AnaptysBio (NasdaqGS:ANAB) FY Conference December 02, 2025 01:30 PM ET Company ParticipantsDaniel Faga - President and CEOConference Call ParticipantsYas Rahimi - Senior Biotech AnalystYas RahimiGood afternoon, everyone. Welcome to our Piper Sandler Healthcare Conference. My name is Yas Rahimi. I'm a Senior Biotech Analyst here at Piper Sandler, and the covering analyst of AnaptysBio. Dan, it's wonderful to have you. We have lots to cover over the next 25 minutes, and you have a packed schedule, so you've b ...

Summary of AnaptysBio Investor Event on ANB033 Company Overview - **Company**: AnaptysBio (NasdaqGS:ANAB) - **Focus**: Development of ANB033, a CD123 antagonist for autoimmune and inflammatory diseases, particularly celiac disease and eosinophilic esophagitis (EoE) [2][3][61] Key Points on ANB033 and Its Development - **Separation of Operations**: In 2026, AnaptysBio plans to separate its biopharma operations from its royalty assets to create two independent publicly traded companies [2] - **Clinical Trials**: - A Phase 1b trial for celiac disease has been initiated, with plans for a second indication trial in 2026 [3][26] - The trial design includes two cohorts: one for patients with minimal mucosal damage and another for those with significant damage [55][56] Mechanism of Action - **Targeting CD123**: ANB033 is designed to inhibit IL-15 and IL-2 signaling pathways, which are crucial in the activation and proliferation of pathogenic immune cells [4][12][20] - **Therapeutic Potential**: The drug has broad therapeutic potential across various areas, including gastrointestinal and dermatological diseases [5][26] Market Opportunity - **Celiac Disease**: - Approximately 2 million celiac patients in the U.S., with a projected 250,000 diagnosed non-responsive patients by early 2030s [8][61] - The market for celiac disease treatments is estimated to exceed $4 billion, with no approved therapies currently available [8][62] - **EoE Market**: - EoE is characterized by inflammation of the esophagus, with limited treatment options available [63] - Dupilumab, the only approved therapy, is expected to generate $2 billion in sales by 2025, indicating a significant market opportunity for ANB033 [63] Clinical Data and Safety Profile - **Phase 1a Trial Results**: - ANB033 demonstrated a favorable safety profile with no severe adverse events reported [36] - The drug maintained full receptor occupancy for over 30 days, with a dose-response observed on relevant pharmacodynamic biomarkers [36] - **Impact on Immune Cells**: - ANB033 significantly reduced CD123 expressing CD8 T cells and NK cells without compromising overall immune competency [37][39] Unmet Medical Need - **Celiac Disease Treatment**: Current treatment options are limited to a gluten-free diet, which is often poorly tolerated [41][62] - **Patient Population**: Many patients continue to suffer from symptoms such as anemia and fatigue despite adherence to a gluten-free diet [41][62] Future Directions - **Additional Indications**: AnaptysBio is exploring other potential indications for ANB033, including EoE, with plans to advance one additional proof of concept trial in 2026 [26][61] - **Regulatory Engagement**: The FDA has shown enthusiasm for new treatments for celiac disease, emphasizing the need for therapies that can prevent symptoms and improve histological injury [51] Conclusion - **Strategic Positioning**: AnaptysBio is well-positioned to address significant unmet needs in the treatment of celiac disease and EoE with ANB033, leveraging its unique mechanism of action and favorable safety profile to capture a substantial market opportunity [62][63]