Avalo Therapeutics (AVTX) investor relations material

HS market and treatment rationale

• HS affects ~3 million U.S. patients; projected market exceeds $10B, with delayed diagnosis and referral contributing to substantial unmet need.

• Three therapies are approved—HUMIRA, Cosentyx and BIMZELX—with activity across anti-TNF, anti-IL-17, IL-1β and JAK approaches.

• IL-1β was described as abundant in HS lesions and upstream of TNF and IL-17; abdakibart’s high-affinity blockade is intended to address this inflammatory driver.

• Lutikizumab’s phase III result was described as a low-30% response versus placebo in the 20% range; abdakibart was said to have at least sevenfold higher IL-1β affinity and a longer half-life.

LOTUS phase II results and safety

• LOTUS was a 16-week, 1:1:1 trial with two active dosing regimens and placebo, run and analyzed to a pivotal standard.

• Both abdakibart arms achieved ~43% HiSCR75; all secondary endpoints were positive, including IHS4-75 at 44.7%.

• Results were consistent over time, across endpoints and between doses; the study included a substantial severe and biologic-experienced population, with 36% prior biologic exposure.

• No serious infections, serious adverse events or clinically significant neutropenia occurred; transient neutrophil reductions were observed.

Phase III plans and execution

• FDA and EMA were reviewing the package, with feedback expected before year-end 2026; enrollment was targeted for early 2027 after protocol finalization.

• The planned program comprises two placebo-controlled studies in early stage II/III HS, with ~40% biologic-experienced patients, HiSCR75 primary endpoint and step-down analysis to HiSCR50.

• Planned studies include 16-week induction and 52-week maintenance; a single dose was proposed to FDA, subject to possible additional dose-ranging requests.

• Phase III secondary endpoints are to include IHS4, skin pain, quality of life and flares; top-line HS data are expected in 2029.

• Plans include rigorous investigator and patient training, careful lesion assessment and adequate statistical power to manage variable disease and placebo response; enrollment was expected to benefit from available patients and experienced sites.