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Due Diligence Report:
Summary: StemCells, Inc. Hit 1 month High Prior to MicroCap Conference
StemCells, Inc. (StemCells), incorporated on August 2, 1988, is engaged 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 therapeutics and therapies. The Company’s lead product development program is its CNS Program, in which it is developing applications for HuCNS-SC cells, its human neural platform technology. It is in clinical development with its HuCNS-SC cells for a range of diseases and disorders of the central nervous system. The CNS consists of the brain, spinal cord and eye, and it is stem cell Company in clinical development for indications in all three compartments comprising the CNS, which include with respect to the brain, with respect to the spinal cord and with respect to the eye.
The Phase I clinical trial was completed in Pelizeaus-Merzbacher Disease. The data showed that the HuCNS-SC cells, the transplantation procedure, and the immunosuppression were all well tolerated. It was demonstrated in vivo proof of principle by showing in the myelin deficient shiverer mouse that transplanted HuCNS-SC cells can generate and integrate myelin producing oligodendrocytes into the mouse brain and tightly wrap the mouse nerve axons to form myelin sheath.
The Phase I clinical trial completed in Neuronal Ceroid Lipofuscinosis (also known as Batten disease). Trial results showed that the HuCNS-SC cells, the transplantation procedure, and the immunosuppression were well tolerated and the cells were not tumorigenic, and that there was evidence of engraftment and survival of the transplanted cells. It was demonstrated in vivo proof of principle by showing in a mouse model for infantile NCL that transplanted HuCNS-SC cells can continuously produce the enzyme that is deficient in infantile NCL; protect host neurons from death; delay the loss of motor function in HuCNS-SC transplanted mice and survive up to six years; five years after stopping immunosuppression. In two mouse models to Alzheimer’s disease report data that showed its HuCNS-SC cells can restore memory.
The Phase I/II clinical trial in multiple sites for chronic spinal cord injury was completed. StemCells reported interim results on all 12 subjects which showed post-transplant gains in sensory function below the level of injury in half of the subjects. Two subjects converted from a complete injury (AIS A) to an incomplete injury (AIS B). StemCells is conducting Pathway Study, a Phase II proof of concept clinical trial using its HuCNS-SC cells for the treatment of cervical spinal cord injury (SCI). It was demonstrated in vivo proof of principle by showing in a mouse model for spinal cord injury that transplanted HuCNS-SC cells can restore motor function in injured animals; directly contribute to functional recovery (and that when human cells are ablated restored function is lost) and become specialized oligodendrocytes and neurons.
The Company is conducting a Phase I/II clinical trial to evaluate the safety and preliminary efficacy of its HuCNS-SC cells as a treatment for dry age-related macular degeneration (AMD). Interim results for the Phase I/II trial based on twelve months of data, showed for all four subjects of cohort one, a 70% reduction in the rate of geographic atrophy (GA) as compared to the control eye and a 65% reduction in the rate of GA as compared to the expected natural history of the disease following a single dose of its HuCNS-SC cells. In addition to these initial efficacy findings, the Phase I/II trial has also demonstrated a favorable safety profile for HuCNS-SC cells as a treatment for dry AMD. It was demonstrated in vivo proof of principle by showing in the Royal College of Surgeons rat, an accepted model for retinal degeneration, that HuCNS-SC cells can protect photoreceptor cells from death and prevent or slow loss of vision.
StemCells, Inc. has a current market capitalization of $33.91 with 138.02 M outstanding shares. Its daily average volume traded is 2.12 M shares.
Financial Highlights (Q4 2015):
Revenue: 0.03 M
Gross Profit: 0.03 M
Net Income: -8.96 M
Cash and Cash Equivalents: 12.11 M
Total Debt: 10.37 M
Recent News and Analysis:
The company recently announced that management will make a presentation on the Company’s programs, pipeline and operations at the 3rd Annual Growth Capital Expo MicroCap Investor Conference, held May 3 – 5, 2016 at Caesars Palace in Las Vegas, NV. The Company will be presenting at 11:00 a.m. Pacific Daylight Time on Wednesday, May 4.
StemCells Inc. (NASDAQ:STEM) is expected to announce first quarter financial results estimated on 05/05/2016. Overall, the average earnings surprise was 2.78 percent over the past four quarters. Back on March 23, 2016, it posted earnings per share at $-0.08 which topped the consensus $-0.09 projection (positive surprise of 11.1%). Revenue came in at 0.03M versus consensus estimate of 0.03M. The stock dropped 0 percent the day following the earnings was released, and on 7th day price change was 0 percent. On November 2, 2015, it posted earnings per share at $-0.09 versus the consensus estimate of $-0.09 (negative surprise of 0%). Revenue of 0.04M was above the $0.03M analysts had expected. The stock dropped 0% the day following the earnings was released, and on 7th day price change was 13.04%. On August 6, 2015, it posted earnings per share at $-0.09, missing the consensus estimate of $-0.09 (negative surprise of 0%). Revenue for the quarter was $0.03M while analysts had expected revenues to come in at $0.03M. The stock dropped -2.5% the day following the earnings was released, and on 7th day price change was 10%. On May 5, 2015, it posted earnings per share at $-0.14 compared with the consensus estimate of $-0.14 (negative surprise of 0%). That came on revenues of $0.02M for the quarter. Analysts had expected $0M in revenue. In front of Q1 earnings release, Wall Street is expecting earnings per share of $-0.07. The analysts’ current consensus range is $-0.1-$-0.05 for EPS.
STEM has fallen down from a 1 – month high that it reached on April 28, 2016. With the upcoming presentation at the MicroCap Investor Conference, we can expect the company to publish some news prior to their presentation to get investors excited about their stock. This can push the stock back to the new 1 month high and possible past to the three month high of $0.43. Investors should watch for news and volume in the next two days as the company prepares for their conference.
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