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Correspondence 0001753926-23-000945 from Pelthos Therapeutics Inc. (PTHS)

Pelthos Therapeutics Inc.
Date: July 24, 2023 · CIK: 0001919246 · Accession: 0001753926-23-000945

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File numbers found in text: 333-269188

Referenced dates: May 19, 2023

Date
July 24, 2023
Author
Not clearly detected
Form
CORRESP
Company
Pelthos Therapeutics Inc.

Letter

FOIA CONFIDENTIAL TREATMENT REQUEST

The entity requesting confidential treatment is:

Chromocell Therapeutics Corporation

Route 9 South, Suite 1000

Freehold, New Jersey, 07728

Telephone: 732-514-2636

CERTAIN PORTIONS OF THIS LETTER AS FILED VIA EDGAR HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. OMITTED INFORMATION HAS BEEN REPLACED IN THIS LETTER AS FILED VIA EDGAR WITH A PLACEHOLDER IDENTIFIED BY THE MARK “[***].”

July 24, 2023

VIA EDGAR AND OVERNIGHT DELIVERY

U.S. Securities and Exchange Commission

Division of Corporation Finance

Mail Stop 4561

F Street, N.E.

Washington, D.C. 20549

Attention: Kristin Lochhead and Daniel Gordon

Re: Chromocell Therapeutics Corporation

Registration Statement on Form S-1

File No. 333-269188

CIK No. 0001919246

Rule 83 Confidential Treatment Request by Chromocell Therapeutics Corporation

Ladies and Gentlemen:

On behalf of Chromocell Therapeutics Corporation (the “Company”), in response to comments from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) in a letter dated May 19, 2023 (the “Original Comment Letter”) relating to the Company’s Registration Statement on Form S-1, initially publicly filed by the Company with the Commission on January 11, 2023, and as amended to date (File No. 333-269188) (the “Registration Statement”), we submit this supplemental letter to further address Comment No. 5 of the Original Comment Letter.

Because of the commercially sensitive nature of information contained herein, this submission is accompanied by the Company’s request for confidential treatment for selected portions of this letter. The Company has concurrently filed a separate letter with the Office of Freedom of Information and Privacy Act Operations in connection with the confidential treatment request, pursuant to Rule 83 of the Commission’s Rules on Information and Requests, 17 C.F.R. § 200.83. For the Staff’s reference, we have enclosed a copy of the Company’s letter to the Office of Freedom of Information and Privacy Act Operations.

We confirm on behalf of the Company that, prior to circulating copies of the preliminary prospectus in connection with the offering, the Company will file a pre-effective amendment to the Registration Statement that will include all information other than information that may be excluded in reliance upon Rule 430A of Regulation C, and the actual price range to be included in such amendment, which will comply with the Staff’s interpretation regarding the parameters of a bona fide price range.

The Company expects to reflect the Stock Split (as defined below) in a pre-effective amendment to the Registration Statement that includes the estimated Preliminary Price Range (as defined below). All dollar amounts and per share amounts in this letter have been prepared based on such assumed Stock Split.

The Company respectfully requests that the bracketed information contained in this letter be treated as confidential information pursuant to Rule 83 promulgated by the Commission, 17 C.F.R. §200.8, and that the Commission provide timely notice to Francis Knuettel II, Chief Financial Officer, Chromocell Therapeutics Corporation, 4400 Route 9 South, Suite 1000, Freehold, New Jersey, 07728, before it permits any disclosure of the bracketed information in this letter.

For the convenience of the Staff, we have recited the prior comment from the Staff in the Original Comment Letter in italicized type and have followed the comment with the Company’s response.

5. As a related matter, since your common stock is not actively traded, please revise to disclose how you determined the underlying fair value of your common stock as an input to the Black-Scholes Option Pricing Model. In addition, once you have an estimated offering price or range, please explain to us the reasons for any differences between the recent valuations of your common stock leading up to the initial public offering and the estimated offering price. This information will help facilitate our review of your accounting for equity issuances including stock compensation. Please discuss with the staff how to submit your response.

