Core Insights - Altimmune, Inc. is approaching significant milestones in the development of pemvidutide for metabolic dysfunction-associated steatohepatitis (MASH) and alcohol use disorder (AUD) [2][12] - The company has strengthened its executive leadership team with key appointments to support its growth strategy [2][9] - Financial results indicate a robust cash position and a reduction in research and development expenses compared to the previous year [7][19] MASH Program Updates - The 48-week data from the Phase 2b IMPACT trial of pemvidutide is expected to be released before the end of 2025 [2][12] - An End-of-Phase 2 meeting with the FDA is scheduled for the fourth quarter of 2025 to discuss the proposed design of the Phase 3 trial [5][12] - The trial design may include flexibility to adapt based on regulatory discussions regarding non-invasive tests and AI-based biopsy readings [2] AUD and ALD Trials - The RECLAIM trial for pemvidutide in AUD has completed patient recruitment ahead of schedule, indicating strong interest in new therapies for this condition [9][12] - The RESTORE trial for pemvidutide in alcohol-associated liver disease (ALD) has also been initiated, with a focus on safety and efficacy [9][12] Executive Leadership Changes - Recent appointments include Dr. Christophe Arbet-Engels as Chief Medical Officer, Linda Richardson as Chief Commercial Officer, and Robin Abrams as Chief Legal Officer [2][9] - These leaders bring extensive experience in clinical development, commercial strategy, and legal compliance to the company [9] Financial Performance - As of September 30, 2025, the company reported cash, cash equivalents, and short-term investments totaling approximately $211 million, a 60% increase from $131.9 million at the end of 2024 [7][19] - Research and development expenses decreased to $15 million from $19.8 million year-over-year, reflecting a strategic focus on cost management [19] - The net loss for the quarter was $19 million, or $0.21 per share, an improvement from a net loss of $22.8 million, or $0.32 per share, in the same period in 2024 [19]
Altimmune Announces Third Quarter 2025 Financial Results and Business Updates