Gyre Therapeutics, Inc. · NASDAQ:GYRE
Gyre Therapeutics — H.C. Wainwright Global Investment Conference 2025
18 slides from Gyre Therapeutics's conference presentation, Sep 10, 2025
Slide 1: Developing Anti-Fibrotic Therapeutics for Chronic Organ Diseases
Developing Anti-Fibrotic Therapeutics for Chronic Organ Diseases H.C. Wainwright Global Investment Conference September 2025
Slide 2: Forward Looking Statements
Forward Looking Statements 2 This presentation contains “forward-looking statements” within the meaning of the federal securities laws regarding the current plans, expectations and strategies of Gyre Therapeutics, Inc. and its subsidiaries (“Gyre”), which statements are subject to substantial risks
Slide 3: Gyre Therapeutics (Nasdaq: GYRE): At a glance
Gyre Therapeutics (Nasdaq: GYRE): At a glance 1. IPF = Idiopathic Pulmonary Fibrosis. 2. Per IQVIA CHPA. 3. Financial data inclusive of pro forma data prior to GNI Group and Catalyst Biosciences business combination for comparison purposes only. 3 1ST to receive IPF1 treatment approval (pirfenidone)
Slide 4: Innovative fibrosis focused development pipeline with sentinel indications in liver and lung
Innovative fibrosis focused development pipeline with sentinel indications in liver and lung 4 Advanced Liver Fibrosis Chronic Hepatitis B (CHB) Liver Fibrosis (hydronidone) Acute Liver Failure / Acute-on-Chronic Liver Failure Pulmonary Arterial Hypertension (PAH) Chronic Obstructive Pulmonary Disea
Slide 5: Strategic moves to strengthen our pirfenidone franchise and prepare for potential Hydronidone launch
Strategic moves to strengthen our pirfenidone franchise and prepare for potential future Hydronidone launch Note: 2017 sales number is audited (China) and 2024 is audited (U.S. GAAP). See Note 2 above for further clarification. 5 ETUARY® (pirfenidone)1 Etorel - Launched in 2025 Contiva – Launched in
Slide 6: Phase 3 CHB-associated liver fibrosis positive topline results
ITT = Intent-To-Treat. 2. NMPA = National Medical Products Administration of China 6 Co-secreted with insulin from pancreatic beta cells Co-secreted with insulin from pancreatic beta cells Co-secreted with insulin from pancreatic beta cells Phase 3 CHB-associated liver fibrosis - recently announced
Slide 7: Phase 3 Safety Profile
Phase 3 Safety Profile 7 Safety Event Hydronidone (N=123) Placebo (N=124) Any TEAE 98 (79.67%) 103 (83.06%) Grade 1 AES 27.64% 33.06% Grade 2 AES 43.90% 43.55% Grade ≥3 AES 8.13% 6.45% Drug-related AEs (ADRs) 32.52% 33.87% Grade ≥3 ADRs 1.63% 1.61% Discontinuation due to AE 0 0 Temporary interruptio
Slide 8: Hydronidone targets CHB fibrosis -- a high-need and untapped market in China
Hydronidone targets CHB fibrosis -- a high-need and untapped market in China Note: The Fourth National Serological Survey on HBV in China (2020) provided baseline HBV prevalence data. The 60-70M total HBV cases and F2-F4 fibrosis estimates are derived using internal modeling based on this survey’s f
Slide 9: Expanding Hydronidone's potential: from CHB fibrosis in China to MASH in the U.S.
Expanding Hydronidone’s potential: from CHB fibrosis in China to MASH in the U.S. 1. Based on analysis of third-party epidemiological research, published academic studies, and internal modeling. 9 Market Opportunity In the U.S., the MASH fibrosis market is approximately 7.2 times larger than the CHB
Slide 10: Hydronidone Targets Fibrosis Specifically for Advanced MASH
Hydronidone Targets Fibrosis Specifically for Advanced MASH 1. We estimate ~650K compensated F2–F4 MASH patients in the U.S., based on market data and internal modeling. 10 Hydronidone Primary Target 1 FIBROSIS STAGING Risk Staging based on: Fibrosis Progression Liver Events CV Events Primary Treatm
Slide 11: What makes Gyre different?
11 What makes Gyre different ? Strong Pipeline Our lead asset, F351 (Hydronidone), has the potential to become a first-in-class therapy for CHB-related liver fibrosis, addressing a significant unmet medical need in China. Robust pipeline spanning various clinical stages focused on treating organ dis
Slide 12: Thank you
Thank you Contact: David Zhang David.Zhang@Gyretx.com
Slide 13: Comparison of Hydronidone and Pirfenidone metabolism
13 Comparison of Hydronidone and Pirfenidone metabolism Hepatic cell Hepatic stellate cell Myofibroblasts Liver fibrosis Activation Liver Injury → TGF-β ↑ triggers multiple fibrosis pathways: 1. → p38γ → HSC Activation → α-SMA ↑ → ECM Accumulation → Fibrosis 2. → Smad2/3 (phosphorylation) → Fibrosis
Slide 14: Smad7 is a negative regulator of TGF-β signaling
Smad7 is a negative regulator of TGF-β signaling. Smad7 knockdown can promote HSC activation and liver fibrosis. Smad7 overexpression can prevent liver fibrosis. Hydronidone is believed to effectively target this pathway. Inhibiting HSC activation is believed to be one of the most effective therapeu
Slide 15: Smad7 is a known negative regulator of liver fibrosis
Smad7 is a known negative regulator of liver fibrosis, suggesting clinical potential in a recognized cascade Note: Statistical significance: *p < .05, **p < .01, *p < .001 (one-way ANOVA with post hoc tests). Data from Xu et al., Liver International (2023), 43(11): 2523–2537. doi:10.1111/liv.15715.
Slide 16: Hydronidone vs. Pirfenidone: Mechanistic and safety advantages
16 Hydronidone vs. Pirfenidone: Mechanistic and safety advantages The introduction of a hydroxyl group shifts its metabolic profile from Pirfenidone's dominant Phase I oxidation to preferential Phase II conjugation (M3/M4 metabolites). Phase II metabolism, known as "detoxification metabolism," can p
Slide 17: Hydronidone shaping up to be Pirfenidone 2.0
17 Hydronidone shaping up to be Pirfenidone 2.0 Feature Hydronidone Pirfenidone Mechanism of Action Tri-pathway mechanism: inhibits p38γ, upregulates Smad7, and suppresses TGF-β/Smad2/3 signaling Broadly downregulates TGF-β levels, with less defined pathway specificity Metabolism Undergoes Phase II
Slide 18: Hydronidone is Purpose-Built on Pirfenidone's Foundation
Hydronidone is Purpose-Built on Pirfenidone’s Foundation - with Enhanced Potency and Safety 18 Pirfenidone → [Structural Analog + Hydroxyl Group] → Hydronidone ↓ ↓ Modest Liver Activity Enhanced Smad7 Upregulation + Phase II Metabolism 1 ↑ Hepatotoxicity → ↓ Hepatotoxicity + ↑ Anti-fibrotic Potency
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