Earnings release
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Galectin G Therapeutics Galectin Therapeutics Reports Financial Results for the Quarter Ended June 30 , 2021 , and Provides Business Update August 16 , 2021 Considering options for a Combination Cancer Immunotherapy trial based on encouraging results of Phase 1b trial which strengthened the rationale to conduct a larger , randomized controlled Phase 2 study 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 .