Gyre Therapeutics swings to $2.5M loss in Q3 2026
Full-year 2026 revenue guidance remains $100.5 million to $111.0 million as Gyre awaits a China regulatory decision on F351.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Filing Summary
Gyre Therapeutics reported third-quarter 2026 revenue of $32.9 million, up 1% from $32.7 million a year earlier, and a net loss of $2.5 million versus net income of $1.9 million. Basic loss per share was $0.04. ETUARY sales were $31.4 million, compared with $27.7 million, while Etorel sales were $1.0 million versus $1.5 million and Contiva sales were $0.1 million versus $1.2 million.
For the first nine months, revenue was $86.5 million, down from $93.0 million, and net loss was $35.3 million versus net income of $4.6 million. The company attributed the revenue decrease primarily to lower collaboration revenue following the Astellas Agreement's end in March 2026; higher research and development spending and transaction costs also contributed to expenses. Cash, deposits, short-term investments and long-term certificates of deposit totaled $98.8 million at September 30, 2026, down from $116.1 million at December 31, 2025.
Gyre affirmed full-year 2026 revenue guidance of $100.5 million to $111.0 million. For F351, the company said an NMPA decision could come by year-end 2026 or in the first quarter of 2027, with a China launch anticipated in the first half of 2027 if approved. It plans CG001419 Phase 2 initiation in China in the first half of 2027 and expects CG009301 Phase 1 dose-escalation data in the second half of 2027.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Positive
- Moderate pointETUARY quarterly sales rose to $31.4 million from $27.7 million.
Negative
- Moderate pointNine-month revenue declined by $6.5 million to $86.5 million.
- Moderate pointNine-month net loss reached $35.3 million, versus $4.6 million net income.
Filing Explained
At
8-K Event Classification
Key Figures
Key Terms
adjusted net income financial
New Drug Application (NDA) regulatory
Investigational New Drug (IND) applications regulatory
degrader antibody conjugate (DAC) technical
national centralized procurement program financial
Earnings Snapshot
Full-year 2026 revenue guidance of $100.5 million to $111.0 million affirmed.
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What was GYRE's third-quarter 2026 revenue?
When could F351 receive approval and launch in China?
When does Gyre expect to start its dual-degrader trials?
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of report (Date of earliest event reported):
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
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(Address of principal executive offices) |
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(Zip Code) |
Registrant’s telephone number, including area code: (
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 |
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Trading Symbol(s) |
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Name of each exchange on which registered |
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The |
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 November 5, 2026, Gyre Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the three and nine months ended September 30, 2026 and other matters described therein. 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 (the “Securities Act”), or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 7.01. Regulation FD
On November 5, 2026, the Company made available an updated corporate presentation on the Company’s website.
A copy of the corporate presentation is furnished as Exhibit 99.2 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 to be incorporated by reference in any filing under the Securities Act or the Exchange Act, regardless of any general incorporate language in such filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits. The following exhibits are being furnished herewith:
Exhibit Number |
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Exhibit Title or Description |
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99.1 |
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Press Release, dated November 5, 2026 |
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99.2 |
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Corporate Presentation, dated November 2026 |
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104 |
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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.
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GYRE THERAPEUTICS, INC. |
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Date: November 5, 2026 |
By: |
/s/ Ying Luo |
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Name: |
Ying Luo |
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Title: |
Chief Executive Officer and President |
Exhibit 99.1
Gyre Therapeutics Reports Third Quarter 2026 and Year-to-Date Financial Results with Business Updates
Q3 2026 revenue of $32.9 million; GAAP basic EPS: $(0.04)
Full year 2026 revenue guidance of $100.5 to $111.0 million affirmed
SAN DIEGO, November 5, 2026 -- Gyre Therapeutics, Inc. (Gyre, Gyre Therapeutics or the Company) (Nasdaq: GYRE), a U.S. biopharmaceutical company with research operations and commercial business in China to advance global development of protein degrader therapeutics, today announced financial results for the third quarter ended September 30, 2026, and provided a business update.
Dr. Ying Luo, President and Chief Executive Officer of Gyre Therapeutics, commented, “I am pleased with our execution in the third quarter, our first full quarter incorporating Cullgen's operations within Gyre Therapeutics. We are advancing our protein degrader pipeline toward first-in-human data and initiating new clinical programs next year. Meanwhile, after recently completing an onsite inspection by China’s National Medical Products Administration, or NMPA, we continue to prepare for the China NMPA decision on F351 for CHB-induced liver fibrosis, which we anticipate launching, if approved, sometime in the first half of 2027. Together, these programs are expected to drive our next phase of growth and demonstrate the strength of our unique business model, combining U.S. innovation with capital-efficient operations in China.”
Third Quarter Business Highlights and Upcoming Milestones
Pipeline Development Updates
F351 (hydronidone)
In May 2026, Gyre announced that the Center for Drug Evaluation (CDE) of the NMPA accepted its New Drug Application (NDA) for F351 (hydronidone) as a treatment for chronic hepatitis B (CHB)-induced liver fibrosis. The acceptance came after Gyre submitted the NDA through its majority-owned subsidiary Gyre Pharmaceuticals Co., Ltd. (Gyre Pharmaceuticals) following the priority review status for F351 granted by the NMPA in March 2026. During the third quarter, Gyre Pharmaceuticals completed an on-site inspection conducted by the NMPA of its manufacturing plants and clinical centers. Gyre believes a decision from the NMPA could occur by the end of 2026 or in the first quarter of 2027.
1
CG001419 for cancer pain and solid tumors
Following the successful completion of a Phase 1 study in Australia of 78 healthy volunteers in December 2025, Gyre is now planning a Phase 2 study to further evaluate CG001419 in cancer-induced bone pain (CIBP) and other metastatic cancer pain syndromes in China to initiate in the first half of 2027.
CG001419 continues to separately be evaluated in a Phase 1 trial in China for the treatment of solid tumors.
CG009301 for AML
CG009301 is a GSPT1 degrader for acute myeloid leukemia (AML), a fast-growing cancer of the blood and bone marrow. This candidate continues to be studied in a Phase 1 dose-escalation trial being conducted in China in patients with high-risk hematologic malignancies. We anticipate Phase 1 dose-escalation data to be available in the second half of 2027.
