Gyre Therapeutics, Inc. · NASDAQ:GYRE
Gyre Therapeutics — Investor Presentation (April 2025)
24 slides from Gyre Therapeutics's investor presentation, Apr 28, 2025
Slide 1: Corporate Presentation April 2025
Corporate Presentation April 2025 Developing Anti-Fibrotic Therapeutics for Chronic Organ Diseases
Slide 2: Forward Looking Statements
Forward Looking Statements 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 an
Slide 3: Gyre Therapeutics: At a glance
3 Gyre Therapeutics (Nasdaq: GYRE): At a glance 1ST to receive IPF1 treatment approval (pirfenidone) in China (2011); Pioneering fibrosis treatment with a track record of success #1 IPF market share in China for 10 consecutive years2 (~50% market share, 90% + share in pirfenidone in 2024) ~ 600 dedi
Slide 4: Investment Thesis: Pioneering anti-fibrotic solutions for unmet global health needs
4 Investment Thesis: Pioneering anti-fibrotic solutions for unmet global health needs 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 spannin
Slide 5: Innovative fibrosis focused development pipeline with sentinel indications in liver and lung
5 Innovative fibrosis focused development pipeline with sentinel indications in liver and lung CANDIDATE INDICATION PRE-CLINICAL PHASE 1 PHASE 2 PHASE 3 MARKETED RIGHTS TRIAL F351(Hydronidone) MASH-associated Liver Fibrosis Global Chronic Hepatitis B (CHB) Liver Fibrosis First F573 Acute Liver Failu
Slide 6: Our lead asset, Hydronidone, targets CHB fibrosis in China
6 Our lead asset, Hydronidone, targets CHB fibrosis -- a high-need and untapped market in China The market for CHB-associated liver fibrosis is significantly unmet. Current standard of treatment, e.g. entecavir, tenofovir, focuses on only reducing liver inflamation. Patients with F2 - F4 fibrosis ar
Slide 7: Hydronidone demonstrates significant fibrosis regression in previous Phase 2 trial
7 Hydronidone demonstrates significant fibrosis regression with improved safety profile in previous Phase 2 trial Trial Overview2 Description Patient Population Treatment Groups Testing Method Primary Endpoint Multicenter, double-blinded, placebo-controlled, Phase 2 trial evaluating Hydronidone in C
Slide 8: Expanding Hydronidone's potential: From CHB fibrosis in China to MASH in the U.S.
8 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. Compensated F2-F4 MASH diagnosed population: ~650K1 CHB diagnozed population: ~ 90K1 Market Opportunity
Slide 9: CHB and MASH share common fibrotic signaling pathway
9 CHB and MASH share common fibrotic signaling pathway CHB- Associated Liver Fibrosis MASH- Associated Liver Fibrosis Etiology Viral (HBV) Metabolic (Obesity, T2 diabetes) Fibrosis Driver Target Cell Type F351 Mechanism TGF-β / p38γ / Smad7 Hepatic Stellate Cells Anti-fibrotic via TGF-β, p38γ & Smad
Slide 10: Hydronidone is purpose-built on pirfenidone's foundation
Hydronidone is purpose-built on pirfenidone’s foundation - with enhanced potency and safety 10 Pirfenidone → [Structural Analog + OH] → Hydronidone ↓ ↓ Modest Liver Activity → Enhanced Smad7 Upregulation + Phase II Metabolism 1 ↑ Hepatotoxicity → ↓ Hepatotoxicity + ↑ Anti-fibrotic Potency Attribute
Slide 11: Hydronidone reduces fibrosis in a validated MASH mouse model
Hydronidone reduces fibrosis in a validated MASH mouse model 11 Vehicle Hydronidone-15mpk Hydronidone-50mpk Endpoint Vehicle F351 (15 mpk) F351 (50 mpk) Fibrosis Severe ↓ ↓↓↓ Ballooning Present ↓ ↓↓ NASH Score High ↓ ↓↓ Hydronidone reduced fibrosis and ballooning in a dose-dependent manner. Validate
Slide 12: Hydronidone targets fibrosis specifically for advanced MASH
12 Hydronidone targets fibrosis specifically for advanced MASH FIBROSIS STAGING Risk Staging based on: Fibrosis Progression Liver Events CV Events Primary Treatment Objectives: Improve glycemic control Improve dyslipidemia Reduce weight Primary Therapeutic Options F1 F2 F3 F4 LOW MEDIUM HIGH VERY HI
Slide 13: Positioning Hydronidone in the evolving MASH treatment landscape
13 Positioning Hydronidone in the evolving MASH treatment landscape ORAL INJECTABLE Hydronidone Rezdiffra VK2809 EFX Pegozafermin Tirzepatide Semaglutide Survodutide Indication CHB MASH MASH MASH MASH MASH MASH MASH Study Phase Phase 2 Approved Phase 2b Phase 2b Phase 2b Phase 2b Phase 2 Phase 2 MOA
Slide 14: Strategic moves to strengthen our pirfenidone franchise
Strategic moves to strengthen our pirfenidone franchise and prepare for potential future hydronidone launch 14 ETUARY® (pirfenidone)1 Nintedanib - Acquired in 2024 Avatrombopag – Acquired in 2024 2017 2024 $15.3m $105.8m 32% CAGR1 Expanding Our IPF Market: Gyre’s ETUARY has dominated China’s IPF mar
Slide 15: Transitioning into a fully integrated global biopharma company
15 Transitioning into a fully integrated global biopharma company Beijing Office Shanghai Office Shunyi Manufacturing Facility CangZhou Manufacturing Facility Dual Global Headquarters San Diego, CA Beijing, China Integrated Manufacturing Infrastructure Shunyi Facility (Beijing): State-of-the-art R&D
Slide 16: Expected milestones for Hydronidone
Expected milestones for Hydronidone 16 1H 2025 2H 2025 1H 2026 Gyre plans to advance additional pipeline compounds including pirfenidone, F573, F528, and F230in a variety of fibrotic and inflammatory diseases Submission of New Drug Approval 2Q 2025 NMPA Approval 2026 Initiate Phase 2 in MASH-Associa
Slide 17: Gyre: Building on proven success with a measured, de-risked approach
Market leader in IPF with ETUARY® in China. China-first, U.S.-second development strategy. De-risked approach with efficient resource allocation. Integrated platform: R&D, regulatory, manufacturing, commercial. 17 Gyre: Building on proven success with a measured, de-risked approach to drive sustaina
Slide 18: APPENDIX: F351 - Mechanism of Action
18 APPENDIX: F351 - Mechanism of Action
Slide 19: Comparison of Hydronidone and Pirfenidone metabolism
19 Comparison of Hydronidone and Pirfenidone metabolism Hepatic cell Hepatic stellate cell Myofibroblasts Liver fibrosis Activation As a key profibrotic cytokine, TGF-β drives hepatic stellate cell (HSC) activation, promotes extracellular matrix (ECM) deposition, and triggers fibrogenesis. The p38γ
Slide 20: 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 21: 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 Xu, Xianjun et al. “Hydronidone ameliorates liver fibrosis by inhibiting activation of hepatic stellate cells via Smad7-mediated degradation of TGFβRI.” Liver international : official journal
Slide 22: Hydronidone vs. Pirfenidone: Mechanistic and safety advantages
22 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 23: Hydronidone shaping up to be Pirfenidone 2.0
23 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 24: Thank you
24 Thank you Contact: David Zhang David.Zhang@Gyretx.com
Gyre Therapeutics — Investor Presentation (April 2025) on 6ix