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Pelthos Therapeutics Inc.
Response Received
2 company response(s)
High - file number match
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Company responded
2025-09-19
Pelthos Therapeutics Inc.
References: September 5, 2025
↓
Pelthos Therapeutics Inc.
Response Received
9 company response(s)
High - file number match
SEC wrote to company
2023-01-23
Pelthos Therapeutics Inc.
Summary
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2023-05-01
Pelthos Therapeutics Inc.
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Company responded
2023-06-30
Pelthos Therapeutics Inc.
Summary
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Company responded
2023-07-24
Pelthos Therapeutics Inc.
References: May 19, 2023
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Company responded
2023-09-01
Pelthos Therapeutics Inc.
Summary
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Company responded
2023-10-13
Pelthos Therapeutics Inc.
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Company responded
2024-01-30
Pelthos Therapeutics Inc.
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Company responded
2024-02-12
Pelthos Therapeutics Inc.
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2024-02-12
Pelthos Therapeutics Inc.
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2024-12-11
Pelthos Therapeutics Inc.
Summary
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Pelthos Therapeutics Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2024-12-05
Pelthos Therapeutics Inc.
Summary
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Pelthos Therapeutics Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-08-02
Pelthos Therapeutics Inc.
Summary
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Company responded
2024-08-02
Pelthos Therapeutics Inc.
Summary
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Pelthos Therapeutics Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2024-01-25
Pelthos Therapeutics Inc.
Summary
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Pelthos Therapeutics Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2023-10-24
Pelthos Therapeutics Inc.
Summary
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Pelthos Therapeutics Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2023-09-12
Pelthos Therapeutics Inc.
Summary
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Pelthos Therapeutics Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2023-07-10
Pelthos Therapeutics Inc.
Summary
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Pelthos Therapeutics Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2023-05-19
Pelthos Therapeutics Inc.
Summary
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Pelthos Therapeutics Inc.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2023-01-11
Pelthos Therapeutics Inc.
Summary
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Pelthos Therapeutics Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2022-10-31
Pelthos Therapeutics Inc.
Summary
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Pelthos Therapeutics Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2022-10-03
Pelthos Therapeutics Inc.
Summary
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-24 | Company Response | Pelthos Therapeutics Inc. | NV | N/A | Read Filing View |
| 2025-09-19 | Company Response | Pelthos Therapeutics Inc. | NV | N/A | Read Filing View |
| 2025-09-05 | SEC Comment Letter | Pelthos Therapeutics Inc. | NV | 333-289916 | Read Filing View |
| 2024-12-11 | Company Response | Pelthos Therapeutics Inc. | NV | N/A | Read Filing View |
| 2024-12-05 | SEC Comment Letter | Pelthos Therapeutics Inc. | NV | 333-269188 | Read Filing View |
| 2024-08-02 | Company Response | Pelthos Therapeutics Inc. | NV | N/A | Read Filing View |
| 2024-08-02 | SEC Comment Letter | Pelthos Therapeutics Inc. | NV | 333-281070 | Read Filing View |
| 2024-02-12 | Company Response | Pelthos Therapeutics Inc. | NV | N/A | Read Filing View |
| 2024-02-12 | Company Response | Pelthos Therapeutics Inc. | NV | N/A | Read Filing View |
| 2024-01-30 | Company Response | Pelthos Therapeutics Inc. | NV | N/A | Read Filing View |
| 2024-01-25 | SEC Comment Letter | Pelthos Therapeutics Inc. | NV | 377-06353 | Read Filing View |
| 2023-10-24 | SEC Comment Letter | Pelthos Therapeutics Inc. | NV | 377-06353 | Read Filing View |
| 2023-10-13 | Company Response | Pelthos Therapeutics Inc. | NV | N/A | Read Filing View |
| 2023-09-12 | SEC Comment Letter | Pelthos Therapeutics Inc. | NV | 377-06353 | Read Filing View |
| 2023-09-01 | Company Response | Pelthos Therapeutics Inc. | NV | N/A | Read Filing View |
| 2023-07-24 | Company Response | Pelthos Therapeutics Inc. | NV | N/A | Read Filing View |
| 2023-07-10 | SEC Comment Letter | Pelthos Therapeutics Inc. | NV | 377-06353 | Read Filing View |
| 2023-06-30 | Company Response | Pelthos Therapeutics Inc. | NV | N/A | Read Filing View |
| 2023-05-19 | SEC Comment Letter | Pelthos Therapeutics Inc. | NV | 377-06353 | Read Filing View |
| 2023-05-01 | Company Response | Pelthos Therapeutics Inc. | NV | N/A | Read Filing View |
| 2023-01-23 | SEC Comment Letter | Pelthos Therapeutics Inc. | NV | 377-06353 | Read Filing View |
| 2023-01-11 | Company Response | Pelthos Therapeutics Inc. | NV | N/A | Read Filing View |
| 2022-10-31 | SEC Comment Letter | Pelthos Therapeutics Inc. | NV | 377-06353 | Read Filing View |
| 2022-10-03 | SEC Comment Letter | Pelthos Therapeutics Inc. | NV | 377-06353 | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-05 | SEC Comment Letter | Pelthos Therapeutics Inc. | NV | 333-289916 | Read Filing View |
| 2024-12-05 | SEC Comment Letter | Pelthos Therapeutics Inc. | NV | 333-269188 | Read Filing View |
| 2024-08-02 | SEC Comment Letter | Pelthos Therapeutics Inc. | NV | 333-281070 | Read Filing View |
| 2024-01-25 | SEC Comment Letter | Pelthos Therapeutics Inc. | NV | 377-06353 | Read Filing View |
| 2023-10-24 | SEC Comment Letter | Pelthos Therapeutics Inc. | NV | 377-06353 | Read Filing View |
| 2023-09-12 | SEC Comment Letter | Pelthos Therapeutics Inc. | NV | 377-06353 | Read Filing View |
| 2023-07-10 | SEC Comment Letter | Pelthos Therapeutics Inc. | NV | 377-06353 | Read Filing View |
| 2023-05-19 | SEC Comment Letter | Pelthos Therapeutics Inc. | NV | 377-06353 | Read Filing View |
| 2023-01-23 | SEC Comment Letter | Pelthos Therapeutics Inc. | NV | 377-06353 | Read Filing View |
| 2022-10-31 | SEC Comment Letter | Pelthos Therapeutics Inc. | NV | 377-06353 | Read Filing View |
| 2022-10-03 | SEC Comment Letter | Pelthos Therapeutics Inc. | NV | 377-06353 | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-24 | Company Response | Pelthos Therapeutics Inc. | NV | N/A | Read Filing View |
| 2025-09-19 | Company Response | Pelthos Therapeutics Inc. | NV | N/A | Read Filing View |
| 2024-12-11 | Company Response | Pelthos Therapeutics Inc. | NV | N/A | Read Filing View |
| 2024-08-02 | Company Response | Pelthos Therapeutics Inc. | NV | N/A | Read Filing View |
| 2024-02-12 | Company Response | Pelthos Therapeutics Inc. | NV | N/A | Read Filing View |
| 2024-02-12 | Company Response | Pelthos Therapeutics Inc. | NV | N/A | Read Filing View |
| 2024-01-30 | Company Response | Pelthos Therapeutics Inc. | NV | N/A | Read Filing View |
| 2023-10-13 | Company Response | Pelthos Therapeutics Inc. | NV | N/A | Read Filing View |
| 2023-09-01 | Company Response | Pelthos Therapeutics Inc. | NV | N/A | Read Filing View |
| 2023-07-24 | Company Response | Pelthos Therapeutics Inc. | NV | N/A | Read Filing View |
| 2023-06-30 | Company Response | Pelthos Therapeutics Inc. | NV | N/A | Read Filing View |
| 2023-05-01 | Company Response | Pelthos Therapeutics Inc. | NV | N/A | Read Filing View |
| 2023-01-11 | Company Response | Pelthos Therapeutics Inc. | NV | N/A | Read Filing View |
2025-09-24 - CORRESP - Pelthos Therapeutics Inc.
CORRESP 1 filename1.htm Pelthos Therapeutics Inc. 4020 Stirrup Creek Drive, Suite 110 Durham, NC 27703 September 24, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, NE Washington D.C. 20549 RE: Pelthos Therapeutics Inc. (CIK 0001919246) File No. 333-289916 Registration Statement on Form S-3 Ladies and Gentlemen: Pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended, Pelthos Therapeutics Inc. hereby requests that the United States Securities and Exchange Commission (the “ Commission ”) take appropriate action to accelerate the effective date of the above-referenced registration statement (the “ Registration Statement ”) so as to become effective on Wednesday, September 24, 2025, at 4:00 p.m. Eastern Time, or as soon thereafter as practicable. Once the Registration Statement is effective, please orally confirm the event with our counsel, Sullivan & Worcester LLP, by calling Charles Chambers Jr., Esq. at (617) 338-2840. We also respectfully request that a copy of the written order from the Commission verifying the effective date and time of the Registration Statement be sent to Mr. Chambers via email at cchambers@sullivanlaw.com. Sincerely, Pelthos Therapeutics Inc. By: /s/ Francis Knuettel II Francis Knuettel II Chief Financial Officer cc: David E. Danovitch, Esq., Sullivan & Worcester LLP
2025-09-19 - CORRESP - Pelthos Therapeutics Inc.
