---
schema_version: "secwatch.filing_event.v1"
accession: "0001641172-25-000207"
form_type: "8-K"
ticker: "IMNN"
cik: "0000749647"
company_name: "Imunon, Inc."
filed_at: "2025-03-24T23:59:59+00:00"
generated_at: "2026-05-24T07:31:19.919616+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# IMUNON finalizes Phase 3 OVATION 3 trial design with FDA for IMNN-001 in advanced ovarian cancer

## Summary
- FDA aligns on Phase 3 protocol for IMNN-001 plus NACT vs NACT alone in newly diagnosed advanced ovarian cancer (stage 3/4).
- Primary endpoint is overall survival; secondary endpoints include surgical response, clinical response, time to second-line treatment.
- Phase 2 data showed median OS of 46 months for IMNN-001+NACT vs 33 months for SoC, a 13-month improvement.
- Company initiating trial sites; IMNN-001 manufactured at in-house facility in Huntsville, AL.
- Conference call on March 25, 2025 at 2:00 p.m. ET to discuss Phase 3 OVATION 3 trial.

## SEC filing metadata
- accession: 0001641172-25-000207
- form_type: 8-K
- ticker: IMNN
- cik: 0000749647
- company_name: Imunon, Inc.
- filed_at: 2025-03-24T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/749647/000164117225000207/0001641172-25-000207-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/749647/000164117225000207/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001641172-25-000207
- JSON: https://secwatch.observer/filing/0001641172-25-000207.json
- Plain text: https://secwatch.observer/filing/0001641172-25-000207.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.