Imunon, Inc. · NASDAQ:IMNN
Imunon — Celsion — Investor Presentation (December 2010)
33 slides from Imunon's investor presentation, Dec 1, 2010
Slide 1: Celsion Corporation – Innovation in oncology
" . NASDAQ: CLSN Ce | sion December, 2010 Corporation Innovation in oncology
Slide 2: Safe Harbor Statement
Safe Harbor Statement Except for historical information, the statements made in this presentation are forward- looking statements and are subject to certain risks, uncertainties and assumptions. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking
Slide 3: Celsion Highlights
Celsion Highlights • Phase III oncology company addressing largest unmet need in oncology, HCC • Technology provides highly effective targeted delivery of known chemotherapeutics • ThermoDox® is in two registrational trials with accelerated commercialization potential • SPA granted • Fast Track Desi
Slide 4: Commercially Focused Pipeline
Commercially Focused Pipeline ThermoDox Clinical Programs IINDICATION RESEARCH PRECLINICAL PHASES 1-2 PHASE 3 Current Programs Primary Liver Cancer (HCC) HEAT Study RCW Breast Cancer (RCW) DIGNITY Study Planned Programs Colorectal Liver Mets (CRLM) Painful Bone Mets 4
Slide 5: Lysolipid Thermally-Sensitive Liposomes (LTSL)
Lysolipid Thermally-Sensitive Liposomes (LTSL) Optimizing Chemotherapeutics Through Improved Delivery ThermoDox is 100 nm, • Exclusive world-wide license from Duke a Fraction of RBC & Artificial cells coined University “nano-soccer ball” WBC • Intravenously administered, heat- activated liposomes or
Slide 6: ThermoDox Delivers High Concentrations of Chemotherapy Directly to Tumor
ThermoDox Delivers High Concentrations of Chemotherapy Directly to Tumor IN VITRO Drug release occurs at clinically IN VIVO After 1 hour at 42C, heat-sensitive achievable temperature formulation delivered most drug to tumor Clinically heatable temperature Free doxorubicin range 39.5C - 42C 30 Non
Slide 7: ThermoDox Provides Superior Therapeutic Activity
ThermoDox Provides Superior Therapeutic Activity Mouse Tumors Heated at 42C for Free Dox 1 Hour After IV Administration ThermoDox 30 25 Amount of 25 ng/mg ≈ 43 µM Doxorubicin Dox bound 20 to DNA, RNA Doxil 15 Doxil Amount of 10 Dox still inside liposomes or 5 bound to protein 0 -5 D34 NT34 LT34 D42
Slide 8: Hepatocellular Carcinoma (HCC): High Unmet Global Need
Hepatocellular Carcinoma (HCC) High Unmet Global Need • #5 most prevalent cancer globally • Age-adjusted HCC incidence rates tripled in US between 1975 and 2005 • 750,000 annual incidence worldwide; growing over 5% per year • By 2020, expected to be the #1 cancer, surpassing lung cancer • High morta
Slide 9: RF Ablation + ThermoDox
RF Ablation + ThermoDox Benefit for smaller lesions “Expanding the Treatment Zone” • RFA misses micro-metastases outside ablation zone ThermoDox • RFA+Thermodox: Infuse Thermodox Ablation Zone ~15 min. prior to RFA Thermal Zone • Drug concentrates in the “Thermal Zone” • Ablation releases doxorubici
Slide 10: ThermoDox / RF Ablation
ThermoDox / RF Ablation Greater Improvement for Larger Lesions Larger lesions require multiple overlapping ablations: With ThermoDox Without ThermoDox Overlapping clefts address 10 Room for micro- micro-metastases and metastases to survive expand kill zone
Slide 11: RFA + ThermoDox
RFA + ThermoDox Dox Deposition surrounding the ablation 11
Slide 12: Phase I Liver Cancer Results
