Imunon, Inc. · NASDAQ:IMNN
Imunon — Investor Day (November 2025)
58 slides from Imunon's investor day presentation, Nov 10, 2025
Slide 1: IMUNON's 2025 Investor Conference: Phase 3 Trial Update
IMUNON’s 2025 Investor Conference Phase 3 Trial Update November 10, 2025 | 7:30-10:00 AM EST Harvard Club, New York City © 2022 IMUNON, Inc. PAGE 1
Slide 2: Agenda
Agenda Welcome Stacy Lindborg, PhD President and CEO, Imunon, Inc. Advancing Ovarian Cancer Care: Premal H. Thaker, MD David & Lynn Mutch Distinguished Professor of Obstetrics & Gyn, IMNN-001’s Potential to Transform the Chief of Gynecologic Oncology, Director of Gynecologic Oncology Clinical Resear
Slide 3: Advancing Ovarian Cancer Care: IMNN-001's Potential to Transform the Tumor Microenvironment
Advancing Ovarian Cancer Care: IMNN-001’s Potential to Transform the Tumor Microenvironment from Cold to Hot Premal H. Thaker, MD David & Lynn Mutch Distinguished Professor of Obstetrics & Gyn, Chief of Gynecologic Oncology, Director of Gynecologic Oncology Clinical Research, Professor in Gynecologi
Slide 4: Great Unmet Need: Frontline Standard of Care Unchanged for 30 years
Great Unmet Need: Frontline Standard of Care Unchanged for 30 years Recurrence Rates are High and Survival Rates are Low Epithelial ovarian cancer (EOC) is insidious and usually diagnosed at an advanced stage. Though EOC initially responds to treatment, the recurrence rate is high. Recent treatments
Slide 5: IL-12 Immunotherapy: Renewing the Elusive Promise for Ovarian Cancer Survival
IL-12 Immunotherapy: Renewing the Elusive Promise for Ovarian Cancer Survival Ovarian Cancer is an immunosuppressive cancer and IL-12 is one of the most powerful anti-tumor cytokines. IMNN-001 approached it differently Over the last 25 years there have been many challenges based on systemically dosi
Slide 6: IMNN-001 Has a Broad Impact on the Tumor Microenvironment
IMNN-001 Has a Broad Impact on the Tumor Microenvironment Translational Data Sampling Confirms 100 mg/m2 as the Phase 3 dose IMNN-001 dose-dependent and local selective expression of IL-12 and IFN-γ levels in patients’ samples ▪ Increases in cytokine levels at tumor site show IMNN-001 OVATION 1 OVAT
Slide 7: IMNN-001: Demonstrating the Ability to Fundamentally Alter the Tumor Microenvironment
IMNN-001: Demonstrating the Ability to Fundamentally Alter the Tumor Microenvironment Checkpoint Inhibitors (ICIs) have been unsuccessful in impacting overall survival; ICIs cannot target a “cold tumor” Decrease in Immunosuppressive Biomarkers in Tumor 0% 10 FoxP3 IDO-1 PD-1 PD-L1 CA 125 % 20 % 30 I
Slide 8: IMNN-001: Unprecedented Overall Survival Data in Frontline Ovarian Treatment
IMNN-001: Unprecedented Overall Survival Data in Frontline Ovarian Treatment No other trial has demonstrated an OS improvement in women newly diagnosed with Ovarian Cancer, including recent Frontline Checkpoint Inhibitor trials Checkpoint Inhibitors in Ovarian Cancer have successfully OVATION 2: 13-
Slide 9: IMNN-001 Overall Survival Data Further Strengthened in PARP-treated Population & HRD
9 IMNN-001 Overall Survival Data Further Strengthened in PARP-treated Population & in patients with HRD tumor genomic analysis OVATION 2 PARP-Treated Population: Larger OS improvement Why might we see such a dramatic response in with IMNN-001 (38% of ITT) HRD tumor and with PARP treatment? Median OS
Slide 10: IMNN-001: The First and Only Treatment to Demonstrate an Impact on Overall Survival
IMNN-001: The First and Only Treatment to Demonstrate an Impact on Overall Survival Potential to Transform the Frontline Standard of Care for Ovarian Cancer Patients An immunotherapy that harnesses A mechanism of action that the patient’s own immune activates both the innate and system; adaptive imm
