Imunon, Inc. · NASDAQ:IMNN
Imunon — Celsion — Investor Presentation (March 2019)
41 slides from Imunon's investor presentation, Mar 14, 2019
Slide 1: Corporate Presentation March 2019
Corporate Presentation March 2019
Slide 2: Safe Harbor Statement
Safe Harbor Statement This presentation and any statements made for and during any presentation or meeting contain forward-looking statements related to Celsion Corporation (“Celsion”) under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are sub
Slide 3: 2019: A Year of Opportunity
2019: A Year of Opportunity LARGE Two distinct and innovative technology platforms at clinical stage COMMERCIAL are : 7 : P : OPPORTUNITY Billion dollar commercial opportunities each in HCC/Primary Liver and Ovarian Cancer where the need for effective treatments remains OPTIMA Study, a global Phase
Slide 4: Two Novel Nanoparticle-Based Technology Platforms
Two Novel Nanoparticle-Based Technology Platforms Both Poised for Success LTSL Lysolipid Thermally Sensitive Liposomes for Delivery of Known Chemotherapeutics ThermoDox? Targeted Doxorubicin Delivery TheraPlas Non-Viral Vector Delivers DNA Plasmids Coded for Therapeutic Proteins GEN-1 Immunotherapy
Slide 5: Celsion Pipeline
Celsion Pipeline Focused Drug Development Strategy PRODUCT INDICATION @ ThermoDox® primary LIVER CANCER OPTIMA STUDY GENE OVARIAN CANCER OVATION 2 Study NON-MUSCLE INVASIVE @ ThermoDox BLADDER CANCER GEN-1 GLIOBLASTOMA PRECLINICAL Efficacy/Safety/ Toxicology Complete Efficacy/Safety/ Toxicology Comp
Slide 6: ThermoDox Chemotherapy
Celsion ThermoDox?® CHEMOTHERAPY
Slide 7: First Target: Hepatocellular Carcinoma
First Target: Hepatocellular Carcinoma High Global Incidence With High Mortality 755,000 Global Incidence! Growing 3% Annually. 7 A, (> Manin ‘ Y US/NA EU China Incidence Incidence Incidence | 35,000 | 65,000 378,000. | SS — — “4 TS 4th Highest Mortality of all Cancers Median survival from 2 time of
Slide 8: Locoregional Therapies (LRT) - A Mainstay Treatment for Unresectable Patients
Locoregional Therapies (LRT) - A Mainstay Treatment for Unresectable Patients Multiple Procedures; Limited Long-term Effect Other therapies include: Radiofrequency Ablation: A dominant treatment )) Microwave Ablation (MWA) = Effectiveness decreases with increasing tumor size = Local recurrence rates
Slide 9: ThermoDox + RFA Expands the Treatment Zone
ThermoDox + Radiofrequency Ablation (RFA) Expands the Treatment Zone Benefits larger, unresectable tumors RFA 3 RFA is applied, using high- frequency radio waves to generate high temperature (up to 90°C) through a probe placed directly in the tumor, killing tumor cells in the immediate vicinity of t
Slide 10: HEAT Study: Results Inform Phase III OPTIMA Study Design
10 HEAT Study: Results Inform Phase Ill OPTIMA Study Design Multivariate Analysis Suggests RFA Dwell Time with ThermoDox was the Key Factor Correlating to Significant Improvement In Overall Survival Computational Model Doxorubicin Concentrations Ablation Time Po cocncene uber et al IntJ Hyperthermia
Slide 11: ThermoDox + RFA Demonstrated a 2-year Improvement in Overall Survival
