Gyre Therapeutics, Inc. 8-K Filings

Gyre Therapeutics, Inc. (GYRE) filed an 8-K to furnish an updated corporate presentation outlining its strategy as a global development engine combining U.S. leadership with China-based discovery, development and commercialization.

The presentation highlights an established China commercial franchise anchored by pirfenidone for idiopathic pulmonary fibrosis, with FY26 total revenue guidance of $100.5–$111 million, intended to help fund a diversified R&D pipeline. The lead China asset F351 (hydronidone) for CHB-induced liver fibrosis has an NDA accepted by the China NMPA, supported by Phase 3 data showing materially higher fibrosis regression and inflammation improvement versus placebo, with potential launch in early 2027.

Gyre describes a broad pipeline of targeted protein degraders and Degrader Antibody Conjugates across oncology, autoimmune disease and pain, including CDK2/Cyclin E, TYK2/JAK1, pan-TRK and GSPT1 degraders, with multiple preclinical and early clinical catalysts planned around 2027.

Gyre Therapeutics reported Q2 2026 revenue of $29.1 million, down 2% from Q2 2025, and GAAP basic EPS of $(0.12). Net loss widened to $14.3 million from a $2.2 million loss, while non-GAAP adjusted net loss was $12.2 million versus $0.6 million a year earlier.

For the first half of 2026, revenue was $53.5 million compared with $60.3 million in 2025, with net loss of $32.8 million versus net income of $2.7 million. Cash, deposits, investments and long-term certificates of deposit totaled $103.2 million as of June 30, 2026. Financial statements were retrospectively recast to treat Gyre and Cullgen as entities under common control.

Key developments included completion of an all-stock acquisition of Cullgen valued at about $300 million, acceptance by China’s CDE of the NDA for F351 for CHB-induced liver fibrosis, continued growth of pirfenidone sales to $28.0 million in Q2, and expanded R&D spending, including F351 Phase 3C costs and milestone payments.

Gyre Therapeutics, Inc. appointed three new members to its board of directors, effective August 1, 2026: Yue Xiong, Ph.D., the company’s Chief Scientific Officer, as a Class I director; Maxwell Kirkby as a Class II director; and Claire Weston, Ph.D., as a Class III director. Mr. Kirkby joins the Compensation Committee and Dr. Weston joins the Audit Committee. Mr. Kirkby and Dr. Weston each receive an initial stock option grant covering 40,000 shares of common stock, vesting in equal monthly installments over three years, plus cash compensation under the non-employee director policy. Dr. Xiong, who already serves as Chief Scientific Officer and is party to the standard indemnification agreement, will receive no additional compensation for board service.

Gyre Therapeutics, Inc. filed Amendment No. 1 to a current report to add audited and interim financial statements for its newly acquired subsidiary Cullgen Inc. and unaudited pro forma condensed combined financials following their all-stock merger valuing Cullgen at approximately $300 million.

Cullgen generated $15,373 (in thousands) of collaboration revenue in 2025, primarily from an Astellas agreement, and recorded a net loss of $10,805 (in thousands), driven by research and development expenses of $19,330 (in thousands) and general and administrative expenses of $10,246 (in thousands). Year-end cash and cash equivalents were $12,122 (in thousands) with short-term investments of $28,085 (in thousands).

For the three months ended March 31, 2026, Cullgen reported collaboration revenue of $1,911 (in thousands) versus $8,513 (in thousands) a year earlier and a net loss of $8,719 (in thousands), leading to an accumulated deficit of $144,834 (in thousands). Management states that existing cash, cash equivalents and short-term investments are expected to fund operations for at least 12 months, while the company continues to anticipate ongoing operating losses.

Gyre Therapeutics, Inc. reported results of its 2026 Annual Meeting of Stockholders. There were 96,994,001 shares of common stock entitled to vote as of the April 16, 2026 record date.

Stockholders elected Class II directors David M. Epstein, Ph.D. and Dan Weng, M.D. to serve until the 2029 annual meeting. A non-binding advisory vote approved executive compensation. Stockholders also ratified Grant Thornton Zhitong Certified Public Accountants LLP as independent auditor for 2026 and approved issuing common stock upon conversion of Series B Convertible Preferred Stock in accordance with Nasdaq Listing Rule 5635(a).

Gyre Therapeutics, Inc. furnished an updated corporate presentation highlighting its fully integrated biopharmaceutical platform focused on fibrosis, inflammatory diseases, cancer and pain, following the recent acquisition of Cullgen.

The company’s first product, ETUARY™ (pirfenidone), is described as a market leader in organ fibrosis in China, with new line-extension programs in radiation-induced lung injury and pneumoconiosis supported by encouraging preclinical and phase 2 data.

