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 Experience - 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] Stock Options and Compensation - The company has approved inducement stock options for Dr. Faller, granting him the option to purchase 100,000 shares of common stock, with a 10-year term and a four-year vesting schedule [4][5][6]

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]

Core Insights - IMUNON, Inc. has successfully aligned with the FDA on Chemistry, Manufacturing, and Controls (CMC) strategy for its IMNN-001 immunotherapy, aimed at treating advanced ovarian cancer [2][3] - The company is on track to initiate a 500-patient Phase 3 pivotal trial of IMNN-001 in the first quarter of 2025 [2][3] 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 [7] - The lead clinical program, IMNN-001, is a DNA-based immunotherapy designed for localized treatment of advanced ovarian cancer, which has completed Phase 2 development [8] Product Details - IMNN-001 is developed using IMUNON's proprietary TheraPlas platform, which enables the delivery of IL-12, a potent cytokine for anticancer immunity [4] - Previous studies have shown positive safety and efficacy results for IMNN-001, including a completed Phase 1b trial and a recently concluded Phase 2 study [4][5] Market Context - Epithelial ovarian cancer is a significant health concern, with approximately 20,000 new cases annually in the U.S., and a high percentage diagnosed at advanced stages [5] - The need for effective therapies is underscored by poor five-year survival rates for patients diagnosed with advanced stages of the disease [5]

Core Insights - IMUNON, Inc. has received FDA support for its Phase 3 trial strategy for the investigational interleukin-12 (IL-12) immunotherapy IMNN-001 aimed at treating advanced ovarian cancer, with plans to initiate a 500-patient trial in Q1 2025 [1][2][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 [7][8] - 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 [8] Clinical Development - The recent End-of-Phase 2 meeting with the FDA confirmed the positive results from the Phase 2 OVATION 2 Study, which showed a 35% improvement in overall survival for patients receiving IMNN-001 in combination with standard chemotherapy compared to chemotherapy alone [3] - IMNN-001 is designed using the proprietary TheraPlas® platform, which allows for the local secretion of IL-12, a potent cytokine for inducing anticancer immunity [4][8] Market Context - Epithelial ovarian cancer is a significant health concern, with approximately 20,000 new cases diagnosed annually in the U.S., and about 70% of these cases are advanced at diagnosis [5] - The current five-year survival rates for patients diagnosed with advanced ovarian cancer are low, highlighting the need for new therapies that can improve overall survival and reduce recurrence rates [5]

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 ...

Results from OVATION 2 Study of IMNN-001 to be highlighted in late-breaking acceptance Company also announces FDA End-of-Phase 2 in-person meeting to discuss Phase 3 trial of IMNN-001 Phase 3 trial is expected to begin in Q1 2025 LAWRENCEVILLE, N.J., Oct. 30, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, today announced the acceptance of a late-breaking presentation featuring new clinical data from the Phase 2 OV ...

LAWRENCEVILLE, N.J., Oct. 07, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN) (the "Company"), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, today announced that the Compensation Committee of the Company's Board of Directors approved the grant of (i) inducement stock options to purchase a total of 60,000 shares of the Company's common stock to one individual hired by Imunon during the fourth quarter of 2024 and (ii) inducement stock options to purchase a total ...