PART I: FINANCIAL INFORMATION [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) Presents the unaudited condensed consolidated financial statements and accompanying notes for the period [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) | 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](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) | (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](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss) | (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](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) | (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)](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity%20(Unaudited)%20for%20the%20Three%20Months%20Ended%20June%2030,%202025%20and%202024) | (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)](index=13&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity%20(Unaudited)%20for%20the%20Six%20Months%20Ended%20June%2030,%202025%20and%202024) | (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](index=15&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) Details the company's business, accounting policies, financial performance, and recent corporate actions [Note 1. Business Description](index=15&type=section&id=Note%201.%20Business%20Description) - Imunon, Inc is a clinical-stage biotechnology company focused on advancing innovative treatments using **non-viral DNA technology**[39](index=39&type=chunk) - 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](index=39&type=chunk)[40](index=40&type=chunk) [Note 2. Basis of Presentation](index=15&type=section&id=Note%202.%20Basis%20of%20Presentation) - The company has incurred approximately **$414 million of cumulative net losses** since inception as of June 30, 2025[44](index=44&type=chunk) - 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](index=44&type=chunk) - These conditions raise **substantial doubt about the company's ability to continue as a going concern**, necessitating additional capital funding[44](index=44&type=chunk)[49](index=49&type=chunk)[50](index=50&type=chunk)[56](index=56&type=chunk) [Note 3. New Accounting Pronouncements](index=17&type=section&id=Note%203.%20New%20Accounting%20Pronouncements) - 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](index=52&type=chunk) - The company is also evaluating ASU No 2024-03, "Expense Disaggregation Disclosures," effective for annual reporting periods beginning after December 15, 2026[53](index=53&type=chunk) [Note 4. Net Loss per Common Share](index=17&type=section&id=Note%204.%20Net%20Loss%20per%20Common%20Share) - Common stock equivalents (**1,198,176 shares for H1 2025**) were excluded from diluted EPS calculations due to their anti-dilutive effect[55](index=55&type=chunk) - The company did not pay any dividends during the first six months of 2025 or 2024[55](index=55&type=chunk) [Note 5. Segment Performance Measures and Expenses](index=18&type=section&id=Note%205.%20Segment%20Performance%20Measures%20and%20Expenses) - The company operates in one segment for the research and development of product candidates, with performance evaluated based on consolidated financial information[57](index=57&type=chunk) 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) | $(3,112) | (31.0)% | [Note 6. Other Accrued Liabilities](index=18&type=section&id=Note%206.%20Other%20Accrued%20Liabilities) Other Accrued Liabilities | Other Accrued Liabilities | June 30, 2025 ($) | 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](index=19&type=section&id=Note%207.%20Stockholders'%20Equity) - The company filed a shelf registration statement (Form S-3) on May 15, 2024, for up to **$75 million** of its securities[60](index=60&type=chunk) - The At the Market (ATM) Offering Agreement was amended to allow the sale of up to **$8,184,733** in common stock[61](index=61&type=chunk)[64](index=64&type=chunk) - In May 2025, the company completed a private placement for approximately **$3.3 million gross proceeds**, issuing common stock and warrants[70](index=70&type=chunk)[71](index=71&type=chunk) [Note 8. Stock-Based Compensation](index=20&type=section&id=Note%208.%20Stock-Based%20Compensation) - 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](index=75&type=chunk) - Total stock-based compensation expense was approximately **$0.3 million** for the six months ended June 30, 2025[78](index=78&type=chunk) - As of June 30, 2025, there was **$0.4 million of total unrecognized compensation cost** related to non-vested stock-based compensation arrangements[79](index=79&type=chunk) [Note 9. Warrants](index=23&type=section&id=Note%209.