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]