Imunon(IMNN)
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Imunon(IMNN) - 2025 Q4 - Earnings Call Transcript
2026-03-31 16:02
Imunon (NasdaqCM:IMNN) Q4 2025 Earnings call March 31, 2026 11:00 AM ET Company ParticipantsDouglas Faller - CMOJason McCarthy - Senior Managing Director and the Head of Biotechnology ResearchJeffrey Church - Interim CFOPeter Vozzo - Managing DirectorStacy Lindborg - President & CEO, Board DirectorConference Call ParticipantsDavid Gaiero - AnalystEmily Bodnar - Biotech Equity Research AnalystJames Molloy - Managing Director, Senior Biotechnology & Specialty Pharmaceuticals Equity AnalystKemp Dolliver - Seni ...
Imunon(IMNN) - 2025 Q4 - Earnings Call Transcript
2026-03-31 16:02
Imunon (NasdaqCM:IMNN) Q4 2025 Earnings call March 31, 2026 11:00 AM ET Company ParticipantsDouglas Faller - CMOJason McCarthy - Senior Managing Director and the Head of Biotechnology ResearchJeffrey Church - Interim CFOPeter Vozzo - Managing DirectorStacy Lindborg - President & CEO, Board DirectorConference Call ParticipantsDavid Welch - AnalystEmily Bodnar - Biotech Equity Research AnalystJames Molloy - Managing Director, Senior Biotechnology & Specialty Pharmaceuticals Equity AnalystKemp Dolliver - Senio ...
Imunon(IMNN) - 2025 Q4 - Annual Report
2026-03-31 12:50
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025. or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______ COMMISSION FILE NO.: 001-15911 (Exact Name of Registrant as Specified in Its Charter) DELAWARE 52-1256615 (State or other jurisdiction of incor ...
Imunon(IMNN) - 2025 Q4 - Annual Results
2026-03-31 12:05
Exhibit 99.1 IMUNON Reports 2025 Financial Results and Provides Business Update Highlighting Significant Progress with Pivotal Phase 3 Study IMNN-001 is the first frontline immunotherapy to demonstrate the potential for a clinically meaningful overall survival benefit in women newly diagnosed with advanced ovarian cancer Final Phase 2 clinical data show continued median overall survival improvement with IMNN-001 Enrollment in the OVATION 3 Study, IMUNON's Phase 3 pivotal trial for IMNN-001, remains ahead of ...
IMUNON Reports 2025 Financial Results and Provides Business Update Highlighting Significant Progress with Pivotal Phase 3 Study
Globenewswire· 2026-03-31 12:00
IMNN-001 is the first frontline immunotherapy to demonstrate the potential for a clinically meaningful overall survival benefit in women newly diagnosed with advanced ovarian cancer Final Phase 2 clinical data show continued median overall survival improvement with IMNN-001 Enrollment in the OVATION 3 Study, IMUNON’s Phase 3 pivotal trial for IMNN-001, remains ahead of plan supported by continued strong interest from principal investigators and the medical community Company to hold conference call today at ...
IMUNON Reports Updated Phase 2 Data Showing Continued Improvement in Median Overall Survival with IMNN-001 in Women with Newly Diagnosed Advanced Ovarian Cancer
Globenewswire· 2026-03-25 12:05
The increase in median overall survival among women treated with IMNN-001 in the OVATION 2 trial rose from the previously reported 11.1 months to 14.7 months following final data analysis Patients treated with PARP inhibitor therapy in addition to IMNN-001 and standard of care chemotherapy demonstrated median increase in OS of 24.2 months Enrollment in IMUNON’s Phase 3 pivotal trial for IMNN-001 remains ahead of plan, supported by continued strong interest from investigators and medical community LAWRENCEVI ...
IMUNON to Hold 2025 Financial Results and Business Update Conference Call on Tuesday, March 31, 2026
Globenewswire· 2026-03-24 12:00
LAWRENCEVILLE, N.J., March 24, 2026 (GLOBE NEWSWIRE) -- IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, today announced that the Company will host a conference call at 11:00 a.m. EDT on Tuesday, March 31, 2026 to discuss financial results for the year ended December 31, 2025, and provide an update on its clinical development program with IMNN-001, a DNA-based interleukin-12 (IL-12) immunotherapy. The Company is hosting a conference call to re ...
IMUNON SHARPENS FOCUS ON ITS PROMISING PIVOTAL PHASE 3 OVARIAN CANCER STUDY
Globenewswire· 2026-02-05 13:05
Core Insights - IMUNON, Inc. is undergoing a strategic reorganization to eliminate non-essential headcount and redefine job roles to reduce operating expenses while advancing its Phase 3 clinical trial for IMNN-001, a DNA-mediated immunotherapy for advanced ovarian cancer [1][2] - Dr. Khursheed Anwer, the Executive Vice President and Chief Scientific Officer, will retire after nearly 12 years, marking a transition period for the company as it focuses on the commercial potential of DNA-mediated immunotherapy [1][2][3] Company Developments - The Phase 3 OVATION 3 study is progressing ahead of schedule, with enrollment exceeding projections and plans to activate additional clinical sites [1][5] - The OVATION 2 study demonstrated a median 13-month increase in overall survival when IMNN-001 was combined with standard chemotherapy, leading to significant interest in presenting the data at major oncology meetings [2][4] - IMUNON's proprietary TheraPlas platform technology is central to the development of IMNN-001, which is designed to enhance immune response against cancer [6][9] Clinical Trial Insights - The OVATION 3 trial is designed with at least 95% statistical power for its primary endpoint of overall survival, including two planned interim analyses to expedite FDA submission if results are favorable [5] - IMNN-001 has shown promising results in previous trials, including a Phase 1b study, and is currently being evaluated in the context of advanced ovarian cancer treatment [6][9] Market Context - Epithelial ovarian cancer remains a significant health challenge, 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 underscored by poor five-year survival rates for advanced-stage patients, highlighting the potential impact of IMUNON's innovative treatments [7]
IMUNON Announces Pricing of $7.0 Million Registered Direct Offering Priced At-The-Market Under NASDAQ Rules
Globenewswire· 2025-12-30 13:30
Group 1 - IMUNON, Inc. has entered into a securities purchase agreement for the sale of 1,939,114 shares of common stock and warrants to purchase an equal number of shares, priced at $3.61 each [1][2] - The gross proceeds from the offering are expected to be approximately $7.0 million before deducting fees and expenses [2] - The offering is expected to close on or about December 31, 2025, subject to customary closing conditions [2] Group 2 - Maxim Group LLC is the lead placement agent, with Brookline Capital Markets acting as co-placement agent for the offering [2] - The securities are being offered under a "shelf" registration statement on Form S-3, which was declared effective by the SEC on May 22, 2024 [3] - A prospectus supplement and accompanying prospectus will be filed with the SEC regarding the registered direct offering [3] Group 3 - IMUNON is a clinical-stage biotechnology company focused on developing innovative treatments that utilize the body's natural mechanisms for effective responses to various diseases [5]
IMUNON 2025, A TRANSFORMATIVE YEAR OF SIGNIFICANT CLINICAL ADVANCES, LOOKING AHEAD TO 2026
Globenewswire· 2025-12-29 16:10
Core Insights - IMUNON, Inc. is making significant progress towards a potential breakthrough in ovarian cancer treatment with its immunotherapy candidate IMNN-001, as evidenced by advancements in the Phase 3 OVATION 3 Study and promising data from the MRD study [1][2][3]. Group 1: Clinical Progress - The Phase 3 OVATION 3 Study is evaluating IMNN-001 in combination with standard chemotherapy for newly diagnosed advanced ovarian cancer, with strong enrollment interest from the medical community [2]. - In the Phase 2 OVATION 2 Study, IMNN-001 demonstrated a 13-month extension in median overall survival (OS) with a hazard ratio of 0.70, and in patients receiving PARP inhibitors, the median OS has not yet been reached, with many patients surpassing five years of follow-up [2]. - The ongoing MRD study shows encouraging preliminary results, including lower MRD positivity rates and higher complete response scores compared to the control arm [4]. Group 2: Immunotherapy Insights - IMNN-001 has shown a broad impact on the tumor microenvironment, leading to IL-12 production by macrophages, which enhances T cell cytotoxic functions [3][7]. - The treatment has resulted in a more inflamed tumor immune microenvironment, effectively converting "cold" tumors to "hot" tumors, thereby activating both innate and adaptive immune systems [7]. Group 3: Financial and Strategic Position - The company has maintained financial discipline throughout 2025, with significant cost reductions in cGMP-compliant manufacturing, positioning for high gross margins upon potential FDA approval [9]. - IMUNON is committed to funding the OVATION 3 trial, with an estimated budget of $30 million for the HRD+ subgroup focus, indicating a strategic approach to clinical development [9]. Group 4: Future Outlook - Looking ahead to 2026, IMUNON is poised for key milestones, including continued enrollment in OVATION 3 and potential early stopping for BLA filing in the HRD+ population [10]. - The company anticipates additional data presentations at major conferences and further insights from OVATION 2 tumor samples, reinforcing its commitment to advancing cancer care [10].