Company: IMNN
Filing Date: 2025-11-13
Form Type: 10-Q
Source: 0001493152-25-022120
Chunk: 16

Company: Imunon, Inc.
Filing Date: 2025-11-13
Form: 10-Q
Item: Part I, Item 8
Chunk 16
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 Note Regarding Forward-Looking
Statements,” and in Item 1A. Risk factors in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024.

Overview

Imunon
is a clinical-stage biotechnology company focused on advancing a portfolio of innovative treatments that harness the body’s natural
mechanisms with the aim to generate safe, effective and durable responses across a broad array of human diseases, constituting a differentiating
approach from conventional therapies. Imunon is developing its non-viral DNA technology across its modalities. The first modality, TheraPlas®,
is developed for the coding of proteins and cytokines in the treatment of solid tumors where an immunological approach is deemed promising.
The second modality, PlaCCine®, is developed for the coding of viral antigens that can elicit a strong immunological response. This
technology may represent a promising platform for the development of vaccines in infectious diseases.

The
Company’s lead clinical program, IMNN-001, is a DNA-based immunotherapy for the localized treatment of advanced ovarian cancer
that has completed multiple clinical trials including one Phase II clinical trial (OVATION 2) and is currently conducting a Phase 3
clinical trial (OVATION 3). IMNN-001 works by instructing the body to produce safe and durable levels of powerful cancer-fighting
molecules, such as interleukin-12 and interferon gamma, at the tumor site. Additionally, the Company has entered into a
first-in-human study of its COVID-19 booster vaccine (IMNN-101). We will continue to leverage these modalities and to advance the
technological frontier of plasmid DNA based treatments to better serve patients with difficult-to-treat conditions.

Technology
Platform

Imunon’s
technology platform is optimized for the delivery of DNA and mRNA therapeutics via synthetic non-viral carriers and is capable of providing
cell transfection for double-stranded DNA plasmids and large therapeutic RNA segments such as mRNA. There are two components to the system,
a backbone with plasmid DNA or mRNA payload encoding therapeutic proteins, or pathogen antigens or tumor associated antigens or cancer
neoantigens and a delivery system. The delivery system is designed to protect the DNA or mRNA from degradation and promote trafficking
into cells and through intracellular compartments. We designed the delivery system by chemically modifying the low molecular weight polymer
to improve its gene transfer activity without increasing toxicity