Delcath Systems, Inc. · NASDAQ:DCTH
Delcath Systems — Investor Presentation (June 2010)
30 slides from Delcath Systems's investor presentation, Jun 9, 2010
Slide 1: Investor Presentation June 2010
Exhibit 99.1 Investor Presentation June 2010 NASDAQ: DCTH
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
Slide 3: Company Highlights
Company Highlights § The Delcath Chemosaturation System (PHP) is a proprietary system delivering ultra-high chemotherapy doses to the liver with manageable systemic toxicities § Minimally invasive approach to targeted, regional cancer therapy that combines a existing drug and straightforward deliver
Slide 4: Deep and Experienced Management Team
Deep and Experienced Management Team Significant Combination Product Approval and Commercialization Experience 4
Slide 5: Recent Accomplishments
Recent Accomplishments § Built new leadership team with in-depth drug and device product and commercialization experience § Established manufacturing facility § Reported successful Phase III Trial results § Increased enrollment momentum in separate Phase II clinical trial § Improved visibility in me
Slide 6: Spectrum of Liver Cancer Treatments
Spectrum of Liver Cancer Treatments Existing Treatments Involves Significant Limitations 6
Slide 7: Open Surgical IHP
Open Surgical IHP IHP: Proof of Concept, but High Morbidity and Non-Repeatable 7
Slide 8: The Delcath Chemosaturation System
The Delcath Chemosaturation System™ Advantages of Chemosaturation § ISOLATION § Treats entire liver § SATURATION § Allows for ~ 100x effective dose escalation of drug agents at tumor site § FILTRATION § Controls systemic toxicities Note: Image not to scale. Converts Traumatic Open Surgery to Minimal
Slide 9: Melphalan
Melphalan § Well understood, dose dependant, tumor preferential, alkylating cytotoxic agent that demonstrates no hepatic toxicity § Manageable systemic toxicities associated with Neutropenia and Cytopenia § Drug dosing over 10x higher than FDA-approved dose via systemic IV chemotherapy § Dose delive
Slide 10: Currently Approved Clinical Trials
Currently Approved Clinical Trials Clinical Development Program Phase I Phase II Phase III Phase III Melanoma Metastases (CS melphalan vs. BAC) Primary Liver Cancer (OS) (CS doxorubicin vs. Nexavar™)* Phase II Neuroendocrine Metastases (melphalan) Primary Liver Cancer (melphalan) Adenocarcinoma Meta
Slide 11: Phase I Trial - Proof of Concept (2005)
Phase I Trial - Proof of Concept (2005) Phase I Ocular Melanoma Patients § 11 evaluable patients Safety data - Phase I Trial (all patients) § Maximum Dose - 3.5 mg/kg • Grade IV toxicities observed § Optimal Dose - 3.0 mg/kg • Manageable hematological toxicities - Neutropenia & Cytopenia Tolerabilit
Slide 12: Phase III Clinical Trial Highlights
Phase III Clinical Trial Highlights § NCI-led pivotal study § Granted Fast Track review designation § Special Protocol Assessment (SPA) with FDA to support NDA (505(b)(2)) regulatory pathway (SPA reviewed and validated by outside counsel) § Randomized, 92 patient multi-center trial (93 enrolled) § T
Slide 13: Phase III Clinical Trial Design
Phase III Clinical Trial Design Randomized to CS 92 patients: ocular or cutaneous melanoma CS/Melphalan Treat every 4 weeks x 4 rounds Cross- (responders can receive up to 6 rounds) over Primary Trial Endpoint Secondary Trial Endpoints § Statistically significant differene in Hepatic § Hepatic respo
Slide 14: Phase III Clinical Trial Results (ASCO)
Phase III Clinical Trial Results (ASCO) § Trial results exceed primary endpoint expectations; p value = 0.001 § Treatment arm shows 5x median hPFS compared to control arm § CS/PHP median hPFS of 245 days compared to 49 days for BAC § Hazard Ratio = .301 § Patients failed prior therapies (radiation,
Slide 15: Phase III Clinical Trial Results (ASCO)
Phase III Clinical Trial Results (ASCO) § Majority of BAC patients crossed over and obtained similar response from treatment § OS Secondary endpoint - No difference (due to cross over treatment response) § OS cohort analysis - all positive trends § Median survival of 298 days for treatment arm compa
Slide 16: Phase III Trial Review
