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Company Description

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7707 Gateway Boulevard

Suite 140

Newark, CA 94560

United States

Phone: 510-456-4000

Fax: 510-456-4001

StemCells, Inc. engages in the research, development, and commercialization of stem cell therapeutics. The company is focused on developing and commercializing stem and progenitor cells as the basis for novel therapeutics and therapies. The company’s primary research and development efforts are focused on identifying and developing stem and progenitor cells as potential therapeutic agents. The company’s major product development program is its CNS (central nervous system) Program, in which the company is developing applications for its HuCNS-SC platform technology, human neural stem cells, as a potential therapeutic to treat diseases and disorders of the CNS. The company is in clinical development with its HuCNS-SC cells for a range of diseases and disorders of the CNS. Therapeutic Product Development Programs CNS Program The company’s CNS Program is initially focusing on developing clinical applications in which transplanting HuCNS-SC cells would protect or restore organ function of the patient before such function is irreversibly damaged or lost due to disease progression. The company’s initial target indications are Pelizeaus-Merzbacher Disease, and more generally, diseases in which deficient myelination plays a central role, such as cerebral palsy or multiple sclerosis; spinal cord injury; and disorders in which retinal degeneration plays a central role, such as age-related macular degeneration or retinitis pigmentosa. The company is the stem cell company in clinical development for indications in all three compartments comprising the CNS, primarily: Diseases and Disorders of the Brain: In February 2012, the company completed a Phase I clinical trial in Pelizaeus-Merzbacher disease, a fatal myelination disorder in the brain. In January 2009, it completed a six-patient Phase I clinical trial of its HuCNS-SC cells in infantile and late infantile neuronal ceroid lipofuscinosis, which is a neurodegenerative disorder of the brain. Diseases and Disorders of the Spinal Cord: In May 2014, the company completed the enrollment and dosing of 12 subjects in a Phase I/II clinical trial of its HuCNS-SC cells for the treatment of thoracic spinal cord injury. In October 2014, the company initiated its Pathway Study, a Phase II proof of concept clinical trial using its HuCNS-SC cells for the treatment of cervical spinal cord injury. Diseases and Disorders of the Eye: In June 2012, the company initiated a Phase I/II clinical trial designed to evaluate the safety and preliminary efficacy of sub-retinal transplantation of its HuCNS-SC cells as a treatment for geographic atrophy (GA), the most advanced form of dry age-related macular degeneration (AMD), the most common form of dry AMD. The trial, an open-label, dose-escalation study, was planned to enroll a total of 16 patients. In June 2014, after enrolling 15 patients and based on positive interim results, it closed enrollment for this study. In July 2015, the company transplanted its first subject in its Radiant Study. This Phase II randomized, controlled proof-of-concept study was designed to evaluate both the safety and efficacy of its proprietary HuCNS-SC cells for the treatment of dry AMD. Other CNS Collaborations The company has collaborated on various research programs to assess both the in vitro potential of the HuCNS-SC cells and the effects of transplanting HuCNS-SC cells into various preclinical animal models. One such collaboration is with researchers at the Stanford University School of Medicine that evaluated the company’s human neural stem cells in animal models of stroke. Licenses Agreements The company has license agreements with academic organizations and commercial entities, including NeuroSpheres, Ltd.; ReNeuron Ltd.; Stem Cell Therapeutics Corp.; genOway SA; and the University of Edinburgh, to either acquire or license out intellectual property rights. In 2014, the company granted fully-paid up, worldwide, field-based licenses to Takara Bio Inc., a Japanese company. Other Commercial Licenses The company has approximately 13 other license agreements with commercial entities, which the company entered into in the ordinary course of business to monetize certain of its patents. Business Strategy The company’s strategy has been to identify multiple types of human stem and progenitor cells with therapeutic and commercial importance, to develop techniques and processes to purify these cells for direct transplant and to expand and bank these cells. The company is focused on advancing these cells through clinical development and into commercialized cell-based therapeutic products, with particular focus on the use of human neural stem cells as a potential treatment for acute spinal cord injury. Government Regulation The Federal Food, Drug and Cosmetic Act, the Public Health Service Act, applicable FDA (the U.S. Food and Drug Administration) regulations, and other federal and state statutes and regulations govern, among other things, the testing, manufacture, labeling, storage, export, record keeping, approval, marketing, advertising, and promotion of the company’s potential products. In addition to safety regulations enforced by the FDA, the company is subject to regulations under the Occupational Safety and Health Act, the Environmental Protection Act, the Toxic Substances Control Act, and other present and potential future foreign, federal, state, and local regulations. History StemCells, Inc. was founded in 1988.

 

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