Core Insights - IMUNON, Inc. announced positive topline results from the Phase 2 OVATION 2 Study of IMNN-001, demonstrating significant improvements in overall survival (OS) and progression-free survival (PFS) for patients with advanced ovarian cancer [1][4] Study Results - The Phase 2 OVATION 2 Study showed a hazard ratio of 0.74 for OS in the intent-to-treat (ITT) population, indicating a 35% improvement in survival compared to standard-of-care [2][3] - Patients receiving three or more doses of IMNN-001 experienced a median OS increase of 15.7 months, with a hazard ratio of 0.64, representing a 56% improvement in survival [2] - For nearly 40% of participants treated with a PARP inhibitor, the hazard ratio further decreased to 0.41, with median OS not yet reached in the IMNN-001 arm compared to 37.1 months in the control arm [2] Progression-Free Survival - The primary endpoint of the trial, PFS, showed a three-month improvement compared to standard-of-care, with a hazard ratio of 0.79, indicating a 27% improvement in delaying disease progression [3] Future Plans - IMUNON plans to initiate a registrational study in Q1 2025 and will hold an End-of-Phase 2 meeting with the U.S. FDA to discuss the protocol for a Phase 3 study [1][6] Company Background - IMUNON is a clinical-stage biotechnology company focused on innovative treatments utilizing non-viral DNA technology, with IMNN-001 being a key product in development for advanced ovarian cancer [12][13]

Core Viewpoint - IMUNON, Inc. is set to announce topline results from the Phase 2 OVATION 2 Study of its DNA-mediated immunotherapy, IMNN-001, for advanced ovarian cancer on July 30, 2024, at 8:00 a.m. Eastern time, followed by a conference call at 8:30 a.m. Eastern time to discuss the results [1]. Group 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 [4]. - The company is advancing its non-viral DNA technology, with its first modality, TheraPlas®, designed for coding cytokines and therapeutic proteins for solid tumors, and a second modality, PlaCCine®, for delivering DNA-coded viral antigens [4]. Group 2: Clinical Programs - The lead clinical program, IMNN-001, is a DNA-based immunotherapy currently in Phase 2 development for localized treatment of advanced ovarian cancer, which instructs the body to produce cancer-fighting molecules at the tumor site [5]. - IMUNON has also initiated a first-in-human study for its COVID-19 booster vaccine, IMNN-101, and aims to leverage its technological advancements to better serve patients with challenging conditions [5].

Core Insights - IMUNON, Inc. is set to announce topline results from the Phase 2 OVATION 2 Study for its DNA-mediated immunotherapy, IMNN-001, targeting advanced ovarian cancer on July 30, 2024, at 8:00 a.m. Eastern time [3] - The company will host a conference call at 8:30 a.m. Eastern time to discuss the results and answer questions from the investment community [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 [5] - The company is advancing its non-viral DNA technology, with its first modality, TheraPlas®, designed for coding cytokines and therapeutic proteins for solid tumors [5] - The second modality, PlaCCine®, is aimed at delivering DNA-coded viral antigens to provoke strong immunological responses [5] Clinical Programs - The lead clinical program, IMNN-001, is a DNA-based immunotherapy in Phase 2 development for localized treatment of advanced ovarian cancer, which instructs the body to produce cancer-fighting molecules at the tumor site [6] - IMUNON has also initiated a first-in-human study for its COVID-19 booster vaccine, IMNN-101, indicating the company's commitment to advancing its technological capabilities in plasmid DNA [6]

