Imunon (IMNN) investor relations material

Executive summary

• IMNN-001 is the sole active product candidate after development of PLACCINE and IMNN-101 was discontinued; Phase III OVATION 3 is underway for advanced ovarian cancer.

• Priorities center on OVATION 3 enrollment, clinical evidence generation, and concentrating capital and staff on IMNN-001.

• NCI/CTEP selected IMNN-001 for partnered development, with NCI/CTEP assuming regulatory sponsorship for additional solid-tumor indications and combinations.

Financial highlights

• Q3 operating expenses were $3.45M vs. $3.48M YoY; R&D was $1.8M vs. $1.9M and G&A was $1.7M vs. $1.6M.

• Q3 net loss was $3.75M vs. $3.43M YoY; loss per share was $0.64 vs. $1.16.

• 9M net loss was $10.81M vs. $10.27M YoY; loss per share was $2.01 vs. $5.53.

• 9M operating cash use was $10.21M; at September 30, cash and equivalents were $4.04M and restricted cash was $5.0M.

• Q3 non-operating expenses were $302K, largely related to debt and equity extinguishment financing costs.

Outlook and guidance

• OVATION 3 is a randomized 1:1 Phase III study designed to enroll ~500 patients, with overall survival as the primary endpoint and two event-driven interim analyses.

• Enrollment averaged >0.4 patients per active site per month vs. a 0.3 planning assumption; nine sites were open at September 30, with 18 selected at quarter-end.

• Enrollment completion is targeted for Q1 2029; 50% enrollment is targeted for Q1 2028, and all planned sites for activation by end-2027, subject to continued site activation and enrollment rates.

• The first planned interim analysis at 60% of target overall-survival events is estimated for Q1 2030; thresholds could support an earlier registration submission.

• Additional capital is required to complete OVATION 3 and activate 50 sites; a proposed securities offering registration statement was filed, with no proceeds received by November 12.