United States securities and exchange commission logo
October 1, 2021
Marc de Garidel
Chief Executive Officer
CinCor Pharma, Inc.
4375 Medpace Way
Cincinnati, OH 45227
Re: CinCor Pharma, Inc.
Draft Registration
Statement on Form S-1
Filed August 27,
2021
CIK No. 0001868734
Dear Mr. de Garidel:
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
Prospectus Summary, page 1
1. Please delete
statements indicating or implying safety or efficacy throughout your filing.
Safety and efficacy
determinations are solely within the authority of the FDA or similar
foreign regulators and
are assessed throughout all clinical trial phases. For example, we
note the following
statements:
We believe data
from this trial has the potential to demonstrate that CIN-107 may
enable patients to
achieve blood pressure control at an earlier time point using fewer
antihypertensive
agents.
By virtue of its
mechanism of action and the pharmacokinetics and
Marc de Garidel
FirstName LastNameMarc de Garidel
CinCor Pharma, Inc.
Comapany
October NameCinCor Pharma, Inc.
1, 2021
October
Page 2 1, 2021 Page 2
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pharmacodynamics profile observed in Phase 1 trials, we believe
that CIN-107 could
be an ideal drug to address the excess aldosterone synthesis that
is the hallmark of
PA.
By virtue of its mechanism of action of directly inhibiting
aldosterone synthesis, we
believe there is strong rationale for the use of CIN-107 in CKD.
We believe CIN-
107 has the potential to lower overall systemic aldosterone
levels, which not only
drives a blood pressure lowering effect, but also has a direct
effect on the progression
of CKD by reducing the non-genomic effects of aldosterone.
Based on CIN-107 s mechanism of directly inhibiting the
synthesis of aldosterone,
we believe CIN-107 is well-suited to address the excess
aldosterone levels resulting
from PA and, thereby, treat the associated hypertension.
Based on the significant reductions of aldosterone levels that
we have observed with
CIN-107 in our preclinical studies and Phase 1 trials, we believe
CIN-107 has the
potential to reduce the aldosterone-mediated end-organ effects on
the kidney, and,
thereby, modify the progression of CKD.
Unlike currently available RAAS-modifying antihypertensive
agents, CIN-
107 directly reduces the amount of aldosterone produced rather
than inhibiting
intermediary steps along the RAAS axis. As a result, CIN-107 not
only modulates the
genomic, blood pressure-lowering effects of aldosterone, but also
has the potential to
mitigate aldosterone s non-genomic effects that contribute to
the pathophysiology of
several cardio-renal diseases.
The results from this trial confirmed the ability of CIN-107 to
significantly lower
aldosterone levels in a dose-dependent manner at daily doses of 5
mg of CIN-107 or
less without affecting levels of cortisol or its precursors.
We believe these results provide further confirmation that
CIN-107 is highly selective
in inhibiting aldosterone synthase with no effect on cortisol
synthesis.
Please revise this disclosure and similar statements throughout your
prospectus to remove
any suggestion that there is an expectation that your product
candidate will be effective or
will have improved performance. You may provide a summary of the
objective
observations from your trials without stating your conclusions or
predictions.
Additionally, discussions of your trial observations are more
appropriate in the Business
section where full and proper context can be provided.
Our Pipeline, page 2
2. Please explain the references to "brightn: and "spark-PA."
CIN-107 Overview, page 3
3. We note your disclosure in this section that CIN-107 "significantly
lowered" aldosterone
levels without affecting cortisol levels across a wide range of doses
in multiple
preclinical in vivo studies, that the selectivity of CIN-107 was
"further confirmed" in
multiple Phase 1 clinical trials in healthy volunteers, and that 10 mg
of CIN-
Marc de Garidel
FirstName LastNameMarc de Garidel
CinCor Pharma, Inc.
Comapany
October NameCinCor Pharma, Inc.
1, 2021
October
Page 3 1, 2021 Page 3
FirstName LastName
107 demonstrated "near complete suppression" of aldosterone levels in
the single
ascending dose trial. Please revise these statements and similar
statements made in the
chart beginning on page 100 to remove any implication that CIN-107 is
effective as
determinations of efficacy are solely within the authority of the FDA
or similar foreign
regulators. You may present clinical trial end points and objective
data resulting from
trials without concluding efficacy, and such discussion is more
appropriate in the Business
section.
