IMUNON 2025, A TRANSFORMATIVE YEAR OF SIGNIFICANT CLINICAL ADVANCES, LOOKING AHEAD TO 2026

Core Insights - IMUNON, Inc. is making significant progress towards a potential breakthrough in ovarian cancer treatment with its immunotherapy candidate IMNN-001, as evidenced by advancements in the Phase 3 OVATION 3 Study and promising data from the MRD study [1][2][3] Group 1: Clinical Progress - The Phase 3 OVATION 3 Study is evaluating IMNN-001 in combination with standard chemotherapy for newly diagnosed advanced ovarian cancer, with strong enrollment interest from the medical community [2] - IMNN-001 demonstrated a 13-month extension in median overall survival (OS) in the Phase 2 OVATION 2 Study, with a hazard ratio of 0.70, and patients receiving PARP inhibitors showed a median OS not yet reached after over 31 months of follow-up [2] - The ongoing MRD study shows lower MRD positivity rates and higher complete response scores with IMNN-001 compared to the control arm, indicating its potential effectiveness [4] Group 2: Mechanism of Action - IMNN-001 induces IL-12 production in macrophages, enhancing T cell cytotoxic functions and remodeling the tumor microenvironment to activate both innate and adaptive immune systems [7][8] - The treatment leads to a more inflamed tumor microenvironment, effectively converting "cold" tumors to "hot" tumors, which is crucial for immunotherapy effectiveness [7] Group 3: Financial and Strategic Position - The company maintained financial discipline in 2025, with an estimated $30 million budget for the OVATION 3 trial, focusing on the HRD+ subgroup [9] - Cost reductions from cGMP-compliant manufacturing may lead to high gross margins upon potential FDA approval, reflecting growing confidence from institutional investors [9] Group 4: Future Outlook - IMUNON is poised for key milestones in 2026, including continued enrollment in OVATION 3 and potential early stopping for BLA filing in the HRD+ population [10] - The company anticipates additional data presentations and progress on business development initiatives, with Fast Track and Orphan Drug designations in place [10]