DNA vaccine proof-of-concept study expected to demonstrate an "mRNA better" platform LAWRENCEVILLE, N.J., June 05, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company focused on developing non-viral DNA-mediated immunotherapy and evaluating an adaptation of the platform's potential as a next-generation vaccine, announces that the first participants have been treated in the IMNN-101 Phase 1 clinical trial. This proof-of-concept study of IMUNON's proprietary PlaCCine® platform is be ...

LAWRENCEVILLE, N.J., May 15, 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, announces that an abstract describing a Phase 2 study with IMNN-001 plus bevacizumab (Avastin®) and neoadjuvant chemotherapy in advanced epithelial ovarian cancer patients has been accepted for presentation at the American Society of Clinical Oncology (ASCO) annual meeting, to be held in Chicago fr ...

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** |

Assumes leadership role as Company anticipates multiple near-term clinical milestones Brings extensive leadership and experience in drug development and business strategy LAWRENCEVILLE, N.J., May 08, 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 the appointment of Stacy R. Lindborg, Ph.D. as President and Chief Executive Officer, effective May 13, 2024. Dr ...

LAWRENCEVILLE, N.J., May 06, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ:IMNN), a clinical-stage drug-development company focused on developing DNA-mediated immunotherapy and next-generation vaccines, announces that the Company will host a conference call at 11:00 a.m. ET on Monday, May 13, 2024 to discuss financial results for the first quarter ended March 31, 2024 and provide an update on its clinical development programs with IMNN-001, a DNA-based interleukin-12 (IL-12) immunotherapy in Phase 2 clinica ...

Company expects enrollment in Phase 1 proof-of-concept study of DNA-based vaccine technology to begin in the second quarter LAWRENCEVILLE, N.J., April 18, 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, announces receipt of clearance from the U.S. Food and Drug Administration (FDA) to begin a Phase 1 clinical trial with a seasonal COVID-19 booster vaccine. The company filed ...

LAWRENCEVILLE, N.J., April 11, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ:IMNN) ("IMUNON" or the "Company"), a clinical-stage drug-development company focused on developing DNA-mediated immuno-oncology therapies and next-generation vaccines, today announced that on April 10, 2024, it received written notice from the staff of The NASDAQ Stock Market LLC ("Nasdaq") informing the Company that it has regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) (the "Minimum ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K 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 NO.: 001-15911 IMUNON, INC. (Exact Name of Registrant as Specified in Its Charter) DELAWARE 52-1256615 (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023. (State or other jurisdic ...