%20Warrants) Warrant Activity | Warrants | Number of Warrants Issued | Weighted Average Exercise Price ($) | | :--- | :--- | :--- | | 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](index=23&type=section&id=Note%2010.%20Leases) - 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](index=83&type=chunk) - The Huntsville facility lease was renewed in January 2023 for a 60-month term, with monthly rent payments of approximately **$28,550 to $30,903**[84](index=84&type=chunk) Lease Payments and Maturity | As of June 30, 2025 | Amount ($) | | :--- | :--- | | 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](index=23&type=section&id=Note%2011.%20Commitments%20and%20Contingencies) - The company is not currently a party to any material legal proceedings[86](index=86&type=chunk) [Note 12. Subsequent Events](index=24&type=section&id=Note%2012.%20Subsequent%20Events) - 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](index=89&type=chunk) - A **15-for-1 reverse stock split** was effected on July 25, 2025, to regain compliance with Nasdaq's minimum bid price requirement[90](index=90&type=chunk)[91](index=91&type=chunk)[94](index=94&type=chunk) - 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](index=92&type=chunk)[93](index=93&type=chunk)[94](index=94&type=chunk)[95](index=95&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Provides management's analysis of financial condition, operational results, and future outlook [Overview](index=26&type=section&id=Overview) - Imunon is a clinical-stage biotechnology company focused on advancing innovative treatments using **non-viral DNA technology**[97](index=97&type=chunk) - 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](index=98&type=chunk) [Technology Platform](index=26&type=section&id=Technology%20Platform) - Imunon's technology platform uses **synthetic non-viral carriers** for DNA and mRNA therapeutics, designed to protect payloads and promote cell trafficking[99](index=99&type=chunk) - The platform offers enhanced molecular versatility, improved activity and safety, and is more **efficient and cost-effective** than viral approaches[99](index=99&type=chunk)[100](index=100&type=chunk) [THERAPLAS MODALITY: IMNN-001 DEVELOPMENT PROGRAM](index=27&type=section&id=THERAPLAS%20MODALITY%3A%20IMNN-001%20DEVELOPMENT%20PROGRAM) Details the development of IMNN-001 for advanced ovarian cancer, from clinical studies to Phase 3 planning [Ovarian Cancer Overview](index=27&type=section&id=Ovarian%20Cancer%20Overview) - Ovarian cancer is the **most lethal gynecological malignancy**, with over 60% of women dying within five years of diagnosis[102](index=102&type=chunk) - There is a significant unmet need for improved treatments, with **Interleukin-12 (IL-12)** considered a promising immunotherapeutic approach[102](index=102&type=chunk)[103](index=103&type=chunk)[104](index=104&type=chunk) [IMNN-001 Immunotherapy](index=27&type=section&id=IMNN-001%20Immunotherapy) - IMNN-001 is a DNA-based immunotherapeutic drug candidate for ovarian cancer, administered intraperitoneally to **locally produce IL-12**[105](index=105&type=chunk)[106](index=106&type=chunk) - The therapy aims to create a potent immune environment against tumor activity for a more **robust and durable antitumor response**[105](index=105&type=chunk) [OVATION 1 Study](index=27&type=section&id=OVATION%201%20Study) - 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](index=105&type=chunk)[106](index=106&type=chunk)[111](index=111&type=chunk) - Key findings included **decreased immunosuppressive T-cell signals** and increased CD8+ cells in the tumor microenvironment[108](index=108&type=chunk)[111](index=111&type=chunk) - Median Progression-Free Survival (PFS) was **21 months** (per protocol) and **18.4 months** (ITT), supporting continued evaluation[108](index=108&type=chunk) [OVATION 2 Study](index=28&type=section&id=OVATION%202%20Study) - The Phase I/II OVATION 2 Study completed enrollment with 113 patients and received **Orphan Drug and Fast Track designations**[113](index=113&type=chunk)[114](index=114&type=chunk) - Positive topline results showed a **13-month increase in median Overall Survival (OS)** (46 vs 33 months) in the IMNN-001 arm[119](index=119&type=chunk)[121](index=121&type=chunk)[123](index=123&type=chunk) - 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](index=115&type=chunk)[120](index=120&type=chunk)[123](index=123&type=chunk) [OVATION 3 Study](index=32&type=section&id=OVATION%203%20Study) - The FDA supported the advancement of IMNN-001 into a **Phase 3 pivotal study (OVATION 3)** for newly diagnosed advanced ovarian cancer[124](index=124&type=chunk)[126](index=126&type=chunk) - The trial will assess IMNN-001 plus chemotherapy, with **Overall Survival (OS) as the primary endpoint**[125](index=125&type=chunk) - The FDA aligned with the company's **Chemistry, Manufacturing, and Controls (CMC) strategy**, and trial sites are now initiating recruitment[125](index=125&type=chunk)[127](index=127&type=chunk) [IMNN-001 in Combination with bevacizumab](index=33&type=section&id=IMNN-001%20in%20Combination%20with%20bevacizumab) - A Phase I/II study is underway to evaluate **IMNN-001 in combination with bevacizumab** in patients with advanced ovarian cancer[128](index=128&type=chunk)[130](index=130&type=chunk) - The study's primary endpoint is the **detection of minimal residual disease (MRD)** by second look laparoscopy[131](index=131&type=chunk) - As of June 30, 2025, **fifteen patients have been enrolled** and treated in the study[132](index=132&type=chunk) [PLACCINE DNA VACCINE MODALITY: IMNN-101](index=34&type=section&id=PLACCINE%20DNA%20VACCINE%20MODALITY%3A%20IMNN-101) Describes the PlaCCine DNA vaccine modality for infectious diseases, with IMNN-101 as the lead candidate [COVID-19 Vaccine Overview](index=35&type=section&id=COVID-19%20Vaccine%20Overview) - First-generation COVID-19 vaccines have raised concerns about **durability and viral resistance** due to rapid Spike (S) protein mutations[138](index=138&type=chunk) - There is an urgent need for new vaccine technologies that can **address viral mutations** and offer efficient manufacturing and distribution[135](index=135&type=chunk)[140](index=140&type=chunk) [Our Next Generation Vaccine Initiative](index=35&type=section&id=Our%20Next%20Generation%20Vaccine%20Initiative) - Imunon's PLACCINE platform uses a single plasmid vector with multiple coding regions, offering **broad-spectrum resistance and durable efficacy**[136](index=136&type=chunk)[137](index=137&type=chunk)[140](index=140&type=chunk)[142](index=142&type=chunk) - Preclinical studies demonstrated **robust immune responses** and protection against SARS-CoV-2 variants, comparable to commercial mRNA vaccines[141](index=141&type=chunk)[143](index=143&type=chunk)[145](index=145&type=chunk)[146](index=146&type=chunk)[147](index=147&type=chunk)[153](index=153&type=chunk) - The Phase 1 clinical trial of IMNN-101 showed safety, tolerability, and **durable neutralizing antibody responses** with cross-reactivity against newer variants[150](index=150&type=chunk)[151](index=151&type=chunk)[152](index=152&type=chunk)[153](index=153&type=chunk) [Business Plan and Going Concern Risk](index=37&type=section&id=Business%20Plan%20and%20Going%20Concern%20Risk) - 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](index=157&type=chunk)[160](index=160&type=chunk)[203](index=203&type=chunk) - 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](index=160&type=chunk)[161](index=161&type=chunk)[203](index=203&type=chunk)[204](index=204&type=chunk) - Management plans to raise capital through equity sales, debt, or collaborations, but warns of **potential dilution** or relinquishing rights[162](index=162&type=chunk)[163](index=163&type=chunk) [Financing Overview](index=39&type=section&id=Financing%20Overview) The company raised approximately $14.0 million in net proceeds from equity issuances in 2025 and 2024 [Equity, Debt and Other Forms of Financing](index=39&type=section&id=Equity%2C%20Debt%20and%20Other%20Forms%20of%20Financing) - The company issued 1.1 million shares of common stock in 2025 and 2024, generating approximately **$14.0 million in net proceeds**[164](index=164&type=chunk) - In Q1 2025, the company sold 8,003 shares of common stock under the ATM program for net proceeds of **$105,693**[165](index=165&type=chunk) [May 2025 Offering](index=40&type=section&id=May%202025%20Offering) - On May 23, 2025, the company completed a private placement for gross proceeds of approximately **$3.3 million**[166](index=166&type=chunk) - The pre-funded warrants were exercised in full in June 2025, and shareholders approved the issuance of the warrants on July 11, 2025[167](index=167&type=chunk)[168](index=168&type=chunk) [Significant Accounting Policies](index=40&type=section&id=Significant%20Accounting%20Policies) - 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](index=169&type=chunk) [FINANCIAL REVIEW FOR THE THREE MONTHS ENDED JUNE 30, 2025 AND 2024](index=40&type=section&id=FINANCIAL%20REVIEW%20FOR%20THE%20THREE%20MONTHS%20ENDED%20JUNE%2030%2C%202025%20AND%202024) Net loss decreased to $2.8 million from $4.8 million year-over-year, driven by reduced operating expenses [Results of Operations](index=40&type=section&id=Results%20of%20Operations%20(Three%20Months)) - **Net loss** for Q2 2025 was **$2.8 million**, a decrease from $4.8 million in Q2 2024[171](index=171&type=chunk) 