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StemCells Inc.


StemCells Inc. is engaged in the research and development of cell-based therapeutics. The company's proprietary HuCNS-SC cells (purified human neural stem cells) are currently in development as a potential treatment for a broad range of central nervous system disorders. The company is currently conducting phase 1/2 clinical trials in chronic spinal cord injury and dry age-related macular degeneration. StemCells Inc. is also pursuing preclinical studies in Alzheimer's disease, with support from the California Institute for Regenerative Medicine. The company markets stem cell research products, including media and reagents, under the SC Proven brand.

The information provided below is from analysts, newsletters and other contributors. Please contact the company and visit its website before making an investment decision.

Expert Comments:

Stephen Dunn, LifeTech Capital (11/17/14) "StemCells Inc. initiated a controlled Phase 2 trial ('the Pathway Study') of its HuCNS-SC in cervical spinal cord injury patients. . .the patients will be randomized to either a HuCNS-SC treatment arm or a nontreatment arm with blinded outcome assessment in approximately 12 centers in North America. It is expected to complete enrollment within one year."

Stephen Dunn, LifeTech Capital (10/7/14) "StemCells Inc. announced it initiated the Phase 2 proof-of-concept clinical trial (the Pathway study) using its proprietary HuCNS-SC platform of human neural stem cells for the treatment of cervical spinal cord injury (SCI). 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."

Jason Kolbert, Maxim Group (10/7/14) "StemCells Inc. announced the launch of the Pathway study, a Phase 2 proof-of-concept clinical trial using its HuCNS-SC platform of human neural stem cells for the treatment of cervical spinal cord injury. . .the first site initiated into the Pathway study is the University of Miami Miller School of Medicine."

Stephen Dunn, LifeTech Capital (9/18/14) "While we remain enthusiastic about StemCells Inc.'s science and clinical prospects, we note the stock price will now be facing headwinds during our next 12–18 month forecast period. . .the company added $18.7M in net cash from their July offering. . .and expect to initiate a controlled Phase 2 efficacy proof-of-concept study in Dry AMD by year-end 2014 and complete enrollment in approximately one year."

Christopher James, Brinson Patrick Securities Corporation (9/8/14) "StemCells Inc. reported $12.1M net income and $0.22 EPS for Q2/14. . .the company expects to initiate a controlled Phase 2 study in cervical spinal cord injury patients in Q3/14. . .its Phase 2 dry age-related geographic atrophy macular degeneration study recently showed a decrease in the rate of geographic atrophy of 70% compared to the control eye. . .the firm is poised to become the first company to initiate a controlled Phase 2 study using human neural stem cells. We reiterate our Outperform rating and our $6/share price target. . .the company ended Q2/14 with $17.8M cash."

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Jolene Furdek, Edison Investment Research (8/26/14) "The interim results from seven patients on StemCells Inc.'s dry age-related macular degeneration trial included a 70% reduction in geographic atrophy with respect to the untreated eye. . .these data are from a small number of patients but are sufficiently compelling for the company to stop enrollment of the Phase 1/2 trial and bring forward the start of a Phase 2 trial to Q4/14, before final data are due in mid-2015."

Jason Kolbert, Maxim Group (8/13/14) "Stem Cells Inc. reported Q2/14, burning $8M in cash and closing the quarter with $38M in cash, enough to fund operations through proof of concept in the current age-related macular degeneration trials, in our opinion. . .expectations are for 12–14 sites and a year to complete enrollment, with the trial to begin by Q4/14."

The Life Sciences Report Interview with Christopher James (7/31/14) "StemCells Inc. is a great company. . .it is rapidly advancing a neural stem cell therapy for multiple indications, particularly for the central nervous system. It is going after chronic spinal cord injury (SCI) and geographic atrophy age-related macular degeneration (GA-AMD). Both indications, we think, will generate significant data over the next 24 months. . .

The main catalyst right now is GA-AMD. Investors like this story because of their familiarity with Genentech/Roche Holding AG's antibody Lucentis (ranibizumab intraocular injection). Before that there was the oncology antibody Avastin (bevacizumab), which was used off-label for AMD until Lucentis was approved. Investors know these stories.

