IMUNON R&D Day Showcases Clinical Progress of Its Novel Immunotherapy, Phase 3 Trial and Significant Potential for Women with Ovarian Cancer

Rhea-AI Summary

IMUNON (Nasdaq: IMNN) held an R&D Day on Nov 10, 2025 in New York to present clinical updates for its DNA-mediated immunotherapy IMNN-001 in newly diagnosed advanced ovarian cancer.

Presentations reviewed Phase 2 OVATION 2 and an MRD study, highlighted a reported median 13-month overall survival (OS) benefit for IMNN-001 plus standard-of-care chemotherapy, safety and tolerability data, translational findings on tumor microenvironment remodeling, and progress on the pivotal Phase 3 OVATION 3 trial including activation and enrollment updates. A live webcast and materials were made available on the company scientific presentations page.

Insights

Clinical development expert

Phase 2 reports a substantial median 13-month overall survival benefit and the program has moved into a Phase 3 pivotal trial.

The data describe a median 13-month overall survival (OS) improvement for IMNN-001 when added to standard-of-care chemotherapy, together with repeated statements of a favorable tolerability and safety profile; this combination of efficacy and tolerability is the core driver for advancing a frontline oncology program.

Key dependencies and risks include confirmation of the OS signal in the ongoing Phase 3 OVATION 3 trial and maintenance of the claimed safety profile across a larger, more diverse patient population; early-phase benefits often attenuate in larger, randomized settings, so independent confirmation matters.

Watch for randomized interim OS analyses, enrollment milestones and any safety signals during interim reviews over the next 12–24 months; the Nov. 10, 2025 presentation suggests active investigator engagement and faster activation, which materially affects timeline.

Biostatistics and regulatory expert

The Phase 3 design reportedly uses an adaptive, event-driven OS endpoint aligned with prior FDA approvals based on interim analyses.

The described statistical strategy emphasizes conservative power assumptions, simulation modeling, and an adaptive, event-driven framework, which can shorten time to a conclusive OS readout if assumptions hold and event rates match projections.

Risks include over-reliance on Phase 2-derived effect sizes and the need for prespecified control of type I error at interim looks; regulatory acceptance of an OS-based interim approval pathway depends on robust, reproducible evidence at analysis.

Monitor formal trial registration updates, specified interim boundaries, and actual event accrual and DSMB decisions over the coming 12–36 months to assess whether the statistical plan and observed data remain aligned.

Event being held today at 8:00 a.m. ET in New York City features presentations from Ovarian Cancer Key Opinion Leaders, Clinicians, Statistical Experts, and IMUNON executives

Investors, stakeholders, analysts and those interested in advances in ovarian cancer treatment and women’s health are encouraged to attend, either In-person or virtually

LAWRENCEVILLE, N.J., Nov. 10, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, today is presenting an update on recent progress with its IMNN-001 development program for the treatment of newly diagnosed advanced ovarian cancer, including a review of positive data from the Company’s Phase 2 OVATION 2 Study and the minimal residual disease (MRD) study conducted in partnership with Break Through Cancer. The program will also include updates on trial activation and patient enrollment in the Company’s ongoing Phase 3 OVATION 3 pivotal trial.

“IMNN-001 represents a potential landmark breakthrough in the treatment of newly diagnosed ovarian cancer in combination with standard of care chemotherapy. Data thus far indicate that our novel immunotherapy has the potential to represent a major advance in treatment that can make a meaningful difference in the lives of thousands of women,” said Stacy Lindborg, Ph.D., President and CEO of IMUNON. “No other frontline ovarian cancer treatment has shown improvement in overall survival, which of course is the ultimate goal. We are very encouraged to see results from our Ovation 2 Study demonstrate that IMNN-001 treatment plus chemotherapy is associated with a 13-month improvement in overall survival with a highly favorable benefit-risk profile. The results from this landmark trial strongly support the advancement of IMNN-001 into our Phase 3 trial. We are excited to share the latest updates in today’s event and to review what’s ahead for this program.”

R&D Day Featured Speakers and Program Highlights:

• Premal H. Thaker, M.D., Washington University School of Medicine, will discuss the significant continuing unmet needs in ovarian cancer, a devastating disease where patient outcomes and frontline standard of care treatment have not changed for about 30 years, and the promise IMNN-001 brings to these patients and clinicians. She will highlight the data from the Phase 2 OVATION 2 clinical trial, with results including:
  • Broad impact observed with IMNN-001 treatment on important cancer-fighting cytokines, effectively turning the tumor microenvironment from “cold” to “hot” by activating both innate and adaptive immune systems, renewing the elusive promise of an immunotherapy for ovarian cancer.
  • Data reinforcing the highly favorable benefit-risk and safety profile of IMMN 001.
  • The remarkable median 13-month overall survival (OS) benefit observed with IMNN-001 plus standard of care (SoC) chemotherapy, an increase that is considered clinically meaningful compared to SoC alone.

• Amir Jazaeri, M.D., University of Texas MD Anderson Cancer Center, will discuss safety, tolerability and translational insights from the Phase 2 MRD study of IMNN-001, including:
  • Rationale for the trial and the importance of frontline therapy as the best opportunity to achieve a cure for ovarian cancer.
  • New translational data that clearly show IMNN-001 preferentially being taken up by macrophages within the peritoneal fluid and tumor tissue, which then induces a robust response and tumor microenvironment remodeling.
  • New data further supporting the highly favorable benefit-risk and tolerability profile of IMNN-001.
  • The positive tolerability profile of IMNN-001, including in combination with SoC chemotherapy plus bevacizumab and in the maintenance setting.
    

