IMNN-001 program is currently advancing its OVATION 3 pivotal Phase 3 trial per plan LAWRENCEVILLE, N.J., Oct. 23, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, today announced that new translational data from the Phase 2 OVATION 2 clinical trial of IMNN-001, its investigational therapy for the treatment of women with newly diagnosed advanced ovarian cancer, will be presented at the Society for Immunotherapy of Canc ...

Investor event to provide update on pivotal Phase 3 study of IMNN-001 to be held in New York City on November 10, 2025 Program will feature presentations from ovarian cancer thought leaders, Phase 3 study investigators, oncology and statistical experts LAWRENCEVILLE, N.J., Oct. 20, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, today announced that it will host an R&D Day for investors at the Harvard Club (35 West 44 ...

Results from OVATION 2 Study reinforce IMNN-001 efficacy benefits observed in the clinic and unique mechanism of action, producing key anti-cancer immune cytokines post-treatment Pivotal Phase 3 trial of IMNN-001 underway, with four trial sites activated to date and on plan for site expansion to accelerate patient recruitment LAWRENCEVILLE, N.J., Sept. 22, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, today announce ...

Core Insights - IMUNON, Inc. has regained compliance with Nasdaq's minimum bid price requirement, ensuring uninterrupted trading on The Nasdaq Capital Market [1][2] - The company recently issued a 15% stock dividend to shareholders, reflecting confidence in its clinical pipeline and commitment to investors [2] - IMUNON's lead clinical program, IMNN-001, is a DNA-based immunotherapy for advanced ovarian cancer, with positive results from the Phase 2 OVATION 2 trial [2][4] Company Overview - IMUNON is a clinical-stage biotechnology company focused on innovative treatments that utilize the body's natural mechanisms to generate effective responses against various diseases [3] - The company is developing non-viral DNA technology, with its first modality, TheraPlas, aimed at gene-based delivery of therapeutic proteins for solid tumors [3] - The second modality, PlaCCine, is designed for gene delivery of viral antigens to elicit strong immunological responses [3] Clinical Development - IMNN-001 instructs the body to produce cancer-fighting molecules at the tumor site and has completed multiple clinical trials, including the Phase 2 OVATION 2 trial [4] - IMUNON has also completed dosing in a first-in-human study of its COVID-19 booster vaccine, IMNN-101 [4] - The company aims to advance its technological capabilities in plasmid DNA to better address difficult-to-treat conditions [4]

Core Insights - IMUNON, Inc. reported financial results for Q2 2025 and highlighted advancements in its Phase 3 clinical trial for IMNN-001, a DNA-mediated immunotherapy for advanced ovarian cancer, along with a 15% stock dividend for shareholders [1][2] Clinical Development - The pivotal Phase 3 OVATION 3 trial for IMNN-001 has commenced, with the first patient treated on July 25, 2025, following robust Phase 2 data showing significant overall survival benefits [2] - The trial design includes two interim analyses and is powered at 95% to detect meaningful overall survival improvements in the intent-to-treat population, with a 99% power in the HRD-positive subgroup [2] - A flexible enrollment strategy will start with a 250-patient HRD-positive subgroup, potentially expanding to a 500-patient all-comers trial, reducing costs by approximately 40% [2] Financial Position - IMUNON has strengthened its balance sheet with over $3 million raised through warrant exercises and ATM sales, while introducing a one-time 15% stock dividend to enhance shareholder value [2] - The company is actively pursuing non-dilutive partnerships to fund the OVATION 3 trial and has achieved compliance with Nasdaq's Shareholder Equity Rule [2] Manufacturing and Operations - IMUNON maintains a reliable in-house manufacturing process for key components of IMNN-001, achieving significant cost reductions compared to outsourcing [2] - Targeted cash conservation measures have been implemented to align resources with the regulatory approval and commercial launch of IMNN-001 [2] Medical Community Engagement - Data from the OVATION 2 study has generated significant interest, leading to unsolicited inquiries from global principal investigators to join the Phase 3 study, indicating strong validation of IMNN-001's potential [2] Background on IMNN-001 - IMNN-001 is designed using IMUNON's TheraPlas® platform and aims to induce potent anticancer immunity through the local secretion of IL-12 [5][8] - The drug has shown positive safety and efficacy results in previous clinical trials, including the recently completed Phase 2 OVATION 2 study [5][8] Market Context - Epithelial ovarian cancer is a significant health concern, with approximately 20,000 new cases annually in the U.S., and a high risk of recurrence, highlighting the need for effective therapies [6]

