Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 1335

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1A
Chunk 1335
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 trial protocol, as part of an IND or similar regulatory submission. The FDA, the EMA or comparable
foreign regulatory authorities may require us to conduct additional preclinical studies for any product candidate before it allows us
to initiate clinical trials under any IND or similar regulatory submission, which may lead to delays and increase the costs of our preclinical
development programs. Moreover, even if we commence clinical trials, issues may arise that could cause regulatory authorities to suspend
or terminate such clinical trials. 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