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stemcells inc (STEM) Key Developments

StemCells, Inc. Transplants First Participant in Phase II Clinical Trial in Cervical Spinal Cord Injury Pathway Study to Assess Potential of Human Neural Stem Cells to Restore Motor Function

StemCells Inc. announced that it has transplanted the first subject in its Phase II Pathway® Study assessing the efficacy of its proprietary HuCNS-SC® (purified human neural stem cells) platform technology for the treatment of cervical spinal cord injury (SCI). The transplant was performed at the University of Miami Hospital within the Miller School of Medicine, home to The Miami Project to Cure Paralysis. The Pathway Study is the first clinical trial designed to evaluate both the safety and efficacy of transplanting human neural stem cells into patients with cervical spinal cord injury. Traumatic injuries to the cervical (neck) region of the spinal cord, also known as tetraplegia or quadriplegia, impair sensation and motor function of the hands, arms, legs, and trunk. The trial will be conducted as a randomized, controlled, single-blind study and efficacy will be primarily measured by assessing motor function according to the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI). The primary efficacy outcome will focus on change in upper extremity strength as measured in the hands, arms, and shoulders. The trial will follow the participants for one year and will enroll up to 52 subjects. The company completed enrollment and dosing in its open-label Phase I/II study in thoracic spinal cord injury in May 2014 and has reported interim results on all 12 subjects. Post-transplant gains in sensory function below the level of injury were demonstrated in half of the subjects. Two subjects converted from a complete injury (AIS A) to an incomplete injury (AIS B). The interim results also continue to confirm the favorable safety profile of the cells and the surgical procedure.

StemCells, Inc. Receives CIRM Notice of Termination to Terminate Loan Award

On December 12, 2014, StemCells Inc. received a CIRM Notice of loan award termination to terminate the company’s loan award, DR2A-05416. In September 2012, CIRM awarded the company up to approximately $19 million to fund the company’s research of restoration of memory in Alzheimers disease using neural stem cell therapy. The decision to terminate the loan award was due to the occurrence of a no go milestone in accordance with Section 8.1(f) of the loan agreement. The final amount of the loan award will be determined upon submission of the final financial report and the loan balance will be forgiven.

StemCells Inc. Reports Unaudited Consolidated Earnings Results for the Third Quarter and Nine Months Ended September 30, 2014

StemCells Inc. reported unaudited consolidated earnings results for the third quarter and nine months ended September 30, 2014. For the quarter, the company reported total revenue of USD 269,000 compared to USD 325,000 a year ago. Loss from operations was USD 6,517,000 compared to USD 6,656,000 a year ago. Net loss was USD 2,757,000 compared to USD 7,192,000 a year ago. Basic and diluted loss per share was USD 0.04 compared to USD 0.28 a year ago. The decrease of 17% in revenue from 2013 to 2014 was primarily due to lower revenue from SC Proven product sales in the third quarter of 2014. For the nine months, the company reported total revenue of USD 851,000 compared to USD 891,000 a year ago. Loss from operations was USD 21,521,000 compared to USD 19,134,000 a year ago. Net loss was USD 22,493,000 compared to USD 19,476,000 a year ago. Basic and diluted loss per share was USD 0.38 compared to USD 0.49 a year ago.

StemCells Inc. - Shareholder/Analyst Call

To provide updates on the ongoing Phase I/II clinical programs in dry age related macular degeneration (AMD) and spinal cord injury; and to provide updates and insights into the follow-on Phase II studies in both of these indications, including the recently initiated Pathway Study in cervical spinal cord injury

StemCells, Inc. Initiates Phase II Clinical Trial in Cervical Spinal Cord Injury

StemCells Inc. announced that it has initiated its Pathway(R) Study, a Phase II proof of concept clinical trial using its proprietary HuCNS-SC(R) platform of human neural stem cells for the treatment of cervical spinal cord injury (SCI). Approximately 1.3 million people in the United States report being paralyzed due to an SCI, and there currently are no effective treatments available. Approximately 56% of the spinal cord injuries occur in the cervical region. Overall, approximately 13% of SCI patients have no mobility and 35% have limited mobility after the traumatic injury. The Pathway Study is the first clinical study designed to evaluate both the safety and efficacy of transplanting stem cells into patients with traumatic injury to the cervical spinal cord. The trial will be conducted as a randomized, controlled, single-blind study and efficacy will be primarily measured by assessing motor function according to the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI). The primary efficacy outcome will focus on change in upper extremity strength as measured in the hands, arms, and shoulders. The trial will follow the patients for one year from the time of enrollment. Earlier this year, the Company completed enrollment in an open-label Phase I/II clinical trial in thoracic SCI and reported interim results from this trial on eight patients with at least six months of follow-up post transplantation. Half of the patients transplanted had significant post-transplant gains in sensory function. The interim results also continue to confirm the favorable safety profile of the cells and the surgical procedure. Based upon the strength of the interim data from its thoracic SCI study, the Company made the decision to move forward with the first in human clinical trial to assess the efficacy of stem cell transplants for the treatment of cervical SCI.

 

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