Company Description
Imunon, Inc. (Nasdaq: IMNN) is a clinical-stage biotechnology company that focuses on DNA-based approaches to treat serious human diseases. The company describes its strategy as advancing a portfolio of treatments that harness the body’s natural mechanisms to generate safe, effective and durable responses across a broad array of human diseases, in a way that differs from conventional therapies. Imunon is classified in pharmaceutical preparation manufacturing within the broader manufacturing sector.
According to multiple company disclosures, Imunon is developing a non-viral DNA technology across distinct modalities. Its first modality, branded TheraPlas®, is developed for gene-based delivery of cytokines and other therapeutic proteins in the treatment of solid tumors where an immunological approach is considered promising. The second modality, PlaCCine®, is developed for gene delivery of viral antigens that can elicit a strong immunological response, supporting vaccine applications.
Core clinical program: IMNN-001 for advanced ovarian cancer
Imunon’s lead clinical program is IMNN-001, a DNA-based immunotherapy designed for the localized treatment of advanced ovarian cancer. Company materials state that IMNN-001 has completed multiple clinical trials, including a Phase 2 clinical trial known as OVATION 2, and is being evaluated in a pivotal Phase 3 trial (OVATION 3) in women with newly diagnosed advanced epithelial ovarian cancer.
IMNN-001 is based on the TheraPlas platform and is described as an interleukin-12 (IL-12) DNA plasmid vector incorporated in a nanoparticle delivery system. This design enables cell transfection followed by local production and secretion of IL-12 in the tumor microenvironment. Company reports explain that IL-12 is a powerful cytokine associated with induction of anti-cancer immunity through activation and proliferation of T-lymphocytes and natural killer cells, while countering tumor-mediated immune suppression.
In its Phase 2 OVATION 2 study, IMNN-001 was administered intraperitoneally in combination with neoadjuvant and adjuvant chemotherapy (paclitaxel and carboplatin) in newly diagnosed advanced ovarian, fallopian tube or primary peritoneal cancer. Imunon reports that this randomized study enrolled 112 patients and evaluated safety, efficacy and biological activity compared with standard-of-care chemotherapy alone. Company communications highlight observations such as a median extension in overall survival and progression-free survival in the IMNN-001 arm compared with control, as well as biomarker evidence that IMNN-001 can shift the tumor microenvironment from “cold” to “hot” by increasing anti-tumor immune cell populations and decreasing immunosuppressive markers.
The ongoing OVATION 3 trial is described as a pivotal Phase 3 study of IMNN-001 in women with advanced stage epithelial ovarian cancer, designed with overall survival as the primary endpoint and incorporating planned interim analyses. Imunon states that OVATION 3 builds on the clinical and translational data from OVATION 2 and related studies, and is intended to support a potential future biologics license application (BLA) if results are favorable.
TheraPlas platform and tumor microenvironment focus
Imunon’s TheraPlas platform is positioned as enabling localized, durable expression of IL-12 and other therapeutic payloads at the tumor site. Company presentations describe how IMNN-001, built on TheraPlas, is intended to remodel the tumor immune microenvironment by:
- Inducing IL-12 expression in macrophages within peritoneal fluid and tumor tissue.
- Increasing anti-tumor immune cell populations such as CD8+ T cells, myeloid dendritic cells and M1 macrophages.
- Reducing immunosuppressive markers including IDO, PDL1, regulatory T cells and other cell types associated with immune evasion.
These changes are reported to create a more inflamed, “hot” tumor microenvironment, which the company associates with improved prognosis in epithelial ovarian cancer. Imunon has also reported translational data from multiple conferences showing favorable shifts in key immune cell ratios and cytokine profiles in patient tumor samples following IMNN-001 treatment.
PlaCCine DNA vaccine technology and IMNN-101
Beyond oncology, Imunon is developing its PlaCCine DNA vaccine technology platform. Company disclosures describe PlaCCine as a gene delivery approach for viral antigens that can elicit strong immune responses. Imunon has advanced IMNN-101, an investigational COVID-19 booster vaccine based on PlaCCine, through a first-in-human proof-of-concept study. The company reports that dosing in this study has been completed and that IMNN-101 has been shown to be safe and well tolerated, with no serious adverse effects reported in the data described.
