LAWRENCEVILLE, N.J., June 05, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, today announced that Stacy Lindborg, Ph.D., President and Chief Executive Officer of Imunon, will present at the Zacks SCR Life Sciences Virtual Investor Forum on Thursday, June 12, 2025, at 11:30 a.m. ET. Pre-register for Imunon’s virtual presentation at the Virtual Investor Conferences site HERE. This will be a live, interactive online eve ...

Consistent OS Efficacy Benefit Across Multiple Treatment Subgroups Demonstrates IMNN-001’s Ability to Recruit a Powerful Anti-Cancer Immune Response Results, presented simultaneously in oral presentation at ASCO 2025 and in peer-reviewed Gynecologic Oncology, suggest very meaningful survival effect of IMNN-001 in women HRP and HRD positive, including those with BRAC1 and BRCA2 mutations LAWRENCEVILLE, N.J., June 03, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in Phase 3 ...

Outstanding Phase 2 Results will be discussed at the 2025 ASCO in an Oral Presentation and featured in peer reviewed medical journal Gynecologic Oncology Phase 3 OVATION 3 Study in progress LAWRENCEVILLE, N.J. , June 02, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN) Dear Valued Shareholders, A Year of Breakthroughs: IMUNON Has Never Been Stronger As I mark my first year as President and CEO of IMUNON, I am thrilled to share the progress we have made in advancing our mission to transform cancer treat ...

$3.25 million upfront with up to an additional $6.5 million of potential aggregate gross proceeds upon the exercise in full of short-term warrants LAWRENCEVILLE, N.J., May 28, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in Phase 3 development of its DNA-mediated immunotherapy, today closed on the previously announced sale of an aggregate of 7,222,223 shares of its common stock (or pre-funded warrants in lieu therof) and short-term warrants to purchase up to an aggregate of ...

Core Insights - IMUNON, Inc. is advancing its DNA-mediated immunotherapy, IMNN-001, which shows promising survival data for women with advanced ovarian cancer, with presentations scheduled at major oncology conferences [1][2][4] - The OVATION 2 Study demonstrated significant improvements in overall survival and progression-free survival for patients treated with IMNN-001 in combination with standard chemotherapy [2][5] - IMNN-001 utilizes a proprietary TheraPlas technology platform, delivering interleukin-12 (IL-12) to enhance anti-cancer immunity, marking it as the first IL-12 immunotherapy to show clinical efficacy in advanced ovarian cancer [3][7] Company Overview - IMUNON is a clinical-stage biotechnology company focused on innovative treatments that leverage the body's immune response, with a particular emphasis on non-viral DNA technology [9][10] - The company is developing multiple modalities, including TheraPlas for gene-based delivery of cytokines and PlaCCine for viral antigens, aiming to address solid tumors and other challenging conditions [9][10] Study Details - The Phase 2 OVATION 2 Study involved 112 patients with newly diagnosed advanced epithelial ovarian cancer, evaluating the safety and efficacy of IMNN-001 combined with neoadjuvant and adjuvant chemotherapy [5][6] - The study's design included a randomized approach comparing IMNN-001 plus standard chemotherapy against standard chemotherapy alone, focusing on overall survival as the primary endpoint [4][6] Future Directions - IMUNON is preparing for the pivotal Phase 3 OVATION 3 Study, which will further assess IMNN-001 in a larger cohort of women with advanced ovarian cancer, including those with specific genetic mutations [4][10] - The company anticipates regulatory review for IMNN-001 in the European Union and other global markets, aiming to improve treatment standards for advanced ovarian cancer [4][10]

Core Viewpoint - IMUNON, Inc. has announced a private placement of common stock and short-term warrants, aiming to raise approximately $3.25 million, with potential additional proceeds of up to $6.5 million from the exercise of warrants [1][3]. Group 1: Financial Details - The company will issue 7,222,223 shares of common stock at a price of $0.45 per share, along with short-term warrants to purchase up to 14,444,446 additional shares [1][3]. - The offering is expected to close around May 27, 2025, pending customary closing conditions [1]. - The net proceeds from the offering will be used for working capital and general corporate purposes [3]. Group 2: Regulatory and Offering Structure - The securities are offered in a private placement under Section 4(a)(2) of the Securities Act of 1933 and Regulation D, and have not been registered under the Act [4]. - The offering is limited to accredited investors, and the company has agreed to file registration statements with the SEC for resale of the shares [4]. Group 3: Company Overview - IMUNON is a clinical-stage biotechnology company focused on DNA-mediated immunotherapy, with a lead program targeting advanced ovarian cancer [6][7]. - The company is developing innovative treatments that utilize the body's natural mechanisms to generate effective responses against various diseases [6]. - IMUNON's first modality, TheraPlas, is aimed at gene-based delivery of therapeutic proteins, while the second modality, PlaCCine, focuses on gene delivery of viral antigens [6].

Data show continuous clinically significant improvement, with median 13-month and 3-month increases in overall and progression-free survival, respectively, in treatment group Women treated with IMNN-001 and standard of care chemotherapy plus PARP inhibitors achieved nearly 12-month increase in PFS compared to standard of care; median OS in IMNN-001 treatment arm not yet reached after more than five years Phase 2 OVATION 2 Study results also published in peer-reviewed journal Gynecologic Oncology LAWRENCEVIL ...

