Announcement • Jul 31
Imunon, Inc. to Report Q2, 2026 Results on Aug 04, 2026 Imunon, Inc. announced that they will report Q2, 2026 results on Aug 04, 2026 Announcement • Jul 30
IMUNON Reports Strong Enrollment Momentum In Phase 3 OVATION 3 Trial Of IMNN-001 In Advanced Ovarian Cancer IMUNON, Inc. provided a progress update on its pivotal Phase 3 OVATION 3 trial of IMNN-001 in patients with newly diagnosed advanced ovarian cancer. Since initiating the trial, the Company has observed rapid site activation and an enrollment rate that is exceeding its forecast. The trial advanced from protocol submission to site activation in approximately 6 months and from protocol approval to first patient randomized in approximately 2 months, a third of the time of the external industry benchmark. The currently observed study-level enrollment rate of approximately 0.5 patients per site per month meaningfully exceeds the assumed rate of 0.3 patients per site per month used in the trial plan. That planning assumption was already set at a premium relative to the Company’s OVATION 2 experience and to historical industry ovarian cancer trials, which have generally enrolled at approximately 0.2 patients per site per month. The strong OVATION 3 enrollment is supported by highly promising clinical and biomarker data, most notably the overall survival (OS) evidence from the large, randomized Phase 2 OVATION 2 study and a high rate of conversion from pre-screening to randomization underscores strong interest in the trial by investigators and patients. More than 70% of sites are currently meeting or exceeding the assumed average enrollment rate of 0.3 patients per month. The Company now projects enrollment to be completed in the second quarter of 2029. Two pre-planned interim analyses are expected with the goal of early BLA filing for full regulatory approval if they achieve the pre-specified threshold. IMNN-001 has continued to demonstrate a highly favorable safety and tolerability profile, with no observed episodes of cytokine release syndrome, systemic toxicities or serious immune-related adverse events that have historically foiled the use of IL-12 to effectively treat cancer patients. Safety profiles have been comparable between the two arms of the study (IMNN-001 plus neoadjuvant and adjuvant chemotherapy {N/ACT} versus N/ACT alone), consistent with observations from the Company’s ongoing Phase 2 Minimal Residual Disease (MRD) study. No safety issues have been raised in recent Independent Data Monitoring Committee (IDMC) reviews of either ongoing study. The pivotal Phase 3 OVATION 3 trial is evaluating intraperitoneal IMNN-001 at 100 mg/m² in combination with standard-of-care neoadjuvant and adjuvant chemotherapy versus chemotherapy alone in patients with newly diagnosed advanced epithelial ovarian cancer. The trial is enrolling an all-comers population that includes both homologous recombination-deficient and homologous recombination-proficient patients; eligible patients who respond to first-line platinum-based chemotherapy will proceed to PARP inhibitor maintenance according to applicable guidelines and prescribing information. The primary endpoint is overall survival, with secondary endpoints including chemotherapy response score, surgical response score at interval debulking surgery, time to second-line treatment or death, and objective response rate. Designed using IMUNON's proprietary TheraPlas platform technology, IMNN-001 is an IL-12 DNA plasmid encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local production of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anticancer immunity acting through the induction of T-lymphocyte and natural killer cell proliferation. IMUNON previously reported positive safety and encouraging Phase 1 results with IMNN-001 administered as monotherapy or as combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer and completed a Phase 1b dose-escalation trial (the OVATION 1 Study) of IMNN-001 in combination with carboplatin and paclitaxel neoadjuvantly in patients with newly diagnosed ovarian cancer. IMUNON previously reported positive results from the recently completed Phase 2 OVATION 2 Study, which assessed IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (N/ACT) of paclitaxel and carboplatin compared to standard-of-care N/ACT alone in 112 patients with newly diagnosed advanced ovarian cancer. Announcement • Jul 01
Imunon, Inc. Announces Chief Financial Officer Changes, Effective July 1, 2026 On June 29, 2026, Jeffrey Church informed Imunon, Inc. of his intent to retire from the position of interim Chief Financial Officer (a position he has held since January of 2026), effective July 1, 2026 (the “Retirement Date”). To help ensure a smooth transition of his responsibilities to his successor, Mr. Church and the Company agreed that he will continue in a consulting role with the Company. Mr. Church’s departure is due to retirement and is without any disagreements with management. As a result of Mr. Church’s retirement, effective July 1, 2026, the Company appointed Josh Blacher to serve as the Company’s new interim Chief Financial Officer under a master services agreement (the “Agreement”), dated June 24, 2026, between the Company and Danforth Health, Inc., a financial advisory services firm (“Danforth”). Mr. Blacher, age 54, currently serves as an employee of Danforth since September 2022, where he has worked as a chief financial officer in a consulting capacity for a number of life sciences companies as well as Managing Partner of Columbus Circle Capital LLC since August 2019. In his capacity as a consultant of Danforth, he has served as Chief Financial Officer of BullFrog AI Holdings, Inc. since December 2024, among others. During his tenure at Columbus Circle Capital, Mr. Blacher has served as chief financial officer at several public and private companies. Prior to his tenure at Columbus Circle Capital, Mr. Blacher served as Chief Business Officer at Inmed Pharmaceuticals from April 2018 to August 2019, as Chief Financial Officer of Therapix Biosciences from April 2017 to April 2018, and as Chief Financial Officer at Galmed Pharmaceuticals from October 2014 to March 2017. Earlier in his career, Mr. Blacher served in senior capacities at Teva Pharmaceuticals, Deutsche Asset Management and Morgan Stanley. Mr. Blacher holds a Bachelor of Arts in Economics from Yeshiva University and a Master of Business Administration in Finance from Columbia Business School.