2 Biotech Stocks Announcing Key Early Stage Clinical Developments

Includes: CUR, GALT
by: Heather Ingrassia

The positive progression of a company's lead-drug candidate through the pre-clinical and clinical trial stages of development has the potential to send these types of biotech stocks much higher. On Wednesday April 17th, there were a number of advancements with regard to the pre-clinical and clinical trial stage developments of two small-cap biotech firms.

Galectin Therapeutics, Inc. (NASDAQ:GALT): Based in Norcross, Georgia, Galectin Therapeutics is a "development stage company, engages in the development of therapies for cancer and fibrotic disease. Its lead product candidates include GR-MD-02, a complex polysaccharide polymer for the treatment of liver fibrosis and fatty liver disease for which the company intends to initiate a Phase I clinical trial in patients with non-alcoholic steatohepatitis; and GM-CT-01, a linear polysaccharide polymer comprising mannose and galactose that is in a Phase I/II clinical trial in Europe as a combination therapy with a tumor vaccine in patients with advanced melanoma". (Yahoo! Finance)

Shares of Galectin Therapeutics, which possess a market cap of roughly $62 million, were trading at $3.84/share on volume of 70,000 shares during Wednesday's trading session. One of the things to point out for growth investors is the fact that shares of GALT are 80.28 % higher since January 1st of this year.

GALT Chart
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GALT data by YCharts

Earlier today, the company announced it had made some very significant strides in terms of the ability its drugs will have when fighting against fibrosis and cirrhosis of the liver. The company intends on presenting key data that will demonstrate such developments on April 27th in Amsterdam, The Netherlands.

According to the company's President, Chief Medical Officer and Chief Executive Officer, Dr. Peter G. Traber, "Data continues to accumulate showing the effectiveness of our galectin inhibitor drugs in pre-clinical models and research will be presented on how both GR-MD-02 and GM-CT-01 are effective in reversing fibrosis and cirrhosis in established disease. The findings add confidence for the possibility of this mechanism extending to human disease". If in fact Dr. Traber and his team can demonstrate what could a complete reversal of both fibrosis and cirrhosis of the liver, GR-MD-02 and GM-CT-01 have the potential to be very important inhibitors in the very near future.

When it comes to investing in Galectin, and although I'm very hopefully on the each inhibitors continued development, I'd remain slightly cautious since both inhibitors are still in pre-clinical stages.

Neuralstem, Inc. (NYSEMKT:CUR): Based in Rockville, Maryland, Neuralstem, Inc. is a "biopharmaceutical company, focuses on the development and commercialization of treatments for central nervous system disease based on human neural stem cells and the use of small molecule compounds". (Yahoo! Finance)

Shares of Neuralstem, which possess a market cap of roughly $75 million, were trading at $1.12/share on volume of 695,000 shares during Wednesday's trading session. One of the things to point out for growth investors is the fact that shares of CUR are 8.26 % lower since January 1st of this year.

CUR Chart
(Click to enlarge)

CUR data by YCharts

Earlier today, the company announced that the FDA has approved the company's request to begin a Phase II trial of NSI-566 human neural stem cells for the treatment of Amyotrophic Lateral Sclerosis, also known as Lou Gehrig's disease. Dr. Karl Johe, Neuralstem's Chairman and Chief Scientific Officer noted that "the aim of this Phase II trial is to obtain the maximum tolerated dose using the same route of administration as in Phase I, which was through direct injections into the gray matter of the spinal cord".

The NSI-566 human neural cells that are slated to be used in patients suffering from ALS will provide two therapeutic effects. Based on the information featured on the company's website, "these cells will create new circuitry and express factors that may in fact protect the patients existing cells" and if they are successful at doing so, NSI-566 could eventually be considered a game-changer in the fight against ALS.

From an investment perspective, and again, although very promising, I'd be very cautious in the size of position I were to establish at these levels, given the fact I wouldn't want to put all my eggs in one basket in the case primary endpoints are not met during latter-stage clinical trials.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.