ThermoDox + RFA Demonstrated a 2-year Improvement in Overall Survival HEAT Study Subgroup Survival Analysis With Standardized Dwell Time and Number of Lesions Survival Probability 1 "Tak wy etal. COR. Oct 10, 2017 Followed Quarterly for 22 Years 285 Patients With Standardized RFA > 45 Minutes (sRFA)
Slide 12: HEAT Study Subgroup
HEAT Study Subgroup Transcends Historic Survival Rates Cancer Therapy: Cnical Phase III HEAT Study Adding Lyso-Thermosensitive Liposomal Doxorubicin to Radiofrequency Ablation in Patients With Unresectable 77 Hepatocellular Carcinoma Lesions Won Young Tak, Shing Lin, Yun Wang, iasheng Zhen, Aldo Vee
Slide 13: ThermoDox + sRFA: Transformative Results
B ThermoDox + sRFA: Transformative Results Widespread Data Dissemination Future 2 Radiology ONCOLOGY fe Research Hepatic Oncology —~
Slide 14: Results Presented at Numerous Conferences
Results Presented at Numerous Conferences Not Celsion’s Opinion Alone! ASC ASCH PWAASLD RONA American Society of American Society of ‘AMERICAN ASSOCIATION FOR Clinical Oncology Clinical Onnlbay TESTA AF INVER DRPARPS Gastrointestinal Cancers Symposium WCIO ILCA Feacl (5m Advancing Interventional Onc
Slide 15: Independent NIH Analysis Confirms the Importance of RFA Dwell Time
Independent NIH Analysis Confirms the Importance of RFA Dwell Time Evaluated RFA burn time per tumor volume (min/mL) for correlation with clinical outcome Overall Findings Increase in burn time per tumor volume improved overall survival (OS) in ThermoDox + RFA patients compared to RFA-only patients,
Slide 16: NIH Analysis Correlates Dwell Time and Volume to OS Benefit
16 NIH Analysis Correlates Dwell Time and Volume to OS Benefit Confirmatory Results and Basis of HCC OPTIMA Study Design ubjects with Burn Time > 2.5 min/ml (~45 minutes for 3 cm tumors) 1.0 | ag 094 Survival Probability ° & L tA u 1 2° oO 1 055 —— Presented at RSNA, 2016 — RFA +LTLD — RFA only —
Slide 17: ThermoDox + sRFA Demonstrates Significant OS Benefit versus Other Locoregional Therapies
ThermoDox + sRFA Demonstrates Significant OS Benefit versus Other Locoregional Therapies sTuoy MEDIAN OVERALL SURVIVAL (MONTHS) ThermoDox + RFA > 45 min* jaa 80 MONTHS Owial27.7.5em OS: Year 1: 94%; Year 2: 85%; Year 3: 77% Mean: 4.2 em; medion: 4 em RFA alone > 45 min* Lesion size: ‘Overall: 3-6.9
Slide 18: ThermoDox + sRFA Results
ThermoDox + sRFA Results High Survival Rates for Patients With Intermediate Size Lesions The Clinical Manager United TABLE 5. Survival Outcomes 3 Years After Surgical scones Resection and Radiofrequency Ablation of Hepato- cellular Carcinoma Based Dichotomized Based on Tumor Size 3-Year OS Rate, 9%
Slide 19: Phase III OPTIMA Study Design
Enrollment Completed Q3 2018 Phase Ill OPTIMA Study Design Applying Broad-based Learnings to OPTIMA Study N=275 ‘ThermoDox? + sRFA* General Eligibility ; * Nonresectable HCC Randomize * Single lesions Dt Infusic RFA* = Lesion > 3 cm but not > 7 em Jummy Infusion + sI ® Treatment naive * Child-Pugh A
Slide 20: OPTIMA Study: Blinded PFS Data Consolidated for Both Arms
OPTIMA Study: Blinded PFS Data Consolidated for Both Arms PFS and OS Tracking with Results of HEAT Study Subgroup 20 val Progression-Free Su — study — study? HEAT Study ITT Progression Free Probability — 701 patients 13.8 Months ic HEAT Study Subgroup Blinded OPTIMA Study (Study 1) 285 patients (Stu
Slide 21: ThermoDox Summary