Dual-degrader programs (next-generation targeted protein degraders)
Gyre expects to submit Investigational New Drug (IND) applications and initiate Phase 1 clinical trials, upon regulatory approval of IND applications, in the United States and/or China around mid-2027 for CG923308, a CDK2-Cyclin E dual degrader for solid tumor indications, and CG620953, a TYK2-JAK1 dual degrader for autoimmune diseases.
DACs, next-generation ADCs
Additional developments from our in-house R&D efforts include discovery/preclinical stage degrader antibody conjugate (DAC) candidates for solid tumors and hematological malignancies, which are considered the next generation of antibody drug conjugates (ADCs). These DACs consist of distinct protein degraders paired with tumor-specific antibodies. We continue to make progress as we screen to identify leads and look to provide more details on our first IND-ready DAC candidate(s) in 2027.
Pirfenidone for Pneumoconiosis
A Phase 3 trial of pirfenidone for the treatment of pneumoconiosis in China 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 pneumoconiosis versus placebo. The potential for additional patient enrollment is currently being evaluated to replace patients that have dropped out of the study.
2
Pirfenidone for Radiation-Induced Lung Injury (RILI)
In April 2026, Gyre Pharmaceuticals initiated its adaptive Phase 2/3 clinical trial in oncology-related pulmonary complications, with the first patient enrolled. The trial is evaluating pirfenidone for RILI, including cases complicated by immune-related pneumonitis, at leading oncology centers.
Commercial Products:
ETUARYTM (pirfenidone for IPF), Etorel™ and Contiva™
ETUARY (pirfenidone), the Company's primary product approved in China for idiopathic pulmonary fibrosis (IPF), generated $31.4 million in sales for the quarter ended September 30, 2026, compared to $27.7 million for the same period in 2025. Etorel (nintedanib ethanesulfonate soft capsules), which was launched in June 2025 and is indicated for systemic sclerosis-associated interstitial lung disease (SSc-ILD) and progressive pulmonary fibrosis (PPF) and IPF, generated $1.0 million in sales for the quarter ended September 30, 2026, compared to $1.5 million for the same period in 2025. Contiva (avatrombopag maleate tablets), which was launched in China in March 2025 and is indicated for thrombocytopenia in adults with chronic liver disease and immune thrombocytopenic purpura, generated $0.1 million in sales for the quarter ended September 30, 2026, compared to $1.2 million for the same period in 2025. Contiva and Etorel product revenues were slightly lower due to the implementation of China’s national centralized procurement program.
Financial Results
Cash Position
As of September 30, 2026, Gyre held $41.6 million in cash and cash equivalents, $15.8 million in short-term bank deposits, $12.6 million in short-term investment, and $28.8 million in long-term certificates of deposit, totaling $98.8 million. Compared to $116.1 million as of December 31, 2025, total cash decreased by $17.3 million, or 15%, primarily driven by a decrease in short-term investment of $15.5 million.
Financial Results for the Three Months Ended September 30, 2026
3
4
Financial Results for the Nine Months Ended September 30, 2026
5
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, provision for income taxes, transaction costs and loss on disposal of assets, net. 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 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.
6
About F351
F351 is Gyre’s lead development candidate for the treatment of liver fibrosis that is being developed for two different indications. It is a structurally modified derivative of pirfenidone designed to optimize metabolic properties while targeting the TGF-β1 signaling pathway, a key mediator of fibrogenesis. Gyre is developing F351 for two primary indications: CHB-associated liver fibrosis in the PRC and MASH-associated liver fibrosis for global markets.
Gyre has completed a Phase 1 U.S. clinical trial in healthy volunteers evaluating F351’s safety, tolerability, and pharmacokinetics (PK). Gyre is further analyzing Phase 3 study results generated in China, together with new pre-clinical results to determine an optimal regulatory path for global Phase 2 studies in MASH fibrosis.
About Gyre Pharmaceuticals
Gyre Pharmaceuticals Co., Ltd., a subsidiary of Gyre Therapeutics, Inc., 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 in 2011 for idiopathic pulmonary fibrosis (IPF) in the PRC. Gyre Pharmaceuticals' pipeline includes F351 (hydronidone), a structural analogue of pirfenidone, which has received Breakthrough Therapy designation by the CDE of the NMPA in March 2021 and is currently under review by the NMPA for a New Drug Application (NDA) for the treatment of CHB-induced liver fibrosis, which is liver damage resulting from the infection of the hepatitis B virus (HBV). Gyre Pharmaceuticals is leveraging the pirfenidone-platform to develop treatments for pneumoconiosis and RILI with or without immune-related pneumonitis. Our expertise in pirfenidone compounds has allowed us to expand development programs with F528 for the treatment of chronic obstructive pulmonary disease (COPD), F230 in development for the treatment of pulmonary arterial hypertension (PAH), and F573 in development for the treatment of acute/acute-on-chronic liver failure (ALF/ACLF). As of September 30, 2026, Gyre Therapeutics owns a 69.7% equity interest in Gyre Pharmaceuticals.
About Gyre Therapeutics
Gyre Therapeutics is a U.S. biopharmaceutical company with research operations and commercial business in China, focused on generating cashflows with marketed therapeutics for fibrosis and leveraging capital efficiencies to advance the pipeline of next-generation protein degrader therapeutics for global markets.
Gyre’s wholly owned subsidiary, Cullgen Inc., is a clinical-stage biopharmaceutical company focused on the discovery and development of targeted protein degrader and DAC therapies for critical conditions, including cancer and inflammatory diseases. Cullgen has created a portfolio of highly selective targeted protein degrader and DAC product candidates designed to eliminate therapeutically relevant proteins in patients.
