Q1 2026 loss and Cullgen deal reshape Gyre Therapeutics (NASDAQ: GYRE)
Rhea-AI Filing Summary
Gyre Therapeutics reported first quarter 2026 revenue of $22.5 million, up slightly from $22.1 million a year earlier, while shifting to a GAAP net loss of $9.9 million versus prior net income of $3.7 million as operating expenses rose sharply.
Marketing, research and development, and general and administrative costs all increased, and the company recorded $2.5 million in transaction costs related to its approximately $300 million all-stock acquisition of Cullgen. Gyre affirmed its full-year 2026 revenue guidance of $100.5 to $111.0 million and ended the quarter with $79.2 million in total cash and deposits. The company advanced its pipeline with a New Drug Application for F351 in China under priority review and enrolled the first patient in a Phase 2/3 trial of pirfenidone for radiation-induced lung injury.
Positive
- Regulatory progress for F351: China’s CDE granted priority review designation and accepted a New Drug Application for F351 in CHB‑associated liver fibrosis, creating a clear path toward potential conditional approval in this indication.
- Strategic Cullgen acquisition: Completed an approximately $300 million all‑stock acquisition of Cullgen, adding targeted protein degrader and degrader‑antibody conjugate programs in inflammatory diseases and cancers to Gyre’s fibrosis‑focused portfolio.
- Guidance affirmed with stable cash: Full‑year 2026 revenue guidance of $100.5M–$111.0M was reaffirmed, and total cash, deposits, and certificates reached $79.2M as of March 31, 2026, slightly higher than year‑end 2025.
Negative
- Shift from profit to loss: Net results moved from $3.7M net income in Q1 2025 to a $9.9M net loss in Q1 2026, driven by a $12.1M increase in operating expenses and lower other income.
- Significant operating expense growth: Selling and marketing, R&D, and G&A expenses rose by 30%, 118%, and 46%, respectively, in Q1 2026 versus Q1 2025, pressuring margins despite only a 2% revenue increase.
- Transaction costs and profitability pressure: The company incurred $2.5M of non‑recurring transaction costs related to the Cullgen acquisition in Q1 2026 and expects additional such expenses after the quarter, further weighing on near‑term profitability.
Insights
Q1 shows higher pipeline investment, Cullgen deal, and a swing to loss.
Gyre Therapeutics delivered modest Q1 2026 revenue growth to $22.5M while expenses surged. Selling and marketing, R&D, and G&A all rose significantly, and transaction costs of $2.5M tied to the Cullgen acquisition contributed to a $9.9M net loss.
Management framed higher R&D spending, which more than doubled year over year to $6.7M, as planned investment in F351 and U.S. preclinical work. The roughly $300M all-stock Cullgen deal adds targeted protein degrader and DAC programs, broadening the pipeline beyond fibrosis.
On the regulatory front, priority review and NDA submission for F351 in China, plus ongoing Phase 3 and Phase 2/3 trials for pirfenidone, indicate multiple potential catalysts. Gyre maintained full-year 2026 revenue guidance of $100.5M to $111.0M. The ultimate balance between near-term losses and future revenue contributions will depend on execution of integration and clinical milestones disclosed for 2026 and beyond.
8-K Event Classification
Key Figures
Key Terms
priority review designation regulatory
New Drug Application (NDA) regulatory
targeted protein degrader medical
non-GAAP adjusted net (loss) income financial
Breakthrough Therapy designation regulatory
Earnings Snapshot
Full-year 2026 revenue guidance of $100.5 million to $111.0 million affirmed.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02. Results of Operations and Financial Condition.
