Investor event to provide update on pivotal Phase 3 study of IMNN-001 to be held in New York City on November 10, 2025 Program will feature presentations from ovarian cancer thought leaders, Phase 3 study investigators, oncology and statistical experts LAWRENCEVILLE, N.J., Oct. 20, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, today announced that it will host an R&D Day for investors at the Harvard Club (35 West 44 ...

Company seeks strategic partners to advance novel PlaCCine technology LAWRENCEVILLE, N.J., Oct. 17, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company focused on developing non-viral DNA-mediated immunotherapies and evaluating an adaptation of the platform’s potential as a next-generation vaccine, today announced that members of its leadership team will deliver oral presentations highlighting IMNN-101, its investigational DNA plasmid vaccine based on the Company’s proprietary Pla ...

Prestigious European Society for Medical Oncology Conference “trials-in-progress” session Pivotal OVATION 3 trial of its DNA-mediated immunotherapy in newly diagnosed patients underway Company on track with established plans to accelerate patient recruitment LAWRENCEVILLE, N.J., Oct. 14, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, today announced that a trials-in-progress abstract on the ongoing Phase 3 OVATION 3 ...

Results from OVATION 2 Study reinforce IMNN-001 efficacy benefits observed in the clinic and unique mechanism of action, producing key anti-cancer immune cytokines post-treatment Pivotal Phase 3 trial of IMNN-001 underway, with four trial sites activated to date and on plan for site expansion to accelerate patient recruitment LAWRENCEVILLE, N.J., Sept. 22, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, today announce ...

Core Insights - IMUNON, Inc. is advancing its pivotal Phase 3 trial, OVATION 3, for its investigational therapy IMNN-001, targeting newly diagnosed advanced ovarian cancer [1][4] - New translational data from the Phase 2 OVATION 2 Study will be presented at the AACR Special Conference, highlighting the potential of IMNN-001 [1][3] Company Overview - IMUNON is a clinical-stage biotechnology company focused on innovative treatments that utilize the body's natural mechanisms for effective responses against various diseases [5] - The company is developing its non-viral DNA technology, with its first modality, TheraPlas, aimed at gene-based delivery of cytokines for solid tumors [5] Product Details - IMNN-001 is based on IMUNON's proprietary TheraPlas technology, utilizing an IL-12 DNA plasmid vector in a nanoparticle delivery system to enhance anti-cancer immunity [2] - The therapy has shown clinically effective responses in advanced ovarian cancer, improving both progression-free survival (PFS) and overall survival (OS) when combined with standard chemotherapy [2][6] Clinical Trial Insights - The OVATION 3 study is currently enrolling patients at four sites, with plans for up to 46 additional sites [4] - Preliminary results from the OVATION 2 Study indicated a median 13-month increase in OS and a median 3-month increase in PFS for patients treated with IMNN-001 compared to standard care [6] - The use of PARP inhibitors in maintenance therapy further improved outcomes, with patients in the IMNN-001 treatment arm surpassing 5 years since randomization [6]

Core Points - IMUNON, Inc. is a clinical-stage biotechnology company focused on DNA-mediated immunotherapy, currently in Phase 3 development [1][3] - The company will present a pre-recorded session at the H.C. Wainwright 27th Annual Global Investment Conference, with availability starting September 5, 2025 [2] - IMUNON's lead clinical program, IMNN-001, targets advanced ovarian cancer and has completed multiple clinical trials, including a Phase 2 trial [4] Company Overview - IMUNON is developing innovative treatments that utilize the body's natural mechanisms to generate effective responses against various diseases, differentiating from conventional therapies [3] - The company employs non-viral DNA technology, with two main modalities: TheraPlas for gene-based delivery of therapeutic proteins and PlaCCine for gene delivery of viral antigens [3] Clinical Programs - IMNN-001 is a DNA-based immunotherapy designed for localized treatment of advanced ovarian cancer, instructing the body to produce cancer-fighting molecules at the tumor site [4] - The company has also completed dosing in a first-in-human study for its COVID-19 booster vaccine, IMNN-101 [4] - IMUNON aims to advance its technological capabilities in plasmid DNA to address challenging medical conditions [4]

Core Insights - IMUNON, Inc. has regained compliance with Nasdaq's minimum bid price requirement, ensuring uninterrupted trading on The Nasdaq Capital Market [1][2] - The company recently issued a 15% stock dividend to shareholders, reflecting confidence in its clinical pipeline and commitment to investors [2] - IMUNON's lead clinical program, IMNN-001, is a DNA-based immunotherapy for advanced ovarian cancer, with positive results from the Phase 2 OVATION 2 trial [2][4] Company Overview - IMUNON is a clinical-stage biotechnology company focused on innovative treatments that utilize the body's natural mechanisms to generate effective responses against various diseases [3] - The company is developing non-viral DNA technology, with its first modality, TheraPlas, aimed at gene-based delivery of therapeutic proteins for solid tumors [3] - The second modality, PlaCCine, is designed for gene delivery of viral antigens to elicit strong immunological responses [3] Clinical Development - IMNN-001 instructs the body to produce cancer-fighting molecules at the tumor site and has completed multiple clinical trials, including the Phase 2 OVATION 2 trial [4] - IMUNON has also completed dosing in a first-in-human study of its COVID-19 booster vaccine, IMNN-101 [4] - The company aims to advance its technological capabilities in plasmid DNA to better address difficult-to-treat conditions [4]

Core Insights - IMUNON, Inc. reported financial results for Q2 2025 and highlighted advancements in its Phase 3 clinical trial for IMNN-001, a DNA-mediated immunotherapy for advanced ovarian cancer, along with a 15% stock dividend for shareholders [1][2] Clinical Development - The pivotal Phase 3 OVATION 3 trial for IMNN-001 has commenced, with the first patient treated on July 25, 2025, following robust Phase 2 data showing significant overall survival benefits [2] - The trial design includes two interim analyses and is powered at 95% to detect meaningful overall survival improvements in the intent-to-treat population, with a 99% power in the HRD-positive subgroup [2] - A flexible enrollment strategy will start with a 250-patient HRD-positive subgroup, potentially expanding to a 500-patient all-comers trial, reducing costs by approximately 40% [2] Financial Position - IMUNON has strengthened its balance sheet with over $3 million raised through warrant exercises and ATM sales, while introducing a one-time 15% stock dividend to enhance shareholder value [2] - The company is actively pursuing non-dilutive partnerships to fund the OVATION 3 trial and has achieved compliance with Nasdaq's Shareholder Equity Rule [2] Manufacturing and Operations - IMUNON maintains a reliable in-house manufacturing process for key components of IMNN-001, achieving significant cost reductions compared to outsourcing [2] - Targeted cash conservation measures have been implemented to align resources with the regulatory approval and commercial launch of IMNN-001 [2] Medical Community Engagement - Data from the OVATION 2 study has generated significant interest, leading to unsolicited inquiries from global principal investigators to join the Phase 3 study, indicating strong validation of IMNN-001's potential [2] Background on IMNN-001 - IMNN-001 is designed using IMUNON's TheraPlas® platform and aims to induce potent anticancer immunity through the local secretion of IL-12 [5][8] - The drug has shown positive safety and efficacy results in previous clinical trials, including the recently completed Phase 2 OVATION 2 study [5][8] Market 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, highlighting the need for effective therapies [6]

Financial Data and Key Metrics Changes - As of June 30, 2025, cash and cash equivalents were $4.7 million, with an additional $3 million received from warrant exercises and sales under the ATM facility after the quarter [30][26] - R&D expenses decreased to $1.2 million for Q2 2025 from $2.8 million in the same period last year, primarily due to the completion of the OVATION II study [30] - G&A expenses were $1.5 million in Q2 2025, down from $2.2 million in the same period last year [30] - Net loss for Q2 2025 was $2.7 million or $2.15 per share, compared to $4.8 million or $7.64 per share in 2024 [31] Business Line Data and Key Metrics Changes - The OVATION III trial is gaining traction, with three clinical sites activated and the first patient randomized and treated [11][20] - The OVATION II study has shown unprecedented improvement in overall survival, with a median increase of 13 months compared to standard care [8][7] Market Data and Key Metrics Changes - The demand for new therapies in ovarian cancer is high, as recent treatments have not significantly improved outcomes in over 25 years [35] - Approximately 50% of frontline ovarian cancer patients are HRD mutant, representing a significant underserved population [37] Company Strategy and Development Direction - The company aims to minimize shareholder dilution while raising sufficient capital for development goals, actively pursuing non-dilutive strategies [24] - A one-time stock dividend of 15% in common stock is introduced to enhance shareholder value [25] - The company is considering expanding clinical trial sites to Europe, although it is not necessary for EU approval to have patients enrolled [51] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of IMMUN-one to redefine treatment for advanced ovarian cancer [9] - The company is optimistic about the interest from investigators and the medical community in the OVATION III trial [19] - Management is focused on funding strategies to support the OVATION III trial and is seeing interest from potential partners [70] Other Important Information - The company has implemented cash conservation methods, including reducing monthly rent commitments and G&A expenses [26] - The company is actively engaging with potential partners for its TheraPlus technology and DNA vaccine platform [26] Q&A Session Summary Question: Initial demand from patients for the Phase III trial - Investigators have a high demand for the Phase III study due to the lack of effective treatments in ovarian cancer [35] Question: Changes in operating expenses for the remainder of the year - Operating expenses are expected to remain stable as the company has controlled costs and invested in necessary areas [39] Question: Status of the combination study with Avastin - Enrollment is ongoing, with increased patient treatment and optimism about meeting corporate goals [44] Question: Requirements for opening additional clinical trial sites - There are no significant barriers to opening additional sites, and the company is prioritizing U.S. and Canadian sites before considering international ones [55] Question: HRD screening impact on enrollment speed - HRD screening is standard care and does not delay patient treatment or enrollment in the trial [64] Question: Potential partnership environment - The company is receiving interest from potential partners and is pursuing discussions to accelerate development [70]

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)