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GALT

Galectin Therapeutics Inc. NASDAQ Capital Market
$2.65
Open: $2.18 High: $2.82 Low: $2.15 Close: $2.66
Range: 2021-04-19 - 2021-04-20
Volume: 14,528,865
Market: Extended-hours
Powered by Finage Stock APIDelayed data
GALT
Galectin Therapeutics Inc. 4960 Peachtree Industrial Boulevard Norcross GA, 30071 http://www.galectintherapeutics.com
Galectin Therapeutics Inc is a clinical stage biopharmaceutical company. The company is engaged in drug research and development to create new therapies for fibrotic disease and cancer.
  • CEO: Harold H. Shlevin
  • Employees: 7
  • Sector: Healthcare
  • Industry: Drug Manufacturers
GALT News
Latest news about the GALT
  • World-Renowned Neurosurgeon Dr. Ben Carson, Sr. Joins Galectin Therapeutics as Special Consultant to Accelerate and Enhance Development of Company’s Galectin-3 Inhibitor, Belapectin

    Galectin Therapeutics also announces new $10 million convertible debt financing from its Chairman, Richard E. UihleinNORCROSS, Ga., April 19, 2021 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins, today announced it has engaged Dr. Ben Carson, Sr., a world-renowned neurosurgeon and the 17th Secretary of the U.S. Department of Housing and Urban Development, as a special consultant to assist with development of the Company’s galectin-3 inhibitor, belapectin, as a treatment for NASH cirrhosis and in combination with immunotherapy for the treatment of cancers. The Company engaged Dr. Carson to increase awareness of Galectin Therapeutics including its ongoing Phase 2b/3 NAVIGATE clinical trial in NASH cirrhosis, its continuing research in combination with cancer immunotherapy, and its potential in addressing other fibrotic diseases. Dr. Carson will also assist in the formation of a scientific advisory committee for the Company, recruit potential members of the committee, and identify potential strategic commercial and/or academic partners for the Company. The Company also announced that it has entered into a $10 million convertible debt financing with Richard E. Uihlein, the Company’s Chairman and largest individual stockholder. The $10 million convertible debt financing is unsecured and bears interest at a rate of 2% compounded annually. Additional interest of 2.5% per quarter will accrue but will only be paid if the debt and interest are converted into shares of the Company’s common stock, at Mr. Uihlein’s option, on or prior to maturity, which is four years from the date of the loan. The conversion price of the debt and interest is fixed at $5.00 per share of common stock. “We are proud to announce our engagement with Dr. Carson, whose scientific and medical knowledge will be invaluable to the Company as we move forward with our current trials in NASH cirrhosis and cancer immunotherapy,” said Joel Lewis, president and Chief Executive Officer of Galectin Therapeutics. “Additionally, we are grateful for the continued leadership and support of Mr. Uihlein. We continue to make progress in our NAVIGATE trial for patients with NASH cirrhosis, and this financing will support those efforts.” Dr. Carson stated, “Galectin Therapeutics and its drug candidate, belapectin, are at the forefront of research into galectin inhibition, which appears to be implicated in many diseases, including NASH cirrhosis, which is a large unmet medical need. More broadly, early results and potential for belapectin’s use in combination with immunotherapy in cancer suggests belapectin could address a multitude of indications where galectin-3 is involved. This has motivated me to apply my scientific and business skills developed over my long medical career to help steer the Company forward in navigating its clinical trials and identifying partnerships.” Richard E. Uihlein, Chairman of Galectin Therapeutics, commented on his $10 million investment, “This financing clearly illustrates that I remain deeply committed to the Company’s success and its goal of addressing large, unmet medical needs. On behalf of the Board of Directors, we are honored to welcome Dr. Carson to the Galectin Therapeutics team and look forward to working with him to enhance and accelerate our progress.” 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 NASH 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. Belapectin binds to galectin-3 and disrupts its function. Preclinical data in animals have shown that belapectin has robust treatment effects in reversing liver fibrosis and cirrhosis. A Phase 2 study showed belapectin may prevent the development of esophageal varices in NASH cirrhosis, and these results provide the basis for the conduct of the NAVIGATE trial. The NAVIGATE trial (NAVIGATEnash.com), 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” began enrolling patients in June 2020 and is posted on www.clinicaltrials.gov (NCT04365868). Galectin-3 also has a significant role in cancer, and the Company is supporting a Phase 1 study in combined immunotherapy of belapectin and KEYTRUDA® in treatment of advanced melanoma and in head and neck cancer. 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. 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 current NAVIGATE 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 COVID-19 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 as well as impact other trial related activities including, amongst others, manufacturing and regulatory reviews. 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, 2020, 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) 620-3186ir@galectintherapeutics.com 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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  • Company News for Apr 15, 2021

    Companies in the news are: FRC, TV, GALT, DG

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  • Galectin Therapeutics Stock Is Trading Higher After Belapectin-Pembrolizumab Combo Study Shows Enhanced Tumor Response

    Galectin Therapeutics Inc (NASDAQ: GALT) has announced that a paper in the peer-reviewed Journal for ImmunoTherapy of Cancer (JITC) published data from an ongoing Phase 1 trial evaluating Galectin's belapectin in head & neck cancer, lung cancer, and melanoma. The study assessing belapectin combined with Merck's & Co's (NYSE: MRK) Keytruda (pembrolizumab) is being conducted to collaborate between Galectin and Providence Cancer Institute in Portland. As previously disclosed, an objective response of 50% in advanced metastatic melanoma and 33% in head and neck squamous cell carcinoma patients was observed in the study. It compares favorably to published response rates on pembrolizumab alone. The publication also noted that the combination was associated with fewer immune-mediated adverse events than anticipated with pembrolizumab alone. Besides, the patient's tumor tissue analysis showed reduced monocytic myeloid-derived suppressor cells and increased effector memory T-cell activation in responders compared with non-responders. An increase in baseline expression of galectin-3 positive tumor cells correlated with clinical response was also seen. Belapectin (GR-MD-02) is a complex carbohydrate drug that targets galectin-3, a critical protein in NASH and fibrosis's pathogenesis. The company believes Galectin-3 has a significant role in cancer as well. The drug candidate binds to galectin-3 and disrupts its function. Price Action: GALT shares are up 24.3% at $2.69 in the premarket session on the last check Wednesday. See more from BenzingaClick here for options trades from BenzingaSouth African Variant Able To Elude Pfizer/BioNTech' Vaccine Protection, Israeli Study Shows: ReportGovernment, Officials Defend AstraZeneca's COVID-19 Shot: CNBC© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

