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Galectin Therapeutics Reports 2018 Third Quarter Financial Results and Provides Business Update

NORCROSS, Ga., Nov. 13, 2018 (GLOBE NEWSWIRE) — Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, today reported financial results for its third fiscal quarter, which ended September 30, 2018, and provided a business update. These results are included in the Company’s Quarterly Report on Form 10-Q, which has been filed with the U.S. Securities and Exchange Commission and is available at www.sec.gov.

Harold H. Shlevin, Ph.D., President and Chief Executive Officer of Galectin Therapeutics, said, “Our central focus remains advancing our plan for a Phase 3 clinical trial program with GR-MD-02 in NASH cirrhosis, for which we continue to make progress. Importantly, we have been collaborating with leading NASH experts who have been enlisted to help strengthen the overall plan. We are simultaneously scaling up manufacture of clinical supplies and conducting other required activities prior to starting the Phase 3 trial.

“In addition, we are pursuing other opportunities where our galectin-3 inhibitor GR-MD-02 has demonstrated encouraging clinical results. On September 20, 2018, we reported that the investigators were encouraged by the reported Objective Response Rate (ORR) of the GR-MD-02 and KEYTRUDA combination immunotherapy trial  for all cohorts relative to the ORR from randomized studies with KEYTRUDA alone in patients with advanced melanoma. The investigators also reported on six patients with head and neck cancer that exhibited a 33% ORR and 67% Disease Control Rate (DCR). As a result of these encouraging preliminary findings, the investigators will be expanding the trial to include additional patients. Further details are available in that press release. As a company, we are very pleased with our productive collaboration with Providence Cancer Institute.

“We continued to enhance the scope of our intellectual property protections and expand basic patent approvals in key markets and countries.  During this quarter, we had the following patents either granted or allowed:

“At quarter end, our funding is sufficient to support continued pursuit of this multi-pronged strategy, all based upon the strong foundation of our proprietary molecule and the potential it represents. Our goal is to unlock the value of our proprietary technology and capitalize on the pressing need for solutions to the growing NASH epidemic and other diseases where our anti-fibrotic compound can be therapeutic.”

Richard E. Uihlein, Chairman of the Board, added, “This has been another quarter of steady progress across the broad range of possibilities for GR-MD-02. I am pleased with the progress Dr. Shlevin and the team are making and look forward to the ultimate submission of our Phase 3 plan and the exciting opportunities it can create.”

Summary of Key Development Programs and Updates

Upcoming Scientific Presentations and Conferences

Other Activities

Dr. Shlevin concluded, “Galectin Therapeutics has developed a novel compound, GR-MD-02, a galectin-3 inhibitor, which we believe has the potential to be effective in treating a wide range of diseases wherein elevated levels of galectin protein and inflammation play key roles in the pathophysiology of the diseases. Most immediately, we are focused on advancing our Phase 3 trial in NASH Cirrhosis. However, we continue to investigate a variety of other preclinical applications where research shows that GR-MD-02’s antifibrotic capabilities may help provide more effective treatment in a variety of conditions. We believe this is the best path to build value in our overall galectin franchise and maximize potential of this platform technology to treat other diseases.”

Financial Results

For the three months ended September 30, 2018, the Company reported a net loss applicable to common stockholders of $3.0 million, or $0.07 per share, compared with a net loss applicable to common stockholders of $4.7 million, or $0.13 per share, for the three months ended September 30, 2017. The decrease is largely due to lower research and development expenses primarily related to the winding down of the Phase 2 NASH clinical program somewhat offset by higher non-cash stock compensation expenses.

Research and development expense for the three months ended September 30, 2018, was $1.5 million, compared with $3.5 million for the three months ended September 30, 2017. The decrease primarily reflects lower research and development expenses primarily related to the winding down of the Phase 2 NASH clinical program somewhat offset by higher non-cash stock compensation expenses.

General and administrative expense for the three months ended September 30, 2018, was $1.2 million, compared with $0.9 million for the three months ended September 30, 2017, with the increase being primarily related to higher investor relations, business development and non-cash stock compensation expenses.

As of September 30, 2018, the Company had $10.1 million of non-restricted cash and cash equivalents. The Company believes current cash on hand and access to a $10 million line of credit (unused at September 30, 2018) are sufficient to fund currently planned operations and research and development activities through at least September 30, 2019.

About Galectin Therapeutics

Galectin Therapeutics is dedicated to developing novel therapies to improve the lives of patients with chronic liver disease and cancer. Galectin’s lead drug (GR-MD-02) is a carbohydrate-based drug that inhibits the galectin-3 protein which 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; advancement of these additional clinical programs is largely dependent on finding a suitable partner. 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 and in other therapeutic indications. 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 may not be successful in scaling up manufacturing and meeting requirements related to chemistry, manufacturing and control matters; 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 December 31, 2017, 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.

Contact:
Jack Callicutt, Chief Financial Officer
(678) 620-3186
ir@galectintherapeutics.com.

Galectin Therapeutics and its associated logo is a registered trademark of Galectin Therapeutics Inc.

Condensed Consolidated Statements of Operations

  Three Months Ended
September 30,
Nine Months Ended
September 30,
  2018 2017 2018 2017
  (in thousands, except per share data)
Operating expenses:        
         
Research and development $ 1,505   $ 3,503   $ 5,279   $ 10,719  
General and administrative   1,175     911     5,338     3,155  
Total operating expenses   2,680     4,414     10,617     13,874  
Total operating loss   (2,680 )   (4,414 )   (10,617 )   (13,874 )
Other income:        
Interest and other   (72 )   6     (233 )   21  
Total other income   (72 )   6     (233 )   21  
                         
Net loss $ (2,752 ) $ (4,408 ) $ (10,850 ) $ (13,853 )
Preferred stock dividends and accretion costs   (294 )   (254 )   (848 )   (827 )
                         
Net loss applicable to common stock $ (3,046 ) $ (4,662 ) $ (11,698 ) $ (14,680 )
                         
Basic and diluted net loss per share $ (0.07 ) $ (0.13 ) $ (0.30 ) $ (0.42 )
Shares used in computing basic and diluted net loss per share   40,921     35,165     38,822     34,600  
                         

Condensed Consolidated Balance Sheet Data

    September 30, 2018     December 31, 2017  
    (in thousands)
Cash and cash equivalents $ 10,136   $ 3,053  
Total assets   10,616     4,161  
Total current liabilities   1,646     2,968  
Total liabilities   1,646     2,968  
Total redeemable, convertible preferred stock   1,723     1,723  
Total stockholders’ equity $ 7,247   $ (530 )