The Company respectfully submits the below additional information to assist the Staff in its review of the Company’s position with respect to its determination of the fair value of the Company’s common stock, par value $0.0001 per share (“Common Stock”), underlying its outstanding equity awards and the reasons for the differences between the recent valuation of its Common Stock and the estimated offering price for its initial public offering (“IPO”).

Preliminary IPO Price Range

The Company advises the Staff that it estimates a preliminary price range of approximately $[***] to $[***] per share (the “Preliminary Price Range”) for its IPO, after giving effect to a [***] reverse stock split that the Company plans to implement prior to effectiveness of the Registration Statement (the “Stock Split”), resulting in a midpoint of the Preliminary Price Range of $[***] per share (the “Midpoint Price”). The actual price range and the ratio of the reverse stock split to be included in a subsequent amendment to the Registration Statement (which will comply with the Staff’s interpretation regarding the parameters of a bona fide price range) have not yet been determined and remain subject to adjustment based on factors outside of the Company’s control. However, the Company believes that the foregoing indicative Preliminary Price Range and reverse Stock Split will not be subject to significant change.

Determining the Fair Value of Common Stock Prior to the IPO

As there has been no public market for the Company’s Common Stock to date, the estimated fair value of the Common Stock has been determined by the Company’s board of directors (the “Board”) as of the date of each option grant. As part of this determination, the Board took into consideration a third-party valuation of the Company’s intellectual property (primarily comprising the patents, trade secrets, know-how and pre-clinical and clinical test results for a non-opioid pain treatment compound known as CC8464) and the Board’s assessment, with input from management, of additional objective and subjective factors that it believed were relevant. These factors may have changed from the date of the applicable third-party valuation through the date of the grant.

The Company had the third-party valuation conducted in conjunction with the Company’s issuance of shares of its Common Stock and its Series A Convertible Preferred Stock, par value $0.0001 per share (the “Series A Preferred Stock”), pursuant to that certain contribution agreement (“Contribution Agreement”), dated August 10, 2022, between the Company and Chromocell Corporation (“Holdings”). The valuation analysis was performed in conformance with Financial Accounting Standards Board Accounting Standards Codification 820, Fair Value Measurements and Disclosure (“ASC 820”).

As a precursor to the analysis of the underlying fair value of the stock options granted by the Company, the table below sets forth the option grants since inception:

Name* Options Issued Exercise Price Vesting Commencement Date

Grants**

Camden Capital [***] $[***] 10/01/2022

Christian Kopfli [***] $[***] 10/01/2022

Jadira Outeiral [***] $[***] 10/01/2022

Grants***

Ezra Friedberg [***] $[***] 01/10/2023

Todd Davis [***] $[***] 01/10/2023

Todd Davis [***] $[***] 01/10/2023

Richard Malamut [***] $[***] 01/10/2023

Chia-Lin Simmons [***] $[***] 03/09/2023

Eric Lang [***] $[***] 05/15/2023

* Table gives effect to the [***] reverse Stock Split.

** 2022 grants were approved on January 10, 2023, with a vesting commencement date of October 1, 2022.

*** 2023 grants were approved on the vesting commencement date, other than in respect of the grant to Mr. Lang, which was approved on June 23, 2023, with a vesting commencement date of May 15, 2023.

Valuation of Intellectual Property (August 10, 2022)

With certain adjustments outlined below, and as summarized above, the Company based its determination of the underlying fair value of the Company’s Common Stock on the findings of an independent third party engaged by the Company to determine the fair value of the Company’s intellectual property transferred pursuant to the Contribution Agreement. Based on both the Company’s balance sheet, which includes only liabilities and de minimis other assets, and the operating status of the Company – no revenue, no current trials, minimal number of employees, no public entity value, and other factors – the Company believes that the intellectual property it owns represents the value of the Company and, subject to the liquidity and control adjustments noted below, the fair value of the Company’s Common Stock prior to the pricing of the IPO.

