-1F-1 (“Amendment No. 1”),
which reflects the Company’s responses to the comments received by the Staff and certain updated information.
For
ease of review, we have set forth below each of the numbered comments of your letter and the Company’s responses thereto. Capitalized
terms used herein but not defined herein have the meanings given to such terms in Registration Statement.
Registration
Statement on Form F-1, Filed June 29, 2022
Company
Overview, page 1
1. We
note your response to prior comment 4. Please revise the disclosure on page 1 to clarify
the significance of FDA having granted you a pre-IND meeting in May 2022. For instance,
it should be clear whether your discussions with FDA confirmed or altered the substance and
timing of your stated development plans.
Response:
In response to the Staff’s comment, the Company has revised its disclosure on pages 1, and 84 of Amendment No. 1 to clarify that
before the pre-IND meeting, the FDA and the company corresponded about not being able to conduct the Phase I portion of the Phase I/IIa
study using only AUD patients. The Company continued to disclose that at the pre-IND meeting, the Company and the FDA discussed the potential
of using a hybrid model consisting of both AUD patients and healthy volunteers in the Phase I portion. In addition, the Company revised
its disclosure to state the significance of the pre-IND meeting, mainly that if the FDA allows for a hybrid model where the Company can
enroll AUD patients in Phase I, the timeline of clinical development of MEAI could accelerate.
Pre-Clinical
Studies, page 89
2. We
note your response to our prior comment number 5, and your added disclosure on page 90: “(p-value
meaning there is a greater than 0.1% chance of the statistic incorrect.” Please revise
this explanation of the disclosed p-value to more clearly explain its meaning and how p-values
are used to measure statistical significance.
Response:
In response to the Staff’s comment, the Company has revised its disclosure on page 91 of Amendment No. 1 to clarify the definition
of “p-value” to more clearly explain its meaning and how p-values are used to measure statistical significance.
National
Institute on Drug Abuse Study, page 90
3. Please
revised to identify the study and indicate when it was conducted and whether it is published.
Additionally, we note the disclosure added to page 90: “This paper concluded that based
on the mechanism of action they elucidated in their work, MEAI has less abuse liability compared
to MDMA, meaning it has less tendency to be used in non-medical situations, even sporadically,
due to underlying psychoactive effects it produces such as euphoria, sedation, or mood changes.”
Please revise to explain in greater detail the basis for the comparison between MEAI and
MDMA and the conclusion, including any limitations of this study.
Response:
In response to the Staff’s comment, the Company has revised its disclosure on page 91 of Amendment No. 1 to indicate where the
aforementioned study was conducted and where it was published. In addition, the Company revised its disclosure to explain that the basis
for comparison between MEAI and MDMA was that the two molecules are chemically comparable and may have similar therapeutic uses. Further,
the Company revised its disclosure to more fully describe the conclusion of the study, which was that MEAI may produce MDMA-like effects
but likely with less abuse liability than MDMA. Finally, the Company revised its disclosure to list limitations of the study.
Research
Agreements, page 92
4.
We note your response to
our prior comment number 7. Please revise to state the exact amount paid in consideration and research fees for the Agreements with
Yissum Research Development Company of the Hebrew University of Jerusalem Ltd and the BIRAD Research and Development Company.
Response:
In response to the Staff’s comment, the Company has revised its disclosure on pages 93-94 of Amendment No. 1 to state the exact
amount paid in consideration and research fees for the Agreements with Yissum and BIRAD.
Please
contact me at +1 312 372 2000 if you have any questions or require any additional information in connection with this letter
or the Company’s submission of its draft Registration Statement on Form S-1.
Sincerely,
/s/
David Huberman
cc: Adi-Zuloff Shani, Chief
Executive Officer
2022-07-07 - UPLOAD - Clearmind Medicine Inc.
United States securities and exchange commission logo
July 7, 2022
Adi Zuloff-Shani
Chief Executive Officer
Clearmind Medicine Inc.
101 – 1220 West 6th Avenue
Vancouver, British Columbia V6H1A5
Re:Clearmind Medicine Inc.
Registration Statement on Form F-1
Filed June 29, 2022
File No. 333-265900
Dear Dr. Zuloff-Shani:
We have reviewed your registration 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 registration 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 registration statement and the information you
provide in response to these comments, we may have additional comments.
Registration Statement on Form F-1, Filed June 29, 2022
Company Overview, page 1
1.We note your response to prior comment 4. Please revise the disclosure on page 1 to
clarify the significance of FDA having granted you a pre-IND meeting in May 2022. For
instance, it should be clear whether your discussions with FDA confirmed or altered the
substance and timing of your stated development plans.
Pre-Clinical Studies, page 89
2.We note your response to our prior comment number 5, and your added disclosure on
page 90: “(p-value meaning there is a greater than 0.1% chance of the statistic incorrect.”
Please revise this explanation of the disclosed p-value to more clearly explain its meaning
and how p-values are used to measure statistical significance.
FirstName LastNameAdi Zuloff-Shani
Comapany NameClearmind Medicine Inc.
July 7, 2022 Page 2
FirstName LastName
Adi Zuloff-Shani
Clearmind Medicine Inc.
