Company: PMVP
Filing Date: 2025-03-03
Form Type: 10-K
Source: 0000950170-25-030414
Chunk: 87

Company: PMV Pharmaceuticals, Inc.
Filing Date: 2025-03-03
Form: 10-K
Item: Item 1A
Chunk 87
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 subject to extensive negotiation and may vary significantly among different CROs and clinical trial sites; 

•obtaining IRB or ethics committee approval at each clinical trial site; 

•recruiting an adequate number of suitable patients to participate in a clinical trial; 

•the number of patients required for clinical trials of our product candidates may be larger than we anticipate; 

•the cost of clinical trials of our product candidates may be greater than we anticipate, for example, if we experience delays or challenges in identifying patients with the mutations required for our clinical trials, we may have to reimburse sites for genomic sequencing costs in order to encourage sequencing of additional patients; 

•having subjects complete a clinical trial or return for post-treatment follow-up;

•clinical trial sites deviating from clinical trial protocol or dropping out of a clinical trial; 

•having third-party contractors fail to complete their obligations in a timely manner or failing to comply with applicable regulatory requirements; 

•addressing subject safety concerns that arise during the course of a clinical trial; 

•adding a sufficient number of clinical trial sites; or 

•obtaining sufficient product supply of product candidate for use in preclinical studies or clinical trials from third-party suppliers.

If we are required to conduct additional clinical trials or other testing of our product candidates beyond those that we currently contemplate, if we are unable to successfully complete clinical trials of our product candidates or other testing, if the results of these trials or tests are not positive or are only moderately positive or if there are safety concerns, our business and results of operations may be adversely affected and we may incur significant additional costs. We could also encounter delays if a clinical trial is suspended or terminated by us, by the IRBs of the institutions in which such clinical trials are being conducted, by the Data Safety Monitoring Board, if any, for such clinical trial or by the FDA or other regulatory authorities. Such authorities may suspend or terminate a clinical trial due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical trial protocols, inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from the product candidates, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial. 

Moreover, principal investigators for our future clinical trials may serve as scientific advisors or consultants to us from time to time and receive compensation in connection with such services. Under certain circumstances