October 5, 2018
Milton Werner
President and Chief Executive Officer
Inhibikase Therapeutics, Inc.
3350 Riverwood Parkway SE, Suite 1900
Atlanta, GA 30339
Re: Inhibikase Therapeutics, Inc.
Draft Registration Statement on Form S-1
Submitted August 31, 2018
CIK No. 0001750149
Dear Dr. Werner:
We have reviewed your draft registration statement and have the
following comments. In
some of our comments, we may ask you to provide us with information so we may
better
understand your disclosure.
Please respond to this letter by providing the requested information and
either submitting
an amended draft registration statement or publicly filing your registration
statement on
EDGAR. If you do not believe our comments apply to your facts and circumstances
or do not
believe an amendment is appropriate, please tell us why in your response.
After reviewing the information you provide in response to these comments
and your
amended draft registration statement or filed registration statement, we may
have additional
comments.
Draft Registration Statement on Form S-1
Our Programs, page 1
1. Please delete the statement that IkT-001Pro is a "near-term commercial
opportunity." The
statement inappropriately assumes the successful result of your clinical
trials and FDA
approval. Additionally, clarify whether the FDA has made a final
determination that a
single 12-24 patient trial is sufficient to support the submission of an
NDA.
2. Please describe the significance of three columns under the Biomarker
column.. For
example, please tell us how you are "Validating" clinical target
engagement prior to
initiating clinical development and the meaning of "Can be used for
patient selection."
Milton Werner
FirstName Therapeutics, Inc.Werner
Inhibikase LastNameMilton
Comapany 2018
October 5, NameInhibikase Therapeutics, Inc.
October 5, 2018 Page 2
Page 2
FirstName LastName
Overview, page 1
3. Please balance your disclosure in the Prospectus Summary regarding the
near-term
commercial opportunity you have with IkT-001Pro by indicating your
current stage of
development, rather than indicating when you anticipate you will
complete the clinical
development, and whether you have filed an IND for IkT-001Pr. Please
also clarify that
validating the pharmacology advantage will require a post-approval
study to demonstrate
comparative efficacy and safety results to Imatinib.
Implications of Being an Emerging Growth Company and a Smaller Reporting
Company , page
6
4. 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.
Some intellectual property may have been discovered through governemt funded
programs ,
page 48
5. Please identify your product candidates that are dependent on patent
rights subject to
"march in" rights.
Use of Proceeds, page 67
6. If any of the net proceeds of the offering, together with existing
resources, will be used to
develop IkT-001Pro, please disclose the amount you will allocate to
its development and
the development stage you expect to reach.
7. Please revise this section to clarify whether you will be able to
complete the Phase 2
clinical trials in early-stage PD patients and treatment-naive PD
patients with your
existing cash and the net proceeds of this offering. To the extent you
will need to raise
additional capital to complete such stage of development, please
disclose the amount and
sources of such other funds needed to complete such trials. Refer to
Instruction 3 to Item
504 of Regulation S-K.
Results of Operations
Research and Development, page 79
8. You disclose on page 78 that external costs are tracked by therapeutic
indication. Please
revise your disclosures here to include the external costs incurred
during each period
presented for each program or therapeutic area separately to provide
more transparency as
to the type of expenses incurred.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Critical Accounting Policies and Significant Judgments and Estimates
Milton Werner
FirstName Therapeutics, Inc.Werner
Inhibikase LastNameMilton
Comapany 2018
October 5, NameInhibikase Therapeutics, Inc.
October 5, 2018 Page 3
Page 3
FirstName LastName
Stock-Based Compensation , page 84
9. Once you have an estimated offering price or range, please explain to
us how you
determined the fair value of the common stock underlying your equity
issuances and the
reasons for any differences between the recent valuations of your
common stock leading
up to the IPO and the estimated offering price. This information will
help facilitate our
review of your accounting for equity issuances including stock
compensation and
beneficial conversion features.
Critical Accounting Policies and Significant Judgments and Estimates
Stock-Based Compensation , page 85
10. On this page, you disclose you estimate the fair value of stock
options using the reduced
Net Product Value, or rNPV, option pricing model as performed by an
independent third
party consultant. On page F-10, you disclose you use the
Black-Scholes-Merton option
pricing model to determine the fair value of stock options. Please
clarify which model
you use and revise your disclosures for consistency.