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  • Journal for ImmunoTherapy of Cancer Publishes Phase 1 Clinical Research Showing Belapectin, Galectin Therapeutics’ Galectin-3 Inhibitor, Enhances Tumor Response in Combination with Anti-PD-1 Therapy

    Combination therapy with belapectin suggests a better objective response rate with fewer adverse events than pembrolizumab (KEYTRUDA®) aloneNORCROSS, Ga., April 13, 2021 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins, today announced that a paper published in the peer-reviewed Journal for ImmunoTherapy of Cancer (JITC), the highest ranked fully open access immunology journal, provides further clinical evidence that using belapectin, a potent galectin-3 inhibitor, in combination with pembrolizumab (KEYTRUDA®), a PD-1 inhibitor, significantly enhances tumor response to immunotherapy in patients with advanced metastatic melanoma (MM) and head and neck squamous cell carcinoma (HNSCC). The paper, titled “Enhancing Clinical and Immunological Effects of anti-PD-1 with Belapectin, a Galectin-3 Inhibitor” (doi:10.1136/jitc-2021-002371) describes results from an ongoing Phase 1 clinical study, a collaboration between Galectin Therapeutics and Providence Cancer Institute in Portland, Oregon. Following the recent publication of positive preclinical results that showed the inhibition of galectin-3 in combination with an agonist anti-OX40 monoclonal antibody reprograms the tumor microenvironment to favor anti-tumor activity, the current study tests the clinical hypothesis that galectin-3 blockade with belapectin in combination with pembrolizumab enhances tumor response for patients with advanced MM or HNSCC. In the study, as previously disclosed, an objective response was observed in 50% of MM (7/14) and 33% of HNSCC (2/6) patients. This compares favorably to published response rates on pembrolizumab alone. The authors noted that the combination was associated with fewer immune-mediated adverse events than anticipated with pembrolizumab alone. In addition, the analysis of patients’ tumor tissue revealed reduced monocytic myeloid-derived suppressor cells and increased effector memory T-cell activation in responders compared with non-responders. Also, an increased baseline expression of galectin-3 positive tumor cells correlated with clinical response. “Immunotherapy is a significant breakthrough in the treatment of many cancers, but tumor-induced immune suppression contributes to treatment resistance. Galectin-3 is an important driver of this tumor-induced immunosuppression, and this clinical study constitutes proof-of-concept that the addition of belapectin, a galectin-3 inhibitor, to a PD-1 inhibitor can benefit cancer patients,” said Dr. Brendan Curti, M.D., Earle A. Chiles Research Institute, a division of Providence, and the first author of the paper. “The analysis of patients’ tumor tissues is consistent with previously published pre-clinical data with belapectin and confirms the ability of belapectin to modulate the tumor microenvironment to favor anti-tumor activity. The possibility to improve the tolerance and safety of immunotherapy is also very exciting,” commented Pol F. Boudes, M.D., Chief Medical Officer of Galectin Therapeutics. “These proof-of-concept clinical data provide a strong rationale to initiate a randomized placebo-controlled phase 2 clinical trial to evaluate the efficacy and safety of belapectin in combination with a PD-1 inhibitor compared to a PD-1 inhibitor alone in this cancer patient population. We look forward to continuing our work with Providence Cancer Institute, and we anticipate the upcoming release of additional data from the expansion cohort in this study.” 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 NASH 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. Belapectin binds to galectin-3 and disrupts its function. Preclinical data in animals have shown that belapectin has robust treatment effects in reversing liver fibrosis and cirrhosis. A Phase 2 study showed belapectin may prevent the development of esophageal varices in NASH cirrhosis; these results provide the basis for the conduct of the NAVIGATE trial. The NAVIGATE trial (NAVIGATEnash.com), 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” began enrolling patients in June 2020 and is posted on www.clinicaltrials.gov (NCT04365868). Galectin-3 also has a significant role in cancer, and the Company is supporting a Phase 1 study in combined immunotherapy of belapectin and KEYTRUDA in treatment of advanced melanoma and in head and neck cancer. 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. About Providence Cancer Institute Providence Cancer Institute, a part of Providence St. Joseph Health, offers the latest in cancer services, including diagnostic, treatment, prevention, education, support and internationally renowned research. Providence Cancer Institute is home to the Earle A. Chiles Research Institute, a world-class research facility located within the Robert W. Franz Cancer Center in Portland, Oregon, and is a recognized leader in the field of cancer immunotherapy since 1993. Investigators lead more than 400 active clinical trials in key areas such as cancers of the: breast, colon/rectum, prostate, lung, esophagus, liver and pancreas, head and neck, ovary, skin and blood. Other studies are investigating treatments for COVID-19. Learn more at providenceoregon.org/cancer. 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 current NAVIGATE 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 COVID-19 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 as well as impact other trial related activities including, amongst others, manufacturing and regulatory reviews. 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, 2020, 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) 620-3186ir@galectintherapeutics.com 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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  • Galectin Therapeutics Launches NAVIGATEnash.com, a Resource for Both Patients and Physicians about its Innovative NASH Cirrhosis Study

