Avalo Therapeutics (AVTX) investor relations material

Key announcements and data updates

• Top-line data from the phase II LOTUS trial in HS with AVTX-009 will be available in Q2, following last patient visits at the end of March and subsequent data analysis.

• Enrollment for the LOTUS trial was completed on October 29, with 250 patients enrolled, exceeding the original target of 222, making it one of the largest phase II HS trials.

• The study is powered at 80% to detect a 20% delta in HiSCR75 and 90% for a 25-30% delta, with over one-third of patients being biologically experienced.

• Subgroup analyses, including bio-experienced versus naive patients, are planned for the top-line data release.

Study design and operational rigor

• Approximately 90 sites participated, mainly in the US and Canada, with strict site and investigator qualification and training protocols.

• Board-certified dermatologists led most sites, and both investigators and patients underwent specialized training to minimize placebo effects.

• Continuous monitoring and retraining ensured data consistency, and site enrollment was capped to avoid bias.

• The CRO selected had prior success in similar studies, and operational measures were implemented to maintain steady, high-quality enrollment.

Competitive positioning and future plans

• The preferred phase III dose is likely the every-four-week regimen, pending FDA discussions and phase II results.

• The program is designed to meet regulatory requirements for two pivotal studies, with dose selection informed by efficacy and safety data.

• AVTX-009 is positioned to differentiate from lutikizumab through higher potency, longer dosing intervals, and potentially superior efficacy.

• The mechanism targets IL-1 beta, with potential for broader application in dermatology, GI, and rheumatology, including crystal arthropathies.