IMUNON Secures Nasdaq Listing Extension to Advance Phase 3 Ovarian Cancer Immunotherapy
Key Insights
IMUNON received approval from the Nasdaq (search) Hearing Panel for a listing extension after demonstrating compliance with equity requirements through recent fundraising activities.
The company's lead program IMNN-001, a DNA-based immunotherapy for advanced ovarian cancer (search), has progressed to Phase 3 trials following unprecedented Phase 2 results.
IMUNON's stockholders' equity exceeded $3.0 million as of May 31, 2025, surpassing Nasdaq (search)'s listing threshold requirements.
IMUNON, Inc. has successfully secured a continued listing extension from the Nasdaq (search) Hearing Panel, allowing the clinical-stage biotechnology company to maintain its position on the Nasdaq Stock Market while advancing its Phase 3 DNA-mediated immunotherapy program for ovarian cancer (search).
The Nasdaq (search) Hearing Panel granted IMUNON's request for an exception to complete its compliance plan after conducting a comprehensive review of the company's strategies to regain compliance. According to the Panel's decision, IMUNON has already achieved compliance with the Equity Rule through recent fundraising activities, with stockholders' equity exceeding $3.0 million as of May 31, 2025, surpassing Nasdaq's listing threshold.
DNA Immunotherapy Platform Advances
IMUNON's lead clinical program, IMNN-001, represents a DNA-based immunotherapy for the localized treatment of advanced ovarian cancer (search). The treatment works by instructing the body to produce safe and durable levels of powerful cancer-fighting molecules, including interleukin-12 (search) and interferon gamma, directly at the tumor site.
The company has completed multiple clinical trials for IMNN-001, including a Phase 2 clinical trial (OVATION 2) that delivered what the company describes as "unprecedented" results. Building on this success, IMUNON has initiated its Phase 3 trial (OVATION 3) in the United States and Canada.
Technology Platform Development
IMUNON is developing its non-viral DNA technology across two distinct modalities. The first modality, TheraPlas®, is designed for gene-based delivery of cytokines and other therapeutic proteins in treating solid tumors (search) where an immunological approach shows promise. The second modality, PlaCCine®, focuses on gene delivery of viral antigens that can elicit strong immunological responses.
Beyond its ovarian cancer (search) program, the company has completed dosing in a first-in-human study of its COVID-19 (search) booster vaccine (IMNN-101), demonstrating the versatility of its DNA technology platform.
Regulatory Compliance Strategy
The Panel approved an exception tailored to the specific time needed for IMUNON to regain compliance, rather than the full 180-day period initially requested. The company is committed to meeting these requirements within the designated timeframe, with the option to request additional extensions if necessary.
"We are pleased with the Nasdaq (search) Hearing Panel's decision, which reflects confidence in our straightforward and executable compliance plan," said Stacy Lindborg, Ph.D., President and CEO of IMUNON. "Our management is fully dedicated to implementing our well thought out plan and taking the necessary steps to maintain our Nasdaq listing."
Clinical Development Focus
Lindborg emphasized the company's commitment to advancing its clinical programs, stating, "We are confident that our plan demonstrates our ability to regain compliance with Nasdaq (search)'s listing requirements, an important step that reflects our commitment to advancing our lead clinical program, IMNN-001, a DNA-based immunotherapy for the localized treatment of advanced ovarian cancer (search) which is now in a Phase 3."
The company continues to leverage its DNA technology modalities to advance the technological frontier of plasmid DNA, either directly or through partnerships, to better serve patients with difficult-to-treat conditions. IMUNON's approach represents a differentiating strategy from conventional therapies by harnessing the body's natural mechanisms to generate safe, effective, and durable responses across a broad array of human diseases.