Delcath Systems Corporate Presentation - (OTCQB: DCTH) December 2019 - Delcath Systems Inc.
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Delcath Systems
Corporate Presentation
(OTCQB: DCTH)
December 2019
Forward-looking Statements
This presentation contains forward-looking statements, which are subject to certain risks and uncertainties
that can cause actual results to differ materially from those described. Factors that may cause such
differences include, but are not limited to, uncertainties relating to: the timing and results of the
Company’s clinical trials including without limitation the OM and ICC clinical trial programs, timely
enrollment and treatment of patients in the global Phase 3 OM and ICC Registration trials, IRB or ethics
committee clearance of the Phase 3 OM and ICC Registration trial protocols from participating sites and the
timing of site activation and subject enrollment in each trial, the impact of the presentations at major medical
conferences and future clinical results consistent with the data presented, the Company’s ability to
successfully commercialize the Melphalan HDS/CHEMOSAT system and the potential of the Melphalan
HDS/CHEMOSAT system as a treatment for patients with primary and metastatic disease in the liver, our
ability to obtain reimbursement for the CHEMOSAT system in various markets, approval of the current or
future Melphalan HDS/CHEMOSAT system for delivery and filtration of melphalan or other chemotherapeutic
agents for various indications in the U.S. and/or in foreign markets, actions by the FDA or other foreign
regulatory agencies, the impact of the Company’s exclusive licensing agreement with medac on commercial
adoption in Europe and resulting revenue, if any, the Company’s ability to successfully enter into other
strategic partnerships and distribution arrangements in foreign markets and the timing and revenue, if any, of
the same, uncertainties relating to the timing and results of research and development projects, and
uncertainties regarding the Company’s ability to obtain financial and other resources for any research,
development, clinical trials and commercialization activities. These factors, and others, are discussed from
time to time in our filings with the Securities and Exchange Commission. You should not place undue reliance
on these forward-looking statements, which speak only as of the date they are made. We undertake no
obligation to publicly update or revise these forward-looking statements to reflect events or circumstances
after the date they are made.
2
Management Team
Jennifer Simpson, PhD., M.S.N., C.R.N.P. -
President & Chief Executive Officer
♦ Vice President, Global Marketing, Oncology Brand Lead at
ImClone Systems, Inc/Eli Lilly
♦ Product Director, Oncology Therapeutics Marketing at Ortho
Biotech
♦ Earlier in her career Dr. Simpson spent over a decade as a
hematology/oncology-nurse practitioner and educator
♦ Dr. Simpson earned a Ph.D. in Epidemiology from the
University of Pittsburgh, an M.S. in Nursing from the University
of Rochester, and a B.S. in Nursing from the State University
of New York at Buffalo
Barbra C. Keck, Chief Financial Officer
♦ Deloitte & Touche, LLP
♦ Earlier in her career, Ms. Keck spent several years in
executive roles in the non-profit sector
♦ Ms. Keck earned her M.B.A. in Accountancy from Baruch
College and Bachelor of Music in Music Education from the
University of Dayton
John Purpura, Executive Vice President - Global
Head of Operations
♦ Vice President and then Executive Director of International
Regulatory Affairs with Bracco/ E-Z-EM
♦ Associate Vice President for Regulatory and CMC with Sanofi-
Aventis
♦ Prior to Sanofi, Mr. Purpura held various quality and regulatory
management roles with Pharma companies from 1985 to
1995. He earned a MS in Management & Policy and BS
degrees in Chemistry and Biology at the State University of
New York at Stony Brook
3
Delcath Systems
♦ Interventional oncology (IO) company with multiple near term catalysts
♦ 2H 2019 - FOCUS trial expected to complete enrollment; Publication from Prospective
Phase 2 Study
♦ 1H 2020 - Topline data expected to be complete
