GALT Galectin Therapeutics Inc.

3.73
-0.03  -1%
Previous Close 3.76
Open 3.76
52 Week Low 1.82
52 Week High 5.7
Market Cap $221,392,241
Shares 59,275,031
Float 24,687,598
Enterprise Value $197,272,613
Volume 110,808
Av. Daily Volume 487,901
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Upcoming Catalysts

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

Drug Stage Notes
GR-MD-02 and KEYTRUDA (pembrolizumab)
Melanoma
Phase 1b
Phase 1b
Phase 1b data released July 9, 2021. 1/9 partial responses in melanoma patients. 2/5 head and neck cancer patients displayed stable disease.

Latest News

  1. NORCROSS, Ga., Sept. 21, 2021 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins, today announced that it has entered into a $20 million convertible debt financing agreement with Richard E. Uihlein, the Company's Chairman and largest individual stockholder. This $20 million convertible debt is in addition to a $10 million convertible debt financing from Mr. Uihlein completed in April 2021.

    The loan agreement comprises two separate $10 million convertible notes, the first of which closed and funded on September 17, 2021 and the second which will close on or before December 17, 2021. The convertible notes are unsecured and bear interest at a rate of 2% compounded…

    NORCROSS, Ga., Sept. 21, 2021 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins, today announced that it has entered into a $20 million convertible debt financing agreement with Richard E. Uihlein, the Company's Chairman and largest individual stockholder. This $20 million convertible debt is in addition to a $10 million convertible debt financing from Mr. Uihlein completed in April 2021.

    The loan agreement comprises two separate $10 million convertible notes, the first of which closed and funded on September 17, 2021 and the second which will close on or before December 17, 2021. The convertible notes are unsecured and bear 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 each loan closing. The conversion price of the debt and interest is fixed at 228% above the price per share of common stock on the day prior to each closing or $5.00 per share, whichever is greater.

    Richard E. Uihlein, Chairman of Galectin Therapeutics, commented on his $20 million investment, "I remain deeply committed to the Company's success and our goal of addressing large, unmet medical needs. We are the only Company addressing NASH cirrhosis using a clinically relevant endpoint to measure efficacy. Additionally, the results from a Phase 1 trial using belapectin in combination with KEYTRUDA®, a checkpoint inhibitor, were very encouraging, particularly in patients with metastatic melanoma. This financing demonstrates my confidence in our team and our science, and I look forward to advancing our programs."

    "I want to thank Mr. Uihlein for his unwavering commitment to the Company. The impact of his financial backing and leadership as Chairman cannot be overstated," said Joel Lewis, president and Chief Executive Officer of Galectin Therapeutics. "We continue to make progress in our NAVIGATE trial for patients with NASH cirrhosis and we also are exploring how to best move forward in the treatment of metastatic melanoma, where we have seen promising early results of belapectin in combination with KEYTRUDA in the treatment of advanced melanoma. This financing, as well as the recent addition of several accomplished and experienced professionals to our management team, provide resources that will help us pursue our goals."

    About Belapectin

    Belapectin 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 randomization of patients in August, 2020, and is posted on www.clinicaltrials.gov (NCT04365868). Galectin-3 has a significant role in cancer, and the Company has supported a Phase 1b study in combined immunotherapy of belapectin and KEYTRUDA in advanced melanoma and in head and neck cancer. This trial provided a strong rationale for moving forward into a Phase 2 development program which the company is considering.

    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 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) 620-3186

    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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  2. NORCROSS, Ga., Sept. 09, 2021 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins, today announced the Company's management will present at the H.C. Wainwright 23rd Annual Global Investment Conference. The virtual conference will take place from September 13–15, 2021. In addition to the presentation, management will conduct 1-on-1 meetings with investors. For more information on the conference or to register, visit: HCW Events.

    Investors may listen to the presentation online beginning on September 13 at 7:00 A.M. (ET) via the link below.