CORRESP 1 filename1.htm Pelthos Therapeutics Inc. 4020 Stirrup Creek Drive, Suite 110 Durham, NC 27703 September 19, 2025 Via EDGAR Alan Campbell and Joe McCann Division of Corporation Finance Office of Life Sciences 100 F Street, NE Securities and Exchange Commission Washington, D.C. 20549 Re: Pelthos Therapeutics Inc. Registration Statement on Form S-3 Filed August 28, 2025 File No. 333-289916 Gentlemen: This correspondence responds to the letter dated September 5, 2025, received from the staff of the Securities and Exchange Commission (the “ Staff ”), regarding the above-mentioned Registration Statement on Form S-3 filed on August 28, 2025 (the “ Registration Statement ”) by Pelthos Therapeutics Inc. (the “ Company ”, “ we ”, “ us ” or “ our ”). For convenience, the Staff’s comments are restated below in bold text, with the comments followed by our responses. We are concurrently filing with this letter an “exhibits-only” Amendment No. 1 to the Registration Statement (“ Amendment No. 1 ”). Registration Statement on Form S-3 General 1. We note that your registration statement incorporates by reference to your Current Report on Form 8-K, filed July 2, 2025, which includes the financial statements of LNHC, Inc. and its audit report. Please revise your registration statement to include an auditor consent for the inclusion of LNHC, Inc.'s financial statements and audit report in your registration statement. Response: In response to the Staff's comment, we have revised the Registration Statement to include the auditor consents of Ernst & Young LLP and BDO USA, P.C. in connection with the inclusion of LNHC, Inc.'s financial statements and audit report in the Registration Statement. We have filed the auditor consent of Ernst & Young LLP as Exhibit 23.3 to Amendment No. 1 and the auditor consent of BDO USA, P.C. as Exhibit 23.4 to Amendment No. 1. 2. We note that you consummated the merger transaction with LNHC, Inc. on July 1,2025. We further note that you do not appear to have included interim or pro forma financial statements for LNHC, Inc. and the combined company for the interim period ended June 30, 2025 in your registration statement. Please revise to include interim and pro forma financial statements for LNHC, Inc. and the combined company for the period ended June 30, 2025 or advise. Response: We respectfully advise the Staff that on September 16, 2025, the Company filed an Amendment to its Current Report on Form 8-K filed on July 2, 2025 (an " 8-K/A "), which included interim and pro forma financial statements for LNHC, Inc. and the combined company for the period ended June 30, 2025. The 8-K/A was filed within 71 calendar days after the deadline for the Item 2.01 information provided in the Current Report on Form 8-K, and will be incorporated by reference into the Registration Statement in accordance with Rule 411 of the Securities Act of 1933, as amended, and Item 12 of Form S-3. We hope the foregoing has been responsive to your comments. If you have any questions or comments regarding the foregoing, please contact Charles Chambers, Esq. at (617) 338-2840 or cchambers@sullivanlaw.com. Very truly yours, /s/ Francis Knuettel II Francis Knuettel II Chief Financial Officer Pelthos Therapeutics Inc. cc: David E. Danovitch, Esq., Sullivan & Worcester LLP Charles E. Chambers Jr., Esq., Sullivan & Worcester LLP 1
2025-09-05 - UPLOAD - Pelthos Therapeutics Inc. File: 333-289916
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> September 5, 2025 Francis Knuettel II Chief Financial Officer Pelthos Therapeutics Inc. 4020 Stirrup Creek Drive, Suite 110 Durham, NC 27703 Re: Pelthos Therapeutics Inc. Registration Statement on Form S-3 Filed August 28, 2025 File No. 333-289916 Dear Francis Knuettel II: We have conducted a limited review of your 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. Registration Statement on Form S-3 General 1. We note that your registration statement incorporates by reference to your Current Report on Form 8-K, filed July 2, 2025, which includes the financial statements of LNHC, Inc. and its audit report. Please revise your registration statement to include an auditor consent for the inclusion of LNHC, Inc.'s financial statements and audit report in your registration statement. 2. We note that you consummated the merger transaction with LNHC, Inc. on July 1, 2025. We further note that you do not appear to have included interim or pro forma financial statements for LNHC, Inc. and the combined company for the interim period ended June 30, 2025 in your registration statement. Please revise to include interim and pro forma financial statements for LNHC, Inc. and the combined company for the period ended June 30, 2025 or advise. September 5, 2025 Page 2 We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate time for us to review any amendment prior to the requested effective date of the registration statement. Please contact Alan Campbell at 202-551-4224 or Joe McCann at 202-551-6262 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Charles E. Chambers Jr., Esq. </TEXT> </DOCUMENT>
2024-12-11 - CORRESP - Pelthos Therapeutics Inc.
CORRESP
1
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Channel Therapeutics Corporation
4400 Route 9 South, Suite 1000
Freehold, NJ 07728
December 11, 2024
Via EDGAR
Jessica Dickerson and Joe McCann
Division of Corporation Finance
Office of Life Sciences
100 F Street, NE
Securities and Exchange Commission
Washington, D.C. 20549
Re: Channel Therapeutics Corporation
Post-Effective Amendment No. 3 to Registration Statement
on Form S-1
Filed November 22, 2024
File No. 333-269188
Ladies and Gentlemen:
This correspondence responds to the letter, dated
December 5, 2024, received from the staff of the Securities and Exchange Commission (the “Staff”) regarding the above-mentioned
Post-Effective Amendment No. 3 to the Registration Statement on Form S-1 filed on November 22, 2024 (“Post-Effective Amendment
No. 3”) by Channel Therapeutics Corporation (the “Company”, “we”, “us”
or “our”). For convenience, the Staff’s comment is restated below in bold text, with the comment followed by
our response. We are concurrently filing with this letter Post-Effective Amendment No. 4 to the Registration Statement on Form S-1 (“Post-Effective
Amendment No. 4”).
Amendment No. 3 to Registration Statement on
Form S-1
Cover Page
1.
We note your disclosure in the explanatory note that you are filing this post-effective amendment pursuant to Securities Act Rule 414(d) to adopt, as your own following a reincorporation, the registration statement initially filed on January 11, 2023 and declared effective on February 14, 2024. We further note that the effective registration statement included a resale prospectus. However, the legal opinion filed as Exhibit 5.2 to the post-effective amendment does not opine as to the shares covered by the resale prospectus. Please revise your post-effective amendment to file an updated legal opinion opining as to such shares or otherwise advise.
Response: In response
to the Staff’s comment, we have revised the legal opinion filed as Exhibit 5.2 to Post-Effective Amendment No. 3 to include an opinion
on the shares covered by the resale prospectus included in the effective registration statement. We have filed the updated legal opinion
as Exhibit 5.2 to Post-Effective Amendment No. 4.
We hope the foregoing has been responsive to your
comments. If you have any questions or comments regarding the foregoing, please contact Charles Chambers, Esq. at (617) 338-2840 or cchambers@sullivanlaw.com.
Very truly yours,
/s/ Francis Knuettel II
Francis Knuettel II
Chief Executive Officer
Channel Therapeutics Corporation
cc:
David E. Danovitch, Esq., Sullivan & Worcester LLP
Aaron M. Schleicher, Esq., Sullivan & Worcester LLP
Charles E. Chambers Jr., Esq., Sullivan & Worcester LLP
2024-12-05 - UPLOAD - Pelthos Therapeutics Inc. File: 333-269188
December 5, 2024
Francis Knuettel II
Chief Executive Officer
Channel Therapeutics Corporation
4400 Route 9 South, Suite 1000
Freehold, NJ 07728
Re:Channel Therapeutics Corporation
Post-Effective Amendment No. 3 to Registration Statement on Form S-1
Filed November 22, 2024
File No. 333-269188
Dear Francis Knuettel II:
We have reviewed your post-effective amendment and have the following comment.
Please respond to this letter by amending your registration statement and providing
the requested information. If you do not believe our 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.
Post-Effective Amendment No. 3 to Registration Statement on Form S-1 Filed November 22,
2024
General
1.We note your disclosure in the explanatory note that you are filing this post-effective
amendment pursuant to Securities Act Rule 414(d) to adopt, as your own following a
reincorporation, the registration statement initially filed on January 11, 2023 and
declared effective on February 14, 2024. We further note that the effective registration
statement included a resale prospectus. However, the legal opinion filed as Exhibit 5.2
to the post-effective amendment does not opine as to the shares covered by the resale
prospectus. Please revise your post-effective amendment to file an updated legal
opinion opining as to such shares or otherwise advise.