Core Insights - IMUNON is advancing its Phase 2 OVATION 2 Study to evaluate the safety and efficacy of IMNN-001 in combination with neoadjuvant chemotherapy for patients with advanced ovarian cancer [9][6] - The study aims to inform the design of a future Phase 3 trial, focusing on primary efficacy endpoints such as Progression Free Survival (PFS) and Overall Survival (OS) [13][17] Company Overview - IMUNON is a clinical-stage biotechnology company developing non-viral DNA-mediated immunotherapy, with a focus on innovative treatments that leverage the body's natural immune responses [3][9] - The company's lead program, IMNN-001, is a DNA-based immunotherapy designed to produce interleukin-12 and interferon gamma at the tumor site, targeting advanced ovarian cancer [15][9] Study Details - The OVATION 2 Study involved 110 patients, with treatment designed to shrink tumors before surgical removal, followed by additional chemotherapy [1][9] - Patients were randomized to receive either NACT plus IMNN-001 or standard-of-care NACT, with the IMNN-001 group receiving up to 17 doses of 100 mg/m² [1][9] Clinical Context - Epithelial ovarian cancer is a significant health concern, with approximately 22,000 new cases annually in the U.S., and a high recurrence rate of 75% in advanced stages [7][9] - The five-year survival rates for patients diagnosed with Stage III/IV disease are notably low, at 41% and 20% respectively, highlighting the need for improved therapies [7][9] Future Expectations - IMUNON anticipates reporting topline results, including hazard ratios, by the end of July 2024, following the completion of data analysis by independent statisticians [9][17] - The company aims to leverage the findings from the OVATION 2 Study to enhance the therapeutic potential of its plasmid DNA technology for challenging conditions [15][9]

Core Insights - IMUNON has achieved a significant milestone by reaching data lock for the OVATION 2 Study, which evaluates the safety and efficacy of IMNN-001 in patients with advanced ovarian cancer [2][6] - The study aims to provide insights for the design of a future Phase 3 trial, focusing on primary efficacy endpoints such as Progression Free Survival (PFS) and Overall Survival (OS) [7][8] Group 1: Study Overview - The OVATION 2 Study is assessing the intraperitoneal administration of IMNN-001 in combination with neoadjuvant chemotherapy for patients newly diagnosed with advanced epithelial ovarian cancer [1][6] - A total of 110 patients were fully enrolled in the study by September 2022, with a randomization of 1:1 for treatment comparison [1][6] - The study has reached a median treatment observation duration of 16 months, as required by the protocol [6] Group 2: Treatment Details - IMNN-001 is administered alongside neoadjuvant chemotherapy, with patients receiving up to 17 doses of 100 mg/m² [1][6] - The treatment strategy is designed to shrink tumors for optimal surgical removal, followed by additional cycles of adjuvant chemotherapy [1][6] Group 3: Expected Outcomes - IMUNON anticipates reporting topline results, including hazard ratios, by the end of July 2024 [6] - The primary efficacy analysis will be based on the Intent to Treat (ITT) population, with secondary endpoints including OS, Objective Response Rate, and Chemotherapy Response Score [7] Group 4: Company Background - IMUNON is a clinical-stage biotechnology company focused on developing innovative treatments using non-viral DNA technology [10][11] - The lead clinical program, IMNN-001, is a DNA-based immunotherapy targeting advanced ovarian cancer, designed to induce the production of cancer-fighting molecules at the tumor site [11]

Core Insights - IMUNON, Inc. has initiated the Phase 1 clinical trial for its IMNN-101 vaccine, utilizing the proprietary PlaCCine platform aimed at providing a seasonal COVID-19 vaccine [1][2][3] - The trial will evaluate the safety, tolerability, and immune response of IMNN-101 against the SARS-CoV-2 Omicron XBB1.5 variant, with topline data expected by the end of 2024 [2][3] - The company aims to demonstrate that its PlaCCine technology offers superior durability of immune protection compared to existing mRNA vaccines [4][7] Company Overview - IMUNON is a clinical-stage biotechnology company focused on non-viral DNA-mediated immunotherapy, with a portfolio that includes the TheraPlas® and PlaCCine® modalities [4][5] - The lead clinical program, IMNN-001, is a DNA-based immunotherapy for advanced ovarian cancer currently in Phase 2 development [5] - The company is leveraging its innovative technologies to address challenging medical conditions and enhance patient outcomes [4][5] Clinical Trial Details - The Phase 1 study will enroll 24 participants, testing three escalating doses of IMNN-101, with eight participants per dose [3] - Primary objectives include assessing safety and tolerability, while secondary objectives focus on evaluating neutralizing antibody responses and their durability [3] - Preclinical data suggests that the immune protection from IMNN-101 may exceed that of published mRNA vaccine data, with immunogenicity and stability at workable temperatures enhancing commercial viability [7]

