Drug Development and Clinical Trials - The company is focused on developing belapectin, a galectin-3 inhibitor, for treating liver fibrosis and cirrhosis in NASH patients, with significant preclinical evidence supporting its efficacy [87]. - A total of 357 patients were randomized in the NAVIGATE trial, which is designed to evaluate the safety and efficacy of belapectin for preventing esophageal varices in MASH cirrhosis patients [88]. - The Phase 2b NASH-CX trial aims to assess the safety and efficacy of belapectin in patients with compensated cirrhosis and portal hypertension, with top-line results expected in December 2024 [97]. - The company has completed two Phase 1 clinical studies and a Phase 2 clinical study in MASH patients with advanced fibrosis, demonstrating the safety of belapectin [87]. - The company is pursuing a development pathway for belapectin in immuno-oncology, having filed a new IND for advanced head and neck cancer in combination with a PD-1 inhibitor [90]. - Belapectin has shown a significant therapeutic effect on liver fibrosis in preclinical models, reducing liver fat, inflammation, and portal pressure [99]. - The Phase 2 NASH-FX trial did not meet its primary endpoint but demonstrated that belapectin was safe and well tolerated [103]. - The NASH-CX trial involved 162 patients with well-compensated MASH cirrhosis and portal hypertension, randomized to receive either belapectin or placebo [104]. - In the total patient population, the mean change in hepatic venous pressure gradient (HVPG) was -0.37 mm Hg for the 2 mg/kg LBM dose and -0.42 mm Hg for the 8 mg/kg LBM dose of belapectin, compared to a 0.3 mm Hg change in placebo [105]. - In patients without esophageal varices at baseline, the 2 mg/kg LBM dose of belapectin showed a statistically significant reduction in HVPG of -1.08 mm Hg (p<0.01) [106]. - The belapectin 2 mg/kg LBM group had a significantly lower incidence of new varices (0%) compared to placebo (18%) over the 54-week treatment period [107]. - Belapectin demonstrated a statistically significant improvement in hepatocyte ballooning and a reduction in the development of new esophageal varices (p=0.02) compared to placebo [108]. - The NAVIGATE Trial is a Phase 2b/3 study evaluating belapectin for the prevention of esophageal varices in patients with MASH cirrhosis, targeting a population with unmet medical needs [111]. - The NAVIGATE trial will compare two belapectin doses (2 mg/kg LBM and 4 mg/kg LBM) against placebo, with an interim analysis planned after 18 months of treatment [111]. - The Company activated over 150 clinical trial sites in 14 countries for the NAVIGATE trial, although patient enrollment faced challenges due to the COVID-19 pandemic [120]. - A Hepatic Impairment Study involving approximately 40 patients indicated that belapectin exposure did not increase with the degree of hepatic insufficiency [122]. - Promising results from a Phase 1b trial combining belapectin with KEYTRUDA showed a 50% objective response rate in advanced melanoma patients [125]. Financial and Regulatory Aspects - The company has incurred significant operating losses since inception and relies on additional outside capital for its development programs [86]. - The company is subject to extensive regulation by the FDA, which could impact the commercialization of its product candidates [86]. Insider Trading - Jack Callicutt adopted a Rule 10b5-1 trading plan for the sale of up to 627,456 shares of the Company's common stock until December 31, 2025 [155]. - Khurram Jamil adopted a Rule 10b5-1 trading plan for the sale of shares needed to cover taxes related to a 30,000 RSU grant, plus up to 60% of remaining shares, and an additional 25,000 shares from stock options until December 31, 2025 [156].

Core Insights - Galectin Therapeutics, Inc. announced that three abstracts from its ongoing Phase 2b/3 NAVIGATE trial have been accepted for presentation at the AASLD's annual meeting in November 2024 [1][2] Group 1: Clinical Data Presentation - The three posters will be presented during the "Portal Hypertension and Other Complications of Cirrhosis" session on November 18, 2024 [2] - The titles of the abstracts include evaluations of esophageal and gastric varices, baseline patient characteristics from the NAVIGATE trial, and findings related to esophageal varices in patients with compensated MASH cirrhosis [2] Group 2: Company Overview - Galectin Therapeutics focuses on developing therapies for chronic liver disease and cancer, with its lead drug belapectin targeting galectin-3 protein [4] - The company is advancing its lead development program in metabolic dysfunction-associated steatohepatitis (MASH) with cirrhosis, which represents a significant medical need and drug development opportunity [4] - Additional development programs include combination immunotherapy for advanced head and neck cancers, with progress dependent on finding suitable partnerships [4]

