Avalo Therapeutics (AVTX) investor relations material

Strategic focus and pipeline

• Advancing novel IL-1β pathway inhibitors for immune-mediated inflammatory diseases, with a focus on unmet medical needs.

• Two lead candidates: abdakibart (AVTX-009) with positive Phase 2 data in hidradenitis suppurativa (HS), and AVTX-010, a long-acting anti-IL-1β mAb expected to enter clinical trials in 1H 2027.

• Targeting high-growth markets such as HS, projected to exceed $10B globally by 2035.

• Exploring IL-1β inhibition for additional indications with significant unmet need.

Clinical results and efficacy

• Abdakibart demonstrated statistically significant efficacy in Phase 2 LOTUS study, with HiSCR75 response rates of 42.5% and HiSCR50 rates of 61.7% at week 16, outperforming placebo.

• Efficacy was consistent across doses and prior biologic exposure, with improvements seen as early as week 4.

• Secondary endpoints, including IHS4, draining tunnel count, and flare rate, were statistically significant or numerically improved.

• Cross-trial comparisons suggest abdakibart may offer leading efficacy among current and pipeline HS therapies.

Safety and dosing profile

• Abdakibart was well-tolerated in ~500 patients, with adverse event rates similar to placebo and no serious infections or neutropenia.

• Differentiated, patient-friendly monthly dosing regimen starting at treatment initiation, with fewer doses required compared to other therapies.