AnaptysBio Conference Call Summary Company Overview - **Company**: AnaptysBio (NasdaqGS:ANAB) - **Date of Conference**: November 12, 2025 Key Points Industry and Product Development - AnaptysBio has had a successful year in 2025, leading to multiple value creation streams for 2026 [4][6] - The company is focusing on several key products: - **Rosnell Lab**: A depleter of pathogenic T cells with a positive study involving 424 patients, set to move into phase three trials for arthritis in the first half of next year [4][6] - **AMB 33**: A CD122 antagonist with an ongoing phase 1b study in celiac patients, with plans to initiate a second disease indication next year [5][6] - **Royalty Stream from Gemperly**: Driven by sales from GSK, with an expected accrued capital of approximately $300 million by year-end [6] Celiac Disease Focus - AnaptysBio is prioritizing celiac disease due to: - Existing human proof of concept studies [21] - Compelling preclinical data indicating potential differentiation from competitors [21] - Lack of approved therapies in the market [22] - The company is conducting a gluten challenge study and treating patients with significant mucosal damage, aiming to improve mucosal injury [24][25] Clinical Trial Design and Endpoints - The company is looking for co-primary endpoints based on FDA guidance, focusing on symptoms and histological benefits [27][28] - The histological endpoint involves the villous height to crypt depth (VHCD) ratio, with a target of greater than two for the gluten challenge cohort [28] - The trial design includes a placebo-controlled approach to assess the drug's efficacy [30][32] Market Potential - AnaptysBio estimates approximately 250,000 patients in the U.S. with celiac disease who are biologic eligible once a therapy is approved [43] - The pricing for the therapy is expected to align with the broader inflammatory bowel disease (IBD) market [44] Future Indications and Competitors - The company is exploring additional indications, including Eosinophilic Esophagitis (EOE) and Atopic Dermatitis, with plans to run a phase 1b trial next year [46][52] - Competitors in the space include Teva and Novartis, with ongoing trials for IL-15 and CD122 targeted therapies [11][12] Rosnell Lab Update - Recent results for Rosnell Lab in ulcerative colitis (UC) did not meet the target product profile (TPP) for significant improvement at six months [54] - Safety data remains clean, with no significant adverse events reported [55] - The drug showed over 90% depletion in peripheral T cells, consistent with previous trials [56] Company Separation and Future Strategy - AnaptysBio plans to separate its royalty business from its biopharma business in 2026, with the potential for the split to occur in the first half of the year [72][75] - The royalty stream from Gemperly is projected to be a significant asset, with potential royalties reaching $390 million in peak years [76][79] - The company aims to maintain profitability in the royalty business while advancing its R&D efforts [81] Financial Outlook - The company is actively working on financing strategies for its programs and plans to meet with the FDA for an end-of-phase two meeting by the end of Q1 next year [64][66] Conclusion - AnaptysBio is positioned for growth with a strong pipeline in autoimmune diseases, particularly celiac disease, and a robust royalty stream from Gemperly, indicating a promising future for investors [81]