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

Investment thesis and HS opportunity

• Abdakibart is a potent, selective IL-1 beta inhibitor being developed for HS, with positive phase II data and a potential monthly regimen.

• Global HS therapeutics market projected to grow ~18% annually through 2032 and exceed $10B by 2035; diagnosis and biologic use are expanding.

• HS can cause painful nodules, abscesses, draining tunnels, tissue damage, and scarring; substantial unmet need remains despite recent treatment advances.

• IL-1 beta is elevated in HS lesions and sits upstream of inflammatory effectors including IL-17 and TNF; the strategy selectively targets IL-1 beta.

LOTUS phase II results

• LOTUS was a randomized, placebo-controlled phase IIb study in 253 patients with moderate to severe HS; regimens were 150 mg every 2 weeks or 300 mg every 4 weeks, each with a loading dose.

• At week 16, HiSCR75 was 42.2% and 42.9% for abdakibart versus 25.6% for placebo; both doses met the primary endpoint with statistically significant treatment differences.

• HiSCR50 was 59% and 64.3% for the two abdakibart regimens versus 40% for placebo; combined response was 61.7%.

• Placebo separation appeared by week 4, particularly with 300 mg monthly dosing, and treatment effect continued to develop through week 16.

• Activity was observed in biologic-naive and biologic-experienced patients; secondary measures generally supported the clinical effect, while pain was variable and not statistically significant.

Safety and dosing profile

• Adverse event and serious adverse event rates were similar to placebo; no neutropenia, serious or opportunistic infections, major cardiovascular events, malignancies, or tuberculosis were observed in LOTUS.

• Intended regimen is one loading dose followed by 300 mg every 4 weeks, potentially via auto-injector; this would mean four doses in the first 16 weeks and ~13 in year one.

• Cross-trial comparisons were described as limited and not head-to-head; phase III aims to reproduce LOTUS efficacy while preserving safety and dosing convenience.