Business
Overview, page 88
11. We note your statement on page 88 that you believe you 'pre-determine'
the human safety
margin of your novel chemical entities using the RAMP drug discovery
program.
Statements regarding safety are determinations that only the FDA has
the authority to
make. Please revise your disclosure here to eliminate any suggestion
that your product
candidates have been or will ultimately be determined safe,
reduced/eliminated risks
related to safety or to have demonstrated safety for purposes of
granting marketing
approval by the FDA or comparable agency.
Clinical Development Strategy for IkT-001Pro in Stable Phase CML, page 97
12. We note that your pipeline table and the discussion of the toxicity
and tolerability
discussion on page 96 appear to indicate that you have completed the
Ikt-001Pro
preclinical trial in monkeys. However, your discussion on page 97
indicates the trial is
still ongoing. Please revise your disclosure to address the apparent
inconsistency. If you
have completed the preclinical study, please describe the observable
data resulting from
the trial. In addition, please explain your statement that you
"believe the FDA is requiring
a single dose comparison study."
Material Agreements, page 101
13. We note that you have funded your operations primarily through
private, state and federal
contracts and grants, including from the National Institutes of
Health, Department of
Defense and State of Georgia. Please expand your disclosure to
describe the terms of the
Milton Werner
FirstName Therapeutics, Inc.Werner
Inhibikase LastNameMilton
Comapany 2018
October 5, NameInhibikase Therapeutics, Inc.
October 5, 2018 Page 4
Page 4
FirstName LastName
research grants you received from these institutions. For instance,
clarify whether the
government has any rights to the products developed with the funds
received, whether
there are any circumstances under which you may have to pay back the
funds received,
etc. Alternatively, provide an analysis as to why you believe such
disclosure is not
required.
Duke University, page 102
14. Please disclose when the agreement expires.
Sphaera Pharma Pte. Ltd., page 103
15. We note your disclosure indicates that Sphaera is entitled to
milestone payments upon the
achievement of certain preclinical, clinical and regulatory
milestones. You have disclosed
the payments related to dosing of the first patient in a Phase 1
clinical trial and FDA
approval. Please revise your disclosure regarding the milestone
payments to also disclose
payments related to your preclinical milestones and indicate whether
the milestone has
been met or you anticipate achieving it in the near future.
Additionally, confirm that the
payments disclosed constitute all milestone payments. Alternatively,
quantify the
milestone payments made to date and all remaining potential milestone
payments.
Sponsored Research Agreements, page 103
16. We note that you have entered into sponsored research agreements with
academic and
research institutions to perform certain testing and research for you
and that you currently
do not have a research and development facility of your own. To the
extent any of the
sponsored research agreements identified are material to your
business, please describe
their material terms , and file them as exhibits to your registration
statement.
Alternatively, please explain why you believe these agreements are not
material.
Government Regulation, page 106
17. We note your belief that approval of IkT-001Pro can be achieved
through the 505(b)(2)
regulation. Please expand your disclosure in this section to explain
the 505(b)(2)
regulatory pathway and how the requirements differ from the
traditional pathway.
Management, page 120
18. Please revise the biographies of each of the key non-executive
officers and non-employee
directors to state the period(s) during which each individual served
in
such capacity. Please also disclose the principal occupations and
employment of Surendra
Singh and Lisa Evr n during the past five years. Refer to Item 401(a),
(c) and (e) of
Regulation S-K.
Notes to Financial Statements
10. Commitments and Contingencies
Milton Werner
Inhibikase Therapeutics, Inc.
October 5, 2018
Page 5
License Agreements, page F-18
19. Please revise your disclosure of the Sphaera Pharma Pte. Ltd.
collaboration agreement to
include the total aggregate amount of potential milestone payments
Sphaera may be
entitled to receive under the agreement.
General
20. Please provide us proofs of all graphics, visual, or photographic
information you will
provide in the printed prospectus prior to its use, for example in a
preliminary prospectus.
You may contact Rolf Sundwall at 202-551-3105 or Sharon Blume at
202-551-3474 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Irene Paik at 202-551-6553 or Suzanne Hayes at 202-551-3675 with any
other questions.
Sincerely,
FirstName LastNameMilton Werner
Division of
Corporation Finance
Comapany NameInhibikase Therapeutics, Inc.
Office of
Healthcare & Insurance
October 5, 2018 Page 5
cc: Merrill M Kraines
FirstName LastName