Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 45

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1
Chunk 45
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 pursuit
of opportunities with other product candidates or for other indications for anti-cancer and anti-viral immunotherapy that later prove
to have greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products
or profitable market opportunities. Our spending on current and future research and development programs and product candidates for specific
indications may not yield any commercially viable products.

Our
product candidates may cause undesirable side effects that could delay or prevent their regulatory approval or commercialization, cause
us to suspend or discontinue clinical trials, abandon a product candidate, limit the commercial profile of an approved product, or result
in other significant adverse implications on our business, financial condition and results of operations.

As
is the case with pharmaceuticals generally, it is likely that there may be side effects and adverse events associated with our product
candidates’ use. Results of our clinical trials could reveal a high and unacceptable severity and prevalence of side effects or
unexpected characteristics. For example, because the mechanism of action of our product candidates depends on stimulation of the immune
system, there is the potential for over-stimulation or undesirable immune reactions. Undesirable side effects caused by our product candidates,
whether used alone or in combination with other therapies, could cause us or regulatory authorities to interrupt, delay or halt clinical
trials or the delay or denial of regulatory approval by the FDA, the EMA or comparable foreign regulatory authorities, or, if such product
candidates are approved, result in a more restrictive label and other post-approval requirements. Any treatment-related side effects
could also affect patient recruitment or the ability of enrolled patients to complete the trial or could result in potential product
liability claims. Any of these occurrences may harm our business, financial condition and prospects significantly.

32

If
our product candidates are associated with undesirable side effects or have unexpected characteristics in preclinical studies or clinical
trial, when used alone or in combination with other approved products or product candidates, we may need to interrupt, delay or abandon
their development or limit development to more narrow uses or subpopulations in which the undesirable side effects or other characteristics
are less prevalent, less severe or more acceptable from a risk-benefit perspective.

Patients
in our ongoing and planned clinical trials may, in the future, suffer significant adverse events or other side effects not observed in
our preclinical studies or previous clinical trials. Patients treated with our product candidates may also be undergoing surgical, radiation
or chemotherapy treatments, which can cause side effects or adverse events that are