Core Insights - IMUNON, Inc. is advancing its IMNN-001 program, currently in the OVATION 3 pivotal Phase 3 trial for advanced ovarian cancer, with new data from the Phase 2 OVATION 2 trial to be presented at the SITC Annual Meeting [1][3] Company Overview - IMUNON is a clinical-stage biotechnology company focused on innovative treatments that utilize the body's natural mechanisms for effective responses against various diseases [10][11] - The company's lead clinical program, IMNN-001, is a DNA-based immunotherapy targeting advanced ovarian cancer, having completed multiple clinical trials including the Phase 2 OVATION 2 and currently conducting the Phase 3 OVATION 3 trial [11] IMNN-001 Therapy Details - IMNN-001 is based on IMUNON's TheraPlas® technology, utilizing an IL-12 DNA plasmid vector in a nanoparticle delivery system to induce strong anti-cancer immunity [2][8] - The therapy has shown clinically effective responses in advanced ovarian cancer, improving both progression-free survival (PFS) and overall survival (OS) when combined with standard chemotherapy [2][4] Clinical Trial Insights - The OVATION 3 trial is designed with at least 95% statistical power for the primary endpoint of overall survival, including two planned interim analyses for potential accelerated FDA submission [5][6] - The OVATION 2 study demonstrated a median OS increase of 13 months and a median PFS increase of 3 months for the IMNN-001 treatment arm compared to standard care [5][7] Presentation and Data Sharing - Positive translational data from the OVATION 2 study was previously presented at the AACR Special Conference, highlighting the safety profile and efficacy of IMNN-001 [3][4] - The upcoming SITC presentation will focus on how IMNN-001 can convert the tumor microenvironment from "cold" to "hot," enhancing immune response in newly diagnosed epithelial ovarian cancer [3]

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].

As filed with the Securities and Exchange Commission on September 20, 2024 Registration No. 333-281834 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 IMUNON, INC. (Exact name of registrant as specified in its charter) DELAWARE 52-1256615 (State or other jurisdiction of incorporation or organization) 997 Lenox Drive, Suite 100 Lawrenceville, New Jersey 08648 (609) 896-9100 (Address, including zip code ...

As filed with the Securities and Exchange Commission on August 29, 2024 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 IMUNON, INC. (Exact name of registrant as specified in its charter) (I.R.S. Employer Identification No.) 997 Lenox Drive, Suite 100 Lawrenceville, New Jersey 08648 (609) 896-9100 (Address, including zip code, and telephone number, including area code, of Registrant's principal exe ...