Core Insights - The article emphasizes the importance of understanding the science behind biotech investments to avoid pitfalls in the industry [1]. Group 1 - The author has a PhD in biochemistry and extensive experience analyzing clinical trials and biotech companies [1]. - The mission is to educate investors on the scientific aspects of biotech businesses to facilitate informed decision-making [1].

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 (Address of Principal Executive Offices) (Zip Code) 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 ...

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 ...

Core Viewpoint - Crescent Biopharma, Inc. has completed a merger with GlycoMimetics and secured $200 million in private financing to advance its pipeline of next-generation therapeutics for solid tumors, with a focus on its lead program, CR-001, a PD-1 x VEGF bispecific antibody, expected to submit an IND application by the end of 2025 [1][2][6]. Corporate Developments - The company appointed a new leadership team with extensive experience in oncology drug development and biotechnology, including Joshua Brumm as CEO and Jonathan McNeill, M.D., as President and COO [6]. - Crescent began trading on the Nasdaq under the ticker symbol "CBIO" on June 16, 2025, following the merger [6]. Pipeline Progress - CR-001 is designed to replicate the pharmacology of ivonescimab, which showed superior efficacy compared to pembrolizumab in a Phase 3 trial for non-small cell lung cancer [4][13]. - The company is on track to submit an IND application for CR-001 in Q4 2025, with proof-of-concept clinical data expected in the second half of 2026 [4][2]. - Two additional antibody-drug conjugates (ADCs), CR-002 and CR-003, are being developed, with an IND application for CR-002 expected in mid-2026 [5]. Financial Performance - As of June 30, 2025, Crescent reported cash reserves of $152.6 million, sufficient to fund operations through 2027 [7][12]. - R&D expenses for Q2 2025 were $12.1 million, while general and administrative expenses were $8.9 million, leading to a net loss of $21.8 million for the quarter [7][11]. - The total operating expenses for the first half of 2025 amounted to $35.3 million, with a net loss of $36.9 million [11].

Core Insights - Crescent Biopharma has appointed Dr. Jan Pinkas as chief scientific officer, bringing over two decades of experience in oncology drug development [1][2] - The company is advancing its portfolio of next-generation therapeutics for solid tumors, with plans to initiate a global Phase 1 trial for CR-001 in early 2026 and an IND submission for CR-002 in mid-2026 [2][5] Company Overview - Crescent Biopharma aims to build a leading oncology company focused on developing innovative therapies for cancer patients, including a PD-1 x VEGF bispecific antibody and novel antibody-drug conjugates [5] - The company’s pipeline is designed to leverage advancements in cooperative PD-1 x VEGF therapies and next-generation ADCs, targeting both monotherapy and combination treatment opportunities [2][5] Leadership Background - Dr. Pinkas previously served as chief scientific officer at Pyxis Oncology, where he established preclinical research for ADC programs [3] - His experience includes significant roles at Magenta Therapeutics and ImmunoGen, where he contributed to the development of approved therapies such as ELAHERE and SARCLISA [3][4]

[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) Presents Gyre Therapeutics' unaudited condensed consolidated financial statements for Q1 2025, covering Balance Sheets, Operations, Equity, Cash Flows, and notes [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets increased to **$129.8 million** from **$125.4 million**, driven by cash, while liabilities decreased and equity grew to **$104.3 million** Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 (Unaudited) | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $15,045 | $11,813 | | Total current assets | $68,448 | $64,786 | | Total assets | $129,790 | $125,406 | | **Liabilities & Equity** | | | | Total current liabilities | $18,991 | $19,516 | | Total liabilities | $25,488 | $27,004 | | Total stockholders' equity | $104,302 | $98,402 | | Total liabilities and stockholders' equity | $129,790 | $125,406 | [Condensed Consolidated Statements of Operations and Comprehensive Income](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Income) Q1 2025 revenues decreased to **$22.1 million** and net income to **$3.7 million**, with basic EPS at **$0.03** Q1 2025 vs Q1 2024 Statement of Operations (in thousands, except per share data) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Revenues | $22,058 | $27,172 | | Income from operations | $2,273 | $8,071 | | Net income | $3,734 | $9,935 | | Net income attributable to common stockholders | $2,698 | $7,532 | | Basic EPS | $0.03 | $0.09 | | Diluted EPS | $0.00 | $0.03 | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations was **$0.1 million** in Q1 2025, a significant change from **$2.9 million** provided in