Aligos Therapeutics (ALGS) 2025 Conference Transcript

Summary of Oligos Therapeutics Conference Call Company Overview - Company: Oligos Therapeutics - CEO: Lawrence Blatt - Focus: Development of therapies for chronic hepatitis B (HBV) and other conditions Key Points on Pipeline and Products - Pipeline Status: Transitioning into Phase II studies, particularly for ALG184, a capsid assembly modulator for chronic hepatitis B treatment [2][49] - Other Products: - ALG184 for chronic hepatitis B [2] - ALG-nine for NASH, with completed Phase II study and ongoing outlicensing discussions [3] - Coronavirus protease inhibitor funded by external sources [3] Chronic Hepatitis B Insights - Prevalence: Approximately 300 million people infected globally [5] - Current Treatments: - Nucleoside analogs block virus replication but do not fully suppress HBV DNA, leading to disease progression [5][6] - Pegylated interferons can achieve functional cures in a subset of patients [6] - Clinical Data: - Study in Taiwan showed 4% of patients on nucleoside analogs developed hepatocellular carcinoma over five years [6] - Incomplete suppression of HBV DNA correlates with poor outcomes [8][10] ALG184 Mechanism and Efficacy - Mechanism: ALG184 blocks encapsulation of pre-genomic RNA and transport of rcDNA into the nucleus, effectively suppressing all viral markers [11] - Clinical Trial Results: - In a Phase 1b study, 60% of E antigen positive patients achieved HBV DNA levels below 10 international units by week 48, and 100% by week 96 [17] - E antigen negative patients also showed rapid reductions in HBV DNA [18] - Comparison with Standard Care: ALG184 demonstrated superior efficacy compared to Gilead's TAF and TDF in achieving undetectable HBV DNA levels [19] Safety and Regulatory Pathway - Safety Profile: No emergence of resistant variants or significant toxicity observed over two years of treatment [25][26] - Regulatory Guidance: FDA and other regulatory bodies have indicated that chronic suppression is an acceptable endpoint for approval [57][58] Market Potential - Economic Burden: The cumulative cost of HBV to the healthcare system is estimated at $45 billion, highlighting the need for effective treatments [45] - Market Differentiation: ALG184 is positioned as a once-daily oral therapy, contrasting with injectable therapies that are difficult to administer and store [41][48] - Potential Revenue: The U.S. market potential for ALG184 exceeds $1 billion, with significant interest from payers due to the economic burden of untreated HBV [46][48] Future Milestones - Upcoming Studies: Initiation of Phase II study (B Supreme) expected soon, with interim analysis planned for 2026 [49][66] - Data Presentation: Off-therapy data from the Phase 1b study will be presented at ASLD [50] Conclusion - Positioning: ALG184 is expected to replace nucleoside analogs as the standard of care for chronic HBV suppression and serve as a backbone for future functional cure therapies [37][48]