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GlobeNewswire·

Gyre Therapeutics Reports Third Quarter 2026 and Year-to-Date Financial Results with Business Updates

GYRE
  • Gyre Therapeutics reported Q3 2026 revenue of $32.9 million & a GAAP basic EPS of $(0.04).
  • The company affirmed its full year 2026 revenue guidance of $100.5 to $111.0 million.
  • ETUARY (pirfenidone) sales generated $31.4 million in Q3 2026, up from $27.7 million in the prior year period.
  • Etorel & Contiva product revenues declined in Q3 2026 due to China's national centralized procurement program.
  • F351 (hydronidone) NDA for CHB-induced liver fibrosis underwent an on-site NMPA inspection in Q3 2026, with a decision anticipated by end-2026 or Q1 2027.
  • Gyre plans to initiate a Phase 2 study for CG001419 in cancer pain syndromes in China during the first half of 2027.
  • Phase 1 dose-escalation data for CG009301 (AML candidate) is expected in the second half of 2027.
  • IND applications for dual-degrader candidates CG923308 & CG620953 are expected around mid-2027.
  • Cash & cash equivalents totaled $41.6 million as of September 30, 2026, with total liquid assets of $98.8 million.
  • Operating loss for Q3 2026 was $1.5 million, primarily driven by increased R&D expenses & transaction costs related to the Cullgen acquisition.
  • Net loss for the nine months ended September 30, 2026, was $35.3 million, compared to net income of $4.6 million in the same period last year.
  • Total operating expenses for the nine months increased significantly due to F351 review expenses, milestone payments, & Cullgen acquisition transaction costs.
  • The Astellas collaboration agreement ended in March 2026, resulting in a $11.2 million decrease in collaboration revenue for the nine-month period.
  • Gyre Therapeutics owns a 69.7% equity interest in its subsidiary Gyre Pharmaceuticals Co., Ltd.
Company
Gyre Therapeutics Inc.
Keywords
Nasdaq:GYRE, Gyre Therapeutics Inc.