Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 44

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1
Chunk 44
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 31, 2025. After this date, all clinical trials (including those which are ongoing)
will become subject to the provisions of the CTR. Compliance with the CTR requirements by us and our third-party service providers, such
as CROs, may impact our developments plans. If we are slow or unable to adapt to changes in existing requirements or the adoption of
new requirements or policies governing clinical trials, our development plans may be impacted.

31

In
addition, many of the factors that cause, or lead to, the termination or suspension of, or a delay in the commencement or completion
of, clinical trials may also ultimately lead to the denial of regulatory approval of a product candidate. Any resulting delays to our
clinical trials could shorten any period during which we may have the exclusive right to commercialize our product candidates. In such
cases, our competitors may be able to bring products to market before we do, and the commercial viability of our product candidates could
be significantly reduced. Any of these occurrences may harm our business, financial condition and prospects.

We
expect to continue to incur significant research and development expenses and other operating expenses, which may make it difficult for
us to attain profitability.

We
expect to expend substantial funds in research and development, including preclinical studies and clinical trials of our product candidates,
and to manufacture and market any product candidates in the event they are approved for commercial sale. We also may need additional
funding to develop or acquire complementary companies, technologies and assets, as well as for working capital requirements and other
operating and general corporate purposes. Moreover, our planned increases in staffing will dramatically increase our costs in the near
and long-term.

Because
the successful development of our product candidates is uncertain, we are unable to precisely estimate the actual funds we will require
to develop and potentially commercialize them. In addition, we may not be able to generate sufficient revenue, even if we are able to
commercialize any of our product candidates, to become profitable.

We
may expend our limited resources to pursue a limited number of research programs, product candidates and specific indications and fail
to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.

Due
to our limited financial and managerial resources, we must focus on a limited number of research programs and product candidates and
on specific indications. As such, we are currently focused on the development of Decoy20. As a result, we may forego or delay