Gyre Therapeutics, Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Gyre Therapeutics, Inc. filed its 2023 10-K report, detailing its financial performance and corporate history, including previous name changes.</b>

AI Summary

GYRE THERAPEUTICS, INC. (GYRE) filed a Annual Report (10-K) with the SEC on March 27, 2024. Gyre Therapeutics, Inc. (formerly Catalyst Biosciences, Inc.) filed its annual report for the fiscal year ending December 31, 2023. The company was formerly known as Catalyst Biosciences, Inc. and Targacept Inc. The filing covers the period from January 1, 2023, to December 31, 2023. Key dates mentioned include October 27, 2023, and October 31, 2023, related to Convertible Preferred Stock. The company's business address is 12770 High Bluff Drive, Suite 150, San Diego, CA 92130.

Why It Matters

For investors and stakeholders tracking GYRE THERAPEUTICS, INC., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Gyre Therapeutics' financial health and operational status for the fiscal year 2023, crucial for investors assessing the company's current standing. The report's historical information, including previous company names and name change dates, offers context on the company's evolution and potential strategic shifts over time.

Risk Assessment

Risk Level: medium — GYRE THERAPEUTICS, INC. shows moderate risk based on this filing. The filing is a standard 10-K, which typically contains a broad range of information, but without specific financial results or forward-looking statements detailed in this snippet, a precise risk assessment is difficult. However, the nature of a 10-K implies ongoing business operations and associated market and regulatory risks.

Analyst Insight

Review the full 10-K filing to understand Gyre Therapeutics' financial performance, strategic initiatives, and risk factors for the fiscal year 2023.

Key Numbers

• 2023-12-31 — Fiscal Year End (Conformed period of report)
• 2024-03-27 — Filing Date (Filed as of date)
• 2015-08-20 — Date of Name Change (Former company name Catalyst Biosciences, Inc.)
• 2000-09-19 — Date of Name Change (Former company name Targacept Inc)

Key Players & Entities

• GYRE THERAPEUTICS, INC. (company) — Filer name
• GYRE (company) — Ticker symbol
• CATALYST BIOSCIENCES, INC. (company) — Former company name
• TARGACEPT INC (company) — Former company name
• 2023-12-31 (date) — Conformed period of report
• 2024-03-27 (date) — Filed as of date
• 20240327 (date) — Date as of change
• SAN DIEGO (location) — Business address city

FAQ

Key Dates

• 2023-12-31: Fiscal Year End — Reporting period for the 10-K
• 2024-03-27: Filing Date — Date the 10-K was filed with the SEC
• 2015-08-20: Name Change — Date Gyre Therapeutics changed from Catalyst Biosciences, Inc.
• 2000-09-19: Name Change — Date Targacept Inc changed its name

Key Financial Figures

• $0.001 — ch registered Common stock, par value $0.001 per share GYRE The Nasdaq Capital M
• $112.1 million — consistently grown each year, reaching $112.1 million in 2023. In addition to IPF, Pirfenidon
• $35,000,000 — 51 Agreement, Catalyst paid the Sellers $35,000,000 in the form of: 6,266,521 shares of Cat
• $0.0001 — shares in the capital of CPI, par value $0.0001 per share to Catalyst (the "CPI Contrib
• $0 — ). The purchase price for each Unit was $0.6165, for an aggregate purchase price o
• $5.0 million — gregate purchase price of approximately $5.0 million. The Private Placement closed on Octobe
• $4,915.00 — ely exercisable at an exercise price of $4,915.00 per share of Convertible Preferred Stoc

Filing Documents

• gyre-20231231.htm (10-K) — 4274KB
• gyre-ex3_6b.htm (EX-3.6(B)) — 12KB
• gyre-ex4_1.htm (EX-4.1) — 43KB
• gyre-ex21_1.htm (EX-21.1) — 9KB
• gyre-ex23_1.htm (EX-23.1) — 4KB
• gyre-ex31_1.htm (EX-31.1) — 14KB
• gyre-ex31_2.htm (EX-31.2) — 14KB
• gyre-ex32_1.htm (EX-32.1) — 8KB
• gyre-ex32_2.htm (EX-32.2) — 8KB
• gyre-ex97_1.htm (EX-97.1) — 32KB
• img98921446_0.jpg (GRAPHIC) — 106KB
• img98921446_1.jpg (GRAPHIC) — 162KB
• img98921446_2.jpg (GRAPHIC) — 2KB
• img98921446_3.jpg (GRAPHIC) — 152KB
• img98921446_4.jpg (GRAPHIC) — 24KB
• img98921446_5.jpg (GRAPHIC) — 110KB
• 0000950170-24-037242.txt (&nbsp;) — 18087KB
• gyre-20231231.xsd (EX-101.SCH) — 2392KB
• gyre-20231231_htm.xml (XML) — 2843KB

Business

Business 5 Item 1A.

