New Risk • Jul 09
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 23% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. This is currently the only risk that has been identified for the company. Recent Insider Transactions Derivative • Jun 09
Chief Operating Officer exercised options and sold US$192k worth of stock On the 5th of June, Weiguo Ye exercised 35k options at a strike price of around US$0.75 and sold these shares for an average price of US$6.25 per share. This trade did not impact their existing holding. Since March 2026, Weiguo has owned 700.00k shares directly. Company insiders have collectively sold US$578k more than they bought, via options and on-market transactions in the last 12 months. Announcement • May 14
Gyre Pharmaceuticals Co., Ltd. Announces Nmpa Acceptance of New Drug Application for F351 (Hydronidone) for Chb-Induced Liver Fibrosis Treatment Gyre Therapeutics, Inc. announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for F351 (hydronidone) as a treatment for chronic hepatitis B (CHB)-induced liver fibrosis, which is liver damage resulting from the infection of the hepatitis B virus (HBV). The acceptance comes after the NMPA previously granted priority review status for F351 in March after Gyre submitted the NDA through its majority-owned subsidiary Gyre Pharmaceuticals Co. Ltd. (Gyre Pharmaceuticals). This marks the second major product for which Gyre has submitted an NDA to the NMPA, and is a significant milestone for the Company in the commercialization of a new medication for the treatment of CHB-induced liver fibrosis. Priority review was established in China in 2017 to facilitate drug registration and accelerate the development of new drugs with clinical value under the guidance of Opinions on Encouraging Pharmaceutical Innovation via Priority Review & Approval. According to these guidelines, the NMPA will prioritize the review of these applications and allocate additional evaluation resources, which is expected to accelerate the review process. F351 is Gyre’s lead development candidate for the treatment of liver fibrosis that is being developed for two different indications. It is a structurally modified derivative of pirfenidone designed to optimize metabolic properties while targeting the TGF-ß1 signaling pathway, a key mediator of fibrogenesis. Gyre is developing F351 for two primary indications: Chronic hepatitis B (CHB)-associated liver fibrosis in the People’s Republic of China (PRC) and MASH-associated liver fibrosis initially in the United States. In the United States, Gyre has completed a Phase 1 clinical trial in healthy volunteers evaluating F351’s safety, tolerability, and PK. Gyre plans to file an Investigational New Drug (IND) application in the U.S. by the end of 2026, and, if the IND becomes effective, to initiate a Phase 2 clinical trial. Liver fibrosis is a condition where healthy tissues in the liver become scarred in response to chronic inflammation. If left untreated, it can progress to cirrhosis—the final, severe stage where extensive scarring permanently distorts the liver’s architecture and significantly impairs its vital functions. Viral hepatitis is estimated to cause up to 50% of fibrosis and 65% of cirrhosis worldwide. Without intervention, liver fibrosis and cirrhosis typically progress from manageable organ damage to systemic, life-threatening liver failure and hepatocellular carcinoma (HCC). No non-viral directed therapy has been shown to reduce fibrosis in viral induced hepatitis. Gyre Pharmaceuticals’ pipeline includes F351 (hydronidone), a structural analogue of pirfenidone, which demonstrated statistically significant fibrosis regression after 52 weeks of treatment in a pivotal Phase 3 clinical trial in CHB-associated liver fibrosis in the PRC. F351 received Breakthrough Therapy designation by the CDE of the NMPA in March 2021. Reported Earnings • May 07
First quarter 2026 earnings: EPS and revenues miss analyst expectations First quarter 2026 results: US$0.095 loss per share (down from US$0.031 profit in 1Q 2025). Revenue: US$22.5m (up 2.1% from 1Q 2025). Net loss: US$8.69m (down 422% from profit in 1Q 2025). Revenue missed analyst estimates by 29%. Earnings per share (EPS) also missed analyst estimates by 36%. Revenue is forecast to grow 21% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in the US. Announcement • May 06
Gyre Therapeutics, Inc. (NasdaqCM:GYRE) completed the acquisition of Cullgen Inc. Gyre Therapeutics, Inc. (NasdaqCM:GYRE) entered into an agreement to acquire Cullgen Inc. on March 2, 2026. The transaction is valued at approximately $300 million. The new combined entity will continue to be listed on the Nasdaq Capital Market under the ticker “GYRE”.
Under the terms of the definitive agreement, Cullgen will become a wholly owned subsidiary of Gyre. Upon the completion of the acquisition, Ping Zhang, will remain as the Executive Chairman of Gyre. Dr. Ying Luo, is expected to become the President and Chief Executive Officer and a member of the board of directors of Gyre.
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 Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976, as amended. (3) approval of Gyre board of directors (4) regulatory approvals and other customary closing conditions. The Board of Directors of the Gyre approved the Merger Agreement and the related transactions, and the consummation of the Merger does not require the approval of the Gyre stockholders. The transaction is expected to close early in the second quarter of 2026.
Ryan Murr, Branden Berns and Evan Shepherd of Gibson, Dunn & Crutcher LLP served as legal advisor to Gyre Therapeutics. Moelis & Company LLC is acting as financial advisor to the special committee to Gyre’s Board of Directors. Scott Stanton and Jason McCaffrey of Mintz, Levin, Cohn, Ferris, Glovsky & Popeo, P.C. served as legal advisor to Cullgen. Equiniti Trust Company, LLC acted as transfer agent for Gyre Therapeutics, Inc.
