Imunon (IMNN) investor relations material

Investment Thesis, Clinical Progress, and Key Presentations

• IMNN-001 is a first-in-class IL-12 DNA immunotherapy for newly diagnosed advanced ovarian cancer, with Fast Track and orphan drug status in the U.S. and Europe.

• Phase II data showed a 14.7-month median overall survival improvement over standard of care, with consistent benefit across all endpoints and subgroups.

• Phase III OVATION-3 registrational study initiated, targeting 500 patients, with overall survival as the primary endpoint and interim analyses for early stopping.

• Enrollment in phase III is ahead of projections, with a target of 60 patients by year-end and full enrollment projected by early 2029.

• Manufacturing capabilities are in-house and cGMP-compliant, supporting robust gross margins and commercial readiness.

Scientific and Clinical Rationale

• IMNN-001 uses a DNA-based plasmid encoding IL-12, delivered intraperitoneally to convert immunologically "cold" tumors to "hot," enhancing immune response and minimizing systemic toxicity.

• Durable local IL-12 expression avoids systemic dose-limiting toxicities, with no cytokine release syndrome observed.

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

• FDA-approved potency assay (interferon gamma) demonstrates strong pharmacodynamic response at the studied dose.

• Benefit/risk profile further supported by MRD trial and combination studies with Bevacizumab.

Market Opportunity and Strategic Positioning

• Ovarian cancer remains a high unmet need, with 80% of diagnoses at late stage, high recurrence, and unchanged frontline outcomes for 30 years.

• IMNN-001 aims to become the first approved immunotherapy for frontline ovarian cancer, targeting a multi-billion dollar market.

• The platform has potential applications in other cancers, including pancreatic, colorectal, bladder, and glioblastoma.

• Combination with immune checkpoint inhibitors is a promising area for future research.

• Ongoing discussions with potential partners, including ex-U.S. companies, to support further development and commercialization.