*SCALPSWINGSTRADDLE*

[glassy]

BCLI~ I think this article from October gives a great history/development of the Co. I know enough about the Isreali ingenuity to give this a serious nod for a longer term move. they are targeting MS, Parkinsons and Lou Gehrigs disease- ALL are in need of a treatment option in this venue-regenerative growth which if they can do it is very very life changing at a basic level. the already granted FDA fast track will greatly facilitate it. This is a very good read. go to link to see charts & graphs.

http://finance.yahoo.com/news/bcli-brainstorm-shares-remain-attractive-170000767.html

BCLI: BrainStorm Shares Remain An Attractive Investment
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By Zacks Small Cap Research October 7, 2014 1:00 PM






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By David Bautz, PhD & Jason Napodano, CFA
NASADQ:BCLI


BrainStorm Cell Therapeutics (BCLI) has had a number of positive developments over the past couple of months that include uplisting to the NASDAQ Capital Market, announcing the final patient visit in the Phase 2a ALS study, and obtaining U.S. Fast Track Designation from the FDA for NurOwn™ for the treatment of ALS. Even with all of this positive news flow, the stock has not advanced appreciably, and with additional catalysts coming in the next few months we continue to believe that BrainStorm is a compelling investment opportunity.

…Quick reminder of the BrainStorm story…

BrainStorm is developing adult stem cells therapies for the treatment of a range of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), and Parkinson’s disease (PD). The company has a proprietary process called NurOwn™ that harvests and propagates autologous Mesenchymal Stem Cells (MSC) and then induces their differentiation into neurotrophic factor (NTF) secreting cells, called MSC-NTF. BrainStorm then returns the cells to the patient at or near the target area for treatment. Because these cells are autologous, there is virtually no risk of rejection or tumor formation.

The company’s current focus is on developing NurOwn™ for the treatment of ALS, with two Phase 2 trials currently underway and a Phase 1/2 trial having already concluded. The Phase 1/2 trial testing NurOwn™ in ALS patients was conducted at Hadassah Medical Center in Jerusalem between June 2011 and Dec. 2012. The trial consisted of 12 ALS patients classified according to their ALSFRS-R score; six patients who were early stage (ALSFRS-R score > 30) and received intramuscular (IM) injections (at 24 separate sites on the biceps and triceps muscles) and an additional six patients who were progressive stage (ALSFRS-R score of 15-30) and received intrathecal (IT) injections. The study met its primary endpoints of safety and tolerability, with no treatment-related adverse events reported in the 12 patients. In addition, some clinical improvements were noted in IT-treated patients. There was a slower decline in overall clinical and respiratory function as measured by the ALSFRS-R and Forced Vital Capacity (FVC) score when comparing the three months pre-treatment with the six months following treatment, as shown in the figures below.




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Following on the success of the Phase 1/2 clinical trial, BrainStorm initiated a Phase 2a prospective, open label, dose-escalating clinical trial. This trial was also conducted at the Hadassah Medical Center in Jerusalem and was initiated in January 2013. The protocol called for 12 early-stage ALS patients to receive both IM and IT injections of NurOwn™ cells in three cohorts with increasing doses between February and August 2013. Just as for the Phase 1/2 trial, eligible patients were observed for 3 months prior to treatment to determine the progressive rate of disease with the patients followed for six months after transplantation. BrainStorm recently announced that the last patient in the Phase 2a trial has completed the last visit, and final results of the study will be released in the fourth quarter of 2014 upon completion of the full statistical analysis.

On April 28, 2014, BrainStorm announced FDA approval for the commencement of a Phase 2 clinical trial (NCT02017912) in the U.S. with NurOwn™ cells for the treatment of ALS. This is a multi-center, randomized, double blind, placebo controlled trial that will evaluate the safety and efficacy of a single combined IM and IT administration of MSC-NTF cells in early-stage ALS patients. Just as with the other studies, patients will be assessed for three months before treatment and then will be followed for six months after treatment. The trial is expected to enroll 48 patients randomized 3:1 to receive either NurOwn™ cells or placebo. Results from the trial are expected in the first half of 2016.

