Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 1352

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1A
Chunk 1352
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 into arrangements with CROs on commercially reasonable terms, or at all. In addition, our CROs will not be our
employees, and except for remedies available to us under our agreements with such CROs, we will not be able to control whether or not
they devote sufficient time and resources to our ongoing preclinical and clinical programs. If CROs do not successfully carry out their
contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the data they
obtain is compromised due to the failure to adhere to our protocols, regulatory requirements, or for other reasons, our clinical trials
may be extended, delayed or terminated, and we may not be able to obtain regulatory approval for or successfully commercialize our product
candidates. CROs may also generate higher costs than anticipated. As a result, our business, financial condition and results of operations
and the commercial prospects for our product candidates could be materially and adversely affected, our costs could increase, and our
ability to generate revenue could be delayed.

In
addition, principal investigators for our clinical trials may be asked to serve as scientific advisors or consultants to us from time
to time and may receive cash or equity compensation in connection with such services. If these relationships and any related compensation
result in perceived or actual conflicts of interest, or the FDA concludes that the financial relationship may have affected the interpretation
of the study, the integrity of the data generated at the applicable clinical trial site may be questioned and the utility of the clinical
trial itself may be jeopardized, which could result in the delay or rejection by the FDA of any BLA or NDA we submit. Any such delay
or rejection could prevent us from commercializing our product candidates.

In
addition, our CROs have the right to terminate their agreements with us in the event of an uncured material breach and under other specified
circumstances. If any of our relationships with these third parties terminate, we may not be able to enter into arrangements with alternative
third parties on commercially reasonable terms or at all. Switching or adding additional CROs, medical institutions, clinical investigators
or contract laboratories involves additional cost and requires management time and focus. In addition, there is a natural transition
period when a new CRO commences work replacing a previous CRO. As a result, delays occur, which can materially impact our ability to
meet our desired clinical development timelines. There can be no assurance that we will