Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 1333

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1A
Chunk 1333
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 restricting our ability to take
specific actions such as incurring debt, making capital expenditures or declaring dividends. If we raise additional funds through collaborations,
strategic alliances and licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future
revenue streams or product candidates, or grant licenses on terms that are not favorable to us.

28

Risks
Related to the Discovery and Development of Our Product Candidates

We
are dependent on the success of one or more of our current product candidates, and we cannot be certain that any of them will receive
regulatory approval or be commercialized.

We
have spent significant time, money and effort on the development of our lead product candidate, Decoy20. As a result, our business is
largely dependent on the commencement of and success of clinical trials evaluating Decoy20 and our ability to complete the development
of, obtain regulatory approval for, and successfully commercialize Decoy20 in a timely manner. The process to develop, obtain regulatory
approval and commercialize Decoy20 is long, complex, costly and uncertain as to the outcome.

To
date, no clinical trials designed to provide substantial evidence of safety, purity, potency or efficacy have been completed with any
of our product candidates. All of our product candidates will require additional development, including clinical trials as well as further
preclinical studies to evaluate their toxicology and optimize their formulation and regulatory approvals before they can be commercialized.
Positive results obtained during early development do not necessarily mean later development will succeed or that regulatory approvals
will be obtained. Our development efforts may not lead to commercial products, either because our product candidates fail to be safe
and effective, or in the case of our product candidates regulated as biologics, safe, pure and potent, or because we have inadequate
financial or other resources to advance our product candidates through the clinical development and approval processes. If any of our
product candidates fail to demonstrate safety, purity, potency or efficacy at any time or during any phase of development, we would experience
potentially significant delays in, or be required to abandon, development of the product candidate.

We
do not anticipate that any of our current product candidates will be eligible to receive regulatory approval from the FDA, the EMA or
comparable foreign authorities and begin commercialization for a number of years, if ever. Even if we ultimately receive regulatory approval
for any of these product candidates, we or our potential future partners, if any, may be unable to commercialize