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A Strong Buy Opportunity, Aastrom Biosciences (ASTM)

ASTM has been volatile based on the recent market depreciation and is held at an extremely low stock price in relation to the market comps and 3 late stage clinical trials targeting niche cardiovascular indications. I updated the model post the last few weeks of downward pricing implying a valuation of $3.56 given the fully diluted shares outstanding with a Sum of the Parts estimation of $5.71 (discounted 20%) which is significantly above the current price of $1.42 and market cap of $40.12 M.

Remember, ASTM is conducting 3 late staged trials; IMPACT-DCM trial, a P2 (cardiac regeneration) with surgical delivery of TRCs in patients with dilated cardiomyopathy (NYSE:DCM) leading to severe chronic heart failure); DCM P2 trial with catheter delivery of TRCs and the RESTORE-CLI trial, a P 2b (vascular regeneration) in patients with CLI (critical limb ischemia).  

  • Compelling efficacy, safety results and anecdotal data has provided a strong signal of the therapeutic benefit of autologous cell therapy in patients with critical limb ischemia (NYSE:CLI),
  • The Phase 2 IMPACT-DCM clinical trial is fully enrolled with 40 patients at 5 sites in the US with plans to report 6 month interim data on all patients in Q4/10 (Nov),
  • The 2nd cardiac trial, a Phase 2 for catheter-based delivery of TRCs to treat DCM patients is currently enrolling patients at 2 sites with patient treatment begun in 5/10,
  • The Phase 2b RESTORE-CLI clinical trial is fully enrolled as of 3/10 with 86 patients at 18 sites of patients suffering from CLI.

ASTM is also active in partnering discussions and in discussions (May) with the FDA for a Phase 3 pivotal study (clinical) program. Dendreon’s (NASDAQ:DNDN) recent approval for Provenge defines a clearer regulatory path for autologous cellular therapies.  Shares of ASTM offer upside in the short term based on impending trial results, partnering opportunities as the regulatory pathway evolve.