Aastrom Biosciences reports third quarter 2010 FY results

Aastrom Biosciences, Inc. (Nasdaq:ASTM), the leading developer of autologous cellular therapies for the treatment of severe cardiovascular diseases, today reported financial results for its third fiscal quarter ended March 31, 2010, and also announced progress in its late-stage clinical development programs and corporate operations.

Third quarter fiscal year 2010 financial results

Total revenues for the quarter and nine months ended March 31, 2010, consisting of product sales, were $0 and $89,000, respectively, compared to $58,000 and $113,000 for the same periods in fiscal year 2009. The fluctuations in product sales is due to the changes in volume of cell production sales for investigator-sponsored clinical trials in Spain and limited cell manufacturing supplies to a research institute in the U.S.

Total costs and expenses for the quarter and nine months ended March 31, 2010, were $4,263,000 and $12,753,000, respectively, compared to $4,070,000 and $12,296,000 for the same periods in fiscal year 2009.

Research and development expenses were $2,845,000 and $9,039,000, respectively, for the quarter and nine months ended March 31, 2010, compared to $2,785,000 and $8,340,000 for the same periods in fiscal year 2009. These increases reflect continued expansion of clinical development activities including the costs associated with recruitment and treatment of the final patients in the IMPACT-DCM Phase 2 clinical trial. Research and development expenses for the nine months ended March 31, 2010, also included a non-cash charge of $335,000, compared to $435,000 for the same period in fiscal year 2009, relating to share-based compensation expense.

General and administrative expenses were $1,418,000 for the quarter ended March 31, 2010, and $3,680,000 for the nine months ended March 31, 2010, respectively, compared to $1,260,000 and $3,909,000 for the same periods in fiscal year 2009. The increase in the quarterly expense is primarily the result of increased legal fees and contract services.   For the quarter and nine months ended March 31, 2010, general and administrative expenses included a non-cash charge of $100,000 and $90,000, respectively, compared to $273,000 and $694,000 for the same periods in fiscal year 2009, relating to share-based compensation expense. 

Interest income for the quarter and nine months ended March 31, 2010, was $34,000 and $83,000, respectively, compared to $57,000 and $253,000 for the same periods in fiscal year 2009. The fluctuations in interest income are due primarily to corresponding changes in the level of cash, cash equivalents and short-term investments during the periods, and lower interest rates.

Interest expense was $9,000 and $33,000, respectively, for the quarter and nine months ended March 31, 2010, compared to $17,000 and $58,000, respectively, for the same periods in fiscal year 2009.

Net loss for the quarter ended March 31, 2010, was $4,238,000 or $.16 per share, compared to a net loss of $3,972,000 or $.24 per share, for the same period in fiscal year 2009. Net loss for the nine months ended March 31, 2010, was $12,614,000 or $.55 per share, compared to $11,988,000 or $.72 per share, for the same period in fiscal year 2009.

At March 31, 2010, the company had $22.8 million in cash and cash equivalents and short-term investments compared to $17 million at June 30, 2009. Cash utilization averaged approximately $1.3 million per month for the nine months ended March 31, 2010. It is expected that cash utilization will average approximately $1.4 million per month for the remainder of fiscal year ending June 30, 2010.

Recent Aastrom developments

Aastrom's U.S. Phase 2 IMPACT-DCM clinical trial (surgical delivery for treatment of dilated cardiomyopathy or DCM) is fully enrolled with 40 patients at five sites across the U.S. The company plans to report 6-month interim data on all patients in the trial during the fourth quarter of calendar year 2010. 

Aastrom's second cardiac trial, also a U.S. Phase 2, has been designed to explore a catheter-based delivery of tissue repair cells (TRCs) to treat DCM patients. This trial is currently enrolling patients at two sites and patient treatment is expected to begin in May 2010.

Aastrom's U.S. Phase 2b RESTORE-CLI clinical trial is fully enrolled as of March 2010 with 86 patients at 18 sites across the U.S.  This trial is evaluating the use of TRCs in the treatment of patients suffering from critical limb ischemia (CLI), the most severe form of peripheral arterial disease (PAD).  In February 2010 a planned interim analysis was performed for this study on 46 patients having completed at least 6 months of the study. According to the interim analysis, the safety profile was similar between the treatment and placebo patients. Based on a composite efficacy endpoint assessing time to treatment failure (including major amputations, doubling of wound size and new gangrene), Aastrom's autologous TRCs were more effective than placebo>

The interim results will be presented by Richard J. Powell, M.D., section chief of vascular surgery at the Dartmouth-Hitchcock Medical Center in Lebanon, NH and a principal investigator of the study, at the Vascular Annual Meeting® of the Society for Vascular Surgery on June 11, 2010.  The company plans to report 6-month interim data on all patients in the trial during the fourth quarter of calendar year 2010.  
 
"In the third quarter of fiscal year 2010, we made outstanding progress in our cardiovascular clinical development programs and we are focused on planned data analyses and presentation of these additional data later this year," said Tim Mayleben, president and CEO of Aastrom. "We look forward to reporting on these milestones throughout 2010."

NASDAQ capital market listing

On February 18, 2010 the company announced that it had regained compliance with the $1.00 minimum bid price requirement for continued listing under NASDAQ Listing Rule 5550(a)(2). Accordingly, the company is currently in full compliance with all listing requirements of the NASDAQ Capital Market. On February 18, 2010 the company effected a one-for-eight reverse stock split to increase the per-share trading price of Aastrom's common stock to meet the NASDAQ requirement and to attract greater institutional ownership of the company's shares.

Source: Aastrom Biosciences