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.