Core Viewpoint - IMUNON, Inc. announces the acceptance of an abstract for a Phase 2 study involving IMNN-001, bevacizumab, and neoadjuvant chemotherapy in advanced epithelial ovarian cancer patients, to be presented at the ASCO annual meeting [1][2]. Group 1: Study Details - The abstract titled "A phase II study evaluating the effect of IMNN-001 on second-look laparoscopy when administered in combination with bevacizumab and neoadjuvant chemotherapy in patients newly diagnosed with advanced epithelial ovarian cancer" will be presented on June 3rd [2]. - The study is actively recruiting patients in the U.S. and is led by Dr. Amir A Jazaeri from The University of Texas MD Anderson Cancer Center [2][3]. Group 2: Funding and Clinical Significance - The study is substantially funded by Break Through Cancer, with MD Anderson as the leading clinical site, highlighting its importance in IMUNON's IL-12 gene therapy development for ovarian cancer [3]. - Dr. Sebastien Hazard, IMUNON's chief medical officer, emphasized the observed synergies in pre-clinical experiments with the combination of IMNN-001 and bevacizumab [3]. Group 3: Company Overview - IMUNON is a clinical-stage biotechnology company focused on developing innovative treatments that utilize the body's natural mechanisms for effective responses to various diseases [4]. - The company's lead clinical program, IMNN-001, is a DNA-based immunotherapy for advanced ovarian cancer, currently in Phase 2 development [5]. - IMUNON is also entering a first-in-human study of its COVID-19 booster vaccine, IMNN-101, showcasing its commitment to advancing plasmid DNA technology [5].

Proof-of-concept study for Imunon's first vaccine utilizing its proprietary PlaCCine platform is now open for enrollment Topline results expected this year LAWRENCEVILLE, N.J., May 13, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ:IMNN), a clinical-stage drug development company focused on developing non-viral DNA-mediated immunotherapy and next-generation vaccines, today announced that DM Clinical Research in Philadelphia is the first site activated and ready for patient recruitment for its Phase 1 study w ...

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, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to ____________ Commission file number: 001-15911 Imunon, Inc. (Exact name of Registrant as specified in its charter) Delaware 52-1256615 (State ...