7
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 development and commercial potential and potential benefits of F351 and Gyre's other product candidates; the timing and progression of commercial approval of F351; and the timing of the NMPA's decision on Gyre’s NDA, and, if the NDA is approved, the anticipated commercial launch of F351; the regulatory path for, and time of, any global Phase 2 clinical trials of F351; initiation of Phase 2 clinical trial of CG001419; the timing of Phase 1 dose-escalation data for CG009301; and the timing of IND applications for CG923308 and CG620953. 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,” “anticipate,” “continue” 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: unexpected costs, charges or expenses resulting from Gyre's acquisition of Cullgen; potential adverse reactions or changes to business relationships resulting from the announcement or completion of the acquisition; the risk that the combined company may not be able to successfully integrate the businesses and realize the expected benefits of the acquisition in a timely manner or at all; the uncertainties associated with Gyre’s and Cullgen’s product candidates, as well as risks associated with the clinical development and regulatory approval of product candidates, including potential delays in the commencement, enrollment and completion of clinical trials; risks related to the inability of the combined entity to obtain sufficient additional capital to continue to advance these product candidates and its pre-clinical programs; uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; risks related to the failure to realize any value from product candidates and pre-clinical programs being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; risks associated with the possible failure to realize certain anticipated benefits of the acquisition, including with respect to future financial and operating results. Additional risks and factors are identified under “Risk Factors” in Gyre’s Annual Report on Form 10-K for the year ended December 31, 2025, filed on March 13, 2026, 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.
8
Contact:
Gyre Therapeutics, Inc.
Thomas Eastling, CFO
ir@gyretx.com
Investors
Sudan Loganathan
Vice President, Investor Relations & Corporate Finance Strategy
sudan.loganathan@gyretx.com
9
Gyre Therapeutics, Inc.
Unaudited Condensed Consolidated Statements of Operations
(In thousands, except share and per share amounts)
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
Revenues |
|
$ |
32,934 |
|
|
$ |
32,694 |
|
|
$ |
86,469 |
|
|
$ |
92,999 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cost of revenues |
|
|
1,947 |
|
|
|
1,628 |
|
|
|
5,383 |
|
|
|
3,673 |
|
Selling and marketing |
|
|
15,028 |
|
|
|
15,328 |
|
|
|
42,918 |
|
|
|
41,363 |
|
Research and development |
|
|
8,484 |
|
|
|
7,797 |
|
|
|
34,265 |
|
|
|
24,239 |
|
Research and development-related parties |
|
|
24 |
|
|
|
— |
|
|
|
4,860 |
|
|
|
— |
|
General and administrative |
|
|
8,921 |
|
|
|
6,447 |
|
|
|
26,964 |
|
|
|
21,928 |
|
Transaction costs |
|
|
50 |
|
|
|
— |
|
|
|
6,936 |
|
|
|
— |
|
Total operating expenses |
|
|
34,454 |
|
|
|
31,200 |
|
|
|
121,326 |
|
|
|
91,203 |
|
(Loss) income from operations |
|
|
(1,520 |
) |
|
|
1,494 |
|
|
|
(34,857 |
) |
|
|
1,796 |
|
Other (loss) income, net: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest income |
|
|
588 |
|
|
|
954 |
|
|
|
2,071 |
|
|
|
2,751 |
|
Change in fair value of warrant liability |
|
|
(315 |
) |
|
|
(23 |
) |
|
|
(95 |
) |
|
|
2,444 |
|
Other (expense) income, net |
|
|
(498 |
) |
|
|
95 |
|
|
|
(1,328 |
) |
|
|
(206 |
) |
(Loss) income before income taxes |
|
|
(1,745 |
) |
|
|
2,520 |
|
|
|
(34,209 |
) |
|
|
6,785 |
|
Provision for income taxes |
|
|
(733 |
) |
|
|
(593 |
) |
|
|
(1,118 |
) |
|
|
(2,156 |
) |
Net (loss) income |
|
|
(2,478 |
) |
|
|
1,927 |
|
|
|
(35,327 |
) |
|
|
4,629 |
|
Accretion of Cullgen redeemable convertible preferred stock |
|
|
— |
|
|
|
(2,707 |
) |
|
|
(3,905 |
) |
|
|
(7,927 |
) |
Net income (loss) attributable to noncontrolling interest |
|
|
1,575 |
|
|
|
(1,805 |
) |
|
|
(10,370 |
) |
|
|
(4,449 |
) |
Net (loss) income attributable to common stockholders |
|
$ |
(4,053 |
) |
|
$ |
1,025 |
|
|
$ |
(28,862 |
) |
|
$ |
1,151 |
|
Net (loss) income per share attributable to common stockholders: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic |
|
$ |
(0.04 |
) |
|
$ |
0.01 |
|
|
$ |
(0.29 |
) |
|
$ |
0.01 |
|
Diluted |
|
$ |
(0.04 |
) |
|
$ |
0.01 |
|
|
$ |
(0.29 |
) |
|
$ |
(0.01 |
) |
Weighted average shares used in calculating net income per share attributable to common stockholders: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic |
|
|
106,302,559 |
|
|
|
90,850,040 |
|
|
|
99,473,991 |
|
|
|
88,812,863 |
|
Diluted |
|
|
106,302,559 |
|
|
|
103,955,878 |
|
|
|
99,473,991 |
|
|
|
88,913,503 |
|
10
Gyre Therapeutics, Inc.