Lead liver-fibrosis candidate F351 (hydronidone) showed ≥1-stage fibrosis regression at Week 52 in 52.85% of patients versus 29.84% on placebo (p=0.0002) in a China phase 3 trial of CHB‑associated liver fibrosis; an NDA was accepted by the China NMPA in May 2026, and a U.S. IND for MASH has been filed. The deck also outlines a broad targeted protein degrader and degrader‑antibody conjugate pipeline, including CDK2/Cyclin E and TYK2/JAK1 degraders and TRK and GSPT1 programs, supported by China-based discovery, development and manufacturing operations and a global workforce of about 740 employees.

Gyre Therapeutics, Inc. furnished a scientific presentation it will deliver at a conference in Shanghai, outlining its strategy as a fully integrated biopharmaceutical company focused on fibrosis, inflammatory diseases and cancer, including the recently announced acquisition of Cullgen.

The presentation highlights a broad pipeline from discovery to marketed products and a global footprint with headquarters in San Diego and major discovery, development, manufacturing and commercial operations in China. Gyre reports about 740 employees worldwide across R&D, manufacturing, sales and marketing, and G&A functions.

A key focus is CG923308, a CDK2/cyclin E degrader for CCNE1-amplified solid tumors and HR+/HER2- breast cancer resistant to CDK4/6 inhibitors. Preclinical data show potent, selective protein degradation, oral bioavailability in multiple species, strong in vitro and in vivo anti-cancer activity versus Phase 2/3 CDK2 inhibitors, and tolerability in animal models. Cullgen anticipates submitting an Investigational New Drug application for CG923308 in the first quarter of 2027. The presentation is furnished as Exhibit 99.1 under Item 7.01 and is not deemed filed under the Exchange Act.

Gyre Therapeutics, Inc. announced that China’s National Medical Products Administration, through its Center for Drug Evaluation, has accepted a New Drug Application for F351 (hydronidone) to treat chronic hepatitis B-induced liver fibrosis. The NDA was submitted via its majority-owned subsidiary, Gyre Pharmaceuticals Co., Ltd., and follows the product’s earlier priority review status. F351 is Gyre’s lead liver fibrosis candidate and has also been developed for MASH-associated liver fibrosis, with plans to file a U.S. IND by the end of 2026.

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.

Gyre Therapeutics has completed its previously announced all-stock acquisition of Cullgen Inc., valuing Cullgen at approximately $300 million. Cullgen is now a wholly owned subsidiary, and the deal is treated as a combination of entities under common control because both companies are controlled by GNI Group Ltd.

Former Cullgen CEO Ying Luo, Ph.D. has become Gyre’s Chief Executive Officer, President and a director, while Ping Zhang remains Chairman. Cullgen shareholders received Gyre common stock or Series B Convertible Preferred Stock, with each preferred share convertible into five common shares after stockholders vote on a conversion proposal on June 10, 2026, subject to a 19.99% ownership cap.

The combined company now pairs Gyre’s commercial fibrosis drug ETUARY and late-stage candidate F351 with Cullgen’s targeted protein degrader and degrader-antibody conjugate pipeline, operating as a fully integrated biopharmaceutical group across the U.S. and China.

Gyre Therapeutics, Inc. filed an amended report to correct how its planned all-stock acquisition of Cullgen Inc. is described. The deal values Cullgen at approximately $300 million.

Under the revised terms, designated Cullgen common holders receive Series B Convertible Preferred Stock, with each Cullgen common share converted into Company preferred shares equal to 0.4753 (the Exchange Ratio) divided by five. Other Cullgen stockholders receive Gyre common stock based on the full Exchange Ratio.

Each share of Company preferred stock is convertible into five common shares, tied to stockholder approval of a Conversion Proposal. Gyre states it will not issue more than 19.99% of its outstanding common stock or voting power before that approval, preserving a cap on pre-approval dilution.

Gyre Therapeutics, Inc. reported that its majority indirectly owned subsidiary, Gyre Pharmaceuticals Co., Ltd., has submitted a New Drug Application to the Center for Drug Evaluation of China’s National Medical Products Administration for F351 (Hydronidone). The NDA seeks approval of Hydronidone as a treatment for chronic hepatitis B–induced liver fibrosis.

The filing explains that the submission will first undergo formatting and completeness checks, after which the company expects an acceptance number before the technical review begins. Gyre notes that forward-looking statements about the NDA process are subject to significant risks and uncertainties described in its prior SEC reports.

Gyre Therapeutics, Inc. reported that a company representative presented information at an investor conference on March 10, 2026. The discussion included future expectations for revenues, margins, tax deductions, and potential indication expansions related to F351 and ETUARY®, as well as anticipated development timelines and possible efficacy for CG001419.

