IMUNON begins Phase 3 trial of ovarian cancer immunotherapy

LAWRENCEVILLE, N.J. - IMUNON, Inc. (NASDAQ:IMNN), a clinical-stage biotechnology company with a market capitalization of $12.7 million, announced Tuesday that its ongoing Phase 3 OVATION 3 clinical trial of IMNN-001 for newly diagnosed advanced ovarian cancer will be featured in a poster presentation at the European Society for Medical Oncology (ESMO) Congress 2025, taking place October 17-21 in Berlin. According to InvestingPro data, the company’s stock has seen significant volatility, trading near its 52-week low of $4.70.

IMNN-001 is a DNA-mediated immunotherapy that delivers interleukin-12 (IL-12) via a nanoparticle system, enabling persistent production of IL-12 protein in the tumor microenvironment. The therapy is designed to enhance anti-cancer immunity by promoting T-lymphocyte and natural killer cell proliferation.

The company treated its first patient in the pivotal Phase 3 OVATION 3 study in July 2025. Currently, four clinical sites are active and enrolling patients, with up to 46 additional sites being considered for activation.

The Phase 3 trial follows promising results from the Phase 2 OVATION 2 study, which included 112 patients. According to the company, the Phase 2 trial showed a median 13-month increase in overall survival and a 3-month increase in progression-free survival in the IMNN-001 treatment arm compared to standard care alone. While InvestingPro analysis shows the company maintains more cash than debt on its balance sheet, it’s currently experiencing rapid cash burn, with negative free cash flow of $14.6 million in the last twelve months.

Dr. Premal H. Thaker, Chief of Gynecologic Oncology at Washington University School of Medicine and Study Chair of the OVATION trials, will present the poster at ESMO.

The OVATION 3 trial is designed with two planned interim analyses of the primary endpoint, which could potentially allow for an accelerated timeline for FDA submission if statistical significance is reached.

Epithelial ovarian cancer is the sixth deadliest malignancy among women in the U.S., with approximately 20,000 new cases annually and 70% diagnosed at advanced stages.

This article is based on a press release statement from IMUNON.

In other recent news, Imunon Inc. reported its second-quarter earnings for 2025, which showed a significant miss in earnings per share (EPS) compared to analysts’ forecasts. The company posted an EPS of -$2.15, considerably below the anticipated -$0.32, marking a surprise of 571.88%. This larger-than-expected loss has raised concerns among investors. Additionally, Imunon presented new translational data from its Phase 2 OVATION 2 Study of IMNN-001, a DNA-mediated immunotherapy for advanced ovarian cancer, at the American Association for Cancer Research Special Conference in Denver. The study involved 112 participants and focused on the administration of IMNN-001 alongside standard chemotherapy treatments. The therapy aims to induce anti-cancer immunity by enhancing T-lymphocyte and natural killer cell proliferation. These developments are part of Imunon’s ongoing efforts in cancer research and treatment innovation.

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