Gyre Therapeutics CEO expects pivotal phase 3 trial results in 2025

Gyre Therapeutics, a biotechnology company, recently reported its financial results for the third quarter and year-to-date ending September 30, 2024, along with various business updates. The company's CEO, Han Ying, emphasized the completion of a pivotal phase 3 trial for F351 in CHB-associated liver fibrosis, with topline results expected in the first quarter of 2025.

Financially, Gyre had cash and cash equivalents totaling $15.9 million as of September 30, 2024. For the third quarter of 2024, the company reported revenues of $25.5 million, compared to $32.0 million for the same period in 2023, primarily driven by a decrease in anti-fibrosis drug sales and generic drug sales due to fluctuations in the Chinese economy. Net income for the third quarter of 2024 was $2.9 million, down from $7.5 million for the same period in 2023.

For the nine months ended September 30, 2024, Gyre reported revenues of $77.9 million, compared to $86.3 million for the same period in 2023. Net income for the nine months ended September 30, 2024, was $17.3 million, up from $15.5 million for the same period in 2023.

In terms of the use of non-GAAP financial measures, Gyre utilized "adjusted net income," which excludes certain items such as gain from change in fair value of warrants, stock-based compensation, and provision for income taxes.

From a business perspective, Gyre's pharmaceutical subsidiary in China, Gyre Pharmaceuticals, reported sales of $25.3 million for Etuary (pirfenidone) for the third quarter of 2024. Additionally, Gyre Pharmaceuticals received approval for Avatrombopag maleate tablets and is planning to start commercializing Nintedanib, a small-molecule drug for the treatment of idiopathic pulmonary fibrosis in 2025.

Gyre is also progressing with its clinical development programs, including the completion of a 52-week phase 3 trial for F351 in CHB-associated liver fibrosis and plans to initiate a phase 2 clinical trial for F351 in MASH-associated liver fibrosis in 2025. Moreover, the company is conducting a phase 2 trial for F573, a caspase inhibitor for injection in the treatment of acute liver failure, and advancing preclinical development of F230 for pulmonary arterial hypertension and F528 for chronic obstructive pulmonary disease.

Following these announcements, the company's shares moved -17.5%, and are now trading at a price of $13.21. If you want to know more, read the company's complete 8-K report here.

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