July 7, 2022
Page 2
National Institute on Drug Abuse Study, page 90
3.Please revise to identify the study and indicate when it was conducted and whether it is
published. Additionally, we note the disclosure added to page 90: “This paper concluded
that based on the mechanism of action they elucidated in their work, MEAI has less abuse
liability compared to MDMA, meaning it has less tendency to be used in non-medical
situations, even sporadically, due to underlying psychoactive effects it produces such as
euphoria, sedation, or mood changes.” Please revise to explain in greater detail the basis
for the comparison between MEAI and MDMA and the conclusion, including
any limitations of this study.
Research Agreements, page 92
4.We note your response to our prior comment number 7. Please revise to state the exact
amount paid in consideration and research fees for the Agreements with Yissum Research
Development Company of the Hebrew University of Jerusalem Ltd and the BIRAD
Research and Development Company.
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.
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
You may contact Christie Wong at 202-551-3684 or Mary Mast at 202-551-3613 if you
have questions regarding comments on the financial statements and related matters. Please
contact Margaret Schwartz at 202-551-7153 or Joe McCann at 202-551-6262 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: David Huberman, Esq.
2022-06-29 - CORRESP - Clearmind Medicine Inc.
CORRESP
1
filename1.htm
Clearmind Medicine, Inc.
101 – 1220 West 6th Avenue
Vancouver, British Columbia V6H1A5
June 29, 2022
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re: Clearmind Medicine Inc. (the “Company”)
Form
F-1 Filed June 29, 2022
Ladies and Gentlemen:
On June 29, 2022, in accordance with the provisions
of the Jumpstart Our Business Startups Act of 2012, the Company filed with the Securities and Exchange Commission a registration statement
on Form F-1 (the “Registration Statement”) for the initial public offering of the Company’s common shares and
warrants. In connection with the filing of the Registration Statement, reference is hereby made to the Compliance and Disclosure Interpretations,
Fixing America’s Surface Transportation (FAST) Act, Question 1, located at https://www.sec.gov/divisions/corpfin/guidance/fast-act-interps.htm
(the “Interim Financial Statement Guidance”).
In accordance with the Interim
Financial Statement Guidance, the Company has omitted from its Registration Statement interim financial information for the three months
ended January 31, 2022 (the “January Interim Financial Statements”), which the Company has filed in Canada, because
the Company reasonably believes that the Company will not be required to present the January Interim Financial Statements separately at
the time of the offering contemplated by the Registration Statement. Instead, the Company has included in the financial information that
forms a part of the Registration Statement headings for financial and related information for the year ended October 31, 2021 and 2020.
Financial and related information for the six months ended April 30, 2022, will be included in a future amendment to the Registration
Statement.
Should the staff of the Division
of Corporation Finance of the Securities and Exchange Commission have any questions with respect to the foregoing, you may contact our
legal counsel, David Huberman at +1 312 372 2000 or by email at dhuberman@mwe.com,
at the offices of McDermott Will & Emery LLP.
Sincerely,
CLEARMIND MEDICINE INC.
By:
/s/ Adi Zuloff-Shani
Adi Zuloff-Shani
Chief Executive Officer
CC:
David Huberman, McDermott Will & Emery LLP
2022-06-29 - CORRESP - Clearmind Medicine Inc.
CORRESP
1
filename1.htm
June 29, 2022
VIA EDGAR AND EMAIL
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn:
Margaret Schwartz
Jeffrey Gabor
Christie Wong
Mary Mast
Re: Clearmind Medicine Inc.
Amendment No. 2 to Draft Registration Statement on Form F-1
Submitted June 10, 2022
CIK No. 0001892500
Dear Ms. Schwartz:
On behalf of Clearmind Medicine Inc. (the “Company”),
we are writing to submit the Company’s responses to the comments of the staff (the “Staff”) of the Division of
Corporation Finance of the Securities and Exchange Commission (the “Commission”) dated June 21, 2022, relating to the
above referenced Amendment No. 2 to Draft Registration Statement on Form F-1 (CIK No. 0001892500) submitted by the Company on June 10,
2022.
Concurrent with the submission of this letter,
the Company is filing via EDGAR its registration statement F-1 (the “Registration Statement”), which reflects the Company’s
responses to the comments received by the Staff and certain updated information.
For ease of review, we have set forth below each
of the numbered comments of your letter and the Company’s responses thereto. Capitalized terms used herein but not defined herein
have the meanings given to such terms in Registration Statement.
Amendment No. 2 to Draft Registration Statement
on Form F-1, Submitted June 10, 2022
Prospectus Summary
Company Overview, page 1
1. We acknowledge your revised disclosures in response to prior comment 1. Please revise to clarify here that most of these programs
remain in the pre-discovery phase. Also revise to balance your reference to your “highly skilled” team with “deep expertise”
by stating that your team has not yet progressed any product candidate to clinical trials.
Response: In response to the Staff’s comment,
the Company has revised its disclosure on page 1 of the Registration Statement to note that a majority of the additional research programs
are in the pre-discovery phase. In addition, the Company has revised its disclosure on page 82 of the Registration Statement to clarify
that the team leading these additional research programs have progressed numerous product candidates to clinical trials for other companies
they have worked with.
Recent Developments, page 2
2. We note your response to our prior comment number 4. Please revise to define novel food product and
explain briefly the actions required and process involved in seeking approval and marketing of a novel food product that contains psychedelic
substances, including applicable regulatory processes. Please also revise page 103 to explain that food products containing MEAI may be
determined to be illegal, including that a similar product containing MEAI was determined to be illegal in Canada.
