Altimmune (ALT) investor relations material

Clinical data and efficacy

• 24-week phase II data showed class-leading MASH resolution, robust weight loss (~6%), and strong anti-inflammatory marker improvement, with effects continuing beyond 24 weeks.

• AI-enabled histological assessments and NITs indicated rapid and significant fibrosis improvement, with expectations of further gains at longer durations.

• Early efficacy is a key differentiator, with significant improvements in liver fat and ALT seen as early as weeks 4–12.

• Excellent tolerability was observed, with the lowest adverse event discontinuation rates in the class, achieved without dose titration.

• Weight loss continues to improve with ongoing treatment, motivating both patients and payers.

Regulatory and trial design strategy

• The phase III program is designed for flexibility, incorporating biopsy, AI-enabled histology, and NIT endpoints to adapt to evolving FDA standards.

• FDA review of AI-based histological assessment is expected in Q4, potentially allowing a shift away from biopsy-based endpoints.

• The trial will likely require a 52-week endpoint and safety data, but early NIT data will be collected to demonstrate rapid efficacy.

• The protocol is structured to pivot quickly as regulatory requirements change, aiming for efficiency and higher probability of success.

Market positioning and competitive landscape

• The drug offers both metabolic (weight loss) and direct liver effects in a single molecule, differentiating it from combination therapies.

• Positioned to treat a broad spectrum of MASH patients (F1–F4), with faster onset of action compared to competitors like semaglutide.

• Large pharma interest in MASH is increasing, with strategic discussions ongoing and the market expected to expand.

• The value proposition supports premium pricing, given the broad applicability and rapid efficacy.