December 5, 2024
Page 2
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence
of action by the staff.
Please contact Jessica Dickerson at 202-551-8013 or Joe McCann at 202-551-6262
with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Charles E. Chambers Jr., Esq.
2024-08-02 - CORRESP - Pelthos Therapeutics Inc.
CORRESP
1
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Chromocell
Therapeutics Corporation
4400
Route 9 South, Suite 1000
Freehold,
NJ 07728
August
2, 2024
VIA
EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, NE
Washington D.C. 20549
RE:
Chromocell Therapeutics Corporation
File No. 333-281070
Registration Statement on Form S-1
Ladies
and Gentlemen:
Pursuant
to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended, Chromocell Therapeutics Corporation hereby
requests that the United States Securities and Exchange Commission (the “Commission”) take appropriate action to accelerate
the effective date of the above-referenced registration statement (the “Registration Statement”) so as to become effective
on Tuesday, August 6, 2024, at 4:30 p.m. Eastern Time, or as soon thereafter as practicable.
Once
the Registration Statement is effective, please orally confirm the event with our counsel, Sullivan & Worcester LLP, by calling David
Danovitch at (212) 660-3060, or in his absence, Charles Chambers Jr at (617) 338-2840. We also respectfully request that a copy of the
written order from the Commission verifying the effective date and time of the Registration Statement be sent to Mr. Danovitch via email
at ddanovitch@sullivanlaw.com.
Sincerely,
Chromocell Therapeutics Corporation
By:
/s/
Francis Knuettel II
Francis Knuettel II
Chief Executive Officer
cc:
David E. Danovitch, Sullivan & Worcester LLP
Charles Chambers Jr., Sullivan & Worcester LLP
2024-08-02 - UPLOAD - Pelthos Therapeutics Inc. File: 333-281070
August 2, 2024
Francis Knuettel II
Chief Executive Officer
Chromocell Therapeutics Corporation
4400 Route 9 South, Suite 1000
Freehold, NJ 07728
Re:Chromocell Therapeutics Corporation
Registration Statement on Form S-1
Filed July 29, 2024
File No. 333-281070
Dear Francis Knuettel II:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that
the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Tyler Howes at 202-551-3370 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:David E. Danovitch, Esq.
2024-02-12 - CORRESP - Pelthos Therapeutics Inc.
CORRESP
1
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Chromocell Therapeutics Corporation
4400 Route 9 South, Suite 1000
Freehold, NJ 07728
February 12,
2024
Via EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, NE
Washington, D.C. 20549
Re:
Chromocell Therapeutics Corporation
File No. 333-269188
Registration Statement on Form S-1, as amended
Dear Sir and Madam:
Pursuant to Rule 461 of the General Rules and Regulations
under the Securities Act of 1933, as amended (the “Act”), Chromocell Therapeutics Corporation (the “Registrant”)
hereby requests that the United States Securities and Exchange Commission (the “Commission”) take appropriate action to accelerate
the effective date of the above-referenced registration statement (the “Registration Statement”) so as to become effective
on February 14, 2024, at 4:01 p.m. Eastern Time, or as soon thereafter as practicable.
The Registrant understands that the Commission will
consider this request for acceleration of the effective date of the Registration Statement as a confirmation of the fact that the Registrant
is aware of its responsibilities under the Act and the Securities Exchange Act of 1934, as amended, as they relate to the proposed sale
of the securities specified in the Registration Statement by the Registrant.
Once the Registration Statement is effective,
please orally confirm the event with our counsel, Sullivan & Worcester LLP, by calling David Danovitch at (212) 660-3060, or in his
absence, Aaron M. Schleicher at (212) 660-3034. We also respectfully request that a copy of the written order from the Commission
verifying the effective date and time of the Registration Statement be sent to Mr. Danovitch via email at ddanovitch@sullivanlaw.com and
Mr. Schleicher via email at aschleicher@sullivanlaw.com.
Under separate cover, you will receive today
a letter from the representative of the underwriters of the proposed offering joining in the Company’s request for acceleration
of the effectiveness of the Registration Statement.
Sincerely,
Chromocell Therapeutics Corporation
By:
/s/ Francis Knuettel II
Name: Francis Knuettel II
Title: Interim Chief Executive Officer and Chief Financial Officer
cc:
David E. Danovitch, Esq., Sullivan & Worcester LLP
Aaron M. Schleicher, Esq., Sullivan & Worcester LLP
2024-02-12 - CORRESP - Pelthos Therapeutics Inc.
CORRESP 1 filename1.htm A.G.P./ALLIANCE GLOBAL PARTNERS 590 Madison Avenue 28th Floor New York, New York 10022 February 12, 2024 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: CHROMOCELL THERAPEUTICS CORPORATION (the “Company”) Registration Statement on Form S-1 (File No. 333-269188) (the “Registration Statement”) Request for Acceleration of Effective Date Ladies and Gentlemen: In accordance with Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended, (the “Act”), A.G.P./Alliance Global Partners, as representative of the underwriters of the offering, hereby joins the Company’s request for acceleration of the above-referenced Registration Statement, requesting effectiveness for 4:01 p.m., Eastern Time on February 14, 2024, or as soon thereafter as practicable. Pursuant to Rule 460 of the General Rules and Regulations of the Securities and Exchange Commission under the Act, we wish to advise you that the underwriters have distributed as many copies of the Preliminary Prospectus dated February 12, 2024 to prospective underwriters and dealers, institutional investors, retail investors and others as appears to be reasonable to secure adequate distribution of the Preliminary Prospectus. The undersigned confirms that it has complied with and will continue to comply with, and it has been informed or will be informed by participating dealers that they have complied with or will comply with, Rule 15c2-8 promulgated under the Securities Exchange Act of 1934, as amended, in connection with the above-referenced issue. Please contact Thomas J. Poletti of Manatt, Phelps & Phillips, LLP, counsel of the representative of the underwriters, at (714) 312-7500 to provide notice of effectiveness, or if you have any questions or concerns regarding the foregoing. We appreciate your assistance in this matter. Very truly yours, A.G.P./ALLIANCE GLOBAL PARTNERS By: /s/ Thomas Higgins Name: Thomas Higgins Title: Managing Director
2024-01-30 - CORRESP - Pelthos Therapeutics Inc.
CORRESP
1
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Chromocell
Therapeutics Corporation
4400 Route 9 South, Suite 1000
Freehold, NJ 07728
January
30, 2024
Via
EDGAR
Doris
Stacey Gama and Jason Drory
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
100
F Street, NE
Washington,
D.C. 20549
Re:
Chromocell
Therapeutics Corporation
Amendment No. 9 to Registration Statement on Form S-1
Filed
January 16, 2024
File
No. 333-269188
Dear
Madam and Sir:
This
correspondence responds to the letter, dated January 24, 2024, received from the staff of the Securities and Exchange Commission (the
“Staff”) regarding the above-mentioned Amendment No. 9 to Registration Statement on Form S-1 filed on January 16, 2024, by
Chromocell Therapeutics Corporation (the “Company”, “we”, “us” or “our”). For convenience,
the Staff’s comments are restated below in bold text, with each comment followed by our response. We are concurrently filing with
this letter Amendment No. 10 to Registration Statement on Form S-1 (“Amendment No. 10”). Capitalized terms used, but not
defined, in this letter have the meanings ascribed to such terms in Amendment No. 10.
Amendment
to Form S-1 filed January 16, 2024
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.
Response: In response to the Staff’s
comment, we have revised the disclosure on page 2 and elsewhere in Amendment No. 10 accordingly. In addition, under the new sub-heading
“Risks Related to our Proposed ELOC”, we have set forth various risks relating to the potential ELOC that we are negotiating,
including, but not limited to, the potential dilutive effect, the potential impact on our liquidity and other potential negative impacts
of the ELOC.
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.
Response:
In response to the Staff’s comment, we have revised the disclosure on pages 6 and 42 of Amendment No. 10 to indicate the aggregate
approximate amount of proceeds we intend to use for the Spray Formulations that we have licensed from Benuvia.
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.
Response: In response to the Staff’s
comment, we have revised the disclosure on pages 2, 47, 54 and 55 in Amendment No. 10 to indicate that while we currently do not have
strategy and development plans for the Spray Formulations licensed from Benuvia, beginning in the third quarter of 2024, we plan to develop
clinical programs for each of the Spray Formulations, determine the labelling strategy that would be obtained from completion of these
programs and discuss with the FDA the requirements for bringing each of the Spray Formulations to market. We anticipate bringing the Spray
Formulations to market through the FDA 505(b)(2) regulatory pathway for new drug applications; however, the exact details will require
further consultation with the FDA.
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.
Response:
In response to the Staff’s comment, we have revised the disclosure on page 55 and elsewhere in Amendment No. 10 accordingly.
Overview,
page 54
5.
6.
7.
8.
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.
