See feature articles below: (NASDAQ: STEM)
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We have a biotech stock that we think is in a position to make significant gains. Stem Cells, Inc. (NASDAQ: STEM) jumped 16% on Tuesday and another 17% yesterday, but we believe that could just be the beginning. The company is making progress, not only in the biotech industry, but in supporting their share price as well.
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 chronic spinal cord injury (SCI). The Company’s Pathway Study, a Phase II proof-of-concept trial in chronic cervical SCI is actively enrolling at thirteen sites in the U.S. and Canada. Six-month interim data for the first cohort of the Pathway Study showed the first-ever clinical evidence of a treatment effect improving both upper muscle strength and motor function following cellular transplant in spinal cord injury.
Stem Cell is the leading company involved in human neural stem cell research and development. They are THE “stem cell” company. The STEM team includes world renowned experts in stem cell biology and biotechnology and business working to bring their extensive strides in stem cell technology to market. Here are a few of the STEM accomplishments so far:
The company is the holder of 45 US patents and 250 foreign patents.
They are the first company to conduct a US clinical trial with human neural stem cells.
Their CNS (central nervous system) program is the most advanced neural stem cell clinical development program.
They were the first to treat a human patient in an FDA authorized clinical trial with ex vivo expanded human neural stem cells.
STEM scientists were the first to isolate and expand human neural stem cells, 17 years ago.
They are the only US company to transplant neural stem cells into the human brain, spinal cord and eye.
The list of accomplishments and milestones achieved by Stem Cells is much longer but those listed above are enough to qualify STEM as a vital player in the future of human health.
Stock Split News
STEM previously announced a reverse 1 for 12 stock split that took effect this past Monday, May 9, 2016. The effect of the reverse stock split was to reduce the number of shares from 140 million to 11.6 million. The share price immediately went to $2.50 per share, placing the company in compliance with NASDAQ listing requirements. The higher share price will make the share more attractive to investors as well as the investment community at large.
Insiders have purchased shares 7 times this year (non-open market acquisitions) and there have been no insider sales this year. Insiders hold 3% of the company shares and institutional investors hold 9%.
On Tuesday, May 10th, stock analysts at Rodman & Renshaw reiterated their “buy” recommendation for STEM. On March 28th both Maxim Group and Chardan Capital had issued a “buy” rating for STEM shares. The average rating of all the analysts is a “buy” and while the price targets for STEM shares range from $3.72 at S&P Equity Research to $36.00 at Maxim Group, the consensus target price (according to Market Beat) is $17.54 per share.
Stem Cells stock has a 52 week low of $2.45 and a high of $9.24. The stocks 50 day moving average price is $3.14 and the 200 day moving average price is $4.34 (see chart below).
In March the company reported its most recent quarterly earnings report showing ($.07) earnings per share, beating the analyst’s consensus of ($.09) per share. In fact, STEM has beaten the analyst’s consensus earnings estimate for the past four quarters.
Clinical Program Updates
Phase II Trial in Cervical Spinal Cord Injury (SCI)
Patients in their Phase II trial in cervical spinal cord injury, which we call the Pathway™ Study, have the most severe degree of SCI as defined by the American Spinal Injury Association Impairment Scale (AIS), with complete loss of motor control below the level of injury, and because their injuries were sustained one to two years prior to their participation in the study, they are classified as having “chronic” SCI.
The company will be presenting top line 12-month data from Cohort I of its Pathway™ Study later this month as part of the Company’s first quarter 2016 analyst call. The Company is planning to then release detailed final data on Cohort I at a scientific venue in June.
Phase I/II Trial in GA-AMD (Completed) for Age-related Macular Degeneration
In June 2014, based on positive interim results, StemCells, Inc. closed enrollment earlier than planned in its Phase I/II clinical trial to assess the tolerability, safety and preliminary efficacy of subretinal HuCNS-SC transplantation in GA-AMD. Top-line results for the Phase I/II clinical trial were presented in June 2015.
In addition to a favorable safety profile for their HuCNS-SC platform technology, patients demonstrated either stable or improved visual acuity and contrast sensitivity at 6 and 12 months post-transplant. Increased macular volume and foveal thickness was observed in the study eye. Analysis and assessment of changes in RPE defects and GA progression is underway.
Completed: Phase I Clinical Trial in PMD (Pelizaeus-Merzbacher Disease)
The Phase I clinical trial, conducted at the University of California, San Francisco, transplanted HuCNS-SC® cells into four patients with connatal PMD. Connatal PMD is the most severe form of the disease and patients are usually diagnosed soon after birth with pronounced neurological dysfunction.
The patients were followed for 12 months after transplantation in the Phase I study, and thereafter were enrolled in a 4-year, long-term, follow-up study. The 12-month Phase I post-transplant results indicated a favorable safety profile for the HuCNS-SC cells and the transplantation procedure. Analysis of MRI data showed changes consistent with increased myelination in the region of the transplantation, which progressed over time and persisted after the withdrawal of immunosuppression at nine months.
The results support the conclusion of durable cell engraftment and the development of donor cell-derived myelin.
Neuronal Ceroid Lipofuscinosis (NCL) Clinical Program
Their clinical study in NCL produced the first evidence of human safety involving direct implantation of up to a total of one billion HuCNS-SC cells into multiple sites within each cerebral hemisphere. The long-term follow-up study has further confirmed long-term safety of HuCNS-SC cells out to five years post-transplant, as well as providing post-mortem evidence of donor cell survival and migration within recipient brains.
Overall, the NCL study results represent the first, and thus far only, multi-year data set following transplantation of neural stem cells into human subjects. This long-term data supports the feasibility of the Company’s approach in other potential neurological and neurodegenerative disorders affecting the brain.
Completed: Phase I Clinical Trial in NCL
The Phase I clinical trial, conducted at Doernbecher Children’s Hospital and Oregon Health & Science University (OHSU), transplanted a total of six patients and was completed in January 2009.
All six patients were followed for 12 months after transplantation in the Phase I trial and five patients were enrolled in the separate, four-year, long-term, follow-up study. The long-term study has completed and three of the five patients survived through the four-year study. The Phase I and long-term follow-up studies assessed cognitive and neurological function.
Outcomes were generally consistent with the expected course of impairment associated with this neurodegenerative disease. It is noteworthy that each patient maintained stable quality-of-life measures.
The research and development being done at Stem Cells represents the future of medicine, at least in degenerative diseases. This is an opportunity to invest in the most advanced company in their field. Start your due diligence now. This stock will rise quickly!
Broad street alerts has been compensated Twenty thousand dollars cash each for the awareness campaign for Stem Cells, Inc. and MGT Capital Investments. We do not own shares in any publicly traded companies in this article nor do we own positions in any of the companies in this article.