Core Viewpoint - Gyre Therapeutics has initiated an underwritten public offering of its common stock to fund its clinical trials and operational needs [1][2]. Group 1: Offering Details - Gyre is granting underwriters a 30-day option to purchase additional shares at the public offering price, subject to market conditions [1]. - The offering is made under a shelf registration statement effective since November 22, 2024, and will be conducted via a prospectus [4]. Group 2: Use of Proceeds - The net proceeds from the offering will be used to advance Gyre's Phase 2 clinical trial of F351 for MASH-associated liver fibrosis, along with funding for research, development, manufacturing, and general corporate purposes [2]. Group 3: Management of the Offering - Jefferies is the lead book-running manager for the offering, with H.C. Wainwright & Co. serving as co-manager [3]. Group 4: Company Overview - Gyre Therapeutics is focused on developing and commercializing treatments for liver fibrosis, including MASH, and has a pipeline that includes various therapeutic programs in the U.S. and China [6].

Core Insights - Gyre Therapeutics announced that its lead compound, Hydronidone (F351), successfully met the primary endpoint in a pivotal Phase 3 trial for treating liver fibrosis in patients with chronic hepatitis B in China [1][2][3] Trial Details - The Phase 3 trial was a 52-week, multicenter, double-blind, placebo-controlled study involving 248 patients with CHB fibrosis across 39 hospitals in China [2][12] - Patients were randomized 1:1 to receive either Hydronidone (270 mg/day) or placebo, alongside entecavir antiviral therapy [2][12] - The trial achieved a statistically significant proportion of patients showing a ≥1-stage regression in liver fibrosis with Hydronidone compared to placebo (52.85% vs. 29.84%, P=0.0002) [6][7] Efficacy and Safety Results - Hydronidone demonstrated a statistically significant regression in liver fibrosis and improvement in liver inflammation compared to placebo [5][6] - Key secondary endpoint results showed a ≥1-grade improvement in inflammation (49.57% for Hydronidone vs. 34.82% for placebo, P=0.0246) [6] - The safety profile of Hydronidone was favorable, with serious adverse events occurring in 4.88% of patients compared to 6.45% in the placebo group, and no discontinuations due to adverse events [7][9] Future Plans - Gyre plans to submit a New Drug Application (NDA) to China's NMPA in Q3 2025 for accelerated approval of Hydronidone [7][11] - A Phase 2 trial in the U.S. for MASH-associated liver fibrosis is expected to begin in the second half of 2025 [7][11] Market Opportunity - Approximately 75 million people in China are chronically infected with hepatitis B, with an estimated 2.6 million diagnosed with compensated F2-F4 CHB fibrosis, representing a significant addressable market for Hydronidone [13][14] - Currently, there are no approved anti-fibrotic therapies for CHB fibrosis in China, highlighting the urgent medical need that Hydronidone aims to address [13][14] About Hydronidone - Hydronidone is a structural analogue of Pirfenidone, exhibiting enhanced potency in inhibiting key drivers of liver fibrosis [15][16] - The compound has shown robust anti-fibrotic activity in multiple preclinical models and is positioned to transform the treatment landscape for liver fibrosis [16] Company Overview - Gyre Therapeutics is a biopharmaceutical company focused on developing and commercializing Hydronidone for liver fibrosis, including MASH in the U.S. [18] - The company is advancing a broad pipeline through its indirect controlling interest in Gyre Pharmaceuticals, including therapeutic expansions and development programs [18]

