Company: PMVP
Filing Date: 2025-03-03
Form Type: 10-K
Source: 0000950170-25-030414
Chunk: 61

Company: PMV Pharmaceuticals, Inc.
Filing Date: 2025-03-03
Form: 10-K
Item: Item 1A
Chunk 61
---
 due to limitations on travel imposed or recommended by federal or state governments, employers and others or interruption of 

 34

clinical trial subject visits and study procedures (such as endoscopies that are deemed non-essential), which may impact the integrity of subject data and clinical study endpoints; 

•interruption or delays in the operations of the FDA or other regulatory authorities, which may impact review and approval timelines; 

•interruption of, or delays in receiving, supplies of our product candidates from our contract manufacturing organizations due to staffing shortages, production slowdowns or stoppages and disruptions in delivery systems; 

•interruptions in preclinical studies due to restricted or limited operations at our laboratory facility; 

•limitations on employee resources that would otherwise be focused on the conduct of our preclinical studies and clinical trials, including because of sickness of employees or their families or the desire of employees to avoid contact with large groups of people; 

•interruption or delays to our sourced discovery and clinical activities; and 

•changes in clinical site procedures and requirements as well as regulatory requirements for conducting clinical trials during the pandemic.

The ultimate impact of a global pandemic or other public health emergency on our business operations is difficult to forecast and highly uncertain, and there can be no assurance that we will be able to avoid a material impact on our business from such global pandemic or other public health emergency or their consequences, including disruption to our business and downturns in business sentiment generally or in our industry. To the extent a global pandemic or other public health emergency adversely affects our business, financial condition and results of operations, it may also have the effect of heightening many of the risks described in this “Risk factors” section. 

If we experience delays or difficulties in the enrollment and/or retention of patients in clinical trials, our regulatory submissions or receipt of necessary marketing approvals could be delayed or prevented. 

We may not be able to initiate or continue clinical trials on a timely basis or at all for our product candidates if we are unable to recruit and enroll a sufficient number of eligible patients to participate in these trials through completion of such trials as required by the FDA or other comparable foreign regulatory authorities. Patient enrollment is a significant factor in the timing of clinical trials. Our ability to enroll eligible patients may be limited or may result in slower enrollment than we anticipate. For example, our enrollment for clinical trials of rezatapopt will require patients to have the specific p53 Y220C mutation. If we are unable to locate a sufficient number of such patients