Risk Factors

Risk Factors 62 Item 1B. Unresolved Staff Comments 123 Item 1C. Cybersecurity 123 Item 2.

Properties

Properties 124 Item 3.

Legal Proceedings

Legal Proceedings 124 Item 4. Mine Safety Disclosures 124 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 125 Item 6. [Reserved] 125 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 126 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 139 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 140 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 141 Item 9A.

Controls and Procedures

Controls and Procedures 141 Item 9B. Other Information 141 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 142 PART III Item 10. Directors, Executive Officers and Corporate Governance 143 Item 11.

Executive Compensation

Executive Compensation 143 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 143 Item 13. Certain Relationships and Related Transactions and Director Independence 143 Item 14. Principal Accountant Fees and Services 143 PART IV Item 15. Exhibit and Financial Statement Schedules 144 Item 16. Form 10-K Summary 145 LIST OF EXHIBITS 146

SIGNATURES

SIGNATURES 150 1 PART I

Forward-Looking Statements and Market Data

Forward-Looking Statements and Market Data This Annual Report on Form 10-K (this "Annual Report") and the documents incorporated by reference herein contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). All statements, other than statements of historical facts, included or incorporated by reference in this Annual Report regarding our strategy, future results of operations, future financial condition, future revenues, projected costs, prospects, plans, intentions and objectives of management, as well as the assumptions that underlie these statements, are forward-looking statements. These forward-looking statements should not be relied upon as predictions of future events as we cannot assure you that the events or circumstances reflected in these statements will be achieved or will occur. Forward-looking statements are identified by words such as "believes," "expects," "may," "will," "should," "seeks," "intends," "plans," "pro forma," "estimates," or "anticipates" or the negative of these words and phrases or other variations of these words and phrases or comparable terminology, although not all forward-looking statements contain these identifying words. Such forward-looking statements are based on our management's assumptions and assessments in light of information currently available to our management, its experience and its perception of historical trends, current conditions, expected future developments and other factors our management believes to be appropriate. You should read these statements carefully because they discuss future expectations, contain projections of future results of operations or financial condition, or state other "forward-looking" information. These statements relate to our plans, objectives, expectations, intentions and financial performance and the assumptions that und

BU SINESS

Item 1. BU SINESS. In this section, unless otherwise specified, references to "we," "our," "us" and "our company" refer to Gyre Therapeutics, Inc. and our majority indirectly owned subsidiary, Beijing Continent Pharmaceuticals Co., Ltd. (d/b/a Gyre Pharmaceuticals Co., Ltd.) ("Gyre Pharmaceuticals"). Summary We are a financially-sustainable pharmaceutical company with a record of financial success that develops and commercializes 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. Fibrosis involves a complex, multi-stage process with multiple pathways. While there are numerous potential targets for anti-fibrotic therapy, both established and emerging, addressing a single molecular pathway may not be sufficient to prevent, halt, or reverse fibrosis. Our strategy is to use our experience in the successful development and commercialization of ETUARY (Pirfenidone) to expand into new indications and develop similar drug candidates. Pirfenidone, the first anti-fibrotic drug approved for idiopathic pulmonary fibrosis ("IPF") in Japan, the European Union ("EU"), the United States ("U.S."), and the PRC, is a small molecule drug that inhibits the synthesis of Tumor Growth Transforming ("TGF")-1, TNF-, and other fibrosis and inflammation modulators. We have obtained approval for ETUARY (pirfenidone) in the PRC for IPF. Gyre Pharmaceuticals successfully advanced Pirfenidone from research and development ("R&D") to commercialization in the PRC for the treatment of IPF. ETUARY's annual sales have consistently grown each year, reaching $112.1 million in 2023. In addition to IPF, Pirfenidone is undergoing three additional Phase 3 studies for connective tissue disease associated with interstitial lung disease ("CTD-ILD") to broaden its indications and market: SSc-ILD, DM-ILD and pneumoconiosis ("PD"). F351, o

View Full Filing

View this 10-K filing on SEC EDGAR