Gyre Therapeutics, Inc. (NasdaqCM:GYRE) completed the acquisition of Cullgen Inc. on May 4, 2026. Announcement • Apr 17
Gyre Therapeutics, Inc., Annual General Meeting, Jun 10, 2026 Gyre Therapeutics, Inc., Annual General Meeting, Jun 10, 2026. Announcement • Mar 23
Gyre Therapeutics, Inc.'S Subsidiary Gyre Pharmaceuticals Co Ltd Submits New Drug Application for F351 Hydronidone Gyre Pharmaceuticals Co. Ltd., Gyre Therapeutics, Inc.'s majority indirectly owned subsidiary, submitted its New Drug Application to the Center for Drug Evaluation of China's National Medical Products Administration for F351 (Hydronidone), the Company's lead product candidate, for the treatment of chronic hepatitis B-induced liver fibrosis. The submission of the New Drug Application will be subject to initial formatting and completeness verification, and the Company plans to work with the Center for Drug Evaluation to submit any supplementary materials, if requested by the Center for Drug Evaluation. Thereafter, the Center for Drug Evaluation is anticipated to issue to the Company an acceptance number before initiating its technical review process. Announcement • Mar 18
Gyre Therapeutics, Inc. Announces China’s NMPA Grants Priority Review to the NDA for Hydronidone (F351) for CHB-Induced Liver Fibrosis Treatment Gyre Therapeutics, Inc. announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted priority review status to the New Drug Application (NDA) for Hydronidone (F351) as a treatment for chronic hepatitis B (CHB)-induced liver fibrosis, which is liver damage resulting from the infection of the hepatitis B virus (HBV). This decision by CDE was made following the pre-NDA communication meeting previously announced on January 5, 2026 and is a major milestone in the NDA process. Gyre, through its majority-owned subsidiary, Gyre Pharmaceuticals Co. Ltd., plans to submit a formal NDA in the near future. Priority review was established in China in 2017 to facilitate drug registration and accelerate the development of new drugs with clinical value under the guidance of Opinions on Encouraging Pharmaceutical Innovation via Priority Review & Approval. According to these guidelines, the NMPA will prioritize the review of these applications and allocate additional evaluation resources, which is expected to accelerate the review process. Hydronidone, also known as F351, is a novel, orally administered anti-fibrotic agent designed to target key liver fibrosis pathways. It attenuates hepatic stellate cell activation and fibrogenesis, at least in part, by suppressing TGF-ß1-induced signal transduction, including reduced p38? phosphorylation and upregulated Smad7 expression. This upregulation of Smad7 subsequently leads to downregulation of TGF-ßRI and inhibition of Smad2/3 activation, thereby disrupting canonical TGF-ß/Smad signaling and reducing fibrotic gene expression in HSCs. The drug has completed Phase 3 clinical evaluation in China for CHB-associated liver fibrosis, including early (compensated) cirrhosis, and is being evaluated for its potential applicability across additional fibrotic diseases in region-specific development programs. Reported Earnings • Mar 12
Full year 2025 earnings: Revenues exceed analysts expectations while EPS lags behind Full year 2025 results: EPS: US$0.056 (down from US$0.14 in FY 2024). Revenue: US$116.6m (up 10% from FY 2024). Net income: US$5.03m (down 58% from FY 2024). Profit margin: 4.3% (down from 11% in FY 2024). The decrease in margin was driven by higher expenses. Revenue exceeded analyst estimates by 1.5%. Earnings per share (EPS) missed analyst estimates by 87%. Revenue is forecast to grow 21% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in the US. Announcement • Mar 12
Gyre Therapeutics, Inc. Provides Revenues Outlook for 2026 Gyre Therapeutics, Inc. provided revenues Outlook for 2026. For the full year 2026, the Company expects to generate revenues of $100.5 million to $111.0 million, representing a decline of approximately 13.8% to 4.8% compared to 2025. Announcement • Mar 03
Gyre Therapeutics, Inc. (NasdaqCM:GYRE) entered into an agreement to acquire Cullgen Inc. Gyre Therapeutics, Inc. (NasdaqCM:GYRE) entered into an agreement to acquire Cullgen Inc. on March 2, 2026. The transaction is valued at approximately $300 million.
Under the terms of the definitive agreement, Cullgen will become a wholly owned subsidiary of Gyre. Upon the completion of the acquisition, Ping Zhang, will remain as the Executive Chairman of Gyre. Dr. Ying Luo, is expected to become the President and Chief Executive Officer and a member of the board of directors of Gyre.
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 Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976, as amended. (3) approval of Gyre board of directors (4) regulatory approvals and other customary closing conditions. The Board of Directors of the Gyre approved the Merger Agreement and the related transactions, and the consummation of the Merger does not require the approval of the Gyre stockholders. The transaction is expected to close early in the second quarter of 2026.
