2 DELCATH SYSTEMS, INC Forward-looking Statements This presentation contains forward-looking statements, within the meaning of the federal securities laws, related to future
events and future financial performance which include statements about our
expectations, beliefs, plans, objectives, intentions, goals, strategies,
assumptions and other statements that are not historical facts. Forward-looking statements are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions, which
could cause actual results to differ materially from expected results, performance or
achievements expressed or implied by statements made herein. Our actual
results could differ materially from those anticipated in forward-looking statements for many reasons, including, but not limited to, uncertainties relating to: the timing and results of future clinical trials
including without limitation the OM, HCC, ICC, and mCRC trials in the Companys
Clinical Development Program, clinical adoption, use and resulting sales,
if any, for the CHEMOSAT system in Europe, our ability to obtain reimbursement for the CHEMOSAT system and the impact on sales, if any, of reimbursement in various markets, including without limitation
Germany and the United Kingdom, our ability to successfully commercialize the
Melphalan/HDS system and the potential of the Melphalan/HDS system as a
treatment for patients with primary and metastatic disease in the liver, the Company's ability to satisfy the requirements of the FDA's Complete Response Letter relating to the ocular melanoma indication and
the timing of the same, approval of the Melphalan/HDS system by the U.S. FDA,
acceptance of the Phase 3 trial publication, the impact of presentations
and abstracts at major medical meetings and congresses (SSO, ASCO, CIRSE,
ESMO, EADO, RSNA) and future clinical results consistent with the data presented, approval of the current or future
Melphalan/HDS 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, our ability to successfully enter into strategic partnership 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 our ability to obtain financial and
other resources for any clinical trials, research, development, and commercialization activities. These factors, and others, are discussed from time to time in our filings with the Securities and Exchange
Commission including the section entitled Risk Factors in our
most recent Annual Report on Form 10-K and our Reports on Form
10-Q and Form 8-K. |