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RAPT Therapeutics (NasdaqGM:RAPT) 2025 Conference Transcript
2025-11-12 20:40
Summary of RAPT Therapeutics Conference Call Company Overview - RAPT Therapeutics is an immunology therapeutics company focusing on high-value indications with the potential to disrupt the standard of care, targeting multi-billion dollar opportunities [4][5] - The lead asset is ozureprubart (RPT-904), a long-acting anti-IgE biobetter designed for less frequent dosing and improved compliance compared to Xolair [4][5] Key Product Insights - Ozureprubart targets food allergies, a $40 billion opportunity in the US, and chronic spontaneous urticaria (CSU) [4][5] - Recent phase two trial data showed superior efficacy to omalizumab across all endpoints, supporting a move to phase three studies for CSU and food allergy [5][30] Acquisition and Licensing Details - The asset was acquired with a $35 million upfront payment and potential milestone payments totaling approximately $670 million, with a significant portion tied to commercial milestones [11][12] - RAPT retains global rights except for China, Taiwan, Hong Kong, and Macau [12] Competitive Landscape - The food allergy market is largely untapped, with 17 million diagnosed patients in the US and a high unmet need [14][15] - Ozureprubart is positioned to potentially replace omalizumab as the standard of care, with a differentiated profile allowing for premium pricing [15][18] Differentiation Factors - Key differentiators include less frequent dosing (Q8 or Q12 weeks) compared to the current Q2 week dosing for most food allergy patients, which enhances compliance [17][18] - The ability to treat patients currently ineligible for omalizumab due to high IgE or weight provides additional market leverage [18] Clinical Trial Design and Progress - The phase 2b food allergy study is modeled after the OutMatch study for Xolair, with a focus on patients sensitive to multiple food allergens [21][22] - Enrollment is ongoing, with plans to complete the study in 18 months and a readout expected in early 2027 [24] Safety and Efficacy Considerations - The safety profile of ozureprubart is expected to be similar to that of omalizumab, with a focus on reducing the need for up-dosing [30][39] - The company is considering post-approval studies to further evaluate the drug's performance against omalizumab [37] Future Development Plans - RAPT plans to initiate phase 3 studies for CSU by the end of next year, leveraging safety data from their partner in China [34][35] - Other indications, such as asthma and allergic rhinitis, are being considered for future development based on the success of the food allergy study [41][42] Financial Position - The company reported a pro forma cash balance of $392 million at the end of Q3, projected to last until mid-2028, covering the upcoming clinical milestones [48]
Anaptys Announces Participation in November Investor Conferences
Globenewswire· 2025-11-04 21:15
Company Overview - AnaptysBio, Inc. is a clinical-stage biotechnology company focused on innovative immunology therapeutics for autoimmune and inflammatory diseases [2] - The lead program, rosnilimab, has completed a Phase 2b trial for rheumatoid arthritis and is currently in a Phase 2 trial for ulcerative colitis [2] - The pipeline includes ANB033, a CD122 antagonist in a Phase 1b trial for celiac disease, and ANB101, a BDCA2 modulator in a Phase 1a trial [2] - Anaptys has out-licensed multiple therapeutic antibodies, including a PD-1 antagonist to GSK and an IL-36R antagonist to Vanda Pharmaceuticals [2] Upcoming Events - Daniel Faga, CEO, and other executives will participate in several investor conferences, including the TD Cowen Immunology & Inflammation Summit and the Jefferies Global Healthcare Conference [1] - Live webcasts of the events will be available on the investor section of the Anaptys website, with replays accessible for at least 30 days [1] Strategic Developments - Anaptys plans to separate its biopharma operations from its royalty assets by the end of 2026, allowing investors to align their investment strategies with the distinct opportunities of each entity [3]
Anaptys Announces Late-Breaking Oral Presentation of Complete Phase 2b Data for Rosnilimab in Rheumatoid Arthritis at Upcoming ACR Convergence 2025
Globenewswire· 2025-10-13 13:15
Core Insights - AnaptysBio, Inc. announced that complete data from the Phase 2b trial of rosnilimab for rheumatoid arthritis has been accepted for a late-breaking oral presentation at the ACR Convergence 2025 [1][2] Company Overview - AnaptysBio is a clinical-stage biotechnology company focused on innovative immunology therapeutics for autoimmune and inflammatory diseases [6] - The lead program, rosnilimab, is a pathogenic T cell depleter that has completed a Phase 2b trial for rheumatoid arthritis and is currently in a Phase 2 trial for ulcerative colitis [6] - The company also has a pipeline that includes ANB033, a CD122 antagonist for celiac disease, and ANB101, a BDCA2 modulator, both in Phase 1 trials [6] Product Details - Rosnilimab is designed to selectively deplete pathogenic T cells while sparing nonpathogenic T cells, aiming to preserve overall immune function [5] - The therapeutic targets activated Tph/Tfh and T effector cells, which are involved in autoimmune and inflammatory diseases [4] Presentation Information - The presentation will be made by Professor Paul Emery from the University of Leeds, highlighting the safety, tolerability, and efficacy of rosnilimab [2][8] - The session is scheduled for October 29, 2025, from 8:00 am to 9:30 am CT [8] Strategic Developments - AnaptysBio plans to separate its biopharma operations from its royalty assets by the end of 2026, allowing investors to align their investment strategies with the distinct objectives of each entity [7]
Anaptys Announces Second Quarter 2025 Financial Results and Provides Business Update
Globenewswire· 2025-08-06 20:15
Core Insights - AnaptysBio reported positive Phase 2b data for rosnilimab in rheumatoid arthritis, demonstrating a favorable safety profile and JAK-like efficacy, with durable responses observed for at least 12-14 weeks off-drug [2][5] - The company completed enrollment for a Phase 2 trial of rosnilimab in ulcerative colitis, with top-line data expected in Q4 2025 [4][9] - AnaptysBio plans to initiate a Phase 1b trial for ANB033, a CD122 antagonist targeting celiac disease, by Q4 2025 [2][4] Financial Updates - As of June 30, 2025, AnaptysBio reported cash and investments totaling $293.7 million, down from $420.8 million at the end of 2024, primarily due to operating activities and share repurchases [13] - Collaboration revenue for Q2 2025 was $22.3 million, compared to $11.0 million in Q2 2024, driven by increased royalties from Jemperli [13] - The net loss for Q2 2025 was $38.6 million, an improvement from a net loss of $46.7 million in Q2 2024, with a net loss per share of $1.34 compared to $1.71 in the prior year [13][19] Pipeline Developments - Rosnilimab's Phase 2b trial for rheumatoid arthritis involved 424 patients and showed a best-in-disease profile with monthly dosing [5] - The company is assessing different dosing levels for rosnilimab in the ulcerative colitis trial, with a primary endpoint focused on the modified Mayo score [9] - Ongoing Phase 1 trials for ANB033 and ANB101 are in healthy volunteers, with plans for further updates on ANB033 at a dedicated R&D event later this year [4][6] Collaboration and Milestones - AnaptysBio anticipates a $75 million milestone payment from GSK in 2025 once Jemperli achieves $1 billion in worldwide net sales [4][10] - GSK reported strong sales performance for Jemperli, with Q2 2025 sales of $262 million, reflecting over 19% quarter-over-quarter growth [10]