Ryan Murr, Branden Berns and Evan Shepherd of Gibson, Dunn & Crutcher LLP served as legal advisor to Gyre Therapeutics. Moelis & Company LLC is acting as financial advisor to the special committee to Gyre’s Board of Directors. Scott Stanton and Jason McCaffrey of Mintz, Levin, Cohn, Ferris, Glovsky & Popeo, P.C. served as legal advisor to Cullgen. Recent Insider Transactions Derivative • Nov 16
Chief Operating Officer notifies of intention to sell stock Weiguo Ye intends to sell 548k shares in the next 90 days after lodging an Intent To Sell Form on the 15th of November. If the sale is conducted around the recent share price of US$8.34, it would amount to US$4.6m. Since March 2025, Weiguo's direct individual holding has increased from 650.00k shares to 700.00k. Company insiders have collectively bought US$629k more than they sold, via options and on-market transactions, in the last 12 months. Reported Earnings • Nov 09
Third quarter 2025 earnings: EPS exceeds analyst expectations while revenues lag behind Third quarter 2025 results: EPS: US$0.04 (up from US$0.013 in 3Q 2024). Revenue: US$30.6m (up 20% from 3Q 2024). Net income: US$3.61m (up 221% from 3Q 2024). Profit margin: 12% (up from 4.4% in 3Q 2024). The increase in margin was driven by higher revenue. Revenue missed analyst estimates by 7.2%. Earnings per share (EPS) exceeded analyst estimates by 12%. Revenue is forecast to grow 17% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in the US. Announcement • Nov 07
Gyre Therapeutics, Inc. Revises Earnings Guidance for the Full Year 2025 Gyre Therapeutics, Inc. revised earnings guidance for the full year 2025. For the year, the company revenue guidance revised from $118 million–128 million to $115 million–118 million, reflecting slower-than-expected commercialization of Etorel (nintedanib) due to early supply chain and distribution challenges, as well as increased market uncertainty related to China’s centralized procurement policy leading to more cautious purchasing behavior in the second half of the year, partially offset by stronger-than-expected ETUARY sales. Announcement • Oct 15
Gyre Therapeutics Announces Completion of Patient Enrollment in Phase 3 Clinical Trial of Pirfenidone Capsules for the Treatment of Pneumoconiosis Gyre Therapeutics announced that its indirect, majority-owned subsidiary, Gyre Pharmaceuticals Co. Ltd. (Gyre Pharmaceuticals), has completed patient enrollment in the 52-week Phase 3 clinical trial of its Class 1 drug, Pirfenidone capsules, for the treatment of pneumoconiosis. A total of 272 patients have been enrolled in this multicenter, randomized, double-blind, placebo-controlled trial being conducted at 18 clinical research centers across China. The trial is designed to evaluate the efficacy and safety of 52 weeks of Pirfenidone capsule treatment in patients with pneumoconiosis, a chronic occupational lung disease characterized by progressive pulmonary fibrosis. Pneumoconiosis remains the most common and severe occupational disease in China, with more than 450,000 survival patients and thousands of new cases reported each year. It results from long-term inhalation of mineral dusts such as silica or coal, which triggers persistent inflammation and progressive fibrosis of the lung tissue. Most adverse events reported to date are mild to moderate, with no unexpected safety signals. Interim Analysis: None planned. Announcement • Oct 14
Gyre Therapeutics to Present Results from Positive Phase 3 Clinical Trial Evaluating Hydronidone for the Treatment of Liver Fibrosis in Chronic Hepatitis B at AASLD--The Liver Meeting® 2025 Gyre Therapeutics announced that it will be presenting results from its positive Phase 3 clinical trial evaluating Hydronidone, a novel anti-fibrotic agent that inhibits hepatic stellate cell (HSC) activation and promotes HSC apoptosis, for the treatment of liver fibrosis in chronic hepatitis B, at The Liver Meeting® 2025, the annual meeting of the American Association for the Study of Liver Diseases (AASLD). The Liver Meeting® 2025 is being held November 7-10, 2025, in Washington D.C. New Risk • Aug 27
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 84% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. This is currently the only risk that has been identified for the company. Announcement • Aug 22
Gyre Therapeutics, Inc. Appoints Dan Weng to Its Board of Directors, Effective August 18, 2025 Gyre Therapeutics, Inc. announced the appointment of Dan Weng, M.D., to its Board of Directors (the “Board”) effective August 18, 2025. Dr. Weng has served as President and Chief Executive Officer of Medelis, Inc., a specialty oncology contract research organization (“CRO”), since 2018. From 2013 to 2017, he served as Chairman, President, and Chief Executive Officer of EPS International Holding Co., a subsidiary of EPS Holdings, Inc., a global CRO where he oversaw significant growth, both organically and through M&A in Asia, and played an active role in corporate strategy and investor relations. Prior to that, Dr. Weng held executive positions at international CROs including MedPace, Inc., ICON Plc, PharmaNet Development Group, and Quintiles Translational Corp. .Dr. Weng also held research positions at Harvard Medical School, Massachusetts General Hospital, and the University of California. Dr. Weng holds an M.D. from the Tongji Medical University, and an M.A. in Health Planning, Policy and Management from the University of Leeds. Reported Earnings • Aug 12