    Company Webcasting Link: https://journey.ct.events/view/611f064c-ce3f-42b5-b780-4bf29062db8c
    Archived: 90 days

    About Belapectin

    NORCROSS, Ga., Sept. 09, 2021 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins, today announced the Company's management will present at the H.C. Wainwright 23rd Annual Global Investment Conference. The virtual conference will take place from September 13–15, 2021. In addition to the presentation, management will conduct 1-on-1 meetings with investors. For more information on the conference or to register, visit: HCW Events.

    Investors may listen to the presentation online beginning on September 13 at 7:00 A.M. (ET) via the link below.

    Company Webcasting Link: https://journey.ct.events/view/611f064c-ce3f-42b5-b780-4bf29062db8c

    Archived: 90 days

    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 Fatty Liver Disease with Advanced Fibrosis and Cirrhosis

    Non-alcoholic steatohepatitis (NASH) has become a common disease of the liver with the rise in obesity and other metabolic diseases. NASH is estimated to affect up to 28 million people in the U.S. It is characterized by the presence of excess fat in the liver along with inflammation and hepatocyte damage (ballooning) in people who consume little or no alcohol. Over time, patients with NASH can develop excessive fibrosis, or scarring of the liver, and ultimately liver cirrhosis. It is estimated that as many as 1 to 2 million individuals in the U.S. will develop cirrhosis as a result of NASH, for which liver transplantation is the only curative treatment available. Approximately 8,890 liver transplants are performed annually in the U.S. There are no drug therapies approved for the treatment of liver fibrosis or cirrhosis.

    About Galectin Therapeutics

    Galectin Therapeutics is dedicated to developing novel therapies to improve the lives of patients with chronic liver disease and cancer. Galectin's lead drug belapectin (formerly known as GR-MD-02) is a carbohydrate-based drug that inhibits the galectin-3 protein which is directly involved in multiple inflammatory, fibrotic, and malignant diseases, for which it has Fast Track designation by the U.S. Food and Drug Administration. The lead development program is in non-alcoholic steatohepatitis (NASH) with cirrhosis, the most advanced form of NASH-related fibrosis. This is the most common liver disease and one of the largest drug development opportunities available today. Additional development programs are in treatment of combination immunotherapy for advanced melanoma and other malignancies. Advancement of these additional clinical programs is largely dependent on finding a suitable partner. Galectin seeks to leverage extensive scientific and development expertise as well as established relationships with external sources to achieve cost-effective and efficient development. Additional information is available at www.galectintherapeutics.com.

    Forward Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance, and use words such as "may," "estimate," "could," "expect" and others. They are based on management's current expectations and are subject to factors and uncertainties that could cause actual results to differ materially from those described in the statements. These statements include those regarding the hope that Galectin's development program for belapectin will lead to the first therapy for the treatment of fatty liver disease with cirrhosis and those regarding the hope that our lead compounds will be successful in cancer immunotherapy and in other therapeutic indications. Factors that could cause actual performance to differ materially from those discussed in the forward-looking statements include, among others, that trial endpoints required by the FDA may not be achieved; Galectin may not be successful in developing effective treatments and/or obtaining the requisite approvals for the use of belapectin or any of its other drugs in development; the Company may not be successful in scaling up manufacturing and meeting requirements related to chemistry, manufacturing and control matters; the Company's currently planned clinical trial and any future clinical studies as modified to meet the requirements of the FDA may not produce positive results in a timely fashion, if at all, and could require larger and longer trials, which would be time consuming and costly; plans regarding development, approval and marketing of any of Galectin's drugs are subject to change at any time based on the changing needs of the Company as determined by management and regulatory agencies; regardless of the results of any of its development programs, Galectin may be unsuccessful in developing partnerships with other companies or raising additional capital that would allow it to further develop and/or fund any studies or trials. Galectin has incurred operating losses since inception, and its ability to successfully develop and market drugs may be impacted by its ability to manage costs and finance continuing operations. Global factors such as coronavirus may 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) 620-3186

    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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  3. NORCROSS, Ga., Aug. 30, 2021 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins, today announced that the Company has recently expanded its management team with multiple key leadership appointments, including Dakshina Reddy, MSM, as Executive Director, Regulatory Affairs; Ezra R. Lowe, Ph.D., as Executive Director, Clinical and Preclinical Pharmacology; Marla Mills-Wilson as Executive Director, Clinical Operations; and Jessica Kopaczewski as Associate Director, Clinical Operations. These strategic appointments strengthen the company's clinical, regulatory, and operational efforts across its ongoing programs in cancer immunotherapy and NASH cirrhosis.

