Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 62

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1
Chunk 62
---
 demand for our product candidates. To the extent that we enter into arrangements
with collaborators or other third parties to perform sales and marketing services, our product revenues are likely to be lower than if
we marketed and sold our product candidates independently. If we are unable to establish adequate sales and marketing capabilities, independently
or with others, we may not be able to generate significant revenues and may not become profitable.

42

Risks
Related to Commercialization

The
successful commercialization of Decoy20 or any future product candidates, if approved, will depend in part on the extent to which governmental
authorities and health insurers establish coverage, adequate reimbursement levels and favorable pricing policies. Failure to obtain or
maintain coverage and adequate reimbursement for our products could limit our ability to market those products and decrease our ability
to generate revenue.

The
availability of coverage and the adequacy of reimbursement by governmental healthcare programs such as Medicare and Medicaid, private
health insurers and other third-party payors are essential for most patients to be able to afford prescription medications such as Decoy20
and any future product candidates, if approved. Our ability to achieve coverage and acceptable levels of reimbursement for our products
by third-party payors will have an effect on our ability to successfully commercialize those products. Accordingly, we will need to successfully
implement a coverage and reimbursement strategy for any approved product candidate. Even if we obtain coverage for a given product by
a third-party payor, the resulting reimbursement payment rates may not be adequate or may require co-payments that patients find unacceptably
high.

If
we participate in the Medicaid Drug Rebate Program or other governmental pricing programs, in certain circumstances, our products would
be subject to ceiling prices set by such programs, which could reduce the revenue we may generate from any such products. Participation
in such programs would also expose us to the risk of significant civil monetary penalties, sanctions and fines should we be found to
be in violation of any applicable obligations thereunder.

For
products administered under the supervision of a physician, obtaining coverage and adequate reimbursement may be particularly difficult
because of the higher prices often associated with such drugs. Additionally, separate reimbursement for the product itself or the treatment
or procedure in which the product is used may not be available, which may impact physician utilization. We cannot be sure that coverage
and reimbursement in the United States, the European Union or elsewhere will be available, or at an acceptable level, for any product
that we may develop, and any reimbursement that may become available