Second quarter 2025 earnings released: EPS: US$0.005 (vs US$0.041 in 2Q 2024) Second quarter 2025 results: EPS: US$0.005 (down from US$0.041 in 2Q 2024). Revenue: US$26.8m (up 6.1% from 2Q 2024). Net income: US$442.0k (down 88% from 2Q 2024). Profit margin: 1.7% (down from 14% in 2Q 2024). The decrease in margin was driven by higher expenses. Announcement • Jun 10
Gyre Therapeutics Announces First Dosing in Phase 1 Trial of F230 for Pulmonary Arterial Hypertension in China Gyre Therapeutics announced that the first volunteer has been successfully dosed in a Phase 1 clinical trial evaluating F230, a novel endothelin A receptor antagonist, for the treatment of pulmonary arterial hypertension. This milestone marks Gyre's entry into the PAH field, a rare, progressive, and high-m mortality cardiovascular condition with limited treatment options. PAH is recognized in China's National Rare Disease Catalog, underscoring its significance in public health. According to Frost & Sullivan, China's PAH market was valued at $370 million in 2023 and is projected to grow to $480 million by 2031. The Phase 1 trial is designed to evaluate safety, tolerability, and pharmacokinetics in healthy volunteers. The trial represents the latest expansion of Gyre's fibrosis-first strategy beyond the liver, leveraging a robust clinical development platform and commercial infrastructure in China. F230 joins Gyre's pipeline alongside lead candidate Hydronidone (F351), which met the primary endpoint in a pivotal Phase 3 trial for CHB-fibrosis. A New Drug Application ("NDA") submission to China's National Medical Products Administration ("NMPA") is planned for the third quarter of 2025, and a pre-IND meeting with the U.S. Food and Drug Administration is being planned for an expected Phase 2 trial in metabolic dysfunction-associated steatohepatitis ("MASH") fibrosis. Reported Earnings • May 09
First quarter 2025 earnings released: EPS: US$0.031 (vs US$0.09 in 1Q 2024) First quarter 2025 results: EPS: US$0.031 (down from US$0.09 in 1Q 2024). Revenue: US$22.1m (down 19% from 1Q 2024). Net income: US$2.70m (down 64% from 1Q 2024). Profit margin: 12% (down from 28% in 1Q 2024). The decrease in margin was driven by lower revenue. Announcement • May 09
Gyre Therapeutics, Inc. Reaffirms Earnings Guidance for the Full Year 2025 Gyre Therapeutics, Inc. reaffirmed earnings guidance for the full year 2025. for the year, the company expects revenue of $118 million to $128 million, compared to $105.8 million in 2024. New Risk • Apr 28
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 16% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (16% average weekly change). High level of non-cash earnings (32% accrual ratio). Announcement • Apr 22
Gyre Therapeutics, Inc., Annual General Meeting, Jun 04, 2025 Gyre Therapeutics, Inc., Annual General Meeting, Jun 04, 2025. Valuation Update With 7 Day Price Move • Apr 15
Investor sentiment improves as stock rises 16% After last week's 16% share price gain to US$8.40, the stock trades at a forward P/E ratio of 70x. Average trailing P/E is 20x in the Biotechs industry in the US. Total loss to shareholders of 48% over the past year. Announcement • Mar 31
Gyre Therapeutics Announces NMPA Approval for Clinical Trial Evaluating Pirfenidone Capsules in Oncology-Related Pulmonary Complications Gyre Therapeutics announced that the National Medical Products Administration (NMPA) of the People's Republic of China ("PRC") has approved its clinical trial application for a potential new indication for pirfenidone in oncology-related pulmonary complications. The trial will evaluate pirfenidone capsules for the treatment of radiation-induced lung injury (RILI), with or without immune-related pneumonitis (CIP). This regulatory milestone marks the expansion of pirfenidone beyond its established role in idiopathic pulmonary fibrosis (IPF) into the oncology supportive care space, offering a novel lung-protective strategy for cancer patients undergoing radiation therapy or immunotherapy. In accordance with the NMPA approval, Gyre intends to pursue an adaptive Phase 2/3 clinical trial design, combining dose exploration with efficacy confirmation, to efficiently evaluate pirfenidone's potential in this new indication. Radiation-Induced Lung Injury (RILI): Radiation therapy is a cornerstone of lung cancer treatment. However, 5%-25% of patients experience lung damage due to radiation exposure, limiting the ability to escalate doses and thereby compromising treatment efficacy. Checkpoint Inhibitor Pneumonitis (CIP): Immune checkpoint inhibitors (ICIs) have revolutionized cancer treatment, but 13%-19% of patients develop CIP. This condition accounts for approximately 35% of immune-related adverse event (irAE) deaths and often necessitates treatment discontinuation. Gyre has held first-in-class status for pirfenidone in the PRC since its original approval in 2011, underscoring its pioneering role in treating fibrotic lung diseases. Announcement • Mar 27
