Gyre Therapeutics Files 8-K with Financials and Exhibits

TL;DR

Gyre Therapeutics (GYRE) filed an 8-K today with financials and exhibits. No major news, just routine updates.

AI Summary

On May 30, 2024, Gyre Therapeutics, Inc. filed an 8-K report. The filing primarily concerns financial statements and exhibits, along with other events and a Regulation FD disclosure. The company was formerly known as Catalyst Biosciences, Inc. and Targacept Inc.

Why It Matters

This filing provides updated financial information and disclosures for Gyre Therapeutics, Inc., which is important for investors to assess the company's current financial health and operational status.

Risk Assessment

Risk Level: low — The filing is a routine 8-K report detailing financial statements and exhibits, with no indication of significant new risks or material adverse events.

Key Players & Entities

• GYRE THERAPEUTICS, INC. (company) — Registrant
• CATALYST BIOSCIENCES, INC. (company) — Former company name
• TARGACEPT INC (company) — Former company name
• 20150820 (date) — Date of name change from Catalyst Biosciences, Inc.
• 20000919 (date) — Date of name change from Targacept Inc
• May 30, 2024 (date) — Date of report

FAQ

Filing Documents

• ef20030279-8k.htm (8-K) — 33KB
• ef20030279_ex99-1.htm (EX-99.1) — 9KB
• logo.jpg (GRAPHIC) — 4KB
• 0001140361-24-028106.txt ( ) — 186KB
• gyre-20240530.xsd (EX-101.SCH) — 4KB
• gyre-20240530_lab.xml (EX-101.LAB) — 21KB
• gyre-20240530_pre.xml (EX-101.PRE) — 16KB
• ef20030279-8k_htm.xml (XML) — 4KB

01

Item 7.01. Regulation FD Disclosure. On May 30, 2024, Gyre Therapeutics, Inc., a Delaware corporation (the "Company"), issued a press release announcing that Gyre Pharmaceuticals Co., Ltd., a company organized under the laws of the People's Republic of China ("Gyre Pharmaceuticals"), which is the Company's majority indirectly owned subsidiary, has received approval from the Center for Drug Evaluation ("CDE") of the People's Republic of China's National Medical Products Administration ("NMPA") for its Investigational New Drug ("IND") application for F230 tablets, a selective endothelin receptor antagonist, for the treatment of pulmonary arterial hypertension ("PAH"). A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein. The exhibit furnished under Item 7.01 of this Current Report on Form 8-K shall not be deemed to be "filed" for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act, regardless of any general incorporation language in such filing.

01

Item 8.01. Other Events. On May 30, 2024, the CDE of the NMPA approved Gyre Pharmaceuticals' IND application for F230 tablets, a selective endothelin receptor antagonist, for the treatment of PAH. In addition to PAH, the Company is also exploring other disease indications for F230.

Forward-Looking Statements

Forward-Looking Statements This Current Report on Form 8-K and the press release furnished as Exhibit 99.1 contain "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this Current Report on Form 8-K and the press release furnished as Exhibit 99.1, including statements concerning expectations regarding Gyre Pharmaceuticals' research and development efforts, including the clinical development of F230 for the treatment of PAH and other disease indications, and statements regarding the therapeutic potential and utility, efficacy and clinical benefits of F230, are forward-looking statements. In some cases, you can identify forward-looking intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this Current Report on Form 8-K. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this Current Report on Form 8-K. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. Additional risks and factors are identified under "Risk Factors" in the Company's Annual Report on Form 10-K filed on March 27, 2024 and subsequent reports filed with the Securities and Exchange Commission.

Financial Statements and Exhibits

Financial Statements and Exhibits. (d) Exhibits . The following exhibits are being furnished herewith: Exhibit Number Exhibit Title or Description 99.1 Press Release, dated May 30, 2024 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. GYRE THERAPEUTICS, INC. Date: May 30, 2024 By: /s/ Ruoyu Chen Name: Ruoyu Chen Title: Chief Financial Officer

View Full Filing

View this 8-K filing on SEC EDGAR