Imunon, Inc. · NASDAQ:IMNN
Imunon — Celsion — Rodman & Renshaw Global Investment Conference 2013
25 slides from Imunon's conference presentation, Sep 9, 2013
Slide 1: Celsion Corporation – Rodman & Renshaw Global Investment Conference
Celsion’ Corporation Rodman & Renshaw Global Investment Conference September 9, 2013 CLSN Michael H. Tardugno President and Chief Executive Officer
Slide 2: Safe Harbor Statement
Safe Harbor Statement Celsion Corporation Except for historical information, the statements made in this presentation are forward-looking statements involving significant risks and uncertainties. These risks and uncertainties, including those related to the future financial position and business str
Slide 3: Celsion Investment Profile
Celsion Investment Profile Celsion Corporation Clinical stage oncology company focused on the development of heat activated tumor targeting liposome technology. 1st Drug ThermoDox Results from Phase III trial "The HEAT Study’ point to a large subgroup of patients showing meaningful benefit in overal
Slide 4: ThermoDox's Elegant Design
ThermoDox’s Elegant Design Celsion Corporation * Transition temperature of 39.5 deg C releases the encapsulated Doxorubicin without compromising healthy tissue » Half-life and nano-particle size provide adequate systemic circulation and vascular leakage allowing tumor biology to concentrate ThermoDo
Slide 5: ThermoDox's Mechanism
ThermoDox’s Mechanism Celsion woe . Corporatic Preclinical Evidence orporation Drug Release Occursat Clinically 1 hourat 42°C, heat-sensitive dosage Achievable Temperature, 39-42°C form deliveredmost drug to tumor 10 Jl Nn G ee Themobox |B Amountof af Y Sos Dox bound ea Y a to DNA/RNA 5° Y, i a5 Y,
Slide 6: ThermoDox's Mechanism: Preclinical Evidence
ThermoDox’s Mechanism Celsion Preclinical Evidence Corporation Nude Mouse - Squamous Cell Tumor Xenograft Model Free Doxorubicin Doxil® 10 10 8 42°C B 7 6 8V é 5 4 4 3 2 2 4 ° ° ° a ee ee Days ThermoDox® 10 LTSL 8 42°C $ sv | =codays All tumors regressed in 6 eee ote So ao so go ses ThermoDox group
Slide 7: ThermoDox Clinical Program
ThermoDox Clinical Program Celsion Evaluating Multiple Oncology Indications Eogporstion INDICATION RESEARCH PRE-CLINICAL PHASES 1.2 PHASE 3 Primary Liver ‘i F Begin Enrollment first half of 2014. RCW Breast ’ i lll ) Cancer (RCW) DIGNITY Study Phase = Phase Il enrolling Pancreatic UW Dept. of Med Ca
Slide 8: Hepatocellular Carcinoma
Hepatocellular Carcinoma Large and Deadly Global Cancer 5th most prevalent = 750,000 annual incidence worldwide; growing over 5% per year = By 2020, expectedto be the #1 cancer, surpassing lung cancer = China has 50% of new cases, 75% in Asia = Age-adjusted HCC incidence rates tripled in U.S. betwee
Slide 9: RF Liver Ablation + ThermoDox
RF Liver Ablation + ThermoDox Celsion Expanding the Treatment Zone Addresses RFA Limitations Seaton RFAmisses micro- metastases outside ablation zone ThermoDox Ablation Zone ThermoDox + RFA: = Infuse ThermoDox ~15 minutes prior to RFA Thermal Zone = Drug concentrates in the “Thermal Zone” » Ablation
Slide 10: Phase I Liver Cancer Results
Phase | Liver Cancer Results Highly Suggestive of Clinical Activity = 2 Clinical Sites: NCI (US) and Queen Mary Hospital (HK) = Single dose treatment; 50mg/m? MTD established = Nounanticipated SAE or AE experienced Bland RFA RFA + ThermoDox® e Days Post RFA Days Post RFA Celsion Corporation Pre-trea
Slide 11: HEAT Study did not meet PFS Endpoint
HEAT 1 Study did not meet PFS Endpoint Celsion Corporation Patients are being followed to determine the OS benefit per Protocol Study did not meet Primary Endpoint PFS: 14.0 mos. vs. 13.9 mos. Patients with smaller lesions (< 5 cm) 79 Clinical Sites in showed ~20% PFS benefit Meaningful Sub-Group, ~
Slide 12: HEAT Study Treatment Window
HEAT 1 Study Treatment Window Celsion Corporation » Ablation time and strategy were not mandated in HEAT Study » Variability exists with ablation cycles and treatment time by lesion size, location, and local practice Mean Plasma Concentration (ngiml) 30000 25000 20000 15000 4 10000 5000 30 min infus
Slide 13: RFA Duration May Have Marked Effect
