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Gyre Therapeutics, Inc.: Q3 FY2026 earnings call

What management said about Q3 FY2026, from the documents filed with the SEC on 5 November 2026: press release. Guidance figures: 5 new, 1 kept. The quarter’s numbers.

Key takeaways

  • Revenue rose slightly in quarter: Q3 revenue was $32.9 million, up $0.2 million or 1%. Gyre Pharmaceuticals revenue rose, offset by a $1.6 million drop in collaboration revenue after the Astellas Agreement ended in March 2026. Source
  • ETUARY sales grew on marketing push: ETUARY sales were $31.4 million against $27.7 million a year earlier. Management linked the rise to ETUARY focused marketing efforts and higher sales volumes. Source
  • Net loss against prior-year profit: Q3 net loss was $2.5 million, against net income of $1.9 million a year earlier. Loss from operations was $1.5 million, against operating income of $1.5 million. Source
  • G&A up 39% on restructuring: Q3 G&A was $8.9 million, against $6.4 million. Restructuring personnel costs added $0.9 million and professional fees added $1.1 million. Source
  • Total cash down 15% since year-end: Total cash, deposits and certificates were $98.8 million, against $116.1 million at December 31, 2025, mainly from a $15.5 million fall in short-term investments. Source

“I am pleased with our execution in the third quarter, our first full quarter incorporating Cullgen’s operations within Gyre Therapeutics.”

Dr. Ying Luo, President and Chief Executive Officer of Gyre Therapeutics

Guidance

AreaPeriodFigureAgainst last quarter
Full-year 2026 revenue SourceFY2026$100.5 to $111.0 millionKept
F351 China NMPA decision Sourceend of 2026 to Q1 2027by the end of 2026 or in the first quarter of 2027New
F351 commercial launch if approved SourceH1 2027sometime in the first half of 2027New
CG001419 Phase 2 start in China SourceH1 2027first half of 2027New
CG009301 Phase 1 dose-escalation data SourceH2 2027second half of 2027New
CG923308 and CG620953 IND and Phase 1 start Sourcearound mid-2027around mid-2027
First IND-ready DAC candidate details Source2027in 2027New

What changed from last quarter

  • Guidance kept: Full-year 2026 revenue guidance was affirmed and is unchanged from the second-quarter release. Source
  • New: The prior release gave no NMPA decision timing for F351; this release gives end-2026 to Q1 2027. Source
  • New: The prior release described a planned CG001419 Phase 2 without a China location or start date; this release adds both. Source

Results and growth drivers

  • Revenue rose slightly in quarter: Q3 revenue was $32.9 million, up $0.2 million or 1%. Gyre Pharmaceuticals revenue rose, offset by a $1.6 million drop in collaboration revenue after the Astellas Agreement ended in March 2026. Source
  • ETUARY sales grew on marketing push: ETUARY sales were $31.4 million against $27.7 million a year earlier. Management linked the rise to ETUARY focused marketing efforts and higher sales volumes. Source
  • Net loss against prior-year profit: Q3 net loss was $2.5 million, against net income of $1.9 million a year earlier. Loss from operations was $1.5 million, against operating income of $1.5 million. Source
  • Nine-month loss widened sharply: Nine-month net loss was $35.3 million against $4.6 million of net income. Operating expenses rose $30.1 million and revenue fell $6.5 million. Source

Products and China sales

  • Etorel sales fell year on year: Etorel sales were $1.0 million, against $1.5 million a year earlier. Contiva sales were $0.1 million, against $1.2 million. Source
  • Collaboration revenue ended with Astellas: Collaboration revenue fell $1.6 million in Q3 as the Astellas Agreement ended in March 2026. Nine-month collaboration revenue fell $11.2 million on the same basis. Source
  • ETUARY remains the main product: ETUARY accounted for most product sales in the quarter, while Etorel and Contiva were smaller lines. Source

“We are advancing our protein degrader pipeline toward first-in-human data and initiating new clinical programs next year.”

Dr. Ying Luo, President and Chief Executive Officer of Gyre Therapeutics

F351 regulatory progress

  • F351 NDA accepted by NMPA: The CDE of the NMPA accepted the F351 NDA for CHB-induced liver fibrosis in May 2026, after priority review status in March. Gyre Pharmaceuticals completed an NMPA on-site inspection in Q3. Source
  • F351 launch planned for H1 2027: Management anticipates launching F351 in China sometime in the first half of 2027, if the NMPA approves it. Source
  • Global MASH path under analysis: Gyre is analyzing China Phase 3 results and new preclinical results to set a regulatory path for global Phase 2 MASH studies. Source

