IMNN-001 / Imunon - LARVOL DELTA

A phase I/II study of the safety and efficacy of intraperitoneal IMNN-001 in combination with neoadjuvant chemotherapy (NACT) of paclitaxel and carboplatin in patients newly diagnosed with advanced epithelial ovarian cancer (EOC): Updated survival analysis from OVATION-2 trial. (ASCO 2025) - P1/2 | "IMNN-001 demonstrated trends towards material improvement in overall survival and acceptable safety in advanced EOC, especially in HRD+ patients. These results are supportive of further development in the upcoming pivotal phase 3 study."

Clinical • Combination therapy • Metastases • P1/2 data • Epithelial Ovarian Cancer • Gene Therapies • Oncology • Ovarian Cancer • Pain • Solid Tumor • HRD • IL12A

IMUNON Enters Cooperative Research and Development Agreement with National Cancer Institute to Advance Clinical Development of IMNN-001 (GlobeNewswire) - "Under the CRADA, IMUNON and the NCI’s Cancer Therapy Evaluation Program (CTEP) who assumes regulatory sponsorship will support further clinical and non-clinical development of IMNN-001...under the NCI Experimental Therapeutics (NExT) Program managed by CTEP....Under the agreement, NCI investigators will evaluate IMNN-001 in new solid tumor indications and combination regimens, building on clinical data from the Company's ongoing ovarian cancer program. IMUNON will retain ownership of its background intellectual property and will retain ownership of new intellectual property solely generated by IMUNON under the collaboration..."

Licensing / partnership • Ovarian Cancer • Solid Tumor

Upcoming Events (GlobeNewswire) - "The Company will host an R&D Day on September 23, 2026, in New York, featuring presentations from leading clinical investigators on IMNN-001 and the Company’s DNA-mediated immunotherapy platform. Additional details, including the full agenda and registration information, will be provided in a subsequent announcement."

Clinical • Ovarian Cancer

IMUNON Reports Strong Enrollment Momentum in Phase 3 OVATION 3 Trial of IMNN-001 in Advanced Ovarian Cancer (GlobeNewswire) - "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....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."

Enrollment status • Epithelial Ovarian Cancer

IMUNON Reports Positive Phase 2 MRD Clinical Data for IMNN-001, Demonstrating the Successful Overcoming of Historical IL-12 Safety Barriers in Frontline Ovarian Cancer (GlobeNewswire) - "Nine patients in each of the control and experimental arms (total target accrual of 30 patients, 15 in each arm) have reached second-look laparoscopy (SLL), the study's primary assessment point for surgical MRD. Compared to control, preliminary results show a deeper antitumor response, as demonstrated by a lower MRD-positive rate, in patients treated with IMNN-001 (44% vs. 67%), a higher rate of circulating tumor DNA (ctDNA) clearance (87.5% vs. 62.5%), and a numerically higher rate of patients achieving no evidence of disease (NED) following frontline therapy (100% vs. 56%)."

P2 data • Fallopian Tube Cancer • Ovarian Cancer • Peritoneal Cancer

IMUNON Announces Data Monitoring Committee Recommends Continuation of Phase 3 OVATION 3 Study Without Modification (GlobeNewswire) - "The pivotal Phase 3 OVATION 3 trial is a robustly designed clinical study with the primary endpoint of overall survival (OS)...With 27 patients enrolled to date, the trial remains on track to complete enrollment of approximately 80 patients by the end of Q1 2027."

DSMB • Trial status • Ovarian Cancer

IMUNON Announces Up to $10 Million Cash Financing (GlobeNewswire) - "The transaction includes 250 shares of non-redeemable, non-convertible preferred stock for $2.5 million and two secured promissory notes in the principal amounts of $2.72 million and $5.0 million....IMUNON intends to use the net proceeds to support continued enrollment of the pivotal Phase 3 OVATION 3 clinical trial in patients newly diagnosed with advanced ovarian cancer."

Financing • Ovarian Cancer

Enrollment in the Phase 3 OVATION 3 Study of IMNN-001 is expected to be completed by Q1 2029 (GlobeNewswire) - "FDA has reviewed and is aligned with Phase 3 protocol, confirms path to BLA Filing...Research and development expenses increased to $2.3 million in the first quarter of 2026 from $2.2 million in the same period of 2025...Net cash used for operating activities was $4.0 million for the first quarter of 2026, compared with $2.8 million for the same period last year. This increase was primarily due to trial-related expenses associated with the OVATION 3 trial."

