For the transition period from ____________ to ____________ Commission file number: 001-15911 Imunon, Inc. UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (Exact name of Registrant as specified in its charter) Delaware 52-1256615 (State ...

Exhibit 99.1 IMUNON Reports First Quarter 2025 Financial Results and Provides Business Update First site initiated for Phase 3 OVATION 3 study of IMNN-001 in treatment of newly diagnosed advanced ovarian cancer New data from Phase 2 OVATION 2 study of IMNN-001 accepted for oral presentation at 2025 ASCO Annual Meeting Company to hold conference call today at 11:00 a.m. ET LAWRENCEVILLE, N.J., May 12, 2025 – IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated im ...

First site initiated for Phase 3 OVATION 3 study of IMNN-001 in treatment of newly diagnosed advanced ovarian cancer New data from Phase 2 OVATION 2 study of IMNN-001 accepted for oral presentation at 2025 ASCO Annual Meeting Company to hold conference call today at 11:00 a.m. ET LAWRENCEVILLE, N.J., May 12, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, today reported financial results for the three months ended Mar ...

Company currently initiating additional trial sites and working with study investigators to enroll participants IMNN-001 is the first and only immunotherapy to show meaningful overall survival benefit in a Phase 2 trial in women with advanced ovarian cancer Data from Phase 2 OVATION 2 Study are encouraging, with new IMNN-001 data to be highlighted in oral presentation at 2025 ASCO Annual Meeting LAWRENCEVILLE, N.J., May 08, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in Ph ...

Data from OVATION 2 trial will also be reviewed in an oral presentation at ASCO Annual Meeting on June 3, 2025 LAWRENCEVILLE, N.J., May 06, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, today announced that data from the company’s Phase 1/2 OVATION 2 trial evaluating intraperitoneal IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy in newly diagnosed patients with advanced epithelial ovarian canc ...

Core Insights - IMUNON, Inc. announced promising Overall Survival data from the Phase 2 OVATION 2 Study of IMNN-001 for treating newly diagnosed advanced ovarian cancer, which will be presented at the 2025 ASCO Annual Meeting [1][3] - The company has aligned with the FDA on the Phase 3 OVATION 3 clinical trial protocol for IMNN-001 and has begun activating trial sites [1][3] Company Overview - IMUNON is a clinical-stage biotechnology company focused on developing innovative treatments using its proprietary TheraPlas technology platform, which enables gene-based delivery of cytokines for cancer treatment [9][10] - The lead clinical program, IMNN-001, is a DNA-based immunotherapy designed to produce interleukin-12 and interferon gamma at the tumor site, targeting advanced ovarian cancer [10] Study Details - The OVATION 2 Study evaluated the safety and efficacy of intraperitoneal IMNN-001 combined with neoadjuvant chemotherapy in patients with advanced epithelial ovarian cancer, enrolling 112 patients [5][6] - The study was not powered for statistical significance but included endpoints such as objective response rate and surgical response [6] Treatment Context - Epithelial ovarian cancer is a significant health concern, with approximately 20,000 new cases annually in the U.S., and about 70% diagnosed at advanced stages [8] - The five-year survival rates for patients with Stage III/IV ovarian cancer are low, highlighting the need for innovative therapies that improve overall survival and reduce recurrence rates [8]

Core Insights - IMUNON, Inc. announced the initiation of a Phase 3 pivotal trial, OVATION 3, for its DNA-mediated immunotherapy IMNN-001, which has shown meaningful overall survival benefits in advanced ovarian cancer patients during Phase 2 trials [1][2][3] Company Overview - IMUNON is a clinical-stage biotechnology company focused on developing innovative treatments that utilize the body's natural mechanisms to generate effective responses against various diseases [10][11] - The company's lead clinical program, IMNN-001, is a DNA-based immunotherapy designed for the localized treatment of advanced ovarian cancer [11] Phase 2 Trial Results - The Phase 2 OVATION 2 study demonstrated that IMNN-001 is the first immunotherapy to achieve a clinically effective response in ovarian cancer, with median overall survival increasing to 46 months, surpassing the standard-of-care by 13 months [2][3] - The study involved 112 patients and assessed the safety and efficacy of IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy [7] Phase 3 Trial Details - The Phase 3 OVATION 3 trial will compare IMNN-001 plus chemotherapy against standard-of-care chemotherapy in women with newly diagnosed advanced ovarian cancer [2][3] - The primary endpoint of the trial is overall survival, with secondary endpoints including surgical response score and time to second-line treatment [2] FDA Alignment - The FDA has aligned with the protocol for the Phase 3 trial, indicating regulatory support for IMUNON's plans [1][2] Future Plans - The company is focused on rapidly enrolling study participants for the Phase 3 trial to provide a much-needed treatment option for women with advanced ovarian cancer [2][3]