Gyre Therapeutics Announces Publication of Protocol for Phase 3 Trial Evaluating F351 for CHB-Associated Liver Fibrosis in Journal of Clinical and Translational Hepatology Gyre Therapeutics announced the publication of the manuscript titled "Hydronidone for the Treatment of Liver Fibrosis Associated with Chronic Hepatitis B: Protocol for a Phase 3 Randomized Trial" in the Journal of Clinical and Translational Hepatology. This publication details the full protocol for the pivotal Phase 3 trial to support the use of hydronidone in Chinese patients with liver fibrosis associated with chronic hepatitis B ("CHB"). The published protocol outlines patient inclusion criteria, randomization and blinding processes, key assessments, and the statistical analysis plan. The randomized, double-blind, placebo-controlled, multicenter Phase 3 trial (NCT05115942) completed the enrollment of 248 patients across 44 clinical research hospitals in the People's Republic of China ("PRC") in October 2024. Together, these results highlight F351's potential as a differentiated treatment for liver fibrosis, with a unique mechanism and strong preclinical and clinical evidence supporting its advancement into later-stage development. Valuation Update With 7 Day Price Move • Mar 24
Investor sentiment deteriorates as stock falls 21% After last week's 21% share price decline to US$9.71, the stock trades at a forward P/E ratio of 81x. Average trailing P/E is 20x in the Biotechs industry in the US. Total loss to shareholders of 40% over the past year. Announcement • Mar 19
Gyre Therapeutics, Inc. Provides Earnings Guidance for the Full Year 2025 Gyre Therapeutics, Inc. provides earnings guidance For the full year 2025. For the full year 2025, the Company expects to generate revenues of $118 million to $128 million, representing growth of 11.3% to 20.8% over 2024 revenue, primarily driven by the anticipated commercial launches of nintedanib and avatrombopag and sales of ETUARY. Reported Earnings • Mar 18
Full year 2024 earnings: Revenues exceed analysts expectations while EPS lags behind Full year 2024 results: EPS: US$0.14 (up from US$1.41 loss in FY 2023). Revenue: US$105.8m (down 6.8% from FY 2023). Net income: US$12.1m (up US$105.0m from FY 2023). Profit margin: 11% (up from net loss in FY 2023). The move to profitability was driven by lower expenses. Products in clinical trials Phase I: 2 Phase II: 1 Phase III: 2 Revenue exceeded analyst estimates by 4.3%. Earnings per share (EPS) missed analyst estimates by 71%. Revenue is forecast to grow 42% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in the US. Announcement • Jan 06
Gyre Therapeutics and Gyre Pharmaceuticals Announces Board and Committee Changes Gyre Therapeutics announced the appointment of Ping Zhang to its Board of Directors as the lead independent director of the Board and a member of the Nominating and Corporate Governance Committee of the Board. In addition, Ying Luo, Ph.D. resigned as Chairman and a member of the Board of Directors of Gyre and Gyre Pharmaceuticals, Gyre’s majority indirectly owned subsidiary in the People’s Republic of China (“PRC”), to focus on other responsibilities at GNI Group Ltd. Songjiang Ma has been appointed Chairman of the Board of Directors of Gyre Pharmaceuticals. Mr. Zhang has served as a Managing Partner of String Capital Management Co., Limited since 2018. Previously he was the Head of Private Equity Investment and Fund of Funds Business at AEON Life Insurance Company Ltd. From 2011 to 2015, he served as a Managing Partner of Japan Asia Investment Co. Ltd. Prior to joining Japan Asia Investment Co., Mr. Zhang served as a Managing Director at AEA Investors LP and as a Managing Director of Mitsubishi UFJ Securities Co. Ltd.Mr. Zhang currently serves on the board of directors of GNI and Asian Star Co. He received his B.S. in Polymer Science from Fudan University and his M.B.A. in Finance from the University of Chicago Booth School of Business. Announcement • Nov 28
Gyre Therapeutics, Inc. has filed a Follow-on Equity Offering in the amount of $50 million. Gyre Therapeutics, Inc. has filed a Follow-on Equity Offering in the amount of $50 million.
Security Name: Common Stock
Security Type: Common Stock
Transaction Features: At the Market Offering Reported Earnings • Nov 14
Third quarter 2024 earnings released: EPS: US$0.013 (vs US$0.68 loss in 3Q 2023) Third quarter 2024 results: EPS: US$0.013 (up from US$0.68 loss in 3Q 2023). Revenue: US$25.5m (down 17% from 3Q 2023). Net income: US$1.12m (up US$53.2m from 3Q 2023). Profit margin: 4.4% (up from net loss in 3Q 2023). Announcement • Oct 25
Gyre Therapeutics Announces Last Patient Completed Pivotal Phase 3 Trial Evaluating F351 for CHB-Associated Liver Fibrosis Gyre Therapeutics, Inc. announced that the last patient in Gyre Pharmaceuticals’ pivotal Phase 3 trial in the People’s Republic of China (“PRC”) evaluating F351 (hydronidone) for Chronic Hepatitis B (“CHB”) -associated liver fibrosis has completed the 52-week study. Gyre Pharmaceuticals expects to report topline data from this trial by the first quarter of 2025. The randomized, double-blind, placebo-controlled, multicenter Phase 3 trial enrolled 248 patients across 39 clinical research hospitals in the PRC. Patients were randomized 1:1 to receive either F351 or placebo in addition to entecavir antiviral basic therapy for CHB. The primary endpoint is a decrease in liver fibrosis (as measured by the Ishak Scoring System) by at least one stage after 52 weeks of treatment relative to baseline. China’s National Medical Products Administration (“NMPA”) designated F351 as a “Breakthrough Therapy” in 2021. New Risk • Aug 15
New major risk - Revenue and earnings growth Revenue has declined by 1.6% over the past year. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If revenues are declining, then it is difficult for the company to prevent its earnings from declining as well. A trend of falling revenue can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risk Revenue has declined by 1.6% over the past year. Minor Risks Less than 3 years of financial data is available. Share price has been volatile over the past 3 months (14% average weekly change). Reported Earnings • Aug 14
