IMNN-001 program is currently advancing its OVATION 3 pivotal Phase 3 trial per plan LAWRENCEVILLE, N.J., Oct. 23, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, today announced that new translational data from the Phase 2 OVATION 2 clinical trial of IMNN-001, its investigational therapy for the treatment of women with newly diagnosed advanced ovarian cancer, will be presented at the Society for Immunotherapy of Canc ...

Investor event to provide update on pivotal Phase 3 study of IMNN-001 to be held in New York City on November 10, 2025 Program will feature presentations from ovarian cancer thought leaders, Phase 3 study investigators, oncology and statistical experts LAWRENCEVILLE, N.J., Oct. 20, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, today announced that it will host an R&D Day for investors at the Harvard Club (35 West 44 ...

Company seeks strategic partners to advance novel PlaCCine technology LAWRENCEVILLE, N.J., Oct. 17, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company focused on developing non-viral DNA-mediated immunotherapies and evaluating an adaptation of the platform’s potential as a next-generation vaccine, today announced that members of its leadership team will deliver oral presentations highlighting IMNN-101, its investigational DNA plasmid vaccine based on the Company’s proprietary Pla ...

Prestigious European Society for Medical Oncology Conference “trials-in-progress” session Pivotal OVATION 3 trial of its DNA-mediated immunotherapy in newly diagnosed patients underway Company on track with established plans to accelerate patient recruitment LAWRENCEVILLE, N.J., Oct. 14, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, today announced that a trials-in-progress abstract on the ongoing Phase 3 OVATION 3 ...

Results from OVATION 2 Study reinforce IMNN-001 efficacy benefits observed in the clinic and unique mechanism of action, producing key anti-cancer immune cytokines post-treatment Pivotal Phase 3 trial of IMNN-001 underway, with four trial sites activated to date and on plan for site expansion to accelerate patient recruitment LAWRENCEVILLE, N.J., Sept. 22, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, today announce ...

Core Insights - IMUNON, Inc. is advancing its pivotal Phase 3 trial, OVATION 3, for its investigational therapy IMNN-001, targeting newly diagnosed advanced ovarian cancer [1][4] - New translational data from the Phase 2 OVATION 2 Study will be presented at the AACR Special Conference, highlighting the potential of IMNN-001 [1][3] Company Overview - IMUNON is a clinical-stage biotechnology company focused on innovative treatments that utilize the body's natural mechanisms for effective responses against various diseases [5] - The company is developing its non-viral DNA technology, with its first modality, TheraPlas, aimed at gene-based delivery of cytokines for solid tumors [5] Product Details - IMNN-001 is based on IMUNON's proprietary TheraPlas technology, utilizing an IL-12 DNA plasmid vector in a nanoparticle delivery system to enhance anti-cancer immunity [2] - The therapy has shown clinically effective responses in advanced ovarian cancer, improving both progression-free survival (PFS) and overall survival (OS) when combined with standard chemotherapy [2][6] Clinical Trial Insights - The OVATION 3 study is currently enrolling patients at four sites, with plans for up to 46 additional sites [4] - Preliminary results from the OVATION 2 Study indicated a median 13-month increase in OS and a median 3-month increase in PFS for patients treated with IMNN-001 compared to standard care [6] - The use of PARP inhibitors in maintenance therapy further improved outcomes, with patients in the IMNN-001 treatment arm surpassing 5 years since randomization [6]

Core Points - IMUNON, Inc. is a clinical-stage biotechnology company focused on DNA-mediated immunotherapy, currently in Phase 3 development [1][3] - The company will present a pre-recorded session at the H.C. Wainwright 27th Annual Global Investment Conference, with availability starting September 5, 2025 [2] - IMUNON's lead clinical program, IMNN-001, targets advanced ovarian cancer and has completed multiple clinical trials, including a Phase 2 trial [4] 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 [3] - The company employs non-viral DNA technology, with two main modalities: TheraPlas for gene-based delivery of therapeutic proteins and PlaCCine for gene delivery of viral antigens [3] Clinical Programs - IMNN-001 is a DNA-based immunotherapy designed for localized treatment of advanced ovarian cancer, instructing the body to produce cancer-fighting molecules at the tumor site [4] - The company has also completed dosing in a first-in-human study for its COVID-19 booster vaccine, IMNN-101 [4] - IMUNON aims to advance its technological capabilities in plasmid DNA to address challenging medical conditions [4]

Core Insights - IMUNON, Inc. has regained compliance with Nasdaq's minimum bid price requirement, ensuring uninterrupted trading on The Nasdaq Capital Market [1][2] - The company recently issued a 15% stock dividend to shareholders, reflecting confidence in its clinical pipeline and commitment to investors [2] - IMUNON's lead clinical program, IMNN-001, is a DNA-based immunotherapy for advanced ovarian cancer, with positive results from the Phase 2 OVATION 2 trial [2][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 [3] - The company is developing non-viral DNA technology, with its first modality, TheraPlas, aimed at gene-based delivery of therapeutic proteins for solid tumors [3] - The second modality, PlaCCine, is designed for gene delivery of viral antigens to elicit strong immunological responses [3] Clinical Development - IMNN-001 instructs the body to produce cancer-fighting molecules at the tumor site and has completed multiple clinical trials, including the Phase 2 OVATION 2 trial [4] - IMUNON has also completed dosing in a first-in-human study of its COVID-19 booster vaccine, IMNN-101 [4] - The company aims to advance its technological capabilities in plasmid DNA to better address difficult-to-treat conditions [4]

