Imunon, Inc. reports developments as a clinical-stage biotechnology company advancing non-viral DNA technologies for immunotherapy and vaccines. Its lead candidate, IMNN-001, is a DNA-based interleukin-12 immunotherapy being developed for localized treatment of newly diagnosed advanced ovarian cancer through the OVATION clinical program.
Company news commonly covers clinical data from OVATION studies, Phase 3 development activity, financial results and business updates, and portfolio work around the TheraPlas platform for cytokine and therapeutic-protein delivery and the PlaCCine platform for viral-antigen delivery. Updates also include capital discipline, organization changes, and presentations of translational or proof-of-concept data.
IMUNON (IMNN) presented Phase 2 survival results and Phase 3 enrollment progress for IMNN-001 in advanced ovarian cancer on September 24, 2026. In the 112-patient randomized OVATION 2 study, median overall survival was 45.1 months with IMNN-001 plus neoadjuvant and adjuvant chemotherapy versus 30.4 months with standard of care alone. The 14.7-month difference came from a study not powered for overall survival.
OVATION 3 is a randomized trial of approximately 500 patients with overall survival as its primary endpoint and two planned, event-driven interim analyses. Enrollment is averaging about 0.5 patients per site per month, versus a 0.3 planning assumption. IMUNON targets completion of enrollment in the first quarter of 2029.
In a separate, preliminary minimal residual disease study, 4 of 9 assessed patients in the IMNN-001 arm had residual disease, versus 6 of 9 controls. The sample is still too small to evaluate efficacy. OVATION 2 reported no cytokine release syndrome or serious systemic immune-related adverse events.
IMUNON (IMNN) reported that an Independent Data Monitoring Committee recommended continuation of its Phase 2 MRD study of IMNN-001 without modification after reviewing all safety data.
The committee found no new safety signals and confirmed comparable safety between treatment arms, with no cytokine release syndrome, systemic toxicities or serious immune-related adverse events observed to date. The MRD trial in newly diagnosed advanced ovarian cancer has now shown safety and tolerability for IMNN-001 both in combination with bevacizumab and in the maintenance setting. Preliminary July data from patients reaching second-look laparoscopy showed IMNN-001 was associated with a lower MRD-positive rate (44% vs 67%), higher ctDNA clearance (87.5% vs 62.5%), and more patients achieving no evidence of disease (100% vs 56%) versus control. The latest review also identified no new safety concerns in the pivotal Phase 3 OVATION 3 trial.
IMUNON (IMNN) has entered a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to advance IMNN-001, its DNA-based IL-12 immunotherapy.
Under the CRADA, NCI’s Cancer Therapy Evaluation Program (CTEP), which assumes regulatory sponsorship, will support further clinical and non-clinical development of IMNN-001 within the NCI Experimental Therapeutics (NExT) Program. NCI investigators will study IMNN-001 in new solid tumor indications and combination regimens, extending work from IMUNON’s ovarian cancer program. IMUNON retains ownership of its background intellectual property and any new IP it solely generates, and it can use collaboration data for IMNN-001 research and development.
The company said this partnership leverages NCI resources and the National Clinical Trials Network to initiate additional trials in a capital-efficient manner while IMUNON continues its pivotal Phase 3 OVATION 3 trial. In a prior Phase 2 study, IMNN-001 was associated with a 14.7‑month increase in median overall survival versus chemotherapy alone (45.1 vs. 30.4 months).
IMUNON (IMNN) will host a 2026 R&D Day in New York City and via live webcast on Wednesday, September 23, 2026, starting at 10:00 a.m. ET, focused on its investigational IL-12 immunotherapy IMNN-001.
The event at Sofitel New York will highlight clinical progress across IMNN-001 programs, including the Phase 3 OVATION 3 trial in advanced ovarian cancer and a Phase 2 minimal residual disease (MRD) study conducted with the Break Through Cancer Foundation. A featured segment will be a conversation with an OVATION 1 trial participant sharing her experience with IMNN-001 and life after the study.
The agenda includes scientific and clinical presentations from IMUNON executives and external gynecologic oncology experts, covering IL-12 delivery via TheraPlas™, translational MRD insights, OVATION 2 overall survival signals informing OVATION 3, and IMUNON’s strategic milestones, catalysts and investment outlook. A live Q&A and networking session will follow.
IMUNON (Nasdaq: IMNN) will host a 2026 R&D Day for investors, analysts and media on September 23, 2026, at the Sofitel New York, beginning at 10:00 a.m. ET, with a live webcast available.
