GYRE 8-K
Gyre Therapeutics, Inc. (GYRE)
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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Registrant’s telephone number, including area code: (
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(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
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The |
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 August 11, 2025, Gyre Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the three and six months ended June 30, 2025 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 (the “Securities Act”), or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 5.02 |
Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. |
Appointment of Interim Chief Executive Officer
On August 5, 2025, the Company appointed current Executive Chair Ping Zhang as Interim Chief Executive Officer of the Company, to succeed Han Ying, Ph.D., who resigned from his position as Chief Executive Officer on such date in order to take on a new role as the Company’s Senior Vice President, Science.
Mr. Zhang, age 51, has served as a director of the Company since January 2025 and as Executive Chair of the board of directors (the “Board”) since March 2025. He has also served as Chairman and legal representative of the Company’s majority, indirectly owned subsidiary, Beijing Continent Pharmaceuticals Co., Ltd. (d/b/a Gyre Pharmaceuticals Co., Ltd.) since April 2025, and as a director and an executive officer of the Company’s parent company, GNI Group Ltd. (TSE: 2160) (“GNI Japan”), since March 2025. Mr. Zhang was the Lead Director of the Company from January 2025 to March 2025. Mr. Zhang has served as a Managing Partner at String Capital Management Co., Limited, a private equity investment firm, since 2018. From 2015 to 2018, he served as Head of Private Equity and Venture Capital Investments at AEON Life Insurance Company, Ltd. Prior to that, from 2011 to 2015, he led the China-focused funds of Japan Asia Investment Co., Ltd., focusing on cross-border investments between Japan and China. From 2008 to 2010, Mr. Zhang was the only mainland Chinese Managing Director and Partner at AEA Investors LP, a New York-based mid-cap buyout fund. Between 2004 and 2008, he established and led the investment banking and venture capital arm of Mitsubishi UFJ Financial Group in China, serving as its Chief Executive Officer. Earlier in his career, he held roles at Mitsui & Co. and Itochu Corporation. Mr. Zhang also currently serves as a director of Asian Star Co. (TSE: 8946). He holds a B.S. in Polymer Science from Fudan University and his M.B.A. in Finance from the University of Chicago Booth School of Business.
In connection with his appointment as Interim Chief Executive Officer, Mr. Zhang received a grant of 250,000 stock options to purchase shares of the Company’s common stock, 25% of which will vest on August 5, 2026, with the remaining vesting in equal monthly installments over the following three years, subject to Mr. Zhang’s continued service to the Company through each vesting date.
There are no arrangements or understandings between Mr. Zhang and any other persons pursuant to which he was selected as an officer; he has no family relationships with any of the Company’s directors or executive officers; and he has no direct or indirect material interest in any transaction required to be disclosed pursuant to Item 404(a) of Regulation S-K.
Departure of Chief Executive Officer and Director
In connection with his resignation as Chief Executive Officer, Dr. Ying also resigned as a member of the Board, effective as of August 5, 2025. Dr. Ying’s departure from the Board was not the result of any dispute or disagreement with the Company on any matter relating to the Company’s operations, policies or practices. Dr. Ying’s Employment Agreement, dated as of January 15, 2024 and filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K/A filed on January 19, 2024, remains in full force and effect, except that the Company and Dr. Ying entered into a Letter Agreement to memorialize Dr. Ying’s employment transition.
Item 7.01 |
Regulation FD Disclosure. |
A copy of the Company’s press release announcing the foregoing appointments is furnished hereto as Exhibit 99.1.
The information in this Item 7.01 (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, except as 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:
Exhibit Number |
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Exhibit Title or Description |
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99.1 |
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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: August 11, 2025 |
By: |
/s/ Ping Zhang |
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Name: |
Ping Zhang |
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Title: |
Executive Chairman and Interim Chief Executive Officer |
Exhibit 99.1
Gyre Therapeutics Reports Second Quarter 2025 and Year-to-Date Financial Results and Provides Business and Leadership Update
Net income of $1.6 million and $5.3 million for the three and six months ended June 30, 2025, respectively; reaffirms full-year revenue guidance of $118-128 million
Ping Zhang, Executive Chairman, appointed interim CEO as Dr. Han Ying transitions to scientific leadership role
SAN DIEGO, August 11, 2025 (GLOBE NEWSWIRE) – Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company dedicated to advancing fibrosis-first therapies across organ systems affected by chronic disease, today announced financial results for the second quarter ended June 30, 2025 and provided a business and leadership update.