Response: In response to the Staff’s comment, the
Company has revised its disclosure on page 3 of the Registration Statement to define “novel food product” and briefly describe
the actions and processes involved in seeking approval and marketing of novel foods. In addition, the Company has revised its disclosure
on page 104 of the Registration Statement to explain that food products containing MEAI may be determined to be illegal, including one
such product found in Canada. The Company went on to disclose that to its knowledge, the product found illegal in Canada was not manufactured
under cGMP conditions, may have contained other substances and no proper regulatory process took place to get the product approved for
sale in Canada.
Business
Overview, page 81
3. We note your response to our prior comment number 6. Please revise the lead-in language to the pipeline table on page 81 to clarify
that the pipeline table represents the current status of development rather than anticipated milestones. We also note that the revised
pipeline table shows that you are at the end of preclinical studies for both binge eating and addiction, but your disclosure on page 88
states that you are continuing to conduct pre-clinical studies. Please revise to describe your preclinical studies for binge eating and
addiction, and if they are ongoing, please revise your pipeline table to correspond to your narrative disclosures, or advise.
Response: In response to the Staff’s comment,
the Company has revised its disclosure on page 81 of the Registration Statement to clarify that the pipeline table represents the current
status of development of MEAI. In addition, the Company has revised the pipeline graphic to shorten the pipelines for its binge eating
and addiction MEAI compounds to better demonstrate that neither has completed pre-clinical studies.
2
Phase I/IIa Clinical Study, page 83
4. We refer to your revised disclosures in response to prior comment 8. You state that you will make a decision based on FDA feedback,
but also note that you state you were granted a pre-IND meeting with the FDA in May. Please revise to update your disclosures as appropriate
to reflect FDA feedback from the meeting.
Response: In response to the Staff’s comment,
the Company has revised its disclosure on page 83 of the Registration Statement to clarify that it intends to submit applications to conduct
its Phase I/IIa study in the European Union, Israel and Australia while it awaits the FDA’s decision on the study in the United
States. Once the Company has full knowledge of where it is approved to conduct the study among the four locations, it will determine the
distribution of the cohorts based on the rate at which it can enroll patients in each location.
Pre-Clinical Studies, page 88
5. We note your response to our prior comment number 9, which we reissue in part. Please revise to expand on your explanations of
the studies conducted by researchers at the Ministry of Agriculture and Rural Development, Volcani Center and Hebrew University and a
researcher from the National Institute on Drug Abuse, National Institutes of Health to provide investors with more context about the significance
of these studies. Additionally, with respect to the disclosed p-value, please provide a brief explanation of the disclosed p-value and
how p-values are used to measure statistical significance. Finally, on page 88 you state: “The data illustrated that MEAI at doses
of 40 mg/kg/day (p>0.001) and above produced a marked and statistically significant reduction in alcohol consumption as compared to
controls, although this did not follow a dose-response.” Please revise to state the meaning of a reduction in alcohol consumption
that did not follow a dose-response and explain the effect observed regarding the reduction in alcohol consumption in the mice. Also for
all studies described, disclose any serious adverse events observed.
Response: In response to the Staff’s comment,
the Company has revised its disclosure on pages 88-89 of the Registration Statement to more clearly provide the significance of the findings
in each of the aforementioned studies. Further, the Company briefly explained the concept of “p-value” and its significance
in the “Binge Alcohol Consumption in Mice” study. In addition, the Company revised its disclosure to more clearly define what
it meant by a reduction in alcohol consumption that did not follow a dose response. Finally, the Company disclosed all serious adverse
events observed (or the absence of any adverse events observed) in all studies mentioned.
Competition, page 89
6. We note your response to our prior comment number 10. In particular, we note the language added under the graphic on page 89, where
you state that the information in the graphic is based on market research and actual information may contradict your findings. We also
note the language on page ii, where you state that you have not independently verified any of the data from third-party sources. It is
not appropriate to directly or indirectly disclaim liability for statements in your registration statement. Please revise the disclosure
on pages 89 and ii or specifically state that you take liability for these statements.
Response: In response to the Staff’s comment,
the Company has revised the graphic on page 90 of the Registration Statement. In addition, the Company has removed the statement disclaiming
liability on page ii of the Registration Statement.
3
Research Agreements, page 90
7. We note your response to our prior comment number 11. You state that under the Agreement with BIRAD Research and Development Company
you have a royalty-bearing license to BIRAD’s ownership rights in any joint inventions or patents that are conceived pursuant to
the research conducted. Please revise to provide the royalty rate or royalty range and royalty term that would apply, or advise. Provide
similar disclosure for the royalty term of the Agreements with Yissum Research Development Company of the Hebrew University of Jerusalem
Ltd., if any. Please also confirm that all termination provisions of the agreements in this section are described, not just those that
provide grounds for you to terminate the agreements.
Response: In response to the Staff’s comment, the
Company has revised its disclosure on page 91 of the Registration Statement to clarify that the terms of royalty rates and ranges for
each license with BIRAD and Yissum will only be determined once the license agreements have been finalized. The Company advised that to
date, no final license agreements have executed, but the Company is currently negotiating one license with BIRAD. In addition, the Company
has revised its disclosure to disclose all grounds to terminate the agreements, including the grounds that Yissum and BIRAD may terminate,
as well as the grounds that the Company may terminate.
