GYRE 10-K & 10-Q changes, risk factors and insider trading
Gyre Therapeutics, Inc. · Nasdaq · Pharmaceutical Preparations · CIK 1124105 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
New heading “Risks Related to the Merger with Cullgen”
New heading “There is no assurance when or if the Merger will be completed. Any delay in completing the Merger may substantially reduce the potential benefits that we expect to obtain from the Merger.”
New heading “The issuance, or expected issuance, of our common stock in connection with the Merger could decrease the market price of our common stock.”
New heading “The intended benefits of the Merger may not be realized.”
New heading “Because the lack of a public market for Cullgen common stock makes it difficult to evaluate the fairness of the Merger, Cullgen stockholders may receive consideration in the Merger that is greater than or less than the fair market value of Cullgen common stock.”
New heading “Our directors and officers may have interests in the Merger that are different from, or in addition to, those of our stockholders generally that may influence them to support or approve the Merger.”
New heading “The announcement and pendency of the Merger could have an adverse effect on our business, financial condition, results of operations or business prospects.”
New heading “During the pendency of the Merger, we may not be able to enter into a business combination with another party and will be subject to contractual limitations on certain actions because of restrictions in the Merger Agreement.”
New heading “Certain provisions of the Merger Agreement may discourage third parties from submitting competing proposals, including proposals that may be superior to the arrangements contemplated by the Merger Agreement.”
New heading “The Exchange Ratio is not adjustable based on the market price of our common stock, so the Merger consideration at the Closing may have a greater or lesser value than at the time the Merger Agreement was signed.”
New heading “We are expected to incur substantial expenses related to the Merger with Cullgen.”
New heading “Failure to complete the Merger could negatively affect the value of our common stock and our future business and financial results.”
New heading “The Merger may be completed even though material adverse changes may result from the announcement of the Merger, industry-wide changes or other causes.”
New heading “We and/or our board of directors may become involved in securities litigation or stockholder derivative litigation in connection with the Merger, and this could divert the attention of our management and harm our business, and insurance coverage may not be available or sufficient to cover all related costs, expenses, and damages.”
New heading “We are substantially dependent on our remaining employees, key contractors and consultants to facilitate the consummation of the Merger.”
Largest changes
“The central or local governments may impose new, stricter regulations or interpretations of existing regulations that would require additional expenditures and efforts on our part to ensure our compliance with such regulations or interpretations. For instance, regulations introduced by the NMPA concerning drug inspection, investigation, evidence collection and disposal are relatively new, and because of the limited volume of published judicial and administrative decisions, which are non-binding in nature, the interpretation and enforcement of these laws and regulations are uncertain. …”see in full comparison
“Failure to comply with the requirements of the GDPR or UK GDR and the related national data protection laws of the EEA countries may result in significant monetary fines for noncompliance of up to €20.0 million or £17.5 million (as applicable), 4% of the total worldwide annual turnover (for higher-tier infringements). This is enforced by ICO and is entirely separate from fines under EU GDPR. …”see in full comparison
“We and/or our board of directors may become involved in securities litigation or stockholder derivative litigation in connection with the Merger, and this could divert the attention of our management and harm our business, and insurance coverage may not be available or sufficient to cover all related costs, expenses, and damages.”see in full comparison
“Due to our operations in the PRC, our business, results of operations and financial condition may be influenced to a certain degree by economic, political, legal and social conditions in the PRC or changes in government relations between the PRC and the United States or other governments. There is significant uncertainty about the future relationship between the United States and the PRC with respect to trade policies, treaties, government regulations and tariffs. …”see in full comparison
Thesee in full comparisoncollection and useprocessing of personalhealthdata,dataincludingand otherhealth-related personal data in theEUEuropean Economic Area (“EEA”) is mainly governed by the provisions of the GDPR,which came into force in May 2018,and related data protection laws in individualEUEEAMembercountries.StatesInasthewellUnitedasKingdom,implementationsthe processing of personal data is mainly governed by the GDPRinas incorporated into UK law pursuant to the EuropeanEconomicUnionArea.(Withdrawal) Act 2018 (the “UK GDPR”). The GDPRestablishesand UK GDPR impose a number of strictrequirementsobligations andrestrictionsrequirementsapplicable tofor theprocessingprocessing,(processing includesincluding collecting, analyzing and transferring)of personal data(i.e.,ofdataindividualswhichinidentifiesthean individualEEA orfrominwhichthean individual is identifiable)UK, in particular with respect to health data from clinical trials and adverse event reporting. The GDPRincludesand UK GDPR include requirements relating to the legal basis of the processing (such as consent of the individuals to whom the personal data relates), the information provided to the individuals prior to processing their personal data, the personal data breaches which may have to be notified to the national data protection authorities and data subjects, the measures to be taken when engaging processors, and obligations relating to the security and confidentiality of the personal data.EUEEAMember Statescountries may also impose additional requirements in relation to the processing of health, genetic and biometric data through their national legislation.Furthermore, it affords various rights to individuals (e.g., the right to access or erasure of personal data), and imposes potential penalties for breaches of up to 4% of the annual worldwide turnover or €20 million, whichever is greater. In case of a breach of the GDPR, individuals (e.g., study subjects) may also have a right to compensation for financial or non-financial losses (e.g., distress).
“In addition, we continue to engage with the FDA regarding the IND requirements for a Phase 2 trial evaluating Hydronidone for the treatment of MASH-associated liver fibrosis. Pending regulatory feedback, we plan to file the U.S. IND for Hydronidone for the treatment of MASH-associated liver fibrosis in 2026 and, subject to clearance, initiate a Phase 2 clinical trial. We plan to conduct a hepatic impairment study in U.S. subjects under our active U.S. IND. …”see in full comparison
Full comparison: every changed paragraph (265)
There is no assurance when or if the Merger will be completed. Any delay in completing the Merger may substantially reduce the potential benefits that we expect to obtain from the Merger.
Our business is significantly dependent on the sales of ETUARY®, one of our marketed productproducts in the PRC, amid a competitive landscape, and there is a possibility that we may not be able to sustain or boost the sales volume, pricing, and profitability of ETUARY.ETUARY®.
There is a risk that our marketed productproducts in the PRC, ETUARY,ETUARY®, Etorel® and Contiva®, along with any other products that we may commercializereceive inapproval the future, including nintedanibfor and avatrombopag, and may receive approvalcommercialize in the future, may not attain sufficient market acceptance among physicians, healthcare facilities, pharmacies, patients, third-party payers, and the broader medical community, which is crucial for their commercial viability.
The future of our business and financial outcomes is largely contingent on the progress and success of our product candidates in clinical and pre-clinicalpreclinical stages, such as ETUARY® for future indications in the PRC, F573 in the PRC, and F351Hydronidone in the PRC and in additional markets beyond the PRC. We face the risk of not being able to finalize their clinical development, secure necessary regulatory approvals, or accomplish their market launch successfully, or we may encounter substantial setbacks in these processes.
We may fail to win bids to sell our commercialized products, ETUARY®, and any other future products, if approved and commercialized, to PRC public hospitals through the centralized tender process.
The true market potential for our product and product candidates may be less than expected. Our expansion could be constrained by the current and emerging number of IPF patients in the PRC, pending the approval and profitable launch of expanded applications for ETUARY® for future indications in the PRC, and our other product candidates.
The approval procedures of the NMPA, FDA, and comparable foreign regulatory authorities are extensive, protracted, and inherently uncertain. Failure to secure necessary approvals, or encountering delays in the approval process, will prevent us from marketing our product candidates, such as ETUARY® for future indications in the PRC, F573 in the PRC, and F351Hydronidone in the PRC and in additional markets beyond the PRC, which may significantly affect our revenue generation.
Should we or our licensors fail to secure, uphold, defend, or extend adequate patent and other intellectual property rights for our products, ETUARY,ETUARY®, nintedanibEtorel® and avatrombopag,Contiva®, which are approved and commercialized by us in the PRC, and any product candidates globally, or if the breadth of these intellectual property rights is insufficient, our ability to effectively compete in our markets could be compromised.
Clinical drug development involves a lengthy and expensive process and outcomes are uncertain, and we may not successfully complete clinical trials for drugs under development, including ETUARY® for future indications in the PRC, F573 in the PRC, and F351Hydronidone in the PRC and in additional markets beyond the PRC, or demonstrate the safety and efficacy of our product candidates to the satisfaction of regulatory authorities.
Modifications to laws, regulations, and rules by the PRC government could lead to alterations in our operational processes and business approaches.
Risks Related to the Merger with Cullgen
There is no assurance when or if the Merger will be completed. Any delay in completing the Merger may substantially reduce the potential benefits that we expect to obtain from the Merger.
Completion of the Merger is subject to the satisfaction or waiver of a number of conditions, as set forth in the Merger Agreement, including (1) approval by the requisite Cullgen stockholders of the adoption and approval of the Merger Agreement and the transactions contemplated thereby, and (2) a filing under HSR Act. There can be no assurance that we and Cullgen will be able to satisfy the closing conditions or that closing conditions beyond our or Cullgen’s control will be satisfied or waived. If the conditions are not satisfied or waived, the Merger may not occur or may not be completed within the expected timeframe, and we may materially and adversely lose some or all of the potential benefits that we expect to achieve as a result of the Merger and could result in additional transaction costs or other effects associated with uncertainty about the Merger. Moreover, we have incurred and expect to continue to incur significant expenses related to the Merger, such as legal and accounting fees, some of which must be paid even if the Merger is not completed.
We and Cullgen can agree at any time to terminate the Merger Agreement, even if the Cullgen securityholders have already adopted the Merger Agreement and thereby approved the Merger and the other transactions contemplated by the Merger Agreement. We and Cullgen can also terminate the Merger Agreement under other specified circumstances.
