Forging a Regulatory Pathway for Autologous Cellular Therapy for Critical Limb Ischemia, Aastrom Biosciences (ASTM)
The NYSE dropped (11/16/10) 147 points while the NASDAQ dropped 43.98 and ASTM still rose; $4.41% ($4.28) to $4.28 at 10:55 am on 11/17/10.
Updating from the analyst review: The blended valuation model implies a pricing of $5.08 given the average weighted shares outstanding of 28.25M. The Sum of the Parts estimation of $7.59 is discounted 10% and is significantly above ASTM current price of $4.28.
Aastrom Biosciences develops autologous cellular therapies for the treatment of severe and chronic cardiovascular diseases. Using its proprietary tissue repair cell (TRC) technology, ASTM is able to expand the numbers of stem and early progenitor cells from a small amount of bone marrow collected from the patient.
- Conducting 3 late staged trials; IMPACT-DCM trial, a Phase 2 (cardiac regeneration) with surgical delivery of TRCs in patients with dilated cardiomyopathy (DCM) leading to severe chronic heart failure); DCM P2 trial with catheter delivery of TRCs and the RESTORE-CLI trial, a Phase 2b (vascular regeneration) in patients with CLI (critical limb ischemia).
- Filed a Phase 3 CLI Special Protocol Assessment (SPA) for its autologous cell therapy.
- Formed of a new strategic partnership with ATEK Medical to supply key components and technology which replaces a previous supplier relationship.
- ASTM has been granted fast track designation as compelling efficacy, safety results and anecdotal data provide a strong signal of the therapeutic benefit of autologous cell therapy in patients with critical limb ischemia (CLI).
- The 2nd interim analysis of 86 patients from ASTM’s Phase 2b RESTORE-CLI clinical trial will be presented at the VEITH symposium satellite event, in NYC, NY, 11/18/10 by Dr. Richard Powell, the PI for this study with Dr. William Marston. On 9/22/10, Sanofi-Aventis and Vical’s late-stage candidate, Temusi (NV1-FGF) failed a Phase III in patients with peripheral arterial disease (PAD). The failure of this phase III program could validate ASTM phase III ready autologous cell therapy treatment.
- ASTM has experienced a meteoric rise in share price of $1.49 from the last reporting (Q4/10) to present $4.28.
- Net loss for Q1/11 was $5.83M or $0.21 per share versus the Q4/10 net loss of $5.1 M or $0.18 per share. There were no revenues in Q1/11 and R&D costs were $4.17M with SG&A clocking in at $1.7M. Total operating expenses were $5.85M. In comparison, R&D expenses for Q1/10 were $2.9M with SG&A costs of $0.9M. The increase was associated with the Phase 3 CLI trial initiation.







