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Pasithea Therapeutics Corp.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2025-11-26
Pasithea Therapeutics Corp.
Summary
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Pasithea Therapeutics Corp.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2025-11-26
Pasithea Therapeutics Corp.
Summary
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Pasithea Therapeutics Corp.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2025-11-24
Pasithea Therapeutics Corp.
Summary
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Pasithea Therapeutics Corp.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2025-11-24
Pasithea Therapeutics Corp.
Summary
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Pasithea Therapeutics Corp.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2025-11-21
Pasithea Therapeutics Corp.
Summary
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Pasithea Therapeutics Corp.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2025-11-21
Pasithea Therapeutics Corp.
Summary
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Pasithea Therapeutics Corp.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2025-11-21
Pasithea Therapeutics Corp.
Summary
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Pasithea Therapeutics Corp.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2025-11-21
Pasithea Therapeutics Corp.
Summary
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Pasithea Therapeutics Corp.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2025-11-19
Pasithea Therapeutics Corp.
Summary
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Pasithea Therapeutics Corp.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2025-11-19
Pasithea Therapeutics Corp.
Summary
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Pasithea Therapeutics Corp.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2025-09-02
Pasithea Therapeutics Corp.
Summary
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Pasithea Therapeutics Corp.
Response Received
2 company response(s)
Medium - date proximity
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Pasithea Therapeutics Corp.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-10-10
Pasithea Therapeutics Corp.
Summary
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Company responded
2024-10-10
Pasithea Therapeutics Corp.
Summary
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Pasithea Therapeutics Corp.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2023-08-15
Pasithea Therapeutics Corp.
Summary
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Company responded
2023-08-21
Pasithea Therapeutics Corp.
References: August 15, 2023
Summary
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Pasithea Therapeutics Corp.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2023-05-19
Pasithea Therapeutics Corp.
Summary
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Company responded
2023-06-01
Pasithea Therapeutics Corp.
Summary
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Pasithea Therapeutics Corp.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2023-04-04
Pasithea Therapeutics Corp.
Summary
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Company responded
2023-04-17
Pasithea Therapeutics Corp.
Summary
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Pasithea Therapeutics Corp.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2022-11-07
Pasithea Therapeutics Corp.
Summary
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Company responded
2022-11-14
Pasithea Therapeutics Corp.
Summary
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Pasithea Therapeutics Corp.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2022-09-30
Pasithea Therapeutics Corp.
Summary
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Pasithea Therapeutics Corp.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2022-07-08
Pasithea Therapeutics Corp.
Summary
Generating summary...
Pasithea Therapeutics Corp.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2021-12-14
Pasithea Therapeutics Corp.
Summary
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Company responded
2021-12-14
Pasithea Therapeutics Corp.
Summary
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Pasithea Therapeutics Corp.
Response Received
6 company response(s)
High - file number match
SEC wrote to company
2021-05-10
Pasithea Therapeutics Corp.
Summary
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Company responded
2021-06-04
Pasithea Therapeutics Corp.
Summary
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2021-06-21
Pasithea Therapeutics Corp.
Summary
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Company responded
2021-08-05
Pasithea Therapeutics Corp.
Summary
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2021-08-26
Pasithea Therapeutics Corp.
Summary
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Company responded
2021-09-10
Pasithea Therapeutics Corp.
Summary
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Company responded
2021-09-10
Pasithea Therapeutics Corp.
Summary
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Pasithea Therapeutics Corp.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2021-08-11
Pasithea Therapeutics Corp.
Summary
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Pasithea Therapeutics Corp.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2021-07-01
Pasithea Therapeutics Corp.
Summary
Generating summary...
Pasithea Therapeutics Corp.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2021-06-16
Pasithea Therapeutics Corp.
Summary
Generating summary...
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-11-26 | Company Response | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2025-11-26 | Company Response | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2025-11-24 | Company Response | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2025-11-24 | Company Response | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2025-11-21 | Company Response | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2025-11-21 | Company Response | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2025-11-21 | Company Response | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2025-11-21 | Company Response | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2025-11-19 | Company Response | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2025-11-19 | Company Response | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2025-09-02 | SEC Comment Letter | Pasithea Therapeutics Corp. | DE | 377-08387 | Read Filing View |
| 2025-05-01 | Company Response | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2025-05-01 | Company Response | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2025-04-14 | SEC Comment Letter | Pasithea Therapeutics Corp. | DE | 377-07863 | Read Filing View |
| 2024-10-10 | Company Response | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2024-10-10 | SEC Comment Letter | Pasithea Therapeutics Corp. | DE | 333-282532 | Read Filing View |
| 2023-08-21 | Company Response | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2023-08-15 | SEC Comment Letter | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2023-06-01 | Company Response | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2023-05-19 | SEC Comment Letter | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2023-04-17 | Company Response | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2023-04-04 | SEC Comment Letter | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2022-11-14 | Company Response | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2022-11-07 | SEC Comment Letter | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2022-09-30 | SEC Comment Letter | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2022-07-08 | SEC Comment Letter | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2021-12-14 | Company Response | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2021-12-14 | SEC Comment Letter | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2021-09-10 | Company Response | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2021-09-10 | Company Response | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2021-08-26 | Company Response | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2021-08-11 | SEC Comment Letter | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2021-08-05 | Company Response | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2021-07-01 | SEC Comment Letter | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2021-06-21 | Company Response | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2021-06-16 | SEC Comment Letter | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2021-06-04 | Company Response | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2021-05-10 | SEC Comment Letter | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-02 | SEC Comment Letter | Pasithea Therapeutics Corp. | DE | 377-08387 | Read Filing View |
| 2025-04-14 | SEC Comment Letter | Pasithea Therapeutics Corp. | DE | 377-07863 | Read Filing View |
| 2024-10-10 | SEC Comment Letter | Pasithea Therapeutics Corp. | DE | 333-282532 | Read Filing View |
| 2023-08-15 | SEC Comment Letter | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2023-05-19 | SEC Comment Letter | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2023-04-04 | SEC Comment Letter | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2022-11-07 | SEC Comment Letter | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2022-09-30 | SEC Comment Letter | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2022-07-08 | SEC Comment Letter | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2021-12-14 | SEC Comment Letter | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2021-08-11 | SEC Comment Letter | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2021-07-01 | SEC Comment Letter | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2021-06-16 | SEC Comment Letter | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2021-05-10 | SEC Comment Letter | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-11-26 | Company Response | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2025-11-26 | Company Response | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2025-11-24 | Company Response | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2025-11-24 | Company Response | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2025-11-21 | Company Response | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2025-11-21 | Company Response | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2025-11-21 | Company Response | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2025-11-21 | Company Response | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2025-11-19 | Company Response | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2025-11-19 | Company Response | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2025-05-01 | Company Response | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2025-05-01 | Company Response | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2024-10-10 | Company Response | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2023-08-21 | Company Response | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2023-06-01 | Company Response | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2023-04-17 | Company Response | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2022-11-14 | Company Response | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2021-12-14 | Company Response | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2021-09-10 | Company Response | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2021-09-10 | Company Response | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2021-08-26 | Company Response | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2021-08-05 | Company Response | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2021-06-21 | Company Response | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
| 2021-06-04 | Company Response | Pasithea Therapeutics Corp. | DE | N/A | Read Filing View |
2025-05-01 - CORRESP - Pasithea Therapeutics Corp.
CORRESP
1
filename1.htm
May 1, 2025
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street NE
Washington, D.C. 20549
Re:
Pasithea Therapeutics Corp.
Registration Statement on Form S-1
File No. 333-286889
Ladies and Gentlemen:
In accordance with Rule 461
under the Securities Act of 1933, as amended (the "Securities Act"), H.C. Wainwright & Co., LLC. ("Wainwright"),
as placement agent on a best-efforts basis, hereby joins Pasithea Therapeutics Corp. in requesting that the Securities and Exchange Commission
take appropriate action to cause the Registration Statement on Form S-1 (File No. 333-286889) (the "Registration Statement")
to become effective on Monday, May 5, 2025, at 12:00 p.m., Eastern Time, or as soon as practicable thereafter. Wainwright affirms that
it is aware of its obligations under the Securities Act as they pertain to the best efforts offering pursuant to the Registration Statement.
[Signature Page Follows]
Very truly yours,
H.C. WAINWRIGHT & CO., LLC.
By:
/s/ Edward
D. Silvera
Name:
Edward D. Silvera
Title:
Chief Operating Officer
[Signature Page to Acceleration Request]
2025-05-01 - CORRESP - Pasithea Therapeutics Corp.
CORRESP 1 filename1.htm May 1, 2025 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Pasithea Therapeutics Corp. (the “Company”) Registration Statement on Form S-1 (File No. 333-333-286889 ) Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, the Company hereby requests that the above-referenced Registration Statement (the “Registration Statement”) be declared effective by the Securities and Exchange Commission at 12 p.m., Eastern Time, on May 5, 2025, or as soon as practicable thereafter. The Company hereby authorizes James B. O'Grady of Lowerstein Sandler LLP, the Company's outside legal counsel, to orally modify or withdraw this request for acceleration. Please call Mr. O’Grady at (646) 414-6849 to confirm the effectiveness of the Registration Statement or with any questions. Very truly yours, PASITHEA THERAPEUTICS CORP. By: /s/ Dr. Tiago Reis Marques Dr. Tiago Reis Marques Chief Executive Officer
2025-04-14 - UPLOAD - Pasithea Therapeutics Corp. File: 377-07863
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> April 14, 2025 Tiago Reis Marques Chief Executive Officer Pasithea Therapeutics Corp. 1111 Lincoln Road, Suite 500 Miami Beach, Florida 33139 Re: Pasithea Therapeutics Corp. Draft Registration Statement Submitted April 7, 2025 CIK No. 0001841330 Dear Tiago Reis Marques: This is to advise you that we do not intend to review your registration statement. We request that you publicly file your registration statement at least two business days prior to the requested effective date and time. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Tim Buchmiller at 202-551-3635 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: James O Grady, Esq. </TEXT> </DOCUMENT>
2024-10-10 - CORRESP - Pasithea Therapeutics Corp.
