UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): April 29, 2013
GALECTIN THERAPEUTICS INC.
(Exact name of registrant as specified in its charter)
| Nevada | 001-31791 | 04-3562325 | ||
| (State or Other Jurisdiction of Incorporation) |
(Commission File Number) | (IRS Employer Identification No.) |
4960 PEACHTREE INDUSTRIAL BOULEVARD
NORCROSS, GA 30071
(Address of principal executive office) (zip code)
Registrant’s telephone number, including area code: (678) 620-3186
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
SECTION 7 – REGULATION FD
Item 7.01 Regulation FD Disclosure.
On April 29, 2013, Galectin Therapeutics Inc. (the “Company”) issued the attached press release, which is being furnished and not filed, and is attached hereto as Exhibit 99.1.
The information in this report is being furnished pursuant to this Item 7.01 and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, and it shall not be deemed incorporated by reference in any filing under the Securities Act of 1933 or under the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing to this report.
SECTION 9 – FINANCIAL STATEMENTS AND EXHIBITS
Item 9.01 Financial Statements and Exhibits.
(a) Financial Statements of Businesses Acquired.
Not applicable.
(b) Pro Forma Financial Information.
Not applicable.
(c) Shell Company Transactions.
Not applicable.
(d) Exhibits.
| Exhibit Number |
Description | |
| 99.1 | Press Release dated April 29, 2013 | |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, Galectin Therapeutics Inc. has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Galectin Therapeutics Inc. | ||||||
| Date: April 29, 2013 |
By: | /s/ Peter G. Traber, M.D. | ||||
| Peter G. Traber, M.D. | ||||||
| President, Chief Executive Officer & Chief Medical Officer | ||||||
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Exhibit 99.1
Galectin Inhibitors Reverse Liver Cirrhosis in Preclinical Studies
— Galectin Therapeutics and Icahn School of Medicine at Mount Sinai Data Presented at
the International Liver Congress 2013 —
Norcross, GA, April 29, 2013 – Galectin Therapeutics (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today released data that was presented on April 27, 2013 at the International Liver Congress in Amsterdam, The Netherlands. The data were generated by the laboratory of Dr. Scott Friedman of the Icahn School of Medicine at Mount Sinai, a world renowned investigator and expert on liver fibrosis. GR-MD-02 and GM-CT-01, drugs that inhibit galectin proteins, were found to reverse the most advanced stage of liver fibrosis, called cirrhosis, in experimental animals given toxin-induced cirrhosis.
“The findings of these experiments show that the anti-galectin drugs had a robust effect on cirrhosis, including reversal of tissue architectural changes in the liver that result from fibrosis as well as reduction in portal hypertension, an important pathophysiological effect of cirrhosis,” said Dr. Friedman, Dean for Therapeutic Discovery and Chief, Division of Liver Diseases at the Icahn School of Medicine at Mount Sinai. “The experimental design of these studies provided a very high hurdle for any drug to show effectiveness, and yet both GR-MD-02 and GM-CT-01 passed the test. These drugs are excellent candidates for evaluation in human cirrhosis.”
“We are gratified that one of the most prominent investigators in the world has shown that our galectin inhibitors were effective in experimental cirrhosis, the most severe form of liver fibrosis, for which there are no currently approved medical therapies” said Dr. Peter G. Traber, President, Chief Executive Officer and Chief Medical Officer, Galectin Therapeutics. “Along with the multiple studies we have presented on liver fibrosis from fatty liver disease, these findings provide added confidence for the potential of this approach in studies of human liver fibrosis and cirrhosis.”
The data presented at the International Liver Congress which is sponsored by the European Association for the Study of the Liver (EASL) are posted on the Company website at http://bit.ly/14xDpKK. Rats were treated with a liver toxin which produced fibrosis that replaced over 25% of the liver tissue and resulted in architectural changes consistent with cirrhosis. While continuing to treat with the liver toxin, rats were treated with either a placebo or four weekly injections of either GR-MD-02 or GM-CT-01. The livers were reviewed by a highly qualified liver pathologist who was unaware of the treatments that the animals had received. Both drugs significantly reduced the amount of fibrotic tissue, and most importantly, reversed the histological findings of cirrhosis. Additionally there was a reduction in the blood pressure in the blood system supplying the liver (portal pressure) in the treated animals. Cirrhosis and portal hypertension are the primary abnormalities that lead to complications and death in humans with liver fibrosis. Galectin previously announced initiation of a Phase 1 clinical trial of GR-MD-02 in patients with fatty liver disease (NASH, non-alcoholic steatohepatitis) with advanced fibrosis which is expected to begin enrolling patients in May 2013 (http://bit.ly/11wj6hr).
About Galectin Therapeutics
Galectin Therapeutics (NASDAQ: GALT) is developing promising carbohydrate-based therapies for the treatment of fibrotic liver disease and cancer based on the Company’s unique understanding of galectin proteins, key mediators of biologic function. We are leveraging extensive scientific and development expertise as well as established relationships with external sources to achieve cost effective and efficient development. We are pursuing a clear development pathway to clinical enhancement and commercialization for our lead compounds in liver fibrosis and cancer. Additional information is available at www.galectintherapeutics.com.
Forward Looking Statements
This press release contains, in addition to historical information, 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 our current expectations and are subject to factors and uncertainties which could cause actual results to differ materially from those described in the statements. Factors that could cause our actual performance to differ materially from those discussed in the forward-looking statements include, among others: incurrence of operating losses since our inception, uncertainty as to adequate financing of our operations, extensive and costly regulatory oversight that could restrict or prevent product commercialization, inability to achieve commercial product acceptance, inability to protect our intellectual property, dependence on strategic partnerships, product competition, and others stated in risk factors contained in our SEC filings. We cannot assure that we have identified all risks or that others may emerge which we do not anticipate. You should not place undue reliance on forward-looking statements. Although subsequent events may cause our views to change, we disclaim any obligation to update forward-looking statements.
Contact
Galectin Therapeutics Inc.
Peter G. Traber
Chief Executive Officer
(678) 620-3186
ir@galectintherapeutics.com