♦ 2H 2020 - FDA NDA submission for indication expected
♦ “IO is the Fourth pillar of Oncology treatment” - ASCO
♦ Competitors include Boston Scientific (BTG), Sirtex
♦ Proprietary IO system (PHP) treats primary/metastatic liver cancers
♦ Delivers chemotherapy directly to the liver
♦ Minimally invasive, repeatable, predictable, manageable systemic toxicity
profile, can delay tumor progression and could potentially improve survival
♦ Commercial / Clinical Status
♦ Commercial stage in the EU under the CHEMOSAT® brand
♦ ~750 commercial procedures performed
♦ Late-stage (Phase 3) clinical development in the US (Melphalan/HDS)
♦ Pursuit of orphan indications in metastatic ocular melanoma (mOM) and
intrahepatic cholangiocarcinoma (ICC)
4
Our Mission is to Make a Clinically Meaningful Difference for Patients with Cancers of the Liver
Our Solution – Liver Focused Disease Control
♦ CHEMOSAT® Melphalan/HDS product uniquely positioned to treat the entire liver as a standalone or a
complementary therapy
♦ System isolates the liver circulation, delivers a high concentration of chemotherapy (melphalan), and filters
most chemotherapy out of the blood prior to returning it to the patient
♦ Repeatable procedure typically takes ~2-3 hours
Liver Isolated Via Double Balloon Melphalan Infused Directly Into Liver Blood Exiting The Liver Filtered By
Catheter In IVC Via Catheter In Hepatic Artery Proprietary Extra-corporeal Filters
5Cancers of the Liver - A Major Unmet Need Need
Large global patient population
~1.2 million* patients diagnosed annually with primary or metastatic liver cancer
Liver a common site of metastases
Often the life-limiting organ for cancer patients
Prognosis is poor
Overall survival (OS) generally < 12 months
Currently available/emerging therapies
Limited
* SOURCE – 2008 GLOBOCAN
6Focused On Fastest Path To U.S. Market
EU & US Total Addressable Market
Annual Potential
Annual Market
Cancer Type Eligible PTS2
Incidence1 Opportunity
(Millions)3,4
Ocular Melanoma ~4,700 ~2,000 ~$200
Orphan
Indications Intrahepatic
~14,000 ~11,000 ~$825
Cholangiocarcinoma (ICC)
Colorectal (CRC) ~411,000 ~47,500 ~$3,563
Total EU & U.S. ~429,700 ~60,500 ~$4,588
Notes:
1) Globocan, American Cancer Society
2) LEK, Strategy&, Company Estimates
3) Assumes 4 TX/patient for OM and 3TX/patient for ICC, CRC
4) Utilizes current reimbursed amount in Europe ~$25,000 USD/TX
Cancers Of The Liver Remain a Multibillion-Dollar Unmet Medical Need 7Metastatic Ocular Melanoma (mOM) Rationale
♦ OM has high incidence of liver metastases
o ~4,700 cases of OM diagnosed in U.S. and EU annually
o Up to 90% of patients with metastases will have liver involvement
o Life expectancy of approximately 6 months
♦ Currently no standard of care; therapies utilized include:
o Immunotherapy
o TACE
o Y-90
♦ Believed to be fastest pathway to NDA approval in the U.S
♦ FDA granted Melphalan hydrochloride orphan drug designation for treatment of
OM
♦ Clear efficacy signal seen in multiple publications with Melphalan/HDS
8Global Registrational Clinical Trial
Clinical Trial For Patients with
Hepatic-Dominant Ocular
Melanoma
Primary Endpoint
(Objective Response Rate)
Multinational, Multicenter
Secondary
Non-Randomized Melphalan/HDS Endpoints
Registration Trial in TX every 6-8 weeks ≤ 6 (Duration of Response,
cycles Disease Control Rate,
Patients with Hepatic Overall Survival, Progression
Dominant Ocular Free Survival)
Melanoma Safety,
(N=~80) Pharmacokinetics,
QoL
(Rigorous Analyses to
Assess Risk/Benefit Profile)
Amendment Highlights
♦ Ability to collect and report Overall Survival data when survival data
matures (all patients followed until death)
♦ Non-randomized, single-arm trial
♦ Prior enrollment counted to amended enrollment target
♦ PTS treated in prior randomized protocol continue to be treated/evaluated
♦ Anticipate completing enrollment in 2H 2019
9Melphalan/HDS Response Comparison - Reasons for Confidence
Publication CR PR ORR SD DCR mOS Safety
(mos)
Majority of adverse events were related to bone marrow
Hughes 2015
suppression. Four deaths were attributed to PHP-Mel,
(n=44) 0.0% 27.3% 27.3% 52.3% 79.6% 10.6 three in the primary PHP-Mel group, and one post-
(Gen 1 Filter) crossover to PHP-Mel from BAC.
