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Gyre Therapeutics, Inc.: Q2 FY2026 earnings call

What management said about Q2 FY2026, from the documents filed with the SEC on 7 August 2026: press release. Guidance figures: 1 kept. The quarter’s numbers.

Key takeaways

  • Revenue edged down on ETUARY volume: Revenue was $29.1 million, down 2%. Gyre Pharmaceuticals revenue rose on higher ETUARY volumes, offset by a $3.0 million drop in collaboration revenue under the Astellas Agreement. Source
  • Net loss rose against a year earlier: Net loss was $14.3 million, against $2.2 million a year earlier. The six-month net loss was $32.8 million, compared with $2.7 million of net income in the prior-year period. Source
  • ETUARY sales rose on marketing: ETUARY sales were $28.0 million, up from $23.5 million a year earlier. Management attributed the higher volumes to focused marketing efforts for the product. Source
  • R&D expense more than doubled: R&D expense was $19.1 million, up $10.8 million or 129%. External clinical research rose $4.7 million, mainly for the F351 Phase 3C experimental review expense. Source
  • Radiation lung injury trial started: The adaptive Phase 2/3 trial of pirfenidone for radiation-induced lung injury, including immune-related pneumonitis, enrolled its first patient in April at leading oncology centers. Source
  • Full-spectrum pipeline after Cullgen: Management says the combined pipeline has clinical and IND-enabling assets across several areas, including a next-generation TPD/DAC platform alongside the commercial fibrosis platform. Source
  • Cash and investments down 11%: Cash and investments totaled $103.2 million, down from $116.1 million at December 31, 2025. The decrease was mainly a $10.6 million fall in short-term investments. Source

“I am very pleased with Gyre's progress over this last quarter”

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

Guidance

AreaPeriodFigureAgainst last quarter
Revenue SourceFull year 2026$100.5 to $111.0 millionKept

What changed from last quarter

  • New: Gyre acquired Cullgen Inc. on May 4, 2026, in an all-stock transaction, and Cullgen became a wholly owned subsidiary. Source
  • New: China's CDE accepted the NDA for F351 (hydronidone) for CHB-induced liver fibrosis in May 2026, after the NDA was submitted through Gyre Pharmaceuticals. Source
  • New: Ying Luo, formerly Cullgen's CEO, was appointed President and CEO of Gyre and joined the Board at the Cullgen closing. Source
  • Ended: The Astellas collaboration agreement ended in March 2026, reducing collaboration revenue by $3.0 million in the quarter. Source
  • Guidance kept: Management affirmed the full-year 2026 revenue guidance range of $100.5 to $111.0 million. Source

Revenue and net loss

  • Revenue edged down on ETUARY volume: Revenue was $29.1 million, down 2%. Gyre Pharmaceuticals revenue rose on higher ETUARY volumes, offset by a $3.0 million drop in collaboration revenue under the Astellas Agreement. Source
  • Net loss rose against a year earlier: Net loss was $14.3 million, against $2.2 million a year earlier. The six-month net loss was $32.8 million, compared with $2.7 million of net income in the prior-year period. Source
  • Per-share loss and non-GAAP loss: GAAP basic and diluted EPS were $(0.12) for the quarter, on 100.6 million weighted basic shares. Non-GAAP adjusted net loss was $12.2 million, against $0.6 million a year earlier. Source
  • Six-month revenue and operating result: Six-month revenue was $53.5 million, against $60.3 million. Six-month loss from operations was $33.3 million, against $0.3 million of operating income a year earlier. Source

Products and sales

  • ETUARY sales rose on marketing: ETUARY sales were $28.0 million, up from $23.5 million a year earlier. Management attributed the higher volumes to focused marketing efforts for the product. Source
  • Etorel and Contiva sales fell: Etorel sales were $0.3 million, against $1.6 million a year earlier. Contiva sales were $0.9 million, against $1.5 million. Etorel was launched in June 2025. Source
  • Cost of revenues up 92%: Cost of revenues was $2.2 million, up $1.0 million or 92%. Etorel production costs rose $0.7 million and ETUARY production costs rose $0.2 million. Source

“Following the close of our acquisition of Cullgen, we gained a portfolio of targeted protein degraders and degrader-antibody conjugates”

