Spyre Therapeutics Q2 2024 Financial Results and Corporate Update

Spyre Therapeutics, Inc. ("Spyre"), a biotechnology company focusing on innovative treatments for inflammatory bowel disease (IBD), has released its second-quarter 2024 financial results and updates on its development programs.

Recent Developments and Pipeline Progress

Spyre has made significant strides in its pipeline of IBD treatments, which include three main antibody programs: SPY001, SPY002, and SPY003.

SPY001 is an anti-α4β7 monoclonal antibody designed for infrequent subcutaneous dosing. In June 2024, Spyre began dosing healthy volunteers in a Phase 1 trial to assess the safety and efficacy of SPY001. The trial involves approximately 48 participants divided into single-ascending dose (SAD) and multi-ascending dose (MAD) cohorts. Interim results are expected by the end of 2024, which could demonstrate the potential of SPY001 for dosing intervals of eight to twelve weeks. Preclinical data presented earlier this year showed SPY001's extended half-life and comparable potency to existing treatments, such as vedolizumab.

SPY002 targets TL1A, a promising protein in IBD treatment. This program includes two monoclonal antibody candidates engineered for high potency and extended half-life. Both candidates are expected to enter first-in-human (FIH) trials in the latter half of 2024, with interim data anticipated in early 2025. Preclinical studies showed these candidates have subnanomolar binding affinity and pharmacokinetic profiles superior to current clinical-stage anti-TL1A therapies.

SPY003 focuses on the IL-23 pathway, specifically targeting the p19 subunit. This candidate also incorporates half-life extension technology. Spyre plans to start IND-enabling studies in the second half of 2024 and initiate FIH trials in the first half of 2025. Recent Phase 3 data from other treatments that target IL-23 underscore the potential efficacy of SPY003.

Corporate and Financial Highlights

Spyre's financial health remains robust, with $426 million in cash and marketable securities as of June 30, 2024. This financial stability is expected to support the company well into 2027, providing ample runway for multiple clinical readouts.

In corporate governance, Sandra Milligan, M.D., J.D., joined the Board of Directors, bringing her extensive experience in clinical development and regulatory affairs. Jeffrey Albers was appointed Chairman of the Board, succeeding Russell Cox.

During the second quarter, Spyre's R&D expenses rose to $32.6 million from $17.4 million in the same period last year, primarily due to increased activity in the IBD pipeline. General and Administrative expenses were $11.5 million for Q2 2024, down slightly from $12.1 million in Q2 2023. There were no in-process R&D expenses this quarter, unlike the $130.5 million recorded in Q2 2023 related to IBD pipeline acquisitions.

Other income for Q2 2024 was $5.3 million, mainly from interest on cash and marketable securities, contrasting with a $57.8 million expense in Q2 2023 due to a non-cash forward contract liability. The net loss for Q2 2024 was $38.8 million, significantly lower than the $217.1 million loss in Q2 2023, which included substantial non-cash stock compensation expenses.

Conclusion

Spyre Therapeutics is advancing its robust IBD pipeline with promising clinical trials on the horizon. With strong financial backing and strategic leadership, the company is well-positioned to develop potentially best-in-class treatments for IBD.

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