Net income of $1.6 million and $5.3 million for the three and six months ended June 30, 2025, respectively; reaffirms full-year revenue guidance of $118-128 million Ping Zhang, Executive Chairman, appointed interim CEO as Dr. Han Ying transitions to scientific leadership role Revenue of $26.8 million and $48.8 million for the three and six months ended June 30, 2025, respectivelyGAAP basic EPS: $0.00 and $0.04 for the three and six months ended June 30, 2025, respectivelyPivotal Phase 3 trial of Hydronidon ...

Company Overview - Gyre Therapeutics is a pioneering fibrosis treatment company with a track record of success, including being the first to receive IPF treatment approval (pirfenidone) in China in 2011[7] - The company has maintained a leading IPF market share in China for 10 consecutive years, with approximately 50% overall market share and over 90% share in pirfenidone in 2024[7] - Gyre Therapeutics has approximately 600 dedicated global employees, including around 400 in commercial teams across China and the U S and about 70 focused on R&D[7] - In 2024, Gyre Therapeutics achieved revenue of $105 8 million[8] Hydronidone (F351) Development - Hydronidone (F351) is Gyre's lead asset with the potential to be a first-in-class therapy for CHB-related liver fibrosis, addressing a significant unmet medical need in China, and is expected to initiate a Phase 2 trial in the U S for the treatment of MASH-associated liver fibrosis[11] - In a Phase 2 trial, Hydronidone demonstrated significant fibrosis improvement, with 54 8% of patients in the combined Hydronidone groups showing ≥1 stage fibrosis improvement at Week 52, compared to 25 6% in the placebo group[17] - The U S MASH fibrosis market is estimated to be 7 2 times larger than the CHB fibrosis market[24] Strategic Acquisitions and Future Outlook - Gyre acquired Nintedanib and Avatrombopag in 2024 to strengthen its pirfenidone franchise and prepare for the potential future launch of Hydronidone[45] - The company forecasts 2025 sales of $118 million to $128 million[45] - Gyre expects to submit a New Drug Application (NDA) for Hydronidone in Q2 2025, with NMPA approval anticipated in 2026[53]

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].

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 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].