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StemCells, Inc. Clinical Programs Overview and Progress Update

NEWARK, Calif., July 9, 2015 (GLOBE NEWSWIRE) -- StemCells, Inc. (Nasdaq:STEM), in cooperation with the International Society for Stem Cell Research (ISSCR), has posted a video of the presentation made by the Company's vice president of clinical research and chief medical officer Dr. Stephen Huhn, at the ISSCR 2015 Annual Meeting. Held last month in Stockholm, the meeting was attended by approximately 3,000 scientists, clinicians and biotechnology industry professionals from 55 countries, who gathered to share new data and discuss advances within the stem cell field that are currently being explored by peers as potential therapeutic treatments.

The video provides a comprehensive review of StemCells, Inc.'s platform technology, which is based on transplantation of the Company's proprietary HuCNS-SC® cells (purified human neural stem cells), as well as the Company's Phase I and Phase I/II clinical trials completed to-date and the Phase II proof-of-concept trials currently underway.

Regarding the Phase I/II trial in thoracic spinal cord injury (SCI) completed in April 2015, Dr. Huhn stated, "Our primary focus in this study was to evaluate safety and also to look for even small signs of an effect that went beyond the possibility of spontaneous recovery. The pattern of sensory gains observed are both durable and meaningful, and indicate that the transplantation has impacted the function of damaged neural pathways." He further postulates, "The corollary of the sensory improvements we observed in our Phase I/II thoracic SCI trial could well be improved motor function in the upper extremities of patients with cervical spinal cord injuries participating in our Phase II trial."

Dr. Huhn also presented the top-line outcomes, at ISSCR 2015, from the Company's Phase I/II study in the advanced form of dry AMD, referred to as geographic atrophy (GA), which was completed in June 2015. Dr. Huhn discussed the methodology used to analyze the progression of geographic atrophy in this study, which involved the first neural stem cell transplants conducted in the eye for a retinal degenerative disorder. While further assessment of the data is currently underway, according to Huhn, "We are encouraged by the emerging safety profile of the cells and the favorable preliminary efficacy data observed in the measurements of best corrected visual acuity, contrast sensitivity and optical coherence tomography." Based on the strength of these results, the Company is now enrolling patients for its Phase II proof-of-concept trial in GA-AMD.

The video of Dr. Huhn's presentation at ISSCR 2015 and more information about StemCells, Inc.'s clinical trials can be found at http://www.stemcellsinc.com/Clinical-Programs/Overview. To view the portions of the presentation specifically addressing the topline results from the recently completed Phase I/II clinical trials, you may wish to advance to the following time-code points in the video:

  • Phase I/II clinical trial in thoracic SCI — content begins at 11:20:00
  • Phase I/II clinical trial in GA-AMD — content begins at 14:55:00

About HuCNS-SC Cells

StemCells, Inc. has demonstrated human safety data from completed and ongoing clinical studies in which its proprietary HuCNS-SC cells have been transplanted directly into all three components of the central nervous system: the brain, the spinal cord and the eye. StemCells, Inc. clinicians and scientists believe that HuCNS-SC cells may have broad therapeutic application for many diseases and disorders of the CNS. Because the transplanted HuCNS-SC cells have been shown to engraft and survive long-term in humans, there is the possibility of a durable clinical effect following a single transplantation. The HuCNS-SC platform technology is a highly purified composition of human neural stem cells (tissue-derived or "adult" stem cells). Manufactured under cGMP standards, the Company's HuCNS-SC cells are purified, expanded in culture, cryopreserved, and then stored as banks of cells, ready to be made into individual patient doses when needed.

About The International Society for Stem Cell Research

The International Society for Stem Cell Research is an independent nonprofit organization and the voice of the stem cell research community. The ISSCR was founded in 2002 to foster the exchange of information on stem cell research and now claims more than 4,100 members worldwide. The mission of ISSCR is to promote and foster the exchange and dissemination of information and ideas relating to stem cells, to encourage the general field of research involving stem cells and to promote professional and public education in all areas of stem cell research and application.

