Forward Looking Statements This presentation contains "forward-looking statements" within the meaning of the federal securities laws regarding the current plans, expectations and strategies of Gyre Therapeutics, Inc. and its subsidiaries ("Gyre"), which statements are subject to substantial risks and uncertainties and are based on management's estimates and assumptions. All statements, other than statements of historical facts included in this presentation, are forward-looking statements, including statemen ...

Company Overview - Gyre Therapeutics is a biopharmaceutical company based in San Diego, CA, focused on developing and commercializing Hydronidone for liver fibrosis, including MASH, in the United States [3] - The company leverages its experience in mechanistic studies using MASH rodent models and clinical studies in CHB-induced liver fibrosis [3] - In China, Gyre is advancing a broad pipeline through its indirect controlling interest in Gyre Pharmaceuticals, which includes therapeutic expansions of ETUARY and development programs for F573, F528, and F230 [3] Upcoming Events - Management will present at the H.C. Wainwright 27 Annual Global Investment Conference on September 10, 2025, at 12:30 p.m. ET [1] - A live webcast of the presentation will be available on Gyre's website, with a replay accessible after the live session [2]

Core Insights - Gyre Therapeutics has appointed Dr. Dan Weng to its Board of Directors, effective August 18, 2025, which is seen as a pivotal moment for the company [1][4]. Company Overview - Gyre Therapeutics is a commercial-stage biopharmaceutical company focused on fibrosis-first therapies for chronic diseases across various organ systems [1]. - The company’s flagship product, ETUARY (Pirfenidone capsule), was the first approved treatment for idiopathic pulmonary fibrosis (IPF) in the People's Republic of China (PRC) in 2011, achieving net sales of $105.0 million in 2024 [4]. - Gyre's pipeline includes Hydronidone, which has shown statistically significant fibrosis regression in a Phase 3 clinical trial for chronic hepatitis B (CHB)-associated liver fibrosis and is expected to file for New Drug Application (NDA) in Q3 2025 [4]. Leadership and Experience - Dr. Weng has nearly four decades of experience in managing global clinical trials and has held executive positions in various international contract research organizations (CROs) [2][4]. - His previous roles include President and CEO of Medelis, Inc., and Chairman and CEO of EPS International Holding Co., where he oversaw significant growth and corporate strategy [2]. Strategic Focus - Gyre Therapeutics aims to expand its commercial reach and advance its multinational pipeline, leveraging Dr. Weng's strategic insight and regulatory experience [4]. - The company is also developing treatments for various conditions, including Parkinson's disease (PD), diabetic kidney disease (DKD), radiation-induced lung injury (RILI), chronic obstructive pulmonary disease (COPD), pulmonary arterial hypertension (PAH), and acute liver failure/acute-on-chronic liver failure (ALF/ACLF) [4][5].

Core Viewpoint - Gyre Therapeutics reported financial results for Q2 2025, highlighting a net income of $1.6 million and reaffirming full-year revenue guidance of $118-128 million, driven by the expansion of its commercial portfolio and ongoing clinical trials [1][2][22]. Financial Performance - For the three months ended June 30, 2025, revenues were $26.8 million, an increase from $25.2 million in the same period of 2024, primarily due to the launch of Etorel and increased sales of Contiva [18][19]. - For the six months ended June 30, 2025, revenues totaled $48.8 million, down from $52.4 million in 2024, mainly due to a decline in ETUARY® sales [19][25]. - Net income for Q2 2025 was $1.6 million, compared to $4.5 million in Q2 2024, reflecting increased operating expenses [20][21]. Product and Pipeline Updates - The pivotal Phase 3 trial of Hydronidone for CHB-associated liver fibrosis showed statistically significant fibrosis regression after 52 weeks, with an NDA filing expected in Q3 2025 [4][15]. - Gyre launched Etorel in June 2025, generating $1.6 million in sales in its first partial quarter [5][6]. - The company plans to initiate a Phase 2 trial for Hydronidone in MASH-associated liver fibrosis in the second half of 2025 [4][15]. Leadership Changes - Dr. Han Ying transitioned from CEO to Senior Vice President, Science, while Ping Zhang was appointed as interim CEO [3][4][16]. Cash Position - As of June 30, 2025, Gyre held $75.9 million in cash and cash equivalents, reflecting an increase due to proceeds from a public offering [17][33]. Full Year Guidance - Gyre expects full-year 2025 revenues to be between $118 million and $128 million, representing growth of 11.3% to 20.8% over 2024, driven by new product launches [22][26].

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].