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]

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 ...

Financial Data and Key Metrics Changes - As of December 31, 2024, the company 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 [32][33] - 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 II and startup costs for OVATION III [32][33] - General and administrative expenses decreased to $7.5 million in 2024 from $9.7 million in 2023, driven by reduced professional fees and employee-related expenses [33] Business Line Data and Key Metrics Changes - The OVATION II study showed a median overall survival improvement of 11.1 months compared to standard care, with some patients approaching five years since trial initiation [23][24] - For patients receiving at least 20% of the planned immunon-one doses, survival increased by 17 months, indicating significant efficacy in the treatment of advanced ovarian cancer [24][25] Market Data and Key Metrics Changes - The company is preparing to initiate the OVATION III trial, targeting women newly diagnosed with advanced ovarian cancer, with a primary endpoint of overall survival [17][18] - The company has received fast track designation and orphan drug status from the FDA, providing a protected commercial runway in the U.S. and Europe [35] Company Strategy and Development Direction - The company aims to accelerate the initiation of the Phase III study, OVATION III, and is focused on identifying the most expeditious path to advance its product towards commercialization [6][18] - The company is exploring partnerships and non-dilutive funding opportunities to support its clinical timelines and long-term strategic objectives [28][29] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the potential for accelerated approval based on emerging data, particularly for patients who received PARP inhibitors [48][49] - The company is confident in its ability to secure funding and partnerships, citing the unique position of its OVATION II trial results as a significant advantage [59] Other Important Information - The company has established internal GMP manufacturing capabilities, allowing for lower production costs compared to external manufacturers [35] - The company is also pursuing the development of its Placine technology for potential partnerships in cancer vaccine development [30][67] Q&A Session Summary Question: Could you discuss the COVID booster neutralizing antibody data? - The study participants had prior COVID-19 infections, which may affect immune responses, but the antibody levels observed are comparable to those expected from mRNA vaccines [39] Question: What is your updated strategy for the Phase III ovarian cancer study? - The protocol is under review and targets a similar population to OVATION II, with a focus on maintaining consistency to strengthen results [41][42] Question: Can you discuss the possibility for accelerated approval? - The company is monitoring overall survival data and believes that as evidence matures, discussions with the FDA regarding accelerated approval could occur [48][49] Question: How is the partnership environment currently? - The company has had successful meetings with institutional investors and believes that the unique results from OVATION II will attract appropriate investors [59] Question: What impressed you about the Phase II data? - The data from OVATION II represents a significant advancement in treatment options for ovarian cancer, offering hope for improved patient survival [69]

