Company: INDP
Filing Date: 2025-11-12
Form Type: 10-Q
Source: 0001493152-25-021759
Chunk: 55

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-11-12
Form: 10-Q
Item: Part I, Item 8
Chunk 55
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 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 tumors where currently approved therapies have failed. In December 2022, we initiated an open label, multi-center,
dose escalation and expansion, single arm (monotherapy) Phase 1 study conducted in 2 parts. The Phase 1 study began with single dose
administration and has now been followed with continuous weekly dosing of Decoy20 in tumor-specific expansion cohorts. The study is enrolling
participants with any one of six advanced/metastatic solid tumors, who have