Avalo Therapeutics is a clinical-stage biotech with no approved products and no revenue, focused entirely on developing abdakibart (AVTX-009), an anti-IL-1β monoclonal antibody for immune-mediated inflammatory diseases. The lead indication is hidradenitis suppurativa (HS), a chronic inflammatory skin disease affecting an estimated 3.4M people in the U.S. Abdakibart works by blocking IL-1β, a pro-inflammatory cytokine that drives inflammation across a range of diseases. Avalo acquired rights to abdakibart through its 2024 acquisition of AlmataBio, which held a worldwide exclusive license from Eli Lilly. Abdakibart is currently in a Phase 2 trial (LOTUS) enrolling roughly 250 adults with moderate-to-severe HS, with topline data expected in Q2 2026; positive results would trigger Phase 3 trials. Avalo is funded by equity capital and spends primarily on clinical trial costs. If approved, Avalo would sell abdakibart as a biologic therapy to dermatology practices, with reimbursement from commercial insurers and government payors. Avalo has no manufacturing facilities (relying on a single CDMO) and no sales force, meaning it would need to build or partner for commercial capabilities. The licensing structure carries meaningful obligations, including up to $70M in milestones and royalties of 5–15% of net sales owed to Eli Lilly, plus up to $650M in sales-based milestones. The composition of matter patent expired in early 2026, so Avalo's primary IP protection would rely on FDA biologics exclusivity rather than patents.
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