Company: PTHS
Filing Date: 2025-05-27
Form Type: DEFM14C
Source: 0001140361-25-020509
Chunk: 375

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-27
Form: DEFM14C
Chunk 375
---
HC and Pelthos names, all of which are allowed by the USPTO.

#### Data Privacy and Security Laws
Numerous state, federal and foreign laws, regulations and standards govern the collection, use, access to, confidentiality and security of health-related and other personal information, and could apply now or in the future to our operations or the operations of our partners. In the United States, numerous federal and state laws and regulations, including data breach notification laws, health information privacy and security laws, and consumer protection laws and regulations govern the collection, use, disclosure, and protection of health-related and other personal information. In addition, certain foreign laws govern the privacy and security of personal data, including health-related data. Privacy and security laws, regulations, and other obligations are constantly evolving, may conflict with each other to complicate compliance efforts, and can result in investigations, proceedings, or actions that lead to significant civil and/or criminal penalties and restrictions on data processing.

#### Government Regulation and Product Approval
Government authorities in the United States, at the federal, state and local level, and other countries extensively regulate, among other things, the research, development, testing, manufacture, quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution, marketing and export and import of products such as those we are developing. A new drug must be approved by the FDA through the NDA process before it may be legally marketed in the United States.

<div align='center'>212</div>

TABLE OF CONTENTS

U.S. drug development process In the United States, the FDA regulates drugs under the federal FDCA and its implementing regulations. The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state and local statutes and regulations require the expenditure of substantial time and financial resources. The process required by the FDA before a drug may be marketed in the United States generally involves the following:

| • | completion of certain preclinical laboratory tests, animal studies and formulation studies in accordance with GLP regulations and other applicable regulations; |

| • | submission to the FDA of an IND, which must become effective before human clinical trials may begin; |

| • | approval by an IRB, or ethics committee at each clinical site before each trial may be initiated; |

| • | performance of adequate and well-controlled human clinical trials in accordance with GCPs to evaluate the safety and efficacy of the product candidate for its intended use; |

| • | submission to the FDA of an NDA after completion of all pivotal