37.5% had Grade 3 or 4 non-hematologic toxicity
Karydis 2018 N=9 (17.6%) of PTS showed cardiovascular toxicity
(n=51) 3.9% 43.1% 47.0% 37.2% 84.3% 15.3 31.3% PTS showed Grade 3 or 4 neutropenia vs 85.7% in
(Gen 2 Filter) prior P3 trial
No TX related deaths
Burgmans Safety analysis showed 14 serious AEs, no deaths, no
2018* (n=35) 3.1% 71.0% 74.1% 12.5% 86.6% 20.3 severe bleeding complications, myocardial or cerebral
(Gen 2 Filter) infarctions observed
Safety analysis showed Grade 3 SAEs observed in 14% of
Artzner 2019
TX (anemia, leukopenia, thrombocytopenia)
(n=15) 0.0% 60.0% 60.0% 33.3% 93.3% 27.4 Most SAEs were Grade 1/2, 5% of reported Grade 3/4
(Gen 2 Filter) SAEs required intervention
* Oral Presentation – ECIO, Not yet published
Superior Results 10ORR trials in oncology
Approval Endpoint Trial Design/Results
Erivedge (vismodegib) Standard ORR 1 single-arm trial; ORR 43%, duration 7.6 months;
(2012) metastatic ORR 30%, duration 7.6 months
Istodax (romidepsin) Standard ORR 2 single-arm trials; ORR 34% duration 454 days,
(2009) ORR 35% duration 336 days
Libtayo (cemiplimab) Standard ORR 2 single-arm trials; ORR 47% from pooled results
(2018)
Odomzo (sonidegib) Standard ORR 1 P2 randomized trial; ORR 58%
(2015)
Mvasi (bevacizumab- Standard ORR 1 randomized trial; ORR 39%
awwb) (2017)
Darzalex (daratumumab) Accelerated ORR Single-arm trial; ORR 29%
(2015)
Kyprolis (carfilzomib) Accelerated ORR Single-arm trial; ORR 23% duration 7.8 months
(2012)
Velcade (bortezomib) Accelerated ORR 2 Single-arm trials; ORR 29.6%
(2003)
Darzalex with Regular-sNDA ORR Single-arm trial; ORR 59.2%
pomalidomide (2017)
Xpovio (selinexor) with Accelerated ORR Single-arm trial; ; ORR 25.3%
dexamethasone (2019) duration 3.8 months
Pemigatinib Topline data released – NDA ORR Single-arm trial; ORR 36%
submission planned shortly
11Multi-Center ICC Outcomes Data Published in European Radiology
Percutaneous Hepatic Perfusion (Chemosaturation) with Melphalan in Patients with Intrahepatic
Cholangiocarcinoma: European Multicentre Study on Safety, Short Term Effects and Survival, European
Radiology 2018, Marquardt, et al
♦ Study evaluated 15 PTS with ICC selected for PHP TX after failing prior therapies; PTS TX at nine hospitals in
Europe between 2012 and 2016
♦ TX outcomes assessed by imaging every three mos following PHP TX
♦ Results after the first PHP TX:
♦ CR: 1 (7%) - CR patient not retreated and is still alive
♦ PR: 2 (13%)
♦ SD: 8 (53%)
♦ Disease Control rate (CR+PR+SD) was 73%
♦ Median OS was 26.9 months from initial diagnosis and 7.6 months from first PHP TX
♦ One-year OS from first PHP TX was 40%, Median PFS was 122 days, and median hepatic hPFS was 131
days
♦ Results after the second PHP TX – 5 patients with SD received 2nd PHP treatment
♦ PR:1 (20%)
♦ SD: 3 (60%)
♦ PD: 1 (20%)
♦ Side-effects were potentially under-reported but were considered by the investigators to be tolerable and
comparable to other systemic and local therapies
♦ Practitioners observed no Grade 3/4 AEs during the PHP procedure; significant hematological toxicity was
observed post-procedure in the form of anemia and thrombocytopenia 5-7 days after the PHP TX
♦ Investigators concluded that PHP Therapy provides “promising response rates in patients with ICC,” and that side-
effects were tolerable and comparable to other treatment strategies
12
Promising response rates in the salvage settingThe ALIGN Trial - Global Pivotal Trial in ICC
A Randomized, Controlled Study to Compare the Efficacy, Safety and Pharmacokinetics of
Melphalan/HDS Treatment Given Sequentially Following Cisplatin/Gemcitabine versus
Cisplatin/Gemcitabine (Standard of Care) in Patients with Intrahepatic Cholangiocarcinoma
