Core Viewpoint - Gyre Therapeutics reported a net income of $3.7 million for Q1 2025 and reaffirmed its full-year revenue guidance of $118 to $128 million, indicating a strategic focus on expanding its market presence and product portfolio in the organ fibrosis treatment space [1][12]. Financial Performance - Revenues for Q1 2025 were $22.1 million, down from $27.2 million in Q1 2024, primarily due to a $5.2 million decline in ETUARY sales, which was anticipated following a one-time marketing campaign in early 2024 [12][18]. - The company reported a decrease in income from operations to $2.3 million from $8.1 million year-over-year, attributed to lower revenues [18]. - Non-GAAP adjusted net income for Q1 2025 was $2.9 million, down from $8.2 million in the same period last year, reflecting the decline in revenue and a slight increase in operating expenses [18][28]. Business Highlights - The launch of avatrombopag in March 2025 is expected to enhance Gyre's presence in hepatology and hematology, targeting thrombocytopenia in adults with chronic liver disease [5][6]. - ETUARY (pirfenidone) generated $21.7 million in sales during Q1 2025, maintaining its position as the market leader for idiopathic pulmonary fibrosis (IPF) in China, despite a year-over-year sales decline [3][12]. - Nintedanib is on track for commercial launch in May 2025, aimed at treating multiple forms of fibrosing interstitial lung disease, which is anticipated to support revenue growth in the second half of 2025 [4][12]. Pipeline Development - Gyre received NMPA approval to initiate a clinical trial of pirfenidone for radiation-induced lung injury (RILI), marking its entry into oncology supportive care, with plans for an adaptive Phase 2/3 trial in the second half of 2025 [6][7]. - The company is also advancing F573, a caspase inhibitor for acute liver failure, with a Phase 2 clinical trial completion expected by the end of 2026 [8][12]. - F230, a selective endothelin receptor agonist for pulmonary arterial hypertension, is set to begin a Phase 1 trial in Q2 2025 [9]. Corporate Updates - In March 2025, Gyre appointed Ping Zhang as Executive Chairman of the Board of Directors, indicating a strategic leadership change [11]. Cash Position - As of March 31, 2025, Gyre held $51.3 million in cash, cash equivalents, and deposits, which the company believes will be sufficient to fund its operating and capital requirements for the next 12 months [12][18].

Financial Performance - Net income for Q1 2025 was $3.7 million, down from $9.9 million in Q1 2024, primarily due to lower revenue and unfavorable changes in fair value of warrant liabilities [19]. - Q1 2025 revenue was $22.1 million, a decrease of $5.1 million compared to $27.2 million in Q1 2024, attributed to a decline in ETUARY® sales and weaker economic conditions in China [14]. - Revenues for Q1 2025 were $22,058 million, a decrease of 18.5% compared to $27,172 million in Q1 2024 [27]. - Net income for Q1 2025 was $3,734 million, down 62.5% from $9,935 million in Q1 2024 [27]. - The company reported a non-GAAP adjusted net income of $2,887 million for Q1 2025, compared to $8,204 million in Q1 2024, reflecting a decline of 64.8% [32]. - Basic net income per share attributable to common stockholders was $0.03 for Q1 2025, down from $0.09 in Q1 2024 [27]. Sales and Revenue Guidance - ETUARY® (pirfenidone) generated $21.7 million in sales during Q1 2025, maintaining its position as the market leader for idiopathic pulmonary fibrosis (IPF) in China [4]. - Gyre Therapeutics reaffirmed its full-year 2025 revenue guidance of $118 to $128 million, compared to $105.8 million in 2024 [14]. Research and Development - The company completed data collection for the pivotal Phase 3 trial of Hydronidone in Chronic Hepatitis B-associated liver fibrosis, with topline results expected in Q2 2025 [5]. - Research and development expenses increased to $3.1 million in Q1 2025, up from $2.2 million in Q1 2024, driven by clinical research costs [16]. - Gyre received NMPA approval to initiate a clinical trial of pirfenidone for radiation-induced lung injury, marking its entry into oncology supportive care [8]. Commercialization Efforts - Commercialization of avatrombopag was initiated in March 2025, targeting thrombocytopenia in adults with chronic liver disease [7]. - Nintedanib is on track for commercialization in May 2025, expanding treatment options for pulmonary fibrosis [6]. Financial Position - As of March 31, 2025, Gyre held $51.3 million in cash and cash equivalents, sufficient to fund operations for the next 12 months [13]. - Cash and cash equivalents increased to $15,045 million as of March 31, 2025, up from $11,813 million at the end of 2024 [30]. - Total assets rose to $129,790 million as of March 31, 2025, compared to $125,406 million at the end of 2024 [30]. - Total liabilities decreased to $25,488 million as of March 31, 2025, down from $27,004 million at the end of 2024 [30]. - The company’s accumulated deficit improved to $(70,755) million as of March 31, 2025, from $(73,453) million at the end of 2024 [30]. Operating Expenses - Operating expenses totaled $19,785 million in Q1 2025, slightly up from $19,101 million in Q1 2024, with significant increases in research and development expenses from $2,182 million to $3,095 million [27]. - The weighted average shares used in calculating diluted net income per share were 101,970,672 for Q1 2025, compared to 102,594,197 for Q1 2024 [27].

