Altimmune (ALT) 8th Annual MASH Investor Conference summary

Key product features and differentiation

• Pemvidutide is a dual GLP-1/glucagon agonist designed for balanced action, offering both appetite suppression and direct liver effects for robust weight loss and liver fat reduction.

• Unique pharmacokinetics with lower Cmax and longer Tmax may improve tolerability and safety.

• Demonstrates rapid and significant liver fat reduction, with effects seen as early as 6 weeks and up to 76% reduction at 24 weeks.

• Preserves lean muscle mass during weight loss, addressing a key concern in obesity management.

• Offers robust reductions in serum lipids, especially beneficial for patients with dyslipidemia.

Clinical development and trial updates

• Fast Track designation granted by FDA for MASH based on strong phase I NAFLD data showing class-leading liver fat reduction.

• Ongoing phase IIb IMPACT trial in MASH is a biopsy-driven study with endpoints of MASH resolution or fibrosis improvement, enrolling about 190 subjects.

• Primary comparison is at 1.8 mg dose, with placebo and 1.2 mg arms; 2.4 mg dose not pursued in MASH due to plateauing effects.

• 24-week readout expected in Q2 next year, aiming for statistical significance in both liver and weight endpoints.

• Non-invasive markers (MRI-PDFF, ELF, FibroScan) and top-line data will also be reported.

Competitive landscape and strategic positioning

• Pemvidutide aims to distinguish itself by offering both rapid MASH resolution and fibrosis improvement at 24 weeks, plus weight loss, unlike FGF21s or other incretins.

• Projected to have comparable or superior weight loss to tirzepatide and semaglutide over longer treatment durations.

• Focused on treating comorbidities of obesity beyond diabetes, such as dyslipidemia and liver fat, leveraging glucagon's benefits.

• Statins alone do not achieve LDL targets for many; pemvidutide shows 21% LDL reduction, with added benefit for those on statins.

• Commercialization in obesity could occur as early as 2028 (pending partnership), and in MASH by 2030.