Core Insights - Gyre Therapeutics reported a net income of $5.9 million for Q3 2025 and $11.2 million for the nine months ended September 30, 2025, reflecting improved commercial execution and cost control [1][7][15] - The company revised its full-year revenue guidance to $115-118 million, down from $118-128 million, due to delays in the rollout of Etorel® and uncertainties in government procurement [1][18] Financial Performance - Q3 2025 revenue reached $30.6 million, a 20% increase year-over-year, driven by growth in ETUARY®, Etorel®, and Contiva® sales [7][16] - For the nine months ended September 30, 2025, total revenue was $79.4 million, slightly above the $77.9 million reported for the same period in 2024 [15][16] - Basic EPS improved to $0.04 for Q3 2025, compared to $0.01 in Q3 2024, while for the nine months, it decreased from $0.14 to $0.08 due to higher operating expenses [7][15] Product Sales - ETUARY® generated $27.7 million in sales for Q3 2025, up from $25.3 million in Q3 2024, while Etorel® and Contiva® contributed $1.5 million and $1.2 million, respectively, in their first full quarter of sales [8][16] - The company faced initial supply chain and distribution challenges for Etorel®, which moderated its launch uptake, but demand is starting to improve [17] Pipeline Development - Gyre is advancing its pipeline with a focus on Hydronidone, which is progressing towards NDA submission in China, and plans to file a U.S. IND for MASH-associated liver fibrosis in 2026 [5][14] - The company completed patient enrollment in a 52-week Phase 3 trial of pirfenidone for pneumoconiosis, with plans to initiate an adaptive Phase 2/3 trial for oncology-related pulmonary complications in Q4 2025 [5][14] Cash Position - As of September 30, 2025, Gyre held $80.3 million in cash and cash equivalents, reflecting a 57% increase year-to-date [7][12]

Core Insights - Gyre Therapeutics announced positive results from its Phase 3 clinical trial of Hydronidone, an anti-fibrotic agent for liver fibrosis in chronic hepatitis B, to be presented at The Liver Meeting® 2025 [1][2] 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 [2] - The company leverages its experience in mechanistic studies and clinical trials related to CHB-induced liver fibrosis [2] - Gyre is also advancing a broad pipeline in China through its indirect controlling interest in Gyre Pharmaceuticals, which includes therapeutic expansions of ETUARY and development programs for F573, F528, and F230 [2] Clinical Trial Details - The Phase 3 trial results of Hydronidone will be presented by Prof. Lungen Lu, M.D., at The Liver Meeting® 2025 on November 7, 2025 [2] - The presentation is categorized under the Hepatitis B session and has been selected as a Poster of Distinction [2]

Company Overview - Gyre Therapeutics is pioneering fibrosis treatment with a track record of success, evidenced by the approval of pirfenidone in China in 2011[7] - The company has treated over 150,000 IPF patients with pirfenidone[7] - Gyre has maintained an approximately 50% IPF market share in China, with over 90% share in pirfenidone in 2024[7] - Gyre's revenue grew at approximately 32% CAGR since 2017, with 2023 revenue at $113.5 million and 2024 revenue at $105.8 million[7] Hydronidone Clinical Trial Results and Regulatory Pathway - In a Phase 3 trial for CHB-associated liver fibrosis, Hydronidone showed a statistically significant ≥1-stage fibrosis regression at Week 52: 52.85% vs Placebo: 29.84% (P = 0.0002)[14] - Hydronidone also achieved a key secondary endpoint with ≥1-grade inflammation improvement without fibrosis progression at Week 52: 49.57% vs Placebo: 34.82% (P = 0.0246)[14] - Serious Adverse Events in the Hydronidone group were 4.88% (6/123) compared to 6.45% (8/124) in the Placebo group[16] - The company expects to file a New Drug Application (NDA) to NMPA in Q3 2025 for Hydronidone, seeking accelerated approval[16] Market Opportunity and Expansion - In China, the total HBV infected population is estimated at 60-70 million, with 2.6 million diagnosed compensated F2-F4 fibrosis patients as the initial target for Hydronidone[21] - The MASH fibrosis market in the U S is approximately 7 2 times larger than the CHB fibrosis market[25]

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].