Brainstorm Cell (BCLI) ALS Trial Results 'Robust' - Maxim Group

Maxim Group analyst Jason Kolbert reiterated a Buy rating and $5 price target on Brainstorm Cell Therapeutics (NASDAQ: BCLI) after the company announced phase II trial results from the NurOwn trial in ALS. The firm's analysis of the presented NurOwn data suggests a significant signal across multiple secondary efficacy endpoints and a clinically meaningful benefit.

Kolbert highlighted:

• Brainstorm announced phase II trial results from the NurOwn trial in ALS. Our analysis of the presented NurOwn data suggests a significant signal across multiple secondary efficacy endpoints and a clinically meaningful benefit. Response rates were higher for NurOwn-treated subjects compared to placebo at all time points in the study out to 24 weeks. We deem the study a success as we believe it creates a solid basis for a pivotal study and defines an approval pathway.
• When response to treatment was evaluated based on the absolute point improvement in ALSFRS-R post treatment slope compared to pre-treatment slope over time, again there was strong evidence of a NurOwn treatment effect. See the chart in the attachment, which shows the results for patients who achieved a 1.5 or greater point improvement per month in the ALSFRS-R slope out to 24 weeks. The data shows a benefit in favor of NurOwn at each time point and was statistically significant at 4, 12 and 16 weeks.
• Conclusion: We see "good data" that clearly shows an effect, a statistically significant one, which is a lot to expect in a variable disease like ALS and in a n=48 patient PII trial. The results suggest the more active the disease, the greater the effect. We also believe that multiple dosing could show an even greater effect. The phase II trial successfully creates the basis for a pivotal trial. We further believe based on the totality of the data that repeat dosing may show an even more pronounced effect. Lastly, we mention NurOwn continues to demonstrate its safety. As such, the approval hurdle, combined with the unmet medical need, suggests this could be an important new therapy in ALS.

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Shares of Brainstorm Cell Therapeutics closed at $2.99 yesterday.

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