The issuance, or expected issuance, of our common stock in connection with the Merger could decrease the market price of our common stock.
In connection with the Merger and as part of the merger consideration, we expect to issue shares of common stock to Cullgen stockholders. The anticipated issuance of our common stock in the Merger may result in fluctuations in the market price of our common stock, including a stock price decrease. In addition, the perception in the market that the holders of a large number of shares of our common stock may intend to sell shares could reduce the market price of our common stock.
The intended benefits of the Merger may not be realized.
The Merger poses risks for our ongoing operations, including, among others:
that senior management’s attention may be diverted from the management of our current operations and development of our products;
costs and expenses associated with any undisclosed or potential liabilities; and unforeseen difficulties may arise in integrating Cullgen’s and our business.
As a result of the foregoing, we may be unable to realize the full strategic and financial benefits currently anticipated from the Merger, and we cannot assure you that the Merger will be accretive to us in the near term or at all. Furthermore, if we fail to realize the intended benefits of the Merger, the market price of our common stock could decline to the extent that the market price reflects those benefits. Our stockholders will have experienced substantial dilution of their ownership interests in us without receiving any commensurate benefit, or only receiving part of the commensurate benefit to the extent we are able to realize only part of the strategic and financial benefits currently anticipated from the Merger.
Because the lack of a public market for Cullgen common stock makes it difficult to evaluate the fairness of the Merger, Cullgen stockholders may receive consideration in the Merger that is greater than or less than the fair market value of Cullgen common stock.
The outstanding Cullgen common stock is privately held and is not traded in any public market. The lack of a public market makes it extremely difficult to determine the fair market value of Cullgen shares. Since the percentage of our common stock to be issued to Cullgen stockholders was determined based on negotiations between the parties, it is possible that the value of our common stock to be issued in connection with the Merger will be greater than the fair market value of Cullgen shares. Alternatively, it is possible that the value of the shares of our common stock to be issued in connection with the Merger will be less than the fair market value of Cullgen shares.
Our directors and officers may have interests in the Merger that are different from, or in addition to, those of our stockholders generally that may influence them to support or approve the Merger.
Our officers and directors may have interests in the Merger that are different from, or are in addition to, those of our stockholders generally. Effective upon the Closing, Ying Luo, Ph.D., current President and Chief Executive Officer of Cullgen, is expected to be employed as Chief Executive Officer and President and appointed as a director of Gyre. Each outstanding option to acquire shares of Cullgen common stock held by Cullgen executive officers and directors will be converted into an option to acquire shares of our common stock.
In addition, our directors and executive officers also have certain rights to indemnification or to directors’ and officers’ liability insurance that will survive the completion of the Merger. These interests may have influenced our directors and executive officers to support or recommend the proposals presented to our stockholders.
The announcement and pendency of the Merger could have an adverse effect on our business, financial condition, results of operations or business prospects.
The announcement and pendency of the Merger could disrupt our business in the following ways, among others:
Our current and prospective employees could experience uncertainty about their future roles, and this uncertainty might adversely affect our ability to retain, recruit and motivate key personnel;
the attention of our management may be directed towards the completion of the Merger and other transaction-related considerations and may be diverted from our day-to-day business operations, as applicable, and matters related to the Merger may require commitments of time and resources that could otherwise have been devoted to other opportunities that might have been beneficial to us;
customers, prospective customers, suppliers, collaborators and other third parties with business relationships with us may decide not to renew or may decide to seek to terminate, change or renegotiate their relationships with us as a result of the Merger, whether pursuant to the terms of their existing agreements with us; and the market price of our common stock may decline to the extent that the current market price reflects a market assumption that the proposed Merger will be completed.
Should they occur, any of these matters could adversely affect our business, or harm our financial condition, results of operations or business prospects.
During the pendency of the Merger, we may not be able to enter into a business combination with another party and will be subject to contractual limitations on certain actions because of restrictions in the Merger Agreement.
Covenants in the Merger Agreement impede our ability to make dispositions or acquisitions or complete other transactions that are not in the ordinary course of business pending completion of the Merger. As a result, if the Merger is not completed, we may be at a disadvantage to our competitors. In addition, while the Merger Agreement is in effect and subject to limited exceptions, each party is prohibited from soliciting, initiating, encouraging or taking actions designed to facilitate any inquiries or the making of any proposal or offer that could lead to the entering into certain extraordinary transactions with any third party, such as a sale of assets, an acquisition, a tender offer, a merger or other business combination outside the ordinary course of business. These restrictions may prevent us from pursuing otherwise attractive business opportunities or other capital structure alternatives and making other changes to our business or executing certain of our business strategies prior to the completion of the Merger, which could be favorable to our stockholders.
Certain provisions of the Merger Agreement may discourage third parties from submitting competing proposals, including proposals that may be superior to the arrangements contemplated by the Merger Agreement.
The terms of the Merger Agreement prohibit each of us and Cullgen from soliciting competing proposals or cooperating with persons making unsolicited takeover proposals, except in limited circumstances if our board of directors determines in good faith, after consultation with its independent financial advisor and outside counsel, that an unsolicited competing proposal constitutes, or would reasonably be expected to result in, a superior competing proposal and that failure to take such action would be reasonably likely to result in a breach of the fiduciary duties of our board of directors.
The Exchange Ratio is not adjustable based on the market price of our common stock, so the Merger consideration at the Closing may have a greater or lesser value than at the time the Merger Agreement was signed.
The Merger Agreement has fixed the Exchange Ratio (as defined in the Merger Agreement) for the Cullgen common stock, and the Exchange Ratio is not adjustable. Any changes in the market price of common stock before the completion of the Merger will not affect the number of shares Cullgen securityholders will be entitled to receive pursuant to the Merger Agreement. Therefore, if before the completion of the Merger, the market price of our common stock declines from the market price on the date of the Merger Agreement, then Cullgen securityholders could receive merger consideration with substantially lower value. Similarly, if before the completion of the Merger, the market price of our common stock increases from the market price on the date of the Merger Agreement, then Cullgen securityholders could receive merger consideration with substantially more value for their shares of Cullgen common stock than the parties had negotiated for in the establishment of the Exchange Ratio.
We are expected to incur substantial expenses related to the Merger with Cullgen.
We expect to continue to incur, substantial expenses in connection with the Merger, as well as operating as a public company. We will incur significant fees and expenses relating to legal, accounting, financial advisory and other transaction fees and costs associated with the Merger. Actual transaction costs may substantially exceed our estimates and may have an adverse effect on our financial condition and operating results.
Failure to complete the Merger could negatively affect the value of our common stock and our future business and financial results.
If the Merger is not completed, our ongoing business could be adversely affected. Moreover, we will be subject to a variety of risks associated with the failure to complete the Merger, including without limitation the following:
diversion of management focus and resources from operational matters and other strategic opportunities while working to implement the Merger;
reputational harm due to the adverse perception of any failure to successfully complete the Merger; and having to pay certain costs relating to the Merger, such as legal, accounting, financial advisory, filing and printing fees.
If the Merger is not completed, the market price of our common stock and our business and financial results could be materially affected.
The Merger may be completed even though material adverse changes may result from the announcement of the Merger, industry-wide changes or other causes.
In general, either party can refuse to complete the Merger if there is a material adverse effect affecting the other party between March 2, 2026, the date of the Merger Agreement, and the Closing of the Merger. However, some types of changes do not permit either party to refuse to complete the Merger, even if such changes would have a material adverse effect on us or Cullgen, as the case may be:
general economic or political conditions or conditions generally affecting the industries in which the parties operate;
any natural disaster, calamity or epidemics, pandemics or other force majeure events, or any act or threat of terrorism or war, any armed hostilities or terrorist activities (including any escalation or general worsening of any of the foregoing) anywhere in the world or any governmental or other response or reaction to any of the foregoing; or changes in GAAP or other applicable law or the interpretation thereof.
If adverse changes occur but we and Cullgen must still complete the Merger, the market price of our common stock may suffer.
We and/or our board of directors may become involved in securities litigation or stockholder derivative litigation in connection with the Merger, and this could divert the attention of our management and harm our business, and insurance coverage may not be available or sufficient to cover all related costs, expenses, and damages.
Securities litigation or stockholder derivative litigation frequently follows the announcement of certain significant business transactions, such as the sale of a business division or announcement of a business combination transaction. We or our board of directors may become involved in this type of litigation in connection with the Merger, and we may become involved in this type of litigation in the future. Litigation often is expensive and diverts management’s attention and resources, which could adversely affect our business.
We are substantially dependent on our remaining employees, key contractors and consultants to facilitate the consummation of the Merger.
Our ability to successfully complete the Merger depends in large part on our ability to retain certain remaining personnel, in addition to key contractors and consultants. Despite our efforts to retain these employees, as well as key contractors and consultants, one or more may terminate their employment or services with us on short notice. The loss of the service of certain employees, key contractors or consultants could potentially harm our ability to consummate the Merger and run our day-to-day business operations, as well as fulfill our reporting obligations as a public company.
Our business is significantly dependent on the sales of ETUARY,ETUARY®, one of our marketed productproducts in the PRC, amid a competitive landscape, and there is a possibility that we may not be able to sustain or boost the sales volume, pricing, and profitability of ETUARY.ETUARY®.
