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Galectin G Therapeutics Galectin Therapeutics Reports Financial Results for the Quarter Ended September 30 , 2021 , and Provides Business Update November 15 , 2021 Board approves exploration of a Company - sponsored belapectin oncology program complementing our ongoing NASH cirrhosis program Leading oncology experts engaged to consult on strategic planning and operational direction in the development of belapectin in cancer immunotherapy Management team strengthened with the appointment of Hugh Huang , Ph.D. , as Vice President , CMC Pharmaceutical Development NORCROSS , Ga . , Nov. 15 , 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 September 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 , " I am extremely impressed with our new team members and our continuing progress this quarter . Building on our previous announcements of additional financing from our Chairman , Richard E. Uihlein , and positive results from a cancer immunotherapy extension trial of belapectin in combination with KEYTRUDAⓇ , we are pleased to inform you about the progress we have made in working with Dr. Ben Carson , our strategic consultant . I am grateful to Board members and to Dr. Carson , who previously noted that belapectin has broad potential applications as it pertains to galectin - 3 inhibition , including in oncology , where data has demonstrated the role that galectin - 3 plays in the tumor micro - environment to stimulate tumor progression . Through Dr. Carson's introductions , we met and retained new oncology consultants who are each affiliated with prestigious university medical centers . These consultants will assist us with strategic planning for the development of belapectin in cancer indications . Such a Company - sponsored oncology program would complement our existing NASH cirrhosis program and leverage belapectin's potential as a galectin - 3 inhibitor . Galectin - 3 plays a major role in liver cirrhosis and is also strongly associated with cancer progression . Last week , the Board approved this important first step in exploring Company - sponsored oncology programs , and I hope to have more details at our annual meeting in December . At our most recent Board meeting , immediately after the Board approved Mr. Uihlein's generous financing , I expressed to Dick and Rick Zordani , our audit committee chairman , that my goal was to assemble a highly qualified team and be able to have further discussions about an oncology program at our Annual Meeting in December . I intend to achieve that goal . " The NAVIGATE trial for NASH cirrhosis is progressing , and we have seen increases in activity in the United States over the past several months . While this program is strongly supported by the hepatology and gastroenterology community , activity in Europe , South Korea and Latin America remains slower than we anticipated due to lingering effects of the COVID - 19 pandemic and the emergence of new COVID - 19 variants . These activities include clinical trial applications , clinical research site start - ups , patient screenings and randomizations . Over the past few weeks our team has thoroughly analyzed these dynamics . While we do need to extend the estimated completion of enrollment in the Phase 2b portion of the NAVIGATE trial by six months to around the end of the second quarter of 2022 , we only need to extend the anticipated initial top - line results by three months , until the end of the first quarter of 2024. This is in large measure due to the additional capacity and expertise of my team . We have added talented and experienced professionals in key leadership roles this year that have and will continue to strengthen the Company . This strategy will progress until we believe we have the best team in place , giving us the critical mass we need for success . " Richard E. Uihlein , Chairman of the Board , added , " I am pleased with the additional management personnel that have been recently attracted to join the Company and believe they will assist in continuing to move us forward . While we are similar to many other companies who have experienced slower than planned clinical trial enrollment during the pandemic , I am encouraged by the recent acceleration that we will fully enroll the NAVIGATE trial . Finally , I am gratified by the interest shown in our combination cancer immunotherapy program by the esteemed physicians that are now collaborating with us . I look forward to hearing their insights , as well as sharing them with you . " Program Review Cancer Immunotherapy In our cancer immunotherapy program , we previously announced positive top - line results in our Phase 1b investigator initiated 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 ) . In furtherance of this program , the Company engaged three new key oncology opinion leaders as consultants to assist the Company in formulating our strategic and operational directions . Additional information will be provided in the near future . NAVIGATE Study ( NASH Cirrhosis ) A protocol amendment adopted in the third quarter , aimed at refining criteria for patients with portal hypertension and based on input from investigators , has been approved by institutional review boards and implemented globally . This protocol amendment has resulted in an improved quality of screening and , importantly , more patients qualifying for enrollment . Our innovative NAVIGATE study web portal , NAVIGATEnash.com , continues to be a useful resource for patients and physicians interested in the trial , NASH cirrhosis , and portal hypertension . The site provides a steady stream of new information about NASH cirrhosis , the diagnosis and consequences of portal hypertension , and the NAVIGATE study . NAVIGATEnash.com is also attracting significant activity as we build a community