Core Viewpoint - Gyre Therapeutics has received approval from the National Medical Products Administration (NMPA) in China for a clinical trial application to evaluate pirfenidone for treating radiation-induced lung injury (RILI) and immune-related pneumonitis (CIP) in cancer patients [1][2]. Company Overview - Gyre Therapeutics is a biotechnology company focused on organ fibrosis, with a commercial-stage product, pirfenidone, which is currently approved for idiopathic pulmonary fibrosis (IPF) [1][7]. - The company is headquartered in San Diego, CA, and is advancing a broad pipeline in China through its indirect controlling interest in Gyre Pharmaceuticals [8]. Clinical Trial Details - The approved trial will utilize an adaptive Phase 2/3 design to explore dosing and confirm efficacy for pirfenidone in the new indication [2]. - Gyre plans to initiate the trial in the second half of 2025 at leading academic and oncology centers across China [6]. Medical Context - RILI affects 5%–25% of lung cancer patients undergoing radiation therapy, which can limit treatment efficacy [3]. - CIP occurs in 13%–19% of patients treated with immune checkpoint inhibitors, contributing to a significant percentage of immune-related adverse event deaths [4]. - Currently, there are no targeted therapies for lung injuries caused by radiation or immunotherapy, with corticosteroids being the standard treatment despite their long-term side effects [5]. Drug Mechanism - Pirfenidone is an orally administered small molecule that inhibits TGF-β signaling and fibroblast proliferation, showing clinical benefits in slowing lung function decline in IPF [7].

SAN DIEGO, March 27, 2025 (GLOBE NEWSWIRE) -- Gyre Therapeutics ("Gyre") (NASDAQ:GYRE), an innovative, commercial-stage biotechnology company with clinical development programs focusing on organ fibrosis, today announced the publication of the manuscript titled "Hydronidone for the Treatment of Liver Fibrosis Associated with Chronic Hepatitis B: Protocol for a Phase 3 Randomized Trial" in the Journal of Clinical and Translational Hepatology. This publication details the full protocol for the pivotal Phase 3 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 For the year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 000-51173 Gyre Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 56-2020050 (State or Other Jurisdiction of Incorporation or Organization) (I.R.S. Employer Identification No.) 12770 High Bluff Drive Suite 150 San Diego ...

Data from pivotal Phase 3 trial in CHB-associated liver fibrosis expected in Q2 2025 Commercial launch in the PRC of generic nintedanib for the treatment of IPF and avatrombopag maleate tablets for the treatment of CLD-associated thrombocytopenia expected in 2025 Initiation of U.S. Phase 2 trial of F351 in MASH-associated liver fibrosis expected in 2025 Full year 2025 total revenue guidance of $118 to $128 million SAN DIEGO, March 17, 2025 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), a se ...

Company Overview - Gyre Therapeutics is a self-sustainable, commercial-stage biotechnology company focused on chronic organ diseases, headquartered in San Diego, CA [1][3] - The company is developing F351 (Hydronidone) for MASH-associated fibrosis in the U.S. and has a diverse pipeline in the PRC through its subsidiary Gyre Pharmaceuticals [3][4] Leadership Changes - Ping Zhang has been appointed as the lead independent director of the Board and a member of the Nominating and Corporate Governance Committee [1] - Ying Luo, Ph.D., resigned as Chairman of the Board to focus on other responsibilities at GNI Group Ltd, with Songjiang Ma appointed as the new Chairman of Gyre Pharmaceuticals [1][3] Financial Performance - Gyre Pharmaceuticals, a subsidiary of Gyre Therapeutics, reported net sales of $112.1 million in 2023 for its flagship product ETUARY® [4] - F351 is currently in a Phase 3 clinical trial for CHB-associated liver fibrosis in the PRC, with topline data expected by early 2025 [4] Product Development - Gyre Therapeutics is advancing F351 based on mechanistic studies and clinical studies related to MASH and CHB-induced liver fibrosis [3] - The company is also developing treatments for other conditions such as COPD, PAH, and ALF/ACLF [4]

Last patient completed pivotal Phase 3 trial in CHB-associated liver fibrosis in the PRC with data expected in Q1 2025 On track to initiate U.S. Phase 2 trial of F351 in MASH-associated liver fibrosis in 2025 Commercial launch of avatrombopag maleate tablets expected by the first half of 2025 Commercial launch of nintedanib expected in 2025 Cash and cash equivalents totaled $15.9 million as of September 30, 2024 SAN DIEGO, Nov. 13, 2024 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), a self-s ...

