It’s been somewhere in the region of six months since we put forward this argument as to why we thought that Neuralstem, Inc. (NASDAQ:CUR) might be a great allocation at its then-current pricing.
At the time, the company had just taken a more than 80% hit to its market capitalization on the release of some data related to its lead development asset, a drug called NSI-189. The data derived from a phase 2 trial looking at the safety and efficacy of the asset in question in a target indication of major depressive disorder (MDD) across a range of safety and efficacy endpoints.
As per the numbers released at the time, certain positive trends were seen when data from patients who took the active drug were compared to the numbers associated with patients who took a placebo in the study but, as per the rules of mathematical evaluation, the data was regarded as statistically insignificant and – as a result – the trial was recorded as failed.
Our argument was this: that this is a neurological disorder and positive trends, even those that are regarded as statistically insignificant, mean a lot more in this sort of trial than they do in say, a trial looking at cancer.
Because in these studies, and especially as relates to MDD, the placebo effect will often be much more amplified than is the case elsewhere, purely because these drugs are designed to work on the brain and the brain is where the placebo effect originates.
It was a bit of a punt, sure, but we suggested that some longer-term follow-up data that the company had said was set to hit press towards the end of the year could add a layer of evidence to the previously statistically insignificant results and could, in turn, prove the drug’s efficacy in this indication.
Well, this data just hit press and it’s shown why, sometimes, and under the right circumstances, it’s okay to take a punt.
On December 4, Neuralstem put out updated data from a follow up of the previous phase 2 study investigating 40 mg dose of NSI-189 in the same target population – those with MDD. And this time around, the numbers were very strong. The 40 mg dose recorded statistical significance versus placebo in antidepressant impact and, at the same time, came in with a relatively clean safety profile. In addition, the 40mg dose also showed statistical advantages on objective measures of attention and memory as per what’s called the Cogscreen test, which is an industry standard test of cognitive capability and function.
In other words, these data have completely turned around the failure that was reported earlier in the year and – as might be expected – Neuralstem is running on the back of the news.
From a share price of around $1.12 a share at its Monday open, the company ran up to $3.06 a share by close of play on Thursday – a 173% appreciation subsequent to the news hitting press.
So what’s next?
Well, right now, the company trades for $2.37, down a little over 20% from highs. Management expects to meet with the FDA during the first half of next year (we are expecting first quarter at the latest) and the outcome of this meeting will dictate the protocol with which the company puts together a phase 3 trial in this indication. If the protocol hits press as similar in nature to the phase 2 trial that just completed successfully, it’s going to push Neuralstem above and beyond the just-mentioned highs.
This means that, at current levels, the company could be a nice discount play.
Cash isn’t great and there’s a good chance we will see a raise near-term, so keep this in mind ahead of opening a position. With that said, however, positive developments on the regulatory front should outweigh the impact of any dilutive equity issue longer-term.
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Image courtesy of GreenFlames09 via Flickr
Disclosure: We have no position in CUR and have not been compensated for this article.