Gni Group Ltd. · TSE:2160

Gni — Q2 2025 Earnings Presentation

77 slides from Gni's earnings presentation, August 2025

  1. Slide 1: GNI Group Ltd. Financial Results for Q2 FY2025

    GNI Group Ltd. Financial Results for Q2 FY2025 Reference Translation Securities Code: 2160

  2. Slide 2: We Bring New Hope to Life

    We Bring New Hope to Life. © 2025 GNI Group Ltd. All rights reserved Reference Translation 1

  3. Slide 3: Agenda

    Agenda 1. Company Overview 2. Financial Highlights 3. Q2 FY2025 Segment 4. Growth Strategy 5. Financial forecast for FY2025 6. Appendix © 2025 GNI Group Ltd. All rights reserved Reference Translation 2

  4. Slide 4: 1. Company Overview

    1. Company Overview © 2025 GNI Group Ltd. All rights reserved Reference Translation 3

  5. Slide 5: Company Overview

    Company Overview Head Office Main Business 3rd Floor, Nihonbashi Honcho YS Building, Global pharmaceutical R&D, 2-2-2, Nihonbashi-Honcho manufacturing and distribution, Chuo-ku, Tokyo 103-0023 and biomaterials business Incorporation Director, Representative Executive November 2001 Officer, President

  6. Slide 6: Ying Luo Ph.D., Director, Representative Executive Officer, President, and CEO

    Director, Representative Executive Officer, President, and CEO Ying Luo Ph.D. To develop new treatments for unmet medical needs, we are leveraging the unique strengths of the pharmaceutical industries in Japan, the U.S., and the PRC, and pioneering a new, highly profitable business model. He obtaine

  7. Slide 7: Major Pharmaceutical & Drug Discovery (Candidate)

    Major Pharmaceutical & Drug Discovery (Candidate) [Pharmaceutical] ETUARY® (Generic name:Pirfenidone) Chinese:艾思瑞、English:ETUARY® • Treatment for idiopathic pulmonary fibrosis (IPF) • Our Current Main Products CONTIVA (Generic Name: Avatrombopag Maleate Hydrochloride) Chinese Name: 康曲欣® • Launched i

  8. Slide 8: Making the leap to a global pharmaceutical company through subsidiary listing strategy

    Making the leap to a global pharmaceutical company through subsidiary listing strategy Promoting the establishment to recruit high talents for a global management structure to achieve sustainable growth and maximize shareholder value, while mitigating CEO-centric management risks Pharmatech Biotech

  9. Slide 9: Main Group Structure

    Main Group Structure GNI Group Ltd. (TSE: 2160) Medical Devices (Biomaterials) Pharmaceuticals / Drug discovery Drug discovery 100% 100% 80% 40% Berkeley Biologics Berkeley Advanced Gyre Therapeutics Cullgen Biomaterials (NASDAQ: GYRE) Biomaterials Manufacturing / Biomaterials Manufacturing / Drug D

  10. Slide 10: 2. Financial Highlights

    2. Financial Highlights © 2025 GNI Group Ltd. All rights reserved Reference Translation 9

  11. Slide 11: Consolidated income statement

    Consolidated income statement Millions of yen Q2 2024 Q2 2025 Inc. / (Dec.) Factors for increase/decrease • Increase from the previous year due to record-high sales in the MedTech Revenue 11,733 12,252 519 business Gross profit 9,568 8,833 (735) SG&A 7,117 7,995 878 R&D 1,419 1,596 177 • Decrease in

  12. Slide 12: Segment result (cumulative total)

    Segment result (cumulative total) Pharmatech Biotech Medtech Others Millions of yen Q2 2024 Q2 2025 Q2 2024 Q2 2025 Q2 2024 Q2 2025 Q2 2024 Q2 2025 Revenue 7,844 7,171 754 480 2,509 3,992 633 604 Operating profit 2,399 1,622 (1,487) (2,274) 707 773 3,060 (1,704) Details of the “Other” Segment (for i

