Aastrom Biosciences, Inc.
ASTM - $1.79, $69M market cap
Jason N. Butler, PhD; +1 212 906-3505; jbutler@jmpsecurities.com
Solid progress as CLI Phase III trial gets underway; reiterate Market Outperform rating and $6 price target. Aastrom announced that it has initiated the Phase III REVIVE trial, evaluating the company's autologous cell therapy, ixmyelocel-T for the treatment of patients with critical limb ischemia (CLI). The timing of this news is in line with our expectations and we anticipate that enrollment could be completed with approximately 18 months, with data read out in 2H14. We continue to believe that the SPA-backed Phase III trial has a higher than average probability of success based on the impressive results from the randomized Phase IIb RESTORE CLI trial as well as the design and powering assumptions for Phase III. Additionally, we anticipate the emergence of further value-driving catalysts in 2012 as we gain more visibility on advancing ixmyelocel-T in broader CLI patient populations and indications (e.g. dilated cardiomyopathy), currently not included in our valuation. Our $6 price target is derived by applying a 5x multiple to our projection for ixmyelocel-T sales of $571MM in 2018, discounted by 35% per year.