    Galectin Therapeutics is actively recruiting patients into NAVIGATE, its seamless, adaptive Phase 2b/3 study of belapectin for the prevention of esophageal varices in NASH cirrhosisNORCROSS, Ga., April 06, 2021 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins, today announced the launch of NAVIGATEnash.com, its dedicated trial website. The new website intends to educate patients and physicians about liver cirrhosis resulting from non-alcoholic steatohepatitis (NASH) as well as support NAVIGATE, the Company’s innovative, seamless adaptive Phase 2b/3 study in NASH cirrhosis. There is currently no treatment to stop the progression and more serious complications of NASH cirrhosis. The NAVIGATE Study is offering patients and their families an opportunity to contribute to the development of the first potential therapy targeted specifically at NASH cirrhosis and designed to improve clinical outcomes. “Discussions in our broad community tend to focus on investment and intervention in early stages of NASH, with little attention given to patients who have progressed to NASH cirrhosis. However, since assuming my role in September, I have been moved by the determination of this overlooked patient community and the physicians who treat them. Both deserve dedication and investment in finding a meaningful treatment,” said Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics. “NAVIGATEnash.com is not only meant to engage this important community – who may be looking to participate in NAVIGATE – and inform others about NASH cirrhosis, it is intended to send a message to a much broader community that we are willing to overcome the largest challenge in this space.” “NASH is quickly becoming the number one cause of liver cirrhosis. Unfortunately, the only treatment option for patients who progress to NASH cirrhosis is a liver transplant, something we, at Galectin Therapeutics, hope to change,” said Pol F. Boudes M.D., Chief Medical Officer of Galectin Therapeutics. “We want to provide the necessary information to patients and physicians about our study, since, unlike other clinical trials in NASH, NAVIGATE specifically targets the prevention of a potentially life-threatening manifestation of NASH cirrhosis.” NAVIGATEnash.com is designed to educate patients, their families, and friends on the causes and potential complications of NASH cirrhosis. The site provides resources for additional information, details about NAVIGATE, and how, potentially, to participate. A “For Physicians” section provides physicians information on NASH cirrhosis and guidance on whether participating or referring patients to NAVIGATE might be appropriate. The goal of the NAVIGATE Study is to prevent the development of esophageal varices, thought to be an early sign of more serious complications of NASH cirrhosis. Bleeding esophageal varices are a cause of death in about one-third of cirrhotic patients. An earlier clinical trial showed that belapectin, a galectin-3 inhibitor, may prevent the development of esophageal varices in patients with compensated NASH cirrhosis and was well tolerated and appeared safe. About NASH Cirrhosis NASH cirrhosis is the end stage of non-alcoholic steatohepatitis (NASH), which is characterized by the presence of excess fat in the liver. Over time, scar tissue and regenerative nodules resulting from the inflammation and fibrosis of NASH replace healthy liver tissue, preventing the liver from functioning normally. Over 28 million people in the U.S. are thought to suffer from NASH, and an estimated 1 to 2 million of them will eventually progress to NASH cirrhosis. NASH cirrhosis will soon become the number one reason for liver transplants. 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 NASH 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. Belapectin binds to galectin-3 and disrupts its function. Preclinical data in animals have shown that belapectin has robust treatment effects in reversing liver fibrosis and cirrhosis. A Phase 2 study showed belapectin may prevent the development of esophageal varices in NASH cirrhosis. Galectin-3 also has a significant role in cancer, and the Company is supporting a Phase 1 study in combined immunotherapy of belapectin and Keytruda® in treatment of advanced melanoma and in head and neck cancer. About the NAVIGATE Study The NAVIGATE Study (originally named the NASH-RX trial) is an international, seamless, adaptively-designed Phase 2b/3 trial of the galectin-3 inhibitor belapectin (GR-MD-02), the company's lead compound, in 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. The NAVIGATE Study 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. After 18 months of treatment, an interim analysis will be conducted to determine the optimum dosage of belapectin, and the NAVIGATE Study will move into Phase 3 with additional patients for another 18 months of treatment. More information on the NAVIGATE Study can be found at NAVIGATEnash.com. 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 current NAVIGATE 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 COVID-19 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 as well as impact other trial related activities including, amongst others, manufacturing and regulatory reviews. 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, 2020, 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) 620-3186ir@galectintherapeutics.com Media Contact:Gregory FCALexi Burchmore, Account Supervisor(215) 301-1181lexib@gregoryfca.com 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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  • Galectin Therapeutics Reports Fiscal 2020 Financial Results and Provides Business Update

