Aligos Therapeutics (ALGS) Piper Sandler 36th Annual Healthcare Conference summary

Key program updates and clinical strategy

• IND cleared for a novel capsid assembly modulator targeting hepatitis B, with phase 2 study to begin in Q1, including both E antigen positive and negative patients.

• Study will be multinational, spanning the US, Europe, and Asia, with over 50 sites and a projected two-year timeline including a 48-week treatment period and open-label rollover.

• Protocol allows for independent unblinding of E antigen negative cohort data, with paired biopsies and quantitative HBV endpoints reported during the blinded study.

• Regulatory consultations confirm monotherapy can proceed with chronic suppression as the primary endpoint, aiming for broad HBV patient eligibility beyond current guidelines.

• Market opportunity estimated above $2 billion, with payer research indicating willingness to pay a premium for the new therapy.

Clinical data and competitive positioning

• The capsid assembly modulator demonstrates superior HBV DNA reduction and antigen drops compared to standard nucleoside analogs, with no drug resistance observed up to 82 weeks.

• Achieved 100% suppression below regulatory cutoff in both E positive and E negative patients, with most E negative patients showing undetectable HBV DNA.

• Therapy blocks cccDNA replenishment, reducing viral burden and integration linked to cancer, and is positioned to become the new standard of care.

• No other capsid assembly modulators have comparable data or resistance profile; therapy expected to replace nukes as first-line treatment.

• Secondary endpoints include antigen and HBV RNA suppression, with RNA reduction linked to lower liver cancer risk.

Strategic direction and partnerships

• Asset considered disease and company transformative, with plans to demonstrate superiority in head-to-head studies before considering partnerships.

• Ongoing partnership with Amoytop for a combination study with pegylated interferon, targeting functional cure in select patient populations.

• Strategic interest remains high, with the company aiming to maximize value by advancing assets further before partnering.