United States securities and exchange commission logo
January 24, 2024
Francis Knuettel II
Interim Chief Executive Officer
Chromocell Therapeutics Corporation
4400 Route 9 South, Suite 1000
Freehold, NJ 07728
Re: Chromocell
Therapeutics Corporation
Amendment No. 9 to
Registration Statement on Form S-1
Filed January 16,
2024
File No. 333-269188
Dear Francis Knuettel II:
We have reviewed your amended registration statement and have the
following
comments.
Please respond to this letter by amending your registration
statement and providing the
requested information. If you do not believe a comment applies to your
facts and circumstances
or do not believe an amendment is appropriate, please tell us why in
your response.
After reviewing any amendment to your registration statement and
the information you
provide in response to this letter, we may have additional comments.
Unless we note otherwise,
any references to prior comments are to comments in our October 24, 2023
letter.
Amendment to Form S-1 filed January 16, 2023
Prospectus Summary
Business
Equity Line of Credit, page 1
1. We note your disclosure
that you are "negotiating an arrangement with the Holder of the
Investor Note to enter
into an Equity Line of Credit (the ELOC ) subsequent to the
IPO." Please revise to
clearly disclose, if true, that an equity line of credit agreement has
not been, and may never
be, finalized and executed and that there is no assurance that you
will enter into an
equity line of credit agreement. In addition, please add a risk factor
discussing the various
risks relating to the potential equity line of credit agreement you are
negotiating. For
example only, you should discuss the potential dilutive effect, the
potential impact on
your liquidity, and any potential negative impact the equity line of
credit agreement may
have.
Francis Knuettel II
FirstName
ChromocellLastNameFrancis Knuettel II
Therapeutics Corporation
Comapany
January 24,NameChromocell
2024 Therapeutics Corporation
January
Page 2 24, 2024 Page 2
FirstName LastName
Use of Proceeds, page 42
2. Please update your disclosure to discuss the approximate amount of
proceeds you intend
to use for each of the Spray Formulations you licensed from Benuvia
Operations, LLC or
otherwise advise.
Business, page 53
3. We note you recently "entered into an exclusive licensing agreement
(the Benuvia
License Agreement ) with Benuvia Operations, LLC ( Benuvia ) for
a sublingual
formulation of a Diclofenac spray for the treatment of acute pain (the
Diclofenac Spray
Formulation ), a Rizatriptan sublingual spray formulation (the
Rizatriptan Spray
Formulation ) and an Ondansetron sublingual spray formulation (the
Ondansetron Spray
Formulation ), diversifying [y]our pipeline of non-opioid pain
treatment therapies, while
adding therapeutic options for related conditions." Please update your
disclosure
throughout your business section where appropriate to discuss your
strategy and
development plans, including a discussion of the regulatory pathway(s)
you plan to pursue
for each of these product candidates or otherwise advise.
Our Strategy, page 54
4. We note you recently entered into a license agreement with Benuvia
Operations, LLC for
certain sublingual spray formulations of certain product candidates.
Please update your
disclosure to discuss your development strategy for these product
candidates or otherwise
advise.
Overview, page 54
5. You state that the Diclofenac spray has started clinical development
in human volunteers.
Please revise your disclosure to identify your current stage of
clinical development for
your spray formulation of Diclofenac and disclose the material details
of the
"development in human volunteers" that has been conducted to date or
you have started.
6. You state that preliminary pharmacokinetics suggest that the
Diclofenac spray formulation
may have a faster onset of action than oral Diclofenac tablets. Please
discuss the
pharmacokinetic results and how you concluded that the Diclofenac
spray formulation
may have a faster onset of action.
7. You state that Rizatriptan is thought to be superior to Sumatriptan by
a number of clinical
measures. Please provide your basis for this statement. In addition,
please discuss if
Sumatriptan is considered a competitor of Rizatriptan.
8. We note your Benuvia License Agreement appears to cover additional
"Spray
Formulations." Please revise your disclosure to clarify the other
spray formulations you
plan to develop pursuant to the Benuvia License Agreement or otherwise
advise. Your
disclosure should discuss the current stage of clinical development
and the results of any
Francis Knuettel II
Chromocell Therapeutics Corporation
January 24, 2024
Page 3
material trials conducted to date as well as the material terms of any
ongoing or planned
trials for the other "Spray Formulations" you plan to develop.
Our Addressable Market, page 57
9. If material, please update your disclosure to discuss the market(s) for
the Spray
Formulations you licensed from Benuvia Operations, LLC or otherwise
advise.
Intellectual Property, page 58
10. We note your disclosure on page 86 that the "Diclofenac Spray
Formulation is patented."
Please update your disclosure here to discuss the material patent(s)
covered by your
license with Benuvia Operations, LLC, including the type(s) of patent
protection, the
expiration dates and the applicable jurisdictions.
Certain Relationships and Related Party and Other Transactions, page 86
11. We note your discussion of the Benuvia License Agreement. Please include
a discussion
all material terms of the agreement including a description of the
rights and obligations of
the parties thereto, financial terms including amounts paid to date,
aggregate milestone
amounts to be paid or received and the termination provisions.
Condensed Interim Financial Statements for the Nine Months ended September 30,
2023
Note 8. Subsequent Events, page F-30
12. Revise to provide disclosure about your accounting for the Benuvia
License Agreement,
including how you valued the 384,226 common shares issued in connection
with the
Agreement.
Please 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 LastNameFrancis Knuettel II
Division of
Corporation Finance
Comapany NameChromocell Therapeutics Corporation
Office of Life
Sciences
January 24, 2024 Page 3
cc: David Danovitch, Esq.
FirstName LastName