Scimitar Equity Blog

    A net loss of $8.6M or $0.22 per share

A net loss attributable to common shareholders for Q2/12 compared to $10M, or $0.26 per share in Q2/11.  The change in net loss is primarily due to the non-cash change in the fair value of warrants, offset by increases in R&D expenses.

R&D expenses were $7.1M versus $5.3M for Q2/12. The increase in R&D expenses was primarily attributable to the advanced preparation for the P3 clinical program for ixmyelocel-T in critical limb ischemia (CLI) and the P2b RENEW program in dilated cardiomyopathy (DCM), which included clinical site identification, training and initiation of patient enrollment.  SG&A expenses were $2.21M compared to $2.20M for Q2/11 basically flat. For Q2/12 cash used for operations was $8M.  Other income (expense) was $2M compared to $2.5M in Q2/11.  These fluctuations were due to non-cash changes in the fair value of the outstanding warrants, as well as the 6/27/12 warrant exchange for the 12/10 warrants.  The net loss was computed by 38.88M shares. Loss from operations was $9.3M versus $7.5M in Q2/11.

• As of 6/30/12, ASTM had $28.7M in cash and cash equivalents

Q2/12 Highlights

• Exchanged 9,691,900 out of 10M warrants that were issued in 12/10 for 4,845,949 shares of common stock, thereby reducing the total number of fully diluted shares outstanding and the potential for further dilution;
• Initiated patient enrollment in the P3 REVIVE-CLI clinical study of ixmyelocel-T in patients with critical limb ischemia;
• Completed preparations to launch the P2b RENEW-DCM clinical study of ixmyelocel-T in patients with ischemic DCM;
• Published positive 12-month results from the Phase 2b RESTORE-CLI clinical study in the journal Molecular Therapy;
• Presented positive results from the Phase 2a clinical trial of ixmyelocel-T in patients with DCM at the Society for Cardiac Angiography and Interventions 2012 scientific sessions;
• Reported results of preclinical research demonstrating the ability of ixmyelocel-T to protect heart tissue from damage in a murine model of heart failure in a poster presentation at the 18th Annual International Society for Cellular Therapy Meeting; and
• Completed a study in collaboration with the University Of Michigan School Of Dentistry and the Michigan Center for Oral Health in patients who required jawbone reconstruction. The positive results from the clinical trial were recently published in the peer-reviewed journal Cell Transplantation and showed that patients receiving ixmyelocel-T tolerated the treatment well, and had greater bone density and quicker bone repair than those who received traditional bone generation therapy.

6 Month Review: Revenues were $2k. A net loss attributable to common shareholders for six months was $18.3M, or $0.47 per share, compared to $14.9M, or $0.39 per share for the 6 months in FY11.  The change in net loss is also primarily due to the non-cash change in the fair value of warrants, offset by increases in R&D expenses. R&D expenses were $13.9M versus $9.7M for the same periods a year ago. The increase in R&D expenses for both periods was primarily attributable to the advanced preparation for the P3 clinical program for CLI and the P2b RENEW program in dilated cardiomyopathy (DCM), which included clinical site identification, training and initiation of patient enrollment. SG&A expenses were $4M compared to $4.1M for the same periods a year ago.  Other income (expense) for six months was $1.1M compared to $1.2M for the same periods a year ago. These fluctuations were also due to non-cash changes in the fair value of the outstanding warrants, as well as the 6/27/12 warrant exchange for the 12/10 warrants.

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