Gyre Therapeutics (GYRE) investor relations material

Executive summary

• Commercial-stage biopharma focused on organ fibrosis and inflammatory diseases, operating in China and the U.S.; main products include ETUARY™, Etorel™, and Contiva™; Hydronidone is the lead pipeline candidate for liver fibrosis, with an NDA submitted in China in March 2026.

• Acquired Cullgen Inc. in May 2026 in an all-stock transaction valued at $300 million, expanding R&D and clinical capabilities into oncology and inflammatory diseases.

• Q1 2026 revenue reached $22.5 million, a 2% increase year-over-year, with GAAP basic EPS of $(0.10).

• Full-year 2026 revenue guidance affirmed at $100.5 to $111.0 million.

• First patient enrolled in Phase 2/3 trial for ETUARY™ in radiation-induced lung injury.

Financial highlights

• Revenue for Q1 2026 was $22.5 million, up 2% year-over-year, driven by new product launches (Contiva™ and Etorel™).

• Net loss for Q1 2026 was $9.9 million, compared to net income of $3.7 million in Q1 2025.

• Non-GAAP adjusted net loss was $4.2 million, versus adjusted net income of $2.9 million a year ago.

• Operating expenses increased 61% year-over-year to $31.9 million, mainly due to higher R&D, selling and marketing, and Cullgen acquisition transaction costs.

• Cash and cash equivalents as of March 31, 2026 were $79.2 million, up $3.3 million from year-end 2025.

Outlook and guidance

• Full-year 2026 revenue guidance remains $100.5 to $111.0 million.

• Management expects existing cash, cash flows from operations, and access to capital markets to fund operations for at least the next 12 months.

• Plans to initiate a Phase 2 trial for Hydronidone in MASH-associated liver fibrosis in the U.S. in 2026, pending IND approval.

• Ongoing evaluation of pipeline and clinical development strategy post-Cullgen acquisition.

• Anticipates continued investment in R&D and integration costs related to Cullgen acquisition.