Gyre Therapeutics — Q3 2026 Earnings Summary

Financial Performance:

• Q3 2026 revenue was $32.9 million, a 1% increase from $32.7 million in Q3 2025.
• YTD 2026 revenue was $86.5 million, a 7% decrease from $93.0 million in the same period of 2025.
• Q3 2026 GAAP net loss was $2.5 million, compared to net income of $1.9 million in Q3 2025.
• YTD 2026 GAAP net loss was $35.3 million, compared to net income of $4.6 million in the same period of 2025.
• Q3 2026 GAAP basic EPS was $(0.04), compared to $0.01 in Q3 2025.
• Q3 2026 loss from operations was $1.5 million, compared to income from operations of $1.5 million in Q3 2025.
• YTD 2026 loss from operations was $34.9 million, compared to income from operations of $1.8 million in the same period of 2025.
• Total cash and cash equivalents, short-term bank deposits, short-term investments, and long-term certificates of deposit totaled $98.8 million as of September 30, 2026, down 15% from $116.1 million as of December 31, 2025.
• Q3 2026 selling and marketing expense was $15.0 million, down 2% from $15.3 million in Q3 2025.
• Q3 2026 research and development expense was $8.5 million, up 9% from $7.8 million in Q3 2025.
• Q3 2026 general and administrative expense was $8.9 million, up 39% from $6.4 million in Q3 2025.
• Q3 2026 transaction costs were $0.1 million, compared to $0 in Q3 2025.
• YTD 2026 transaction costs were $6.9 million, compared to $0 in the same period of 2025.
• Non-GAAP adjusted net loss for Q3 2026 was $0.4 million, compared to adjusted net income of $3.9 million in Q3 2025.
• Non-GAAP adjusted net loss for YTD 2026 was $20.8 million, compared to adjusted net income of $7.6 million in the same period of 2025.

Guidance and Future Outlook:

• Full year 2026 revenue guidance of $100.5 million to $111.0 million is affirmed.
• Management anticipates an NMPA decision on F351 for CHB-induced liver fibrosis by the end of 2026 or in the first quarter of 2027.
• If approved, F351 is expected to launch in the first half of 2027.
• A Phase 2 study for CG001419 in cancer-induced bone pain is planned to initiate in the first half of 2027.
• Phase 1 dose-escalation data for CG009301 is anticipated in the second half of 2027.
• IND applications and Phase 1 clinical trials for dual-degrader programs CG923308 and CG620953 are expected around mid-2027.
• Details on the first IND-ready DAC candidate(s) are expected in 2027.

Business Segments and Product Lines:

• ETUARY (pirfenidone) sales were $31.4 million in Q3 2026, up from $27.7 million in Q3 2025.
• Etorel (nintedanib ethanesulfonate) sales were $1.0 million in Q3 2026, down from $1.5 million in Q3 2025.
• Contiva (avatrombopag) sales were $0.1 million in Q3 2026, down from $1.2 million in Q3 2025.
• Lower Contiva and Etorel revenues were attributed to China's national centralized procurement program.
• Higher ETUARY sales were driven by increased sales volumes from focused marketing efforts.
• Collaboration revenue decreased by a net $1.6 million in Q3 2026 and $11.2 million YTD, primarily due to the Astellas Agreement ending in March 2026.
• F351 (hydronidone) NDA for CHB-induced liver fibrosis was accepted by the NMPA in May 2026; an onsite inspection was completed in Q3 2026.
• CG001419 is being evaluated in a Phase 1 trial for solid tumors in China and a Phase 2 study for cancer pain is planned.
• CG009301 is in a Phase 1 dose-escalation trial for AML in China.
• Pirfenidone Phase 3 trial for pneumoconiosis completed enrollment in 2025; additional patient enrollment is being evaluated.
• Pirfenidone Phase 2/3 trial for Radiation-Induced Lung Injury (RILI) initiated in April 2026 with the first patient enrolled.
• Gyre acquired Cullgen in early May 2026, integrating its operations into the first full quarter of 2026.

Market and Competitive Landscape:

• The company operates with a business model combining U.S. innovation with capital-efficient operations in China.
• China's national centralized procurement program has impacted revenues for Contiva and Etorel.
• F351 received Breakthrough Therapy designation by the CDE of the NMPA in March 2021.
• The company is advancing next-generation targeted protein degraders and DACs for global markets.

Risks and Challenges:

• Risks include unexpected costs from the Cullgen acquisition and potential difficulties in integrating the businesses.
• Clinical development risks include delays in trial commencement, enrollment, and completion, as well as regulatory approval uncertainties.
• Risks associated with the inability to obtain sufficient additional capital to advance product candidates.
• Potential adverse reactions or changes to business relationships resulting from the Cullgen acquisition.
• Risks related to the failure to realize value from product candidates and pre-clinical programs.

Management Commentary and Tone:

• Dr. Ying Luo, President and CEO, expressed pleasure with execution in Q3 2026, marking the first full quarter incorporating Cullgen's operations.
• Management highlighted the strength of the unique business model combining U.S. innovation with capital-efficient operations in China.
• Management noted that programs are expected to drive the next phase of growth.

Other Key Points:

• The acquisition of Cullgen closed in early May 2026.
• Transaction costs included $3.1 million related to the Cullgen acquisition and $3.8 million related to the termination of a proposed merger between Cullgen and Pulmatrix, Inc. in February 2026.
• Gyre Therapeutics owns a 69.7% equity interest in Gyre Pharmaceuticals as of September 30, 2026.
• The Astellas Pharma Inc. Collaboration, Option, and License Agreement ended in March 2026.
• The company reported a decrease in fair value of warrant liabilities of $2.5 million YTD 2026 compared to an increase in the prior year.
• Stock-based compensation expense increased by $1.9 million YTD 2026 compared to the same period in 2025.