Core Insights - IMUNON, Inc. announced promising Overall Survival data from the Phase 2 OVATION 2 Study of IMNN-001 for treating newly diagnosed advanced ovarian cancer, which will be presented at the 2025 ASCO Annual Meeting [1][3] - The company has aligned with the FDA on the Phase 3 OVATION 3 clinical trial protocol for IMNN-001 and has begun activating trial sites [1][3] Company Overview - IMUNON is a clinical-stage biotechnology company focused on developing innovative treatments using its proprietary TheraPlas technology platform, which enables gene-based delivery of cytokines for cancer treatment [9][10] - The lead clinical program, IMNN-001, is a DNA-based immunotherapy designed to produce interleukin-12 and interferon gamma at the tumor site, targeting advanced ovarian cancer [10] Study Details - The OVATION 2 Study evaluated the safety and efficacy of intraperitoneal IMNN-001 combined with neoadjuvant chemotherapy in patients with advanced epithelial ovarian cancer, enrolling 112 patients [5][6] - The study was not powered for statistical significance but included endpoints such as objective response rate and surgical response [6] Treatment Context - Epithelial ovarian cancer is a significant health concern, with approximately 20,000 new cases annually in the U.S., and about 70% diagnosed at advanced stages [8] - The five-year survival rates for patients with Stage III/IV ovarian cancer are low, highlighting the need for innovative therapies that improve overall survival and reduce recurrence rates [8]

First and only immunotherapy to show meaningful overall survival benefit in a Phase 2 trial in patients with advanced ovarian cancer Initiation of trial sites underway for ground-breaking Phase 3 pivotal trial of DNA-mediated IL-12 therapeutic Company to hold conference call on Tuesday, March 25, 2025, at 2:00 p.m. ET LAWRENCEVILLE, N.J., March 24, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, today announced that t ...

Imunon, Inc. (NASDAQ:IMNN) Q4 2024 Results Conference Call February 26, 2025 11:00 AM ET Company Participants Peter Vozzo - ICR Healthcare, IR Stacy Lindborg - President & Chief Executive Officer Douglas Faller - Chief Medical Officer David Gaiero - Interim Chief Financial Officer Michael Tardugno - Executive Chairman Khursheed Anwer - Chief Scientific Officer Conference Call Participants David Bautz - Zacks Small-Cap Research James Molloy - Alliance Global Partners Jason Kolbert - D. Boral Capital Kemp Dol ...

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______ UNITED STATES SECURITIES AND EXCHANGE COMMISSION FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Washington, D.C. 20549 For the fiscal year ended December 31, 2024. or COMMISSION FILE NO.: 001-15911 IMUNON, INC. (Exact Name of Registrant as Specified in Its Charter) DELAWARE 52-1256615 (State or other jurisdic ...

Exhibit 99.1 IMUNON Reports 2024 Financial Results and Provides Business Update Highlighting Significant Progress Towards the Initiation of a Pivotal Phase 3 Study IMNN-001 remains the first immunotherapy to achieve a meaningful overall survival benefit in advanced ovarian cancer Patient enrollment in Phase 3 pivotal trial of IMNN-001 scheduled to begin in Q1 2025 Company to hold conference call today at 11:00 a.m. ET LAWRENCEVILLE, N.J., Feb. 27, 2025 (GLOBE NEWSWIRE) – IMUNON, Inc. (NASDAQ: IMNN), a clini ...

IMNN-001 remains the first immunotherapy to achieve a meaningful overall survival benefit in advanced ovarian cancer Patient enrollment in Phase 3 pivotal trial of IMNN-001 scheduled to begin in Q1 2025 Company to hold conference call today at 11:00 a.m. ET LAWRENCEVILLE, N.J., Feb. 27, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, today reported financial results for the year ended December 31, 2024 and highlig ...

Results of IMNN-101 Proof-of-Concept study demonstrate persistent immunogenicity in trial participants and further validate PlaCCine® technology IMNN-101 induced 2- to 4-fold increase in neutralizing antibody (NAb) titers from baseline through Week 4 IMNN-101 continues to show an acceptable safety profile LAWRENCEVILLE, N.J., Feb. 26, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company focused on developing non-viral DNA-mediated immunotherapy and evaluating an adaptation of the p ...

