United States securities and exchange commission logo
August 14, 2020
Milton H. Werner
President and Chief Executive Officer
Inhibikase Therapeutics, Inc.
3350 Riverwood Parkway SE, Suite 1927
Atlanta, GA 30339
Re: Inhibikase
Therapeutics, Inc.
Registration
Statement on Form S-1
Filed July 23, 2020
File No. 333-240036
Dear Dr. Werner:
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-3
Inside Cover Page, page i
1. Please revise the
gatefold "Method of Action" graphic to include a textual description
putting graphics in
context. Without this information it is difficult to understand what the
graphics are attempting
to convey. We note that the line item for BCR-Abl in the pipeline
table appears to say
that you will rely on the 505(b)(2) process in lieu of conducting Phase
1 and Phase 2 trials.
This is inconsistent with later tables on page 3 and 96, which
indicate you intend to
rely on 505(b)(2) for all phases of clinical trials. The tables are also
inconsistent with the
disclosure on page 105 indicating clinical trials are likely necessary
for purposes of dose
escalation and to demonstrate superiority. Please revise your tables
accordingly.
Milton H. Werner
FirstName LastNameMilton
Inhibikase Therapeutics, Inc.H. Werner
Comapany
August 14, NameInhibikase
2020 Therapeutics, Inc.
August
Page 2 14, 2020 Page 2
FirstName LastName
2. We note your pipeline table includes line items for drug candidates
for treatment of
dementia with Lewy Body, multiple system atrophy and progressive
multifocal
leukoencephalophy. Given the lack of disclosure of these programs in
your registration
statement, they do not appear material to your operations. Please
limit your pipeline table
to your material product candidates.
Prospectus Summary
Overview, page 1
3. Please refer to comment 2 and comments 1 and 3 of our October 5, 2018
letter. On pages
2, 4, 82, and 93 you state, "Subject to future FDA agreements . . .
clinical development of
IkT-001 Pro could possibly be completed in the first half of 2022." In
the "Our Programs"
section, you state, "If approved by the FDA, this product might
provide a revenue stream
to help support other programs in neurodegeneration." On pages 2 and
82, you state that
you could complete clinical development of IkT-148009 in 2024. Please
explain, how
IKT-001 might provide a revenue stream to support clinical development
of IkT-148009.
If this expectation is dependent on revenue from potential
collaboration agreements,
please make that clear. Alternatively, clarify that this financing
strategy is dependent on
FDA approval and successful commercialization which is highly
uncertain.
4. Briefly explain all defined terms at first use. For example, on page
2, briefly describe the
process and significance of submitting the NDA for IkT-001Pro pursuant
to Section
505(b)(2) of the Federal Food, Drug and Cosmetic Act.
5. On pages 2 and 81, you state, "We believe IkT-001Pro will improve
patient experience
and treatment compliance and could become the standard-of-care as a
result," while
acknowledging you will not submit an IND until the fourth quarter of
2020. On page 103,
you state, "We believe IkT-001Pro will have superior safety and at
least equivalent
efficacy relative to generic Imatinib. As a consequence, we believe we
have an
opportunty to capture a significant portion of the generic Imatinib
sales in the U.S.
market." Please remove these and all statements suggesting that your
product candidates
are effective. Safety and efficacy determinations are solely within
authority of the FDA or
other regulatory agencies. As your product candidates have not
received approval, it is
premature to state or suggest that they are effective.
Our Portfolio, page 94
6. On page 96, Table 1 depicts the development of IkT-001Pro while the
footnote relates to
the development of IkT-148009. Revise accordingly.
Material Agreements, page 109
7. Tell us why you eliminated disclosure of the Duke license. We note
from pages F-19-
20, that it appears the Duke license agreement continues to be in
effect.
Milton H. Werner
FirstName LastNameMilton
Inhibikase Therapeutics, Inc.H. Werner
Comapany
August 14, NameInhibikase
2020 Therapeutics, Inc.
August
Page 3 14, 2020 Page 3
FirstName LastName
Certain Relationships and Related Party Transactions, page 148
8. Describe the material terms of the CEO note and the 2018 consulting
agreement with
Flagship Consulting, through which you agreed to compensate Mr.
Frattaroli, your CFO,
discussed on page 148, and file these agreements as exhibits. Refer to
Item
601(b)(10)(ii)(A) and (iii)(A). We note you have filed the 2018
promissory note;
however, the terms of that note (based on monthly statements for
services rendered,
maximum $75,000) do not appear to match your disclosure for that time
period ($12,500
per month accruing on convertible revolving demand promissory note).
Revise to clarify.
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 Rolf Sundwall at (202) 551-3105 or Sasha Parikh at (202)
551-3627 if
you have questions regarding the financial statements and related matters.
Please contact Abby
Adams at (202) 551-6902 or Suzanne Hayes at (202) 551-3675 with any other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Merrill M. Kraines, Esq.