Company: PMVP
Filing Date: 2025-03-03
Form Type: 10-K
Source: 0000950170-25-030414
Chunk: 56

Company: PMV Pharmaceuticals, Inc.
Filing Date: 2025-03-03
Form: 10-K
Item: Item 1A
Chunk 56
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 (or in vitro diagnostic devices) and must themselves be approved for marketing by the FDA and comparable foreign regulatory agencies before we may commercialize such companion diagnostics with our product candidates. The success of our product candidates will depend on several factors, including the following:

•timely and successful completion of our ongoing clinical trials; 

•our ability to continue our business operations and product candidate research and development, and adapt to any changes in the regulatory approval process, manufacturing supply or clinical trial requirements and timing stemming from a global pandemic or other public health emergencies;

•receipt of authorization to proceed under INDs for our planned clinical trials or future clinical trials; 

•FDA acceptance of our tumor-agnostic development strategy; 

•the initiation and successful patient enrollment in and completion of additional preclinical and clinical trials of our product candidates on a timely basis; 

•successful development with third party collaborators of companion diagnostics for use with our product candidates; 

•safety, tolerability and efficacy profiles for our product candidates that are satisfactory to the FDA or any foreign regulatory authority for marketing approval; 

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•receipt of marketing approvals for our product candidates and any companion diagnostics from applicable regulatory authorities, which must be approved contemporaneously; 

•completion of any required post-marketing approval commitments to applicable regulatory authorities; 

•obtaining and maintaining patent and trade secret protection and regulatory exclusivity for our product candidates; 

•making arrangements with third-party manufacturers, or establishing manufacturing capabilities, for both clinical and commercial supplies of our product candidates, if any product candidates are approved; 

•establishing sales, marketing and distribution capabilities and launching commercial sales of our products, if and when approved, whether alone or in collaboration with others; 

•acceptance of our products, if and when approved, by patients, the medical community and third-party payors; 

•effectively competing with other cancer therapies; 

•obtaining and maintaining third-party coverage and adequate reimbursement; and 

•maintaining a continued acceptable safety profile of our products following approval.

Many of these factors are beyond our control, and it is possible that we may never obtain regulatory approval for our product candidates even if we expend substantial time and resources seeking their development and approval. If we do not achieve regulatory approval in a timely manner or at all, we could experience significant delays or an inability to commercialize our current or future product candidates, which would materially adversely affect our business. If we do not receive regulatory approvals for our current or future product candidates, we will not be able to continue our operations.