4
Please contact me at +1 312 372 2000 if
you have any questions or require any additional information in connection with this letter or the Company’s submission of its draft
Registration Statement on Form S-1.
Sincerely,
/s/ David Huberman
cc: Adi-Zuloff Shani, Chief Executive Officer
5
2022-06-21 - UPLOAD - Clearmind Medicine Inc.
United States securities and exchange commission logo
June 21, 2022
Adi Zuloff-Shani
Chief Executive Officer
Clearmind Medicine Inc.
101 – 1220 West 6th Avenue
Vancouver, British Columbia V6H1A5
Re:Clearmind Medicine Inc.
Amendment No. 2 to Draft Registration Statement on Form F-1
Submitted June 10, 2021
CIK No. 0001892500
Dear Dr. Zuloff-Shani:
We have reviewed your amended draft registration 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 providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR. 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 the information you provide in response to these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Amendment No. 2 to Draft Registration Statement on Form F-1, Submitted June 10, 2022
Prospectus Summary
Company Overview, page 1
1.W acknowledge your revised disclosures in response to prior comment 1. Please revise to
clarify here that most of these programs remain in the pre-discovery phase. Also revise to
balance your reference to your "highly skilled" team with "deep expertise" by stating that
your team has not yet progressed any product candidate to clinical trials.
FirstName LastNameAdi Zuloff-Shani
Comapany NameClearmind Medicine Inc.
June 21, 2022 Page 2
FirstName LastName
Adi Zuloff-Shani
Clearmind Medicine Inc.
June 21, 2022
Page 2
Recent Developments, page 2
2.We note your response to our prior comment number 4. Please revise to define novel food
product and explain briefly the actions required and process involved in seeking approval
and marketing of a novel food product that contains psychedelic substances, including
applicable regulatory processes. Please also revise page 103 to explain that food products
containing MEAI may be determined to be illegal, including that a similar product
containing MEAI was determined to be illegal in Canada.
Business
Overview, page 81
3.We note your response to our prior comment number 6. Please revise the lead-in language
to the pipeline table on page 81 to clarify that the pipeline table represents the current
status of development rather than anticipated milestones. We also note that the revised
pipeline table shows that you are at the end of preclinical studies for both binge eating and
addiction, but your disclosure on page 88 states that you are continuing to conduct pre-
clinical studies. Please revise to describe your preclinical studies for binge eating and
addiction, and if they are ongoing, please revise your pipeline table to correspond to your
narrative disclosures, or advise.
Phase I/IIa Clinical Study, page 83
4.We refer to your revised disclosures in response to prior comment 8. You state that you
will make a decision based on FDA feedback, but also note that you state you were
granted a pre-IND meeting with the FDA in May. Please revise to update your disclosures
as appropriate to reflect FDA feedback from the meeting.
Pre-Clinical Studies, page 88
5.We note your response to our prior comment number 9, which we reissue in part. Please
revise to expand on your explanations of the studies conducted by researchers at the
Ministry of Agriculture and Rural Development, Volcani Center and Hebrew University
and a researcher from the National Institute on Drug Abuse, National Institutes of Health
to provide investors with more context about the significance of these studies.
Additionally, with respect to the disclosed p-value, please provide a brief explanation of
the disclosed p-value and how p-values are used to measure statistical significance.
Finally, on page 88 you state: “The data illustrated that MEAI at doses of 40 mg/kg/day
(p>0.001) and above produced a marked and statistically significant reduction in alcohol
consumption as compared to controls, although this did not follow a dose-response.”
Please revise to state the meaning of a reduction in alcohol consumption that did not
follow a dose-response and explain the effect observed regarding the reduction in alcohol
consumption in the mice. Also for all studies described, disclose any serious adverse
events observed.
FirstName LastNameAdi Zuloff-Shani
Comapany NameClearmind Medicine Inc.
June 21, 2022 Page 3
FirstName LastName
Adi Zuloff-Shani
Clearmind Medicine Inc.
June 21, 2022
Page 3
Competition, page 89
6.We note your response to our prior comment number 10. In particular, we note the
language added under the graphic on page 89, where you state that the information in the
graphic is based on market research and actual information may contradict your
findings. We also note the language on page ii, where you state that you have not
independently verified any of the data from third-party sources. It is not appropriate to
directly or indirectly disclaim liability for statements in your registration statement. Please
revise the disclosure on pages 89 and ii or specifically state that you take liability for these
statements.
Research Agreements, page 90
7.We note your response to our prior comment number 11. You state that under the
Agreement with BIRAD Research and Development Company you have a royalty-bearing
license to BIRAD’s ownership rights in any joint inventions or patents that are conceived
pursuant to the research conducted. Please revise to provide the royalty rate or royalty
range and royalty term that would apply, or advise. Provide similar disclosure for the
royalty term of the Agreements with Yissum Research Development Company of the
Hebrew University of Jerusalem Ltd., if any. Please also confirm that all termination
provisions of the agreements in this section are described, not just those that provide
grounds for you to terminate the agreements.
