Company: IMNN
Filing Date: 2025-11-13
Form Type: 10-Q
Source: 0001493152-25-022120
Chunk: 23

Company: Imunon, Inc.
Filing Date: 2025-11-13
Form: 10-Q
Item: Part I, Item 8
Chunk 23
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 and scientific experts was held to review efficacy
and safety data from the OVATION 2 study.

On
July 30, 2024, the Company announced positive topline results from the Phase II OVATION 2 Study. Highlights from patients treated with
IMNN-001 plus standard-of-care in a first-line treatment setting include:

    ●
    An
    11.1 month increase in median OS compared with standard-of-care alone in the ITT population.

    ●
    A
    hazard ratio in the ITT population of 0.74, which indicates a 35% improvement in survival.

    ●
    Among
    the approximately 90% of trial participants who received at least 20% of specified treatments per-protocol in both study arms, patients
    in the IMNN-001 arm had a 15.7 month increase in median OS, representing a further extension of life with a hazard ratio of 0.64,
    a 56% improvement in survival.

    ●
    For
    nearly 40% of trial participants treated with a PARP inhibitor, the hazard ratio decreased further to 0.41, with median OS in the
    IMNN-001 treatment arm not yet reached at the time of database lock, compared with median OS of 37.1 months in the standard-of-care
    treatment arm.

The
PFS results, the trial’s primary endpoint, support the OS results with:

    ●
    A
    three-month improvement in PFS compared with standard-of-care alone. All patients treated with IMNN-001 remained progression free
    during the treatment period, while patients in the Standard of Care treatment arm progressed.

    ●
    A
    hazard ratio in the intent-to-treat population of 0.79, indicating a 27% improvement in delaying progression for the IMNN-001 treatment
    arm.

These
initial results from the OVATION 2 Study were presented in a late-breaking session at the Society
for Immunotherapy of Cancer (SITC) 39th Annual Meeting in November 2024.

In
December 2024, the Company announced additional clinical data from ongoing analyses of results from the Phase 2 OVATION 2 Study. The
updated results (including a post announcement, immaterial statistical correction), based on an additional seven months of patient monitoring, showed the hazard ratio (HR) decreased from 0.74 to
0.70 in the ITT population,