Correspondence 0001753926-23-000945 from Pelthos Therapeutics Inc. (PTHS)
Pelthos Therapeutics Inc.
Date: July 24, 2023 · CIK: 0001919246 · Accession: 0001753926-23-000945
AI Filing Summary & Sentiment
File numbers found in text: 333-269188
Referenced dates: May 19, 2023
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CORRESP
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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