Unaudited Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
|
|
September 30, 2026 |
|
|
December 31, 2025 |
|
||
|
|
(Unaudited) |
|
|
(As Recast) |
|
||
Assets |
|
|
|
|
|
|
||
Current assets: |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
41,643 |
|
|
$ |
49,192 |
|
Short-term bank deposits |
|
|
15,772 |
|
|
|
15,355 |
|
Short-term investment |
|
|
12,629 |
|
|
|
28,085 |
|
Notes receivable |
|
|
793 |
|
|
|
5,638 |
|
Accounts receivables, net |
|
|
32,663 |
|
|
|
31,078 |
|
Other receivables from GNI |
|
|
263 |
|
|
|
230 |
|
Inventories |
|
|
12,219 |
|
|
|
10,171 |
|
Prepaid assets and other current assets |
|
|
7,419 |
|
|
|
9,613 |
|
Total current assets |
|
|
123,401 |
|
|
|
149,362 |
|
Property and equipment, net |
|
|
27,011 |
|
|
|
27,549 |
|
Intangible assets, net |
|
|
4,404 |
|
|
|
4,727 |
|
Long-term prepayments |
|
|
741 |
|
|
|
112 |
|
Deferred tax assets |
|
|
10,130 |
|
|
|
6,873 |
|
Long-term certificates of deposit |
|
|
28,775 |
|
|
|
23,516 |
|
Other assets, noncurrent |
|
|
6,789 |
|
|
|
7,624 |
|
Total assets |
|
$ |
201,251 |
|
|
$ |
219,763 |
|
Liabilities and stockholders' equity |
|
|
|
|
|
|
||
Current liabilities: |
|
|
|
|
|
|
||
Accounts payable |
|
$ |
2,636 |
|
|
$ |
1,335 |
|
Due to related parties |
|
|
4,933 |
|
|
|
227 |
|
Accrued expenses and other current liabilities |
|
|
17,044 |
|
|
|
18,161 |
|
Income tax payable |
|
|
2,830 |
|
|
|
2,940 |
|
Operating lease liabilities, current |
|
|
1,143 |
|
|
|
1,119 |
|
Total current liabilities |
|
|
28,586 |
|
|
|
23,782 |
|
Operating lease liabilities, noncurrent |
|
|
1,867 |
|
|
|
2,303 |
|
Deferred government grants |
|
|
1,555 |
|
|
|
852 |
|
Warrant liability, noncurrent |
|
|
3,056 |
|
|
|
2,961 |
|
Other noncurrent liabilities |
|
|
119 |
|
|
|
1,506 |
|
Total liabilities |
|
|
35,183 |
|
|
|
31,404 |
|
Commitments and Contingencies |
|
|
|
|
|
|
||
Series B preferred stock, $0.001 par value, 5,000,000 shares authorized; 3,552,427 shares and zero shares issued and outstanding at September 30, 2026 and December 31, 2025, respectively |
|
|
21,551 |
|
|
|
— |
|
Redeemable convertible preferred stock, $0.001 par value, 5,000,000 shares authorized; zero shares and 2,601,826 shares issued and outstanding at September 30, 2026 and December 31, 2025, respectively |
|
|
— |
|
|
|
15,784 |
|
Redeemable noncontrolling interests — Cullgen redeemable convertible preferred stock |
|
|
— |
|
|
|
113,030 |
|
Stockholders’ equity: |
|
|
|
|
|
|
||
Common stock, $0.001 par value, 400,000,000 shares authorized; 107,068,625 shares and 91,314,007 shares issued and outstanding at September 30, 2026 and December 31, 2025, respectively |
|
|
107 |
|
|
|
91 |
|
Additional paid-in capital |
|
|
243,489 |
|
|
|
172,819 |
|
Statutory reserve |
|
|
3,648 |
|
|
|
3,098 |
|
Accumulated deficit |
|
|
(142,015 |
) |
|
|
(112,603 |
) |
Accumulated other comprehensive income (loss) |
|
|
2,725 |
|
|
|
(908 |
) |
Total Gyre stockholders’ equity |
|
|
107,954 |
|
|
|
62,497 |
|
Noncontrolling interest |
|
|
36,563 |
|
|
|
(2,952 |
) |
Total equity |
|
|
144,517 |
|
|
|
59,545 |
|
Total liabilities, Series B preferred stock, redeemable convertible preferred stock, and stockholders’ equity |
|
$ |
201,251 |
|
|
$ |
219,763 |
|
11
Gyre Therapeutics, Inc.
Unaudited Reconciliation of GAAP to Non-GAAP Financial Measures
(In thousands)
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
Net (loss) income |
$ |
(2,478 |
) |
|
$ |
1,927 |
|
|
$ |
(35,327 |
) |
|
$ |
4,629 |
|
Gain (Loss) from change in fair value of warrant liability (1) |
|
315 |
|
|
|
23 |
|
|
|
95 |
|
|
|
(2,444 |
) |
Stock-based compensation |
|
1,734 |
|
|
|
1,334 |
|
|
|
6,392 |
|
|
|
3,277 |
|
Provision for income taxes |
|
733 |
|
|
|
593 |
|
|
|
1,118 |
|
|
|
2,156 |
|
Transaction costs (2) |
|
50 |
|
|
|
— |
|
|
|
6,936 |
|
|
|
— |
|
Loss on disposal of assets, net (3) |
|
— |
|
|
|
1 |
|
|
|
18 |
|
|
|
2 |
|
Non-GAAP adjusted net (loss) income |
$ |
354 |
|
|
$ |
3,878 |
|
|
$ |
(20,768 |
) |
|
$ |
7,620 |
|
12
1 November 2026 A Global Innovator Expanding And Reinventing Protein Degrader Therapeutics
This presentation contains “forward-looking statements” within the meaning of the federal securities laws, including Section 27A of the United States Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, regarding the current plans, expectations and strategies of Gyre Therapeutics, Inc. and its subsidiaries (“Gyre”), which statements are subject to substantial risks and uncertainties and are based on management’s estimates and assumptions. All statements, other than statements of historical facts included in this presentation, are forward-looking statements, including Gyre’s ability to leverage China operations for discovery, validation and development of therapeutics, clinical development plans, anticipated timelines and milestones of Gyre’s degrader antibody-conjugate platform, CG923308, CG620953, CG009301, CG001419, F351 and ETUARYTM, including the geographic location and timing of anticipated regulatory submissions and approvals, and the potential therapeutic benefits, efficacy, safety and differentiation of such product candidates, and market size and commercial opportunity estimates, Gyre’s plans, objectives, goals, strategies, future events, or intentions relating to Gyre’s products and markets, the safety, efficacy and clinical benefits of Gyre’s product candidates, the anticipated timing and design of any planned and ongoing preclinical studies and clinical trials, Gyre’s research and development efforts, plans and objectives of management for future operations and future results of anticipated product development efforts, potential addressable market size and Gyre’s liquidity and capital resources and business trends. In some cases, you can identify forward-looking statements by terms such as “believe,” “can,” “could,” “anticipate”, “design,” “estimate,” “expect,” “forecast,” “intend,” “may,” “might,” “plan,” “target”, “seek”, “goal”, “assume”, “milestones”, “potential,” “predict,” “objective,” “should,” “strategy,” “will,” “would,” “forthcoming,” or the negative of these terms, and similar expressions that are predictions of or indicate future events