Aspire-202: A Phase 2 Multi-center, Randomized, Open-label Study to Assess the Efficacy and Safety of AHB-137 in Nucleos(t)ide Analogue-treated Participants with Chronic Hepatitis B in the North America and Europe Regions

Chronic Hepatitis B

• Proportion of participants with sustained response XX post AHB-137 treatment., Sustained response defined as hepatitis B surface antigen (HBsAg) level below the limit of detection (LOD, 0.05 international units [IU]/mL) and HBV deoxyribonucleic acid (DNA) below the lower limit of quantification (LLOQ) at XX post AHB-137 treatment. XX

Efficacy • Proportion of participants with functional cure (FC) or sustained HBV DNA response off all HBV treatment • Proportion of participants with FC at XX • Proportion of participants with sustained HBV DNA response, • XX • XX • Proportion of participants with complete response (CR) at each scheduled visit, • Categorical changes from baseline in HBsAg (e.g. ≥ 0.5 log10, ≥ 1 log10, ≥ 1.5 log10, ≥2 log10, ≥ 3 log10 IU/mL) at each visit • Proportion of participants with anti-HBs seroconversion XX, • Actual values of and change from baseline over time for available quantitative HBsAg, HBsAb, HBV DNA, HBV ribonucleic acid (RNA), hepatitis B core related antigen (HBcrAg), hepatitis B e antibody (HBeAb), and qualitative and/or quantitative hepatitis B e antigen (HBeAg) levels at each visit, • Proportion of participants who experience virologic relapse • Time from NA therapy discontinuation to virologic relapse, • Change from baseline over time in alanine aminotransferase (ALT) at each scheduled visit • Proportion of participants with ALT normalization in participants with baseline ALT > upper limit of normal (ULN) at each scheduled visit • Proportion of patients with drug-resistant mutations, Safety and immunogenicity • Proportion of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and treatment discontinuation due to Adverse Events (AEs) • Proportion of participants with anti-drug antibody (ADA) to AHB-137 and titers at each scheduled visit, PK • Derived AHB plasma PK parameters including, but not limited to, area under the concentrationtime curve (AUC), concentration at the end of the dosing interval (Ct), maximum observed concentration (Cmax), time of maximum observed concentration (tmax), and apparent plasma clearance (CL/F, apparent subcutaneous plasma clearance for AHB-137)., • Population PK (PopPK) modeling, covariate analysis, and exposure-response evaluation (separate report), • Proportion of participants with HBsAg < or ≥ LOD (0.05 IU/mL) and/or XX at each scheduled visit • Proportion of participants with XX at each evaluated visit • Proportion of participants with XX and XX at each scheduled visit • Proportion of participants that meet NA discontinuation criteria at XX

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