Response: We respectfully advise the Staff that we
have not conducted or started clinical development in human volunteers for the Diclofenac Spray Formulation; however, in response to the
Staff’s comment, we have added revised disclosure on page 58 and elsewhere in Amendment No. 10 to disclose the details of preliminary
studies conducted by others.
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.
Response:
In response to the Staff’s comment, we have added revised disclosure on page 58 of Amendment No. 10 of Amendment No. 10 accordingly.
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.
Response:
In response to the Staff’s comment, we have added revised disclosure on page 58 of Amendment No. 10 accordingly.
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 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.
Response:
We respectfully advise the Staff that we do not believe the Benuvia License Agreement covers any “Spray Formulations”
other than the three Spray Formulations disclosed in Amendment No. 10 – i.e., the Diclofenac Spray Formulation, the
Rizatriptan Spray Formulation and the Ondansetron Spray Formulation. We have not had any conversations with Benuvia regarding any
other “Spray Formulations” and have no intentions to pursue any other programs related to other “Spray
Formulations” with Benuvia other than those that have been disclosed in Amendment No. 10.
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.
Response: In response to the Staff’s
comment, we have revised the disclosure on page 58 of Amendment No. 10 to indicate that the three Spray Formulations licensed from Benuvia
are currently indicated for acute pain, migraine and the prevention of nausea and vomiting associated with chemotherapy or surgical anesthesia.
All three of these conditions have a relatively high number of potential patients who may be candidates for the medication; however, we
have performed no further market assessment and the performance of any such market assessment would be pre-mature. We plan to assess the
addressable markets for the three Spray Formulations after we have collected further pharmacokinetic data and we have developed a strategy
and development plan for the Spray Formulations in connection with our discussions with the FDA.
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.
Response:
In response to the Staff’s comment, we have revised the disclosure on page 58 of Amendment No. 10 accordingly.
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.
Response:
In response to the Staff’s comment, we have revised the disclosure on page 86 of Amendment No. 10 accordingly.
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.
Response:
In response to the Staff’s comment, we have revised the disclosure on page F-30 of Amendment No. 10 to provide additional disclosure
about our accounting for the Benuvia License Agreement, including how we valued the 3,458,033 shares (384,226 shares after giving effect
to the Reverse Stock Split) of our Common Stock issued in connection with the Benuvia License Agreement.
If
you have any questions or require additional information, please contact the Company’s counsel, David E. Danovitch at (212) 660-3060
or at ddanovitch@sullivanlaw.com or Aaron M. Schleicher at (212) 660-3034 or at aschleicher@sullivanlaw.com, of Sullivan & Worcester
LLP.
Sincerely,
Chromocell Therapeutics Corporation
By:
/s/ Francis
Knuettel II
Francis Knuettel II
Interim Chief Executive Officer and
Chief Financial Officer
cc:
Kristin Lochhead and Daniel Gordon, Securities
and Exchange Commission
David E. Danovitch, Esq., Sullivan &
Worcester LLP
Aaron M. Schleicher, Esq., Sullivan &
Worcester LLP
2024-01-25 - UPLOAD - Pelthos Therapeutics Inc. File: 377-06353
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.
FirstName LastNameFrancis Knuettel II
Comapany NameChromocell Therapeutics Corporation
January 24, 2024 Page 2
FirstName LastNameFrancis Knuettel II
Chromocell Therapeutics Corporation
January 24, 2024
Page 2
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
FirstName LastNameFrancis Knuettel II
Comapany NameChromocell Therapeutics Corporation
January 24, 2024 Page 3
FirstName LastName
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,
Division of Corporation Finance
Office of Life Sciences
cc: David Danovitch, Esq.
2023-10-24 - UPLOAD - Pelthos Therapeutics Inc. File: 377-06353
United States securities and exchange commission logo
October 24, 2023
Francis Knuettel II
Chief Executive Officer
Chromocell Therapeutics Corporation
4400 Route 9 South, Suite 1000
Freehold, NJ 07728
Re:Chromocell Therapeutics Corporation
Amendment No. 6 to Registration Statement on Form S-1
Filed October 16, 2023
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 September 11, 2023 letter.
Amendment No. 6 to Registration Statement on Form S-1
Cover Page
1.We note you have removed the disclosure regarding the Representative's Warrants from
the cover page. Please revise to include this disclosure on your cover page.
Risk Factors
Risks Related to Our Business Operations
We have not received signatures for the amendment to the senior secured convertible note in the
April Bridge Financing..., page 28
2.We note your risk factor on page 28 stating that you have not received signatures for the
amendment to the senior secured convertible note in the April Bridge Financing or the
lock-up agreement from Mr. Kopfli, the director and authorized signatory of Chromocell
Holdings and that you may not receive such signatures before closing. Please revise your
FirstName LastNameFrancis Knuettel II
Comapany NameChromocell Therapeutics Corporation
October 24, 2023 Page 2
FirstName LastNameFrancis Knuettel II
Chromocell Therapeutics Corporation
October 24, 2023
Page 2
risk factor disclosure to describe the specific ramifications of not receiving the signatures.
We note the amendment to the April Bridge Financing extended the October 17, 2023
maturity date to November 1, 2023.
Principal Stockholders, page 87
3.Please revise your disclosure to identify the natural person or persons who have voting
and/or investment control of the shares held by the 5% or more holders in the table on
page 87.
Shares Eligible for Future Sale
Lock-Up Agreement, page 93
4.We note your risk factor on page 28 stating that you have not received signatures for the
lock-up agreement from Mr. Kopfli, the director and authorized signatory of Chromocell
Holdings and that you may not receive such signatures before closing. Please also include
such disclosure on page 93 or otherwise advise.
General
5.Please revise your disclosure to clarify whether you have issued any Series C Preferred
Stock and clarify if you will have any Series C Preferred Stock issued and outstanding
following your offering. We note your disclosure appears inconsistent throughout your
registration statement. For example only, we note your disclosure in your prospectus
summary stating you "will issue to Chromocell Holdings 2,600 shares of Series C
Convertible Redeemable Preferred Stock" and you Principal Stockholders table on page
89 does not appear to indicate 2,600 shares of Series C Convertible Redeemable Preferred
Stock owned after the offering.
6.We note that Dominion Capital LLC, will own 100% of your Series B Preferred Stock and
your risk factor disclosure on page 35 that “the Series B Preferred Stock, if issued, will
contain various prohibitions that may restrict [y]our ability to undertake certain corporate
actions.” Please disclose on your prospectus cover page and in your prospectus summary
the percent of the Series B Preferred Stock held by Dominion Capital LLC. In addition,
please revise your disclosure to highlight the disparate voting rights of your Preferred
Stock in your prospectus summary section and on the prospectus cover page.
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.
FirstName LastNameFrancis Knuettel II
Comapany NameChromocell Therapeutics Corporation
October 24, 2023 Page 3
FirstName LastName
Francis Knuettel II
Chromocell Therapeutics Corporation
October 24, 2023
Page 3
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: David Danovitch, Esq.
2023-10-13 - CORRESP - Pelthos Therapeutics Inc.
CORRESP
1
filename1.htm
Chromocell Therapeutics Corporation
4400 Route 9 South, Suite 1000
Freehold, NJ 07728
October 13, 2023
Via EDGAR
Doris Stacey Gama and Jason Drory
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, NE
Washington, D.C. 20549
Re:
Chromocell Therapeutics Corporation
Amendment No. 5 to Registration Statement on Form S-1
Filed September 1, 2023
File No. 333-269188
Dear Madam and Sir:
This correspondence
responds to the letter, dated September 11, 2023, received from the staff of the Securities and Exchange Commission (the “Staff”)
regarding the above-mentioned Amendment No. 5 to Registration Statement on Form S-1 filed on September 1, 2023 by Chromocell Therapeutics
Corporation (the “Company”, “we”, “us” or “our”). For convenience, the Staff’s
comments are restated below in bold text, with each comment followed by our response. We are concurrently filing with this letter
Amendment No. 6 to Registration Statement on Form S-1 (“Amendment No. 6”). Capitalized terms used, but not defined,
in this letter have the meanings ascribed to such terms in Amendment No. 6.
Amendment No. 5 to Registration Statement
on Form S-1 filed September 1, 2023
Business Overview, page 52
1.
We note your disclosure that you “plan to proceed with [y]our clinical trials in 2023, focusing on a study to evaluate this rash mitigation strategy and a Phase 2a proof-of-concept study assessing the potential efficacy of CC8464 in EM patients with a genetic disposition” and your revised disclosure that you are “evaluating doing the rash mitigation and [y]our proof-of-concept study in a different national jurisdiction acceptable to the FDA.” Please update your disclosure to clarify whether you still plan to begin these studies in 2023 or whether your timeline has been delayed. In addition, please expand your disclosure of the planned trials to describe the material elements of the trial design and your anticipated timeline for completion of the trials or otherwise advise.
