Imunon(IMNN) - 2025 Q2 - Quarterly Results

IMUNON Reports Second Quarter 2025 Financial Results and Provides Business Update Overview IMUNON reported Q2 and H1 2025 results, advanced Phase 3 IMNN-001 in ovarian cancer, and issued a stock dividend - IMUNON reported financial results for Q2 and H1 2025 and provided business updates, including Phase 3 clinical development of its lead candidate IMNN-001 in newly diagnosed advanced ovarian cancer[2] - A stock dividend was issued to IMUNON shareholders, reflecting confidence in clinical programs, long-term growth strategy, and dedication to rewarding shareholders[2] - CEO Stacy Lindborg highlighted IMUNON's significant progress in transforming cancer treatment with IMNN-001, attracting investor interest and strategically funding the pivotal Phase 3 OVATION 3 Study[3] Recent Developments IMNN-001 Immunotherapy (Ovarian Cancer) IMUNON initiated Phase 3 OVATION 3 for IMNN-001, showing positive Phase 2 data and validating its anti-tumor mechanism - First patient dosed in Phase 3 OVATION 3 Study for IMNN-001 on July 30, 2025, with a corporate goal of having 20 sites activated by the end of 2025[4] - Phase 3 OVATION 3 trial will assess the safety and efficacy of IMNN-001 plus neoadjuvant and adjuvant chemotherapy (N/ACT) compared to standard of care (SoC) N/ACT alone, with overall survival (OS) as the primary endpoint[5] - Positive data from Phase 2 OVATION 2 Study presented at ASCO 2025 showed IMNN-001 treatment resulted in consistent, clinically meaningful improvements in OS, progression-free survival (PFS), chemotherapy response score, and surgical response, with a favorable safety profile[6] Phase 2 OVATION 2 Study Key Highlights (ITT Population) | Endpoint | IMNN-001 + SoC N/ACT | SoC N/ACT alone | Hazard Ratio | | :-------------------------------- | :------------------- | :-------------- | :----------- | | Median OS (months) | 46 | 33 | 0.69 | | PFS + OS extension (months) | 6.5 | N/A | N/A | | Median OS (with PARP inhibitors, months) | Not yet reached (>60) | 37 | 0.38 | - Positive Phase 2 translational data demonstrated IMNN-001 creates a 'hot' anti-tumor microenvironment by recruiting CD8+ T cells, macrophages, and dendritic cells, validating its mechanism of action[8] PlaCCine DNA Vaccine Technology (COVID-19) Phase 1 data for IMNN-101 COVID-19 vaccine showed durable protection, but the program is deprioritized for partnership - Six-month data from the Phase 1 proof-of-concept trial of IMNN-101 (COVID-19 vaccine) showed up to a 3-fold median increase in serum neutralizing antibody (NAb) titers from baseline at six months[9] - PlaCCine's demonstrated advantages include durability of protection, simplified manufacturing, and stability (up to one year at 4°C and one month at 37°C)[10] - The Company plans to seek partners for further development of IMNN-101 due to strategic deprioritization of this program[10] Corporate Highlights Shareholder Value Initiatives (Stock Dividend) IMUNON announced a 15% stock dividend, reflecting confidence in clinical programs and commitment to shareholder returns - Announced a 15% stock dividend (0.15 shares of common stock per share) on July 28, 2025, payable August 21, 2025, to holders of record as of August 7, 2025[12] Financing Activities (Private Placement) A private placement raised $3.25 million, with potential for $6.50 million more, funding Phase 3 OVATION 3 Study - Private placement offering on May 28, 2025, raised approximately $3.25 million in aggregate gross proceeds from the sale of common stock and short-term warrants[13] - Potential additional gross proceeds of approximately $6.50 million if short-term warrants are fully exercised on a cash basis[13] - Net proceeds from the offering are intended for working capital focused on the pivotal Phase 3 OVATION 3 Study of IMNN-001 and general corporate purposes[13] Nasdaq Compliance & Listing Status Nasdaq granted an extension for compliance, noting Equity Rule achievement and requiring a plan for sustained compliance - Nasdaq Hearing Panel granted an exception for IMUNON to maintain its listing, noting compliance with the Equity Rule achieved through recent fundraising activities[14] - Company will implement a compliance plan to ensure sustained compliance with minimum shareholder equity and regain compliance with minimum bid price requirements within the designated timeframe[14] Capital Structure Changes (Reverse Stock Split & Authorized Shares) IMUNON effected a 15-for-1 reverse stock split and increased authorized common shares to 350 million - A 15-for-1 reverse stock split was effective July 25, 2025, consolidating 31,828,425 outstanding shares into 2,121,895 shares[15] - Authorized common stock increased from 112,500,000 shares to 350,000,000 shares, approved by stockholders on July 11, 2025[16] Second Quarter 2025 Financial Results Q2 2025 Financial Performance Q2 2025 net loss improved to $2.7 million due to reduced operating