Phase I Liver Cancer Results Highly Suggestive of Clinical Activity Ablation Volume increases with the addition of ThermoDox • 2 Clinical Sites: NCI (USA) RFA Alone RFA + ThermoDox and Queen Mary Hospital (Hong Kong) • Single dose treatment; 50mg/m² MTD established • No unanticipated SAE or AE exper
Slide 13: Phase I Liver Cancer Results
Phase I Liver Cancer Results High Response Rate and Direct Dose Correlation Phase I Dose Diagnosis Time to progression (mg/m2) (days) MLC, n = 2 20 32 HCC, n = 1 MLC, n = 4 30 53 HCC, n = 2 MLC, n = 3 40 145 HCC, n = 3 MLC, n = 5 50 185 HCC, n = 1 Phase I data presented at IHPBA Conference, Mumbai,
Slide 14: Phase I Liver Cancer Results
Phase I Liver Cancer Results Highly Suggestive of Clinical Activity in HCC Patients Phase I Data HCC Only Patients RFA Type ThermoDox P = percutaneous Dose Tumor Size OS = open Time Treatment Median By Median Time Median Time (mg/mm) (cm) surgical (days) Failure Dose < 40 mg/mm > 50 mg/mm 20 3.1 P 8
Slide 15: Phase I Liver Cancer Results
Phase I Liver Cancer Results Highly Suggestive of Clinical Activity Manuscript: Poon, Borys, Expert Opinion, Pharmcother, 2009 Table 3. Phase I RFA/LTLD time to treatment failure (TTF) by primary site, tumor size, RFA type, and LTLD dose. Factor Failed Censored Median TTF p-Value (days) Primary site
Slide 16: BCLC Staging System and Treatment
BCLC Staging System and Treatment > 50% of Intent To Cure Receive RFA 15% 5% 25% 25% 30% 16
Slide 17: Modified BCLC Staging Criteria
Modified BCLC Staging Criteria ThermoDox Expands RFA Reach; Adds Order to Treatment Strategy RFA + ThermoDox Curative Treatments 17
Slide 18: Phase III HEAT Study Regulatory Strategy
Phase III HEAT Study Regulatory Strategy Accelerates Approval, Minimizes Uncertainty Accelerated • SPA granted in 2008 Ph 1 Ph 3 supported by 10 Trial International regulatory agencies • Accelerated endpoint PFS ~12 months after last patient Accelerated • Fast track granted Rolling NDA Submission in
Slide 19: Phase III HEAT Study
Phase III HEAT Study Randomized, Double Blind, Placebo Controlled • Primary Endpoint (per SPA): Progression Free Survival • Secondary Endpoints: Overall survival, time to local recurrence, time to definite worsening and safety Gen Eligibility: • Non-resectable HCC • No more than 4 lesions • At least
Slide 20: Phase III HEAT Study Status & Milestones
Phase III HEAT Study Status & Milestones 76 sites enrolling in 11 countries • 79% enrolled: 4–5 months to enrollment completion • Rate may be favorably impacted by • Add’l clinical site in Italy added November 2010 • National Referral Center for Liver Disease • Resumption of Japan enrollment • Enrol
Slide 21: ThermoDox 2nd Indication: Recurrent Chest Wall Breast Cancer
ThermoDox 2nd Indication Recurrent Chest Wall (RCW) Breast Cancer • Breast cancer recurring in the chest wall affects ~35,000 post mastectomy patients in the US and Europe • Up to 40% of women undergoing a mastectomy as primary treatment will experience local recurrence • Reappearance of cancer in t
Slide 22: ThermoDox + Hyperthermia for RCW
ThermoDox + Hyperthermia for RCW Local Treatment Local Control • ThermoDox 50mg/m2 IV in ½ liter D5W BSD 500 • Hyperthermia applied to local lesion • 45°C for 60 minutes • Heat penetration 2-4 cm • Doxorubicin is concentrated at the lesion • Multiple cycles, up to 6 22
Slide 23: Duke Phase I Data: ThermoDox for RCW
