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Pluristem Therapeutics (NASDAQ: PSTI)

Pluristem Therapeutics (NASDAQ: PSTI) is engaged in the production, research and development of placental-derived adherent stromal cells (ASCs). PSTI commercializes  non-personalized (allogeneic) cell therapy products for the treatment of various severe degenerative, ischemic and autoimmune disorders.

Focus: PSTI develops a pipeline of products that are derived from the human placenta, a non-controversial, non-embryonic, adult stem cell source. These placental adherent stromal cells (ASCs) are expanded in proprietary PluriXTM  3 dimensional bio-reactors; which imitates the natural micro-structure of bone marrow and does not require supplemental growth factors or other exogenous materials.

  • Their principal product in development is PLX-PAD for people suffering from peripheral artery disease and also include PLX-IBD, which targets inflammatory bowel disease; PLX-MS, targeting multiple sclerosis; PLX-BMT that targets the global shortfall of matched tissue for bone marrow transplantation (BMT) by enhancing the engraftment of hematopoietic stem cells (HSCs) contained in umbilical cord blood and PLX-STROKE, targeting ischemic stroke.

Market Opportunity: PSTI’s 1st product targets a $4 B market for treating patients suffering from the critical stage of peripheral artery disease (PAD) manifested as limb ischemia.

  • PAD affects millions of patients whose symptoms stem from a decrease in blood supply primarily to the lower extremities. PAD is aggravated by conditions such as atherosclerosis, diabetes and smoking. PLX-BMT, PSTI’s second product, targets an annual $2 B market and is intended to resolve the global shortfall of matched hematopoietic stem cells (HSCs) for bone marrow transplantation (BMT),
  • Approximately 60% of the 150,000 patients diagnosed annually with leukemia and other hematological malignancies are unable to find a suitable bone marrow donor match and are left with no reasonable therapeutic alternatives. In animals PLX-BMT, combined with the HSCs found in umbilical cord blood (UCB), has been shown to significantly increase the engraftment of these HSCs in bone marrow.  PLX-STROKE targets an annual $4 B market and has potential to become a treatment for the functional recovery from an ischemic stroke.

Bottom Line: Pluristem could have an alternative to bone marrow transplantation by using UCB with PLX-BMT …  an off-the-shelf product that requires no matching.

  • PSTI, recently announced  interim results from a Phase I  trial utilizing their placenta derived cell therapy product, PLX-PAD for the treatment of critical limb ischemia (NYSE:CLI), the end-stage of peripheral artery disease (PAD). Data suggested that PLX-PAD is safe and potentially efficacious. 9 patients, representing 1/3rd of the patients needed to complete the Phase I dose-escalating studies in the US and Germany have been dosed with PLX-PAD. Patients experienced no significant unfavorable effects related to PLX-PAD administration; but only, 3 of the 9 patients dosed completed their 3 month follow up and “preliminary” data from those patients demonstrated a trend towards efficacy,
  • PSTI trades at $1.2o with a 52 week range of $0.45 to $2.29 and a  market cap of $22.16 M, an enterprise value of $20.06 M with 18.50 M shares outstanding, a 14.76 M share float, a short interest ratio of 0.4 % of float, $2.14 M in cash, zero debt and cash of $0.116 a share,
  • 23% held by Insiders and  with 0 .20% held by Institutions – TOO LOW,
  • Pluristem’s governance quotient is also LOW; only better than 7.1% of  Biotechnology & Life Sciences companies,
  • Institutional holders (3) include JP Morgan, Wexford Capital and UBS AG,
  • I agree a more rigorous scientific analysis is needed … but, that is to the future as most of us (investors) want critical reviews that reflect the short and near term “share pricing” future,
  • Definitely a questionable  HOLD although eventually a SELL.