GALT Galectin Therapeutics Inc.

2.92
-0.19  -6%
Previous Close 3.11
Open 3.16
52 Week Low 1.5
52 Week High 4.5
Market Cap $166,525,290
Shares 57,029,209
Float 30,560,696
Enterprise Value $136,373,839
Volume 167,379
Av. Daily Volume 279,041
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Upcoming Catalysts

Drug Stage Catalyst Date
GR-MD-02
Non-alcoholic steatohepatitis (NASH) with cirrhosis
Phase 2/3
Phase 2/3
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Drug Pipeline

Drug Stage Notes
GR-MD-02 and pembrolizumab (KEYTRUDA)
Melanoma
Phase 1b
Phase 1b
Phase 1b data released September 20, 2018. ORR 50%.
GR-MD-02
moderate-to-severe plaque psoriasis.
Phase 2a
Phase 2a
Phase 2a interim data released May 2016

Latest News

  1. Clinical trial for patients with NASH cirrhosis who have the highest need for effective therapy

    Belapectin has previously shown ability to prevent the development of esophageal varices in this patient population

    Compelling NASH-RX trial result could potentially lead to accelerated FDA approval and/or partnership opportunities and fulfill an acute unmet medical need

    NORCROSS, Ga., June 30, 2020 (GLOBE NEWSWIRE) -- Galectin Therapeutics, the leading developer of therapeutics that target galectin proteins, announced today that it has enrolled its first patients in the NASH-RX trial. NASH-RX is an international, seamless, adaptively-designed Phase 2b/3 trial of its galectin-3 inhibitor belapectin (GR-MD-02), the company's lead compound…

    Clinical trial for patients with NASH cirrhosis who have the highest need for effective therapy

    Belapectin has previously shown ability to prevent the development of esophageal varices in this patient population

    Compelling NASH-RX trial result could potentially lead to accelerated FDA approval and/or partnership opportunities and fulfill an acute unmet medical need

    NORCROSS, Ga., June 30, 2020 (GLOBE NEWSWIRE) -- Galectin Therapeutics, the leading developer of therapeutics that target galectin proteins, announced today that it has enrolled its first patients in the NASH-RX trial. NASH-RX is an international, seamless, adaptively-designed Phase 2b/3 trial of its galectin-3 inhibitor belapectin (GR-MD-02), the company's lead compound, in nonalcoholic steatohepatitis (NASH) cirrhosis patients who have clinical signs of portal hypertension and are at risk of developing esophageal varices. Belapectin had previously been shown that it could prevent the development of new varices in this patient population in the Phase 2 NASH-CX clinical trial (Gastroenterology 2020;158:1334–1345 or https://doi.org/10.1053/j.gastro.2019.11.296).

    NASH-RX is expected to enroll approximately 315 NASH patients in the Phase 2b part of the trial at approximately 130 sites in 12 countries in North America, Europe, Asia and Australia. During the Phase 2b part of the trial, two belapectin doses, 2 mg/kg of lean body mass (LBM) and 4 mg/kg LBM, will be compared to placebo. Prior trials have demonstrated the good tolerance profile and apparent safety of belapectin with doses of up to 8 mg/kg LBM, notably for up to 52 weeks of treatment in patients with NASH cirrhosis (Phase 2b NASH-CX Study).

    The study design provides for a prespecified interim analysis (IA) of efficacy and safety data conducted after all planned subjects in the Phase 2b component have completed at least 78 weeks (18 months) of treatment and a gastro-esophageal endoscopic assessment. This adaptive design allows for patients to seamlessly transition from the Phase 2b component into the Phase 3 stage, as well as helps determine the optimal dose, bolsters the efficacy signal, and re-evaluates the sample size and statistical power for the Phase 3 stage of the trial. These adaptations are designed to increase the statistical power for detecting a successful outcome. The IA also provides for adjustment in the randomization ratio, refinement of inclusion/exclusion criteria and the potential termination of the study for overwhelming efficacy or for futility.

