Gyre Therapeutics, Inc. · NASDAQ:GYRE
Gyre Therapeutics — Investor Presentation (June 2026)
42 slides from Gyre Therapeutics's investor presentation, Jun 2, 2026
Slide 1: A Fully-Integrated Biopharmaceutical Company Focused on Fibrosis, Inflammatory Diseases and Cancer
A Fully-Integrated Biopharmaceutical Company Focused on Fibrosis, Inflammatory Diseases and Cancer
Slide 2: Forward-looking statements
This presentation contains “forward-looking statements” within the meaning of the federal securities laws, including Section 27A of the United States Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, regarding the current plans, expectations and
Slide 3: Gyre Therapeutics: At-A-Glance Following Recent Acquisition of Cullgen
Gyre Therapeutics (Nasdaq: GYRE): At-A-Glance Following Recent Acquisition of Cullgen Pipeline ranges from discovery stage to marketed products with programs covering multiple therapeutic areas including fibrosis, inflammatory diseases and cancer ~740 Employees WW ~170 R&D ~85 Manufacturing ~370 Sal
Slide 4: China Innovation and Validation Engine: Driving Strategic Value and Efficiency
China Innovation and Validation Engine: Driving Strategic Value and Efficiency Fibrosis, Inflammatory Diseases, Cancer Portfolio Based on US-China Innovation F528 Chronic Obstructive Pulmonary Disease (COPD) CG923308 CDK2/Cyclin E Degrader for Solid Cancers IND Enabling Phase 1 Phase 2 Phase 3 NDA F
Slide 5: Gyre's ETUARY is the Market Leader of Pirfenidone for Treatment of Organ Fibrosis
Gyre’s ETUARY™ is the Market Leader of Pirfenidone for Treatment of Organ Fibrosis
Slide 6: First Product ETUARY Demonstrates Gyre's Capability from Innovation to Commercialization
First Product ETUARY™ Demonstrates Gyre’s Capability from Innovation to Commercialization and Managing Life Cycle of Innovative Drugs Third party pirfenidone sales outside of China fell substantially during same period and never recovered due to generic competition. Upcoming line extensions for ETUA
Slide 7: Promising Preclinical and Clinical Results for Two ETUARY Line Extensions
Promising Preclinical and Clinical Results for Two ETUARY™ Line ExtensionsPotential to Drive Market Expansion Ref 1. Bai et al. (2025) https://pubmed.ncbi.nlm.nih.gov/39546810/ Ref 2. Hou et al (2025) https://pubmed.ncbi.nlm.nih.gov/41207313/ B. A phase 2 trial demonstrates efficacy of Etuary™ in tr
Slide 8: F351 (hydronidone) A Next Generation Liver Fibrosis Therapy
F351 (hydronidone) A Next Generation Liver Fibrosis Therapy
Slide 9: F351 (hydronidone): An NDA Stage Next-Generation Fibrosis Therapy
F351 (hydronidone): An NDA Stage Next-Generation Fibrosis Therapy Primary Indication Liver fibrosis caused by Chronic Hepatitis B (CHB) and Metabolic dysfunction-Associated Steatohepatitis (MASH) Summary Next-Generation Pirfenidone: An Antifibrotic Agent with Enhanced Potency, Improved Safety, and F
Slide 10: F351 Phase 3 Results Demonstrate New Global Potential in Liver Fibrosis and Cirrhosis
F351 Phase 3 Results Demonstrate New Global Potentialin Liver Fibrosis and Cirrhosis ≥1-stage fibrosis regression at Week 52: F351: 52.85% (n=123) vs. Placebo: 29.84% (n=124) Delta: 23.01% p = 0.0002 (ITT1 analysis with central blinded pathology review) Consistent with fibrosis regression rates obse
Slide 11: U.S. MASH Fibrosis Market Provides Significant Opportunity for F351
U.S. MASH Fibrosis Market Provides Significant Opportunity for F351China First Strategy Provides Accelerated POC USA MASH Therapeutics Sales forecast from Evaluate Pharma as of 5-13-2026 Assumes 50% of all MASH patients progress to MASH fibrosis (Stage ≥F2) based on Luthra & Sheth (2025). 1 Le et al
Slide 12: Promising Path for Future Growth: TPDs and DACs Pipeline
Promising Path for FutureGrowth: Targeted Protein Degraders (TPDs) and Degrader-Antibody Conjugates (DACs) Pipeline CDK2 - Cyclin E Dual-Degrader for Solid Tumors TYK2 - JAK1 Dual-Degrader for Inflammatory Diseases
Slide 13: CDK2-Cyclin E Dual-Degrader for Solid Tumors
13 CDK2 - Cyclin EDual-Degraderfor Solid Tumors
Slide 14: Hyperactivation of the CDK2–Cyclin E Complex Drives Solid Tumor Progression
Hyperactivation of the CDK2–Cyclin E Complex Drives Solid Tumor Progression and Confers Resistance to Breast Cancer Therapy A. CDK2-cyclin E promotes cell proliferation and cancer development B. Cyclin E is frequently amplified across multiple cancer types D. Diverse CDK4/6i resistance converge on a
