ETUARY

Search documents
Gyre Therapeutics Announces Closing of its Public Offering and Full Exercise of Underwriters' Option to Purchase Additional Shares
GlobeNewswire News Room· 2025-05-29 20:01
Core Viewpoint - Gyre Therapeutics has successfully completed a public offering of 2,555,555 shares at a price of $9.00 per share, raising approximately $23.0 million in gross proceeds to advance its clinical trials and operations [1][3]. Group 1: Offering Details - The public offering included the full exercise of an option by underwriters to purchase an additional 333,333 shares [1]. - Jefferies acted as the lead book-running manager, while H.C. Wainwright & Co. served as co-manager for the offering [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized to advance Gyre's Phase 2 clinical trial of F351 for MASH-associated liver fibrosis, along with funding for research and development, manufacturing scale-up, and general corporate purposes [3]. Group 3: Company Overview - Gyre Therapeutics is focused on developing and commercializing therapies for liver fibrosis, particularly targeting MASH in the U.S. market [6]. - The company leverages its experience in mechanistic studies and clinical trials related to liver fibrosis [6].
Gyre Therapeutics Announces Pricing of $20.0 Million Public Offering of Common Stock
Globenewswire· 2025-05-23 00:57
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].
Gyre Therapeutics Announces Proposed Underwritten Public Offering of Common Stock
GlobeNewswire News Room· 2025-05-22 20:02
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].
Gyre Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Update
Globenewswire· 2025-05-09 10:00
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].