Response: In response to the Staff’s
comment, we have revised the disclosure throughout Amendment No. 6 to clarify that (i) we plan to begin recruiting patients for
the rash mitigation study in late 2023 and, once we initiate dosing of patients in early 2024, we expect that the study will be
completed within nine months and (ii) we plan to begin the Phase 2a proof-of-concept study design in the fourth quarter of 2024
and, once initiated, we expect that the Phase 2a proof-of-concept study will be completed within twelve months. In addition,
we have expanded the disclosure of each of these planned trials throughout Amendment No. 6 to describe the material elements of
the trial design.
2.
Please revise your disclosure to clarify when you plan to conduct in vivo and in vitro studies on the treatment of eye pain with CC8464 as a topical agent. In addition, we note your prior Phase 1 study of CC8464 appeared to evaluate administering CC8464 with oral doses. Please clarify whether you have already developed CC8464 as a topical agent or otherwise advise.
Response: In response to the Staff’s
comment, we have revised the disclosure in Amendment No. 6 to clarify that (i) we have commenced development of a topical ophthalmic
formulation of CC8464 and (ii) we plan to conduct in vivo and toxicology studies in early 2024, after which we may pursue a proof-of-concept
trial in human patients.
If you have any questions
or require additional information, please contact the Company’s counsel, David E. Danovitch at (212) 660-3060 or at ddanovitch@sullivanlaw.com
or Aaron M. Schleicher at (212) 660-3034 or at aschleicher@sullivanlaw.com, of Sullivan & Worcester LLP.
Sincerely,
Chromocell Therapeutics Corporation
By:
/s/ Francis Knuettel II
Francis Knuettel II
Interim Chief Executive Officer and Chief Financial Officer
cc:
Kristin Lochhead and Daniel Gordon, Securities and Exchange Commission
David E. Danovitch, Esq., Sullivan & Worcester LLP
Aaron M. Schleicher, Esq., Sullivan & Worcester LLP
2023-09-12 - UPLOAD - Pelthos Therapeutics Inc. File: 377-06353
United States securities and exchange commission logo
September 11, 2023
Francis Knuettel II
Chief Executive Officer
Chromocell Therapeutics Corporation
4400 Route 9 South, Suite 1000
Freehold, NJ 07728
Re:Chromocell Therapeutics Corporation
Amendment No. 5 to Registration Statement on Form S-1
Filed September 1, 2023
File No. 333-269188
Dear Francis Knuettel II:
We have reviewed your amended 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 amending your registration statement and providing the
requested information. 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 any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments. Unless we note
otherwise, our references to prior comments are to comments in our July 28, 2023 letter.
Amendment No. 5 to Registration Statement on Form S-1 filed September 1, 2023
Business
Overview, page 52
1.We note your disclosure that you "plan to proceed with [y]our clinical trials in 2023,
focusing on a study to evaluate this rash mitigation strategy and a Phase 2a proof-of-
concept study assessing the potential efficacy of CC8464 in EM patients with a genetic
disposition" and your revised disclosure that you are "evaluating doing the rash mitigation
and [y]our proof-of-concept study in a different national jurisdiction acceptable to the
FDA." Please update your disclosure to clarify whether you still plan to begin these
studies in 2023 or whether your timeline has been delayed. In addition, please expand
FirstName LastNameFrancis Knuettel II
Comapany NameChromocell Therapeutics Corporation
September 11, 2023 Page 2
FirstName LastName
Francis Knuettel II
Chromocell Therapeutics Corporation
September 11, 2023
Page 2
your disclosure of the planned trials to describe the material elements of the trial
design and your anticipated timeline for completion of the trials or otherwise advise.
2.Please revise your disclosure to clarify when you plan to conduct in vivo and in vitro
studies on the treatment of eye pain with CC8464 as a topical agent. In addition, we note
your prior Phase 1 study of CC8464 appeared to evaluate administering CC8464 with oral
doses. Please clarify whether you have already developed CC8464 as a topical agent or
otherwise advise.
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,
Division of Corporation Finance
Office of Life Sciences
cc: David Danovitch, Esq.
2023-09-01 - CORRESP - Pelthos Therapeutics Inc.
CORRESP
1
filename1.htm
Chromocell Therapeutics Corporation
4400 Route 9 South, Suite 1000
Freehold, NJ 07728
September 1, 2023
Via EDGAR
Doris Stacey Gama and Jason Drory
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, NE
Washington, D.C. 20549
Re:
Chromocell Therapeutics Corporation
Amendment No. 3 to Registration Statement on Form S-1
Filed June 30, 2023
File No. 333-269188
Dear Madam and Sir:
This correspondence responds
to the letter, dated July 10, 2023, received from the staff of the Securities and Exchange Commission (the “Staff”) regarding
the abovementioned Amendment No. 3 to Registration Statement on Form S-1 filed on June 30, 2023 by Chromocell Therapeutics Corporation
(the “Company”, “we”, “us” or “our”). For convenience, the Staff’s comments are
restated below in bold text, with each comment followed by our response. We are concurrently filing with this letter Amendment No. 5 to
Registration Statement on Form S-1 (“Amendment No. 5”). Capitalized terms used, but not defined, in this letter have the meanings
ascribed to such terms in Amendment No. 5.
Amendment No. 3 to Registration Statement
on Form S-1 filed June 30, 2023
Recent Developments, page 1
1.
We note the liquidation preference on your Series B preferred stock. Please include a summary risk factor disclosure, and a full risk factor, addressing the material risks to your common stockholders associated with the liquidation preference on the preferred stock, including that the liquidation preference could have the effect of preventing your common stockholders from receiving any proceeds in the event your company is liquidated. In addition, please revise your risk factors and similar statements throughout your filing to acknowledge that your Series B preferred stock is entitled to an 10% annual dividend.
Response: In response to the Staff’s
comment, we have revised the disclosure regarding Series B Preferred Stock throughout Amendment No. 5 accordingly.
If you have any questions
or require additional information, please contact the Company’s counsel, David E. Danovitch at (212) 660-3060 or at ddanovitch@sullivanlaw.com
or Aaron M. Schleicher at (212) 660-3034 or at aschleicher@sullivanlaw.com, of Sullivan & Worcester LLP.
Sincerely,
Chromocell Therapeutics Corporation
By:
/s/ Francis Knuettel II
Francis Knuettel II
Interim Chief Executive Officer and Chief Financial Officer
cc:
Kristin Lochhead and Daniel Gordon, Securities and Exchange Commission
David E. Danovitch, Esq., Sullivan & Worcester LLP
Aaron M. Schleicher, Esq., Sullivan & Worcester LLP
2023-07-24 - CORRESP - Pelthos Therapeutics Inc.
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
2023-07-10 - UPLOAD - Pelthos Therapeutics Inc. File: 377-06353
United States securities and exchange commission logo
July 10, 2023
Christian Kopfli, Esq.
Chief Executive Officer
Chromocell Therapeutics Corporation
675 US Highway Route 1 South
North Brunswick, NJ 08906
Re:Chromocell Therapeutics Corporation
Amendment No. 3 to Registration Statement on Form S-1
Filed June 30, 2023
File No. 333-269188
Dear Christian Kopfli:
We have reviewed your amended registration statement and have the following
comment. In our comment, we may ask you to provide us with information so we may better
understand your disclosure.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our 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 comment, we may have additional comments. Unless we note
otherwise, our references to prior comments are to comments in our May 19, 2023 letter.
Amendment No. 3 to Registration Statement on Form S-1 filed June 30, 2023
Recent Developments, page 1
1.We note the liquidation preference on your Series B preferred stock. Please include a
summary risk factor disclosure, and a full risk factor, addressing the material risks to your
common stockholders associated with the liquidation preference on the preferred stock,
including that the liquidation preference could have the effect of preventing your common
stockholders from receiving any proceeds in the event your company is liquidated. In
addition, please revise your risk factors and similar statements throughout your filing to
acknowledge that your Series B preferred stock is entitled to an 10% annual dividend.
FirstName LastNameChristian Kopfli, Esq.
Comapany NameChromocell Therapeutics Corporation
July 10, 2023 Page 2
FirstName LastName
Christian Kopfli, Esq.
Chromocell Therapeutics Corporation
July 10, 2023
Page 2
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,
Division of Corporation Finance
Office of Life Sciences
cc: David Danovitch, Esq.
2023-06-30 - CORRESP - Pelthos Therapeutics Inc.
