What: 2015 was a breakout year for Intra-Cellular Therapies (NASDAQ:ITCI) as the clinical-stage biopharma focused on treating diseases of the central nervous system saw its share price more than triple during the year, according to data from S&P Capital IQ.
So what: Plenty of updates were provided during the year, but the outsized returns can mostly be traced back to one event. The stock jumped 83% in a single day after it released updated clinical information related to its phase 3 study of its lead compound ITI-007 for the treatment of schizophrenia.
The data showed that the 60 mg version of ITI-007 demonstrated a statistically significant improvement in patients' Positive and Negative Syndrome Scale total score compared to those receiving placebo. Impressively, the drug did so while showing placebo-like safety.
The company looked at its huge share price jump as a great time to raise additional capital and sold enough common stock to add $345 million to its balance sheet. That capital raise gives it a massive cash position -- it currently holds more than $510 million in total cash on its books.
With a war chest of capital in hand, it also decided to initiate another phase 3 study of ITI-007, this time studying its use as a potential treatment for bipolar depression.
Now what: I think investors would be wise to continue to approach Intra-Cellular with caution going forward. While the reported data in September looked good overall, it wasn't as perfect as the market's reaction implied. While the 60 mg version of ITI-007 demonstrated statistical significance in improving patients' PANSS scores, the 40 mg version was unable to show the same results.
It's also worth remembering that ITI-007 was not a homegrown compound -- it was actually acquired in 2005 from pharma giant Bristol-Myers Squibb (NYSE:BMY) for only $1 million up front. While the terms of the deal will entitle Bristol-Myers Squibb to additional milestone payments and single-digit royalties on sales if ITI-007 finds its way to market, those figures pale in comparison to the most lofty estimates of ITI-007's potential. Sure, Bristol-Myers could have just made a mistake -- but it's possible that the company had good reason to not believe in ITI-007's future.
Intra-Cellular is slated to release additional clinical-data second phase 3 trial of ITI-007 in treating schizophrenia in the middle of the year, so it makes sense to keep this as a radar stock for the time being. If that additional data looks good, then it will go a long way toward de-risking ITI-007's future.
Brian Feroldi has no position in any stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.