Galectin Therapeutics Reports 2017 First Quarter Financial Results and Provides Business Update
Summary of Key Development Programs and Updates
- Received a Decision to Grant from the Japanese Patent Office for its patent application for "Composition of Novel Carbohydrate Drug for Treatment of Human Diseases," which, when issued, will extend composition of matter patent coverage of the Company's lead compound, GR-MD-02, to Japan through 2032.
- Presented a late-breaking abstract at The International Liver Congress™ 2017 with data demonstrating the effectiveness of the Exalenz 13C-Methacetin Breath Test (MBT) as a non-invasive test of liver function.
May 9, 2017, 92 patients have completed all 52 weeks of infusions and 155 patients have completed 26 weeks of infusions in the Company's NASH-CX Phase 2b Clinical Trial. Approximately 92% of the entire study's total number of infusions have been administered.
Company remains on track to report top line data from the NASH-CX trial in
- Company is funded through the end of 2017, which is sufficient to report top line data of NASH-CX.
"Galectin Therapeutics continues to make steady progress in the development of our lead compound, GR-MD-02, both in our NASH-CX trial for NASH liver cirrhosis, as well as in related ailments such as psoriasis and atopic dermatitis," said
"We are also very pleased to have continued to expand our intellectual property protection on a global basis, most recently in
"And, finally, in our efforts to help develop a non-invasive test for diagnosing and following treatment of fatty liver disease, NASH, and cirrhosis, we recently announced important results of a study we sponsored that found that MBT non-invasively detects clinically significant portal hypertension with high sensitivity and specificity (
"Galectin continues to remain focused on the NASH-CX trial, while also supporting and encouraging complementary trials in skin disease and cancer. As is customary in our industry, many organizations throughout the pharmaceutical industry have shown interest in our trials, all strictly informal. More recently, we have seen the increase in the number of NASH trials create new challenges for the industry, such as the difficulty in finding trial participants, which makes us feel fortunate with the timing chosen to initiate and report on the NASH-CX trial. Our team is dedicated to unlocking the value of our proprietary GR-MD-02 molecule and will continue to vigorously conduct our trials, while also examining additional potential uses that could enlarge our growth opportunity.
"Finally, we are pleased to highlight that Mr.
For the three months ended
Research and development expense for the three months ended
General and administrative expense for the three months ended
Galectin Therapeutics is dedicated to developing novel therapies to improve the lives of patients with chronic liver and skin diseases and cancer. Galectin's lead drug (GR-MD-02) is a carbohydrate-based drug that inhibits the galectin-3 protein that is directly involved in multiple inflammatory, fibrotic, and malignant diseases. The lead development program is in non-alcoholic steatohepatitis (NASH) with cirrhosis, the most advanced form of NASH related fibrosis. This is the most common liver disease and one of the largest drug development opportunities available today. Additional development programs are in treatment of severe atopic dermatitis, moderate-to-severe plaque psoriasis, and in combination immunotherapy for advanced melanoma and other malignancies. Galectin seeks to leverage extensive scientific and development expertise as well as established relationships with external sources to achieve cost-effective and efficient development. Additional information is available at www.galectintherapeutics.com.
Forward Looking Statements
This press release 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 the treatment of severe atopic dermatitis, moderate-to-severe plaque psoriasis and in 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 any 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
|Condensed Consolidated Statements of Operations|
Three Months Ended
|(in thousands, except per share data)|
|Research and development||$||3,772||$||4,377|
|General and administrative||1,174||2,437|
|Total operating expenses||4,946||6,814|
|Total operating loss||(4,946||)||(6,814||)|
|Interest and other||9||14|
|Total other income||9||14|
|Preferred stock dividends and accretion costs||(272||)||(210||)|
|Net loss applicable to common stock||$||(5,209||)||$||(7,010||)|
|Basic and diluted net loss per share||$||(0.15||)||$||(0.24||)|
|Shares used in computing basic and diluted net loss per share||33,928||28,827|
|Condensed Consolidated Balance Sheet Data|
|Cash and cash equivalents||$||13,644||$||15,362|
|Total current liabilities||4,362||3,780|
|Total redeemable, convertible preferred stock||1,723||1,723|
|Total stockholders' equity||$||7,912||$||10,292|
Jack Callicutt, Chief Financial Officer (678) 620-3186 firstname.lastname@example.org
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