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United States securities and exchange commission logo
June 3, 2021
Lisa Ricciardi
Chief Executive Officer
COGNITION THERAPEUTICS INC
2403 Sidney Street
Pittsburgh, Pennsylvania 15203
Re: COGNITION
THERAPEUTICS INC
Draft Registration
Statement on Form S-1
Submitted May 7,
2021
CIK No. 0001455365
Dear Ms. Ricciardi:
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, Submitted May 7, 2021
Summary, page 1
1. We note your statement
on page 1 that CT1812 demonstrated a favorable safety profile
and on page 2 that
CT1812 has continued to be generally safe. Please revise these and all
similar statements
throughout your prospectus that state or imply that your product
candidates are safe as
this determination is solely within the authority of the FDA and
comparable regulatory
bodies.
2. On page 2 you state
that you intend to advance CT1812 directly into a Phase 2 clinical
trial in the second
half of 2021 for dry AMD. Please revise to state whether you have
consulted the FDA on
this approach, and if not, state that the FDA may disapprove of
your ability to rely on
prior studies, similar to your risk factor on page 19.
Lisa Ricciardi
COGNITION THERAPEUTICS INC
June 3, 2021
Page 2
3. Please tell us why you feel CT2168 and CT2074 are material enough to
be included in the
pipeline table given their early stage, lack of discussion in the
prospectus and, with respect
to CT2168, lack of a specific indication.
Management s Discussion and Analysis of Financial Condition and Results of
Operations
Critical Accounting Policies
Common Stock Valuations, page 88
4. 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. Please discuss with the staff how to submit your
response.
Business
Our Pipeline, page 91
5. On page 91 you state that you currently have four ongoing clinical
trials. Please reconcile
with the chart on page 99, which shows three ongoing clinical trials.
CT1812 for the Treatment of Alzheimers Disease (AD), page 96
6. Please revise to provide support for your statement on page 98 that
[d]rugs that mimic a
naturally occurring protective mutation are more likely to succeed in
the clinical setting.
7. Please revise page 99 to state whether you powered the SHINE study for
statistical
significance, and, if so, state the p-value for the significant
decline cited in your interim
results. Please provide p-values for any other study results as
available. With respect to
the p-value shown on page 102, or the first time a p-value is
mentioned if earlier, please
provide a brief explanation of the disclosed p-values and how p-values
are used to
measure statistical significance.
Grant Funding, page 110
8. On pages 92-93 you state that the majority of your clinical trials have
been funded by
grants awarded by the NIA. Please revise page 110 to describe the terms
of such grants
FirstName LastNameLisa Ricciardi
and the other grants listed on page 110. To the extent you have an
agreement with NIA,
Comapany NameCOGNITION
tell us THERAPEUTICS
your basis for deciding not to file anyINC
agreement with NIA as an
exhibit pursuant to
Item 601(b)(10)
June 3, 2021 Page 2 of Regulation S-K.
FirstName LastName
Lisa Ricciardi
FirstName LastNameLisa Ricciardi
COGNITION THERAPEUTICS INC
Comapany
June 3, 2021NameCOGNITION THERAPEUTICS INC
June 3,
Page 3 2021 Page 3
FirstName LastName
Intellectual Property, page 110
9. Please confirm that you do not in-license any technology that is
material to your business.
To the extent that you do, please revise your intellectual property
discussion accordingly,
and to the extent such technology is material, describe the terms of
such agreements and
file such agreements as exhibits pursuant to Item 601(b)(10) of
Regulation S-K.
Executive Compensation, page 137
10. Please revise page 137 to provide the number of shares and exercise
price for the options
that are intended to be granted to Ms. Ricciardi in connection with
this offering.
Note 2 - Summary of Significant Accounting Policies
Grant income, page F-9
11. Please revise to more clearly describe the arrangement(s) underlying
your grant revenue
stream, including nature and parameters of the research, determination
of eligible costs,
limits on reimbursement, etc.
Exhibits
12. Please file the Employee Stock Purchase Plan as an exhibit pursuant to
Item 601(b)(10) of
Regulation S-K.
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 Eric Atallah at 202-551-3663 or Kevin Kuhar at
202-551-3662 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Margaret Schwartz at 202-551-7153 or Celeste Murphy at 202-551-3257
with any other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Rachael M. Bushey, Esq.