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](index=42&type=section&id=Research%20and%20Development%20Expenses%20(Three%20Months)) - **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](index=176&type=chunk) - PlaCCine DNA vaccine technology platform development costs were **$0 in 2025** compared to $0.7 million in 2024[176](index=176&type=chunk) - 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](index=176&type=chunk) [General and Administrative Expenses](index=42&type=section&id=General%20and%20Administrative%20Expenses%20(Three%20Months)) - **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](index=177&type=chunk) - **Investment income, net, decreased significantly** to $27,000 in Q2 2025 from $225,000 in Q2 2024, attributed to a lower cash balance[177](index=177&type=chunk) [FINANCIAL REVIEW FOR THE SIX MONTHS ENDED JUNE 30, 2025 AND 2024](index=42&type=section&id=FINANCIAL%20REVIEW%20FOR%20THE%20SIX%20MONTHS%20ENDED%20JUNE%2030%2C%202025%20AND%202024) 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](index=42&type=section&id=Results%20of%20Operations%20(Six%20Months)) - **Net loss** for H1 2025 was **$6.9 million**, a decrease from $9.7 million in H1 2024[178](index=178&type=chunk) 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](index=43&type=section&id=Research%20and%20Development%20Expenses%20(Six%20Months)) - **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](index=182&type=chunk) - 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](index=182&type=chunk) [General and Administrative Expenses](index=43&type=section&id=General%20and%20Administrative%20Expenses%20(Six%20Months)) - **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](index=183&type=chunk) - **Investment income, net, decreased to $70,000** in H1 2025 from $307,000 in H1 2024, due to a lower cash balance[183](index=183&type=chunk) [FINANCIAL CONDITION, LIQUIDITY AND CAPITAL RESOURCES](index=43&type=section&id=FINANCIAL%20CONDITION%2C%20LIQUIDITY%20AND%20CAPITAL%20RESOURCES) - The company has an **accumulated deficit of $414 million** and **$4.7 million in cash** and cash equivalents as of June 30, 2025[184](index=184&type=chunk)[185](index=185&type=chunk) - **Net cash used in operating activities** for H1 2025 was **$5.8 million**, indicating substantial future capital requirements[186](index=186&type=chunk) - These conditions raise **substantial doubt about the company's ability to continue as a going concern**, necessitating additional capital[187](index=187&type=chunk)[188](index=188&type=chunk)[189](index=189&type=chunk) [Off-Balance Sheet Arrangements and Contractual Obligations](index=44&type=section&id=Off-Balance%20Sheet%20Arrangements%20and%20Contractual%20Obligations) - The company reported no off-balance sheet arrangements or material contractual obligations[190](index=190&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=44&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) 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](index=191&type=chunk) [Item 4. Controls and Procedures](index=44&type=section&id=Item%204.%20Controls%20and%20Procedures) 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](index=192&type=chunk) - **No material changes** in internal control over financial reporting were identified during the period[193](index=193&type=chunk) - The company acknowledges that control systems have inherent limitations and can only provide **reasonable, not absolute, assurance**[194](index=194&type=chunk) PART II: OTHER INFORMATION [Item 1. Legal Proceedings](index=45&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings - The company is not currently a party to any material legal proceedings[196](index=196&type=chunk) [Item 1A. Risk Factors](index=45&type=section&id=Item%201A.%20Risk%20Factors) 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](index=198&type=chunk) - The company faces a significant risk of **delisting from Nasdaq** due to non-compliance with minimum bid price and stockholders' equity requirements[200](index=200&type=chunk) - The company will need to **raise additional capital** to fund future operations, with no assurance of securing it without significant dilution[203](index=203&type=chunk)[204](index=204&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=46&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) 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](index=205&type=chunk) [Item 3. Defaults Upon Senior Securities](index=46&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities during the period - No defaults upon senior securities were reported[206](index=206&type=chunk) [Item 4. Mine Safety Disclosures](index=46&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - This item is not applicable to the company[207](index=207&type=chunk) [Item 5. Other Information](index=46&type=section&id=Item%205.%20Other%20Information) 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](index=208&type=chunk) [Item 6. Exhibits](index=47&type=section&id=Item%206.%20Exhibits) 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](index=209&type=chunk) 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](index=212&type=chunk)