Core Insights - IMUNON, Inc. is advancing its clinical programs, particularly the Phase 3 OVATION 3 Study of IMNN-001 for newly diagnosed advanced ovarian cancer, reflecting confidence in its long-term growth strategy and commitment to shareholders [1][2][10] Recent Developments - The first patient was dosed in the Phase 3 OVATION 3 Study on July 30, 2025, with a goal of activating 20 clinical sites by the end of 2025 [3] - The OVATION 3 trial will compare IMNN-001 combined with chemotherapy against standard care, focusing on overall survival and other key efficacy endpoints [4] - Positive data from the Phase 2 OVATION 2 Study was presented at the 2025 ASCO Annual Meeting, showing significant improvements in overall survival and safety profile for IMNN-001 [5][6] Financial Highlights - For Q2 2025, the company reported a net loss of $2.7 million, a reduction from $4.8 million in Q2 2024, with operating expenses decreasing by 45% [17] - R&D expenses for Q2 2025 were $1.2 million, down from $2.8 million in Q2 2024, primarily due to lower costs associated with clinical trials [18] - As of June 30, 2025, cash and cash equivalents were $4.7 million, with additional funds raised through warrant exercises and sales under its ATM facility [20] Corporate Actions - A 15% stock dividend was announced, reflecting the company's confidence in its clinical programs and commitment to shareholder value [10] - A reverse stock split of 15-for-1 was executed on July 25, 2025, consolidating shares to improve market perception [14] - The company received an extension from Nasdaq to complete its compliance plan, allowing it to maintain its listing [13] Clinical Program Overview - IMNN-001 is a DNA-based immunotherapy targeting advanced ovarian cancer, with a mechanism that promotes the production of cancer-fighting molecules at the tumor site [29] - The OVATION 3 Study aims to evaluate the safety and efficacy of IMNN-001 in combination with standard chemotherapy for patients with advanced ovarian cancer [4][11]

Core Viewpoint - IMUNON, Inc. is set to host a conference call on August 5, 2025, to discuss its Q2 2025 financial results and provide updates on its clinical development program, particularly focusing on the Phase 3 trial of its DNA-based immunotherapy, IMNN-001, for advanced ovarian cancer [1]. Company Overview - IMUNON is a clinical-stage biotechnology company that develops innovative treatments utilizing the body's natural mechanisms to generate effective responses against various diseases, differentiating itself from conventional therapies [4]. - The company is advancing its non-viral DNA technology through two main modalities: TheraPlas® for gene-based delivery of cytokines and PlaCCine® for gene delivery of viral antigens [4]. Clinical Development - The lead clinical program, IMNN-001, is a DNA-based immunotherapy targeting advanced ovarian cancer, which has completed multiple trials, including a Phase 2 trial (OVATION 2) [5]. - The first site for the Phase 3 pivotal study (OVATION 3) was initiated in Q2 2025, with IMNN-001 designed to instruct the body to produce cancer-fighting molecules at the tumor site [5]. - Additionally, the company has completed dosing in a first-in-human study of its COVID-19 booster vaccine (IMNN-101) [5].