expenses, with sufficient capital into Q4 2025 Q2 2025 vs. Q2 2024 Financial Highlights | Metric | Q2 2025 | Q2 2024 | Change (YoY) | | :------------------- | :------ | :------ | :----------- | | Net Loss (million) | $(2.7) | $(4.8) | $(2.1) decrease | | Net Loss per Share | $(2.15) | $(7.64) | $(5.49) decrease | | Operating Expenses (million) | $2.8 | $5.0 | $(2.2) (45% decrease) | | R&D Expenses (million) | $1.2 | $2.8 | $(1.6) decrease | | G&A Expenses (million) | $1.5 | $2.2 | $(0.7) decrease | | Investment Income (thousands) | $27 | $225 | $(198) decrease | - Cash and cash equivalents were $4.7 million as of June 30, 2025[21] - The Company received $3.1 million in net proceeds from warrant exercise and ATM sales during July 2025, believing it has sufficient capital resources to fund planned operations into the fourth quarter of 2025[21] First Half 2025 Financial Results H1 2025 Financial Performance H1 2025 net loss decreased to $6.8 million, driven by a 31% reduction in operating expenses and lower cash usage H1 2025 vs. H1 2024 Financial Highlights | Metric | H1 2025 | H1 2024 | Change (YoY) | | :-------------------------------- | :------ | :------ | :----------- | | Net Loss (million) | $(6.8) | $(9.7) | $(2.9) decrease | | Net Loss per Share | $(6.08) | $(15.51) | $(9.43) decrease | | Operating Expenses (million) | $6.9 | $10.0 | $(3.1) (31% decrease) | | Net Cash Used for Operating Activities (million) | $5.8 | $10.4 | $(4.6) decrease | | R&D Expenses (million) | $3.4 | $6.1 | $(2.7) decrease | | G&A Expenses (million) | $3.5 | $3.9 | $(0.4) decrease | | Other Non-Operating Income (thousands) | $70 | $307 | $(237) decrease | - The decrease in net cash used for operating activities was due to lower operating costs coupled with higher accounts payable and accrued liabilities[24] Conference Call and Company Information Conference Call and Webcast IMUNON hosted a conference call on August 5, 2025, to discuss Q2 2025 results and provide a business update - A conference call was hosted on August 5, 2025, at 11:00 a.m. ET to review second quarter 2025 financial results and provide a business update[27] About IMUNON IMUNON is a clinical-stage biotech company developing non-viral DNA technologies for solid tumors and viral antigens - IMUNON is a clinical-stage biotechnology company focused on advancing a portfolio of innovative treatments that harness the body's natural mechanisms using non-viral DNA technology[29] - The company develops two modalities: TheraPlas® for gene-based delivery of cytokines in solid tumors (lead program IMNN-001) and PlaCCine® for gene delivery of viral antigens (IMNN-101)[29][30] - IMNN-001, a DNA-based immunotherapy for advanced ovarian cancer, has completed multiple clinical trials including Phase 2 (OVATION 2) and initiated Phase 3 (OVATION 3)[30] Forward-Looking Statements This section contains standard cautionary statements regarding forward-looking information and associated risks - Forward-looking statements in this news release are made pursuant to the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995[31] - Readers are cautioned that such statements involve risks and uncertainties, including those related to regaining Nasdaq compliance, clinical trial outcomes, and unforeseen changes in research and development activities[31] Contacts Provides contact information for media and investor relations inquiries - Contact information is provided for media (Jenna Urban, CG Life) and investors (Peter Vozzo, ICR Healthcare)[32] Financial Statements Condensed Statements of Operations Condensed statements show reduced net loss for Q2 and H1 2025, driven by lower operating expenses Condensed Statements of Operations (in thousands except per share amounts) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $1,227 | $2,819 | $3,392 | $6,114 | | General and administrative | $1,541 | $2,194 | $3,521 | $3,911 | | Total operating expenses | $2,768 | $5,013 | $6,913 | $10,025 | | Loss from operations | $(2,768) | $(5,013) | $(6,913) | $(10,025) | | Investment Income | $27 | $225 | $70 | $307 | | Net loss | $(2,741) | $(4,788) | $(6,843) | $(9,718) | | Net loss per common share (Basic and diluted) | $(2.15) | $(7.64) | $(6.08) | $(15.51) | | Weighted average shares outstanding (Basic and diluted) | 1,277 | 627 | 1,124 | 627 | Selected Balance Sheet Information Total assets and stockholders' equity decreased from December 2024 to June 2025, primarily due to lower cash Selected Balance Sheet Information (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :---------------------------------- | :-------------- | :---------------- | | Cash and cash equivalents | $4,729 | $5,873 | | Total current assets | $6,891 | $8,009 | | Total assets | $8,788 | $9,717 | | Accounts payable and accrued liabilities | $4,935 | $4,334 | | Total current liabilities | $5,317 | $4,786 | | Total liabilities | $6,128 | $5,473 | | Total stockholders' equity | $2,660 | $4,244 |