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]

Core Viewpoint - IMUNON, Inc. has reported significant progress in its clinical development of IMNN-001 for advanced ovarian cancer, demonstrating promising survival benefits and preparing for a pivotal Phase 3 study in 2025 [2][6][19]. Clinical Development - The OVATION 2 Study results showed an overall survival improvement of 11.1 months for patients treated with IMNN-001 compared to standard care, with a hazard ratio of 0.74 indicating a 35% improvement in survival [2][6]. - For patients receiving both IMNN-001 and PARP inhibitors, the hazard ratio improved to 0.41, with median overall survival not yet reached in the IMNN-001 group [6]. - The primary endpoint of progression-free survival (PFS) also showed a three-month improvement compared to standard care, with a hazard ratio of 0.79, indicating a 27% improvement in delaying disease progression [7]. Recent Developments - IMUNON will present new OVATION 2 data at the Society for Immunotherapy of Cancer Annual Meeting, highlighting the significance of the findings [3][4]. - The company is preparing for an End-of-Phase 2 meeting with the FDA to discuss the design of the upcoming registrational study [2]. Financial Results - As of September 30, 2024, the company reported $10.3 million in cash and investments, sufficient to fund operations into Q3 2025 [11]. - Research and development expenses for Q3 2024 were $3.3 million, up from $2.0 million in Q3 2023, while general and administrative expenses decreased to $1.7 million from $1.9 million [12]. - The net loss for Q3 2024 was $4.9 million, or $0.34 per share, compared to a net loss of $3.5 million, or $0.37 per share, in Q3 2023 [13]. Corporate Developments - The company raised $10 million through a registered direct offering, issuing 5 million shares at $2.00 per share [8]. - New leadership appointments include Susan Eylward as General Counsel and Kristin Longobardi as Senior Vice President of Operations, aimed at enhancing operational excellence [9][10].

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 ...

September 18th Event in New York City to Include a Review of the Opportunity for Investigational Therapy IMNN-001 (IL-12) to Treat Advanced Ovarian Cancer and Clinical Development Timeline LAWRENCEVILLE, N.J., Sept. 09, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, will hold its first Ovarian Cancer R&D Day on September 18, 2024 at the Harvard Club (35 West 44th Street) in New York City. The event will feature pr ...

R&D Discussion in New York City to Review IL-12's Potential to Treat Ovarian Cancer IMUNON LHA Investor Relations David Gaiero Kim Sutton Golodetz 978-376-6352 212-838-3777 dgaiero@imunon.com kgolodetz@lhai.com Program Features Ovarian Cancer Thought Leaders, OVATION 2 Study Investigators, and Oncology Experts LAWRENCEVILLE, N.J., Aug. 28, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, invites investors to mark th ...