Galectin Therapeutics Reports Fiscal 2018 Financial Results and Provides Business Update
Planning for Phase 3 clinical trial (NASH-RX) nearing completion for GR-MD-02, the first drug to show positive results in a clinical trial in patients with compensated NASH cirrhosis
“Since presenting the results of the NASH-CX trial, the Company has had ongoing discussions with
“Beyond our NASH trial, we will continue to pursue other paths forward for GR-MD-02, such as the significant market for evolving new combination cancer therapies. Illustrative of these opportunities, investigators plan to expand a combination immunotherapy trial involving GR-MD-02 and KEYTRUDA as a result of the favorable Objective Response Rate (ORR) reported in the first 3 cohorts.
“Throughout fiscal 2018, we also continued to strengthen our global intellectual property portfolio with a number of new patents awarded and/or submitted. As the understanding of GR-MD-02 improves, it is becoming increasingly clear that galectins, and specifically galectin-3, play an important role in a number of critical pathologies, contributing value to our patent portfolio.
“Finally, we believe that our capital structure is substantially improved as a result of the recent conversion of the preferred stock by 10X
Summary of Key Development Programs and Updates
- Continued to develop plans for its NASH-RX Phase 3 clinical trial program with the galectin-3 inhibitor GR-MD-02 in NASH cirrhosis, incorporating advice and guidance obtained in a meeting with the
FDAand our external advisors. Details of the NASH-RX Phase 3 clinical trial design, including projected timings and costs, will be announced once the planning phase has been completed and the Company has a final clinical trial protocol.
- Received a three-year extension on the
$10 millionunsecured line of credit entered into on December 19, 2017, for both borrowings and maturity. The line of credit arrangement with Richard E. Uihlein, Chairman of the Board of Directors and a shareholder, originally provided for borrowings to occur through December 31, 2018, with all principal and any interest maturing and coming due on December 31, 2019. There were two amendments that extended borrowings through December 31, 2021, and maturity of principal and interest to December 31, 2022. To date, the Company has not made any borrowings under this line of credit.
- Announced that its largest institutional shareholder, 10X
Fund L.P., has converted all of its Series B Convertible Preferred Stock into Common Stock of Galectin Therapeutics. All special voting rights and protective provisions that previously benefited the Series B Preferred Stock were extinguished by the conversion to Common Stock.
Scientific Presentations and Conferences
Harold H. Shlevinpresented at the 2nd Annual Anti-Fibrotic Drug Development Summit (AFDD) on November 29. In his presentation, titled “Physiological Control Systems Involving Galectins in the Treatment of Diseases,” Dr. Shlevin discussed the following: The significant involvement of galectins in various biological functions and pathologies and how this has driven recent interest in therapeutic discovery and development for clinical intervention against fibrosis, cancer, and other disorders; and the role of galectins in mediating physiological control processes, including an understanding of structure-function relationships, the mechanisms of action at the molecular level, and the evolving clinical data on their role in the treatment of various diseases.
Harold H. Shlevinwill be presenting at the H.C. Wainwright Global Life Sciences Conferencebeing held in London April 7– 9, 2019.
Dr. Shlevin concluded, “Galectin Therapeutics continues to advance GR-MD-02 as a potential therapy for NASH cirrhosis where elevated levels of galectin protein and inflammation play key roles in the pathophysiology of the diseases. This past year has been a period of steady progress, culminating in the collaboration of a number of leading clinicians in the formulation of our NASH-RX Phase 3 trial plan in selected NASH cirrhosis patients and the recent meeting with the
For the year ended December 31, 2018, the Company reported a net loss applicable to common stockholders of
Research and development expense for 2018 was
As of December 31, 2018, the Company had $8.3 million of cash and cash equivalents. In
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
Condensed Consolidated Statements of Operations
|(in thousands, except
per share data)
|Research and development||$||6,471||$||11,721|
|General and administrative||7,131||4,526|
|Total operating expenses||13,602||16,247|
|Total operating loss||(13,602)||(16,247)|
|Interest and other||(298)||12|
|Total other income||(298)||12|
|Preferred stock dividends||(1,147)||(1,232)|
|Net loss applicable to common stock||$||(15,047)||$||(17,467)|
|Basic and diluted net loss per share||$||(0.38)||$||(0.49)|
|Shares used in computing basic and diluted net loss per share||39,414||35,521|
Condensed Consolidated Balance Sheet Data
|Cash and cash equivalents||$||8,253||$||3,053|
|Total current liabilities||2,108||2,968|
|Total redeemable, convertible preferred stock||1,723||1,723|
|Total stockholders’ equity||$||5,175||$||(530)|
Source: Galectin Therapeutics Inc.