Slide 11: OVATION 2 Treatment Effect Consistently Favors IMNN-001 Across All Endpoints
OVATION 2 Treatment Effect Consistently Favors IMNN-001 Across All Trial Endpoints and Pre-specified Subgroups • Overall Survival (OS) benefit increased with further observation. • HR: 0.74 → 0.70 • Median OS: 11 months → 13 months • Pronounced OS effect in IMNN-001 treated patients receiving PARPi
Slide 12: OVATION 3: Purposeful Protocol Design & Rigorous Methodology
OVATION 3: Purposeful Protocol Design & Rigorous Methodology Frontline Therapy Maintenance Therapy Laparoscopy NACT (3 cycles) + ACT (3 cycles) + PARPi treatment: HRD Interval Debulking Surgery IMNN-001 (weekly) IMNN-001 (weekly) participants only 500 (or 250 HRD) Stage IIIB/C or IV EOT visit EOC pa
Slide 13: Compelling Scientific Evidence of IMNN-001: Phase 3 Well-Positioned for Success
Compelling Scientific Evidence of IMNN-001 Phase 3 Well-Positioned for Success IMNN-001 has the potential to • Data from Phase 2 continues to improve and further strengthen our confidence in Phase 3 transform the treatment paradigm • Leveraging the schema and dosing in Phase 2 • Overall survival end
Slide 14: Use of IMNN-001 in Combination with Chemotherapy to Prevent MRD After Frontline Therapy
Use of IMNN-001 in Combination with Chemotherapy to Prevent Minimal Residual Disease (MRD) After Frontline Therapy (NCT05739981) Amir A. Jazaeri, MD Professor | Gynecologic Oncology and Reproductive Medicine Vice Chair Clinical Research Director of the Gynecologic Cancer Immunotherapy Program
Slide 15: Changing the Current Paradigm by Targeting MRD
Changing the Current Paradigm by Targeting MRD Frontline Therapy Maintenance (surgery + carboplatin + taxol chemotherapy) Therapy & Surveillance Clinically detectable Trials of novel recurrence & additional therapies lines of therapy 14-22 months Ovarian Cancer Tumor Burden Accelerated MRD detection
Slide 16: Study Rationale
Study Rationale • Frontline therapy is the best opportunity to achieve cure for ovarian cancer • IL-12 promotes inflammation in “cold” tumors • Systemic IL-12 is poorly tolerated; intraperitoneal delivery has a favorable safety profile • IMNN-001 is a nanoparticle encapsulated DNA plasmid encoding I
Slide 17: Building Off Efficacy Signal from OVATION 2
Building Off Efficacy Signal from OVATION 2 • RCT of IMNN-001 in combination with platinum-based doublet • Differences from current study: • No bevacizumab or IMNN-001 maintenance • Survival-based phase 2 endpoint • Key efficacy results: • 3-month PFS advantage • 13-month OS advantage • Higher survi
Slide 18: MRD Study Design
Screening Frontline Therapy Maintenance Therapy NACT+BEV+IMNN001 ACT+BEV+IMNN001 HRD: BEV+Olaparib for 4-6 cycles for 3 cycles HRP: BEV+IMNN001 Interval Cytoreductive Surgery Diagnostic Laparoscopy MRD Detection by SLL Experimental Suspected Arm Stage III/IV OVCA patients IP Port recommended R Place
Slide 19: Surgical MRD as a Prognostic Marker
Surgical MRD as a Prognostic Marker 19 MD ANDERSON CANCER CENTER Knisely et al, Clin Cancer Res (2025)
Slide 20: Surgical MRD as a Prognostic Marker
Surgical MRD as a Prognostic Marker Not reached Median 24.6 months Median 32.4 months Median 7.4 months HR 3.0, 95% CI 1.8-4.9 MRD neg HR 6.4, 95% CI 2.8-14.6 p-value < 0.0005 MRD pos p-value < 0.0005 20 MD ANDERSON CANCER CENTER Knisely et al, Clin Cancer Res (2025)
Slide 21: Enrollment and Allocation
Assessed for eligibility Enrollment (n=35) Excluded (n=10) • Pathology not meeting inclusion criteria (n=4) • Underwent primary debulking (n=3) • Co-morbidities preclude participation (n=1) • Withdrew consent (n=2) Randomized Allocation (n=25) Discontinued due to progression after C2 (n=1) Withdrew
