Pemvidutide's Potential in Liver Diseases - Pemvidutide targets both liver and metabolic components with a differentiated 1:1 glucagon/GLP-1 ratio, showing potential in various steatotic liver diseases[10] - The IMPACT Phase 2b trial of Pemvidutide in MASH patients showed promising 24-week data, with 48-week data and an FDA meeting expected in Q4 2025[14] - Pemvidutide demonstrated a favorable tolerability profile with no dose titration, and a low rate of AEs leading to treatment discontinuation (1.2% in the 1.8 mg group)[55] MASH (NASH) Market and Clinical Data - The IMPACT Phase 2b trial enrolled 212 subjects with MASH (F2/F3), liver fat content ≥ 8%, and BMI ≥ 27.0 kg/m2, HbA1c < 9.5%[23] - Pemvidutide shows potential for best-in-class MASH resolution without worsening of fibrosis[24] - IMPACT data shows significant weight loss at 24 weeks, addressing an underlying cause of MASH[48] - In a Phase 2 obesity study, Pemvidutide demonstrated a lean loss ratio of 21.9% at 48 weeks, indicating class-leading lean mass preservation[52] AUD and ALD Programs - The RECLAIM Phase 2 trial enrollment for AUD is expected to be completed in Q4 2025, while the RESTORE Phase 2 trial for ALD was initiated in Q3 2025[14] - Approximately 66% of AUD patients have obesity or overweight, similar to ALD patients, making them potential targets for Pemvidutide treatment[60] - ALD patients are approximately 3 times more likely to have liver-related disease progression compared to MASH patients[65] Financial Position - The company reported $211 million in total cash as of September 30, 2025, with access to a $125 million credit facility[75] - The company's 9-month year-to-date operating expenses (OPEX) were $54.5 million[75]

Core Insights - Altimmune, Inc. announced positive results from the IMPACT Phase 2b trial for pemvidutide, indicating its potential as a differentiated therapy for Metabolic Dysfunction-Associated Steatohepatitis (MASH) with statistically significant MASH resolution and weight loss at 24 weeks [1][3][11] - The company is preparing for an End-of-Phase 2 Meeting with the FDA, expected in Q4 2025, to discuss the next steps for pemvidutide's development [5][11] - Financial results show a cash position of $183.1 million as of June 30, 2025, reflecting a 39% increase from the previous year [4][8] Clinical Trial Results - The IMPACT Phase 2b trial reported that up to 59.1% of patients receiving pemvidutide experienced statistically significant MASH resolution without worsening fibrosis [4] - Improvements in corrected T1 (cT1), a marker of liver inflammation and fibrosis, were observed, with mean decreases of 145.0 ms and 147.9 ms in the pemvidutide 1.2 mg and 1.8 mg groups, respectively, compared to a decrease of 27.5 ms in the placebo group [4][11] - Statistically significant weight loss of up to 6.2% was recorded at 24 weeks, with a trajectory indicating continued weight loss [4][11] Financial Overview - For the second quarter ended June 30, 2025, Altimmune reported a net loss of $22.1 million, or $0.27 per share, an improvement from a net loss of $24.6 million, or $0.35 per share, in the same period in 2024 [8][17] - Research and development expenses decreased to $17.2 million from $21.2 million year-over-year, attributed to the timing of clinical trial costs [8][17] - General and administrative expenses remained stable at approximately $5.7 million [8][17] Future Developments - The company plans to report full 48-week data from the IMPACT trial in Q4 2025, which will provide further insights into the long-term efficacy and safety of pemvidutide [3][4] - Altimmune has initiated two additional Phase 2 trials: RECLAIM for Alcohol Use Disorder (AUD) and RESTORE for Alcohol-Associated Liver Disease (ALD), both expected to enroll around 100 subjects [9][11]