Imunon, Inc. · NASDAQ:IMNN
Imunon — Celsion — Investor Presentation (January 2017)
32 slides from Imunon's investor presentation, Jan 27, 2017
Slide 1: Corporate Presentation January 2017
| Celsion Corporate Presentation January 2017 Celsion saree aren cnn crane enon nares nen emecean sree neers
Slide 2: Safe Harbor Statement
Safe Harbor Statement This presentation and ony statements made for and during any presentation ar 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 ond are sub
Slide 3: Oncology Company
Oncology Company a Capital Efficient Drug Development Nanoparticle-Based Technology Platforms Driving Growth Phase Ill Study in Primary Liver Cancer (The OPTIMA Study) Phase Il Study in RCW Breast Cancer (The Euro-DIGNITY Study) ated Immuno-Oncology Phase | Neoadjuvant Therapy in 1* Line Ovarian Can
Slide 4: Our Two Clinical Stage Platforms
Our Two Clinical Stage Platforms — @ LTSL Lysolipid Thermally Sensitive Liposomes Known Chemotherapeutics ThermoDox® Targeted Doxorubicin Delivery + Phase Ill Study Enrolling in HCC * Phase Il Study in RCW Breast Cancer @ TheraPlas™ Synthetic Non-viral Vector DNA-based Plasmids Therapeutic Proteins
Slide 5: Pipeline of Targeted Therapeutics
| | ipeline of Targeted Therapeutics INDICATION PRODUCT CANDIDATE PRE-CLINICAL PHASE 1-2 PHASE 3 Phase ill enrolling ‘ThermoDox Efficacy/Safety/Toxicology Complete GEN-1 Efficacy Safely Toxicology TheraSilence Efficacy/Toxicology Celsion
Slide 6: Celsion
Celsion
Slide 7: Hepatocellular Carcinoma
Hepatocellular Carcinoma Large and Deadly Global Cancer © 5 most prevalent * 800,000 global incidence growing 5% annually * By 2020, expected to be the #1 cancer China has 50% of new cases; 75% in Asia © 4" highest mortality 5-year survival rate less than 10% time of diagnosis is less than 3 years!
Slide 8: ThermoDox + RF Liver Ablation
ThermoDox + RF Liver Ablation Sal Expanding the Treatment Zone Addresses RFA Limitations RFA misses mi metastases outsi ablation zone ThermoDox infused IV ~15 minutes prior to sRFA ThermoDox - Thermal Zone RFA ablates tumor and creates a “Thermal Zone” in margin surrounding the tumor Doxorubicin is
Slide 9: RFA Dwell Time Matters!
RFA Dwell Time Matters! Learnings from the 700 patient HEAT Study Pre-specified analysis of HEAT Study data showed that patients with smaller lesions (3-5 cm) appeared to do better with ThermoDox When standardized for dwell time and lesion number, ThermoDox patients demonstrated difference in Overal
Slide 10: ThermoDox: HCC Sub-Group Analysis of HEAT Study Data
ThermoDox: HCC Sub-Group Analysis of HEAT Study Data Greater than Two Years Overall Survival Benefit 285 Patients with Standardized RFA>45 minutes (sRFA) Product-Limit Survivall Estimate wd Survival Probability RFA + ThormoDox — Median OS: 80+ RFA Alone Median OS: 57 months Chart Legend HR=0.65 (95%
Slide 11: RFA Dwell Time Matters! Independent Confirmation from NIH
RFA Dwell Time Matters! Independent Confirmation from NIH Analysis of HEAT Study Data Evaluated RFA burn time per tumor volume (min/ml) for correlation with clinical outcomes: Results: Increase in burn time per tumor volume improves OS in ThermoDox + RFA patients compared to RFA only patients For RF
Slide 12: NIH Confirms HEAT Study Sub-Group
NIH Confirms HEAT Study Sub-Group =| KM of subjects with burn time > 2.5 min/ml (~45mins/3cm tumors) e4 ~ | 3 zo | as En Bo} = ao | 3 2 | 3 =x | so T T T T 0 20 40 60 80 Celsion
Slide 13: ThermoDox + RFA vs TACE
ThermoDox + RFA vs TACE Intermediate HCC Median OS (mos) Overall: 27 -7.5 em Lea TSuey, ‘Mean: 4.2 cm 701 53 mos. 85% 76% 64% ITT Population eyes Overall: 3 - 6.9 em HEAT Study Subgroup aS oa min, ‘Meon: 4.2 cm 147-57 mos. 88% 79% «69% Median: 3.9 am Theda et ol {TACE) Medion: 3.9; range 1-11 99-37
Slide 14: Review Article: Clinical Management of Hepatocellular Carcinoma
Review Article The Clinical Management of Hepatocellular Carcinoma in the United States, Europe, and Asia A Comprehensive and Evidence-Based Comparison and Review Zhi Ven Fong, MD: and Kenneth K. Tanabe, MD Hepatocellular carcinoma (HES). the most common primary mallanancy of the liver represents 1
Slide 15: Phase III OPTIMA Study Design
Phase Ill OPTIMA Study Design =z Ge eral y Non-resectable HCC Lesion > 3 om but not > 7 em ig |—€) ThermoDox plus sRFA* Randomize [s) N=275 |—€) Dummy infusion + sRFA Lesion size: 3-5 em / 5-7 em RFA Technique (Percutaneous, Laparoscopy, or Surgical) Primary Endpoint Overall Survival (OS) Secondary
Slide 16: ThermoDox: RCW Breast Cancer