Slide 22: Patients Treated in the Control Arm
Patients Treated in the Control Arm Diagnostic Neoadjuvant Adjuvant ICS SLL Maintenance Follow up Laparoscopy chemo chemo 01-3007 CRS 3 negative 01-3012 CRS 3 negative 01-3006 CRS 1 positive * 01-3011 CRS 2 positive * 01-3016 CRS 2 positive 02-3003 CRS 1 positive * 01-3021 CRS 2 01-3027 01-3028 MRD
Slide 23: Patients Treated in the Experimental Arm
Patients Treated in the Experimental Arm Diagnostic Neoadjuvant Adjuvant ICS SLL Maintenance Follow up Laparoscopy chemo chemo 01-3003 CRS 2 negative * 01-3010 CRS 3 negative 02-3002 CRS 2 negative 01-3006 01-3005 CRS 2 positive 01-3006 01-3015 CRS 2 positive 01-3020 CRS 3 01-3025 MRD positivity 01-
Slide 24: Preliminary Clinical Read Out
Preliminary Clinical Read Out* MRD positivity rate Experimental: 40% (2/5) Progression-Free Survival Control: 66.7% (4/6) 1.0 Experimental Probability of Survival Control Percentage of biopsies positive in 0.5 MRD positive patients Experimental: 9.5% (1/10, 1/11) 0.0 Control: 44.8% (6/8, 1/1, 1/12,
Slide 25: Key Translational Questions
Key Translational Questions • How does treatment with IL-12 + chemotherapy reshape the tumor microenvironment and impact immune activation? • Can surgical MRD function as a reliable surrogate endpoint for survival outcomes? • Does ctDNA assessment correlate with surgical MRD and provide validation f
Slide 26: Prospective Translational Study Design
Prospective Translational Study Design scRNA-seq CODEX Visium HD 26 MD ANDERSON CANCER CENTER
Slide 27: IMNN-001 Treatment Leads to IL12 Production by Macrophages in IP Fluid
IMNN-001 Treatment Leads to IL12 Production by Macrophages in IP Fluid22 scRNA-seq scRNA-seq (IP fluid) Macrophage expression profile (IP fluid) n = 415,082 UMAP2 UMAP1 Major cell types MD ANDERSON CANCER CENTER
Slide 28: Workflow for Imunon Visium HD Data Analysis
Visium HD Workflow for Imunon Visium HD Data Analysis (tumor tissue) MD ANDERSON CANCER CENTER
Slide 29: IMNN-001 Treatment Leads to IL12 Production by Macrophages in Tumor Tissues
IMNN-001 Treatment Leads to IL12 Production by Macrophages in Tumor Tissues Visium HD (tumor tissue) Baseline Interval cytoreductive surgery Second-look laparoscopy 01-3005 (Exp. arm) Macrophage expression profile DEGs of Exp. arm LogFC Baseline MD ANDERSON CANCER CENTER Interval cytoreductive surge
Slide 30: IMNN-001 Treatment Boosts T cell Cytotoxic functions
IMNN-001 Treatment Boosts T cell Cytotoxic functions Visium HD (tumor tissue) Visium HD (tumor tissue) 01-3010 (ICS sample) GZMB expression in T cells Cytotoxic T cells IL12+ macrophages Other cells GNLY expression in T cells MD ANDERSON CANCER CENTER
Slide 31: IMNN-001 Boosts T cell Cytotoxic Functions & May Synergize with ICB
IMNN-001 Treatment Boosts T cell Cytotoxic Functions & May Synergize with ICB Checkpoint expression in T cells BATF expression in T cells Visium HD (tumor tissue) scRNA-seq (IP fluid) MD ANDERSON CANCER CENTER
Slide 32: Democratization of Spatial Technology
Democratization of Spatial Technology 10X Visium (HD) Rich molecular data, but … Time Labor Costly consuming intensive H&E AI-powered model Akoya PhenoCycler Scalability Simple workflow Cost effectiveness MD ANDERSON CANCER CENTER
Slide 33: Key Translational Findings to Date
Key Translational Findings to Date Clinical value of MRD: Enrollment on Imunon trial, the first clinical trial to utilize MRD as a primary endpoint, is ongoing with 19 of a planned 30 patient cohort enrolled ✓ Favorable benefit/risk profile further strengthened ✓ Patients successfully treated with I
Slide 34: OVATION 3 Probability of Success: Statistical Properties of Phase 3 Trial Design