and future trends. These forward-looking statements may include express or implied statements relating to: the estimated future financial performance and financial position of Gyre; the therapeutic potential and utility, efficacy and clinical benefits of the product candidates of Gyre; the risk/benefit profile of Gyre’s product candidates; expectations regarding Gyre’s research and development efforts, including geographic location and timing of initiation of clinical trials for Gyre’s product candidates; Gyre’s expectations regarding the advancement of product candidates into IND-enabling studies; and Gyre’s expectations, hopes, beliefs, intentions and strategies; and other statements that are not historical fact. These statements involve known and unknown risks, uncertainties and other factors that could cause Gyre’s actual results to differ materially from the forward-looking statements expressed or implied in this presentation, in addition to those risks and uncertainties, such as the uncertainties inherent in the clinical drug development process, the regulatory approval process, the timing of any regulatory filings, the potential for substantial delays, the risk that earlier study results may not be predictive of future study results, manufacturing risks, competition from other therapies or products and the impacts of current macroeconomic and geopolitical risks. A discussion of these and other factors, is set forth in Gyre’s Annual Report on Form 10-K for the year ended December 31, 2025 filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2026 and elsewhere in such other filings and in Gyre’s periodic reports and subsequent disclosure documents filed with the SEC. Gyre cannot assure you that it will realize the results, benefits or developments that it expects or anticipates or, even if substantially realized, that they will result in the consequences or affect Gyre or its business in the way expected. Forward-looking statements are not historical facts and reflect management’s current views with respect to future events. Given the significant uncertainties, you should evaluate all forward-looking statements in the context of these risks and uncertainties and not place undue reliance on these forward-looking statements as predictions of future events. All forward-looking statements in this presentation apply only as of the date made and are expressly qualified in their entirety by the cautionary statements included in this presentation. Gyre has no intention to publicly update or revise any forward-looking statements to reflect subsequent events or circumstances, except as required by law. Certain information contained in this presentation and statements made orally during this presentation relate to or is based on studies, publications, surveys and other data obtained from third-party sources and Gyre’s own internal estimates and research. While Gyre believes these third-party studies, publications, surveys and other data to be reliable as of the date of this presentation, it has not independently verified, and makes no representation as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. In addition, no independent sources have evaluated the reasonableness or accuracy of Gyre’s internal estimates or research, and no reliance should be made on any information or statements made in this presentation relating to or based on such internal estimates and research. This presentation contains trademarks, trade names and service marks of other companies which are the property of their respective owners. This presentation concerns a discussion of investigational drugs that are under preclinical and/or clinical investigation, and which have not yet been approved for marketing by the U.S. Food and Drug Administration. They are currently limited by Federal law to investigational use, and no representations are made as to their safety or effectiveness for the purposes for which they are being investigated. Forward-looking Statements
*TPDs = targeted protein degraders; DACs = degrader antibody conjugates Gyre Is A Global Development Engine Fueled by its China Discovery and Commercialization Platform Value Drivers Key Features Details A Commercial Foundation and Integrated U.S. – China R&D Engine Support Capital-Efficient Advancement of a Diversified Pipeline Growth Opportunities Established Innovation Engine Global Infrastructure Commercial Footprint Diversified R&D programs spanning across multiple indications Both early- and late-stage pipeline assets provide near- and long-term catalysts Supports next-generation TPD and DAC platform development Fully-integrated R&D capabilities Leveraging cost-efficient China operations for accelerated discovery, preclinical validation, and early clinical-stage development ETUARYTM has been the market-leading pirfenidone brand in China for treatment of idiopathic pulmonary fibrosis (IPF) F351 adds a near-term revenue growth catalyst for the China commercial portfolio Degrader platform for the development of TPDs & DACs Dual degraders for oncology/I&I DACs in pre-IND studies ETUARYTM FY26 Total Revenue Guidance $100.5M-$111M F351 potential launch in 1H27 San Diego: Headquarters Shanghai: Discovery Beijing: Manufacturing & Sales
Gyre’s Flexible, Capital-Efficient Global Development Strategy China Revenue Builds & De-Risks the Early Pipeline U.S. Capital Advances Priority Assets Globally Cash-flow Generation: Established commercial operations in China to help offset cash burn. Reinvestment to R&D Engine: China-generated cash funds preclinical development quickly, at scale, and cost-efficiently, leveraging Gyre’s already-established China infrastructure. Translational De-risking: Conduct broader preclinical and translational studies to select strongest candidates and build IND-enabling packages. Focused Capital Allocation: U.S.-raised capital invests into the highest-priority U.S. and global clinical programs. Flexible Clinical Routing: Initiate studies in the U.S., China or both based on the most efficient development path. Pivotal Development and Launch: Advance selected assets through U.S. and global clinical studies, pivotal trials, regulatory approvals and launch.