    "The addition…

    NORCROSS, Ga., Aug. 30, 2021 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins, today announced that the Company has recently expanded its management team with multiple key leadership appointments, including Dakshina Reddy, MSM, as Executive Director, Regulatory Affairs; Ezra R. Lowe, Ph.D., as Executive Director, Clinical and Preclinical Pharmacology; Marla Mills-Wilson as Executive Director, Clinical Operations; and Jessica Kopaczewski as Associate Director, Clinical Operations. These strategic appointments strengthen the company's clinical, regulatory, and operational efforts across its ongoing programs in cancer immunotherapy and NASH cirrhosis.

    "The addition of these talented and experienced leaders to our team reflects another inflection point in our growth and development as we advance our exciting programs in NASH cirrhosis and cancer immunotherapy," said Joel Lewis, President and Chief Executive Officer of Galectin Therapeutics. "These hires, together with the recent appointment of Dr. Ben Carson, Sr., as Senior Advisor, demonstrate our commitment to building a world-class organization and a renewed culture focused on advancing our proprietary galectin-3 inhibitor to significant new milestones. These new team members bring valuable experience that will be instrumental at this critical point in our trials and other research. The Board of Directors and I share a vision for the potential of Galectin Therapeutics. I am grateful that the Board fully supports my goal in continuing to expand our team in these key areas of the organization, in order to achieve our next step in creating value for shareholders."

    Dakshina Reddy

    Executive Director, Regulatory Affairs

    Dakshina Reddy has over 22 years of experience in regulatory affairs and clinical research. He has particular expertise in global regulatory, drug development and regulatory life-cycle management strategies, having worked with the FDA, EMA, PMDA and Health Canada amongst other leading regulatory agencies and emerging regulatory bodies in developing economies.

    He most recently worked for Novartis as Global Program Regulatory Director, where he led and achieved successful approvals of IND's, NDA's, sNDA's and MAA's in the U.S., E.U., Japan, China, Brazil and Mexico.

    Dakshina holds a Bachelor of Pharmacy from Rhodes University (South Africa) and a Master of Science Medicine (Pharmaceutical Affairs) from the University of Witwatersrand (South Africa).

    Ezra R. Lowe, Ph.D.

    Executive Director, Clinical and Preclinical Pharmacology

    Ezra Lowe brings a depth of experience in clinical pharmacology, drug metabolism, and pharmacokinetics. He has a broad base of experience working with various drug formats across a diverse array of therapeutic areas. Prior to joining Galectin, Ezra was Senior Director, Clinical Pharmacology in Global R&D with the Bausch Health Companies.

    Ezra holds a B.A. in Chemistry from Colgate University and a Ph.D. in Pharmacology from the University of Michigan. He is also an alumnus of the McKinsey Black Executive Leadership Program.

    Marla Mills-Wilson

    Executive Director, Clinical Operations

    Marla Mills-Wilson has over 24 years of industry experience and brings to Galectin Therapeutics a deep experience in program management, project management, study operations, site management and progression across Phase 1 to 4 in a variety of therapeutic indications, including liver-related diseases, oncology, ophthalmology, and vaccines.  She holds a B.S. from the University of Tennessee at Chattanooga, and continues to be a member of several professional clinical research organizations and is lean Six Sigma certified.

    Jessica Kopaczewski

    Associate Director, Clinical Operations

    Jessica Kopaczewski is an accomplished clinical operations professional with over 24 years of diverse experience in the pharmaceutical research industry supporting global study operations, site management, and personnel management across Phase 1 to 4 studies in a variety of therapeutic indications including liver-related diseases, oncology, and infectious diseases. 

         

    Jessica holds a B.S. from the University of Wisconsin - Eau Claire in Biochemistry and Molecular Biology.