2 ThermoDox Summary iS 3 OPTIMA Study addresses the largest global unmet medical need remaining in oncology ©) HCC Cancer: A § Billion+ Commercial Opportunity ; ws Published HEAT Study subgroup analysis demonstrates ability to deliver clinically YA H meaningful results for early-stage and intermedia
Slide 22: GEN-1 IL-12 Immuno-Oncology Program
22 Celsion GEN-1 IL-12 IMMUNO-ONCOLOGY PROGRAM
Slide 23: IL-12: A Powerful Immune-Modulating Agent
IL-12: A Powerful Immune-Modulating Agent Interleukin 12 (IL-12) Can Induce Anti-cancer Immunity Through Multiple Mechanisms Stimulates the proliferation of CD-8 positive T-cells and natural Activation/Proliferation killer (NK) cells and their cytotoxic activity against the tumor Shifts the differen
Slide 24: GEN-1 Addresses IL-12 Toxicity and Poor Pharmacokinetics
GEN-1 Addresses IL-12 Toxicity and Poor Pharmacokinetics (pK) First-In-Class IL-12 Novel Delivery Poor Kinetics of rlL-12 Requires Frequent, Novel Polymer-Plasmid DNA Transfection Nanoparticle of GEN- High, and Toxic Doses 1 provides persistent local therapy Gn toxic level GED toviciever GEN-1: Pers
Slide 25: GEN-1 Clinical Development Program Published in Peer-Reviewed Journals
25 GEN-1 Clinical Development Program Published in Peer-Reviewed Journals GeneTherapy Future ONCOLOGY Anwer et al, Gene Therapy, Phase | Monotherapy Anwer et al, Gynecol Oncol, Combination with Plat/Doxil Alvarez et al, Gynecol Oncol, Phase II monotherapy Thaker et al, Gynecol Oncol, Combination wit
Slide 26: GEN-1 Composition
26 GEN-1 Composition Three Components of Polyethylene Glycol (PEG) Polyethyleneimine (PEI) Cholesterol Delivery System into nanoparticles AAry PE] Condenses DNA strands POET ES PEG Oa Cholesterol Improves stability and protects 2 a3 Facilitates uptake and trafficking plesmid from degradation ae td ‘
Slide 27: GEN-1 Targets Ovarian Cancer Metastases Throughout the Peritoneal Cavity
GEN-1 Targets Ovarian Cancer Metastases Throughout the Peritoneal Cavity intracavity infusion of GEN-1 produces durable and local expression of IL-12 in the peritoneum Persistent local therapy Peritoneal-plasma barrier minimizes systemic exposure of IL-12, thereby improving safety profile of GEN-1 L
Slide 28: First Target: Ovarian Cancer
First Target: Ovarian Cancer High Global Incidence and Mortality 8th Most Diagnosed Cancer Among Women 5th Highest Mortality Among Women in iy SSE PHIRI TAPIPPPATA) creme an * Survival rate dramatically reduced if not localized cancer 225,000 annual 22,280 in US and inci eeeorldwide 100,000 in devel
Slide 29: Treatment Options in Advanced Ovarian Cancer Are Limited
23 Treatment Options in Advanced Ovarian Cancer Are Limited Recurrence Rates are High and Survival Rates Low % of Incidence: Stage III/IV 1 Line 2”) Line *Aurelia Trial Treatment Naive Population Platinum/Taxane followed by surgery PFS 12 months | OS 36 months ¥ s ¥ Treatment-failed Population Plati
Slide 30: Five Completed Trials of GEN-1 in Patients With Ovarian Cancer
Five Completed Trials of GEN-1 in Patients With Ovarian Cancer as Well tolerated in all completed studies to-date SAFETY Maximum tolerated dose (MTD) has not been reached BIOLOGIC & Evidence of biological activity CLINICAL and clinical benefits have been EFFECTS demonstrated pe ee Peritoneal adminis
Slide 31: OVATION 1 Ovarian Cancer Study
