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United States securities and exchange commission logo
May 10, 2021
Daniel O Connell
Chief Executive Officer
Acumen Pharmaceuticals, Inc.
427 Park St.
Charlottesville, VA 22902
Re: Acumen
Pharmaceuticals, Inc.
Draft Registration
Statement on Form S-1
Submitted April 12,
2021
CIK No. 0001576885
Dear Mr. O Connell:
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
General
1. 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
retain copies of the
communications.
Prospectus Summary
Our Differentiated Approach to the Treatment of AD, page 2
2. 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
Daniel O Connell
Acumen Pharmaceuticals, Inc.
May 10, 2021
Page 2
statements are appropriate given the early stage of your product
candidates. We note, by
way of example, the statements that your product candidate, ACU193:
has the potential for improved efficacy and for a favorable safety
profile and
tolerability allowing higher dosing on page 2 under the section
Our Differentiated
Approach to the Treatment of AD; and
"has the potential to be an effective and safe therapy for the
treatment of AD"; and
is positioned "to be potentially best-in-class" on pages 3 and
100, and a similar
statement on page 107.
Summary of Our Nonclinical Data, page 3
3. Please expand to disclose the nonclinical studies from which you base
your statements
related to ACU193.
Our Team, page 3
4. We note that you identify certain entities on page 4 as investors in
your company, several
of which do not appear to be among your principal stockholders as
disclosed on page 160.
If material, please expand your disclosure to describe the nature of
each named entity's
investment in you or explain to us why including this information is
appropriate.
Use of Proceeds, page 78
5. Please disclose your intended use of the proceeds from the offering in
your next
amendment or public filing. Your disclosure should describe how far
the proceeds are
expected to enable you to progress in the clinical development of
ACU193.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Liquidity and Capital Resources
Sources of Liquidity, page 90
6. You state on page 90 that upon achievement of a certain milestone
event for ACU193, or
upon election of the Series B investors to waive the requirement for
the milestone event to
be achieved prior to its achievement, you are obligated to issue and
sell a second tranche
of Series B shares to the Series B purchasers for gross proceeds of
$30.0 million. On page
85 you refer to certain defined clinical milestones. Please clarify
the nature of the clinical
milestone and anticipated timing and if it is likely the purchasers
will waive the
requirement for the milestone event prior to the IPO.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Research and Development Expenses, page 90
FirstName LastNameDaniel O Connell
7. Please revise to provide more detail of the specific nature of your
research and
Comapany NameAcumen
development Pharmaceuticals,
expenses for each periodInc.
presented.
May 10, 2021 Page 2
FirstName LastName
Daniel O Connell
FirstName LastNameDaniel O Connell
Acumen Pharmaceuticals, Inc.
Comapany
May NameAcumen Pharmaceuticals, Inc.
10, 2021
May 10,
Page 3 2021 Page 3
FirstName LastName
Critical Accounting Estimates and Policies
Fair Value of Common Stock, page 94
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 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.
Principal Stockholders, page 160
9. Please ensure that you identify the natural persons who are the
beneficial owners of the
shares held by the 5% or greater stockholder identified in your table.
Financial Statements
Statements of Operations, page F-4
10. Given the automatic conversion upon the completion of this offering of
all of your
convertible preferred stock into shares of common stock, please tell
us how you
considered providing a pro forma presentation of the affected line
items on the face of
your balance sheet as well as pro forma loss per share on the face of
your statements of
operations and related footnote discussion thereof.
Item 15. Recent Sales of Unregistered Securities
Issuances of Preferred Stock, page II-2
11. Please expand your disclosure related to Issuances of Preferred Stock
to name the persons
or more clearly identify the class of persons to whom the securities
were sold and indicate
the section of the Securities Act or the rule of the Commission under
which exemption
from registration was claimed. Refer to Item 701 of Regulation S-K for
guidance.
You may contact Jeanne Bennett at 202-551-3606 or Mary Mast at
202-551-3613 if you
have questions regarding comments on the financial statements and related
matters. Please
contact David Gessert at 202-551-2326 or Celeste Murphy at 202-551-3257 with
any other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Darren DeStefano