    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) 620-3186

    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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  4. NORCROSS, Ga., Aug. 16, 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 quarter ended June 30, 2021. 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, "Galectin continued its progress on our strategic initiatives this quarter, actively working towards achieving our goals for the Company, which include advancing our NASH cirrhosis program through global registration trials and…

    NORCROSS, Ga., Aug. 16, 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 quarter ended June 30, 2021. 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, "Galectin continued its progress on our strategic initiatives this quarter, actively working towards achieving our goals for the Company, which include advancing our NASH cirrhosis program through global registration trials and expanding our research. We reported positive new results in a cancer immunotherapy extension trial of belapectin in combination with KEYTRUDA® in a patient cohort with more advanced disease compared to earlier results, and our NASH cirrhosis trial continues to initiate new sites and increase enrollment despite the continued challenges arising from COVID-19. Organizationally, we have added and will continue to add talented and experienced professionals in key leadership roles that will strengthen the company, preparing us for significant new milestones. As my new team, including employees and external consultants, reshapes our culture internally, we continue to engage our strategic consultant, Dr. Ben Carson, in formulating new opportunities. These are exciting times, and we expect the second half of the year to bring continued success."



    Richard E. Uihlein, Chairman of the Board, added, "I am excited by the idea that we have the opportunity to potentially save thousands of lives, not just in NASH cirrhosis but in cancer and other areas where galectins have been implicated. I encourage you to visit our website to study and learn more from Dr. Carson and our talented team, who have just created a series of new videos to help educate our various constituencies and provide a better understanding of why our work is so important."

    Program Review

    Cancer Immunotherapy

    In our cancer immunotherapy program, we announced on July 9, 2021, positive top-line results in our Phase 1b clinical trial extension of belapectin in combination with KEYTRUDA in advanced metastatic melanoma and head and neck cancer. The study provided 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 results demonstrated that belapectin potentially improves treatment response while simultaneously reducing adverse effects often seen with KEYTRUDA alone. Most impressive, these results were obtained despite the patients in this extension cohort having a significantly higher tumor burden when enrolled as compared to the initial study – especially the melanoma patients. Furthermore, there were no toxicities deemed related, probably related, or possibly related to belapectin and the severity of toxicities in this trial were less than the anticipated toxicity with KEYTRUDA alone. Dr. Brendan Curti, M.D., the study's principal investigator at the Earle A. Chiles Research Institute, a division of Portland Providence Cancer Institute, observed that these results highlight the potential benefit and immunological effects of this combination and were sufficiently encouraging to strengthen the rationale to conduct a larger, randomized controlled Phase 2 study.

    NAVIGATE Study (NASH Cirrhosis)



    Enrollment in our NAVIGATE trial in NASH cirrhosis continues, with new sites coming online in both the U.S. and Europe. A protocol amendment aimed at refining criteria for patients with portal hypertension, based on input from investigators, has been approved by institutional review boards and implemented globally resulting in an improved quality of screening and, importantly, more patients qualifying for enrollment.

    Our relationship with Dr. Ben Carson as a Senior Consultant is helping increase awareness of Galectin Therapeutics, which is expected to help attract additional clinical trial sites and patients. 

    Our innovative NAVIGATE study web portal, NAVIGATEnash.com, has experienced a strong response. Many clinicians from our various study sites have registered for the site's steady stream of new information and resources about NASH cirrhosis and the NAVIGATE study for both patients and physicians. NAVIGATEnash.com is also attracting significant web traffic as we build a community where NASH cirrhosis patients and the physicians can share information.

    Corporate Development

    The Company has been aggressively building out its management team and is in the process of making a number of key hires. Ezra R. Lowe, Ph.D. has joined as Executive Director, Clinical and Preclinical Pharmacology. Ezra Lowe brings a depth of experience in clinical pharmacology, drug metabolism, and pharmacokinetics. He has a broad base of experience working with various drug formats across a diverse array of therapeutic areas. Prior to Galectin, Ezra was Senior Director, Clinical Pharmacology in Global R&D with the Bausch Health Companies. He previously held Clinical and Nonclinical Pharmacology positions at Salix Pharmaceuticals, Bausch+Lomb, and Valeant Pharmaceuticals International, Inc. and spent time as Lead Scientist in Biotransformation and Toxicology at The Dow Chemical Company. In the course of his career, he has completed 10 different global drug approvals. The Company expects to add additional key senior resources in the remainder of 2021.

