Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 1342

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1A
Chunk 1342
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 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
    are investigating;

    ●
    efforts
    to facilitate timely enrollment in clinical trials;

    ●
    patient
    referral practices of physicians;

    ●
    the
    ability to monitor patients adequately during and after treatment;

    ●
    proximity
    and availability of clinical trial sites for prospective patients;

    ●
    continued
    enrollment of prospective patients by clinical trial sites; and

    ●
    the
    risk that patients enrolled in clinical trials will drop out of such trials before completion.

Additionally,
other pharmaceutical companies targeting these same diseases are recruiting clinical trial patients from these patient populations, which
may make it more difficult to fully enroll our clinical trials. We also rely on, and will continue to rely on, CROs and clinical trial
sites to ensure proper and timely conduct of our clinical trials and preclinical studies. Though we have entered into agreements governing
their services, we will have limited influence over their actual performance. Our inability to enroll a sufficient number of patients
for our clinical trials would result in significant delays or may require us to abandon one or more clinical trials altogether. Enrollment
delays in our clinical trials may result in increased development costs for our product candidates and jeopardize our ability to obtain
regulatory approval for the sale of our product candidates. Furthermore, even if we are able to enroll a sufficient number of patients
for our clinical trials, we may have difficulty maintaining enrollment of such patients in our clinical trials.

Interim,
“topline” and preliminary data from our clinical trials and preclinical studies that we announce or publish from time to
time may change as more patient data become available and are subject to audit and verification procedures that could result in material
changes in the final data.

34

From
time to time, we may publicly disclose interim, topline, or preliminary data from our clinical trials and preclinical studies, which
is based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change
following a more comprehensive review