Spyre Therapeutics Announces Q3 2024 Financial Results and Corporate Update

Spyre Therapeutics, Inc., a biotechnology company specializing in advanced antibody engineering and precision medicine for inflammatory bowel disease (IBD), has released its financial results for the third quarter of 2024 and shared updates on its programs. The company, based in Waltham, Massachusetts, is making significant strides in developing treatments for IBD, including ulcerative colitis (UC) and Crohn's disease (CD), with an estimated 2.4 million people affected in the United States.

Spyre's pipeline includes four key programs, three of which are validated IBD targets, and one undisclosed target. The company is also exploring rational combinations of its antibody candidates to enhance efficacy in treating UC and CD. Spyre's approach aims to maximize the efficacy, safety, and convenience of its IBD treatments through innovative antibody engineering and therapeutic combinations.

The company has provided updates on its three main programs: SPY001, SPY002, and SPY003. SPY001, a highly potent anti-α4β7 monoclonal antibody with half-life extension technology, is designed for high concentration and infrequent subcutaneous maintenance dosing. The Phase 1 trial of SPY001, initiated in June 2024, is expected to enroll approximately 56 healthy volunteers. Interim data from this trial are anticipated by the end of 2024. Preclinical data presented in October 2024 at the United European Gastroenterology Week (UEGW) Congress showed that SPY001 has comparable potency to vedolizumab and a significantly extended half-life of 22 days in non-human primates.

SPY002 involves two investigational anti-TL1A monoclonal antibody candidates with potential best-in-class binding affinity. TL1A is considered a promising target in IBD and other immunology indications. The lead SPY002 candidates have shown superior in vitro potency and extended half-lives in preclinical studies. First-in-human trials for SPY002 are expected to begin in the fourth quarter of 2024, with interim data anticipated in the first half of 2025.

SPY003, targeting the IL-23 p19 subunit, demonstrated robust preclinical potency and extended half-life in non-human primates. Initial data for SPY003, presented at UEGW in October 2024, indicated a pharmacokinetic half-life of 30 days, significantly longer than risankizumab. The initiation of first-in-human trials for SPY003 has been accelerated to the first quarter of 2025.

Spyre is also researching combinations of its proprietary antibodies to potentially achieve best-in-class efficacy in IBD with less frequent dosing. Preclinical data for combination treatments involving SPY003, SPY001, and SPY002 showed enhanced efficacy and pharmacodynamics.

In addition to program updates, Spyre announced the appointment of Dr. Sheldon Sloan as Chief Medical Officer in October 2024. Dr. Sloan brings over 25 years of experience in inflammation and immunology to the company, providing valuable leadership as Spyre advances its IBD portfolio.

Financially, Spyre reported a cash position of $414 million as of September 30, 2024, expected to sustain operations well into 2027. Net cash used in operating activities for the third quarter of 2024 was $29.4 million. Research and Development (R&D) expenses for the quarter increased to $44.7 million, primarily due to nonclinical and clinical development activities. General and Administrative (G&A) expenses rose to $10.6 million, driven by higher personnel costs. The company recorded a net loss of $69 million for the third quarter of 2024, compared to $40.1 million for the same period in 2023.

Spyre Therapeutics continues to make significant progress in its mission to develop next-generation treatments for IBD through advanced antibody engineering and precision medicine. The company's robust financial position and strategic program advancements position it for continued success in the coming years.