Research and Development - Research and development expenses were approximately $11.6 million and $11.3 million for the years ended December 31, 2024 and 2023, respectively, indicating a slight increase of 2.65% year-over-year [87]. - The majority of research and development spending is focused on funding IMNN-001 clinical trials and the next generation vaccine initiative [87]. - The company collaborates with various research institutions, including the NIH and the Wistar Institute, for its research and development programs [87]. - The company is engaged in clinical trials for IMNN-001, which are subject to extensive regulatory oversight and must comply with good clinical practices [93]. - The process of obtaining regulatory approvals requires substantial time and financial resources, with no assurance of approval for any product [97]. Regulatory Approvals - The FDA granted Fast Track designation for IMNN-001 for the treatment of ovarian cancer in January 2021, which may expedite the development and review process [104]. - The FDA aims to complete its review of most standard review applications within ten months and priority review applications within six months after acceptance for filing [98]. - The FDA may require additional testing for safety and efficacy before granting approval for any drug candidate [97]. - Regulatory applications based on foreign clinical data must meet specific criteria to be considered valid by the FDA [117]. - The company must disclose clinical trial information to the NIH, including results within one year of completion, which can be delayed under certain circumstances [108]. Orphan Drug Designation - The company has received orphan drug designation for IMNN-001 for the treatment of ovarian cancer, providing potential exclusivity for seven years upon FDA approval [109]. - The U.S. Court of Appeals ruled that FIRDAPSE®'s orphan drug exclusivity protects the rare disease, not just the approved indication [110]. - The FDA announced it will continue to limit orphan drug exclusivity to a product's approved uses, potentially leading to further litigation [110]. - Orphan medicinal product designation in the EU grants ten years of market exclusivity, with specific conditions for approval of similar products [141]. Pricing and Reimbursement - The Inflation Reduction Act (IRA) of 2022 may significantly reduce the prices pharmaceutical manufacturers can charge and the reimbursement they can receive for approved products [128]. - The IRA requires manufacturers to pay rebates for Medicare Part B and Part D drugs where price increases exceed inflation [131]. - The IRA's Price Negotiation Program will begin in 2026, applying to high-cost drugs, with negotiated prices capped at a statutorily determined ceiling price [131]. - Coverage and reimbursement for drug products can differ significantly from payor to payor, impacting sales and financial condition [126]. - The implementation of cost-containment measures by governments may further limit revenue generated from the sale of approved products [127]. - In the EU, pricing and reimbursement schemes vary widely, with some countries requiring reimbursement price agreements before marketing [130]. - The company may need to conduct expensive pharmacoeconomic studies to demonstrate medical necessity and cost-effectiveness for reimbursement [126]. - Legislative changes in the U.S. and abroad may continue to affect pricing, coverage, and reimbursement methodologies for pharmaceutical products [132]. Manufacturing and Compliance - Manufacturing establishments must comply with cGMP, ensuring consistent quality and stability of drug candidates [115]. - The company operates a cGMP clinical-scale manufacturing facility for IMNN-001 in Huntsville, Alabama, and relies on third-party CMOs for clinical trial supplies [144]. - Post-approval requirements include compliance with cGMP, adverse reaction reporting, and potential additional clinical trials mandated by the FDA [114]. - The scope of healthcare laws, including anti-kickback and false claims laws, poses significant compliance risks for the company [121]. - The evolving landscape of privacy laws, such as the California Consumer Privacy Act, may increase potential liabilities for the company [124]. Competition and Market Position - The company faces intense competition from larger pharmaceutical and biotechnology companies, which have greater financial resources and experience [148]. - The company is exposed to risks related to patent validity and potential infringement claims, which could adversely affect its business [159]. - The company holds five patents related to TheraPlas technology, with expiration dates ranging from 2025 to 2028, and filed four new patents in 2023 [156]. - The company does not currently have marketing, sales, and distribution capabilities but plans to establish these if drug candidates receive approval [145]. Employment and Corporate Changes - As of February 21, 2025, the company employed 25 full-time employees and maintains relationships with independent contractors [161]. - The company changed its name from Celsion Corporation to Imunon, Inc. on September 19, 2022, reflecting its focus on immunotherapies and vaccines [162]. Clinical Focus - IMNN-001 is being studied for newly diagnosed Stage III/IV ovarian cancer, with standard care including carboplatin and paclitaxel [149].

Financial Performance - IMUNON reported a net loss of $18.6 million for 2024, a decrease from a net loss of $19.5 million in 2023, resulting in a loss per share of $1.62 compared to $2.16 in the previous year[15]. - Operating expenses for 2024 were $19.1 million, down 9% from $21.0 million in 2023[15]. - General and administrative expenses decreased by 23% to $7.5 million in 2024, primarily due to lower legal and employee-related costs[17]. - Investment income from short-term investments decreased to $0.5 million in 2024 from $1.2 million in 2023[23]. - Total operating expenses for 2024 were $19.132 million, down from $21.030 million in 2023, representing a reduction of approximately 9.0%[28]. - The net loss for 2024 was $18.620 million, compared to a net loss of $19.515 million in 2023, indicating an improvement of about 4.6%[28]. - Total current assets decreased to $8.009 million in 2024 from $18.241 million in 2023, a decline of approximately 56.0%[30]. - Cash and cash equivalents slightly increased to $5.873 million in 2024 from $5.839 million in 2023[30]. - Total liabilities decreased to $5.473 million in 2024 from $8.530 million in 2023, a reduction of approximately 35.0%[30]. - The company incurred $0.2 million in interest expense in the first half of 2023 related to the terminated loan facility[23]. - The weighted average shares outstanding increased to 11.508 million in 2024 from 9.045 million in 2023[28]. Research and Development - Research and development (R&D) expenses were $11.6 million for 2024, slightly up from $11.3 million in 2023, with costs associated with the OVATION 2 Study at $1.4 million[16]. - The lead clinical program, IMNN-001, has completed Phase 2 development for advanced ovarian cancer treatment[24]. - IMUNON plans to initiate a Phase 3 pivotal trial of IMNN-001 in advanced ovarian cancer in Q1 2025[3]. - The Phase 1 clinical trial of IMNN-101 demonstrated a persistent 2- to 4-fold increase in serum neutralizing antibody titers, indicating strong immunogenicity[9]. - IMUNON received positive feedback from the FDA regarding the Chemistry, Manufacturing, and Controls (CMC) for IMNN-001, supporting its production for the upcoming Phase 3 trial[5]. Clinical Outcomes - The median overall survival for patients treated with IMNN-001 plus standard-of-care chemotherapy increased to 13 months, compared to 11.1 months previously, with a hazard ratio improvement from 0.74 to 0.69[6]. - More than one-third of patients in the trial survived over 36 months, with 62% from the IMNN-001 treatment arm[6]. Technology Development - The company is advancing its non-viral DNA technology, including the development of its COVID-19 booster vaccine (IMNN-101)[24].

