DELCATH TO CONDUCT THIRD QUARTER 2012 RESULTS CONFERENCE CALL
NEW YORK, October 26, 2012 -- Delcath Systems, Inc. (Nasdaq: DCTH) announced today that it will host a conference call and webcast on Wednesday, November 7, 2012 at 4:30 p.m. ET to discuss its financial results for the third quarter ended September 30, 2012, and provide an update on recent corporate progress.
The dial-in numbers for the conference call are 800-299-0148 (U.S. participants) and 617-801-9711 (International participants); both numbers require passcode 42632846. To access the live webcast, go to the Events & Presentations page on the Investor Relations section of the company's website at http://www.delcath.com/investors/events/.
A taped replay of the call will be available beginning approximately two hours after the call's conclusion and will be available for seven days. Dial-in numbers for the replay are 888-286-8010 and 617-801-6888 for U.S. and International callers, respectively. The replay passcode for both U.S. and international callers is 87111973. An archived webcast will also be available at http://www.delcath.com/investors/events/.
About Delcath Systems
Delcath Systems, Inc. is a specialty pharmaceutical and medical device company focused on oncology. Delcath's proprietary system for chemosaturation is designed to administer high dose chemotherapy and other therapeutic agents to diseased organs or regions of the body while controlling the systemic exposure of those agents. The Company's initial focus is on the treatment of primary and metastatic liver cancers. In 2010, Delcath announced that its randomized Phase 3 clinical trial for patients with metastatic melanoma in the liver had successfully achieved the study's primary endpoint of extended hepatic progression-free survival. The Company also completed a multi-arm Phase 2 trial to treat other liver cancers. The Company obtained authorization to affix a CE Mark for the for the Generation Two CHEMOSAT® Delivery System for melphalan hydrochloride in April 2012. The right to affix the CE mark allows the Company to market and sell CHEMOSAT system for melphalan hydrochloride in Europe. In October 2012, the Company satisfied all of the requirements to affix the CE Mark to its CHEMOSAT Delivery System for use with doxorubicin hydrochloride injection, providing a regulatory pathway for CHEMOSAT with doxorubicin hydrochloride injection for countries in Asia that accept CE Marking as part of their national regulatory requirements. The Company has not yet received FDA approval for commercial sale of its system in the United States. The Company's NDA has been accepted for filing and substantive review by the FDA. The Company is seeking approval for its proprietary chemosaturation system with melphalan hydrochloride as a treatment for patients with unresectable metastatic melanoma in the liver.
For more information, please visit the Company's website at www.delcath.com.
Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This news release 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 contents of the 74 Day FDA letter and our ability to address the same, timing of the PDUFA date, timing of completion of the FDA's review of our NDA, the extent to which the FDA may request additional information or data and our ability to provide the same in a timely manner, FDA approval of the Company's NDA for the treatment of metastatic melanoma to the liver, acceptability of the Phase 1, 2 and 3 clinical trial data by the FDA, adoption, use and resulting sales, if any, in the United States, patient outcomes using the Generation 2 system, adoption, use and resulting sales, if any, for the CHEMOSAT system in the EEA, our ability to successfully commercialize the chemosaturation system and the potential of the chemosaturation system as a treatment for patients with primary and metastatic disease in the liver, approval of the current or future chemosaturation system for other indications, actions by the FDA or other foreign regulatory agencies, our ability to successfully enter into strategic partnership and distribution arrangements in foreign markets including key Asian markets and timing of the same, the initiation of clinical trials in key Asian markets with the CHEMOSAT system with doxorubicin and timing and results of the same, approval of the CHEMOSAT system with doxorubicin in key Asian markets, patient outcomes using the CHEMOSAT system with doxorubicin, our ability to obtain reimbursement for the CHEMOSAT system, uncertainties relating to the results of research and development projects and future clinical trials, and uncertainties regarding our ability to obtain financial and other resources for any research, development 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.
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