Imunon(IMNN) - 2025 Q2 - Quarterly Report

PART I: FINANCIAL INFORMATION Item 1. Financial Statements Presents the unaudited condensed consolidated financial statements and accompanying notes for the period Condensed Consolidated Balance Sheets | ASSETS | June 30, 2025 (Unaudited) ($) | December 31, 2024 ($) | | :--- | :--- | :--- | | Cash and cash equivalents | 4,728,776 | 5,872,767 | | Total current assets | 6,891,245 | 8,008,959 | | Total assets | 8,788,327 | 9,717,364 | | LIABILITIES AND STOCKHOLDERS' EQUITY | | | | Total current liabilities | 5,317,287 | 4,786,131 | | Total liabilities | 6,128,477 | 5,473,066 | | Total stockholders' equity | 2,659,850 | 4,244,298 | Condensed Consolidated Statements of Operations | (in dollars, except per share data) | For the Three Months Ended June 30, | For the Six Months Ended June 30, | | :--- | :--- | :--- | | | 2025 | 2024 | 2025 | 2024 | | Total operating expenses | 2,767,864 | 5,013,351 | 6,913,163 | 10,024,797 | | Loss from operations | (2,767,864) | (5,013,351) | (6,913,163) | (10,024,797) | | Investment income, net | 27,305 | 225,334 | 70,109 | 307,255 | | Net loss | (2,740,559) | (4,788,017) | (6,843,054) | (9,717,542) | | Net loss per common share (Basic and diluted) | (2.15) | (7.64) | (6.08) | (15.51) | | Weighted average shares outstanding (Basic and diluted) | 1,277,217 | 626,726 | 1,124,730 | 626,726 | Condensed Consolidated Statements of Comprehensive Loss | (in dollars) | For the Three Months Ended June 30, | For the Six Months Ended June 30, | | :--- | :--- | :--- | | | 2025 | 2024 | 2025 | 2024 | | Change in realized and unrealized gains (losses) on available for sale securities, net | - | (72,306) | - | - | | Net loss | (2,740,559) | (4,788,017) | (6,843,054) | (9,717,542) | | Total comprehensive loss | (2,740,559) | (4,860,323) | (6,843,054) | (9,717,542) | Condensed Consolidated Statements of Cash Flows | (in dollars) | For the Six Months Ended June 30, | | :--- | :--- | | | 2025 | 2024 | | Cash flows from operating activities: | | | Net loss | (6,843,054) | (9,717,542) | | Net cash used in operating activities | (5,798,440) | (10,378,517) | | Cash flows from investing activities: | | | Net cash (used in) provided by investing activities | (276,983) | 9,846,519 | | Cash flows from financing activities: | | | Net cash provided by financing activities | 4,931,432 | - | | Net change in cash and cash equivalents | (1,143,991) | (531,998) | | Cash and cash equivalent at end of period | 4,728,776 | 5,306,568 | Condensed Consolidated Statements of Changes in Stockholders' Equity (Three Months) | (in dollars, except share data) | Common Stock Outstanding Shares | Common Stock Amount | Additional Paid-in Capital | Treasury Stock Amount | Accumulated Deficit | Total Stockholders' Equity | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Balance at April 1, 2025 (unaudited) | 974,717 | 9,747 | 411,433,008 | (85,188) | (410,905,539) | 452,028 | | Net loss | - | - | - | - | (2,740,559) | (2,740,559) | | Sale of equity through equity financing facilities, net of costs | 481,482 | 4,815 | 2,853,231 | - | - | 2,858,046 | | Issuance of common stock upon exercise of common stock warrants | 260,323 | 2,603 | 1,965,091 | - | - | 1,967,694 | | Stock-based compensation expense | - | - | 122,631 | - | - | 122,631 | | Balance at June 30, 2025 (unaudited) | 1,717,502 | 17,175 | 416,373,961 | (85,188) | (413,646,098) | 2,659,850 | Condensed Consolidated Statements of Changes in Stockholders' Equity (Six Months) | (in dollars, except share data) | Common Stock Outstanding Shares | Common Stock Amount | Additional Paid-in Capital | Treasury Stock Amount | Accumulated Deficit | Total Stockholders' Equity | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Balance at January 1, 2025 | 966,714 | 9,667 | 411,122,863 | (85,188) | (406,803,044) | 4,244,298 | | Net loss | - | - | - | - | (6,843,054) | (6,843,054) | | Sale of equity through equity financing facilities, net of costs | 489,485 | 4,895 | 2,958,843 | - | - | 2,963,738 | | Issuance of common stock upon exercise of common stock warrants | 260,323 | 2,603 | 1,965,091 | - | - | 1,967,694 | | Stock-based compensation expense | - | - | 327,164 | - | - | 327,164 | | Balance at June 30, 2025 (unaudited) | 1,717,502 | 17,175 | 416,373,961 | (85,188) | (413,646,098) | 