Correspondence 0001753926-23-001340 from Pelthos Therapeutics Inc. (PTHS)
Pelthos Therapeutics Inc.
Date: Oct. 13, 2023 · CIK: 0001919246 · Accession: 0001753926-23-001340
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File numbers found in text: 333-269188
Letter
Via EDGAR Division of Corporation Finance Office of Life Sciences 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
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CORRESP
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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