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United States securities and exchange commission logo
July 28, 2021
Shane Schaffer
Chief Executive Officer
Cingulate Inc.
1901 W. 47th Place
Kansas City, KS 66205
Re: Cingulate Inc.
Amendment No. 1 to
Draft Registration Statement on Form S-1
Submitted July 19,
2021
CIK No. 0001862150
Dear Mr. Schaffer:
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. 2 to Draft Registration Statement
Prospectus Summary
Our Clinical Development Pipeline, page 2
1. We note your response
to comment 2. As it concerns CTx-1302 in your pipeline table,
please remove the Phase
3 initiation as an anticipated milestone. In this regard, we re-
assert our prior
request that you only provide the anticipated milestone for the next trial
(e.g., a phase 1/2
trial), rather than listing all future phases. Relatedly, please remove the
statement in the
amended pipeline table that "Phase 3 Trials to be initiated upon successful
outcome of Phase 1/2BA
Trial" because it improperly implies that this trial will be
successful.
Shane Schaffer
Cingulate Inc.
July 28, 2021
Page 2
Business
Cingulate's Product Candidates versus Major ADHD Competitors (>75% of the ADHD
Market),
page 82
2. We note your response to comment 16 and reissue the comment. Please
remove both
charts from this page. As neither CTx-1301 nor CTx-1302 have completed
clinical
trials, the information provided in the first two rows of each table is
unsupported and
therefore the tabular comparison to competitors' products is
inappropriate.
Our CTx-1301 Clinical Development Program, page 86
3. We note your response to comment 17 and related amendment on page 89 that
you "plan
to initiate the additional Phase 1 studies concurrently with our Phase 3
Mastery studies."
Please clarify whether your Planned Phase 3 Mastery Study will be
impacted by the
results of these two Phase 1 studies.
Figure 3: Comparative Bioavailability Study of CTx-1301 versus Focalin XR in
individual Adult
ADHD subjects under Fasted Conditions , page 89
4. We note your response to comment 19 and reissue the comment, as it does
not appear that
this figure was changed. Please advise or revise.
You may contact Gary Newberry at 202-551-3761 or Daniel Gordon at
202-551-3486 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Dillon Hagius at 202-551-7967 or Laura Crotty at 202-551-7614 with any
other
questions.
Sincerely,
FirstName LastNameShane Schaffer
Division of
Corporation Finance
Comapany NameCingulate Inc.
Office of Life
Sciences
July 28, 2021 Page 2
cc: Steven Skolnick
FirstName LastName