We are a biotechnology company and have onlyprimarily generated revenues from the commercial sale of ETUARY,ETUARY®, which is approved in the PRC, Etorel®, Contiva® and certain generic drugs. We only have onethree productproducts and certain generic drugs for commercial sale and are still in the early stages of development of our other product candidates. We are largely dependent on sales of ETUARY,ETUARY®, but we may not be able to maintain ETUARY’sETUARY®’s sales volumes, pricing levels or profit margins. Sales of ETUARY® accounted for 99.3%91.0% and 98.9%99.3% of our total revenue in 20242025 and 2023,2024, respectively, and we expect that sales of ETUARY® will continue to comprise a substantial portion of our total revenue in the near future. In 2025, we initiated commercialization of Etorel® and Contiva®, which accounted for 4.0% and 4.7% of our total revenue in 2025, respectively. However, our commercialization efforts, including increasing market access, physician education and patient support programs, for Etorel® and Contiva® may not successful and we may not be able to develop sufficient sales volume, optimal pricing or sustained profitability of Etorel® or Contiva®, and sales of Etorel® and Contiva® may not offset any future declines in ETUARY® sales. As a result, any reduction in sales or profit margins of ETUARY® will have a material negative impact on our business and results of operations.
In addition, the pharmaceutical industries are characterized by rapid changes in technology, constant enhancement of industrial know-how and frequent emergence of new products, which renders our targeted markets highly competitive. Notably, the IPF drug market in the PRC is characterized by increasingly fierce competition, with several pirfenidone and nintedanib products approved and commercialized, in addition to our products ETUARY®, Etorel® and nintedanib, which Gyre Pharmaceuticals acquired the commercial rights to in May 2024.Contiva®. There are also several drug candidates that have entered into Phase 2 or more advanced clinical trial stage. With the increase in the penetration rate of IPF drugs and the expansion of the overall market, including past new market participants, we expect that more market players will join the IPF market, and, consequently, the sales of ourETUARY®, productEtorel® ETUARYand Contiva® may decrease. For details, see “—Business—Our ProductsCommercial andPortfolio—Pulmonary Product PipelineFibrosis—ETUARY:® National Category 1.1 New Drug for IPF Approved in 2011—Market Opportunities and Competition(pirfenidone)” in this Annual Report. New entrants to the IPF market in the PRC may exert downward pressure on our average selling price of ETUARY,ETUARY®, Etorel® and/or Contiva®, which may negatively impact sales and/or profit of ETUARY.ETUARY®, Etorel® and/or Contiva®, respectively.
Many of our competitors, including foreign pharmaceutical companies, may have substantially greater clinical, research, regulatory, manufacturing, marketing, financial and human resources compared to us. Certain of our competitors may be actively engaged in research and development in areas where we have products or where we are developing product candidates or new indications for our existing products. Other companies may discover, develop, acquire or commercialize products more quickly or more successfully than we do. Moreover, there may also be significant consolidation in the pharmaceutical industry among our competitors or ventures among competitors that may increase their market share. Furthermore, our competitors may apply for and obtain marketing approvals in the PRC, United States or other countries for products with the same intended use as our generic products, ETUARY®, Etorel®, Contiva® and product candidates more rapidly than we do. The capacity of the relevant authorities, such as the NMPA, FDA or other comparable foreign regulatory authorities, to concurrently review multiple marketing applications for the same type of innovative drug may be limited. Therefore, such authorities’ review of our product candidates may be delayed when there is concurrent review of our product candidates with our competitors’ products, and the registration process of our products may be prolonged.
In addition to market competition from generic drugs and other products or therapies indicated for the same disease, many of the factors discussed in this Risk Factors section could adversely affect sales of ETUARY,ETUARY®, Etorel® and Contiva® including but not limited to, pricing pressures caused by government policies and inclusion or removal from the governmental medical insurance coverage, market acceptance among the medical community, disruptions in manufacturing or distribution, issues with product quality or side effects and disputes over intellectual property. Moreover, despite our efforts, we may be unable to achieve expected sales of Etorel® and Contiva® or develop or acquire new products that would diversify our business and reduce our dependence on ETUARY.ETUARY®.
The future of our business and financial outcomes is largely contingent on the progress and success of our product candidates in clinical and pre-clinicalpreclinical stages, such as ETUARY® for future indications in the PRC, F573 in the PRC, and F351Hydronidone in the PRC and in additional markets beyond the PRC. We face the risk of not being able to finalize their clinical development, secure necessary regulatory approvals, or accomplish their market launch successfully, or we may encounter substantial setbacks in these processes.
Management's Discussion & Analysis (MD&A)
New heading “Our Commercial Portfolio”
New heading “ETUARY® (pirfenidone)”
New heading “Etorel® (nintedanib esilate soft capsules)”
New heading “Contiva® (avatrombopag maleate tablets)”
New heading “Our Product Candidate Pipeline”
New heading “CHB-Associated Liver Fibrosis (PRC)”
New heading “MASH-Associated Liver Fibrosis (United States)”
New heading “Other Product Candidates”
New heading “Etorel® IP Rights”
New heading “SDM Service Agreement”
Removed heading “F351 Asset Acquisition”
Removed heading “Business Combination Agreement”
Removed heading “Reverse Stock Split”
Removed heading “Jiangsu Wangao Agreement”
Removed heading “** Not meaningful.”
Removed heading “Divestiture Losses”
Removed heading “Loss on Disposal of Property and Equipment”
Removed heading “Other Contractual Obligations and Commitments”
Largest changes
Full comparison: every changed paragraph (125)
We are a commercial-stage biopharmaceutical company focused on the development and commercialization of small-molecule therapies for the treatment of organ fibrosis and inflammatory diseases. We operate through our majority indirectly owned subsidiary, Gyre Pharmaceuticals, in the PRC, and through our U.S. operations headquartered in San Diego, California.
Our strategy is to leverage our established commercial portfolio to support and de-risk the advancement of late-stage product candidates, expand approved products into additional indications, and build a diversified pipeline targeting significant unmet medical needs in fibrosis and related inflammatory diseases.
On March 2, 2026, we entered into the Merger Agreement with Cullgen and Merger Sub, pursuant to which, among other matters, and subject to the satisfaction or waiver of the conditions set forth in the Merger Agreement, Merger Sub will merge with and into Cullgen, with Cullgen continuing as a wholly owned subsidiary of Gyre and the surviving corporation of the Merger. The Merger is intended to qualify for federal income tax purposes as a tax-free reorganization under the provisions of Section 368(a) of the Internal Revenue Code of 1986, as amended.
The consummation of the Merger is subject to certain closing conditions, including, among other things, (1) approval by the requisite Cullgen stockholders of the adoption and approval of the Merger Agreement and the transactions contemplated thereby, and (2) a filing under the HSR Act.
There can be no assurances that the Merger will be successfully consummated, and the intended benefits of the Merger may not be realized.
Our Commercial Portfolio
ETUARY® (pirfenidone)
Pirfenidone is a small-molecule anti-fibrotic therapy for the treatment of IPF. It was first approved in Japan and subsequently approved in the PRC, the EU, and the United States. These approvals were obtained by different sponsors in their respective jurisdictions under separate regulatory frameworks.
In the PRC, we conducted independent research and development to support our regulatory submission and received first-in-class approval in 2011 as a National Category 1.1 New Drug. We commercialized pirfenidone under the brand name ETUARY®, which was included in the NRDL in 2017 and has since maintained a leading market position.
In addition to IPF, we are pursuing potential label expansion into additional indications in the PRC, including PD, for which, in 2025, we completed enrollment of 272 patients in our 52-week Phase 3 trial, and RILI, including cases with or without immune-related pneumonitis, for which the NMPA approved our clinical trial application in March 2025, and we expect to initiate an adaptive Phase 2/3 study in the first half of 2026.
Etorel® (nintedanib esilate soft capsules)
In May 2024, Gyre Pharmaceuticals entered into a comprehensive agreement with Jiangsu Wangao Pharmaceuticals Co., Ltd. to obtain the drug registration certificate for Etorel® (nintedanib) and become the marketing authorization holder in the PRC. Etorel® is approved as a standard-of-care therapy for IPF, SSc-ILD, and PF-ILD. The addition of Etorel® to our commercial portfolio expanded treatment options for patients and strengthened Gyre’s leading position in the pulmonary fibrosis market. Commercialization of Etorel® in the PRC commenced in June 2025.
On November 7, 2025, the NHSA released the Announcement of the Winning Bids for the National Centralized Drug Procurement, under which Etorel® was selected. As of the filing date, we are in the process of entering into procurement contracts with various participating hospitals under the National Centralized Drug Procurement program. We are currently assessing the potential impact of this development on its future operating performance.
Contiva® (avatrombopag maleate tablets)
In June 2021, Gyre Pharmaceuticals acquired avatrombopag maleate tablets pursuant to a transfer agreement with Nanjing Healthnice Pharmaceutical Technology Co., Ltd. Avatrombopag is an oral thrombopoietin receptor agonist. In June 2024, the NMPA approved avatrombopag maleate tablets for the treatment of TP associated with CLD in adult patients undergoing elective diagnostic procedures or therapy. In January 2025, the NMPA approved an additional indication for chronic ITP. Gyre Pharmaceuticals commenced commercialization of avatrombopag under the brand name Contiva® in the PRC in March 2025.
Our Product Candidate Pipeline
Hydronidone
Hydronidone is our lead development candidate for the treatment of liver fibrosis. 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. We are developing Hydronidone for two primary indications: CHB-associated liver fibrosis in the PRC and MASH-associated liver fibrosis in the United States. Hydronidone represents our primary liver-focused development program and reflects our commitment to advancing therapies targeting both viral- and metabolic-associated liver fibrosis.
CHB-Associated Liver Fibrosis (PRC)
For CHB-associated liver fibrosis, antiviral therapy may suppress viral infection but is not able to prevent, slow or reverse fibrosis progression, and anti-fibrotic treatment is recommended for intermediate and advanced liver fibrosis and early-stage cirrhosis. As of December 31, 2025, no small molecule or biologic drugs treating CHB-associated liver fibrosis have been approved globally. In recognition of the severity of the disease and the preliminary clinical evidence generated to date, the CDE of the NMPA granted Hydronidone Breakthrough Therapy designation in March 2021.
