Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 47

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1
Chunk 47
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 their treatment;

    ●
    we
    may be required to create a medication guide outlining the risks of a product for patients, or to conduct post-marketing studies;

    ●
    we
    may be required to change the way a product is administered;

    ●
    we
    could be subject to fines, injunctions, or the imposition of criminal or civil penalties, or be sued and held liable for harm caused
    to subjects or patients; and

    ●
    a
    product may become less competitive, and our reputation may suffer.

Any
of these events could diminish the usage or otherwise limit the commercial success of our product candidates and prevent us from achieving
or maintaining market acceptance of our product candidates, if approved by the FDA or other regulatory authorities.

33

We
may find it difficult to enroll patients in our clinical trials. If we encounter difficulties enrolling patients in our clinical trials,
our clinical development activities could be delayed or otherwise adversely affected.

Patient
enrollment is a significant factor in the timing of clinical trials, and the timing of our clinical trials depends, in part, on the speed
at which we can recruit patients to participate in our trials, as well as completion of required follow-up periods. We may not be able
to initiate or continue clinical trials for our product candidates if we are unable to locate and enroll a sufficient number of eligible
patients to participate in these trials to such trial’s conclusion as required by the FDA or other comparable regulatory authorities.
The conditions for which we currently plan to evaluate our product candidates are diseases with limited patient pools from which to draw
for clinical trials. The eligibility criteria of our clinical trials, once established, may further limit the pool of available trial
participants.

Patient
enrollment for any of our clinical trials may be affected by other factors, including:

    ●
    size
    and nature of the targeted patient population;

    ●
    severity
    of the disease or condition under investigation;

    ●
    availability
    and efficacy of approved therapies for the disease or condition under investigation;

    ●
    patient
    eligibility criteria for the trial in question as defined in the protocol;

    ●
    perceived
    risks and benefits of the product candidate under study;

    ●
    clinicians’
    and patients’ perceptions as to the potential advantages of the product candidate being studied in relation to other available
    therapies, including any products that may be approved for, or any product candidates under investigation for, the indications we