United States securities and exchange commission logo
March 11, 2021
Adrian Adams
President and Chief Executive Officer
Impel NeuroPharma, Inc.
201 Elliott Avenue West, Suite 260
Seattle, WA 98119
Re: Impel NeuroPharma,
Inc.
Draft Registration
Statement on Form S-1
Submitted February
12, 2021
CIK No. 0001445499
Dear Mr. Adams:
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
Prospectus Summary
Overview, page 1
1. We note your disclosure
that "your pipeline of late-stage proprietary product candidates
also includes INP107
for the treatment of OFF episodes in Parkinson s Disease." We
further note your
disclosure on pages 5 and 92 that you expect to initiate a
pharmacokinetic and
tolerability trial with respect to INP107 in 2022 and that INP107 is
depicted as in Phase 1
in your pipeline chart. Please revise your disclosure to remove the
implication that INP107
is a late-stage product candidate, or advise.
Adrian Adams
FirstName LastNameAdrian
Impel NeuroPharma, Inc. Adams
Comapany
March NameImpel NeuroPharma, Inc.
11, 2021
March2 11, 2021 Page 2
Page
FirstName LastName
Our Product Candidates, page 3
2. We note your discussion of the exploratory efficacy results of your
STOP301 trial to
evaluate the safety and tolerability of long-term, intermittent use of
TRUDHESA as an
acute treatment of migraine with or without aura in adult patients.
Given that the trial was
not powered to determine statistical significance of the exploratory
efficacy endpoints as
you disclose on page 4, please revise your disclosure here and
throughout to eliminate
comparisons of the results of your study with best optimal care
baselines and results of
other approved treatments. Alternately, provide the basis for which
such comparisons can
reliably be made.
3. We note your disclosure in the first paragraph following the bullet
point on page 4 that
there were no serious adverse events related to TRUDHESA observed in
the STOP301
trial. Please clarify whether any serious adverse events were observed
at all, whether or
not related to TRUDHESA. If there were, you may describe how you
determined the
SAEs were not related to TRUDHESA.
INP105 (Acute Treatment of Agitation and Aggression in Autism Spectrum
Disorder), page 5
4. Please revise throughout to remove any inference regarding regulatory
approval or the
safety, tolerability and efficacy of your product candidates or
explain to us why these
statements are appropriate given the stage of your product candidates.
We note, by way of
example, the statement that you "believe INP105 has the potential to
be a preferred choice
for the acute treatment of agitation and aggression events." In this
regard we also note the
statement on page 98 that: "TRUDHESA administration resulted in a
total plasma
exposure of DHE in the first two hours of dosing similar to IV, which
has been shown in
our exploratory efficacy analyses to enable rapid pain relief."
5. We note that you plan to initiate a double-blind, placebo-controlled
Phase 2 proof-of-
concept clinical trial of INP105 in adolescents with ASD by the end of
2021. Please
disclose the country and clinical phase of this planned study here and
where you discuss
your Product Candidates in the Business section of your Prospectus.
INP107 (Treatment of OFF Episodes in Parkinson's Disease), page 5
6. We note your disclosure that your expect to initiate a pharmacokinetic
and tolerability trial
in 2022. Please disclose the country where the anticipated trial will
be conducted, and the
clinical phase of this planned study, here and where you discuss your
Product Candidates
in the Business section of your Prospectus.
Implications of Being an Emerging Growth Company, page 8
7. Please 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
Adrian Adams
Impel NeuroPharma, Inc.
March 11, 2021
Page 3
retain copies of the communications.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Critical Accounting Polices and Estimates
Stock-Based Compensation, page 84
8. 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 significant differences between the recent valuations
of your common
stock leading up to the initial public offering 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.
Please discuss with
the staff how to submit your response.
Business
Intellectual Property, page 115
9. Please expand your disclosure to address the following:
disaggregate the number of your owned patents by type of patent or
patent family and
disclose the related expiration dates for each group;
clarify whether you have composition of matter patents for the
formulations of the
product candidates referenced in your pipeline table; and
disclose the patent expiration dates for your licensed patent
portfolio and file the
related licensing agreement(s) as exhibits to your registration
statement. Refer to
Item 601(b)(10)(ii)(B) for guidance.
Description of Capital Stock
Anti-Takeover Provisions
Restated Certificate of Incorporation and Restated Bylaw Provisions
Choice of Forum, page 165
10. Please expand your disclosure to discuss the provision of your restated
bylaws that will
FirstName LastNameAdrian Adams
provide that the federal district courts of the United States of America
will be the
Comapany NameImpel
exclusive NeuroPharma,
forum for Inc.of any complaint asserting a cause
of action under the
the resolution
March Securities Act. 3In this regard, we note your risk factor disclosure on
page 62.
11, 2021 Page
FirstName LastName
Adrian Adams
FirstName LastNameAdrian
Impel NeuroPharma, Inc. Adams
Comapany
March NameImpel NeuroPharma, Inc.
11, 2021
March4 11, 2021 Page 4
Page
FirstName LastName
You may contact Jeanne Bennett at 202-551-3606 or Lynn Dicker at
202-551-3616 if you
have questions regarding comments on the financial statements and related
matters. Please
contact David Gessert at 202-551-2326 or Tim Buchmiller at 202-551-3635 with
any other
questions.
Sincerely,
Division of Corporation
Finance
Office of Life Sciences
cc: Amanda L. Rose, Esq.