Core Insights - Altimmune, Inc. is advancing its lead candidate pemvidutide, which has received FDA Breakthrough Therapy Designation for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH) [3][15] - The company plans to initiate a Phase 3 trial for pemvidutide in MASH in 2026, with topline data from the RECLAIM Phase 2 trial in Alcohol Use Disorder (AUD) expected in the third quarter of 2026 [1][3] Financial Performance - As of December 31, 2025, Altimmune reported cash, cash equivalents, and short-term investments totaling $274 million, a 107% increase from $132 million at the end of 2024 [11] - The company completed a registered direct offering in January 2026, raising $75 million, and an additional $8 million through its At-the-Market facility [11] - For the fourth quarter of 2025, the net loss was $27.4 million, or $0.27 per share, compared to a net loss of $23.2 million, or $0.33 per share, in the same period in 2024 [21] Clinical Development - The IMPACT Phase 2b trial of pemvidutide in MASH reported positive 48-week data, showing statistically significant improvements in key non-invasive markers of fibrosis and inflammation [6] - The RECLAIM trial for AUD is evaluating pemvidutide's safety and efficacy against placebo in approximately 100 patients over a 24-week period, with enrollment completed ahead of schedule in November 2025 [7][11] - The RESTORE Phase 2 trial of pemvidutide in Alcohol-Associated Liver Disease (ALD) is ongoing, with approximately 100 patients enrolled [11] Leadership and Strategy - Jerry Durso has been appointed as the Chief Executive Officer, bringing over 30 years of experience in life sciences and corporate strategy [11] - The company is focused on strengthening its financial and operational foundation to support the successful execution of its clinical programs [3]
Altimmune Announces Fourth Quarter and Full-year 2025 Financial Results and Business Updates