Recently, we saw initial interim data from the Phase 1/2 study with the company's HuCNS-SC cells (purified adult human neuronal cells of fetal origin) in GA-AMD. These data were extraordinarily encouraging. In fact, when you compare them to Phase 2 data from Roche's drug, lampalizumab, they are actually quite favorable. StemCells saw a reduction in GA progression of approximately 65–70% at one year, whereas in a broader population, lampalizumab showed a 20.4% reduction, and in a specific subpopulation of GA patients, a 44% reduction. . .the program is rapidly moving into a randomized, controlled Phase 2 study that would be the first with a human neural stem cell. It's a large opportunity—with more than 8M GA patients worldwide—and that gets the attention of investors and analysts." More >

Stephen Dunn, LifeTech Capital (7/7/14) "StemCells Inc. continues to build on its strong management team from last month with the appointment of Dr. Alan Trounson to its board of directors. Trounson most recently served as president of the California Institute of Regenerative Medicine. . .he has been the recipient of over 30 awards and distinctions for his scientific work, including pioneering work in the fields of in vitro fertilization and stem cells."

Christopher James, Brinson Patrick Securities Corporation (7/2/14) "We are initiating coverage on StemCells Inc. with a Market Outperform and a $7 one-year price target. . .we expect both indications, chronic spinal cord injury and geographic atrophy age-related macular degeneration, to generate a robust set of controlled Phase 2 data over the next 24 months."

Keay Nakae, Ascendiant Capital Markets (6/19/14) "StemCells Inc. has reported positive interim results from its Phase 1/2 clinical trial evaluating the use of its HuCNS-SC stem cells in dry age-related macular degeneration (AMD), at the annual meeting of the International Society for Stem Cell Research. . .we view the initial AMD data, while from a small sample size, as very encouraging."

Stephen Dunn, LifeTech Capital (6/19/14) "StemCells Inc. reported positive interim data from the Phase 1/2 trial of its HuCNS-SC human neural stem cell platform in dry age-related macular degeneration (AMD) at the International Society for Stem Cell Research conference. . .investors should note that even with early data in significantly vision-impaired patients, it appears that HuCNS-SC is disease modifying based on the improvements in geographic atrophy and contrast sensitivity."

Stephen Dunn, LifeTech Capital (6/17/14) "StemCells Inc. announced a promotion and three new appointments to its executive team, strengthening what we believe is already one of the strongest management teams in the stem cell space. . .our Strong Speculative Buy rating and 12–18 month target price of $4.50 are based on 35x estimated 2020 EPS discounted 50% for cumulative risks in a first-in-class stem cell therapy."

Jason Zhang, Edison Investment Research (5/22/14) "Investigators of a Phase 1/2 trial reported data suggesting biological and clinical function of a single-dose injection of StemCells Inc.'s HuCNS-SC in patients with spinal cord injury (SCI); the treatment was also well tolerated without treatment-related severe adverse events. These data, despite being limited to only eight subjects with six-month follow-up, support a planned Phase 2 randomized trial, which will test HuCNS-SC against placebo in patients with SCI using well-defined, hard clinical endpoints."

Stephen Dunn, LifeTech Capital (5/20/14) "On May 17, 2014, StemCells Inc. presented interim results on five additional thoracic spinal cord injury (SCI) patients and included the AIS-B patients. . .with 50% (4 out of 8) of the patients with six- to 12-month follow-up experiencing segmental sensory improvement, which would normally be unexpected in these patients, we believe these results are very significant and fully support the planned cervical SCI trial."

Jason Kolbert, Maxim Group (5/19/14) "Dr. Armin Curt, study principal investigator, presented an interim update on StemCells Inc.'s Phase 1/2 trial in spinal cord injury at the Annual Meeting of the American Spinal Injury Association. . .interim analysis of clinical data to date has shown that the significant post-transplant gains in sensory function first reported in two patients have now been observed in two additional patients."

Stephen Dunn, LifeTech Capital (4/17/14) "StemCells Inc. announced today it completed enrollment in the Phase 1/2 clinical trial in thoracic spinal cord injury. . .six-month interim data for the first six patients will be presented at the American Spinal Injury Association conference May 14-17. . .final results are expected in mid-2015."