  13. Slide 13: Consolidated Balance Sheet

    Consolidated Balance Sheet Millions of yen Q4 FY2023 Q4 FY2024 Q2 FY2025 Inc. / (Dec.) Total non-current Assets 33,475 42,720 40,300 (2,420) Goodwill 14,246 15,994 14,666 (1,328) Intangible assets 8,852 11,026 11,268 242 Total Current Assets 30,793 29,222 27,422 (1,800) Trade accounts receivable 3,9

  14. Slide 14: Consolidated Balance Sheet/ Goodwill and Intangible Assets

    Consolidated Balance Sheet/ Goodwill and Intangible Assets Millions of yen Major Breakdown Q4 FY2023 Q4 FY2024 Q2 FY2025 Inc. / (Dec.) Variance Factors All changes in goodwill are due to exchange rate 14,246 15,995 14,666 (1,329) fluctuations. Gyre Pharmaceuticals 173 188 175 (13) Gyre Therapeutics

  15. Slide 15: Cash Flow

    Cash Flow Q2 FY2025 Note Millions of yen • Although the pre-tax loss of JPY 1.43 billion had a significant impact, the deficit in cash flow narrowed Cash Flow from Operating Activities (931) due to factors such as a reduction in corporate tax expenses. • approx. JPY 740 million was spent to acquire

  16. Slide 16: R&D expense

    R&D expense • The development costs related to Phase III and subsequent clinical trials meet the criteria for capitalization. • The capitalization of F351’s Phase 3 clinical trial conducted in China has been accounted for in accordance with accounting standards and tax regulations. • Capitalized dev

  17. Slide 17: Forex sensitivity

    Forex sensitivity Exchange rate FY 2025 FY2023 Actual FY2024 Actual Forecast Q2 Actual USD/JPY 140.67 151.69 145.00 148.40 CNY/JPY 19.82 21.04 20.50 20.44 Forex sensitivity Foreign exchange fluctuations affect yen-converted figures, with only a limited impact on profit margins. Revenue Operating pro

  18. Slide 18: 3. Q2 FY2025 Segment

    4. Q1 FY2025 Segment © 2025 GNI Group Ltd. All rights reserved Reference Translation 17

  19. Slide 19: Pharmatech

    Pharmatech Financial Results FY2024(Quarterly) FY2025(Quarterly) Q2(Cumulative) FY2021 FY2022 FY2023 FY2024 FY2025 Actual Actual Actual Actual Inc. / Forecast Q1 Q2 Q1 Q2 2024 2025 Millions of yen (Dec.) Revenue 9,868 13,346 15,742 15,847 3,982 3,862 3,315 3,856 7,844 7,171 (8.6%) 20,202 Operating p

  20. Slide 20: F351: Bring New Hope to Life, Powering a Brighter Future for CHB Patients

    F351: Bring New Hope to Life, Powering a Brighter Future for CHB Patients. © 2025 GNI Group Ltd. All rights reserved Reference Translation 19

  21. Slide 21: F351 Chronic Hepatitis B timeline in China

    F351: Bring New Hope to Life, Powering a Brighter Future for CHB Patients. Initial Nationwide Epidemiological Survey Conducted: HBsAg Positivity 1 1992 Rate — 9.72% (General Population) Second Nationwide Epidemiological Survey: HBsAg Positivity Rate — 2 2006 7.18% (General Population) 3 Third Nation

  22. Slide 22: Changes in Chronic Hepatitis B Prevention and Treatment Guidelines

    F351: Bring New Hope to Life, Powering a Brighter Future for CHB Patients. Changes in Chronic Hepatitis B Prevention and Treatment Guidelines The PRC has been working at the national level to address hepatitis B and regularly revises the Chronic Hepatitis B Prevention and Treatment Guidelines (Stand

