Galectin Therapeutics Inc (NASDAQ:GALT): Here's What's Important

Galectin Therapeutics Inc (NASDAQ:GALT) was a big first quarter winner. The company opened 2017 in and around the dollar mark, and currently trades for around $3.7 – a 185% appreciation during the period. There have been a couple of value-add events that hit press and helped the stock to rise, but the vast majority of the capital being allocated to the company has been done with one eye on a major end-2017 catalyst – the reporting of top line from Galectin's lead NASH study.We actually touched on this one back in February, but with the company continuing to run, let's take a look at what's going on and what markets are looking for from Galectin going forward.So, the lead asset is called GR-MD-02 and it is part of a family of drugs called galectin inhibitors. These are becoming an increasingly high interest area of healthcare, and they play a key roll in a whole host of cell actions and interactions – one of which is rooted in inflammation. NASH, for those not familiar with it, stands for nonalcoholic steatohepatitis, and it's rooted in the buildup of fat in the liver, and the inflammation associated with this buildup. There are a couple of other companies working on NASH therapies right now, most notably Novartis AG (ADR) (NYSE: NVS), and selonsertib, by Gilead Sciences, Inc. (NASDAQ: GILD), and Galectin has actually picked up a bit of strength in the past on the back of these big names' success in their respective clinical trials. For 2017, however, Galectin has center stage – it's the only company set to put out data from a NASH trial this year, and it's this data that markets are looking to as an inflection point for the company.The thing is, NASH is expected to be one of the largest therapeutic areas in the world by 2025 – valued at almost $40 billion by some analysts. Combine this with the fact that there are no currently approved drugs in the space, and there's huge potential for a company that can get one to market. That's why Galectin is such an attractive prospect, and specifically a prospect ahead of the release of data that's basically going to tell us whether its drug works or not.The data comes on the back of an ongoing phase IIb trial investigating the drug in the NASH population. Many of these patients, if left untreated, would need liver transplants. However, NASH can develop for a long time before they become candidates for such a transplant, and it's in this set of patients that Galectin is looking at potential clinical impact. The trial has enrolled 162 patients in three treatment arms: placebo and two doses of drugs, the treatment given every other week for 52 weeks, or essentially, one year of therapy. At the time of the most recent conference call (March 28), 71 of the enrolled patients had completed therapy, but these are set to remain blinded until trial completion. At the current rate of dosing and dose completion, then, the study is on track to complete in December this year, at which point we'll see Galectin put out topline. From there, it's all about the numbers. If the drug looks good, there's a chance that the data could underpin an application and that the FDA would approve it without a (pre-marketing) phase III. That's optimistic, but not unrealistic.On the other side of the equation, of course, there's a large risk in getting in ahead of the NASH readout. This company has a couple of other promising programs (psoriasis, an oncology effort), but the majority of its value hinges on NASH as things stand. As such, if the data isn’t good, we're going to see it collapse, at least near term immediate post release.Cash on hand is enough to carry through until end 2017, so we're probably also going to see raise just ahead of the numbers hitting press.We will be updating our subscribers as soon as we know more. For the latest updates on GALT, sign up below!Disclosure: We have no position in any of the securities mentioned and have not been compensated for this article.