Scimitar Equity Blog

ASTM develops autologous cellular therapies for the treatment of severe and chronic cardiovascular diseases.

Approximately 1M people in the US suffer from Critical Limb Ischemia (CLI).

• This disease results in more than 160,000 amputations each year.  CLI is the term used for patients with chronic ischemic rest pain, ulcers, or gangrene that is attributable to inadequate blood flow or arterial occlusive disease which is attributed to severe obstruction of the arteries which decreases blood flow to the extremities (feet, legs and sometimes hands);
•  CLI is typically identified as the end stage of peripheral arterial disease (PAD); the most severe form of the disease which progresses to the point of severe pain and skin ulcers or sores; caused by ischemia, tissue loss, ischemic neuropathy or a combination of these factors. The pain typically occurs at night when the patient is resting, and episodes can last for hours;
• A large percentage of patients with CLI have co-morbidities, such as cardiovascular and renal disorders; that are at high risk for myocardial infarction, stroke, and vascular death. Therefore, prompt referral to a specialized vascular center improves the success of their treatment and reduces the systemic risk in this population. People with CLI face a high risk of amputation and in some cases death;
• No effective pharmacologic therapy is available, and amputation is often the only option left, but is associated with an even worse prognosis: perioperative mortality rate of 5% to 20% with a 2nd amputation required in 30% of all patients.

• ASTM has retained all commercial rights to products in both DCM and CLI for future partnering initiatives which are on-going. The potential to partner ixmyelocel-T for CLI in the  US, outside the US, or both, is significant and highly probable.  In addition, ASTM has a program in late stage development for cardiac applications in dilated cardiomyopathy (DCM), the most severe form of heart failure. 

The Bottom Line: ASTM’s stock is held at a low share price as compared to its P3 status, pending catalysts, completed milestones and valuation. On-going execution offers upside in the near and long-term. However, the share pricing remains challenging based on market volatility, cash positions and negative sentiment. It is believed the treatment has a very good chance to reach the market by 2015 and that it should be well accepted by patients and physicians.  ASTM’s leading therapeutic, clinical and competitive position is further enhanced by speculation and probability that … Pluristem (PSTI) is shopping <hoping to sell> its CLI platform to alleviate a long clinical development process. PSTI is a much earlier stage in its development program, which provides ASTM, a significant advantage given its later stage.

New Analyst Review:  http://www.scimitarequity.com/upload/ASTM-catalysts-milestones308163.pdf