On May 7, 2026, Gyre Therapeutics, Inc. issued a press release announcing its financial results for the three months ended March 31, 2026 and other matters described. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
As provided in General Instruction B.2 of Form 8-K, the information in this Item 2.02 and Exhibit 99.1 incorporated herein shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall such information or Exhibit 99.1 be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits. The following exhibits are being furnished herewith:
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Exhibit Title or Description |
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99.1 |
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Press Release, dated May 7, 2026 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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GYRE THERAPEUTICS, INC. |
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Date: May 7, 2026 |
By: |
/s/ Ying Luo |
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Name: |
Ying Luo |
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Title: |
Chief Executive Officer and President |
Exhibit 99.1
Gyre Therapeutics Reports First Quarter 2026 Results and Provides Business Update
Q1 2026 revenue of $22.5 million; GAAP basic EPS: $(0.10)
Full year 2026 revenue guidance of $100.5 to $111.0 million affirmed
NDA for F351 (hydronidone) for CHB-associated liver fibrosis submitted to China’s CDE in March 2026
Completed acquisition of Cullgen in an approximately $300 million all-stock transaction, expanding pipeline into inflammatory diseases and cancers
First patient enrolled in Phase 2/3 trial evaluating ETUARYTM for radiation-induced lung injury, including immune-related pneumonitis
SAN DIEGO, May 7, 2026 (GLOBE NEWSWIRE) -- Gyre Therapeutics, Inc. (Gyre, the Company or Gyre Therapeutics) (Nasdaq: GYRE), an innovative, commercial stage biopharmaceutical company with operations in the United States and China, today announced financial results for the first quarter ended March 31, 2026, and provided a business update.
“Building on our successful pre-NDA meeting with China’s CDE at the beginning of the year, we are particularly encouraged by the NMPA’s priority review designation for F351, reinforcing both the strength of our clinical data and the significant unmet need in liver fibrosis,” said Ying Luo, Chief Executive Officer of Gyre Therapeutics. “In parallel, our acquisition of Cullgen expands our capabilities into targeted protein degradation, positioning Gyre to drive long-term innovation beyond fibrosis. We believe these achievements strengthen our foundation as a fully integrated, multi-national biopharmaceutical company as we advance our mission to deliver transformative therapies to patients worldwide.”
First Quarter Business Highlights and Upcoming Milestones
Commercial Products:
ETUARYTM (pirfenidone), the Company's primary product, generated $21.0 million in sales for the quarter ended March 31, 2026, compared to $21.7 million for the same period in 2025. EtorelTM (nintedanib ethanesulfonate soft capsules), which was launched in June 2025, generated $0.7 million in sales for the quarter ended March 31, 2026. ContivaTM (avatrombopag maleate tablets), launched in March 2025, generated $0.8 million in sales for the quarter ended March 31, 2026, compared to $0.3 million for the same period in 2025.
1
Pipeline Development Updates
Hydronidone (F351):
In March 2026, Gyre announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) granted priority review designation to F351 for the treatment of chronic hepatitis B (CHB)-associated liver fibrosis. Subsequently, Gyre, through its majority-owned subsidiary Gyre Pharmaceuticals Co., Ltd., submitted a New Drug Application (NDA) to the CDE to seek conditional approval for this indication, which is currently under completeness review for acceptance.
Pirfenidone (ETUARYTM):
A Phase 3 trial of pirfenidone for the treatment of pneumoconiosis (PD) in the People's Republic of China (PRC) completed enrollment in 2025. A total of 272 patients were enrolled evaluating the efficacy and safety of 52 weeks of pirfenidone capsule treatment in patients with PD versus placebo. The final patient is expected to complete the study in the third quarter of 2026.
In April 2026, Gyre initiated its adaptive Phase 2/3 clinical trial in oncology-related pulmonary complications, with the first patient enrolled. The trial is evaluating pirfenidone for radiation-induced lung injury (RILI), including cases complicated by immune-related pneumonitis, at leading oncology centers.
Corporate Updates:
Financial Results
Cash Position
As of March 31, 2026, Gyre held $37.5 million in cash and cash equivalents, $12.3 million in short-term bank deposits, and $29.4 million in long-term certificates of deposit, totaling $79.2 million. Compared to $75.9 million as of December 31, 2025, total cash increased by $3.3 million, or 4%, primarily driven by higher customer collections and reduced tax payments.
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Financial Results for the Three Months Ended March 31, 2026
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Use of Non-GAAP Financial Measures by Gyre Therapeutics, Inc.
Gyre reports financial results in accordance with accounting principles generally accepted in the United States (“GAAP”). This release presents the financial measure “adjusted net income,” which is not calculated in accordance with GAAP. The most directly comparable GAAP measure for this non-GAAP financial measure is “net income.” Adjusted net income presents Gyre’s results of operations after excluding gain from change in fair value of warrants, stock-based compensation, and provision for income taxes. This is meant to supplement, and not substitute, Gyre’s financial information presented in accordance with GAAP. Adjusted net income as defined by Gyre may not be comparable to similar non-GAAP measures presented by other companies. Management believes that presenting adjusted net income provides investors with additional useful information in evaluating Gyre’s performance and valuation. See the reconciliation of adjusted net income to net income in the section titled “Reconciliation of GAAP to Non-GAAP Financial Measures” below.