Q1 2024, with cash ending at **$15.0 million** Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash (used in) provided by operating activities | $(129) | $2,884 | | Net cash provided by (used in) investing activities | $1,967 | $(7,220) | | Net cash provided by financing activities | $1,344 | $658 | | Net increase (decrease) in cash and cash equivalents | $3,232 | $(3,724) | | Cash and cash equivalents at end of period | $15,045 | $29,785 | [Notes to the Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20the%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Detailed notes cover accounting policies, business operations, liquidity, fair value, revenue concentration, intangible assets, R&D commitments, and segment reporting - The company is a commercial-stage biotechnology firm focusing on anti-inflammatory and anti-fibrotic drugs, holding a **65.2%** indirect interest in its PRC-based subsidiary, Gyre Pharmaceuticals[16](index=16&type=chunk)[17](index=17&type=chunk) - Management believes existing cash, cash flows from operations, and capital market access are sufficient to fund operations for at least **12 months** from the financial statement issuance date[18](index=18&type=chunk) - For Q1 2025, three customers (Sinopharm, Resources Pharmaceutical, Shanghai Pharmaceuticals) accounted for **50.3%**, **15.5%**, and **12.4%** of total revenue, respectively[30](index=30&type=chunk) - In March 2025, the company acquired technology rights for Nintedanib for approximately **$4.9 million**, which is recorded as an intangible asset[56](index=56&type=chunk) - The company has future commitments including **$12.7 million** for the F351 program and an additional **$20.0 million** for other R&D activities[96](index=96&type=chunk) - The company operates in two reportable segments: Gyre Pharmaceuticals (operations in China) and Gyre (operations in the U.S.). Gyre Pharmaceuticals generated all of the company's **$22.1 million** in revenue for Q1 2025[105](index=105&type=chunk)[109](index=109&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q1 2025 financial condition and operations, including commercialization, pipeline, financial results, liquidity, and funding [Overview](index=27&type=section&id=Overview) Gyre, a commercial-stage biotech, focuses on anti-fibrotic drugs, expanding its portfolio and advancing F351 in Phase 3 and Phase 2 trials - The company is planning to initiate commercialization of Nintedanib in the PRC in Q2 2025 to offset declines in ETUARY sales and drive revenue growth[116](index=116&type=chunk) - Topline results for the Phase 3 trial of F351 in CHB-associated liver fibrosis are expected in Q2 2025[120](index=120&type=chunk) - A Phase 2 trial of F351 for MASH-associated liver fibrosis is expected to begin in the U.S. in 2025, pending IND approval[121](index=121&type=chunk) - The company initiated commercialization of avatrombopag maleate tablets in the PRC in March 2025 for treating thrombocytopenia[123](index=123&type=chunk) [Results of Operations](index=33&type=section&id=Results%20of%20Operations) Q1 2025 revenues decreased **19%** to **$22.1 million**, with R&D and G&A expenses rising, resulting in a **72%** drop in operating income Comparison of Operations for the three months ended March 31 (in thousands) | Metric | 2025 | 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Revenues | $22,058 | $27,172 | $(5,114) | (19)% | | Gross profit | $21,164 | $26,193 | $(5,029) | (19)% | | Research and development | $3,095 | $2,182 | $913 | 42% | | General and administrative | $4,955 | $3,398 | $1,557 | 46% | | Income from operations | $2,273 | $8,071 | $(5,798) | (72)% | | Net income | $3,734 | $9,935 | $(6,201) | (62)% | - The **19%** decrease in revenue was anticipated, attributed to a one-time marketing campaign in early 2024 that was not repeated, weaker economic conditions in China, and increased competition[151](index=151&type=chunk) - R&D expenses increased by **$0.9 million** (**42%**), mainly due to a **$1.3 million** increase in clinical research expenses for F351 data analysis[155](index=155&type=chunk) [Liquidity and Capital Resources](index=35&type=section&id=Liquidity%20and%20Capital%20Resources) The company holds **$15.0 million** in cash and believes current resources are sufficient for 12 months, with future funding dependent on clinical trials and M&A - The company believes its existing cash of **$15.0 million**, plus other deposits and operational cash flow, will be sufficient to fund operations for at least the next **12 months**[161](index=161&type=chunk) Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash (used in) provided by operating activities | $(129) | $2,884 | | Net cash provided by (used in) investing activities | $1,967 | $(7,220) | | Net cash provided by financing activities | $1,344 | $658 | - As of March 31, 2025, the company has committed **$32.7 million** for future R&D activities and **$4.8 million** for property and equipment purchases[175](index=175&type=chunk)[176](index=176&type=chunk) - PRC regulations restrict the transfer