Q2 2026 revenue of
Full year 2026 revenue guidance of
NDA for F351 (hydronidone) for CHB-induced liver fibrosis accepted by China’s CDE in
Dr.
Second Quarter Business Highlights and Upcoming Milestones
Commercial Products:
ETUARYTM (pirfenidone), the Company's primary product approved in
Pipeline Development Updates
F351 (hydronidone):
In
Pirfenidone (ETUARYTM):
A Phase 3 trial of pirfenidone for the treatment of pneumoconiosis (PD) in
In
Cullgen Acquisition Closes in the Second Quarter of 2026
On
The transaction has been accounted for as a transaction between entities under common control. Accordingly, the accompanying unaudited condensed consolidated financial statements have been retrospectively recast for all periods presented during which the Company and Cullgen were under common control to reflect the combined financial position and results of operations of the Company and Cullgen as if the common-control transfer had occurred at the beginning of the earliest period presented.
Updates on Programs in Development Following Cullgen Acquisition
CG001419 for cancer pain and solid tumors: Following the successful completion of a Phase 1 study in
CG001419 continues to separately be evaluated in a Phase 1 trial in
CG009301 for AML: The second product candidate from Cullgen, CG009301, is a GSPT1 Degrader for acute myeloid leukemia (AML), a fast-growing cancer of the blood and bone marrow. This candidate continues to be studied in a Phase 1 dose-escalation trial being conducted in
Dual-degrader programs, next-generation TPDs: Gyre expects to submit Investigational New Drug (IND) applications in
DACs, next-generation ADCs: Additional candidates include degrader antibody conjugates (DACs), which are considered to be the next generation of antibody drug conjugates (ADCs), and which are in development to target both solid tumors and hematological malignancies by pairing distinct protein degraders with tumor-specific antibodies.
Financial Results
Cash Position
As of
Financial Results for the Three Months Ended
- Revenues: Revenues for the three months ended
June 30, 2026 were$29.1 million , compared to$29.7 million for the same period in 2025, representing a$0.6 million , or 2%, decrease.Gyre Pharmaceuticals revenue increased during the period, primarily driven by higher ETUARYTM sales volumes resulting from ETUARYTM focused marketing efforts, despite lowerContiva TM and EtorelTM product revenues earned following the implementation ofChina's national centralized procurement program. The increase was offset by a$3.0 million decrease in collaboration revenue from the Collaboration, Option, and License Agreement with Astellas Pharma Inc. (the Astellas Agreement) which ended inMarch 2026 , resulting in an overall decrease in revenues of$0.6 million , or 2%, compared to the prior-year period. - Cost of Revenues: For the three months ended
June 30, 2026 , cost of revenues was$2.2 million , compared to$1.2 million for the same period in 2025. The$1.0 million , or 92%, increase was primarily driven by a$0.7 million increase in production costs associated with EtorelTM products, a$0.2 million increase in production costs for ETUARYTM, and a$0.1 million increase in stock-based compensation expense. - Selling and Marketing Expense: For the three months ended
June 30, 2026 , selling and marketing expense was$13.8 million , compared to$15.2 million for the same period in 2025. The$1.4 million , or 9%, decrease was primarily attributable to a$2.5 million decrease in promotional and conference expenses as certain promotional objectives were achieved in the first quarter of 2026, reducing spending in the second quarter, partially offset by a$0.6 million increase in stock-based compensation expenses, and a$0.5 million increase in personnel-related costs, primarily due to increased sales commissions resulting from higher sales volumes during the second quarter of 2026. - Research and Development Expense: For the three months ended
June 30, 2026 , research and development expense was$19.1 million , compared to$8.4 million for the same period in 2025. The$10.8 million , or 129%, increase was primarily related to a$4.7 million increase in external clinical research expenses, mainly attributable to the F351 Phase 3C experimental review expense; a$4.8 million increase for the milestone paymentGyre Pharmaceuticals owed to GNI Group Ltd. (GNI) related toChina's NMPA acceptance of NDA for F351 as a treatment for CHB-induced liver fibrosis; a$0.7 million increase in pre-clinical expenses, and a$0.6 million increase in facilities, depreciation and other expenses. - General and Administrative Expense: For the three months ended