  23. Slide 23: Revision of Chronic Hepatitis B Guidelines by the Chinese Society of Hepatology

    F351: Bring New Hope to Life, Powering a Brighter Future for CHB Patients. Revision of Chronic Hepatitis B Guidelines by the Chinese Society of Hepatology Overview of Guideline Revision Expansion of Eligible Patients Impact on F351 The Chinese Society of Hepatology (CSH) and As a result of this revi

  24. Slide 24: Favorable New Policies in China and Their Impact on F351

    Favorable New Policies in China and Their Impact on F351 On June 30, 2025, the Chinese government announced a comprehensive reform package to support pharmaceutical innovation. The reform adopts a groundbreaking “Full-Chain Support” approach, providing seamless assistance from research and developme

  25. Slide 25: Departure from across-the-board price cuts

    Departure from “across-the-board price cuts”: The dawn of a new era where pricing strategies can reflect the true value of medicines [Background] The National Healthcare Security Administration (NHSA) has established a new “Commercial Health Insurance Innovative Drug List” (commonly referred to as t

  26. Slide 26: NRDL versus Commercial Health Insurance Innovative Drug List

    Departure from “across-the-board price cuts”: The dawn of a new era where pricing strategies can reflect the true value of medicines Commercial Health Insurance Innovative Drug List National Reimbursement Drug List (NRDL) (Category C) Commercial Insurance Premiums and Out-of-Pocket Costs Funding Sou

  27. Slide 27: The Culmination of a Decade of Policy Evolution

    The Culmination of a Decade of Policy Evolution The series of reforms announced on June 30, 2025, represents the culmination of a decade of policy evolution since the groundbreaking CFDA reforms in 2015. Behind these policies lies the intent to cultivate globally competitive pharmaceutical companies

  28. Slide 28: Hepatitis is the second most common cause of death from infectious disease

    F351: Bring New Hope to Life, Powering a Brighter Future for CHB Patients. Hepatitis is the second most common cause of death from infectious disease in the world World Hepatitis Summit 9 April 2024 WHO: Global hepatitis report 2024 Estimated deaths from viral hepatitis will increase from • People i

  29. Slide 29: An estimated 60-79.7 million people in China are infected with hepatitis B

    F351: Bring New Hope to Life, Powering a Brighter Future for CHB Patients. An estimated 60-79.7 million people in China are infected with hepatitis B virus Stage Description Infection with the hepatitis B virus. If the acute hepatitis does not resolve and becomes chronic, it is referred 1. HBV Infec

  30. Slide 30: F351 patient estimate changed to 3-7.5 million

    F351: Bring New Hope to Life, Powering a Brighter Future for CHB Patients. Due to changes in underlying assumptions, number of F351 patients has been changed from approximately 3 million into to a range of 3–7.5 million, raising the upper end of the range. (based on GNI’s own view) [Previous Estimat

  31. Slide 31: Estimated number of patients for F351: approximately 7.5 million

    F351: Bring New Hope to Life, Updated on 14 August 2025 Powering a Brighter Future for CHB Patients. Estimated number of patients for F351: approximately 7.5 million# (based on GNI’s own view) 1. Number of Hepatitis B Patients Terms Number of people proportion Survey results: published in 2024 Popul

  32. Slide 32: Shifts in the Era of New Drug Approval Applications

    Shifts in the Era of New Drug Approval Applications Background: The Early Stage of China’s New Drug Development Market In the 2000s, “drug development” in China primarily referred to generic medicines, and the development of new drugs was not mainstream. At that time, the approval process for new dr

  33. Slide 33: 1. New Drug Application Process

    F351: Bring New Hope to Life, Powering a Brighter Future for CHB Patients. 1. New Drug Application Process The Era of F647: An Opaque Process One reason the process was opaque was the lack of experienced personnel on both the regulatory and company sides. Although the new drug application was submit

