Altimmune (ALT) Barclays 28th Annual Global Healthcare Conference summary

Clinical progress and data highlights

• Phase II MASH trial delivered 24-week and 48-week data, showing strong MASH resolution and promising anti-fibrotic effects, with 48-week results reinforcing the product profile for phase III design.

• Pemvidutide demonstrated a unique dual mechanism (glucagon and GLP-1) with strong tolerability, lower discontinuation rates than placebo, and preservation of lean mass during weight loss.

• Phase II trials in alcohol use disorder (AUD) and alcohol-associated liver disease (ALD) are progressing, with AUD top-line data expected in Q3 2026 and ALD enrollment completing this year.

• Positive end-of-phase II FDA meeting for MASH, with phase III trial design incorporating lessons from prior data and leveraging AI-assisted histology for improved consistency.

• Phase III MASH trial will use three arms (placebo, 1.8 mg, 2.4 mg), with AI-based AIM-MASH Assist to reduce variability and placebo response in biopsy readings.

Financial and organizational developments

• Significant progress in strengthening the balance sheet through a mix of debt, equity, and strategic discussions to support phase III trial execution.

• Leadership team evolved to support late-stage development, with new CEO, CMO, and Chief Legal Officer joining in the past year.

Phase III trial design and innovation

• Phase III MASH trial features two cohorts (biopsy-proven and NIT-assessed F2/F3), with primary powering on the 1.8 mg dose and use of AIM-MASH AI Assist for histology.

• AI Assist digitizes biopsy slides, prompts pathologists to key features, and aims to reduce inter-reader variability and placebo response.

• Enrollment for the phase III MASH trial is targeted at 18–24 months, leveraging strong site relationships and favorable tolerability profile.