delcath systems inc (DCTH) Key Developments
Delcath Adds New U.S. Center to Global Phase 2 Hepatocellular Carcinoma Program
Apr 7 15
Delcath Systems, Inc. announced the expansion of its global Phase 2 program for the treatment of patients with unrespectable hepatocellular carcinoma (HCC) or primary liver cancer. Montefiore Medical Center in the Bronx, New York has joined the U.S. Phase 2 HCC study and is now open for patient enrollment. The Company now has two centers participating in the U.S. Phase 2 HCC study, with another three centers in Gerany enrolling patients in the EU Phase 2 HCC study. The Company expects to include up to seven centers in Europe and the United States in its global Phase 2 HCC program, and will seek to enroll approximately 30 patients in total.
Delcath Systems, Inc. Announces Auditor Changes
Mar 16 15
On March 12, 2015, Delcath Systems, Inc. dismissed Ernst & Young LLP as its independent registered public accounting firm. On March 13, 2015, the company engaged Grant Thornton, LLP as its new independent registered public accounting firm for the fiscal year ending December 31, 2015. The company's stockholders will be asked to ratify this engagement at the company's 2015 annual meeting of stockholders.
Delcath Systems, Inc. Announces Cessation of Peter J. Graham, Executive Vice President, General Counsel, Chief Compliance Officer and Global Human Resources
Mar 11 15
Peter J. Graham, Executive Vice President, General Counsel, Chief Compliance Officer and Global Human Resources of Delcath Systems, Inc., ceased to be employed by the Company effective March 9, 2015. The company has determined to eliminate its in-house legal functions to increase flexibility and cost efficiencies
and to focus resources on the clinical development programs of the company.
Delcath Systems, Inc. Reports Consolidated Earnings Results for the Fourth Quarter and Year Ended December 31, 2014
Mar 10 15
Delcath Systems, Inc. reported consolidated earnings results for the fourth quarter and year ended December 31, 2014. For the quarter, the company reported total revenue of $0.3 million was comparable to total revenue of $0.3 million in the fourth quarter of 2013. Net loss was $2.9 million or $0.31 per diluted share, a decrease of approximately 40%, compared with a net loss of $4.8 million or $0.63 per diluted share a year ago. Operating loss was $3.285 million against $5.526 million a year ago.
For the year, the company reported total revenue of $1.1 million compared with $0.8 million in 2013, of which $0.3 million related to the recognition of previously deferred revenue. Operating loss was $19.3 million, compared with $33.0 million in 2013. Net loss was $17.4 million or $1.84 per diluted share, a decrease of $12.9 million, or 43%, compared with a net loss in 2013 of $30.3 million or $4.81 per diluted share. The narrowing of the net loss is primarily due to a $13.3 million decrease in operating expenses in 2014.
Delcath Announces Submission Of Phase 3 Trial Results for Publication in a a Medical Journal
Mar 3 15
Delcath Systems, Inc. announced that the results from its Phase 3 clinical study, which completed enrollment in 2009, have been submitted for publication in a peer-reviewed medical journal. The clinical study utilized Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) for the treatment of melanoma patients with liver metastases. The manuscript details the findings from the Company's Phase 3 clinical study, and is entitled "A Random-Assignment Study of Hepatic Arterial Infusion of Melphalan with Venous Filtration via Peripheral (Percutaneous) Hepatic Perfusion (PHP) (Delcath System) versus Best Alternative Care for Ocular and Cutaneous Melanoma Metastatic to the Liver".