Giorgio Paulon, Ph.D., Berry Consultants, LLC, will review the Phase 2 and ongoing Phase 3 trial designs and the strength of evidence for IMNN-001 from a statistical perspective. He will highlight the well-precedented nature of the Phase 3 design with the FDA, which leverages an innovative, adaptive, event-driven approach aligned with prior successful oncology trials that resulted in full approval by FDA based on interim analyses of overall survival. This foundation, supported by conservative power assumptions drawn from Phase 2 data, strong simulation modeling and robust statistical properties, underpins the Phase 3 trial's high probability for success.

• Douglas V. Faller, M.D., Ph.D., IMUNON, will share new data further demonstrating that IMNN-001 shifted the balance in favor of immune stimulation, remodeling the tumor microenvironment in favor of anti-tumor responses, which is established to be associated with better prognosis. He will share the rapid progress to-date on the Phase 3 trial of IMNN-001, including expansion to additional sites and enrollment exceeding the Company’s expectations, strong levels of support and interest from investigators and the scientific community, and key clinical and other milestones for the company moving forward.
  

A live webcast of the event and presentation materials will be available on the “Scientific Presentations” page of the IMUNON website at https://investors.imunon.com/scientific-presentations.

About IMUNON

IMUNON is a clinical-stage biotechnology company focused on advancing a portfolio of innovative treatments that harness the body’s natural mechanisms to generate safe, effective and durable responses across a broad array of human diseases, constituting a differentiating approach from conventional therapies. IMUNON is developing its non-viral DNA technology across its modalities. The first modality, TheraPlas^®, is developed for the gene-based delivery of cytokines and other therapeutic proteins in the treatment of solid tumors where an immunological approach is deemed promising. The second modality, PlaCCine^®, is developed for the gene delivery of viral antigens that can elicit a strong immunological response.

The Company’s lead clinical program, IMNN-001, is a DNA-based immunotherapy for the localized treatment of advanced ovarian cancer that has completed multiple clinical trials including one Phase 2 clinical trial (OVATION 2) and is currently conducting a Phase 3 clinical trial (OVATION 3). IMNN-001 works by instructing the body to produce safe and durable levels of powerful cancer-fighting molecules, such as interleukin-12 and interferon gamma, at the tumor site. Additionally, the Company has completed dosing in a first-in-human study of its COVID-19 booster vaccine (IMNN-101). The Company will continue to leverage these modalities and to advance, either directly or through partnership, the technological frontier of plasmid DNA to better serve patients with difficult-to-treat conditions. For more information, please visit www.imunon.com.

Forward-Looking Statements

IMUNON wishes to inform readers that forward-looking statements in this news release are made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, but not limited to, statements regarding the timing of enrollment of the Company’s clinical trials, the potential of any therapies developed by the Company to fulfill unmet medical needs, the market potential for the Company’s products, if approved, the potential efficacy and safety profile of our product candidates, and the Company’s plans and expectations with respect to its development programs more generally, are forward-looking statements. We generally identify forward-looking statements by using words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances). Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, uncertainties relating to unforeseen changes in the course of research and development activities and in clinical trials, including the fact that interim results are not necessarily indicative of final results; the uncertainties of and difficulties in analyzing interim clinical data; the significant expense, time and risk of failure in conducting clinical trials; the need for IMUNON to evaluate its future development plans; possible actions by customers, suppliers, competitors or regulatory authorities; and other risks detailed from time to time in IMUNON’s filings with the Securities and Exchange Commission. IMUNON assumes no obligation, except to the extent required by law, to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise.

Contacts:

Media	Investors
Jenna Urban	Peter Vozzo
CG life	ICR Healthcare
212-253-8881	443-213-0505
jurban@cglife.com	peter.vozzo@icrhealthcare.com

FAQ

What did IMUNON announce about IMNN-001 at its Nov 10, 2025 R&D Day?

IMUNON presented Phase 2 OVATION 2 and MRD data and updates on the Phase 3 OVATION 3 trial, including enrollment and trial activation progress.

How large was the overall survival benefit reported for IMNN-001 in OVATION 2?

The company reported a median 13-month improvement in overall survival for IMNN-001 plus standard-of-care chemotherapy versus standard of care alone.

What is the status of the Phase 3 OVATION 3 trial for IMNN-001 (IMNN)?

OVATION 3 is an ongoing pivotal Phase 3 trial; presenters reported trial activation, expansion to additional sites, and enrollment exceeding company expectations.

What safety and tolerability findings did IMUNON report for IMNN-001?

Presentations described a highly favorable benefit-risk and tolerability profile for IMNN-001 alone and combined with standard chemotherapy and bevacizumab.

What translational insights were shared about IMNN-001’s mechanism of action?

Data showed IMNN-001 uptake by macrophages in peritoneal fluid and tumor tissue and remodeling of the tumor microenvironment from 'cold' to 'hot' with innate and adaptive immune activation.

Where can investors watch the IMUNON R&D Day webcast and access materials?

A live webcast and presentation materials are available on IMUNON’s Scientific Presentations page at https://investors.imunon.com/scientific-presentations.