Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 1361

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1A
Chunk 1361
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 in the future may result in additional reductions
in Medicare and other healthcare funding, more rigorous coverage criteria, new payment methodologies and additional downward pressure
on the price that we receive for any approved product. Any reduction in reimbursement from Medicare or other government programs may
result in a similar reduction in payments from private payors. The implementation of cost containment measures or other healthcare reforms
may prevent us from being able to generate revenue, attain profitability or commercialize Decoy20 and any future product candidates,
if approved.

Product
liability lawsuits against us could cause us to incur substantial liabilities and could limit commercialization of any product candidates
that we may develop.

We
will face an inherent risk of product liability exposure related to the testing of our product candidates in human clinical trials and
will face an even greater risk if we commercially sell any product candidates that we may develop. If we cannot successfully defend ourselves
against claims that our product candidates caused injuries, we could incur substantial liabilities. Regardless of merit or eventual outcome,
liability claims may result in:

    ●
    decreased
    demand for any product candidates that we may develop;

    ●
    injury
    to our reputation and significant negative media attention;

    ●
    regulatory
    investigations that could require costly recalls or product modifications;

    ●
    withdrawal
    of clinical trial participants;

    ●
    significant
    costs to defend the related litigation;

    ●
    substantial
    monetary awards to trial participants or patients;

    ●
    loss
    of potential revenue;

    ●
    the
    diversion of management’s attention away from managing our business; and

    ●
    the
    inability to commercialize any product candidates that we may develop.

45

Although
we maintain product liability insurance coverage, it may not be adequate to cover all liabilities that we may incur and is subject to
deductibles and coverage limitations. We anticipate that we will need to increase our insurance coverage when and if we successfully
commercialize any product candidate. Insurance coverage is increasingly expensive. We may not be able to maintain insurance coverage
at a reasonable cost or in an amount adequate to satisfy any liability that may arise. If we are unable to obtain insurance at acceptable
cost or otherwise protect against potential product liability claims, we will be exposed to significant liabilities, which may materially
and adversely affect our business and financial position. These liabilities could prevent or interfere with our commercialization efforts.

We
are subject to a multitude of manufacturing risks, any of which could substantially