Company: SHPH
Filing Date: 2025-02-26
Form Type: 10-K
Source: 0001493152-25-008300
Chunk: 201

Company: Shuttle Pharmaceuticals Holdings, Inc.
Filing Date: 2025-02-26
Form: 10-K
Item: Item 1A
Chunk 201
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 from our Phase I clinical trial for IPdR and proceeding to Phase II and Phase III clinical trials, which may
    be slower or cost more than we currently anticipate;

    ●
    our
    ability to demonstrate safety and efficacy of our product candidates, which are ongoing determinations that are solely within the
    authority of the FDA;

    ●
    even
    if our clinical trials are completed, there can be no assurance that the FDA will agree that we have satisfactorily demonstrated
    safety or efficacy or that the FDA will not raise new issues regarding the design of our clinical trials;

    ●
    whether
    we are required by the FDA to conduct additional clinical trials to support the approval of our product candidates;

    ●
    the
    acceptance by the FDA of our proposed parameters for regulatory approval, including our proposed indication, endpoints and endpoint
    measurement tools relating to our product candidates;

    ●
    the
    incidence, duration and severity of adverse side effects;

    ●
    the
    timely receipt of necessary marketing approvals from the FDA;

    ●
    whether
    we are able to secure collaborations for completing the development and, if approved, commercialization of our product candidates;

    ●
    the
    effectiveness of our and our potential collaborators’ marketing, sales and distribution strategy and operations of product
    candidates that are approved;

    ●
    our
    success in educating physicians and patients about the benefits, administration and use of our product candidates;

    ●
    the
    ability of our third-party manufacturers and potential collaborators to manufacture clinical trial and commercial supplies of our
    product candidates to remain in good standing with regulatory bodies, and to develop, validate and maintain commercially viable manufacturing
    processes that are compliant with cGMP regulations;

    ●
    our
    ability to commercialize our product candidates, if approved for marketing;

    ●
    our
    ability to enforce our intellectual property rights;

    ●
    our
    ability to avoid third-party patent interference or patent infringement claims;

    ●
    acceptance
    of our product candidates as safe and effective by patients and the medical community; and

    ●
    a
    continued acceptable quality profile of our product candidates following approval.

Many
of the risk factors detailed herein are beyond our control. Accordingly, we cannot assure you that we will ever be able
to generate revenue through the sale of our product candidates. Any one of these factors or other factors discussed in this Annual