Company: PTHS
Filing Date: 2025-05-09
Form Type: PREM14C
Source: 0001140361-25-018219
Chunk: 70

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-09
Form: PREM14C
Chunk 70
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 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 contamination could materially adversely affect Channel’s ability to produce CC8464, CT2000 and CT3000 on schedule and could, therefore, harm its results of operations and cause reputational damage.

Some of the raw materials required in Channel’s manufacturing process may be derived from biologic sources. Such raw materials are difficult to procure and may be subject to contamination or recall. A material shortage, contamination, recall or restriction on the use of biologically derived substances in the manufacture of CC8464, CT2000 and CT3000 could adversely impact or disrupt the commercial manufacturing or the production of clinical material, which could materially and adversely affect Channel’s development timelines and our business, financial condition, results of operations and prospects.**

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**Risks Related to Commercialization of Channel’s Compounds**

**If Channel is unable to expand its market development capabilities or enter into agreements with third parties to market and sell its compounds, it may be unable to generate any revenue.

Channel currently does not have a market development organization. To successfully commercialize CC8464, CT2000 and CT3000, if approved, it will need to expand its capabilities to promote market access and build awareness. To successfully commercialize any other products that may result from its development programs, Channel will need to further expand its market development organization, either on its own or with a third party. The development of its own market development team will be expensive and time-consuming and could delay any product launch. Moreover, Channel cannot be certain that it will be able to successfully develop this capability. Channel may enter into collaboration agreements regarding any of its compounds with third parties to utilize their established marketing and distribution capabilities, but Channel may be unable to enter into such agreements on favorable terms, if at all. If any future collaborators do not commit sufficient resources to commercialize Channel’s products, or Channel is unable to develop the necessary capabilities on its own, it will be unable to generate sufficient product revenue to sustain its business. Channel competes with many companies that currently have extensive, experienced and well-funded medical affairs, marketing and sales operations to recruit, hire, train and retain marketing and sales personnel. Channel also faces competition in its search for third parties to assist it with the sales and marketing efforts of its compounds. Without an internal