Commercial • Enrollment status • FDA event • Ovarian Cancer

Final Phase 2 OVATION 2 Study Data Show Continued Overall Survival Improvement with IMNN-001 in Women with Newly Diagnosed Advanced Ovarian Cancer (GlobeNewswire) - "Following the most recent and final data assessment, the Company reported a median 14.7-month increase in overall survival (45.1 vs. 30.4 months) in women in the IMNN-001 treatment arm compared to SoC alone, demonstrating continuous improvement in overall survival (3.6 months delta). In addition, the new IMNN-001 data showed that women treated with IMNN-001 and SoC chemotherapy plus poly ADP-ribose polymerase (PARP) inhibitors as part of maintenance therapy achieved a median increase in overall survival of 24.2 months (65.6 vs. 41.4 months) compared to SoC chemotherapy alone."

P2 data • Ovarian Cancer

MRD: Phase II IMNN-001 (Also Known as GEN-1) on SLL With BEV and NACT, Newly Diagnosed Advanced Ovarian, Fallopian Tube or Primary Peritoneal Cancer (clinicaltrials.gov) - P1/2 | N=30 | Recruiting | Sponsor: Imunon | Trial primary completion date: Dec 2026 ➔ Jun 2027

Trial primary completion date • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

MRD: Phase II IMNN-001 (Also Known as GEN-1) on SLL With BEV and NACT, Newly Diagnosed Advanced Ovarian, Fallopian Tube or Primary Peritoneal Cancer (clinicaltrials.gov) - P1/2 | N=30 | Recruiting | Sponsor: Imunon | Trial completion date: Jan 2028 ➔ Aug 2028 | Trial primary completion date: Aug 2026 ➔ Dec 2026

Trial completion date • Trial primary completion date • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Potential of IMNN-001 in epithelial ovarian cancer: assessment of clinical findings. (PubMed, Expert Opin Investig Drugs) - "IMNN-001 gene therapy could add clinically meaningful IL-12-driven immunotherapy to newly diagnosed ovarian cancer patients. IMNN-001 holds promise for synergistic combinations with immunotherapies requiring intrinsic immune activity."

IO biomarker • Journal • Review • Epithelial Ovarian Cancer • Gene Therapies • Oncology • Ovarian Cancer • Solid Tumor • IFNG • IL12A

MRD: Phase II IMNN-001 (Also Known as GEN-1) on SLL With BEV and NACT, Newly Diagnosed Advanced Ovarian, Fallopian Tube or Primary Peritoneal Cancer (clinicaltrials.gov) - P1/2 | N=30 | Recruiting | Sponsor: Imunon | N=50 ➔ 30

Enrollment change • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

IMUNON Announces Webcast of In-Person R&D Day Highlighting Progress on OVATION 3 Study in Pursuit of First Frontline Immunotherapy for Advanced Ovarian Cancer (GlobeNewswire) - "The investor event will feature ovarian cancer thought leaders, principal investigators from the Company’s Phase 3 OVATION 3 Study and Phase 2 minimal residual disease (MRD) clinical trial, conducted in partnership with Break Through Cancer Foundation, statistical experts and members of IMUNON’s management team, delivering updates on new IMNN-001 data and discussing progress with the OVATION 3 Study and IMNN-001’s potential role in transforming the treatment landscape for women with advanced ovarian cancer."

P3 data • Ovarian Cancer

IMNN-001, IL-12 gene therapy, added to Neo/Adjuvant chemotherapy safely turns the tumor microenvironment cold-to-hot in newly diagnosed epithelial ovarian cancer (EOC) (SITC 2025) - P3 | "Further immunophenotypic analysis will be presented at the Congress.Conclusions IMNN-001induces T cell and myeloid cell mediated anti-tumoral responses across the heterogeneous TMEs characteristic of HGSC, likely driven by the multifaceted actions of IL-12 on both the innate and adaptive immune systems.The ability of IMNN-001 to generate IL-12, IFN-γ and TNF-α locally and the induction of a 'hot' TME collectively support the safety and efficacy observed in the OVATION-2 trial. A Phase III trial (OVATION-3, NCT06915025) is currently enrolling.Trial Registration NCT03393884Ethics Approval This study as part of the translational research of the OVATION-2 trial was approved by all participant clinical sites' Ethics Boards."

Biomarker • Clinical • Gene therapy • IO biomarker • Tumor microenvironment • Epithelial Ovarian Cancer • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor • CD14 • CD163 • CD20 • CD3E • CD68 • CD8 • FOXP3 • IDO1 • IFNG • IL12A • ITGAM • ITGAX • PD-1 • PD-L1 • PTPRC • TNFA

OVATION-3: A randomized phase III trial evaluating the safety and efficacy of intraperitoneal IL-12 gene therapy administered in combination with standard neoadjuvant and adjuvant chemotherapy (N/ACT) in newly-diagnosed patients with advanced epithelial ovarian cancer (EOC) (ESMO 2025) - P3 | "Trial design 500 patients from approximately 50 sites in Canada and USA will be randomized 1:1 to receive SoC N/ACT with or without IMNN-001, followed by PARPi (olaparib or niraparib) maintenance if homologous recombination-deficient (HRD)...Legal entity responsible for the study Imunon, Inc. Funding Imunon, Inc."