CORRESP
1
filename1.htm
Chromocell
Therapeutics Corporation
4400 Route 9 South, Suite 1000
Freehold, NJ 07728
June
30, 2023
Via
EDGAR
Doris
Stacey Gama and Jason Drory
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
100
F Street, NE
Washington,
D.C. 20549
Re:
Chromocell
Therapeutics Corporation
Amendment No. 2 to Registration Statement on Form S-1 Filed
May 1, 2023
File
No. 333-269188
Dear
Madam and Sir:
This
correspondence responds to the letter, dated May 19, 2023, received from the staff of the Securities and Exchange Commission (the “Staff”)
regarding the abovementioned Amendment No. 2 to Registration Statement on Form S-1 filed on May 1, 2023 by Chromocell Therapeutics Corporation
(the “Company”, “we”, “us” or “our”). For convenience, the Staff’s comments are
restated below in bold text, with each comment followed by our response. We are concurrently filing with this letter Amendment No. 3
to Registration Statement on Form S-1 (“Amendment No. 3”). Capitalized terms used, but not defined, in this letter have the
meanings ascribed to such terms in Amendment No. 3.
Amendment
No. 2 to Registration Statement on Form S-1 filed May 1, 2023
Cover
Page
1.
Please
revise the heading to reflect that in addition to the units you are also registering common shares underlying the Representative’s
Warrants and Advisor Warrants.
Response:
In response to the Staff’s comment, we have revised the disclosure on the cover page of Amendment No. 3 accordingly.
Capitalization
Table, page 44
2.
Please
explain how you calculated Total Capitalization in the table on page 44.
Response: In response to the Staff’s
comment, we have revised the Capitalization table on page 44 of Amendment No. 3 to reflect the Company’s capitalization as of March
31, 2023, calculating Total Capitalization as total debt plus total stockholders’ (deficit).
Biographical
Information - Non-Employee Directors, page 78
3.
Please
revise your disclosure to specifically identify the experience, qualifications, attributes or skills that led to the conclusion that
each director should serve as a director. Refer to Item 401(e) of Regulation S-K.
Response: In response to the Staff’s
comment, we have revised the disclosure on pages 78 and 79 of Amendment No. 3 accordingly.
Chromocell
Therapeutics Corporation
June
30, 2023
Page
2
Audited
Financial Statements for the Year Ended December 31, 2022
Note
7. Stockholder’s Equity, page F-16
4.
We
see that you issued 450,000 stock options on January 10, 2023 but you recognized the grant date in October 2022. Please clarify how
you determined the grant date of the stock options and why it is appropriate to record the related expense during FY22. Reference
ASC 718-10-25-5 and ASC 718-55-80 through 83.
Response: The Company respectfully acknowledges
the Staff’s comment and we have revised the disclosure on page F-28 of Amendment No. 3 accordingly to provide greater clarity.
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.
Response: The Company respectfully acknowledges
the Staff’s comment. We respectfully advise the Staff that we have revised the disclosure on pages F-28 and F-29 of Amendment No.
3 to provide greater clarity on the determination by the Company of the fair value of our common stock.
Exhibits
6.
Please
file as exhibits the executed bridge financing documents, rather than a form of agreement. Refer to Item 601(b)(10) of Regulation
S-K.
Response: In response to the Staff’s
comment, we will file the required executed agreements related to the bridge financing with a subsequent amendment (other than the note,
the form of which will be included in Exhibit 10.4 pursuant to General Instruction 2 of Item 601 of Regulation S-K).
If
you have any questions or require additional information, please contact the Company’s counsel, David E. Danovitch at (212) 660-3060
or at ddanovitch@sullivanlaw.com or Aaron M. Schleicher at (212) 660-3034 or at aschleicher@sullivanlaw.com, of Sullivan & Worcester
LLP.
Sincerely,
Chromocell Therapeutics Corporation
By:
/s/ Christian Kopfli
Christian Kopfli
Chief Executive Officer
cc:
Kristin
Lochhead and Daniel Gordon, Securities and Exchange Commission
David E. Danovitch,
Esq., Sullivan & Worcester LLP
Aaron M. Schleicher,
Esq., Sullivan & Worcester LLP
2023-05-19 - UPLOAD - Pelthos Therapeutics Inc. File: 377-06353
United States securities and exchange commission logo
May 19, 2023
Christian Kopfli, Esq.
Chief Executive Officer
Chromocell Therapeutics Corporation
675 US Highway Route 1 South
North Brunswick, NJ 08906
Re:Chromocell Therapeutics Corporation
Amendment No. 2 to Registration Statement on Form S-1
Filed May 1, 2023
File No. 333-269188
Dear Christian Kopfli:
We have reviewed your amended 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 amending your registration statement and providing the
requested information. 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 any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments. Unless we note
otherwise, our references to prior comments are to comments in our January 23, 2023 letter.
Amendment No. 2 to Registration Statement on Form S-1
Cover Page
1.Please revise the heading to reflect that in addition to the units you are also
registering common shares underlying the Representative's Warrants and Advisor
Warrants.
Capitalization Table , page 44
2.Please explain how you calculated Total Capitalization in the table on page 44.
FirstName LastNameChristian Kopfli, Esq.
Comapany NameChromocell Therapeutics Corporation
May 19, 2023 Page 2
FirstName LastName
Christian Kopfli, Esq.
Chromocell Therapeutics Corporation
May 19, 2023
Page 2
Biographical Information - Non-Employee Directors, page 78
3.Please revise your disclosure to specifically identify the experience, qualifications,
attributes or skills that led to the conclusion that each director should serve as a director.
Refer to Item 401(e) of Regulation S-K.
Audited Financial Statements for the Year Ended December 31, 2022
Note 7. Stockholder's Equity, page F-16
4.We see that you issued 450,000 stock options on January 10, 2023 but you recognized the
grant date in October 2022. Please clarify how you determined the grant date of the stock
options and why it is appropriate to record the related expense during FY22. Reference
ASC 718-10-25-5 and ASC 718-55-80 through 83.
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.
Exhibits
6.Please file as exhibits the executed bridge financing documents, rather than a form of
agreement. Refer to Item 601(b)(10) of Regulation S-K.
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,
Division of Corporation Finance
Office of Life Sciences
cc: David Danovitch, Esq.
2023-05-01 - CORRESP - Pelthos Therapeutics Inc.
CORRESP
1
filename1.htm
Chromocell
Therapeutics Corporation
4400 Route 9 South, Suite 1000
Freehold, NJ 07728
May
1, 2023
Via
EDGAR
Lauren
Sprague Hamill and Jason Drory
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
100
F Street, NE
Washington,
D.C. 20549
Re: Chromocell
Therapeutics Corporation
Registration Statement on Form S-1
Filed
January 11, 2023
File
No. 333-269188
Dear
Madam and Sir:
This
correspondence responds to the letter, dated January 23, 2023, received from the staff of the Securities and Exchange Commission
(the “Staff”) regarding the abovementioned Registration Statement on Form S-1 filed on January 11, 2023 by Chromocell
Therapeutics Corporation (the “Company”, “we”, “us” or “our”). For convenience,
the Staff’s comments are restated below in bold text, with each comment followed by our response. We are concurrently filing
with this letter Amendment No. 2 to Registration Statement on Form S-1 (“Amendment No. 2”). Capitalized terms used,
but not defined, in this letter have the meanings ascribed to such terms in Amendment No. 2.
Registration
Statement on Form S-1 filed January 11, 2023
Cover
Page
1. We
note that you have applied to list your common stock on the Nasdaq Global Market. Please
revise the cover page of the IPO Prospectus as follows:
● State
that no assurance can be given that your listing application will be approved, as you
have on page 89.
● State
that your offering is contingent upon final approval of your NASDAQ listing and that
the offering will terminate absent receipt of such approval, as you have on page 4.
Please
ensure your disclosure is consistent with your underwriting agreement.
Response:
In response to the Staff’s comment, we have revised the disclosure on the cover page of Amendment No. 2 accordingly.
Chromocell
Therapeutics Corporation
May 1, 2023
Page 2
2. According
to your preliminary fee table and disclosure on pages 7 and 105, it appears that you
will issue warrants to your underwriter, Maxim Group LLC, and warrants to your financial
advisor, A.G.P./Alliance Global Partners, and seek to register these warrants and common
stock underlying these warrants as part of your initial public offering registration
statement. If true, please revise your cover page and offering summary to clarify the
issuance and registration of these warrants and underlying common stock or otherwise
advise.
Response:
We respectfully advise the Staff that only the common stock underlying the Representative’s Warrants and the Advisor Warrants,
but not the Representative’s Warrants and the Advisor Warrants, are being registered as part of the initial public offering.
We have revised the cover page and Exhibit 107 accordingly.
The
price of our securities may be volatile and fluctuate substantially . . ., page 36
3. We
note recent instances of extreme stock price run-ups followed by rapid price declines
and stock price volatility seemingly unrelated to company performance following a number
of recent initial public offerings, particularly among companies with relatively smaller
public floats. As such:
● Please
revise this risk factor or include a separate risk factor addressing the potential for
rapid and substantial price volatility and any known factors specific to your offering
that may add to this risk.
● Clarify
that any such volatility, including any stock-run up, may be unrelated to your actual
or expected operating performance and financial condition or prospects, which could make
it difficult for prospective investors to assess the rapidly changing value of your stock.
● Discuss
the risks to investors when investing in securities where the price may change rapidly.