Second quarter 2024 earnings released: EPS: US$0.041 (vs US$0.029 in 2Q 2023) Second quarter 2024 results: EPS: US$0.041 (up from US$0.029 in 2Q 2023). Revenue: US$25.2m (down 14% from 2Q 2023). Net income: US$3.53m (up 90% from 2Q 2023). Profit margin: 14% (up from 6.3% in 2Q 2023). Announcement • Aug 09
Gyre Therapeutics Announces Appointment of David M. Epstein, Ph.D., to Board of Directors Gyre Therapeutics announced the appointment of David M. Epstein, Ph.D., to Gyre’s Board of Directors, effective August 6, 2024. Dr. Epstein will serve as a member of the Audit Committee of the Board and as member of the Compensation Committee of the Board. Dr. Epstein is a co-founder of PairX Bio Pte. Ltd., a Singapore-based biotechnology company that is developing next-generation cancer-selective biologics, where he currently serves as director, President and Chief Executive Officer. Dr. Epstein co-founded and served as President and Chief Executive Officer of Black Diamond Therapeutics. Prior to Black Diamond, Dr. Epstein was Vice Dean, Innovation & Entrepreneurship and Associate Professor at Duke-NUS Medical School in Singapore, and prior to that he served as Chief Scientific Officer of OSI Pharmaceuticals (“OSI”), which was acquired by Astellas Pharma for over $4 billion in 2010. Before his time at OSI, Dr. Epstein was a scientific founder and director at Archemix Corp., where he developed avacincaptad pegol (Izervay), an anti-C5 aptamer for treatment of geographic atrophy secondary to age-related macular degeneration. Izervay™ was acquired by Iveric Bio and sold to Astellas Pharma Inc. for $5.9 billion in 2023. Buy Or Sell Opportunity • Aug 06
Now 21% overvalued Over the last 90 days, the stock has fallen 31% to US$10.79. The fair value is estimated to be US$8.90, however this is not to be taken as a sell recommendation but rather should be used as a guide only. Revenue has grown by 11% over the last year. Earnings per share has declined by 76,086%. Board Change • Jul 12
Less than half of directors are independent Following the recent departure of a director, there are only 3 independent directors on the board. The company's board is composed of: 3 independent directors. 4 non-independent directors. Independent Director Rod Nussbaum was the last independent director to join the board, commencing their role in 2024. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Announcement • Jul 06
Nasdaq Confirms Gyre Therapeutics No Longer in Compliance with Nasdaq’s Audit Committee Composition Requirements as Set Forth in Nasdaq Listing Rule 5605 On June 30, 2024, Gyre Therapeutics, Inc. (the ‘Company’) notified the Nasdaq Stock Market LLC (‘Nasdaq’) that, following Nassim Usman’s resignation as a member of the Company’s Board of Directors (the ‘Board’) and as a member of the Audit Committee of the Board (the ‘Audit Committee’), the Company has a vacancy on its Audit Committee and intends to rely on the cure period set forth in the Nasdaq Listing Rules while it recruits a new Audit Committee member, as described in more detail below. On July 2, 2024, the Company received a letter from Nasdaq confirming that the Company is no longer in compliance with Nasdaq’s audit committee composition requirements as set forth in Nasdaq Listing Rule 5605, which requires that the audit committee of a listed company be comprised of at least three ‘independent directors’ (as defined in Nasdaq Listing Rule 5605(a)(2)). Pursuant to Nasdaq Listing Rule 5605(c)(4), the Company intends to rely on the cure period to reestablish compliance with Nasdaq Listing Rule 5605. The cure period is generally defined as until the earlier of the Company’s next annual meeting of stockholders or June 30, 2025. The Board is in the process of identifying and selecting a new member of the Board who qualifies as ‘independent’ and meets the audit committee criteria set forth in Nasdaq Listing Rule 5605. The Board intends to comply fully with Nasdaq audit committee requirements by or before the end of the cure period described above. Recent Insider Transactions Derivative • Jul 05
Independent Director notifies of intention to sell stock Nassim Usman intends to sell 12k shares in the next 90 days after lodging an Intent To Sell Form on the 1st of July. If the sale is conducted around the recent share price of US$12.14, it would amount to US$148k. Since March 2024, Nassim has owned 2.28k shares directly. Company insiders have collectively sold US$346k more than they bought, via options and on-market transactions in the last 12 months. Announcement • Jul 03
Gyre Therapeutics Announces China's NMPA Approval of Avatrombopag Maleate Tablets for the Treatment of CLD-Associated Thrombocytopenia Gyre Therapeutics announced that China's National Medical Products Administration ("NMPA") has approved Gyre Pharmaceuticals' (Gyre's indirectly controlled subsidiary) avatrombopag maleate tablets for the treatment of thrombocytopenia ("TP") associated with chronic liver disease ("CLD") in adult patients undergoing elective diagnostics procedures or therapy. TP is the most common hematologic complication in patients with CLD and can be life threatening in severe cases. Gyre Pharmaceuticals acquired avatrombopag under a transfer agreement with Nanjing Health nice Pharmaceutical Technology Co. Ltd. ("Nanjing Health nice") in June 2021. Avatrombopag is an oral thrombopoietin receptor antagonist ("TPO-RA"). Avatrombopag was approved by the U.S. Food and Drug Administration ("FDA") 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. Buy Or Sell Opportunity • Jul 02