You may contact Christie Wong at 202-551-3684 or Mary Mast at 202-551-3613 if you
have questions regarding comments on the financial statements and related matters. Please
contact Margaret Schwartz at 202-551-7153 or Dorrie Yale at 202-551-8776 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: David Huberman, Esq.
2022-05-24 - UPLOAD - Clearmind Medicine Inc.
United States securities and exchange commission logo
May 24, 2022
Adi Zuloff-Shani
Chief Executive Officer
Clearmind Medicine Inc.
101 – 1220 West 6th Avenue
Vancouver, British Columbia V6H1A5
Re:Clearmind Medicine Inc.
Amendment No. 1 to Draft Registration Statement on Form F-1
Submitted April 27, 2021
CIK No. 0001892500
Dear Dr. Zuloff-Shani:
We have reviewed your amended draft registration 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 providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR. 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 the information you provide in response to these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Amendment No. 1 to Draft Registration Statement, Submitted on April 27, 2022
Prospectus Summary
Company Overview, page 1
1.We note your response to our prior comment number 2 and that you indicate certain of
your major therapeutic programs that target verticals with significant potential market
opportunities include depression and treatment resistant depression. However, although
you briefly explain why you believe MEAI may be effective in reducing alcohol intake,
you have not included similar disclosure regarding why MEAI may be useful in treating
certain of the other disorders you indicate you will potentially address, such as depression,
anxiety disorder, and post-traumatic stress disorder. As you have only briefly described
pre-clinical studies for binge alcohol consumption, please explain why it is appropriate for
FirstName LastNameAdi Zuloff-Shani
Comapany NameClearmind Medicine Inc.
May 24, 2022 Page 2
FirstName LastNameAdi Zuloff-Shani
Clearmind Medicine Inc.
May 24, 2022
Page 2
you to state that you have "15 different drug research programs." For each current "drug
research program" you reference, please ensure that you have corresponding disclosure
regarding why you believe MEAI may be an appropriate drug for such disorder, and a
description of the material trials conducted to date. You may also separately indicate that
you have future programs you may research.
2.We note your response to our prior comment number 3. In addition to listing the
conditions related to the $238.4 million figure, please revise to state the cost components
of this figure (e.g., the types of treatments that are accounted for, medication costs).
3.Please revise your Summary to affirmatively state that your product candidates contains
psychedelic substances and may be deemed controlled substances, and briefly state the
risks involved, including that you may never be able to commercialize a product candidate
containing psychedelic substances.
Recent Developments, page 2
4.We note on page 2 you discuss the intended joint venture with Medigus, including your
statement on page 2 that "Medigus will be entitled to 10% of the initial equity of such
joint venture." Please state whether you have entered into a binding letter of intent or other
agreement with Medigus, and revise to provide additional known details concerning this
joint venture, such as allocation of intellectual property, duration, and other material
terms. Clarify the equity allocation and whether it will remain constant for the duration of
the joint venture. Additionally, we note that you state Medigus will help with the
development of MEAI for recreational use. Expand your disclosures to state the
jurisdictions in which you expect to target to sell MEAI for recreational use, disclose all
applicable current laws and regulations relating to the ability to develop and market MEAI
for recreational use, including any prohibitions. Add balancing disclosure that MEAI may
never be approved in any jurisdiction as a recreational drug, and ensure that your
regulatory disclosures are updated as appropriate to include a discussion of developing
and marketing MEAI as a recreational drug.
Risk Factors
Our current product candidates and future therapeutic candidates contain psychedelic
substances..., page 19
5.We note your response to our prior comment number 8. Please revise the risk factor to
specifically discuss the consequences if your molecule is determined to be Schedule I by
the DEA. Discuss the process you would need to undergo and the risks if it is never
rescheduled, such as that you can never commercialize your product candidates.
Business
Overview, page 80
6.We note the pipeline table on page 80. Please include a column for Phase III trials and
separate columns for Phase I and II trials since you have not received authorization to
FirstName LastNameAdi Zuloff-Shani
Comapany NameClearmind Medicine Inc.
May 24, 2022 Page 3
FirstName LastNameAdi Zuloff-Shani
Clearmind Medicine Inc.
May 24, 2022
Page 3
proceed with a Phase I/II combined trial and may also not receive such authorization with
respect to any clinical trials of your other product candidates shown in the table. Please
revise the columns so they are clearly delineated from each other and ensure the font and
type used is clearly legible. Please remove the row of MEAI for an indication of
"mechanism of action" from your pipeline table because this is not an indication. Please
remove the language about the expected timing from the arrows; you may show this
information elsewhere such as in an additional column or footnotes. Clarify that these are
anticipated milestones, not definitive timing. Additionally, for each row, ensure your
narrative disclosure corresponds to the information reflected in your graphic. For example,
your narrative disclosure should have corresponding information regarding your trial for
MEAI for binge eating and metabolic disorder, which based on your graphic, is an
ongoing trial that has already commenced. Ensure that your rows accurately reflect your
current progress. For example, since it does not appear you have commenced Phase I
trials, the arrows should end no further than the end of the preclinical trials column for any
of the MEAI rows, and where there are additional pre-clinical trials to be conducted, the
arrow length should reflect that information accordingly. Finally, we note the table shows
three separate rows for research projects at the Hebrew University, none of which name a
compound and all of which cite Mental Health Disorders as the indication. Please tell us
why you feel these programs are material enough to be included in your pipeline table and
included as separate rows.
