United States securities and exchange commission logo
October 29, 2021
Marc de Garidel
Chief Executive Officer
CinCor Pharma, Inc.
4375 Medpace Way
Cincinnati, OH 45227
Re: CinCor Pharma, Inc.
Amendment No. 1 to
Draft Registration Statement on Form S-1
Submitted October
14, 2021
CIK No. 0001868734
Dear Mr. de Garidel:
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
Overview, page 1
1. Please delete your
statement that "you believe CIN-107 has the potential to dramatically
improve the paradigm
for patients suffering from hypertension, or high blood pressure."
Your statements
regarding the data from the clinical trial should be limited to objective
observations and the
next steps in the development process. Predictions related to
efficacy and
comparisons to currently available treatments are not appropriate.
2. We note your disclosure
here and elsewhere in the prospectus of a review that you
conducted of blinded,
preliminary safety data from your ongoing BrigHtn trial. Please
Marc de Garidel
FirstName LastNameMarc de Garidel
CinCor Pharma, Inc.
Comapany
October 29,NameCinCor
2021 Pharma, Inc.
October
Page 2 29, 2021 Page 2
FirstName LastName
limit this disclosure to provide it once in the summary, rather than
providing it in multiple
sections within the summary. Additionally, clearly state that due to
the blinded nature of
the study you currently do not know if participants receiving CIN-107
experienced any
decrease in blood pressure or of the decreases in blood pressure
differed from participants
receiving a placebo. Clearly explain the potential consequences of the
lack of quality
control measures and revise the statement that you will not know
whether treatment with
CIN-107 lowers blood pressure in a meaningful way until completion of
the trial,
validation of the data and statistical analysis to clarify that you
will not know if treatment
with CIN-107 lowers blood pressure in a meaningful way until all
clinical trials have been
conducted and the FDA makes its efficacy determination. We also note
that the disclosure
compares the preliminary safety data from your ongoing BrigHtn trial
to data from
placebo cohorts in previous placebo-controlled trials for hypertension
conducted by
others. Given your disclosure that you do not know how comparable the
data from
placebo cohorts in those studies may be to your ongoing trial, it does
not appear
appropriate for you to make this comparison in the prospectus. Please
revise the
disclosure in the Business section and elsewhere in the prospectus to
remove this
comparison.
CIN-107 Overview, page 3
3. We note your revisions in response to prior comments 1 and 3. Please
remove or revise
the following statements to eliminate any suggestion that your product
candidate is or will
be effective:
Replace your reference to a "substantial reduction" in
aldosterone levels observed in
the CIN-107 10 mg dose group in the single ascending dose Phase 1
clinical trial
(page 3) to quantified disclosure of the reduction;
Replace your statement that the results from your single
ascending dose Phase 1
clinical trial "confirmed" the high selectivity of CIN-107 for
aldosterone synthesis
over cortisol synthesis with the trial observations that that led
you to your
conclusion (page 103); and
Delete the statement that your the results from your multiple
ascending dose Phase 1
clinical trial "confirmed" the ability of CIN-107 to
significantly lower aldosterone
levels (page 104).
You may provide a summary of the objective observations from your
trials without stating
your conclusions, and such discussion is more appropriate in the
Business section where
full and proper context can be provided. Your disclosure should not
indicate that the
candidate is safe or that the observations were a result of the use of
the product candidate.
Marc de Garidel
CinCor Pharma, Inc.
October 29, 2021
Page 3
You may contact Michael Fay at 202-551-3812 or Daniel Gordon at
202-551-3486 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Ada D. Sarmento at 202-551-3798 or Suzanne Hayes at 202-551-3675 with
any other
questions.
Sincerely,
FirstName LastNameMarc de Garidel
Division of
Corporation Finance
Comapany NameCinCor Pharma, Inc.
Office of Life
Sciences
October 29, 2021 Page 3
cc: Ryan Sansom, Esq.
FirstName LastName