Company: IMNN
Filing Date: 2025-05-12
Form Type: 10-Q
Source: 0001641172-25-009572
Chunk: 119

Company: Imunon, Inc.
Filing Date: 2025-05-12
Form: 10-Q
Item: Part I, Item 8
Chunk 119
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, 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 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 have a disproportionately
positive or negative impact on our results of operations, financial condition, prospects, and market value.

22

Our
current business strategy includes the possibility of entering into collaborative arrangements with third parties to complete the development
and commercialization of our drug candidates. In the event that third parties are contracted to manage the clinical trial process for
one or more of our drug candidates, the estimated completion date would largely be under the control of that third party rather than
us. We cannot forecast with any degree of certainty which proprietary products or indications, if any, will be subject to future collaborative
arrangements, in whole or in part, and how such