In presentations summarized in recent news, Imunon has highlighted PlaCCine’s design and composition, including features such as duration of antigen expression, safety profile, user compliance considerations and storage stability at temperatures described as workable in comparison to certain other vaccine platforms. The company has reported immunogenicity data in multiple species and in healthy human participants, including neutralizing antibody responses over several months following a single dose in individuals previously vaccinated or infected with SARS-CoV-2. Imunon has also indicated that it is seeking partnerships with pharmaceutical and biotechnology companies to further develop and potentially commercialize the PlaCCine platform in vaccines for infectious diseases and cancer.
Capital markets, listing status and corporate actions
Imunon’s common stock trades on the Nasdaq Capital Market under the symbol IMNN, as confirmed in multiple Form 8-K filings. In 2025, the company received Nasdaq notices related to the minimum bid price and minimum stockholders’ equity requirements for continued listing. A July 2025 Form 8-K describes a delisting determination and the company’s request for a hearing before a Nasdaq Hearings Panel, which granted an exception tailored to the time needed to regain compliance. A later Form 8-K dated August 28, 2025 reports that Imunon received written notification from the Nasdaq Hearings Panel indicating that the company had regained compliance with the $1.00 minimum closing bid price requirement for continued listing on the Nasdaq Capital Market.
To address listing requirements and capital structure, Imunon’s board and stockholders approved several corporate actions in 2025. These included an amendment to the Restated Certificate of Incorporation to increase the number of authorized shares of common stock, and authorization of a reverse stock split within a specified range. A subsequent Form 8-K details that the company implemented a 1-for-15 reverse stock split of its outstanding common stock, effective July 25, 2025, with the post-split shares continuing to trade under the IMNN ticker on Nasdaq and a new CUSIP number. Another 8-K describes a 15% stock dividend approved by the board, payable to stockholders of record on a specified date.
Imunon also uses at-the-market (ATM) offerings and registered direct offerings as part of its financing strategy. A July 2025 Form 8-K notes the filing of a prospectus supplement to register additional shares under an existing ATM agreement with a sales agent. A December 2025 news release describes a registered direct offering priced at-the-market under Nasdaq rules, involving common stock (or pre-funded warrants) and accompanying warrants, with expected gross proceeds of approximately $7.0 million before expenses, conducted under an effective shelf registration statement on Form S-3.
Regulatory filings and investor communications
Imunon regularly files current reports on Form 8-K to disclose material events such as quarterly financial results, capital markets transactions, stockholder meeting outcomes, and changes to its charter or listing status. Several 8-K filings in 2025 reference press releases reporting financial results for quarterly periods and announcing related conference calls and webcasts. These filings specify that the information is being furnished, not filed, for purposes of certain sections of the Securities Exchange Act and Securities Act.
The company also holds investor-focused events, such as R&D Days and public webcasts, where clinical investigators, statistical experts and company executives discuss the OVATION 3 Phase 3 trial, translational data from OVATION 2 and the minimal residual disease (MRD) study, and the potential role of IMNN-001 in frontline treatment of advanced ovarian cancer. Presentation materials and webcasts are made available through the company’s investor-facing channels as described in news releases.
Business focus and development stage
Across its disclosures, Imunon consistently describes itself as a clinical-stage biotechnology company. Its primary focus is on the development of DNA-mediated immunotherapies and DNA vaccines rather than on commercialized products. The company emphasizes its intent to continue leveraging the TheraPlas and PlaCCine modalities, either directly or through partnerships, to advance plasmid DNA technologies for patients with difficult-to-treat conditions.
Imunon’s sector classification as pharmaceutical preparation manufacturing reflects its role in developing therapeutic candidates and vaccine technologies in oncology and infectious disease. However, based on the information provided, its programs remain in clinical and translational development, with no statement that any product has received marketing approval.