Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 1351

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1A
Chunk 1351
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 duties, meet expected deadlines, or comply with regulatory requirements, we may not be able to obtain regulatory
approval for or commercialize our product candidates and our business, financial condition and results of operations could be substantially
harmed.

39

We
rely upon third-party CROs, medical institutions, clinical investigators and contract laboratories to monitor and manage data for our
ongoing preclinical and clinical programs. These CROs, investigators and other third parties play a significant role in the conduct and
timing of these trials and subsequent collection and analysis of data. Though we expect to carefully manage our relationships with such
CROs, investigators and other third parties, there can be no assurance that we will not encounter challenges or delays in the future,
or that these delays or challenges will not have a material adverse impact on our business, financial condition and prospects. Further,
while we have and will have agreements governing the activities of our third-party contractors, we have limited influence over their
actual performance. Nevertheless, we maintain responsibility for ensuring that each of our clinical trials and preclinical studies is
conducted in accordance with the applicable protocol, legal, regulatory, and scientific standards and our reliance on these third parties
does not relieve us of our regulatory responsibilities. We and our CROs and other vendors are required to comply with requirements for
cGMP, or similar foreign requirements, GCP, and good laboratory practice (GLP), which are a collection of laws and regulations enforced
by the FDA, the EMA and comparable foreign authorities for all of our product candidates in clinical development. Regulatory authorities
enforce these regulations through periodic inspections of preclinical study and clinical trial sponsors, principal investigators, preclinical
study and clinical trial sites, and other contractors. If we or any of our CROs or vendors fail to comply with applicable regulations,
the data generated in our preclinical studies and clinical trials may be deemed unreliable, and the FDA, the EMA or comparable foreign
authorities may require us to perform additional preclinical studies and clinical trials before approving our marketing applications.
We cannot assure you that upon inspection by a given regulatory authority, such regulatory authority will determine that any of our clinical
trials comply with GCP regulations. In addition, our clinical trials must be conducted with products produced consistent with cGMP regulations,
or similar foreign requirements. Our failure to comply with these regulations may require it to repeat clinical trials, which would delay
the development and regulatory approval processes.

We
may not be able to enter