MENLO PARK, Calif., Nov. 2 /PRNewswire-FirstCall/ -- XTENT, Inc. (Nasdaq: XTNT) today reported financial results for the third quarter ended September 30, 2007.
The company reported a net loss of $9.5 million, or $0.42 per share, for the third quarter of 2007, compared to a net loss of $8.0 million, or $2.84 per share, for the same period last year. The company's net loss per share for the third quarter of 2007 was based on weighted average shares outstanding of 22.7 million as compared to 2.8 million weighted average shares outstanding for the quarter ended September 30, 2006. For the nine months ended September 30, 2007, XTENT had a net loss of $26.9 million, compared to $17.9 million for the same period last year. The net loss attributable to common stockholders was $26.9 million for the nine months ended September 30, 2007, compared to $31.0 million for the same period last year. At September 30, 2007, XTENT had cash, cash equivalents and short-term investments of $68.1 million.
Research and development expenses increased to $7.8 million in the third quarter of 2007 from $5.8 million for the same period last year primarily due to an increased number of research and development personnel and expenditures for prototype parts, supplies, and outside services related to product development for our Custom NX DES systems. General and administrative expenses were unchanged at $2.6 million in the third quarter of 2007 versus $2.6 million for the same period last year. Research and development expenses for the nine month period ended September 30, 2007, totaled $21.7 million, compared to $13.4 million for the same period last year. General and administrative expenses for the nine months ended September 30, 2007, totaled $7.9 million, compared to $5.3 million for the same period in 2006.
"We continue to make excellent progress in the development of our innovative stent systems," commented Gregory D. Casciaro, XTENT's President and CEO. "In October, we announced very encouraging results from our CUSTOM I and CUSTOM II clinical trials at the Transcatheter Cardiovascular Therapeutics (TCT) conference. At two year follow-up for CUSTOM I and one year follow-up for CUSTOM II, no new major adverse cardiac (MACE) events were reported. In addition, the incidence of late stent thrombosis in both trials was zero. Everyone at XTENT continues to be very focused on the execution of clinical, regulatory and product development milestones."
Third Quarter 2007 Highlights:
-- Completion of patient enrollment in the 90-patient CUSTOM III clinical
-- Appointment of Michael Eagle, former Vice President, Manufacturing, at
Eli Lilly and Company, to the Board of Directors
-- Filed an Investigational Device Exemption (IDE) application with the
United States Food and Drug Administration (FDA) to begin the CUSTOM IV
pivotal trial. As the company announced on October 22, 2007, at the
Transcatheter Cardiovascular Therapeutics meeting in Washington D.C.,
it recently received questions back from the FDA regarding the IDE
application, and it is working to address these questions which must be
resolved before the company can initiate its Custom IV pivotal trial.
Conference Call and Webcast Information
The company will not be hosting a quarterly earnings call for the third quarter of 2007 as it provided an update during its conference call and webcast at TCT on October 22, 2007.
XTENT, Inc. is a medical device company focused on developing and commercializing innovative customizable drug eluting stent (DES) systems for the treatment of coronary artery disease (CAD). CAD is the most common form of cardiovascular disease and the number one cause of death in the United States and Europe. XTENT(R) Custom NX(R) DES Systems are designed to enable the treatment of single lesions, long lesions and multiple lesions of varying lengths and diameters, in one or more arteries with a single device. Note: XTENT(R) Custom NX(R) DES Systems have not been approved for sale by any regulatory authority.
(a development stage company)
Condensed Statements of Operations
(unaudited; in thousands, except per share amounts)
Three Months Ended Nine Months Ended
September 30, September 30,
2007 2006 2007 2006
Research and development (1) $7,767 $5,844 $21,694 $13,403
General and administrative (1) 2,632 2,594 7,894 5,277
Total operating expenses 10,399 8,438 29,588 18,680
Loss from operations (10,399) (8,438) (29,588) (18,680)
Interest and other income, net 860 396 2,658 801
Net loss (9,539) (8,042) (26,930) (17,879)
Deemed dividend related to
beneficial conversion feature
of redeemable convertible preferred
stock - - - (13,095)
Net loss attributable to common
stockholders $(9,539) $(8,042) $(26,930) $(30,974)
Net loss per share attributable to
common stockholders - basic and
diluted $(0.42) $(2.84) $(1.35) $(11.65)
Weighted-average common shares
outstanding used in per share
calculation 22,656 2,830 19,999 2,658
(1) Includes the following stock-based
Research and development $294 $524 $1,030 $850
General and administrative $490 $362 $1,322 $578
(a development stage company)
Condensed Balance Sheets
(unaudited, in thousands)
September 30, December 31,
Cash and cash equivalents and short term
investments $68,095 $23,105
Working capital 64,911 21,066
Total assets 72,338 27,121
Redeemable convertible preferred stock - 75,593
Deficit accumulated during the development
stage (80,996) (54,066)
Total stockholders' equity (deficit) 68,671 (50,780)
|SOURCE XTENT, Inc.|
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