ThermoDox: RCW Breast Cancer Difficult to Treat with Severe Complications Breast cancer recurring in the chest wall affects ~35,000 post-mastectomy patients in the US and Europe annually’ Umited Treatment Options Complete Response Up to 40% of women undergoing a mastectomy 5 primary treatment will e
Slide 17: ThermoDox: Euro-DIGNITY Study
ThermoDox: Euvro-DIGNITY Study | ThermoDox + Hyperthermia + Radiation Primary Objectives Evaluate complete and partial response after 3 cycles of ThermoDox + Hyperthermia and Radiation Treatment (Tri-Modal Therapy) Evaluate loco-regional breast tumor control in patients undergoing Tri-Modal Therapy
Slide 18: GEN-1 IL-12 Immuno-Oncology Program
Slide 19: IL-12: A Powerful Immune Modulating Agent; Multiple Mechanisms
IL-12 A Powerful Immune Modulating Agent; Multiple Mechanisms @© Mechanisms of Action 1. NK Cell Activation 3. Anti-angiogenesis 2. T Cell Activation 4, T Reg suppression ‘TUMOR DEATH ast Drees | pos Celsion
Slide 20: GEN-1: Novel Polymer-Plasmid DNA Nanoparticle
GEN-1 Novel Polymer-Plasmid DNA Nanoparticle (@ Rationale for Local therapy with GEN-1 DNA Nanoparticles * Loco-regional production of potent cytokine IL-12 avoid toxicities and poor pK associated with systemic recombinant IL-12 Persistent local delivery of IL-12 lasts up to one week and dosing can
Slide 21: Ovarian Cancer: Large and Deadly Global Cancer
Ovarian Gana Large and Deadly Global Cancer © 8% most diagnosed cancer among women * 225,000 annual incidence worldwide * 22,280 in US and 100,000 in developed © 5 highest mortality among women * 5-year survival rate for all stages is >50% * Survival rate reduces dramatically if not © Local therapie
Slide 22: GEN-1 for Ovarian Cancer
GEN-1 for Ovarian Cancer Local Immunotherapy PPC Delivery System (PEG-PEL-Chol) 112 Plasmid Stable Nanoparticles for Local Delivery Peritoneal Met * GEN-1causes the controlled local production of IL-12 at the cancer site + IL-12 addresses cancer cells by recruiting the immune system, inducing powerf
Slide 23: Ovarian Cancer Treatment Path
Ovarian Cancer Treatment Path (Ci Stage 1/11(25%) _) ( Stage III/IV (75%) } Plat/Taxane followed by Surgery PES 18 mos. a OS 36 mos, Followed by Chemo” i ey ae Recurrent Population (80 - 90%) Plat, Sensitive Plat Resistant. Plat, Refractory Plat/Toxane —> ~L- ‘AURELIA Trial Plat. Resistant Drea Chen
Slide 24: GEN-1: Preclinical Studies
GEN-1: Preclinical Studies a GEN-1 + Doxil + Avastin * Doxil + Avastin is 2"? line SoC for platinum-resistant ovarian cancer. » Adding Avastin Results in a > 98% Reduction in Tumor Burden 450 100 mr) %0 E sso 7° rs £5 7 $0 z 2 $5 00 3 Bes q # = EP 0 gis * = 100 28 ! il 10 4, fo ha LESSEE Neajeses Ce
Slide 25: GEN-1 + Doxil Phase 1b Trial
GEN-1 + Doxil Phase 1b Trial 2 Line GEN-1 Doxil Clinical Observations (mg/m?) (mg/m?) * All doses well tolerated with no DLTs 24 40 © Clinical response rate: * All doses: > 50% 36 40 * Highest dose: 86% * Single agent Doxil comparison 4 previous studiest 36 50 * Clinical RR < 50% Translational Data
Slide 26: GEN-1 Phase I Study: The OVATION Study
GEN-1Phase | Study a 1* Line in Ovarian Cancer The OVATION Study Not Surgical NEN, Canaldate ae aaa i zg Traditional Toten: 343 Dose wr Reba Cancer Escalation © EN- Neoadjuvant Study in Newly Diagnosed Ovarian Cancer Patients Primary Endpoint Secondary Endpoints Celsion
Slide 27: OVATION Study: Totality of Results
OVATION Study Totality of Results in the First Four Patient Cohorts, n=12 » 1* 12 patients dosed, there has been a * 100% disease control rate (DCR) ~ 75% objective response rate (ORR) » Of the 11 surgically treated patients: » All patients had successful resections of their tumors * One patient dem
Slide 28: GEN-1+Avastin and Doxil Trial Design
GEN-1+Avastin and Doxil Trial Design 2nd Line Platinum= Resistant Standard x Ovarian Cancer Dose Escalating Design jary Endpoint Phase | Primary Endpoint Phase Il Secondary Endpoint Treatment period, 28 Day Dosing Cycle Day 1: Doxil+-Avastin¢GEN-1 Day 8: GEN-1 +O Bsme Day 15: Avastin +GEN-1 Day 22:
Slide 29: Milestones & Financials
Slide 30: Milestone Events (2016 - 2018)
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Slide 31: Financial Overview
31 Financial Overview Cash & Investments (9/30/16) $8.7 million Estimated cash usage per month ~$1.5 million Market Capitalization $10 million Common shares outstanding 31 million Fully diluted shares outstanding 55 million Ayg Daily Trading Volume ~700,000 Celsion
Slide 32: Corporate Information