Company: IMNN
Filing Date: 2025-05-12
Form Type: 10-Q
Source: 0001641172-25-009572
Chunk: 60

Company: Imunon, Inc.
Filing Date: 2025-05-12
Form: 10-Q
Item: Part I, Item 2
Chunk 60
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 24 subjects to evaluate three escalating
doses of IMNN-101. For this study, IMMN-101 has been designed to protect against the SARS-CoV-2 Omicron XBB1.5 variant, in accordance
with the FDA’s Vaccines and Related Biological Products Advisory Committee’s June 2023 announcement of the framework for
updated COVID-19 doses.

In
February 2025, the Company announced topline safety and immunogenicity data from ongoing analyses of results from the Company’s
Phase 1 proof-of-concept clinical trial of IMNN-101. The Phase 1 study was conducted in 24 healthy volunteers as a seasonal COVID-19
vaccine, targeting the SARS-CoV-2 Omicron XBB1.5 spike antigen. IMNN-101 was administered as a single dose vaccine without a booster
dose in study participants who were previously vaccinated against the Omicron XBB1.5 variant. Results demonstrated that IMNN-101 is safe
and well-tolerated with no serious adverse effects. IMNN-101 induced a persistent 2- to 4-fold increase in serum neutralizing antibody
(NAb) titers from baseline through Week 4, further increasing NAb titers between Week 2 and Week 4. The immune response was observed
against the XBB1.5 variant and many newer variants following treatment, demonstrating the IMNN-101 vaccine’s cross-reactivity.

The
participants in the Phase 1 trial had high baseline immune characteristics presumably from prior infection and multiple previous vaccinations
against COVID-19 and ongoing infection as evidenced by the rise in viral nucleocapsid antigen during the study period. Modest increases
in T cell responses were observed in this setting of trial participants having received multiple immunizations prior to the study.

The
Phase I trial was designed to establish PoC for IMNN-101 as an advancement in vaccine technology. Imunon intends to seek partnership
and/or business development opportunities to develop the scientific and business case for IMNN-101 as a future vaccine to address viral
mutations.

Business
Plan and Going Concern Risk

We
have not generated and do not expect to generate any revenue from product sales in the next several years, if at all. An element of our
business strategy has been to pursue, as resources permit, the research and development of a range of drug candidates for a variety of
indications. We may also evaluate licensing products from third parties to expand our