Response:
In response to the Staff’s comment, we have revised the disclosure on page 33 of Amendment No. 2 accordingly.
Management’s
Discussion and Analysis of Financial Condition and Results of Operations Critical Accounting Policies, page 52
4. We
reference the disclosure on page 52 and F-21 that the valuation of the intellectual property
related to Chromocell Holding’s NaV1.7 program and its clinical-stage CC8464 lead
compound was valued at $44,808,301 by an outside valuation firm based on the cost approach
of valuation. Please tell us the nature and extent of the specialist’s involvement
and whether you believe the specialist was acting as an expert as defined under Section11(a)
of the Securities Act of 1933 and Section 436(b) of Regulation C, such that you must
disclose the name of the specialist in the Form S-1 along with a consent from the specialist.
If you conclude the specialist is not considered an expert under the Securities Act,
please revise your disclosures to clarify.
Chromocell
Therapeutics Corporation
May 1, 2023
Page 3
Response:
The Company respectfully acknowledges the Staff’s comment. We respectfully advise the Staff that prior accounting treatment
of the acquisition treatment and fair value as of and for the period ending September 30, 2022 was preliminary and pursuant to
our final analysis, we determined that historical book value was warranted. Correspondingly, the financial statements as of and
for the period ended December 31, 2022 are presented in a manner that recognizes the historical book value, obviating the fair
value analysis and the need for an outside expert or other party to assist in the valuation.
Unaudited
Condensed Consolidated Financial Statements of Chromocell Therapeutics Corporation
Note
6. Intangible Assets, page F-21
5. Please
revise the disclosure to clearly explain your accounting for the intangible assets acquired
through the contribution agreement in August 2022. Please address the following:
● Disclose
how you valued the intangible assets, including the specific assumptions that were used
in the valuation;
● Discuss
the basis for a valuation in excess of $44 million;
● Identify
the accounting literature upon which you relied in determining your accounting for the
acquisition of the intangible assets;
● Tell
us whether the contribution agreement is between entities under common control and how
that impacted your accounting. In that regard, please address how you considered that
the contributed assets should not be recorded at their historical amounts on the Contribution
Date;
● Explain
the basis for the 12 year useful life of the intangible asset.
Response:
The Company respectfully acknowledges the Staff’s comment. We respectfully advise the Staff that, similar to our response
to comment 4 above, the Company’s final accounting treatment recognizes the transferred intangible assets at historical
book value, obviating the need for and results of a valuation analysis and determination of fair value and eliminating the amortization
of the fair value over the useful life.
If
you have any questions or require additional information, please contact the Company’s counsel, David E. Danovitch at (212)
660-3060 or at ddanovitch@sullivanlaw.com or Aaron M. Schleicher at (212) 660-3034 or at aschleicher@sullivanlaw.com, of Sullivan
& Worcester LLP.
Sincerely,
Chromocell
Therapeutics Corporation
By:
/s/
Christian Kopfli
Christian
Kopfli
Chief
Executive Officer
cc:
Kristin
Lochhead and Daniel Gordon, Securities and Exchange Commission
David
E. Danovitch, Esq., Sullivan & Worcester LLP
Aaron
M. Schleicher, Esq., Sullivan & Worcester LLP
2023-01-23 - UPLOAD - Pelthos Therapeutics Inc. File: 377-06353
United States securities and exchange commission logo
January 23, 2023
Christian Kopfli, Esq.
Chief Executive Officer
Chromocell Therapeutics Corporation
675 US Highway Route 1 South
North Brunswick, NJ 08906
Re:Chromocell Therapeutics Corporation
Registration Statement on Form S-1
Filed January 11, 2023
File No. 333-269188
Dear Christian Kopfli:
We have reviewed your 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 amending your registration statement and providing the
requested information. 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 any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.
Registration Statement on Form S-1 filed January 11, 2023
Cover Page
1.We note that you have applied to list your common stock on the Nasdaq Global Market.
Please revise the cover page of the IPO Prospectus as follows:
•State that no assurance can be given that your listing application will be approved, as
you have on page 89.
•State that your offering is contingent upon final approval of your NASDAQ listing
and that the offering will terminate absent receipt of such approval, as you have on
page 4.
Please ensure your disclosure is consistent with your underwriting agreement.
2.According to your preliminary fee table and disclosure on pages 7 and 105, it appears that
you will issue warrants to your underwriter, Maxim Group LLC, and warrants to your
FirstName LastNameChristian Kopfli, Esq.
Comapany NameChromocell Therapeutics Corporation
January 23, 2023 Page 2
FirstName LastNameChristian Kopfli, Esq.
Chromocell Therapeutics Corporation
January 23, 2023
Page 2
financial advisor, A.G.P./Alliance Global Partners, and seek to register these warrants and
common stock underlying these warrants as part of your initial public offering registration
statement. If true, please revise your cover page and offering summary to clarify the
issuance and registration of these warrants and underlying common stock or otherwise
advise.
The price of our securities may be volatile and fluctuate substantially . . ., page 36
3.We note recent instances of extreme stock price run-ups followed by rapid price declines
and stock price volatility seemingly unrelated to company performance following a
number of recent initial public offerings, particularly among companies with relatively
smaller public floats. As such:
•Please revise this risk factor or include a separate risk factor addressing the potential
for rapid and substantial price volatility and any known factors specific to your
offering that may add to this risk.
•Clarify that any such volatility, including any stock-run up, may be unrelated to your
actual or expected operating performance and financial condition or prospects, which
could make it difficult for prospective investors to assess the rapidly changing value
of your stock.
•Discuss the risks to investors when investing in securities where the price may
change rapidly.
Management's Discussion and Analysis of Financial Condition and Results of Operations
Critical Accounting Policies, page 52
4.We reference the disclosure on page 52 and F-21 that the valuation of the intellectual
property related to Chromocell Holding’s NaV1.7 program and its clinical-stage CC8464
lead compound was valued at $44,808,301 by an outside valuation firm based on the cost
approach of valuation. Please tell us the nature and extent of the specialist’s
involvement and whether you believe the specialist was acting as an expert as defined
under Section11(a) of the Securities Act of 1933 and Section 436(b) of Regulation C, such
that you must disclose the name of the specialist in the Form S-1 along with a consent
from the specialist. If you conclude the specialist is not considered an expert under the
Securities Act, please revise your disclosures to clarify.
Unaudited Condensed Consolidated Financial Statements of Chromocell Therapeutics
Corporation
Note 6. Intangible Assets, page F-21
5.Please revise the disclosure to clearly explain your accounting for the intangible assets
acquired through the contribution agreement in August 2022. Please address the
following:
•Disclose how you valued the intangible assets, including the specific assumptions
that were used in the valuation;
FirstName LastNameChristian Kopfli, Esq.
Comapany NameChromocell Therapeutics Corporation
January 23, 2023 Page 3
FirstName LastName
Christian Kopfli, Esq.
Chromocell Therapeutics Corporation
January 23, 2023
Page 3
•Discuss the basis for a valuation in excess of $44 million;
•Identify the accounting literature upon which you relied in determining your
accounting for the acquisition of the intangible assets;
•Tell us whether the contribution agreement is between entities under common control
and how that impacted your accounting. In that regard, please address how you
considered that the contributed assets should not be recorded at their historical
amounts on the Contribution Date;
•Explain the basis for the 12 year useful life of the intangible asset.
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
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 Lauren Sprague Hamill at 303-844-1008 or Jason Drory at 202-551-8342 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: David Danovitch, Esq.
2023-01-11 - CORRESP - Pelthos Therapeutics Inc.
CORRESP
1
filename1.htm
Chromocell Therapeutics Corporation
675 US Highway Route 1 South
North Brunswick, NJ 08906
January 11, 2023
Via EDGAR
Doris Stacey Gama and Jason Drory
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, NE
Washington, D.C. 20549
Re: Chromocell Therapeutics Corporation
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted October 17, 2022
CIK No. 0001919246
Dear Madam and Sir:
This correspondence responds to the letter,
dated October 31, 2022, received from the staff of the Securities and Exchange Commission (the “Staff”) regarding the
abovementioned Amendment No. 1 to Draft Registration Statement on Form S-1 confidentially submitted on October 17, 2022 by Chromocell
Therapeutics Corporation (the “Company”, “we”, “us” or “our”). For convenience,
the Staff’s comments are restated below in bold text, with each comment followed by our response. We are concurrently filing
with this correspondence a Registration Statement on Form S-1 (the “Registration Statement”). Capitalized terms used,
but not defined, in this letter have the meanings ascribed to such terms in the Registration Statement.
Amendment No. 1 to Draft Registration Statement on Form
S-1 submitted October 17, 2022
Use of Proceeds, page 42
1. We note your Investor Note appears to be debt that was incurred within one year. Please describe the use of proceeds of
such indebtedness. Refer to Instruction 4 to Item 504 of Regulation S-K.
