Altimmune (NasdaqGM:ALT) 2025 Conference Transcript

Summary of Altimmune Conference Call Company Overview - Company: Altimmune (NasdaqGM:ALT) - Focus: Development of a glucagon GLP-1 dual receptor agonist, pemvidutide, targeting liver diseases such as MASH (Metabolic Associated Steatotic Liver Disease), AUD (Alcohol Use Disorder), and ALD (Alcoholic Liver Disease) [4][39] Core Points and Arguments Product Development - Pemvidutide: A rationally designed molecule with a one-to-one ratio of GLP-1 and glucagon, aimed at providing both direct liver effects and metabolic benefits such as weight loss [4][36] - Unique PK Profile: The proprietary UPORT domain slows drug entry into the bloodstream, resulting in longer Tmax and lower Cmax, contributing to a favorable tolerability profile [5][28] - Clinical Trials: - Completed enrollment in a 48-week trial for MASH, with 24-week data already presented [5][6] - Anticipating 48-week data release in Q4 2025 and an FDA end-of-phase two meeting [5][6] Clinical Data - 24-Week Results: Showed a 60% response rate in MASH resolution, comparable to other programs at longer durations [8][36] - Non-Invasive Tests: Focus on non-invasive tests for assessing liver fat and fibrosis, with expectations for continued improvement in these markers [10][15] - Weight Loss: Significant weight loss observed without plateauing, with a focus on preserving lean mass, crucial for older patients [20][21][22] Regulatory Strategy - FDA Engagement: Seeking alignment with the FDA on phase three program design, particularly regarding non-invasive testing (NITs) and potential for accelerated approval [24][26] - Flexibility in Design: Prepared to adapt trial designs based on evolving regulatory requirements, including the potential shift from biopsy to NIT endpoints [26][30] Market Positioning - Differentiation: Pemvidutide is positioned as a first-line therapy for MASH due to its dual mechanism of action, targeting both liver health and metabolic aspects [31][35] - Competitive Landscape: Distinction from other GLP-1 therapies, emphasizing direct liver impact and rapid fibrosis improvement [32][36] - Pricing Strategy: Focus on broad-spectrum benefits, including weight loss and liver health improvement, to appeal to patients, physicians, and payers [36][38] Additional Insights - ALD and AUD Programs: Enrollment completed for AUD study, with ongoing ALD study, highlighting the potential for a comprehensive liver health portfolio [39][40] - Patient Demographics: Targeting older populations with MASH, AUD, and ALD, emphasizing the importance of tolerability and quality of life improvements [21][41] Conclusion Altimmune is advancing its pemvidutide program with promising clinical data and a strategic approach to regulatory engagement, positioning itself favorably in the liver disease treatment landscape. The dual mechanism of action and focus on tolerability are key differentiators that may enhance its market potential.