View:
Download DOC
Download PDF
Download XLS
8-K

 

 

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): January 8, 2014

 

 

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, Ste 240

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 January 8, 2014, Galectin Therapeutics Inc. (the “Company) issued the attached press release which includes a link to a document on the Company’s website, which are being furnished and not filed, and are attached hereto as Exhibit 99.1 and Exhibit 99.2.

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 January 8, 2014
99.2    2013 Year In Review

 

- 2 -

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: January 8, 2014     By:  

/s/ Jack W. Callicutt

      Jack W. Callicutt
      Chief Financial Officer

 

- 3 -

EX-99.1

Exhibit 99.1

 

 

LOGO

Galectin Therapeutics Reports on Key 2013 Scientific, Development and

Regulatory Milestones, Highlights Corporate and Financial Activity

Norcross, GA (January 8, 2014) – Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today released a report on the Company’s key scientific, development and regulatory milestones and corporate activity that contributed to the Company’s progress in 2013.

Key activity in 2013 included:

 

  •   Submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the Company’s proprietary galectin inhibitor GR-MD-02 in fatty liver disease, and subsequent notification from the FDA to proceed with a Phase 1 clinical trial for GR-MD-02 in fatty liver disease with advanced fibrosis.

 

  •   Receipt of Fast Track designation from the FDA for GR-MD-02 in fatty liver disease.

 

  •   First patient enrolled in the first-in-man Phase 1 clinical trial for GR-MD-02 in fatty liver disease, currently taking place at six trial sites across the U.S.

 

  •   Preclinical data showed the Company’s galectin inhibitors may have therapeutic effect in diabetic kidney disease, contribute to reversal of cirrhosis and reduction of fibrosis, and significantly improve non-alcoholic steatohepatitis (NASH) activity.

 

  •   Two executives were added to the Company’s management team and several key investments occurred, including the exercise of common stock purchase warrants and a private placement of 500,000 shares of unregistered common stock.

“I am pleased to report that 2013 was a year of noteworthy progress for Galectin Therapeutics,” said Peter G. Traber, M.D., Chief Executive Officer, President and Chief Medical Officer, Galectin Therapeutics. “We believe strongly that galectin inhibitors hold immense promise for the treatment of fibrosis and inflammation, and the Company will continue to work diligently toward the ultimate goal of bringing a first-in-class treatment to the millions of Americans suffering from fatty liver disease with advanced fibrosis.”

A summary of Galectin Therapeutics’ accomplishments in 2013 can be found on the Company’s website at www.galectintherapeutics.com/GALT2013.

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. These statements include those regarding preclinical data and the potential role for GR-MD-02 and GM-CT-01 in the treatment of liver fibrosis and cirrhosis in humans. Factors that could cause our actual performance to differ materially from those discussed in the forward-looking statements include, among others, that our plans, expectations and goals regarding any preclinical data and potential therapeutic uses and benefits of our drugs and any future pre-clinical or clinical studies are subject to factors beyond our control. Future clinical studies may not begin or 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 our drugs are subject to change at any time based on the changing needs of our company as determined by management and regulatory agencies. Regardless of the results of current or future studies, we may be unsuccessful in developing partnerships with other companies or obtaining capital that would allow us to further develop and/or fund any studies or trials. To date, we have incurred operating losses since our inception, and our ability to successfully develop and market drugs may be impacted by our ability to manage costs and finance our continuing operations. For a discussion of additional factors impacting our business, see our Annual Report on Form 10-K for the year ended December 31, 2012, and our subsequent filings with the SEC. 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, MD, 678-620-3186

President, CEO, & CMO

ir@galectintherapeutics.com

EX-99.2

Exhibit 99.2

 

LOGO

 

Happy New Year!

2013 was a year of significant activity and noteworthy progress for Galectin Therapeutics. Over the past twelve months, we have achieved a number of major development milestones, including the submission of an investigational new drug (IND) application, the receipt of a Fast Track designation from the FDA, and the first patient dosed in a Phase 1 clinical trial.

With the addition of two new executives to our leadership team and renewed financial investment in the Company, we have continued to diligently and efficiently pursue development pathways to clinical enhancement and commercialization for our lead compounds.

We believe strongly that galectin inhibitors hold immense promise for the treatment of fibrosis and inflammation. Fatty liver disease affects as many as 15 million Americans, and there are no currently approved pharmaceutical therapies. Galectin Therapeutics perceives a substantial unmet medical need and the opportunity to provide a treatment to the millions suffering from this condition.

In this new year, I am excited for what is on the horizon for Galectin. Most notably, we expect clinical data from the first cohort of our Phase 1 clinical trial of GR-MD-02 in fatty liver disease early this year. Also in the first quarter, we will launch our updated website and hope that you take the time to visit to learn what is new with the Company.

2014 promises to be a busy year for us. We are at a key stage in the development of our novel compounds and remain optimistic in the advancement of our clinical programs. I am confident in our team and strategy for advancing our drug candidates in 2014 and beyond. Thank you for your continued support and interest in Galectin Therapeutics.

 

Sincerely,

 

LOGO

 

Peter G. Traber, M.D.
Chief Executive Officer, President and Chief Medical Officer

 

 

LOGO

2013 DEVELOPMENT & REGULATORY MILESTONES

A key priority in 2013 was the GR-MD-02 development program. Preclinical data demonstrate that GR-MD-02 has a powerful therapeutic effect on liver fibrosis. Our milestones in 2013 included:

 

  •   January – Submitted IND application to the FDA for GR-MD-02 in fatty liver disease

 

  •   March – Received notification from the FDA to proceed with a Phase 1 clinical trial for GR-MD-02 in fatty liver disease with advanced fibrosis

 

  •   April – Investigators and sites announced for first- in-man Phase 1 clinical trial for GR-MD-02 in fatty liver disease

 

  •   July – First patient enrolled in the first-in-man Phase 1 clinical trial for GR-MD-02 in fatty liver disease, currently taking place at six trial sites across the U.S.

