IMUNON Reports 2024 Financial Results and Provides Business Update Highlighting Significant Progress Towards the Initiation of a Pivotal Phase 3 Study

Core Insights - IMUNON, Inc. has reported that its lead immunotherapy candidate, IMNN-001, is the first to demonstrate a significant overall survival benefit in advanced ovarian cancer, achieving an overall survival of 13 months compared to the current standard of care [3][7] - The company is preparing to initiate a Phase 3 pivotal trial for IMNN-001 in Q1 2025, following positive interactions with the FDA regarding the trial design and manufacturing processes [2][8][5] Financial Performance - For the year ended December 31, 2024, IMUNON reported a net loss of $18.6 million, or$1.62 per share, an improvement from a net loss of $19.5 million, or$2.16 per share in 2023 [17][29] - Operating expenses decreased by 9% to $19.1 million in 2024 from$21.0 million in 2023, with research and development expenses slightly decreasing to $11.6 million [17][18] - The company ended 2024 with$5.9 million in cash and cash equivalents, indicating sufficient capital resources to fund operations into late Q2 2025 [21] Clinical Development - The Phase 2 OVATION 2 Study of IMNN-001 showed a decrease in the hazard ratio from 0.74 to 0.69, with more than one-third of patients surviving over 36 months [7][3] - New translational data from the OVATION 2 Study indicated a 20% increase in IL-12 levels in patients treated with IMNN-001, supporting its mechanism of action [4] - The company has engaged with the FDA to finalize the design of the planned registrational study, reflecting strong support from trial investigators and regulators [3][8] Corporate Developments - Douglas V. Faller, M.D., Ph.D., was appointed as Chief Medical Officer to lead the clinical strategy for advancing IMNN-001 [14][15] - The company held an Ovarian Cancer R&D Day to discuss advancements in its clinical programs and engage with leaders in oncology research [9] Technology and Innovation - IMUNON is advancing its DNA-mediated immunotherapy platform, TheraPlas, which aims to enhance the immune response against cancer [24][25] - The company is also developing a COVID-19 vaccine, IMNN-101, which has shown promising safety and immunogenicity results in a Phase 1 trial [10][13]