CORRESP
1
filename1.htm
October 10, 2024
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
Mail Stop 4720
100 F Street, N.E.
Washington, D.C. 20549
Re:
Pasithea Therapeutics Corp.
Registration Statement on Form S-3
File No. 333-282532
Acceleration Request
Requested Date:
October 11, 2024
Requested Time:
5:00 p.m., Eastern Time
Dear Ladies and Gentlemen:
Pursuant to Rule 461
under the Securities Act of 1933, as amended, Pasithea Therapeutics Corp. (the “Company”) hereby requests that the above-referenced
Registration Statement (the “Registration Statement”) be declared effective by the Securities and Exchange Commission (the
“Commission”) at the “Requested Date” and “Requested Time” set forth above or at such later time as
the Company or its counsel may orally request via telephone call to the staff of the Division of Corporation Finance of the Commission.
Please call Tracy Buffer of Lowenstein Sandler LLP
at (973) 597-2434 to confirm the effectiveness of the Registration Statement or with any questions.
Sincerely,
PASITHEA THERAPEUTICS CORP.
By:
/s/ Tiago Reis Marques
Name:
Tiago Reis Marques
Title:
Chief Executive Officer
2024-10-10 - UPLOAD - Pasithea Therapeutics Corp. File: 333-282532
October 10, 2024
Tiago Reis Marques
Chief Executive Officer
Pasithea Therapeutics Corp.
1111 Lincoln Road, Suite 500
Miami Beach, FL 33139
Re:Pasithea Therapeutics Corp.
Registration Statement on Form S-3
Filed October 7, 2024
File No. 333-282532
Dear Tiago Reis Marques:
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 Daniel Crawford at 202-551-7767 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Tracy Buffer, Esq.
2023-08-21 - CORRESP - Pasithea Therapeutics Corp.
CORRESP
1
filename1.htm
James B. O’Grady
1251 Avenue of the Americas
Partner
New York, New York 10020
T (646) 414-6849
E: jogrady@lowenstein.com
August 21, 2023
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
Attention:
Christina Chalk
Blake Grady
Re:
Pasithea Therapeutics Corp.
Schedule TO-I filed on August 9, 2023
File No. 005-92867
Ladies and Gentlemen:
On behalf of Pasithea Therapeutics Corp. (the “Company”), we hereby submit this letter in response to comments from the staff (the “Staff”)
of the Securities and Exchange Commission (the “Commission”) contained in its letter dated August 15, 2023 (the “Comment Letter”), relating to the above referenced
Schedule TO filed with the Commission (the “Schedule TO”). We are concurrently filing via EDGAR this letter and an amendment to the Schedule TO (“Amendment No. 2”).
In this letter, we have recited the comments from the Staff in italicized, bold type and have followed each comment with the Company’s response in ordinary type.
Securities and Exchange Commission
Division of Corporation Finance
August 21, 2023
Page 2
The Company has authorized us to respond to the Comment Letter as follows:
Schedule TO-I filed August 9, 2023
General
1. We note your disclosure that if you “have not accepted for payment the Shares [stockholders] have tendered to [you] by 5:00 P.M., New York City time, on October
5, 2023, the 40th business day from the commencement of the Offer, [stockholders] may also withdraw [their] Shares at any time thereafter.” Please reconcile this date with the requirement set forth in Exchange Act Rule 13e-4(f)(2)(ii) and the
definition of business day in Rule 13e-4(a)(3).
Response: The Company respectfully acknowledges the Staff’s comment and the Company has revised the disclosure on pages 5 and 20 to make it clear that October 6th, 2023 is the 40th
business day from the commencement of the Offer.
2. Given the significant percentage of outstanding Shares sought in the Tender Offer, please supplementally explain your conclusion that pro forma financial
information showing the effect of the Tender Offer (if fully subscribed) are not required pursuant to Item 10 of Schedule TO and Item 1010(b) of Regulation M-A.
Response: The Company does not believe that the pro forma financial information described in Item 1010(b) of Regulation M-A is material under the circumstances. The Company notes that Instruction 2 to
Item 10 of Schedule TO indicates that financial statements are not material to a tender offer if (i) the consideration offered consists solely of cash, (ii) there is no financing condition to the offer and (iii) the offeror is a public reporting
company under Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended, that files reports electronically on EDGAR. The Company confirms to the Staff that all three of these conditions are satisfied in the present tender offer.
As disclosed on pages 8 and 15 of the Offer to Purchase, the accounting for the purchase of shares of common stock in the Offer will result in (i) a reduction of our total equity in an amount equal to the aggregate
purchase price of the shares we purchase, (ii) a corresponding reduction in cash and cash equivalents and (iii) a reduction in the weighted average number of outstanding shares for the purposes of calculating earnings per share in an amount equal to
the weighted average number of shares that we repurchase pursuant to the Offer.
Purpose of the Offer; Certain Effects of the Offer; Plans and Proposals, page 14
3. We note your disclosure that in determining to proceed with the offer, management and the Board of Directors “considered certain evaluations of [y]our current
assets and business development strategies.” Please revise this statement to provide additional detail regarding such evaluations and how they informed your intention to seek to purchase approximately 21.9% of the outstanding Shares. Refer to Item
1006(a) and Item 1011(c) of Regulation M-A.
Securities and Exchange Commission
Division of Corporation Finance
August 21, 2023
Page 3
Response: The Company respectfully acknowledges the Staff’s comment and the Company has revised the disclosure on pages 1 and 13 to include more disclosure regarding management’s and the Board of
Directors’ considerations of the Company’s assets and business development strategies and how they informed the decision to pursue the Offer.
Conditions of the Offer, page 22
4. You have included a condition that will be triggered by “any general suspension of trading in, or limitation on prices for, securities on any United States
national securities exchange or in the over-the-counter market.” Please revise to explain what would be considered a limitation on prices for securities on any United States national securities exchange or in the over-the-counter market.
Response: The Company respectfully acknowledges the Staff’s comment and the Company has revised the disclosure on pages 3 and 23 to remove the reference to the limitation on prices.
5. We note the following statement on page 24: “Any determination by us concerning the events described above will be final and binding on all parties.” Please
revise this statement to include a qualifier indicating that stockholders are not foreclosed from challenging your determination in a court of competent jurisdiction.
Response: The Company respectfully acknowledges the Staff’s comment and the Company has revised the disclosure on page 22 to state that stockholders are not foreclosed from challenging the Company’s
determination in a court of competent jurisdiction.
6. Refer to the first paragraph in this section and the statement in the parenthetical that your own actions or inactions may "trigger" an offer condition and allow
you to terminate this tender offer. All offer conditions must be objective and outside the control of the bidder in a tender offer to avoid implicating Regulation 14E's prohibition on illusory offers. Revise the language in the parenthetical
accordingly, to avoid implying that your own actions or inactions may allow you to terminate the offer.
Response: The Company respectfully acknowledges the Staff’s comment and the Company has revised the disclosure on page 22 to remove reference to any action by the Company may allow for termination of the
offer.
7. Refer to the third bullet point on page 23, which allows you to terminate this tender offer based on a "material change in United States or any other currency
exchange rates or a suspension of or limitation on the markets therefor." A condition that is triggered by any significant change in ANY currency exchange rates of any currency would appear to be extremely broad and difficult to measure. Please
revise to quantify how a material change would be measured in this context, or advise.
Securities and Exchange Commission
Division of Corporation Finance
August 21, 2023
Page 4
Response: The Company respectfully acknowledges the Staff’s comment and the Company has revised the disclosure on pages 3 and 23 to remove reference to any other currency exchange rates.
Incorporation by Reference, page 25
8. Refer to the following disclosure on page 25 of the offer materials: "Any statement contained in any document incorporated by reference into this Offer to
Purchase shall be deemed to be modified or superseded to the extent that an inconsistent statement is made in this Offer to Purchase or any subsequently filed document. Any statement so modified or superseded shall not be deemed, except as so
modified or superseded, to constitute a part of this Offer to Purchase." To the extent that information in this Offer to Purchase materially changes, these offer materials must be amended. See Rule 13e-4(c)(3). Please revise to confirm, and to
avoid implying that an obligation to amend may be satisfied by any (emphasis added) subsequently filed document.
Response: The Company respectfully acknowledges the Staff’s comment and the Company has revised the disclosure on page 26 to make it clear that if any material changes were to occur that would require an
amendment to the Offer to Purchase, the Company would amend the Offer to Purchase and any related documents.
Any questions regarding the contents of this letter or Amendment No. 2 should be addressed to the undersigned at (646) 414-6849.
Very truly yours,
/s/ James B. O’Grady
James B. O’Grady
cc:
Tiago Reis Marques, Ph.D., Pasithea Therapeutics Corp.
2023-08-15 - UPLOAD - Pasithea Therapeutics Corp.
United States securities and exchange commission logo
August 15, 2023
James O’Grady
Partner
Lowenstein Sandler LLP
1251 Avenue of the Americas
New York, New York 10020
Re:Pasithea Therapeutics Corp.
Schedule TO-I filed August 9, 2023
File No. 005-92867
Dear James O’Grady:
We have reviewed your filing 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 these comments by providing the requested information or advise us as
soon as possible when you will respond. If you do not believe our comments apply to your facts
and circumstances, please tell us why in your response.
After reviewing your response to these comments, we may have additional comments.
Defined terms used herein have the same meaning as in your filing.
Schedule TO-I filed August 9, 2023
General
1.We note your disclosure that if you “have not accepted for payment the Shares
[stockholders] have tendered to [you] by 5:00 P.M., New York City time, on October 5,
2023, the 40th business day from the commencement of the Offer, [stockholders] may
also withdraw [their] Shares at any time thereafter.” Please reconcile this date with the
requirement set forth in Exchange Act Rule 13e-4(f)(2)(ii) and the definition of business
day in Rule 13e-4(a)(3).
2.Given the significant percentage of outstanding Shares sought in the Tender Offer, please
supplementally explain your conclusion that pro forma financial information showing the
effect of the Tender Offer (if fully subscribed) are not required pursuant to Item 10 of
Schedule TO and Item 1010(b) of Regulation M-A.