OVATION 3 Probability of Success: Statistical Properties of Phase 3 Trial Design Giorgio Paulon, PhD Statistical Scientist, Berry Consultants
Slide 35: Phase 2 Results: Foundation for Phase 3
Phase 2 Results: Foundation for Phase 3
Slide 36: IMNN-001 Program Methodologies & Data Brings Statistical Confidence to Phase 3
IMNN-001 Program Methodologies & Data Brings Statistical Confidence to Phase 3 Phase 2 data & study design provide foundation for statistical rigor in phase 3 OVATION 2 Design OVATION 2 Data • Well-designed trial: randomized & controlled • Consistency of effect across all endpoints and • Treatment A
Slide 37: Consistency Across Subgroups
Consistency Across Subgroups All subgroups and endpoints favor Imunon treatment – An uncommon result in Phase 2 • The totality of favorable data brings great confidence in how we approach Phase 3 • Across all pre-specified participant sub-groups, a positive treatment effect of IMNN-001 is seen • Pri
Slide 38: Totality of Effect
Totality of Effect Combining PFS + OS demonstrates durable benefit across multiple clinical dimensions • Consistency of effect is reinforced by looking at the “Totality of Effect” • The two FDA-recommended endpoints, OS and PFS, are combined to assess the strength of the observed evidence Area under
Slide 39: Phase 3 Design and Statistical Properties
Phase 3 Design and Statistical Properties
Slide 40: OVATION 3: Purposeful Protocol Design & Rigorous Methodology
OVATION 3: Purposeful Protocol Design & Rigorous Methodology Frontline Therapy Maintenance Therapy Laparoscopy NACT (3 cycles) + ACT (3 cycles) + PARPi treatment: HRD Interval Debulking Surgery IMNN-001 (weekly) IMNN-001 (weekly) participants only 500 (or 250 HRD) Stage IIIB/C or IV EOT visit EOC pa
Slide 41: OVATION 3: Robust Positioning for Early Readout and BLA Filing
OVATION 3: Robust Positioning to Test for an Early Readout and BLA Filing for Full Approval Purpose-built to enable early success in HRD while preserving confirmatory power in ITT • Trial allows for early readout in an HRD+ population • Full, combined ITT (HRD + HRP) tested later, increasing the lik
Slide 42: Regulatory Precedent of FDA Full Approval Based on Interim OS Data
Regulatory Precedent of FDA Full Approval Based on Interim OS Data Regulatory Outcome / Early Trial / Setting Design Features Filing Phase 3, active control, Accelerated approval (PD-L1+ IMpassion130 (TNBC) prespecified interim OS look TNBC) after interim data Phase 3 vs standard chemo, Early stop f
Slide 43: Conservative Power Assumptions: Power = 98%
Conservative Power Assumptions Expected Scenario Weaker Power = 98% Stronger A denotes the assumed HR, O the observed HR in OVATION 2 (beyond Month 15). Even in the expected scenario, the assumption in the HRD subgroup is conservative. 43
Slide 44: Conservative Power Assumptions: Power = 82%
Conservative Power Assumptions Weaker Scenario Weaker Power = 82% Stronger • Conservative assumptions for power provide confidence in probability of success • Phase 3 powered using Phase II data, but dialed back assumptions to ensure robustness • “Margin of safety” added between the observed effect
Slide 45: Evidence-based Simulation Framework Used to Design the Trial
Evidence-based Simulation Framework Used to Design the Trial • Strong simulation modeling provided the framework and confidence of the innovative trial design (adaptive, event-driven) • Expected by FDA, led to efficient, full acceptance of the statistical plan and framework Analysis choices: • Endpo
Slide 46: Evidence-based Simulation Framework Used to Design the Trial
