Company: INDP
Filing Date: 2025-05-14
Form Type: 10-Q
Source: 0001641172-25-010099
Chunk: 59

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-05-14
Form: 10-Q
Item: Part I, Item 2
Chunk 59
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 in the planning, managing, and analyzing the work of the CROs and CMOs and materials used for
research and development activities. We expense research and development costs as incurred.

We
accrue expenses for manufacturing, preclinical studies and clinical trial activities performed by third parties based on estimates of
services received and efforts expended pursuant to agreements with CROs, CMOs, and other outside service providers. We determine these
estimates based on contracted amounts applied to the proportion of work performed and determined through analysis with internal personnel
and external service providers as to the progress or stage of completion of the services. In the event advance payments are made to a
CRO, CMO, or outside service provider, we record the payments as a prepaid asset, which will be amortized or expensed as the contracted
services are performed. However, actual costs and timing of these activities are highly uncertain, subject to risks and may change depending
upon a number of factors, including our clinical development plan.

2

We
expect our research and development expenses to increase substantially for the foreseeable future as we continue to ramp up our clinical
development activities and incur expenses associated with hiring additional personnel to support our research and development efforts.
Our expenditures on future nonclinical and clinical development programs are subject to numerous uncertainties in timing and cost to
completion. The duration, costs and timing of preclinical studies and clinical trials and development of product candidates will depend
on a variety of factors, including:

    ●
    the
    timing and receipt of regulatory approvals;

    ●
    the
    scope, rate of progress and expenses of preclinical studies and clinical trials and other research and development activities;

    ●
    potential
    safety monitoring and other studies requested by regulatory agencies; and

    ●
    significant
    and changing government regulation.

The
process of conducting the necessary clinical research to obtain FDA and other regulatory approval is costly and time consuming and the
successful development of product candidates is highly uncertain. As a result of these risks and uncertainties, we are unable to determine
with any degree of certainty the duration and completion costs of our research and development projects, or if, when, or to what extent
we will generate revenues from the commercialization and sale of any of our product candidates that obtain regulatory approval. We may
never succeed in achieving regulatory approval for any of our product candidates.

General
and Administrative Expenses

General
and administrative expenses include compensation, employee benefits, and stock-based