We conducted a Phase 3 randomized, double-blind, placebo controlled, Entecavir-based, multi-center trial in the PRC assessing Hydronidone in CHB-associated liver fibrosis. This trial was designed to randomize 248 patients, with a primary endpoint of ≥1-stage reduction in Ishak fibrosis score at Week 52 for Hydronidone in combination with Entecavir.
In May 2025, we reported that in the pivotal Phase 3 trial, Hydronidone met its primary endpoint: 52.85% of treated patients achieved ≥1-stage fibrosis regression at Week 52, compared with 29.84% in the placebo group (p=0.0002), based on centralized, blinded Ishak histologic assessment. Hydronidone also met a key secondary endpoint with statistically significant inflammation improvement without fibrosis progression at Week 52 versus placebo. Hydronidone was well tolerated, with a comparable incidence of serious adverse events (4.88% vs. 6.45% in placebo) and no discontinuations due to adverse events in the Hydronidone group.
Following our pre-NDA meeting in December 2025, the CDE indicated that the existing Phase 3 data support submission for conditional approval and potential priority review eligibility, subject to formal acceptance and approval by the NMPA. We currently expect to submit an NDA seeking conditional approval in the first half of 2026, subject to completion of regulatory and technical preparations.
MASH-Associated Liver Fibrosis (United States)
In the United States, we have completed a Phase 1 clinical trial in healthy volunteers evaluating Hydronidone’s safety, tolerability, and PK. We continue to engage with the FDA regarding IND requirements for a Phase 2 clinical trial in MASH-associated liver fibrosis. Pending regulatory feedback, we intend to file a U.S. IND in 2026 and, if the IND becomes effective, initiate a Phase 2 clinical trial.
Other Product Candidates
We have completed a Phase 1 clinical trial of F573 in healthy volunteers in the PRC and are currently evaluating it in a multi-stage Phase 2 clinical trial initiated in March 2023 in patients with liver injury and liver failure. The Phase 2 clinical trial is expected to be completed in 2026.
F230 is our clinical-stage product candidate for the treatment of PAH in the PRC. F230 is a selective endothelin receptor A antagonist designed to address vascular remodeling and elevated pulmonary arterial pressure associated with PAH. F230 complements our broader organ-focused portfolio by expanding our development efforts into pulmonary vascular disease while remaining aligned with our strategy of targeting fibrotic and inflammatory pathways across organ systems. We submitted an IND application for F230 to the NMPA in March 2024, and the IND was approved in May 2024. The first subject was enrolled in the Phase 1 clinical trial in June 2025.
F528 is our preclinical-stage product candidate for the treatment of COPD in the PRC. F528 is an anti-inflammatory small-molecule compound designed to inhibit multiple inflammatory cytokines and potentially modify disease progression. F528 expands our pulmonary-focused development efforts beyond fibrosis and vascular disease into chronic inflammatory respiratory conditions, supporting our broader strategy of addressing organ diseases driven by inflammatory and fibrotic pathways. We anticipate submitting an IND application to the NMPA for F528 in the first quarter of 2027.
We are a commercial-stage biotechnology company with a proven track record of financial success developing and commercializing 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 and 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 build on our success in the development and commercialization of ETUARY® (pirfenidone) to expand into new indications and advance our pipeline of innovative drug candidates. Pirfenidone, the first anti-fibrotic drug approved for IPF in Japan, the EU, the United States, and the PRC, is a small molecule drug that inhibits the synthesis of TGF-ß1, Tumor Necrosis Factor-α, 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 to commercialization in the PRC for the treatment of IPF. In addition to IPF, pirfenidone is undergoing one additional Phase 3 trial in the PRC for the treatment of pneumoconiosis (“PD”) to broaden its indications and market. In May 2024, Gyre Pharmaceuticals executed a comprehensive agreement with Jiangsu Wangao Pharmaceuticals Co., Ltd. to acquire the commercial rights to nintedanib, a small-molecule drug for the treatment of IPF. With this acquisition, we acquired the other product approved for the treatment of IPF, which is currently approved globally for the treatment of IPF. Nintedanib is expected to provide patients with more choices and benefits, and further enhance Gyre Pharmaceuticals’ leading position in the pulmonary fibrosis market. Gyre Pharmaceutical is planning to initiate commercialization of the nintedanib product in the PRC in 2025, which is to help offset declines in ETUARY sales as a result of the fluctuations in the Chinese economy significantly affecting demand for anti-fibrosis drugs and decreasing healthcare spending generally. We believe that this launch can drive meaningful revenue growth, expand our market penetration, and enhance brand recognition within the respiratory disease space. Additionally, the commercialization of nintedanib aligns with our broader strategy of building a comprehensive pulmonary care portfolio, potentially creating opportunities for synergies with our existing and future product offerings. We expect to continue to invest in commercialization efforts, including market access, physician education, and patient support programs, to optimize uptake and maximize the long-term value of this product.
F351, our lead development candidate in both the United States and the PRC, is a structural derivative of ETUARY (pirfenidone). It is a new oral chemical entity with an anti-fibrotic, TGF-ß1-targeting mechanism of action. Studies suggest that F351 and its major metabolites have minimal drug-drug interaction risks. We are prioritizing F351 for the treatment of liver fibrosis due to the large potential addressable market and significant unmet need.
Gyre Pharmaceuticals has completed a Phase 2 trial of F351 in the PRC for CHB-associated liver fibrosis. The Phase 2 trial showed that F351 was well-tolerated without notable toxicity and patients treated showed statistically-significant improvement of liver fibrosis, with the best efficacy results achieved at 270 mg/day dosing. Based on these results, a confirmatory Phase 3 trial is ongoing in the PRC with a primary endpoint of the reduction of the liver fibrosis score (Ishak Scoring System) by at least one stage after taking F351 in combination with Entecavir. In October 2024, the last patient completed the 52-week pivotal Phase 3 trial. Gyre Pharmaceuticals expects to report top-line data from this trial by the second quarter of 2025.
In the United States, we have completed a Phase 1 clinical trial of F351 in healthy volunteers. Following results from the PRC Phase 3 trial in CHB-associated liver fibrosis and pending approval of an IND submission, we expect to initiate a Phase 2 trial to evaluate F351 for the treatment of MASH-associated liver fibrosis in 2025. We cannot guarantee that a Phase 2 trial will be initiated or estimate the funding needed for such trial at this time, but may need to raise additional capital to fund this program.
In parallel, we are also conducting a randomized, double-blind, placebo-controlled Phase 2 clinical trial in the PRC to assess the safety and efficacy of F573, a caspase inhibitor for the treatment of acute/acute on-chronic liver failure. In addition, in May 2024, we obtained the approval from the NMPA for the IND to launch a new clinical trial in the PRC of another new drug candidate, F230, a selective endothelin receptor agonist for the treatment of pulmonary arterial hypertension. We are preparing for the anticipated launch of the clinical trial in the PRC. We are also evaluating F528, a novel anti-inflammation agent that targets the inhibition of multiple inflammatory cytokines, in preclinical studies as a potential first-line therapy for the treatment of chronic obstructive pulmonary disease.
In June 2024, Gyre Pharmaceuticals received approval from the NMPA for avatrombopag maleate tablets for the treatment of TP with CLD and ITP disease indications. TP is the most common hematologic complication in patients with CLD and can be life threatening in severe cases. Avatrombopag is an oral thrombopoietin receptor agonist. Avatrombopag was approved by the U.S. Food and Drug Administration for the treatment of adults with CLD-associated TP in May 2018, and its indication was subsequently expanded to include the treatment of immune thrombocytopenia in June 2019. Gyre Pharmaceuticals acquired avatrombopag under a transfer agreement with Nanjing Healthnice Pharmaceutical Technology, Co., Ltd. (“Nanjing Healthnice”) in June 2021 and is planning to start commercializing the avatrombopag product by 2025.
F351 Asset Acquisition
On December 26, 2022, we purchased the F351 Assets from GNI Japan and GNI Hong Kong, other than such assets and intellectual property rights located in the PRC, pursuant to the F351 Agreement.
Business Combination Agreement
On December 26, 2022, Catalyst entered into a Business Combination Agreement, as amended on March 29, 2023 and August 30, 2023 (the “Business Combination Agreement”) with GNI USA, GNI Japan, GNI Hong Kong, SG (collectively with GNI USA, GNI Japan and GNI Hong Kong, the “Contributors,” and each a “Contributor”), certain individuals and CPI. On October 30, 2023 (the “Effective Time”), the Contributions (as defined below) became effective and Catalyst acquired an indirect controlling interest in Beijing Continent Pharmaceuticals Co., Ltd. (doing business as Gyre Pharmaceuticals Co., Ltd.).
Pursuant to the Business Combination Agreement, at the Effective Time of the Contributions, and after giving effect to the 1-for-15 reverse stock split:
a)
GNI USA contributed all of its ordinary shares in the capital of CPI to Catalyst in exchange for 45,923,340 shares of Common Stock (the “CPI Contribution”), b) GNI USA contributed its interest in Further Challenger International Limited (“Further Challenger”) for 17,664,779 shares of Common Stock (the “FC Contribution” and together with the CPI Contribution, the “GNI USA Contributions”), and c) each Minority Holder contributed 100% of the interest he or she held in his or her respective entity in exchange for an aggregate of 10,463,627 shares of Common Stock (the “Minority Holder Contributions” and together with the GNI USA Contributions, the “Contributions”).
As a result of the GNI USA Contributions, Gyre directly and indirectly holds 100% of CPI’s shares. Through Gyre’s ownership of CPI, prior to the Minority Holder Contributions, Gyre held a 56.0% indirect interest in Gyre Pharmaceuticals. Upon completion of the Minority Holder Contributions, Gyre obtained additional indirect interests in Gyre Pharmaceuticals and holds, in aggregate, a 65.2% indirect interest in Gyre Pharmaceuticals.