Evidence-based Simulation Framework Used to Design the Trial Analysis choices: • Endpoint • Model Check robustness Evaluate Design • Power / Type I Data Assumptions: Error • Accrual rate • Trial Duration • Dropout rate • Average Sample • Control hazard rates Size • Treatment effect profiles Check ro
Slide 47: Adaptive Design Enables Earlier Market Authorization
Adaptive Design Enables Earlier Market Authorization Interim analysis for early success: accelerate timelines1 and bring the drug to patients sooner This graph denotes, under simulated scenarios, the probability that the trial stops at each of the interims, and the decision made when stopping. For e
Slide 48: Summary
Summary BERRY
Slide 49: Summary
Summary • Robust design → higher probability of success • Adaptive features → earlier insight, faster value realization • FDA-aligned simulation framework → regulatory confidence 49
Slide 50: IMNN-001 Potential and Progress in Phase 3
IMNN-001 Potential and Progress in Phase 3 Douglas V. Faller, M.D., Ph.D.
Slide 51: IMNN-001: The Potential to Transform the Standard of Care in Ovarian Cancer
IMNN-001: The Potential to Transform the Standard of Care in Ovarian Cancer • An effective mechanism of action: An immunotherapy that alters the microenvironment immune from immuno-suppressive to immuno-responsive • Activating both Innate & Adaptive Immune System: Allowing for a more effective, dura
Slide 52: IMNN-001 Mechanism of Action and Data Provides an Extremely Compelling Promise
IMNN-001 Mechanism of Action and Data Provides an Extremely Compelling Promise • Unprecedented Overall Survival data • Consistent benefit across other endpoints and subgroups • No cytokine release syndrome or elevation in immune related adverse events And Scientific Rationale • Clear evidence of an
Slide 53: IMNN-001 Translational Data: Treatment Shifted the Balance Toward Immune Stimulation
IMNN-001 Translational Data: Treatment Shifted the Balance in Favor of Immune Stimulation Increases seen in the Numbers and Ratios of Immunostimulatory vs Immunosuppressive Agents in the tumor and/or the tumor microenvironment TME is shifted in favor of Immune stimulation and anti-tumor Biomarkers o
Slide 54: Phase 3: A Robust Study Design and Innovative Statistical Plan
Phase 3: A Robust Study Design and Innovative Statistical Plan • 1:1 randomized treatment/control, leveraging standard of care • Well established biomarker, predictive of response to IMNN-001 – and a trial (and statistical plan) that takes advantage of this • Limited duration of treatment (17 infusi
Slide 55: OVATION 3 Successfully Underway
OVATION 3 Successfully Underway • Multiple study sites activated • Enrollment is exceeding our internal forecast • FDA approval to treat Phase 3 participants with IMNN- 001 originating in our cGMP facility – At a significant cost and strategic advantage • Imunon clinical and executive teams are phys
Slide 56: Excitement for IMNN-001 from both Investigators & Scientific Community
Excitement for IMNN-001 from both Investigators & Scientific Community • Engagements at ESMO, AACR, SITC, IGCS • Attracting new investigator interest for OVATION 3, including international interest • Great enthusiasm for a new agent and a new mechanism of action in this difficult disease © 2022 IMUN
Slide 57: Conclusion
Conclusion • Unprecedented and clinically compelling overall survival data from Phase 2 drives our Phase 3 OVATION 3 study • Continued positive safety and efficacy data from MRD Phase 2 study, and new translational data, confirm IMNN-001 potential and novel, operative mechanism of action. • Biomarke
Slide 58: IMUNON's 2025 Investor Conference: Phase 3 Trial Update
IMUNON’s 2025 Investor Conference Phase 3 Trial Update November 10, 2025 | 7:30-10:00 AM EST Harvard Club, New York City © 2022 IMUNON, Inc. PAGE 58