Dr. Han Ying has stepped down as Chief Executive Officer and will transition into the role of Senior Vice President, Science and will oversee research and discovery activities to support Gyre’s fibrosis focused pipeline. Ping Zhang, Executive Chairman, has been appointed Interim Chief Executive Officer, and will lead the company’s day-to-day operations and strategic global expansion.
“I want to thank Dr. Ying for his contributions and dedication during his tenure as CEO. His deep background in research and discovery will be invaluable to advance our science and continued innovation,” said Mr. Zhang. “As interim CEO, I am excited to work closely with our leadership team to strengthen Gyre’s global footprint and accelerate our progress toward delivering transformative therapies to patients.”
1
“Looking ahead, we are thrilled with the rapid progress we have made towards expanding our commercial footprint and advancing our pipeline of fibrosis-first therapies. Our lead compound, Hydronidone, demonstrated statistically significant fibrosis regression in patients with CHB-associated liver fibrosis in a pivotal Phase 3 trial in the PRC, a critical step that not only underscores the potential of Hydronidone, but also lays the foundation to expand into additional fibrotic indications,” continued Mr. Zhang. “In the second half of 2025 we are well-positioned to grow our footprint in the United States with our planned Phase 2 trial evaluating Hydronidone in MASH-associated liver fibrosis, while continuing to advance our robust pipeline in the PRC, highlighted by a new Phase 2/3 trial of pirfenidone in oncology-related pulmonary complications expected to initiate later this year. In addition, Gyre Pharmaceuticals remains on track to file an NDA for Hydronidone with the NMPA in the third quarter of 2025 to potentially support our growing commercial portfolio.”
Second Quarter Business Highlights and Upcoming Milestones
Commercial Portfolio Expansion
ETUARY® (pirfenidone): Generated $23.5 million in sales of ETUARY® for the quarter ended June 30, 2025, compared to $25.1 million for the same period in 2024.
Etorel (nintedanib ethanesulfonate soft capsules): In June 2025, Gyre launched Etorel in the PRC for the treatment of systemic sclerosis-associated ILD, and progressive fibrosing ILD, and generated sales of $1.6 million in the first partial quarter of launch.
Contiva (avatrombopag maleate tablets): In March 2025, Gyre initiated commercialization of Contiva in the PRC for thrombocytopenia in adults with chronic liver disease and immune thrombocytopenic purpura, and generated sales for $1.5 million in the second quarter of 2025.
Pipeline Development Updates
Hydronidone:
2
ETUARY® (Pirfenidone):
F573:
F230:
F528:
Corporate Updates
3
Financial Results
Cash Position
As of June 30, 2025, Gyre held $36.5 million in cash and cash equivalents, $17.9 million in short-term bank deposits, and $21.5 million in long-term certificates of deposit, totaling $75.9 million. The increase of cash and cash equivalents mainly includes net proceeds of approximately $21.3 million received from the May 2025 underwritten public offering.
Financial Results for the Three Months Ended June 30, 2025
Gyre anticipates revenue growth over the remainder of the year, driven by the commercial launch of Etorel in June 2025 and the continued expansion of Contiva.
4
Financial Results for the Six Months Ended June 30, 2025
Gyre anticipates revenue growth over the remainder of the year, driven by the continued expansion of Contiva in March 2025 and the commercial launch of Etorel in June 2025.
5
Full Year 2025 Financial Guidance
For the full year 2025, the Company expects to generate revenues of $118 to $128 million, representing growth of 11.3% to 20.8% over 2024 revenue, primarily driven by the anticipated commercial launches of Etorel and Contiva and sales of ETUARY®.
Guidance Range
Total Revenue $118 to $128 million
Please note that total revenue guidance assumes a constant foreign currency exchange rate and no significant economic disruption or downturn.
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 the 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.
