LAWRENCEVILLE, N.J., June 30, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in Phase 3 development of its DNA-mediated immunotherapy, today announced that, in consultation with The Nasdaq Stock Market LLC (Nasdaq), it has submitted its plan to Nasdaq to regain compliance with the minimum bid price requirement and the minimum stockholders' equity requirement for continued listing on The Nasdaq Capital Market. On May 29, 2025, the Company requested a hearing before The Nasdaq ...

Core Points - IMUNON, Inc. is a clinical-stage biotechnology company focused on DNA-mediated immunotherapy, currently in Phase 3 development [1][4] - The company will present at the Zacks SCR Life Sciences Virtual Investor Forum on June 12, 2025, at 11:30 a.m. ET [1] - IMUNON's lead clinical program, IMNN-001, is a DNA-based immunotherapy targeting advanced ovarian cancer, having completed multiple clinical trials including a Phase 2 trial [5] Company Overview - IMUNON is developing innovative treatments that utilize the body's natural mechanisms to generate effective responses against various diseases, differentiating from conventional therapies [4] - The company is advancing its non-viral DNA technology through two main modalities: TheraPlas for gene-based delivery of cytokines and PlaCCine for gene delivery of viral antigens [4] Clinical Programs - IMNN-001 instructs the body to produce cancer-fighting molecules at the tumor site, specifically interleukin-12 and interferon gamma [5] - The company has also completed dosing in a first-in-human study of its COVID-19 booster vaccine, IMNN-101 [5] - IMUNON aims to leverage its technologies to address difficult-to-treat conditions, either directly or through partnerships [5]

Core Viewpoint - IMUNON, Inc. has successfully closed a private placement, raising approximately $3.25 million, with potential additional proceeds of up to $6.5 million from short-term warrants [1][3]. Group 1: Financial Details - The company sold 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]. - The total gross proceeds from the private placement are approximately $3.25 million before deducting fees and expenses [3]. - If fully exercised, the short-term warrants could provide an additional $6.5 million in gross proceeds [3]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for working capital and general corporate purposes [3]. Group 3: Regulatory and Offering Details - The securities were 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 was made only to accredited investors, and the company has agreed to file registration statements with the SEC for resale of the shares [4]. Group 4: Company Overview - IMUNON is a clinical-stage biotechnology company focused on developing innovative treatments using non-viral DNA technology [6]. - The company's lead clinical program, IMNN-001, is a DNA-based immunotherapy for advanced ovarian cancer, which has completed multiple clinical trials [7]. - IMUNON is also advancing a COVID-19 booster vaccine (IMNN-101) and aims to leverage its technologies to address difficult-to-treat conditions [7].

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].

Core Insights - IMUNON, Inc. announced positive results from its Phase 2 OVATION 2 Study of IMNN-001, an investigational therapy for advanced ovarian cancer, showing significant improvements in overall and progression-free survival [1][3][4] - The company has initiated the pivotal Phase 3 OVATION 3 Study following alignment with the FDA, focusing on newly diagnosed advanced ovarian cancer patients [2][5] Group 1: Study Results - The Phase 2 OVATION 2 Study demonstrated a median increase in overall survival (OS) of 13 months for patients treated with IMNN-001 plus standard of care (SoC) compared to SoC alone (46 months vs. 33 months) [3][8] - Patients receiving IMNN-001 in conjunction with PARP inhibitors showed a median OS not yet reached after more than five years, compared to 37 months in the control group, indicating a hazard ratio of 0.38 [3][8] - The study also reported a median 3-month increase in progression-free survival (PFS) for the intent-to-treat population (14.9 months vs. 11.9 months) with a hazard ratio of 0.79 [3][8] Group 2: Treatment Details - IMNN-001 is administered intraperitoneally at a dose of 100 mg/m weekly, combined with neoadjuvant and adjuvant chemotherapy [6][7] - The study enrolled 112 patients with newly diagnosed advanced epithelial ovarian cancer, randomized 1:1 to evaluate the safety and efficacy of IMNN-001 plus chemotherapy versus standard chemotherapy alone [6][7] Group 3: Future Directions - The Phase 3 OVATION 3 Study will include women with newly diagnosed advanced ovarian cancer (stage IIIC or IV) and will assess overall survival as the primary endpoint [5] - The study will also evaluate secondary endpoints such as surgical response score and time to second-line treatment, with a focus on patients with homologous recombination deficiency (HRD+) [5] Group 4: Company Overview - IMUNON is a clinical-stage biotechnology company developing innovative treatments using its proprietary TheraPlas technology platform, which focuses on gene-based delivery of cytokines for cancer treatment [10][11] - The company aims to leverage its technology to provide effective and durable responses for patients with difficult-to-treat conditions, including advanced ovarian cancer [10][11]

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]

Imunon (IMNN) Q4 2024 Earnings Call February 27, 2025 11:00 AM ET Company Participants Peter Vozzo - Managing DirectorStacy Lindborg - President, CEO & DirectorDouglas Faller - Chief Medical OfficerDavid Gaiero - Chief Financial OfficerJoey Brusca - Equity Research AssociateKhursheed Anwer - Executive VP & Chief Scientific OfficerJason Kolbert - Managing Director Conference Call Participants David Bautz - Senior AnalystJames Molloy - Managing Director, Senior Biotechnology & Specialty Pharmaceuticals Equity ...