[IMUNON Reports Second Quarter 2025 Financial Results and Provides Business Update](index=1&type=section&id=IMUNON%20Reports%20Second%20Quarter%202025%20Financial%20Results%20and%20Provides%20Business%20Update) [Overview](index=1&type=section&id=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](index=2&type=chunk) - A stock dividend was issued to IMUNON shareholders, reflecting confidence in clinical programs, long-term growth strategy, and dedication to rewarding shareholders[2](index=2&type=chunk) - 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](index=3&type=chunk) [Recent Developments](index=1&type=section&id=RECENT%20DEVELOPMENTS) [IMNN-001 Immunotherapy (Ovarian Cancer)](index=1&type=section&id=IMNN-001%20Immunotherapy) 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](index=4&type=chunk) - 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](index=5&type=chunk) - 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](index=6&type=chunk) 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](index=8&type=chunk) [PlaCCine DNA Vaccine Technology (COVID-19)](index=2&type=section&id=PlaCCineDNA%20Vaccine%20Technology) 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](index=9&type=chunk) - 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](index=10&type=chunk) - The Company plans to seek partners for further development of IMNN-101 due to strategic deprioritization of this program[10](index=10&type=chunk) [Corporate Highlights](index=3&type=section&id=Corporate%20Highlights) [Shareholder Value Initiatives (Stock Dividend)](index=3&type=section&id=IMUNON%20Announces%20Stock%20Dividend%20Boosting%20Shareholder%20Value) 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](index=12&type=chunk) [Financing Activities (Private Placement)](index=3&type=section&id=Up%20To%20%249.75%20Million%20Private%20Placement%20Offering%20Priced%20At-The-Market) 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](index=13&type=chunk) - Potential additional gross proceeds of approximately **$6.50 million** if short-term warrants are fully exercised on a cash basis[13](index=13&type=chunk) - 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](index=13&type=chunk) [Nasdaq Compliance & Listing Status](index=3&type=section&id=Continued%20Listing%20Extension%20Granted%20by%20Nasdaq%20to%20Complete%20Compliance%20Plan) 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](index=14&type=chunk) - 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](index=14&type=chunk) [Capital Structure Changes (Reverse Stock Split & Authorized Shares)](index=3&type=section&id=Effected%20Reverse%20Stock%20Split%20and%20Increase%20in%20Authorized%20Shares) 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](index=15&type=chunk) - Authorized common stock increased from **112,500,000 shares to 350,000,000 shares**, approved by stockholders on July 11, 2025[16](index=16&type=chunk) [Second Quarter 2025 Financial Results](index=4&type=section&id=SECOND%20QUARTER%202025%20FINANCIAL%20RESULTS) [Q2 2025 Financial Performance](index=4&type=section&id=Q2%202025%20Financial%20Performance) 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](index=21&type=chunk) - 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](index=21&type=chunk) [First Half 2025 Financial Results](index=4&type=section&id=FIRST%20HALF%20OF%202025%20FINANCIAL%20RESULTS) [H1 2025 Financial Performance](index=4&type=section&id=H1%202025%20Financial%20Performance) 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](index=24&type=chunk) [Conference Call and Company Information](index=5&type=section&id=Conference%20Call%20and%20Company%20Information) [Conference Call and Webcast](index=5&type=section&id=Conference%20Call%20and%20Webcast) 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](index=27&type=chunk) [About IMUNON](index=5&type=section&id=About%20IMUNON) 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](index=29&type=chunk) - 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](index=29&type=chunk)[30](index=30&type=chunk) - 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](index=30&type=chunk) [Forward-Looking Statements](index=5&type=section&id=Forward-Looking%20Statements) 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](index=31&type=chunk) - 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](index=31&type=chunk) [Contacts](index=5&type=section&id=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](index=32&type=chunk) [Financial Statements](index=6&type=section&id=Financial%20Statements) [Condensed Statements of Operations](index=6&type=section&id=Condensed%20Statements%20of%20Operations) 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](index=7&type=section&id=Selected%20Balance%20Sheet%20Information) 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 |