Core Insights - IMUNON, Inc. has reported that its lead immunotherapy candidate, IMNN-001, is the first to demonstrate a significant overall survival benefit in advanced ovarian cancer, achieving an overall survival of 13 months compared to the current standard of care [3][7] - The company is preparing to initiate a Phase 3 pivotal trial for IMNN-001 in Q1 2025, following positive interactions with the FDA regarding the trial design and manufacturing processes [2][8][5] Financial Performance - For the year ended December 31, 2024, IMUNON reported a net loss of $18.6 million, or $1.62 per share, an improvement from a net loss of $19.5 million, or $2.16 per share in 2023 [17][29] - Operating expenses decreased by 9% to $19.1 million in 2024 from $21.0 million in 2023, with research and development expenses slightly decreasing to $11.6 million [17][18] - The company ended 2024 with $5.9 million in cash and cash equivalents, indicating sufficient capital resources to fund operations into late Q2 2025 [21] Clinical Development - The Phase 2 OVATION 2 Study of IMNN-001 showed a decrease in the hazard ratio from 0.74 to 0.69, with more than one-third of patients surviving over 36 months [7][3] - New translational data from the OVATION 2 Study indicated a 20% increase in IL-12 levels in patients treated with IMNN-001, supporting its mechanism of action [4] - The company has engaged with the FDA to finalize the design of the planned registrational study, reflecting strong support from trial investigators and regulators [3][8] Corporate Developments - Douglas V. Faller, M.D., Ph.D., was appointed as Chief Medical Officer to lead the clinical strategy for advancing IMNN-001 [14][15] - The company held an Ovarian Cancer R&D Day to discuss advancements in its clinical programs and engage with leaders in oncology research [9] Technology and Innovation - IMUNON is advancing its DNA-mediated immunotherapy platform, TheraPlas, which aims to enhance the immune response against cancer [24][25] - The company is also developing a COVID-19 vaccine, IMNN-101, which has shown promising safety and immunogenicity results in a Phase 1 trial [10][13]

Core Insights - IMUNON, Inc. announced positive results from its Phase 1 proof-of-concept clinical trial for IMNN-101, a DNA plasmid vaccine targeting the SARS-CoV-2 Omicron XBB1.5 variant, demonstrating safety and immunogenicity [2][3][4] Group 1: Clinical Trial Results - The Phase 1 trial involved 24 healthy volunteers and showed that IMNN-101 induced a persistent 2- to 4-fold increase in neutralizing antibody (NAb) titers from baseline through Week 4, with further increases observed between Week 2 and Week 4 [2][4] - No serious adverse effects were reported, indicating an acceptable safety profile for IMNN-101 [2][3] - The immune response was effective against the XBB1.5 variant and other newer variants, showcasing the vaccine's cross-reactivity [2][3] Group 2: Technology and Development - IMNN-101 is based on the proprietary PlaCCine technology platform, which allows for flexible manufacturing and stable storage conditions, making it a potential alternative to mRNA vaccines [5][6] - The vaccine demonstrated strong immunogenicity in preclinical studies, with over 95% protection in non-human primates, comparable to existing mRNA vaccines [5] - The PlaCCine platform's design accommodates single or multiple antigens, enhancing its potential for developing vaccines against various infectious diseases [6] Group 3: Future Prospects - The company anticipates interest from potential partners for further development of IMNN-101 based on the strong immunogenicity evidence and competitive advantages in stability [3][5] - IMUNON is also advancing its lead clinical program, IMNN-001, a DNA-based immunotherapy for advanced ovarian cancer, indicating a broader focus on innovative treatments [10]