  34. Slide 34: Approval Process and Timelines for Breakthrough Therapies at China's NMPA

    F351: Bring New Hope to Life, Powering a Brighter Future for CHB Patients. Approval Process and Timelines for Breakthrough Therapies at China’s NMPA Key Points: NMPA Review Period – 130 Overview of the Breakthrough Therapy Working Days Designation System China’s National Medical Products Administrat

  35. Slide 35: 2. Insurance System

    F351: Bring New Hope to Life, Powering a Brighter Future for CHB Patients. 2. Insurance System The Era of F647: Underdeveloped Insurance Reimbursement Process At the time F647 was approved, the process for obtaining insurance reimbursement for new drugs was not well defined. There was only unverifie

  36. Slide 36: 3. Disease Awareness

    F351: Bring New Hope to Life, Powering a Brighter Future for CHB Patients. 3. Disease Awareness The Era of F647: Current Status of F351: Extremely low awareness High public awareness as a widespread disease At the time F647 was approved as a treatment for On the other hand, hepatitis B, the target i

  37. Slide 37: 4. GMP-Certified Manufacturing Facilities

    F351: Bring New Hope to Life, Powering a Brighter Future for CHB Patients. 4. GMP-Certified Manufacturing Facilities The Era of F647: Current Status of F351: Lack of Experience and Established Manufacturing Opaque Processes Infrastructure At that time, there were no GMP- Currently, two facilities ar

  38. Slide 38: 5. Sales Infrastructure

    F351: Bring New Hope to Life, Powering a Brighter Future for CHB Patients. 5. Sales Infrastructure The Era of F647: Current Status of F351: Building the Infrastructure from Scratch Leveraging an established sales network At the time, F647 was recognized as China’s “Class This time, we are able to le

  39. Slide 39: 6. Government-backed support

    F351: Bring New Hope to Life, Powering a Brighter Future for CHB Patients. 6. Government-backed support The Era of F647: Approval process without support Although F647 was a groundbreaking “Class 1.1” new drug, it took many years from the application to eventual approval. Current Status of F351: Str

  40. Slide 40: F528: Bring New Hope to Life, Powering a Brighter Future for COPD Patients

    F528: Bring New Hope to Life, Powering a Brighter Future for COPD Patients. © 2025 GNI Group Ltd. All rights reserved Reference Translation 39

  41. Slide 41: COPD is the third leading cause of death worldwide

    F528: Bring New Hope to Life, Powering a Brighter Future for COPD Patients. Chronic obstructive pulmonary disease (COPD) is the third leading cause of death worldwide According to a WHO report The “Silent Killer”: Chronic Obstructive According to the WHO report, there are approx. Pulmonary Disease (

  42. Slide 42: A massive market of 100 million driven by national policy

    A massive market of 100 million driven by national policy — the next decade of growth starts here COPD (Chronic Obstructive Pulmonary Disease) COPD is a disease in which the lung structure is irreversibly destroyed, leading to progressive shortness of breath. Its main pathological features are: 1. N

  43. Slide 43: Potential paradigm shift in global standard of care for COPD

    A massive market of 100 million driven by national policy — the next decade of growth starts here GNI Group has the potential to bring about a groundbreaking paradigm shift in the global standard of care for COPD The current standard treatment for COPD (Chronic Obstructive Pulmonary Disease) focuses

  44. Slide 44: Features and Mechanism of Action of F528

    A massive market of 100 million driven by national policy — the next decade of growth starts here Features and Mechanism of Action of F528 The majority of COPD patients (60–80%) exhibit non-type 2 inflammation (neutrophilic inflammation), which is resistant to existing steroid therapies and for whic

  45. Slide 45: Shifting COPD Treatment from Symptom Management to Root-Cause Therapy

    A massive market of 100 million driven by national policy — the next decade of growth starts here Shifting COPD Treatment from Symptom Management to Root-Cause Therapy F528 Targets True Disease-Modifying Effects (based on GNI’s own view) In studies using COPD model mice treated with F528, the follow