    NORCROSS, Ga., March 31, 2021 (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, 2020. 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. Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics, said, “I am very encouraged by the progress achieved in fiscal 2020, and remain extremely optimistic for 2021. Given the current challenging environment, I am proud of our success, highlighted by site activations and ongoing enrollment of our innovative NAVIGATE study. This global program continues to be the only active late-stage trial of patients with compensated NASH cirrhosis, where the medical need is greatest and with a clinically meaningful endpoint. Our concurrent hepatic impairment study will also provide important information on belapectin tolerance, safety and exposure in advanced cirrhotic patients. Over the course of the last year at the Board’s direction we have taken aggressive steps to strengthen our organization, adding Pol Boudes as Chief Medical Officer, as well as Mr. Richard Zordani and Dr. Elissa Schwartz to our Board of Directors. These changes informed my decision to accept the role of Chief Executive Officer, and they afforded me the confidence to receive 80% of my compensation in the form of Galectin stock. Additionally, I believe this breadth of talent reinvigorated Galectin and placed the Company in a position to monetize our assets. This has served to strengthen my commitment to my compensation strategy, which aligns my interests with all shareholders. More recently, the peer-reviewed publication of a well-recognized mouse model has shown that the combination of belapectin, a galectin-3 inhibitor, with immunotherapy reprograms the tumor microenvironment. This favors anti-tumor immunity, results in better anti-tumor activity, and most importantly, brings further rationale for our ongoing cancer trial combining belapectin with Keytruda®, a potent PD-1 inhibitor. Providence Cancer Institute is currently conducting the study and preliminary results suggest improved activity and, potentially, improved tolerance of this regimen. I am extremely confident in our science, our team, and our progress,” concluded Lewis. The upcoming year will be dedicated to advancing our trial in NASH cirrhosis and supporting investigations of belapectin’s safety and efficacy in other indications, such as the ongoing cancer trial in conjunction with the Providence Cancer Institute. I also want to recognize the outstanding efforts of our entire team, who persevered through the challenges precipitated by COVID-19 in the interest of developing a therapy for NASH cirrhosis, a critical, unmet medical need. Let me once again thank the investigators and patients participating in our NAVIGATE trial, where a positive outcome would be very clinically relevant for patients with NASH cirrhosis.” Richard E. Uihlein, Chairman of the Board, added, “I want to echo Joel’s sentiment and thank Pol, Jack and our entire team for their dedication throughout this past year, especially their commitment to initiating our exciting NAVIGATE trial under less than optimal circumstances due to the global pandemic. Joel has proven to be the leader we all expected, and I am pleased with the progress he has achieved since assuming the role and confident in his ability to unlock the value of our proprietary compound, belapectin. Peer-reviewed research, such as that recently published in OncoImmunology, clearly confirms our basic scientific premise regarding belapectin’s anti-inflammatory characteristics in a broad range of fibrosis as well as its ability to potentially enhance the efficacy of cancer therapies. As such, the NAVIGATE trial represents an opportunity to further demonstrate the anti-inflammatory activity of belapectin, which would open up vast new opportunities to investigate other indications and establish our compound as a foundation for a platform technology.” NAVIGATE Trial Update The NAVIGATE trial uses a seamless, adaptive design to confirm dose selection and reaffirm the observed efficacy of belapectin to prevent the development of esophageal varices in the NASH-CX trial. Pre-planned adaptations will inform the larger Phase 3 trial component.Key clinical study milestones: First patient randomized August 2020130+ sites, 12 countries in North America, Europe, Asia and AustraliaPhase 2b part to Interim Analysis will be ~315 patientsRecruiting period for phase 2b portion now expected to conclude around the end of 2021 due to COVID-19 impact on recruitmentKey inclusion criteria - NASH cirrhosis (baseline or historical liver biopsy), clinical sign of portal hypertension, no esophageal varices (esophago-gastro endoscopy)Interim analysis expected late 2023 Peer-reviewed publication, Scientific Presentations and Conferences OncoImmunology published a peer-reviewed article describing how belapectin, a potent galectin-3 inhibitor, in combination with an anti-OX40 (CD134) monoclonal antibody, reduces tumor progression compared to either agent alone. The paper, titled “Galectin-3 inhibition with belapectin combined with anti-OX40 therapy reprograms the tumor microenvironment to favor anti-tumor immunity,” describes results from a collaboration between Galectin Therapeutics and Providence Cancer Institute highlighting the mechanism of action of the combination which is explained by a reduction in myeloid-derived suppressor cell infiltration and function coupled to an increase in T-cell effector function. For many years, galectin-3 has been known to play a key role in the control of tumor-induced immunosuppression. Galectin-3 acts to maintain tumor growth, in part, by supporting the generation of suppressive macrophages and inhibiting T cell function. This creates an attractive rationale for the use of a galectin-3 inhibitor, such as belapectin, to improve anti-tumor activities of multiple cancer therapies. Financial Results For the year ended December 31, 2020, the Company reported a net loss applicable to common stockholders of $23.6 million, or ($0.41) per share, compared to a net loss applicable to common stockholders of $20.2 million, or ($0.39) per share for the full year 2019. The increase is largely due to an increase in research and development expenses related to our NAVIGATE clinical trial, partially offset by a non-cash, one-time warrant modification charge of $6.6 million in 2019.Research and development expense for 2020 was $18.0 million compared with $7.5 million for 2019. The increase was primarily due to costs related to our NAVIGATE clinical trial, along with preparations and some preclinical activities incurred in support of the clinical program, such as development and reproductive toxicity studies, clinical supplies and other supportive activities. General and administrative expenses for 2020 were $5.5 million, down from $6.0 million for the full year 2019, primarily due to decreases in legal, investor relations and non-cash stock-based compensation expenses partially offset by an increase in insurance expenses.As of December 31, 2020, the Company had $27.1 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 March 31, 2022.The Company expects that it will require more cash to fund operations after March 31, 2022, and believes it will be able to obtain additional financing as needed. The currently planned operations include costs related to our adaptively designed NAVIGATE Phase 2b/3 clinical trial. Currently, we expect to require an additional approximately $45-$50 million to cover costs of the trial to reach the planned interim analysis estimated to occur in the second half of 2023 along with drug manufacturing and other scientific support activities and general and administrative costs and further amounts to complete the Phase 3 portion of the trial. However, there can be no assurance that we will be successful in obtaining such new financing or, if available, that such financing will be on terms favorable to us. About Galectin TherapeuticsGalectin 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 StatementsThis 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 continue to impact 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, 2020, 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) 620-3186ir@galectintherapeutics.com. 