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Imunon, Inc. (symbol: IMNN) is a biopharmaceutical company focused on the research and development of targeted therapies to address unmet medical needs in oncology. With the recent acquisition of EGEN, Inc., Imunon has transformed into a fully integrated company boasting a comprehensive, multi-phase clinical pipeline. The company specializes in nucleic acid-based immunotherapies and other anti-cancer DNA/RNA therapies. Their platform technologies are designed to leverage the body's natural mechanisms, aiming to generate safe, effective, and durable responses across a wide range of human diseases.
Imunon is committed to innovation and excellence in the field of biotechnology, seamlessly integrating research from the laboratory to clinical applications. By harnessing the building blocks of life, the company strives to work in harmony with the body's immune system to develop groundbreaking treatments.
The company's current projects include a variety of clinical trials that seek to validate the efficacy and safety of their therapies. These efforts are supported by a team of experts with extensive experience in drug development. Imunon's financial health is robust, enabling continuous research and the potential for future growth. Additionally, the company values strategic partnerships that bolster its capabilities and extend its reach in the biotech industry.
For investors and stakeholders, Imunon, Inc. represents a promising opportunity in the field of biopharmaceuticals, with a strong focus on innovative cancer treatments and a commitment to addressing significant healthcare challenges.
IMUNON (NASDAQ: IMNN) reported significant progress in 2024 for its DNA-mediated immunotherapy IMNN-001. The company announced robust Phase 2 OVATION 2 Study results showing 13 months overall survival benefit in advanced ovarian cancer patients when combined with chemotherapy. The study demonstrated IMNN-001 as the first immunotherapy to show clinical benefits in both progression-free and overall survival in ovarian cancer.
Key developments include: positive FDA CMC meeting, improved survival data with hazard ratio decreasing from 0.74 to 0.69, and successful End-of-Phase 2 FDA meeting. The company plans to initiate Phase 3 pivotal trial in Q1 2025.
Financial results show a net loss of $18.6 million ($1.62 per share) for 2024, compared to $19.5 million in 2023. Operating expenses decreased 9% to $19.1 million, with R&D expenses at $11.6 million. The company raised $9.1 million through equity offerings in 2024.
IMUNON (NASDAQ: IMNN) has announced new data from its Phase 1 clinical trial of IMNN-101, a DNA plasmid vaccine using their PlaCCine® technology platform. The trial, involving 24 healthy volunteers previously vaccinated against Omicron XBB1.5, demonstrated promising results as a seasonal COVID-19 vaccine.
Key findings include:
- A 2-4 fold increase in neutralizing antibody titers from baseline through Week 4
- Cross-reactivity against XBB1.5 and newer variants
- Safe and well-tolerated profile with no serious adverse effects
- Vaccine stability up to one year at 4°C and one month at 37°C
The vaccine's performance aligns with preclinical results showing over 95% protection in non-human primates, comparable to mRNA vaccines. The company is now seeking potential partners for further development, highlighting IMNN-101's potential as a next-generation vaccine alternative.
IMUNON (NASDAQ: IMNN), a clinical-stage company developing DNA-mediated immunotherapy, has scheduled its full year 2024 financial results announcement and business update conference call for Thursday, February 27, 2025. The company will release its financial results before U.S. markets open, followed by a conference call at 11:00 a.m. ET.
Investors can participate by dialing 833-816-1132 (North America Toll-Free) or 412-317-0711 (International). The call replay will be available until March 12, 2025, accessible via 877-344-7529 (U.S.), 855-669-9658 (Canada), or 412-317-0088 (International) using code 7147564. A webcast replay will be available for 90 days.
IMUNON (NASDAQ: IMNN) has announced new translational data from its Phase 1/2 OVATION 2 Study of IMNN-001 in advanced ovarian cancer. The study demonstrated a 20% increase in IL-12 levels with the 100mg/m2 dose compared to the 79mg/m2 dose when administered with standard-of-care chemotherapy.
The data showed increased levels of anti-cancer immune cytokines IFN-γ and TNF-α in the tumor microenvironment, with minimal systemic impact. The treatment maintained a favorable safety profile with no serious immune-related adverse events. Previous December 2024 results showed a 13-month improvement in median overall survival with IMNN-001 plus standard care versus standard care alone. More than one-third of patients survived beyond 36 months, with 62% from the IMNN-001 treatment arm.