Purpose of the Offer; Certain Effects of the Offer; Plans and Proposals, page 14
FirstName LastNameJames O’Grady
Comapany NameLowenstein Sandler LLP
August 15, 2023 Page 2
FirstName LastNameJames O’Grady
Lowenstein Sandler LLP
August 15, 2023
Page 2
3.We note your disclosure that in determining to proceed with the offer, management and
the Board of Directors “considered certain evaluations of [y]our current assets and
business development strategies.” Please revise this statement to provide additional detail
regarding such evaluations and how they informed your intention to seek to purchase
approximately 21.9% of the outstanding Shares. Refer to Item 1006(a) and Item 1011(c)
of Regulation M-A.
Conditions of the Offer, page 22
4.You have included a condition that will be triggered by “any general suspension of trading
in, or limitation on prices for, securities on any United States national securities exchange
or in the over-the-counter market.” Please revise to explain what would be considered a
limitation on prices for securities on any United States national securities exchange or in
the over-the-counter market.
5.We note the following statement on page 24: “Any determination by us concerning the
events described above will be final and binding on all parties.” Please revise this
statement to include a qualifier indicating that stockholders are not foreclosed from
challenging your determination in a court of competent jurisdiction.
6.Refer to the first paragraph in this section and the statement in the parenthetical that your
own actions or inactions may "trigger" an offer condition and allow you to terminate this
tender offer. All offer conditions must be objective and outside the control of the bidder
in a tender offer to avoid implicating Regulation 14E's prohibition on illusory offers.
Revise the language in the parenthetical accordingly, to avoid implying that your own
actions or inactions may allow you to terminate the offer.
7.Refer to the third bullet point on page 23, which allows you to terminate this tender offer
based on a "material change in United States or any other currency exchange rates or a
suspension of or limitation on the markets therefor." A condition that is triggered by any
significant change in ANY currency exchange rates of any currency would appear to be
extremely broad and difficult to measure. Please revise to quantify how a material change
would be measured in this context, or advise.
Incorporation by Reference, page 25
8.Refer to the following disclosure on page 25 of the offer materials: "Any statement
contained in any document incorporated by reference into this Offer to Purchase shall be
deemed to be modified or superseded to the extent that an inconsistent statement is made
in this Offer to Purchase or any subsequently filed document. Any statement so modified
or superseded shall not be deemed, except as so modified or superseded, to constitute a
part of this Offer to Purchase." To the extent that information in this Offer to Purchase
materially changes, these offer materials must be amended. See Rule 13e-4(c)(3). Please
revise to confirm, and to avoid implying that an obligation to amend may be satisfied
by any (emphasis added) subsequently filed document.
FirstName LastNameJames O’Grady
Comapany NameLowenstein Sandler LLP
August 15, 2023 Page 3
FirstName LastName
James O’Grady
Lowenstein Sandler LLP
August 15, 2023
Page 3
We remind you that the filing persons are responsible for the accuracy and adequacy of
their disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please direct any questions to Christina Chalk at (202) 551-3263 or Blake Grady at (202)
551-8573.
Sincerely,
Division of Corporation Finance
Office of Mergers & Acquisitions
2023-06-01 - CORRESP - Pasithea Therapeutics Corp.
CORRESP
1
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June 1, 2023
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Pasithea Therapeutics Corp. (the “Company”)
Registration Statement on Form S-3 (File No. 333-271896)
Ladies and Gentlemen:
In accordance with Rule 461 under
the Securities Act of 1933, as amended, the Company hereby requests that the above-referenced Registration Statement (the “Registration
Statement”) be declared effective by the Securities and Exchange Commission at 4:00 p.m., Eastern Time, on June 5, 2023, or as soon
as practicable thereafter.
Please call James O’Grady
of Lowenstein Sandler LLP at (646) 414-6849 to confirm the effectiveness of the Registration Statement or with any questions.
Very truly yours,
PASITHEA THERAPEUTICS CORP.
By:
/s/ Tiago Reis Marques
Name:
Tiago Reis Marques
Title:
Chief Executive Officer
(Principal Executive Officer)
2023-05-19 - UPLOAD - Pasithea Therapeutics Corp.
United States securities and exchange commission logo
May 19, 2023
Tiago Reis Marques, M.D., Ph.D.
Chief Executive Officer
Pasithea Therapeutics Corp.
1111 Lincoln Road, Suite 500
Miami Beach, FL 33139
Re:Pasithea Therapeutics Corp.
Registration Statement on Form S-3
Filed May 12, 2023
File No. 333-271896
Dear Tiago Reis Marques:
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 Tyler Howes at 202-551-3370 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: James O’Grady, Esq.
2023-04-17 - CORRESP - Pasithea Therapeutics Corp.
CORRESP
1
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Pasithea Therapeutics Corp.
1111 Lincoln Road, Suite 500
Miami Beach, Florida 33139
Tel: (702) 514-4174
April 17, 2023
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Pasithea Therapeutics Corp.
Registration Statement on Form S-3 (File No. 333-271010)
Filed on March 30, 2023
Ladies and Gentlemen:
Pasithea Therapeutics Corp. (the
“Registrant”) hereby requests that the U.S. Securities and Exchange Commission (the “Commission”) take appropriate
action to cause the above-referenced Registration Statement on Form S-3 to become effective on Wednesday April 19, 2023, at 4:05
p.m., Eastern Time, or as soon thereafter as is practicable or at such later time as the Registrant, or its representative, may orally
request via telephone call to the staff of the Commission.
Please call James O’Grady
of Lowenstein Sandler LLP at (646) 414-6849 to confirm the effectiveness of the Registration Statement or with any questions.
Very truly yours,
PASITHEA THERAPEUTICS CORP.
By:
/s/ Tiago Reis Marques
Name:
Tiago Reis Marques
Title:
Chief Executive Officer
2022-11-14 - CORRESP - Pasithea Therapeutics Corp.
CORRESP
1
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mwe.com
Heidi Steele
Attorney at Law
hsteele@mwe.com
+1 312 984 3624
November 14, 2022
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Pasithea Therapeutics Corp.
Schedule 14A Response to SEC comments
Ladies and Gentelment:
On behalf of our client, Pasithea Therapeutics
Corp. (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”)
provided in a letter to the Company dated November 7, 2020 dated February 6, 2019, relating to the above referenced Schedule 14A of the
Company filed with the Commission on November 1, 2022 (the “Proxy Statement”).
The Company is concurrently submitting via EDGAR
this letter and a revised Proxy Statement that reflects the Company’s responses to the comments received by the Staff and certain
updated information. For your convenience, the Company is also delivering via email delivery a copy of this letter together with a courtesy
copy of the revised Proxy Statement, marked to show changes from Proxy Statement as originally filed.
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 Proxy Statement Statement.
Comment 1: You must avoid issuing statements that
directly or indirectly impugn the character, integrity or personal reputation or make charges of illegal, improper or immoral conduct
without factual foundation. Note that the factual foundation for such assertion must be reasonable. Refer to Rule 14a-9. Provide
us supplementally, or disclose, the factual foundation for your statement that the company "is likely to be run for the sole benefit
of the Dissident Group.”
Response: While the Company believes
that the Dissident Group plans to operate the Company for its own self-interest, we have removed the reference to this belief in the Proxy
Statement as revised.
November 14, 2022
Page 2
Comment 2: Each statement or assertion of opinion
or belief must be clearly characterized as such, and a reasonable factual basis must exist for each such opinion or belief. Support for
opinions or beliefs should be self-evident, disclosed in the proxy statement or provided to the staff on a supplemental basis. Provide
support for the statements in the bullet points at the end of page 11. We note, with respect to the second bullet point, that security
holders would continue to have as much of a "say in the future" as they currently do through their annual vote for the election
of directors. We note, with respect to the third, fourth and fifth bullet points, that the Dissident Group has not made any statement
in its preliminary proxy statement about liquidating the company or acquiring other companies.
Response: With respect to the Staff’s
comment regarding the second bullet, we have removed the bullet stating that on the stockholders’ “say in the future”.
With respect to the third, fourth and fifth bullet points, in a communication to stockholders filed with the Commission on July 25, 2022,
the Dissident Group outlined its proposed strategic review where it identified on page 16 of the communication the following options:
(i) “whether to keep, sell or close the Ketamine Clinics,” (ii) “evaluated a spin-off or sale of the drug development
pipeline,” (iii) “strategic combinations or acquisitions or cash flow positive businesses with excess cash”,
and (iv) “a partial or full return of capital to shareholders.” [emphasis added] The options identified in clauses
(iii) and (iv) reference acquisitions and full return of capital to stockholders which is a liquidation. The Dissident Group has not made
any updates to this communication that suggest that these plans have been changed by the Dissident Group.
The Company thanks the Staff for its time and consideration.
November 14, 2022
Page 3
Please direct any questions that you may have with
respect to the foregoing or any requests for supplemental information to Heidi Steele at (312) 984-3624.
Very truly yours,
Heidi Steele
HS/lr
cc:
Tiago Reis Marques
Chief Executive Officer and Director
Pasithea Therapeutics Corp.
2022-11-07 - UPLOAD - Pasithea Therapeutics Corp.
United States securities and exchange commission logo
November 7, 2022
Heidi Steele
Partner
McDermott Will & Emery LLP
444 West Lake Street
Suite 4000
Chicago, IL 60606-0029
Re:Pasithea Therapeutics Corp.
Preliminary Proxy Statement
Filed November 1, 2022
File No. 001-40804
Dear Heidi Steele:
We have reviewed your filing 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 these comments by providing the requested information or advise us as
soon as possible when you will respond. If you do not believe our comments apply to your facts
and circumstances, please tell us why in your response.
After reviewing your response to these comments, we may have additional comments.
Preliminary Proxy Statement
Proposals 1A through 1E, page 10
1.You must avoid issuing statements that directly or indirectly impugn the character,
integrity or personal reputation or make charges of illegal, improper or immoral conduct
without factual foundation. Note that the factual foundation for such assertion must be
reasonable. Refer to Rule 14a-9. Provide us supplementally, or disclose, the factual
foundation for your statement that the company "is likely to be run for the sole benefit of
the Dissident Group."
