Company: PTHS
Filing Date: 2025-09-16
Form Type: 8-K/A
Source: 0001753926-25-001500
Chunk: 49

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-09-16
Form: 8-K/A
Chunk 49
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 on us, including clinical holds, fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, seizures or recalls, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect our financial position.

Our or a third party’s failure to execute on our manufacturing requirements on commercially reasonable terms and in compliance with cGMP or other regulatory requirements could adversely affect our business in a number of ways, including:

| ● | an                                    
 inability to meet commercial demands; |

| ● | an                                                                    
 inability to initiate or complete clinical trials in a timely manner; |

| ● | delays                                                                    
 in submitting regulatory applications, or receiving regulatory approvals; |

| ● | subjecting                                                                                    
 third-party manufacturing facilities to additional inspections by regulatory authorities; and |

| ● | requirements                                       
 to cease development or to recall product batches. |

In addition, we may be unable to establish additional long-term supply agreements with third-party manufacturers or to do so on acceptable terms, which increases the risk of failing to timely obtain sufficient quantities of our products or any future product candidates or such quantities at an acceptable cost, which would have a material adverse impact on our financial position. There are risks associated with scaling up manufacturing to commercial volumes including, among others, cost overruns, technical or other problems with process scale-up, process reproducibility, stability issues, lot consistency and timely availability of raw materials. There is no assurance that our manufacturers will be successful in establishing a larger-scale commercial manufacturing process for ZELSUVMI that achieves our objectives for manufacturing capacity and cost of goods, in a timely manner, or at all.

Unexpected results in the analysis of raw materials, the API or drug product or problems with the execution of or quality systems supporting the analytical testing work, whether conducted internally or by third-party service providers, could adversely affect our development and commercialization timelines and result in increased costs of potential development programs initiated by us.

Third parties engaged directly by us or
by our API and drug product CMOs, test all of the raw materials and finished API and drug products. It is a regulatory requirement
that raw materials are tested and there are a limited number of suppliers for testing these raw materials. There may be a need
to assess alternate suppliers to prevent a possible disruption of the supply of these raw materials for the manufacture of API
or drug product. Additionally, the analytical equipment used by these third parties must be maintained and operational. Except
for the terms established within our or our CMOs’ contracts with the third parties responsible for testing