RFA Duration May Have Marked Effect Projection for OS improves >50% Product-Limit Survival Function Estimates Death/Survival Day 1 TiAl * rn] + 08 = Bos He 3 g é sith teat $ 444Single Lesion & | RFA> 45 minutes 02 0 ° 2 0 6 No of Subjects Event Censored Median Survival (55% CL) Tta 138 20% (28) 80%(
Slide 14: RFA Duration May Have Marked Effect
RFA Duration May Have Marked Effect Celsion Projection for OS improves >50% Corporation # of Pts Deaths HR <45 mins RFA+TDox 96 29) 30% RFA Only 71 27 38% 167 56 1.139 >45<90mins RFA+TDox 76 14 18% RFA Only 105 27 26% 181 41 0.585 >90 mins RFA+TDox 62 14 23% RFA Only 42 15 36% 104 29 0.584 >45 mins
Slide 15: ThermoDox + RFA HCC Thesis
ThermoDox + RFA HCC Thesis Celsion Under-Treating When Heat < 45 min SEE Recent simulation studies show that longer heating time is required in order to achieve increased tissue concentrations of doxorubicin Heat for 5 minutes Heat for 60 minutes —E—— Lo mperature [degC] Temperature [degC] 300 [s] 0
Slide 16: Healthy Swine RFA Dwell Time Study
Healthy Swine RFA Dwell Time Study Celsion Preliminary data supportive of clinical hypothesis Seaton 15 Minute Duration 45 Minute Duration 90 Minute Duration Pos i \ : \ + 0.0 0 2 4 6 8 0 2 4 6 8 0 2 4 6 8 distance from ablation edge distance from ablation edge distance from ablation edge Mean proce
Slide 17: Findings From Post-Hoc Analysis
Findings From Post-Hoc Analysis Celsion - Astrong relationship exists between heating duration and clinical outcome. In general, the longer the RFA time the better the outcome. » ThermoDox appears to markedly enhance this effect » Hypothesis: High local tissue concentration of ThermoDox prevents HCC
Slide 18: HEAT Study Design
HEAT 2 Study Celsion Preliminary Design requires a well defined RFA procedure Seaton iJelit-la"a-tie|**)iti@am Progression Free Survival Secondary Overall Survival, Time to Local Recurrence, Time to Definite Endpoints: Worsening and Safety General Eligi Non-resectable No previous treatment Child-Pug
Slide 19: ThermoDox + Hyperthermia: RCW Breast Cancer DIGNITY
ThermoDox + Hyperthermia Celsion Corporation RCW Breast Cancer DIGNITY 16 pts, all show clinical activity any, 2 % 55 At 30 mg/m, 6/6 subjects showeda clinical Overall Response Rate (ORR) of 48% response, 2 CR Limited Treatment Options Complete Response pnt | 11 Pts. 50 mgim? dose established Enroll
Slide 20: ThermoDox + Hyperthermia: RCW Breast Cancer Phase I Studies
ThermoDox + Hyperthermia Celsion RCW Breast Cancer Phase | Studies Combined Local Response Rate 48.3% 14 12 ™Complete Response 10 iP Pi Partial Response 8 Stable Disease = Progressive Disease Subjects 6 4 ° | Lo | 0 20 30 40 50 Dose Level mg/m? 22 of 23 (29) evaluable, per protocol, subjects demonst
Slide 21: ThermoDox + MRI guided HIFU
ThermoDox + MRI guided HIFU Celsion Broadens Reach to Indications with Significant Need Eogporstion Collaboration with University of Oxford + Phase I] ThermoDox + HIFU for metastatic liver cancer- Significant unmet need * Pre-Clinical studies complete = fess ) | Pre-Clinical Studies University of Wa
Slide 22: Patent and Regulatory Protection
Celsion Investment Profile Celsion Patent and Regulatory Protection eae Exclusive world-wide rights from University Patent to 2019 Additional U.S Patent extension expected under Hatch-Waxman New method patents issued in China, Taiwan, South Korea and Japan extending into 2026 Orphan Drug Designation
Slide 23: Next Steps and Milestones
Next Steps and Milestones Celsion Q3 - 2013 Q4 - 2013 1H -— 2014 Corporation Complete HEAT Study 1 Analysis = Present Post Hoc Findings (WCIO, ECIO, ILCA) Confirm hypothesis through modeling & animal studies = Proposed HEAT 2 Study Design = Steering (Advisory) Committee to finalize HEAT 2 Study Desi
Slide 24: Financial Summary
Financial Summary Cash & Investments @ 6/30/13 Est. Cash Usage Common shares outstanding 52-week PPS Range Market Cap Average Daily Trading Volume Celsion Corporation $49 M ~ $1 M/mo. 61.2M $0.77 - $9.44 $75 M >2.5M
Slide 25: Corporate Information
Celsion’ Corporation Corporate Information P 609-896-9100 997 Lenox Drive F 609-896-2200 Suite 100 www.celsion.com Lawrenceville, NJ 08648 CLSN
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