    As a strategic consultant, Dr. Carson will also help amplify our story, by raising awareness with key constituencies. During a recent television appearance, in fact, he was asked about new and interesting projects he was working on, and he took the opportunity to discuss his involvement and support of Galectin. In addition, Dr. Carson was very much involved in a recent meeting of key members of the company's leadership, where he participated in the taping of a number of videos discussing Galectin, belapectin, the management team and the road forward. His vision for the company can be seen on these videos on the company's website: https://galectintherapeutics.com/video-library/ .

    Evolving Areas of Interest

    Clinical and pre-clinical research shows the recently demonstrated mechanism of action for belapectin in cancer immunotherapy reinforces the potential for belapectin in NASH cirrhosis and other diseases driven by galectin-3. This has led to Galectin being approached by researchers from a variety of unrelated specialties that are interested in initiating collaborative research.

    Dr. Carson observed, "Belapectin has broad potential applications as it pertains to galectin-3 and the whole family of galectins, which affect almost every organ system. Not just in oncology, where data has demonstrated the nefarious role that galectin-3 plays in the tumor micro-environment to stimulate tumor progression, but also in areas such as heart disease. Clearly, there are a whole host of processes that are affected, particularly those where the fibrotic and immunologic impact of galectin-3 are clinically relevant."



    Mr. Lewis commented, "Having a respected physician and leader such as Dr. Carson is strategic. He is a great resource and uniquely qualified to seek out partnerships, such as collaborations that could rapidly advance additional trials in cancer immunotherapy where we already have strong Phase 1b data that encourages further study."



    Financial Results

    For the three months ended June 30, 2021, the Company reported a net loss applicable to common stockholders of $8.5 million, or ($0.15) per share, compared to a net loss applicable to common stockholders of $6.2 million, or ($0.11) per share for the three months ended June 30, 2020. The increase is largely due an increase in 2021 research and development expenses related to the Company's NAVIGATE trial.

    Research and development expense for the three months ended June 30, 2021, was $6.5 million compared with $4.7 million for the three months ended June 30, 2020. The increase was primarily due to costs related to our NAVIGATE clinical trial and other supportive activities. General and administrative expenses for the three months ended June 30, 2021, were $1.7 million, compared to $1.4 million for the three months ended June 30, 2020.

    As of June 30, 2021, the Company had $31.6 million of cash and cash equivalents. On April 16, 2021, the Company received $10 million in proceeds from an unsecured convertible promissory note from its Board Chairman, Richard E. Uihlein. The Company also has a $10 million unsecured line of credit, under which no borrowings have been made to date. The Company believes it has sufficient cash, including availability under the line of credit, to fund currently planned operations and research and development activities through at least September 30, 2022.

    The Company expects that it will require more cash to fund operations after September 30, 2022, and believes it will be able to obtain additional financing as needed. Currently, we expect to require an additional approximately $30-$35 million to cover costs of the NAVIGATE 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. 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 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 has a significant role in cancer, and the Company has supported a Phase 1b study in combined immunotherapy of belapectin and KEYTRUDA in advanced melanoma and in head and neck cancer. This trial provided a strong rationale for moving forward into a Phase 2 development program which the company is considering.

