WALTHAM, Mass., Nov. 17, 2025 (GLOBE NEWSWIRE) -- Crescent Biopharma, Inc. (“Crescent” or the “Company”) (Nasdaq: CBIO), a biotechnology company dedicated to rapidly advancing the next wave of therapies for cancer patients, today announced that the independent Compensation Committee of its Board of Directors approved the grant of options to purchase an aggregate of 451,448 shares of the Company’s ordinary shares to eight non-executive employees as equity inducement awards under the Crescent Biopharma, Inc. ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q ☐ 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) (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2025 OR Delaware 56-2020050 (State or Other Ju ...

Financial Performance - Net income for Q3 2025 was $5.9 million, doubling from $2.9 million in Q3 2024[20] - Basic EPS improved to $0.04 in Q3 2025, compared to $0.01 in Q3 2024[4] - Net income for the nine months ended September 30, 2025, was $11.2 million, a decrease from $17.3 million in 2024, primarily due to a $5.6 million increase in operating expenses[6] - Non-GAAP adjusted net income for the nine months ended September 30, 2025, was $14.6 million, down from $15.7 million in 2024, mainly due to a $3.3 million increase in operating expenses[6] - Non-GAAP adjusted net income for the nine months ended September 30, 2025, was $14,618 million, slightly down from $15,737 million in the same period of 2024, reflecting a decrease of 7.1%[39] Revenue and Sales - Quarterly revenue reached $30.6 million, a 20% increase year-over-year, driven by growth in ETUARY® and contributions from Etorel® and Contiva®[4] - Sales of ETUARY® for Q3 2025 were $27.7 million, compared to $25.3 million in Q3 2024[7] - Etorel® generated $1.5 million in sales during its first full quarter of launch[7] - Contiva® sales amounted to $1.2 million for Q3 2025[8] - Revenues for the nine months ended September 30, 2025, were $79.4 million, compared to $77.9 million in 2024, reflecting a $1.5 million increase[34] - Gyre Pharmaceuticals' flagship product, ETUARY®, achieved net sales of $105.8 million in 2024, maintaining a prominent market share[28] Expenses and Costs - For the nine months ended September 30, 2025, research and development expenses increased to $8.9 million from $8.3 million in 2024, primarily due to a $1.0 million rise in clinical trial costs[6] - General and administrative expenses rose to $14.1 million for the nine months ended September 30, 2025, compared to $10.6 million in 2024, driven by a $2.8 million increase in personnel and stock compensation costs[6] - Income from operations decreased to $11.4 million for the nine months ended September 30, 2025, down from $15.5 million in 2024, attributed to a $5.6 million increase in total operating expenses[6] - Stock-based compensation expenses increased to $1,147 million in Q3 2025 from $237 million in Q3 2024, marking a rise of 384%[39] Cash and Assets - Cash and cash equivalents totaled $80.3 million as of September 30, 2025, up 57% year-to-date[15] - Cash and cash equivalents increased significantly to $40.4 million as of September 30, 2025, from $11.8 million at the end of 2024[36] - Total assets grew to $159.4 million as of September 30, 2025, compared to $125.4 million at the end of 2024[36] Corporate Developments - The company completed patient enrollment in a 52-week Phase 3 trial for pirfenidone pneumoconiosis with 272 patients across 18 sites[6] - The anticipated U.S. IND filing for Hydronidone is expected in 2026, following the completion of ongoing regulatory interactions[10] - Gyre Therapeutics increased its indirect majority interest in Gyre Pharmaceuticals from 65.2% to 69.7% in Q3 2025 through additional capital contributions[28] Tax and Liabilities - Provision for income taxes for Q3 2025 was $1,693 million, compared to $1,074 million in Q3 2024, indicating an increase of 57.7%[39] - The loss from the change in fair value of warrant liability was $23 million in Q3 2025, a decrease from a gain of $228 million in Q3 2024[39]

Core Insights - Crescent Biopharma is advancing its pipeline of next-generation therapeutics for solid tumors, with significant progress expected in the coming years [2][3] Pipeline Developments - CR-001, a PD-1 x VEGF bispecific antibody, is on track for an IND submission in the fourth quarter of 2025, with a global Phase 1 trial planned to start in early 2026 [1][6] - Preclinical data for CR-001 shows cooperative pharmacology and in vivo anti-tumor activity, with initial clinical data anticipated in the second half of 2026 [2][6] - CR-002 and CR-003, novel antibody-drug conjugates (ADCs), are expected to have an IND submission in mid-2026 [4][2] Financial Performance - As of September 30, 2025, Crescent Biopharma reported a cash position of $133.3 million, which is projected to fund operations through 2027 [5][13] - Research and development expenses for Q3 2025 were $20.3 million, while general and administrative expenses were $5.5 million [5][11] - The net loss for the third quarter of 2025 was $24.6 million, equating to a loss of $1.27 per share [7][11]

WALTHAM, Mass., Nov. 05, 2025 (GLOBE NEWSWIRE) -- Crescent Biopharma, Inc. (“Crescent” or the “Company”) (Nasdaq: CBIO), a biotechnology company dedicated to rapidly advancing the next wave of therapies for cancer patients, today announced that management is scheduled to present at the following investor conferences in November: Guggenheim 2nd Annual Healthcare Innovation Conference, fireside chat on Tuesday, November 11, 2025, at 8:00 a.m. ET in Boston.Stifel 2025 Healthcare Conference, fireside chat on We ...

