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About Imunon Inc (IMNN)
Imunon Inc is a clinical-stage biotechnology company dedicated to advancing innovative therapies that harness the body's natural immune mechanisms to combat a wide range of human diseases. Operating at the intersection of biotechnology and immunotherapy, Imunon focuses on developing safe, effective, and durable treatments that address critical unmet medical needs, particularly in oncology. The company leverages cutting-edge platform technologies to create novel nucleic acid-based therapies, including DNA and RNA-based treatments, positioning itself as a pioneer in the next generation of precision medicine.
Core Business Areas
Imunon’s business model is centered around the research, development, and clinical testing of targeted therapies. The company’s portfolio includes a multi-phase clinical pipeline that spans various stages of development, reflecting its commitment to bringing innovative solutions from the lab to the clinic. By integrating advanced platform technologies, Imunon is able to design and optimize therapies that deliver precise, targeted effects, minimizing side effects and enhancing therapeutic outcomes.
Platform Technologies and Expertise
With the acquisition of Egen, Inc., Imunon has significantly expanded its capabilities, becoming a fully integrated biotechnology company. This strategic move has enriched its technological portfolio, particularly in the realm of nucleic acid-based immunotherapies. The company’s proprietary platforms enable the discovery and development of groundbreaking DNA/RNA therapies that work in harmony with the body’s immune system. These platforms are designed to address a broad spectrum of diseases, with a primary focus on oncology, where the need for innovative treatments is most pressing.
Market Position and Competitive Landscape
Imunon operates within the highly competitive biopharmaceutical industry, which includes major players in oncology and immunotherapy. Its focus on nucleic acid-based therapies and immunotherapy differentiates it from traditional pharmaceutical approaches, offering a unique value proposition to the market. The company’s emphasis on addressing unmet medical needs positions it as a key player in the development of next-generation cancer treatments and other disease-targeted therapies.
Challenges and Opportunities
As a clinical-stage company, Imunon faces the typical challenges of high R&D costs, regulatory approval processes, and the need to demonstrate clinical efficacy and safety. However, its integrated approach, combining proprietary platform technologies with a robust clinical pipeline, provides significant opportunities for innovation and market impact. By focusing on diseases with limited treatment options, Imunon aims to carve out a niche in the competitive biotechnology landscape.
Commitment to Innovation
Imunon’s mission is rooted in leveraging the building blocks of life to create therapies that align with the body’s natural processes. This commitment to innovation is evident in its focus on nucleic acid-based treatments and its dedication to advancing the field of immunotherapy. By prioritizing safety, efficacy, and durability, the company seeks to deliver transformative solutions that improve patient outcomes and set new standards in medical treatment.
IMUNON (NASDAQ: IMNN) has scheduled its Third Quarter 2024 Financial Results conference call for Thursday, November 7, 2024, at 11:00 a.m. ET. The company will discuss Q3 2024 financial performance and provide updates on two key programs: IMNN-001, a DNA-based IL-12 immunotherapy for first-line ovarian cancer treatment, and PlaCCine, their DNA plasmid technology for next-generation vaccine development. The call will be accessible via phone and webcast, with replay available until November 21, 2024.
IMUNON announced the acceptance of late-breaking data presentation from Phase 2 OVATION 2 Study of IMNN-001 at SITC's 39th Annual Meeting. The study showed an 11.1-month increase in median overall survival among patients treated with IMNN-001 compared to standard care, representing a 35% improvement in survival. The company will hold an in-person End-of-Phase 2 meeting with the FDA to discuss the design of a Phase 3 pivotal study, expected to begin in Q1 2025. IMNN-001 is a DNA-mediated immunotherapy using TheraPlas® platform technology, designed to produce and secrete IL-12 protein for strong anti-cancer immunity.
IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company developing DNA-mediated immunotherapy, has announced the approval of inducement stock options by its Compensation Committee. The grants include:
1. Options to purchase 60,000 shares of common stock for one individual hired in Q4 2024.
2. Options to purchase 50,000 shares of common stock for Susan Eylward, hired as General Counsel and Secretary effective October 7, 2024.
These grants, made on October 7, 2024, comply with Nasdaq Listing Rule 5635(c)(4). The options have a 10-year term and a four-year vesting schedule, with 25% vesting on the first anniversary and the remainder vesting annually until fully vested on the fourth anniversary, subject to continued employment.