…Interim data from clinical trials show early signs of efficacy…

The company has presented interim data from the Phase 2a trial along with data from the Phase 1/2 trial, with results showing the treatment was well tolerated along with early signs of efficacy, as exhibited by a decrease in the decline in both the Amyotrophic Lateral Sclerosis Functional Rating Scale – Revised (ALSFRS-R) score along with forced vital capacity (FVC), a measure of lung strength. The following two graphs show the change in ALSFRS-R score for patients in the two clinical trials, as well as the data when divided by those who responded to treatment versus those who did not appear to respond to treatment as well.



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Similar results were seen with FVC, as there was evidence for a decrease in the rate of decline following NurOwn™ treatment.



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…FDA grants Fast Track Designation to NurOwn™ for the treatment of ALS…

On October 7, 2014 BrainStorm announced that the U.S. Food and Drug Administration (FDA) has designated NurOwn™ as aFast Track product for the treatment of ALS. The Fast Track program was put into place under the FDA Modernization Act of 1997 and is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. A drug that receives Fast Track designation is eligible for the following:

- More frequent meetings with the FDA to discuss the drug’s development plan and ensure that the appropriate data is being collected to support drug approval.

- More frequent written communication from the FDA about things such as clinical trial design.

- Eligibility for accelerated approval and priority review, including the submission of a New Drug Application (NDA) or a Biologics License application (BLA) on a rolling basis. What this means is that a company can submit completed sections of an NDA or BLA as they are completed and have them reviewed by the FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed.

Since no treatment for ALS such as NurOwn™ currently exists, the Fast Track Designation will be very helpful to the company as frequent communication between the FDA and BrainStorm will be necessary to ensure that the company is performing the clinical trials properly and obtaining the necessary data that the FDA believes will be important for gaining approval.

…Uplist to the NASDAQ Capital Market complete…

On September 9, 2014, BrainStorm announced a 1 for 15 reverse split of its common stock as part of the intended plan to pursue a listing on the NASDAQ Capital Market. A reverse split is not always met with excitement by investors, however we have long maintained that a reverse split in order to accomplish an uplisting is a sign of strength for a company, versus a reverse split to avoid de-listing that is typically a sign of weakness. This is evidenced by examining BrainStorm’s share price both before and after the reverse split showing that the stock price has held up reasonably well.



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Uplisting to the NASDAQ requires a minimum closing price of $3.00 per share for at least five consecutive trading days. On September 24, 2014 the company announced approval for uplisting to the NASDAQ Capital Market with the stock commencing trading on the NASDAQ Capital Market on September 30, 2014. This was an important milestone for the company, as management had previously stated their intention to accomplish this goal and is an example of management’s ability to execute the company’s goals effectively.

Conclusion and Recommendation

Since we first initiated coverage of BrainStorm the company has strengthened the balance sheet through a major financing,raising $10.5 million in June 2014, and they successfully uplisted to the NASDAQ Capital Market. In addition, the company has reached the last patient visit of the Phase 2a trial and continued to enroll patients in the Phase 2 trial in the U.S., with eight patients enrolled to date.

In spite of all of this, the stock price has not moved appreciably since we first initiated coverage, when the stock was trading at a split adjusted $4.25. We continue to view BrainStorm as a solid investment opportunity, even more so now that the stock is trading on a major exchange and is no longer trading for under $1.00. We remind investors of the following catalysts that will be forthcoming for the company:

- Full data from the Phase 2a study in the fourth quarter of 2014

- Mayo Clinic will begin enrolling patients for the Phase 2 trial in the fourth quarter of 2014

- An IND is expected to be filed for the next indication for NurOwn™ in the first half of 2015

- A multi-dose ALS study is expected to be initiated in the first half of 2015

Based on the aforementioned, we continue to rate Brainstorm as a ‘Buy’ and believe that the current market capitalization of approximately $75 million on a fully diluted basis does not adequately reflect the potential of NurOwn™ technology. We believe the market is underappreciating the simplicity of BrainStorm’s approach, and that both increased exposure and continued evidence of clinical efficacy will help to drive BrainStorm’s stock price higher. In addition, the Fast Track designation should accelerate the development timeline for NurOwn™ and increase the odds of approval. Our price target is $10 per share.