On May 11, 2020 Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, reported financial results and provided a business update for the quarter ended March 31, 2020 (Press release, Galectin Therapeutics, MAY 11, 2020, View Source [SID1234557518]). 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.
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Harold H. Shlevin, Ph.D., President and Chief Executive Officer of Galectin Therapeutics, said, "We are excited to have recently submitted the NASH-RX clinical trial protocol to the U.S. Food and Drug Administration (FDA). Taken together, the adaptations in this protocol should optimize conduct of the NASH-RX trial to give belapectin (GR-MD-02) the best opportunity to show a positive therapeutic effect. Most notably, if the results of the NASH-RX trial are compelling, there could be the potential for accelerated FDA approval and/or partnership opportunity with a large pharmaceutical company. While the filing currently anticipates clinical trials will begin in the second quarter of this year, this is a particularly challenging time to start a new clinical trial. Factors beyond our control, specifically related to the COVID-19 pandemic, may delay the trial’s initiation. Notwithstanding that, we remain optimistic in moving forward. The unmet medical need for effective treatment for patients with NASH cirrhosis remains an important motivation."
Richard E. Uihlein, Chairman of the Board, added, "I am very proud of our entire team at Galectin Therapeutics. Their efforts, along with invaluable assistance from our Co-Primary Investigators and based on input received from the FDA, resulted in a trial protocol which is designed to give our drug the best chance of demonstrating efficacy and safety. Additionally, it should also help to maximize patient retention and enhance participation. Our goal of slowing or otherwise preventing the development of new varices in our target clinical trial patient population, NASH patients with compensated cirrhosis, if attained, can help patients to avoid further cirrhosis complications. These include variceal bleeding and other decompensating events accompanying disease progression, which could ultimately lead to liver failure. Since there are currently no treatment options for NASH cirrhosis, liver transplantation is the only viable option. Alternatively, a reduction in the number of patients who progress to liver failure has the potential to save many lives."
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.
Galectin Therapeutics will share more details about the protocol at the time the clinical trial begins.
Other Updates
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 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 Securities and Exchange Commission (the "SEC") for the registration of up to $100.0 million of any combination of shares of the Company’s common stock, warrants, or rights (collectively, the "Securities"). The Registration Statement is being filed to replace the Company’s current "shelf" registration statement, which expires on June 1, 2020.
When the Registration Statement is declared effective by the SEC, Securities may be offered, separately or together, from time to time and in one or more offerings. A prospectus supplement related to the offer and sale of shares of common stock to be sold pursuant to an At The Market Issuance Sales Agreement with H. C. Wainwright & Co., LLC, is included within the Registration Statement. The terms of any other offering, including the specific terms and prices of the Securities, will be determined at the time of such offering and be made solely by means of the prospectus included in the Registration Statement and any prospectus supplement that may be filed with the SEC relating to such offering.
The Registration Statement has been filed with the SEC but has not yet become effective. The Securities may not be sold, nor may offers to buy the Securities be accepted, prior to the time the Registration Statement becomes effective. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the Securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities law of any such state.
Financial Results
For the three months ended March 31, 2020, the Company reported a net loss applicable to common stockholders of $3.6 million, or ($0.06) per share, compared to a net loss applicable to common stockholders of $9.1 million, or ($0.20) per share for the three months ended March 31, 2019. The decrease is largely due to a one-time, non-cash $6.6 million charge in the period ended March 31, 2019, related to extending the life of warrants held by the holder of the Company’s Series B preferred stock in connection with the conversion of all the Series B preferred stock into common stock, somewhat offset by an increase in 2020 research and development expense related to the Company’s planned NASH-RX trial.
Research and development expense for the three months ended March 31, 2020 was $2.1 million compared with $0.6 million for the three months ended March 31, 2019. The increase was primarily due to costs related to our NASH-RX clinical trial planning and site start-up and qualification processes globally, along with preparations and some preclinical activities incurred in support of the planned clinical program, such as development and reproductive toxicity studies, clinical supplies and other supportive activities. General and administrative expenses for the three months ended March 31, 2020, were $1.4 million, down from $1.7 million for the three months ended March 31, 2019, primarily due to a decrease in legal expenses partially offset by an increase in insurance expenses.
As of March 31, 2020, the Company had $43.3 million of cash and cash equivalents. The Company also has a $10 million unsecured line of credit, under which no borrowings have been made to date. The Company believes it has sufficient cash, including availability under the line of credit, to fund currently planned operations and research and development activities through at least September 30, 2021.
The Company expects that it will require more cash to fund operations after September 30, 2021 and believes it will be able to obtain additional financing as needed. The total cost to obtain the interim analysis data of the planned trial, including general overhead, is currently estimated to be approximately $125 million; however, the costs and timing of such trial are not yet completely finalized. These costs will require additional funding. There can be no assurance that we will be successful in obtaining financing to support our operations beyond September 30, 2021, or, if available, that any such financing will be on terms acceptable to us.
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 U.S. It is characterized by the presence of excess fat in the liver along with inflammation and hepatocyte damage (ballooning) in people who consume little or no alcohol. Over time, patients with NASH can develop excessive fibrosis, or scarring of the liver, and ultimately liver cirrhosis. It is estimated that as many as 1 to 2 million individuals in the U.S. will develop cirrhosis as a result of NASH, for which liver transplantation is the only curative treatment available. Approximately 8,890 liver transplants are performed annually in the U.S. There are no drug therapies approved for the treatment of liver fibrosis or cirrhosis.