United States securities and exchange commission logo





                             October 3, 2022

       Christian Kopfli, Esq.
       Chief Executive Officer
       Chromocell Therapeutics Corporation
       675 US Highway Route 1 South
       North Brunswick, NJ 08906

                                                        Re: Chromocell
Therapeutics Corporation
                                                            Draft Registration
Statement on Form S-1
                                                            Submitted September
6, 2022
                                                            CIK No. 0001919246

       Dear Christian Kopfli:

              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 submitted September 6, 2022

       Prospectus Summary
       Our Business
       Overview, page 1

   1.                                                   You make several
assertions regarding the safety of your lead candidate, CC8464,
                                                        including your
statement that CC8464 has "demonstrated a good safety and tolerability
                                                        profile in Phase 1
clinical trials" and "[CC8464] demonstrated safety in a Phase 1
                                                        study." Safety is a
determination that is within the authority of the FDA. Please revise or
                                                        remove these statements
and similar statements throughout your prospectus. Note that you
                                                        may state your product
candidate has been well tolerated, if accurate. In addition, please
 Christian Kopfli, Esq.
Chromocell Therapeutics Corporation
October 3, 2022
Page 2
         update your disclosure here to disclose your "Phase 1 clinical trials
have shown that
         CC8464 can lead to rashes," consistent with your risk factor
disclosure on page 15.
2.       You state that "[a]ccording to Mordor Intelligence, the global pain
management market
         was valued at approximately $67 billion in 2021, and it is expected to
have revenues of
         $89 billion in 2027, with a CAGR of 4.65% over the forecast period."
However, you state
         elsewhere that you "are currently focusing [y]our research and product
development
         efforts on CC8464 for the management of EM." Please balance your
disclosure to discuss
         the current size of the market for pain management in EM patients and
make it clear that
         you do not currently have product candidates that address the broad
pain management
         market at this time or otherwise advise.
3.       You state on page 52 that your "development programs are initially
designed to address
         pain and pain-related symptoms in EM." However, on page 53 you state
that CC8464 is
         your lead candidate for the treatment of EM. Please revise this
section to include such
         information in the prospectus summary and clarify throughout your
prospectus whether
         your product candidate is designed to treat EM or whether it is
designed to treat only the
         pain-related symptoms in EM or otherwise advise.
4.       We note your references here and throughout your prospectus to third
party research,
         including Mordor Intelligence and Transparency Market Research. Please
clarify whether
         you commissioned research from Mordor Intelligence, Transparency
Market Research or
         any other third party research referenced in your prospectus. If so,
please revise your
         filing to identify such third party and file a consent from such third
party. Please refer to
         Securities Act Rule 436 and Question 233.02 of the Securities Act
Rules Compliance and
         Disclosure Interpretations.
Risks Related to Development, Clinical Testing, and Regulatory Approval, page
12

5.       We note your disclosure throughout this section where you disclose
"[y]our pipeline of
         products" and "[y]our other lead candidates." However, your disclosure
on page 55
         appears to indicate that you currently only have one product
candidate, CC8464, and that
         you "plan to allocate future resources towards the discovery and
development of other
         compounds that could potentially modulate NaV1.7 or related
sodium-channels." Please
         update your disclosure here and throughout your prospectus to clarify
that your current
         pipeline consists of one clinical candidate, CC8464, or otherwise
advise.
FDA designations to expedite drug development and review, including orphan drug
designation,
Breakthrough Therapy designation..., page 18
FirstName LastNameChristian Kopfli, Esq.
6.     We note your disclosure on page 55 that you "are considering submitting
a request to the
Comapany
       FDANameChromocell
             for Orphan Drug Therapeutics
                             Designation" Corporation
                                           for CC8464. Please update your risk
factor to clarify
       that you have not
October 3, 2022 Page 2   submitted an application to date or otherwise advise.
FirstName LastName
 Christian Kopfli, Esq.
FirstName
ChromocellLastNameChristian   Kopfli, Esq.
             Therapeutics Corporation
Comapany
October     NameChromocell Therapeutics Corporation
         3, 2022
October
Page 3 3, 2022 Page 3
FirstName LastName
Our certificate of incorporation and our bylaws provide that the Court of
Chancery of the State of
Delaware will be the exclusive forum..., page 34

