Delcath Systems, Inc. · NASDAQ:DCTH

Delcath Systems — Canaccord Growth Conference 2009

27 slides from Delcath Systems's conference presentation, Aug 13, 2009

  1. Slide 1: Investor Presentation August 2009

    Investor Presentation August 2009 www.delcath.com www.livercancertrials.com Nasdaq: DCTH www.delcath.com

  2. Slide 2: Forward-looking Statements

    Forward-looking Statements This presentation contains forward-looking statements, within the meaning of federal securities laws, related to future events and future financial performance. Many of these statements involve known and unknown risks and uncertainties, which could cause actual results to

  3. Slide 3: Our Mission

    Our Mission Emerge as the Leader in Ultra High Dose Regional Targeted Chemotherapy  Establish Delcath’s Percutaneous Hepatic Perfusion (PHP™) technology as the new paradigm first line treatment for unresectable liver cancers  Become a global standard neo-adjuvant and adjunctive treatment option fo

  4. Slide 4: Liver Cancer High Unmet Medical Need

    Liver Cancer High Unmet Medical Need  Cancers of the liver are the 5th most common type of cancer and the 3rd leading cause of cancer-related deaths  Approximately 250,000 cases of primary or secondary cancer of the liver are diagnosed each year in the U.S.  Approximately 2,600,000 cases globally

  5. Slide 5: PHP evolved from Open Surgical IHP

    PHP evolved from Open Surgical IHP www.delcath.com

  6. Slide 6: Proof of Concept - IHP

    Proof of Concept - IHP A Solution to an Unmet Need  Delivering cancer drugs directly to the tumor site can allow for dramatic dose escalation of drug agents  Regional therapy capitalizes on the unique vascular anatomy of the liver  Eliminates or dramatically reduces systemic toxicities by isolati

  7. Slide 7: Innovation: The Delcath PHP System

    Innovation: The Delcath PHP System™ www.delcath.com

  8. Slide 8: Melphalan Dosing Levels

    Melphalan Dosing Levels Multiple Myeloma (label) 0.25 mg/kg1 Chemoembolization 0.62 mg/kg2 Surgical Isolated Hepatic Perfusion 1.5 mg/kg3 Percutaneous Hepatic Perfusion (PHP™) 3.0 mg/kg Myeloablation 2.5-3.5 mg/kg  Drug dosing over 10x higher than FDA approved dose via traditional i.v. systemic che

  9. Slide 9: The Delcath PHP System

    The Delcath PHP System Strengths  PHP is a non-surgical and repeatable procedure  Clinical studies have demonstrated very compelling results  Platform Technology - other organs and body regions  Platform Technology – other cancers and infectious diseases such as primary liver cancer (HCC), metas

  10. Slide 10: Current Clinical Trials

    Current Clinical Trials Clinical Development Program Phase I Phase II Phase III Phase III Melanoma Metastases (PHP™ melphalan vs. BAC) Primary Liver Cancer (PHP™ doxorubicin vs. Nexavar ™) Phase II Neuroendocrine Metastases (melphalan) Primary Liver Cancer (melphalan) Adenocarcinoma Metastases (melp

  11. Slide 11: Clinical Trials Metastatic Melanoma

    Clinical Trials Metastatic Melanoma www.delcath.com

  12. Slide 12: Phase I Trial – Proof of Concept (2005)

    Phase I Trial – Proof of Concept (2005)  Phase I Ocular Melanoma Patients 11 evaluable patients - Response (duration in months):  PD 2  MR (14+, 9, 7) 3  PR (17, 15, 7+, 7) 4  CR (12, 11) 2 Objective Response Rate 6 (55%) Overall Response Rate 9 (82%)  Safety Data – Phase I Trial (all patients

  13. Slide 13: Phase I Trial – Metastatic Melanoma

    Phase I Trial – Metastatic Melanoma Radiographic Treatment Response (n=16) Response n % Duration  Overall 8 50  Complete 2 13 10, 15  Partial 6 37.5 2+,8, 8, 12, 15, 16  Stable Disease 4 25 7, 7, 8, 8+  Progressive Disease 4 25  Not Evaluable 2 13 (vascular anomaly) Site of Disease Recurrence/

  14. Slide 14: Phase III Trial – Metastatic Melanoma

    Phase III Trial – Metastatic Melanoma  Phase III Trial Design  92 patients - PHP™ vs. Best Alternative Care (BAC)  Primary trial endpoint: Hepatic Progression Free Survival (PFS)  Cross-over from BAC to PHP™ permitted after progression  80 patients enrolled as of August 10, 2009 Expected Hepati