    "The unmet medical need for an effective treatment for patients with NASH cirrhosis remains a compelling motivation to vigorously pursue our therapy," commented Harold H. Shlevin, Ph.D., President and Chief Executive Officer of Galectin Therapeutics. "Moreover, if the results of the NASH-RX trial are compelling, there could be the potential for accelerated FDA approval and/or partnership opportunities."

    Unlike most other clinical trials focused primarily on earlier stages of NASH, the NASH-RX study population will comprise patients with compensated liver cirrhosis. Based on the results of the NASH-CX trial, NASH-RX is focused on patients who have not yet developed esophageal varices but are at increased risk of developing these potentially life-threatening complications. Consequently, patient selection for both Phase 2b and Phase 3 will be based on clinical signs of portal hypertension such as a depressed platelet count (thrombocytopenia), an enlargement of the spleen (splenomegaly) and/or evidence of collateral vessels.

    The primary endpoint of the trial is to assess the effect of belapectin on the incidence of new varices. A centralized review system of video recording of esophagogastroduodenoscopy (EGD) has been put in place, and the primary endpoint will be adjudicated by expert EGD readers. Key secondary endpoints will assess the type of varices (sizes and/or bleeding) and other clinical events, such as ascites, hepatic encephalopathy, listing for liver transplantation or death.

    NASH-RX was designed in accordance with advice from the U.S. Food and Drug Administration (FDA) and with key contributions from our NASH-RX co-primary study investigators, Dr. Naga Chalasani and Dr. Stephen Harrison, both widely recognized expert hepatologists for NASH, biostatistical experts and numerous other collaborators at Covance, the CRO for the study. The design of the NASH-RX trial optimizes patient enrollment and retention and minimizes the need for invasive tests.

    Pol Boudes, M.D., Chief Medical Officer for Galectin commented, "Once liver fibrosis has progressed to cirrhosis, NASH patients can no longer expect significant improvements from changes in their lifestyle. These patients are in dire need of new options, and this trial may prove pivotal in improving their condition. The study's seamless and adaptive design is very innovative, and the primary endpoint minimizes the inconvenience for patients while being relevant to real life medical practice. We are extremely excited to start the study and give thanks in advance to all the patients who will participate and the medical teams that will support them."

    Details on the trial, entitled "A Seamless Adaptive Phase 2b/3, Double-Blind, Randomized, Placebo-controlled Multicenter, International Study Evaluating the Efficacy and Safety of Belapectin (GR-MD-02) for the Prevention of Esophageal Varices in NASH Cirrhosis," are posted on www.clinicaltrials.gov (NCT04365868) and WHO's trial registry platform. 

    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), also known as fatty liver disease, has become a common disease of the liver with the rise in obesity rates. NASH is estimated to affect up to 28 million people in the U.S. Fatty liver disease is characterized by the presence of fat in the liver along with inflammation and damage in people who consume little or no alcohol. Over time, patients with fatty liver disease can develop fibrosis, or scarring of the liver, and it is estimated that as many as 1-2 million individuals in the U.S. will develop cirrhosis, a severe liver disease for which liver transplantation is the only treatment available. Approximately 6,300 liver transplants are performed annually in the U.S. There are no drug therapies approved for the treatment of liver fibrosis.

    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 U.S. Food and Drug Administration. 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 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 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 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 NASH-RX trial and any future clinical studies 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 complete the NASH-RX trial or further develop and/or fund additional 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 December 31, 2019, 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.

    Company Contact:

    Jack Callicutt, Chief Financial Officer

    (678) 620-3186

    Media Contact:

    Gregory FCA

    Lexi Burchmore, Account Supervisor

    (215) 297-3607

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

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  2. 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 June 1, 2020

    NORCROSS, Ga., May 11, 2020 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins, today reported financial results and provided a business update for the quarter ended March 31, 2020. 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…

    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 June 1, 2020

    NORCROSS, Ga., May 11, 2020 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins, today reported financial results and provided a business update for the quarter ended March 31, 2020. 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, "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 the 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 an 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 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 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.

