delcath systems inc (DCTH) Key Developments
Delcath Systems Receives Non-Compliance Notice From NASDAQ
Aug 14 15
On August 11, 2015, Delcath Systems, Inc. received a notification letter from The NASDAQ Stock Market (NASDAQ) advising the Company that for 30 consecutive trading days preceding the date of the Notice, the bid price of the Company’s common stock had closed below the $1.00 per share minimum required for continued listing on The NASDAQ Capital Market pursuant to NASDAQ Marketplace Rule 5550(a)(2). The Notice has no effect on the listing of the Company’s common stock at this time and the Company’s common stock will continue to trade on The NASDAQ Capital Market. The Notice also stated that the Company will be provided 180 calendar days, or until February 8, 2016, to regain compliance with the Minimum Bid Price Rule. To do so, the bid price of the Company’s common stock must close at or above $1.00 per share for a minimum of ten consecutive business days prior to that date. If, by February 8, 2016, the Company cannot demonstrate compliance with Marketplace Rule 5550(a)(2), then the NASDAQ staff will determine whether or not the Company meets The NASDAQ Capital Market initial listing criteria set forth in NASDAQ Marketplace Rule 5550, except for the bid price requirement. If the Company meets the initial listing criteria (with the exception of the bid price requirement) and provides written notice of its intention to cure the deficiency during the second compliance period, the NASDAQ staff will notify the Company that it has been granted an additional 180 calendar day compliance period. If the Company is not eligible for an additional 180-day compliance period, the NASDAQ staff will provide written notice that the Company’s securities will be delisted. At that time, the Company may appeal the NASDAQ staff’s determination to delist its securities to a Listing Qualifications Panel.
Delcath Systems, Inc. Reports Unaudited Consolidated Earnings Results for the Second Quarter and Six Months Ended June 30, 2015
Aug 5 15
Delcath Systems, Inc. reported unaudited consolidated earnings results for the second quarter and six months ended June 30, 2015. Total revenue for the second quarter of 2015 of $0.5 million increased 85.7% from $0.3 million for the second quarter of 2014. The Company recorded a net loss for the second quarter of 2015 of $3.7 million or $0.30 per diluted share, a decrease of $0.9 million or 19.6%, compared with a net loss of $4.6 million or $0.52 per diluted share for the same period in 2014. This decrease is primarily due to a $2.1 million reduction in operating expenses, a $0.1 million improvement in gross profit and a $1.3 million change in the fair value of the warrant liability, a non-cash item. Operating loss was $3.623 million compared to $5.904 million a year ago.
Total revenue for the first half of 2015 of $0.9 million increased 62.2% from $0.6 million for the first half of 2014. The Company recorded a net loss for the first half of 2015 of $7.2 million or $0.62 per diluted share, a decrease of $2.7 million or 27.2% compared with a net loss of $9.9 million or $1.08 per diluted share for the same period in 2014. This decrease is primarily due to a $3.4 million reduction in operating expenses, a $0.2 million improvement in gross profit and a $0.9 million change in the fair value of the warrant liability, a non-cash item. Operating loss was $7.332 million compared to $10.964 million a year ago.
Delcath Receives Orphan Drug Designation from FDA for Melphalan to Treat Cholangiocarcinoma
Jul 20 15
Delcath Systems, Inc. announced that the U.S. Food and Drug Administration(FDA) Office of Orphan Products Development
(OOPD) has granted Orphan Drug Designation for melphalan for the treatment of cholangiocarcinoma. The OOPD is tasked with evaluating the scientific and clinical data submissions from sponsors to identify and designate products as promising for rare diseases and to further advance scientific development of such promising medical products. Intrahepatic cholangiocarcinoma (ICC), a sub-category of cholangiocarcinoma, is a tumor in the bile duct that arises within the liver.Â It is the second most common primary liver tumor and represents approximately 15% of new HCC cases diagnosed annually. Surgical resection, the standard of care, is not possible for an estimated 80% to 90% of patients diagnosed with ICC. The Company recently announced the expansion of its global Phase 2 clinical study in primary liver cancer (HCC) to include an ICC cohort, which is investigating the safety and efficacy of Melphalan/HDS treatment in patients with unresectable ICC confined to the liver. The study is being conducted at the same hospitals in Europe participating in the Company's Phase 2 HCC trial, and is expected to enroll 11 patients. The ICC cohort will evaluate tumor response (objective response rate) as measured by modified Response Evaluation Criteria in Solid Tumor (mRECIST), and will assess progression-free survival and safety. Additional analyses will be conducted to characterize the systemic exposure of melphalan administered by Melphalan/HDS, as well as to assess patient-reported clinical outcomes, or quality-of-life.
Delcath Systems, Inc. Approves the Appointment of Grant Thornton, LLP as Independent Registered Public Accounting Firm for the Year Ending December 31, 2015
Jun 11 15
Delcath Systems, Inc. approved the appointment of Grant Thornton, LLP as the company's independent registered public accounting firm for the fiscal year ending December 31, 2015 at its AGM held on June 10, 2015.
Delcath Systems, Inc. - Shareholder/Analyst Call
Jun 5 15
Annual Meeting of Shareholders