6
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, ETUARY® (pirfenidone capsule), was the first approved treatment for IPF in the PRC in 2011 and has maintained a prominent market share (2024 net sales of $105.0 million). In addition, Gyre Pharmaceuticals’ pipeline includes Hydronidone, 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. Hydronidone received Breakthrough Therapy designation by the NMPA Center for Drug Evaluation in March 2021 and NDA filing is expected in the third quarter of 2025. Gyre Pharmaceuticals is also developing treatments for PD, DKD, RILI with or without immune-related pneumonitis, COPD, PAH and ALF/ACLF. In October 2023, Gyre Therapeutics acquired an indirect majority interest of 65.2% in Gyre Pharmaceuticals. In the third quarter of 2025, this indirect interest was increased from 65.2% to 69.7% through the increased capital contribution from BJContinent Pharmaceuticals Limited to Gyre Pharmaceuticals.
About Gyre Therapeutics
Gyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, primarily focused on the development and commercialization of Hydronidone for liver fibrosis, including MASH, in the United States Gyre’s strategy builds on its experience in mechanistic studies using MASH rodent models and clinical studies in CHB-induced liver fibrosis. In the People’s Republic of China, Gyre is advancing a broad pipeline through its indirect controlling interest in Gyre Pharmaceuticals, including therapeutic expansions of ETUARY®, and development programs for F573, F528, and F230.
7
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, timing of expected clinical readouts, including timing of the initiation of Gyre’s Phase 2 trial in the U.S. for Hydronidone for the treatment of MASH-associated liver fibrosis, the initiation of Gyre’s Phase 2/3 trial in the PRC for pirfenidone capsules for the treatment of RILI, including cases complicated by immune-related pneumonitis, the filing of an NDA with the NMPA for Hydronidone for the treatment of CHB-related liver fibrosis, timing of completion of Gyre’s Phase 2 clinical trial in the PRC of F573 for ALF/ACLF, and IND submission of F528 in COPD, the expectations regarding commercial revenues from the sales of Etorel and Contiva maleate tablets, interactions with regulators, expectations regarding future product sales, and Gyre’s financial position and cash resources. 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. Additional risks and factors are identified under “Risk Factors” in Gyre’s Annual Report on Form 10-K for the year ended December 31, 2024 filed on March 17, 2025 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.
For Investors:
David Zhang
Gyre Therapeutics
[email protected]
8
Gyre Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except share and per share amounts)
(Unaudited)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2025 |
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2024 |
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2025 |
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2024 |
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Revenues |
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$ |
26,771 |
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$ |
25,225 |
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$ |
48,829 |
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$ |
52,397 |
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Operating expenses: |
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Cost of revenues |
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1,151 |
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770 |
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2,045 |
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|
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1,749 |
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Selling and marketing |
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15,194 |
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14,414 |
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26,035 |
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26,956 |
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Research and development |
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3,425 |
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3,355 |
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6,520 |
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5,537 |
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General and administrative |
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4,829 |
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3,424 |
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9,784 |
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6,822 |
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Loss on disposal of assets, net |
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1 |
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68 |
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1 |
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68 |
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Total operating expenses |
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24,600 |
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22,031 |
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44,385 |
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|
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41,132 |
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Income from operations |
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2,171 |
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|
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3,194 |
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4,444 |
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11,265 |
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Other income, net: |
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Change in fair value of warrant liability |
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212 |
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2,913 |
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2,467 |
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7,201 |
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Other (expense) income, net |
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(145 |
) |
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(72 |
) |
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(38 |
) |
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50 |
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Income before income taxes |
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2,238 |
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|
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6,035 |
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6,873 |
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18,516 |
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Provision for income taxes |
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(662 |
) |
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(1,497 |
) |
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(1,563 |
) |
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(4,043 |
) |
Net income |
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1,576 |
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4,538 |
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5,310 |
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14,473 |
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Net income attributable to noncontrolling interest |
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1,134 |
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1,010 |
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2,170 |
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3,413 |
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Net income attributable to common stockholders |
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$ |
442 |
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$ |
3,528 |
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$ |
3,140 |
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$ |
11,060 |
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Net income per share attributable to common stockholders: |
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Basic |
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$ |
0.00 |
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$ |
0.04 |
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$ |
0.04 |
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$ |
0.13 |
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Diluted |
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$ |
0.00 |
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$ |
0.01 |
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$ |
0.01 |
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$ |
0.04 |
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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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89,119,344 |
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85,502,403 |
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87,295,099 |
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84,384,141 |
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Diluted |
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102,701,707 |
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102,205,888 |
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101,868,781 |
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102,421,084 |
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9
Gyre Therapeutics, Inc.