Core Insights - Galectin Therapeutics is advancing its NAVIGATE Phase 2b/3 trial of belapectin, targeting MASH associated liver cirrhosis and portal hypertension, with an interim analysis expected in December 2024 [2][3]. Company Overview - Galectin Therapeutics focuses on developing therapies for chronic liver disease and cancer, with its lead drug belapectin targeting galectin-3, a protein involved in inflammatory and fibrotic diseases [5]. Clinical Trial Progress - The NAVIGATE trial is evaluating the efficacy and safety of belapectin in 357 patients across 14 countries, with interim data readout anticipated in late December 2024 [3]. - Recent data presented at the EASL 2024 Congress indicated that collagen content in liver biopsies of MASH cirrhotic patients does not correlate with portal pressure, emphasizing the need for endoscopies in assessing disease progression [2][3]. Financial Highlights - As of June 30, 2024, the company had $25.6 million in cash and cash equivalents, with an additional $10 million available under a line of credit [4]. - Research and development expenses for Q2 2024 were $9.8 million, up from $7.4 million in Q2 2023, primarily due to the NAVIGATE trial [4]. - The net loss applicable to common stockholders for Q2 2024 was $12.4 million, or $0.20 per share, compared to a net loss of $9.2 million, or $0.15 per share, in Q2 2023 [4][8]. Balance Sheet Data - Total assets as of June 30, 2024, were $27.7 million, with total liabilities amounting to $109.8 million [9]. - The total stockholders' equity deficit was $83.9 million as of June 30, 2024 [9].

Exhibit 99.1 Galectin Therapeutics Reports Financial Results for the Quarter Ended June 30, 2024 and Provides Business Update • NAVIGATE trial on track for interim top-line analysis in December 2024 NORCROSS, Ga., August 13, 2024 (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, 2024. Joel Lewis, Chief Executive Officer and President ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock GALT The Nasdaq Stock Market FORM 10-Q ☒ Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended June 30, 2024 ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission File No. 001-31791 GALECTIN THERAPEUT ...

NORCROSS, Ga., Aug. 01, 2024 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, today announced the appointment of Khurram Jamil, M.D., an accomplished senior executive with expertise in liver disease to Chief Medical Officer effective immediately. Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics, said "We are very excited to elevate Dr. Jamil to Chief Medical Officer. After joining us in March 2024 a ...

NORCROSS, Ga., June 04, 2024 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin-3, today announced that it will attend the EASL 2024 meeting and deliver a scientific presentation. The meeting will be held June 5-8, 2024, in Milan, Italy. "At this year's meeting we are again pleased to share important scientific information with the hepatology community. Through the knowledge captured from our belapectin program, we are adding knowledge on ...

NORCROSS, Ga., June 04, 2024 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin-3, today announced that it will attend the EASL 2024 meeting and deliver a scientific presentation. The meeting will be held June 5-8, 2024, in Milan, Italy. "At this year's meeting we are again pleased to share important scientific information with the hepatology community. Through the knowledge captured from our belapectin program, we are adding knowledge on ...

NORCROSS, Ga., May 15, 2024 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins, today reported financial results and provided a business update for the quarter ended March 31, 2024. Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics, said "This quarter we remained laser-focused on progressing the NAVIGATE Phase 2b/3 trial of belapectin, which has a Fast Track Designation from the U.S. Food & Drug Administ ...

Pol Boudes, M.D., Chief Medical Officer added, "We are deeply saddened by the recent passing of Dr. Stephen A. Harrison. Stephen was involved in the belapectin clinical program since its inception. As the coordinating investigator of NAVIGATE, he was also a driving force to change the way we are designing clinical research in cirrhotic patients. Most notably, Stephen championed the prevention of esophageal varices as a clinical outcome that is both less subjective and more closely related to real world clin ...