Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 46

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1
Chunk 46
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 unrelated to our product candidate, but may still
impact the success of our clinical trials. The inclusion of critically ill patients in our clinical trials may result in deaths or other
adverse medical events due to other therapies or medications that such patients may be using or due to the gravity of such patients’
illnesses. If such significant adverse events or other side effects are observed in any of our current or future clinical trials, we
may have difficulty recruiting patients to the clinical trials, or we may be required to abandon the trials or our development efforts
of that product candidate altogether. We, the FDA, other comparable regulatory authorities or an IRB may suspend clinical trials of a
product candidate at any time for various reasons, including a belief that subjects in such trials are being exposed to unacceptable
health risks or adverse side effects. Even if the side effects do not preclude the product candidate from obtaining or maintaining regulatory
approval, undesirable side effects may inhibit market acceptance due to tolerability concerns as compared to other available therapies.
Any of these developments could materially harm our business, financial condition and prospects.

Additionally,
if any of our product candidates receives regulatory approval, and we or others later identify undesirable side effects caused by such
product, a number of potentially significant negative consequences could result. For example, the FDA could require us to adopt a Risk
Evaluation and Mitigation Strategy (REMS), to ensure that the benefits of treatment with such product candidate outweigh the risks for
each potential patient, which may include, among other things, a communication plan to health care practitioners, patient education,
extensive patient monitoring or distribution systems and processes that are highly controlled, restrictive and more costly than what
is typical for the industry. We or our collaborators may also be required to adopt a REMS or engage in similar actions, such as patient
education, certification of health care professionals or specific monitoring, if we or others later identify undesirable side effects
caused by any product that we develop alone or with collaborators. Other potentially significant negative consequences associated with
adverse events include:

    ●
    we
    may be required to suspend marketing of a product, or we may decide to remove such product from the marketplace;

    ●
    regulatory
    authorities may withdraw or change their approvals of a product;

    ●
    regulatory
    authorities may require additional warnings on the label or limit access of a product to selective specialized centers with additional
    safety reporting and with requirements that patients be geographically close to these centers for all or part of