Core Points - IMUNON, Inc. has received approval from the Nasdaq Hearing Panel for an exception to complete its compliance plan, allowing the company to maintain its Nasdaq listing [1][2] - The Nasdaq Hearing Panel noted that IMUNON has achieved compliance with the Equity Rule through recent fundraising activities and will implement a compliance plan to meet minimum shareholder equity and bid price requirements [2][3] - The Panel approved a tailored exception for IMUNON to regain compliance within a designated timeframe, rather than the full 180 days initially requested [3] Company Overview - IMUNON is a clinical-stage biotechnology company focused on developing innovative treatments that utilize the body's natural mechanisms to generate effective responses against various diseases [5] - The company is advancing its non-viral DNA technology, with its lead clinical program, IMNN-001, being a DNA-based immunotherapy for advanced ovarian cancer [6] - IMNN-001 has completed multiple clinical trials, including a Phase 2 trial, and the company has also conducted a first-in-human study for its COVID-19 booster vaccine, IMNN-101 [6]

Core Viewpoint - IMUNON, Inc. is actively working to regain compliance with Nasdaq's listing requirements, focusing on its lead clinical program, IMNN-001, a DNA-based immunotherapy for advanced ovarian cancer [1][2]. Group 1: Compliance and Financial Status - The company has submitted a plan to Nasdaq to regain compliance with minimum bid price and stockholders' equity requirements [1]. - As of May 31, 2025, the company's stockholders' equity exceeds $3.0 million, surpassing Nasdaq's listing threshold [2]. Group 2: Clinical Development - IMUNON is in Phase 3 development of its lead clinical program, IMNN-001, which targets advanced ovarian cancer [2][4]. - The company has initiated its Phase 3 trial (OVATION 3) in the U.S. and Canada following positive results from the Phase 2 trial (OVATION 2) [2]. - IMNN-001 aims to instruct the body to produce cancer-fighting molecules at the tumor site [4]. Group 3: Technology Platforms - IMUNON is developing two main technology platforms: TheraPlas for gene-based delivery of cytokines and PlaCCine for gene delivery of viral antigens [3]. - The company is also advancing a COVID-19 booster vaccine (IMNN-101) through clinical trials [4].

Core Insights - IMUNON, Inc. announced positive results from its Phase 2 OVATION 2 Study, demonstrating the efficacy of IMNN-001 in improving overall survival and progression-free survival in women with newly diagnosed advanced ovarian cancer [1][4][9] Group 1: Study Results - The Phase 2 OVATION 2 Study involved 112 participants randomized to receive IMNN-001 plus neoadjuvant and adjuvant chemotherapy versus standard of care, with a median follow-up of 31 months [2][5] - IMNN-001 treatment resulted in a median overall survival increase of 13 months (46 months vs. 33 months) and a median progression-free survival increase of 3 months (14.9 months vs. 11.9 months) compared to standard care [4][5] - The chemotherapy response score indicated a response rate of 26.1% in the IMNN-001 group versus 13.0% in the control group, highlighting a significant therapeutic effect [4] Group 2: Safety Profile - IMNN-001 exhibited a favorable safety profile with no serious immune-related adverse events reported, and the most common adverse events included abdominal pain, nausea, and vomiting [4][6] - The study showed a surgical response rate of 64.6% for the IMNN-001 treatment arm compared to 52.1% for the control arm, indicating better surgical outcomes [4] Group 3: Mechanism and Technology - IMNN-001 is based on IMUNON's proprietary TheraPlas technology, designed to induce a potent anti-cancer immune response through the local secretion of IL-12 [6][9] - The treatment is particularly effective in patients with homologous recombination deficiency (HRD+), including those with BRCA1 and BRCA2 mutations, as indicated by a hazard ratio of 0.42 [4][6] Group 4: Future Directions - The company plans to advance its pivotal Phase 3 OVATION 3 trial of IMNN-001, with initial trial sites recently initiated [3][9] - IMUNON aims to leverage its non-viral DNA technology to develop innovative treatments for various diseases, focusing on solid tumors [8][9]