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]

The following is a summary of remarks by Imunon's President and CEO Stacy Lindborg, PhD. on the second quarter 2025 financial results conference call, provided for Shareholders unable to join the call: Advancing the Pivotal Phase 3 OVATION 3 Trial for IMNN-001 in Newly Diagnosed Advanced Ovarian Cancer: The Company is well-positioned for efficient and timely execution of this pivotal Phase 3 study, and has enrolled and begun treating its first patient on the protocol, building on the robust Phase 2 OVATION ...

Stock dividend issued to IMUNON shareholders reflects confidence in clinical programs, long-term growth strategy and dedication to rewarding shareholders First patient dosed in Phase 3 OVATION 3 Study of IMNN-001 for treatment of newly diagnosed advanced ovarian cancer Company to hold conference call today at 11:00 a.m. ET LAWRENCEVILLE, N.J., Aug. 05, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, today reported fin ...

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]

Core Insights - IMUNON, Inc. announced positive results from its Phase 2 OVATION 2 Study of IMNN-001, an investigational therapy for advanced ovarian cancer, showing significant improvements in overall and progression-free survival [1][3][4] - The company has initiated the pivotal Phase 3 OVATION 3 Study following alignment with the FDA, focusing on newly diagnosed advanced ovarian cancer patients [2][5] Group 1: Study Results - The Phase 2 OVATION 2 Study demonstrated a median increase in overall survival (OS) of 13 months for patients treated with IMNN-001 plus standard of care (SoC) compared to SoC alone (46 months vs. 33 months) [3][8] - Patients receiving IMNN-001 in conjunction with PARP inhibitors showed a median OS not yet reached after more than five years, compared to 37 months in the control group, indicating a hazard ratio of 0.38 [3][8] - The study also reported a median 3-month increase in progression-free survival (PFS) for the intent-to-treat population (14.9 months vs. 11.9 months) with a hazard ratio of 0.79 [3][8] Group 2: Treatment Details - IMNN-001 is administered intraperitoneally at a dose of 100 mg/m weekly, combined with neoadjuvant and adjuvant chemotherapy [6][7] - The study enrolled 112 patients with newly diagnosed advanced epithelial ovarian cancer, randomized 1:1 to evaluate the safety and efficacy of IMNN-001 plus chemotherapy versus standard chemotherapy alone [6][7] Group 3: Future Directions - The Phase 3 OVATION 3 Study will include women with newly diagnosed advanced ovarian cancer (stage IIIC or IV) and will assess overall survival as the primary endpoint [5] - The study will also evaluate secondary endpoints such as surgical response score and time to second-line treatment, with a focus on patients with homologous recombination deficiency (HRD+) [5] Group 4: Company Overview - IMUNON is a clinical-stage biotechnology company developing innovative treatments using its proprietary TheraPlas technology platform, which focuses on gene-based delivery of cytokines for cancer treatment [10][11] - The company aims to leverage its technology to provide effective and durable responses for patients with difficult-to-treat conditions, including advanced ovarian cancer [10][11]

Core Insights - IMUNON, Inc. is advancing its lead candidate IMNN-001 in a Phase 3 clinical trial for newly diagnosed advanced ovarian cancer, with the first trial site initiated for the OVATION 3 study [5][6] - The Phase 2 OVATION 2 study data has been accepted for oral presentation at the 2025 ASCO Annual Meeting, highlighting the potential of IMNN-001 in improving patient outcomes [8][9] - The company reported a net loss of $4.1 million for Q1 2025, a decrease from $4.9 million in Q1 2024, indicating improved financial management [15][18] Recent Developments - The initiation of the first trial site for the OVATION 3 study is a significant milestone in the development of IMNN-001, which aims to provide a new treatment option for women with advanced ovarian cancer [5][6] - The OVATION 2 study demonstrated that IMNN-001, when combined with chemotherapy, is the first immunotherapy to extend both progression-free and overall survival in newly diagnosed ovarian cancer patients [3][4] - New translational data from the OVATION 2 study showed a 20% increase in IL-12 levels in patients treated with IMNN-001 compared to those receiving a lower dose, reinforcing the drug's mechanism of action [10] Financial Performance - For Q1 2025, operating expenses were reported at $4.1 million, down 18% from $5.0 million in Q1 2024, primarily due to reduced R&D costs [15][16] - Research and development expenses decreased to $2.2 million in Q1 2025 from $3.3 million in Q1 2024, reflecting lower costs associated with ongoing clinical trials [16] - As of March 31, 2025, the company had cash and cash equivalents of $2.9 million, which is expected to fund operations into late Q2 2025 [18] Clinical Trials and Research - The Phase 3 OVATION 3 trial will evaluate the safety and efficacy of IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy compared to standard care [6] - The study will include women with newly diagnosed advanced ovarian cancer, focusing on overall survival as the primary endpoint [6] - Data from the OVATION 2 study will be published in the peer-reviewed journal Gynecologic Oncology, further validating the findings of the trial [7]

Core Insights - IMUNON, Inc. announced that data from its Phase 1/2 OVATION 2 trial will be published in the peer-reviewed journal Gynecologic Oncology and presented at the ASCO Annual Meeting on June 3, 2025, highlighting the significance of its findings in the treatment of advanced epithelial ovarian cancer [1][2][3][4] 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, differentiating itself from conventional therapies [9] - The company's lead clinical program, IMNN-001, is a DNA-based immunotherapy designed for localized treatment of advanced ovarian cancer, which has completed Phase 2 development [10] Study Details - The OVATION 2 study evaluated the safety and efficacy of intraperitoneal administration of IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy in patients newly diagnosed with advanced epithelial ovarian cancer, enrolling 112 patients [5] - The study was an open-label trial that randomized patients 1:1 to receive either NACT plus IMNN-001 or standard-of-care NACT, with patients in the IMNN-001 arm receiving up to 17 weekly doses of 100 mg/m [5] Treatment Context - Epithelial ovarian cancer is the sixth deadliest malignancy among women in the U.S., with approximately 20,000 new cases annually, and about 70% diagnosed at advanced stages [7] - The disease is characterized by a high risk of recurrence, with a 75% recurrence rate in Stage III/IV patients, underscoring the need for new therapies that can improve overall survival [8] Technology Platform - IMNN-001 is developed using IMUNON's proprietary TheraPlas platform technology, which enables the delivery of IL-12, a potent cytokine that induces strong anticancer immunity [6] - The technology aims to provide localized treatment by instructing the body to produce cancer-fighting molecules at the tumor site, enhancing the therapeutic effect [10]