Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 40

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1
Chunk 40
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 our financial condition may decline.

Clinical
and preclinical development involves a lengthy and expensive process with an uncertain outcome. Any difficulties or delays in the commencement
or completion, or the termination or suspension, of our current or planned clinical trials could result in increased costs to us, delay
or limit our ability to generate revenue or adversely affect our commercial prospects.

Before
obtaining approval from regulatory authorities for the commercialization of any of our product candidates, we must conduct extensive
clinical trials to demonstrate the safety, purity, and potency, or efficacy of the product candidate in humans. Preclinical and clinical
drug development is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any
time during the preclinical study or clinical trial process. Despite promising preclinical or clinical results, any product candidate
can unexpectedly fail at any stage of preclinical or clinical development. The historical failure rate for product candidates in our
industry is high.

The
results from preclinical studies or early clinical trials of a product candidate may not predict the results of later clinical trials
of the product candidate, and interim results of a clinical trial are not necessarily indicative of final results. Product candidates
in later stages of clinical trials may fail to show the desired safety and efficacy characteristics despite having progressed through
preclinical studies and initial clinical trials. It is not uncommon to observe results in clinical trials that are unexpected based on
preclinical studies and early clinical trials, and many product candidates fail in clinical trials despite very promising early results.
Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses. A number of companies in the pharmaceutical
and biotechnology industries have suffered significant setbacks in clinical development even after achieving promising results in earlier
studies.

29

Before
we can initiate clinical trials for any product candidates, we must submit the results of preclinical studies to the FDA, the EMA or
comparable foreign regulatory authorities along with other information, including information about product candidate chemistry, manufacturing
and controls and our proposed clinical 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