2.Each statement or assertion of opinion or belief must be clearly characterized as such, and
a reasonable factual basis must exist for each such opinion or belief. Support for opinions
or beliefs should be self-evident, disclosed in the proxy statement or provided to the staff
on a supplemental basis. Provide support for the statements in the bullet points at the end
FirstName LastNameHeidi Steele
Comapany NameMcDermott Will & Emery LLP
November 7, 2022 Page 2
FirstName LastName
Heidi Steele
McDermott Will & Emery LLP
November 7, 2022
Page 2
of page 11. We note, with respect to the second bullet point, that security holders would
continue to have as much of a "say in the future" as they currently do through their annual
vote for the election of directors. We note, with respect to the third, fourth and fifth bullet
points, that the Dissident Group has not made any statement in its preliminary proxy
statement about liquidating the company or acquiring other companies.
We remind you that the filing persons are responsible for the accuracy and adequacy of
their disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please direct any questions to Dan Duchovny at 202-551-3619.
Sincerely,
Division of Corporation Finance
Office of Mergers & Acquisitions
2022-09-30 - UPLOAD - Pasithea Therapeutics Corp.
United States securities and exchange commission logo
September 30, 2022
Douglas Schnell
Partner
Wilson Sonsini Goodrich & Rosati
650 Page Mill Road
Palo Alto, CA 94304
Re:Pasithea Therapeutics Corp.
Preliminary Proxy Statement filed by Concord IP2 LTD. et. al.
Filed September 23, 2022
File No. 001-40804color:white;"_
Soliciting Materials filed pursuant to Rule 14a-12
Filed September 29, 2022
File No. 001-40804
Dear Mr. Schnell:
We have reviewed your filings 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 these comments by providing the requested information or advise us as
soon as possible when you will respond. If you do not believe our comments apply to your facts
and circumstances, please tell us why in your response.
After reviewing your response to these comments, we may have additional comments.
Preliminary Proxy Statement
General, page i
1.It has come to our attention that the company has disputed your ability to require the
company to call a special meeting of security holders as a result of not having delivered
sufficient valid shareholder consents. Please revise your disclosure to describe the dispute
and the effects this dispute may have on the special meeting being called.
Cover Page, page 1
2.Each statement or assertion of opinion or belief must be clearly characterized as such, and
a reasonable factual basis must exist for each such opinion or belief. Support for opinions
FirstName LastNameDouglas Schnell
Comapany NameWilson Sonsini Goodrich & Rosati
September 30, 2022 Page 2
FirstName LastName
Douglas Schnell
Wilson Sonsini Goodrich & Rosati
September 30, 2022
Page 2
or beliefs should be self-evident, disclosed in the proxy statement or provided to the staff
on a supplemental basis. Provide support for the following statements:
•That Mr. Delaney, Mr. Geller and Mr. Shahinian each "have a track record of
investing success, including in situations like those at Pasithea ." (emphasis added)
•That "...management’s alarming (negative) track record and believe that the Board
has made decisions that are not in the best interests of stockholders."
•That the company completed the "...acquisition of a business that we believe was
and is largely non-existent and worthless." With respect to this bullet point, please
include supporting disclosure in the proxy statement.
Reasons for this Proxy Solicitation, page 1
3.Please revise your first bullet point to state that the stock has been traded for 12 months,
not nine.
Questions and Answers about this Proxy Solicitation, page 2
4.Please revise the answer to the last question on page 4 to state whether shareholders will
vote on the election of your nominees at the current meeting or at a later date.
Soliciting Material filed pursuant to Rule 14a-12
Cover Letter, page 1
5.As noted above, we understand the company has disputed the validity of the consents you
delivered as support for your request that company call a special meeting of security
holders. Please confirm that you will include a reference to this dispute in any future
soliciting materials.
6.You must avoid issuing statements that directly or indirectly impugn the character,
integrity or personal reputation or make charges of illegal, improper or immoral conduct
without factual foundation. Provide us supplementally, or disclose, the factual foundation
for the statements included below. In this regard, note that the factual foundation for such
assertion must be reasonable. Refer to Rule 14a-9.
•That the company is "wasting stockholders' capital" by not calling the special
meeting.
•That the company board "would rather dig its heels in than honor the will of
stockholders."
•The company board has "attempt[ed] to maintain control."
7.Please revise your disclosure to remove the sentence "We are pleased that Dr. Steinman
determined that stepping down from this position was in the Company’s best interest" or
provide support for the statement. The company's filing contains no such statement.
FirstName LastNameDouglas Schnell
Comapany NameWilson Sonsini Goodrich & Rosati
September 30, 2022 Page 3
FirstName LastName
Douglas Schnell
Wilson Sonsini Goodrich & Rosati
September 30, 2022
Page 3
We remind you that the filing persons are responsible for the accuracy and adequacy of
their disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please direct any questions to Daniel Duchovny at (202) 551-3619.
Sincerely,
Division of Corporation Finance
Office of Mergers & Acquisitions
2022-07-08 - UPLOAD - Pasithea Therapeutics Corp.
United States securities and exchange commission logo
July 8, 2022
Douglas Schnell
Partner
Wilson Sonsini Goodrich & Rosati
650 Page Mill Road
Palo Alto, CA 94304
Re:Pasithea Therapeutics Corp.
Preliminary Proxy Statement filed by Concord IP2 LTD. et. al.
Filed July 1, 2022
File No. 001-40804
Dear Mr. Schnell:
We have reviewed your filing 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 these comments by providing the requested information or advise us as
soon as possible when you will respond. If you do not believe our comments apply to your facts
and circumstances, please tell us why in your response.
After reviewing your response to these comments, we may have additional comments.
Preliminary Proxy Statement
Cover letter, page 1
1.Please describe any effects of removing all of the company's directors on the company's
contractual obligations.
2.Each statement or assertion of opinion or belief must be clearly characterized as such, and
a reasonable factual basis must exist for each such opinion or belief. Support for opinions
or beliefs should be self-evident, disclosed in the proxy statement or provided to the staff
on a supplemental basis. Provide support for the following statements.
•"Each of the Concerned Stockholders has a track record of investing success,
including in situations like those at Pasithea."
•"...management’s alarming (negative) track record..."
•that Alpha-5 is "...a business that we believe was and is largely non-existent and
worthless."
FirstName LastNameDouglas Schnell
Comapany NameWilson Sonsini Goodrich & Rosati
July 8, 2022 Page 2
FirstName LastName
Douglas Schnell
Wilson Sonsini Goodrich & Rosati
July 8, 2022
Page 2
•that "...Pasithea is suffering from significant corporate governance lapses..."
3.You must avoid issuing statements that directly or indirectly impugn the character,
integrity or personal reputation or make charges of illegal, improper or immoral conduct
without factual foundation. Please provide a factual foundation for the disclosure copied
below. In this regard, note that the factual foundation for such assertion must be
reasonable. Refer to Rule 14a-9.
•"We believe that the problems at Pasithea are systemic and are the result of directors
who have abdicated their responsibility to create value for all stockholders. We
believe that the sitting directors are more focused on entrenchment and enriching
themselves than on advancing stockholders’ best interests."
•"This transaction appears to be undertaken for entrenchment purposes..." (page 2)
•"We believe that this transaction raises troubling questions about the motivations of
the Board and management, and exposes that they are not acting in the best interests
of stockholders." (page 2)
•"...related-party transaction is an egregious example of the directors’ indifference to,
and disregard for, stockholders." (page 3)
Background, page 2
4.Refer to footnote ii of your June 1, 2022 letter. Please revise your disclosure to clarify
what portion of the compensation received by Dr. Marques and by Mr. Gloss was in cash
or securities or vested option grants and what portion was made in unvested securities or
option grants.
Why You Were Sent This Statement, page 2
5.Please clarify, if true, that the $5 IPO price you reference was for a unit consisting of a
share and a warrant.
We remind you that the filing persons are responsible for the accuracy and adequacy of
their disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please direct any questions to Daniel Duchovny at 202-551-3619.
Sincerely,
Division of Corporation Finance
Office of Mergers & Acquisitions
2021-12-14 - CORRESP - Pasithea Therapeutics Corp.
CORRESP
1
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Pasithea Therapeutics Corp.
1111 Lincoln Road, Suite 500
Miami Beach, Florida 33139
December 14, 2021
VIA EDGAR & TELECOPY
Division of Corporation Finance
Office of Trade and Services
U.S. Securities & Exchange Commission
100 F Street, NE
Washington, D.C. 20549
RE: Pasithea Therapeutics Corp. (the “Company”)
Registration Statement on Form S-1
(File No. 333-261573) (the “Registration Statement”)
Ladies and Gentlemen:
The Company hereby
requests, pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, acceleration of effectiveness of the Registration
Statement so that such Registration Statement will become effective as of 4:00 p.m. EST on December 16, 2021, or as soon thereafter as
practicable.
Very truly yours,
Pasithea Therapeutics Corp.
By:
/s/ Tiago Reis Marques
Name:
Title:
Tiago Reis Marques
Chief Executive Officer
2021-12-14 - UPLOAD - Pasithea Therapeutics Corp.
United States securities and exchange commission logo
December 14, 2021
Tiago Reis Marques
Chief Executive Officer
Pasithea Therapeutics Corp.
1111 Lincoln Road, Suite 500
Miami Beach, FL 33139
Re:Pasithea Therapeutics Corp.
Registration Statement on Form S-1
Filed December 9, 2021
File No. 333-261573
Dear Dr. Marques:
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: Richard Bass, Esq.
2021-09-10 - CORRESP - Pasithea Therapeutics Corp.
CORRESP
1
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Pasithea Therapeutics Corp.
1111 Lincoln Road, Suite 500
Miami Beach, FL 33139
September 10, 2021
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Pasithea Therapeutics Corp.
Registration Statement on Form S-1
File No. 333-255205
VIA EDGAR
Ladies and Gentlemen:
Pursuant to Rule 461 under
the Securities Act of 1933, as amended, Pasithea Therapeutics Corp. (the “Registrant”) hereby respectfully requests
that the effectiveness of the Registration Statement on Form S-1 (File No. 333-255205) of the Registrant (the “Registration Statement”)
be accelerated so that it will be declared effective at 4:30 p.m., Eastern Time, on September 14, 2021 or as soon thereafter as may be
practicable.
