Form 8-K

8-K — GYRE THERAPEUTICS, INC.

Accession: 0001140361-26-028716

Filed: 2026-07-16

Period: 2026-07-10

CIK: 0001124105

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

8-K — ef20078088_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (ef20078088_ex99-1.htm)

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8-K

8-K (Primary)

Filename: ef20078088_8k.htm · Sequence: 1

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of report (Date of earliest event reported): July 10, 2026

Gyre Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

Delaware

000-51173

56-2020050

(State or other jurisdiction of incorporation)

(Commission File Number)

(IRS Employer Identification No.)

12730 High Bluff Drive

Suite 250

San Diego, CA

92130

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (858) 284-0115

N/A

(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

Trading Symbol(s)

Name of each exchange on which

registered

Common Stock

GYRE

The Nasdaq Capital Market

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 5.02.

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

On July 10, 2026, the board of directors (the “Board”) of Gyre Therapeutics, Inc. (the “Company”) appointed Yue Xiong, Ph.D. as a Class I director of the Company, Maxwell Kirkby as a Class II director of the Company and Claire Weston, Ph.D. as a Class III director of the Company, in each case effective as of August 1, 2026. Mr. Kirkby was also appointed to serve on the Compensation Committee of the Board and Dr. Weston was appointed to serve on the Audit Committee of the Board.

Mr. Kirkby and Dr. Weston will each receive an initial grant of stock options to purchase 40,000 shares of our common stock, vesting in equal monthly installments over three years, and will be entitled to receive cash compensation in accordance with the Company’s non-employee director compensation policy as generally described in the Company’s Definitive Proxy Statement filed on April 27, 2026. Mr. Kirkby and Dr. Weston are also entering into the Company’s standard form of indemnification agreement, a form of which was previously filed as Exhibit 10.3 to the Company’s Current Report on Form 8-K filed on October 30, 2023. Dr. Xiong previously entered into the Company’s standard form of indemnification agreement in connection with his appointment as the Company’s Chief Scientific Officer and will receive no additional compensation for his service on the Board.

There are no arrangements or understandings between any of Mr. Kirkby and Drs. Xiong and Weston and any other person pursuant to which such individual was appointed as director of the Company; there are no family relationships between any of Mr. Kirkby and Drs. Xiong and Weston and any director or executive officer of the Company; and none of Mr. Kirkby or Drs. Xiong and Weston are party to any transactions of the type that would require disclosure under Item 404(a) of Regulation S-K.

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 Securities Exchange Act of 1934, as amended (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 of 1933, as amended 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

Exhibit Title or Description

99.1

Press Release, dated July 16, 2026

104

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.

GYRE THERAPEUTICS, INC.

Date: July 16, 2026

By:

/s/ Thomas Eastling

Name:

Thomas Eastling

Title:

Chief Financial Officer

NASDAQ

0001124105

false

0001124105

2026-07-10

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: ef20078088_ex99-1.htm · Sequence: 5

Exhibit 99.1

Gyre Therapeutics Appoints Three New Members to its Board of Directors

SAN DIEGO, July 16, 2026 -- Gyre Therapeutics, Inc. (“Gyre”, “Gyre Therapeutics” or the “Company”) (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company with operations in the United States and China, today announced that its Board of Directors has appointed three new members, effective August 1, 2026: Yue Xiong, Ph.D., the Company's Chief Scientific Officer; Maxwell (“Max”) Kirkby; and Claire Weston, Ph.D. With these appointments, the Board expands its scientific, clinical development, and cross-border biopharmaceutical operating expertise as Gyre advances its broad pipeline of products targeting numerous therapeutic areas including fibrosis, cancer, inflammation and pain.

Dr. Xiong will serve as a Class I director, with a term expiring at the Company's 2028 annual meeting of stockholders. Mr. Kirkby will serve as a Class II director, with a term expiring at the Company's 2029 annual meeting of stockholders, and has also been appointed to the Compensation Committee of the Board. Dr. Weston will serve as a Class III director, with a term expiring at the Company's 2027 annual meeting of stockholders, and has been appointed to the Audit Committee of the Board.

“We are pleased to welcome Max and Claire to our Board, and to formally recognize Yue's expanded role as a director,” said Dr. Ying Luo, President and Chief Executive Officer of Gyre. “Max brings decades of cross-border drug development experience spanning China, Japan, the U.S. and Europe, which is directly relevant as we continue to advance our programs through the clinic worldwide and expand our global footprint. Claire's background building and scaling life sciences companies, together with her operating and governance experience, will strengthen our Audit Committee as we grow as a public company. And Yue's deep scientific leadership, both in ubiquitin biology and in building Cullgen's degrader platform, has already been instrumental to our pipeline — we're glad to have his perspective formally represented at the Board level. Together, these appointments reflect our continued commitment to strong governance as Gyre advances its portfolio of clinical assets and targeted protein degrader and degrader-antibody conjugates platforms.”

