Organization and Basis of Presentation |
6 Months Ended |
|---|---|
Jun. 30, 2026 | |
| Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
| Organization and Basis of Presentation | 1. Organization and Basis of Presentation The Company Gyre Therapeutics, Inc. (the “Company” or “Gyre”), formerly known as Catalyst Biosciences, Inc. (“Catalyst”), is a commercial-stage biopharmaceutical company originally incorporated in Delaware on March 7, 1997 under the name Targacept, Inc. As of June 30, 2026, the Company holds a 69.7% indirect interest in Beijing Continent Pharmaceuticals Co., Ltd. (d/b/a Gyre Pharmaceuticals Co., Ltd., “Gyre Pharmaceuticals”), a commercial-stage biopharmaceutical company registered and established in the People’s Republic of China (“PRC”) in 2002. The majority shareholder of Gyre is GNI USA, Inc. (“GNI USA”), which is indirectly wholly owned by GNI Group Ltd. (“GNI Japan”). Gyre is a commercial-stage biotechnology company with a proven track record of success in developing and commercializing small-molecule anti-inflammatory and anti-fibrotic drugs targeting organ diseases, focusing specifically on organ fibrosis. Fibrotic diseases represent a large patient population with significant unmet medical needs. On May 4, 2026 (the “Merger Closing Date”), the Company completed the merger (the “Merger”) with Cullgen Inc. (“Cullgen”) pursuant to the Agreement and Plan of Merger and Reorganization (the “Merger Agreement”), dated March 2, 2026, by and among Gyre, Cullgen, and Helix Merger Sub Corp. (“Merger Sub”). Upon consummation of the Merger, Cullgen became a wholly owned subsidiary of Gyre. Cullgen, a biopharmaceutical company dedicated to the development of medicines for the treatment of diseases lacking effective therapeutic approaches, was incorporated in the state of Delaware on January 12, 2018. Liquidity For the six months ended June 30, 2026, the Company had a net loss of $32.8 million, while net cash used in operating activities was $13.5 million. As of June 30, 2026, the Company had an accumulated deficit of $138.0 million and cash and cash equivalents of $43.3 million. Based on the Company’s current operating plan, management believes that existing cash and cash equivalents, cash flows from operations, and access to capital markets will be sufficient to fund the Company’s operating activities and obligations for at least twelve months following the issuance of these condensed consolidated financial statements. Basis of Presentation and Principles of Consolidation The accompanying condensed consolidated financial statements include the accounts of the Company and its controlled subsidiaries after elimination of all intercompany accounts and transactions among consolidated entities. On May 4, 2026, the Company completed the Merger with Cullgen, an entity under common control with the Company through GNI Japan. The Merger has been accounted for as a transaction between entities under common control. Accordingly, the accompanying unaudited condensed consolidated financial statements have been retrospectively recast for all periods presented during which the Company and Cullgen were under common control to reflect the combined financial position, results of operations, changes in stockholders’ equity, and cash flows of the Company and Cullgen as if the common-control transfer had occurred at the beginning of the earliest period presented. For periods prior to the Merger Closing Date, the retrospective recast reflects the common-control transfer of Cullgen to the Company but does not give effect to the Company’s acquisition or exchange of Cullgen ownership interests held by parties other than GNI Japan before the date such interests were acquired or exchanged. Accordingly, Cullgen’s historical equity, net income or loss, and comprehensive income or loss attributable to ownership interests held by parties other than GNI Japan have been presented as noncontrolling interests for periods prior to the Merger Closing Date. Upon completion of the Merger, Cullgen became a wholly owned subsidiary of the Company and the related Cullgen noncontrolling interests were eliminated within equity, with no gain or loss recognized in the condensed consolidated statements of operations or comprehensive income. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) and the requirements of the Securities and Exchange Commission (the “SEC”) for interim reporting. The December 31, 2025 consolidated balance sheet has been derived from the audited consolidated financial statements included in the Annual Report on Form 10-K for the fiscal year ended December 31, 2025, as filed with the SEC, and has been retrospectively recast to reflect the Merger, which was accounted for as a transaction between entities under common control (see Note 2, Summary of Significant Accounting Policies). The retrospective recast reflects a change in reporting entity resulting from a combination of entities under common control and does not represent the correction of an error in previously issued financial statements. As permitted under the SEC’s interim reporting rules, certain footnotes or other financial information that are normally required by GAAP can be condensed or omitted. These unaudited condensed consolidated financial statements have been prepared on the same basis as the Company’s annual consolidated financial statements after giving effect to the retrospective recast described above, and, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments, which are necessary for a fair presentation of the Company’s condensed consolidated financial information. These unaudited condensed consolidated results of operations and cash flows for any interim period are not necessarily indicative of the results to be expected for the year ending December 31, 2026, or for any other future annual or interim period. The accompanying unaudited condensed consolidated financial statements and related financial information should be read in conjunction with the consolidated financial statements filed with the Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC on March 13, 2026 (the “Annual Report”), together with the disclosures included herein regarding the retrospective recast resulting from the Merger. |