The undersigned respectfully
requests that it be notified of the effectiveness of the Registration Statement by telephone call to our counsel, McDermott Will &
Emery LLP, by calling Robert Cohen at (212) 547-5885. The Company hereby authorizes Mr. Cohen to orally modify or withdraw this request
for acceleration.
Very truly yours,
PASITHEA THERAPEUTICS CORP.
By:
/s/ Dr. Tiago Reis Marques
Name:
Dr. Tiago Reis Marques
Title:
Chief Executive Officer and Director
2021-09-10 - CORRESP - Pasithea Therapeutics Corp.
CORRESP
1
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EF HUTTON, DIVISION OF BENCHMARK INVESTMENTS, LLC
590 Madison Avenue, 39th Floor
New York, NY 10022
September 10, 2021
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
Attention: Alan Campbell
Re:
Pasithea Therapeutics Corp.
Registration Statement on Form S-1
Filed April 13, 2021, as amended
File No. 333-255205
Dear Mr. Campbell:
As representative of the underwriters
of the proposed public offering of securities of Pasithea Therapeutics Corp. (the “Company”), we hereby join the Company’s
request that the effective date of the above-referenced Registration Statement on Form S-1 be accelerated so that it will be declared
effective at 4:30 p.m., Eastern Time, on Tuesday, September 14, 2021, or at such later time as the Company or its counsel may orally request
via telephone call to the staff of the Division of Corporation Finance of the Securities and Exchange Commission.
Pursuant to Rule 460 under
the Act, we, as representative of the underwriters, wish to advise you that there will be distributed to each underwriter, who is reasonably
anticipated to participate in the distribution of the securities, as many copies of the proposed form of preliminary prospectus as appears
to be reasonable to secure adequate distribution of the preliminary prospectus.
The undersigned advises that
it has complied and will continue to comply, and that it has been informed by the participating underwriters that they have complied with
and will continue to comply, with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended.
Very truly yours,
EF Hutton, division of Benchmark Investments, LLC
By:
/s/ Sam Fleischman
Name:
Sam Fleischman
Title:
Supervisory Principal
2021-08-26 - CORRESP - Pasithea Therapeutics Corp.
CORRESP
1
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mwe.com
August 26, 2021
VIA EDGAR AND EMAIL
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention:
Alan Campbell
Christine Westbrook
Franklin Wyman
Lynn Dicker
Re:
Pasithea Therapeutics Corp.
Amendment No. 3 to Registration Statement on Form S-1
Filed August 6, 2021
File No. 333-255205
Dear Mr. Campbell:
On behalf of Pasithea Therapeutics Corp. (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 August 11, 2021,
relating to the above referenced Amendment No. 3 to Registration Statement on Form S-1 (File No. 333-255205) filed by the Company on August
6, 2021 (the “Registration Statement”).
Concurrent with the submission of this letter,
the Company is filing via EDGAR Amendment No. 4 to the Registration Statement on Form S-1 (File No. 333-255205) (“Amendment No.
4”), which reflects the Company’s responses to the comments received by the Staff and certain updated information. We have
also enclosed a courtesy copy of Amendment No. 4, marked to indicate changes from the Registration Statement filed on August 6, 2021,
as Exhibit A. For your convenience, the Company is also delivering via email a copy of this letter and its enclosures.
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 Amendment No. 4.
Amendment No. 3 to Registration Statement on
Form S-1
Cover Page
1. We note your disclosure indicating that the shares of common stock and warrants are only being offered
together. To the extent you are offering the common shares and warrants together, you must register them as Units in your offering, even
if the common stock and warrants are immediately separable following the offering. If you plan to offer Units, please revise the registration
statement fee table and prospectus cover page to identify the Units as securities in the offering, identifying the components of the Units.
For guidance, please refer to Questions 240.05 and 240.06 of our Compliance and Disclosure Interpretations, Securities Act Rules.
Response: In response to the
Staff’s comments, we have revised the registration statement to identify the Units as securities in the offering and we have also
revised the registration statement to identify the components of the Units.
2. Please revise the cover page to disclose the limitations on warrant exercise which are described on
pages 14 and 100 of the prospectus.
Response: In response to the
Staff’s comments, we have revised the cover page to disclose the limitations on warrant exercise.
Business
License Agreements and Strategic Collaborations,
page 75
3. Your disclosure in this section does not describe the amended and restated collaboration agreements,
both entered into on August 4, 2021, with Portman and Purecare that are referenced on page F-20 of the prospectus. Please revise this
section, as well as the Prospectus Summary, to describe the terms of the amended and restated collaboration agreements or advise.
Response: In response to the
Staff’s comments, we have revised our registration statement to clarify and describe the amended and restated collaboration agreements,
both entered into on August 4, 2021, with Portman and Purecare.
Please contact me at 212 547-5885 if you have
any questions or require any additional information in connection with this letter or the Company’s submission of its Registration
Statement on Form S-1.
Sincerely,
/s/ Robert Cohen
cc:
Tiago Reis Marques, Chief Executive Officer
2021-08-11 - UPLOAD - Pasithea Therapeutics Corp.
United States securities and exchange commission logo
August 11, 2021
Tiago Reis Marques
Chief Executive Officer
Pasithea Therapeutics Corp.
1111 Lincoln Road
Suite 500
Miami Beach, FL 33139
Re:Pasithea Therapeutics Corp.
Amendment No. 3 to Registration Statement on Form S-1
Filed August 6, 2021
File No. 333-255205
Dear Dr. Marques:
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.
Amendment No. 3 to Registration Statement on Form S-1
Cover Page
1.We note your disclosure indicating that the shares of common stock and warrants are only
being offered together. To the extent you are offering the common shares and warrants
together, you must register them as Units in your offering, even if the common stock and
warrants are immediately separable following the offering. If you plan to offer Units,
please revise the registration statement fee table and prospectus cover page to identify the
Units as securities in the offering, identifying the components of the Units. For guidance,
please refer to Questions 240.05 and 240.06 of our Compliance and Disclosure
Interpretations, Securities Act Rules.
FirstName LastNameTiago Reis Marques
Comapany NamePasithea Therapeutics Corp.
August 11, 2021 Page 2
FirstName LastName
Tiago Reis Marques
Pasithea Therapeutics Corp.
August 11, 2021
Page 2
2.Please revise the cover page to disclose the limitations on warrant exercise which are
described on pages 14 and 100 of the prospectus.
Business
License Agreements and Strategic Collaborations, page 75
3.Your disclosure in this section does not describe the amended and restated collaboration
agreements, both entered into on August 4, 2021, with Portman and Purecare that are
referenced on page F-20 of the prospectus. Please revise this section, as well as the
Prospectus Summary, to describe the terms of the amended and restated collaboration
agreements or advise.
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 Frank Wyman at 202-551-3660 or Lynn Dicker at 202-551-3616 if you
have questions regarding comments on the financial statements and related matters. Please
contact Alan Campbell at 202-551-4224 or Joe McCann at 202-551-6262 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Richard Bass, Esq.
2021-08-05 - CORRESP - Pasithea Therapeutics Corp.
CORRESP
1
filename1.htm
mwe.com
August 5, 2021
VIA
EDGAR AND EMAIL
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington, D.C. 20549
Attention:
Alan
Campbell
Christine
Westbrook
Franklin
Wyman
Lynn
Dicker
Re:
Pasithea
Therapeutics Corp.
Amendment
No. 2 to Registration Statement on Form S-1
Filed
June 22, 2021
File
No. 333-255205
Dear
Mr. Campbell:
On
behalf of Pasithea Therapeutics Corp. (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 1, 2021, relating to the above referenced Amendment No. 2 to Registration Statement on Form S-1 (File No. 333-255205) filed
by the Company on June 22, 2021 (the “Registration Statement”).
Concurrent
with the submission of this letter, the Company is filing via EDGAR Amendment No. 3 to the Registration Statement on Form S-1 (File No.
333-255205) (“Amendment No. 3”), which reflects the Company’s responses to the comments received by the Staff and certain
updated information. We have also enclosed a courtesy copy of Amendment No. 3, marked to indicate changes from the Registration Statement
filed on June 22, 2021, as Exhibit A. For your convenience, the Company is also delivering via email a copy of this letter and its enclosures.
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 Amendment No. 3.
Amendment
No. 2 to Registration Statement on Form S-1
Prospectus
Summary
Services,
page 5
1. We
note your response to comment 2 and comment 3. You state on page 6 that you have no immediate
plans to obtain regulatory approvals from the referenced agencies in the UK and on page 7
that the care quality commission will initially be under Purecare Ltd. Please revise your
description of the Zen Knightsbridge and Holborn and Zen Baker collaboration agreements,
the lead in to the graphic on page 7 and the related graphic to make clear the limited services
you currently perform as distinct from the services you have agreed to perform. Ensure that
the graphic does not suggest that you currently operate any clinics in the UK. Additionally,
your revised disclosure indicates that you will receive 30% of the gross revenue which results
from the provision of the treatments provided at the Zen Knightsbridge Clinic and the Zen
Baker Clinic. However, the terms of each agreement, filed as exhibits to your registration
statement, state that you will receive 30% of the revenues from ketamine infusion treatments
and any other treatments agreed by the parties and that you will not be entitled to any revenues
for any other treatments. Please reconcile your disclosure or advise.
Response: In response to the Staff’s
comments, we have revised our disclosure to clarify that the Company has no plan to obtain CQC registration, and that Purecare and Portman
will be obtaining and maintaining CQC registrations for the Zen clinics in the UK. We have also revised our disclosure to clarify that
the Company will receive 30% of all revenue (less certain staff costs) which results from the provision of ketamine infusion treatments
and other treatments as agreed by the parties from time to time.