At the Effective Time, Gyre Pharmaceuticals terminated its 2021 Stock Incentive Plan (the “2021 Plan”) and the options (the “Gyre Pharmaceuticals Options”) outstanding under the 2021 Plan were terminated and replaced with options granted under a subplan for Chinese participants under the Gyre 2023 Omnibus Incentive Plan (the “2023 Omnibus Incentive Plan”) that are substantially similar in all material respects to the Gyre Pharmaceuticals Options previously outstanding under the 2021 Plan.
The majority shareholder of Gyre Pharmaceuticals is BJContinent Pharmaceuticals Limited (“BJC”). The immediate holding company of BJC is CPI. Immediately following the GNI USA Contributions, the immediate holding company of CPI is Gyre. The majority stockholder of Gyre is GNI USA, which is indirectly wholly owned by GNI Japan.
The GNI USA Contributions were treated as an asset acquisition under U.S. generally accepted accounting principles (“U.S. GAAP”), with CPI treated as the accounting acquirer and presented as the predecessor for post-acquisition reporting purposes. Since Catalyst is the legal acquirer, the GNI USA Contributions were accounted for as a reverse asset acquisition. This determination was based upon the terms of the Business Combination Agreement and other factors including that, immediately following the GNI USA Contributions: (i) GNI USA (as the parent company of CPI immediately prior to the GNI USA Contributions) owns a substantial majority of the voting power of the combined company; (ii) GNI USA has the ability to control the board of directors of the combined company; and (iii) senior management of Gyre Pharmaceuticals and GNI USA hold a majority of the key positions in senior management of the combined company. Immediately prior to the closing of the GNI USA Contributions, Catalyst did not meet the definition of a business because Catalyst did not have an organized workforce that significantly contributed to its ability to create output, and substantially all of its fair value was concentrated in in-process research and development (“IPR&D”).
As of the closing date of the GNI USA Contributions, the net assets of Catalyst were recorded at their acquisition-date relative fair values in the consolidated financial statements included in Part II, Item 8 of this Annual Report on Form 10-K and the reported operating results prior to the GNI USA Contributions are those of CPI.
The Minority Holder Contributions were treated as an equity transaction, where we obtained additional indirect interests in and maintained our control over Gyre Pharmaceuticals.
Concurrent with the signing of the Businesspreviously Combinationdisclosed Agreementbusiness combination agreement pursuant to which we acquired an indirect controlling interest in Gyre Pharmaceuticals, on December 26, 2022, Catalystthe Company and the Rights Agent (as defined in the CVR Agreement) executed a contingent value rights agreement (the “CVR Agreement”), as amended on March 29, 2023, pursuant to which each CVR Holder,Holder (as defined in the CVR Agreement), excluding GNI Japan and GNI Hong Kong,Kong Limited, received one contractual contingent value right (a “CVR”) issued by the Company for each share of Catalyst common stock held by such holders. Each CVR entitles the CVR Holder thereof to receive certain cash payments in the future. ForIn additionalthe information,first seequarter Noteof 132025, —we Commitmentshad fully settled the CVR liability and Contingenciescollected all outstanding amounts related to theCVR consolidated financial statements included in Part II, Item 8 of this Annual Report on Form 10-K.receivables.
Reverse Stock Split
On October 30, 2023, we effected a 1-for-15 reverse stock split immediately prior to the Effective Time of the Contributions. The par value of the Catalyst Common Stock following the Reverse Stock Split was not adjusted and remains at $0.001 per share. All of the Catalyst’s issued and outstanding common stock and options have been retroactively adjusted to reflect this Reverse Stock Split for all periods presented.
All share and per share information has been retroactively adjusted to give effect to the Reverse Stock Split for all periods presented, unless otherwise indicated. Proportionate adjustments were made to the per share exercise price and the number of shares issuable upon the exercise or vesting of all stock options and warrants outstanding, which resulted in a proportional decrease in the number of shares of our common stock reserved for issuance upon exercise or vesting of such stock options, warrants, and in the case of stock options and warrants, a proportional decrease in the exercise price of such stock options and warrants.
No fractional shares were issued in connection with the Reverse Stock Split and stockholders who would otherwise be entitled to a fraction of one share received a proportional cash payment.
PrivateShare PlacementCapital and Securities PurchaseIncrease Agreement
In the third quarter of 2025, pursuant to an agreement previously entered into by and among BJContinent Pharmaceuticals Limited (“BJC”), Gyre Pharmaceuticals and the other parties thereto, BJC increased its capital contribution in Gyre Pharmaceuticals by $1.28 million in exchange for 9,184,910 additional shares of Gyre Pharmaceuticals. As a result, our indirect interest in Gyre Pharmaceuticals increased from 65.2% to 69.7%.
On October 27, 2023, we entered into the Securities Purchase Agreement for a private placement with GNI USA (the “Private Placement”). Pursuant to the Securities Purchase Agreement, GNI USA agreed to purchase (i) 811 shares of our Convertible Preferred Stock, par value $0.001 per share (the “Convertible Preferred Stock”) and (ii) warrants to purchase up to 811 shares of Convertible Preferred Stock (the “Preferred Stock Warrants”) for an aggregate purchase price of $5.0 million. The Private Placement closed immediately after the closing of the Contributions.
The Preferred Stock Warrants are exercisable at an exercise price of $4,915.00 per share of Convertible Preferred Stock and expire on October 30, 2033.
Jiangsu Wangao Agreement
What changed in the latest 10-Q
Risk Factors
New heading “Our common stock is thinly traded and our outstanding shares are concentrated among a small number of holders. Sales of a substantial number of shares of our common stock, including in connection with the expiration of contractual lock-up agreements or any foreclosure upon shares pledged by our controlling stockholder, or the perception that such sales could occur, could cause the market price of our common stock to decline significantly.”
Largest changes
“In that regard, GNI Japan has publicly disclosed that on June 26, 2026 it entered into a loan agreement with Mizuho Bank, Ltd. and SBI Shinsei Bank, Limited providing for a JPY 20 billion term loan to finance GNI Japan’s acquisition of Ayumi Pharmaceutical Holdings Co., Ltd. and related expenses, and that the loan is secured by a pledge of shares of our common stock held by the GNI Parties. …”see in full comparison
“Our common stock is thinly traded and our outstanding shares are concentrated among a small number of holders. Sales of a substantial number of shares of our common stock, including in connection with the expiration of contractual lock-up agreements or any foreclosure upon shares pledged by our controlling stockholder, or the perception that such sales could occur, could cause the market price of our common stock to decline significantly.”see in full comparison
“Ownership of our common stock is highly concentrated. GNI Japan and its subsidiaries, including GNI USA (collectively, the “GNI Parties”), beneficially own a majority of our outstanding common stock, and our directors, executive officers and other principal stockholders hold a substantial portion of the remainder. As a result, the number of shares available for trading in the public market is limited, and the trading volume of our common stock is modest. …”see in full comparison
“Substantial sales of our common stock could occur through a number of channels. Shares may be sold under our effective registration statements, including registration statements covering resales by existing holders, or under Rule 144 following the expiration of contractual lock-up agreements, including the lock-up agreements entered into in connection with our acquisition of Cullgen that expire in stages beginning six months after the May 4, 2026 closing. …”see in full comparison
You should carefully consider the factors discussed in Part I, Item 1A, “Risk Factors” in our Annual Report, which could materially affect our business, financial position, or future results of operations. The risks described in our Annual Report are not the only risks we face. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial position, or future results of operations. We may disclose changes to such factors or disclose additional factors from time to time in our future filings with the SEC.see in full comparisonThereExcept for the addition of the risk factor set forth below, there have been no material changes from the risk factors disclosed in Part I, Item 1A, “Risk Factors” in our Annual Report.
Full comparison: every changed paragraph (5)
You should carefully consider the factors discussed in Part I, Item 1A, “Risk Factors” in our Annual Report, which could materially affect our business, financial position, or future results of operations. The risks described in our Annual Report are not the only risks we face. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial position, or future results of operations. We may disclose changes to such factors or disclose additional factors from time to time in our future filings with the SEC. ThereExcept for the addition of the risk factor set forth below, there have been no material changes from the risk factors disclosed in Part I, Item 1A, “Risk Factors” in our Annual Report.
Our common stock is thinly traded and our outstanding shares are concentrated among a small number of holders. Sales of a substantial number of shares of our common stock, including in connection with the expiration of contractual lock-up agreements or any foreclosure upon shares pledged by our controlling stockholder, or the perception that such sales could occur, could cause the market price of our common stock to decline significantly.
Ownership of our common stock is highly concentrated. GNI Japan and its subsidiaries, including GNI USA (collectively, the “GNI Parties”), beneficially own a majority of our outstanding common stock, and our directors, executive officers and other principal stockholders hold a substantial portion of the remainder. As a result, the number of shares available for trading in the public market is limited, and the trading volume of our common stock is modest. Sales of a substantial number of shares of our common stock in the public market, or the perception that these sales could occur, could exceed the capacity of the trading market to absorb them at prevailing prices and could cause the market price of our common stock to decline significantly, and the concentration of our ownership and limited trading volume may make it difficult for our other stockholders to sell shares at the times and prices they consider appropriate.
Substantial sales of our common stock could occur through a number of channels. Shares may be sold under our effective registration statements, including registration statements covering resales by existing holders, or under Rule 144 following the expiration of contractual lock-up agreements, including the lock-up agreements entered into in connection with our acquisition of Cullgen that expire in stages beginning six months after the May 4, 2026 closing. In addition, holders of our common stock, including the GNI Parties and our directors and officers, may from time to time pledge their shares to secure indebtedness or other obligations, and a foreclosure upon pledged shares could result in the sale of a substantial number of shares at times and prices over which neither we nor the pledgor has control.
