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.
Tiago Reis Marques
FirstName LastNameTiago
Pasithea Therapeutics Corp.Reis Marques
Comapany
May NamePasithea Therapeutics Corp.
10, 2021
May 10,
Page 2 2021 Page 2
FirstName LastName
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.
Tiago Reis Marques
FirstName LastNameTiago
Pasithea Therapeutics Corp.Reis Marques
Comapany
May NamePasithea Therapeutics Corp.
10, 2021
May 10,
Page 3 2021 Page 3
FirstName LastName
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
Tiago Reis Marques
FirstName LastNameTiago
Pasithea Therapeutics Corp.Reis Marques
Comapany
May NamePasithea Therapeutics Corp.
10, 2021
May 10,
Page 4 2021 Page 4
FirstName LastName
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.
Tiago Reis Marques
FirstName LastNameTiago
Pasithea Therapeutics Corp.Reis Marques
Comapany
May NamePasithea Therapeutics Corp.
10, 2021
May 10,
Page 5 2021 Page 5
FirstName LastName
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
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,
FirstName LastNameTiago Reis Marques
Division of
Corporation Finance
Comapany NamePasithea Therapeutics Corp.
Office of Life
Sciences
May 10, 2021 Page 6
cc: Richard Bass, Esq.
FirstName LastName