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]

Imunon (IMNN) Q1 2025 Earnings Call May 12, 2025 11:00 AM ET Company Participants Peter Vozzo - Managing DirectorStacy Lindborg - President, CEO & DirectorDouglas Faller - Chief Medical OfficerDavid Gaiero - Chief Financial OfficerLaura Suriel - Equity Research Associate Conference Call Participants Emily Bodnar - Biotech Equity Research Analyst Operator Good morning. My name is Dave and I will be your operator today. At this time, I would like to welcome you to the Immuno's First Quarter twenty twenty five ...

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]

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 ...

Financial Performance - IMUNON reported a net loss of $4.1 million, or $0.28 per share, for Q1 2025, compared to a net loss of $4.9 million, or $0.52 per share, in Q1 2024, reflecting a decrease in losses[14]. - Net loss narrowed to $4,102,000 in Q1 2025 compared to a net loss of $4,929,000 in Q1 2024, representing a decrease of about 16.7%[25]. - Net loss per common share improved to $(0.28) in Q1 2025 from $(0.52) in Q1 2024, reflecting a 46.2% reduction[25]. Operating Expenses - Operating expenses decreased by 18% to $4.1 million in Q1 2025 from $5.0 million in Q1 2024[14]. - Total operating expenses decreased to $4,145,000 in Q1 2025 from $5,011,000 in Q1 2024, a reduction of approximately 17.3%[25]. - General and administrative expenses increased to $2.0 million in Q1 2025 from $1.7 million in Q1 2024, mainly due to higher employee-related expenses[16]. - General and administrative expenses increased to $1,980,000 in Q1 2025 from $1,717,000 in Q1 2024, an increase of about 15.3%[25]. - Research and development (R&D) expenses were $2.2 million in Q1 2025, down from $3.3 million in Q1 2024, primarily due to lower costs associated with the OVATION 2 Study and the Phase 1 PlaCCine DNA vaccine trial[15]. - Research and development expenses decreased to $2,165,000 in Q1 2025 from $3,294,000 in Q1 2024, a reduction of approximately 34.3%[25]. Cash and Assets - As of March 31, 2025, cash and cash equivalents were $2.9 million, with the company believing it has sufficient capital to fund operations into late Q2 2025[17]. - Cash and cash equivalents decreased to $2,872,000 as of March 31, 2025, down from $5,873,000 as of December 31, 2024, a decline of 51.1%[27]. - Total assets decreased to $6,862,000 as of March 31, 2025, from $9,717,000 as of December 31, 2024, a reduction of approximately 29.5%[27]. - Stockholders' equity decreased to $452,000 as of March 31, 2025, down from $4,244,000 as of December 31, 2024, a decline of about 89.4%[27]. Liabilities - Total liabilities increased to $6,410,000 as of March 31, 2025, compared to $5,473,000 as of December 31, 2024, an increase of about 17.1%[27]. - Current liabilities rose to $5,797,000 as of March 31, 2025, up from $4,786,000 as of December 31, 2024, an increase of approximately 21.1%[27]. Clinical Trials and Research - The first trial site for the Phase 3 OVATION 3 study of IMNN-001 was initiated on May 8, 2025, focusing on newly diagnosed advanced ovarian cancer[5]. - Data from the Phase 1/2 OVATION 2 study of IMNN-001 will be published in the peer-reviewed journal Gynecologic Oncology on June 3, 2025[7]. - An abstract from the OVATION 2 study was accepted for oral presentation at the 2025 ASCO Annual Meeting, scheduled for June 3, 2025[8]. - The Phase 3 OVATION 3 trial will assess the safety and efficacy of IMNN-001 combined with chemotherapy compared to standard care[6]. - IMUNON plans to seek potential partners for further development of the IMNN-101 vaccine based on its PlaCCine technology platform[12].

