Altimmune (ALT) Guggenheim Securities Inaugural Healthcare Innovation Conference summary

Program overview and clinical differentiation

• Pemvidutide is a balanced GLP-1/glucagon dual agonist, showing strong effects on weight loss, serum lipids, liver fat, and lean mass preservation, positioning it uniquely in the incretin space.

• The VELOCITY phase III program is designed to highlight not only weight loss but also improvements in comorbidities like dyslipidemia and liver disease, with FDA support for this differentiated approach.

• Three independent doses (1.2, 1.8, 2.4 mg) will be tested, allowing direct initiation at effective doses and minimizing titration, aiming for best-in-class tolerability.

• The program includes four studies targeting approximately 5,000 subjects, focusing on weight loss, LDL cholesterol, liver fat (MASLD), and lean mass preservation, including elderly and sarcopenic populations.

• No dedicated type 2 diabetes trial is included, but well-controlled diabetics are enrolled, reflecting the compound’s focus beyond glycemic control.

Clinical results and regulatory progress

• The MOMENTUM phase II trial showed 15.6% weight loss at the highest dose over 48 weeks, with significant LDL and liver fat reductions.

• The FDA confirmed safety and efficacy, requiring no additional safety studies, and endorsed the tailored approach to comorbidities.

• The phase IIb MASH (IMPACT) trial will read out in 2Q25, with dual primary endpoints of NASH resolution or fibrosis improvement at 24 weeks, leveraging Pemvidutide’s direct hepatic effects.

• Non-invasive markers will be tracked to 48 weeks, with biopsy-based primary readout at 24 weeks and subsequent data on weight and liver markers.

• The program’s design and positive regulatory feedback are expected to accelerate further development and partnership discussions.

Competitive positioning and future milestones

• Pemvidutide’s 1:1 GLP-1/glucagon ratio offers greater glucagon potency compared to competitors like Survodutide, with superior weight loss and tolerability.

• The FDA granted a clean safety profile, unlike some competitors requiring additional safety studies.

• The drug is positioned as a comprehensive solution for MASH, combining direct liver effects with weight loss, potentially leading the class.

• Key upcoming milestones include earnings, additional conference presentations, phase IIb MASH data in 2Q25, and a planned end-of-phase II meeting for MASH by late 2025.

• Ongoing efforts aim to secure a partner for obesity while advancing MASH and other indications independently to maximize asset value.