Gyre Therapeutics Reports Third Quarter 2024 and Year-To-Date Financial Results and Provides Business Update

Last patient completed pivotal Phase 3 trial in CHB-associated liver fibrosis in the PRC with data expected in Q1 2025

On track to initiate U.S. Phase 2 trial of F351 in MASH-associated liver fibrosis in 2025

Commercial launch of avatrombopag maleate tablets expected by the first half of 2025

Commercial launch of nintedanib expected in 2025

Cash and cash equivalents totaled $15.9 million as of September 30, 2024

SAN DIEGO, Nov. 13, 2024 (GLOBE NEWSWIRE) -- Gyre Therapeutics ("Gyre") (Nasdaq: GYRE), a self-sustainable, commercial-stage biotechnology company with clinical development programs focusing on a variety of chronic organ diseases, today announced financial results for the third quarter and nine months ended September 30, 2024, and provided a business update.

"Our team has made great progress over the last several months and recently achieved a significant milestone with the final patient completing 52 weeks of study in our pivotal Phase 3 trial for F351 in CHB-associated liver fibrosis. We are encouraged by F351's potential as a novel treatment for this fibrotic disease and are excited to share topline results in the first quarter 2025," said Han Ying, Ph.D., Chief Executive Officer of Gyre Therapeutics. "With several upcoming milestones in 2025, including the commercial launch of two new products in the PRC as well as the anticipated initiation of a U.S. Phase 2 trial of F351 in MASH-associated liver fibrosis, we remain confident in Gyre's ability to deliver in the clinic and the commercial market for patients in need."

Third Quarter 2024 Business Highlights and Upcoming Milestones

Commercial-Stage Updates

   -- ETUARY (Pirfenidone) sales update: For the quarter ended September 30, 
      2024, Gyre Pharmaceuticals, Gyre's majority indirectly owned subsidiary 
      in the People's Republic of China ("PRC"), generated $25.3 million in 
      sales of ETUARY. 
 
   -- Avatrombopag: In June 2024, Gyre Pharmaceuticals received approval from 
      China's National Medical Products Administration ("NMPA") for 
      avatrombopag maleate tablets for the treatment of thrombocytopenia 
      associated with chronic liver disease ("CLD") in adult patients 
      undergoing elective diagnostics procedures or therapy. This approval 
      expands Gyre's rare disease product lines and provides a treatment option 
      for a common and potentially life-threatening hematologic complication in 
      patients with CLD. Gyre anticipates launching avatrombopag in the PRC in 
      the first half of 2025 and plans to leverage its existing extensive sales 
      and marketing platform. 
 
   -- Nintedanib: Gyre Pharmaceuticals is planning to start commercializing 
      nintedanib, a small-molecule drug for the treatment of idiopathic 
      pulmonary fibrosis ("IPF"), which was acquired from Jiangsu Wangao 
      Pharmaceuticals Co., Ltd., in the PRC in 2025. Nintedanib is 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 more choices and benefits, and further enhance Gyre 
      Pharmaceuticals' leading position in the pulmonary fibrosis market. 

Clinical Development Updates

F351 (Hydronidone):

   -- All patients completed 52-week Phase 3 trial evaluating F351 for the 
      treatment of Chronic Hepatitis B ("CHB")-associated liver fibrosis. In 
      October 2024, Gyre Pharmaceuticals announced the final patient had 
      completed the 52-week pivotal Phase 3 trial in patients with 
      CHB-associated liver fibrosis in the PRC. The trial evaluated 248 
      patients 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. Gyre Pharmaceuticals remains on track to 
      report topline data in the first quarter of 2025. 
 
   -- Plans to initiate a Phase 2 clinical trial in metabolic 
      dysfunction-associated steatohepatitis ("MASH")-associated liver fibrosis 
      in 2025. Pending the results from the PRC Phase 3 trial in CHB-associated 
      liver fibrosis, Gyre intends to initiate a Phase 2 proof-of-concept 
      clinical trial to evaluate F351 for the treatment of MASH-associated 
      liver fibrosis in 2025. 

F573:

   -- Ongoing Phase 2 trial in the PRC. Gyre Pharmaceuticals is 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 injection in the treatment of acute/acute on-chronic liver failure. 

