Imunon (IMNN) investor relations material

Investment thesis and clinical progress

• Strong investment thesis supported by robust clinical data and a clear path to market for a first-in-class IL-12 DNA immunotherapy in ovarian cancer.

• Ongoing phase III registration trial in newly diagnosed ovarian cancer, with full funding targeted for trial completion and enrollment ahead of projections.

• Product addresses a multi-billion dollar unmet medical need, with potential for broad application beyond ovarian cancer.

• FDA alignment includes Fast Track and orphan drug status in the U.S. and Europe, with agreed potency assay and cGMP manufacturing for commercialization.

• Internal manufacturing capabilities support cost control and strong gross margins for future commercialization.

Scientific innovation and clinical differentiation

• IMNN-001 is a DNA-based IL-12 immunotherapy delivered intraperitoneally, converting immunologically "cold" tumors to "hot" and targeting the tumor microenvironment.

• Unlike previous IL-12 therapies, IMNN-001 avoids systemic toxicity by local administration and induces natural IL-12 production.

• Phase II data show a 14.7-month median overall survival improvement, with consistent benefit across all endpoints and subgroups.

• Translational data confirm dose-dependent local immune activation, with increased dendritic and effector memory T cells and reduction in immunosuppressive biomarkers.

• Safety profile is favorable, with no systemic dose-limiting toxicities or cytokine release syndrome observed.

Regulatory and trial design

• Phase III trial design includes two interim analyses, allowing for potential early stopping and accelerated approval if efficacy is demonstrated.

• Group sequential design is FDA-approved, with event-driven interim analyses based on overall survival.

• Enrollment is ahead of internal projections, with targets of 60 patients by year-end and 80 by end of Q1, and full enrollment projected by early 2029.

• Consistent treatment effect observed across all endpoints and subgroups in phase II, supporting confidence in phase III outcomes.

• Phase 3 design includes stratification, quality of life measures, and enhancements for interpretability and reimbursement.