In that regard, GNI Japan has publicly disclosed that on June 26, 2026 it entered into a loan agreement with Mizuho Bank, Ltd. and SBI Shinsei Bank, Limited providing for a JPY 20 billion term loan to finance GNI Japan’s acquisition of Ayumi Pharmaceutical Holdings Co., Ltd. and related expenses, and that the loan is secured by a pledge of shares of our common stock held by the GNI Parties. According to GNI Japan’s public disclosures, the loan was funded on July 1, 2026, matures on July 1, 2027 and is repayable in a single payment at maturity, and the loan agreement contains financial covenants tied to GNI Japan’s consolidated financial results that are tested as of the end of each of GNI Japan’s fiscal years, beginning with the fiscal year ending December 31, 2026. The loan agreement may also contain events of default and other terms that have not been publicly disclosed. If there was a default under the loan agreement, the lenders could foreclose upon and sell the pledged shares. Given the limited trading volume of our common stock, sales of all or a portion of the pledged shares, or the perception that such sales could occur, could cause the market price of our common stock to decline significantly. A foreclosure upon and sale of the pledged shares could also result in a change in control of the Company, could cause us to cease to qualify as a “controlled company” under Nasdaq rules and could result in one or more new significant stockholders whose interests may differ from those of our other stockholders.
Management's Discussion & Analysis (MD&A)
New heading “Pipeline Assets Following Cullgen Acquisition”
New heading “TRKA Degrader for Pain (CG001419)”
New heading “TRKA Degrader for Solid Tumors (CG001419)”
New heading “GSPT1 Degrader for AML (CG009301)”
New heading “CDK2-Cyclin E Dual Degrader for Solid Tumors (CG923308)”
New heading “TYK2-JAK1 Degrader for Autoimmune Diseases (CG620953)”
New heading “Degrader – Antibody Conjugates (“DACs”) as the Next-Generation of Antibody-Drug Conjugates (“ADCs”)”
New heading “Comparison of the six months ended June 30, 2026 and 2025”
New heading “Cost of Revenues”
New heading “Selling and Marketing Expenses”
New heading “Research and Development Expenses”
New heading “General and Administrative Expenses”
New heading “Change in Fair Value of Warrant Liability”
New heading “Other (loss) income, Net”
New heading “Provision for Income Taxes”
Largest changes
“Degrader – Antibody Conjugates (“DACs”) as the Next-Generation of Antibody-Drug Conjugates (“ADCs”)”see in full comparison
“Revenues for the three months ended June 30, 2026 and 2025 were $29.1 million and $29.7 million, respectively, representing a decrease of $0.6 million, or 2%. Gyre Pharmaceuticals revenue increased during the period, primarily driven by higher ETUARYTM sales volumes resulting from ETUARYTM focused marketing efforts, despite lower ContivaTM and EtorelTM product revenues earned following the implementation of China's national centralized procurement program. …”see in full comparison
“Revenues for the six months ended June 30, 2026 and 2025 were $53.5 million and $60.3 million, respectively, representing a decrease of $6.8 million or 11%. Revenue from Gyre Pharmaceuticals increased during the period, primarily driven by higher ETUARYTM sales volumes resulting from ETUARYTM focused marketing efforts, despite lower ContivaTM and EtorelTM product revenues following the implementation of China's national centralized procurement program. …”see in full comparison
Full comparison: every changed paragraph (89)
In this Quarterly Report on Form 10-Q (this “Quarterly Report”), unless otherwise specified, references to “we,” “our,” “us” and “our company” refer to Gyre Therapeutics, Inc. ("Gyre"), its directly owned subsidiary, Cullgen Inc. (“Cullgen”), and our majority indirectly owned subsidiary, Beijing Continent Pharmaceuticals Co., Ltd. (d/b/a Gyre Pharmaceuticals Co., Ltd.) (“Gyre Pharmaceuticals”). The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the unaudited condensed consolidated financial statements and related notes that appear in this Quarterly Report and with the audited consolidated financial statements and related notes that are included as part of our Annual Report on Form 10-K for the year ended December 31, 2025 (the “Annual Report”).
Our strategy is to leverage our established commercial portfolio to support and de-risk the advancement of late-stage product candidates, expand approved products into additional indications, and build a diversified pipeline targeting significant unmet medical needs in fibrosis and related inflammatory diseases.
In May 2026, we acquired Cullgen Inc., a Delaware corporation (“Cullgen”), in accordance with the terms of the Agreement and Plan of Merger and Reorganization, dated March 2, 2026 (the “Merger Agreement”), by and among the Company, Helix Merger Sub Corp., a Delaware corporation and wholly owned subsidiary of the Company (“Merger Sub”), and Cullgen. Pursuant to the Merger Agreement, among other matters, Merger Sub merged with and into Cullgen, with Cullgen continuing as a wholly owned subsidiary of the Company and the surviving corporation of the merger (the “Merger”). The related transaction costs were expensed as incurred. See Note 16 — Subsequent Events to the unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report.
Cullgen is a clinical-stage biopharmaceutical company focused on the discovery and development of targeted protein degrader and degrader-antibody conjugate therapies designed to improve the lives of patients suffering from critical conditions such as pain, cancer and inflammatory diseases. Cullgen has created a portfolio of highly selective targeted protein degrader product candidates designed to potently and efficiently eliminate therapeutically relevant proteins in patients. By leveraging its expertise in targeted protein degraders, Cullgen believes its product candidates have many distinct advantages over other therapeutic modalities, including higher selectivity, improved therapeutic profile and avoidance of known toxicities.
TheAs Companyalways, haswe been,are in the process of reviewing our programs and continuesevaluating to be, engaged in an evaluation of itsour pipeline and clinical development strategy, including in connection with the Cullgen acquisition, to optimize capital allocation and prioritize programs across the organization. As a result of the Cullgen acquisition, thewe Company intendsintend to leverage Cullgen’s capabilities in the PRC for the development and early-stage clinical trials of various product candidates.
HydronidoneF351 (hydronidone)
HydronidoneF351 is our lead development candidate for the treatment of liver fibrosis. It is a structurally modified derivative of pirfenidone designed to optimize metabolic properties while targeting the transforming growth factor (“TGF”)-β1 signaling pathway, a key mediator of fibrogenesis. We are developing HydronidoneF351 for two primary indications: chronic hepatitis B (“CHB”)-associated liver fibrosis in the PRC and metabolic dysfunction-associated steatohepatitis (“MASH”)-associated liver fibrosis in the United States. HydronidoneF351 represents our primary liver-focused development program and reflects our commitment to advancing therapies targeting both viral- and metabolic-associated liver fibrosis.
For CHB-associated liver fibrosis, antiviral therapy may suppress viral infection but is not able to prevent, slow or reverse fibrosis progression, and anti-fibrotic treatment is recommended for intermediate and advanced liver fibrosis and early-stage cirrhosis. As of December 31, 2025, no small molecule or biologic drugs treating CHB-associated liver fibrosis have been approved globally. In recognition of the severity of the diseasedisease, lack of current therapies and the preliminary clinical evidence generated to date, the Center for Drug Evaluation (“CDE”) of the NMPA granted HydronidoneF351 Breakthrough Therapy designation in March 2021.
We conducted a Phase 3 randomized, double-blind, placebo controlled, Entecavir-based,entecavir-based, multi-center trial in the PRC assessing HydronidoneF351 in CHB-associated liver fibrosis. This trial was designed to randomize 248 patients, with a primary endpoint of ≥1-stage reduction in Ishak fibrosis score at Week 52 for HydronidoneF351 in combination with Entecavir.entecavir.
In May 2025, we reported that in the pivotal Phase 3 trial, HydronidoneF351 met its primary endpoint: 52.85% of treated patients achieved ≥1-stage fibrosis regression at Week 52, compared with 29.84% in the placebo group (p=0.0002), based on centralized, blinded Ishak histologic assessment. Hydronidoneand also met a key secondary endpoint with statistically significant inflammation improvement without fibrosis progression at Week 52 versus placebo. HydronidoneF351 was well tolerated,tolerated in the study, with a comparable incidence of serious adverse events (4.88% vs. 6.45% in placebo) and no patient discontinuations due to adverse events in the HydronidoneF351 group.
The CDE of the NMPA granted priority review status to the New Drug Application (“NDA”) for HydronidoneF351 in March 2026. On March 22, 2026, Gyre Pharmaceuticals submitted its NDA to the CDE of the NMPA to seek conditional approval for Hydronidone,F351, the Company’s lead product candidate, for the treatment of CHB-induced liver fibrosis. TheOn submissionMay of12, the NDA will be subject to initial formatting and completeness verification, and2026, the Company plansannounced to work withthat the CDENMPA to submit any supplementary materials, if requested by the CDE. Thereafter, the CDE is anticipated to issue to the Company an acceptance number before initiatingaccepted its technical review process.NDA.
In the United States, we have completed a Phase 1 clinical trial in healthy volunteers evaluating Hydronidone’sF351’s safety, tolerability, and PK.pharmacokinetics (“PK”). We continue to engage with the U.S. Food and Drug Administration regarding investigational new drug (“IND”) requirements for a Phase 2 clinical trial in MASH-associated liver fibrosis. Pending regulatory feedback, we intend to file a U.S. IND in 2026 and, if the IND becomes effective, initiate a Phase 2 clinical trial.
Pipeline Assets Following Cullgen Acquisition
On May 4, 2026, Gyre Therapeutics acquired Cullgen Inc. in an all-stock transaction valued at approximately $300 million, and Cullgen became a wholly owned subsidiary of Gyre. Upon the closing of this transaction, Cullgen's former Chief Executive Officer (“CEO”), Dr. Ying Luo, was appointed President and CEO of Gyre and joined Gyre's Board. Additionally, Yue Xiong, former Chief Scientific Officer (“CSO”) of Cullgen, was appointed CSO of Gyre, and Thomas Eastling, former Chief Financial Officer (“CFO”) of Cullgen, was appointed CFO of Gyre, and Ping Zhang was named Executive Chairman. The combined company remains headquartered in San Diego with subsidiaries in Beijing and Shanghai, roughly 740 employees, and numerous announced therapeutic programs spanning inflammation/pain and cancer.