Now 53% overvalued Over the last 90 days, the stock has fallen 29% to US$12.04. The fair value is estimated to be US$7.89, however this is not to be taken as a sell recommendation but rather should be used as a guide only. Revenue has grown by 11% over the last year. Earnings per share has declined by 76,086%. Buy Or Sell Opportunity • Jun 27
Now 25% overvalued Over the last 90 days, the stock has fallen 43% to US$9.89. The fair value is estimated to be US$7.91, however this is not to be taken as a sell recommendation but rather should be used as a guide only. Revenue has grown by 11% over the last year. Earnings per share has declined by 76,086%. Announcement • Jun 19
Gyre Therapeutics, Inc. Announces Publication of Liver Fibrosis in Journal of Gastroenterology and Hepatology Gyre Therapeutics, Inc. announced the publication of the manuscript titled Hydronidone induces apoptosis in activated hepatic stellate cells through endoplasmic reticulum stress-associated mitochondrial apoptotic pathway in the Journal of Gastroenterology and Hepatology. This publication includes both in vivo and in vitro studies supporting the potential of hydronidone (F351), a novel derivate of pirfenidone, as a promising therapy for the treatment of liver fibrosis. Liver fibrosis is characterized by the progressive accumulation of extracellular matrix (ECM), which disrupts the normal liver architecture. Research has shown that quiescent HSCs undergo activation and transform into myofibroblast-like cells to produce ECM in chronic liver disease, and therefore that liver fibrosis can be reversed by eliminating aHSCs. This study found that treatment with hydronidone significantly promoted apoptosis in aHSCs in both the CCl4- and DDC-induced liver fibrosis in mice and LX-2 cells. Mechanistic studies revealed that hydronidone triggered ERS and subsequently activated the IRE1a-ASK1-JNK pathway and subsequent dysfunction of the mitochondria, ultimately resulting in the apoptosis of aHSCs. Gyre Pharmaceuticals is currently evaluating hydronidone in a Phase 3 trial for the treatment of Chronic Hepatitis B (CHB)-associated liver fibrosis in the PRC with topline data anticipated by early 2025. The trial is evaluating 248 patients with a primary endpoint of the reduction of the liver fibrosis score (Ishak Scoring System) by at least one grade after taking hydronidone in combination with entecavir. Pending results from the Phase 3 trial, Gyre intends to initiate a Phase 2 a proof-of-concept trial to evaluate hydronidone for the treatment of NASH-associated liver fibrosis in 2025. Announcement • May 31
Gyre Pharmaceuticals Receives IND Approval from China’s NMPA to Evaluate F230 for the Treatment of Pulmonary Arterial Hypertension Gyre Therapeutics announced that the Center for Drug Evaluation (“CDE”) of China’s National Medical Products Administration (“NMPA”) has approved Gyre Pharmaceuticals’ (Gyre’s indirectly controlled subsidiary) Investigational New Drug (“IND”) application for F230 tablets, a selective endothelin receptor antagonist, for the treatment of pulmonary arterial hypertension (“PAH”). F230 was originally licensed from Eisai through Gyre’s indirect majority stockholder, GNI Group Ltd. In preclinical animal studies, F230 resulted in significant decreases of, or exhibited a decrease trend based on different dose groups in, mean pulmonary arterial pressure, right ventricular systolic pressure, right ventricular/left ventricular plus septum and pulmonary artery wall thickness. Even at the minimum effective dosage, the differences of those indexes between the treatment group and the PAH model group were statistically significant. In addition to PAH, Gyre is also exploring other disease indications for F230. Gyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, with a primary focus on the development and commercialization of F351 (Hydronidone) for the treatment of NASH-associated fibrosis in the U.S. Gyre’s development strategy for F351 in NASH is based on the company’s experience in NASH rodent model mechanistic studies and CHB-induced liver fibrosis clinical studies. Gyre is also advancing a diverse pipeline in the PRC through its indirect controlling interest in Gyre Pharmaceuticals, including ETUARY therapeutic expansions, F573, F528, and F230. Reported Earnings • May 10
First quarter 2024 earnings released First quarter 2024 results: EPS: US$0.09. Revenue: US$27.2m (down 1.6% from 1Q 2023). Net income: US$7.53m (up 27% from 1Q 2023). Profit margin: 28% (up from 21% in 1Q 2023). Announcement • May 01
Gyre Therapeutics, Inc., Annual General Meeting, Jun 12, 2024 Gyre Therapeutics, Inc., Annual General Meeting, Jun 12, 2024, at 10:00 Pacific Standard Time. Agenda: To elect the three class III director nominees named in the proxy statement to serve until the 2027 annual meeting of stockholders and until their successors are duly elected and qualified; to approve, on a non-binding, advisory basis, the compensation of the company’s named executive officers; to ratify the appointment of Grant Thornton Zhitong Certified Public Accountants LLP as the company’s independent registered public accounting firm for the year ending December 31, 2024; and to consider other matters. Recent Insider Transactions Derivative • Apr 03