    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 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) 620-3186

    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 

    June 30,





    Six Months Ended 


    June 30,



      2021  2020  2021  2020 
     (in thousands, except per share data)
    Operating expenses:



        
    Research and development$6,450 $4,681 $11,349 $6,825 
    General and administrative 1,743  1,421  3,161  2,861 
    Total operating expenses 8,193  6,102  14,510  9,686 
    Total operating loss (8,193) (6,102) (14,510) (9,686)
    Other income (expense):    
    Interest income 1  9  2  59 
    Interest expense (85) (21) (107) (43)
            -    
    Change in fair value of derivative (172) -  (172) - 
    Total other income (256) (12) (277) 16 
                 
    Net loss$(8,449)$(6,114)$(14,787)$(9,670)
    Preferred stock dividends (65) (66) (67) (60)
    Warrant modification    
                 
    Net loss applicable to common stock$(8,514)$(6,180)$(14,854)$(12,158)
                 
    Basic and diluted net loss per share$(0.15)$(0.11)$(0.26)$(0.17)
    Shares used in computing basic and diluted net loss per share 58,312  57,035  57,725  56,995 

    Condensed Consolidated Balance Sheet Data

      June 30, 2021 December 31, 2020
      (in thousands)
    Cash and cash equivalents$31,598$27,142
    Total assets 33,405 29,600
    Total current liabilities 6,054 5,399
    Total liabilities 16,289 5,407
    Total redeemable, convertible preferred stock 1,723 1,723
    Total stockholders' equity$15,393$22,470

     



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    • Belapectin and KEYTRUDA® combination immunotherapy in patients with treatment-refractory and progressive diseases shows a cancer control rate of 56% in melanoma and of 40% in head and neck cancer
    • Melanoma patients in the study had a particularly severe prognosis, with four out of nine having choroidal primary tumors and six out of nine having liver metastasis
    • No toxicities deemed related, probably related, or possibly related to Belapectin were reported
    • Similar to the previously announced phase I study, the frequency and severity of toxicities observed with the combination were less than the anticipated toxicity with KEYTRUDA alone
    • Portland's Earle A. Chiles Research Institute team, a division of Providence, led by principal investigator Dr. Brendan…
    • Belapectin and KEYTRUDA® combination immunotherapy in patients with treatment-refractory and progressive diseases shows a cancer control rate of 56% in melanoma and of 40% in head and neck cancer
    • Melanoma patients in the study had a particularly severe prognosis, with four out of nine having choroidal primary tumors and six out of nine having liver metastasis
    • No toxicities deemed related, probably related, or possibly related to Belapectin were reported
    • Similar to the previously announced phase I study, the frequency and severity of toxicities observed with the combination were less than the anticipated toxicity with KEYTRUDA alone
    • Portland's Earle A. Chiles Research Institute team, a division of Providence, led by principal investigator Dr. Brendan Curti, M.D., is further encouraged by the results that strengthen the rationale to conduct a larger, randomized controlled Phase 2 study

    NORCROSS, Ga., July 09, 2021 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins, and the Earle A. Chiles Research Institute, a division of the Providence Cancer Institute, today announced top-line clinical data from the extension cohort of an investigator-initiated Phase 1b clinical trial of Belapectin, a galectin-3 inhibitor, in combination with KEYTRUDA® (pembrolizumab) in patients with metastatic melanoma and head and neck cancer1. The study is conducted under the direction of Dr. Brendan D. Curti, M.D., a renowned cancer and melanoma expert2.

    The extension study enrolled nine melanoma patients and five head and neck squamous cell carcinoma cancer patients. Compared to the initial phase 1b patients, reported earlier, the cohort in this extension study was heavily pretreated with systemic therapy, including chemotherapy, immunotherapy with checkpoint inhibitors and cytokines, melanoma mutation-directed therapies (BRAF inhibitors and MEK inhibitors), as well as surgery and radiation therapies (external and radio-labeled). Patients also had a high burden of metastasis, with the lungs, soft tissues, and the liver being the most frequently involved organs. Four of the nine melanoma patients had a choroidal (ocular) tumor as a primary site of their cancer and had also developed liver metastasis.

    The treatment consisted of Belapectin 4 mg/Kg of lean body mass administered every three weeks by infusion, after the infusion of pembrolizumab. Pembrolizumab was administered according to its label. Patients' response was evaluated at day 85, according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. The median number of treatment cycles was four (range 3-15) for melanoma patients and five (range 4-8) for head and neck cancer patients.