    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 U.S. Food and Drug Administration. 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 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 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 December 31, 2019, 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.

    Company Contact:
    Jack Callicutt, Chief Financial Officer
    (678) 620-3186
    .

    Galectin Therapeutics and its associated logo is a registered trademark of Galectin Therapeutics Inc. Belapectin is the USAN assigned name for Galectin Therapeutics' galectin-3 inhibitor GR-MD-02


    Condensed Consolidated Statements of Operations

      Three Months Ended March 31,
      2020
    2019
       
    Operating expenses:

       
    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):    
    Interest income   50     14  
    Interest expense   (22 )   (22 )
    Total other income   28     (8 )
    Net loss $ (3,556 ) $ (2,375 )
    Preferred stock dividends   6     (96 )
    Warrant modification   -     (6,622 )
    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

        March 31, 2020   December 31, 2019
        (in thousands)
    Cash and cash equivalents $ 43,328 $ 47,480
    Total assets   44,111   48,467
    Total current liabilities   1,316   2,820
    Total liabilities   1,358   2,872
    Total redeemable, convertible preferred stock   1,723   1,723
    Total stockholders' equity $ 41,030 $ 43,872

     

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  3. NORCROSS, Ga., April 30, 2020 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins, today announced that it has submitted to the U.S. Food and Drug Administration (FDA) its protocol for a seamless adaptively-designed Phase 2b/3 clinical study, the NASH-RX trial, evaluating the safety and efficacy of its galectin-3 inhibitor, belapectin (GR-MD-02), for the prevention of esophageal varices in patients with non-alcoholic steatohepatitis (NASH) cirrhosis. 

    The filing anticipates clinical trials will begin in the second quarter of this year. The major features of the innovative, seamless adaptively-designed Phase 2b/3 study design are summarized below and graphically…

    NORCROSS, Ga., April 30, 2020 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins, today announced that it has submitted to the U.S. Food and Drug Administration (FDA) its protocol for a seamless adaptively-designed Phase 2b/3 clinical study, the NASH-RX trial, evaluating the safety and efficacy of its galectin-3 inhibitor, belapectin (GR-MD-02), for the prevention of esophageal varices in patients with non-alcoholic steatohepatitis (NASH) cirrhosis. 

    The filing anticipates clinical trials will begin in the second quarter of this year. The major features of the innovative, seamless adaptively-designed Phase 2b/3 study design are summarized below and graphically depicted in the figure:

    • In patients with NASH cirrhosis and clinical signs of portal hypertension but without esophageal varices at baseline, this trial will assess the effect of belapectin on the incidence of new varices (the primary endpoint) – as well as assessing the effect on the incidence of long-term, clinically significant cirrhosis-related "hard" outcomes (a key secondary efficacy endpoint).
       
    • 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. 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 ultimately liver failure.
       
    • During the first 18 months of the trial, two belapectin dose levels (2 mg/kg LBM and 4 mg/kg LBM) will be compared to placebo. Then, at the interim analysis (IA), one belapectin dose will be selected based on efficacy and safety, for continued evaluation in Stage 2 (Phase 3). Prior trials have demonstrated the safety of belapectin with doses of up to 8 mg/kg for 52 weeks (Phase 2b Study GT-026).

