Financial Data and Key Metrics Changes - The company is currently trading at close to multi-year highs, indicating a positive market sentiment and performance [14] - The results of the stockholder vote showed a plurality of shares voted in favor of all 11 nominees for director, reflecting strong shareholder support [10] Business Line Data and Key Metrics Changes - The Navigate trial results indicated that the two-milligram dose of belapectin showed a lower rate of new varices compared with placebo after 18 months, particularly in the completer population [20] - Belapectin demonstrated a significant reduction in liver stiffness and a lower rate of new varices across various fibrosis levels, indicating its potential effectiveness in treating MASH cirrhosis [22] Market Data and Key Metrics Changes - The company has engaged with key opinion leaders (KOLs) and presented findings at major hepatology conferences, enhancing its visibility and credibility in the market [18] - The unique nature of the patient population in the Navigate trial has led to groundbreaking discussions regarding treatment options for patients with MASH cirrhosis and portal hypertension [19] Company Strategy and Development Direction - The company aims to maximize the value of its program and believes that belapectin has the potential to change the treatment landscape for patients with no FDA-approved therapy [19] - There is a focus on strengthening, validating, and communicating the evidence supporting belapectin's clinical findings, with plans for additional KOL events and peer-reviewed publications [18][25] Management's Comments on Operating Environment and Future Outlook - Management expressed excitement about the company's current position and the extensive amount of meaningful information available, indicating a positive outlook for the future [14] - The company anticipates feedback from the FDA regarding its submitted package and is actively discussing potential partnerships to advance belapectin [19][25] Other Important Information - The company has maintained a clean safety profile for belapectin, with no drug-related serious adverse events reported during the trial [24] - The final results of the stockholder vote will be disclosed in a current report on Form 8-K filed with the SEC within four business days [13] Q&A Session Summary Question: What are the key findings from the Navigate trial? - The two-milligram dose of belapectin showed a lower rate of new varices compared to placebo, particularly in the completer population [20] - Belapectin demonstrated significant reductions in liver stiffness and lower rates of new varices across various fibrosis levels [22] Question: What is the company's strategy moving forward? - The company aims to maximize the value of its program and believes belapectin can change the treatment landscape for patients with no approved therapies [19] - There are plans for additional KOL events and peer-reviewed publications to strengthen the evidence supporting belapectin [18][25]

Belapectin for MASH Cirrhosis and Portal Hypertension - Belapectin, a galectin-3 inhibitor, has shown potential in reducing galectin-3 expression and fibrogenic activity in preclinical studies[7] - A Phase 2b trial (GT-026) indicated that Belapectin at a 2 mg dose significantly improved portal pressure (HVPG) and reduced the incidence of esophageal varices in patients without baseline varices at 52 weeks[7] - There are currently no FDA-approved therapies to reverse fibrosis in MASH cirrhosis, highlighting a significant unmet need[7] Market Opportunity and Patient Landscape - MASH cirrhosis affects an estimated 3%-5% of the global population and is considered underdiagnosed[14] - In the U S, approximately 5 million people progress to MASH cirrhosis, with 3.3 million having cirrhosis and portal hypertension[16] - The addressable market in the U S for compensated MASH cirrhosis is significant, with peak Belapectin sales estimated at $18 billion[28] NAVIGATE Trial Results - The NAVIGATE trial design involved randomizing 357 patients with MASH cirrhosis and no varices at baseline into three groups: Placebo, Belapectin 2 mg/kg/LBM, and Belapectin 4 mg/kg/LBM[37] - In the per-protocol population, Belapectin 2 mg/kg significantly reduced the incidence of varices compared to placebo (11 3% vs 22 3%, p=0 04)[48] - In the U S subgroup of the per-protocol population, Belapectin 2 mg/kg significantly reduced the incidence of new esophageal varices compared to placebo (6 7% vs 21 0%, p=0 02)[56] - The study showed a favorable safety profile for Belapectin, with adverse events and discontinuation rates comparable to placebo[59]