of **$64.3 million** in capital and statutory reserves from the Chinese subsidiary, but this is not expected to materially impact the company's ability to meet cash obligations[171](index=171&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=38&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, the company is not required to provide market risk disclosures - As a smaller reporting company, Gyre Therapeutics is not required to provide quantitative and qualitative disclosures about market risk[181](index=181&type=chunk) [Controls and Procedures](index=38&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of March 31, 2025, with no material changes in internal control over financial reporting - Based on an evaluation as of March 31, 2025, the principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were effective[183](index=183&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended March 31, 2025, that materially affected, or are reasonably likely to materially affect, internal controls[184](index=184&type=chunk) [PART II. OTHER INFORMATION](index=39&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=39&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - As of the report date, the company is not involved in any material legal proceedings[186](index=186&type=chunk) [Risk Factors](index=39&type=section&id=Item%201A.%20Risk%20Factors) No material changes to risk factors previously disclosed in the Annual Report on Form 10-K - The company states there have been no material changes from the risk factors disclosed in its Annual Report[187](index=187&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=39&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities or use of proceeds were reported during the period - None reported[188](index=188&type=chunk) [Other Information](index=39&type=section&id=Item%205.%20Other%20Information) No director or executive officer adopted or terminated a Rule 10b5-1 trading arrangement during Q1 2025 - No director or executive officer adopted or terminated a Rule 10b5-1 trading arrangement during the three months ended March 31, 2025[191](index=191&type=chunk) [Exhibits](index=40&type=section&id=Item%206.%20Exhibits) Lists exhibits filed as part of the Quarterly Report on Form 10-Q, including CEO and CFO certifications - The report includes a list of all exhibits filed, such as agreements and officer certifications pursuant to the Sarbanes-Oxley Act[192](index=192&type=chunk)[193](index=193&type=chunk)[194](index=194&type=chunk)

[Business Highlights and Upcoming Milestones](index=1&type=section&id=Business%20Highlights%20and%20Upcoming%20Milestones) Gyre Therapeutics advanced commercial and clinical strategies in Q1 2025, launching avatrombopag, preparing nintedanib, and progressing pipeline milestones - ETUARY® (pirfenidone) sales were **$21.7 million** in Q1 2025, remaining the market leader for idiopathic pulmonary fibrosis (IPF) in the PRC despite a year-over-year decline[4](index=4&type=chunk) - Commercialization of avatrombopag in China began in March 2025, targeting liver disease specialists, with nintedanib on track for a May 2025 launch to expand IPF treatment options[5](index=5&type=chunk)[6](index=6&type=chunk)[7](index=7&type=chunk) - China's NMPA granted IND approval for a new pirfenidone indication to treat radiation-induced lung injury (RILI), marking the company's entry into oncology supportive care, with an adaptive Phase 2/3 trial planned for the second half of 2025[3](index=3&type=chunk)[5](index=5&type=chunk)[8](index=8&type=chunk) - Database lock was achieved for the pivotal Phase 3 trial of Hydronidone in Chronic Hepatitis B (CHB)-associated liver fibrosis, with topline results expected in Q2 2025[5](index=5&type=chunk) Pipeline Development Status | Candidate | Indication | Stage / Next Milestone | | :--- | :--- | :--- | | **F573** | Acute/Acute on-Chronic Liver Failure (ALF/ACLF) | Phase 2 trial completion expected by end of 2026 | | **F230** | Pulmonary Arterial Hypertension (PAH) | Phase 1 trial expected to begin in Q2 2025 | | **F528** | Chronic Obstructive Pulmonary Disease (COPD) | IND application planned for 2026 | - Ping Zhang was appointed as Executive Chairman of the Board of Directors in March 2025[12](index=12&type=chunk) [Financial Results](index=2&type=section&id=Financial%20Results) Gyre's Q1 2025 financial results showed decreased revenues and net income due to strategic marketing shifts, with the company reaffirming its full-year revenue guidance Q1 2025 Key Financial Metrics | Metric | Q1 2025 (in millions) | Q1 2024 (in millions) | | :--- | :--- | :--- | | Revenues | $22.1 million | $27.2 million | | Income from Operations | $2.3 million | $8.1 million | | Net Income | $3.7 million | $9.9 million | | GAAP Basic EPS | $0.03 | $0.09 | | Non-GAAP Adjusted Net Income | $2.9 million | $8.2 million | - The **$5.1 million** year-over-year revenue decrease was primarily due to a **$5.2 million** decline in ETUARY® sales, resulting from a deliberate reallocation of marketing resources to support new product