Response: In response to the Staff’s comment,
we have revised the disclosure on page 42 of the Registration Statement accordingly.
Chromocell Therapeutics Corporation
January 11, 2023
Page 2
Management's Discussion and Analysis of Financial Condition
and Results of Operations Results of Operations, Research and Development Expenses, page 48
2. We reissue prior comment 9. For all periods presented, revise to provide quantitative disclosure of the type of research
and development expenses incurred. For example, separately disclose the amount of expense incurred in each period for consultants
in regulatory, clinical development and CMC matters, maintenance fees and lab material costs.
Response: In response to the Staff’s comment,
we have revised the disclosure on page 48 of the Registration Statement accordingly.
3. For the six months ended June 30, 2022, please elaborate on the underlying reasons for the 41% decrease in research and
development expense compared to the prior period. Explain how "evaluating your operating and development plans" contributed
to a decrease in research and development expenditures and disclose if it represents a known trend or uncertainty under Item 303
of Regulation S-K.
Response: In response to the Staff’s
comment, we have revised the disclosure on page 48 of the Registration Statement accordingly in respect of the nine months
ended September 30, 2022 (as opposed to June 30, 2022).
Critical Accounting Estimates, page 52
4. You indicate that your significant accounting policies are fully described in Note 3 to your financial statements. As required
by Item 303(b)(3) of Regulation S-X, provide qualitative and quantitative information necessary to understand the estimation uncertainty
and the impact your critical accounting estimates has had or is reasonably likely to have on financial condition or results of
operations to the extent the information is material and reasonably available.
Response: In response to the Staff’s
comment, we have revised the disclosure on page 52 of the Registration Statement to provide a summary of significant
accounting policies for the nine months ended September 30, 2022 and 2021.
Business
Our Strategy, page 54
5. We note your response to prior comment 11. Please further revise to clarify if the studies presented in the Journal of Clinical
Investigation are the genetic studies you reference that suggest that NaV1.7 could be a target to address EM. In addition, please
describe the studies in the Journal of Clinical Investigation and how they show a correlation between SCN9A and the expression
of the disease phenotype in EM patients or otherwise advise.
Response: In response to the Staff’s comment,
we have revised the disclosure on page 54 of the Registration Statement accordingly.
6. We note your response to prior comment 12 where you discuss the pre-clinical profile of CC8464. You state you conducted
in vitro and in vivo studies that showed a "high potency and selectivity of CC8464." Please update your disclosure to
provide your basis for this statement by including a description of the studies, the results, and how the results show high potency
and selectivity of CC8464.
Response: In response to the Staff’s comment,
we have revised the disclosure on page 54 of the Registration Statement accordingly.
Chromocell Therapeutics Corporation
January 11, 2023
Page 3
Intellectual Property, page 58
7. We note your response to prior comment 20 and reissue in part. For your two pending patents in India and the Philippines,
please update your disclosure to include type of patent protections expected, the specific product(s) to which the patent relates
to, and whether the patent is expected to be owned or licensed.
Response: In response to the Staff’s comment,
we have revised the disclosure on page 58 of the Registration Statement accordingly. In addition, we respectfully advise the
Staff that a matter of composition patent for CC8464 has been granted in the Philippines on June 8, 2022, which was previously
disclosed as pending.
If you have any questions
or require additional information, please contact the Company’s counsel, David E. Danovitch at (212) 660-3060 or at ddanovitch@sullivanlaw.com
or Aaron M. Schleicher at (212) 660-3034 or at aschleicher@sullivanlaw.com, of Sullivan & Worcester LLP.
Sincerely,
Chromocell Therapeutics Corporation
By:
/s/ Christian Kopfli
Christian Kopfli
Chief Executive Officer
cc:
Kristin Lochhead and Daniel Gordon, Securities and Exchange Commission
David E. Danovitch, Esq., Sullivan & Worcester LLP
Aaron M. Schleicher, Esq., Sullivan & Worcester LLP
2022-10-31 - UPLOAD - Pelthos Therapeutics Inc. File: 377-06353
United States securities and exchange commission logo
October 31, 2022
Christian Kopfli, Esq.
Chief Executive Officer
Chromocell Therapeutics Corporation
675 US Highway Route 1 South
North Brunswick, NJ 08906
Re:Chromocell Therapeutics Corporation
Amendment No. 1 to
Draft Registration Statement on Form S-1
Submitted October 17, 2022
CIK No. 0001919246
Dear Christian Kopfli:
We have reviewed your amended 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.
Amendment No. 1 to Draft Registration Statement on Form S-1 submitted October 17, 2022
Use of Proceeds, page 42
1.We note your Investor Note appears to be debt that was incurred within one year. Please
describe the use of proceeds of such indebtedness. Refer to Instruction 4 to Item 504 of
Regulation S-K.
Management's Discussion and Analysis of Financial Condition and Results of Operations
Results of Operations, Research and Development Expenses, page 48
2.We reissue prior comment 9. For all periods presented, revise to provide quantitative
disclosure of the the type of research and development expenses incurred. For example,
FirstName LastNameChristian Kopfli, Esq.
Comapany NameChromocell Therapeutics Corporation
October 31, 2022 Page 2
FirstName LastNameChristian Kopfli, Esq.
Chromocell Therapeutics Corporation
October 31, 2022
Page 2
separately disclose the amount of expense incurred in each period for consultants in
regulatory, clinical development and CMC matters, maintenance fees and lab material
costs.
3.For the six months ended June 30, 2022, please elaborate on the underlying reasons for the
41% decrease in research and development expense compared to the prior period. Explain
how "evaluating your operating and development plans" contributed to a decrease in
research and development expenditures and disclose if it represents a known trend or
uncertainty under Item 303 of Regulation S-K.
Critical Accounting Estimates, page 52
4.You indicate that your significant accounting policies are fully described in Note 3 to your
financial statements. As required by Item 303(b)(3) of Regulation S-X, provide qualitative
and quantitative information necessary to understand the estimation uncertainty and the
impact your critical accounting estimates has had or is reasonably likely to have on
financial condition or results of operations to the extent the information is material and
reasonably available.
Business
Our Strategy, page 54
5.We note your response to prior comment 11. Please further revise to clarify if the studies
presented in the Journal of Clinical Investigation are the genetic studies you reference that
suggest that NaV1.7 could be a target to address EM. In addition, please describe the
studies in the Journal of Clinical Investigation and how they show a correlation between
SCN9A and the expression of the disease phenotype in EM patients or otherwise advise.
6.We note your response to prior comment 12 where you discuss the pre-clinical profile of
CC8464. You state you conducted in vitro and in vivo studies that showed a "high potency
and selectivity of CC8464." Please update your disclosure to provide your basis for this
statement by including a description of the studies, the results, and how the results show
high potency and selectivity of CC8464.
Intellectual Property, page 58
7.We note your response to prior comment 20 and reissue in part. For your two pending
patents in India and the Philippines, please update your disclosure to include type of
patent protections expected, the specific product(s) to which the patent relates to, and
whether the patent is expected to be owned or licensed.
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.
FirstName LastNameChristian Kopfli, Esq.
Comapany NameChromocell Therapeutics Corporation
October 31, 2022 Page 3
FirstName LastName
Christian Kopfli, Esq.
Chromocell Therapeutics Corporation
October 31, 2022
Page 3
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: David Danovitch, Esq.
2022-10-03 - UPLOAD - Pelthos Therapeutics Inc. File: 377-06353
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
FirstName LastNameChristian Kopfli, Esq.
Comapany NameChromocell Therapeutics Corporation
October 3, 2022 Page 2
FirstName LastName
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
6.We note your disclosure on page 55 that you "are considering submitting a request to the
FDA for Orphan Drug Designation" for CC8464. Please update your risk factor to clarify
that you have not submitted an application to date or otherwise advise.
FirstName LastNameChristian Kopfli, Esq.
Comapany NameChromocell Therapeutics Corporation
October 3, 2022 Page 3
FirstName LastName
Christian Kopfli, Esq.
Chromocell Therapeutics Corporation
October 3, 2022
Page 3
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.
FirstName LastNameChristian Kopfli, Esq.
Comapany NameChromocell Therapeutics Corporation
October 3, 2022 Page 4
FirstName LastName
Christian Kopfli, Esq.
Chromocell Therapeutics Corporation
October 3, 2022
Page 4
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.
FirstName LastNameChristian Kopfli, Esq.
Comapany NameChromocell Therapeutics Corporation
October 3, 2022 Page 5
FirstName LastName
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
example, composition of matter, use or process), the specific product(s) to which the
patent relates, whether the patent is owned or licensed, the patent expiration dates, and the
applicable jurisdictions.
FirstName LastNameChristian Kopfli, Esq.
Comapany NameChromocell Therapeutics Corporation
October 3, 2022 Page 6
FirstName LastName
Christian Kopfli, Esq.
Chromocell Therapeutics Corporation
October 3, 2022
Page 6
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 writ