Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 41

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1
Chunk 41
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. Any such delays in the commencement or completion of our ongoing and planned clinical trials for our
product candidates could significantly affect our product development timelines and product development costs and harm our financial
position.

We
do not know whether our planned clinical trials will begin on time or be completed on schedule, if at all. The commencement, data readouts
and completion of clinical trials can be delayed for a number of reasons, including delays related to:

    ●
    inability
    to generate sufficient preclinical, toxicology, or other in vivo or in vitro data to support the initiation or continuation of clinical
    trials;

    ●
    failure
    in obtaining allowance or approval from regulatory authorities to commence a trial or reaching a consensus with regulatory authorities
    on trial design;

    ●
    the
    FDA, the EMA or comparable foreign regulatory authorities disagreeing as to the design or implementation of our clinical trials;

    ●
    any
    failure or delay in reaching an agreement with CROs and clinical trial sites, the terms of which can be subject to extensive negotiation
    and may vary significantly among different CROs and trial sites;

    ●
    delays
    in identifying, recruiting and training suitable clinical investigators;

    ●
    failure
    in obtaining approval from one or more institutional review boards (IRBs) or ethics committees at clinical trial sites;

    ●
    IRBs
    refusing to approve, suspending or terminating the trial at an investigational site, precluding enrollment of additional subjects,
    or withdrawing their approval of the trial;

    ●
    changes
    or amendments to the clinical trial protocol;

    ●
    clinical
    sites deviating from the trial protocol or dropping out of a trial;

    ●
    failure
    by our CROs to perform in accordance with Good Clinical Practice (GCP) requirements or applicable regulatory rules and guidelines
    in other countries;

    ●
    failure
    in manufacturing sufficient quantities of our product candidates, or obtaining sufficient quantities of combination therapies, for
    use in clinical trials;

    ●
    subjects
    failing to enroll or remain in our trials at the rate we expect, or failing to return for post-treatment follow-up, including subjects
    failing to remain in our trials;

    ●
    patients
    choosing an alternative product for the indications for which we are developing our product candidates, or participating in competing
    clinical trials;

    ●
    lack
    of adequate funding to