April 17, 2020
Emmanuel Simons, Ph.D., M.B.A.
President and Chief Executive Officer
Akouos, Inc.
645 Summer Street
Boston, Massachusetts 02210
Re: Akouos, Inc.
Draft Registration Statement on Form S-1
Filed March 24, 2020
CIK No. 0001722271
Dear Dr. Simons:
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
Overview, page 1
1. Please clarify the meaning of any significant scientific or technical
terms the first time
they are used in the prospectus in order to ensure that lay readers will
understand the
disclosure. For example, and without limitation, please define each of
the following at
their first use in this section or where appropriate in the prospectus:
adeno-associated viral vector library
ancestral AAV
dual vector delivery
vector-mediated gene transfer
gene knockdown
vector-mediated therapeutic protein expression
Emmanuel Simons, Ph.D., M.B.A.
FirstName LastNameEmmanuel Simons, Ph.D., M.B.A.
Akouos, Inc.
Comapany NameAkouos, Inc.
April 17, 2020
April 2 2020 Page 2
Page 17,
FirstName LastName
2. We refer to the disclosure in the second paragraph regarding the
number of people who
live with disabling hearing loss. Please include disclosure regarding
the market size for
individuals suffering from the type of hearing loss that can be
treated with your lead
product candidate, AK-OTOF. Please provide similar disclosure on page
96 where you
discuss the estimated annual costs associated with hearing loss.
3. We note your disclosure that the epidemiology and severity of the
disorders you are
initially targeting have the potential for more rapid clinical
development and regulatory
approval. Please clarify the reasons for the more rapid development
and approval.
4. Please clarify the activities you have undertaken to sponsor and build
The Sing Registry.
Our Pipeline, page 3
5. Please revise the label of the "Pivotal" column of the pipeline table
to Phase 3. It is
premature to suggest that the completion of the Phase 1/2 clinical
trials will lead to a
pivotal Phase 3 trial for the products listed in the table.
6. We note that your pipeline table includes five preclinical programs
you are exploring. As
your narrative disclosure only briefly discusses these programs and
you have not allocated
any proceeds for their development in your use of proceeds section,
please explain to us
why you believe these programs are sufficiently material to your
business to be included
in a pipeline table.
Risks Associated with Our Business, page 4
7. Please revise to highlight your first risk factor on page 10, which
explains that you
incurred significant losses during all fiscal periods since inception
and expect to incur
substantial losses for the foreseeable future.
Use of Proceeds, page 68
8. Please revise your disclosure in this section to indicate how far the
proceeds from the
offering will allow you to advance clinical development for AK-OTOF.
Please also
disclose the second product candidate for which you intend to initiate
clinical
development. In addition, please specify the amount of capacity of the
internal
manufacturing capabilities you intend to establish with proceeds from
the offering.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Results of Operations, Comparison of the Years Ended December 31, 2018 and
2019, page 82
9. We see that you have multiple product candidates in various stages of
development. If
material, please revise to provide research and development expenses
for the AK-
antiVEGF and CLRN1 program, which are both also in the pre-clinical
stage. In
addition, provide a more robust discussion of the nature of research
and development
expenses generated each period for each significant product candidate.
If based on a
known event, trend, demand, commitment or uncertainty, future R&D
expense or the mix
Emmanuel Simons, Ph.D., M.B.A.
Akouos, Inc.
April 17, 2020
Page 3
of R&D expense is reasonably likely to differ from current trends, please
disclose the
reasons for and the amount of the expected change. Reference Item
303(a)(3) of
Regulation S-X.
Critical Accounting Policies and Significant Judgments and Estimates, Stock
Based
Compensation , page 87
10. Once you have an estimated offering price or range, please explain to us
the reasons for
any differences between the recent valuations of your common stock
leading up to the
IPO, the estimated offering price, and the consideration of preferred
stock issuances. This
information will help facilitate our review of your accounting for stock
compensation.
Our Manufacturing Approach, page 119
11. Please clarify whether you will manufacture the surgical delivery devices
to administer
your product candidates or if that will be performed by an outside party.
Licensed Intellectual Property, page 123
12. The disclosure in this section states that the MEE License and Lonza
Sublicense limit you
to hearing diseases and disorders with total prevalence in the United
States of less than
3,000 patients. Please tell us whether this limits your ability to
generate revenues for these
products given that the potential market sizes for the products under
these licenses
appear to be small.
General
13. 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.
You may contact Kristin Lochhead at (202) 551-3664 or Daniel Gordon at
(202) 551-
3486 if you have questions regarding comments on the financial statements and
related
matters. Please contact Chris Edwards at (202) 551-6761 or Celeste Murphy at
(202) 551-
3257 with any other questions.
Sincerely,
FirstName LastNameEmmanuel Simons, Ph.D., M.B.A.
Division of
Corporation Finance
Comapany NameAkouos, Inc.
Office of Life
Sciences
April 17, 2020 Page 3
cc: Molly W. Fox, Esq.
FirstName LastName