2. We
note your revised disclosure indicating that you intend to enter into BSSAs with Nadelson
Medical PLLC and Nadelson Medical of CA, P.C. We note that Adam Nadelson is one of your stockholders
and that he also appears to be the CEO of The IV Doc. Please revise your disclosure to briefly
discuss (i) the nature of the relationship between you, Adam Nadelson and The IV Doc and
(ii) any regulatory risks associated with affiliated entities regarding the corporate practice
of medicine or fee-splitting.
Response:
In response to the Staff’s comments, we have revised our disclosure to disclosure that (i) Adam Nadelson is the CEO of The IV Doc
and he also has voting power over 450,000 shares of our Common Stock held by Living Trust of Adam Nadelson, and (ii) any regulatory risks
associated with affiliated entities regarding the corporate practice of medicine or fee-splitting.
Please
contact me at 212 547-5885 if you have any questions or require any additional information in connection with this letter or the Company’s
submission of its Registration Statement on Form S-1.
Sincerely,
/s/
Robert Cohen
cc: Tiago
Reis Marques, Chief Executive Officer
2021-06-21 - CORRESP - Pasithea Therapeutics Corp.
CORRESP
1
filename1.htm
mwe.com
June 21, 2021
VIA EDGAR AND EMAIL
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention:
Alan Campbell
Christine Westbrook
Franklin Wyman
Lynn Dicker
Re:
Pasithea Therapeutics Corp.
Registration Statement on Form S-1
Filed April 13, 2021
File No. 333-255205
Dear Mr. Campbell:
On behalf of Pasithea Therapeutics Corp. (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 16, 2021, relating
to the above referenced Registration Statement on Form S-1 (File No. 333-255205) filed by the Company on April 13, 2021 (the “Registration
Statement”).
Concurrent with the submission of this letter,
the Company is filing via EDGAR Amendment No. 2 to the Registration Statement on Form S-1 (File No. 333-255205) (“Amendment No.
2”), which reflects the Company’s responses to the comments received by the Staff and certain updated information. We have
also enclosed a courtesy copy of Amendment No. 2, marked to indicate changes from the Registration Statement filed on April 13, 2021,
as Exhibit A. For your convenience, the Company is also delivering via email a copy of this letter and its enclosures.
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 Amendment No. 2.
Amendment No. 1 to Registration Statement on Form S-1
Prospectus Summary, page 2
1. We note your revised disclosure indicating that the use of ketamine has been subject to consensus statements by various institutions.
Please revise to provide a brief and balanced summary of the findings discussed in these consensus statements.
Response: In response to the Staff’s
comments, we have revised our disclosure to include a summary of the findings discussed in these consensus statements.
Services, page 5
2. We refer to prior comment 4. Please revise your discussion of your partnership with Zen Healthcare to clarify the material terms
of the partnership including (i) what services you are providing to Zen Healthcare; (ii) what revenues will be subject to the partnership
and how your share will be calculated; and (iii) your anticipated timing to begin receiving revenues pursuant to the partnership.
Response: In response to the Staff’s
comments, we have revised the discussion of our partnership with Zen Healthcare to clarify the material terms of the partnership, including
the services we are providing, how our share will be calculated, and our anticipated timing to begin receiving revenues pursuant to the
partnership.
3. We refer to prior comment 8. Please revise to clearly disclose whether your UK subsidiary has hired any employees or initiated
the process with applicable regulators in order to obtain regulatory approvals.
Response: In response to the Staff’s
comments, we have revised our disclosure to clarify that our UK subsidiary has hired one employees and initiated the process with applicable
regulators in order to obtain regulatory approvals.
4. We note your revised disclosure indicating that you are "in the process" of establishing management services agreements
with independent professional services companies in the U.S. Please place your disclosure in appropriate context with reference to steps
you have taken, what steps remain and your anticipated timeline for entering into these agreements.
Response: In response to the Staff’s
comments, we have revised the disclosure to indicate steps we have taken, what steps remain and our anticipated timeline for entering
into these agreements..
The Offering, page 13
5. Your disclosure on page 54 indicates that the proceeds from the offering will be used to fund preclinical R&D work for future
product candidates; however, the "Use of proceeds" subsection on page 13 continues to state that proceeds from the offering
will be used for clinical trials. Please reconcile your disclosure or advise.
Response: In response to the Staff’s
comments, we have revised the "Use of proceeds" subsection to clarify that the proceeds from the offering will be used to fund
preclinical R&D work for future product candidates.
Business
License Agreements and Strategic Collaborations,
page 72
6. We note your response to prior comment 16, which we reissue in part. We note that Section 15.1 of the
Zen Knightsbridge and Holborn Collaboration Agreement and Section 15.1 of the Zen Baker and Portman Collaboration Agreement provide for
mutual termination rights. Please revise to disclose the termination provisions under these agreements as well as under the IV Docs Subcontract
Agreement.
Response: In response to the Staff’s
comments, we have revised to disclose the termination provisions under Zen Knightsbridge and Holborn Collaboration Agreement as well as
under the IV Docs Subcontract Agreement.
Executive and Director Compensation, page 89
7. We note your response to prior comment 17. Please explain to us why Mr. Gloss and Dr. Bendiabdallah
are not identified as named executive officers. For guidance, please refer to Item 402(m)(2)(iii) of Regulation S-K.
Response: We have not identified
Mr. Gloss or Dr. Bendiabdallah as named executive officers (NEOs) because NEOs for smaller reporting companies are: (i) the
principal executive officer (PEO), (ii) the two most highly compensated executive officers other than the PEO, and (ii) up to two
additional individuals from whom disclosure would have been provided but for the fact they were not serving as an executive officer.
Mr. Gloss or Dr. Bendiabdallah are not the principal executive officer and they do not meet the compensation threshold of $100,000
(see Regulation S-K 402(m), including instruction 1 thereof).
Item 15. Recent Sales of Unregistered Securities,
page II-2
8. We note your response to prior comment 19 and revised disclosure. However, your disclosure on page
F-12 continues to state that you sold shares in the Offering in 2021 at $0.08 per share and in the Offering 2 in 2021 at $0.12 per share.
Please advise.
Response: In response to the Staff’s
comments, we have revised our disclosure in this section to indicate that the correct share price of $1.60 and $2.40.
Please contact me at 212 547-5885 if you have any questions or require
any additional information in connection with this letter or the Company’s submission of its Registration Statement on Form S-1.
Sincerely,
/s/ Robert Cohen
cc:
Tiago Reis Marques, Chief Executive Officer
2021-06-16 - UPLOAD - Pasithea Therapeutics Corp.
United States securities and exchange commission logo
June 16, 2021
Tiago Reis Marques
Chief Executive Officer
Pasithea Therapeutics Corp.
1111 Lincoln Road
Suite 500
Miami Beach, FL 33139
Re:Pasithea Therapeutics Corp.
Amendment No. 1 to Registration Statement on Form S-1
Filed June 4, 2021
File No. 333-255205
Dear Dr. Marques:
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 May 10, 2021 letter.
Amendment No. 1 to Registration Statement on Form S-1
Prospectus Summary, page 2
1.We note your revised disclosure indicating that the use of ketamine has been subject to
consensus statements by various institutions. Please revise to provide a brief and balanced
summary of the findings discussed in these consensus statements.
Services, page 5
2.We refer to prior comment 4. Please revise your discussion of your partnership with Zen
Healthcare to clarify the material terms of the partnership including (i) what services you
are providing to Zen Healthcare; (ii) what revenues will be subject to the partnership and
FirstName LastNameTiago Reis Marques
Comapany NamePasithea Therapeutics Corp.
June 16, 2021 Page 2
FirstName LastNameTiago Reis Marques
Pasithea Therapeutics Corp.
June 16, 2021
Page 2
how your share will be calculated; and (iii) your anticipated timing to begin receiving
revenues pursuant to the partnership.
3.We refer to prior comment 8. Please revise to clearly disclose whether your UK subsidiary
has hired any employees or initiated the process with applicable regulators in order
to obtain regulatory approvals.
4.We note your revised disclosure indicating that you are "in the process" of establishing
management services agreements with independent professional services companies in the
U.S. Please place your disclosure in appropriate context with reference to steps you have
taken, what steps remain and your anticipated timeline for entering into these agreements.
The Offering, page 13
5.Your disclosure on page 54 indicates that the proceeds from the offering will be used to
fund preclinical R&D work for future product candidates; however, the "Use of proceeds"
subsection on page 13 continues to state that proceeds from the offering will be used for
clinical trials. Please reconcile your disclosure or advise.
Business
License Agreements and Strategic Collaborations, page 72
6.We note your response to prior comment 16, which we reissue in part. We note that
Section 15.1 of the Zen Knightsbridge and Holborn Collaboration Agreement and Section
15.1 of the Zen Baker and Portman Collaboration Agreement provide for mutual
termination rights. Please revise to disclose the termination provisions under these
agreements as well as under the IV Docs Subcontract Agreement.
Executive and Director Compensation, page 89
7.We note your response to prior comment 17. Please explain to us why Mr. Gloss and
Dr. Bendiabdallah are not identified as named executive officers. For guidance, please
refer to Item 402(m)(2)(iii) of Regulation S-K.
Item 15. Recent Sales of Unregistered Securities, page II-2
8.We note your response to prior comment 19 and revised disclosure. However, your
disclosure on page F-12 continues to state that you sold shares in the Offering in 2021 at
$0.08 per share and in the Offering 2 in 2021 at $0.12 per share. Please advise.
FirstName LastNameTiago Reis Marques
Comapany NamePasithea Therapeutics Corp.
June 16, 2021 Page 3
FirstName LastName
Tiago Reis Marques
Pasithea Therapeutics Corp.
June 16, 2021
Page 3
You may contact Franklin Wyman at 202-551-3660 or Lynn Dicker at 202-551-3616 if
you have questions regarding comments on the financial statements and related matters. Please
contact Alan Campbell at 202-551-4224 or Christine Westbrook at 202-551-5019 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Richard Bass, Esq.
2021-06-04 - CORRESP - Pasithea Therapeutics Corp.
CORRESP
1
filename1.htm
mwe.com
June
4, 2021
VIA
EDGAR AND EMAIL
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington, D.C. 20549
Attention:
Alan
Campbell
Christine
Westbrook
Franklin
Wyman
Lynn
Dicker
Re:
Pasithea
Therapeutics Corp.
