Company: INDP
Filing Date: 2025-08-13
Form Type: 10-Q
Source: 0001641172-25-023333
Chunk: 15

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-08-13
Form: 10-Q
Item: Part I, Item 8
Chunk 15
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 our Annual Report on
Form 10-K for the year ended December 31, 2024 filed with the Securities and Exchange Commission (“SEC”) on March 13, 2025
(the “2024 Annual Report on Form 10-K”). The following discussion contains forward-looking statements that are subject to
risks, uncertainties and assumptions. You should review the sections titled “Summary Risk Factors” and Part II. Item 1A.
Risk Factors in this Quarterly Report for a discussion of important factors that could cause actual results to differ materially from
the results described below. Please also see the “Cautionary Note Regarding Forward-Looking Statements” section in the forepart
of this Quarterly Report.

All
information in this Quarterly Report relating to shares or price per share reflects the 1-for-28 reverse stock split effected by us on
June 26, 2025 which began trading on a post-split basis on the Nasdaq Capital Market on June 27, 2025.

Overview

We
are a clinical biotechnology company developing a novel and patented systemically-administered anti-cancer and anti-viral immunotherapy.
We have evolved from more than a century of immunotherapy advances. Our approach is based on the hypothesis that efficient activation
of both innate and adaptive immune cells and associated anti-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
was associated with induction of both innate and adaptive immunological memory and, importantly, did not require provision of or targeting
a tumor antigen in preclinical models. We have carried out successful current Good Manufacturing Practice (cGMP) manufacturing of our
lead clinical candidate, Decoy20.

In
May 2022, the U.S. Food and Drug Administration, or the FDA, allowed us to proceed under our IND for a Phase 1 clinical trial in participants
with advanced solid