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Therapeutics Developer Secures Patents, Continues Phase 3 Trial Planning
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An H.C. Wainwright & Co. report provided an update on the Q3/18 activities and achievements of this company targeting NASH.

In a Dec. 19 research note, H.C. Wainwright & Co. analyst Ed Arce reported that Galectin Therapeutics Inc. (GALT:NASDAQ) continues to advance its corporate programs while working to finalize the plan for a Phase 3 trial of its galectin-3 inhibitor, GR-MD-02, in patients with nonalcoholic steatohepatitis (NASH) cirrhosis without esophageal varices.

Those efforts pertaining to the Phase 3 study, Arce summarized, include incorporating and refining advice and guidance from the FDA and outside NASH experts. Additionally, the company's strategic adviser, Back Bay Life Science Advisors, continues discussions with potential partners about securing the rights to GR-MD-02. Galectin's management indicated it will announce the Phase 3 trial design and specifics, including cost and timeline, once planning is done and a protocol is in place that the FDA deems acceptable.

As for its financial standing, at the end of Q3/18, Galectin had $10.1 million in cash, Arce relayed. That, along with access to a $10 million credit line, is enough to fund operations and research and development activities through September 2019, management estimates.

H.C. Wainwright & Co. is confident Galectin will obtain the required capital for the Phase 3 trial. "We believe it likely," Arce noted, "that management finalizes and announces some type of agreement for longer-term financial stability (and perhaps a cleaner balance sheet) as well as sufficient funding to complete the Phase 3 NASH trial and, if successful, submit a new drug application."

Arce reported that in other news, the biotech expanded its collection of intellectual property during Q3/18, during which it was granted or allowed patents for:

1. Galactose-pronged carbohydrate compounds for treatment of diabetic nephropathy and related conditions (in Europe, Australia and China)
2. Composition of a unique carbohydrate drug for treatment of human disease (in Japan)
3. A method for enhancing certain immunotherapies (in China, Israel and Japan)
4. Compositions of distinctive carbohydrate drugs for treatment of NASH and nonalcoholic fatty liver disease (in Mexico and South Africa)

About this activity, Arce commented, "We view this as an incremental positive as it can only help with discussions with potential partners."

H.C. Wainwright affirmed its Buy rating and $13 per share target price on Galectin, which is currently trading at about $3.65 per share.


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Disclosures from H.C. Wainwright & Co., Galectin Therapeutics Inc., Earnings Update, December 19, 2018

I, Ed Arce, certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.

None of the research analysts or the research analyst’s household has a financial interest in the securities of Avenue Therapeutics, Inc. (including, without limitation, any option, right, warrant, future, long or short position).

As of November 30, 2018 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Galectin Therapeutics, Inc.

Neither the research analyst nor the Firm has any material conflict of interest in of which the research analyst knows or has reason to know at the time of publication of this research report.

The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services.

The Firm or its affiliates did not receive compensation from Galectin Therapeutics, Inc. for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report.

The Firm does not make a market in Galectin Therapeutics, Inc. as of the date of this research report.

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