TRKA Degrader for Pain (CG001419)
Gyre acquired Cullgen’s most advanced legacy product candidate, CG001419, an oral tropomyosin receptor kinase A (“TRKA”) degrader. CG001419 has been in development as a non-opioid alternative for pain management and, separately, as a treatment for various indications within oncology.
In December 2025, Cullgen completed a Phase 1 study (NCT06636500) that was a single-center, randomized, placebo-controlled, double-blind, single-ascending-dose/food-effect (with or without food) and multiple-ascending-dose trial that evaluated the safety, tolerability and PK characteristics of CG001419 in 78 healthy volunteers. The study was conducted in Australia after receiving ethics committee approval in early 2025. Results from the study showed that all doses were well-tolerated with no drug-related serious adverse events observed.
TRKA Degrader for Solid Tumors (CG001419)
CG001419 is also currently being studied in a Phase 1 trial for the treatment of solid tumors. TRK proteins also act as oncogenic drivers when mutated or rearranged, leading to uncontrolled cell growth and tumor development. Cullgen’s TRK degrader for cancer is being developed as a selective, clinically active oral TRK degrader for the treatment of adult cancer patients with neurotrophic TRK gene abnormalities. For this indication, CG001419 is being evaluated in a Phase 1 clinical trial in China.
GSPT1 Degrader for AML (CG009301)
Gyre acquired Cullgen’s second product candidate, CG009301, a highly selective degrader targeting the GSPT1 protein for the treatment of cancer, with development initially focused on hematologic malignancies. GSPT1 is a protein translation termination factor and plays a vital role in cancer cell survival and proliferation. Rapidly dividing hematologic cancer cells such as leukemia, including AML and acute lymphoblastic leukemia, high-risk myelodysplastic syndrome (“MDS”) and leukemia stem cells rely on GSPT1 to maintain protein synthesis during oncogenesis. These tumor cells are highly sensitive to GSPT1 depletion, which leads to impaired protein translation, activation of the integrated stress response and TP53-independent cell death. Cullgen initiated a Phase 1, dose-escalation trial in China of CG009301 in patients with high-risk hematologic malignancies in April 2025.
CDK2-Cyclin E Dual Degrader for Solid Tumors (CG923308)
We are developing CG923308, a highly potent and selective dual degrader of both the cyclin dependent kinase 2 (“CDK2”) and cyclin E proteins. In preclinical models of breast cancer resistant to endocrine therapies alone or in combination with a CDK4/6 inhibitor or other solid tumors characterized by cyclin E amplification, CG923308 demonstrated precise target degradation and outperformed the leading, late-stage clinical CDK2 inhibitors in development in blocking cell proliferation and achieving durable tumor suppression. Furthermore, CG923308 exhibits a favorable PK and safety profile. We plan to develop CG923308 for the treatment of solid tumors with CCNE1 amplification or HR+ / HER2- advanced breast cancer with resistance to current therapies. We intend to submit an IND application for CG923308 in the first quarter of 2027.
TYK2-JAK1 Degrader for Autoimmune Diseases (CG620953)
We are developing CG620953, a highly potent and selective dual degrader of Tyrosine kinase 2 (“TYK2”) and Janus kinase 1 (“JAK1”) while sparing JAK2. In preclinical studies, CG620953 demonstrated selective target degradation and outperformed commercialized TYK2 selective inhibitors in reducing disease activity. CG620953 also exhibits a favorable PK and safety profile, providing rationale for further evaluation in the clinic. We intend to submit an IND application for CG620953 in the first quarter of 2027.
Degrader – Antibody Conjugates (“DACs”) as the Next-Generation of Antibody-Drug Conjugates (“ADCs”)
We are developing a robust suite of DACs that target both solid tumors and hematological malignancies by pairing distinct protein degraders with tumor-specific antibodies. These preclinical DAC candidates demonstrate tumor associated antigen (“TAA”)-dependent cytotoxicity in vitro and drive potent, durable tumor regression in vivo, including success in models resistant to standard therapies.
In May 2024, Gyre Pharmaceuticals entered into an agreement with Jiangsu Wangao Pharmaceuticals Co., Ltd. (the “Jiangsu Wangao Agreement”), effective from May 7, 2024 to May 6, 2035. Pursuant to the Jiangsu Wangao Agreement, Gyre Pharmaceuticals obtained the drug registration certificate for and became the marketing authorization holder of EtorelTM (nintedanib, ethanesulfonate soft capsules), a small-molecule drug for the treatment of IPF, SSc-ILD and progressive pulmonary fibrosis, within the PRC. The total minimum payments under the Jiangsu Wangao Agreement are Chinese Renminbi (“RMB”) 35.0 million, or approximately $5.1 million, based on the MarchJune 31,30, 2026 spot exchange rate. This includes an upfront transfer fee of RMB 15.0 million, or approximately $2.1$2.2 million, payable in three installments, and subsequent payments based on annual sales over eight years following the commencement of commercial sales. Additionally, Gyre Pharmaceuticals will bear the costs associated with relocating the production site to a designated location and will cover all expenses related to the manufacturing process. As of MarchJune 31,30, 2026, we had paid threefour installments totaling RMB 15.023.0 million, or approximately $2.2$3.4 million, based on the MarchJune 31,30, 2026 spot exchange rate.
As of MarchJune 31,30, 2026 and December 31, 2025, our total investment into the partnership was $1.7$1.8 million and $1.7 million, respectively, and the carrying value of the Company’s long-term investment in this affiliate was $1.6 million and $1.6 million, respectively.
During the three months ended MarchJune 31,30, 2026, we had a net loss of $9.9$14.3 million and net loss attributable to common stockholders of $8.7$11.7 million. For the six months ended June 30, 2026, we had net loss of $32.8 million and net loss attributable to common stockholders of $24.8 million. During the three months ended MarchJune 31,30, 2025, we had net loss of $2.2 million and net loss attributable to common stockholders of $2.0 million. For the six months ended June 30, 2025, we had net income of $3.7$2.7 million and net income attributable to common stockholders of $2.7$0.1 million. As of MarchJune 31,30, 2026, we had an accumulated deficit of $77.7$138.0 million and cash and cash equivalents of $37.5$43.3 million. As of December 31, 2025, we had an accumulated deficit of $68.4$112.6 million and cash and cash equivalents of $37.1$49.2 million.
Collaborations
We also generate revenue through collaboration and license agreements with a strategic partner. Revenue consists of upfront nonrefundable payments and reimbursements for research and development services provided under the agreement and is recognized over time as the related research activities are performed.
We record accrued expenses for estimated costs of the research and development activities conducted by third party service providers, which include outsourced research and development expenses, stock-based compensation and professional services. We record the estimated costs of research and development activities based upon the estimated amount of services provided but not yet invoiced, and include these costs in current liabilities and within research and development expense.
Provision for income taxes areis comprised primarily of current income tax provision, mainly attributable to the profitable Gyre Pharmaceuticals operations in the PRC, and deferred income tax provision, mainly including deferred tax recognized for temporary differences in relation to research and development tax credit and net operating loss carryforwards for U.S. tax purposes and fixed and intangible assets, net of valuation allowances.
On July 4, 2025, the One Big Beautiful Bill Act (the “OBBBA”) was enacted into law, which introduced several U.S. income tax provisions that have and may continue to potentially impact our provision for income taxes. The provisions include, but are not limited to, the immediate expensing of domestic research and development expenses beginning in 2025, as well as a modification to the Global Intangible Low-Taxed Income effective in 2026. We have recognized the effects of the OBBBA provisions on our financial results to the extent they are applicable to the threesix months ended MarchJune 31,30, 2026. We will continue to evaluate the impact of the OBBBA on our unaudited condensed consolidated financial statements.
Comparison of the three months ended MarchJune 31,30, 2026 and 2025
*Not meaningful
Revenues for the three months ended June 30, 2026 and 2025 were $29.1 million and $29.7 million, respectively, representing a decrease of $0.6 million, or 2%. Gyre Pharmaceuticals revenue increased during the period, primarily driven by higher ETUARYTM sales volumes resulting from ETUARYTM focused marketing efforts, despite lower ContivaTM and EtorelTM product revenues earned following the implementation of China's national centralized procurement program. The increase was offset by a $3.0 million decrease in collaboration revenue from the Astellas Agreement which ended in March 2026, resulting in an overall decrease in revenues of $0.6 million, or 2%, compared to the prior-year period.
Revenues for the three months ended March 31, 2026 and 2025 were $22.5 million and $22.1 million, respectively. The $0.4 million, or 2%, increase was primarily due to the increase in ContivaTM and EtorelTM sales by approximately $0.5 million and $0.7 million, respectively, partially offset by the decrease in ETUARYTM sales and other products sales by approximately $0.7 million and $0.1 million, respectively. ContivaTM was launched in March 2025, and EtorelTM was not commercially launched until June 2025. ETUARYTM revenue declined by approximately 3% year-over-year, primarily attributable to the seasonal fluctuation in 2026 compared to 2025.
Cost of revenues for the three months ended MarchJune 31,30, 2026 and 2025 were $1.2$2.2 million and $0.9$1.2 million, respectively. The $0.3$1.0 million, or 37%,92%, increase was primarily driven by a $0.3$0.7 million riseincrease in early production costs ofassociated with EtorelTM andproducts, a $0.2 million increase in production costs for the ETUARYTM, and a $0.1 million increase in stock-based compensation expense, partially offset by a $0.2 million decrease in ETUARYTM cost of sales.expense.
