Avalo Therapeutics (AVTX) 12th Annual Cantor Fitzgerald Global Healthcare Conference summary

Company overview and pipeline priorities

• Clinical-stage biotech focused on anti-IL-1 beta therapies, with a major recap and strategic shift in 2024.

• Lead asset abdakibart, a potent anti-IL-1 beta monoclonal antibody, advanced rapidly through phase II and is preparing for phase III in moderate-to-severe HS.

• Expansion plans include AVTX-010, a long-acting version, and preparations for additional indications.

• Capital raised to support phase III through 2029, with aggressive enrollment timelines set.

• Focused on building a premier anti-inflammatory company centered on IL-1 beta and inflammasome biology.

Clinical data and physician feedback

• Phase II data for abdakibart showed robust, consistent efficacy across multiple endpoints and patient subgroups.

• Physician feedback highlighted strong validation of the IL-1 beta hypothesis in HS and high enthusiasm for the results.

• Safety profile was favorable, with no significant differences in adverse events compared to placebo.

• Additional biomarker data to be presented at EADV, expected to reinforce target engagement.

Phase III plans and regulatory strategy

• End-of-phase II package to be submitted before year-end, aiming for FDA alignment on trial design.

• Phase III to follow established HS trial standards: 16-week induction, 52-week chronic treatment, and key efficacy endpoints (HiSCR75, HiSCR50, IHS4).

• Differentiated dosing planned (600 mg loading, 300 mg monthly), with auto-injector device in development.

• Confident in trial powering and design to address placebo variability and ensure robust results.