Board Member notifies of intention to sell stock Nassim Usman intends to sell 20k shares in the next 90 days after lodging an Intent To Sell Form on the 1st of April. If the sale is conducted around the recent share price of US$16.15, it would amount to US$323k. Nassim currently holds less than 1% of total shares outstanding. There have been no trades via on-market transactions or options from company insiders in the last 12 months. Announcement • Mar 27
Gyre Therapeutics Regains Compliance of Nasdaq Audit Committee Composition Requirement On March 22, 2024, Gyre Therapeutics, Inc. (the Company") received a letter from The Nasdaq Stock Market LLC (Nasdaq") informing the Company that it had regained compliance with the audit committee composition requirements as set in Nasdaq Listing Rule 5605 for continued listing on The Nasdaq Capital Market. As previously disclosed, on January 17, 2024, the Company was notified by Nasdaq that it was not in compliance with Nasdaq Listing Rule 5605 because its Audit Committee was not comprised of at least three independent directors" (as defined in Nasdaq Listing Rule 5605(a)(2)). The Company was initially given 180 days to regain compliance. To regain compliance, the Company was required to identify and select a member of the board of directors of the Company (the Board") who qualifies as independent" and would meet the audit committee criteria set in Nasdaq Listing Rule 5605. This requirement was met on March 20, 2024, when the Board appointed Rodney Nussbaum as a member of the Audit Committee of the Board. Announcement • Mar 21
Gyre Therapeutics Announces Appointment of Rodney L. Nussbaum to the Board of Directors and Member of Audit Committee Gyre Therapeutics announced the appointment of Rodney L. Nussbaum to the Company’s Board of Directors and as a member of its Audit Committee. Mr. Nussbaum currently serves as a Managing Executive at Atago Advisory, which provides accounting and financial reporting services to clients in the United States and the Asia Pacific Region. Prior to Atago, he was a Senior Partner with clients in Japan and the Asia Pacific Region with Ernst & Young (2004-2016) and KPMG (2002-2004), and a Partner with Arthur Andersen (1991-2002). Prior to his position as Senior Partner, Mr. Nussbaum spent over 20 years at Arthur Andersen, where he held audit and client relationship partner responsibilities for a diverse portfolio of clients ranging from start-ups to those in the Global 100 across multiple industries, including pharmaceuticals and medical devices. Mr. Nussbaum is a retired Certified Public Accountant and currently serves as an independent board member for Cullgen and Zeal Senior Living. He holds a B.S. in Business Administration and Accounting from Boston University School of Management. Recent Insider Transactions Derivative • Mar 18
Board Member notifies of intention to sell stock Nassim Usman intends to sell 20k shares in the next 90 days after lodging an Intent To Sell Form on the 15th of March. If the sale is conducted around the recent share price of US$17.26, it would amount to US$345k. Nassim currently holds less than 1% of total shares outstanding. There have been no trades via on-market transactions or options from company insiders in the last 12 months. Announcement • Jan 21
Gyre Therapeutics, Inc. Receives Non-Compliance Notice From Nasdaq On January 15, 2024, Gyre Therapeutics, Inc. notified the Nasdaq Stock Market LLC (“Nasdaq”) that, following Dr. Charles Wu’s retirement and resignation as the Company’s Chief Executive Officer and as a member of the Board, and Dr. Han Ying’s appointment as the Company’s Chief Executive Officer, effective on January 15, 2024, to succeed Dr. Wu, Dr. Ying stepped down as a member of the Audit Committee of the Company. The Company has a vacancy on its Audit Committee and intends to rely on the cure period set in the Nasdaq Listing Rules while it recruits a new Audit Committee member, as described in more detail below. On January 17, 2024, the Company received a letter from Nasdaq confirming that the Company is no longer in compliance with Nasdaq’s audit committee composition requirements as set in Nasdaq Listing Rule 5605, which requires that the audit committee of a listed company be comprised of at least three “independent directors” (as defined in Nasdaq Listing Rule 5605(a)(2)). Pursuant to Nasdaq Listing Rule 5605(c)(4), the Company intends to rely on the cure period to reestablish compliance with Nasdaq Listing Rule 5605. The cure period is generally defined as until the earlier of the Company’s next annual meeting of stockholders or July 15, 2024. The Board is in the process of identifying and selecting a new member of the Board who qualifies as “independent” and would meet the audit committee criteria set in Nasdaq Listing Rule 5605. The Board intends to comply fully with Nasdaq audit committee requirements by or before the end of the cure period described above. Announcement • Dec 18
Gyre Therapeutics, Inc. and Beijing Continent Pharmaceuticals Co., Ltd. Announce the Resignation of Charles Wu as Member of the Board of Directors. Effective on January 15, 2024 In connection with his resignation and departure from Gyre Therapeutics, Inc., Dr. Charles Wu also resigned as a member of the board of directors of the Company. and as a member of the board of directors of Beijing Continent Pharmaceuticals Co. Ltd., of which the Company holds an indirect controlling interest, each effective on January 15, 2024.