[Business Update and Outlook](index=1&type=section&id=Business%20Update%20and%20Outlook) IMUNON is advancing key milestones in mid-2024, including OVATION 2 study results and a Phase 1 IMNN-101 COVID-19 vaccine trial [Key Highlights and Strategic Outlook](index=1&type=section&id=Key%20Highlights%20and%20Strategic%20Outlook) IMUNON expects mid-2024 OVATION 2 results and IMNN-101 Phase 1 trial initiation, advancing an 'mRNA-better' vaccine platform - The company is on track to report topline results from the OVATION 2 Study for IMNN-001 in advanced ovarian cancer in mid-2024[3](index=3&type=chunk) - The FDA has accepted the Investigational New Drug (IND) application for the seasonal COVID-19 booster vaccine (IMNN-101), and a Phase 1 study has begun, with first patients expected to be enrolled in the current quarter[4](index=4&type=chunk) - The company's strategic goal is to offer an "**mRNA-better**" vaccine platform with excellent commercial promise, citing advantages in immune response duration and stability[2](index=2&type=chunk)[4](index=4&type=chunk) [Management Changes](index=2&type=section&id=Management%20Changes) The company announced the appointment of a new President and CEO, effective May 13, 2024 [Appointment of New President and CEO](index=2&type=section&id=Appointment%20of%20New%20President%20and%20CEO) Dr. Stacy R. Lindborg, a seasoned biostatistician, was appointed President and CEO effective May 13, 2024 - Stacy R. Lindborg, Ph.D. was appointed President and Chief Executive Officer, effective May 13, 2024[5](index=5&type=chunk) - Dr. Lindborg has served on IMUNON's board of directors since 2021 and brings nearly **30 years** of pharmaceutical and biotech industry experience, with a focus on R&D, regulatory affairs, and strategy[5](index=5&type=chunk)[6](index=6&type=chunk) [Clinical Program Updates](index=2&type=section&id=Clinical%20Program%20Updates) IMUNON provides updates on its IMNN-001 immunotherapy program and the PlaCCine vaccine platform [IMNN-001 Immunotherapy Program](index=2&type=section&id=IMNN-001%20Immunotherapy%20Program) The IMNN-001 program for advanced ovarian cancer advances with OVATION 2 results expected mid-2024 and a new Phase 1/2 combination trial [OVATION 2 Study in Advanced Ovarian Cancer](index=2&type=section&id=OVATION%202%20Study%20in%20Advanced%20Ovarian%20Cancer) Interim OVATION 2 data indicated delayed disease progression and improved survival, with final results due mid-2024 for Phase 3 design - Interim data showed an approximate **three-month** delay in disease progression and a **nine-month** improvement in overall survival in the treatment arm versus the control arm[8](index=8&type=chunk) Subgroup Analysis (PARPi Maintenance) | Subgroup Analysis (PARPi Maintenance) | PARPi + NACT | PARPi + NACT + IMNN-001 | | :--- | :--- | :--- | | Median PFS (months) | 15.7 | 23.7 | | Median OS (months) | 45.6 | Not yet reached | - Final readout of the study is expected in mid-2024, which will inform the Phase 3 study design[8](index=8&type=chunk) [Phase 1/2 Trial in Combination with Bevacizumab](index=3&type=section&id=Phase%201%2F2%20Trial%20in%20Combination%20with%20Bevacizumab) A Phase 1/2 trial combining IMNN-001 with bevacizumab for advanced ovarian cancer commenced enrollment, assessing MRD and PFS - The first patient was enrolled in October 2023 in a Phase 1/2 trial combining IMNN-001 with bevacizumab for advanced ovarian cancer[9](index=9&type=chunk) - The trial is expected to enroll **50 patients**, with the primary endpoint being detection of minimal residual disease (MRD) and the secondary endpoint being progression-free survival (PFS)[9](index=9&type=chunk) [PlaCCine Vaccine Platform](index=3&type=section&id=PlaCCine%20Vaccine%20Platform) The PlaCCine DNA vaccine platform progresses with FDA IND clearance for IMNN-101 and published strong preclinical data [IMNN-101 (COVID-19 Booster) Phase 1 Trial](index=3&type=section&id=IMNN-101%20%28COVID-19%20Booster%29%20Phase%201%20Trial) FDA cleared IND for IMNN-101 COVID-19 booster, with Phase 1 trial starting Q2 2024 to assess safety and immunogenicity - The FDA cleared the IND application to begin a Phase 1 clinical trial for IMNN-101, a seasonal COVID-19 booster vaccine, in April 2024[10](index=10&type=chunk) - The Phase 1 study will enroll **24 subjects** to evaluate safety, tolerability, and durability of immunogenicity against the SARS-CoV-2 Omicron XBB1.5 variant[11](index=11&type=chunk)[12](index=12&type=chunk) - Preclinical studies demonstrated longer duration of IgG responses and higher T cell activation than an mRNA vaccine, and stability at standard refrigerated temperature (**4°C**) for more than **12 months**[4](index=4&type=chunk) [Preclinical Data Publication](index=3&type=section&id=Preclinical%20Data%20Publication) PlaCCine DNA vaccine preclinical data published in *Vaccine* showed strong immunogenicity, viral