Financial Data and Key Metrics Changes - As of December 31, 2024, Imunon, Inc. had $5.9 million in cash and cash equivalents, with a net loss of $18.6 million or $1.62 per share, compared to a net loss of $19.5 million or $2.16 per share for 2023 [45][47]. - Research and development expenses increased slightly to $11.6 million in 2024 from $11.3 million in 2023, primarily due to increased clinical spending related to OVATION 2 and startup costs for OVATION 3 [46]. Business Line Data and Key Metrics Changes - The OVATION 2 study showed an improvement in median overall survival of 13 months compared to standard care, with a hazard ratio dropping from 0.74 to 0.69 [11][36]. - For patients receiving at least 20% of the planned Imunon-001 dose, survival increased by 17 months, indicating significant efficacy in the treatment of advanced ovarian cancer [33][34]. Market Data and Key Metrics Changes - The company is preparing to initiate the Phase 3 study, OVATION 3, in March 2025, targeting women newly diagnosed with advanced ovarian cancer [20][22]. - The Phase 2 MRD study, in partnership with Breakthrough Cancer Foundation, is expected to provide insights into combination therapies and is seeing increased enrollment [19][20]. Company Strategy and Development Direction - The company aims to expedite the advancement of Imunon-001 towards commercialization, with a focus on initiating the Phase 3 study as soon as possible [10][20]. - Imunon, Inc. is exploring partnerships and non-dilutive funding opportunities to support its clinical timelines and long-term strategic objectives [40][41]. Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the potential for accelerated approval based on emerging data from the OVATION 2 study, particularly for specific patient populations [66][70]. - The company is confident in its ability to secure funding and partnerships, citing the unique position of OVATION 2 as the only trial demonstrating a meaningful overall survival benefit [86][87]. Other Important Information - The company has established an internal GMP manufacturing capability, which will significantly reduce clinical trial costs and improve the cost of goods for future commercialization [50][25]. - Imunon-001 has been granted fast-track designation by the FDA, providing additional commercial advantages [50]. Q&A Session Summary Question: Could you discuss the COVID booster neutralizing antibody data? - The neutralizing antibody response levels are comparable to those from mRNA vaccines, and all subjects had prior COVID-19 infection or vaccination [56]. Question: What is your updated strategy in terms of patient population for the Phase 3 ovarian cancer study? - The protocol is under review, targeting a similar population to OVATION 2, with a 500-patient study planned [60][62]. Question: Can you discuss the possibility for accelerated approval? - The company is monitoring overall survival data, and if it continues to strengthen, discussions with the FDA regarding accelerated approval could occur [68][70]. Question: How is the partnership environment currently impacting potential fundraising? - The company has had successful meetings with institutional investors and is optimistic about finding appropriate investors to fund the trial [85][87]. Question: Can you provide an update on enrollment for the combination study? - Enrollment has picked up due to more sites coming on board, with a goal of enrolling 35 patients this year [132][133].

Imunon, Inc. (NASDAQ:IMNN) Q4 2024 Results Conference Call February 26, 2025 11:00 AM ET Company Participants Peter Vozzo - ICR Healthcare, IR Stacy Lindborg - President & Chief Executive Officer Douglas Faller - Chief Medical Officer David Gaiero - Interim Chief Financial Officer Michael Tardugno - Executive Chairman Khursheed Anwer - Chief Scientific Officer Conference Call Participants David Bautz - Zacks Small-Cap Research James Molloy - Alliance Global Partners Jason Kolbert - D. Boral Capital Kemp Dol ...

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 ...