7.We note your response to our prior comment number 13 and your statement on page 81:
“While determinations of safety and efficacy are solely within the authority of the FDA
and comparable regulatory bodies, in pre-clinical studies, MEAI has shown a promising
safety profile.” Please revise so as to remove any implication that your product candidate
is safe. You may say that your product candidate was well-tolerated. Additionally, we
note your revised disclosure on pages 2 and 81 that preclinical studies suggest that 5-
HT1A receptor agonists "may be effective in reducing alcohol intake." We also refer to
your statements on pages 1 and 80 that a pre-clinical animal model of AUD
"characterize[d] the effect of MEAI on alcohol consumption with promising initial
results," and that such study tested "the efficacy of MEAI’s ability to curb alcohol
cravings." Please revise such statements to remove the implication of efficacy as such
statements are premature.
Phase I/IIa Clinical Study, page 81
8.We refer to your revised disclosure regarding your proposed Phase I/IIa trial, and that the
primary endpoint will be safety and tolerability. You also state that the trial will be
assessing the potential effect of MEAI on drinking patterns and cravings in individuals
with AUD. Please revise to state the primary endpoint that will be used to assess this
effect, or advise. Please also revise to clarify how you intend to distribute the planned 3-5
cohorts among the locations listed (U.S., Europe, Australia, and Israel), or whether these
jurisdictions are all potential options and you may conduct the trial only in the U.S. if your
IND request is approved. In this regard, we note your statement in your response letter
FirstName LastNameAdi Zuloff-Shani
Comapany NameClearmind Medicine Inc.
May 24, 2022 Page 4
FirstName LastNameAdi Zuloff-Shani
Clearmind Medicine Inc.
May 24, 2022
Page 4
that your immediate clinical strategy is not dependent on the receipt of an IND protocol,
as you intend to also submit applications in jurisdictions such as Europe, Australia and
Israel.
Pre-Clinical Studies, page 87
9.We note your response to our prior comment number 17. Please revise to state who
conducted the U.S. based study against the 29 targets. For the rat study, please provide the
number of subjects, dosage, duration and any adverse effects, as well as who conducted
the study. Please also expand on your explanations of these two studies to provide
investors with more context about the significance of these studies. Expand the discussion
of your alcohol consumption study to provide additional context, such as explaining how
the mice were allocated among the different dosages and vehicle. You state that you
performed statistical analysis and found "significant effects." Describe these results and
explain their significance. If you observed statistical significance, provide the p-values, a
brief explanation of the disclosed p-values and how p-values are used to measure
statistical significance.
Competition, page 88
10.We refer to your revised graphic disclosures. With respect to the first chart on page 88,
titled “Psychedelic Therapy Competitive Landscape for AUD,” please remove the row for
Clearmind. This comparison is not appropriate given Clearmind’s compound is in
preclinical stage. Additionally, we note that there appears to be footnotes for some of the
columns, but the corresponding disclosures are missing. With respect to the columns titled
"Immediate Results," Therapy Independent Efficacy," and "Supports Reduction
& Abstinence," which all appear to refer to the efficacy of these drugs, please explain
whether these drugs were all tested in head-to-head comparisons. As it is inappropriate to
make comparisons of the results of drugs without head-to-head trials, if these were not
tested in such trials, please remove these columns, or advise. Please also revise to
name the four companies shown in the second chart on page 88.
Research Agreements, page 89
11.Please expand your description of each of your agreements with Yissum and with BIRAD
to describe: (i) the research being conducted and how it relates to your research programs,
(ii) the amount of the consideration you paid to date and the amount of aggregate
milestone payments, (iii) the royalty term for those agreements that have royalty
obligations, and (iv) the termination provisions of the agreements. In addition, for each of
these agreements, describe the intellectual property transferred, if any.
Intellectual Property, page 90
12.We note your response to our prior comment number 19, which we reissue in part. Given
your statement on page 90 and elsewhere that your portfolio consists of four utility patent
FirstName LastNameAdi Zuloff-Shani
Comapany NameClearmind Medicine Inc.
May 24, 2022 Page 5
FirstName LastName
Adi Zuloff-Shani
Clearmind Medicine Inc.
May 24, 2022
Page 5
families that are assigned to you, please provide the information cited in our prior
comment number 19 for any of your material license or assignment agreements and file
such agreements as exhibits. We note that page 78 references an assignment agreement
whereby the Company acquired patents and patent applications to be used in pre-clinical
drug research programs. Additionally, with respect to the provisional patent
applications, please revise to state whether you currently plan to submit a non-provisional
application for them.
Government Regulation, page 91
13.We note your response to our prior comment number 20 and disagree that disclosure
concerning government regulation of your business in Israel is not material. For instance,
on page 1 you state that you plan to submit applications to conduct a Phase I study in
Israel. Please revise to describe the governmental regulation of your business in Israel.
You may contact Christie Wong at 202-551-3684 or Mary Mast at 202-551-3613 if you
have questions regarding comments on the financial statements and related matters. Please
contact Margaret Schwartz at 202-551-7153 or Dorrie Yale at 202-551-8776 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: David Huberman, Esq.
2022-01-24 - UPLOAD - Clearmind Medicine Inc.
