Imunon(IMNN) - 2024 Q1 - Quarterly Results

Business Update and Outlook 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 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] - 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] - 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][4] Management Changes The company announced the appointment of a new President and CEO, effective May 13, 2024 Appointment of New President and CEO 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] - 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][6] Clinical Program Updates IMUNON provides updates on its IMNN-001 immunotherapy program and the PlaCCine vaccine platform IMNN-001 Immunotherapy Program 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 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] 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] Phase 1/2 Trial in Combination with Bevacizumab 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] - 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] PlaCCine Vaccine Platform 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 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] - 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][12] - 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] Preclinical Data Publication 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] - 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] Corporate Developments IMUNON secured non-dilutive funding through the sale of net operating losses Non-Dilutive Funding 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] - 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] Financial Results (Q1 2024) 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 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 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] - 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] Cash Flow and Liquidity 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] - The company ended Q1 2024 with $9.8 million in cash, investments, and accrued interest receivable[21] - Management believes current capital resources are sufficient to fund operations to the end of 2024[21] Financial Statements Detailed financial statements for Q1 2024, including condensed consolidated statements of operations and selected balance sheet information Condensed Consolidated Statements of Operations 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 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 |