Degrader and other pipeline

  • CG001419 Phase 2 planned in China: After an Australian Phase 1 in 78 healthy volunteers, Gyre plans a China Phase 2 in cancer-induced bone pain. A China Phase 1 in solid tumors continues. Source
  • CG009301 AML trial ongoing in China: CG009301, a GSPT1 degrader for AML, continues Phase 1 dose-escalation in China in high-risk hematologic malignancies. Source
  • Dual degrader INDs now mid-2027: Two dual degraders, for solid tumors and autoimmune disease, are now expected to reach IND and Phase 1 start around mid-2027. Source
  • Pneumoconiosis trial enrolled 272 patients: The Phase 3 pneumoconiosis trial enrolled 272 patients for 52 weeks of pirfenidone against placebo. The enrolment figure is unchanged from the prior release. Source
  • RILI Phase 2/3 trial began in April: Gyre Pharmaceuticals started an adaptive Phase 2/3 trial of pirfenidone in radiation-induced lung injury in April 2026, with first patient enrolled. Source

“Together, these programs are expected to drive our next phase of growth and demonstrate the strength of our unique business model, combining U.S. innovation with capital-efficient operations in China.”

Dr. Ying Luo, President and Chief Executive Officer of Gyre Therapeutics

Costs and margins

  • G&A up 39% on restructuring: Q3 G&A was $8.9 million, against $6.4 million. Restructuring personnel costs added $0.9 million and professional fees added $1.1 million. Source
  • Promotion spend fell in Q3: Selling and marketing expense fell $0.3 million to $15.0 million, as promotional objectives reached in the first half lowered Q3 spend. Source
  • F351 review cost lifted R&D: Q3 R&D expense was $8.5 million, against $7.8 million. The increase included $0.4 million of external clinical research, mainly the F351 review expense. Source
  • Etorel production costs drove COGS: Cost of revenues was $1.9 million, against $1.6 million, mainly from higher production costs for Etorel products. Source
  • Milestone to GNI affiliate in nine months: Nine-month R&D includes a $4.8 million milestone payment owed by Gyre Pharmaceuticals to an affiliate of GNI Group on NDA acceptance. Source
  • Transaction costs of $6.9 million: Nine-month transaction costs were $6.9 million, including $3.8 million for the terminated Pulmatrix merger and $3.1 million for the Cullgen acquisition. Source

Cash, balance sheet and capital

  • Total cash down 15% since year-end: Total cash, deposits and certificates were $98.8 million, against $116.1 million at December 31, 2025, mainly from a $15.5 million fall in short-term investments. Source
  • Cash, deposits and CDs total: Components at September 30, 2026 were $12.6 million short-term investment and $28.8 million long-term certificates of deposit. Source
  • Series B preferred on balance sheet: Series B preferred stock was $21.6 million at September 30, 2026, against none at December 31, 2025. The documents give no further narrative on it. Source
  • Gyre Pharmaceuticals ownership 69.7%: Gyre Therapeutics held a 69.7% equity interest in Gyre Pharmaceuticals as of September 30, 2026. Source

Strategy and integration

  • Cullgen acquisition closed early May: The Cullgen acquisition closed in early May 2026. Q3 was the first full quarter including Cullgen operations. Source
  • Fibrosis cash flow funds degrader pipeline: Management describes the company as generating cash from marketed fibrosis therapeutics while advancing next-generation protein degrader therapeutics. Source

Coming up, as management said on 5 November 2026

  • F351 NMPA decision window: Management said an NMPA decision on F351 could occur by end-2026 or in Q1 2027. Source
  • Dual degrader INDs and Phase 1 starts: Management expects to submit IND applications and start Phase 1 trials for the dual degraders, pending IND approval, around mid-2027. Source
  • New clinical programs next year: Management said it is initiating new clinical programs in the coming year, alongside the move toward first-in-human data. Source

Figures management reported

FigureReported
ETUARY (pirfenidone) sales, Q3 2026 Source$31.4 million
Etorel sales, Q3 2026 Source$1.0 million
Contiva sales, Q3 2026 Source$0.1 million
Research and development expense, Q3 2026 Source$8.5 million
Pneumoconiosis Phase 3 patients enrolled Source272 patients
RILI Phase 2/3 trial first patient Sourceenrolled April 2026

Risks management discussed

  • Operational: The company is evaluating additional pneumoconiosis enrolment to replace patients who dropped out of the Phase 3 study. Source
  • External: Contiva and Etorel product revenues were slightly lower because of China's national centralized procurement program. Source

Earlier plans management reported on

  • Met: Management said promotional objectives were achieved in the first half, which lowered Q3 promotional spend. Source
  • Met: Management described the Phase 1 study of CG001419 in Australia as successfully completed in December 2025. Source
  • Not stated: The prior release expected the final pneumoconiosis patient to complete the study by Q4 2026; the current release does not restate this.

Other quarters

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.