OVATION | Ovarian Cancer Study Phase | to Determine Dose, Efficacy, and Biological Activity With NAC in Stage III/IV Patients Newly Diagnosed Ovarian Cancer Tissue Collection G Standard Neoadjuvant Chemotherapy (NAC) + 8 weekly cycles of GEN-1 ° im) > Interval Debulking Surgery Tissue Collection Ova
Slide 32: OVATION 1 Study: Improved Progression-Free Survival with GEN-1
OVATION | Study: Improved Progression-Free Survival with GEN-1 vs Historic Outcomes in Comparable Patient Populations Historical Estimated PFS* (Vergote, Kehoe) — 12 months OVATION |—ITT 17 months Final Median PFS Per OVATION 1 Protocol —— 21 months Similar Baseline Patient Characteristics in the OV
Slide 33: OVATION 1 Study
OVATION | Study Clinical and Molecular Dose Responses Demonstrated Clinical Responses* GEN-1 Low-Dose Cohorts High-Dose Cohorts 36mg&47mg «61 mg & 79 mg Objective Tumor Response (CR/PR) RECIST 1.1 Interval Debulking Status 40% 88% RO Resection Rate 33 *Chemotherapy dose consistent across all GEN-1 d
Slide 34: OVATION 1 Study
OVATION | Study Pro-immune Changes in Tumor Microenvironment Key Immunosuppressive Biomarkers in Ovarian Cancer . Significantly Inhibited Density of immune biomarkers (Post- vs Pre-Treatment) measured in tissue sections via immunocytochemical staining Final CA125 measured in blood upon enrollment an
Slide 35: GEN-1 OVATION 2 Ovarian Cancer Study
GEN-1 OVATION 2 Ovarian Cancer Study To Determine Efficacy and Biological Activity With NAC in Stage III/IV Patients je) 1:1 Randomization Added Control Arm to [0] (im) < OVATION 2 on Newly Diagnosed Standard Neoadjuvant Interval Debulking j me io 7 Ovarian Cancer Chemotherapy (NAC) + Surgery wee es
Slide 36: GEN-1 Summary
GEN-1 Summary aye GEN-1 offers a novel way to harness the powerful immunological properties of IL-12; The “Master Switch” to the body’s immune system Five completed ovarian cancer trials demonstrate biologic and clinical activity; Strong efficacy signals in Phase I; Mechanism of action confirmed OVA
Slide 37: Financials
37 Celsion Financials
Slide 38: Financial Overview
38 Financial Overview Cash & Investments at 9/30/2018 $22.0 million + NOL sale by 12/31/2018 $10.4 million Total Cash & Investments $32.4 million Estimated cash usage per month $1.5 million Market Capitalization ~$40 million *includes 1.2 million warrants exercisable at $6.20/share (expiring on 4/4/
Slide 39: Advanced Stage Clinical Development Programs
Advanced Stage Clinical Development Programs Milestone Events 2019-2021 PROGRAM & 2018 2019 | 2020 | 2028 INDICATION am ja @ oe os an 2 a3 os aa a2 3 oa ThermoDox® pmcreview -— 1 Interim Efficacy Analysis (118 events) Phase il After Full . . OPTIMAStudy Enrollment 24 Interim Efficacy Analysis (158 e
Slide 40: Celsion Leadership Team
Celsion Leadership Team ? ‘Michael H. Tardugno Chairman, President and Chief Executive Officer ‘Michael Tardugno’s career has been focused exclusively in healthcare, with 40 years of experience in the pharmaceutical and medical device industries. Mr. Tardugno was appointed President and Chief Execut
Slide 41: Corporate Information
a1 Celsion Corporate Information Celsion Corporation 997 Lenox Drive Suite 100 Lawrenceville, NJ 08648 P 609-896-9100 F 609-896-2200 www.celsion.com NASDAQ; CLSN