Selling and marketing expenses increaseddecreased by $3.3$1.4 million, or 30%,9%, for the three months ended MarchJune 31,30, 2026 compared to the three months ended MarchJune 31,30, 2025. The increasedecrease was primarily drivenattributable to a $2.5 million decrease in promotional and conference expenses as certain promotional objectives were achieved in the first quarter of 2026, reducing spending in the second quarter, partially offset by a $2.9 million increase in promotion expenses for EtorelTM and ContivaTM and early-stage preparation activities for F351 commercial launch, and a $1.0$0.6 million increase in stock-based compensation expense,expenses, partially offset byand a $0.5 million decreaseincrease in staffpersonnel-related costcosts, primarily due to aincreased decreasesales incommissions bonusresulting andfrom ahigher $0.1sales millionvolumes decreaseduring inthe travelsecond andquarter otherof expenses.2026.
*Not meaningful
Research and development expenses increased by $3.6$10.8 million, or 118%,129%, for the three months ended MarchJune 31,30, 2026 compared to the three months ended MarchJune 31,30, 2025. The increase was primarily attributablerelated to Gyre Pharmaceuticals and was driven by a $2.0$4.7 million increase in external clinical research expenses, primarilymainly relatingcontributed to the F351 Phase 3c3C clinicalexperimental trialreview expense; a $4.8 million increase for Hydronidone in the PRCmilestone requestedpayment byGyre thePharmaceuticals NMPA.owed Theto increaseGNI alsorelated reflectsto China's NMPA acceptance of NDA for F351 as a $0.5treatment for CHB induced liver fibrosis; a $0.7 million increase in materials and utilitiespre-clinical expenses, and a $1.1$0.6 million increase attributable to Gyre Therapeutics’ pre-clinical activities for future IND filings in thefacilities, United States. These costs represent planned investmentsdepreciation and areother expected to continue in the near- to medium-term.expenses.
General and administrative expenses increased by $2.3$0.6 million, or 46%,8%, for the three months ended MarchJune 31,30, 2026 compared to the three months ended MarchJune 31,30, 2025. The increase was primarily driven by a $0.8 million increase in stock-based compensation costs, a $0.9 million increase in staffpersonnel costs duerelated to ourthe Company's internal realignment of responsibilities and compensation adjustments,restructuring, and a $0.6$0.2 million increase in miscellaneous expenses.expenses, partially offset by a $0.2 million decrease in stock-based compensation expenses and a $0.3 million decrease in professional fees.
For the three months ended MarchJune 31,30, 2026, $2.5$0.5 million in transaction costs were incurred in connection with the acquisition of Cullgen. As the MergerCullgen closed in early May 2026, we expect there will be additional non-recurring transaction costs incurred after the first quarter of 2026.
Change in fair value of warrant liability decreased $2.2by million,$80 thousand, or 96%,38%, for the three months ended MarchJune 31,30, 2026 compared to the three months ended MarchJune 31,30, 2025. The decrease was related to the remeasurement of the Preferredpreferred Stockstock Warrantswarrants liability.
Other (loss) Income, Net
OtherInterest income, netincome decreased by $0.1$0.2 million, or 73%,21%, for the three months ended MarchJune 31,30, 2026 compared to the three months ended MarchJune 31,30, 2025. The decrease was primarily duerelated to increase in donation expense of $0.3 million, partially offset by a $0.1 million increase indecreased interest incomerates andon athe $0.1Company's millionbank increase in government grant.deposits.
Other expense, net increased by $0.5 million, or 93%, for the three months ended June 30, 2026 compared to the three months ended June 30, 2025. The increase was primarily due to higher foreign currency exchange loss.
Benefit for income taxes was $0.2 million and provision for income taxes was $0.7 million for the three months ended June 30, 2026 and 2025, respectively. The change in income tax provision and effective tax rate was primarily due to the retrospective presentation of the common-control combination with Cullgen and increased research and development expenditures.
Comparison of the six months ended June 30, 2026 and 2025
The following table summarizes our results of operations for the periods presented (in thousands, except percentage change):
*Not meaningful
Revenues for the six months ended June 30, 2026 and 2025 were $53.5 million and $60.3 million, respectively, representing a decrease of $6.8 million or 11%. Revenue from Gyre Pharmaceuticals increased during the period, primarily driven by higher ETUARYTM sales volumes resulting from ETUARYTM focused marketing efforts, despite lower ContivaTM and EtorelTM product revenues following the implementation of China's national centralized procurement program. The overall increase in revenue from Gyre Pharmaceuticals is offset by a $9.6 million decrease in collaboration revenue under the Astellas Agreement which ended in March 2026.
Cost of Revenues
Cost of revenues for the six months ended June 30, 2026 and 2025 was $3.4 million and $2.0 million, respectively. The $1.4 million, or 68%, increase was primarily attributable to higher EtorelTM product costs of $1.1 million and increased stock-based compensation expense of $0.3 million.
Selling and Marketing Expenses
Selling and marketing expenses increased by $1.9 million, or 7%, for the six months ended June 30, 2026 compared to the six months ended June 30, 2025. The increase was primarily attributable to a $1.6 million increase in stock-based compensation expense, and a $0.4 million increase in promotional and conference expenses, partially offset by a $0.1 million decrease in travel and other expense.
Research and Development Expenses
The table below details our costs for research and development for the periods presented (in thousands, except percentage change):
GYRE insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 9 filings (2 insiders, 16 trade dates, 147,729 shares, about $952.9K; 1 of these filings say the sales were made under a Rule 10b5-1 trading plan). Net open-market shares: -147,729 (purchases minus sales); net value about -$952.9K.Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
| Trade date | Insider | Transaction | Shares | Price | Value |
|---|---|---|---|---|---|
| 2026-06-18 | Ye Weiguo |
Option exercise | 3,000 | $0.75 | $2.2K |
| 2026-06-18 | Ye Weiguo |
Open-market sale | 3,000 | $6.35 | $19.1K |
| 2026-06-11 | Ye Weiguo |
Option exercise | 2,800 | $0.75 | $2.1K |
| 2026-06-11 | Ye Weiguo |
Open-market sale | 2,800 | $6.17 | $17.3K |
| 2026-06-10 | Ye Weiguo |
Open-market sale | 5,000 | $6.24 | $31.2K |
| 2026-06-10 | Ye Weiguo |
Option exercise | 5,000 | $0.75 | $3.8K |
| 2026-06-10 | Ye Weiguo |
Option exercise | 6,418 | $0.75 | $4.8K |
| 2026-06-10 | Ye Weiguo |
Open-market sale | 6,418 | $6.21 | $39.9K |
| 2026-06-09 | Ye Weiguo |
Open-market sale | 3,000 | $6.15 | $18.4K |
| 2026-06-09 | Ye Weiguo |
Option exercise | 3,000 | $0.75 | $2.2K |
| 2026-06-09 | Ye Weiguo |
Option exercise | 14,500 | $0.75 | $10.9K |
| 2026-06-09 | Ye Weiguo |
Open-market sale | 14,500 | $6.14 | $89.0K |
| 2026-06-05 | Ye Weiguo |
Open-market sale | 15,401 | $6.40 | $98.6K |
| 2026-06-05 | Ye Weiguo |
Option exercise | 15,401 | $0.75 | $11.6K |
| 2026-06-04 | Ye Weiguo |
Open-market sale | 19,575 | $6.13 | $120.0K |
| 2026-06-04 | Ye Weiguo |
Option exercise | 19,575 | $0.75 | $14.7K |
| 2026-05-26 | Ye Weiguo |
Open-market sale | 4,000 | $6.10 | $24.4K |
| 2026-05-26 | Ye Weiguo |
Option exercise | 4,000 | $0.75 | $3.0K |
| 2026-05-22 | Ye Weiguo |
Open-market sale | 3,500 | $6.08 | $21.3K |
| 2026-05-22 | Ye Weiguo |
Option exercise | 3,500 | $0.75 | $2.6K |
| 2026-05-21 | Ye Weiguo |
Option exercise | 12,820 | $0.75 | $9.6K |
| 2026-05-21 | Ye Weiguo |
Open-market sale | 12,820 | $6.15 | $78.8K |
| 2026-05-20 | Ye Weiguo |
Option exercise | 9,400 | $0.75 | $7.0K |
| 2026-05-20 | Ye Weiguo |
Open-market sale | 9,400 | $6.15 | $57.8K |
| 2026-05-19 | Ye Weiguo |
Open-market sale | 9,120 | $6.37 | $58.1K |
| 2026-05-19 | Ye Weiguo |
Option exercise | 9,120 | $0.75 | $6.8K |
| 2026-05-18 | Ye Weiguo |
Option exercise | 200 | $0.75 | $150 |
| 2026-05-18 | Ye Weiguo |
Open-market sale | 200 | $6.62 | $1.3K |
| 2026-05-15 | Ye Weiguo |
Open-market sale | 13,100 | $6.65 | $87.1K |
| 2026-05-15 | Ye Weiguo |
Option exercise | 13,100 | $0.75 | $9.8K |
| 2026-05-14 | Ye Weiguo |
Option exercise | 15,580 | $0.75 | $11.7K |
| 2026-05-14 | Ye Weiguo |
Open-market sale | 15,580 | $6.91 | $107.7K |
| 2026-05-06 | Luo Ying |
Open-market sale |
10,136 | $8.04 | $81.5K |
| 2026-05-05 | Luo Ying |
Open-market sale |
179 | $8.01 | $1.4K |
Well-known investors holding GYRE (13F)
| Investor | Quarter | Shares | Reported value | % of their 13F | Change vs prior quarter |
|---|---|---|---|---|---|
| Millennium Management (Israel Englander) | 2026-06-30 | 18,488 | $121.8K | 0.0% | New position |