Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 44

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 44
---
 countries that do not ensure an adequate
level of protection, like the United States. Failure to comply with the requirements of the GDPR and the related national data
protection laws of the EEA member states, which may deviate slightly from the GDPR, may result in fines of up to 4% of a company’s
global revenue for the preceding financial year, or €20 million, whichever is greater. Moreover, the GDPR grants data subjects
the right to claim material and non-material damages resulting from infringement of the GDPR. Given the breadth and depth of changes
in data protection obligations, maintaining compliance with the GDPR will require significant time, resources and expense, and
we may be required to put in place additional controls and processes ensuring compliance with the new data protection rules. There
has been limited enforcement of the GDPR to date, particularly in biopharmaceutical development, so we face uncertainty as to
the exact interpretation of the new requirements on any future trials and we may be unsuccessful in implementing all measures
required by data protection authorities or courts in interpretation of the new law. Further, the United Kingdom’s decision
to leave the European Union, means that it has in force its own legislation, which is aligned with the GDPR, known as the Data
Protection Act 2018. The requirements are similar except that the United Kingdom is now regarded as a “third country”
for the purposes of transfers of personal data from the EEA. Transfers continue to flow freely from the UK to the EEA following
an adequacy decision from the European Commission adopted on June 28, 2021 and valid for four years. 

24 

Data
protection authority activity differs across the European Union, with certain authorities applying their own agenda which shows
there is uncertainty in the manner in which data protection authorities will seek to enforce compliance with GDPR. For example,
it is not clear if the authorities will conduct random audits of companies doing business in the European Union, or if the authorities
will wait for complaints to be filed by individuals who claim their rights have been violated. Enforcement uncertainty and the
costs associated with ensuring GDPR compliance are onerous and may adversely affect our business, financial condition, results
of operations and prospects.

Should
we utilize third-party distributors, compliance with such foreign governmental regulations would generally be the responsibility
of such distributors, who may be independent contractors over whom we have limited control.

Recent
Developments of the Company

Bridge
Note

On
February 25, 2025,