Primary Endpoint
Melphalan/HDS (Overall Survival)
TX every 6-8 weeks ≤ 6 cycles
Screening Phase GEM/CIS
Induction Phase R 1:1
(4 cycles)
(N=295) Secondary
GEM/CIS Endpoints
Re-Induction (Progression Free
Survival, Objective
Response Rate, Safety)
♦ Continuing to support enrollment in existing network of enrolling centers
♦ Utilizing efficient allocation of resources to advance this trial in conjunction with OM
Registration Trial
13Building Shareholder Value Through Clinical Development
Tumor Type Program Tasks 2018 1H 2019 2H 2019 1H 2020 2H 2020
Amended
Protocol
Focus Trial
Pivotal Registration FPI Amended
Study in Trial
Ocular Melanoma Hepatic Dominant Safety Analysis
(OM) OM (DSMB)
** Fastest path to US LPI
market approval Top Line Data
FDA Submission
ALIGN Trial Enrollment Open
Intrahepatic P3 Pivotal Trial in ICC
Cholangiocarcinoma
(ICC) ** Strong signal in First PTS TX
commercial setting
Completed
14Broad Device Indication in Europe Demonstrates Potential
Device label permits use in broad range of primary &
Tumor Types Treated metastatic liver cancers
13 tumor types treated since CHEMOSAT launch
Vast Majority:
Presence established in several major markets (~22
OM Mets cancer centers)
~750 commercial procedures performed
Other Types Treated:
German Guidelines Program in Oncology added
HCC CHEMOSAT to national treatment guidelines for
ICC metastatic melanoma
CRC Added to Medical Oncology National Treatment
Guidelines for Ocular Melanoma liver metastases in
Breast the Netherlands
Pancreatic European centers producing data to support
mNET reimbursement applications in additional markets
Cutaneous Data from EU experience providing steady flow of
supporting abstracts and publications
15European Commercialization – medac Licensing
Licensing agreement announced December 2018 Extensive network throughout Europe
€6 million in upfront and milestone payments Allows Delcath to focus on Clinical
Fixed transfer price and royalty payments Development Program
Agreement includes EU member states plus
United Kingdom, Norway, Switzerland,
Liechtenstein
162019 Private Placements
$29.5 Million raised (July 2019 - August 2019)
♦ $12.0 million in debt equitized in addition to cash proceeds
♦ Cash runway beyond top line data
♦ Clean capitalization table
♦ Foundation for a possible path to National Exchange listing
Positioned for success through multiple value inflection points
♦ Full enrollment 2H 2019
♦ Top line data 1H 2020
♦ NDA filing Q4 2020
17Capitalization
Authorized Issued and Outstanding
Preferred Shares 10,000,000 41,716
Common Shares 1,000,000,000 24,388,054
Shares reserved for conversion of Preferred Stock: 695,263,245
Warrants and Options:
Feb 2015 Warrants ($0.01; exp 2/2020) 9
July 2015 Warrants ($0.01; exp 7/2020) 9
Oct 2016 Warrants ($0.01; exp 10/2021) 11
2019 Warrants ($0.06; exp XX/202X) 701,373,492
Options 1,150,000
Total shares reserved for warrants and options: 702,523,521
Shares reserved for conversion of convertible notes: 44,444,444
Total shares issued and reserved: 1,466,619,264
18Summary
Ocular Melanoma (OM)
Late-stage clinical development trial expected to complete accrual in 2H 2019
Topline data expected to complete in 1H 2020
FDA NDA submission for indication expected in 2H 2020
Focused on cancers of the liver with high unmet medical need & no established SOC
Commercial experience from Europe & recent clinical data provide confidence in clinical
development path
~750 commercial procedures performed
Pursuing indications representing ~$1 billion opportunity in the U.S. & Europe with additional
potential in Latin America
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