2,659,850 | Notes to the Condensed Consolidated Financial Statements Details the company's business, accounting policies, financial performance, and recent corporate actions Note 1. Business Description - Imunon, Inc is a clinical-stage biotechnology company focused on advancing innovative treatments using non-viral DNA technology[39] - The company has two modalities: TheraPlas® for solid tumors (lead program IMNN-001 for advanced ovarian cancer) and PlaCCine® for viral antigens (IMNN-101 for COVID-19 booster vaccine)[39][40] Note 2. Basis of Presentation - The company has incurred approximately $414 million of cumulative net losses since inception as of June 30, 2025[44] - For the six months ended June 30, 2025, the company had a net loss of $6.8 million and used $5.8 million to fund operations, with $4.7 million in cash and cash equivalents remaining[44] - These conditions raise substantial doubt about the company's ability to continue as a going concern, necessitating additional capital funding[44][49][50][56] Note 3. New Accounting Pronouncements - The company is evaluating ASU No 2023-09, "Improvements to Income Tax Disclosures," effective for its Annual Report for the year ended December 31, 2025[52] - The company is also evaluating ASU No 2024-03, "Expense Disaggregation Disclosures," effective for annual reporting periods beginning after December 15, 2026[53] Note 4. Net Loss per Common Share - Common stock equivalents (1,198,176 shares for H1 2025) were excluded from diluted EPS calculations due to their anti-dilutive effect[55] - The company did not pay any dividends during the first six months of 2025 or 2024[55] Note 5. Segment Performance Measures and Expenses - The company operates in one segment for the research and development of product candidates, with performance evaluated based on consolidated financial information[57] Operating Expenses | Operating Expenses (in thousands) | For the six months ended June 30, 2025 | For the six months ended June 30, 2024 | Change Increase (Decrease) | % Change | | :--- | :--- | :--- | :--- | :--- | | Research and development expenses | $3,392 | $6,114 | $(2,722) | (44.5)% | | General and administrative expenses | $3,521 | $3,911 | $(390) | (10.0)% | | Total operating expenses | $6,913 | $10,025 | $(3,112) | (31.0)% | | Loss from operations | $(6,913) | $(10,025) | $(3,112) | (31.0)% | Note 6. Other Accrued Liabilities Other Accrued Liabilities | Other Accrued Liabilities | June 30, 2025 ($) | December 31, 2024 ($) | | :--- | :--- | :--- | | Amounts due to contract research organizations and other contractual agreements | 843,003 | 1,048,036 | | Accrued payroll and related benefits | 2,273,259 | 1,945,111 | | Accrued professional fees and other | 83,240 | 40,600 | | Total | 3,199,502 | 3,033,747 | Note 7. Stockholders' Equity - The company filed a shelf registration statement (Form S-3) on May 15, 2024, for up to $75 million of its securities[60] - The At the Market (ATM) Offering Agreement was amended to allow the sale of up to $8,184,733 in common stock[61][64] - In May 2025, the company completed a private placement for approximately $3.3 million gross proceeds, issuing common stock and warrants[70][71] Note 8. Stock-Based Compensation - The 2018 Stock Incentive Plan was amended on July 11, 2025, increasing the number of shares available by 133,333 to a total of 264,667[75] - Total stock-based compensation expense was approximately $0.3 million for the six months ended June 30, 2025[78] - As of June 30, 2025, there was $0.4 million of total unrecognized compensation cost related to non-vested stock-based compensation arrangements[79] Note 9. Warrants Warrant Activity | Warrants | Number of Warrants Issued | Weighted Average Exercise Price ($) | | :--- | :--- | :--- | | Warrants outstanding at January 1, 2025 | 343,671 | 37.65 | | Warrants issued | 1,283,334 | 5.22 | | Warrants exercised – cashless | (194,734) | - | | Warrants exercised | (361,888) | 5.44 | | Warrants outstanding at June 30, 2025 | 1,070,383 | 11.07 | | Aggregate intrinsic value of outstanding warrants at June 30, 2025 | $5,141,320 | | | Weighted average remaining contractual terms at June 30, 2025 | 3.1 years | | Note 10. Leases - The Lawrenceville office lease was renewed in April 2025 until November 30, 2028, with