launches[14](index=14&type=chunk) - The company reaffirmed its full-year 2025 revenue guidance of **$118 to $128 million**, anticipating growth driven by the launch of Nintedanib and expansion of avatrombopag[1](index=1&type=chunk)[14](index=14&type=chunk) - As of March 31, 2025, the company held **$51.3 million** in cash, cash equivalents, and short/long-term deposits, deemed sufficient to fund operations for the next 12 months[5](index=5&type=chunk)[13](index=13&type=chunk) Q1 2025 Operating Expense Changes (YoY) | Expense Category | Q1 2025 (in millions) | Q1 2024 (in millions) | Change Driver | | :--- | :--- | :--- | :--- | | Cost of Revenues | $0.9M | $1.0M | Decreased in line with sales decline | | Selling & Marketing | $10.8M | $12.5M | Decreased due to lower commission costs from reduced sales | | Research & Development | $3.1M | $2.2M | Increased due to higher clinical research expenses for F351 | | General & Administrative | $5.0M | $3.4M | Increased due to higher personnel/stock costs and annual meeting expenses | [Financial Statements](index=7&type=section&id=Financial%20Statements) The unaudited condensed consolidated financial statements detail Gyre's Q1 2025 performance, showing revenue and net income declines, balance sheet changes, and GAAP to Non-GAAP reconciliation [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For Q1 2025, Gyre reported revenues of **$22.1 million** and net income attributable to common stockholders of **$2.7 million**, both decreasing year-over-year Statement of Operations Summary (in thousands) | Line Item | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Revenues | $22,058 | $27,172 | | Total operating expenses | $19,785 | $19,101 | | Income from operations | $2,273 | $8,071 | | Net income | $3,734 | $9,935 | | Net income attributable to common stockholders | $2,698 | $7,532 | | Basic EPS | $0.03 | $0.09 | [Condensed Consolidated Balance Sheets](index=8&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, Gyre's balance sheet showed total assets of **$129.8 million**, total liabilities of **$25.5 million**, and total stockholders' equity of **$104.3 million**, with increased cash and cash equivalents Balance Sheet Summary (in thousands) | Line Item | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $15,045 | $11,813 | | Total current assets | $68,448 | $64,786 | | Total assets | $129,790 | $125,406 | | Total current liabilities | $18,991 | $19,516 | | Total liabilities | $25,488 | $27,004 | | Total stockholders' equity | $104,302 | $98,402 | [Reconciliation of GAAP to Non-GAAP Financial Measures](index=9&type=section&id=Reconciliation%20of%20GAAP%20to%20Non-GAAP%20Financial%20Measures) The company reconciled Q1 2025 GAAP net income of **$3.7 million** to a non-GAAP adjusted net income of **$2.9 million**, primarily by excluding a **$2.3 million** gain from warrant liability and adding **$0.5 million** in stock-based compensation GAAP to Non-GAAP Reconciliation (in thousands) | Line Item | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net income (GAAP) | $3,734 | $9,935 | | Adjustments: | | | | Gain from change in fair value of warrant liability | $(2,255) | $(4,288) | | Stock-based compensation | $507 | $11 | | Provision for income taxes | $901 | $2,546 | | **Non-GAAP adjusted net income** | **$2,887** | **$8,204** | [Company and Product Overview](index=4&type=section&id=Company%20and%20Product%20Overview) Gyre Therapeutics is a biopharmaceutical company focused on organ fibrosis, developing F351 for MASH-associated fibrosis in the U.S. and commercializing ETUARY® (pirfenidone) in the PRC while advancing a diverse pipeline - F351 (Hydronidone), a structural analogue of pirfenidone, inhibits key pathways in liver fibrosis and is being evaluated in a Phase 3 trial for CHB-associated liver fibrosis in the PRC, with topline data expected in Q2 2025[18](index=18&type=chunk)[20](index=20&type=chunk) - Gyre Pharmaceuticals' flagship product, ETUARY® (pirfenidone), was the first approved IPF treatment in the PRC and generated **$105.8 million** in net sales in 2024[20](index=20&type=chunk) - Gyre Therapeutics' primary focus in the U.S. is the development and commercialization of F351 for MASH-associated fibrosis[21](index=21&type=chunk) [Forward-Looking Statements](index=6&type=section&id=Forward-Looking%20Statements) This section contains a standard "safe harbor" provision, cautioning that forward-looking statements regarding clinical trials, regulatory approvals, commercial launches, and financial performance are subject to significant risks and uncertainties - The press release contains forward-looking statements concerning R&D efforts, clinical trial timing, commercial launches, and financial position, which are subject to substantial risks and uncertainties[23](index=23&type=chunk) - Actual results could differ materially from expectations due to various risks, including the ability to execute clinical strategies, unpredictable trial outcomes, regulatory hurdles, competition, and economic conditions[23](index=23&type=chunk)