GYRE THERAPEUTICS, INC.

Gyre Therapeutics, Inc. (GYRE) announced on June 1, 2026, that it made available an updated corporate presentation. The presentation details the company's pipeline, which includes marketed products like ETUARY™ (pirfenidone) and drug candidates such as F351 (hydronidone) for liver fibrosis, with an NDA accepted by China's NMPA. It also highlights advancements in targeted protein degraders for cancer and inflammatory diseases, including a CDK2-Cyclin E degrader with an anticipated IND in Q1 2027, and a TYK2-JAK1 degrader. Furthermore, Gyre is advancing Degrader-Antibody Conjugates (DACs) as a next-generation therapeutic platform and emphasizes the strategic advantages of its China-based operations for drug discovery and development.

GYRE Therapeutics, Inc. announced it will present data on its CDK2-Cyclin E degrader, CG923308, at a scientific conference in Shanghai, China, on May 15, 2026. The presentation highlights CG923308's potential for treating solid tumors with CCNE1 amplification and CDK4/6i-resistant HR+/HER2- breast cancers, showing superior preclinical efficacy. The company, which recently acquired Cullgen, anticipates submitting an Investigational New Drug (IND) application for CG923308 in the first quarter of 2027.

Gyre Therapeutics announced that its majority indirectly owned subsidiary, Gyre Pharmaceuticals Co., Ltd., received notification of acceptance of its New Drug Application (NDA) from China's National Medical Products Administration (NMPA) for F351 (Hydronidone). This lead product candidate is intended for the treatment of chronic hepatitis B-induced liver fibrosis. The acceptance follows a priority review status granted in March and represents a significant milestone towards commercialization for a large patient population in China.

Gyre Therapeutics announced the acquisition of Cullgen Inc. on May 4, 2026, a significant strategic move. For the first quarter of 2026, the company reported a net loss attributable to common stockholders of $(8.69) million, a shift from a net income of $2.70 million in the prior year period, despite a 2.1% increase in revenues to $22.52 million. The loss was primarily driven by substantial increases in research and development, selling and marketing expenses, and $2.55 million in merger-related transaction costs. However, the company generated $3.18 million in net cash from operating activities, improving from a cash outflow in the previous year.

Gyre Therapeutics announced its first quarter 2026 financial results and provided a business update. The company reported $22.5 million in revenue and a GAAP basic EPS of $(0.10) for the quarter, compared to $22.1 million revenue and $0.03 EPS in the prior year. Gyre affirmed its full-year 2026 revenue guidance of $100.5 million to $111.0 million. A significant corporate development was the completion of the approximately $300 million all-stock acquisition of Cullgen Inc. in May 2026, expanding Gyre's pipeline into inflammatory diseases and cancers. Additionally, the company submitted an NDA for F351 in China, which received priority review, and initiated a Phase 2/3 trial for ETUARYTM.

Gyre Therapeutics reported Q1 2026 revenue of $22.5 million and a GAAP basic EPS of $(0.10), with a net loss of $9.9 million compared to a net income of $3.7 million in Q1 2025. The company affirmed its full-year 2026 revenue guidance of $100.5 million to $111.0 million. Key strategic developments include the submission of an NDA for F351 (hydronidone) for CHB-associated liver fibrosis to China’s CDE in March 2026, which received priority review. Additionally, Gyre completed the acquisition of Cullgen in an approximately $300 million all-stock transaction, expanding its pipeline into inflammatory diseases and cancers. The first patient was also enrolled in a Phase 2/3 trial for ETUARY™ for radiation-induced lung injury.

Gyre Therapeutics, Inc. announced the completion of its previously announced all-stock acquisition of Cullgen Inc., valued at approximately $300 million. Cullgen now operates as a wholly owned subsidiary of Gyre, creating a U.S.- and China-based fully integrated biopharmaceutical company. The combined entity boasts a revenue-producing commercial asset, ETUARY®, and a robust pipeline of products and candidates, including targeted protein degraders and degrader-antibody conjugates. Dr. Ying Luo, former CEO of Cullgen, has been appointed President and CEO of Gyre, which will continue to trade on Nasdaq under the ticker "GYRE".

Gyre Therapeutics, Inc. announced the closing of its all-stock acquisition of Cullgen Inc., valued at approximately $300 million. Following the transaction, Cullgen became a wholly owned subsidiary, and Dr. Ying Luo, former Cullgen CEO, was appointed President and Chief Executive Officer of Gyre. The combined entity now boasts a revenue-producing commercial asset, ETUARY®, and a robust pipeline focused on fibrosis and inflammatory diseases, including F351 which recently received priority review status in China.

Gyre Therapeutics, Inc. will hold its 2026 Annual Meeting of Stockholders on June 10, 2026, to vote on several key proposals. These include the election of two Class II directors, an advisory vote on executive compensation, and the ratification of Grant Thornton as the independent auditor. Most notably, shareholders will vote on the issuance of common stock related to the conversion of Series B Convertible Preferred Stock, which is part of the previously announced all-stock acquisition of Cullgen Inc. for approximately $300 million. Upon the merger's closing, Cullgen's CEO, Ying Luo, Ph.D., will become GYRE's CEO and President.

GYRE Therapeutics, Inc. announced its 2026 Annual Meeting of Stockholders will be held virtually on June 10, 2026. Stockholders will vote on several proposals, including the election of two Class II director nominees, an advisory vote on executive compensation, and the ratification of Grant Thornton as the independent auditor. A key proposal involves approving the issuance of common stock for the conversion of Series B Preferred Stock, related to the previously announced $300 million all-stock acquisition of Cullgen Inc. The company also detailed board changes contingent on the merger's closing, including the appointment of Cullgen's CEO, Ying Luo, as GYRE's new CEO and President.