Avalo Therapeutics (NasdaqCM:AVTX) FY Conference Transcript

Summary of Avalo Therapeutics FY Conference Call (December 02, 2025) Company Overview - Company: Avalo Therapeutics (NasdaqCM:AVTX) - Focus: Development of AVTX-009 for hidradenitis suppurativa (HS) Key Points Industry Context - 2025 Performance: The year was described as exciting, with expectations for 2026 to be even more promising [4][5] - Competitor Landscape: Mention of Lutikismab, a competitor in the HS market, currently in phase 3 studies [49] Clinical Trial Updates - LOTUS Trial: - Phase 2 trial for HS with AVTX-009 has completed enrollment as of October 29, 2025, exceeding the target of 222 patients, reaching 250 [6][16] - The trial is designed to show a 20% delta difference in HiSCR75 on a placebo-adjusted basis with 80% power, and 90% power for a 25-30% difference [16][18] - Top-line data expected in Q2 2026, following a 16-week treatment duration and a six-week follow-up [10][11][12] Trial Design and Execution - Demographics: The trial includes a higher proportion of biologically experienced patients, with over a third expected to be biologically experienced [21][22] - Site Management: - Approximately 90 sites involved, primarily in the U.S. and Canada, with rigorous site qualification and training processes implemented [29][30] - Emphasis on managing the placebo effect through strict protocols and training for both investigators and patients [30][35] Future Development Plans - Phase 3 Trials: - The anchor dose for the phase 3 program will likely be one of the two doses tested in phase 2, with a preference for a more patient-friendly dosing schedule [43][44] - Discussions with the FDA will determine the need for additional dose-ranging studies [44][45] Competitive Positioning - Differentiation from Lutikismab: - AVTX-009 is expected to offer a longer dosing interval and potentially higher efficacy due to its higher potency [49][51] - The company aims to demonstrate a benign side effect profile similar to Lutikismab while exploring efficacy in various patient populations [52][56] Financial Considerations - Capital Needs: Significant capital will be required for two large phase 3 trials, with expectations of strong investor interest due to the drug's potential [58] - Expansion Opportunities: Potential to explore other indications related to IL-1 beta, including dermatology and rheumatology [59] Conclusion - Outlook: The company is optimistic about the upcoming data and its potential impact on the market, with a strong focus on execution and differentiation in a competitive landscape [62]