Company: SHPH
Filing Date: 2025-02-26
Form Type: 10-K
Source: 0001493152-25-008300
Chunk: 41

Company: Shuttle Pharmaceuticals Holdings, Inc.
Filing Date: 2025-02-26
Form: 10-K
Item: Item 1
Chunk 41
---
 a new product candidate require the enrollment of a sufficient number of patients, including patients
who are suffering from the disease the product candidate is intended to treat and who meet other eligibility criteria. Rates of patient
enrollment are affected by many factors, including the size of the patient population, the eligibility criteria for the clinical trial,
the age and condition of the patients, the stage and severity of disease, the nature of the protocol, the proximity of patients to clinical
sites and the availability of effective treatments for the relevant disease.

27

A
product candidate can unexpectedly fail at any stage of preclinical and clinical development. The historical failure rate for product
candidates is high due to scientific feasibility, lack of quality and effectiveness, changing standards of medical care and other variables.
The results from preclinical testing or early clinical trials of a product candidate may not predict the results that will be obtained
in later phase clinical trials of the product candidate. We, the FDA or other applicable regulatory authorities may suspend clinical
trials of a product candidate at any time for various reasons, including a belief that subjects participating in such trials are being
exposed to unacceptable health risks or adverse side effects. We may not have the financial resources to continue development of, or
to enter into collaborations for, a product candidate if we experience any problems or other unforeseen events that delay or prevent
regulatory approval of, or our ability to commercialize, product candidates, including:

    ●
    negative
    or inconclusive results from our clinical trials or the clinical trials of others for product candidates similar to ours, leading
    to a decision or requirement to conduct additional preclinical testing or clinical trials or abandon a program;

    ●
    serious
    and unexpected drug-related side effects experienced by participants in our clinical trials or by individuals using drugs similar
    to our product candidates;

    ●
    delays
    in submitting an Investigational New Drug application (“IND”) or delays or failure in obtaining the necessary approvals
    from regulators to commence a clinical trial, or a suspension or termination of a clinical trial once commenced;

    ●
    conditions
    imposed by the FDA or comparable foreign authorities regarding the scope or design of our clinical trials;

    ●
    delays
    in enrolling research subjects in clinical trials;

    ●
    high
    drop-out rates of research subjects;

    ●
    greater
    than anticipated clinical trial costs;

    ●
    poor
    effectiveness of our product candidates during clinical trials;

    ●