Core Insights - IMUNON, Inc. is advancing its clinical programs, particularly the Phase 3 OVATION 3 Study of IMNN-001 for newly diagnosed advanced ovarian cancer, reflecting confidence in its long-term growth strategy and commitment to shareholders [1][2][10] Recent Developments - The first patient was dosed in the Phase 3 OVATION 3 Study on July 30, 2025, with a goal of activating 20 clinical sites by the end of 2025 [3] - The OVATION 3 trial will compare IMNN-001 combined with chemotherapy against standard care, focusing on overall survival and other key efficacy endpoints [4] - Positive data from the Phase 2 OVATION 2 Study was presented at the 2025 ASCO Annual Meeting, showing significant improvements in overall survival and safety profile for IMNN-001 [5][6] Financial Highlights - For Q2 2025, the company reported a net loss of $2.7 million, a reduction from $4.8 million in Q2 2024, with operating expenses decreasing by 45% [17] - R&D expenses for Q2 2025 were $1.2 million, down from $2.8 million in Q2 2024, primarily due to lower costs associated with clinical trials [18] - As of June 30, 2025, cash and cash equivalents were $4.7 million, with additional funds raised through warrant exercises and sales under its ATM facility [20] Corporate Actions - A 15% stock dividend was announced, reflecting the company's confidence in its clinical programs and commitment to shareholder value [10] - A reverse stock split of 15-for-1 was executed on July 25, 2025, consolidating shares to improve market perception [14] - The company received an extension from Nasdaq to complete its compliance plan, allowing it to maintain its listing [13] Clinical Program Overview - IMNN-001 is a DNA-based immunotherapy targeting advanced ovarian cancer, with a mechanism that promotes the production of cancer-fighting molecules at the tumor site [29] - The OVATION 3 Study aims to evaluate the safety and efficacy of IMNN-001 in combination with standard chemotherapy for patients with advanced ovarian cancer [4][11]

Core Viewpoint - IMUNON, Inc. has initiated the pivotal Phase 3 OVATION 3 Study for its lead candidate IMNN-001, aimed at treating newly diagnosed advanced ovarian cancer, with the first patient dosed [1][2]. Company Overview - IMUNON is a clinical-stage biotechnology company focused on innovative treatments that utilize the body's natural mechanisms for effective disease responses [8]. - The company is advancing its non-viral DNA technology, with its first modality, TheraPlas, designed for gene-based delivery of cytokines in solid tumors [8][9]. Product Development - IMNN-001 is a DNA-mediated immunotherapy that has shown significant therapeutic potential in previous clinical trials, including improvements in overall survival and progression-free survival [2][3]. - The Phase 3 OVATION 3 trial will assess IMNN-001 in combination with standard chemotherapy, targeting women with advanced ovarian cancer [1][4]. Clinical Trial Details - The OVATION 3 trial will randomize participants 1:1 to receive either IMNN-001 plus neoadjuvant/adjuvant chemotherapy or standard chemotherapy alone, focusing on overall survival as the primary endpoint [1][4]. - The Phase 2 OVATION 2 Study demonstrated consistent improvements in key endpoints, including overall survival and safety profile, with 112 patients enrolled [3][4]. Mechanism of Action - IMNN-001 utilizes a proprietary TheraPlas platform to deliver IL-12, a potent cytokine that induces strong anti-cancer immunity by promoting T-lymphocyte and natural killer cell proliferation [6][9]. - Recent data indicates that IMNN-001 creates a "hot" anti-tumor microenvironment by recruiting immune cells to the tumor site, enhancing its therapeutic efficacy [3][6]. Market Context - Epithelial ovarian cancer is a significant health concern, with approximately 20,000 new cases annually in the U.S., and a high percentage diagnosed at advanced stages [7]. - The need for effective therapies is critical, as current options primarily include chemotherapy and surgery, with poor five-year survival rates for advanced stages [7].