United States securities and exchange commission logo
January 24, 2022
Adi Zuloff-Shani
Chief Executive Officer
Clearmind Medicine Inc.
101 – 1220 West 6th Avenue
Vancouver, British Columbia V6H1A5
Re:Clearmind Medicine Inc.
Draft Registration Statement on Form F-1
Submitted December 27, 2021
CIK No. 0001892500
Dear Dr. Zuloff-Shani:
We have reviewed your draft registration 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 providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR. 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 the information you provide in response to these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Draft Registration Statement on Form F-1, Submitted December 27, 2021
Prospectus Summary
Company Overview, page 1
1.We note your statement that you are approaching Phase 1 clinical trials. Please revise your
Summary to briefly state the current stage of development of MEAI, such as the types of
studies conducted thus far and, if you expect to submit an IND, when.
2.Please revise to briefly describe your other 15 therapeutic programs that also "target
verticals with significant potential market opportunities."
3.On page 1 you state that the amount spent on alcohol use disorders was estimated at $225
billion in the United States in 2019, and on page 79 you state that “[b]etween 2009 and
FirstName LastNameAdi Zuloff-Shani
Comapany NameClearmind Medicine Inc.
January 24, 2022 Page 2
FirstName LastName
Adi Zuloff-Shani
Clearmind Medicine Inc.
January 24, 2022
Page 2
2019, spending on mental health care in the United States increased by more than 50%,
reaching $225 billion.” Please clarify whether both statements are referring to the same
statistic, and if so please revise to reconcile. Please also briefly state the cost components
of the $225 billion figure.
4.Please revise here and in the Business section to briefly describe the steps that you have
taken to date to commence your business and any obstacles involved before you can
commence the planned operations. Please include any contingencies such as raising
additional funds and the timelines and associated costs accompanying each proposed step
in your business plan so that an investor can get a clearer understanding of how and when
you expect to generate revenue.
5.Please clarify the mechanisms of MEAI (5-methoxy-2-aminoindane) and disclose whether
this molecule is synthetic or natural. Please also revise to disclose here and in the
Business section, if true, that you have yet to manufacture any MEAI (5-methoxy-2-
aminoindane) or psychedelics-based products, have not yet sold any products and have yet
to generate any revenue.
Corporate Information, page 2
6.Please revise here to state that you underwent a change of business in September 2020
and May 2021.
Risk Factors
Our current product candidates and future therapeutic candidates may be subject to controlled
substance laws and regulations..., page 19
7.We note that your current product candidates and future product candidates may
potentially be regulated by the DEA as “Controlled Substances” or scheduled substances,
under the CSA. Please revise to clearly disclose the controlled substances or scheduled
substances status of your product candidates, including MEAI (5-methoxy-2-
aminoindane). If you are not able to state the current controlled substances or scheduled
substances status of your product candidates, please disclose the facts and
circumstances that prevent their determination. Additionally, to the extent that regulatory
bodies within the United States, British Columbia, and/or Israel have made any
determinations on the status of MEAI (5-methoxy-2-aminoindane) as a controlled
substances or scheduled substances, please disclose that here and in the Business section.
8.Please revise to present a separate risk factor discussing hallucinogenic or psychedelic
substances generally, including a discussion that your product candidates, including
MEAI (5-methoxy-2-aminoindane) could be determined to be a Schedule I controlled
substance, that you would be dependent on the FDA rescheduling the drug, the
consequences if the FDA does not reschedule the drug, and the possibility that you may be
subject to quotas.
FirstName LastNameAdi Zuloff-Shani
Comapany NameClearmind Medicine Inc.
January 24, 2022 Page 3
FirstName LastName
Adi Zuloff-Shani
Clearmind Medicine Inc.
January 24, 2022
Page 3
Use of Proceeds, page 68
9.Please revise to disclose an estimate of how far in your development of your MEAI
compounds the proceeds from this offering will allow you to reach, including specific
phases of preclinical and clinical trials.
Critical Accounting Policies, page 75
10.Your disclosure refers to Note 2 to your financial statements for significant accounting
policies and estimates. Please revise to provide the disclosure required by Item 303(b)(3)
of Regulation S-K relating to accounting estimates that involve a significant level of
estimation uncertainty and have had or are reasonably likely to have a material impact on
the financial condition or results of operations. It is not anticipated that all of your
accounting policies would fall under critical accounting policies.
Results of Operations
Year Ended October 31, 2021 Compared to Year Ended October 31, 2020
Research and development expenses, page 75
11.Please tell us whether you track your research and development costs by program area. If
so, provide disaggregate disclosure of your research and development expenses by
program for each period presented. If not, state the fact that you do not track such costs by
program area and disclose other quantitative and qualitative disclosure that provides
transparency as to the types of costs incurred.
Business
Overview, page 79
12.We note that you are approaching phase 1 clinical trials. Please disclose your plans if the
FDA or other applicable regulatory bodies do not approve your IND protocol.
13.We refer to your disclosure on page 80 that in pre-clinical studies MEAI has show a "high
safety profile and promising efficacy." Please note that determinations of safety and
efficacy are solely within the authority of the FDA and comparable regulatory bodies;
therefore, please revise your prospectus to remove all references and/or implications
of safety and efficacy.