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, 2020 2019 Operating expenses: Research and development $17,976 $7,467 General and administrative 5,468 5,971 Total operating expenses 23,444 13,438 Total operating loss (23,444) (13,438)Other income (expense): Interest income 66 231 Interest expense (87) (87)Total other income (21) 144 Net loss $(23,465)$(13,294)Preferred stock dividends (137) (263)Warrant modification - (6,622) Net loss applicable to common stock $(23,602)$(20,179) Basic and diluted net loss per share $(0.41)$(0.39)Shares used in computing basic and diluted net loss per share 57,029 52,238 Condensed Consolidated Balance Sheet Data December 31, 2020 December 31, 2019 (in thousands)Cash and cash equivalents$27,142$47,480Total assets 29,600 48,467Total current liabilities 5,399 2,820Total liabilities 5,407 2,872Total redeemable, convertible preferred stock 1,723 1,723Total stockholders’ equity$29,600$43,872

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  • OncoImmunology Publishes Pre-clinical Research Showing Galectin Therapeutics’ Belapectin Galectin-3 Inhibitor Reduces Tumor Progression in Combination with Anti-OX40 Therapy

    Research deciphers belapectin’s mechanism of action, further rationalizing its use in combination with checkpoint inhibitors or T cell agonists in oncology and as a monotherapy in NASH cirrhosisNORCROSS, Ga., March 08, 2021 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins, today announced that a paper published in the peer-reviewed journal OncoImmunology demonstrates how belapectin, a potent galectin-3 inhibitor, in combination with an anti-OX40 (CD134) monoclonal antibody, significantly reduces tumor progression compared to either agent alone. For many years, galectin-3 has been known to play a key role in the control of tumor-induced immunosuppression. Galectin-3 acts to maintain tumor growth, in part, by supporting the generation of suppressive macrophages and inhibiting T cell function. The paper, titled “Galectin-3 inhibition with belapectin combined with anti-OX40 therapy reprograms the tumor microenvironment to favor anti-tumor immunity,” describes results from a collaboration between Galectin Therapeutics and Providence Cancer Institute in Portland, Oregon. The paper highlights the mechanism of action of the combination which is explained by a reduction in myeloid-derived suppressor cell infiltration and function coupled to an increase in T-cell effector function. In tumor-bearing mice, these effects led to both tumor regression and improved survival. “Immunotherapy represents a significant breakthrough in the treatment of many cancers. However, tumor-induced suppression could decrease response to anti-OX40 therapy,” said senior author William L. Redmond, Ph.D., Associate Member, Laboratory of Cancer Immunotherapy, and Director, Immune Monitoring Laboratory at the Earle A. Chiles Research Institute, a division of Providence. “As galectin-3 drives this tumor-induced immunosuppression, it was an attractive hypothesis to combine belapectin with anti-OX40 immunotherapy. We demonstrated that the addition of belapectin could overcome this resistance and we were also able to decipher the underlying mechanism of action.” “This is very significant research,” noted Pol F. Boudes, M.D., Chief Medical Officer of Galectin Therapeutics. “It further validates the rationale for the ongoing clinical research at Providence Cancer Institute, combining belapectin with pembrolizumab (Keytruda®), a programmed death receptor-1 (PD-1)-blocking antibody. Preliminary results indicated that the combination of Keytruda® and belapectin may improve the efficacy of this potent PD-1 inhibitor while also improving its tolerance.” Dr. Boudes added, “These data, demonstrating the essential role of cells of the monocytic macrophages lineage can also be translated to our ongoing belapectin clinical program in patients affected with NASH cirrhosis. In cirrhosis, as with the tumor microenvironment of cancer, activated macrophages invade the hepatic parenchyma and promote inflammation, fibrosis and ultimately the failure of this essential organ. Belapectin, thanks to its molecular structure, is uniquely able to target macrophages, which, incidentally, are also the main producer of galectin-3 in liver cirrhosis.” The OncoImmunology paper is now openly accessible online on the journal website and at galectintherapeutics.com/publications/. 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 NASH 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. Belapectin binds to galectin-3 and disrupts its function. Preclinical data in animals have shown that belapectin has robust treatment effects in reversing liver fibrosis and cirrhosis. A Phase 2 study showed belapectin may prevent the development of esophageal varices in NASH cirrhosis; these results provide the basis for the conduct of the NAVIGATE trial. The NAVIGATE 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” began enrolling patients in June 2020 and is posted on www.clinicaltrials.gov (NCT04365868). Galectin-3 also has a significant role in cancer, and the Company is supporting a Phase 1 study in combined immunotherapy of belapectin and Keytruda in treatment of advanced melanoma and in head and neck cancer. About Galectin TherapeuticsGalectin 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. About Providence Cancer InstituteProvidence Cancer Institute, a part of Providence St. Joseph Health, offers the latest in cancer services, including diagnostic, treatment, prevention, education, support and internationally renowned research. Providence Cancer Institute is home to the Earle A. Chiles Research Institute, a world-class research facility located within the Robert W. Franz Cancer Center in Portland, Oregon, and is a recognized leader in the field of cancer immunotherapy since 1993. Investigators lead more than 400 active clinical trials in key areas such as cancers of the: breast, colon/rectum, prostate, lung, esophagus, liver and pancreas, head and neck, ovary, skin and blood. Other studies are investigating treatments for COVID-19. Learn more at providenceoregon.org/cancer. Forward Looking StatementsThis 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 current NASH-RX 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 COVID-19 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 as well as impact other trial related activities including, amongst others, manufacturing and regulatory reviews. 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) 620-3186ir@galectintherapeutics.com 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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  • Galectin Therapeutics to Present at H.C. Wainwright Global Life Sciences Conference

