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Additional Funds for Galectin

Zacks Equity Research

Galectin Therapeutics, Inc. (GALT) recently raised $3 million through the exercise of 710,834 warrants, slated to expire on Aug 25, 2013.

The funds are in addition to the $3 million raised through the recent private placement of common stock issuance by Galectin.

Galectin intends to use the funds to speed up the process of starting a phase II study on GR-MD-02. GR-MD-02 is currently in phase I development for the treatment of nonalcoholic steatohepatitis (NASH) with advanced fibrosis.

The company had submitted an Investigational New Drug (IND) to the U.S. Food and Drug Administration (:FDA) in Jan 2013, and received approval for starting a phase I study in Mar 2013.

The company signed an agreement with Clinical Trial Services, Inc. in Feb 2013, to study the safety and efficacy of GR-MD-02 in humans in a phase I study. Under the terms of the agreement, Clinical Trial Services will be responsible for the review and supply notices regarding IND safety reports, selection of investigators and monitoring the study, supplying information to the investigators regarding new observations, and other services for helping Galectin in conducting the study.

Galectin started enrolling patients in the phase I study on GR-MD-02 in Jul 2013. The company expects to report top-line results from the first cohort of the study later this year/early next year. Data from the remaining cohorts should be out in mid-2014. The company might start a phase II study in the third quarter of 2014 based on phase I study results and expects phase II study data by late 2015 or early 2016 depending on the design of the study.

Furthermore, Galectin received Fast Track Designation from the FDA for the development of GR-MD-02 in Aug 2013, for the treatment of NASH.

We note that Galectin also has an oncology candidate, GM-CT-01, in its portfolio. It is currently in phase I/II study in Europe for treating patients with advanced melanoma (skin cancer).

Currently, Galectin carries a Zacks Rank #3 (Hold). Companies that currently look well-positioned include Actelion Ltd. (ALIOF) and Gilead Sciences Inc. (GILD) with a Zacks Rank #1 (Strong Buy) and Jazz Pharmaceuticals (JAZZ) with a Zacks Rank #2 (Buy).

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