Program and Description Indication Pre-IND Studies Phase 1 Phase 2 Phase 3 NDA Submitted Catalyst DAC Platform / Next-Gen Degrader Technologies Oncology / Inflammatory Disease Discovery Platform Lead DAC selection ongoing / IND-enabling advancement CDK2 / Cyclin E Degrader CG923308 CDK4/6i-resistant Breast Cancer and Other Solid Tumors Anticipate IND-application submission in U.S. and/or China and Phase 1 initiation around mid-2027 TYK2 / JAK1 Degrader CG620953 Systemic Lupus Erythematosus (SLE) & Rheumatoid Arthritis (RA) Anticipate IND-application submission in U.S. and/or China and Phase 1 initiation around mid-2027 GSPT1 Degrader CG009301 R/R AML, HR-MDS, R/R ALL; Solid Tumor Cancers Phase 1 dose-escalation data in patients with high-risk hematologic malignancies in 2H27 TRK Degrader CG001419 Cancer-induced Bone Pain (CIBP) Planning Phase 2 initiation in China 1H27 Hydronidone F351 Chronic Hepatitis B (CHB)-induced Liver Fibrosis Decision expected from NMPA by YE26/1Q27 & potential launch in 1H27 Global Development Programs and Upcoming Catalysts China R&D incubator provides new promising clinical assets for global development in cancer, immunology & inflammatory (I&I) diseases, and pain Discovery & lead selection in China IND-enabling development in China; Phase 1 in U.S. and/or China IND-enabling development in China; Phase 1 in U.S. and/or China Phase 1 dose escalation ongoing in China Phase 1 in healthy volunteers completed in Australia; Phase 2 in China Inflammation / Fibrosis Cancer Degrader DAC
Targeted Protein Degraders (TPDs)
Gyre’s Proprietary Targeted Protein Degraders’ Enables: Drugging ‘undruggable’ disease-causing proteins Catalytic high potency High target selectivity Overcome drug resistance Sustained target depletion Our expertise also translates well into implementing TPD technology in combination with Antibody- drug conjugates (ADCs) to make next-gen ADCs, called Degrader Antibody Conjugates (DACs). A Modular Degrader Platform: From Discovery to Clinic One Platform. Multiple Degraders. Built for Broad Impact Across Oncology and Immunology. Ubiquitin Proteasome System (UPS) – Our Engine for Targeted Protein Degradation Disease causing protein Lys E3 ligase Degrader Disease causing protein Lys E3 ligase RING Ub Ub Ub Ub Ub E2 Targeted protein degrader molecule (drug) Degrader brings E3 ligase and disease-causing protein together Ubiquitylation (tagging) Disease Protein for degradation Degraded protein Proteasome Ubiquitin Chain Disease-causing protein Disease-causing protein is degraded by the proteasome Degrader recycles to find next disease protein
8 CDK2-Cyclin E Dual Degrader: Novel Strategy for Multiple Solid Cancer Types Cyclin E Is Functionally Amplified or Overexpressed Across Multiple Cancer Types :[1] Lee et al (2026) Clin Cancer Res. PMID:41870274 [1] Turner NC (2019) J Clin Oncol. PMID: 30807234; [2] Herrera-Abreu MT (2016) Cancer Res. PMID: 27020857; [3] Costa C (2020) Cancer Discov. PMID: 31594766 [4] Freeman-Cook (2021) Cancer Cell. PMID: 34520734; [5] Wander SA (2020) Cancer Discov. PMID: 32404308; [6] Al-Qasem AJ(2022) NPJ Precis Oncol. 2022 PMID: 36153348 [7] Josefine B (2012) Breast Cancer Res Treat. PMID: 23242584; [8] Caldon CE (2012) Mol. Cancer Ther. PMID: 22564725 Diverse CDK4/6i or Endocrine Therapy Resistance Converge on Activation of CDK2/Cyclin E N = 486,340 CDK2-Cyclin E Dual Degrader Cyclin E overexpression CCNE amplification Rb loss PTEN loss PI3K upregulation MYC overexpression Erα alterations [1, 4, 5, 6] [2,4] [2,5] [3] [2] [7] [4] [8] CCNE1 Amplification Prevalence (%) [1] Market Opportunity & Unmet Medical Need [9] Strategic Market Research, July 2026 CDK2 / Cyclin E TYK2 / JAK1 TRK DAC Fibrosis GSPT1 ET Resistance CDK2/ cyclin E CDK4/6i Resistance Verzenio, Kisqali, and Ibrance ~$14.6B Total Global Revenues in 2025 [9] Projected total global revenues between $25.8B - $35.7B by early 2030s[9] ~50% of patients develop resistance to CDK4/6 inhibitors within 2 years of starting therapy
CG923308 Demonstrates Anti-Cancer Efficacy in Resistant Preclinical Models INCB123667: A phase 2/3 CDK2 inhibitor by Incyte; Palbo: Palbociclib (Ibrance), CDK4/6 inhibitor developed by Pfizer; TQB3616: CDK2/4/6 inhibitor developed by Chia Tai Tianqing; TNBC: triple-negative breast cancer CG923308 produces meaningful anti-cancer efficacy in multiple solid tumor preclinical mouse models, including CDK4/6i-resistant models CDK2 / Cyclin E TYK2 / JAK1 TRK DAC Fibrosis GSPT1 C. Gastric Cancer CDX D. TNBC CDX A. Ovarian Cancer CDX B. Chemo-resistant TNBC PDX E. CDK4/6i-resistant breast cancer CDX F. CDK4/6i-resistant breast cancer PDX
TYK2-JAK1 Dual Degrader: Next-Generation Therapy for Autoimmune Diseases Notes: https://www.psoriasis.org/psoriasis-statistics/ https://www.who.int/news-room/fact-sheets/detail/rheumatoid-arthritis; https://www.niams.nih.gov/health-topics/lupus/basics/symptoms-causes; Significant Unmet Need and Market Opportunity Across Autoimmune Diseases 125MM+ Patients Worldwide(1) Psoriasis 18MM Patients Worldwide(2) Rheumatoid Arthritis 204K+ Patients U.S.(3) Systemic Lupus Erythematosus Other Inflammatory and Autoimmune Indications Chronic Inflammation and Autoimmune Diseases Cytokine signaling mediated by TYK2 and JAK1 IL-12 Drives Th1 differentiation and activation IL-23 Drives Th17 differentiation and maintenance Type I IFNs Antiviral response and inflammation TYK2 JAK2 TYK2 JAK1 STAT Activation Pro-inflammatory Gene Expression TYK2 TYK2 JAK1 + (Heterodimer) CDK2 / Cyclin E TYK2 / JAK1 TRK DAC Fibrosis GSPT1 Efficacy High Broad / key disease-driving cytokines Low Limited relevance to core IMID pathways Safety High Risk (severe immunosuppression, hematologic, infection, others) Low Risk (more favorable safety profile) JAK1 JAK3 JAK2 TYK2 TYK2 & JAK1 ✓ Broad disease coverage ✓ Synergistic activity via dual degradation enhances efficacy ✓ Sparing JAK2 and JAK3 leads to a favorable safety profile Sweet Spot of TYK2/JAK1 Dual Targeting