    NORCROSS, Ga., March 04, 2021 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins, today announced that Dr. Pol Boudes, M.D., Chief Medical Officer, will provide a corporate overview at the upcoming H.C. Wainwright Global Life Sciences Conference to be held March 9-10, 2021. The presentation will be available for on-demand listening beginning March 9, 2021 at 7:00 am (EST) and archived for 90 days. Webcast link: https://journey.ct.events/view/13f2dc13-e58d-46ec-aba7-9bf66a19982e About Galectin TherapeuticsGalectin 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 StatementsThis 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 current NASH-RX 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 COVID-19 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 as well as impact other trial related activities including, amongst others, manufacturing and regulatory reviews. 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) 620-3186ir@galectintherapeutics.com 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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  • What Kind Of Investors Own Most Of Galectin Therapeutics, Inc. (NASDAQ:GALT)?

    A look at the shareholders of Galectin Therapeutics, Inc. ( NASDAQ:GALT ) can tell us which group is most powerful...

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  • Insider Sells Galectin Therapeutics Stock

    A Form 4 filing filed with the SEC on Tuesday, January 19 showed that Amelio Gilbert F sold 60,000 shares of Galectin Therapeutics Inc (NASDAQ:GALT)at an average price of $2.17. The transaction moved the executive's stake in Galectin Therapeutics Inc. to 60,614 shares. Shares of Galectin Therapeutics decreased by 0.5% from the previous closing price.Why Insider Transactions Are Important? While transactions from an insider shouldn't be used as the sole item to make an investment or trading decision, an insider buying or selling stock in their company can be a good added factor that leads to more conviction in a decision.When an insider buys stock after an important sell off, that can indicate the insider's faith in the success of the organization. Henceforth, if the stock is bought at new highs, it might be because the insider feels that the stock is not overvalued. Conversely, insiders who are selling stock at new lows can potentially indicate some kind of capitulation moment. Insiders selling at new highs can indicate that exec wants to "take some profit" and "lock in a gain."Important Transaction Codes Investors prefer focusing on transactions which take place in the open market, indicated in the Form 4 with codes P for purchase and S for sale. An open-market transaction means the insider went into the market of their own volition and made an active decision about the potential path for a company and its stock moving forward.Transaction codes other than P or S are often viewed with less conviction as they are often not tied to a decision by the exec. As an example, transaction code C indicates the conversion of an option. Transaction code A indicates the insider may have been forced to sell shares in order to receive compensation the exec was promised upon being hired by a company.See more from Benzinga * Click here for options trades from Benzinga * ROCE Insights For Nike * Looking Into Energy Transfer's Return On Capital Employed(C) 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

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  • Galectin Therapeutics, Inc. to Present at the 4th Annual Digital NASH Summit on December 17, 2020

    NORCROSS, Ga., Dec. 11, 2020 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins, today announced that Pol F. Boudes, M.D., Chief Medical Officer, has been invited to make a presentation, entitled “Belapectin, a Galectin-3 Inhibitor in Phase 2b/3 for the Treatment of NASH Cirrhosis,” at the 4th Annual Digital NASH Summit. Dr. Boudes will be speaking at 09:00 AM EST on December 17, 2020. To register for the 4th Annual NASH Summit, click here: https://nash-summit.com/get-involved/register/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 models have shown that belapectin has robust treatment effects in reversing liver fibrosis and cirrhosis. Belapectin results in the NASH-CX clinical trial, which were published in Gastroenterology, exhibited a favorable safety profile and clinically meaningful efficacy results in patients without esophageal varices at baseline demonstrated by a prevention of development of varices when compared to placebo; these results provide the basis for the conduct of the NASH-RX trial. The NASH-RX 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” began enrolling patients in June 2020 and is posted on www.clinicaltrials.gov (NCT04365868).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 current NASH-RX 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 COVID-19 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 as well as impact other trial related activities including, amongst others, manufacturing and regulatory reviews. 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 ir@galectintherapeutics.comGalectin 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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  • Galectin Therapeutics Inc. Recaps Results of Annual Meeting of Stockholders Presentation