The Company worked with CFGI, an independent, unaffiliated third party that is the largest US non-audit accounting advisory firm that specializes in valuation, IPO readiness, financial planning and analysis and other services, to determine the scope of the valuation and analyze potential valuation methodologies, including cash flow, comparable company comparisons (the “Market Approach”) and cost basis (the “Cost Approach”). The Company provided CFGI with all relevant materials, including the Astellas License (as defined below), financial statements, descriptions of the pre-clinical and Phase I studies, study protocols and other materials in support of the development of and Phase II plans for CC8464. In addition, the Company had numerous discussions with CFGI regarding the three primary valuation approaches, and more specifically, which costs to include in their cost-based analysis. The Company also reviewed CFGI’s interim and draft final analysis as part of its review of the Company’s accounting statements and its IPO planning process. Further, both principals at CFGI who assisted with the valuation have extensive experience in intangible valuation, purchase price allocation, and both are accredited as appraisers or financial analysts by the relevant professional bodies. Finally, principals at the Company have worked with the CFGI project team leader on many prior intangible valuation projects. Based on this prior experience with CFGI and after reviewing their work product in connection with the valuation, the Company believes that the valuation was conducted in a professional manner and yielded a fair and reasonable value of the assets contributed to the Company by Holdings pursuant to the Contribution Agreement.

With respect to each of the three primary methodologies, the Company determined:

1) Cash flow: The Company determined that based on the current clinical stage of the CC8464 compound and the need to be approved by the FDA after a dose escalation study and Phases II and III, and potentially Phase IV, combined with the length of time to progress through each stage, that there was too much variability to appropriately set forth a valuation based on potential future cash flows.

2) Market Approach: The Company analyzed the comparability of various other entities in the public markets that develop alternative (i.e., non-opioid) pain management medications. However, after finding the number of comparable companies to be limited, the Company concluded that a comparable company comparison was not an appropriate valuation methodology for the Company.

3) Cost Approach: Based on facts and circumstances, the Company did determine, however, that the cost approach was the most logical approach to determining the specific value of the Company’s intellectual property. This conclusion was reached based on the fact that the CC8464 compound was subject to a license agreement (the “Astellas License”) entered into on an arm’s length basis with Astellas Pharma Inc. (“Astellas”), a multi-billion-dollar international pharmaceutical company. Under the Astellas License, Astellas provided much of the funding that went into the later stages of pre-clinal research and development and the entirety of the funding for the Phase I study, which it did so to derive economic gain from CC8464, leading to the conclusion that the Cost Approach was a good facsimile of the value of the intellectual property underlying the Contribution Agreement. Under the Astellas License, Astellas acquired a worldwide license to CC8464 in exchange for an upfront license payment and the obligation to conduct all future development of CC8464. Following the conclusion of pre-clinical development, completion of the Phase I study and subsequent approval by the FDA to proceed to Phase II, the parties agreed to terminate the Astellas License effective January 26, 2019. The decision to terminate the Astellas License was based on internal decisions by Astellas to direct its development investment to cancer and other illnesses. As part of the Astellas License termination, Astellas renounced all intellectual property rights in connection with CC8464.

The inputs for the cost-based valuation methodology, or Cost Approach, included historical direct expenses associated with the research and development expenses for the pre-clinical development of CC8464 and the Phase I study program related to CC8464. These historical expenses totaled approximately $37.4 million and were incurred over a multi-year period which, when adjusted for time and reasonable developer’s profit, yield an estimated fair value of $44.8 million. These historical expenses included the fees paid to the Company’s third-party Contract Research organization, (“CRO”) as well as other vendors responsible for manufacture, storage or other aspects of research with respect to CC8464, internal research and development expenses, including for laboratory, materials and personnel and applicable overhead in support of the development program.

In analyzing the valuation methodologies, the Company determined that the Cost Approach was most relevant in determining the fair value of the Company’s intellectual property but did so with consideration for the Market Approach. The Market Approach validated the findings pursuant to the Cost Approach. The conclusion was that the fair value of the Company’s intellectual property was $44.8 million. At the time of the Contribution Agreement and the op

Show Raw Text
CORRESP
1
filename1.htm

FOIA
CONFIDENTIAL TREATMENT REQUEST

The
entity requesting confidential treatment is:

Chromocell
Therapeutics Corporation

4400
Route 9 South, Suite 1000

Freehold,
New Jersey, 07728

Telephone:
732-514-2636

    CERTAIN
    PORTIONS OF THIS LETTER AS FILED VIA EDGAR HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT
    HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. OMITTED INFORMATION HAS BEEN REPLACED IN THIS LETTER AS FILED VIA
    EDGAR WITH A PLACEHOLDER IDENTIFIED BY THE MARK “[***].”

