Aligos Therapeutics (ALGS) 12th Annual Cantor Fitzgerald Global Healthcare Conference summary

Strategic overview of HBV therapeutic landscape

• Current HBV treatments with nucleoside analogues reduce disease progression but do not eliminate risk of liver cancer, highlighting unmet needs in the field.

• Functional cure is defined as shifting immune control over the virus, but most approaches targeting HBV surface antigen have not achieved broad success.

• Antisense oligonucleotides (ASOs) like bepirovirsen show functional cure in only 6-8% of all HBV patients due to eligibility restrictions.

• Over 90% of HBV patients remain unaddressed by current ASO therapies, necessitating new mechanisms.

CAM-E (pevifoscorvir) mechanism and clinical development

• Pevy, a capsid assembly modulator, blocks HBV replication, cccDNA replenishment, and integration, targeting multiple disease pathways.

• Demonstrated prolonged S-antigen reduction post-therapy, indicating cccDNA knockdown and potential for disease modification.

• Superior potency and oral bioavailability distinguish pevy from legacy CAMs, enabling higher liver concentrations and dual mechanism action.

• Ongoing phase II superiority study compares pevy to NUCs, with endpoints including HBV DNA suppression and antigen/RNA reduction.

• Interim analysis showed favorable differentiation from NUCs, leading to increased enrollment and robust powering for final readout.

ASO-675 program and combination strategy

• ASO-675, developed in partnership with Amoytop, is optimized for both S-antigen knockdown and controlled TLR8 activation.

• Preclinical data show greater potency than GSK’s ASO, with clinical development progressing rapidly in China.

• Collaboration allows data sharing for global regulatory filings and leverages expedited Chinese regulatory pathways.

• Combination of pevy and ASO-675 is synergistic in preclinical models, aiming to expand the functional cure population.

• Future strategy includes chronic suppression with pevy and combination therapy for patients meeting S-antigen criteria, with adaptive treatment based on response.