Following an End-of-Phase 2 FDA meeting, IMUNON is proceeding with a Phase 3 pivotal trial in Q1 2025.
IMUNON (NASDAQ: IMNN) has appointed Douglas V. Faller, M.D., Ph.D., as Chief Medical Officer, effective February 18, 2025. Dr. Faller brings over 30 years of industry, academic, and laboratory experience, specializing in oncology and immunology. He will lead the company's clinical strategy, including advancing IMNN-001 for newly diagnosed advanced ovarian cancer into a Phase 3 pivotal trial in Q1 2025.
Dr. Faller previously served as Chief Medical Officer at Skyhawk Therapeutics and Oryzon Genomics, and held executive positions at Takeda. The Phase 2 OVATION 2 Study has shown promising results, demonstrating clinically meaningful improvements in overall survival and progression-free survival in women treated with IL-12 immunotherapy plus chemotherapy.
As part of his appointment, Dr. Faller will receive inducement stock options to purchase 100,000 shares of common stock, vesting over four years.
IMUNON (NASDAQ: IMNN) announced a successful Type C Chemistry, Manufacturing, and Controls (CMC) meeting with the FDA regarding IMNN-001, their DNA-mediated immunotherapy for advanced ovarian cancer. The FDA aligned with IMUNON's manufacturing strategy and requirements for their upcoming 500-patient Phase 3 pivotal trial, scheduled to begin in Q1 2025.
Key outcomes include FDA's acceptance of the company's potency assay measuring interferon-gamma (IFN-γ) for both Phase 3 and commercial use, and agreement on the strategy to establish comparability between IMUNON's in-house manufacturing and previous CDMO-produced components. The company's Huntsville, Alabama facility will handle the manufacturing process, ensuring cost-efficient production for both clinical trials and potential commercialization.
IMUNON (NASDAQ: IMNN) reported improved overall survival (OS) data from its Phase 2 OVATION 2 Study of IMNN-001 for advanced ovarian cancer treatment. After seven additional months of monitoring, the hazard ratio improved from 0.74 to 0.69, with median OS increasing from 11.1 to 13 months in the IMNN-001 plus standard-of-care (SoC) treatment group compared to SoC alone.
The study, involving 112 newly diagnosed advanced ovarian cancer patients, showed that over one-third of participants survived beyond 36 months, with 62% from the IMNN-001 treatment arm. The treatment maintained its favorable safety profile with no serious immune-related adverse events. IMUNON plans to initiate a Phase 3 pivotal trial in Q1 2025.
IMUNON (NASDAQ: IMNN) announced successful results from its End-of-Phase 2 meeting with the FDA for IMNN-001, its DNA-mediated immunotherapy for advanced ovarian cancer. The FDA supported the company's proposed Phase 3 trial strategy, including trial design, patient population, and endpoints. The 500-patient Phase 3 trial is scheduled to begin in Q1 2025. The company's Phase 2 OVATION 2 Study showed approximately one-year (35%) improvement in overall survival when IMNN-001 was combined with standard chemotherapy compared to chemotherapy alone. The treatment demonstrated good tolerability with no serious immune-related adverse events.
IMUNON announced positive Phase 2 OVATION 2 trial results for IMNN-001 in advanced ovarian cancer. The study of 112 patients showed that IMNN-001 plus standard chemotherapy improved overall survival by 35% (40.5 vs 29.4 months) and progression-free survival by 25% (14.9 vs 11.9 months) compared to chemotherapy alone. The treatment demonstrated better surgical outcomes with a 64.6% response rate versus 52.1% for standard care. IMNN-001 was well-tolerated with no serious immune-related adverse events. The company plans to initiate a Phase 3 pivotal trial in Q1 2025 following FDA discussions.
IMUNON reported Q3 2024 financial results and provided updates on its clinical developments. The company highlighted compelling topline results from the OVATION 2 Study with IMNN-001 in advanced ovarian cancer, showing an 11.1-month overall survival improvement compared to standard care. The company plans to begin a 500-patient pivotal Phase 3 study in Q1 2025. Financial results showed $10.3 million in cash and investments as of September 30, 2024, with Q3 net loss of $4.9 million ($0.34 per share). Research and development expenses increased to $3.3 million from $2.0 million in Q3 2023.
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