July
24, 2023

VIA
EDGAR AND OVERNIGHT DELIVERY

U.S.
Securities and Exchange Commission

Division
of Corporation Finance

Mail
Stop 4561

100
F Street, N.E.

Washington,
D.C. 20549

Attention:
Kristin Lochhead and Daniel Gordon

    Re:
    Chromocell
    Therapeutics Corporation

Registration
Statement on Form S-1

File
No. 333-269188

CIK
No. 0001919246

Rule
83 Confidential Treatment Request by Chromocell Therapeutics Corporation

Ladies
and Gentlemen:

On
behalf of Chromocell Therapeutics Corporation (the “Company”), in response to comments from the staff (the
“Staff”) of the Securities and Exchange Commission (the “Commission”) in a letter dated
May 19, 2023 (the “Original Comment Letter”) relating to the Company’s Registration Statement on Form
S-1, initially publicly filed by the Company with the Commission on January 11, 2023, and as amended to date (File No. 333-269188)
(the “Registration Statement”), we submit this supplemental letter to further address Comment No. 5 of the
Original Comment Letter.

Because
of the commercially sensitive nature of information contained herein, this submission is accompanied by the Company’s request
for confidential treatment for selected portions of this letter. The Company has concurrently filed a separate letter with the
Office of Freedom of Information and Privacy Act Operations in connection with the confidential treatment request, pursuant to
Rule 83 of the Commission’s Rules on Information and Requests, 17 C.F.R. § 200.83. For the Staff’s reference,
we have enclosed a copy of the Company’s letter to the Office of Freedom of Information and Privacy Act Operations.

We
confirm on behalf of the Company that, prior to circulating copies of the preliminary prospectus in connection with the offering,
the Company will file a pre-effective amendment to the Registration Statement that will include all information other than information
that may be excluded in reliance upon Rule 430A of Regulation C, and the actual price range to be included in such amendment,
which will comply with the Staff’s interpretation regarding the parameters of a bona fide price range.

The
Company expects to reflect the Stock Split (as defined below) in a pre-effective amendment to the Registration Statement that
includes the estimated Preliminary Price Range (as defined below). All dollar amounts and per share amounts in this letter have
been prepared based on such assumed Stock Split.

The
Company respectfully requests that the bracketed information contained in this letter be treated as confidential information pursuant
to Rule 83 promulgated by the Commission, 17 C.F.R. §200.8, and that the Commission provide timely notice to Francis Knuettel
II, Chief Financial Officer, Chromocell Therapeutics Corporation, 4400 Route 9 South, Suite
1000, Freehold, New Jersey, 07728, before it permits any disclosure of the bracketed information in this letter.

For
the convenience of the Staff, we have recited the prior comment from the Staff in the Original Comment Letter in italicized type
and have followed the comment with the Company’s response.

5. As
a related matter, since your common stock is not actively traded, please revise to disclose how you determined the underlying
fair value of your common stock as an input to the Black-Scholes Option Pricing Model. In addition, once you have an estimated
offering price or range, please explain to us the reasons for any differences between the recent valuations of your common stock
leading up to the initial public offering and the estimated offering price. This information will help facilitate our review of
your accounting for equity issuances including stock compensation. Please discuss with the staff how to submit your response.

The
Company respectfully submits the below additional information to assist the Staff in its review of the Company’s position
with respect to its determination of the fair value of the Company’s common stock, par value $0.0001 per share (“Common
Stock”), underlying its outstanding equity awards and the reasons for the differences between the recent valuation of its
Common Stock and the estimated offering price for its initial public offering (“IPO”).