Jason Zhang, Edison Investment Research (4/17/14) "With plans to open more clinical sites to enroll patients in two upcoming Phase 2 trials, StemCells Inc. moves closer to demonstrating proof-of-concept efficacy of its HuCNS-SC (human neural stem cells) platform in spinal cord injury and age-related macular degeneration. The company has enough cash until the end of 2014."

Stephen Dunn, LifeTech Capital (3/24/14) "We are reiterating a Strong Buy with a price target of $4.50 as StemCells Inc. continues to be one of the most advanced players in the stem cell space. . .the company is now progressing with controlled phase 2 trials in cervical spinal cord injury and dry age-related macular degeneration, and it is also expecting to file an investigational new drug application for Alzheimer's disease a year early in 2016."

Keay Nakae, Ascendiant Capital Markets (3/13/14) "The pace of enrollment in StemCells Inc.'s two phase 1/2 clinical studies has picked up, benefitting from the addition of more clinical sites. . .as we near completion of enrollment in its two current clinical studies, investors will soon have additional human clinical data, which could further support our investment thesis."

Jason Kolbert, Maxim Group (3/13/14) "StemCells Inc. received authorization from Health Canada to expand the phase 1/2 clinical trial for spinal cord injury (SCI) into Canada. . .we also note that the company received U.S. Food and Drug Administration authorization to begin U.S. clinical testing in SCI. . .we look forward to a more rapid enrollment in 2014 as the company moves toward bigger patient numbers and more definitive point-of-care data."

Stephen Dunn, LifeTech Capital (1/10/14) "StemCells Inc.'s HuCNS-SC (purified human neural stem cells) have shown unprecedented results in human patients for Pelizaeus-Merzbacher disease and for complete thoracic spinal cord Injury, and both programs are continuing to progress. In addition, the dry age-related macular degeneration trial is progressing with additional trial sites. California Institute for Regenerative Medicine's $19M funding for HuCNS-SC in Alzheimer's disease validates the company's research, demonstrating for the first time that human neural stem cells can have a significant effect on memory in two different animal models."

Ling Wang, Chardan Capital Markets (1/10/14) "StemCells Inc. has announced that the HuCNS-SC phase 1/2 spinal cord injury trial expanded enrollment in North America. . .we reiterate our Buy rating. . .with two phase 1/2 trials to report data in 2014, the planned initiation of two definitive proof-of-concept efficacy trials in 2014 and a healthy balance sheet, we believe the company's shares are currently significantly undervalued."

Stephen Dunn, LifeTech Capital (1/2/14) "StemCells Inc. begins 2014 with a very strong balance of over $30M cash, which enables the company Inc. to continue developing its HuCNS-SC cells (purified human neural stem cells) for multiple indications uninterrupted. . .StemCells Inc. continues to be one of the most advanced players in the stem cell space. . .the company's strong management team and strong science continues to be successfully validated."

The Life Sciences Report Interview with Jason Kolbert (5/10/13) "StemCells Inc. operates at the next level of cell therapy. When I talk about mesenchymal cells and the trophic effects, it's exciting. But when I talk about potentially pluripotent cells and the ability for cells to remyelinate a demyelinating disorder like Batten disease, or to impact dry macular degeneration, or to impact the outcome in spinal paralysis. . .we're talking about the next level of science.

While it's been painstakingly meticulous, with the science and evolution of the field taking a long time, the way that StemCells is going about its clinical trials and developing its product and its cell line has been brilliant. I think it is a true leader in the field. When we look central nervous system disorders, we should look at companies like StemCells—and the way it is accomplishing its science—as the right way to do things. . .this company is doing pioneering work." More >

Jason Kolbert, Maxim Group (1/8/13) "StemCells Inc.'s spine cord trial has now officially been expanded to the U.S. and Canada. . .we expect to see this trial transition to a phase 2 study by mid 2014. We also believe that this indication [as well as age-related macular degeneration (AMD) and Pelizaeus-Merzbacher disease (PMD)] may qualify for breakthrough designation, resulting in an accelerated pathway to the marketplace. . .we expect the dry AMD trial to complete enrollment by mid-2014. . .the number of clinical sites has now been expanded to five. The dry AMD market is approximately 10x the wet AMD market. As such, point-of-care data from this trial has the potential to be transformative for the company. . .the market opportunities in spine and AMD are large and totally unmet."

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