Core Insights - IMUNON, Inc. has reported that its lead immunotherapy candidate, IMNN-001, is the first to demonstrate a significant overall survival benefit in advanced ovarian cancer, achieving an overall survival of 13 months compared to the current standard of care [3][7] - The company is preparing to initiate a Phase 3 pivotal trial for IMNN-001 in Q1 2025, following positive interactions with the FDA regarding the trial design and manufacturing processes [2][8][5] Financial Performance - For the year ended December 31, 2024, IMUNON reported a net loss of $18.6 million, or $1.62 per share, an improvement from a net loss of $19.5 million, or $2.16 per share in 2023 [17][29] - Operating expenses decreased by 9% to $19.1 million in 2024 from $21.0 million in 2023, with research and development expenses slightly decreasing to $11.6 million [17][18] - The company ended 2024 with $5.9 million in cash and cash equivalents, indicating sufficient capital resources to fund operations into late Q2 2025 [21] Clinical Development - The Phase 2 OVATION 2 Study of IMNN-001 showed a decrease in the hazard ratio from 0.74 to 0.69, with more than one-third of patients surviving over 36 months [7][3] - New translational data from the OVATION 2 Study indicated a 20% increase in IL-12 levels in patients treated with IMNN-001, supporting its mechanism of action [4] - The company has engaged with the FDA to finalize the design of the planned registrational study, reflecting strong support from trial investigators and regulators [3][8] Corporate Developments - Douglas V. Faller, M.D., Ph.D., was appointed as Chief Medical Officer to lead the clinical strategy for advancing IMNN-001 [14][15] - The company held an Ovarian Cancer R&D Day to discuss advancements in its clinical programs and engage with leaders in oncology research [9] Technology and Innovation - IMUNON is advancing its DNA-mediated immunotherapy platform, TheraPlas, which aims to enhance the immune response against cancer [24][25] - The company is also developing a COVID-19 vaccine, IMNN-101, which has shown promising safety and immunogenicity results in a Phase 1 trial [10][13]

Core Insights - IMUNON, Inc. announced positive results from its Phase 1 proof-of-concept clinical trial for IMNN-101, a DNA plasmid vaccine targeting the SARS-CoV-2 Omicron XBB1.5 variant, demonstrating safety and immunogenicity [2][3][4] Group 1: Clinical Trial Results - The Phase 1 trial involved 24 healthy volunteers and showed that IMNN-101 induced a persistent 2- to 4-fold increase in neutralizing antibody (NAb) titers from baseline through Week 4, with further increases observed between Week 2 and Week 4 [2][4] - No serious adverse effects were reported, indicating an acceptable safety profile for IMNN-101 [2][3] - The immune response was effective against the XBB1.5 variant and other newer variants, showcasing the vaccine's cross-reactivity [2][3] Group 2: Technology and Development - IMNN-101 is based on the proprietary PlaCCine technology platform, which allows for flexible manufacturing and stable storage conditions, making it a potential alternative to mRNA vaccines [5][6] - The vaccine demonstrated strong immunogenicity in preclinical studies, with over 95% protection in non-human primates, comparable to existing mRNA vaccines [5] - The PlaCCine platform's design accommodates single or multiple antigens, enhancing its potential for developing vaccines against various infectious diseases [6] Group 3: Future Prospects - The company anticipates interest from potential partners for further development of IMNN-101 based on the strong immunogenicity evidence and competitive advantages in stability [3][5] - IMUNON is also advancing its lead clinical program, IMNN-001, a DNA-based immunotherapy for advanced ovarian cancer, indicating a broader focus on innovative treatments [10]

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]

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 ...