About StemCells, Inc.

StemCells, Inc. is currently engaged in clinical development of its HuCNS-SC® platform technology (purified human neural stem cells) as a potential treatment for disorders of the central nervous system (CNS). Top-line data from the Company's Phase I/II clinical trial in thoracic spinal cord injury (SCI) showed measurable gains involving multiple sensory modalities and segments, including the conversion of two of seven patients enrolled in the study with complete injuries to incomplete injuries, post-transplant. The Company's Pathway™ Study, a Phase II proof-of-concept trial in cervical SCI is actively enrolling at eight sites and interim data from the first cohort is anticipated to be forthcoming in Q4 2015. StemCells, Inc. has also completed its Phase I/II clinical trial in geographic atrophy of age-related macular degeneration (GA-AMD), the most severe form of dry AMD and the leading cause of blindness in the elderly. Top-line results for patients who completed twelve months of follow-up show a positive safety profile and favorable preliminary efficacy data related to visual acuity and contrast sensitivity. The Company's Radiant™ Study, a Phase II proof-of-concept trial in GA-AMD is now enrolling at the first of approximately twenty U.S. sites expected to participate. In a Phase I clinical trial in Pelizaeus-Merzbacher disease (PMD), a fatal myelination disorder in children, the Company showed preliminary evidence of progressive and durable donor-derived myelination by MRI. Further information about StemCells, Inc. is available at http://www.stemcellsinc.com.

Apart from statements of historical fact, the text of this press release constitutes forward-looking statements within the meaning of the U.S. securities laws, and is subject to the safe harbors created therein. These statements include, but are not limited to, statements regarding the future business operations of StemCells, Inc. (the "Company"); the timing and prospects associated with detecting potential clinical benefit from the use of the Company's HuCNS-SC cells; the ability of HuCNS-SC cells to affect the rate of geographic atrophy; the prospect for continued clinical development of the Company's HuCNS-SC cells in CNS disorders; the prospect that the Company can initiate the necessary clinical trial sites and enroll study subjects in a timely fashion, if at all, in the Radiant and Pathway Phase II Studies; and the likelihood that early signs of clinical efficacy can be replicated in future clinical studies. These forward-looking statements speak only as of the date of this news release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Such statements reflect management's current views and are based on certain assumptions that may or may not ultimately prove valid. The Company's actual results may vary materially from those contemplated in such forward-looking statements due to risks and uncertainties to which the Company is subject, including uncertainties with respect to the fact that additional trials will be required to confirm the safety and demonstrate the efficacy of the Company's HuCNS-SC cells for the treatment of spinal cord injury, AMD, PMD, or any other condition; uncertainties about whether data in any Phase I or Phase I/II clinical study will prove to be reproducible or biologically meaningful in any future clinical study; risks whether the FDA or other applicable regulatory agencies will permit the Company to continue clinical testing or conduct future clinical trials; uncertainties regarding the Company's ability to obtain the increased capital resources needed to continue its current and planned research and development operations; uncertainty as to whether HuCNS-SC cells and any products that may be generated in the future in the Company's cell-based programs will prove safe and clinically effective and not cause tumors or other adverse side effects; uncertainties regarding the Company's manufacturing capabilities given its increasing clinical commitments; uncertainties regarding the validity and enforceability of the Company's patents; uncertainties as to whether the Company will become profitable; and other factors that are described under the heading "Risk Factors" disclosed in Part I, Item 1A in the Company's Annual Report on Form 10-K for the year ended December 31, 2014 and in its subsequent reports on Form 10-Q and Form 8-K.

CONTACT: Greg Schiffman StemCells, Inc. Chief Financial Officer (510) 456-4128 Lena Evans Russo Partners (212) 845-4262

Source:StemCells, Inc.