Registration
Statement on Form S-1
Filed
April 13, 2021
File
No. 333-255205
Dear
Mr. Campbell:
On
behalf of Pasithea Therapeutics Corp. (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 May 10, 2021, relating to the above referenced Registration Statement on Form S-1 (File No. 333-255205) filed by the Company on
April 13, 2021 (the “Registration Statement”).
Concurrent
with the submission of this letter, the Company is filing via EDGAR Amendment No. 1 to the Registration Statement on Form S-1 (File No.
333-255205) (“Amendment No. 1”), which reflects the Company’s responses to the comments received by the Staff and certain
updated information. We have also enclosed a courtesy copy of Amendment No. 1, marked to indicate changes from the Registration Statement
filed on April 13, 2021, as Exhibit A. For your convenience, the Company is also delivering via email a copy of this letter and its enclosures.
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 Amendment No. 1.
Registration
Statement on Form S-1
Cover
Page
1. Your
disclosure on pages 10 and 101 indicates that you have agreed to issue warrants to Kingswood
Capital Markets (“Kingswood”) as part of the underwriter compensation for the offering.
Please revise the cover page to disclose your agreement to issue the warrants to Kingswood,
including the number of warrants to be issued and the exercise price. Your disclosure further
indicates that this registration statement is intended to cover the warrants to be issued
to Kingswood. Please revise the registration statement fee table to reflect the warrants
and file a form of the warrant to be issued to Kingswood as an exhibit.”
Response:
In response to the Staff’s comments, we have revised the registration statement and prospectus to reflect the issuance of the warrants
and have included the form of warrant as an exhibit to the S-1/A.
Prospectus
Summary
Business
Overview, page 1
2. We
note that you have not discussed any activities related to drug development, e.g. activities
related to drug discovery or identifying compounds to develop or acquire. Please revise your
prospectus throughout to make clear the current status of your operations including your
heading entitled “Development Pipeline.” Remove the reference to your company
as a “clinical stage biotechnology company” on page 11 and explain the reference
on page 65 to your “ketamine drug candidate” and on page 70 to “COMP360.”
Please also briefly explain what you mean by “cross talk” between the immune
system and brain disorders. Additionally, revise your statement that you have not commenced
“core” operations to make it clear that you have not yet entered into any agreements
with independent professional services companies, as referenced on page 29.
Response:
In response to the Staff’s comments, we have revised the prospectus to clarify the status of our operations by changing the reference
from “Development Pipeline” to “Development Plan” and removed the references to “clinical stage biotechnology
company” on page 11 and to “COMP360” on page 70. Additionally, we have revised the reference on page 65 from “our
ketamine drug candidate” to “our drug candidates”. Furthermore, we have revised the registration statement to explain
what we mean by “cross talk” between the immune system and brain disorders. Lastly, we have revised the prospectus to clarify
that we have not commenced core operations or entered into agreements with independent professional services companies or other potential
counterparties relating to our ketamine infusion business in the United States.
3. Please
revise here and in the Business section to provide the basis for your claim that current
therapies for Major Depressive Disorder (MDD) and bipolar depression (BDep) have a distinct
lag of onset that can generate further distress and impairment in patients.
Response:
In response to the Staff’s comments, we have revised the prospectus summary and Business section to include sources for the claim
that current therapies for Major Depressive Disorder (MDD) and bipolar depression (BDep) have a distinct lag of onset that can generate
further distress and impairment in patients.
2
4. With
respect to your plans to establish anti-depression clinics across the UK and provide business
support services and administer intravenous infusions of ketamine using psychiatric assessment
combined with physician medical providers, revise your disclosure throughout to make clear
which services you plan to provide, your plans for doing so and which services are to be
performed by third parties. Be sure to clearly explain how you plan to earn revenue and describe
the material terms of your “partnership” arrangements. As an example only, your
disclosure here and throughout refers to your partnership with The IV Doc to provide private
intravenous infusions of ketamine. However, the terms of your agreement with The IV Doc state
that The IV Doc intends to only provide nonprofessional administrative, back office and business
support services and that The IV Doc will not assume responsibility for the care of patients.
Please revise the disclosure in your registration statement, including in the second paragraphs
of the Prospectus Summary and the Business section and the first paragraph on page 4, to
clarify that The IV Doc will be providing administrative services as a subcontractor, rather
than clinical care.
Response:
In response to the Staff’s comments, we have revised the prospectus and Business section to clarify which services we plan to provide,
our plans for doing so and which services are to be performed by third parties. Furthermore, we revised the registration statement to
clarify how we plan to earn revenue and described the material terms of our “partnership” arrangements.
5. Please
revise your disclosure here and in the Business section to discuss the study or trial in
which a single subanesthetic dose infusion of ketamine was shown to have potential antidepressant
effects in treatment-resistant MDD and PTSD.
Response:
In response to the Staff’s comments, we have revised the prospectus and Business section to discuss studies in which a single subanesthetic
dose infusion of ketamine was shown to have potential antidepressant effects in treatment-resistant MDD and PTSD.
6. We
note your statement that ketamine’s potential safety and effectiveness have been demonstrated
in multiple research studies. Safety and efficacy are determinations are solely within the
authority of the U.S. Food and Drug Administration (FDA) or similar foreign regulators. Please
revise your disclosure to remove any implication that IV ketamine has been determined to
be safe or effective for the treatment of MDD or Bdep. We further note your claim that as
many as 70% of those who receive ketamine infusions show a response, typically after the
first session. Please revise to describe the studies that provide the basis for this claim,
including who performed the studies, when they were conducted, the indications that were
treated, the length of the studies and the number of participants, dosages used and what
is meant by the phrase “show a response.” Disclose also all serious adverse events
and the number of patients who experienced them.
Response: In response to the Staff’s
comments, we have revised the prospectus and Business section to remove the statement that “As many as 70% of those who get ketamine
infusions show a response, typically after the first session”. Additionally, we have added disclosure describing various studies
that provide the basis for the claim that IV ketamine infusions produce a significant and rapid response in patients with treatment-resistant
MDD and BDep.
3
Clinical
Services, page 3
7. Please
revise this section to clearly describe the regulatory landscape applicable to your business
model in this area in the UK and the United States including applicable government regulations
and laws concerning the corporate practice of medicine and feesplitting, along with any associated
risks and liabilities that you may become subject to by entering into management agreements
with independent professional services companies. Additionally, indicate in each diagram
on pages 3 and 5 which party will perform the relevant services so that your role is clear.
Identify what entities will be responsible for obtaining, administering and storing ketamine,
including the ownership and maintenance of applicable controlled substances licenses and
compliance with DEA requirements. Please also revise to clarify how you anticipate recruiting
individual clinicians and independent professional services companies in the United States
to enter into agreements with you and disclose the challenges you may face in doing so. Discuss
also the significance of establishing insurance reimbursement for ketamine treatments, which
party will be responsible for establishing reimbursement and any challenges in doing so.
Revise your discussion on page 62 in your Business section to explain why the formation process
to establish an independent professional services company in New York and California is material
to an understanding of your business. Additionally, revise your Business section to disclose
the material terms of your planned management agreements with independent professional services
companies.
Response:
In response to the Staff’s comments, we have revised this section to describe the regulatory landscape applicable to our business
model in the UK and the United States. Additionally, we have inserted a footnote under the diagram on page 3 identifying what entities
will be responsible for obtaining, administering and storing ketamine. We have removed the diagram on page 5 and clarified that Pasithea
will not provide medical services in the Unites States. Furthermore, we have clarified how we anticipate recruiting individual clinicians
and independent professional services companies in the United States to enter into agreements with us and disclosed the challenges we
may face in doing so. We have also revised our discussion on page 62 in the Business section to explain why the formation process to
establish an independent professional services company in New York and California is material to an understanding of our business. Lastly,
we have revised our Business section to disclose the material terms of our planned management agreements with independent professional
services companies. We did not discuss the significance of establishing insurance reimbursement for ketamine treatments since we are
private pay only.
8. Please
revise your disclosure in this section and in the Business section to indicate whether you
have commenced the process to obtain applicable regulatory approvals in the UK and in the
United States. Please also revise to discuss FDA regulation of off-label promotion and the
impact such regulation may have on your business. Additionally, please balance your disclosure
with reference to competition you face from approved products, as referenced on page 65.
Response: In response to the Staff’s comments, we have revised
our disclosure in this section and in the Business section to clarify that under English law, we must obtain approvals from agencies including
the following: MHRA, Care Quality Commission (CQC), General Medical Council (GMC) and the General Pharmaceutical Council (GPhC). We have
clarified that we will not provide professional medical services, establish or own anti-depression clinics, provide psychiatric assessments,
or be responsible for the administration of intravenous infusions of ketamine in the United States. Furthermore, we have clarified that
we will not obtain or administer ketamine, nor will we maintain any license or registration to own, maintain or dispense controlled substances
in the United States.
Our
Team, page 5
9. Please
provide us with the basis for your claim that you are led by a “best-in-class”
management team. Alternatively, please remove this disclosure. Your disclosure also ind
2021-05-10 - UPLOAD - Pasithea Therapeutics Corp.
United States securities and exchange commission logo
May 10, 2021
Tiago Reis Marques
Chief Executive Officer
Pasithea Therapeutics Corp.
1111 Lincoln Road
Suite 500
Miami Beach, FL 33139
Re:Pasithea Therapeutics Corp.
Registration Statement on Form S-1
Filed April 13, 2021
File No. 333-255205
Dear Dr. Marques:
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 S-1
Cover Page
1.Your disclosure on pages 10 and 101 indicates that you have agreed to issue warrants to
Kingswood Capital Markets ("Kingswood") as part of the underwriter compensation for
the offering. Please revise the cover page to disclose your agreement to issue the warrants
to Kingswood, including the number of warrants to be issued and the exercise price. Your
disclosure further indicates that this registration statement is intended to cover
the warrants to be issued to Kingswood. Please revise the registration statement fee table
to reflect the warrants and file a form of the warrant to be issued to Kingswood as an
exhibit.