CG620953 Demonstrates Efficacy in Lupus and RA Preclinical Models Lupus RA CG620953 exhibit enhanced efficacy signals in preclinical models CDK2 / Cyclin E TYK2 / JAK1 TRK DAC Fibrosis GSPT1 Sotyktu (10 mpk, qd, po) Disease model 10 mpk Control 30 mpk 60 mpk CG620953 (qd, po) Nose lesion score Percent of survival Days since dosing Control-vehicle Disease model CG620953 (10 mpk, qd, po) CG620953 (30 mpk, qd, po) CG620953 (60 mpk, qd, po) Deucravacitinib (10 mpk, qd, po) Survival rate Doral skin lesion score Kidney injury histopathology Kidney histopathological Score Disease model 10 mpk Control 30 mpk 60 mpk CG620953 (qd, po) Vehicle Sotyktu (10 mpk, qd, po) Joint thickness (mm) Control Disease model CG620953 (30 mpk, qd, po) Tofacitinib (10 mpk, qd, po) Days since dosing Joint inflammation & cartilage destruction Days since dosing Plantar thickness (mm) Control Disease model CG620953 (30 mpk, qd, po) Tofacitinib (10 mpk, qd, po) Hind paw edema TYK2/JAK1 degradation & JAK2/3 sparing
Pan-TRK Degrader: Potential First-in-Class, Non-Opioid Therapeutic Degrader for Cancer-Induced Bone Pain 1. https://pubmed.ncbi.nlm.nih.gov/22570568; 2. https://pubmed.ncbi.nlm.nih.gov/26229504; 3. https://pubmed.ncbi.nlm.nih.gov/23344095; 4.https://pubmed.ncbi.nlm.nih.gov/25919474; 5. https://pubmed.ncbi.nlm.nih.gov/37343145; 6. Company data; CG001419-101 (NCT06636500). CG001419 Degrades TrkA & TrkB proteins to achieve high potency. Non-brain-penetrance to avoid CNS side effects. - Phase 1a target engagement in high single-digit / low double-digit nanomolar ranges. - Well-tolerated up to highest dose tested.6 U.S.‒China clinical development enables parallel execution and faster timelines. Mechanism Early Validation Speed Advantage 12 New cases of malignant bone metastasis in the U.S. annually 1,2 70-90% develop symptomatic pain with limited current treatment options 3 Average treatment duration for cancer-induced bone pain 4,5 CDK2 / Cyclin E TYK2 / JAK1 TRK DAC Fibrosis GSPT1 Cancer-Induced Bone Pain U.S. Market Opportunity Our Differentiated Approach Nerve growth factor (NGF) stimulates the TRKA signaling pathway to transmit pain to the central nervous system TrkA Dorsal root ganglion (DRG) NGF Injury / Inflammation Brain NGF-TRKA complex Oral Pan-TRK Degrader 280K – 330K Significant Unmet Need 193-225 Days
CG001419 Phase 1 Results: PD Target Engagement and Safety Source: Company data; CG001419-101 (NCT06636500). Safety / Tolerability from Phase 1 Pharmacodynamics: potential target engagement demonstrated Plasma-to-reporter cell assay showed TRKA degradation, supporting potential target engagement Potent surrogate PD activity observed: DC50 = 2.1 ng/mL; DC90 = 16 ng/mL Favorable safety / tolerability profile Single and multiple oral doses were well tolerated up to the highest tested dose levels Most TEAEs were mild or moderate; no Grade 4 TEAEs reported Common TEAEs were largely general / administration-site events, likely related to blood collection procedures Predictable exposure profile supports continued development Single-dose CG001419 exposure increased dose-proportionally Fed condition increased systemic exposure; 7-day MAD exposure increased less than dose-proportionally for CG001419 and metabolites M2/M8 Surrogate PD Assay Demonstrated Degradation Potency in the Low-nM Range. 0 87 8.7 0.87 GFP TRKA Patient Plasma Reporter Cell Line DC50 = 2.1 ng/mL DC90 = 16 ng/mL Completed Phase 1 studies in healthy volunteers; currently planning Phase 2 for cancer-induced bone pain to commence in U.S. or China CDK2 / Cyclin E TYK2 / JAK1 TRK DAC Fibrosis GSPT1 Multiple Ascending Dose (MAD) PK – Day 7 Pharmacodynamics: Potential Target Engagement Concentration (ng/ mL)
14 CG009301: Targeting GSPT1 for AML and Solid Tumor Cancers GSPT1 controls protein translation termination and plays important function for leukemia stem cells and tumor cells with MYC overproduction GSPT1 lacks an active site and is often considered “undruggable” Other programs targeting GSPT1 show insufficient therapeutic index. CG009301 demonstrate encouraging safety profile in our preclinical studies and early clinical development. Notes: 2024 by American Cancer Society estimates The Cancer Genome Atlas (TCGA) estimates Schaub et al (2018) Cell Syst PMID: 295967830 Volpe et al. (2022) Clin Lymphoa Myelom Leuk, PMID: 34544674 GTP Hydrolysis Peptide Release GTP GSPT1 60S CAG UAA 40S eRF1 GDP GSPT1 60S CAG UAA 40S eRF1 GDP GSPT1 60S CAG UAA 40S eRF1 Global Blood Cancer Treatment Market U.S. Patient Population ~20,800 new cases ~10,000 new cases ~6,500 new cases 28% 11,220 mortality 1,330 mortality 30-40% MDS progress to AML (4) AML (1) MDS (1) ALL (1) MYC-amplified Solid Tumors (2),(3) The Market will Grow 10.3% The Forecasted Market 15.7Bn At the CAGR of: size for 2033 in US$: CDK2 / Cyclin E TYK2 / JAK1 TRK DAC Fibrosis GSPT1 Size, by Treatment Type, 2023-2033 (USD Bn)
15 CG009301: Ongoing Phase 1 in China for Patients with High-risk Heme Malignancies CDK2 / Cyclin E TYK2 / JAK1 TRK DAC Fibrosis GSPT1 Dose Escalation Dose Expansion RP2D Dose X：xx mg, n=9~18 Dose X：xx mg, n=9~18 28 days as one cycle R/R-AML, HR-MDS & R/R-ALL Recurrent or refractory haematological malignancies 50-86 subjects BOIN Design Rapid titration Dose level 1 - mg QD, n =1 Dose level 2 - mg QD, n=1 Dose level 3 - mg QD, n=3 Dose level 6 - mg QD,n=6~12 Dose level 7 - mg QD,n=6~12 Dose level 8 - mg QD,n=xx Dose level 4 - mg QD, n=3~6 Dose level 5 - mg QD,n=3~6 Dose level 9 - mg QD,n=xx Dose level 10 - mg QD,n=xx Dose level 2 - mg QD, n=3 Dose level 3a - mg QD,n=3~6 Dose level 2a - mg QD, n=3~6 Dose level 3 - mg QD,n=3~6 D1-7 each cycle iv. administration BOIN Design D1-14 each cycle iv. administration