suppression, and stability - A study published in the peer-reviewed journal *Vaccine* in February 2024 highlighted the PlaCCine platform's strong immunogenicity and protection in mice[13](index=13&type=chunk) - Key findings include vaccine stability for up to **one year** at **4°C**, induction of neutralizing antibodies and cytotoxic T cells, and suppression of viral replication[18](index=18&type=chunk) [Corporate Developments](index=4&type=section&id=Corporate%20Developments) IMUNON secured non-dilutive funding through the sale of net operating losses [Non-Dilutive Funding](index=4&type=section&id=Non-Dilutive%20Funding) IMUNON secured **$1.3 million** in non-dilutive funding from selling 2022 New Jersey NOLs in March 2024 - Received **$1.3 million** in net cash proceeds from the sale of approximately **$1.4 million** of its unused New Jersey net operating losses (NOLs) in March 2024[15](index=15&type=chunk) - The sale was for the 2022 tax year and administered through the New Jersey Economic Development Authority's Technology Business Tax Certificate Transfer (NOL) program, providing non-dilutive funding[15](index=15&type=chunk) [Financial Results (Q1 2024)](index=4&type=section&id=FINANCIAL%20RESULTS%20FOR%20THE%20THREE%20MONTHS%20ENDED%20MARCH%2031%2C%202024) IMUNON reported a reduced net loss in Q1 2024, driven by lower operating expenses, while cash used in operations increased [Overview of Q1 2024 Performance](index=4&type=section&id=Overview%20of%20Q1%202024%20Performance) IMUNON reported a Q1 2024 net loss of **$4.9 million** (or **$0.52** per share), an improvement driven by lower operating expenses Key Financial Metrics | Metric | Q1 2024 (in millions) | Q1 2023 (in millions) | | :--- | :--- | :--- | | Net Loss | $4.9 | $5.6 | | Net Loss per Share | $0.52 | $0.68 | | Operating Expenses | $5.0 | $5.7 | [Operating Expenses Analysis](index=4&type=section&id=Operating%20Expenses%20Analysis) Total operating expenses decreased to **$5.0 million** in Q1 2024, due to lower G&A despite increased R&D for clinical programs - Research and development (R&D) expenses increased to **$3.3 million** in Q1 2024 from **$2.6 million** in Q1 2023, driven by higher clinical and regulatory costs[17](index=17&type=chunk) - General and administrative (G&A) expenses decreased to **$1.7 million** in Q1 2024 from **$3.1 million** in Q1 2023, due to lower non-cash stock compensation, legal, employee-related, consulting, and insurance costs[19](index=19&type=chunk) [Cash Flow and Liquidity](index=5&type=section&id=Cash%20Flow%20and%20Liquidity) Net cash used in operations was **$5.9 million** in Q1 2024, with **$9.8 million** cash, sufficient to fund operations through 2024 - Net cash used in operating activities was **$5.9 million** for Q1 2024, compared with **$4.0 million** for the same period in 2023[21](index=21&type=chunk) - The company ended Q1 2024 with **$9.8 million** in cash, investments, and accrued interest receivable[21](index=21&type=chunk) - Management believes current capital resources are sufficient to fund operations to the end of 2024[21](index=21&type=chunk) [Financial Statements](index=7&type=section&id=Financial%20Statements) Detailed financial statements for Q1 2024, including condensed consolidated statements of operations and selected balance sheet information [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company reported no licensing revenue, with Q1 2024 net loss of **$4.929 million** and improved loss per share of **$0.52** Condensed Consolidated Statements of Operations | | Three Months Ended March 31, (in thousands) | | | :--- | :--- | :--- | | | **2024** | **2023** | | **Operating expenses:** | | | | Research and development | $3,294 | $2,620 | | General and administrative | $1,717 | $3,064 | | **Total operating expenses** | **$5,011** | **$5,684** | | **Loss from operations** | **($5,011)** | **($5,684)** | | Other income (expense), net | $82 | $93 | | **Net loss** | **($4,929)** | **($5,591)** | | **Net loss per common share** | **($0.52)** | **($0.68)** | | Weighted average shares outstanding | 9,400 | 8,281 | [Selected Balance Sheet Information](index=8&type=section&id=Selected%20Balance%20Sheet%20Information) As of March 31, 2024, total assets were **$14.3 million** and stockholders' equity **$8.5 million**, decreasing from year-end 2023 Selected Balance Sheet Information | | March 31, 2024 (in thousands) | December 31, 2023 (in thousands) | | :--- | :--- | :--- | | **ASSETS** | | | | Cash and cash equivalents | $2,347 | $5,839 | | Total current assets | $12,094 | $18,241 | | **Total assets** | **$14,325** | **$21,918** | | **LIABILITIES AND STOCKHOLDERS' EQUITY** | | | | Total current liabilities | $4,817 | $7,391 | | **Total liabilities** | **$5,825** | **$8,530** | | **Total stockholders' equity** | **$8,500** | **$13,388** | | **Total liabilities and stockholders' equity** | **$14,325** | **$21,918** |