Commercialization and Product Development - Gyre Pharmaceuticals successfully advanced pirfenidone to commercialization in the PRC for the treatment of idiopathic pulmonary fibrosis (IPF) and has acquired commercial rights to Nintedanib, enhancing its position in the pulmonary fibrosis market[116] - Nintedanib is expected to be commercialized in the PRC in Q2 2025, aimed at offsetting declines in ETUARY sales due to increased competition and economic fluctuations[116] - Pirfenidone is undergoing a Phase 3 trial in the PRC for pneumoconiosis and has received approval for a new indication for radiation-induced lung injury[118] - F351, a lead development candidate, has shown statistically significant improvement in liver fibrosis in a Phase 2 trial, with a confirmatory Phase 3 trial ongoing[120] - The Phase 3 trial of Hydronidone in CHB-associated liver fibrosis is on track to report topline results in Q2 2025[120] - The commercialization of avatrombopag in the PRC was initiated in March 2025, targeting thrombocytopenia in chronic liver disease[123] - Gyre Pharmaceuticals is preparing to launch a clinical trial for F230, a selective endothelin receptor agonist for pulmonary arterial hypertension[122] - The company is also evaluating F528, a novel anti-inflammation agent, in preclinical studies for chronic obstructive pulmonary disease[122] Financial Performance - For the three months ended March 31, 2025, the company reported revenues of $22.1 million, a decrease of $5.1 million or 19% compared to $27.2 million in the same period of 2024[150] - The net income for the three months ended March 31, 2025, was $3.7 million, down 62% from $9.9 million in the same period of 2024[137] - Research and development expenses increased by $0.9 million, or 42%, for the three months ended March 31, 2025, totaling $3.1 million compared to $2.2 million in 2024[155] - Selling and marketing expenses decreased by $1.7 million, or 14%, for the three months ended March 31, 2025, totaling $10.8 million compared to $12.5 million in 2024[154] - The cost of revenues for the three months ended March 31, 2025, was $0.9 million, a decrease of 9% from $1.0 million in the same period of 2024[153] - The provision for income taxes was $0.9 million for the three months ended March 31, 2025, down from $2.5 million in 2024, primarily due to lower profits[159] Cash Flow and Financial Position - The company had cash and cash equivalents of $15.0 million as of March 31, 2025, an increase from $11.8 million as of December 31, 2024[137] - The accumulated deficit as of March 31, 2025, was $70.8 million, a slight improvement from $73.5 million as of December 31, 2024[137] - Cash used in operating activities was $0.1 million, reflecting a net income of $3.7 million, offset by non-cash items totaling $0.5 million[166] - Cash provided by investing activities for the same period was $2.0 million, primarily from $11.2 million cash acquired from maturing certificates of deposit, offset by $8.4 million in purchases of certificates of deposit[168] - Cash provided by financing activities for the three months ended March 31, 2025, was $1.3 million, driven by $0.9 million from stock options exercise and $0.5 million from common stock issuance[170] - As of March 31, 2025, the aggregate amounts of restricted capital and statutory reserves not available for distribution were $64.3 million[171] Commitments and Obligations - The company has committed to allocate $32.7 million toward future research and development activities as of March 31, 2025[175] - The company has fixed lease payment obligations of $1.8 million as of March 31, 2025, with $0.8 million payable within 12 months[173] - The company has commitments related to the purchase of property and equipment totaling $4.8 million as of March 31, 2025[176] - The company expects to pay a total of $1.0 million to New Jiyuan for the transfer of minocycline hydrochloride foam, with $0.7 million paid as of March 31, 2025[174] Reporting Status - The company remains a smaller reporting company but became an "accelerated filer" as of December 31, 2024, requiring compliance with additional reporting requirements[180]

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 ...

