Avalo Therapeutics (AVTX) investor relations material

Company and product overview

• Focused on immunology and inflammation, with lead product AVTX-009, an anti-IL-1β monoclonal antibody, in phase II-B for hidradenitis suppurativa (HS).

• LOTUS trial completed enrollment in October, with data expected in Q2 2025.

• Trial was upsized to over 250 patients to enable subgroup analyses, making it one of the largest HS studies.

Differentiation and competitive landscape

• AVTX-009 targets IL-1β specifically, unlike Lutikizumab which also targets IL-1α, potentially reducing efficacy and increasing off-target effects.

• Higher affinity for IL-1β and longer half-life may enable better efficacy and more patient-friendly dosing (every four weeks).

• AbbVie's Lutikizumab has shown strong phase II data in difficult-to-treat HS patients, but AVTX-009 aims to surpass this efficacy.

Mechanism and rationale

• IL-1β is central to HS pathology, driving neutrophil recruitment and inflammation, and is upstream of TNF-α and IL-17.

• Targeting IL-1α is not beneficial in HS, as shown by failed trials and mechanistic understanding.

• AVTX-009’s selectivity avoids drug diversion to normal epithelial cells, maximizing lesion targeting.