Clinical • Combination therapy • Gene therapy • Metastases • P3 data • Epithelial Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor • HRD • IL12A

OVATION-3: A RANDOMIZED PHASE III TRIAL EVALUATING THE SAFETY AND EFFICACY OF INTRAPERITONEAL IL-12 GENE THERAPY ADMINISTERED IN COMBINATION WITH STANDARD NEOADJUVANT AND ADJUVANT CHEMOTHERAPY IN NEWLY DIAGNOSED PATIENTS WITH ADVANCED EPITHELIAL OVARIAN CANCER (IGCS 2025) - P3 | " Patients from ≈50 sites in Canada and USA will be randomized 1:1 to receive SoC N/ACT±IMNN-001, followed by olaparib or niraparib maintenance if HRD...IMNN-001 (100 mg/m2 IP) will be administered weekly through the last CT cycle for a total of 17 treatments. Current Status & Future Directions: The trial will open in May 2025"

Clinical • Combination therapy • Gene therapy • Metastases • P3 data • Epithelial Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor • HRD • IL12A

IMUNON to Present Phase 3 OVATION 3 Study of IMNN-001 in Advanced Ovarian Cancer at IGCS 2025 Annual Global Meeting (GlobeNewswire) - "Four sites have been activated to date and are open for patient enrollment, with up to 46 additional sites being considered for activation."

Trial status • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Peritoneal Cancer

IMUNON to Present New Translational Data from Phase 2 OVATION 2 Study of IMNN-001 at SITC 40th Annual Meeting (GlobeNewswire)

P2 data • Ovarian Cancer

IMUNON Hosts R&D Day Highlighting Progress on OVATION 3 Study in Pursuit of First Frontline Immunotherapy for Advanced Ovarian Cancer (GlobeNewswire) - "The investor event will feature ovarian cancer thought leaders, principal investigators from the Company’s Phase 3 OVATION 3 Study and Phase 2 minimal residual disease (MRD) clinical trial, conducted in partnership with Break Through Cancer Foundation, statistical experts and members of IMUNON’s management team, delivering updates on new IMNN-001 data and discussing progress with the OVATION 3 Study and IMNN-001’s potential role in transforming the treatment landscape for women with advanced ovarian cancer."

Clinical data • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Peritoneal Cancer

IMUNON to Present Phase 3 Ovarian Cancer Study of IMNN-001 at ESMO Congress (GlobeNewswire) - "...Trials-in-progress abstract on the ongoing Phase 3 OVATION 3 clinical trial of IMNN-001, its investigational therapy for the treatment of women with newly diagnosed advanced ovarian cancer, was accepted for poster presentation....The Company...is working with trial investigators to expand clinical sites and accelerate enrollment. Four sites have been activated to date and are open for patient enrollment, with up to 46 additional sites being considered for activation."

Trial status • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Peritoneal Cancer

IMUNON to Present New Translational Data of IMNN-001 Supporting Phase 3 Trial of Immunotherapy for Ovarian Cancer at AACR Special Conference in Cancer Research (GlobeNewswire)

P1/2 data • Epithelial Ovarian Cancer

IMUNON Reports Second Quarter 2025 Financial Results and Provides Business Update (GlobeNewswire) - "On July 30, 2025, the Company announced treatment of the first patient in the OVATION 3 Study and is working with trial investigators to expand clinical sites and accelerate enrollment. Three sites have been activated and are open for patient enrollment, with a corporate goal of having 20 sites activated by the end of 2025."

Trial status • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Ovarian Cancer • Peritoneal Cancer

IMUNON Announces First Patient Dosed in Phase 3 OVATION 3 Study of IMNN-001 in Newly Diagnosed Advanced Ovarian Cancer (GlobeNewswire) - "IMUNON...announced that the first patient has been dosed in the pivotal Phase 3 OVATION 3 Study evaluating the Company’s lead candidate, IMNN-001, for the treatment of women with newly diagnosed advanced ovarian cancer. The first patient was dosed by Melanie K. Bergman, M.D., FACOG, Gynecologic Oncologist with Providence Medical Group at Providence Health in Spokane, Washington....The Phase 3 OVATION 3 trial is designed to assess the safety and efficacy of IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (N/ACT) of paclitaxel and carboplatin compared to standard of care (SoC) N/ACT alone."

Trial status • Ovarian Cancer

OVATION-3: Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w/ Standard NACT & Adjuvant Chemotherapy in Newly Diagnosed Patients w/ Advanced EOC, Fallopian Tube or Primary Peritoneal Cancer (clinicaltrials.gov) - P3 | N=500 | Recruiting | Sponsor: Imunon | Not yet recruiting ➔ Recruiting

Enrollment open • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor