Assembly Biosciences (NasdaqGS:ASMB) FY Conference Transcript

Summary of Assembly Biosciences FY Conference Call Company Overview - Company: Assembly Biosciences (NasdaqGS: ASMB) - Focus: Originally a capsid assembly modulator company targeting Hepatitis B Virus (HBV), now expanded to include herpes virus treatments, particularly for recurrent genital herpes [3][4] Recent Developments - Pipeline Expansion: The company has developed two lead compounds for recurrent genital herpes, 5366 and 1179, both currently in phase 1b trials [3][4] - Positive Data: Recently announced positive interim data for 5366, showing significant efficacy in reducing viral shedding and lesions [10][12][13] Market Opportunity - Unmet Need: There is a significant unmet need in the genital herpes market, with the last treatment approval nearly 20 years ago. Many patients experience multiple recurrences annually, and current treatments are inadequate [5][6] - Patient Population: Focus on patients with three to ten lesions per year, who often rely on daily suppressive therapy with valacyclovir, which has a high failure rate [5][6] Product Details - 5366: A helicase-primase inhibitor, 400 times more potent than valacyclovir, with a 20-day half-life, designed for long-acting oral or injectable use [8][9] - 1179: Discovered at Gilead, approximately 1,000 times more potent than valacyclovir, with a four-day half-life, supporting potential once-a-week treatment [8][9] Clinical Data Highlights - Efficacy Results: In the phase 1b trial for 5366, there was over a 90% reduction in shedding rates and a 98% reduction in high viral load swabs compared to placebo. Additionally, there was a greater than 90% reduction in lesions [12][13] - Safety Data: Upcoming unblinded safety data for 5366 will be shared in December, with expectations of confirming its well-tolerated profile [17][22] Future Plans - Phase 2 Trials: Plans to conduct head-to-head trials against valacyclovir, focusing on longer duration studies to evaluate efficacy and safety [26][31] - Market Potential: Estimated market size for recurrent genital herpes treatment in the U.S. is around 1.3-1.4 million patients, with over 800,000 on chronic suppressive therapy, indicating a multi-billion dollar market opportunity [33] Additional Programs - Hepatitis Delta: Development of an oral small molecule (6250) targeting the same mechanism as Gilead's Bulevirtide, with promising phase 1 results [36][39] - Hepatitis B: Ongoing development of a capsid assembly modulator (4334) with high antiviral effects, awaiting Gilead's review for potential opt-in [42][43] Financial Position - Cash Reserves: The company reported a cash position of over $230 million, expected to last until at least the end of 2027, with additional contributions from Gilead anticipated [43][44] Conclusion - Strategic Collaboration: The partnership with Gilead provides optionality for advancing both HSV and HBV programs, with a focus on bringing effective treatments to market quickly [44]