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

Company: Imunon, Inc.
Filing Date: 2025-11-13
Form: 10-Q
Item: Part I, Item 8
Chunk 25
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 13.0% in the control arm. Surgical response rate of no macroscopic residual tumor
left after surgery 64.6% in the IMNN-001 treatment arm compared to 52.1% in the control arm. Hazard ratio of 0.78 in study participants
who are homologous recombination proficient (HRP) and hazard ratio of 0.42 in women positive for homologous recombination deficiency
(HRD+), including BRCA1 or BRCA2 mutations, suggesting increased therapeutic activity. IMNN-001 was generally safe and well tolerated,
with no reports of cytokine release syndrome, systemic toxicity or serious immune-related adverse events.

21

On
June 18, 2025, the Company announced the presentation of new positive translational data from the Phase 2 OVATION 2 Study of IMNN-001
at the ESMO Gynecological Cancers Congress 2025, that took place on June 19-21, 2025, in Vienna, Austria. Results presented at the ESMO
Congress showed that treatment with IMNN-001 induced substantial increases in IL-12 and interferon-gamma (IFN-γ) and tumor necrosis
factor-alpha (TNF-α), key downstream anti-cancer immune cytokines. Increases in IL-12, IFN-γ and TNF-α levels in the
peritoneal cavity were approximately 27-, 62- and 36-fold following treatment, respectively, demonstrating the tumor-localized effect
of IMNN-001 in women with advanced ovarian cancer. IMNN-001 continues to show a favorable safety profile.

OVATION
3 Study. On September 11, 2024, a scientific advisory board was held with DSMB members, principal investigators, and scientific
experts to discuss and seek input on the protocol synopsis for the Phase III trial. A protocol synopsis was submitted along with a briefing
document for review and input at the End-of-Phase II (“EOP2”) meeting with the U.S. Food and Drug Administration focused
on the Phase III study. The EOP2 meeting was conducted in the fourth quarter of 2024.

    ●
    The
    positive outcome of the EOP2 in-person meeting with the U.S. Food and Drug Administration (FDA),
    supported the advancement of IMNN-001 for the treatment of advanced ovarian cancer into a Phase 3 pivotal study. The interaction
    with the FDA included an extensive