Having transitioned from a development stage company to a
commercial organization with operational activities in April of this year, Delcath Systems Inc. (DCTH) is gearing up to play its part of NDA resubmission in the upcoming binary event.
The company's shares have lost over 40% of their value year-to-date, and trade near their 52-week low. With the company scheduled to resubmit the New Drug Application for its proprietary chemosaturation system in a couple of days, it will be interesting to watch how the stock price plays out in the coming days.
For readers who are new to Delcath, here's brief overview of the company's business and the upcoming events to watch out for.
Delcath is a medical device company focused on oncology. The company's proprietary technology - chemosaturation therapy, is designed to administer high dose of anti-cancer drugs to diseased organs without exposing the patient's entire body to those same potent levels of drug, thereby limiting the toxic side-effects.
The company's initial focus is on the treatment of primary and metastatic liver cancers. The product for which Delcath is seeking FDA approval is Hepatic CHEMOSAT delivery system, and the filing is scheduled for mid-August.
Whether or not the FDA accepts the NDA for review will be known within 60 days after submission of the NDA.
This is CHEMOSAT's second go-around with the FDA. Initially, the NDA for CHEMOSAT was submitted in December of 2010. The filing was made on a rolling basis. Much to the disappointment of the company, which was optimistic that its NDA will be accepted for review, the FDA, on February 22, 2011, refused the filing over concerns that the information provided was insufficient for review.
Earlier this year, Delcath held a pre-NDA meeting with the FDA to discuss the CHEMOSAT NDA submission and the reasons for refusing the NDA filing.
Last April, CHEMOSAT received CE Mark as a Class III medical device with an indication for the percutaneous intra-arterial administration of a chemotherapeutic agent (melphalan hydrochloride) to the liver. The first CHEMOSAT procedure in Europe was conducted in February of this year, and to date 16 such procedures have been performed at five EU centers.
The CHEMOSAT System received regulatory approval in Australia in February of this year. In a recent SEC filing, the company noted that it has completed the product notification process in New Zealand, with the launch of the CHEMOSAT System expected in the second half of 2012 through authorized distributors.
Hong Kong, South Korea, Singapore, Canada and Israel are the countries where Delcath has submitted applications for regulatory approval of the CHEMOSAT System.
Delcath has also developed Generation Two version of the CHEMOSAT system, and
it received CE Mark approval as recently as April 5, 2012.
A quick look at the company's balance sheet...
Delcath generated its first product revenue in the company's history during the second quarter of 2012.
In the second quarter ended June 30, 2012, Delcath incurred a net loss of $14.51 million or $0.26 per share on revenue of $106 thousand. This compares with a net loss of $5.46 million or $0.13 per share on no revenue in the year-ago quarter.
The company ended June 2012 with $29.3 million of cash and cash equivalents.
The monthly cash spend for the remainder of 2012 is expected to decline following the NDA submission, and the company believes that it has
access to sufficient capital to fund operating activities through this year.
Delcath shares have thus far hit a 52-week low of $1.40 and a 52-week high of $4.74. The stock gained over 8% on Thursday to close the day's trading at $1.82.
If all goes well as planned, Delcath expects to receive FDA approval in 2013.
Will CHEMOSAT pass muster with the FDA? Stay tuned...
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