Gyre Therapeutics Reports Second Quarter 2024 and Year-To-Date Financial Results and Provides Business Update

Core Insights - Gyre Therapeutics has received NMPA approval for avatrombopag maleate tablets for treating CLD-associated thrombocytopenia, expanding its rare disease product lines [1][3] - The company has also received IND approval for F230 to treat pulmonary arterial hypertension and plans to initiate a Phase 1 trial in 2025 [2][6] - Financial results for Q2 2024 show revenues of $25.2 million, a decrease from $29.3 million in Q2 2023, primarily due to normalized anti-fibrosis drug sales [8][10] Business Updates - Gyre Pharmaceuticals generated $25.1 million in sales of ETUARY for Q2 2024, supporting future revenue growth through the acquisition of rights to nintedanib [3] - The approval of avatrombopag provides a treatment option for a common hematologic complication in patients with CLD [3] - Gyre expects to report data from its Phase 3 trial of F351 in CHB-associated liver fibrosis by early 2025 [2][5] Clinical Development - F351 has shown promise in preclinical studies for treating liver fibrosis, with topline data from a Phase 3 trial expected by early 2025 [4][5] - Gyre plans to initiate a Phase 2a trial for F351 in MASH-associated liver fibrosis in 2025, pending FDA review [5][6] - Ongoing Phase 2 trial for F573 is assessing its safety and efficacy in treating acute liver failure [5] Financial Performance - As of June 30, 2024, Gyre had cash and cash equivalents of $16.1 million, with total revenues for the first half of 2024 at $52.4 million [8][10] - The company reported a net income of $4.5 million for Q2 2024, compared to $3.8 million in Q2 2023 [9][10] - General and administrative expenses increased to $3.4 million in Q2 2024, primarily due to costs associated with being a public company [9][10] Corporate Developments - David M. Epstein was appointed to Gyre's Board of Directors, bringing extensive pharmaceutical industry experience [7] - Gyre was added to the small-cap Russell 2000 and all-cap Russell 3000 Indexes in June 2024 [7]