Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 42

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1
Chunk 42
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 continue a clinical trial, or costs being greater than we anticipate;

    ●
    subjects
    experiencing severe or serious unexpected drug-related adverse effects;

    ●
    occurrence
    of serious adverse events in trials of the same class of agents conducted by other companies that could be considered similar to
    our product candidates;

    ●
    selection
    of clinical endpoints that require prolonged periods of clinical observation or extended analysis of the resulting data;

    ●
    transfer
    of manufacturing processes to larger-scale facilities operated by a contract manufacturing organization (CMO), delays or failure
    by our CMOs or us to make any necessary changes to such manufacturing process, or failure of our CMOs to produce clinical trial materials
    in accordance with current Good Manufacturing Practice (cGMP), regulations or other applicable requirements; and

    ●
    third
    parties being unwilling or unable to satisfy their contractual obligations to us in a timely manner.

30

Clinical
trials must be conducted in accordance with the FDA and other applicable regulatory authorities’ legal requirements, regulations
and guidelines, and remain subject to oversight by these governmental agencies and ethics committees or IRBs at the medical institutions
where such clinical trials are conducted. We could also encounter delays if a clinical trial is suspended or terminated by us, by the
IRBs of the institutions in which such trials are being conducted, by a Data Safety Monitoring Board for such trial or by the FDA, the
EMA or comparable foreign regulatory authorities. Such authorities may impose such a suspension or termination due to a number of factors,
including failure to conduct the clinical trial in accordance with regulatory requirements or applicable clinical trial protocols, adverse
findings from inspections of clinical trial sites by the FDA, the EMA or comparable foreign regulatory authorities, unforeseen safety
issues or adverse side effects, failure to demonstrate a benefit from using a product candidate, changes in governmental regulations
or administrative actions or lack of adequate funding to continue the clinical trial. In addition, changes in regulatory requirements
and policies may occur, and we may need to amend clinical trial protocols to comply with these changes. Amendments may require us to
resubmit our clinical trial protocols to regulators or to IRBs for reexamination, which may impact the costs, timing or successful completion
of a clinical trial.

Moreover,
principal investigators for our clinical trials may serve as scientific advisors or consultants to us from time to time and receive compensation
in connection with such services. Under certain circumstances, we may be required to report some of