  46. Slide 46: GNI Group Growth Vision through In-House Development Pipeline

    GNI Group Growth Vision through In-House Development Pipeline Sustainable Growth Through the Development of Multiple Blockbuster Candidates (based on GNI’s own view) Drug Value Launch of Next-Generation Blockbuster Candidate, F528 Grobal Expansion Based on Cullgen • Estimated patient population in C

  47. Slide 47: [Pharmatech] Development Pipeline

    [Pharmatech] Development Pipeline Product Indication Location Preclinical Phase 1 Phase 2 Phase 3 NDA Marketed Chronic Obstructive Pulmonary Disease Plan to submit an IND application in 2026 F528 (COPD) - Plan to initiate Phase 2 trial in 2025 MASH-Associated Liver Fibrosis USA F351 (Hydronidone) ND

  48. Slide 48: [Biotech]

    [Biotech] FY2024(Quarterly) FY2025(Quarterly) Q2(Cumulative) FY2021 FY2022 FY2023 FY2024 FY2025 Actual Actual Actual Actual Inc. / Forecast Q1 Q2 Q1 Q2 2024 2025 Millions of yen (Dec.) Revenue 0 0 5,805 1,439 401 353 353 127 754 480 (36.3)% 955 Operating profit (1,920) (2,794) 2,374 (3,371) (744) (7

  49. Slide 49: [Biotech] Reverse Merger Transaction

    [Biotech] Reverse Merger Transaction The process for listing on Nasdaq is awaiting response (based on GNI’s own view) • One of the listing conditions — approval of the proposal at Pulmatrix’s shareholders’ meeting — was achieved on June 16, 2025, completing the reverse merger transaction. • The rema

  50. Slide 50: Cullgen's Challenge: Next-Generation Medicines with uSMITE Technology

    [Biotech] Cullgen’s Challenge Cullgen’s Challenge: Creating Next-Generation Medicines with uSMITE Technology Cullgen is a clinical-stage biopharmaceutical company The uSMITE platform is designed to efficiently specializing in the innovative drug discovery approach generate potential first-in-class d

  51. Slide 51: Drugs developed using the uSMITE platform act as a bridge

    [Biotech] Cullgen’s Challenge Drugs developed using the uSMITE platform act as a bridge The core of this technology lies in harnessing the cell’s natural protein degradation system, the Ubiquitin-Proteasome System (UPS), to work in its favor. Target Capture Induces the degradation system The other e

  52. Slide 52: Innovative Drug Discovery Enabled by uSMITE

    [Biotech] Cullgen’s Challenge Innovative Drug Discovery Enabled by uSMITE This innovative approach holds the potential to overcome challenges associated with conventional drugs, such as inhibitors. Tackling “Undruggable” Targets Overcoming Drug Resistance Proteins that are not affected by convention

  53. Slide 53: Cullgen's Novel Drug Candidate Compound (CG001419)

    [Biotech] Cullgen’s Challenge Cullgen’s Novel Drug Candidate Compound (Development Code: CG001419) CG001419 is a first-in-class, orally available drug candidate compound created by Cullgen using its proprietary targeted protein degradation platform, uSMITE . This compound entered a Phase 1 clinical

  54. Slide 54: Pain relief through a novel approach distinct from existing drugs

    [Biotech] Cullgen’s Challenge Pain relief through a novel approach distinct from existing drugs There are problems, but no alternative treatments are available Current pain treatments face issues such as dependency and constipation with opioid analgesics, and gastrointestinal and cardiovascular risk

  55. Slide 55: The Vast Pain Market and Expectations for New Treatment Options

    [Biotech] Cullgen’s Challenge The Vast Pain Market and Expectations for New Treatment Options Massive Market Size Promising Target Market The global pain management drug market is a massive Among them, the neuropathic pain market is showing industry, valued at over USD 60 to 80 billion as of 2024 pa

