Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 728

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 5
Chunk 728
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-tumor and anti-viral immune responses will require a multi-targeted package
of immune system activating signals that can be administered safely intravenously. Our patented technology is composed of single strains
of attenuated and killed, non-pathogenic, Gram-negative bacteria, designed to have reduced i.v. toxicity, but largely uncompromised ability
to prime or activate many of the cellular components of innate and adaptive immunity. This approach has led to broad anti-tumor and anti-viral
activity in preclinical models, including durable anti-tumor response synergy observed with each of four different classes of existing
agents, including NSAIDs, checkpoint therapy, targeted antibody therapy and low-dose chemotherapy. Tumor eradication by our technology
has demonstrated activation of both innate and adaptive immunological memory and, importantly, did not require provision of or targeting
a tumor antigen in preclinical models. In 2023, we initiated a Phase 1 clinical trial with our
lead clinical candidate, Decoy20, in patients with advanced solid tumors where currently approved therapies have failed. For further
information regarding our business and operations, see “Part I. Item 1. Business.”

Impact
of Macroeconomic Conditions on our Operations

Economic
developments such as inflation and interest rates have negatively affected the global financial markets and may reduce our ability to
access capital, which could negatively impact our short-term and long-term liquidity. The ultimate impact of current economic conditions
is highly uncertain and subject to change. While it is unknown how long these conditions will last and what the complete financial effect
will be to us, capital raise efforts and additional development of our technologies may be negatively affected. In addition, our business
operations expose us to risks associated with public health crises and epidemics/pandemics.

Components
of Operating Results

Research
and Development Expenses

Research
and development expenses account for a significant portion of our operating expenses. Research and development expenses consist primarily
of fees paid to contract research organizations, or CROs, and contract manufacturing organizations, or CMOs, as well as compensation
expenses for certain employees involved 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