GYRE Gyre Therapeutics Inc

 

 

 

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 17, 2025

 

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. ☐

 

 

 

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Item 2.02. Results of Operations and Financial Condition.

 

On March 17, 2025, Gyre Therapeutics, Inc. issued a press release announcing its financial results for the fourth quarter and year ended December 31, 2024 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 17, 2025
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

 

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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 17, 2025	By:	/s/ Han Ying, Ph.D.
	Name:	Han Ying, Ph.D.
	Title:	Chief Executive Officer

 

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Exhibit 99.1

Gyre Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update

Data from pivotal Phase 3 trial in CHB-associated liver fibrosis expected in Q2 2025

Commercial launch in the PRC of generic nintedanib for the treatment of IPF and avatrombopag maleate tablets for the treatment of CLD-associated thrombocytopenia expected in 2025

Initiation of U.S. Phase 2 trial of F351 in MASH-associated liver fibrosis expected in 2025

Full year 2025 total revenue guidance of $118 to $128 million

 

SAN DIEGO, March 17, 2025 (GLOBE NEWSWIRE) – Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), a self-sustainable, commercial-stage biotechnology company with clinical development programs focusing on organ fibrosis, today announced financial results for the fourth quarter and full year ended December 31, 2024 and provided a business update.

“2025 is shaping up to be a pivotal year for Gyre across both our commercial-stage and clinical-stage portfolios. We plan to expand and enhance our commercial product offerings through the additions of nintedanib for IPF, SSc-ILD and PF-ILD, as well as avatrombopag for CLD-associated thrombocytopenia and chronic idiopathic thrombocytopenia (“ITP”). Given our proven track record and extensive sales and marketing platform, we are confident in our ability to successfully launch and expand these two products in the PRC,” said Han Ying, Ph.D., Chief Executive Officer of Gyre Therapeutics. “In parallel, we expect to share topline data from our pivotal Phase 3 trial in CHB-associated liver fibrosis in the second quarter of 2025, which will help inform our U.S. Phase 2 proof-of-concept trial of F351 in MASH-associated liver fibrosis.”

Full Year 2024 Business Highlights and Upcoming Milestones

 

Commercial-Stage Updates

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Pipeline Development Updates

F351 (Hydronidone):

F573:

F230:

F528:

 

Corporate Updates

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Financial Results

Cash Position

As of December 31, 2024, Gyre had cash, cash equivalents, short-term and long-term bank deposits of $51.2 million.

 

Financial Results for the Three Months Ended December 31, 2024

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Financial Results for the Full Year Ended December 31, 2024

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Full Year 2025 Financial Guidance

For the full year 2025, the Company expects to generate revenues of $118 to $128 million, representing growth of 11.3% to 20.8% over 2024 revenue, primarily driven by the anticipated commercial launches of nintedanib and avatrombopag and sales of ETUARY.

Guidance Range

Total Revenue $118 to $128 million

Please note the following regarding the total revenue guidance:

 

 

Use of Non-GAAP Financial Measures by Gyre Therapeutics, Inc.

Gyre reports financial results in accordance with accounting principles generally accepted in the United States (“GAAP”). This release presents the financial measure “adjusted net income,” which is not calculated in accordance with GAAP. The most directly comparable GAAP measure for this non-GAAP financial measure is “net income.” Adjusted net income presents Gyre’s results of operations after excluding gain from change in fair value of warrants, stock-based compensation, and provision

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for income taxes. This is meant to supplement, and not substitute, Gyre’s financial information presented in accordance with GAAP. Adjusted net income as defined by Gyre may not be comparable to similar non-GAAP measures presented by other companies. Management believes that presenting adjusted net income provides investors with additional useful information in evaluating the Gyre’s performance and valuation. See the reconciliation of adjusted net income to net income in the section titled “Reconciliation of GAAP to Non-GAAP Financial Measures” below.

About Hydronidone (F351)

F351 is a structural analogue of the approved anti-fibrotic (IPF) drug Pirfenidone and has been shown to inhibit in vitro both p38γ kinase activity and TGF-β1-induced excessive collagen synthesis in hepatic stellate cells (“HSCs”), which are recognized as critical event in the development and progression of fibrosis in the liver. This is further supported by its anti-proliferative effects on the HSCs in the liver. In vitro anti-fibrotic effects of F351 were also confirmed in several established in vivo models of liver fibrosis such as CCI4-induced liver fibrosis mouse model, DMN-induced liver fibrosis rat model, and HSA-induced liver rat model, as well as mouse model of MASH fibrosis (CCI4+Western High Fat Diet).