Core Insights - IMUNON, Inc. has withdrawn its Registration Statement on Form S-1 for a public offering, indicating a strategic shift in its funding approach [1] - The Registration Statement was initially filed on April 4, 2025, and has not been declared effective by the SEC, meaning no securities have been sold [1] Company Overview - IMUNON is a clinical-stage biotechnology company focused on developing innovative treatments that utilize the body's natural mechanisms to address various human diseases [3] - The company is advancing its non-viral DNA technology, with two main modalities: TheraPlas for gene-based delivery of cytokines and PlaCCine for gene delivery of viral antigens [3] Clinical Programs - The lead clinical program, IMNN-001, is a DNA-based immunotherapy targeting advanced ovarian cancer, which has completed multiple clinical trials, including a Phase 2 trial [4] - IMNN-001 aims to instruct the body to produce cancer-fighting molecules at the tumor site, enhancing localized treatment effectiveness [4] - The company has also completed dosing in a first-in-human study of its COVID-19 booster vaccine, IMNN-101, and plans to continue advancing its technological capabilities [4]

Core Insights - IMUNON, Inc. announced promising results from its Phase 1 clinical trial of IMNN-101, a DNA plasmid vaccine utilizing the PlaCCine technology platform, demonstrating better durability and safety compared to mRNA vaccines [1][2][4] Group 1: Clinical Trial Results - The Phase 1 trial involved 24 healthy volunteers and showed that IMNN-101 provided a durable immune response, with a median increase of up to 3-fold in serum neutralizing antibody titers at six months post-vaccination [1][6] - The highest observed increase in neutralizing antibody titers among participants was 8-fold from baseline, indicating a strong immune response [1][4] - IMNN-101 was well tolerated with no serious adverse effects reported, reinforcing its safety profile [1][2] Group 2: Technology and Competitive Advantages - The PlaCCine technology platform offers several advantages, including stability at workable temperatures and ease of manufacturing compared to existing mRNA vaccines [2][5] - IMNN-101 is designed to accommodate single or multiple antigens, providing flexibility in vaccine development [5] - The vaccine demonstrated cross-reactivity against the Omicron XBB1.5 variant and other newer variants, indicating its potential effectiveness against emerging pathogens [4][6] Group 3: Future Development and Strategic Goals - The company is in discussions for further development of the PlaCCine platform for prophylactic vaccines, aiming for long-term strategic partnerships to advance these technologies [2][3] - IMUNON's broader goal is to expand its vaccine toolkit to address unaddressed infectious diseases and reduce hospitalizations [3][8] - The company is also advancing its other clinical programs, including IMNN-001 for advanced ovarian cancer, showcasing its commitment to innovative treatments [7][8]

Financial Data and Key Metrics Changes - As of March 31, 2025, the company had $2.9 million in cash and cash equivalents, focusing on securing near-term financing to strengthen its financial condition and advance the OVATION III trial [21] - Research and development costs were $2.2 million for Q1 2025, down from $3.3 million in the same period in 2024, primarily due to lower costs associated with the Phase I proof of concept Plascene DNA vaccine trial [22] - General and administrative expenses increased to $2 million in Q1 2025 from $1.7 million in Q1 2024, mainly due to higher employee-related expenses [22] - The net loss for Q1 2025 was $4.1 million or $0.28 per share, compared to a net loss of $4.9 million or $0.52 per share for the same period in 2024 [23] Business Line Data and Key Metrics Changes - The company is advancing its Phase III pivotal study of IMMUN-one for treating advanced ovarian cancer, with the first clinical site initiated [5][6] - The OVATION III trial will assess the efficacy of IMMUN-one plus standard care versus standard care alone, with a focus on overall survival as the primary endpoint [8][9] Market Data and Key Metrics Changes - The Phase III trial will enroll women newly diagnosed with advanced ovarian cancer, with a subgroup of patients positive for homologous recombination deficiency (HRD) [7] - The study aims to provide a new frontline treatment option for women with limited options and unmet medical needs, which is recognized by the medical community [6] Company Strategy and Development Direction - The company is focused on securing financing to support the OVATION III trial and is exploring partnerships to enhance its cash runway [19][20] - The strategy includes leveraging data from the Placine vaccine technology for potential licensing opportunities and partnerships in oncology and vaccine development [20] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of IMMUN-one to reset the standard of care for advanced ovarian cancer if safety and efficacy are confirmed in the Phase III trial [10][12] - The company is excited about presenting data at major conferences, which underscores the critical need for new therapies in ovarian cancer [13][15] Other Important Information - The company has orphan drug designation in both the U.S. and Europe, which may facilitate regulatory approval processes [9] - The OVATION II study results will be presented at the ASCO Annual Meeting and published in a peer-reviewed journal, highlighting the strength of the company's data [13] Q&A Session Summary Question: Inquiry about ASCO presentation and new data analyses - Management indicated that due to ASCO's embargo, specific details about the presentation content cannot be disclosed, but new information will be shared [25] Question: Status of Phase III trial sites and statistical plans - The company projects about 45 sites for the Phase III trial, with overall survival as the primary endpoint for all populations [30][31] Question: Current status of inventory and manufacturing capabilities for OVATION III - The company has brought the manufacturing of core active pharmaceutical ingredients in-house and is prepared for upcoming enrollment plans [33] Question: Status of clinical trial in collaboration with the Breakthrough Cancer Foundation - The company expects to have preliminary results from this trial by the end of the year, with ongoing site activations [34]