June 30, 2026 , general and administrative expense was$7.9 million , compared to$7.3 million for the same period in 2025. The$0.6 million , or 8%, increase was primarily driven by a$0.9 million increase in personnel costs related to the Company's internal restructuring, and a$0.2 million increase in miscellaneous expenses, partially offset by a$0.2 million decrease in stock-based compensation expenses and a$0.3 million decrease in professional fees. - Transaction Costs: For the three months ended
June 30, 2026 ,$0.5 million in transaction costs were incurred in connection with the acquisition of Cullgen closed in earlyMay 2026 . - Loss from Operations: For the three months ended
June 30, 2026 , loss from operations was$14.4 million , compared to loss from operations of$2.2 million for the same period in 2025. The$12.1 million increase was primarily driven by an increase in total operating expenses including transaction costs, increased stock-based compensation, expanded marketing expenses for EtorelTM andContiva TM, and Phase 3C and other clinical trial and pre-clinical activities. - Net (Loss) Income: For the three months ended
June 30, 2026 , net loss was$14.3 million , compared to net loss of$2.2 million for the same period in 2025. The$12.0 million increase in net loss was primarily driven by an increase in operating expenses of$11.5 million , a decrease in other income of$0.7 million , and a decrease in revenue of$0.6 million , partially offset by a decrease in income tax expense of$0.8 million . - Non-GAAP Adjusted Net Income: For the three months ended
June 30, 2026 , non-GAAP adjusted net loss was$12.2 million , compared to non-GAAP adjusted net loss of$0.6 million for the same period in 2025. The$11.6 million decrease was primarily driven by an increase in operating expenses of$10.3 million , a decrease in other income of$0.7 million , and a decrease in revenue of$0.6 million .
Financial Results for the Six Months Ended
- Revenues: Revenues for the six months ended
June 30, 2026 , were$53.5 million , compared to$60.3 million for the same period in 2025, resulting in a$6.8 million decrease. Revenue fromGyre Pharmaceuticals increased during the period, primarily driven by higher ETUARYTM sales volumes resulting from ETUARYTM focused marketing efforts, despite lowerContiva TM and EtorelTM product revenues following the implementation ofChina's national centralized procurement program. The overall increase in revenue fromGyre Pharmaceuticals was offset by a$9.6 million decrease in collaboration revenue under the Astellas Agreement which ended inMarch 2026 . - Cost of Revenues: For the six months ended
June 30, 2026 , cost of revenues was$3.4 million , compared to$2.0 million for the same period in 2025. The$1.4 million increase was primarily driven by higher EtorelTM product costs of$1.1 million and increased stock-based compensation expense of$0.3 million . - Selling and Marketing Expense: For the six months ended
June 30, 2026 , selling and marketing expense was$27.9 million , compared to$26.0 million for the same period in 2025. The$1.9 million increase was primarily attributable to a$1.6 million increase in stock-based compensation expense, and a$0.4 million increase in promotional and conference expenses, partially offset by a$0.1 million decrease in travel and other expense. - Research and Development Expense: For the six months ended
June 30, 2026 , research and development expense was$30.6 million , compared to$16.4 million for the same period in 2025. The$14.2 million increase was primarily related to an$8.9 million increase in external clinical research expenses, mainly attributable to the F351 Phase 3C experimental review expense; a$0.4 million increase in personnel-related expenses including stock-based compensation expenses, a$4.8 million increase for the milestone paymentGyre Pharmaceuticals owed to GNI related toChina's NMPA acceptance of NDA for F351 as a treatment for CHB-induced liver fibrosis; a$0.5 million increase in pre-clinical expenses, and a$0.4 million increase in materials and utilities expenses, partially offset by a$0.8 million decrease in facilities, depreciation and other expenses. - General and Administrative Expense: For the six months ended
June 30, 2026 , general and administrative expense was$18.0 million , compared to$15.4 million for the same period in 2025. The$2.6 million increase was primarily driven by a$2.7 million increase in personnel costs related to the Company's internal restructuring, a$0.9 million increase in miscellaneous expenses, a$0.6 million increase in stock-based compensation expenses, partially offset by a$1.6 million decrease in professional fees. - Transaction Costs: For the six months ended
