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]

First and only immunotherapy to show meaningful overall survival benefit in a Phase 2 trial in patients with advanced ovarian cancer Initiation of trial sites underway for ground-breaking Phase 3 pivotal trial of DNA-mediated IL-12 therapeutic Company to hold conference call on Tuesday, March 25, 2025, at 2:00 p.m. ET LAWRENCEVILLE, N.J., March 24, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, today announced that t ...

Imunon (IMNN) Q4 2024 Earnings Call February 28, 2025 12:33 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 ...

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].

Exhibit 99.1 IMUNON Reports 2024 Financial Results and Provides Business Update Highlighting Significant Progress Towards the Initiation of a Pivotal Phase 3 Study IMNN-001 remains the first immunotherapy to achieve a meaningful overall survival benefit in advanced ovarian cancer Patient enrollment in Phase 3 pivotal trial of IMNN-001 scheduled to begin in Q1 2025 Company to hold conference call today at 11:00 a.m. ET LAWRENCEVILLE, N.J., Feb. 27, 2025 (GLOBE NEWSWIRE) – IMUNON, Inc. (NASDAQ: IMNN), a clini ...

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]

Results of IMNN-101 Proof-of-Concept study demonstrate persistent immunogenicity in trial participants and further validate PlaCCine® technology IMNN-101 induced 2- to 4-fold increase in neutralizing antibody (NAb) titers from baseline through Week 4 IMNN-101 continues to show an acceptable safety profile LAWRENCEVILLE, N.J., Feb. 26, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company focused on developing non-viral DNA-mediated immunotherapy and evaluating an adaptation of the p ...

Core Viewpoint - IMUNON, Inc. is set to report its full year 2024 financial results on February 27, 2025, and will host a conference call to discuss these results and provide a business update [1] 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 [3] - The company is advancing its non-viral DNA technology through two main modalities: TheraPlas for gene-based delivery of cytokines in solid tumors, and PlaCCine® for gene delivery of viral antigens to elicit strong immunological responses [3] Clinical Programs - The lead clinical program, IMNN-001, is a DNA-based immunotherapy for advanced ovarian cancer that has completed Phase 2 development, aiming to produce cancer-fighting molecules at the tumor site [4] - IMUNON has also initiated a first-in-human study for its COVID-19 booster vaccine, IMNN-101, and plans to leverage its technologies to address difficult-to-treat conditions while enhancing its financial position through business development opportunities [4]

Core Insights - IMUNON, Inc. announced new data from the Phase 2 OVATION 2 Study of its investigational immunotherapy IMNN-001, showing a 20% increase in IL-12 levels with the 100 mg/m dose compared to the 79 mg/m dose, reinforcing the dose-dependent mechanism of action [1][2][3] - The study demonstrated favorable safety profiles for IMNN-001, with no serious immune-related adverse events reported, indicating a positive benefit-risk profile for the treatment of advanced ovarian cancer [2][3] - IMUNON is preparing to advance IMNN-001 into a Phase 3 pivotal trial, expected to start in the first quarter of 2025, following positive outcomes from an End-of-Phase 2 meeting with the FDA [4][10] Study Results - The OVATION 2 Study evaluated the safety and efficacy of IMNN-001 in combination with standard-of-care chemotherapy in patients with newly diagnosed advanced ovarian cancer, showing significant increases in IL-12 levels in the tumor microenvironment [5][6] - The study reported a median overall survival improvement of 13 months for patients treated with IMNN-001 plus chemotherapy compared to those receiving chemotherapy alone, with over one-third of patients surviving more than 36 months [3][4] - The treatment demonstrated local increases in other key anti-cancer cytokines, such as interferon-gamma (IFN-γ) and tumor necrosis factor-alpha (TNF-α), further supporting its efficacy [2][3] Company Overview - IMUNON is a clinical-stage biotechnology company focused on developing innovative treatments using its proprietary TheraPlas technology platform, which enables localized delivery of cytokines for cancer treatment [9][10] - The company is advancing its lead clinical program, IMNN-001, which is designed to instruct the body to produce cancer-fighting molecules at the tumor site, aiming to improve outcomes for patients with difficult-to-treat conditions [10] - Epithelial ovarian cancer, the target indication for IMNN-001, is a significant health concern, with approximately 20,000 new cases diagnosed annually in the U.S., and a high rate of recurrence after treatment [8]