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

Operating expenses and operating loss

  • R&D expense more than doubled: R&D expense was $19.1 million, up $10.8 million or 129%. External clinical research rose $4.7 million, mainly for the F351 Phase 3C experimental review expense. Source
  • GNI milestone payment added $4.8 million: Gyre Pharmaceuticals owed a $4.8 million milestone payment to GNI Group, triggered by China's NMPA acceptance of the F351 NDA. It is recorded as R&D expense to related parties. Source
  • Selling and marketing spend fell 9%: Selling and marketing expense was $13.8 million, down $1.4 million or 9%. Promotional and conference spending fell $2.5 million, partly offset by higher stock-based compensation. Source
  • Transaction costs and operating loss: Transaction costs were $0.5 million in the quarter and $6.9 million year to date, tied to the Cullgen acquisition and a terminated Pulmatrix merger. Loss from operations was $14.4 million. Source
  • General and administrative up 8%: G&A expense was $7.9 million, up $0.6 million or 8%. The increase was mainly $0.9 million of personnel costs tied to the internal restructuring. Source

Pipeline and regulatory milestones

  • Radiation lung injury trial started: The adaptive Phase 2/3 trial of pirfenidone for radiation-induced lung injury, including immune-related pneumonitis, enrolled its first patient in April at leading oncology centers. Source
  • Pneumoconiosis Phase 3 enrollment complete: The pneumoconiosis Phase 3 trial enrolled 272 patients, comparing 52 weeks of pirfenidone capsules with placebo. Enrollment completed in 2025. Source
  • CG001419 moving to Phase 2: After a Phase 1 study of 78 healthy volunteers in Australia completed in December 2025, Gyre plans a Phase 2 study in cancer-induced bone pain. A China Phase 1 in solid tumors continues. Source
  • CG009301 in Phase 1 for AML: The GSPT1 degrader CG009301 for acute myeloid leukemia continues a Phase 1 dose-escalation trial in China in patients with high-risk hematologic malignancies. Source
  • F351 MASH regulatory path under analysis: Gyre is analyzing China Phase 3 results for F351 with new preclinical data to set the regulatory path for MASH Phase 2 studies. A US Phase 1 in healthy volunteers is complete. Source

“increased sales from our Gyre Pharmaceuticals division, which demonstrates our commercialization capabilities”

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

Cullgen platform and team

  • Full-spectrum pipeline after Cullgen: Management says the combined pipeline has clinical and IND-enabling assets across several areas, including a next-generation TPD/DAC platform alongside the commercial fibrosis platform. Source
  • CFO and Chairman appointed: Thomas Eastling, former Cullgen CFO, became Gyre's CFO. Ping Zhang was named Chairman of the company. Source
  • Chief scientific officer appointed: Yue Xiong, former Cullgen chief scientific officer, was appointed Gyre's CSO following the closing of the acquisition. Source
  • Headquarters and staff footprint: Headquarters remains in San Diego, with subsidiaries in Beijing and Shanghai and about 740 employees across the combined company. Source

Cash, equity and balance sheet

  • Cash and investments down 11%: Cash and investments totaled $103.2 million, down from $116.1 million at December 31, 2025. The decrease was mainly a $10.6 million fall in short-term investments. Source
  • Total equity more than doubled: Total equity was $142.5 million, up from $59.5 million at December 31, 2025. Noncontrolling interest was $34.6 million, against a deficit of $3.0 million a year earlier. Source
  • Series B preferred stock outstanding: Series B preferred stock was $22.4 million at June 30, 2026, with 3,697,235 shares outstanding. No Series B shares were outstanding at December 31, 2025. Source
  • Receivables and inventory levels: Accounts receivable were $27.8 million and inventories $11.4 million at June 30, 2026, against $31.1 million and $10.2 million at December 31, 2025. Source

Coming up, as management said on 7 August 2026

  • PD Phase 3 final patient completion: The last patient in the pneumoconiosis Phase 3 trial is expected to complete the study by the fourth quarter of 2026. Source
  • Cullgen IND filings planned: Gyre expects to submit INDs in the US and/or China in the first quarter of 2027 for two Cullgen dual degrader assets. Source

Figures management reported

FigureReported
ETUARY sales, Q2 2026 Source$28.0 million (Q2 2025: $23.5 million)
Etorel sales, Q2 2026 Source$0.3 million (Q2 2025: $1.6 million)
Contiva sales, Q2 2026 Source$0.9 million (Q2 2025: $1.5 million)
F351 NDA status SourceAccepted by China NMPA CDE, May 2026
PD Phase 3 patients enrolled Source272
R&D expense, Q2 2026 Source$19.1 million (Q2 2025: $8.4 million)

Risks management discussed

  • Regulatory: Contiva and Etorel revenue fell following implementation of China's national centralized procurement program, while ETUARY sales rose. Source

Earlier plans management reported on

  • Not stated: Management affirmed the full-year 2026 revenue guidance in this release. Source
  • Met: Certain promotional objectives were achieved in the first quarter of 2026, which reduced promotional spending in the second quarter. Source

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.