Akero Therapeutics (AKRO) H.C. Wainwright 8th Annual NASH Virtual Conference summary

Key program updates and milestones

• Efruxifermin is in a global phase III program for both non-cirrhotic and cirrhotic NASH patients, with first patient enrolled in December last year.

• Phase II-B HARMONY study showed strong fibrosis improvement in F2/F3 patients, with 75% achieving one-stage improvement and 36% achieving two-stage improvement at 96 weeks on the 50 mg dose.

• Upcoming phase II-B SYMMETRY study readout for compensated cirrhosis (F4) patients is expected in Q1 next year.

• Three phase III studies are ongoing: SYNCHRONY Histology (F2/F3), SYNCHRONY Real-World (F1+), and SYNCHRONY Outcomes (F4), designed to support both accelerated and full approvals.

• $848 million cash balance funds non-cirrhotic phase III studies through primary endpoints and operations into H2 2027.

Mechanism of action and differentiation

• Efruxifermin is a bivalent FGF21 analog with direct and indirect anti-fibrotic effects, including rapid fibrosis improvement and reduction in liver fat and hepatocyte stress.

• Unique bivalent structure enables stronger receptor binding and sustained engagement, differentiating it from other FGF21 agents.

• Dosing and pharmacology differ from competitors, with once-weekly subcutaneous administration and sustained trough levels believed to drive efficacy.

Positioning in the NASH treatment landscape

• NASH market is large and segmented by disease stage and comorbidities, supporting multiple mechanisms and combination therapies.

• Efruxifermin offers rapid and deep antifibrotic response, with potential for both monotherapy and combination with GLP-1s.

• Combination with GLP-1s showed no additional safety concerns and provided added benefits in liver and metabolic markers.