Core Viewpoint - Gyre Therapeutics has announced a public offering of 2,222,222 shares at a price of $9.00 per share, aiming to raise approximately $20 million to support its clinical trials and operational needs [1][3]. Group 1: Offering Details - The public offering consists of 2,222,222 shares priced at $9.00 each, with an option for underwriters to purchase an additional 333,333 shares [1]. - The gross proceeds from the offering are expected to be around $20 million before deducting underwriting discounts and commissions [1]. - The offering is anticipated to close on or about May 27, 2025, pending customary closing conditions [1]. Group 2: Use of Proceeds - Gyre plans to utilize the net proceeds from the offering, along with existing cash and cash flows, to advance its Phase 2 clinical trial of F351 for liver fibrosis associated with metabolic dysfunction [3]. - The funds will also be allocated for research and development, manufacturing scale-up, working capital, and general corporate purposes [3]. Group 3: Company Background - Gyre Therapeutics is a biotechnology company based in San Diego, focusing on organ fibrosis, particularly liver fibrosis related to metabolic dysfunction [6]. - The company is advancing a pipeline in China through its indirect controlling interest in Gyre Pharmaceuticals, which includes various therapeutic developments [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]

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].

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].