    "The protocol filed today reflects the previous feedback received from the FDA, as well as key contributions from Dr. Naga Chalasani and Dr. Stephen Harrison, NASH opinion leaders who are co-primary investigators for the study, biostatistical experts and numerous other collaborators at Covance, our CRO," said Harold H. Shlevin, Ph.D., President and Chief Executive Officer of Galectin Therapeutics. "We are very grateful for all of their efforts, and for the previous feedback and suggestions from the FDA. The study design has been modified and further refined such that it provides for a prespecified interim analysis (IA). The IA of efficacy and safety data will be conducted after all planned subjects in Phase 2b component have completed at least 78 weeks (18 months) of treatment and a gastro-esophageal endoscopic assessment. The purpose of the IA is to allow potential seamless adaptive modifications of the study, including: (1) the selection of the optimal dose of belapectin for Phase 3; (2) the re-estimation of the study sample size for Phase 3 portion of the trial; (3) the re-evaluation of the randomization ratio for the Phase 3 portion of the trial; (4) the refinement of the inclusion and exclusion criteria for the Phase 3 portion of the trial, including the CTP status; (5) and/or termination of the study for overwhelming efficacy or futility.

    The new trial design also minimizes invasive testing requirements, which we believe will enhance the enrollment and retention of patients. It also provides for a seamless transition of patients from the phase 2b component into the phase 3 stage, as well as provides for the potential addition of new patients. The trial design preserves the surrogate end-point concepts previously discussed with the FDA.

    As previously communicated, this is a uniquely challenging time to start a new clinical trial, and we are doing everything in our direct control to prepare for the initiation of the study later this quarter; however, 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.

    The trial, entitled "A Seamless Adaptive Phase 2b/3, Double-Blind, Randomized, Placebo-controlled Multicenter, International Study Evaluating the Efficacy and Safety of Belapectin (GR-MD-02) for the Prevention of Esophageal Varices in NASH Cirrhosis" is now posted on www.clinicaltrials.gov (NCT04365868). Galectin Therapeutics will share more details about the protocol at the time the clinical trial begins. In addition, the FDA has received Galectin's protocol for the hepatic impairment study which will be conducted in subjects with normal hepatic function and subjects with varying degrees of hepatic impairment (NCT04332432). This filing anticipates that this study will also begin in the second quarter of this year.

    About Belapectin (GR-MD-02)

    Belapectin 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 belapectin 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 hepatocytes 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 1-2 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.

    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 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 U.S. Food and Drug Administration. 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 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 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 established in our clinical trials 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 complete the NASH-RX trial or further develop and/or fund any other 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 December 31, 2019, 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.

    Company Contact:
    Jack Callicutt, Chief Financial Officer
    (678) 620-3186

    Media Contact:
    Gregory FCA
    Lexi Burchmore, Account Supervisor
    (215) 297-3607

    Galectin Therapeutics and its associated logo is a registered trademark of Galectin Therapeutics Inc. Belapectin is the USAN assigned name for Galectin Therapeutics' galectin-3 inhibitor GR-MD-02

    A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/535ab060-4a23-4e52-b9d6-527cf591fd12

     

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  4. NORCROSS, Ga., April 02, 2020 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins today provided an update on the impact of the COVID-19 pandemic on the Company and its clinical trial activities.

    As the global COVID-19 pandemic continues to quickly evolve, we have put measures in place intended to safeguard the health of our employees in line with many other companies. In doing so, we aim to do our part to help slow the spread of COVID-19 in our communities and protect our employees and their families, all while continuing the critical work necessary to initiate and conduct our NASH-RX clinical trial for patients with NASH cirrhosis. 

    In accordance with guidance…

    NORCROSS, Ga., April 02, 2020 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins today provided an update on the impact of the COVID-19 pandemic on the Company and its clinical trial activities.

    As the global COVID-19 pandemic continues to quickly evolve, we have put measures in place intended to safeguard the health of our employees in line with many other companies. In doing so, we aim to do our part to help slow the spread of COVID-19 in our communities and protect our employees and their families, all while continuing the critical work necessary to initiate and conduct our NASH-RX clinical trial for patients with NASH cirrhosis. 

