United States securities and exchange commission logo
March 30, 2021
Adrian Adams
President and Chief Executive Officer
Impel NeuroPharma, Inc.
201 Elliott Avenue West, Suite 260
Seattle, WA 98119
Re: Impel NeuroPharma,
Inc.
Amendment No. 1 to
Draft Registration Statement on Form S-1
Submitted March 23,
2021
CIK No. 0001445499
Dear Mr. Adams:
We have reviewed your amended 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.
Amendment No. 1 to Draft Registration Statement on Form S-1
Prospectus Summary
Our Product Candidates, page 3
1. We note your response
to prior comment 2. However, we also note in several places in
your prospectus you
continue to make comparisons with the results of your STOP301 trial
to evaluate the safety
and tolerability of long-term, intermittent use of TRUDHESA
with standard acute
migraine medication and results of other approved treatments, such
as MAP0004, despite
your disclosure that (i) the efficacy endpoints in your clinical trials
have been only
exploratory in nature, (ii) the STOP301 trial was not powered for such
significance
comparisons and (iii) you have not studied MAP0004 and TRUDHESA in a
head-to-head clinical
trial. In addition to the comparisons made in the bullet points of this
Adrian Adams
Impel NeuroPharma, Inc.
March 30, 2021
Page 2
section, we note similar comparisons made on pages 91 and 101-104.
Please revise to
discuss the statistical test or tests you employed that provide
confidence that your
comparisons of the results of your STOP301 trial, or other applicable
trials, to a baseline
or to the results of other approved treatments are reliable. If you did
not employ such
statistical controls, please remove such comparisons or tell us why such
disclosure is
appropriate.
2. We note from your revised disclosure in response to prior comment 3 that
there were a
total of seven treatment emergent SAEs none of which were determined by
the
investigator to be related to TRUDHESA or led to withdrawal from the
trial. Please
expand your disclosure to identify the SAEs and discuss the basis for
the investigator's
determination that each was unrelated to TRUDHESA.
Business
Intellectual Property, page 116
3. We note your response to prior comment 9. Please expand to identify the
ex-U.S.
jurisdictions where patent applications are pending with respect to your
INP105
composition of matter and method of use patent family.
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,
FirstName LastNameAdrian Adams
Division of
Corporation Finance
Comapany NameImpel NeuroPharma, Inc.
Office of Life
Sciences
March 30, 2021 Page 2
cc: Amanda L. Rose, Esq.
FirstName LastName