Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 14

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1
Chunk 14
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    ●
    expanding our bacterial
    product platform to target additional types of cancer, as well as additional infectious diseases;

14

    ●
    maintaining, expanding
    and protecting our intellectual property portfolio; and

    ●
    seeking regulatory approvals
    for any product candidates that successfully complete clinical trials.

Competitive
Advantages

Our
bacteria contain multiple constituents, capable of priming or activating many of the cellular components of both innate and adaptive
immunity, but have been attenuated by a patented process to reduce the potential for over-stimulation of the immune system and consequential
induction of undesirable autoimmune reactions. Our bacteria are also likely to be cleared very quickly by the liver and spleen, which
may further reduce the risk of non-specific autoimmune side effects, relative to other types of immunotherapy that are designed for continuous
exposure. We believe a short exposure of our products is sufficient to act alone and as a “primer” to enhance other products.
Additionally, our products can be manufactured by a highly cost-efficient process, potentially providing accelerated patient access in
both developed and developing geographical regions.

Governmental
Regulation

Among
others, the FDA and comparable regulatory authorities in state and local jurisdictions and in other countries impose substantial and
burdensome requirements upon companies involved in the clinical development, manufacture, marketing and distribution of drugs such as
those we are developing. These agencies and other federal, state and local entities regulate, among other things, the research and development,
testing, manufacture, quality control, safety, effectiveness, labeling, storage, record keeping, approval, advertising and promotion,
distribution, post-approval monitoring and reporting, sampling and export and import of our product candidates.

U.S.
Regulation of Drugs and Biologics

In
the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act (FDCA) and its implementing regulations, and
biologics under the FDCA and the Public Health Service Act (PHSA) and its implementing regulations. FDA approval is required before any
new unapproved drug or dosage form, including a new use of a previously approved drug, can be marketed in the United States. Drugs and
biologics are also subject to other federal, state, and local statutes and regulations. The process required by the FDA before product
candidates may be marketed in the United States generally involves the following:

    ●
    completion of extensive
    preclinical laboratory tests, animal studies and formulation studies,