monthly rent payments of approximately $10,361 to $10,863[83] - The Huntsville facility lease was renewed in January 2023 for a 60-month term, with monthly rent payments of approximately $28,550 to $30,903[84] Lease Payments and Maturity | As of June 30, 2025 | Amount ($) | | :--- | :--- | | 2025 | 240,391 | | 2026 | 488,821 | | 2027 | 498,086 | | 2028 and thereafter | 149,896 | | Subtotal future lease payments | 1,377,194 | | Less imputed interest | (183,787) | | Total lease liabilities | 1,193,407 | Note 11. Commitments and Contingencies - The company is not currently a party to any material legal proceedings[86] Note 12. Subsequent Events - The One Big Beautiful Bill Act (OBBBA) was enacted on July 4, 2025, with the company currently evaluating its impact on income tax disclosures[89] - A 15-for-1 reverse stock split was effected on July 25, 2025, to regain compliance with Nasdaq's minimum bid price requirement[90][91][94] - Authorized common stock was increased from 112,500,000 to 350,000,000 shares on July 11, 2025, and a 15% stock dividend was approved on July 28, 2025[92][93][94][95] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Provides management's analysis of financial condition, operational results, and future outlook Overview - Imunon is a clinical-stage biotechnology company focused on advancing innovative treatments using non-viral DNA technology[97] - The company's lead clinical program, IMNN-001, is a DNA-based immunotherapy for advanced ovarian cancer, and IMNN-101 is a COVID-19 booster vaccine[98] Technology Platform - Imunon's technology platform uses synthetic non-viral carriers for DNA and mRNA therapeutics, designed to protect payloads and promote cell trafficking[99] - The platform offers enhanced molecular versatility, improved activity and safety, and is more efficient and cost-effective than viral approaches[99][100] THERAPLAS MODALITY: IMNN-001 DEVELOPMENT PROGRAM Details the development of IMNN-001 for advanced ovarian cancer, from clinical studies to Phase 3 planning Ovarian Cancer Overview - Ovarian cancer is the most lethal gynecological malignancy, with over 60% of women dying within five years of diagnosis[102] - There is a significant unmet need for improved treatments, with Interleukin-12 (IL-12) considered a promising immunotherapeutic approach[102][103][104] IMNN-001 Immunotherapy - IMNN-001 is a DNA-based immunotherapeutic drug candidate for ovarian cancer, administered intraperitoneally to locally produce IL-12[105][106] - The therapy aims to create a potent immune environment against tumor activity for a more robust and durable antitumor response[105] OVATION 1 Study - The Phase I OVATION 1 Study established a tolerable and therapeutically active dose of IMNN-001, showing dose-dependent increases in local IL-12 and IFNγ[105][106][111] - Key findings included decreased immunosuppressive T-cell signals and increased CD8+ cells in the tumor microenvironment[108][111] - Median Progression-Free Survival (PFS) was 21 months (per protocol) and 18.4 months (ITT), supporting continued evaluation[108] OVATION 2 Study - The Phase I/II OVATION 2 Study completed enrollment with 113 patients and received Orphan Drug and Fast Track designations[113][114] - Positive topline results showed a 13-month increase in median Overall Survival (OS) (46 vs 33 months) in the IMNN-001 arm[119][121][123] - Patients treated with a PARP inhibitor showed further enhanced outcomes, with median OS not yet reached in the IMNN-001 arm after >5 years[115][120][123] OVATION 3 Study - The FDA supported the advancement of IMNN-001 into a Phase 3 pivotal study (OVATION 3) for newly diagnosed advanced ovarian cancer[124][126] - The trial will assess IMNN-001 plus chemotherapy, with Overall Survival (OS) as the primary endpoint[125] - The FDA aligned with the company's Chemistry, Manufacturing, and Controls (CMC) strategy, and trial sites are now initiating recruitment[125][127] IMNN-001 in Combination with bevacizumab - A Phase I/II study is underway to evaluate IMNN-001 in combination with bevacizumab in patients with advanced ovarian cancer[128][130] - The study's primary endpoint is the detection of minimal residual disease (MRD) by second look laparoscopy[131] - As of June 30, 2025, fifteen patients have been enrolled and treated in the