UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 000-51173 Gyre Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 56-2020050 (State or Other Jurisdi ...

 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 ...

Exhibit 99.1 Gyre Therapeutics Reports Second Quarter 2025 and Year-to-Date Financial Results and Provides Business and Leadership Update 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 SAN DIEGO, August 11, 2025 (GLOBE NEWSWIRE) – Gyre Therapeutics ("Gyre") (Nasdaq: GYRE), an innov ...

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]

Company Overview - Gyre Therapeutics is a biopharmaceutical company focused on advancing fibrosis-first therapies across various organ systems affected by chronic diseases [1][6] - The company is headquartered in San Diego, CA, and is primarily engaged in the development and commercialization of Hydronidone for liver fibrosis, including metabolic dysfunction-associated steatohepatitis (MASH) [6] Clinical Development - Gyre has successfully dosed the first volunteer in a Phase 1 clinical trial for F230, a novel endothelin A receptor antagonist aimed at treating pulmonary arterial hypertension (PAH) [1][4] - The Phase 1 trial is designed to evaluate the safety, tolerability, and pharmacokinetics of F230 in healthy volunteers [4] - F230 is a fully synthetic small molecule that selectively blocks the ETA receptor, intended to reduce pulmonary vascular remodeling and lower pulmonary pressure, which are critical factors in PAH progression [3] Market Potential - Gyre's entry into the PAH field is significant due to the condition's rarity, progressive nature, and high mortality rate, with limited treatment options available [2] - The PAH market in China was valued at $370 million in 2023 and is projected to grow to $480 million by 2031, highlighting the commercial potential for Gyre's F230 [2] Pipeline and Future Plans - F230 joins Gyre's pipeline alongside its lead candidate Hydronidone (F351), which has met the primary endpoint in a pivotal Phase 3 trial for chronic hepatitis B (CHB)-induced liver fibrosis [5] - A New Drug Application (NDA) submission for F351 to China's National Medical Products Administration (NMPA) is planned for the third quarter of 2025 [5] - Gyre is also planning a pre-IND meeting with the U.S. Food and Drug Administration for an expected Phase 2 trial in MASH fibrosis [5]

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].

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]

Commercialization and Product Development - Gyre Pharmaceuticals successfully advanced pirfenidone to commercialization in the PRC for the treatment of idiopathic pulmonary fibrosis (IPF) and has acquired commercial rights to Nintedanib, enhancing its position in the pulmonary fibrosis market[116] - Nintedanib is expected to be commercialized in the PRC in Q2 2025, aimed at offsetting declines in ETUARY sales due to increased competition and economic fluctuations[116] - Pirfenidone is undergoing a Phase 3 trial in the PRC for pneumoconiosis and has received approval for a new indication for radiation-induced lung injury[118] - F351, a lead development candidate, has shown statistically significant improvement in liver fibrosis in a Phase 2 trial, with a confirmatory Phase 3 trial ongoing[120] - The Phase 3 trial of Hydronidone in CHB-associated liver fibrosis is on track to report topline results in Q2 2025[120] - The commercialization of avatrombopag in the PRC was initiated in March 2025, targeting thrombocytopenia in chronic liver disease[123] - Gyre Pharmaceuticals is preparing to launch a clinical trial for F230, a selective endothelin receptor agonist for pulmonary arterial hypertension[122] - The company is also evaluating F528, a novel anti-inflammation agent, in preclinical studies for chronic obstructive pulmonary disease[122] Financial Performance - For the three months ended March 31, 2025, the company reported revenues of $22.1 million, a decrease of $5.1 million or 19% compared to $27.2 million in the same period of 2024[150] - The net income for the three months ended March 31, 2025, was $3.7 million, down 62% from $9.9 million in the same period of 2024[137] - Research and development expenses increased by $0.9 million, or 42%, for the three months ended March 31, 2025, totaling $3.1 million compared to $2.2 million in 2024[155] - Selling and marketing expenses decreased by $1.7 million, or 14%, for the three months ended March 31, 2025, totaling $10.8 million compared to $12.5 million in 2024[154] - The cost of revenues for the three months ended March 31, 2025, was $0.9 million, a decrease of 9% from $1.0 million in the same period of 2024[153] - The provision for income taxes was $0.9 million for the three months ended March 31, 2025, down from $2.5 million in 2024, primarily due to lower profits[159] Cash Flow and Financial Position - The company had cash and cash equivalents of $15.0 million as of March 31, 2025, an increase from $11.8 million as of December 31, 2024[137] - The accumulated deficit as of March 31, 2025, was $70.8 million, a slight improvement from $73.5 million as of December 31, 2024[137] - Cash used in operating activities was $0.1 million, reflecting a net income of $3.7 million, offset by non-cash items totaling $0.5 million[166] - Cash provided by investing activities for the same period was $2.0 million, primarily from $11.2 million cash acquired from maturing certificates of deposit, offset by $8.4 million in purchases of certificates of deposit[168] - Cash provided by financing activities for the three months ended March 31, 2025, was $1.3 million, driven by $0.9 million from stock options exercise and $0.5 million from common stock issuance[170] - As of March 31, 2025, the aggregate amounts of restricted capital and statutory reserves not available for distribution were $64.3 million[171] Commitments and Obligations - The company has committed to allocate $32.7 million toward future research and development activities as of March 31, 2025[175] - The company has fixed lease payment obligations of $1.8 million as of March 31, 2025, with $0.8 million payable within 12 months[173] - The company has commitments related to the purchase of property and equipment totaling $4.8 million as of March 31, 2025[176] - The company expects to pay a total of $1.0 million to New Jiyuan for the transfer of minocycline hydrochloride foam, with $0.7 million paid as of March 31, 2025[174] Reporting Status - The company remains a smaller reporting company but became an "accelerated filer" as of December 31, 2024, requiring compliance with additional reporting requirements[180]