June 30, 2026 ,$3.8 million in transaction costs were incurred in connection with the termination of proposed merger betweenCullgen and Pulmatrix, Inc. inFebruary 2026 and$3.1 million were incurred related to the acquisition of Cullgen, which transaction closed in earlyMay 2026 , totaling$6.9 million . - (Loss) Income from Operations: For the six months ended
June 30, 2026 , loss from operations was$33.3 million , compared to$0.3 million income from operations for the same period in 2025. The$33.6 million decrease was primarily driven by an increase in total operating expense including transaction costs, increased stock-based compensation, expanded marketing expenses for EtorelTM andContiva TM, and Phase 3C and other clinical trial and pre-clinical activities. - Net (Loss) Income: For the six months ended
June 30, 2026 , net loss was$32.8 million , compared to$2.7 million net income for the same period in 2025. The$35.6 million increase was primarily driven by an increase in operating expenses of$26.9 million , a decrease in other income of$3.1 million , and a decrease in revenue of$6.8 million , partially offset by a decrease in income tax expense of$1.2 million . - Non-GAAP Adjusted Net (Loss) Income: For the six months ended
June 30, 2026 , non-GAAP adjusted net loss was$21.1 million , compared to$3.7 million non-GAAP adjusted net income for the same period in 2025. The decrease was primarily driven by an increase in operating expenses of$17.2 million , a decrease in other income of$0.8 million , and a decrease in revenue of$6.8 million .
Use of Non-GAAP Financial Measures by
Gyre reports financial results in accordance with accounting principles generally accepted in
About F351
F351 is Gyre’s lead development candidate for the treatment of liver fibrosis that is being developed for two different indications. It is a structurally modified derivative of pirfenidone designed to optimize metabolic properties while targeting the TGF-ß1 signaling pathway, a key mediator of fibrogenesis. Gyre is developing F351 for two primary indications: CHB-associated liver fibrosis in the PRC and MASH-associated liver fibrosis initially in
In
About
About Gyre Therapeutics
Gyre Therapeutics is a commercial-stage biopharmaceutical company headquartered in San Diego, CA focused on the development and commercialization of small-molecule therapeutics with its most advanced programs addressing organ fibrosis and inflammatory diseases.
Gyre’s wholly-owned subsidiary, Cullgen Inc., is a clinical-stage biopharmaceutical company focused on the discovery and development of targeted protein degrader and DAC therapies for critical conditions including cancer and inflammatory diseases. Cullgen has created a portfolio of highly selective targeted protein degrader and DAC product candidates designed to potently and efficiently eliminate therapeutically relevant proteins in patients.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, are forward-looking statements, including statements concerning: the development and commercial potential and potential benefits of F351; the timing and progression of commercial approval of F351; and the timing of Gyre’s IND application, and, if the IND becomes effective, initiation of a Phase 2 clinical trial for F351. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: unexpected costs, charges or expenses resulting from the acquisition; potential adverse reactions or changes to business relationships resulting from the announcement or completion of the acquisition; the risk that the combined company may not be able to successfully integrate the businesses and realize the expected benefits of the acquisition in a timely manner or at all; the uncertainties associated with Gyre’s and Cullgen’s product candidates, as well as risks associated with the clinical development and regulatory approval of product candidates, including potential delays in the commencement, enrollment and completion of clinical trials; risks related to the inability of the combined entity to obtain sufficient additional capital to continue to advance these product candidates and its pre-clinical programs; uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; risks related to the failure to realize any value from product candidates and pre-clinical programs being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; risks associated with the possible failure to realize certain anticipated benefits of the acquisition, including with respect to future financial and operating results. Additional risks and factors are identified under “Risk Factors” in Gyre’s Annual Report on Form 10-K for the year ended December 31, 2025 filed on March 13, 2026, and in other filings with the Securities and Exchange Commission.
