Avalo Therapeutics (AVTX) investor relations material

Strategic focus and pipeline development

• Lead asset abdakibart, a selective anti-IL-1 beta antibody, showed differentiated efficacy and safety in phase II LOTUS trial, meeting all primary and secondary endpoints with consistent results across dosing regimens.

• Phase III registrational program in HS is prioritized for launch in the first half of 2027, with IND submission for next-generation AVTX-010 planned in the same timeframe.

• AVTX-010, a long-acting anti-IL-1 beta antibody, is engineered for extended dosing intervals, franchise expansion, and enhanced intellectual property protection.

• Over $400 million in cash as of June 2026, providing runway through 2029 and supporting both phase III and pipeline expansion.

Clinical data and competitive positioning

• LOTUS phase II trial demonstrated HiSCR75 response rates above 42% for both dosing regimens, with a strong safety profile and no serious adverse events.

• Consistent efficacy observed in biologic-experienced and naive patients, supporting use in both first-line and refractory settings.

• Placebo response rates in HS trials remain variable; robust effect size and rigorous trial design increase confidence in phase III success.

• LOTUS trial run to pivotal standards; two phase III trials planned, with potential for LOTUS to serve as pivotal if needed.

Market landscape and future outlook

• HS market estimated above $3 billion, projected to exceed $10 billion by mid-2030s, driven by earlier diagnosis and biologic adoption.

• IL-1 beta identified as a central inflammatory driver in HS, with mechanistic rationale supported by biomarker and clinical data.

• Multiple mechanisms expected to coexist in HS, similar to IBD, with combination therapies likely to emerge; IL-1 beta suppression seen as a key component.

• Ongoing monitoring of competitor data (e.g., lutikizumab, tulisokibart) to inform development strategy, but confidence in abdakibart is based on internal data strength.