    In accordance with guidance issued by the Centers for Disease Control and Prevention (CDC), the World Health Organization (WHO) and local authorities, our employees are working remotely from home. We are now leveraging digital communication technologies to continue important interactions with healthcare professionals, patients and other stakeholders. We remain committed to completing and filing the NASH-RX protocol with the US Food and Drug Administration (FDA) in the near term. To date, we have suffered no significant financial hardships, delays or loss of any employees or contractors related to COVID-19.

    The COVID-19 pandemic has substantially impacted the global healthcare delivery system including the conduct of clinical trials. As appropriate, many healthcare systems and providers have understandably prioritized caring for those suffering from COVID-19 and redirected resources in support of the broader community currently. This burden on the healthcare system has also impaired the ability of many clinical research centers to start new studies, enroll new patients and/or continue ongoing clinical trials. Most importantly, we must consider the risk to the patients of asking them to leave their homes and travel in an environment governmental authorities have deemed unsafe. At this time and as previously communicated, we plan to initiate the NASH-RX trial during the second quarter of 2020; however, this may be impacted by the COVID-19 pandemic.

    Galectin Therapeutics Inc. has developed several overarching principles to guide its conduct of clinical research in light of COVID-19. Number one among these is the safety of patients, site personnel and our own employees. In addition, several health authorities have provided guidance for the conduct of clinical trials during this pandemic and suggestions related to assuring study integrity and the value of the data. Following this guidance, we can report the following actions and developments:

    Galectin Therapeutics and the team at Covance, our CRO, are focused on those activities that we can directly control. For example, these include the completion of protocol and associated documents for new clinical trials and filing of protocols and associated documents with regulatory agencies, both in the US and internationally. This also includes numerous activities in conjunction with Covance and external vendors to ensure all internal systems such as study databases, adjudication systems, laboratory systems, data monitoring committee charters and the like are fully ready when trial sites are willing to restart their clinical research activities.

    Clinical supply distribution and related activities with our external vendors are so far only minimally impacted. However, this could change in the coming weeks and months. Fortunately, we currently have an adequate supply of belapectin. External activities directed toward specific site start-up activities such as pre-study visits (using virtual techniques) by Covance employees, site contracting activities, training activities and site-directed ethic committee submissions will continue moving forward in conjunction with the site principal investigators and site coordinators, as well as with managers of the NASH site-specific network we are using.

    We remain strongly committed to initiating our adaptive Phase 3 trial as soon as reasonably possible considering COVID-19. We are doing everything we can to minimize disruption and delays in site-related activities and patient enrollment and striving to do so in a safe and considerate manner. Further information will be forthcoming as we all navigate this situation.

    Our hearts and thoughts go out to everyone whose lives have been seriously affected by COVID-19, and to our medical professionals on the front lines who are combating the virus. 

    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 U.S. Food and Drug Administration. 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 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 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 December 31, 2019, 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.

    Company Contact:
    Jack Callicutt, Chief Financial Officer
    (678) 620-3186

    Galectin Therapeutics and its associated logo is a registered trademark of Galectin Therapeutics Inc. Belapectin is the USAN assigned name for Galectin Therapeutics' galectin-3 inhibitor GR-MD-02

     

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  5. NORCROSS, Ga., March 16, 2020 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins, today reported financial results and provided a business update for the year ended December 31, 2019. These results are included in the Company's Annual Report on Form 10-K, 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, "The focus of the past few months has been on finalizing the refinements to our planned NASH-RX trial based on feedback from the U.S. Food and Drug Administration (FDA). Our Adaptive-Designed Phase 2b/3 trial protocol…

    NORCROSS, Ga., March 16, 2020 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins, today reported financial results and provided a business update for the year ended December 31, 2019. These results are included in the Company's Annual Report on Form 10-K, 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, "The focus of the past few months has been on finalizing the refinements to our planned NASH-RX trial based on feedback from the U.S. Food and Drug Administration (FDA). Our Adaptive-Designed Phase 2b/3 trial protocol is nearly complete, and we anticipate initiating the trial in the second quarter of 2020. We have been very successful working with our partners to modify our initial trial design, incorporating a new biostatistics element to verify the rate of varices development and accordingly adjust trial sizing to help assure a key assumption related to the rate of varices development is met. Most recently, we strengthened our executive team with the addition of Dr. Pol F. Boudes, a Chief Medical Officer who has experience running NASH drug trials. In addition, as a result of the modifications to our trial, our clinical research organization Covance has been able to identify additional international clinical trial sites. Drug manufacturing capacity has been established to meet the needs of the entire trial. 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."