Core Viewpoint - IMUNON, Inc. is set to report its full year 2024 financial results on February 27, 2025, and will host a conference call to discuss these results and provide a business update [1] 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 [3] - The company is advancing its non-viral DNA technology through two main modalities: TheraPlas for gene-based delivery of cytokines in solid tumors, and PlaCCine® for gene delivery of viral antigens to elicit strong immunological responses [3] Clinical Programs - The lead clinical program, IMNN-001, is a DNA-based immunotherapy for advanced ovarian cancer that has completed Phase 2 development, aiming to produce cancer-fighting molecules at the tumor site [4] - IMUNON has also initiated a first-in-human study for its COVID-19 booster vaccine, IMNN-101, and plans to leverage its technologies to address difficult-to-treat conditions while enhancing its financial position through business development opportunities [4]

Core Insights - IMUNON, Inc. announced new data from the Phase 2 OVATION 2 Study of its investigational immunotherapy IMNN-001, showing a 20% increase in IL-12 levels with the 100 mg/m dose compared to the 79 mg/m dose, reinforcing the dose-dependent mechanism of action [1][2][3] - The study demonstrated favorable safety profiles for IMNN-001, with no serious immune-related adverse events reported, indicating a positive benefit-risk profile for the treatment of advanced ovarian cancer [2][3] - IMUNON is preparing to advance IMNN-001 into a Phase 3 pivotal trial, expected to start in the first quarter of 2025, following positive outcomes from an End-of-Phase 2 meeting with the FDA [4][10] Study Results - The OVATION 2 Study evaluated the safety and efficacy of IMNN-001 in combination with standard-of-care chemotherapy in patients with newly diagnosed advanced ovarian cancer, showing significant increases in IL-12 levels in the tumor microenvironment [5][6] - The study reported a median overall survival improvement of 13 months for patients treated with IMNN-001 plus chemotherapy compared to those receiving chemotherapy alone, with over one-third of patients surviving more than 36 months [3][4] - The treatment demonstrated local increases in other key anti-cancer cytokines, such as interferon-gamma (IFN-γ) and tumor necrosis factor-alpha (TNF-α), further supporting its efficacy [2][3] Company Overview - IMUNON is a clinical-stage biotechnology company focused on developing innovative treatments using its proprietary TheraPlas technology platform, which enables localized delivery of cytokines for cancer treatment [9][10] - The company is advancing its lead clinical program, IMNN-001, which is designed to instruct the body to produce cancer-fighting molecules at the tumor site, aiming to improve outcomes for patients with difficult-to-treat conditions [10] - Epithelial ovarian cancer, the target indication for IMNN-001, is a significant health concern, with approximately 20,000 new cases diagnosed annually in the U.S., and a high rate of recurrence after treatment [8]

Core Insights - IMUNON, Inc. has appointed Dr. Douglas V. Faller as Chief Medical Officer, effective February 18, 2025, to lead the clinical strategy for its DNA-mediated immunotherapy [1][2] - The company is advancing its lead program, IMNN-001, for treating newly diagnosed advanced ovarian cancer, which is set to enter a Phase 3 pivotal trial in Q1 2025 [1][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 [8] - The company is developing non-viral DNA technology, with its first modality, TheraPlas®, aimed at gene-based delivery of cytokines for solid tumors [8][9] Leadership and Expertise - Dr. Faller brings over 30 years of experience in biotechnology and pharmaceuticals, with a strong background in oncology and immunology [2][3] - His previous roles include Chief Medical Officer at Skyhawk Therapeutics and Oryzon Genomics, as well as significant experience at Takeda [2][3] Clinical Development - IMNN-001 is designed using IMUNON's proprietary TheraPlas® platform and has shown positive safety and encouraging results in Phase 1 trials [7][9] - The recently completed Phase 2 OVATION 2 Study demonstrated clinically meaningful improvements in overall survival and progression-free survival for patients treated with IMNN-001 combined with chemotherapy [4][7] Financial Incentives - The company has approved inducement stock options for Dr. Faller, granting him the option to purchase 100,000 shares of common stock as part of his compensation package [4][5]