 

  •   August – Received Fast Track designation from the FDA for GR-MD-02 in fatty liver disease

 

  •   September – Received US patent for GR-MD-02 in patients with fatty liver disease with or without fibrosis or cirrhosis

 

  •   November – Reported that five of the eight patients were enrolled and had been infused in cohort 1 of the clinical trial of GR-MD-02 in fatty liver disease

Looking ahead, completion of the enrollment of the first cohort will be an important milestone in the development of our proprietary, novel technology. Clinical data from the first cohort should be available early in 2014.

Outside of liver disease, the Company is working with Providence Portland Medical Center in planning for a Phase 1 clinical trial to evaluate the combination of Bristol-Myers Squibb’s Yervoy® (ipilimumab) and the Company’s GR-MD-02 in patients with metastatic melanoma. This trial is based on pre-clinical data obtained in collaboration with Dr. Will Redmond at the center which demonstrated that the combination of immune checkpoint inhibitors like ipilimumab with GR-MD-02 enhances the antitumor effect in syngeneic mouse cancer models.

Development programs for GR-MD-02 in other liver diseases, lung fibrosis and kidney fibrosis will require partnerships to initiate, which we are actively seeking.

 

 

4960 Peachtree Industrial Blvd, Ste 240 | Norcross, Georgia 30071 | (678) 620-3186 | galectintherapeutics.com

LOGO

 

2013 SCIENTIFIC MILESTONES

The knowledge base for our lead compounds – GR-MD-02 and GM-CT-01 – was meaningfully enhanced in 2013. Our ongoing preclinical studies and newly-initiated Phase 1 trial revealed scientific data that further support our development programs particularly in the areas of fatty liver disease, lung fibrosis and cancer immunotherapy. Key scientific milestones in 2013 included:

 

  •   January – Preclinical data showed that treatment of diabetic mice with GR-MD-02 was found to reverse diabetic kidney disease including interstitial fibrosis.

 

  •   February – Established a collaborative drug discovery program with Dr. Geert-Jan Boons’ laboratory located in the Complex Carbohydrate Research Center at the University of Georgia to focus on the discovery and synthesis of new carbohydrate molecules that inhibit galectin proteins.

 

  •   February – Presented data at a Keystone Conference in a collaboration with Dr. William Redmond of the Robert W. Franz Cancer Research Center of the Providence Portland Medical Center. These data in part showed that inhibition of galectin-3 with GR-MD-02 in animals enhances CD8 T cell proliferation and activation in response to antigen.

 

  •   April – Presented data, along with the Icahn School of Medicine at Mount Sinai, at the prestigious International Liver Congress 2013. Data showed that GR-MD-02 and GM-CT-01 were found to reverse cirrhosis, the most advanced stage of liver fibrosis, in experimental animals given toxin-induced cirrhosis.

 

  •   June – Preclinical data found that combining GR-MD-02 with monoclonal antibodies that function as immune checkpoint blockade inhibitors enhance shrinkage of prostate and breast cancer tumors.

 

  •   August – Preclinical data found that treatment with GR- MD-02 showed a robust effect in reducing lung fibrosis, with somewhat lesser effect of GM-CT-01.

 

  •   October – Preclinical data published in PLOS ONE, demonstrated that GR-MD-02 and GM-CT-01 led to significantly reduced fibrosis, reversal of cirrhosis and a significant reduction in portal hypertension.

 

  •   December – A second study published in PLOS ONE, revealed that treatment with GR-MD-02 significantly improved NASH activity and reduced fibrosis. Similar effects were seen with GM-CT-01 but with approximately four-fold lower potency than GR-MD-02.

2013 CORPORATE & FINANCIAL MILESTONES

2013 was an active year throughout our business operations, as we continued to build a solid foundation for growing the Company. From a financial perspective, the company continued to gain confidence of investors as demonstrated by several key investments. Our 2013 corporate and financial milestones included:

 

  •   January – Galectin welcomed industry veteran Rex Horton as Executive Director of Regulatory Affairs and Quality Assurance. Mr. Horton is an experienced professional with 20 years of management and leadership experience in global regulatory affairs matters including drugs, biologics and vaccines.

 

  •   July – Galectin welcomed Jack W. Callicutt to the position of Chief Financial Officer. Mr. Callicutt plays a key role in shaping corporate strategy as we advance key product assets in the clinic. Mr. Callicutt brings over 24 years of relevant experience including serving as CFO of publicly traded companies and raising capital.

 

  •   August – All of the 710,834 common stock purchase warrants scheduled to expire on August 25, 2013 were exercised for total cash proceeds of $3 million. These proceeds added to the $3 million private placement of 500,000 shares of unregistered common stock.

 

  •   October/November – 10X Fund exercised 500,000 common stock purchase warrants of Galectin Therapeutics at $3 per share for total cash proceeds of $1,500,000. Following this transaction, the Company’s total cash position was approximately $10.29 million and the total outstanding common shares were approximately 17.97 million.

 

LOGO

 

 

4960 Peachtree Industrial Blvd, Ste 240 | Norcross, Georgia 30071 | (678) 620-3186 | galectintherapeutics.com