Market Trends and Projections - The prevalence of idiopathic pulmonary fibrosis (IPF) in China increased from 89,002 patients in 2018 to 145,776 patients in 2023, with projections to reach 322,000 patients by 2031, reflecting a CAGR of 10.38%[34] - The total market size for IPF in China grew from $23.9 million in 2018 to $156.8 million in 2023, with expectations to reach $344.9 million by 2027 and $698.6 million by 2031, representing a CAGR of 20.5%[34] - The prevalence of CHB-associated liver fibrosis in the PRC is estimated to be stable between 63.6 million and 66.4 million patients from 2018 to 2023, with a projected market growth from $167.8 million in 2023 to $801.2 million by 2031, reflecting a CAGR of 21.58%[46] - The market for anti-fibrosis drugs for pneumoconiosis is projected to reach $12.1 million by 2027 and $64.1 million by 2031, with a CAGR of 58.1% from 2027 to 2031[39] - The DKD market in China grew from $26.4 billion in 2018 to $40.2 billion in 2023, with expectations to expand to $54.0 billion by 2028 and $60.5 billion by 2031[77] - The prevalence of PAH in China increased from 50,600 patients in 2018 to 60,600 patients in 2023, with projections of 68,600 patients by 2028 and 70,600 patients by 2031[94] - The prevalence of COPD in China rose from 103.5 million patients in 2018 to 107.3 million patients in 2023, with forecasts of 113.1 million patients by 2028 and 116.4 million patients by 2031[97] Product Development and Trials - F351 (hydronidone) is currently in a Phase 3 trial for chronic hepatitis B-associated liver fibrosis, with topline results expected in Q2 2025[21][24] - F573 is in Phase 2 trials for acute liver failure, initiated in March 2023, while F230 is expected to begin Phase 1 trials for pulmonary arterial hypertension in 2025[31][20] - The Phase 3 clinical trial of ETUARY for the treatment of pneumoconiosis has enrolled 172 patients as of December 31, 2024, with a target of 272 patients[41][42] - F351 demonstrated a statistically significant improvement in liver fibrosis score in a Phase 2 trial, with 56.10% of patients in the 270 mg/day group achieving fibrosis regression compared to 25.58% in the placebo group[54] - The Phase 3 trial of F351 is designed to enroll 248 patients, with the primary endpoint being a reduction in liver fibrosis score by at least one stage[57][58] - The Phase 2 clinical trial for F351 in MASH-associated liver fibrosis is expected to be initiated in the first half of 2025, following IND filing[70] - The first stage of the Phase 2 trial for F573 is expected to enroll 16 patients with drug-induced liver injury and 9 patients with chronic hepatitis B, with completion anticipated in December 2024[91] Regulatory and Compliance - F351 received Breakthrough Therapy designation from the Center for Drug Evaluation in China, expediting its review process due to its potential for substantial improvement over existing therapies[25] - The FDA's review process for NDAs typically aims for completion within ten months, with priority review applications targeted for six months[140] - The FDA may require a REMS plan to mitigate serious risks associated with a drug, which can include various risk management tools[142] - The FDA conducts inspections of manufacturing facilities and clinical sites to ensure compliance with GMP and GCP before approving an NDA[141] - The FDA may issue a complete response letter outlining deficiencies in an NDA submission, requiring additional testing or information for reconsideration[144] - Drug manufacturers must register with the FDA and are subject to inspections to ensure compliance with current Good Manufacturing Practices (cGMP)[154][155] Company Strategy and Operations - The company has paused two Phase 3 trials for pirfenidone to prioritize other product candidates, indicating a strategic shift in development focus[17][22] - Gyre Pharmaceuticals plans to start commercializing avatrombopag in China in 2025 after receiving NMPA approval for its use in treating TP associated with CLD[101] - Gyre owns 26 granted patents globally and 20 pending patent applications in China, critical for protecting its core technology and intellectual property[104] - The company has developed a pipeline of pharmaceutical product candidates, including F351, F528, F230, and F573, through in-house R&D and collaboration with GNI Japan[193] - The company has implemented various internal occupational health and safety procedures to maintain a safe work environment, with no material claims or labor disputes reported in 2024[198] - The company actively identifies and monitors environmental, social, and climate-related risks, incorporating these considerations into its business and financial planning[200] Financial Performance - ETUARY (pirfenidone) achieved annual sales of $105.0 million in 2024, down from $112.1 million in 2023, indicating a decline in market share due to competition from new drugs[26][37] - Gyre Pharmaceuticals has achieved sustained profitability, primarily due to increased market demand for ETUARY, with limited competition in the IPF drug market[192] Clinical Insights - The average five-year survival rate for IPF patients is 32%, with a ten-year survival rate dropping to 16%, highlighting the critical need for effective treatments[34] - MASH affects approximately 25% of the global population, with 20% to 30% of MASLD patients developing MASH, indicating a significant market opportunity[60] - F351 was well tolerated in clinical trials, with no serious adverse events reported and treatment-emergent adverse events including headache (25.0%), constipation (16.7%), and somnolence (12.5%) observed[69] Intellectual Property and Acquisitions - Catalyst Biosciences, Inc. acquired assets and intellectual property rights related to the proprietary F351 compound for $35 million, consisting of 6,266,521 shares of common stock and 12,340 shares of Series X Convertible Preferred Stock[121] - Following the business combination, GNI USA owned approximately 85.3% of Gyre's outstanding shares, while minority shareholders held about 12.3% and pre-combination Catalyst stockholders retained approximately 2.5%[123]

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]