Slide 15: CDK2-Cyclin E Degrader for CCNE1-amplified Solid Tumors and Resistant Breast Cancer
CDK2-Cyclin E Degrader for Treating CCNE1-amplified Solid Tumors and Breast Cancer Resistant to CDK4/6 Inhibitors; IND Anticipated Q1 2027 Indication Solid tumors with CCNE1 amplification (CCNE1amp); HR+/HER2- breast cancer with CDK4/6i resistance; Patient Population Estimated in the US for 2024 by
Slide 16: CDK2-Cyclin E Degrader Demonstrates Greater In Vivo Efficacy Than CDK2 Inhibitors
CDK2-Cyclin E Degrader Demonstrates Greater In Vivo Anti-Cancer Efficacy Than Phase 2/3 CDK2 Inhibitors in CDX and PDX Models All doses were well tolerated in animals, with no significant body weight loss observed during the studies B. CCNE1-amp MKN1 Gastric CDX C. CCNE1-amp HCC1599 TNBC CDX A. CCNE
Slide 17: TYK2-JAK1 Dual-Degrader for Inflammatory Diseases
17 TYK2 - JAK1Dual-Degraderfor Inflammatory Diseases
Slide 18: Dual Targeting of TYK2 and JAK1 for Autoimmune Diseases
A. TYK2/JAK - STAT signaling Tsokos GC.(2011) NEJM PMID: 22129255 McInnes & Schett (2011) NEJM PMID: 22150039 B. SLE Mechanism C. RA Mechanism Platanias, LC. (2005) Nat Rev Immunol PMID:15864272 Significant Opportunity 125,000,000 psoriasis patients worldwide1 18,000,000 rheumatoid arthritis patient
Slide 19: CG620953 Demonstrates Superior Efficacy in Preclinical Models of Lupus and RA
A. CG620953 is effective in a mouse model of systemic lupus erythematosus (SLE) CG620953 Demonstrates Superior Efficacy in Preclinical Models of Lupus and Rheumatoid Arthritis (RA) B. CG620953 shows efficacy in a rat model of rheumatoid arthritis C. Targeted protein degradation in RA model Rat PBMC
Slide 20: Leveraging China Innovation Advantages to Advance Pipeline Products
Leveraging China Innovation Advantages to Advance Pipeline Products
Slide 21: Gyre's China Innovation and Validation Engine Leverages China's Unique Ecosystem
Gyre’s China Innovation and Validation Engine Provides Ability to Leverage China’s Unique Ecosystem Pillars ARC Group Insights – July 21, 2025 Comparison vs. Boehringer Ingelheim nerandomilast phase 3 study Drug Discovery Capabilities Streamlined Clinical Enrollment Cooperative Regulatory Environmen
Slide 22: Degraders for Cancer and Cancer-induced Bone Pain
Degraders for Cancer andCancer-induced Bone Pain- TRK degrader (CG001419)- GSPT1 degrader (CG009301)
Slide 23: Targeting TRK for Pain and Cancer
Targeting TRK for Pain and Cancer Cocco, Scaltriti & Drilon (2018) Nat Rev Clin Oncol PMID: 30333516 B. Activation of TRK in multiple solid tumors A. TRK signaling pathways
Slide 24: Clinical Development of CG001419 for Cancer
Clinical Development of CG001419 for Cancer Future Data Points Data from first 22 patients demonstrated no observed DLTs, treatment-related SAEs or grade ≥3 treatment related AEs. Enrollment in Phase 1b (dose expansion portions) began Q1 2026. RDE Phase 1a Dose Escalation 1b Dose Expansion Phase 2 B
Slide 25: Summary of CG001419 for Cancer
Summary of CG001419 for Cancer 2 1 3 Clinical Strategy Clinical Development Plan Positioning and Differentiation Exploratory study in cancer patients with NTRK amplification, overexpression and point mutations A rational, step-wise, biomarker-driven Phase 1/2 study design with expansion cohorts to p
Slide 26: NGF And TRK Are Key Mediators of Acute and Chronic Pain
NGF And TRK Are Key Mediators of Acute and Chronic Pain A. Nerve growth factor (NGF) stimulates the TrkA signaling pathway to transmit pain to the central nervous system TrkA Dorsal root ganglion (DRG) NGF Injury / Inflammation Brain NGF-TRKA complex C. Blocking NGF reduces cancer bone pain B. TRKA
Slide 27: Summary of Phase 1 PD, PK and Safety Study of CG001419
Summary of Phase 1 PD, PK and Safety Study of CG001419 CG001419-101 (NCT06636500): a SAD/MAD/FE study in healthy subjects in Australia The surrogate PD assay demonstrated DC50 and DC90 values of 2.4 nM and 18.2 nM, respectively Single and multiple oral doses of CG001419 up to the highest dosing leve
Slide 28: CG001419: Differentiated as a Potential First in Class Non-Opioid Medicine for Pain
CG001419: Differentiated as a Potential First in Class Non-Opioid Medicine for the Treatment of Pain Opioids NSAIDs Cebranopadol Journavx (Suzetrigine,VX-548) VX-993 LTG-001 STC-004 CG001419 Safety Concerns Risk to develop dependency GI issues, headache, dizziness Nausea - - - - - Effective Modera