    Chairman Dick Uihlein, CEO and President Joel Lewis, and Chief Medical Officer Pol Boudes Provide Corporate Highlights on Company’s Three Active Clinical TrialsNORCROSS, Ga., Dec. 04, 2020 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins, today announced the passing of the two items on the Agenda for the 2020 Annual Meeting of Stockholders, that being the election of 11 nominees to the Board of Directors, and the ratification of Cherry Bekaert LLP as the company’s independent, registered public accounting firm.In addition, Chairman Dick Uihlein, CEO and President Joel Lewis, and Chief Medical Officer Pol Boudes provided a corporate update. Among the Highlights of the Presentation: Chairman Dick Uihlein noted that this year’s management transition has been seamless, and he has every confidence that we have the right team in place. Chief Executive Officer and President Joel Lewis noted that the Company’s open-label pharmacokinetic hepatic impairment study, “…is related to the cirrhotic population we are targeting for belapectin, we intend to fully utilize the knowledge we gain from the data derived from the study, not only for regulatory interaction, but to help create a roadmap for future research.” Chief Medical Officer Pol Boudes noted that relative to the Company’s cancer immunotherapy trial, “Our colleagues at Providence have already concluded that a phase 2 combination program where the combination of belapectin to Keytruda could be compared to Keytruda alone would be justified, first to confirm the efficacy of the combination but also to test the hypothesis on the reduction of auto-immune toxicities associated with PD-1 inhibitor monotherapy. We are currently evaluating the best options regarding the financing as well as the operational conduct of such a study that could identify an important advance for patients affected with these cancers.” A Full Transcript of the presentation is available on the Company’s website https://investor.galectintherapeutics.com/investor-relations.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 models have shown that belapectin has robust treatment effects in reversing liver fibrosis and cirrhosis. Belapectin results in the NASH-CX clinical trial, which were published in Gastroenterology, exhibited a favorable safety profile and clinically meaningful efficacy results in patients without esophageal varices at baseline demonstrated by a prevention of development of varices when compared to placebo; these results provide the basis for the conduct of the NASH-RX trial. The NASH-RX 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” began enrolling patients in June 2020 and is posted on www.clinicaltrials.gov (NCT04365868).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 current NASH-RX 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 COVID-19 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 as well as impact other trial related activities including, amongst others, manufacturing and regulatory reviews. 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 ir@galectintherapeutics.com 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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  • Galectin Therapeutics to Webcast Corporate Update on December 3, 2020 after Annual Meeting of Stockholders

    NORCROSS, Ga., Dec. 01, 2020 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins, announced today that management will present a corporate update via live webcast immediately following the business portion of its 2020 Annual Meeting of Stockholders to be held on Thursday, December 3, 2020, beginning at 11:00 a.m. EST. The Annual Meeting of Stockholders and webcast can be accessed via www.virtualshareholdermeeting.com/GALT2020 .Please log in approximately 10 minutes before the event to ensure a timely connection.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 for NASH cirrhosis 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.Contact Jack Callicutt, Chief Financial Officer (678) 620-3186 ir@galectintherapeutics.comGalectin 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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  • Galectin Therapeutics Provides Business Update And Reports Financial Results for the Quarter Ended September 30, 2020

    Innovative Phase 2b/3 NASH-RX Trial in NASH Cirrhosis Initiated Board Member Joel Lewis Assumes CEO Role – Board Adds Two New Highly Accomplished ProfessionalsNORCROSS, Ga., Nov. 09, 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 September 30, 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.Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics, said, “With the June launch of our innovative NASH-RX clinical trial, we now have one of the very few, if not only, active late stage trial of patients with compensated NASH-cirrhosis, where the medical need is greatest.  Continuing our progress, the first patient was randomized in August and we are enrolling patients and adding sites to this global clinical trial of belapectin, our proprietary galectin-3 inhibiting compound.  We believe our innovative trial design, experienced medical and clinical teams and clear primary endpoint provide a strong foundation for success.  A positive result will be very clinically relevant. If the trial shows that belapectin is effective and safe, it will be a medical breakthrough for patients with NASH cirrhosis.”“As I close out my first quarter as the head of Galectin Therapeutics, I want to reiterate how excited I am to be leading this team,” concluded Lewis. “I also want to thank the investigators and patients who will participate in our NASH-RX trial.  Without your commitment, there is no way the company would be where we are today nor would we have a future.”Richard E. Uihlein, Chairman of the Board, added, “Galectin Therapeutics is competitively well-positioned in the industry, and we are fortunate to have Joel leading these efforts. I am also glad to welcome Mr. Richard Zordani and Dr. Elissa Schwartz to our Board of Directors, both seasoned professionals that will strengthen our financial and clinical capabilities, respectively.”“Success in NASH cirrhosis potentially opens new treatment possibilities for belapectin's use in other types of liver cirrhosis and in other forms of organ fibrosis affecting kidney, lung, as well as other organs. More research is warranted to expand our understanding of galectins and the role that a galectin-3 inhibitor like belapectin may play in preventing and treating disease. Thus, our NASH-RX trial will set the stage for realizing the full potential of our proprietary compound, belapectin.”Summary of Key Development Programs and Updates * On June 30 announced that we had enrolled our first patients in the NASH-RX trial. NASH-RX is an international, seamless, adaptively-designed Phase 2b/3 trial of our 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). * Announced the appointment of current board member, Joel Lewis, to the position of Chief Executive Officer (CEO) and President. In this position, Mr. Lewis will set corporate strategy and oversee operations, most importantly the Company’s global NASH-RX adaptively-designed trial for the prevention of varices in NASH cirrhosis patients using its proprietary galectin-3 inhibiting compound, belapectin (GR-MD-02).  * Engaged Dr. Harold Shlevin, who retired from the CEO position, to a consulting agreement through which he has agreed to devote significant effort to advancing the NASH-RX trial and will remain a member of the Board of Directors. * Enhanced its Board of Directors with the addition of two additional directors, Mr. Richard Zordani and Dr. Elissa Schwartz. Mr. Zordani is a seasoned financial executive with extensive public accounting and Family Office experience and has assumed the role of Audit Committee Chairman. Dr. Schwartz has extensive experience in epidemiology and clinical research, biomathematics, and biostatistics, which complements the Company's clinical development capabilities. * Hosted a virtual conference call and webinar with the investment community on September 29th that provided a comprehensive description and update on the status of the NASH-RX trial and introduced our new CEO, Joel Lewis.  A replay of the Investor Call can be accessed at this link: https://edge.media-server.com/mmc/p/hmudntygAbout the NASH-RX Trial * The NASH-RX trial will use a seamless, adaptive design to confirm dose selection and reaffirm the observed efficacy of belapectin to prevent the development of esophageal varices in the NASH-CX trial. Pre-planned adaptations will inform the larger Phase 3 trial component. NASH-RX is expected to enroll approximately 315 NASH cirrhotic patients in the Phase 2b part of the trial at approximately 130 sites in 12 countries in North America, Europe, Asia and Australia.Financial ResultsFor the three months ended September 30, 2020, the Company reported a net loss applicable to common stockholders of $5.955 million, or ($0.10) per share, compared to a net loss applicable to common stockholders of $2.819 million, or ($0.05) per share for the three months ended September 30, 2019. The increase is due to 2020 research and development expense related to the Company’s NASH-RX trial. Research and development expense for the three months ended September 30, 2020 was $4.780 million compared with $1.503 million for the three months ended September 30, 2019. The increase was primarily due to costs related to our NASH-RX clinical trial, along with preparations and some preclinical activities incurred in support of the clinical program, such as development and reproductive toxicity studies, clinical supplies and other supportive activities. General and administrative expenses for the three months ended September 30, 2020, were $1.146 million, down from $1.360 million for the three months ended September 30, 2019, primarily due to a decrease in stock-based compensation expenses. As of September 30, 2020, the Company had $32.6 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 December 31, 2021. The Company expects that it will require more cash to fund operations after December 31, 2021 and believes it will be able to obtain additional financing as needed. Currently, we expect to require an additional approximately $40 million to cover costs of the trial to reach the planned interim analysis estimated to occur in the second quarter of 2023 along with drug manufacturing and other scientific support activities and general and administrative costs. These costs will require additional funding. There can be no assurance that we will be successful in obtaining financing to support our operations beyond December 31, 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 NASH 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. Belapectin binds to galectin-3 and disrupts its function. Preclinical data in animals have shown that belapectin has robust treatment effects in reversing liver fibrosis and cirrhosis.  Galectin-3 has a significant role in cancer and the Company is supporting a Phase 1 study in combined immunotherapy of belapectin and Keytruda in treatment of advanced melanoma and in head and neck cancer. About Non-alcoholic steatohepatitis (NASH) with Advanced Fibrosis and Cirrhosis 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 currently the only curative treatment available. 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 for NASH cirrhosis 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 ir@galectintherapeutics.com.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 September 30, Nine Months Ended September 30,   2020  2019  2020  2019   (in thousands, except per share data) Operating expenses:            Research and development$4,780 $1,503 $11,605 $3,671  General and administrative 1,146  1,360  4,007  4,579  Total operating expenses 5,926  2,863  15,612  8,250  Total operating loss (5,926) (2,863) (15,612) (8,250) Other income (expense):                   Interest income 5  101  64  158  Interest expense (22) (22) (65) (65) Total other income (17) 79  (1) 93                Net loss$(5,943)$(2,784)$(15,613)$(8,157) Preferred stock dividends (12) (35) (72) (198) Warrant modification    (6,622)               Net loss applicable to common stock$(5,955)$(2,819)$(15,685)$(14,977)               Basic and diluted net loss per share$(0.10)$(0.05)$(0.28)$(0.27) Shares used in computing basic and diluted net loss per share 57,047  56,631  57,013  55,494  Condensed Consolidated Balance Sheet Data   September 30, 2020  December 31, 2019    (in thousands) Cash and cash equivalents $32,556 $47,480  Total assets 34,049  48,467  Total current liabilities 2,488  2,820  Total liabilities 2,507  2,872  Total redeemable, convertible preferred stock 1,723  1,723  Total stockholders’ equity $29,819 $43,872

