Altimmune (ALT) investor relations material

Strategic focus and clinical progress

• Emphasis on developing pemvidutide for liver diseases, particularly MASH and alcohol-related conditions, with robust phase II data supporting advancement to phase III trials.

• Pemvidutide's dual mechanism (1:1 glucagon:GLP-1) offers strong efficacy and tolerability, differentiating it from other agents in the landscape.

• Market research and clinical data indicate strong interest and unique positioning for pemvidutide among patients and providers.

• The company is targeting both MASH and AUD populations, leveraging overlapping disease mechanisms and patient needs.

Differentiation and competitive landscape

• Pemvidutide stands out due to its balanced dual agonist profile, direct liver effects, and minimal titration requirements.

• Compared to survodutide and retatrutide, pemvidutide shows superior tolerability and potentially better patient adherence.

• The molecule's strong affinity for both GLP-1 and glucagon receptors is believed to drive its efficacy in both metabolic and liver endpoints.

• No other balanced glucagon/GLP-1 agents are currently in development, further supporting its unique market position.

Phase III study design and endpoints

• The PERFORMA phase III trial incorporates lessons from phase II, including improved biopsy reading consistency using AIM-MASH Assist and top pathologists.

• The study features three arms: placebo, 1.8 mg, and 2.4 mg doses, with the higher dose expected to provide additional efficacy.

• Key endpoints include MASH resolution, antifibrotic effect, weight loss, adherence, and preservation of lean muscle mass, measured by MRI-PDFF and biomarkers.

• Enrollment has been efficient due to trial design and investigator enthusiasm, with ongoing regulatory readiness for potential NIT endpoint acceptance.