Preliminary
IPO Price Range

The
Company advises the Staff that it estimates a preliminary price range of approximately $[***] to $[***] per share
(the “Preliminary Price Range”) for its IPO, after giving effect to a [***] reverse stock split that
the Company plans to implement prior to effectiveness of the Registration Statement (the “Stock Split”), resulting
in a midpoint of the Preliminary Price Range of $[***] per share (the “Midpoint Price”). The actual
price range and the ratio of the reverse stock split to be included in a subsequent amendment to the Registration Statement (which
will comply with the Staff’s interpretation regarding the parameters of a bona fide price range) have not yet been
determined and remain subject to adjustment based on factors outside of the Company’s control. However, the Company believes
that the foregoing indicative Preliminary Price Range and reverse Stock Split will not be subject to significant change.

Determining
the Fair Value of Common Stock Prior to the IPO

As
there has been no public market for the Company’s Common Stock to date, the estimated fair value of the Common Stock has
been determined by the Company’s board of directors (the “Board”) as of the date of each option grant.
As part of this determination, the Board took into consideration a third-party valuation of the Company’s intellectual property
(primarily comprising the patents, trade secrets, know-how and pre-clinical and clinical test results for a non-opioid pain treatment
compound known as CC8464) and the Board’s assessment, with input from management, of additional objective and subjective
factors that it believed were relevant. These factors may have changed from the date of the applicable third-party valuation through
the date of the grant.

The
Company had the third-party valuation conducted in conjunction with the Company’s issuance of shares of its Common Stock
and its Series A Convertible Preferred Stock, par value $0.0001 per share (the “Series A Preferred Stock”), pursuant
to that certain contribution agreement (“Contribution Agreement”), dated August 10, 2022, between the Company and
Chromocell Corporation (“Holdings”). The valuation analysis was performed in conformance with Financial Accounting
Standards Board Accounting Standards Codification 820, Fair Value Measurements and Disclosure (“ASC 820”).

As
a precursor to the analysis of the underlying fair value of the stock options granted by the Company, the table below sets forth
the option grants since inception:

    Name*
    Options
    Issued
    Exercise
    Price
    Vesting
    Commencement Date

    2022
    Grants**

    Camden
    Capital
    [***]
    $[***]
    10/01/2022

    Christian
    Kopfli
    [***]
    $[***]
    10/01/2022

    Jadira
    Outeiral
    [***]
    $[***]
    10/01/2022

    2023
    Grants***

    Ezra
    Friedberg
    [***]
    $[***]
    01/10/2023

    Todd
    Davis
    [***]
    $[***]
    01/10/2023

    Todd
    Davis
    [***]
    $[***]
    01/10/2023

    Richard
    Malamut
    [***]
    $[***]
    01/10/2023

    Chia-Lin
    Simmons
    [***]
    $[***]
    03/09/2023

    Eric
    Lang
    [***]
    $[***]
    05/15/2023

 * Table
                                         gives effect to the  [***] reverse Stock Split.

 ** 2022
                                         grants were approved on January 10, 2023, with a vesting commencement date of October
                                         1, 2022.

 *** 2023 grants were approved on the vesting commencement date, other than
in respect of the grant to Mr. Lang, which was approved on June 23, 2023, with a vesting commencement date of May 15, 2023.

Valuation
of Intellectual Property (August 10, 2022)

With
certain adjustments outlined below, and as summarized above, the Company based its determination of the underlying fair value
of the Company’s Common Stock on the findings of an independent third party engaged by the Company to determine the fair
value of the Company’s intellectual property transferred pursuant to the Contribution Agreement. Based on both the Company’s
balance sheet, which includes only liabilities and de minimis other assets, and the operating status of the Company – no
revenue, no current trials, minimal number of employees, no public entity value, and other factors – the Company believes
that the intellectual property it owns represents the value of the Company and, subject to the liquidity and control adjustments
noted below, the fair value of the Company’s Common Stock prior to the pricing of the IPO.