Revenue Performance - Gyre Therapeutics reported revenues of $25.5 million for Q3 2024, a decrease of 20.3% from $32.0 million in Q3 2023, primarily due to a $6.4 million drop in anti-fibrosis drug sales[12]. - For the nine months ended September 30, 2024, total revenue was $77.9 million, down 9.7% from $86.3 million in the same period in 2023, driven by an $8.0 million decrease in anti-fibrosis drug sales[14]. - For the three months ended September 30, 2024, Gyre's revenues were $25.5 million, a decrease of 20.5% compared to $32.0 million for the same period in 2023[21]. - Gyre Pharmaceuticals reported net sales of $112.1 million for ETUARY® in 2023, maintaining a significant market share in the PRC[17]. Income and Expenses - Net income for Q3 2024 was $2.9 million, compared to $7.5 million in Q3 2023, reflecting a significant decrease[14]. - Selling and marketing expenses for Q3 2024 were $13.7 million, slightly down from $13.9 million in Q3 2023[12]. - General and administrative expenses increased to $3.8 million in Q3 2024 from $1.2 million in Q3 2023, primarily due to costs associated with being a public company[12]. - Total operating expenses for the three months ended September 30, 2024, were $21.3 million, an increase of 10.3% from $19.3 million in the same period last year[21]. - Gyre's net income for the three months ended September 30, 2024, was $2.9 million, down 61.9% from $7.5 million in the prior year[21]. - Non-GAAP adjusted net income for the nine months ended September 30, 2024, was $15,737,000, compared to $23,313,000 for the same period in 2023, reflecting a decline of about 32.5%[26]. - Non-GAAP adjusted net income for the three months ended September 30, 2024, was $4,395,000, down from $11,188,000 in the same period of 2023, a decrease of about 60.7%[26]. - The company reported a significant decrease in net income for the nine months ended September 30, 2024, compared to the previous year, indicating potential challenges in revenue generation[26]. Cash Position - Cash and cash equivalents stood at $15.9 million as of September 30, 2024, expected to fund operations for at least the next 12 months[12]. - The company has a cash and cash equivalents balance of $15.9 million as of September 30, 2024, down from $33.5 million at the end of 2023[23]. Clinical Trials and Product Development - The pivotal Phase 3 trial for F351 in CHB-associated liver fibrosis was completed with 248 patients, and topline results are expected in Q1 2025[1]. - Gyre plans to initiate a U.S. Phase 2 trial of F351 in MASH-associated liver fibrosis in 2025[1]. - The commercial launch of avatrombopag maleate tablets is anticipated in the first half of 2025, expanding Gyre's rare disease product lines[3]. - Gyre is advancing F351 in a Phase 3 clinical trial for CHB-associated liver fibrosis, with topline data expected by early 2025[17]. - The company anticipates the U.S. IND submission of F351 for MASH-associated liver fibrosis and the initiation of a Phase 2 trial in the near future[19]. - The company is also developing treatments for COPD, PAH, and ALF/ACLF, indicating a diverse pipeline[17]. Financial Adjustments and Strategy - The loss from the change in fair value of warrants for the nine months ended September 30, 2024, was $(6,973,000), compared to no gain or loss in the same period of 2023[26]. - Provision for income taxes for the three months ended September 30, 2024, was $1,074,000, down from $3,678,000 in the same period of 2023, a decrease of approximately 70.8%[26]. - The adjustments for fair value of warrants were based on the Black-Scholes option pricing model, reflecting the company's financial strategy[26]. - The financial results indicate a need for the company to reassess its operational strategies to improve profitability moving forward[26]. - Overall, the financial performance shows a trend of declining income and increased tax provisions, which may impact future investment decisions[26].

SAN DIEGO, Oct. 01, 2024 (GLOBE NEWSWIRE) -- Gyre Therapeutics ("Gyre") (Nasdaq: GYRE), a selfsustainable, commercial-stage biotechnology company with clinical development programs focusing on a variety of chronic organ diseases, today announced that Han Ying, PhD, Chief Executive Officer, will be presenting a company overview at the 8th Annual H.C. Wainwright MASH Investor Conference on Monday, October 7, 2024, at 2:30 PM ET (11:30 AM PT). The live webcast will be available on the Events and Presentations ...