Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 1334

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1A
Chunk 1334
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 them successfully for
a variety of reasons. These include, for example, the availability of alternative treatments, lack of cost-effectiveness, the cost of
manufacturing the product on a commercial scale and competition with other products. The success of our product candidates may also be
limited by the prevalence and severity of any adverse side effects. If we fail to commercialize one or more of our current product candidates,
we may be unable to generate sufficient revenues to attain or maintain profitability, and 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