Company: CPMV
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001683168-25-002584
Chunk: 123

Company: Mosaic ImmunoEngineering Inc.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1A
Chunk 123
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 The outcome of preclinical and
clinical trials is inherently uncertain. Failure can occur at any time during the development program, including during the clinical trial
process. Further, the results of preclinical studies and early clinical trials for new product candidates may not be predictive of the
results of later-stage clinical trials. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses,
and many companies that have believed their product candidates performed satisfactorily in preclinical and clinical trials have nonetheless
failed to obtain marketing approval of their products. It is impossible to predict when or if product candidates will prove effective
and safe in humans or will receive regulatory approval.

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If we are able to raise sufficient capital and potentially
license or acquire new technologies, then we may also experience delays in clinical trials, and we do not know whether any planned clinical
trials will begin or enroll subjects on time, need to be redesigned or be completed on schedule, if at all. There can be no assurance
that the FDA or any other foreign regulatory body will not put any product candidate on clinical hold in the future. We may experience
numerous unforeseen events during, or as a result of, clinical trials that could delay or prevent our ability to receive marketing approval
or commercialize potential product candidates. If we are able to raise sufficient capital and potentially license or acquire new technologies,
then any planned clinical trials may be delayed, suspended or prematurely terminated for a variety of reasons, such as:

    ·
    delay or failure in reaching agreement with the FDA, European Medicines Agency (“EMA”), or a comparable foreign regulatory authority on a trial design that we want to execute;

    ·
    delay or failure in obtaining authorization to commence a trial or inability to comply with conditions imposed by a regulatory authority regarding the scope or design of a clinical study;

    ·
    delays in reaching, or failure to reach, agreement on acceptable clinical trial contracts or clinical trial protocols with prospective trial sites;

    ·
    inability, delay, or failure in identifying and maintaining a sufficient number of trial sites, many of which may already be engaged in other clinical programs;

    ·
    delay or failure in recruiting and enrolling suitable subjects to participate in a trial;

    ·
    delay or failure in having subjects complete a trial or return for post-treatment follow-up;

    ·
    clinical sites and investigators deviating from trial protocol, failing to conduct the trial in accordance with regulatory requirements, or dropping out of a trial;

    ·