Core Insights - IMUNON, Inc. reported financial results for Q2 2025 and highlighted advancements in its Phase 3 clinical trial for IMNN-001, a DNA-mediated immunotherapy for advanced ovarian cancer, along with a 15% stock dividend for shareholders [1][2] Clinical Development - The pivotal Phase 3 OVATION 3 trial for IMNN-001 has commenced, with the first patient treated on July 25, 2025, following robust Phase 2 data showing significant overall survival benefits [2] - The trial design includes two interim analyses and is powered at 95% to detect meaningful overall survival improvements in the intent-to-treat population, with a 99% power in the HRD-positive subgroup [2] - A flexible enrollment strategy will start with a 250-patient HRD-positive subgroup, potentially expanding to a 500-patient all-comers trial, reducing costs by approximately 40% [2] Financial Position - IMUNON has strengthened its balance sheet with over $3 million raised through warrant exercises and ATM sales, while introducing a one-time 15% stock dividend to enhance shareholder value [2] - The company is actively pursuing non-dilutive partnerships to fund the OVATION 3 trial and has achieved compliance with Nasdaq's Shareholder Equity Rule [2] Manufacturing and Operations - IMUNON maintains a reliable in-house manufacturing process for key components of IMNN-001, achieving significant cost reductions compared to outsourcing [2] - Targeted cash conservation measures have been implemented to align resources with the regulatory approval and commercial launch of IMNN-001 [2] Medical Community Engagement - Data from the OVATION 2 study has generated significant interest, leading to unsolicited inquiries from global principal investigators to join the Phase 3 study, indicating strong validation of IMNN-001's potential [2] Background on IMNN-001 - IMNN-001 is designed using IMUNON's TheraPlas® platform and aims to induce potent anticancer immunity through the local secretion of IL-12 [5][8] - The drug has shown positive safety and efficacy results in previous clinical trials, including the recently completed Phase 2 OVATION 2 study [5][8] Market Context - Epithelial ovarian cancer is a significant health concern, with approximately 20,000 new cases annually in the U.S., and a high risk of recurrence, highlighting the need for effective therapies [6]

Financial Data and Key Metrics Changes - As of June 30, 2025, cash and cash equivalents were $4.7 million, with an additional $3 million received from warrant exercises and sales under the ATM facility after the quarter [30][26] - R&D expenses decreased to $1.2 million for Q2 2025 from $2.8 million in the same period last year, primarily due to the completion of the OVATION II study [30] - G&A expenses were $1.5 million in Q2 2025, down from $2.2 million in the same period last year [30] - Net loss for Q2 2025 was $2.7 million or $2.15 per share, compared to $4.8 million or $7.64 per share in 2024 [31] Business Line Data and Key Metrics Changes - The OVATION III trial is gaining traction, with three clinical sites activated and the first patient randomized and treated [11][20] - The OVATION II study has shown unprecedented improvement in overall survival, with a median increase of 13 months compared to standard care [8][7] Market Data and Key Metrics Changes - The demand for new therapies in ovarian cancer is high, as recent treatments have not significantly improved outcomes in over 25 years [35] - Approximately 50% of frontline ovarian cancer patients are HRD mutant, representing a significant underserved population [37] Company Strategy and Development Direction - The company aims to minimize shareholder dilution while raising sufficient capital for development goals, actively pursuing non-dilutive strategies [24] - A one-time stock dividend of 15% in common stock is introduced to enhance shareholder value [25] - The company is considering expanding clinical trial sites to Europe, although it is not necessary for EU approval to have patients enrolled [51] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of IMMUN-one to redefine treatment for advanced ovarian cancer [9] - The company is optimistic about the interest from investigators and the medical community in the OVATION III trial [19] - Management is focused on funding strategies to support the OVATION III trial and is seeing interest from potential partners [70] Other Important Information - The company has implemented cash conservation methods, including reducing monthly rent commitments and G&A expenses [26] - The company is actively engaging with potential partners for its TheraPlus technology and DNA vaccine platform [26] Q&A Session Summary Question: Initial demand from patients for the Phase III trial - Investigators have a high demand for the Phase III study due to the lack of effective treatments in ovarian cancer [35] Question: Changes in operating expenses for the remainder of the year - Operating expenses are expected to remain stable as the company has controlled costs and invested in necessary areas [39] Question: Status of the combination study with Avastin - Enrollment is ongoing, with increased patient treatment and optimism about meeting corporate goals [44] Question: Requirements for opening additional clinical trial sites - There are no significant barriers to opening additional sites, and the company is prioritizing U.S. and Canadian sites before considering international ones [55] Question: HRD screening impact on enrollment speed - HRD screening is standard care and does not delay patient treatment or enrollment in the trial [64] Question: Potential partnership environment - The company is receiving interest from potential partners and is pursuing discussions to accelerate development [70]