Company: PMVP
Filing Date: 2025-03-03
Form Type: 10-K
Source: 0000950170-25-030414
Chunk: 64

Company: PMV Pharmaceuticals, Inc.
Filing Date: 2025-03-03
Form: 10-K
Item: Item 1A
Chunk 64
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 our clinical development and business operations in foreign countries; 

•foreign regulatory authorities may disagree with the design, implementation or results of our clinical trials or our interpretation of data from preclinical studies or clinical trials; 

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•approval policies or regulations of foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval; 

•impact of a global pandemic or other public health emergencies on our ability to produce our product candidates and conduct clinical trials in foreign countries; 

•sociopolitical instability in particular foreign economies and markets;

•unexpected changes in tariffs, trade barriers, price and exchange controls and other regulatory requirements;

•legislation or other measures that restrict business, trade, or use of government funding for any product or service rendered by certain companies based in China or Chinese-owned U.S. companies due to national security concerns or geopolitical issues, and our reliance on such Chinese companies, including CROs, contract manufacturing organization, or CMOs, suppliers, and other vendors or contractors based in China. For example, proposed legislation in Congress known as the BIOSECURE Act, or similar legislation, could limit our ability to work with CROs or CMOs in China and would restrict the purchase of services or products from certain specified companies in China. This new or proposed legislation, or similar legislation in the future, could adversely impact our current or future third-party arrangements with certain companies, including those in China or Chinese-owned U.S. companies, which could delay or impact clinical trials and consequently delay or obstruct successful commercialization of our drug candidates;

•regulations or other potentially new measures that, for national security or geopolitical reasons, affect the transfer of certain types of data abroad, including to China; for example, the Department of Justice recently issued a final rule which takes effect in April 2025 that places limitations, and in some cases prohibitions, on certain transfers of sensitive personal data to business partners located in China and other designated countries, or with other specified links to China and other designated countries;

•economic weakness, including inflation, or political instability in particular foreign economies and markets; 

•compliance with tax, employment, immigration and labor laws for employees living or traveling abroad; 

•foreign taxes, including withholding of payroll taxes; 

•foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and obligations incident to doing business in another country; 

•difficulties staffing and managing foreign operations; 

•workforce uncertainty in countries where labor unrest is more common than in the United States