The
Company worked with CFGI, an independent, unaffiliated third party that is the largest US non-audit accounting advisory firm that
specializes in valuation, IPO readiness, financial planning and analysis and other services, to determine the scope of the valuation
and analyze potential valuation methodologies, including cash flow, comparable company comparisons (the “Market Approach”)
and cost basis (the “Cost Approach”). The Company provided CFGI with all relevant materials, including the Astellas
License (as defined below), financial statements, descriptions of the pre-clinical and Phase I studies, study protocols and other
materials in support of the development of and Phase II plans for CC8464. In addition, the Company had numerous discussions with
CFGI regarding the three primary valuation approaches, and more specifically, which costs to include in their cost-based analysis.
The Company also reviewed CFGI’s interim and draft final analysis as part of its review of the Company’s accounting
statements and its IPO planning process. Further, both principals at CFGI who assisted with the valuation have extensive experience
in intangible valuation, purchase price allocation, and both are accredited as appraisers or financial analysts by the relevant
professional bodies. Finally, principals at the Company have worked with the CFGI project team leader on many prior intangible
valuation projects. Based on this prior experience with CFGI and after reviewing their work product in connection with the valuation,
the Company believes that the valuation was conducted in a professional manner and yielded a fair and reasonable value of the
assets contributed to the Company by Holdings pursuant to the Contribution Agreement.

With
respect to each of the three primary methodologies, the Company determined:

 1) Cash
                                         flow: The Company determined that based on the current clinical stage of the CC8464
                                         compound and the need to be approved by the FDA after a dose escalation study and Phases
                                         II and III, and potentially Phase IV, combined with the length of time to progress through
                                         each stage, that there was too much variability to appropriately set forth a valuation
                                         based on potential future cash flows.

 2) Market
                                         Approach: The Company analyzed the comparability of various other entities in the
                                         public markets that develop alternative (i.e., non-opioid) pain management medications.
                                         However, after finding the number of comparable companies to be limited, the Company
                                         concluded that a comparable company comparison was not an appropriate valuation methodology
                                         for the Company.

 3) Cost
                                         Approach: Based on facts and circumstances, the Company did determine, however, that
                                         the cost approach was the most logical approach to determining the specific value of
                                         the Company’s intellectual property. This conclusion was reached based on the fact
                                         that the CC8464 compound was subject to a license agreement (the “Astellas License”)
                                         entered into on an arm’s length basis with Astellas Pharma Inc. (“Astellas”),
                                         a multi-billion-dollar international pharmaceutical company. Under the Astellas License,
                                         Astellas provided much of the funding that went into the later stages of pre-clinal research
                                         and development and the entirety of the funding for the Phase I study, which it did so
                                         to derive economic gain from CC8464, leading to the conclusion that the Cost Approach
                                         was a good facsimile of the value of the intellectual property underlying the Contribution
                                         Agreement. Under the Astellas License, Astellas acquired a worldwide license to CC8464
                                         in exchange for an upfront license payment and the obligation to conduct all future development
                                         of CC8464. Following the conclusion of pre-clinical development, completion of the Phase
                                         I study and subsequent approval by the FDA to proceed to Phase II, the parties agreed
                                         to terminate the Astellas License effective January 26, 2019. The decision to terminate
                                         the Astellas License was based on internal decisions by Astellas to direct its development
                                         investment to cancer and other illnesses. As part of the Astellas License termination,
                                         Astellas renounced all intellectual property rights in connection with CC8464.

The
inputs for the cost-based valuation methodology, or Cost Approach, included historical direct expenses associated with the research
and development expenses for the pre-clinical development of CC8464 and the Phase I study program related to CC8464. These historical
expenses totaled approximately $37.4 million and were incurred over a multi-year period which, when adjusted for time and reasonable
developer’s profit, yield an estimated fair value of $44.8 million. These historical expenses included the fees paid to
the Company’s third-party Contract Research organization, (“CRO”) as well as other vendors responsible for manufacture,
storage or other aspects of research with respect to CC8464, internal research and development expenses, including for laboratory,
materials and personnel and applicable overhead in support of the development program.

In analyzing the valuation methodologies, the Company
determined that the Cost Approach was most relevant in determining the fair value of the Company’s intellectual property but did
so with consideration for the Market Approach. The Market Approach validated the findings pursuant to the Cost Approach. The conclusion
was that the fair value of the Company’s intellectual property was $44.8 million. At the time of the Contribution Agreement and
the op