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]

Financial Data and Key Metrics Changes - The company reported a cash balance of just under $300 million entering the second half of the year, which is expected to sustain operations through the end of 2027 [7][75]. - The royalty asset from GSK for the drug Jemperli is projected to generate significant revenue, with estimates suggesting potential royalties of $80 million for every $1 billion in sales [79][82]. Business Line Data and Key Metrics Changes - The lead program, rozanolimab, showed positive results in clinical trials for arthritis, with stable off-drug data through nine months and a second trial for ulcerative colitis fully enrolled [5][10]. - The company has two additional drugs in clinical development: AMB033, a CD122 antagonist, and AMB101, a BCA2 modulator, both in Phase 1a trials [6][71]. Market Data and Key Metrics Changes - The market for ulcerative colitis is seen as a growth opportunity, with a significant number of patients likely to switch classes of drugs, indicating a demand for new mechanisms of action [43][44]. - The competitive landscape in rheumatoid arthritis (RA) is noted to be stagnant, with no new classes launched in over a decade, positioning the company favorably [50]. Company Strategy and Development Direction - The company is considering two primary paths forward: advancing independently in ulcerative colitis or pursuing multiple diseases, including RA and UC [45][48]. - The focus is on maximizing clinical remissions and ensuring patient tolerability to drive long-term engagement with the drug [32][36]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming data readouts for ulcerative colitis, emphasizing the importance of demonstrating efficacy at three and six months [19][20]. - The company is optimistic about the potential for rozanolimab to provide a differentiated treatment option in a competitive market, particularly given the observed long-lasting effects in RA [49][51]. Other Important Information - The company highlighted the significance of the royalty from GSK, which is expected to provide a valuation backstop and support future growth initiatives [82]. - There is a strong emphasis on the translational research capabilities of the company's platform, which is seen as a competitive advantage in developing new therapies [87][88]. Q&A Session Summary Question: What are the expectations around the three-month update for ulcerative colitis? - Management indicated that the primary endpoint is the change in MMS versus placebo, with expectations for clinical response and remission rates to be comparable to existing biologic classes [36][40]. Question: How does the company balance resources between ulcerative colitis and rheumatoid arthritis? - The decision-making process will depend on the six-month data from the ulcerative colitis trial, with a focus on patient safety and efficacy [41][42]. Question: What is the competitive landscape for the company's drugs? - Management noted that while there are no new RA classes in development, the company is well-positioned due to the potency and tolerability of its drug compared to competitors [50][51]. Question: What is the potential market opportunity for AMB033 in celiac disease? - The company highlighted the significant unmet need in celiac disease, with over two million patients in the U.S. and no approved treatments, making it an attractive market [61][62]. Question: How does the company view its antibody platform's value? - The platform is seen as a critical asset for developing differentiated therapies, with a focus on translational research and process development to optimize drug candidates [87][88].