Preclinical Development Updates

   -- F230: F230 is a selective endothelin receptor agonist for the treatment 
      of pulmonary arterial hypertension ("PAH"). In May 2024, Gyre 
      Pharmaceuticals received NMPA approval for its Investigational New Drug 
      ("IND") application to evaluate for F230 tablets for the treatment of PAH 
      and expects to initiate a Phase 1 trial in 2025. 
 
   -- F528: F528 is a novel anti-inflammation agent that targets the inhibition 
      of multiple inflammatory cytokines and has the potential to modify the 
      progression of chronic obstructive pulmonary disease ("COPD") with low 
      toxicity in vivo. Gyre Pharmaceuticals is evaluating F528 in preclinical 
      studies as a potential first-line therapy for the treatment of COPD. 

Corporate Updates

   -- In August 2024, Gyre announced the appointment of David M. Epstein, 
      Ph.D., to its Board of Directors. Dr. Epstein has extensive global 
      experience in biotech companies across the United States and Asia. Dr. 
      Epstein is a co-founder of PairX Bio Pte. Ltd., 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, leading the company through its January 2020 IPO. 
      Prior to Black Diamond, Dr. Epstein was Vice Dean, Innovation & 
      Entrepreneurship and Associate Professor at Duke-NUS Medical School in 
      Singapore. 

Financial Results

Cash Position

As of September 30, 2024, Gyre had cash and cash equivalents of $15.9 million. Based on current plans, Gyre anticipates that its cash resources as of September 30, 2024 will enable it to fund operations through at least 12 months following the issuance of the condensed financial statements.

Financial Results for the Three Months Ended September 30, 2024

   -- Revenues: Revenues for the three months ended September 30, 2024 were 
      $25.5 million, compared to $32.0 million for the same period in 2023. The 
      $6.5 million decrease was primarily driven by a $6.4 million decrease in 
      anti-fibrosis drug sales and a $0.1 million decrease in generic drug 
      sales due to fluctuations in the Chinese economy significantly affecting 
      demand for anti-fibrosis drugs and decreasing healthcare spending 
      generally. To support future revenue growth, we plan to commercially 
      launch new products, such as nintedanib and avatrombopag, in early 2025, 
      which will be supported by our extensive sales and marketing platform 
      across the PRC. 
 
   -- Cost of Revenues: For the three months ended September 30, 2024, cost of 
      revenues was $1.0 million, compared to $1.2 million for the same period 
      in 2023. The decrease was primarily driven by a $0.1 million factory 
      stoppage loss due to factory renovation in 2023 and a $0.1 million 
      decrease in sales quantity. 
 
   -- Selling & Marketing Expense: For the three months ended September 30, 
      2024, selling and marketing expense was $13.7 million, compared to $13.9 
      million for the same period in 2023. The decrease was primarily driven by 
      a $0.9 million decrease in conference costs due to a decrease in 
      conference activity, a $0.9 million decrease in staff cost as well as a 
      $0.1 million decrease in other expenses, partially offset by a $1.5 
      million increase in promotional expenses and a $0.2 million increase in 
      travel expense. 
 
   -- R&D Expense: For the three months ended September 30, 2024, research and 
      development expense was $2.8 million, compared to $3.0 million for the 
      same period in 2023. The decrease was primarily from Gyre Pharmaceuticals, 
      and was driven by a $0.5 million decrease in pre-clinical research 
      expense and a $0.2 million decrease in staff cost due to the decrease in 
      headcount in the research and development department, partially offset by 
      a $0.5 million increase in our clinical trial expense and clinical trial 
      expense from Gyre Pharmaceuticals. 
 
   -- G&A Expense: For the three months ended September 30, 2024, general and 
      administrative expense was $3.8 million, compared to $1.2 million for the 
      same period in 2023. The increase was primarily driven by costs 
      associated with being a public company, including a $0.9 million increase 
      in functional and administrative department's personnel and stock 
      compensation costs, a $0.6 million increase in miscellaneous expenses, 
      and a $1.2 million increase in professional expense. 
 
   -- Income from operations: For the three months ended September 30, 2024, 
      income from operations was $4.2 million, compared to $12.8 million for 
      the same period in 2023. 
 
   -- Net Income: For the three months ended September 30, 2024, net income was 
      $2.9 million, compared to $7.5 million in net income for the same period 
      in 2023. 

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November 13, 2024 06:00 ET (11:00 GMT)