Avalo Therapeutics (AVTX) Corporate presentation summary

Pipeline and LOTUS results

• Abdakibart (AVTX-009) is a highly potent, specific IL-1β inhibitor; Phase 2 LOTUS tested it in moderate-to-severe hidradenitis suppurativa (HS).

• At Week 16, HiSCR75 was 42.2% with 150 mg Q2W and 42.9% with 300 mg Q4W versus 25.6% with placebo; both active arms met the primary endpoint.

• Combined HiSCR75 was 42.5% (p=0.004); HiSCR50 was 59.0% and 64.3% by dose versus 40.7% with placebo; the combined HiSCR50 analysis was post hoc.

• HiSCR75 separation from placebo was seen by Week 4; responses were similar among participants with and without prior biologic exposure.

• Key secondary endpoints were statistically significant or numerically favorable versus placebo, including IHS4 and draining-tunnel count changes.

Safety and dosing profile

• In LOTUS, any TEAE occurred in 51.8% and 55.4% of abdakibart arms versus 53.5% with placebo; no neutropenia, serious infections, opportunistic infections or deaths were reported.

• The presentation describes potential monthly maintenance dosing from treatment initiation; the regimen used four doses in the first 16 weeks and 13 in the first year.

• LOTUS results are cross-trial compared with other therapies; the presentation cautions that differing trial designs and populations limit comparisons and no head-to-head trials were conducted.

HS market and IL-1β rationale

• HS is projected to exceed a $10B global therapeutics market by 2035; the presentation cites 18% projected CAGR for HS from 2025–2032 and prevalence of 1–4% globally.

• Current HS biologics leave substantial unmet need: 64–77% of moderate-to-severe patients did not achieve HiSCR75; pain, draining fistula and odor rank among the most burdensome symptoms.

• IL-1β is presented as an upstream inflammatory driver in HS; its gene expression was reported up to 100x higher in lesions than healthy skin, while IL-1α expression was not elevated.