Gyre Therapeutics Inc Stock Price, News & Analysis

Gyre Therapeutics (NASDAQ: GYRE) has announced the pricing of its public offering of 2,222,222 shares of common stock at $9.00 per share, aiming to raise approximately $20.0 million in gross proceeds. The underwriters have a 30-day option to purchase up to an additional 333,333 shares. The offering is expected to close around May 27, 2025.

The biotechnology company plans to use the proceeds to advance its Phase 2 clinical trial of F351 in MASH-associated liver fibrosis in the United States, fund research and development, manufacturing scale-up, and support working capital needs. Jefferies is serving as the lead book-running manager, with H.C. Wainwright & Co. as co-manager for the offering.

- Commercial launch of avatrombopag in March 2025 for thrombocytopenia - Upcoming nintedanib launch in May 2025 for fibrosing interstitial lung disease - NMPA approval for pirfenidone clinical trial in radiation-induced lung injury - Database lock achieved for Phase 3 Hydronidone trial in Chronic Hepatitis B

The company's flagship product ETUARY® (pirfenidone) generated $21.7 million in Q1 sales, maintaining market leadership in IPF treatment despite year-over-year decline. Gyre maintains a strong financial position with $51.3 million in cash and equivalents as of March 31, 2025, which is expected to fund operations for the next 12 months.

Gyre Therapeutics (GYRE) has received NMPA approval in China for a clinical trial evaluating pirfenidone capsules in treating oncology-related pulmonary complications. The study will focus on radiation-induced lung injury (RILI) and checkpoint inhibitor pneumonitis (CIP).

The company plans to conduct an adaptive Phase 2/3 trial to assess pirfenidone's effectiveness beyond its current use in idiopathic pulmonary fibrosis. This expansion targets significant unmet needs, as 5-25% of radiation therapy patients experience lung damage, while 13-19% of patients on immune checkpoint inhibitors develop CIP, accounting for 35% of immune-related adverse event deaths.

The trial is scheduled to begin in the second half of 2025 at leading academic and oncology centers across China. This initiative aims to provide an alternative to corticosteroids, the current standard treatment which has significant long-term side effects.

Gyre Therapeutics (GYRE) has published the protocol for its Phase 3 trial of hydronidone (F351) in the Journal of Clinical and Translational Hepatology. The trial evaluates the treatment of liver fibrosis in patients with chronic hepatitis B (CHB).

The randomized, double-blind, placebo-controlled multicenter study has completed enrollment of 248 patients across 44 clinical research hospitals in China. Patients were divided equally between F351 and placebo groups, with both receiving entecavir antiviral basic therapy for CHB. The primary endpoint measures the decrease in liver fibrosis by at least one stage after 52 weeks using the Ishak Scoring System.

The drug received 'Breakthrough Therapy' designation from China's NMPA in 2021. Topline results are expected in Q2 2025.

Gyre Therapeutics (NASDAQ: GYRE) reported its Q4 and full year 2024 financial results, highlighting key developments in both commercial and clinical portfolios. The company generated $105.8 million in revenue for 2024, down from $113.5 million in 2023, primarily due to decreased ETUARY sales.

Key highlights include:

• Pivotal Phase 3 trial data in CHB-associated liver fibrosis expected in Q2 2025
• Planned commercial launch of nintedanib for IPF and avatrombopag for CLD-associated thrombocytopenia in 2025
• Full year 2025 revenue guidance of $118-128 million, projecting 11.3-20.8% growth
• Cash position of $51.2 million as of December 31, 2024

For Q4 2024, the company reported net income of $0.6 million, compared to a $101.0 million loss in Q4 2023. Full-year 2024 net income was $17.9 million, versus an $85.5 million loss in 2023.

Gyre Therapeutics (NASDAQ: GYRE) announced significant changes to its Board of Directors. Ping Zhang has been appointed as the lead independent director and will serve on the Nominating and Corporate Governance Committee. Zhang, currently Managing Partner at String Capital Management, brings extensive financial experience from roles at AEON Life Insurance, Japan Asia Investment, AEA Investors, and Mitsubishi UFJ Securities.

Concurrent with Zhang's appointment, Ying Luo, Ph.D. has stepped down as Chairman and Board member of both Gyre and Gyre Pharmaceuticals to focus on responsibilities at GNI Group Songjiang Ma has been appointed as the new Chairman of Gyre Pharmaceuticals, the company's majority-owned subsidiary in China.