Aug 18 2010
Aastrom Biosciences, Inc. (Nasdaq:ASTM), the leading developer of autologous cellular therapies for the treatment of severe cardiovascular diseases, today reported operating results for the fourth quarter and fiscal year ended June 30, 2010.
"We have made significant progress during the past 12 months and are now in a much stronger position to execute our clinical programs and commercialize our autologous cell therapies," said Tim Mayleben, president and CEO of Aastrom Biosciences. "During fiscal year 2010, we reported positive Phase 2b interim results in the treatment of critical limb ischemia, expanded our clinical research program in dilated cardiomyopathy, raised more than $17 million in new capital, executed a reverse stock split to improve our capital structure, increased institutional ownership of our stock, strengthened our management team with several key appointments and sharpened our focus on promising late-stage opportunities to treat cardiovascular diseases.
"Based on these achievements, we are now preparing to move our critical limb ischemia program into Phase 3 development, report final results from the ongoing Phase 2 CLI study, report interim data from the IMPACT-DCM study and complete the ongoing Phase 2 Catheter DCM trial. We look forward to reporting our progress with these programs during the year ahead."
Fiscal Year 2010 Fourth Quarter and Year Ended June 30, 2010 Financial Results
As of June 30, 2010, the company had a total of $19.1 million in cash, cash equivalents and short term investments, compared to $17.0 million in cash and equivalents at June 30, 2009. Aastrom expects that its cash spending will average approximately $4 – $5 million per quarter over the next 12 months which includes Phase 3 clinical program planning and initiation costs for the critical limb ischemia program.
Research and development expenses for the quarter and twelve months ended June 30, 2010 were $3.6 million and $12.7 million, respectively, compared to $2.9 million and $11.3 million for the same periods in fiscal year 2009. These changes reflect the company's increased clinical activity related to its DCM and CLI programs.
Selling, general and administrative expenses for the quarter and twelve months ended June 30, 2010 were $1.5 million and $5.2 million, respectively, compared to $1.0 million and $5.0 million for the same periods in fiscal year 2009. These changes are primarily due to increased employment costs and external legal and consulting fees.
Net loss for the quarter ended June 30, 2010 was $5.1 million, or $0.18 per share, compared to a net loss of $4.0 million, or $0.20 per share, for the same period in fiscal year 2009. Net loss for the twelve months ended June 30, 2010 was $17.7 million, or $0.72 per share, compared to a net loss of $15.9 million, or $0.89 per share, for the same period in fiscal year 2009. The increase in net loss for the twelve months and quarter ended June 30, 2010 is primarily due to increased research and development costs. Loss per share comparisons were impacted by the issuance of 6.5 million shares of common stock on January 21, 2010.