  15. Slide 15: Phase III Metastatic Melanoma Trial

    Phase III Metastatic Melanoma Trial Treat every 4 weeks x 4 R (Responders can be treated up to 6x) A N Melphalan PHP 92 patients D • Predominantly or O liver-only metastatic M Cross-over ocular or cutaneous I melanoma Z E BAC (best alternative care) - Investigator’s and patient’s decision - Any syst

  16. Slide 16: Phase III – Current Clinical Trial Centers

    Phase III – Metastatic Melanoma  Current Clinical Trial Centers:  National Cancer Institute – Bethesda  University of Pittsburgh Medical Center – Pennsylvania  University of Maryland Medical Center – Maryland  Moffitt Cancer Center – Florida  University of Texas - Texas  John Wayne Cancer Ins

  17. Slide 17: Leading Clinical Investigators

    Leading Clinical Investigators Marybeth S. Hughes, M.D., F.A.C.S H. Richard Alexander, Jr., M.D. Associate Chair for Assistant Member Clinical Research Principal Investigator Jonathan S. Zager, MD, FACS Department of Surgery Surgery Branch, National Cancer Institute, NIH Moffitt Cancer Center Univer

  18. Slide 18: Phase I/II Clinical Trials Metastatic Neuroendocrine Tumors

    Phase I/II Clinical Trials Metastatic Neuroendocrine Tumors www.delcath.com

  19. Slide 19: Phase I/II Trials – Neuroendocrine Tumors

    Phase I/II Trials – Neuroendocrine Tumors Neuroendocrine Tumors Trial Results (n=23*) Pre-PHP:  Primary Tumor Histology: Baseline Carcinoid 6 Pancreatic Islet Cell 17  Median Hepatic PFS: 39  Overall survival after PHP™ : 40 Post-  Response: PHP#1: NE (Tox**, Incomplete Tx, OLT) 4 PD 1 + 6 weeks

  20. Slide 20: Metastatic Neuroendocrine Tumors

    Metastatic Neuroendocrine Tumors Pre-PHP: Baseline Post- PHP#1: + 6 weeks Post- PHP#2: +4 months www.delcath.com 20

  21. Slide 21: Business Strategy – LEGS

    Business Strategy – 3 LEGS  World Class Device Company  Transition from developmental stage to operational stage  Manufacturing, sales, marketing OUS in 2010 and USA 2011  Complete trial enrollment 2009  Goal: Receive CE approval by mid 2010  Goal: Receive FDA approval by mid 2011  Pursue USA

  22. Slide 22: Business Strategy – Partnerships

    Business Strategy – Partnerships  HEP – C/B Initiate testing of high dose interferon/anti- virals for HCV and HBV  Primary liver cancer survival trial-doxorubicin vs. sorafenib  CRC trials with melphalan delivered via PHP  Neuroendocrine Phase II/III survival study with melphalan  Develop syste

  23. Slide 23: Strong Intellectual Property Protection

    Strong Intellectual Property Protection Patent Protection  Seven US Patents and 20 foreign counterparts granted  Primary device patent set to expire August 2016  Portfolio protection extends through 2023 – portfolio includes use of the Delcath PHP System™ for glandular, organ and pelvic perfusion

  24. Slide 24: Initial Markets

    Initial Markets Disease US Prevalence* Predominant Liver Mets Potential Revenue** Cutaneous Melanoma 36,300 25% $ 340,312,500 Ocular Melanoma 2,000 90% $ 67,500,000 Hepatocellular Carcinoma 18,400 95% $ 655,500,000 Neuroendocrine 26,900 33% $ 332,887,500 Colorectal 194,000 40% $ 2,910,000,000 * Stag

  25. Slide 25: Financial Position and Capitalization

    Financial Position and Capitalization  Ticker: DCTH (NASDAQ)  Share Price: $3.16 (August 10, 2009)  52-Week Range: $0.82 – $4.11  Cash: $8.9 million (June 30, 2009)  Debt: None  Burn Rate: Approximately $925,000/month  Shares Out: 26.3 million (32.5 million* FD)  Market Value: $83 million (A

  26. Slide 26: Investment Considerations

    Investment Considerations  Large Unmet Medical Need  Proprietary Clinical Approach  Strong Phase I/II Data  Phase III Enrollment 85% Complete  2010 OUS Revenue Potential www.delcath.com 26

  27. Slide 27: Investor Presentation August 2009

    Investor Presentation August 2009 www.delcath.com www.livercancertrials.com Nasdaq: DCTH www.delcath.com

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