IMUNON (NASDAQ: IMNN) announced its first Ovarian Cancer R&D Day on September 18, 2024, in New York City. The event will focus on IMNN-001, their investigational DNA-mediated immunotherapy for advanced ovarian cancer. Key presentations will cover:
1. Positive topline data from the Phase 2 OVATION 2 Study, showing an 11.1-month increase in median overall survival.
2. Insights from clinical investigators, immunology experts, and biostatisticians.
3. The role of IL-12 in cancer treatment.
4. Ongoing Phase 1/2 study of IMNN-001 with bevacizumab.
5. Plans for a Phase 3 registration study.
The event aims to highlight IMNN-001's potential to change the treatment paradigm for newly diagnosed ovarian cancer patients.
IMUNON (NASDAQ: IMNN) is hosting an R&D Day on September 18th at the Harvard Club in New York City from 10:00 a.m. to 1:00 p.m. Eastern time. The event follows the announcement of top-line data from their randomized Phase II Ovation 2 Study, which showed an 11.1-month increase in median overall survival for advanced ovarian cancer patients, representing a 35% improvement in survival.
The program will feature ovarian cancer experts, principal investigators from the OVATION 2 Study, and discussions on IMNN-001's potential role in treating advanced ovarian cancer. Management will also discuss next steps for their immunotherapy and prospects for extending patient survival. While in-person attendance is encouraged, a virtual option will be available. Program details and RSVP information will be provided soon.
IMUNON (NASDAQ: IMNN) reported positive topline results from its Phase 2 OVATION 2 Study of IMNN-001 in advanced ovarian cancer. Key highlights include:
- 11.1 month increase in median overall survival (OS) compared to standard-of-care
- 35% improvement in survival (hazard ratio 0.74) in intent-to-treat population
- 15.7 month increase in median OS for patients receiving at least 20% of specified treatments
- 56% improvement in survival (hazard ratio 0.64) for per-protocol population
The company plans to hold an End-of-Phase 2 meeting with the FDA to discuss a Phase 3 study protocol, anticipated to begin in Q1 2025. IMUNON also reported financial results, with a net loss of $4.8 million for Q2 2024 and $9.7 million for H1 2024. The company raised $10 million in a registered direct offering, extending its cash runway into Q3 2025.
IMUNON, Inc. (NASDAQ: IMNN) has announced a conference call scheduled for August 14, 2024, at 11:00 a.m. ET to discuss its second quarter 2024 financial results and provide updates on its clinical development programs. The company will focus on two key areas:
1. IMNN-001: A DNA-based interleukin-12 (IL-12) immunotherapy in Phase 2 clinical development for first-line, locally advanced-stage ovarian cancer.
2. PlaCCine modality: A proprietary DNA plasmid and synthetic DNA delivery technology for expressing pathogen antigens in next-generation vaccine development.
Interested parties can join the call via phone or webcast, with replay options available until August 28, 2024.
IMUNON (NASDAQ: IMNN) has announced a $10 million registered direct offering of its common stock, priced at-the-market under Nasdaq rules. The offering includes 5,000,000 registered shares at $2.00 per share, along with unregistered warrants to purchase up to 5,000,000 additional shares. The warrants have an exercise price of $2.00 per share and are exercisable immediately for 5.5 years. The company expects to close the offering around August 1, 2024, with H.C. Wainwright & Co. as the lead placement agent. IMUNON plans to use the net proceeds for working capital and general corporate purposes. The offering is made pursuant to a previously filed and effective shelf registration statement.
IMUNON announces positive topline results from the Phase 2 OVATION 2 Study of IMNN-001 in patients with advanced ovarian cancer. Key highlights include:
- 11.1-month increase in median overall survival (OS) compared to standard-of-care in the intent-to-treat population
- 15.7-month increase in median OS for patients receiving at least 20% of specified treatments
- Hazard ratio of 0.41 for patients also receiving PARP inhibitor therapy
- 3-month improvement in progression-free survival
IMUNON plans to initiate a Phase 3 registrational study in Q1 2025, pending FDA discussions.
IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company, is set to announce topline results from its Phase 2 OVATION 2 Study on July 30, 2024, at 8:00 a.m. Eastern time. The study focuses on IMNN-001, the company's DNA-mediated immunotherapy for advanced ovarian cancer. IMNN-001 is an interleukin-12 (IL-12) immunotherapy based on IMUNON's TheraPlas™ technology.
Following the announcement, IMUNON will host an investment community conference call at 8:30 a.m. Eastern time to discuss the results and answer questions. Interested parties can participate by dialing 833-816-1132 (Toll-Free/North America) or 412-317-0711 (International/Toll). A live webcast and replay of the call will be available, with the replay accessible until August 13, 2024.
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