Galectin Therapeutics Reports Financial Results for the Quarter Ended March 31, 2020, and Provides Business Update
NASH-RX Clinical Trial Protocol Filed with FDA; First Patient Currently Expected to be Enrolled in Second Quarter 2020
Filed a New Form S-3 Shelf Registration Statement Which Replaces the Company’s Existing Shelf Registration Statement, which Expires on
Belapectin (formerly known as GR-MD-02) is the first drug that has been shown to prevent the development of esophageal varices in patients with compensated NASH cirrhosis. If confirmed, these results would constitute a significant benefit for patients.
NASH-RX Trial Update
The NASH-RX trial will use an adaptive design, confirm dose selection, and reaffirm the efficacy data observed in the NASH-CX trial and, with pre-planned adaptations, inform the larger Phase 3 trial component.
- The protocol for a seamless adaptively-designed Phase 2b/3 clinical study, the NASH-RX trial, was submitted to the
U.S. Food and Drug Administration(FDA) on April 30, 2020. Details are available at www.clinicaltrials.gov NCT 04365868
- The filing currently anticipates clinical trials will begin in the second quarter of this year.
- The design of this trial reflects the unmet medical needs of the target patient population for belapectin treatment: NASH patients with compensated cirrhosis who develop esophageal varices. Bleeding varices are a cause of death in about one-third of cirrhotic patients. Currently, there is no approved treatment for preventing varices in these patients. The development of new varices reflects the progression of hepatic cirrhosis and thus portends the development of other cirrhosis complications and outcomes such as significant ascites, hepatic encephalopathy, and eventual liver failure.
- In addition on
March 31, 2020, the Company also filed with the FDA a protocol for the hepatic impairment study (www.clinicaltrials.gov NCT04332432), with the study also currently anticipated to begin in the second quarter of this year.
Pol F. Boudes, M.D. has now joined the company as Chief Medical Officer, where his background in NASH and other liver disease drug development has proven instrumental to the filing of the NASH-RX protocol and is expected to add significantly to the conduct of the trial.
New Articles Published to the Company’s Website
- Shamseddeen H,
Vilar-Gomez E, Chalasani N, Myers RP, Subramanian GM, Shlevin HH, Allgood AE, Orman ES (2020) Spontaneous Fluctuations in Liver Biochemistries in Patients with Compensated NASH Cirrhosis: Implications for Drug Hepatotoxicity Monitoring. Drug Safety 43:281–290. doi.org/10.1007/s40264-019-00896-1
- Patients with cirrhosis may have spontaneous fluctuations in liver enzymes, which may confound the detection of drug-induced liver injury (DILI), but these fluctuations have not been described.
- Study concluded that spontaneous liver enzyme abnormalities are common in patients with NASH cirrhosis in clinical trials, and these abnormalities rarely met criteria for DILI suspicion. Further work to better define these abnormalities and continued vigilance to detect DILI in this population is needed.
- Chalasani N, Abdelmalek MF,
Garcia-Tsao G, Vuppalanchi R, Alkhouri N, Rinella M, Noureddin M, Pyko M, Shiffman M, Sanyal A, Allgood A, Shlevin H, Horton R, Zomer E, Irish W, Goodman Z, Harrison SA, Traber PG (2019) Effects of Belapectin, an Inhibitor of Galectin-3, in Patients with Nonalcoholic Steatohepatitis With Cirrhosis And Portal Hypertension. Gastroenterology S0016-5085(19)41895-7.
Shelf Registration Statement
The Company has filed a “shelf” registration statement on Form S-3 (the “Registration Statement”) with the
When the Registration Statement is declared effective by the
The Registration Statement has been filed with the
For the three months ended March 31, 2020, the Company reported a net loss applicable to common stockholders of
Research and development expense for the three months ended March 31, 2020, was
As of March 31, 2020, the Company had $43.3 million of cash and cash equivalents. The Company also has a
The Company expects that it will require more cash to fund operations after
About Belapectin (GR-MD-02)
Belapectin (GR-MD-02) is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of fatty liver disease and fibrosis. Galectin-3 plays a major role in diseases that involve scarring of organs including fibrotic disorders of the liver, lung, kidney, heart and vascular system. The drug binds to galectin proteins and disrupts their function. Preclinical data in animals have shown that GR-MD-02 has robust treatment effects in reversing liver fibrosis and cirrhosis.
About Fatty Liver Disease with Advanced Fibrosis and Cirrhosis
Non-alcoholic steatohepatitis (NASH) has become a common disease of the liver with the rise in obesity and other metabolic diseases. NASH is estimated to affect up to 28 million people in 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 FDA may not be achieved; Galectin may not be successful in developing effective treatments and/or obtaining the requisite approvals for the use of belapectin 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 currently planned clinical trial and any future clinical studies as modified to meet the requirements of the FDA may not produce positive results in a timely fashion, if at all, and could require larger and longer trials, which would be 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. Global factors such as coronavirus may limit access to NASH patient populations around the globe and slow trial enrollment and prolong the duration of the trial and significantly impact associated costs. 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
|Three Months Ended
|Research and development||$||2,144||$||646|
|General and administrative||1,440||1,721|
|Total operating expenses||3,584||2,367|
|Total operating loss||(3,584||)||(2,367||)|
|Other income (expense):|
|Total other income||28||(8||)|
|Preferred stock dividends||6||(96||)|
|Net loss applicable to common stock||$||(3,550||)||$||(9,093||)|
|Basic and diluted net loss per share||$||(0.06||)||$||(0.20||)|
|Shares used in computing basic and diluted net loss per share||56,956||44,975|
Condensed Consolidated Balance Sheet Data
|Cash and cash equivalents||$||43,328||$||47,480|
|Total current liabilities||1,316||2,820|
|Total redeemable, convertible preferred stock||1,723||1,723|
|Total stockholders’ equity||$||41,030||$||43,872|
Source: Galectin Therapeutics Inc.