Degrader-Antibody Conjugates (DACs)
Leveraging Expertise in TPDs and China ADC Platform to Develop Degrader-Antibody Conjugates (DACs) Gyre’s DAC Platform for Multiple Cancer Types 24 HIGH POTENCY IMPROVED pk Gyre’s DAC Mechanism of Action & Benefits two layers of selectivity 17 CDK2 / Cyclin E TYK2 / JAK1 TRK DAC Fibrosis GSPT1 mAbs – monoclonal antibodies TAAs – Tumor-assisted Antigens
Gyre’s Degrader Molecule 1-DAC Demonstrates Durable Prostate Tumor Growth Inhibition 18 CDK2 / Cyclin E TYK2 / JAK1 TRK DAC Fibrosis GSPT1 Prostate cancer causes 35,000 – 36,500 deaths each year and is the second-leading cause of cancer death in American men.[1] Degrader 1 targets epigenetic factors that are frequently mutated across human malignancies and drive oncogenic signaling, including AR-mediated transcription in prostate cancer. Prior developments targeting the epigenetic factors for prostate cancer has been limited by the toxicity. D. Degrader Molecule 1-Targeting DACs Demonstrate Demonstrates TAA-Dependent Cell Killing Activity When Conjugated to Additional Antibodies C. Non-human primate pilot toxicity B. Enzalutamide-resistant CRPC PDX model A. Prostate cancer CDX model [1] American Cancer Society estimates as of August 2026
Gyre’s Degrader Molecule 2-DAC Demonstrate Broad Efficacy Across Diverse Tumor Types mAb: monoclonal antibody recognizing a specific antigen; DXd-ADC: HER2-DXd ADC (Enhertu) Developed by Daiichi Sankyo and AstraZeneca 19 CDK2 / Cyclin E TYK2 / JAK1 TRK DAC Fibrosis GSPT1 A. AML CDX model B. AML CDX model C. Breast Cancer model F. NSCLC CDX model D. Breast Cancer model E. Gastric Cancer CDX model
Commercial Foundation and Growth Opportunities with F351 (Hydronidone)
ETUARYTM: The Commercial Anchor of Our Fibrosis Franchise Since 2011 A Durable Revenue Base that Funds Innovation and Supports Our Next-generation Degrader / DAC Platform Notes: 1. ETUARY market position based on IQVIA CHPA data for pirfenidone in China [2014-2026]: legal review required. Financial data inclusive of pro forma data prior to GNI Group and Catalyst Biosciences business combination. 2017 sales in audited China GAAP; 2025 in audited U.S. GAAP 21 Established Leadership ETUARYTM has anchored our IPF franchise in China through consistent execution and broad physician reach, supported by ῀370 commercial personnel across 3,000+ hospitals and pharmacies. Durable Market Position ETUARYTM was approved by China’s National Medical Products Administration (NMPA) in 2011 before Esbriet approval by US FDA. GYRE Pharmaceuticals has maintained market leadership positions in China since then, which demonstrated GYRE’s capability to manage the drug life cycle. Funds the Innovation Pipeline ETUARYTM's recurring commercial revenue supports our next-generation degrader / DAC platform without dilution dependence. ETUARYTM (Pirfenidone) (1) 1 Etorel TM – Launched in 2025 2 F351 (Hydronidone) 3 China’s Leading Pirfenidone Brand For the Treatment of IPF (1) Complementary PF option that extends the fibrosis toolkit alongside ETUARYTM. New Drug Application (NDA) accepted for priority review by NMPA in May 2026. A One-stop Shop for Fibrosis – Building Physician Reach Ahead of F351 CDK2 / Cyclin E TYK2 / JAK1 TRK DAC Fibrosis GSPT1
F351 Phase 3 Results in CHB-associated Liver Fibrosis Supports Regulatory Filing CDK2 / Cyclin E TYK2 / JAK1 TRK DAC Fibrosis GSPT1 F351 poised to be the next-generation of fibrosis therapy ≥1-stage fibrosis regression at Week 52: F351: 52.85% (n=123) vs. Placebo: 29.84% (n=124) Delta: 23.01% p = 0.0002 (ITT1 analysis with central blinded pathology review) Consistent with fibrosis regression rates observed in Phase 2 Primary Endpoint Met with High Statistical Significance ≥1-grade inflammation improvement without fibrosis progression at Week 52: F351: 49.57% (n=123) vs. Placebo: 34.82% (n=124) Delta: 14.75% p = 0.0246 Reinforces anti-inflammatory activity Key Secondary Endpoint Reduction in Liver Inflammation NDA accepted by NMPA in May 2026 Breakthrough Therapy Designation Priority Review of NDA (China NMPA, 2021, 2026)
Key Value Drivers Lead TPD Assets Opportunities in cancer and autoimmune diseases with dual degraders TPD portfolio highly validated for large unmet need indications TPD / DAC R&D Engine Multiple shots on goal DACs paint a promising picture as the next-gen to ADCs / TPDs alone Global Exposure Lean operations to de-risk assets U.S. headquarters and integrated U.S. and China R&D operations Revenues to Support Operations ETUARYTM and anticipated F351 sales in China expected to cover operation expenses to support early-stage R&D and proof-of-concepts studies 1 2 3 4
U.S. Management Team with Cross-Culture Operational Experience Ying Luo, Ph.D. Chief Executive Officer Thomas Eastling Chief Financial Officer Weiguo Ye Chief Operating Officer Yue Xiong, Ph.D. Chief Scientific Officer Ruoyu Chen Chief Information Officer Jialiang Wang, Ph.D. Executive Vice President, General Manager Joshua Bergmann, J.D. General Counsel and Corporate Secretary Seth Goldblum, MBA Senior Vice President – Corporate Development Jing Liu, Ph.D. Senior Vice President – Platform Chemistry Michael Plewe, Ph.D. Senior Vice President - Medicinal Chemistry Mark Marino, M.D. Senior Vice President – Clinical Development Leslie Robinson, Ph.D., J.D. Vice President - Intellectual Property and Licensing Liang Zhao Vice President – Corporate Controller Sudan Loganathan, Ph.D. Vice President – Investor Relations & Finance Strategy Chuck Monahan Senior Vice President – Regulatory Affairs
Thank You!