study[132] PLACCINE DNA VACCINE MODALITY: IMNN-101 Describes the PlaCCine DNA vaccine modality for infectious diseases, with IMNN-101 as the lead candidate COVID-19 Vaccine Overview - First-generation COVID-19 vaccines have raised concerns about durability and viral resistance due to rapid Spike (S) protein mutations[138] - There is an urgent need for new vaccine technologies that can address viral mutations and offer efficient manufacturing and distribution[135][140] Our Next Generation Vaccine Initiative - Imunon's PLACCINE platform uses a single plasmid vector with multiple coding regions, offering broad-spectrum resistance and durable efficacy[136][137][140][142] - Preclinical studies demonstrated robust immune responses and protection against SARS-CoV-2 variants, comparable to commercial mRNA vaccines[141][143][145][146][147][153] - The Phase 1 clinical trial of IMNN-101 showed safety, tolerability, and durable neutralizing antibody responses with cross-reactivity against newer variants[150][151][152][153] Business Plan and Going Concern Risk - The company has an accumulated deficit of $414 million as of June 30, 2025, and does not expect product sales revenue in the near term[157][160][203] - With $4.7 million in cash, there is substantial doubt about the company's ability to continue as a going concern, requiring significant additional capital[160][161][203][204] - Management plans to raise capital through equity sales, debt, or collaborations, but warns of potential dilution or relinquishing rights[162][163] Financing Overview The company raised approximately $14.0 million in net proceeds from equity issuances in 2025 and 2024 Equity, Debt and Other Forms of Financing - The company issued 1.1 million shares of common stock in 2025 and 2024, generating approximately $14.0 million in net proceeds[164] - In Q1 2025, the company sold 8,003 shares of common stock under the ATM program for net proceeds of $105,693[165] May 2025 Offering - On May 23, 2025, the company completed a private placement for gross proceeds of approximately $3.3 million[166] - The pre-funded warrants were exercised in full in June 2025, and shareholders approved the issuance of the warrants on July 11, 2025[167][168] Significant Accounting Policies - The company's significant accounting policies are described in its 2024 Annual Report on Form 10-K and Note 3 of this Quarterly Report[169] FINANCIAL REVIEW FOR THE THREE MONTHS ENDED JUNE 30, 2025 AND 2024 Net loss decreased to $2.8 million from $4.8 million year-over-year, driven by reduced operating expenses Results of Operations - Net loss for Q2 2025 was $2.8 million, a decrease from $4.8 million in Q2 2024[171] Operating Expenses | Operating Expenses (in thousands) | For the three months ended June 30, 2025 | For the three months ended June 30, 2024 | Change Increase (Decrease) | % Change | | :--- | :--- | :--- | :--- | :--- | | Research and development expenses | $1,227 | $2,819 | $(1,592) | (56.5)% | | General and administrative expenses | $1,541 | $2,194 | $(653) | (29.8)% | | Total operating expenses | $2,768 | $5,013 | $(2,245) | (44.8)% | | Loss from operations | $(2,768) | $(5,013) | $(2,245) | (44.8)% | Research and Development Expenses - R&D expenses decreased to $1.2 million in Q2 2025 from $2.8 million in Q2 2024, due to lower clinical and CMC costs[176] - PlaCCine DNA vaccine technology platform development costs were $0 in 2025 compared to $0.7 million in 2024[176] - R&D costs for IMNN-001 to support the OVATION program increased to $0.6 million in Q2 2025 from $0.2 million in Q2 2024[176] General and Administrative Expenses - General and administrative expenses decreased to $1.5 million in Q2 2025 from $2.2 million in Q2 2024, due to a $0.7 million reduction in employee-related expenses[177] - Investment income, net, decreased significantly to $27,000 in Q2 2025 from $225,000 in Q2 2024, attributed to a lower cash balance[177] FINANCIAL REVIEW FOR THE SIX MONTHS ENDED JUNE 30, 2025 AND 2024 Net loss decreased to $6.9 million from $9.7 million year-over-year, driven by a 31.0% reduction in operating expenses Results of Operations - Net loss for H1 2025 was $6.9 million, a decrease from $9.7 million in H1 2024[178] Operating Expenses | Operating Expenses (in thousands) | For the six months ended June 30, 2025 | For