    Richard E. Uihlein, Chairman of the Board, added, "I am extremely pleased with the progress achieved over the past few months. We are now in the final stages of finalizing our NASH-RX trial, which improves the likelihood of showing belapectin's effects. And, with the recent addition of Dr. Boudes as Chief Medical Officer, we have a strong executive with extensive experience conducting trials of this nature. As always, our goal is to provide a therapy for the growing NASH epidemic around the world."

    NASH-RX Trial Update

    The NASH-RX trial is planned to 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 adaptive design being considered allows pre-planned adjustments of the trial that may include, amongst other factors, optimization of dose selection, confirmation of efficacy and proof of concept observed in the NASH-CX trial, 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 (GR-MD-02) the best opportunity to show a positive therapeutic effect. 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.

    The trial protocol is based on feedback from several interactions with the FDA during the last few months of 2019, including the November 14, 2019, telephone conference which included the FDA and Company representatives along with its co-primary investigators, biostatistical experts and other experts at Covance. In this meeting, the FDA indicated the new design was reasonable (subject to review of the protocol), and FDA indicated that they were still supportive of the surrogate end-point concepts originally proposed. 

    We believe the study design potentially could improve the likelihood of showing drug efficacy because:

    • It clarifies and reaffirms NASH-CX efficacy and safety at two distinct drug doses supported by robust pharmacokinetic analysis
    • It provides for appropriate selection of optimal dose – e.g., single dose (2 or 4 mg/kg) for Phase 3 component
    • A separate Hepatic Impairment study may allow inclusion of more severe patients who are believed to have a much higher rate of esophageal varices progression and bleeding and other decompensating events
    • Reduced frequency of esophagogastroduodenoscopys (EGD), elimination of biopsy endpoints and elimination of hepatic venous pressure gradient (HVPG) testing may make it easier to enroll trial patients and retain these patients during the duration of the trial 
    • Adaptation to size and power calculations based on sample size re-estimation and the interim analysis will allow better estimates of Phase 3 cohort sizing and of statistical power
    • A planned interim analysis after 18 months of completed treatment will assess affirmation of Phase 2 efficacy and safety results, help select a single optimal dosage, and inform the Phase 3 stage of the study, including its size

    In the Phase 3 component of this trial, the primary endpoint is development of new esophageal varices. Patients already enrolled for the Phase 2b component of the trial will continue on the selected single dose into the Phase 3 component of the trial. Patient selection for both Phase 2b and 3 components will be based on routine clinical signs of portal hypertension, including, amongst others, the presence or absence of varices, depressed platelet count (thrombocytopenia), enlargement of the spleen size and evidence of collateral blood vessels by imaging. The current study design and protocol are subject to modification after review by FDA.

    The focus and goal of the therapeutic program is to prevent the development of large esophageal varices, which are strongly correlated with patient mortality due to sudden and severe bleeding. Based on the results of the NASH-CX trial, the clinical program will focus on patients who are at increased risk of developing varices, i.e. patients who have clinical signs of portal hypertension, such as low platelet counts or increased spleen size (splenomegaly).

    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 FDA feedback. However, we currently expect the first patient to be initiated in the second quarter of 2020. The study overall will likely involve approximately 130 sites in 11 countries in North America, Europe, Asia, and Australia.

