Company: IMNN
Filing Date: 2025-05-12
Form Type: 10-Q
Source: 0001641172-25-009572
Chunk: 109

Company: Imunon, Inc.
Filing Date: 2025-05-12
Form: 10-Q
Item: Part I, Item 8
Chunk 109
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7 months and 23.7 months, respectively.

    ●
    The
    median OS in the PARPi + NACT group was 45.6 months and has not yet been reached in the PARPi + NACT + IMNN-001 group.

Imunon
also continues to see benefits in other secondary endpoints including an approximately 20% higher R0 tumor resection score and a doubling
of the CRS 3 chemotherapy response score to approximately 30% in the treatment arm versus 14% in the control arm. Chemotherapy response
score is considered a good prognostic indicator in ovarian cancer. The DSMB determined that safety analyses continue to show good tolerability
of IMNN-001 in this setting.

In
June 2024, the Company announced database lock for the OVATION 2 Study. At that time, median OS and PFS had been reached, and all patients
in the open-label study had achieved treatment observation duration of 16 months, as required by protocol to evaluate efficacy. On July
11, 2024, a scientific advisory board with DSMB members, principal investigators, 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