Company: CPMV
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001683168-25-002584
Chunk: 124

Company: Mosaic ImmunoEngineering Inc.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1A
Chunk 124
---
    lack of adequate funding to continue the clinical trial, including the incurrence of unforeseen costs due to enrollment delays, requirements to conduct additional clinical studies and increased expenses associated with the services of our contract research organizations (“CROs”) and other third parties;

    ·
    clinical trials of product candidates may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon product development programs;

    ·
    the number of patients required for clinical trials of product candidates may be larger than we anticipate, enrollment in these clinical trials may be slower than we anticipate, or participants may drop out of these clinical trials at a higher rate than we anticipate;

    ·
    we may experience delays or difficulties in the enrollment of patients that product candidates are designed to target based on the inclusion and exclusion criteria;

    ·
    our third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all;

    ·
    we may have difficulty partnering with experienced Clinical Research Organization and study sites that can identify patients that product candidates are designed to target and run our clinical trials effectively;

    ·
    regulators or institutional review boards (“IRBs”) may require that we or our investigators suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements or a finding that the participants are being exposed to unacceptable health risks;

    ·
    the supply or quality of product candidates or other materials necessary to conduct clinical trials of product candidates may be insufficient or inadequate; or

    ·
    there may be changes in governmental regulations or administrative actions.

If we are required to conduct additional clinical
trials or other testing of any potential product candidates, or if we are unable to successfully complete clinical trials or other testing,
or if the results of these trials or tests are not positive or are only modestly positive, or if there are safety concerns, we may:

    ·
    be delayed in obtaining marketing approval for product candidates, if ever;

    ·
    obtain approval for indications or patient populations that are not as broad as intended or desired;

    ·
    obtain approval with labeling that includes significant use or distribution restrictions or safety warnings that would reduce the potential market for products or inhibit our ability to successfully commercialize product candidates;

    ·
    be subject to additional post-marketing restrictions and/or testing requirements; or

    ·
    have the product removed from the market after obtaining marketing approval.

 14 

If we