Strategic Focus, page 80
14.We note your statement on page 80: “Pre-clinical in-vivo results demonstrate longtail
tapering off of activity via oral administration. This may explain the anecdotal reports on
the self-limiting property of MEAI….” Please revise to explain the anecdotal reports you
are referring to, including the limitations thereof, or remove this statement.
FirstName LastNameAdi Zuloff-Shani
Comapany NameClearmind Medicine Inc.
January 24, 2022 Page 4
FirstName LastName
Adi Zuloff-Shani
Clearmind Medicine Inc.
January 24, 2022
Page 4
15.Please revise to clarify the meaning of the following statement on page 81: “An increasing
validation of preclinical clinical and regulatory studies of new psychedelics
pharmacological classes have been approved by the FDA.”
Markets Overview and Opportunity, page 81
16.Please revise the graphic on page 83 to clarify what the $2.05 per drink and $807 per
person represent. For example, is the $807 figure shown the economic cost per person
with alcohol use disorders per year?
17.Please revise to provide more detail concerning the studies you and others have conducted
thus far with respect to MEAI, such as the location of the studies, types of studies, and
results.
Intellectual Property, page 87
18.Please revise your patent discussion to provide the patent expiration dates or expected
patent expiration dates.
19.We note your statement on page 87 that you have entered into three different research
agreements with scientists from the Hebrew University of Jerusalem, and elsewhere you
indicate that you may have entered other similar agreements, such as with Bar Ilan
University. Additionally, on page 45 you state that you are currently party to "license and
collaboration agreements with a number of universities and pharmaceutical companies."
Please revise to disclose each license and collaboration agreement. In your revised
disclosure, disclose to the extent applicable: (i) the nature and scope of intellectual
property transferred, (ii) each parties’ rights and obligations, (iii) the duration of the
agreement and any royalty term, (iv) the termination provisions, (v) up-front or execution
payments received or paid, (vi) aggregate amounts paid or received to date under
agreement, (vii) aggregate future potential milestone payments to be paid or received and
(viii) royalty rates or a royalty range. Please also file the agreements as exhibits pursuant
to Item 601(b)(10) of Regulation S-K or advise. Given your statement on page 87 that
your portfolio consists of four utility patent families that are assigned to you, please also
provide the above information for any of your material license agreements and file such
agreements as exhibits.
Government Regulation, page 88
20.Please revise to describe the government regulation of your business in Israel, including a
discussion of the controlled substance laws and regulations applicable to MEAI (5-
methoxy-2-aminoindane).
Executive Compensation, page 104
21.Please revise to provide the information required by Item 6B of Form 20-F. Please also
disclose the share ownership as required by Item 6.E of Form 20-F.
FirstName LastNameAdi Zuloff-Shani
Comapany NameClearmind Medicine Inc.
January 24, 2022 Page 5
FirstName LastName
Adi Zuloff-Shani
Clearmind Medicine Inc.
January 24, 2022
Page 5
Principal Shareholders, page 113
22.Please revise your disclosure to identify the natural person or persons who have voting
and/or investment control of the shares held by More Provident Fund on page 113.
Description of Share Capital, page 117
23.Once you have an estimated offering price range, please explain to us the reasons for any
differences between recent valuations of your common shares leading up to the planned
initial public offering and the midpoint of your estimated offering price range. This
information will help facilitate our review of your accounting for equity issuance
including stock compensation. Please discuss with the staff how to submit your response.
24.Please revise to provide the information required by Item 10.A.6 and 10.B.6 of Form 20-F
as required by Item 4.a of Form F-1.
Shares Eligible for Future Sale, page 130
25.We note your statement on page 130: “Certain of our existing shareholders, including
entities affiliated with certain of our directors and beneficial owners of greater than 5% of
our share capital, have indicated an interest in purchasing up to an aggregate of $27
million of Common Shares in this offering at the initial public offering price per share.”
Please revise to identify the shareholders that have indicated an interest in purchasing your
shares. To the extent these indications of interest could result in a shareholder acquiring
more than 5% of your shares, or a current 5% shareholder increasing further above 5%
ownership, please also revise the Principal Shareholders section to reflect such.
Underwriting, page 141
26.We note your cover page states: “For a discussion of the factors considered in determining
the initial public offering price of the Common Shares, see “Underwriting.” However, no
such discussion appears in the Underwriting section. Please revise to provide this
information.
General
27.Please supplementally provide us with copies of all written communications, as defined in
Rule 405 under the Securities Act, that you, or anyone authorized to do so on your behalf,
present to potential investors in reliance on Section 5(d) of the Securities Act, whether or
not they retain copies of the communications.
28.We note that you appear to be listed on the Frankfurt Stock Exchange. If so, please
disclose this in the appropriate section. See Item 9.C of Form 20-F, as required by Item
4.a of Form F-1.
FirstName LastNameAdi Zuloff-Shani
Comapany NameClearmind Medicine Inc.
January 24, 2022 Page 6
FirstName LastName
Adi Zuloff-Shani
Clearmind Medicine Inc.
January 24, 2022
Page 6
You may contact Christie Wong at 202-551-3684 or Mary Mast at 202-551-3613 if you
have questions regarding comments on the financial statements and related matters. Please
contact Margaret Schwartz at 202-551-7153 or Jeffrey Gabor at 202-551-2544 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: David Huberman, Esq.