Anti-TL1A Phase 1 Results and Phase 2 Development Updates June 2025 Disclosures The information contained in this presentation has been prepared by Spyre Therapeutics, Inc. and its affiliates ("Spyre" or the "Company") and contains information pertaining to the business and operations of the Company. The information contained in this presentation: (a) is provided as at the date hereof, is subject to change without notice, and is based on publicly available information, internally developed data as well as t ...

WALTHAM, Mass., June 16, 2025 /PRNewswire/ -- Spyre Therapeutics, Inc. (NASDAQ: SYRE), a clinical-stage biotechnology company advancing best-in-class antibody engineering, dose optimization, and rational therapeutic combinations for the treatment of Inflammatory Bowel Disease ("IBD") and other immune-mediated diseases, today announced it will report interim results from the Phase 1 SPY002 healthy volunteer trials on Tuesday, June 17, 2025. Following the announcement, the Company will host a conference call ...

Core Insights - Spyre Therapeutics is advancing its clinical pipeline with planned Phase 2 studies in ulcerative colitis (UC) and rheumatoid arthritis (RA), aiming for over 7 proof-of-concept readouts by 2026 and 2027 [1][2] - The company reported strong financials with $565 million in cash and equivalents as of March 31, 2025, providing a runway into the second half of 2028 [1][9] Development Pipeline Overview - The company is focused on developing best-in-class therapies for inflammatory bowel disease (IBD) and other immune-mediated diseases, with a pipeline that includes SPY001, SPY002, and SPY003 [1][3] - IBD affects approximately 2.4 million individuals in the U.S., while RA impacts over 1.5 million individuals [3] Clinical Programs - SPY001 is a monoclonal antibody targeting α4β7, showing a favorable safety profile and a pharmacokinetic (PK) profile that supports infrequent dosing [5][6] - SPY002 consists of two investigational anti-TL1A monoclonal antibodies, with potential to become a first-in-class treatment for IBD and RA [6][11] - SPY003 targets the p19 subunit of IL-23, also engineered for infrequent dosing [7] Financial Performance - For Q1 2025, the company reported R&D expenses of $41.6 million, an increase from $34.9 million in Q1 2024, driven by higher clinical development costs [10] - General and administrative expenses were $11.9 million for Q1 2025, slightly down from $12.8 million in Q1 2024 [10] - The net loss for Q1 2025 was $44.8 million, compared to $43.9 million in Q1 2024, including non-cash stock-based compensation [13][20] Future Outlook - The company plans to initiate two fully funded Phase 2 trials in mid-2025, targeting markets with annual revenues totaling approximately $50 billion [2][11] - Interim data for SPY002 is expected later in Q2 2025, which may demonstrate a superior product profile compared to first-generation TL1A antibodies [2][11]

Core Insights - SPY001 is a novel, half-life extended α4β7 antibody in development for the treatment of Inflammatory Bowel Disease (IBD) with a pharmacokinetic profile supporting a potential best-in-class status [1][3] - The company plans to initiate a Phase 2 trial in mid-2025, which will include SPY001 and other candidates, with initial data expected in 2026 [1][2] Group 1: SPY001 Development - SPY001 has shown a human half-life of approximately 80 days, which is more than three times that of vedolizumab, allowing for potential quarterly or biannual dosing [3][4] - Interim data from the Phase 1 trial indicates that SPY001 is well tolerated and maintains target engagement at expected Phase 2 trough concentrations [4] Group 2: Clinical Trials and Future Plans - The Phase 2 platform trial will test SPY001 as a monotherapy and in combination with other therapies for ulcerative colitis patients, expected to begin mid-2025 [2][3] - Initial monotherapy data from the Phase 2 trial is anticipated in 2026 [1] Group 3: Preclinical and Clinical Data - Preclinical studies indicate that combined inhibition of α4β7 integrin and TL1A cytokine is superior to either monotherapy in mouse models of colitis [4] - The pharmacodynamic data supports rapid and sustained saturation of α4β7 receptors with a single dose of SPY001 [1][4] Group 4: Company Overview - Spyre Therapeutics focuses on developing next-generation therapies for IBD and other immune-mediated diseases through advanced antibody engineering and therapeutic combinations [5] - The company's pipeline includes extended half-life antibodies targeting α4β7, TL1A, and IL-23 [5]