FirstName LastNameTiago Reis Marques
Comapany NamePasithea Therapeutics Corp.
May 10, 2021 Page 2
FirstName LastNameTiago Reis Marques
Pasithea Therapeutics Corp.
May 10, 2021
Page 2
Prospectus Summary
Business Overview, page 1
2.We note that you have not discussed any activities related to drug development, e.g.
activities related to drug discovery or identifying compounds to develop or acquire. Please
revise your prospectus throughout to make clear the current status of your operations
including your heading entitled “Development Pipeline.” Remove the reference to your
company as a “clinical stage biotechnology company” on page 11 and explain the
reference on page 65 to your "ketamine drug candidate" and on page 70 to “COMP360.”
Please also briefly explain what you mean by “cross talk” between the immune system
and brain disorders. Additionally, revise your statement that you have not commenced
“core” operations to make it clear that you have not yet entered into any agreements with
independent professional services companies, as referenced on page 29.
3.Please revise here and in the Business section to provide the basis for your claim that
current therapies for Major Depressive Disorder (MDD) and bipolar depression (BDep)
have a distinct lag of onset that can generate further distress and impairment in patients.
4.With respect to your plans to establish anti-depression clinics across the UK and provide
business support services and administer intravenous infusions of ketamine using
psychiatric assessment combined with physician medical providers, revise your disclosure
throughout to make clear which services you plan to provide, your plans for doing so and
which services are to be performed by third parties. Be sure to clearly explain how you
plan to earn revenue and describe the material terms of your “partnership” arrangements.
As an example only, your disclosure here and throughout refers to your partnership with
The IV Doc to provide private intravenous infusions of ketamine. However, the terms of
your agreement with The IV Doc state that The IV Doc intends to only provide non-
professional administrative, back office and business support services and that The IV
Doc will not assume responsibility for the care of patients. Please revise the disclosure in
your registration statement, including in the second paragraphs of the Prospectus
Summary and the Business section and the first paragraph on page 4, to clarify that The
IV Doc will be providing administrative services as a subcontractor, rather than clinical
care.
5.Please revise your disclosure here and in the Business section to discuss the study or trial
in which a single subanesthetic dose infusion of ketamine was shown to have potential
antidepressant effects in treatment-resistant MDD and PTSD.
6.We note your statement that ketamine's potential safety and effectiveness have been
demonstrated in multiple research studies. Safety and efficacy are determinations are
solely within the authority of the U.S. Food and Drug Administration (FDA) or similar
foreign regulators. Please revise your disclosure to remove any implication that IV
ketamine has been determined to be safe or effective for the treatment of MDD or Bdep.
FirstName LastNameTiago Reis Marques
Comapany NamePasithea Therapeutics Corp.
May 10, 2021 Page 3
FirstName LastNameTiago Reis Marques
Pasithea Therapeutics Corp.
May 10, 2021
Page 3
We further note your claim that as many as 70% of those who receive ketamine infusions
show a response, typically after the first session. Please revise to describe the studies that
provide the basis for this claim, including who performed the studies, when they were
conducted, the indications that were treated, the length of the studies and the number of
participants, dosages used and what is meant by the phrase "show a response." Disclose
also all serious adverse events and the number of patients who experienced them.
Clinical Services, page 3
7.Please revise this section to clearly describe the regulatory landscape applicable to your
business model in this area in the UK and the United States including applicable
government regulations and laws concerning the corporate practice of medicine and fee-
splitting, along with any associated risks and liabilities that you may become subject to by
entering into management agreements with independent professional services companies.
Additionally, indicate in each diagram on pages 3 and 5 which party will perform the
relevant services so that your role is clear. Identify what entities will be responsible for
obtaining, administering and storing ketamine, including the ownership and maintenance
of applicable controlled substances licenses and compliance with DEA requirements.
Please also revise to clarify how you anticipate recruiting individual clinicians and
independent professional services companies in the United States to enter into agreements
with you and disclose the challenges you may face in doing so. Discuss also the
significance of establishing insurance reimbursement for ketamine treatments, which party
will be responsible for establishing reimbursement and any challenges in doing
so. Revise your discussion on page 62 in your Business section to explain why the
formation process to establish an independent professional services company in New York
and California is material to an understanding of your business. Additionally, revise your
Business section to disclose the material terms of your planned management agreements
with independent professional services companies.
8.Please revise your disclosure in this section and in the Business section to indicate
whether you have commenced the process to obtain applicable regulatory approvals in the
UK and in the United States. Please also revise to discuss FDA regulation of off-label
promotion and the impact such regulation may have on your business. Additionally,
please balance your disclosure with reference to competition you face from approved
products, as referenced on page 65.
Our Team, page 5
9.Please provide us with the basis for your claim that you are led by a "best-in-class"
management team. Alternatively, please remove this disclosure.
Your disclosure also indicates that Professor Steinman currently serves as a professor at
Stanford University and that Dr. Marques is a senior clinical fellow at Imperial College
London and a lecturer at King's College London. Please disclose if each of Professor
Steinman and Dr. Marques will work full-time or part-time for the company and, if less
FirstName LastNameTiago Reis Marques
Comapany NamePasithea Therapeutics Corp.
May 10, 2021 Page 4
FirstName LastNameTiago Reis Marques
Pasithea Therapeutics Corp.
May 10, 2021
Page 4
than full-time, disclose the number of hours per week or month that you plan for each of
Professor Steinman and Dr. Marques to work for the company. To the extent that either
Professor Steinman or Dr. Marques will be working part-time for the Company, please
add related disclosure under an appropriate heading in the Risk Factors section
highlighting the risks related to their limited time devoted to your business.
Summary of Risk Factors, page 7
10.Your risk factor summary currently exceeds two pages. Please revise your risk factor
summary to be no more than two pages and to discuss the principal factors that make an
investment in you or in the offering speculative or risky, rather than listing each heading
that appears in the Risk Factors section. For guidance, please refer to Item 105(b) of
Regulation S-K.
Implications of Being an Emerging Growth Company and a Smaller Reporting Company, page 9
11.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.
Risk Factors, page 12
12.Revise and organize the risk factors section to disclose the material risks related to your
current status and planned operations with the most significant risks clearly identified. As
examples only, we note your disclosure in the first risk factor on page 12 stating that you
have devoted substantially all of your resources to building and equipping your research
and development laboratories, building and equipping your manufacturing suites,
acquiring raw materials for manufacturing and securing related intellectual property
rights. However, it appears from your disclosure elsewhere that you have not performed
these activities and do not own any intellectual property. Additionally, you state in the risk
factor on page 16 that you face increased labor costs due to nationwide nursing shortages.
Please explain how these conditions will materially impact your business. Include under
an appropriate heading a discussion of risks associated with ketamine use and its status as
a Schedule III controlled substance under the Controlled Substances Act. Additionally,
relocate risks that could generically apply to any registrant or offering to the end of the
section under the caption “General Risk Factors.” Refer to Item 105 of Regulation S-K.
Industry and Other Data, page 49
13.Your statements that (i) you have not independently verified third-party publications and
studies and (ii) no independent source has verified your internal research and market
definitions may imply an inappropriate disclaimer of responsibility with respect to the
third party information and your own research. Please either delete these statements or
specifically state that you are liable for such information.
FirstName LastNameTiago Reis Marques
Comapany NamePasithea Therapeutics Corp.
May 10, 2021 Page 5
FirstName LastNameTiago Reis Marques
Pasithea Therapeutics Corp.
May 10, 2021
Page 5
Use of Proceeds, page 50
14.We note your disclosure that you intend to use portions of the proceeds of this offering to
(i) fund research and development, including clinical trials and product development for
your pipeline and (ii) develop your U.S. and UK clinic businesses. Please indicate how far
the proceeds of the offering will allow you to proceed with respect to each specified
purpose. If any material amounts of other funds are necessary to accomplish the specified
purposes, state the amounts and sources of other funds needed for each specified purpose
and the sources. For guidance, please refer to Item 504 of Regulation S-K.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Critical Accounting Policies, page 57
15.Please provide a description and quantification of the methods and assumptions used to
determine the fair value of your common stock, as discussed in Note 5.
Business
License Agreements and Strategic Collaborations, page 65
16.Please revise your disclosure in this section to (i) discuss the termination provisions
contained in the agreements with the Zen clinics and (ii) disclose the material terms of the
IV Doc agreement, including the respective party's rights and obligations, term and
termination provisions.
Executive and Director Compensation, page 82
17.Please revise this section to clearly identify your named executive officers ("NEOs") and
to describe the materials terms of any employment arrangements that you have with each
of your NEOs. In this regard, we note that you have identified in the exhibit index an
employment agreement with Dr. Marques.
Certain Relationships and Related Party Transactions
Brio Financial Group , page 86
18.Please file your agreement with Brio Financial Group as an exhibit to your registration
statement or explain to us why it is not required to be filed. Refer to Item 601(b)(10) of
Regulation S-K.
Item 15. Recent Sales of Unregistered Securities, page II-2
19.Your disclosure here indicates that you sold 395,625 shares of common stock for proceeds
of approximately $633,000 subsequent to December 31, 2020 (implying a price per share
of approximately $1.60) and then an additional 239,969 shares of common stock for
proceeds of approximately $1,200,000 (implying a price per share of approximately
$5.00). However, your disclosure here and on page F-12 indicates that you sold shares at a
price of $0.08 per share and $0.12 per share. Your disclosure on page F-10 also indicates
FirstName LastNameTiago Reis Marques
Comapany NamePasithea Therapeutics Corp.
May 10, 2021 Page 6
FirstName LastName
Tiago Reis Marques
Pasithea Therapeutics Corp.
May 10, 2021
Page 6
that you raised $576,000 in Offering 2, rather than $1.2 million. Please reconcile your
disclosure.
Exhibits
20.When available, please file the 2021 Incentive Plan as an exhibit to your registration
statement.
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 Franklin Wyman at 202-551-3660 or Lynn Dicker at 202-551-3616 if
you have questions regarding comments on the financial statements and related matters. Please
contact Alan Campbell at 202-551-4224 or Christine Westbrook at 202-551-5019 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Richard Bass, Esq.