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]

Dr. Faller joins IMUNON with more than 30 years of industry, academic and laboratory experience, with specialized expertise in oncology and immunology LAWRENCEVILLE, N.J., Feb. 10, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, today announced the appointment of Douglas V. Faller, M.D., Ph.D., as chief medical officer, effective February 18, 2025. In this role, Dr. Faller will lead the company’s clinical strategy ...

Company aligned with FDA on CMC strategy and requirements in preparation of Phase 3 pivotal trial of IMNN-001 Vertical integration of major components assures a high-quality, commercially viable future manufacturing capability On track to initiate Phase 3 pivotal trial of IMNN-001 in first quarter of 2025 LAWRENCEVILLE, N.J., Dec. 19, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, today announced the positive outc ...

FDA Project Team supports the company’s proposed Phase 3 trial strategy, including overall trial design, target patient population, treatment schedule, and primary endpoint Final Protocol submission on track for December, supporting initiation of Phase 3 registrational trial in Q1 2025 LAWRENCEVILLE, N.J., Nov. 25, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, today announced the outcome of its recent End-of-Phas ...

Imunon, Inc. (NASDAQ:IMNN) Q3 2024 Earnings Conference Call November 7, 2024 11:00 AM ET Company Participants Kim Golodetz - Alliance Advisors IR Stacy Lindborg - President & Chief Executive Officer David Gaiero - Interim Chief Financial Officer Michael Tardugno - Executive Chairman Conference Call Participants David Bautz - Zacks Kemp Dolliver - Brookline Capital Markets James Molloy - Alliance Global Partners Operator Hello everyone. Good morning. My name is Malone, and I will be your operator today. At ...

Exhibit 99.1 IMUNON Reports Third Quarter 2024 Financial Results and Provides Business Updates Conference call today at 11:00 a.m. ET LAWRENCEVILLE, N.J., Nov. 7, 2024 – IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, today reported financial results for the three and nine months ended September 30, 2024. The Company also provided an update on its clinical development of IMNN-001 including progress toward commencing a Phase 3 study in adva ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to ____________ Commission file number: 001-15911 Imunon, Inc. (Exact name of Registrant as specified in its charter) | --- | --- | --- | --- ...

Conference call today at 11:00 a.m. ET LAWRENCEVILLE, N.J., Nov. 07, 2024 (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 three and nine months ended September 30, 2024. The Company also provided an update on its clinical development of IMNN-001 including progress toward commencing a Phase 3 study in advanced ovarian cancer, and an update on IMNN-101, its seasonal COVID-19 booste ...

LAWRENCEVILLE, N.J., Oct. 31, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development company focused on developing DNA-mediated immunotherapy and next-generation vaccines, announces that the Company will host a conference call at 11:00 a.m. ET on Thursday, November 7, 2024 to discuss financial results for the third quarter ended September 30, 2024 and provide an update on its clinical development programs with IMNN-001, a DNA-based interleukin-12 (IL-12) immunotherapy for th ...