Company: SHPH
Filing Date: 2025-02-26
Form Type: 10-K
Source: 0001493152-25-008300
Chunk: 210

Company: Shuttle Pharmaceuticals Holdings, Inc.
Filing Date: 2025-02-26
Form: 10-K
Item: Item 1A
Chunk 210
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 manner, or at all;

    ●
    delays
    and changes in regulatory requirements, policy and guidelines, including the imposition of additional regulatory oversight around
    clinical testing generally or with respect to our technology in particular; or

    ●
    varying
    interpretations of data by the FDA and similar foreign regulatory agencies.

If
third parties on which we depend to conduct our preclinical studies, or any future clinical trials, do not perform as contractually required,
fail to satisfy regulatory or legal requirements or miss expected deadlines, our development program could be delayed with materially
adverse effects on our business, financial condition, results of operations and prospects.

We
are relying on third party collaborators to conduct our efficacy clinical trials for Ropidoxuridine and plan to rely on third party clinical
investigators, CROs, clinical data management organizations and consultants to design, conduct, supervise and monitor preclinical studies
of our product candidates and will do the same for any clinical trials. Because we plan to largely rely on third parties and do not have
the ability to conduct preclinical studies or clinical trials independently, we have less control over the timing, quality and other
aspects of preclinical studies and clinical trials than we would if we conducted them on our own. These investigators, CROs, and consultants
are not our employees and we have limited control over the amount of time and resources that they dedicate to our programs. These third
parties may have contractual relationships with other entities, some of which may be our competitors, which may draw time and resources
from our programs. The third parties with whom we contract might not be diligent, careful or timely in conducting our preclinical studies
or clinical trials, resulting in the preclinical studies or clinical trials being delayed or unsuccessful.

If
we cannot contract with acceptable third parties on commercially reasonable terms, or at all, or if these third parties do not carry
out their contractual duties, satisfy legal and regulatory requirements for the conduct of preclinical studies or clinical trials or
meet expected deadlines, our clinical development programs could be delayed and otherwise adversely affected. In all events, we are responsible
for ensuring that each of our preclinical studies and clinical trials is conducted in accordance with the general investigational plan
and protocols for the trial. The FDA requires clinical trials to be conducted in accordance with good clinical practices, including for
conducting, recording and reporting the results of preclinical studies and clinical trials to assure that data and reported results are
credible and accurate and