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-β1 signaling pathway, a key mediator of fibrogenesis. Gyre is developing F351 for two primary indications: Chronic hepatitis B (CHB)-associated liver fibrosis in the PRC and MASH-associated liver fibrosis initially in the United States.
In the United States, Gyre has completed a Phase 1 clinical trial in healthy volunteers evaluating F351’s safety, tolerability, and PK. Gyre plans to file an Investigational New Drug (IND) application in the U.S. by the end of 2026, and, if the IND becomes effective, initiate a Phase 2 clinical trial.
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About Gyre Pharmaceuticals
Gyre Pharmaceuticals is a commercial-stage biopharmaceutical company committed to the research, development, manufacturing and commercialization of innovative drugs for organ fibrosis. Its flagship product, ETUARYTM, was the first approved treatment for idiopathic pulmonary fibrosis in the PRC in 2011 and has maintained a prominent market share (2025 net sales of $116.6 million). In addition, Gyre Pharmaceuticals’ pipeline includes F351, a structural analogue of pirfenidone, which demonstrated statistically significant fibrosis regression after 52 weeks of treatment in a pivotal Phase 3 clinical trial in CHB-associated liver fibrosis in the PRC. F351 received Breakthrough Therapy designation by the NMPA CDE in March 2021. CDE granted priority review status to the NDA for F351 in March 2026. In March 2026, Gyre Pharmaceuticals Co., Ltd., submitted its NDA to the CDE to seek conditional approval for F351. Gyre Pharmaceuticals is also developing treatments for pneumoconiosis, RILI with or without immune-related pneumonitis, chronic obstructive pulmonary disease, pulmonary arterial hypertension and acute/acute-on-chronic liver failure. As of the first quarter of 2026, Gyre Therapeutics owns a 69.7% equity interest in Gyre Pharmaceuticals.
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 degrader-antibody conjugate (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.
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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 expectations regarding Gyre’s research and development efforts and the timing of expected clinical readouts and regulatory filings, including the timing of the CDE’s review of Gyre Pharmaceuticals’ submission of formal NDA for F351 as a treatment for CHB-induced liver fibrosis and Gyre Pharmaceuticals’ adaptive Phase 2/3 trial of pirfenidone for the treatment of RILI, the future operations of Gyre, the nature, strategy and focus of Gyre, the development and commercial potential and potential benefits of any product candidates of Gyre, the ability of Cullgen’s degraders and DACs to strengthen Gyre’s asset portfolio and the additional expected benefits of the acquisition, including Gyre’s ability to successfully integrate the businesses and operations of Gyre and Cullgen. 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: Gyre’s ability to execute on its clinical development strategies; positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; the timing or likelihood of regulatory filings and approvals; competition from competing products; the impact of general economic, health, industrial or political conditions in the United States or internationally; the sufficiency of Gyre’s capital resources and its ability to raise additional capital; supply chain and distribution delays and challenges. 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:
Ying Luo, Chief Executive Officer and President
ying.luo@gyretx.com
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Gyre Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except share and per share amounts)
(Unaudited)
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Three Months Ended March 31, |
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2026 |
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2025 |
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Revenues |
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$ |
22,519 |
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$ |
22,058 |
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Operating expenses: |
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Cost of revenues |
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1,227 |
|
|
|
894 |
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Selling and marketing |
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14,136 |
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|
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10,841 |
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Research and development |
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6,738 |
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|
|
3,095 |
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General and administrative |
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7,220 |
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|
|
4,955 |
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Transaction costs |
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2,553 |
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|
|
— |
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Total operating expenses |
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31,874 |
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19,785 |
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(Loss) income from operations |
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(9,355 |
) |
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2,273 |
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Other income, net: |
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Change in fair value of warrant liability |
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89 |
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2,255 |
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Other income, net |
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29 |
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107 |
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(Loss) income before income taxes |
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(9,237 |
) |
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4,635 |
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Provision for income taxes |
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(621 |
) |
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(901 |
) |
Net (loss) income |
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(9,858 |
) |
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3,734 |
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Net (loss) income attributable to noncontrolling interest |
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(1,167 |
) |
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1,036 |
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Net (loss) income available to common stockholders |
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$ |
(8,691 |
) |
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$ |
2,698 |
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Net (loss) income per share attributable to common stockholders: |
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Basic |
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$ |
(0.10 |
) |
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$ |
0.03 |
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Diluted |
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$ |
(0.10 |
) |
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$ |
0.00 |
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Weighted average shares used in calculating net income per share attributable to common stockholders: |
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Basic |
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91,317,142 |
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86,420,530 |
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Diluted |
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91,344,584 |
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101,970,672 |
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8
Gyre Therapeutics, Inc.