    Other Updates

    • Announced that Pol F. Boudes, M.D. has been appointed Chief Medical Officer - a key development for the company as it nears launch of its NASH-RX trial, an adaptively-designed Phase 3 trial in NASH cirrhosis. Dr. Boudes' diverse background in drug development, especially his experience in NASH and other liver diseases, bolsters Galectin's global advanced clinical development of belapectin for NASH cirrhosis.

      Peer-reviewed publication, Scientific Presentations and Conferences
    • Gastroenterology, a prominent journal in the field of gastrointestinal disease, published a peer reviewed paper titled, "Effects of Belapectin, an Inhibitor of Galectin-3, in Patients with Nonalcoholic Steatohepatitis with Cirrhosis and Portal Hypertension," highlighting the potential prevention of esophageal varices of its NASH-CX Phase 2 clinical trial in NASH cirrhosis. We were greatly honored that such a prestigious, peer-reviewed publication felt the quality of our science merited the industry-wide attention they provide.

    • Initial results of the efforts at Galectin Sciences LLC (our majority-owned subsidiary) were presented by Dr. E. Zomer, Ph.D., Vice President, Discovery Research and Product Development, at the 3rd Annual Anti-Fibrotic Drug Development (AFDD) Summit regarding Galectin's discovery program of its next generation of oral galectin-3 inhibitors.  The presentation entitled "Therapeutic Integrin Inhibition," discussed the next generation of galectin-3 inhibitors, as well as the discovery of functional allosteric inhibitors.

    Financial Results

    For the year ended December 31, 2019, the Company reported a net loss applicable to common stockholders of $13.6 million, or ($0.26) per share, compared to a net loss applicable to common stockholders of $15.0 million, or ($0.38) per share for the full year 2018. The decrease is largely due a decrease in general and administrative expenses, primarily stock-based compensation, and preferred stock dividends, somewhat offset by an increase in research and development expense.

    Research and development expense for 2019 was $7.5 million compared with $6.5 million for 2018. 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, somewhat offset by lower non-cash stock compensation expenses. General and administrative expenses for 2019 were $6.0 million, down from $7.1 million for the full year 2018, primarily due to a decrease in non-cash stock-based compensation expenses.

    As of December 31, 2019, the Company had $47.5 million of cash and cash equivalents. During 2019, the company effected a Rights Offering which, together with other common stock and warrants issued, raised $50.5 million in net proceeds. 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 efficacy 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 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 U.S. Food and Drug Administration. 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 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 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 December 31, 2019, 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.

    Company Contact:
    Jack Callicutt, Chief Financial Officer
    (678) 620-3186
    .

    Galectin Therapeutics and its associated logo is a registered trademark of Galectin Therapeutics Inc.    Belapectin is the USAN assigned name for Galectin Therapeutics' galectin-3 inhibitor GR-MD-02


    Condensed Consolidated Statements of Operations

      Year Ended 
    December 31,
      2019 2018
     
    Operating expenses:

       
    Research and development $   7,467 $   6,471
    General and administrative 5,971 7,131
    Total operating expenses 13,438 13,602
    Total operating loss (13,438) (13,602)
    Other income (expense):    
    Interest income 231 38
    Interest expense (87) (336)
    Total other income 144 (298)
    Net loss $ (13,294) $ (13,900)
    Preferred stock dividends (263) (1,147)
    Warrant modification (6,622) -
    Net loss applicable to common stock $ (20,179) $ (15,047)
    Basic and diluted net loss per share $   (0.39) $   (0.38)
    Shares used in computing basic and diluted net loss per share 52,238 39,414

    Condensed Consolidated Balance Sheet Data

        December 31, 2019   December 31, 2018
        (in thousands)
    Cash and cash equivalents $ 47,480 $ 8,253
    Total assets   48,467   9,006
    Total current liabilities   2,820   2,108
    Total liabilities   2,872   2,108
    Total redeemable, convertible preferred stock   1,723   1,723
    Total stockholders' equity $ 43,872 $ 5,175


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