About Gyre Pharmaceuticals

Gyre Pharmaceuticals is a commercial-stage biopharmaceutical company committed to the research, development, manufacturing and commercialization of innovative drugs for organ fibrosis. Its flagship product, ETUARY® (Pirfenidone capsule), was the first approved treatment for IPF in the PRC in 2011 and has maintained a prominent market share (2024 net sales of $105.0 million). In addition, Gyre Pharmaceuticals is evaluating F351 in a Phase 3 clinical trial in CHB-associated liver fibrosis in the PRC, which is expected to readout topline data by Q2 2025. F351 received Breakthrough Therapy designation by the NMPA Center for Drug Evaluation in March 2021. Gyre Pharmaceuticals is also developing treatments for PD, DKD, COPD, PAH and ALF/ACLF. In October 2023, Gyre Therapeutics acquired an indirect majority interest in Gyre Pharmaceuticals (also known as Beijing Continent Pharmaceuticals Co., Ltd.).

About Gyre Therapeutics

Gyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, with a primary focus on the development and commercialization of F351 (Hydronidone) for the treatment of MASH-associated fibrosis in the U.S. Gyre’s development strategy for F351 in MASH is based on the company's experience in MASH rodent model mechanistic studies and CHB-induced liver fibrosis clinical studies. Gyre is also advancing a diverse pipeline in the PRC through its indirect controlling interest in Gyre Pharmaceuticals, including ETUARY therapeutic expansions, F573, F528, and F230.

Forward-Looking Statements

This press release contains “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 press release, are forward-looking statements, including statements concerning: the expectations regarding Gyre’s research and development

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efforts, timing of expected clinical readouts, including timing of topline data from Gyre Pharmaceuticals’ Phase 3 clinical trial evaluating F351 for the treatment of CHB-associated liver fibrosis in the PRC, initiation of Gyre’s Phase 2 trial in the U.S. for F351 for the treatment of MASH-associated liver fibrosis, timing of completion of Gyre’s Phase 2 clinical trial in the PRC of F573 for ALF/ACLF, initiation of Phase 1 trial of F230 for the treatment of PAH and IND submission of F528 in COPD, the expectations regarding commercial launch of nintedanib and avatrombopag maleate tablets, interactions with regulators, expectations regarding future product sales, and Gyre’s financial position and cash resources. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. 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 press release. 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, which include, without limitation: Gyre’s ability to execute on its clinical development strategies; positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; the timing or likelihood of regulatory filings and approvals; competition from competing products; the impact of general economic, health, industrial or political conditions in the United States or internationally; the sufficiency of Gyre’s capital resources and its ability to raise additional capital. Additional risks and factors are identified under “Risk Factors” in Gyre’s Annual Report on Form 10-K for the year ended December 31, 2023 filed on March 27, 2024 and in other filings with the Securities and Exchange Commission.

Gyre expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.

 

 

For Investors:
Stephen Jasper
stephen@gilmartinir.com

 

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Gyre Therapeutics, Inc.

Consolidated Statements of Operations

(In thousands, except share and per share amounts)

 

		Three Months Ended December 31, (Unaudited)								Year Ended December 31,
		2024				2023				2024				2023
Revenues		$	27,872			$	27,148			$	105,757			$	113,450
Operating expenses:
Cost of revenues			1,177				1,250				3,884				4,636
Selling and marketing			16,856				16,464				57,511				61,159
Research and development			3,712				4,568				12,024				13,780
General and administrative			5,464				10,055				16,109				14,662
Acquired in-process research and development			—				83,104				—				83,104
Divestiture losses			—				2,711				—				2,711
Loss on disposal of property and equipment			(2	)			102				66				628
Total operating expenses			27,207				118,254				89,594				180,680
Income (loss) from operations			665				(91,106	)			16,163				(67,230	)
Other income (expense), net:
Interest income, net			346				326				1,547				1,044
Other expense, net			(433	)			(237	)			(1,659	)			(1,518	)
Change in fair value of warrant liability			194				(9,261	)			7,167				(9,261	)
Income (loss) before income taxes			772				(100,278	)			23,218				(76,965	)
Provision for income taxes			(203	)			(699	)			(5,320	)			(8,515	)
Net income (loss)			569				(100,977	)			17,898				(85,480	)
Net income attributable to noncontrolling interest			668				29				5,813				7,453
Net income (loss) attributable to common stockholders		$	(99	)		$	(101,006	)		$	12,085			$	(92,933	)
Net income (loss) per share attributable to common stockholders:
Basic		$	(0.00	)		$	(1.39	)		$	0.14			$	(1.41	)
Diluted		$	(0.00	)		$	(1.39	)		$	0.05			$	(1.41	)
Weighted average shares used in calculating net income (loss) per share attributable to common stockholders:
Basic			85,952,413				72,489,183				85,094,948				65,831,675
Diluted			85,952,413				72,489,183				102,293,526				65,831,675

 

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Gyre Therapeutics, Inc.

