GYRE

EX-99.1

3 ef20077460_ex99-1.htm

EXHIBIT 99.1

Exhibit 99.1

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Shareholders and the Board of Directors of Cullgen Inc.

Opinion on the Financial Statements

We have audited the accompanying consolidated balance sheet of Cullgen Inc. (the Company) as of December 31, 2025, the related consolidated statements of comprehensive loss, redeemable convertible preferred stock and stockholders’ deficit and cash flows for the year then ended, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2025, and the results of its operations and its cash flows for the year then ended, in conformity with U.S. generally accepted accounting principles.

Basis for Opinion

These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.

Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.

/s/ Ernst & Young Hua Ming LLP

We have served as the Company’s auditor since 2025.

Shanghai, the People’s Republic of China

July 15, 2026

1

INDEX TO CULLGEN’S CONSOLIDATED FINANCIAL STATEMENTS

Page

Consolidated Balance Sheet as of December 31, 2025

3

Consolidated Statement of Comprehensive Loss for the Year Ended December 31, 2025

4

Consolidated Statement of Changes in Redeemable Convertible Preferred Stock and Stockholders’ Deficit for the Year Ended December 31, 2025

5

Consolidated Statement of Cash Flows for the Year Ended December 31, 2025

6

Notes to audited Consolidated Financial Statement for the Year Ended December 31, 2025

7

2

Index

Cullgen Inc.

Consolidated Balance Sheet

(in thousands, except share and per share data)

December 31,

2025

Assets

Current assets:

Cash and cash equivalents

$

12,122

Short-term investments

28,085

Prepaid expenses and other current assets

6,786

Amounts due from related parties

-

Total current assets

46,993

Non-current assets:

Property and equipment, net

3,951

Operating lease right-of-use assets

2,478

Other non-current assets

209

Total non-current assets

6,638

Total assets

$

53,631

Liabilities, redeemable convertible preferred stock, and stockholders’ deficit

Current liabilities:

Accounts payable

$

1,211

Accrued expenses and other current liabilities

2,633

Operating lease liabilities, current

483

Deferred revenue, current

1,170

Total current liabilities

5,497

Non-current liabilities:

Operating lease liabilities, non-current

2,001

Deferred revenue, non-current

57

Total non-current liabilities

2,058

Total liabilities

7,555

Commitments and contingencies (Note 15)

Redeemable convertible preferred stock, $0.0001 par value per share, 57,821,355 shares authorized, 57,821,355 shares issued and outstanding as of December 31, 2025; aggregate liquidation preference of $116,000 as of December 31, 2025.

173,467

Stockholders’ deficit:

Common stock, $0.0001 par value per share, 143,329,269 shares authorized, 10,023,615 shares issued and outstanding as of December 31, 2025

1

Additional paid-in capital

5,127

Accumulated deficit

(132,179

)

Accumulated other comprehensive loss

(340

)

Total stockholders’ deficit

(127,391

)

Total liabilities, redeemable convertible pref

EX-99.1

2 gyre-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

Gyre Therapeutics Reports First Quarter 2026 Results and Provides Business Update

Q1 2026 revenue of $22.5 million; GAAP basic EPS: $(0.10)

Full year 2026 revenue guidance of $100.5 to $111.0 million affirmed

NDA for F351 (hydronidone) for CHB-associated liver fibrosis submitted to China’s CDE in March 2026

Completed acquisition of Cullgen in an approximately $300 million all-stock transaction, expanding pipeline into inflammatory diseases and cancers

First patient enrolled in Phase 2/3 trial evaluating ETUARYTM for radiation-induced lung injury, including immune-related pneumonitis

SAN DIEGO, May 7, 2026 (GLOBE NEWSWIRE) -- Gyre Therapeutics, Inc. (Gyre, the Company or Gyre Therapeutics) (Nasdaq: GYRE), an innovative, commercial stage biopharmaceutical company with operations in the United States and China, today announced financial results for the first quarter ended March 31, 2026, and provided a business update.

“Building on our successful pre-NDA meeting with China’s CDE at the beginning of the year, we are particularly encouraged by the NMPA’s priority review designation for F351, reinforcing both the strength of our clinical data and the significant unmet need in liver fibrosis,” said Ying Luo, Chief Executive Officer of Gyre Therapeutics. “In parallel, our acquisition of Cullgen expands our capabilities into targeted protein degradation, positioning Gyre to drive long-term innovation beyond fibrosis. We believe these achievements strengthen our foundation as a fully integrated, multi-national biopharmaceutical company as we advance our mission to deliver transformative therapies to patients worldwide.”