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  • Galectin Therapeutics (NASDAQ:GALT) Is In A Good Position To Deliver On Growth Plans

    There's no doubt that money can be made by owning shares of unprofitable businesses. For example, although Amazon.com...

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  • New Strong Sell Stocks for October 12th

    Here are 5 stocks added to the Zacks Rank 5 (Strong Sell) List today

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  • These 2 Penny Stocks Could Quadruple (Or More), Says H.C. Wainwright

    Out on Wall Street, one group of stocks divides investors into either fans or critics. Penny stocks, or tickers that trade for less than $5 per share, are known for stirring up mixed reactions among market watchers, as these names are unrivaled in terms of both their risk and reward potential.Some argue the bargain prices are just too good to be true, noting that there could be a very legitimate reason they are trading at such low levels. Problems like weak fundamentals or overwhelming headwinds come to mind here.However, the more risk-tolerant see the possibility of colossal returns as too enticing to ignore. With these stocks, you get more bang for your buck. Additionally, given the lower price tags, even minor share price appreciation can translate to massive percentage gains.Taking this into account, we turned to the pros from investment firm H.C. Wainwright for some inspiration. Looking at two penny stocks with the H.C. Wainwright stamp of approval, the firm’s top analysts believe both could quadruple, or more, in the next year.Running the tickers through TipRanks’ database, we wanted to find out what makes both names so compelling even with the risk involved.ObsEva SA (OBSV)Hoping to usher in a new era in women’s reproductive health, ObsEva works to bring the products women need to market. Currently going for $2.5 apiece, H.C. Wainwright thinks that the share price presents an attractive entry point.Representing the firm, 5-star analyst Raghuram Selvaraju points out that pivotal data for linzagolix, the company’s lead candidate, in uterine fibroids appears “best-in-class.” Linzagolix is an orally administered gonadotropin-releasing hormone (GnRH) receptor antagonist that could potentially provide effective management of endometriosis-associated pain while mitigating bone mineral density loss and other adverse effects typically associated with the currently approved treatment.Looking at the data from the pivotal trials of the therapy, PRIMROSE 1 and PRIMROSE 2, the former met the primary endpoint at 24 weeks, demonstrating that women receiving linzagolix experienced a statistically significant and clinically meaningful reduction in menstrual blood loss compared to placebo. Additionally, patients that received the 200mg dose of linzagolix with add-back therapy (ABT) achieved a 75.5% responder rate and those receiving the 100mg dose of linzagolix without ABT achieved a 56.4% responder rate.As for PRIMROSE-2, longer-term data revealed that continued treatment with linzagolix for 52 weeks provided sustained efficacy, with the drug also well-tolerated. Responder rates of 91.6% and 53.2% were observed in women receiving 200mg with ABT and 100mg without ABT, respectively, both of which are similar to the responder rates observed at week 24 of the study. Weighing in on this result, Selvaraju stated, “This underscores the durability of the efficacy achieved with linzagolix.”Given that both studies saw women receiving linzagolix experience statistically significant improvements across a number of clinically relevant secondary endpoints, including reduction in pain, improvement in anemia and quality of life, Selvaraju has high hopes.“From our vantage point, linzagolix appears to have best-in-class potency among the clinical-stage gonadotropin-releasing hormone (GnRH) receptor antagonists, along with the ability to be deployed without ABT. Thus, we continue to see it as a best-in-class drug,” the analyst opined.On top of this, Selvaraju highlights the Phase 3 EDELWEISS trials evaluating linzagolix, with the data readout set for next year, in endometriosis as another area to watch. “Positive data for relugolix from Myovant Sciences in the SPIRIT Phase 3 trials appear to have reduced the risk profile of linzagolix in treating endometriosis-associated pain. Relugolix met both co-primary endpoints in each of the SPIRIT studies. We remain confident that linzagolix could be an even more effective GnRH receptor antagonist than relugolix, with the added edge of utility without add-back therapy (ABT),” he said.To this end, Selvaraju rates OBSV a Buy along with a $23 price target. Should this target be met, a twelve-month gain of 812% could be in store. (To watch Selvaraju’s track record, click here)Do other analysts agree with Selvaraju? As it turns out, most do. 3 Buy ratings and a single Hold add up to a Strong Buy analyst consensus. At $15.75, the average price target indicates 535% upside potential from current levels. (See ObsEva stock analysis on TipRanks)Galectin Therapeutics (GALT)Using its unique carbohydrate technology target galectin proteins, which are key mediators of biologic and pathologic function, Galectin Therapeutics develops new therapies to improve the lives of patients with chronic liver and skin diseases as well as cancer. While H.C. Wainwright says investors need patience when it comes to this name, which changes hands for $2.70 a share, the firm sees it as a long-term winner.On September 29, the company provided more detail on its NASH-RX Phase 2b/3 trial evaluating its galectin-3 inhibitor candidate, belapectin (GR-MD-02), designed for the treatment of NASH cirrhosis patients who have clinical signs of portal hypertension (PH) and are at risk of developing esophageal varices. It should be noted that GALT is one of the few companies with a late clinical stage candidate for NASH cirrhosis, and NASH-RX is the first and only pivotal program for the cirrhotic NASH population.NASH-RX evaluates two belapectin doses versus placebo in about 315 NASH patients in its Phase 2b portion. In addition, following a pre-specified interim analysis (IA) conducted by the trial's Data Monitoring Committee (DMC) when all patients in the Phase 2b portion have completed at least 78 weeks of treatment and underwent a gastroesophageal endoscopic (EGD) assessment, belapectin could either be eligible for accelerated approval if the primary endpoint of reduced incidence of new varices is achieved, or advance into a Phase 3 portion with an optimal belapectin dose enrolling an additional 210 patients.Covering the stock for H.C. Wainwright, 5-star analyst Ed Arce noted: “For the Phase 3 portion, Galectin could choose to implement adaptations including sample size and randomization ratio adjustments, inclusion/exclusion criteria changes, and to incorporate results of a separate hepatic impairment study. Therefore, NASH-RX has two shots on goal for success, with the interim analysis of the Phase 2b portion that is expected in Q2 2023 as its first shot on goal.”When it comes to the available clinical data, top-line results from the Phase 2b NASH-CX study demonstrated a statistically significant and clinically meaningful reduction in the absolute change of the hepatic venous pressure gradient (HVPG) at 54 weeks within a patient subset, without varices at baseline, who were treated with belapectin 2mg/kg. Arce believes it’s encouraging that no patients in this NASH-CX patient subset reported the formation of new varices, compared to 18% of patients in the placebo group.Expounding on this, Arce stated, “We note that patients with no baseline varices represented approximately 50% of the total NASH-CX study population, and is now an entry criteria for the NASH-RX study... While this subset analysis represents a small patient sample size, it nonetheless provides the early clinical rationale to support belapectin's entry into the NASH-RX trial with a specific patient population.” He added, “We continue to believe in belapectin's potential in NASH cirrhosis.”Taking all of this into consideration, Arce maintains a Buy rating and $12 price target. This target conveys his confidence in GALT’s ability to climb 358% higher in the next year. (To watch Arce’s track record, click here)Turning to the rest of the Street, it has been quiet with respect to other analyst activity. As Arce is the only analyst that has thrown an opinion into the mix over the last three months, GALT is a Moderate Buy. (See GALT stock analysis on TipRanks)To find good ideas for penny stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights.Disclaimer: The opinions expressed in this article are solely those of the featured analysts. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.

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  • Galectin Therapeutics Investor Conference Call and Webinar Taking Place Today

    Presentation to discuss the details of the newly launched Phase 2b/3 NASH-RX clinical trial; Introduce new CEO and President Joel LewisNORCROSS, Ga., Sept. 29, 2020 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins, announced that the Company will host an investor conference call and webinar to discuss the Company’s NASH-RX clinical trial and to introduce its new CEO, Joel Lewis. The Investor Call is scheduled for today at 4:00 p.m. EDT. The presentation can be accessed by dialing (844) 899-6544 and entering the conference ID: 3695038 or at the following webcast link: https://edge.media-server.com/mmc/p/hmudntyg. A copy of the presentation to be used for the call can be found on the Company’s website at https://investor.galectintherapeutics.com/investor-relations. The call is expected to last one hour, including a Q&A session that will follow the formal remarks.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 current NASH-RX 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 COVID-19 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 as well as impact other trial related activities including, amongst others, manufacturing and regulatory reviews. 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 ir@galectintherapeutics.com.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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  • Implied Volatility Surging for Galectin Therapeutics (GALT) Stock Options

    Investors need to pay close attention to Galectin Therapeutics (GALT) stock based on the movements in the options market lately.

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  • Galectin Therapeutics Announces Investor Conference Call and Webinar on September 29, 2020

    Presentation to discuss the details of the newly launched Phase 2b/3 NASH-RX clinical trial; Introduce new CEO and President Joel LewisNORCROSS, Ga., Sept. 22, 2020 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins, announced today that the Company will host an investor conference call and webinar to discuss the Company’s NASH-RX clinical trial and to introduce its new CEO, Joel Lewis. The Investor Call is scheduled for Tuesday, September 29, 2020, at 4:00 p.m. EDT. The presentation can be accessed by dialing (844) 899-6544 and entering the conference ID: 3695038 or at the following webcast link: https://edge.media-server.com/mmc/p/hmudntyg. A copy of the presentation to be used for the call can be found on the Company’s website at https://investor.galectintherapeutics.com/investor-relations.The call is expected to last one hour, including a Q&A session that will follow the formal remarks. The Company encourages the investment community to submit their questions in advance to: info@galectintherapeutics.com and no later than Friday, September 25th at 4 PM EDT.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 current NASH-RX 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 COVID-19 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 as well as impact other trial related activities including, amongst others, manufacturing and regulatory reviews. 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 ir@galectintherapeutics.com.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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