Core Viewpoint - IMUNON, Inc. is set to host a conference call on August 5, 2025, to discuss its Q2 2025 financial results and provide updates on its clinical development program, particularly focusing on the Phase 3 trial of its DNA-based immunotherapy, IMNN-001, for advanced ovarian cancer [1]. Company Overview - IMUNON is a clinical-stage biotechnology company that develops innovative treatments utilizing 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 through two main modalities: TheraPlas® for gene-based delivery of cytokines and PlaCCine® for gene delivery of viral antigens [4]. Clinical Development - The lead clinical program, IMNN-001, is a DNA-based immunotherapy targeting advanced ovarian cancer, which has completed multiple trials, including a Phase 2 trial (OVATION 2) [5]. - The first site for the Phase 3 pivotal study (OVATION 3) was initiated in Q2 2025, with IMNN-001 designed to instruct the body to produce cancer-fighting molecules at the tumor site [5]. - Additionally, the company has completed dosing in a first-in-human study of its COVID-19 booster vaccine (IMNN-101) [5].

Core Viewpoint - IMUNON, Inc. announced a 15% stock dividend, reflecting the company's confidence in its Phase 3 clinical study and long-term growth potential, while also demonstrating dedication to its shareholders [1][3]. Group 1: Stock Dividend Details - The stock dividend program will distribute approximately 448,000 additional shares of IMUNON common stock for each share held, payable to holders of record as of August 7, 2025, with distribution expected on August 21, 2025 [2]. - Stockholders will not need to take any action to receive the dividend, as additional shares will be credited to their accounts [2]. Group 2: Company Strategy and Clinical Programs - The stock dividend is a way for the company to share its recent clinical progress and optimism with shareholders, emphasizing its commitment to creating value while advancing its innovative pipeline of therapies [3]. - IMUNON is focused on developing transformative treatments, including its lead program IMNN-001 for advanced ovarian cancer, which has shown promising Phase 2 clinical data and is currently in a Phase 3 pivotal trial [3][5]. Group 3: Company Overview - IMUNON is a clinical-stage biotechnology company that develops innovative treatments utilizing non-viral DNA technology, with a focus on solid tumors and immunological responses [4]. - The lead clinical program, IMNN-001, is a DNA-based immunotherapy for advanced ovarian cancer, instructing the body to produce cancer-fighting molecules at the tumor site [5].

Core Viewpoint - IMUNON, Inc. is implementing a reverse stock split at a ratio of 1-for-15 to meet Nasdaq's minimum bid price requirement for continued listing, effective July 25, 2025 [1][2]. Company Overview - IMUNON is a clinical-stage biotechnology company focused on developing innovative treatments using non-viral DNA technology for various human diseases [5]. - The company's lead clinical program, IMNN-001, is a DNA-based immunotherapy targeting advanced ovarian cancer, which has completed multiple clinical trials [6]. Reverse Stock Split Details - The reverse stock split will reduce the number of outstanding shares from approximately 31.8 million to about 2.1 million shares, with no fractional shares issued [3]. - Stockholders will not need to take action for the exchange of their shares if held in brokerage accounts [4].

