ALGS News & Events

Aligos Therapeutics has entered into an exclusive license agreement to develop and commercialize pevifoscorvir sodium with Xiamen Amoytop in Greater China, which includes Mainland China, Taiwan, Hong Kong, and Macau for chronic hepatitis B virus, or HBV, infection. Aligos will receive an upfront milestone of $25M and is eligible to receive up to $420M in clinical, regulatory, and sales milestones along with tiered, high single-digit royalties on net sales in Amoytop's licensed territories. Aligos retains all development and commercialization rights for pevifoscorvir sodium in the U.S., Europe, South Korea, Japan, and all other markets. In addition, Aligos will retain the right to conduct clinical trials in Greater China. As a result of this agreement, Aligos expects that current cash, cash equivalents and investments will be extended into Q4 based on the current operating plan. Pevifoscorvir sodium is a potential first and best-in-class capsid assembly modulator under development for chronic HBV infection. Pevifoscorvir sodium is currently being evaluated in the Phase 2 study vs. the nucleoside analog, tenofovir disoproxil fumarate, with the second interim analysis expected in the second half of 2026 and topline data planned for 2027. The closing of this transaction is conditional and automatically effective upon Amoytop receiving approval at a Shareholders' Meeting, which is anticipated within 30 days.

Aligos Therapeutics announced the first interim analysis results of the Phase 2 B-SUPREME study of pevifoscorvir sodium in participants with chronic hepatitis B virus infection for the Part 2a where the independent Data Safety Monitoring Review Board has recommended continuation of the study with an increase in sample size for this cohort in order to optimize statistical powering; futility criteria for the cohort was not met. Additionally, Aligos announced that the FDA has granted fast track designation to pevifoscorvir sodium, a capsid assembly modulator under investigation for the treatment of chronic hepatitis B virus infection. The study design for the Phase 2 B-SUPREME study includes pre-specified sample size re-estimations for both Parts 1a and 2a to ensure sufficient power to demonstrate a statistically significant treatment effect at the primary endpoint. The first pre-specified interim analysis of the Phase 2 B-SUPREME study was performed after approximately 60% of HBeAg- participants (N=34, Part 2a) reached Week 12 or later. In addition, safety data was reviewed for all participants enrolled in the study (N=174) at the time the interim analysis was performed. The DSMB recommended increasing the sample size of Part 2a from 74 currently enrolled to 100 participants. A futility analysis was performed; the prespecified futility criteria was not met, per the statistical analysis plan. The study drugs were well-tolerated with no clinically concerning laboratory, physical examination, vital sign, or ECG abnormalities. No viral breakthrough related to study drugs has been observed in the study to date. Aligos remains blinded to participant-level data. Completion of enrollment in the HBeAg- cohort is expected in the second half of 2026. Currently, there are 74 participants enrolled in the HBeAg- cohort, with 103 participants enrolled in the HBeAg+ cohort. Topline data remains on track for 2027.