Gyre expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.
Contact:
Gyre Therapeutics, Inc.
Thomas Eastling, CFO
ir@gyretx.com
Investors
Chuck Padala
Managing Director, LifeSci Advisors
chuck@lifesciadvisors.com
Unaudited Condensed Consolidated Statements of Operations (In thousands, except share and per share amounts) | ||||||||||||||||
| Three Months Ended | Six Months Ended | |||||||||||||||
| 2026 | 2025 (As Recast) | 2026 | 2025 (As Recast) | |||||||||||||
| Revenues | $ | 29,105 | $ | 29,734 | $ | 53,535 | $ | 60,305 | ||||||||
| Operating expenses: | ||||||||||||||||
| Cost of revenues | 2,209 | 1,151 | 3,436 | 2,045 | ||||||||||||
| Selling and marketing | 13,754 | 15,195 | 27,890 | 26,035 | ||||||||||||
| Research and development | 14,300 | 8,351 | 25,781 | 16,442 | ||||||||||||
| Research and development-related parties | 4,836 | — | 4,836 | — | ||||||||||||
| General and administrative | 7,867 | 7,277 | 18,043 | 15,481 | ||||||||||||
| Transaction costs | 502 | — | 6,886 | — | ||||||||||||
| Total operating expenses | 43,468 | 31,974 | 86,872 | 60,003 | ||||||||||||
| (Loss) income from operations | (14,363 | ) | (2,240 | ) | (33,337 | ) | 302 | |||||||||
| Other (loss) income, net: | ||||||||||||||||
| Interest income | 740 | 941 | 1,483 | 1,797 | ||||||||||||
| Change in fair value of warrant liability | 132 | 212 | 220 | 2,467 | ||||||||||||
| Other expense, net | (943 | ) | (488 | ) | (830 | ) | (301 | ) | ||||||||
| (Loss) Income before income taxes | (14,434 | ) | (1,575 | ) | (32,464 | ) | 4,265 | |||||||||
| Benefit (provision) for income taxes | 164 | (662 | ) | (385 | ) | (1,563 | ) | |||||||||
| Net (loss) income | (14,270 | ) | (2,237 | ) | (32,849 | ) | 2,702 | |||||||||
| Accretion of Cullgen redeemable convertible preferred stock | (1,058 | ) | (2,642 | ) | (3,905 | ) | (5,220 | ) | ||||||||
| Net loss attributable to noncontrolling interest | (3,665 | ) | (2,835 | ) | (11,945 | ) | (2,644 | ) | ||||||||
| Net (loss) income attributable to common stockholders | $ | (11,663 | ) | $ | (2,044 | ) | $ | (24,809 | ) | $ | 126 | |||||
| Net (loss) income per share attributable to common stockholders: | ||||||||||||||||
| Basic | $ | (0.12 | ) | $ | (0.02 | ) | $ | (0.26 | ) | $ | 0.00 | |||||
| Diluted | $ | (0.12 | ) | $ | (0.03 | ) | $ | (0.26 | ) | $ | (0.03 | ) | ||||
| Weighted average shares used in calculating net income per share attributable to common stockholders: | ||||||||||||||||
| Basic | 100,637,599 | 89,119,344 | 96,003,117 | 87,295,099 | ||||||||||||
| Diluted | 100,637,599 | 89,203,138 | 96,003,117 | 87,430,167 | ||||||||||||
Unaudited Condensed Consolidated Balance Sheets (In thousands, except share and per share amounts) | ||||||||
| (Unaudited) | (As Recast) | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 43,287 | $ | 49,192 | ||||
| Short-term bank deposits | 14,058 | 15,355 | ||||||
| Short-term investment | 17,451 | 28,085 | ||||||
| Notes receivable | 232 | 5,638 | ||||||
| Accounts receivables, net | 27,760 | 31,078 | ||||||
| Other receivables from GNI | 255 | 230 | ||||||
| Inventories, net | 11,428 | 10,171 | ||||||
| Prepaid assets and other current assets | 7,601 | 9,613 | ||||||
