Gyre Therapeutics (NASDAQ: GYRE) has announced its third-quarter 2024 financial results and provided a business update, highlighting upcoming milestones in clinical development and commercial expansion. The company is poised for significant data releases and product launches in 2025, with a focus on addressing chronic liver diseases and pulmonary conditions.
Financial Overview
For Q3 2024, Gyre Therapeutics reported revenues of $25.5 million, a decrease from $32.0 million in the same period in 2023. The company's net income for the quarter was $2.9 million, down from $7.5 million in Q3 2023. As of September 30, 2024, Gyre held cash and cash equivalents of $15.9 million, which the company believes is sufficient to fund operations for at least the next 12 months.
The decline in revenue was primarily attributed to decreased sales of anti-fibrosis drugs in China, influenced by fluctuations in the Chinese economy. However, Gyre anticipates that upcoming product launches will help offset these market pressures.
F351 Clinical Trial Update
A significant milestone for Gyre is the completion of its pivotal Phase 3 trial evaluating F351 (Hydronidone) for the treatment of Chronic Hepatitis B (CHB)-associated liver fibrosis. The trial, which enrolled 248 patients in the People’s Republic of China (PRC), assessed the efficacy of F351 in combination with Entecavir, with a primary endpoint of reducing the liver fibrosis score (Ishak Scoring System) by at least one stage after 52 weeks of treatment. Topline data from this trial are expected in the first quarter of 2025.
"Our team has made great progress over the last several months and recently achieved a significant milestone with the final patient completing 52 weeks of study in our pivotal Phase 3 trial for F351 in CHB-associated liver fibrosis," said Han Ying, Ph.D., Chief Executive Officer of Gyre Therapeutics.
Pending positive results from the Phase 3 trial, Gyre plans to initiate a Phase 2 proof-of-concept clinical trial in the U.S. to evaluate F351 for the treatment of metabolic dysfunction-associated steatohepatitis (MASH)-associated liver fibrosis in 2025. This expansion into MASH demonstrates Gyre's strategic diversification of its clinical platform.
Commercial Expansion
Gyre is preparing for the commercial launch of avatrombopag maleate tablets in the PRC in the first half of 2025. This product received approval from China’s National Medical Products Administration (NMPA) in June 2024 for the treatment of thrombocytopenia associated with chronic liver disease (CLD) in adult patients undergoing elective diagnostic procedures or therapy. Avatrombopag expands Gyre’s rare disease product line and provides a treatment option for a common hematologic complication in patients with CLD.
The company also plans to commercialize nintedanib, a small-molecule drug for the treatment of idiopathic pulmonary fibrosis (IPF), in the PRC in 2025. Nintedanib, acquired from Jiangsu Wangao Pharmaceuticals Co., Ltd., is expected to provide patients with more choices and further enhance Gyre Pharmaceuticals’ position in the pulmonary fibrosis market.
Other Pipeline Developments
Gyre Pharmaceuticals is conducting a Phase 2 clinical trial in the PRC to assess the safety and efficacy of F573, a caspase inhibitor for injection in the treatment of acute/acute on-chronic liver failure.
Additionally, Gyre is advancing preclinical development of F230, a selective endothelin receptor agonist for the treatment of pulmonary arterial hypertension (PAH), and F528, a novel anti-inflammation agent for the treatment of chronic obstructive pulmonary disease (COPD).
Financial Outlook
Gyre Therapeutics anticipates that its cash resources will enable it to fund operations through at least 12 months following the issuance of the condensed financial statements. The company's strategy to diversify revenue streams through new product launches and clinical pipeline advancements is expected to drive future growth.
