IMNN-001 program is currently advancing its OVATION 3 pivotal Phase 3 trial per plan LAWRENCEVILLE, N.J., Oct. 23, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, today announced that new translational data from the Phase 2 OVATION 2 clinical trial of IMNN-001, its investigational therapy for the treatment of women with newly diagnosed advanced ovarian cancer, will be presented at the Society for Immunotherapy of Canc ...

Core Insights - IMUNON, Inc. reported financial results for Q2 2025 and highlighted advancements in its Phase 3 clinical trial for IMNN-001, a DNA-mediated immunotherapy for advanced ovarian cancer, along with a 15% stock dividend for shareholders [1][2] Clinical Development - The pivotal Phase 3 OVATION 3 trial for IMNN-001 has commenced, with the first patient treated on July 25, 2025, following robust Phase 2 data showing significant overall survival benefits [2] - The trial design includes two interim analyses and is powered at 95% to detect meaningful overall survival improvements in the intent-to-treat population, with a 99% power in the HRD-positive subgroup [2] - A flexible enrollment strategy will start with a 250-patient HRD-positive subgroup, potentially expanding to a 500-patient all-comers trial, reducing costs by approximately 40% [2] Financial Position - IMUNON has strengthened its balance sheet with over $3 million raised through warrant exercises and ATM sales, while introducing a one-time 15% stock dividend to enhance shareholder value [2] - The company is actively pursuing non-dilutive partnerships to fund the OVATION 3 trial and has achieved compliance with Nasdaq's Shareholder Equity Rule [2] Manufacturing and Operations - IMUNON maintains a reliable in-house manufacturing process for key components of IMNN-001, achieving significant cost reductions compared to outsourcing [2] - Targeted cash conservation measures have been implemented to align resources with the regulatory approval and commercial launch of IMNN-001 [2] Medical Community Engagement - Data from the OVATION 2 study has generated significant interest, leading to unsolicited inquiries from global principal investigators to join the Phase 3 study, indicating strong validation of IMNN-001's potential [2] Background on IMNN-001 - IMNN-001 is designed using IMUNON's TheraPlas® platform and aims to induce potent anticancer immunity through the local secretion of IL-12 [5][8] - The drug has shown positive safety and efficacy results in previous clinical trials, including the recently completed Phase 2 OVATION 2 study [5][8] Market Context - Epithelial ovarian cancer is a significant health concern, with approximately 20,000 new cases annually in the U.S., and a high risk of recurrence, highlighting the need for effective therapies [6]

Core Viewpoint - IMUNON, Inc. is set to host a conference call on August 5, 2025, to discuss its Q2 2025 financial results and provide updates on its clinical development program, particularly focusing on the Phase 3 trial of its DNA-based immunotherapy, IMNN-001, for advanced ovarian cancer [1]. Company Overview - IMUNON is a clinical-stage biotechnology company that develops innovative treatments utilizing the body's natural mechanisms to generate effective responses against various diseases, differentiating itself from conventional therapies [4]. - The company is advancing its non-viral DNA technology through two main modalities: TheraPlas® for gene-based delivery of cytokines and PlaCCine® for gene delivery of viral antigens [4]. Clinical Development - The lead clinical program, IMNN-001, is a DNA-based immunotherapy targeting advanced ovarian cancer, which has completed multiple trials, including a Phase 2 trial (OVATION 2) [5]. - The first site for the Phase 3 pivotal study (OVATION 3) was initiated in Q2 2025, with IMNN-001 designed to instruct the body to produce cancer-fighting molecules at the tumor site [5]. - Additionally, the company has completed dosing in a first-in-human study of its COVID-19 booster vaccine (IMNN-101) [5].