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
(Unaudited)
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March 31, 2026 |
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December 31, 2025 |
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(Unaudited) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
37,501 |
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$ |
37,070 |
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Short-term bank deposits |
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12,307 |
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15,355 |
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Notes receivable |
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3,817 |
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5,638 |
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Accounts receivables, net |
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22,763 |
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31,078 |
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Other receivables from GNI |
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230 |
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230 |
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Inventories |
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11,352 |
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10,171 |
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Prepaid assets and other current assets |
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3,762 |
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2,827 |
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Total current assets: |
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91,732 |
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102,369 |
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Property and equipment, net |
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23,572 |
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23,599 |
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Intangible assets, net |
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4,627 |
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4,727 |
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Deferred tax assets |
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7,723 |
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6,873 |
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Long-term certificates of deposit |
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29,419 |
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23,516 |
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Other assets, noncurrent |
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4,942 |
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|
5,048 |
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Total assets |
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$ |
162,015 |
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$ |
166,132 |
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Liabilities and stockholders’ equity |
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Current liabilities: |
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Accounts payable |
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$ |
265 |
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$ |
124 |
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Due to related parties |
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226 |
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227 |
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Accrued expenses and other current liabilities |
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15,415 |
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|
|
14,359 |
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Income tax payable |
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3,131 |
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|
|
2,940 |
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Operating lease liabilities, current |
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|
751 |
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|
636 |
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Total current liabilities: |
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19,788 |
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|
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18,286 |
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Operating lease liabilities, noncurrent |
|
|
72 |
|
|
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303 |
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Deferred government grants |
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|
840 |
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|
|
852 |
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Warrant liability, noncurrent |
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2,872 |
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|
|
2,961 |
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Other noncurrent liabilities |
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|
1,458 |
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|
|
1,448 |
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Total liabilities |
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25,030 |
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|
|
23,850 |
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Stockholders’ equity: |
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Common stock, $0.001 par value, 400,000,000 shares authorized; 91,337,121 shares and 91,314,007 shares issued and outstanding at March 31, 2026 and December 31, 2025, respectively |
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91 |
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|
91 |
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Additional paid-in capital |
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174,651 |
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|
172,047 |
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Statutory reserve |
|
|
3,648 |
|
|
|
3,098 |
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Accumulated deficit |
|
|
(77,667 |
) |
|
|
(68,426 |
) |
Accumulated other comprehensive income (loss) |
|
|
586 |
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|
|
(779 |
) |
Total Gyre stockholders’ equity |
|
|
101,309 |
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|
|
106,031 |
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Noncontrolling interest |
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|
35,676 |
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|
|
36,251 |
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Total equity |
|
|
136,985 |
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|
|
142,282 |
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Total liabilities and stockholders' equity |
|
$ |
162,015 |
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|
$ |
166,132 |
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9
Gyre Therapeutics, Inc.
Reconciliation of GAAP to Non-GAAP Financial Measures
(in thousands)
(Unaudited)
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Three Months Ended March 31, |
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|||||
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2026 |
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2025 |
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Net (loss) income |
$ |
(9,858 |
) |
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$ |
3,734 |
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Gain from change in fair value of warrant liability (1) |
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(89 |
) |
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(2,255 |
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Stock-based compensation |
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2,583 |
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507 |
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Provision for income taxes |
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621 |
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901 |
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Transaction costs (2) |
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2,553 |
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— |
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Loss on disposal of assets, net (3) |
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16 |
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— |
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Non-GAAP adjusted net (loss) income |
$ |
(4,174 |
) |
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$ |
2,887 |
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10