Galectin Therapeutics Reports Q3 2019 Financial Results
NASH-RX Trial Update
The NASH-RX Trial was initially designed as a Phase 3 trial of belapectin in NASH cirrhosis patients based on
Currently, as a result of the Agency’s feedback and after consultation with external experts, the Company plans to conduct an adaptive-designed trial that confirms dose selection and data observed in the NASH-CX trial and where, in a seamless fashion with pre-planned adaptations, an interim analysis informs the larger Phase 3 trial component. The adaptive design being considered allows pre-planned adjustments of the trial which may include, amongst other factors, optimization of dose selection, confirmation of efficacy and proof of concept, optimized sizing and statistical powering of the Phase 3 component, and possible inclusion of more advanced cirrhotic patients. We believe that these adaptations taken together should optimize conduct of the NASH-RX trial giving belapectin the best opportunity to show a positive therapeutic effect. Existing patients in the first component of the trial are expected to be seamlessly transitioned to the Phase 3 trial component. An important aspect of the adaptive design is potential early termination of the study for futility after evaluation of the results from the first part of the trial, thereby saving the company resources that it could expend on other trials. Conversely, if the final results of the NASH-RX trial are compelling, there could be the potential for
In the Phase 3 component of this trial, the primary endpoint would likely be a composite clinical outcomes endpoint, including varices requiring treatment (development of large varices or varices with a red wale), decompensated events, all-cause mortality, MELD score increase as defined earlier and liver transplant. Patient selection would be based on clinical criteria indicative of clinically significant portal hypertension, amongst others, including presence or absence of varices, platelet count, spleen size and evidence of collaterals by imaging. In addition, in parallel, a hepatic impairment study in patients with Child-Turcotte-Pugh (CTP) classes A, B, and C would be conducted to potentially allow inclusion of patients with CTP Class B and/or C who are at increased risk of decompensating. Subject to additional assessments to assure appropriate study sizing and other operational considerations, these changes are believed to be relatively straight-forward modifications of the protocols submitted to the Agency in
The focus and goal of the therapeutic program is to stop the progression of and reverse the fibrosis and/or portal hypertension in the liver and thereby improve liver function and prevent the development of varices and clinical complications of fibrosis/cirrhosis and liver-related mortality in patients. Based on the results of the NASH-CX trial and subject to confirmation in later-stage clinical trials, we believe that this goal is achievable in a significant portion of the NASH cirrhosis patient population, i.e. those NASH cirrhosis patients with portal hypertension.
The key milestones and associated target dates for the NASH-RX trial will be announced as elements of design of the trial are finalized based on the recent
- Along with
Providence Cancer Institute, received a notice of issuance of a U.S. patent titled "Method for Enhancing Specific Immunotherapies in Cancer Treatment” to cover the method of use of belapectin (GR-MD-02) as a means to enhance the effectiveness of specific immunotherapies in cancer treatment. The patent coverage extends to 2033.
- Revamped the corporate and investor websites to increase transparency and improve mobile accessibility.
Scientific Presentations and Conferences
- An abstract based on results obtained in a subsequent ad hoc analysis of Galectin Therapeutics’ NASH-CX Phase 2 Clinical Trial by investigators at the
University of Indianawas presented at The Liver Meeting (AASLD) in Boston, Massachusettson November 8-12. The poster presentation was titled “Enhanced liver fibrosis (ELF) score significantly predicts 52-week liver decompensation in patients with compensated NASH cirrhosis.”
Eliezer Zomer, Vice President, will present at the 3rd Annual Anti-Fibrotic Drug Development Summit (AFDD) on November 19, 2019, in Cambridge, Massachusetts. Dr. Zomer’s presentation, titled “Therapeutic Integrin Inhibition,” will discuss the next generation of Galectin-3 inhibitors as well as the discovery of functional allosteric inhibitors as part of efforts of Galectin Sciences LLC, our majority-owned subsidiary.
For the three months ended September 30, 2019, the Company reported a net loss applicable to common stockholders of
Research and development expense for the three months ended September 30, 2019, was
As of September 30, 2019, the Company had $50.3 million of cash and cash equivalents. The Company also has a
About Galectin Therapeutics
Galectin Therapeutics is dedicated to developing novel therapies to improve the lives of patients with chronic liver disease and cancer. Galectin’s lead drug belapectin (formerly known as GR-MD-02) is a carbohydrate-based drug that inhibits the galectin-3 protein which is directly involved in multiple inflammatory, fibrotic, and malignant diseases for which it has Fast Track designation by the
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance, and use words such as “may,” “estimate,” “could,” “expect” and others. They are based on management’s current expectations and are subject to factors and uncertainties that could cause actual results to differ materially from those described in the statements. These statements include those regarding the hope that Galectin’s development program for belapectin will lead to the first therapy for the treatment of fatty liver disease with cirrhosis and those regarding the hope that our lead compounds will be successful in cancer immunotherapy and in other therapeutic indications. Factors that could cause actual performance to differ materially from those discussed in the forward-looking statements include, among others, that trial endpoints required by the
Condensed Consolidated Statements of Operations
|(in thousands, except per share data)|
|Research and development||$||1,503||$||1,505||$||3,671||$||5,279|
|General and administrative||1,360||1,175||4,579||5,338|
|Total operating expenses||2,863||2,680||8,250||10,617|
|Total operating loss||(2,863)||(2,680)||(8,250)||(10,617)|
|Other income (expense):|
|Total other income||79||(72)||93||(233)|
|Preferred stock dividends||(35)||(294)||(198)||(848)|
|Net loss applicable to common stock||$||(2,819)||$||(3,046)||$||(14,977)||$||(11,698)|
|Basic and diluted net loss per share||$||(0.05)||$||(0.07)||$||(0.27)||$||(0.30)|
|Shares used in computing basic and diluted net loss per share||56,631||40,921||55,493||38,822|
Condensed Consolidated Balance Sheet Data
|September 30, 2019||December 31, 2018|
|Cash and cash equivalents||$||50,337||$||8,253|
|Total current liabilities||1,216||2,108|
|Total redeemable, convertible preferred stock||1,723||1,723|
|Total stockholders’ equity||$||47,759||$||5,175|
Source: Galectin Therapeutics Inc.