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FY09 Results, StemCells,Inc (NASDAQ: STEM)


Reported a smaller FY09 net loss of $27.02 M or $0.25 per share, an increase in revenues but, increased operational losses; versus a net loss of $29.08 M, or $0.35 per share for 2008.

For Q4/09, STEM reported a net loss of $5.234 M, or $(0.05) per share.  Loss from operations was $8.081 M. Total revenue was $418 K.  For FY09, STEM, losses from operations were $29.378 M compared to $26.738 M for 2008.  T otal revenue was $993 K a 328% increase over total revenue of $232,000 reported in 2008.  This increase was primarily due to the SCS operations, which included a total of $385 K in product sales from the SC Proven business for 4/1 to 12/31/09. 

  • Total operating expenses in 2009 were $30.11 M, compared to $26.97 M in 2008.  Approximately 80%, or $2.537 M of the increase in 2009 was due to SCS operations,
  • Operating expenses in 2009 also included 2 non-recurring items:  transaction expenses of $693 K related to the SCS acquisition and a charge of $310 K to set up a reserve for expenses associated with STEM’s exit, 
  • For FY09, cash used in operations totaled $24.683 M compared to $22.74 M in 2008, 
  • For FY09, STEM recorded other income of $1.899 M … due to a decrease in warrant liability.  In 2008, STEM recorded a charge of $937 K to reflect an increase in warrant liability while  also recording a charge of $2.083 M to write down the value of its investment in marketable equity securities ( no write downs in 2009),

 Highlights:

  • 1/09, completed a Phase I clinical trial of HuCNS-SC® (purified human neural stem cells) in infantile and late infantile neuronal ceroid lipofuscinosis (NCL/Batten disease),
  • 4/09 closed the acquisition of substantially all of the operating assets and liabilities of SCS for 2.65 M shares of common stock and approximately $700 K in cash,    
  • 4/09, announced that a major international pharmaceutical company acquired a non-exclusive license to their Internal Ribosome Entry Site (IRES) technology, which was acquired as part of the SCS operations, 
  • 5/09, the U.S. Patent and Trademark Office (NYSEARCA:PTO) upheld the validity of 2 remaining neural stem cell patents that were subjected to reexamination proceedings commenced by Neuralstem, Inc.  The decision by the PTO to uphold the 2 patents is final and cannot be appealed. A total of 5 patents were reexamined in proceedings requested by Neuralstem, and the validity of all 5 has been upheld by the PTO.  4 of the upheld patents are the subject of litigation initiated by us against Neuralstem; in which STEM allege various unfair competition torts and infringement of a total of 6 patents. These 6 patents collectively claim the manufacture and use of human neural stem and progenitor cells as tools for drug discovery and as therapeutic agents. In 8/09, the court approved a scheduling order for discovery and trial,  
  • 6/09, announced positive results from the NCL trial. The Phase I data demonstrated that: the HuCNS-SC cells, the transplantation procedure, the immunosuppression regimen were well tolerated,  the patients’ medical, neurological and neuropsychological conditions following transplantation, appeared consistent with the normal course of the disease,
  • 9/09, announced realignment of activities within the UK and California locations, as well as the wind-down of operations in Australia,  
  • 11/09, met with the FDA to review the results of the NCL trial and proposed clinical development plans with the FDA acknowledging that the risk-benefit profile shown by the Phase I data merits further clinical evaluation of HuCNS-SC cells in NCL,
  • 11/09, initiated a P I clinical trial designed to test the safety and preliminary efficacy of HuCNS-SC cells in Pelizaeus-Merzbacher Disease (NASDAQ:PMD). This study, which is the 2nd clinical trial of HuCNS-SC cells in a neurodegenerative disease, 
  • 12/09, received a Notice of Allowance and a Notice of Issuance from the PTO for 2 patents claiming technologies for the establishment and maintenance of cell pluripotency including the reprogramming of cells to create pluripotent stem cells,
  • 12/09, raised $12.5 M in proceeds through the sale of of common stock and warrants.

STEM ended the year with cash, cash equivalents and marketable debt securities totaling $38.618 M while closing at $1.21 M with a market cap 0f $143.20 M.