Avalo Therapeutics (AVTX) H.C. Wainwright 28th Annual Global Investment Conference summary

Strategic focus and market opportunity

• Focus on developing innovative therapies for immune-mediated inflammatory diseases, with initial emphasis on hidradenitis suppurativa (HS), a market projected to exceed $10 billion globally by 2035.

• HS market is growing at an estimated 18% annually through 2032, with increasing diagnosis rates and expanding biologic treatment adoption.

• Substantial unmet need remains in HS, as current biologics only help a minority of moderate to severe patients achieve deep disease control.

Lead program: abdakibart clinical data and differentiation

• Abdakibart is a selective IL-1 beta inhibitor showing positive phase II results, with a 43% HiSCR75 response and favorable safety profile in nearly 500 patients.

• LOTUS phase II trial met its primary endpoint, with HiSCR75 rates of 42.2% and 42.9% for two dosing regimens, both statistically superior to placebo.

• Consistent efficacy observed across both biologic-naive and experienced patients, with rapid onset and improvement through week 16.

• Safety profile similar to placebo, with no serious infections or major adverse events observed.

• Monthly dosing regimen with auto-injector planned, offering a simpler schedule than competitors.

Pipeline and future plans

• AVTX-010, a next-generation long-acting IL-1 beta antibody, is in development with IND submission planned for the first half of 2027.

• Plans to expand IL-1 beta inhibition into additional immune-mediated inflammatory diseases beyond HS.

• End of phase II regulatory discussions expected in the second half of this year, with phase III HS program initiation and AVTX-010 IND in the first half of 2027.

• $472 million in cash and investments at the end of June, providing capital to execute through anticipated phase III top-line data.