Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 1362

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1A
Chunk 1362
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 increase our costs and limit the supply of our product
candidates.

The
process of manufacturing our product candidates is complex, highly regulated, and subject to several risks. For example, the process
of manufacturing our product candidates is extremely susceptible to product loss due to contamination, equipment failure or improper
installation or operation of equipment, or vendor or operator error. Even minor deviations from normal manufacturing processes for any
of our product candidates could result in reduced production yields, product defects, and other supply disruptions. If microbial, viral,
or other contaminations are discovered in our product candidates or in the manufacturing facilities in which our product candidates are
made, such manufacturing facilities may need to be closed for an extended period of time to investigate and remedy the contamination.
In addition, the manufacturing facilities in which our product candidates are made could be adversely affected by equipment failures,
labor shortages, natural disasters, power failures and numerous other factors.

In
addition, any adverse developments affecting manufacturing operations for our product candidates may result in shipment delays, inventory
shortages, lot failures, withdrawals or recalls, or other interruptions in the supply of our product candidates. We also may need to
take inventory write-offs and incur other charges and expenses for product candidates that fail to meet specifications, undertake costly
remediation efforts, or seek costlier manufacturing alternatives.

Risks
Related to Competition, Retaining Key Employees and Managing Growth

If
our competitors have product candidates that are approved faster, marketed more effectively, are better tolerated, have a more favorable
safety profile or are demonstrated to be more effective than our product candidates, our commercial opportunity may be adversely affected.

The
industry in which we operate is characterized by rapidly advancing technologies, intense competition and a strong emphasis on proprietary
products. While we believe that our technology, knowledge, experience and scientific resources provide it with competitive advantages,
we face potential competition from many different sources, including commercial biotechnology enterprises, academic institutions, government
agencies and private and public research institutions. Any product candidates that we successfully develop and commercialize will compete
with existing immunotherapies and new immunotherapies that may become available in the future.

Many
of our competitors have significantly greater financial resources and expertise in research and development, manufacturing, preclinical
studies, clinical trials, regulatory approvals and marketing approved products than we do. Smaller or early-stage companies may also
prove to be significant competitors, particularly through collaborative arrangements with large and established companies. Our competitors
may succeed in developing technologies and therapies that