Avalo Therapeutics (AVTX) investor relations material

Company and asset overview

• Recapitalized in 2024, raising $185 million and acquiring AVTX-009, a high-affinity anti-IL-1 beta monoclonal antibody originally developed by Lilly for type 2 diabetes.

• AVTX-009 targets hidradenitis suppurativa (HS), with a fully enrolled phase 2b Lotus trial expected to report data mid-next year.

• The asset is positioned as more potent and with a longer half-life than competitors, aiming for superior efficacy.

• The company has a strong biotech investor base and a core team in place.

• Current cash position is $115 million, sufficient to fund operations through 2028 and phase 3 preparations.

Mechanism of action and differentiation

• IL-1 beta is identified as the master regulator of inflammation in HS lesions, with high local abundance and central role in disease pathology.

• IL-1 alpha plays a minor role in HS, with clinical data showing negligible effect from its blockade.

• AVTX-009 has 15-fold higher affinity for IL-1 beta than AbbVie’s lutikizumab and a longer half-life, potentially leading to higher drug concentration and efficacy in lesions.

• The drug’s mechanism is differentiated by its selective targeting and pharmacokinetic advantages.

Competitive landscape and clinical data

• AbbVie’s lutikizumab, a bispecific anti-IL-1 beta/alpha, demonstrated strong efficacy in both TNF-exposed and biologic-naive HS patients, setting a high benchmark.

• AVTX-009 is expected to match or exceed this efficacy due to higher affinity and better lesion penetration.

• The Lotus trial is designed with a robust placebo control and over-enrollment to ensure statistical power.

• Patient demographics and trial design are similar to other leading studies, with a higher proportion of biologic-experienced patients.