Company: PTHS
Filing Date: 2025-05-27
Form Type: DEFM14C
Source: 0001140361-25-020509
Chunk: 69

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-27
Form: DEFM14C
Chunk 69
---
8464, CT2000, CT3000 or any of Channel’s other compounds or disruptions in its manufacturing process may delay or disrupt its product development and commercialization efforts.

Before Channel can begin to commercially manufacture CC8464, CT2000, CT3000 or any of its other compounds, whether in a third-party facility or in its own facility, if established, Channel must pass a pre-approval inspection of its manufacturing facility by the FDA. A manufacturing authorization must also be obtained from the appropriate regulatory authorities. The timeframe required for Channel to obtain such approvals is uncertain. To obtain approval, Channel will need to ensure that all its processes, methods and equipment are compliant with cGMP, and perform extensive audits of vendors, contract laboratories and suppliers. If any of its vendors, contract laboratories or suppliers is found to be out of compliance with cGMP, Channel may experience delays or disruptions in manufacturing while it works with these third parties to remedy the violation or while Channel works to identify suitable replacement vendors. The cGMP requirements govern quality control of the manufacturing process and documentation policies and procedures. In complying with cGMP, Channel will be obligated to expend time, money and effort in production, record keeping and quality control to assure that the product meets applicable specifications and other requirements. If Channel fails to comply with these requirements, it would be subject to possible regulatory action and may not be permitted to sell any compound that it may develop.

In addition, the manufacturing process used to produce Channel’s existing compounds is complex, novel and has not been validated for commercial use. To produce enough quantities of its existing compounds for future clinical trials and initial U.S. commercial demand, Channel will need to increase the scale of its manufacturing process. Channel employs multiple steps to control its manufacturing process to assure that the process works and that CC8464, CT2000 and CT3000 are made strictly and consistently in compliance with the process. Problems with, or deviations from, the manufacturing process, even if minor, could result in product defects or manufacturing failures that result in lot failures, product recalls, product liability claims or insufficient inventory. Channel may encounter problems achieving adequate quantities and quality of clinical-grade materials that meet FDA, EMA or other applicable standards or specifications with consistent and acceptable production yields and costs.

Any contamination in Channel’s manufacturing process, shortages of raw materials or failure of any of its key suppliers to deliver necessary components could result in delays in its clinical development or marketing schedules.

Given the nature of sterile product manufacturing, there is a risk of contamination. Any