7.       We note your disclosure here that "the exclusive forum provision does
not apply to suits
         brought to enforce any liability or duty created by the Securities
Act, the Securities
         Exchange Act of 1934, as amended (the    Exchange Act   ), or any
other claim for which
         the federal courts have exclusive jurisdiction." However, we also note
your disclosure that
         "[u]nless [you] consent in writing to the selection of an alternative
forum, the United
         States federal district courts shall, to the fullest extent permitted
by applicable law, be the
         sole and exclusive forum for the resolution of any complaint asserting
a cause of action
         arising under the Securities Act," which appears to indicate that the
exclusive forum
         provision would apply to causes of action arising under the Securities
Act. Please update
         your disclosure to clarify whether this provision applies to actions
arising under the
         Securities Act. In that regard, we note that Section 22 of the
Securities Act creates
         concurrent jurisdiction for federal and state courts over all suits
brought to enforce any
         duty or liability created by the Securities Act or the rules and
regulations thereunder. If the
         provision applies to Securities Act claims, please also revise your
prospectus to state that
         there is uncertainty as to whether a court would enforce such
provision and that investors
         cannot waive compliance with the federal securities laws and the rules
and regulations
         thereunder. Please make corresponding changes to your Choice of Forum
disclosure on
         page 89.
Use of Proceeds, page 42

8.       We note your disclosure on page 49 that "[y]our primary use of cash is
to repay assumed
         liabilities associated with the execution of the Contribution
Agreement on July 12, 2022."
         Please update your disclosure here to more clearly describe the
assumed liabilities that
         will be repaid with the net proceeds or otherwise advise. Please
refere to Item 504 of
         Regulation S-K and Instruction 4 thereto.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Results of Operations, Comparison of the Fiscal Years Ended December 31, 2021
and 2020
Research and Development Expenses, page 48

9.       Please revise to provide quantitative and/or qualitative disclosure
for all periods presented
         that provides more transparency as to the type of research and
development expenses
         incurred (i.e. by nature or type of expense) which should reconcile to
total research and
         development expense on the Consolidated Statements of Operations. For
example, your
         disclosure should elaborate on the nature of consulting expense and
lab materials, as
         disclosed on page F-9.
 Christian Kopfli, Esq.
FirstName
ChromocellLastNameChristian   Kopfli, Esq.
             Therapeutics Corporation
Comapany
October     NameChromocell Therapeutics Corporation
         3, 2022
October
Page 4 3, 2022 Page 4
FirstName LastName
Business
Overview, page 52

10.      We note your disclosure on page 53 that you plan to begin Phase 2a
trial in 2023 and
         believe it will provide guidance for other indications of peripheral
neuropathic pain.
         Expand this section or where you deem appropriate in your Business
section, to include a
         description of your planned Phase 2a trial.
Our Strategy, page 52

11.      Please define the acronym EM at first use. In addition, we note your
statement that
         "[b]ased on genetic studies, a scientific consensus emerged that
NaV1.7 could be critical
         in mediating pain in EM." Please describe the genetic studies, and
revise your disclosure
         to provide your basis for this statement.
12.      We note your disclosure here that "[b]ased on [CC8464's] pre-clinical
profile ...CC8464
         has the potential to become a first-in-class drug for treatment of EM
patients." Please
         expand this section or where you deem appropriate in your Business
section to discuss the
         "pre-clinical profile" of CC8464, including a discussion of the
objective results of any
         preclinical studies preformed to date.
13.      We note your disclosure where you state that your focus is to address
pain and pain-
         related symptoms in EM. However, on page 54, you disclose that there
are two types of
         EM, primary and secondary EM, and further state that there is also EM
cases where a
         known genetic variation caused the illness and cases where it is
unknow. Please clarify
         whether CC8464 is intended to target all types of EM or otherwise
advise.
14.      We note your disclosure here that "CC8464 has the potential to become
a first-in-class
         drug for treatment of EM patients." Please remove references
throughout your prospectus
         to potential "first-in-class" when describing your product candidate
as these descriptions
         imply an expectation of regulatory approval and are inappropriate
given the length of time
         and uncertainty with respect to securing marketing approval.
CC8464 Current Study Results, page 54

15.      We note you have completed a Phase 1 clinical trial for CC8464. Please
expand your
         description of this trial to provide specific details, parameters and
results of the trial,
         including, for example only:
             dates of the trial and location;
             identity of trial sponsor(s);
             trial design;
             patient information (e.g., number of patients enrolled and treated
and the criteria for
              participation in the study);
             duration of treatment and dosage information;
             primary and secondary endpoints; and
             discussion of results, including adverse events and serious
adverse events, if any.
 Christian Kopfli, Esq.
Chromocell Therapeutics Corporation
October 3, 2022
Page 5
         In addition, please revise to clarify whether the Phase 1 trial was
powered for statistical
         significance. If the Phase 1 trial was powered for statistical
significance please provide p-
         values for the results of the trial.
16.      You state that "[a] does-escalation-regime is a standard method to
mitigate rashes as a side
         effect and the FDA has approved drugs with such prescriptions." Please
revise your
         disclosure to eliminate any suggestion that CC8464 is likely to be
approved. Safety and
         efficacy determinations are solely within the authority of the FDA or
comparable foreign
         regulators. Please revise further to clarify that although the FDA has
approved prior drugs
         with similar side effects there is no guarantee that CC8464 may be
approved with such
         side effects.
CC8464's Mechanisms of Action, page 54