    Melanoma patient results included one partial response, four stable disease, and four progressive disease, providing a disease control rate of 56% (five out of nine patients). Head and neck cancer patients observed included two stable disease and three progressive disease, providing a disease control rate of 40% (two out of five patients).

    The combination of Belapectin and pembrolizumab was well tolerated and appeared safe. The most frequent adverse event related to pembrolizumab, in six patients, was grade 1 (mild) pruritus (itching), a known and labeled side-effect of pembrolizumab. The second most frequent adverse event related to pembrolizumab was grade 2 fatigue in three patients. All other adverse events were mild (grade 1). There were no grade 3 or above adverse events. Similar to the initial phase 1 study results, the frequency and severity of toxicities related to pembrolizumab, notably immune-mediated adverse events, was less than anticipated. No adverse event was deemed related to belapectin.

    Dr. Brendan Curti, M.D., the Principal Investigator of the study, stated, "Patients in this extension cohort had a significantly higher tumor burden when enrolled as compared to the initial study, and I view these results as encouraging. The results of the extension cohort support the rationale to conduct a Phase 2 randomized controlled-study to further evaluate the combination of belapectin with KEYTRUDA compared to KEYTRUDA alone and fully establish the benefit and immunological effects of this combination."

    Dr. Ben Carson, M.D., Emeritus Professor of Oncology at the Johns Hopkins School of Medicine and Senior Advisor to Galectin Therapeutics, further commented, "A very significant volume of data has recently accumulated demonstrating the nefarious role that galectin-3 plays in the tumor micro-environment to stimulate tumor progression. More recently, we have been able to understand how the inhibition of galectin-3 helps to modify this microenvironment to possibly enhance the action of cancer immunotherapeutic endeavors while perhaps decreasing the side effects 1, 3. With these new clinical data, I strongly support Galectin Therapeutics moving into the next step of development to bring hope to cancer patients in dire need of new treatments."

    Dr. Pol Boudes, M.D., Chief Medical Officer at Galectin Therapeutics, added, "The advantageous tolerance and safety profile of the combination appears to be confirmed with the extension study. This may help patients to avoid frustrating side-effects that lead them to discontinue pembrolizumab (KEYTRUDA) for safety reasons even though they seem to benefit from the drug. A better tolerance would also lead to better compliance and, ultimately, a better risk/benefit profile of the combination. The apparent good safety profile is also consistent with what we see in cirrhotic patients who, like advanced cancer patients, are also very fragile. The dose used in the extension is indeed the highest dose that we are using in our NAVIGATE study in NASH cirrhosis."

    "I look forward to launching a more ambitious oncology program for the combination of belapectin with a PD-1 inhibitor that could bring pivotal data to regulators," concluded Dr. Boudes. "We are exploring the best options to operationalize such a program and believe that potential partners will interpret these confirmatory results as compelling."

    Additional information about the Providence clinical trial may be found at:

    www.clinicaltrials.gov/ct2/show/NCT02575404

    Additional information about the NASH NAVIGATE clinical study may be found at:

    The NAVIGATE Study Clinical Trial in NASH Cirrhosis (navigatenash.com)

    1. Curti BD, Koguchi Y, Leidner RS, et al. Enhancing Clinical and Immunological Effects of anti-PD-1 with Belapectin, a Galectin-3 Inhibitor. J ImmunoTher Cancer 2021;9:e002371.

    2. Curti BD, Faries MB. Recent advances in the treatment of melanoma. N Engl J Med 2021;384:2229-40.

    3. Sturgill ER, Rolig AS, Linch SN et al. Galectin-3 inhibition with belapectin combined with anti-OX40 therapy reprograms the tumor microenvironment to favor anti-tumor immunity, Oncoimmunol 2021 Mar 1;10(1):1892265

    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.

    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. Visit providenceoregon.org/cancer to learn more.

    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 studies, 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 may be unable to raise funds or locate a partner for a possible controlled phase 2 study comparing Belapectin in combination with Keytruda® to Keytruda® alone; the Company's current NAVIGATE clinical trial and any future clinical studies, including such possible controlled phase 2 study 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) 620-3186

    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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