SEC Comment Letter 0000000000-23-010044 to Pelthos Therapeutics Inc. (PTHS)
Pelthos Therapeutics Inc.
Date: Sept. 12, 2023 · CIK: 0001919246 · Accession: 0000000000-23-010044
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File numbers found in text: 333-269188
Letter
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.
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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.