Company: DVAX
Filing Date: 2025-11-05
Form Type: 10-Q
Source: 0001628280-25-049536
Chunk: 30

Company: DYNAVAX TECHNOLOGIES CORP
Filing Date: 2025-11-05
Form: 10-Q
Item: Part I, Item 3
Chunk 30
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 or other foreign regulatory authorities or we ourselves could delay, suspend or halt our clinical trials of a product candidate for numerous reasons, including with respect to our product candidates and those of our partners in combination agent studies:

•deficiencies in the trial design;

•deficiencies in the conduct of the clinical trial including failure to conduct the clinical trial in accordance with regulatory requirements or clinical protocols;

•deficiencies in the clinical trial operations or trial sites resulting in the imposition of a clinical hold;

•a product candidate may have unforeseen adverse side effects, including fatalities, or a determination may be made that a clinical trial presents unacceptable health risks;

•the time required to determine whether a product candidate is effective may be longer than expected;

•fatalities or other adverse events arising during a clinical trial that may not be related to clinical trial treatments;

•a product candidate or combination study may appear to be no more effective than current therapies;

•the quality or stability of a product candidate may fail to conform to acceptable standards;

•the inability to produce or obtain sufficient quantities of a product candidate to complete the trials;

•our inability to reach agreement on acceptable terms with prospective CROs and trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;

•our inability to obtain IRB or Ethics Committee approval to conduct a clinical trial at a prospective site;

•the inability to obtain regulatory approval to conduct a clinical trial;

•lack of adequate funding to continue a clinical trial, including the occurrence of unforeseen costs due to enrollment delays, requirements to conduct additional trials and studies and increased expenses associated with the services of our CROs and other third parties;

•the inability to recruit and enroll individuals to participate in clinical trials for reasons including competition from other clinical trial programs for the same or similar indications; or

•the inability to retain participants who have initiated a clinical trial but may withdraw due to side effects from the product, lack of efficacy or personal issues, or who are otherwise unavailable for further follow-up.

In addition, we may experience significant setbacks in advanced clinical trials, even after promising results in earlier trials, such as unexpected adverse events that occur when our product candidates are given to larger patient populations, which often occur in later-stage clinical trials, or less favorable clinical outcomes. Moreover, clinical results are frequently susceptible to varying interpretations that may delay, limit or prevent regulatory approvals. 

Negative or inconclusive results or adverse medical events, including participant fatalities that may be attributable to our product candidates, during a