Consolidated Balance Sheets

(In thousands, except share and per share amounts)

 

		December 31, 2024				December 31, 2023
Assets
Current assets:
Cash and cash equivalents		$	11,813			$	33,509
Short-term bank deposits			14,858				—
Notes receivable			4,373				389
Accounts receivable, net			19,589				15,163
Other receivables from GNI			230				1,287
Inventories, net			6,337				4,281
Prepaid assets			1,189				1,547
Receivable from GCBP			4,961				—
Other current assets			1,436				1,045
Total current assets:			64,786				57,221
Property and equipment, net			23,880				23,288
Long-term receivable from GCBP			—				4,722
Intangible assets, net			273				205
Right-of-use assets			1,818				489
Land use rights, net			1,432				1,493
Deferred tax assets			5,619				4,695
Long-term certificates of deposit			24,568				23,431
Other assets, noncurrent			3,030				995
Total assets		$	125,406			$	116,539
Liabilities, convertible preferred stock, and equity
Current liabilities:
Accounts payable		$	108			$	355
Contract liabilities			61				39
Due to related parties			227				1,369
CVR excess closing cash payable			—				1,085
Accrued expenses and other current liabilities			10,615				11,935
Income tax payable			2,831				5,054
Operating lease liabilities, current			713				210
CVR derivative liability			4,961				—
Total current liabilities:			19,516				20,047
Operating lease liabilities, noncurrent			885				199
Deferred government grants			928				213
CVR derivative liability, noncurrent			—				4,722
Warrant liability, noncurrent			5,668				12,835
Other noncurrent liabilities			7				49
Total liabilities		$	27,004			$	38,065
Commitments and Contingencies
Convertible Preferred Stock, $0.001 par value, 5,000,000 shares authorized; nil shares and 13,151 shares issued and outstanding at December 31, 2024 and 2023, respectively			—				64,525
Equity:
Common stock, $0.001 par value, 400,000,000 shares authorized; 86,307,544 shares and 76,595,616 shares issued and outstanding at December 31, 2024 and 2023, respectively			86				77
Additional paid-in capital			136,185				68,179
Statutory reserve			3,098				3,098
Accumulated deficit			(73,453	)			(85,538	)
Accumulated other comprehensive loss			(2,597	)			(1,644	)
Total Gyre stockholders’ equity (deficit)			63,319				(15,828	)
Noncontrolling interest			35,083				29,777
Total equity			98,402				13,949
Total liabilities, convertible preferred stock, and equity		$	125,406			$	116,539

 

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Gyre Therapeutics, Inc.

Reconciliation of GAAP to Non-GAAP Financial Measures

(in thousands)

(unaudited)

 

	Three Months Ended December 31,								Years Ended December 31,
	2024				2023				2024				2023
Net income (loss)	$	569			$	(100,977	)		$	17,898			$	(85,480	)
Acquired in-process research and development (1)		—				83,104				—				83,104
(Gain) loss from change in fair value of warrants (2)		(194	)			9,261				(7,167	)			9,261
Stock-based compensation		567				7,281				831				7,281
Divestiture losses (3)		—				2,711				—				2,711
Provision for income taxes		203				699				5,320				8,515
Non-GAAP adjusted net income	$	1,145			$	2,079			$	16,882			$	25,392

 

 

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v3.25.1

Document and Entity Information	Mar. 17, 2025
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Mar. 17, 2025
Entity File Number	000-51173
Entity Registrant Name	Gyre Therapeutics, Inc.
Entity Central Index Key	0001124105
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	56-2020050
Entity Address, Address Line One	12770 High Bluff Drive
Entity Address, Address Line Two	Suite 150
Entity Address, City or Town	San Diego
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	92130
City Area Code	858
Local Phone Number	567-7770
Title of 12(b) Security	Common Stock
Trading Symbol	GYRE
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false

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