Core Insights - Crescent Biopharma is advancing CR-001, a PD-1 x VEGF bispecific antibody, with promising preclinical data demonstrating its cooperative pharmacology and robust anti-tumor activity, set to be presented at the SITC Annual Meeting [1][2][3] Group 1: Product Development - CR-001 combines two validated mechanisms in oncology by blocking PD-1 and VEGF, enhancing T-cell activation and reducing tumor blood supply [2][4] - Preclinical studies show CR-001's increased binding to PD-1 in the presence of VEGF, leading to enhanced PD-1/PD-L1 signaling blockade [2][4] - The company plans to initiate a global Phase 1 trial for CR-001 in patients with solid tumors in the first quarter of 2026 [3] Group 2: Clinical Data and Efficacy - CR-001 demonstrated potent anti-tumor activity in xenograft mouse models and was well-tolerated in non-human primates after a single intravenous dose [2][4] - The cooperative mechanism of CR-001 is expected to reduce tumor growth in vivo, positioning it as a next-generation immuno-oncology therapy [3] Group 3: Company Vision and Pipeline - Crescent Biopharma aims to build a leading oncology company with a pipeline that includes CR-001 and novel antibody-drug conjugates (ADCs) [5] - The company focuses on leveraging multiple modalities and established targets to advance transformative therapies for solid tumors [5]

Core Insights - Crescent Biopharma is advancing CR-001, a PD-1 x VEGF bispecific antibody, for the treatment of solid tumors, with IND submission expected in Q4 2025 to initiate a global Phase 1 trial in early 2026 [1][3]. Group 1: Product Development - CR-001 combines two validated mechanisms in oncology by blocking PD-1 and VEGF, demonstrating cooperative pharmacology and enhanced T-cell activation in preclinical studies [2][4]. - Preclinical data indicates CR-001 showed potent anti-tumor activity in xenograft mouse models and was well-tolerated in non-human primates [2][4]. - The upcoming presentation at the Society for Immunotherapy of Cancer's 40th Annual Meeting will detail the preclinical development of CR-001 [3]. Group 2: Competitive Landscape - CR-001's mechanism of action is consistent with ivonescimab, which outperformed pembrolizumab in a Phase 3 trial for non-small cell lung cancer, suggesting potential competitive advantages [2][4]. - The anti-VEGF activity of CR-001 may normalize tumor vasculature, potentially enhancing the effectiveness of combination therapies with other antibody-drug conjugates in development [4]. Group 3: Company Vision - Crescent Biopharma aims to establish itself as a leading oncology company by developing transformative therapies for cancer patients, leveraging multiple modalities and established targets [5].

Pipeline and Programs - Crescent Biopharma is developing CR-001, a PD-1 x VEGF bispecific antibody with the same mechanism of action (MoA) as ivonescimab, with an IND expected in 4Q25[7, 9] - CR-002 and CR-003 are Antibody-Drug Conjugates (ADCs) with topoisomerase inhibitor payloads, targeting undisclosed solid tumor targets, with CR-002's IND expected in mid-2026[7, 9] - CR-001 is designed to reproduce ivonescimab's established pharmacology and has the potential to move to frontline use in the $50 billion+ PD-(L)1 immunotherapy market[9] Market and Clinical Data - The anti-PD-(L)1 global sales reached $50 billion in 2024, with Keytruda leading with approximately $30 billion in revenue across 20+ oncology indications[9, 25, 26] - Ivonescimab demonstrated superiority in Progression-Free Survival (PFS) over pembrolizumab in a Phase 3 Non-Small Cell Lung Cancer (NSCLC) trial, with a PFS Hazard Ratio (HR) of 0.51[27, 28] - Ivonescimab at 9 months showed 56% progression-free survival compared to pembrolizumab's 40%[28] Financial and Corporate - Crescent Biopharma was launched with assets discovered and developed by Paragon Therapeutics, which was founded by Fairmount Funds in 2021[8] - Prior companies founded using Paragon's antibody technology have collectively raised >$2 billion[8] - Current cash is expected to fund operations through 2027, supporting key milestones such as the CR-001 IND in 4Q25 and initial clinical data in 2H26[3, 97]

Core Insights - Crescent Biopharma, Inc. is focused on advancing innovative therapies for cancer patients, with a pipeline that includes a PD-1 x VEGF bispecific antibody and novel antibody-drug conjugates [2] Company Overview - Crescent Biopharma aims to become a leading oncology company by developing transformative therapies for solid tumors, utilizing multiple modalities and established targets [2] Upcoming Events - The company will present at the Cantor Global Healthcare Conference on September 4, 2025, and at the Morgan Stanley Annual Global Healthcare Conference on September 8, 2025 [3]

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].