From Zacks report 8/25/2016
BCLI: Planning for Phase 3 Study of NurOwn™ in ALS Following Successful Phase 2 Results…
Excerpt
Conclusion
In addition to showing that NurOwn™ treatment was safe and well tolerated, the results from the Phase 2 clinical trial were described by one investigator as showing “clinically meaningful beneficial response” and another was “very encouraged and excited by the trial results” having conducted clinical studies in ALS for 30 years. Thus, it appears as though clinicians who work with ALS patients are excited about the data.
In our opinion, the most encouraging data may have to do with the cohort of patients whose disease was progressing the fastest in the pre-treatment period (a decrease in ALSFRS-R slope of >-0.7 points/month), as these are the patients most in need of an effective treatment and who appeared to respond best to NurOwn™ treatment. The fact that BrainStorm has identified this cohort as being most responsive to treatment with NurOwn™ will aid in designing future clinical trials, as the company can specifically target this group of patients, with one possibility being that those early in the disease would not receive treatment with NurOwn™ until their disease begins to progress more rapidly.
These results are also highly supportive of the notion that multiple doses of NurOwn™ will be necessary to see an extended clinical benefit. The company is conducting a multi-dose clinical trial of NurOwn™ in Israel, in which 24 patients will be treated with three consecutive doses of the drug in order to explore the safety and efficacy of a multi-dose treatment.
The company is also planning to meet with the FDA in order to plan a placebo controlled, randomized, double blind, multi-dose clinical trial in the U.S. and Israel.
From a valuation standpoint, we continue to believe BrainStorm’s shares remain highly attractive. Before becoming generic, Riluzole® cost $50,000 per year and was shown to only extend survival by two to three months. The results shown above indicate that NurOwn™ may be able to slow down the progression of ALS, and for some patients it may even lead to disease stabilization. Multiple doses of NurOwn™ could increase these effects.
As such, we currently model for NurOwn™ to cost $100,000 per year. We have also increased the probability of success to 40% based upon the results of the Phase 2 trial, and continue to believe that upon approval NurOwn™ could generate peak revenues of $1.6 billion. Our current valuation for BrainStorm is $12 per share.