Slide 29: Cancer-induced Bone Pain Market Opportunity
Cancer-induced Bone Pain Market Opportunity Current pharmacological therapies to treat CIBP are inadequate, with 70% treated with opioids reporting continued bone pain1 Tanezumab, an NGF antibody, showed reduction in pain in phase III trials of cancer patients with bone pain2 Opioids – Marginally ef
Slide 30: Summary of CG001419 for Pain
2 1 3 Clinical Strategy Clinical Development Plan Positioning and Differentiation Rational, mechanism-based selection of indications and target populations Planned Phase 2 study in cancer-induced bone pain applications Objectives: 1) magnitude and time course of CG001419 analgesia relative to placeb
Slide 31: Targeting GSPT1 for AML and MYC+ Cancers
Targeting GSPT1 for AML and MYC+ Cancers GSPT1 controls protein translation termination and plays important function for leukemia stem cells and tumor cells with MYC overproduction. GSPT1 lacks an active site and is often considered “undruggable”. Cullgen has developed a potent and selective GSPT1 d
Slide 32: Clinical Development of CG009301 in Recurrent or Refractory Hematologic Malignancies
Dose Escalation Stage Dose Expansion Stage* Dose level 1, n =1 Dose level 2, n=1 Dose level 3, n=3~6 Dose level 6, n=6~12 Dose level 7, n=6~12 BOIN Design Dose #1, n=9~18 Dose #2, n=9~18 Dose level 4, n=3~6 Dose level 5, n=3~6 Accelerated Titration Phase 2* R/R AML or HR-MDS or R/R ALL RDE Dose leve
Slide 33: Summary of CG009301 for Cancer
2 1 3 Clinical Strategy Clinical Development Plan Positioning and Differentiation Cullgen initiated a Phase 1 clinical trial in subjects with refractory hematologic malignancies in April 2025 in China. The expansion cohorts will focus on R/R AML, HR-MDS and ALL patients with hopes of identifying the
Slide 34: Degrader-Antibody Conjugates (DACs)
34 Degrader-Antibody Conjugates (DACs)
Slide 35: DACs Are the Next-Generation of ADCs
Degrader-Antibody Conjugates (DACs) Are the Next-Generation of ADCs DAC (Degrader antibody conjugate) TPD (Targeted protein degradation) E3 ligase E3 ligase ADC (Antibody drug conjugate) Modality ADCs TPD DAC Mechanism of Delivery Intravenous Oral or IV Intravenous Payload Indiscriminate Tumor targe
Slide 36: DAC Mechanism of Action Overview
DAC Mechanism of Action Overview The catalytic mechanism of action of TPDs ensures small quantity of degrader delivered by the antibody to achieve sufficient efficacy. HIGH POTENCY Extended half-life, reduced systemic clearance, improved solubility, and bypassing the need for oral bio-availability o
Slide 37: Epigenetic Factor DAC Demonstrates Potent and TAA-dependent Target Degradation
Epigenetic Factor DAC Demonstrates Potent and TAA-dependent Target Degradation and Cell Killing Cell Line TAA Positive Cell Line Compounds (nM） DMSO Degrader DAC DMSO Linker-degrader DMSO 0.01 0.1 1 10 100 0.01 0.1 1 10 100 0.01 0.1 1 10 100 Lane 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 Cell Lin
Slide 38: DACs: Durable Tumor Regression, Superior to Dxd-ADC, in CDX and PDX Models
Degrader-Antibody Conjugates: Durable Tumor Regression, Superior to Dxd-ADC, and Overcoming Resistance in CDX and PDX Animal Models A. DACs exhibit durable tumor growth inhibition in various solid tumor models B. DACs are more effective than Dxd-based ADCs C. DACs are effective in a CRPC PDX model r
Slide 39: Gyre Has Established a Robust DAC Platform
Degrader 2 Gyre Has Established a Robust DAC Platform DACs represent the next generation of ADC therapies Cullgen has developed >7,000 active degraders targeting >20 distinct proteins, serving as a valuable resource for payload selection We have successfully generated multiple DACs and demonstrated
Slide 40: Management Team
Ying Luo, Ph.D. Chief Executive Officer Thomas Eastling Chief Financial Officer Weiguo Ye Chief Operating Officer Yue Xiong, Ph.D. Chief Scientific Officer Mark Marino, M.D. Senior Vice President –Clinical Development Michael Plewe, Ph.D. Senior Vice President - Medicinal Chemistry Leslie Robinson,
Slide 41: Key Value Drivers
Key Value Drivers Robust and balanced therapeutic pipeline including assets from discovery to marketed products, with established manufacturing and commercialization operations 1 Utilization of highly efficient and cost-effective drug discovery and innovation capabilities in China to advance risk-mi
Slide 42: Nw THERAPEUTICS
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