DELCATH ANNOUNCES EXTENSION TO REGAIN COMPLIANCE WITH NASDAQ'S MINIMUM BID PRICE RULE
(Thomson Reuters ONE via COMTEX) --Company Intends to Hold a Special Shareholder Meeting to Authorize Reverse Stock Split
New York, NY - December 13, 2013 - Delcath Systems, Inc. (NASDAQ: DCTH) today reported that NASDAQ granted the Company an additional 180 calendar day period, or until June 9, 2014, 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 trading days prior to that date.
NASDAQ's determination to grant the additional 180 day period was based on the Company meeting the continued listing requirement for market value of publicly held shares and all other applicable requirements for initial listing on the NASDAQ Capital Market, with the exception of the bid price requirement, and the Company's written notice to NASDAQ of its intention to cure the deficiency during the second compliance period by effecting a reverse stock split, if necessary.
Additionally, the Company announced that it has filed preliminary proxy materials requesting stockholder approval for an amendment to the Company's Certificate of Incorporation that would authorize the Board of Directors to effect a reverse stock split of the Company's common stock, if deemed necessary. A reverse stock split may enable the Company to regain compliance with NASDAQ's $1.00 minimum bid price requirement and maintain its listing on the NASDAQ Capital Market. As described in the preliminary proxy materials, Delcath intends to hold a special meeting of stockholders on Monday, February 24, 2014.
About Delcath Systems
Delcath Systems, Inc. is a specialty pharmaceutical and medical device company focused on oncology. Our proprietary drug/device combination product, the Delcath Hepatic Delivery System, is designed to administer high dose chemotherapy and other therapeutic agents to the liver, while controlling the systemic exposure of those agents. The Company's initial focus is on the treatment of primary and metastatic liver cancers. Outside of the United States, our proprietary product to deliver and filter melphalan hydrochloride is marketed under the trade name Delcath Hepatic CHEMOSAT® Delivery System for melphalan hydrochloride. The Company obtained authorization to affix a CE Mark for the Generation Two CHEMOSAT Delivery System for Melphalan in April 2012. The right to affix the CE mark allows the Company to market and sell the CHEMOSAT Delivery System for Melphalan in Europe. The Delcath Hepatic Delivery System for Melphalan has not been approved for sale in the United States by the United States Food and Drug Administration. The Company has initiated plans to investigate Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System for primary liver cancer.
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: stockholder approval of the proposed reverse stock split and the Board of Directors implementation of the same, the impact of the reverse stock split on the Company's stock price and the desired effect of a reverse stock split to regain compliance with the NASDAQ Marketplace Rules, the Company's ability to regain compliance with the NASDAQ Marketplace Rules and maintain its listing on the NASDAQ Capital market, efficiencies and reduction in cash utilization achieved through September 2013 staff reductions, the leadership transition plan and its impact on the Company, the timing and results of future clinical trials including without limitation the HCC trials, clinical adoption, use and resulting sales, if any, for the CHEMOSAT system to deliver and filter melphalan in Europe, 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, our ability to obtain reimbursement for the CHEMOSAT system in various markets, the Company's ability to satisfy the requirements of the FDA's Complete Response Letter and provide the same in a timely manner, approval of the current or future chemosaturation system for delivery and filtration of melphalan, doxorubicin or other chemotherapeutic agents for various indications in the US 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 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.
Contact Information: Contact Information: Investor Contact: Media Contact: Michael Polyviou/Patty Eisenhaur John Carter EVC Group EVC Group 212-850-6020/951-316-0577 212-850-6021
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Source: Delcath Systems, Inc via Globenewswire