Duke Phase I Data: ThermoDox for RCW • 16 patients, 100% show evidence of clinical activity SD, PR, or CR • At 30 mg/m2, 6 of 6 subjects showed a clinical response with 2 Complete Responses (CR) Limited Treatment Options Complete Response After 3 Cycles After 4 Cycles 23 Phase I Data Presented at th
Slide 24: RCW Phase I/II Trial Design: The DIGNITY Study
RCW Phase I/II Trial Design The DIGNITY Study • Phase I: MTD of ThermoDox + mild hyperthermia. • Phase II (Registrational Trial): To determine the Durable Complete Local Response rate following treatment with ThermoDox + mild hyperthermia. • Phase I enrolled, 50mg/m2 dose established pending DMC agr
Slide 25: ThermoDox 3rd Indication: Metastasis Liver Cancer
ThermoDox 3rd Indication Metastasis Liver Cancer (MLC) • ThermoDox experience in 2 Phase I studies • Treated 24 metastatic liver cancer Breast patients from 9 primary sites Lung • Local control and dose response Adrenal relationship established Pancreas • Phase II Study of ThermoDox in Colon Colorec
Slide 26: Philips Joint Research Agreement: ThermoDox + MRI guided HIFU
Phillips Joint Research Agreement: ThermoDox + MRI guided HIFU • ThermoDox in combination with High Intensity Focused Ultrasound (HIFU) for non-invasive treatment of inaccessible, difficult to treat solid tumors • Broadens ThermoDox’s reach to indications with significant need • Bone metastases 4th
Slide 27: Studied Cancers Represent High Unmet Need
Studied Cancers Represent High Unmet Need ThermoDox addresses $billion + market Region Indication 2012 2013 2014 2015 2016 USA HCC 28 29 31 32 34 USA MLC 0 360 370 381 393 Europe HCC 37 38 39 40 42 Europe MLC 0 370 382 393 405 Asia-Pac HCC 0 0 450 472 495 Total Incidence (thousands) 66 797 1,272 1,3
Slide 28: ThermoDox Commercialization Strategy
ThermoDox Commercialization Strategy • Global commercialization plans maximize shareholder value • US strategy is to market and sell directly • Ex-US strategy is through license agreements with Pharma. partners • Japan license completed with Yakult Honsha in December 2008 • $2.5 million at signing a
Slide 29: Financial Summary
Financial Summary As of 9/30/2010 • Cash and equivalents $ 3.2 M • Committed equity financing (June 2010) $ 15.0 M • Transactions at will over 24 months at discount of 5% - 6% • Two draws in 2010 aggregating $1.4 M • Expected 12 month operating average cash usage per month ~ $1.3 M • Common shares o
Slide 30: Management Team
Management Team Michael H. Tardugno Mylan Technologies Inc, Songbird Hearing, Bristol-Myers President and Chief Executive Officer Squibb, Bausch & Lomb, Abbott Laboratories Nicholas Borys, MD Molecular Insight Pharmaceuticals, Cytogen Corp, Anthra Pharmaceuticals, Amersham Healthcare, Hoffmann La- V
Slide 31: Near Term Milestones
Near Term Milestones Lead ThermoDox Program - HCC Ph III HCC Trial Enrollment Completion Ph III HCC Blinded Interim Analysis (190 PFS events) Rolling NDA Submission for HCC Ph III HCC Final Analysis (380 PFS events) 2nd License Agreement for ThermoDox ThermoDox Pipeline Programs Complete Ph I RCW Di
Slide 32: Celsion Highlights
Celsion Highlights • Phase III oncology company addressing largest unmet need in oncology, HCC • Technology provides highly effective targeted delivery of known chemotherapeutics • Significantly increases likelihood of technical success • Reduces regulatory risk • Accelerates market adoption • Therm
Slide 33: Celsion Corporation
Celsion Corporation Celsion Corporation 10220 Old Columbia Road Suite L Columbia, MD 21046 P 410-290-5390 F 410-290-5319 www.celsion.com 33