Risk Factors, page 13
4. Given the length of your risk factor section, please revise to comply
with Regulation S-K
Item 105 by relocating risks that could generically apply to any
registrant or offering to
the end of the section under the caption "General Risk Factors."
Our amended and restated certificate of incorporation provides that the Court
of Chancery of the
State of Delaware, page 69
5. Please revise this risk factor to disclose that there is also a risk
that your exclusive forum
provision may result in increased costs for investors to bring a
claim.
Market and Industry Data, page 72
6. We note your disclosure that you obtained the industry, statistical
and market data
included in the prospectus from your own internal estimates and
research as well as from
industry and general publications and research, surveys and studies
conducted by third
parties, and the sources of such data cannot guarantee the accuracy or
completeness of
such information. This statement appears to imply a disclaimer of
responsibility for this
information in the registration statement. Please either revise this
section to remove such
implication or specifically state that you are liable for all
information in the registration
statement.
Summary of Completed Phase 1 Clinical Trials of CIN-107, page 100
7. Please revise to disclose the primary and secondary endpoints and
whether they were met.
Our Solution--CIN-107, page 107
8. We note your disclosure in this section that you believe CIN-107 has
the potential to
become the "standard-of-care" for the treatment of hypertension,
including potential use
as an earlier line of therapy. This statement implies that your
product candidate will be
effective and will replace the current standard of care before a
competing product
candidate does, neither of which is appropriate at this stage of
development. Please revise
your registration statement to remove this language.
Additional Planned Clinical Trials for CIN-107 in Hypertension
Planned Pivotal Phase 3 Clinical Trials in Hypertension, page 108
Marc de Garidel
FirstName LastNameMarc de Garidel
CinCor Pharma, Inc.
Comapany
October NameCinCor Pharma, Inc.
1, 2021
October
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FirstName LastName
9. We note your disclosure that you expect to satisfy the safety database
requirement based
on the combination of your ongoing and planned Phase 2 clinical trials
and your planned
Phase 3 pivotal clinical trials of CIN-107. Please explain the
reference to "safety database
requirement" and tate that there is no guarantee that you will not
have to complete
additional trials or studies.
CIN-107 for the Treatment of Chronic Kidney Disease
Preclinical Data, page 110
10. Please revise your disclosure that you believe the "encouraging"
results of the in
vivo preclinical study discussed in this section support the further
evaluation of CIN-
107 in a clinical trial to assess the potential of CIN-107 in delaying
the progression of
CKD to avoid any suggestion that your product candidate has
demonstrated safety or
efficacy.
License with Roche, page 112
11. Please revise to narrow the your disclosure of the applicable royalty
percentage to a range
that is clearly ten percentage points or less.
Intellectual Property, page 113
12. For each of your patent portfolios, please revise to disclose the
material foreign
jurisdictions where you own or license patents or patent applications.
Management
Non-Employee Directors, page 126
13. Please revise to briefly discuss the specific experience,
qualifications, attributes or skills
that led to the conclusion that Mr. Ignelzi should serve as a director
for your company, in
light of your business and structure. Refer to Item 401(e) of
Regulation S-K.
Employment Arrangements with Our Named Executive Officers, page 137
14. We note your disclosure that you have entered into employment
agreements with Mr. de
Garidel, Dr. Isaacsohn and Ms. Pearce. Please file these agreements as
exhibits. Refer to
Item 601(b)(10) of Regulation S-K for guidance.
Principal Stockholders, page 151
15. Please revise your disclosure to identify the natural person or
persons who have voting
and investment control of the shares held by CinRx Pharma LLC.
General
16. 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,
Marc de Garidel
CinCor Pharma, Inc.
October 1, 2021
Page 5
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 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 Sarmento at 202-551-3798 or Suzanne Hayes at 202-551-3675 with any
other
questions.
FirstName LastNameMarc de Garidel Sincerely,
Comapany NameCinCor Pharma, Inc.
Division of
Corporation Finance
October 1, 2021 Page 5 Office of Life
Sciences
FirstName LastName