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
(Unaudited)
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June 30, 2025 |
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December 31, 2024 |
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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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$ |
36,491 |
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$ |
11,813 |
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Short-term bank deposits |
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17,874 |
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14,858 |
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Notes receivable |
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499 |
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4,373 |
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Accounts receivables, net |
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24,629 |
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19,589 |
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Other receivables from GNI |
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230 |
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|
230 |
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Inventories, net |
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8,861 |
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6,337 |
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Receivable from GCBP |
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— |
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|
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4,961 |
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Prepaid assets and other current assets |
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2,701 |
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|
2,625 |
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Total current assets |
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91,285 |
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64,786 |
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Property and equipment, net |
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23,401 |
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23,880 |
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Intangible assets, net |
|
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4,962 |
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|
|
273 |
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Deferred tax assets |
|
|
6,134 |
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|
|
5,619 |
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Long-term certificates of deposit |
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21,528 |
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|
|
24,568 |
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Other assets, noncurrent |
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|
5,336 |
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|
|
6,280 |
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Total assets |
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$ |
152,646 |
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$ |
125,406 |
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Liabilities and stockholders' equity |
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Current liabilities: |
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Accounts payable |
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$ |
71 |
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$ |
108 |
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Contract liabilities |
|
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— |
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|
|
61 |
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Due to related parties |
|
|
219 |
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|
|
227 |
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Accrued expenses and other current liabilities |
|
|
14,924 |
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|
|
10,615 |
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Income tax payable |
|
|
1,084 |
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|
|
2,831 |
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Operating lease liabilities, current |
|
|
622 |
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|
|
713 |
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CVR derivative liability |
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— |
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4,961 |
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Total current liabilities |
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16,920 |
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19,516 |
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Operating lease liabilities, noncurrent |
|
|
771 |
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|
|
885 |
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Deferred government grants |
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|
884 |
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|
928 |
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Warrant liability, noncurrent |
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3,201 |
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|
|
5,668 |
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Other noncurrent liabilities |
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|
1,427 |
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7 |
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Total liabilities |
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23,203 |
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|
27,004 |
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Stockholders’ equity: |
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Common stock, $0.001 par value, 400,000,000 shares authorized; 90,822,828 shares and 86,307,544 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively |
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|
91 |
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|
|
86 |
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Additional paid-in capital |
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161,437 |
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|
|
136,185 |
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Statutory reserve |
|
|
3,098 |
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|
|
3,098 |
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Accumulated deficit |
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(70,313 |
) |
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(73,453 |
) |
Accumulated other comprehensive loss |
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(2,287 |
) |
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|
(2,597 |
) |
Total Gyre stockholders’ equity |
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92,026 |
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|
|
63,319 |
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Noncontrolling interest |
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37,417 |
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|
|
35,083 |
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Total equity |
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129,443 |
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|
|
98,402 |
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Total liabilities and stockholders' equity |
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$ |
152,646 |
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$ |
125,406 |
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10
Gyre Therapeutics, Inc.
Reconciliation of GAAP to Non-GAAP Financial Measures
(In thousands)
(Unaudited)
|
Three Months Ended June 30, |
|
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Six Months Ended June 30, |
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2025 |
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2024 |
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2025 |
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2024 |
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Net income |
$ |
1,576 |
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|
$ |
4,538 |
|
|
$ |
5,310 |
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|
$ |
14,473 |
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Gain from change in fair value of warrant liability (1) |
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(212 |
) |
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(2,913 |
) |
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(2,467 |
) |
|
|
(7,201 |
) |
Stock-based compensation |
|
906 |
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|
|
16 |
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|
|
1,413 |
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|
|
27 |
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Provision for income taxes |
|
662 |
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|
|
1,497 |
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|
|
1,563 |
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|
|
4,043 |
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Non-GAAP adjusted net income |
$ |
2,932 |
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$ |
3,138 |
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$ |
5,819 |
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$ |
11,342 |
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(1) Reflects adjustments for fair value of warrant liability based on the Black-Scholes option pricing model.
11