52wk high is $4.74 and 52wk low is $1.01. With upcoming catalysts, the share price should move significantly higher with an ADCOM in May & PDUFA date on June 15th
On the cusp of realizing the potential: (Slide 3 on 8K) o EU commercial launch underway o Reimbursement in additional key EU markets expected in Q1 o U.S. NDA under review – PDUFA date June 15, 2013
Goals: (Slide 14 on 8k) Expand US (CS-PHP: MEL) label indications beyond the initial indication we are seeking Generate robust clinical data to support commercialization • FDA has accepted IND Amendment to include Gen 2 device in Expanded Access Program (EAP), compassionate use (CU), and all future clinical trials • On track to initiate EAP to treat first patient • Activate EU Registry to systematically collect data from commercial experience
Planned 2013 studies, pending discussion with the FDA: (Slide 15 on 8K) Hepatocellular carcinoma (HCC) o Global Phase 3 Randomized CHEMOSAT Melphalan vs. BSC for Sorafenib Failure Advanced colorectal cancer (CRC) with liver dominant metastasis o Global Phase 3 Randomized CHEMOSAT Melphalan vs. Available Alternatives Neuroendocrine tumor (NET) with liver dominant disease o Global Phase 3 Randomized CHEMOSAT Melphalan vs. Available Alternatives • Phase 2 studies in multiple indications: HCC, NET, CRC, melanoma • Global Investigator-initiated trials (IITs) – opportunity-driven
U.S. NDA Under Review • PDUFA date: June 15, 2013 (Slide 19 on 8K) • Initial indication: unresectable metastatic ocular melanoma in the liver o Provides lowest risk pathway to FDA approval and fastest access
• NDA filing included: o Comprehensive set of additional data in a new FDA compliant CDISC database o Gen 2 filter as part of the Chemistry, Manufacturing and Control (CMC) module • Oncology Drug Advisory Committee (ODAC) panel expected May 2013 • Three meetings scheduled with FDA to discuss clinical programs for planned label expansions in each of NET, HCC,CRC
2013 Anticipated Milestones 2013 Anticipated Milestones • First patient enrolled in EAP - Q1 2013 • Secure interim reimbursement in Germany and UK - Q1 2013 • Submission for publications of Phase 3 data and mNET arm of
Phase 2 data in Q1 2013 • Initiate EU Registry - Q1 2013 • First commercial sale in APLA – Q2 2013 • ODAC Panel Meeting May 2013 • Receive NDA approval of Delcath’s chemosaturation system by PDUFA date of June 15, 2013 • Commence Company’s first investigator initiated trial (IIT) – Q2 2013 • First patient enrolled in Company sponsored trial (CST) to expand indications – Q4 2013 • US commercial launch of Delcath’s chemosaturation system – Q4 2013 • First patient enrolled in Taiwan HCC pivotal trial – Q4 2013 • Execute strategic partnership for China
A Compelling Investment Opportunity • Commercial stage company focused on oncology (Slide 26) • CHEMOSAT provides a unique whole organ therapy for the liver • CHEMOSAT system has demonstrated extension of progression free survival (PFS) • Addressing large unmet market need for cancer patients who usually die of liver failure • EU commercial launch underway • 2013 estimated addressable market opportunity of $2.3 billion • Reimbursement in additional key EU markets expected in Q1 • U.S. NDA under review • Expanding clinical data expected to broaden clinical use and US labeling • Attractive financial model, $80 million in available resources and experienced management team to execute plan
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