Company: PTHS
Filing Date: 2025-09-16
Form Type: 8-K/A
Source: 0001753926-25-001500
Chunk: 51

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-09-16
Form: 8-K/A
Chunk 51
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 operations, injury to our service providers and
others and environmental damage resulting in costly clean-up and liabilities under applicable laws and regulations governing the
use, storage, handling and disposal of these materials and specified waste products. Although we believe that the manufacturing
controls and safety procedures utilized by us and our third-party suppliers and manufacturers for handling, transporting and disposing
of these materials generally comply with the standards prescribed by these laws and regulations, we cannot guarantee that this
is the case or eliminate the risk (i) that the laws and regulations will not restrict our or our third-party suppliers’ or
manufacturers’ ability to use, manufacture, store, transport, handle or dispose of such materials or (ii) of accidental contamination
or injury from these hazardous materials and processes. If these risks were to materialize, we could experience an interruption
of our business operations, and we may be held liable for any resulting damages, and such liability could exceed our financial
resources.

We may be adversely affected by the effects of inflation or trade tariffs.

We have been impacted, and may continue to be impacted, by inflation and/or trade tariffs which have the potential to adversely affect our liquidity, business, financial condition and results of operations by increasing our overall cost structure. The existence of inflation and the recent uncertainty in the levying of certain trade tariffs by the U.S. government, has resulted in, and may continue to result in, higher interest rates and capital costs, supply shortages, increased costs of labor, components, manufacturing and shipping, as well as weakening exchange rates and other similar effects. As a result of inflation and tariffs, we have experienced and may continue to experience cost increases. Although we may take measures to mitigate the effects of inflation and tariffs, if these measures are not effective and if the inflationary and tariff pressure is sustained or increased, our business, financial condition, results of operations and liquidity could be negatively affected. Even if such measures are effective, there could be a difference between the timing of when these beneficial actions impact our results of operations and when the cost of inflation and/or tariffs are incurred.

Risks Related to Our Dependence on Third Parties

We will rely on third parties to conduct any preclinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may be unable to obtain regulatory approval for or commercialize any of our future product candidates.

We currently do not have the ability to
conduct in-house preclinical studies that comply with the regulatory requirements known as GLP,