Avalo Therapeutics (AVTX) investor relations material

Company overview and lead program

• Developing AVTX-009, a high-affinity anti-IL-1β antibody, currently in Phase 2b for hidradenitis suppurativa (HS), with full enrollment expected by end of year and data anticipated mid-2026.

• AVTX-009 targets IL-1β, a key driver of inflammation in HS, with higher affinity and specificity compared to competitors.

• The drug is designed for better lesion penetration, longer half-life, and improved dosing frequency.

Scientific rationale and competitive landscape

• IL-1β is identified as the main pathologic driver in HS, with IL-1α not elevated in lesions and not contributing to chronic inflammation.

• Previous anti-IL-1α therapies showed no effect in HS, supporting the focus on IL-1β.

• Lutacisumab data in severe HS patients validated the IL-1β mechanism, showing significant efficacy even in TNF inhibitor failures.

• AVTX-009 aims for higher efficacy due to pure IL-1β targeting and higher affinity.

• The market is shifting from TNF inhibitors to IL-17s, but there remains a need for alternative mechanisms due to limited response rates.

Clinical trial design and progress

• Phase 2b trial includes three arms (two active, one placebo), 222+ patients, 16-week duration, and HiSCR75 as the primary endpoint.

• Dosing regimens include monthly and biweekly options with loading doses, aiming for rapid therapeutic levels and patient-friendly administration.

• Enrollment is highly competitive but progressing well, with 75% completed and full enrollment expected in the fall.

• Comprehensive endpoints include skin pain, quality of life, and draining tunnel assessments.

• Statistical analysis will use appropriate imputation methods, avoiding exclusion of patients for incidental antibiotic use.