First Quarter Business Highlights and Upcoming Milestones

Commercial Products:

ETUARYTM (pirfenidone), the Company's primary product, generated $21.0 million in sales for the quarter ended March 31, 2026, compared to $21.7 million for the same period in 2025. EtorelTM (nintedanib ethanesulfonate soft capsules), which was launched in June 2025, generated $0.7 million in sales for the quarter ended March 31, 2026. ContivaTM (avatrombopag maleate tablets), launched in March 2025, generated $0.8 million in sales for the quarter ended March 31, 2026, compared to $0.3 million for the same period in 2025.

1

Pipeline Development Updates

Hydronidone (F351):

In March 2026, Gyre announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) granted priority review designation to F351 for the treatment of chronic hepatitis B (CHB)-associated liver fibrosis. Subsequently, Gyre, through its majority-owned subsidiary Gyre Pharmaceuticals Co., Ltd., submitted a New Drug Application (NDA) to the CDE to seek conditional approval for this indication, which is currently under completeness review for acceptance.

Pirfenidone (ETUARYTM):

A Phase 3 trial of pirfenidone for the treatment of pneumoconiosis (PD) in the People's Republic of China (PRC) completed enrollment in 2025. A total of 272 patients were enrolled evaluating the efficacy and safety of 52 weeks of pirfenidone capsule treatment in patients with PD versus placebo. The final patient is expected to complete the study in the third quarter of 2026.

In April 2026, Gyre initiated its adaptive Phase 2/3 clinical trial in oncology-related pulmonary complications, with the first patient enrolled. The trial is evaluating pirfenidone for radiation-induced lung injury (RILI), including cases complicated by immune-related pneumonitis, at leading oncology centers.

Corporate Updates:

• In March 2026, Gyre announced its acquisition of Cullgen Inc., a clinical-stage biopharmaceutical company, to create a fully integrated biopharmaceutical company with U.S.- and China-based capabilities. The transaction was completed in May 2026. The acquisition will supplement Gyre’s fibrosis-focused pipeline with novel targeted protein degrader and degrader antibody conjugate product candidates designed to eliminate therapeutically relevant proteins in patients for the treatment of critical conditions including inflammatory diseases and cancers.

• Concurrent with the acquisition of Cullgen, Gyre is undertaking a comprehensive evaluation of its pipeline and clinical development strategy to prioritize programs across the combined organization. The Company intends to provide further updates regarding its strategic direction upon completion of this evaluation.

Financial Results

Cash Position

As of March 31, 2026, Gyre held $37.5 million in cash and cash equivalents, $12.3 million in short-term bank deposits, and $29.4 million in long-term certificates of deposit, totaling $79.2 million. Compared to $75.9 million as of December 31, 2025, total cash increased by $3.3 million, or 4%, primarily driven by higher customer collections and reduced tax payments.

2

Financial Results for the Three Months Ended March 31, 2026

• Revenues: Revenues for the three months ended Marc

8-K

false0001124105March 12, 202600011241052026-03-122026-03-12

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of report (Date of earliest event reported): March 12, 2026

Gyre Therapeutics, Inc. (Exact name of registrant as specified in its charter)

Delaware

000-51173

56-2020050

(State or other jurisdiction of incorporation)

(Commission File Number)

(IRS Employer Identification No.)

12770 High Bluff Drive Suite 150 San Diego, CA

92130

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (858) 567-7770

N/A (Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock

GYRE

The Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02. Results of Operations and Financial Condition.

On March 12, 2026, Gyre Therapeutics, Inc. issued a press release announcing its financial results for the fourth quarter and year ended December 31, 2025 and other matters described. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

As provided in General Instruction B.2 of Form 8-K, the information in this Item 2.02 and Exhibit 99.1 incorporated herein shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall such information or Exhibit 99.1 be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

Item 9.01. Financial Statements and Exhibits. (d) Exhibits. The following exhibits are being furnished herewith:

Exhibit Number

Exhibit Title or Description

99.1

Press Release, dated March 12, 2026

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURE

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: March 12, 2026

By:

/s/ Ping Zhang

Name:

Ping Zhang

Title:

Executive Chairman and Interim Chief Executive Officer