Spyre Therapeutics, Inc. (NASDAQ: SYRE) has announced its 2025 priorities and a robust pipeline of upcoming clinical readouts, according to a recent press release. The company highlighted several key developments, including the expected phase 1 interim results for its spy002 and spy003 programs in the second quarter and second half of 2025, respectively.
Spyre also revealed that a phase 2 platform trial in ulcerative colitis (UC) is on track for initiation in mid-2025, with spy001, spy002, spy003, and combinations thereof, and initial results are expected in 2026.
Furthermore, the company disclosed its plans for an indication expansion into rheumatoid arthritis (RA) with its spy002 program, with a phase 2 trial initiation anticipated in mid-2025 and topline results expected in 2026.
Key financial highlights include a preliminary cash, cash equivalents, and marketable securities balance of over $600 million as of December 31, 2024, providing an anticipated cash runway into the second half of 2028.
The CEO of Spyre, Cameron Turtle, emphasized the company's progress in 2024, including entering first-in-human studies with spy001 and spy002. He also expressed optimism about reporting interim phase 1 results for spy002 and spy003 in 2025, as well as advancing all three programs into a groundbreaking phase 2 platform study in UC patients.
The press release also outlined anticipated milestones for Spyre's next-generation monotherapies, including spy001, spy002, and spy003, as well as the company's plans to advance these programs into a double-blind, randomized, placebo-controlled, phase 2 platform trial in patients with moderately-to-severely active ulcerative colitis.
Additionally, the expansion of the spy002 program into RA was highlighted, with potential benefits supported by multiple lines of evidence, including human genetics, blood and tissue samples from RA patients, and animal models of the disease.
The strong financial position of the company, with a preliminary cash balance of approximately $603 million as of December 31, 2024, was also underscored in the press release.
It's important to note that the aforementioned financial results are unaudited and subject to adjustment, and the company expects to report its final and complete fourth quarter and full-year 2024 financial results in late February 2025.
Spyre Therapeutics, Inc. is a clinical-stage biotechnology company focusing on developing next-generation products for inflammatory bowel disease (IBD) and other immune-mediated diseases through antibody engineering, rational therapeutic combinations, and precision medicine approaches.
Please note that the information provided is based on the contents of the press release and does not include any external analysis or commentary. Today the company's shares have moved -2.9% to a price of $21.81. For more information, read the company's full 8-K submission here.