Aastrom (ASTM) reported a Q3/11 net loss of $1.9M, or $0.05 per share, compared to a net loss of $5.9M, or $0.21 per share for Q3/10.
Revenue was $9K. Cost of product was $2K. R&D expenses for Q3/11 were $5.8M, versus $4.2M for Q3/10.The increase in R&D expenses was primarily attributable to advanced preparations for the P3 REVIVE-CLI clinical program for ixmyelocel-T as well as an increase in non-cash stock-based compensation expense.
G&A expenses were $1.7M, compared to $1.7M for Q3/10. Other income (expense) for Q3/11 was $5.5M compared to $79K for Q3/10. The fluctuations are due to non-cash changes in the fair value of the company’s outstanding warrants, driven by the change in the fair market value of the company’s common stock in these periods. Total costs and expenses were $7.44M. Weighted average number of common shares outstanding (basic and diluted) were 38.63M.
- ASTM had $11.9M in cash and cash equivalents
For the first 9 Months: Aastrom reported a net loss of $16.9M, or $0.44 per share, compared to $12.4M, or $0.45 per share for FY10. R&D expenses were $15.4M so far in FY11 versus $10.6M for FY10. The increase in expenses was primarily attributable to advanced preparations for the P3 REVIVE-CLI clinical program for ixmyelocel-T as well as an increase in non-cash stock-based compensation expense. SG&A expenses were $5.8M, compared to $4.6M for FY10. The increase in G&A expenses was primarily due to an increase in consulting and employee-related expenses, including non-cash stock-based compensation expenses, as well as costs related to the previously announced restatement of the company’s historical financial results in Q1/11.
Quarterly Achievement: Recent financial results reflect the advancement of clinical programs this year (2011), including plans to initiate the REVIVE-CLI P3 clinical trial of ixmyelocel-T in Q4/11. This trial will enroll patients with critical limb ischemia (CLI) who have no other treatment options available. Reached agreement with the FDA regarding the special protocol assessment for the proposed P3 REVIVE-CLI clinical program for ixmyelocel-T in patients with critical limb ischemia who have no other treatment options, positioning us to launch the P3 trial … this quarter;
- Presented 12-month results from the P1/2 IMPACT-DCM dilated cardiomyopathy surgical study at the Heart Failure Society of America meeting. The study showed that treatment with ixmyelocel-T was well-tolerated and consistent with improved myocardium function in patients with DCM, especially those with ischemic cardiomyopathy;
- Reported top-line 6 month interim results from the DCM catheter study showing evidence of fewer adverse events and comparable efficacy results compared to the 12-month results from the IMPACT-DCM surgical study;
- ASTM plans to initiate a P2b study of ixmyelocel-T in the treatment of DCM in the first 1/2 of 2012;
- Received a key composition-of-matter patent from the European Patent Office providing protection throughout the EU for various claims regarding the composition and production of mixed cell populations which characterize ixmyelocel-T.
Guidance: Aastrom anticipates spending 6-7M in Q4/11 having used $6.6M in Q3/11. ASTM will be presenting the final results from the P2b RESTORE-CLI clinical study on 11/14/11 at the American Heart Association Scientific Sessions in Orlando, Florida.
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.