The event will focus on IMUNON’s lead program IMNN-001, an IL-12 DNA-mediated immunotherapy, including progress and upcoming milestones for the pivotal Phase 3 OVATION 3 trial in newly diagnosed advanced ovarian cancer and insights from a Phase 2 minimal residual disease trial run with Break Through Cancer and MD Anderson. Leading oncology experts, company management, and a patient treated with IMNN-001 will present clinical data, treatment experience and program direction.
IMUNON (NASDAQ: IMNN) reported second quarter 2026 net loss of $2.8 million ($0.54 per share), similar to $2.7 million a year earlier, on operating expenses of $2.8 million in both periods. For the first half, net loss was $7.1 million versus $6.8 million in 2025.
Research and development expenses rose to $1.5 million in Q2 and $3.8 million in H1 2026, while general and administrative costs declined. Net cash used in operations was $7.0 million in H1, with cash and cash equivalents of $6.9 million at June 30, 2026.
According to IMUNON, Phase 2 OVATION 2 showed a median overall survival of 45.1 vs. 30.4 months for IMNN-001 plus chemotherapy versus standard of care alone. An independent committee recommended continuation of the Phase 3 OVATION 3 trial, which is enrolling faster than forecast, and preliminary Phase 2 MRD data showed lower MRD positivity and higher ctDNA clearance with IMNN-001.
The company also raised $10 million on June 4, 2026 via preferred stock and two secured promissory notes bearing 5–8% interest.
IMUNON (Nasdaq: IMNN) will hold a conference call at 11:00 a.m. EDT on Tuesday, August 11, 2026 to discuss its second quarter 2026 financial results and provide a business update.
Management will also review progress in advancing Phase 3 clinical development of lead DNA-based IL-12 immunotherapy IMNN-001 for newly diagnosed advanced ovarian cancer, part of IMUNON’s non-viral DNA-based gene therapy portfolio. Investors can join via phone using Conference ID 8021948 or by live webcast, with a 90-day audio replay available by phone with replay code 8021948#.
IMUNON (Nasdaq: IMNN) reported that its pivotal Phase 3 OVATION 3 trial of IMNN-001 in newly diagnosed advanced ovarian cancer is enrolling patients faster than planned. The company cites rapid site activation and a current study-level enrollment rate of about 0.5 patients per site per month, versus the trial plan assumption of 0.3 and historical ovarian cancer rates near 0.2.
More than 70% of sites are meeting or exceeding the 0.3 patients-per-month assumption. IMUNON now projects enrollment completion in the second quarter of 2029 and anticipates two pre-planned interim analyses, which could support an earlier BLA filing if pre-specified thresholds are met. Across OVATION 3 and an ongoing Phase 2 MRD study, IMNN-001 has shown a safety and tolerability profile with no observed cytokine release syndrome, systemic toxicities or serious immune-related adverse events, and recent Independent Data Monitoring Committee reviews have raised no safety issues.
IMUNON (Nasdaq: IMNN) will present new translational and clinical data on its DNA-based IL-12 immunotherapy IMNN-001 for advanced ovarian cancer at the inaugural AACR Drug Discovery and Development (AACR D3) conference, held July 21-24, 2026, in Boston.
The poster highlights IMUNON’s TheraPlas platform and randomized Phase 2 OVATION-2 data, where IMNN-001 plus chemotherapy showed numerical median overall survival of 40.5 vs. 27.6 months versus chemotherapy alone, along with local IL-12 delivery, favorable immune cell ratios, and a safety profile without cytokine release syndrome.
IMUNON (Nasdaq: IMNN) reported preliminary Phase 2 minimal residual disease (MRD) data for its IL‑12 DNA immunotherapy IMNN-001 in newly diagnosed advanced ovarian cancer, given with neoadjuvant/adjuvant chemotherapy plus bevacizumab. At second-look laparoscopy, 9 patients per arm had been evaluated.
According to IMUNON, IMNN-001 showed a lower MRD-positive rate vs. control (44% vs. 67%), higher circulating tumor DNA clearance (87.5% vs. 62.5%), and a numerically higher rate of no evidence of disease (100% vs. 56%) following frontline therapy. No cytokine release syndrome, systemic toxicities, or serious immune-related adverse events have been observed to date.
The MRD findings complement prior Phase 2 OVATION 2 data, where IMNN-001 plus chemotherapy was associated with median overall survival of 45.1 vs. 30.4 months, and 65.6 vs. 41.4 months in patients also receiving PARP maintenance. IMNN-001 is now in the pivotal Phase 3 OVATION 3 trial in frontline ovarian cancer.