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Expert Financial Analysis and Reporting

Neuralstem: When Will We See the Phase 2 Data for NSI-566 in ALS? (CUR, Buy, $3.75)

Management has guided that the phase 2 data on 15 patients treated in the phase 2 trial of NSI-566 neural stem cells in the treatment of ALS will be released in 1Q, 2015, which of course has only three weeks remaining. My guess is that we will see the results on Wednesday March 11. Why? Because Neuralstem is presenting at the Barclay’s Healthcare conference on Thursday March 12 at 2:35 PM. In addition to the presentation, CUR management will be meeting with investors all day. There is a strong incentive to have the data out before Thursday so that the Company can talk about it with investors.

The question is how good the data is and how investors encouraged will be by the data. The lead investigator for the drug, Eva Feldman, has given some strong signals that she was encouraged by the results. In fact, she said some time ago that she is working on the protocol for what could be an upcoming pivotal trial. For those who would like more detail on the phase 2 trial, you can follow this link.

Could investors be disappointed by the data? I suppose that if some are looking for all 15 patients to have the dramatic response of Ted Harrada, that they will be disappointed. There will almost certainly be some patients who do not do well, but on balance it should be an encouraging report and I expect that the Company will use this as a basis to talk with the FDA about a pivotal phase 3 trial.

On an encouraging note, Neuralstem recently was included in the coverage universe of Brean Murray. I know the analyst at Brean, Jonathan Aschoff, and I think he will provide sophisticated coverage. Barclay’s invites primarily potential investment banking clients to its conference so it is a fair guess that they will also soon pick up coverage.

Wall Street has been late to the party on Neuralstem and these could be the first of what could be a long string of analysts who pick up coverage if NSI-566 advances into phase 3 trial in ALS. This will bring CUR to the attention of large institutional investors who have the potential to roll out some strong buying power. It is an important step on the right of passage for Neuralstem to be accepted as a promising late stage biotechnology investment.

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  1. My guess is the topline aggregated data will be out with the year-end press release tomorrow or Thursday morning. And Dr. Feldman will present each and every patient case in a medical conference in the near future.

    Because Mr. Garr has done 2 presentations lately, there is no need for him to provide anything investors already knew. And if the topline data is not good, Mr. Garr will not attend an important investor meeting just to look stupid. But Mr. Garr did hint that this time the focus may be on the respiration function, not on overall ALSFRS-r score.

    Of course, with AF lurking around, it will be a fun game to watch in the following days. Let’s see how creative AF could be.

  2. Check out ISLE. the traffic at the casino is bumper to bumper
    and casino owns forty or more acres surrounding the operation.
    Florida is about to allow full type gambling. Worth a look at.


    Oh, poor Damifino. You seem to have confused Smith On Stocks with the pump and dump boards at Yahoo. Unless ISLE is running a Phase III trial down in its basement alongside their dusty 1960’s Bally slot machines, you’ve come to the wrong place. Borrowing from a favorite Simon Cowell phrase… Off you go!

  4. Top line data out.

    I have to say I have mixed feelings about the data. It’s very encouraging to see 47% of pts have their disease stabilized. But the non-responders’ ALSFRS-r scores seem decline too quickly, much quicker than normal placebo pts.

    And we lack several key information like how did the last cohort respond as pts from that group received both cervical and lumbar injections? Was there a dose dependent effect seen?

    Non responders respiratory function preserved better compared to their ALSFRS-r scores. Does this mean some kind of response?

    I hope I will know more answers to the above questions in the coming weeks.


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