Company: CPMV
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001683168-25-002584
Chunk: 24

Company: Mosaic ImmunoEngineering Inc.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 24
---
 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 are able to raise sufficient capital and potentially
license or acquire new technologies, product development costs may also increase if we experience delays in testing or marketing approvals.
We do not know whether preclinical studies or clinical trials will need to be restructured or will be completed on schedule, or at all.
Significant preclinical or clinical trial delays also could shorten any periods during which we may have the exclusive right to commercialize
product candidates or may allow our competitors to bring products to market before we do and impair our ability to successfully commercialize
new product candidates and may harm our business and results of operations. In addition, enrollment delays in clinical trials may result
in increased development costs, which would cause the value of the Company to decline and limit our ability to obtain additional financing.

If serious adverse events or unacceptable side
effects are identified during the development of any product candidates, we may need to abandon or limit our development of those future
product candidates. 

If any potential product candidates are associated
with undesirable effects in preclinical or clinical trials or have characteristics that are unexpected, we may need to interrupt, delay
or abandon their development or limit development to more narrow uses or subpopulations in which the