17.      We note your disclosure that "mutations of NaV1.7 are a leading cause
for EM."
         However, you do not appear to describe CC8464's mechanisms of action
in this section as
         the subheading appears to indicate. Please expand your discussion here
to explain the
         potential mechanism of action of CC8464 for treatment of EM and the
basis for this claim
         or otherwise advise.
CC8464 Manufacturing, page 55

18.      We note you have rights to two proprietary methods to produce CC8464.
Please revise
         your disclosure to discuss your manufacturing process in more detail,
including
         describing both methods in greater detail and state how you have
proprietary right i.e.
         patent protection, trade secret, etc. or otherwise advise.
19.      We note you plan to use CROs to manufacture CC8464 in the future.
Please discuss your
         current manufacturing process for the CC8464 used in your clinical
trials and state
         whether it has been conducted in-house or outsourced from a
third-party. In addition,
         please update your disclosure to discuss if you currently have enough
supply of CC8464
         to begin your anticipated Phase 2a study or otherwise advise.
Intellectual Property, page 55

20.    You state that you have received a patent from USPTO for the composition
and use of
       CC8464. Please expand your disclosure to clearly state if patent is
owned or licensed and
       disclose the expected expiration date. Please also disclose such
information for the
       pending patent applications referenced on page 56, including type of
patent protection (for
FirstName LastNameChristian Kopfli, Esq.
       example, composition of matter, use or process), the specific product(s)
to which the
Comapany    NameChromocell
       patent relates, whether Therapeutics   Corporation
                                the patent is owned or licensed, the patent
expiration dates, and the
Octoberapplicable  jurisdictions.
         3, 2022 Page   5
FirstName LastName
 Christian Kopfli, Esq.
FirstName
ChromocellLastNameChristian   Kopfli, Esq.
             Therapeutics Corporation
Comapany
October     NameChromocell Therapeutics Corporation
         3, 2022
October
Page 6 3, 2022 Page 6
FirstName LastName
Our Competition, page 56

21.      We note your disclosure that "[t]he market exclusivity associated with
Orphan
         Designation plus the CC8464 market exclusivity associated with [y]our
patent and
         pending patent applications are key elements of [y]our
commercialization strategy."
         Please balance such statement by indicating that you currently do not
have and may not
         receive Orphan Designation by the FDA.
22.      We note your disclosure here that "the advanced clinical development
of CC8464, if
         approved by the FDA, provides a viable pathway to realize [y]our
commercialization
         plans." Given your current stage of development, please provide your
basis for you
         statement that the clinical development of CC8464 is "advanced" or
otherwise advise.
Management, page 75

23.      We note several of your executive and director biographies where the
principal occupation
         and employment is unclear during the past five years. Please discuss
the principal
         occupation and employment for the past five years, including the name
and principal
         business of any corporation or other organization. Please also
indicate any other
         directorships held during the last five years for each director. See
Item 401 of Regulation
         S-K.
24.      You state that Christian Kopfli, Esq. has served as CEO and as a
director since your
         inception. You also state that he is currently CEO of Chromocell
Holdings. Please state
         whether Christian Kopfli will be working as CEO for Chromocell
Therapeutics
         Corporation on a non-full time basis. If so, please revise your
discussion to include
         appropriate risk factors.
General

25.      We note that pursuant to your contribution agreement Chromocell
Corporation
         contributed all assets, liabilities, and results of operations
relating to Chromocell
         Holdings' therapeutic business. We further note that in 2015
Chromocell Corporation
         entered into a license and collaboration agreement with Astellas
Pharma Inc whereby
         Astellas obtained worldwide rights to commercialize CC8464. With
reference to
         Regulation S-K, Item 601, please update your exhibit index to include
all required
         exhibits, including all your material contracts such as your
collaboration agreement with
         Astellas Pharma Inc., and any other material agreements, or tell us
why you believe such
         filing is not required. In addition, please disclose the material
terms of the collaboration
         agreement.
26.      Please provide us with supplemental 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,
         have presented or expect to present to potential investors in reliance
on Section 5(d) of the
         Securities Act, whether or not you retained, or intend to retain,
copies of those
         communications.
 Christian Kopfli, Esq.
Chromocell Therapeutics Corporation
October 3, 2022
Page 7

       You may contact Kristin Lochhead at 202-551-3664 or Daniel Gordon at
202-551-3486 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Doris Stacey Gama at 202-551-3188 or Jason Drory at 202-551-8342 with
any other
questions.



                                                         Sincerely,
FirstName LastNameChristian Kopfli, Esq.
                                                         Division of
Corporation Finance
Comapany NameChromocell Therapeutics Corporation
                                                         Office of Life
Sciences
October 3, 2022 Page 7
cc:       David Danovitch, Esq.
FirstName LastName