Summary of AnaptysBio Conference Call Company Overview - **Company**: AnaptysBio - **Industry**: Biopharmaceuticals Key Points Business Separation - AnaptysBio is planning to split its operations into two distinct entities: a royalty management business and a biopharma business by the end of 2026 [1][2] - The rationale for the split is to allow investors to focus on different asset portfolios, as the royalty business (including Jemperli, LIMS, and Dolomap) is substantial enough to operate independently [2][3] - The separation aims to protect and return value to shareholders, with expectations of significant upside for both businesses [3] Operational Timeline - The separation process includes regulatory approvals, financial audits, and logistical arrangements, with a potential update on rosnilimab expected in the first half of the year [4][5] - AnaptysBio anticipates ending the year with $300 million in cash, which will support the biopharma business post-separation [12] Rosnilimab and Celiac Disease Programs - Rosnilimab is being advanced for rheumatoid arthritis (RA), with positive phase 2b data indicating sustained low disease activity and remission rates [37] - The company is preparing for an end-of-phase 2 meeting with the FDA to discuss the next steps for Rosnilimab [38] - AnaptysBio is also conducting a phase 1b trial for AMB-033, a CD122 antagonist targeting celiac disease, with two cohorts designed to assess the drug's efficacy [20][21] Clinical Trial Insights - The phase 1b trial for AMB-033 includes a gluten challenge for one cohort and a focus on inflammation in the second cohort, aiming to demonstrate healing of the mucosal injury [22][24] - The target population for AMB-033 includes over two million patients with celiac disease, with a focus on statistically significant healing compared to placebo [27][31] Market Potential - The biopharma business is expected to have at least two years of capital to operate post-separation, ensuring a solid financial foundation [12] - The company is exploring strategic and financial collaborations to support the phase 3 program for Rosnilimab [39] - AnaptysBio is positioned to be the first approved drug for celiac disease, which currently has no approved treatments [31] Future Developments - Multiple catalysts are expected in the coming year, including updates on Rosnilimab, AMB-033, and ongoing growth in Jemperli's monotherapy indications [41] - The company is committed to maintaining a streamlined infrastructure for the royalty business post-separation [7][9] Additional Important Information - The litigation with GSK and Tesaro is deemed independent of the biopharma business's optimization efforts, with no expected impact on timelines [10][11] - The company is focused on minimizing operational complexity while maximizing shareholder value through the separation [7][8]

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]