Core Insights - IMUNON, Inc. is advancing its lead candidate IMNN-001 in a Phase 3 clinical trial for newly diagnosed advanced ovarian cancer, with the first trial site initiated for the OVATION 3 study [5][6] - The Phase 2 OVATION 2 study data has been accepted for oral presentation at the 2025 ASCO Annual Meeting, highlighting the potential of IMNN-001 in improving patient outcomes [8][9] - The company reported a net loss of $4.1 million for Q1 2025, a decrease from $4.9 million in Q1 2024, indicating improved financial management [15][18] Recent Developments - The initiation of the first trial site for the OVATION 3 study is a significant milestone in the development of IMNN-001, which aims to provide a new treatment option for women with advanced ovarian cancer [5][6] - The OVATION 2 study demonstrated that IMNN-001, when combined with chemotherapy, is the first immunotherapy to extend both progression-free and overall survival in newly diagnosed ovarian cancer patients [3][4] - New translational data from the OVATION 2 study showed a 20% increase in IL-12 levels in patients treated with IMNN-001 compared to those receiving a lower dose, reinforcing the drug's mechanism of action [10] Financial Performance - For Q1 2025, operating expenses were reported at $4.1 million, down 18% from $5.0 million in Q1 2024, primarily due to reduced R&D costs [15][16] - Research and development expenses decreased to $2.2 million in Q1 2025 from $3.3 million in Q1 2024, reflecting lower costs associated with ongoing clinical trials [16] - As of March 31, 2025, the company had cash and cash equivalents of $2.9 million, which is expected to fund operations into late Q2 2025 [18] Clinical Trials and Research - The Phase 3 OVATION 3 trial will evaluate the safety and efficacy of IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy compared to standard care [6] - The study will include women with newly diagnosed advanced ovarian cancer, focusing on overall survival as the primary endpoint [6] - Data from the OVATION 2 study will be published in the peer-reviewed journal Gynecologic Oncology, further validating the findings of the trial [7]

Core Insights - IMUNON, Inc. is advancing its lead candidate IMNN-001, a DNA-mediated immunotherapy, into Phase 3 trials for treating advanced ovarian cancer, marking a significant milestone in its development program [1][4] - IMNN-001 is the first immunotherapy to demonstrate a meaningful overall survival benefit in a Phase 2 trial for women with advanced ovarian cancer [1][2] - The Phase 3 OVATION 3 trial will compare IMNN-001 combined with chemotherapy against standard care, focusing on overall survival as the primary endpoint [2][5] Company Developments - The first trial site for the OVATION 3 study has been initiated at Washington University School of Medicine, with additional sites being established [1][4] - The OVATION 3 trial will include women with newly diagnosed advanced ovarian cancer, specifically those eligible for neoadjuvant therapy, and will assess various endpoints including surgical response and time to second-line treatment [2][5] - IMUNON plans to present new data from the Phase 2 OVATION 2 study at the upcoming ASCO Annual Meeting in May 2025 [3] Product Information - IMNN-001 is designed using IMUNON's TheraPlas platform, which allows for localized delivery of IL-12, a potent cytokine for inducing anticancer immunity [7][10] - The Phase 2 OVATION 2 study involved 112 patients and evaluated the safety and efficacy of IMNN-001 in combination with standard chemotherapy [5][6] - Epithelial ovarian cancer, the target of IMNN-001, has a high recurrence rate and poor five-year survival rates, highlighting the need for new treatment options [8] Industry Context - Approximately 20,000 new cases of ovarian cancer are diagnosed annually in the U.S., with a significant percentage presenting at advanced stages [8] - The development of IMNN-001 represents a potential breakthrough in a field where standard treatment options have not changed significantly in over 25 years [2][4]

Core Insights - IMUNON, Inc. announced that data from its Phase 1/2 OVATION 2 trial will be published in the peer-reviewed journal Gynecologic Oncology and presented at the ASCO Annual Meeting on June 3, 2025, highlighting the significance of its findings in the treatment of advanced epithelial ovarian cancer [1][2][3][4] 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, differentiating itself from conventional therapies [9] - The company's lead clinical program, IMNN-001, is a DNA-based immunotherapy designed for localized treatment of advanced ovarian cancer, which has completed Phase 2 development [10] Study Details - The OVATION 2 study evaluated the safety and efficacy of intraperitoneal administration of IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy in patients newly diagnosed with advanced epithelial ovarian cancer, enrolling 112 patients [5] - The study was an open-label trial that randomized patients 1:1 to receive either NACT plus IMNN-001 or standard-of-care NACT, with patients in the IMNN-001 arm receiving up to 17 weekly doses of 100 mg/m [5] Treatment Context - Epithelial ovarian cancer is the sixth deadliest malignancy among women in the U.S., with approximately 20,000 new cases annually, and about 70% diagnosed at advanced stages [7] - The disease is characterized by a high risk of recurrence, with a 75% recurrence rate in Stage III/IV patients, underscoring the need for new therapies that can improve overall survival [8] Technology Platform - IMNN-001 is developed using IMUNON's proprietary TheraPlas platform technology, which enables the delivery of IL-12, a potent cytokine that induces strong anticancer immunity [6] - The technology aims to provide localized treatment by instructing the body to produce cancer-fighting molecules at the tumor site, enhancing the therapeutic effect [10]

LAWRENCEVILLE, N.J., May 05, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, announces that the Company will host a conference call at 11:00 a.m. ET on Monday, May 12, 2025 to discuss financial results for the first quarter ended March 31, 2025 and provide an update on its clinical development program with IMNN- 001, a DNA-based interleukin-12 (IL-12) immunotherapy, including progress in advancing the IMNN-001 deve ...

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]