The company also highlighted potential future licensing opportunities. It emphasized that these are forward-looking statements based on current beliefs and assumptions, and that actual results may differ due to various risks described in its previously filed Annual and Quarterly Reports with the SEC.

Gyre Therapeutics reported full-year 2025 revenue of $116.6 million, up 10.2% year-over-year, driven by ETUARY®, and launches of Contiva® and Etorel®. Fourth-quarter revenue was $37.2 million, up 33.3%.

GAAP net income for 2025 declined to $9.9 million from $17.9 million, while non-GAAP adjusted net income rose to $18.9 million from $16.9 million. In the fourth quarter, Gyre posted a GAAP net loss of $1.4 million but non-GAAP adjusted net income of $4.3 million, reflecting higher operating expenses, especially sales, marketing and stock-based compensation.

The company issued 2026 revenue guidance of $100.5–$111.0 million, implying a 13.8% to 4.8% decline versus 2025 as it treats 2026 as a transition year focused on regulatory work for Hydronidone and moderates promotion for Contiva® and Etorel®. Gyre also agreed to acquire Cullgen in an approximately $300 million all-stock deal, aiming to add a targeted protein degradation pipeline, and advanced Hydronidone and pirfenidone programs toward key regulatory and clinical milestones in China and the United States.

Gyre Therapeutics is acquiring Cullgen in an all‑stock deal valuing Cullgen at approximately $300 million. Cullgen will become a wholly owned subsidiary, bringing a targeted protein degradation and degrader antibody conjugate platform, plus clinical programs in pain, solid tumors and blood cancers, into Gyre’s portfolio.

The merger uses new Series B Convertible Preferred Stock, each share convertible into five common shares after stockholders approve a Conversion Proposal, with issuance capped at 19.99% of Gyre’s pre‑vote common stock and voting power until that approval. Existing Cullgen equity and in‑the‑money options will roll into Gyre equity, and a registration rights agreement requires Gyre to file a resale registration statement shortly after closing. Selected Gyre and Cullgen insiders signed support agreements and staggered 6‑, 12‑ and 18‑month lock‑ups. Two Gyre directors will resign at closing, and Cullgen CEO Ying Luo will become Gyre’s Chief Executive Officer, President and a director. The companies expect the transaction to close early in the second quarter of 2026, subject to customary regulatory and stockholder conditions, including Hart‑Scott‑Rodino review and Cullgen stockholder approval.

Gyre Therapeutics, Inc. furnished a press release announcing financial results for the three and nine months ended September 30, 2025. The press release is included as Exhibit 99.1 to this Form 8-K.

Consistent with General Instruction B.2, the information in Item 2.02 and Exhibit 99.1 is not deemed filed for purposes of Section 18 of the Exchange Act. Gyre’s common stock trades on The Nasdaq Capital Market under the symbol GYRE. The report was signed by Ping Zhang, Executive Chairman and Interim Chief Executive Officer.

Gyre Therapeutics, Inc. filed a Form 8-K reporting that on September 10, 2025 the company made an updated corporate presentation available on its website and filed that presentation as Exhibit 99.1 to the report. The filing notes the exhibit is dated September 2025 and that the report was signed by Ping Zhang, Executive Chairman and Interim Chief Executive Officer. The 8-K does not include financial results, transaction details, or other operational disclosures; it solely documents the availability and filing of the corporate presentation.

Gyre Therapeutics, Inc. appointed Dr. Dan Weng as a Class II director on August 18, 2025. Dr. Weng, age 63, is the President and CEO of Medelis, Inc. and previously led EPS International Holding Co., with extensive senior roles at global contract research organizations and research positions at Harvard Medical School and Massachusetts General Hospital. The company states that GNI Group Ltd., its parent, identified and supports his appointment. Dr. Weng will receive standard non-employee director compensation per the company’s proxy and will enter the company’s standard indemnification agreement. The filing notes there are no family relationships or reportable related-party transactions requiring disclosure.

Gyre Therapeutics reported a leadership transition and furnished a press release with its quarterly results. Ping Zhang was appointed Interim Chief Executive Officer effective August 5, 2025, succeeding Han Ying, Ph.D., who resigned as CEO and as a director to become the companys Senior Vice President, Science. Mr. Zhang has served as a company director since January 2025 and as Executive Chair since March 2025, and his background includes senior roles in private equity, venture capital and corporate leadership in China and Japan.

In connection with the interim CEO appointment, Mr. Zhang received a grant of 250,000 stock options, with 25% vesting on August 5, 2026 and the remainder vesting in equal monthly installments over the following three years, subject to continued service. The company furnished a press release as Exhibit 99.1 announcing financial results for the three and six months ended June 30, 2025, and listed the interactive data cover page as Exhibit 104.