| Total current assets | 122,072 | 149,362 | ||||||
| Property and equipment, net | 27,284 | 27,549 | ||||||
| Intangible assets, net | 4,525 | 4,727 | ||||||
| Long-term prepayments | 302 | 112 | ||||||
| Deferred tax assets | 9,284 | 6,873 | ||||||
| Long-term certificates of deposit | 28,444 | 23,516 | ||||||
| Other assets, noncurrent | 7,344 | 7,624 | ||||||
| Total assets | $ | 199,255 | $ | 219,763 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,236 | $ | 1,335 | ||||
| Due to related parties | 5,085 | 227 | ||||||
| Accrued expenses and other current liabilities | 18,810 | 18,161 | ||||||
| Income tax payable | 2,147 | 2,940 | ||||||
| Operating lease liabilities, current | 1,385 | 1,119 | ||||||
| Total current liabilities | 28,663 | 23,782 | ||||||
| Operating lease liabilities, noncurrent | 2,033 | 2,303 | ||||||
| Deferred government grants | 829 | 852 | ||||||
| Warrant liability, noncurrent | 2,741 | 2,961 | ||||||
| Other noncurrent liabilities | 70 | 1,506 | ||||||
| Total liabilities | 34,336 | 31,404 | ||||||
| Commitments and Contingencies (Note 11) | ||||||||
| Series B preferred stock, | 22,430 | — | ||||||
| Redeemable convertible preferred stock, | — | 15,784 | ||||||
| Redeemable noncontrolling interests — Cullgen redeemable convertible preferred stock | — | 113,030 | ||||||
| Stockholders’ equity: | ||||||||
| Common stock, | 106 | 91 | ||||||
| Additional paid-in capital | 240,644 | 172,819 | ||||||
| Statutory reserve | 3,648 | 3,098 | ||||||
| Accumulated deficit | (137,962 | ) | (112,603 | ) | ||||
| Accumulated other comprehensive income (loss) | 1,492 | (908 | ) | |||||
| Total Gyre stockholders’ equity | 107,928 | 62,497 | ||||||
| Noncontrolling interest | 34,561 | (2,952 | ) | |||||
| Total equity | 142,489 | 59,545 | ||||||
| Total liabilities, Series B preferred stock, redeemable convertible preferred stock, and stockholders’ equity | $ | 199,255 | $ | 219,763 | ||||
Unaudited Reconciliation of GAAP to Non-GAAP Financial Measures (in thousands) | ||||||||||||||||
| Three Months Ended | Six Months Ended | |||||||||||||||
| 2026 | 2025 (As Recast) | 2026 | 2025 (As Recast) | |||||||||||||
| Net (loss) income | $ | (14,270 | ) | $ | (2,237 | ) | $ | (32,849 | ) | $ | 2,702 | |||||
| Gain from change in fair value of warrant liability (1) | (132 | ) | (212 | ) | (220 | ) | (2,467 | ) | ||||||||
| Stock-based compensation | 1,833 | 1,120 | 4,658 | 1,943 | ||||||||||||
| Provision for income taxes | (164 | ) | 662 | 385 | 1,563 | |||||||||||
| Transaction costs (2) | 502 | — | 6,886 | — | ||||||||||||
| Loss on disposal of assets, net (3) | 2 | (1 | ) | 18 | (1 | ) | ||||||||||
| Non-GAAP adjusted net (loss) income | $ | (12,229 | ) | $ | (668 | ) | $ | (21,122 | ) | $ | 3,740 | |||||
| (1) | Reflects adjustments for fair value of warrants based on the Black-Scholes option pricing model. | |||||||||||||||
| (2) | Reflects non-recurring expenses related to the transaction costs related to the merger with | |||||||||||||||
| (3) | Reflects non-recurring losses from the disposal of assets that are not part of the Company’s ongoing operations. | |||||||||||||||
Source: