LAWRENCEVILLE, N.J., May 22, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, today announced that it has filed a request for withdrawal with the Securities and Exchange Commission (SEC) of the Company’s Registration Statement on Form S-1 (No. 333-286403), as amended, originally filed on April 4, 2025 (Registration Statement), as the Company no longer intends to pursue a public offering under the Registration Statement ...

Company’s PlaCCine® technology platform demonstrates better durability and other advantages compared to mRNA vaccines Results further validate PlaCCine as a novel vaccine platform with potential applications in COVID-19 and other infectious diseases with epidemic implications LAWRENCEVILLE, N.J., May 15, 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 ...

Imunon (IMNN) Q1 2025 Earnings Call May 12, 2025 11:00 AM ET Company Participants Peter Vozzo - Managing DirectorStacy Lindborg - President, CEO & DirectorDouglas Faller - Chief Medical OfficerDavid Gaiero - Chief Financial OfficerLaura Suriel - Equity Research Associate Conference Call Participants Emily Bodnar - Biotech Equity Research Analyst Operator Good morning. My name is Dave and I will be your operator today. At this time, I would like to welcome you to the Immuno's First Quarter twenty twenty five ...

财务数据和关键指标变化 - 截至2025年3月31日，公司现金及现金等价物为290万美元 [21] - 2025年第一季度研发成本为220万美元，2024年同期为330万美元，减少主要因一期概念验证Plascene DNA疫苗试验及相关技术平台开发成本降低 [21] - 2025年第一季度一般及行政费用为200万美元，2024年同期为170万美元，增加主要因员工相关费用增加 [22] - 2025年第一季度净亏损410万美元，合每股亏损0.28美元，2024年同期净亏损490万美元，合每股亏损0.52美元 [23] 各条业务线数据和关键指标变化 癌症治疗业务 - 公司启动IMMUN - one的三期关键研究首个临床站点，若二期研究结果在三期复制，患者和医生可能获得有意义的延长生命疗法 [5] - 三期研究OVATION three被医学界认可，新的OVATION II结果获邀在即将召开的ASCO年会上口头报告，并将在同行评审期刊《妇科肿瘤学》上发表 [6] 疫苗业务 - Placine技术相比其他疫苗平台有优势，如在4摄氏度可存活一年、37摄氏度可存活一个月，能快速适应新病原体或变种，保护期长，生产成本低 [20] - 公司在2025年4月的AACR年会和世界疫苗大会上分享Placine概念验证试验和临床前试验见解，并与疫苗领域公司跟进沟通 [20] 公司战略和发展方向及行业竞争 - 公司专注确保为所有利益相关者做好工作，筹集资金实现产品开发目标，同时关注稀释问题 [18] - 采取措施节约现金，使关键需求与现有资金匹配，通过增值融资和合作确保支持临床时间表和长期战略目标的资金流 [19] - 围绕TheraPlas和Placine技术与潜在合作伙伴讨论，探索地理合作及加速IMMUN - one在其他地区开发，打算利用Placine疫苗技术概念验证试验数据出售或授权该技术 [19] 管理层对经营环境和未来前景的评论 - 公司接近解锁白细胞介素 - 12有效治疗卵巢癌的潜力，致力于满足未满足的医疗需求，为卵巢癌治疗带来变革 [4] - 对OVATION three试验充满信心，认为若安全性和有效性在三期得到证实，ABN - 9001可能成为新产品，重置一线治疗标准 [10] - 期待在未来几个月报告正在进行的临床研究数据，对公司进展保持兴奋并将持续更新 [37] 其他重要信息 - 公司在国际ESMO妇科会议上获邀展示OVATION II试验的新转化数据，该数据表明INNON - one技术按设计发挥作用，能将高效IL - 12基因疗法直接输送到肿瘤部位，同时保持全身IL - 12暴露极低 [15] 问答环节所有提问和回答 问题1: ASCO报告是否有新的亚组分析或数据分析，届时能否有HRD阳性患者的中位总生存期数据 - 因ASCO的保密规定，不能谈论报告内容，但会分享新信息，公司对报告非常期待 [25] 问题2: 三期试验预计有多少个站点，总生存期是否作为HRD阳性和ITP人群的双重主要终点，统计计划如何划分 - 分析首先基于HRD人群，无论选择整个HRD和HRP人群还是仅关注HRD人群，结果读出不变，有两次中期分析和一次最终分析（如有需要），均基于HRD事件 [27] - 预计约45个站点 [30] - 总生存期是所有人群的单一主要终点，并非双重 [31] 问题3: OVATION three试验的库存和制造能力现状，特别是针对250 - 500名患者的入组计划 - 公司将核心活性药物成分的制造收回内部，已准备好并监控各种入组计划，确保产品供应，已有产品通过所有放行规格，数周前就可发货，为未来做好准备 [33] 问题4: 与突破癌症基金会合作的临床试验现状，是否仍按计划在今年晚些时候公布初步结果 - 与主要研究者每两周通话一次，最近一次是周五，已启动俄克拉荷马大学新站点，约翰霍普金斯大学已重新配备临床研究团队，期待年底获得数据 [34]

For the transition period from ____________ to ____________ Commission file number: 001-15911 Imunon, Inc. UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (Exact name of Registrant as specified in its charter) Delaware 52-1256615 (State ...

Exhibit 99.1 IMUNON Reports First Quarter 2025 Financial Results and Provides Business Update First site initiated for Phase 3 OVATION 3 study of IMNN-001 in treatment of newly diagnosed advanced ovarian cancer New data from Phase 2 OVATION 2 study of IMNN-001 accepted for oral presentation at 2025 ASCO Annual Meeting Company to hold conference call today at 11:00 a.m. ET LAWRENCEVILLE, N.J., May 12, 2025 – IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated im ...

First site initiated for Phase 3 OVATION 3 study of IMNN-001 in treatment of newly diagnosed advanced ovarian cancer New data from Phase 2 OVATION 2 study of IMNN-001 accepted for oral presentation at 2025 ASCO Annual Meeting Company to hold conference call today at 11:00 a.m. ET LAWRENCEVILLE, N.J., May 12, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, today reported financial results for the three months ended Mar ...

Company currently initiating additional trial sites and working with study investigators to enroll participants IMNN-001 is the first and only immunotherapy to show meaningful overall survival benefit in a Phase 2 trial in women with advanced ovarian cancer Data from Phase 2 OVATION 2 Study are encouraging, with new IMNN-001 data to be highlighted in oral presentation at 2025 ASCO Annual Meeting LAWRENCEVILLE, N.J., May 08, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in Ph ...

Data from OVATION 2 trial will also be reviewed in an oral presentation at ASCO Annual Meeting on June 3, 2025 LAWRENCEVILLE, N.J., May 06, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, today announced that data from the company’s Phase 1/2 OVATION 2 trial evaluating intraperitoneal IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy in newly diagnosed patients with advanced epithelial ovarian canc ...

Highly promising survival data from OVATION 2 Study of treatment of newly diagnosed advanced ovarian cancer to be presented Initiation of Phase 3 trial sites underway for pivotal study of IMNN-001 following alignment on protocol with FDA LAWRENCEVILLE, N.J., April 21, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in Phase 3 development of its DNA-mediated immunotherapy, today announced that an abstract highlighting new, highly encouraging, Overall Survival data from the Pha ...