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Galectin Therapeutics Reports Third Quarter 2016 Financial Results and Provides Business Update NORCROSS, Ga. (

Key Takeaway: Galectin Therapeutics Reports Third Quarter 2016 Financial Results and Provides Business Update NORCROSS, Ga. (November 8, 2016) Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today r

Full Press Release Details

Galectin Therapeutics Reports Third Quarter 2016
Financial Results and Provides Business Update
NORCROSS, Ga. (November 8, 2016) Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins
to treat fibrosis and cancer, today reported financial results for the three and nine months ended September 30, 2016. These results are included in the Company s Form 10-Q, which has been filed with the U.S. Securities and Exchange
Commission and is available at www.sec.gov.
Summary of Key Development Programs, Updates and Anticipated Milestones
Management Commentary
co-lead investigators, Dr. Stephen Harrison and Dr. Naga Chalasani, it is important to complete our ongoing NASH-CX Phase 2b trial focused on the treatment of NASH cirrhosis as one year may provide an appropriate length of therapy and the
endpoints may serve as a surrogate for outcomes for registration trials in this patient population, said Peter G. Traber, M.D., president, chief executive officer and chief medical officer of Galectin Therapeutics. NASH cirrhosis has
always been, and remains, the lead indication for GR-MD-02. Presently, we are the only company with a compound for NASH cirrhosis in an active Phase 2 clinical trial.
The market seemingly recognizes the concerns about the rising incidence of NASH and the need for therapies to counter a potential health epidemic as
Allergan s $1.7 billion purchase of Tobira appears to have been motivated by a NASH drug in clinical trials.
The NASH-CX trial is a one-year
of treatment, multi-center trial in patients with NASH cirrhosis that is being conducted at 36 outstanding liver centers in the United States. It completed enrollment one month early with 162 well-compensated patients with NASH cirrhosis
(Child-Pugh-Turcotte Class A) with elevated portal pressure (HVPG 6 mmHg). Only five patients of the 162 enrolled have dropped out of the trial thus far,
with this low attrition rate highlighting the importance, urgency, and need for patients suffering from NASH-cirrhosis to find an effective medical treatment. And, a total of 2,240 drug infusions
(including placebo) have been given in this trial, representing 53% of the total number of infusions in the entire trial. So we are quite pleased that this study is well along in its development and on track for reporting of top-line results in
As a company, Galectin Therapeutics attention has always been focused on completing the NASH-CX clinical trial and
reporting results in a timely fashion. With an outstanding safety profile, inhibition of galectin-3 with GR-MD-02 remains a potential treatment of NASH cirrhosis and provides us encouragement about our continuation of the NASH-CX clinical
For the three months
ended September 30, 2016, the Company reported a net loss applicable to common stockholders of $5.6 million, or $0.19 per share, compared with a net loss applicable to common stockholders of $6.2 million, or $0.26 per share, for the three
months ended September 30, 2015. The decrease is largely due to lower non-cash stock based compensation expense and timing of research and development expenses related to the Phase 2 clinical program in NASH.
Research and development expense for the three months ended September 30, 2016 was $3.3 million, compared with $4.4 million for the three months ended
September 30, 2015. The decrease primarily relates to timing of research and development expenses related to the Phase 2 clinical program in NASH.
General and administrative expense for this quarter was $1.2 million, compared with $1.4 million for the prior year, with the decrease being primarily related
to non-cash stock compensation. As of September 30, 2016, the Company had $16.1 million of non-restricted cash and cash equivalents. The Company believes it has sufficient cash to fund currently planned operations and research and development
activities through August 2017.
About Galectin Therapeutics
Galectin Therapeutics is developing promising therapies for the treatment of fibrotic liver disease and cancer based on the Company s unique understanding
of galectin proteins, which are key mediators of biologic function. Galectin seeks to leverage extensive scientific and development expertise as well as established relationships with external sources to achieve cost-effective and efficient
development. The Company is pursuing a development pathway to clinical enhancement and commercialization for its lead compounds in liver fibrosis and cancer. Additional information is available at www.galectintherapeutics.com.
Forward Looking Statements
contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance, and use words such as may, estimate,
could, expect and others. They are based on management s current expectations and are subject to factors and uncertainties that could cause actual results to differ materially from those described in the statements.
These statements include those regarding the hope that Galectin s development program for GR-MD-02 will lead to the first therapy for the treatment of fatty liver disease with cirrhosis and those regarding the hope that our lead compounds will
be successful in connection with cancer immunotherapy. Factors that could cause actual performance to differ materially from those discussed in the forward-looking statements include, among others, that Galectin may not be successful in developing
effective treatments and/or obtaining the requisite approvals for the use of GR-MD-02 or any of its other drugs in development; the Company s current clinical trial and any future clinical studies may not produce positive results in a timely
fashion, if at all, and could prove time consuming and costly; plans regarding development, approval and marketing of any of Galectin s drugs are subject to change at any time based on the changing needs of the Company as determined by
management and regulatory agencies; regardless of the results of any of its development programs, Galectin may be unsuccessful in developing partnerships with other companies or raising additional capital that would allow it to further develop
and/or fund current or future studies or trials. Galectin has incurred operating losses since inception, and its ability to successfully develop and market drugs may be impacted by its ability to manage costs and finance continuing operations. For a
discussion of additional factors impacting Galectin s business, see the Company s Annual Report on Form 10-K for the year ended December 31, 2015, and subsequent filings with the SEC. You should not place undue reliance on
forward-looking statements. Although subsequent events may cause its views to change, management disclaims any obligation to update forward-looking statements.
Jack Callicutt, Chief Financial Officer
Galectin Therapeutics and its associated logo is a registered trademark of Galectin Therapeutics Inc.
Yervoy is a registered trademark of Bristol-Myers Squibb
Keytruda is a registered trademark of Merck & Co.
Condensed Consolidated Statements of Operations
Three Months Ended September 30, Nine Months Ended September 30,
2016 2015 2016 2015
(in thousands, except per share data)
Operating expenses:
Research and development $ 3,289 $ 4,464 $ 11,892 $ 10,200
General and administrative 1,248 1,435 4,990 5,196
Total operating expenses 4,537 5,899 16,882 15,396
Total operating loss (4,537 ) (5,899 ) (16,882 ) (15,396 )
Other income:
Interest and other 11 12 37 40
Total other income 11 12 37 40
Net loss $ (4,526 ) $ (5,887 ) $ (16,845 ) $ (15,356 )
Preferred stock dividends and accretion costs (119 ) (265 ) (637 ) (801 )
Deemed dividend related to beneficial conversion feature of convertible preferred stock (991 ) (991 )
Net loss applicable to common stock $ (5,636 ) $ (6,152 ) $ (18,473 ) $ (16,157 )
Basic and diluted net loss per share $ (0.19 ) $ (0.26 ) $ (0.64 ) $ (0.69 )
Shares used in computing basic and diluted net loss per share 29,282 23,793 29,045 23,531
Condensed Consolidated Balance Sheet Data
September 30, 2016 December 31, 2015
(in thousands)
Cash and cash equivalents $ 16,059 $ 25,846
Total assets 16,115 26,408
Total current liabilities 4,087 1,360
Total liabilities 4,087 1,360
Total redeemable, convertible preferred stock 12,028 7,008
Total stockholders equity $ 16,115 $ 18,040
Last updated: Nov 8, 2016