About the New Directors

Yue Xiong, Ph.D.

Dr. Xiong has served as Gyre’s Chief Scientific Officer since May 2026. Dr. Xiong previously served as a member of the board of directors of Cullgen, Inc., a biopharmaceutical company, from 2018 until the closing of Cullgen’s merger with Gyre, and as Chief Scientific Officer of Cullgen from August 2020 until closing of Cullgen’s merger with Gyre. After completing a postdoctoral fellowship in cell biology at Cold Spring Harbor Lab, Dr. Xiong joined the Department of Biochemistry and Biophysics at University of North Carolina at Chapel Hill in 1993. He was a William R. Kenan Professor of Biochemistry and Biophysics from January 2005 to July 2020, where he was responsible for classroom teaching and laboratory mentoring of students and trainees, conducting research, recruitment and mentoring of junior faculty and participating other university activities. From September 2006 to July 2020, Dr. Xiong also led the Cancer Cell Biology Program the UNC Lineberger Comprehensive Cancer Center, where he was responsible for organizing program activity such as monthly seminars, annual retreat and symposium, preparing annual program progress report to NCI and competing renewal cancer center core grant, and other research activity in the cancer center. Dr. Xiong has an undergraduate degree from Fudan University and a Ph.D. in Biology from the University of Rochester. Dr. Xiong has received several awards for his scholarship and research, published more than 200 research articles in peer-reviewed journals and is a named inventor on two U.S. patents. He was elected as a fellow of American Association for the Advancement of Science (“AAAS”) in 2012.

Maxwell Kirkby

Maxwell Kirkby is the co-owner of Huang and Kirkby Pharma Consulting, a consulting company that he co-founded in May 2024. Mr. Kirkby previously served in various leadership roles at Bristol-Myers Squibb Company (NYSE: BMS), a global biopharmaceutical company, including as the Executive Director and Head of R&D Strategy, China, from March 2022 to May 2024 and Interim Head of R&D, China from May 2023 to November 2024. Prior to joining Bristol-Myers, Mr. Kirkby served as the Executive Director and Head of Japan & Asia Pacific Development at Amgen Inc. (Nasdaq: AMGN), a global biopharmaceutical company, from February 2020 to March 2022. Prior to joining Amgen, from August 1989 to January 2020, Mr. Kirkby held positions of increasing responsibility at AstraZeneca plc (NYSE: AZN), a global biopharmaceutical company, most recently serving as VP of Development, China.

Claire Weston, Ph.D.

Claire Weston, Ph.D. is the Founder & Chief Executive Officer of Tactus AI LLC an AI healthcare company, which she has led since January 2025. Dr. Weston previously served as a member of the Executive Leadership Team and a Board Observer at CellCarta Biosciences, Inc., a private biotechnology company, from May 2021 to February 2023. Dr. Weston founded and served as the Chief Executive Officer of Reveal Biosciences Inc., a private AI-powered digital pathology platform, from June 2012 until the company was acquired by CellCarta Biosciences in May 2021. She also served as the Chair of the Board of Directors of Reveal Biosciences from 2019 to May 2021. Prior to this, Dr. Weston served as senior scientist at Vala Sciences, Inc., a private biotechnology company, from April 2011 to July 2012. Dr. Weston was a Board Director for Athena, a non-profit supporting women in STEM, from January 2020 to December 2022. Dr. Weston received a B.Sc. in Biotechnology from Cardiff University and a Ph.D. in Cell Biology from the University of Cambridge and completed postdoctoral studies at the UMass Chan Medical School.

About Gyre Pharmaceuticals

Gyre Pharmaceuticals Co., Ltd., a subsidiary of Gyre Therapeutics, Inc., 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 over the past several years. In addition, Gyre Pharmaceuticals' pipeline includes F351 (hydronidone), 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. In May 2026, China’s National Medical Products Administration (NMPA) accepted Gyre Pharmaceutical’s New Drug Application (NDA) for F351 as a treatment for chronic hepatitis B (CHB)-induced liver fibrosis, which is liver damage resulting from the infection of the hepatitis B virus (HBV). F351 received Breakthrough Therapy designation by the CDE of the NMPA in March 2021. Gyre Pharmaceuticals is also developing treatments for PD, RILI with or without immune-related pneumonitis, COPD, PAH and ALF/ACLF. As of March 31, 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.

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 expected contributions of the newly appointed directors to the Company's strategy and governance. 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. 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.

CONTACTS:

Gyre Therapeutics, Inc.

Thomas Eastling, CFO

ir@gyretx.com

Investors

Chuck Padala

Managing Director, LifeSci Advisors

chuck@lifesciadvisors.com

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