Phase III Trial Review § Conducted under valid SPA § PFS primary endpoint often used for FDA approval* (OS used < 20%) § Primary endpoint exceeded § Secondary endpoints supports results § OS cohort analysis - favorable § Safety profile - expected and in accordance with currently approved labeling fo
Slide 17: Phase III Trial “Questions”
Phase III Trial “Questions” § Do we have a valid SPA? § FDA letter dated February 9, 2006 - SPA deemed acceptable § SPA reviewed and deemed valid in written opinion of outside, independent counsel § “No statistically significant overall survival benefit demonstrated”? § Trial design required by FDA
Slide 18: Phase III Trial “Questions”
Phase III Trial “Questions” § Primary endpoint exceeded? § YES § Secondary endpoints supportive? § YES § Safety profile? § Expected and in accordance with currently approved melphalan § What indication will FDA potentially approve? § March 9th Pre-NDA meeting with FDA - Phase III and other data pres
Slide 19: Leading Clinical Sites & Investigators
Leading Clinical Sites & Investigators National Cancer Institute (Bethesda, MD) — Marybeth S. Hughes, M.D., FACS University of Pittsburgh Medical Center (Pittsburgh, PA) — James F. Pingpank, Jr., M.D., FACS University of Maryland Medical Center (Baltimore, MD) — H. Richard Alexander, Jr., M.D., FACS
Slide 20: Phase I/II NCI Trials - Neuroendocrine
Phase I/II NCI Trials - Neuroendocrine Neuroendocrine Tumor Trial Results (n=23)* Pre-CS (Baseline) Post-CS #1 (+6 Weeks) Post-CS #2 (+4 Months) *Presentation at American Hepato-Pancreo-Biliary Association 2008 annual meeting Promising Response Rate in Potentially Large Market 20
Slide 21: Phase I/II NCI Trials - Neuroendocrine
Phase I/II NCI Trials - Neuroendocrine Pre-CS (Baseline) Post-CS Treatment #1 (+6 Weeks) Post-CS Treatment #2 (+4 Months) 21
Slide 22: Intellectual Property
Intellectual Property Patent Protection § 7 issued U.S. patents, 9 foreign counterparts granted and 5 pending § Primary device patent set to expire August 2016 § Portfolio protection extends through 2023 § Post FDA approval up to 5 years of patent extension available FDA Protection § Orphan Drug Des
Slide 23: Initial U.S. Liver Cancer Market Potential
Initial U.S. Liver Cancer Market Potential § On label annual market estimated over $775 Million in U.S. alone § Less than 10% of global liver cancer cases in U.S. § Less than 10% of liver cancer patients qualify for surgery, currently the “gold standard” treatment option, § 90% of liver cancer patie
Slide 24: Commercialization “Questions”
Commercialization “Questions” § Not an IV or pill…will clinicians embrace CS procedure? § Liver cancer patients have typically failed all Medical Oncology treatments and are sent to the Surgeon for management. Surgeons can only resect 10%, so patients currently have few, if any options. Surgeons, On
Slide 25: Three-Pronged Business Strategy
Three-Pronged Business Strategy Commercialization § Gain regulatory approval • Goal: receive CE approval by mid 2011 • Goal: receive FDA approval by mid 2011 § Build out direct specialty sales force for U.S. § Direct and Distribution partners OUS Pursue Asian Strategic Alliances § Invest and develop
Slide 26: Partnering Opportunities
Partnering Opportunities § HCC — survival trial - CS doxorubicin vs. sorafenib § HCC — survival trial - CS melphalan vs. sorafenib § Neuroendocrine Liver Mets — hPFS trial with melphalan § Colorectal Liver Mets — hPFS trial CS melphalan vs. BAC § Colorectal Liver Mets — hPFS trial CS irinotecan/oxal
Slide 27: Financials
Financials 27
Slide 28: Financial Summary
Financial Summary Financial & Operating Overview § Follow On Offering: Raised ~ $35 million in 2009 § Burn Rate: Approximately $1.8 million/month § Cash: ~$29.6 million at May 31, 2010 § Debt: None § Shares Out: 37.3 million (43.9 million fully diluted*) § Institutional Ownership: ~ 28% at December
Slide 29: Company Highlights
Company Highlights § The Delcath Chemosaturation System is a proprietary system delivering ultra- high chemotherapy doses to the liver with manageable systemic toxicities § Minimally invasive approach to targeted, regional cancer therapy that combines a existing drug and straightforward delivery sys
Slide 30: Investor Presentation June 2010
Investor Presentation June 2010 NASDAQ: DCTH 30