Core Points - IMUNON, Inc. has received approval from the Nasdaq Hearing Panel for an exception to complete its compliance plan, allowing the company to maintain its Nasdaq listing [1][2] - The Nasdaq Hearing Panel noted that IMUNON has achieved compliance with the Equity Rule through recent fundraising activities and will implement a compliance plan to meet minimum shareholder equity and bid price requirements [2][3] - The Panel approved a tailored exception for IMUNON to regain compliance within a designated timeframe, rather than the full 180 days initially requested [3] 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 lead clinical program, IMNN-001, being a DNA-based immunotherapy for advanced ovarian cancer [6] - IMNN-001 has completed multiple clinical trials, including a Phase 2 trial, and the company has also conducted a first-in-human study for its COVID-19 booster vaccine, IMNN-101 [6]

Core Viewpoint - IMUNON, Inc. is actively working to regain compliance with Nasdaq's listing requirements, focusing on its lead clinical program, IMNN-001, a DNA-based immunotherapy for advanced ovarian cancer [1][2]. Group 1: Compliance and Financial Status - The company has submitted a plan to Nasdaq to regain compliance with minimum bid price and stockholders' equity requirements [1]. - As of May 31, 2025, the company's stockholders' equity exceeds $3.0 million, surpassing Nasdaq's listing threshold [2]. Group 2: Clinical Development - IMUNON is in Phase 3 development of its lead clinical program, IMNN-001, which targets advanced ovarian cancer [2][4]. - The company has initiated its Phase 3 trial (OVATION 3) in the U.S. and Canada following positive results from the Phase 2 trial (OVATION 2) [2]. - IMNN-001 aims to instruct the body to produce cancer-fighting molecules at the tumor site [4]. Group 3: Technology Platforms - IMUNON is developing two main technology platforms: TheraPlas for gene-based delivery of cytokines and PlaCCine for gene delivery of viral antigens [3]. - The company is also advancing a COVID-19 booster vaccine (IMNN-101) through clinical trials [4].

Core Insights - IMUNON, Inc. is advancing its investigational gene-based immunotherapy IMNN-001 for the treatment of newly diagnosed advanced ovarian cancer, with positive translational data presented at the ESMO Gynaecological Cancers Congress 2025 [1][3] - The Phase 2 OVATION 2 Study demonstrated significant increases in key anti-cancer immune cytokines IL-12, IFN-γ, and TNF-α, indicating the localized effect of IMNN-001 in the tumor microenvironment [2][4] - The company is currently progressing to a Phase 3 pivotal trial (OVATION 3) following encouraging overall survival results from the OVATION 2 trial presented at ASCO 2025 [3][4] Company Overview - IMUNON is a clinical-stage biotechnology company focused on innovative treatments that utilize the body's natural mechanisms for effective responses against diseases [8] - The company's lead clinical program, IMNN-001, is a DNA-based immunotherapy designed to produce cancer-fighting molecules at the tumor site [9] - IMUNON's proprietary TheraPlas technology platform enables the delivery of cytokines and therapeutic proteins for solid tumors [6][9] Study Details - The Phase 2 OVATION 2 Study involved 112 participants receiving IMNN-001 in combination with standard-of-care chemotherapy, showing a favorable safety profile [2][4] - The study assessed the efficacy and biological activity of IMNN-001, with treatment leading to substantial increases in IL-12 levels by approximately 27-fold, IFN-γ by 62-fold, and TNF-α by 36-fold in the peritoneal cavity [2][4] - The study design included neoadjuvant and adjuvant chemotherapy followed by interval debulking surgery, aiming for optimal tumor removal [4] Industry Context - Epithelial ovarian cancer is a significant health concern, with approximately 20,000 new cases annually in the U.S., and a high risk of recurrence after treatment [7] - The need for effective therapies is underscored by poor five-year survival rates for patients diagnosed with advanced stages of the disease [7]