Altimmune (ALT) R&D Day 2025 summary

Pipeline overview and program updates

• Pemvidutide is advancing in obesity, MASH, and two new indications: alcohol use disorder (AUD) and alcohol-associated liver disease (ALD), with phase II trials for AUD and ALD starting in Q2 and Q3 2025, respectively.

• The obesity program is phase III ready following a successful end-of-phase II meeting; MASH phase IIb top-line data is expected in Q2 2025.

• FDA has cleared INDs for both AUD and ALD, allowing direct entry into phase II based on robust prior data.

Clinical trial data and development milestones

• Pemvidutide demonstrated >15% weight loss at 48 weeks, class-leading lean mass preservation, and up to 75% liver fat reduction in phase II trials.

• In MASH, up to 100% of patients achieved ≥30% liver fat reduction, 85% achieved ≥50%, and 50% normalized liver fat within 24 weeks.

• The IMPACT phase IIb MASH trial will report 24-week paired liver biopsy data in Q2 2025, with secondary endpoints including weight loss and non-invasive testing.

• Phase II AUD trial will assess reduction in heavy drinking days and weight loss; ALD trial will use liver stiffness measurement as the primary endpoint.

R&D strategy and innovation priorities

• Focus on dual GLP-1/glucagon agonism to address obesity, liver diseases, and related comorbidities.

• Strategy includes targeting overlapping metabolic and liver conditions to maximize clinical and commercial impact.

• Emphasis on non-invasive biomarkers and endpoints to streamline regulatory pathways and reduce reliance on liver biopsy.