the six months ended June 30, 2024 | Change Increase (Decrease) | % Change | | :--- | :--- | :--- | :--- | :--- | | Research and development expenses | $3,392 | $6,114 | $(2,722) | (44.5)% | | General and administrative expenses | $3,521 | $3,911 | $(390) | (10.0)% | | Total operating expenses | $6,913 | $10,025 | $(3,112) | (31.0)% | | Loss from operations | $(6,913) | $(10,025) | $(3,112) | (31.0)% | Research and Development Expenses - R&D expenses decreased to $3.4 million in H1 2025 from $6.1 million in H1 2024, due to reductions in PlaCCine clinical and development costs[182] - R&D costs for IMNN-001 to support the OVATION program increased to $1.5 million in H1 2025 from $0.7 million in H1 2024[182] General and Administrative Expenses - General and administrative expenses decreased to $3.5 million in H1 2025 from $3.9 million in H1 2024, due to lower employee, legal, and travel costs[183] - Investment income, net, decreased to $70,000 in H1 2025 from $307,000 in H1 2024, due to a lower cash balance[183] FINANCIAL CONDITION, LIQUIDITY AND CAPITAL RESOURCES - The company has an accumulated deficit of $414 million and $4.7 million in cash and cash equivalents as of June 30, 2025[184][185] - Net cash used in operating activities for H1 2025 was $5.8 million, indicating substantial future capital requirements[186] - These conditions raise substantial doubt about the company's ability to continue as a going concern, necessitating additional capital[187][188][189] Off-Balance Sheet Arrangements and Contractual Obligations - The company reported no off-balance sheet arrangements or material contractual obligations[190] Item 3. Quantitative and Qualitative Disclosures about Market Risk As a smaller reporting company, these disclosures are not required - The company is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk[191] Item 4. Controls and Procedures Management concluded disclosure controls and procedures were effective at a reasonable assurance level - Management, including the CEO and CFO, concluded that disclosure controls and procedures were effective at a reasonable assurance level as of June 30, 2025[192] - No material changes in internal control over financial reporting were identified during the period[193] - The company acknowledges that control systems have inherent limitations and can only provide reasonable, not absolute, assurance[194] PART II: OTHER INFORMATION Item 1. Legal Proceedings The company is not currently involved in any material legal proceedings - The company is not currently a party to any material legal proceedings[196] Item 1A. Risk Factors Details risks including short selling impact, potential Nasdaq delisting, and the need for capital - Any market activity involving short selling could result in a negative impact on the market price for the company's Common Stock[198] - The company faces a significant risk of delisting from Nasdaq due to non-compliance with minimum bid price and stockholders' equity requirements[200] - The company will need to raise additional capital to fund future operations, with no assurance of securing it without significant dilution[203][204] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds The company reported no unregistered sales of equity securities or use of proceeds - No unregistered sales of equity securities or use of proceeds were reported[205] Item 3. Defaults Upon Senior Securities The company reported no defaults upon senior securities during the period - No defaults upon senior securities were reported[206] Item 4. Mine Safety Disclosures This item is not applicable to the company - This item is not applicable to the company[207] Item 5. Other Information No directors or officers entered into, modified, or terminated Rule 10b5-1 trading plans - No directors or executive officers entered into, modified, or terminated Rule 10b5-1 trading plans during the quarter ended June 30, 2025[208] Item 6. Exhibits Lists the exhibits filed with the Form 10-Q, including corporate amendments and agreements - Exhibits include Certificate of Amendment, forms of Warrant, Securities Purchase Agreement, and CEO/CFO certifications[209] SIGNATURES - The report was signed on August 5, 2025, by Stacy R. Lindborg, Ph.D., Chief Executive Officer, and Kimberly Graper, Chief Financial Officer[212]