Company: IMNN
Filing Date: 2025-11-13
Form Type: 10-Q
Source: 0001493152-25-022120
Chunk: 35

Company: Imunon, Inc.
Filing Date: 2025-11-13
Form: 10-Q
Item: Part I, Item 8
Chunk 35
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 which showed IMNN-101 induced a persistent 2- to 4-fold increase in serum NAb titers from baseline through Week 4, further increasing
NAb titers between Week 2 and Week 4. The immune response was also observed against the XBB1.5 variant and many newer variants following
treatment, demonstrating the IMNN-101 vaccine’s cross-reactivity. The Phase 1 clinical data of IMNN-101 is consistent with strong
evidence of immunogenicity and protection for the PlaCCine platform in rodents and non-human primates, with prior preclinical results
showing comparable protection efficiency (>95%) to a commercial mRNA vaccine in non-human primates.

On
June 17, 2025, the Company announced that an abstract highlighting Phase 1 proof-of-concept clinical trial results of IMNN-101 was accepted
for oral presentation at the 10th International Conference on Vaccines Research & Development. The meeting is being held
November 5-7, 2025, in Boston, MA.

26

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 current product pipeline. This is intended to allow
us to diversify the risks associated with our research and development expenditures. To the extent we are unable to maintain a broad
range of drug candidates, our dependence on the success of one or a few drug candidates would increase and would have a more significant
impact on our financial prospects, financial condition, and market value. We may also consider and evaluate strategic alternatives, including
investment in, or acquisition of, complementary businesses, technologies, or products. Drug research and development is an inherently
uncertain process and there is a high risk of failure at every stage prior to approval. The timing and the outcome of clinical results
are extremely difficult to predict. The success or failure of any preclinical development and clinical trial can