Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 1344

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1A
Chunk 1344
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 assets. However, the process of researching and developing new product candidates is expensive,
time-consuming and unpredictable. Data from our current preclinical programs may not support the clinical development of our product
candidates, and we may not identify any additional products suitable for recommendation for clinical development. Moreover, any product
candidate we recommend for clinical development may not demonstrate, through preclinical studies, indications of safety and potential
efficacy that would support advancement into clinical trials. Such findings would potentially impede our ability to maintain or expand
our clinical development pipeline. Our ability to develop new product candidates and advance them into clinical development also depends
upon our ability to fund our research and development operations, and we cannot be certain that additional funding will be available
on acceptable terms, or at all.

The
regulatory approval processes of the FDA, the EMA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable,
and if we are ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmed.

The
clinical development, manufacturing, labeling, storage, record-keeping, advertising, promotion, import, export, marketing and distribution
of our product candidates are subject to extensive regulation by the FDA in the U.S. and by comparable foreign regulatory authorities
in foreign markets, such as the EMA in Europe. In the U.S., we are not permitted to market our product candidates in the U.S. until we
receive regulatory approval of a Biologics License Application (BLA) or New Drug Application (NDA) from the FDA. The process of obtaining
such regulatory approval is expensive, often takes many years following the commencement of clinical trials and can vary substantially
based upon the type, complexity and novelty of the product candidates involved, as well as the target indications and patient population.
Approval policies or regulations may change, and the FDA, EMA and comparable regulatory authorities have substantial discretion in the
approval process, including the ability to delay, limit or deny approval of a product candidate for many reasons. Despite the time and
expense invested in clinical development of product candidates, regulatory approval of a product candidate is never guaranteed. Of the
large number of drugs in development, only a small percentage successfully complete the FDA, EMA or comparable regulatory approval processes
and are commercialized.

35

Prior
to obtaining approval to commercialize a product candidate in the U.S. or abroad, we must demonstrate with substantial evidence from
adequate and well-controlled clinical trials, and to the satisfaction of the FDA, E