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]

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]

Core Insights - IMUNON, Inc. has appointed Dr. Douglas V. Faller as Chief Medical Officer, effective February 18, 2025, to lead the clinical strategy for its DNA-mediated immunotherapy [1][2] - The company is advancing its lead program, IMNN-001, for treating newly diagnosed advanced ovarian cancer, which is set to enter a Phase 3 pivotal trial in Q1 2025 [1][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 [8] - The company is developing non-viral DNA technology, with its first modality, TheraPlas®, aimed at gene-based delivery of cytokines for solid tumors [8][9] Leadership and Expertise - Dr. Faller brings over 30 years of experience in biotechnology and pharmaceuticals, with a strong background in oncology and immunology [2][3] - His previous roles include Chief Medical Officer at Skyhawk Therapeutics and Oryzon Genomics, as well as significant experience at Takeda [2][3] Clinical Development - IMNN-001 is designed using IMUNON's proprietary TheraPlas® platform and has shown positive safety and encouraging results in Phase 1 trials [7][9] - The recently completed Phase 2 OVATION 2 Study demonstrated clinically meaningful improvements in overall survival and progression-free survival for patients treated with IMNN-001 combined with chemotherapy [4][7] Financial Incentives - The company has approved inducement stock options for Dr. Faller, granting him the option to purchase 100,000 shares of common stock as part of his compensation package [4][5]

Dr. Faller joins IMUNON with more than 30 years of industry, academic and laboratory experience, with specialized expertise in oncology and immunology LAWRENCEVILLE, N.J., Feb. 10, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, today announced the appointment of Douglas V. Faller, M.D., Ph.D., as chief medical officer, effective February 18, 2025. In this role, Dr. Faller will lead the company’s clinical strategy ...

Company aligned with FDA on CMC strategy and requirements in preparation of Phase 3 pivotal trial of IMNN-001 Vertical integration of major components assures a high-quality, commercially viable future manufacturing capability On track to initiate Phase 3 pivotal trial of IMNN-001 in first quarter of 2025 LAWRENCEVILLE, N.J., Dec. 19, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, today announced the positive outc ...

FDA Project Team supports the company’s proposed Phase 3 trial strategy, including overall trial design, target patient population, treatment schedule, and primary endpoint Final Protocol submission on track for December, supporting initiation of Phase 3 registrational trial in Q1 2025 LAWRENCEVILLE, N.J., Nov. 25, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, today announced the outcome of its recent End-of-Phas ...