Altimmune(US:ALT)2025-05-20 15:00Financial Data and Key Metrics Changes - The company is preparing for a significant data readout for its NASH drug candidate, pemidutide, expected by the end of the current quarter, which is crucial for future development plans [27][20]. - The highest dose in the MOMENTUM trial showed a weight loss of 15.6% at 48 weeks, indicating strong efficacy compared to competitors [30]. Business Line Data and Key Metrics Changes - The company is focusing on the dual mechanism of action of pemidutide, which combines weight loss with direct effects on liver health, positioning it uniquely in the market [15][18]. - The upcoming Phase 2b trial for NASH is designed to control placebo responses, which have been problematic in previous trials, aiming for a more accurate assessment of drug efficacy [12][14]. Market Data and Key Metrics Changes - NASH is now the leading cause of liver transplantation in the U.S., with a growing prevalence linked to the obesity epidemic, highlighting a significant unmet medical need [10][11]. - The company is expanding its pipeline to include Alcohol Use Disorder (AUD) and Alcoholic Liver Disease (ALD), both of which have critical unmet needs and overlap with obesity-related conditions [38][42]. Company Strategy and Development Direction - The company aims to treat serious conditions resulting from obesity rather than pursuing a pure obesity indication, which is becoming increasingly competitive and price-sensitive [36][39]. - The strategy includes leveraging a large safety database from previous trials to support the development of AUD and ALD treatments, enhancing the overall market opportunity [43][41]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming data readout and the potential for a Phase III program to start in early 2026, contingent on positive results [20][40]. - The company believes that the combination of metabolic and liver health benefits will allow it to cover a broad spectrum of patients with NASH and related conditions, improving treatment options [60][61]. Other Important Information - The company has noted that the weight loss profile of pemidutide is expected to be comparable to semaglutide at 48 weeks, with potential for even greater efficacy beyond that timeframe [24][25]. - The design of the IMPACT trial includes unique features aimed at controlling placebo responses, which could lead to more reliable results [12][14]. Q&A Session Summary Question: Can you tell us about the unmet need in NASH? - Management highlighted that there is only one approved drug for NASH with modest effects, and the condition is increasingly prevalent due to obesity, creating a significant need for more effective treatments [10][11]. Question: What are the expectations around the upcoming Phase 2b trial? - The company plans to have its end of Phase 2 meeting after the 24-week readout, focusing on the primary endpoint of biopsy results at that time [20][21]. Question: How does the company view the competitive landscape for obesity treatments? - Management indicated that the obesity market is changing, and the company is focusing on serious diseases related to obesity rather than solely on obesity itself, which is becoming a price-sensitive market [36][39]. Question: What are the key differentiators of pemidutide compared to other treatments? - The company believes that pemidutide's dual action of promoting weight loss while directly affecting liver health sets it apart from other drugs in development [15][18]. Question: What is the timeline for the AUD and ALD studies? - The AUD study has just started, and initial data readouts are expected by the end of next year, with the ALD study anticipated to begin in the third quarter [45][41].