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BioRay Biopharmaceutical Co., Ltd.(H0288) - Application Proof (1st submission)
2026-01-05 16:00
The Stock Exchange of Hong Kong Limited and the Securities and Futures Commission take no responsibility for the contents of this Application Proof, make no representation as to its accuracy or completeness and expressly disclaim any liability whatsoever for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this Application Proof. Application Proof of BioRay Biopharmaceutical Co., Ltd. 浙 江 博 銳 生 物 製 藥 股 份 有 限 公 司 (the "Company") (A joint stock company incorporated ...
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]