  56. Slide 56: Clinical Trial Status

    [Biotech] Cullgen’s Challenge Clinical Trial Status July 31, 2023 Initiation of Clinical Trial in the Oncology Field (China) Future Outlook An adaptive Phase 1/2 clinical trial targeting patients with advanced or In general, there are cases where results from metastatic solid tumors harboring NTRK f

  57. Slide 57: Medtech

    Medtech FY2024(Quarterly) FY2025(Quarterly) Q2(Cumulative) FY2021 FY2022 FY2023 FY2024 FY2025 Actual Actual Actual Actual Inc. / Forecast Q1 Q2 Q1 Q2 2024 2025 Millions of yen (Dec.) Revenue 1,795 2,428 2,841 5,189 1,290 1,220 1,370 2,621 2,509 3,992 +59.1% 6,159 Operating profit 844 1,110 1,133 942

  58. Slide 58: Expansion into Osderma and Medical Aesthetics Market

    [Medtech] Expansion into Osderma and Medical Aesthetics Market GNI Group's Business Platform Synergies to be Realized Expand market share in the high-end cosmetic Competitive advantage over peers medicine market and establish a brand Tighter regulations on off-label use in the cosmetic surgery field

  59. Slide 59: 4. Growth Strategy

    4. Growth Strategy © 2025 GNI Group Ltd. All rights reserved Reference Translation 58

  60. Slide 60: Group structure

    Group structure GNI Group Ltd. Tokyo, Japan (TSE: 2160) 100% 74% 100% GNI GNI 26% Shanghai USA Hong Kong Genomics 60% 100% 20% 80% 40% 65% 80% Micren Berkeley Advanced Gyre Therapeutics Shanghai Shanghai Healthcare OsDerma Cullgen Genomics Biomaterials (NASDAQ: GYRE) REEF Technology DMAH Biomaterial

  61. Slide 61: New Share Issuance Project through International Offering

    New Share Issuance Project through International Offering In July 2025, GNI Group conducted its largest-ever fundraising since its IPO. Amount Raised (JPY) Dilution Rate Discount Rate 12.59bn 9.98% 7.5% Purpose / Use of Funds • Aiming to become a global pharmaceutical company and enhance recognition

  62. Slide 62: Background for Choosing an International Offering

    New Share Issuance Project through International Offering Background for Choosing an International Offering Current Situation of Japan’s Biotech / Pharmaceutical Industry and the Advantages of Overseas Markets As indicated in reports such as the Ministry of Economy, Trade and Industry’s “Innovation

  63. Slide 63: Use of Funds: 1. Direct Acquisition of Shares in Gyre Pharmaceuticals

    New Share Issuance Project through International Offering Use of Funds: 1. Direct Acquisition of Shares in Gyre Pharmaceuticals Additional acquisition of a minority interest in the core subsidiary responsible for the manufacturing and marketing of new drugs F351, regarded by our company as a major n

  64. Slide 64: Use of Funds: 1. Direct Acquisition of Shares in Gyre Pharmaceuticals

    New Share Issuance Project through International Offering Use of Funds: 1. Direct Acquisition of Shares in Gyre Pharmaceuticals Additional acquisition of a minority interest in the core subsidiary responsible for the manufacturing and marketing of new drugs Shareholding Structure of GP (at the time

  65. Slide 65: Use of Funds: 2. M&A

    New Share Issuance Project through International Offering Use of Funds: 2. M&A The “Essential Piece” in the GNI Group’s Business Model Positioning 2025 as the “Second Founding Period” following the public offering fundraising in 2007, the Company will embark on establishing a solid foundation for bu

  66. Slide 66: Use of Funds: 3. Loans and Investments for Medtech Businesses

    New Share Issuance Project through International Offering Use of Funds: 3. Loans and Investments for the Rapidly Growing Medtech Businesses To seize growth opportunities, provide working capital through financing. Revenue and profit reached record highs on both a monthly Due to new clients and order

  67. Slide 67: Use of Funds: 3. Loans and Investments for Medtech Businesses

    New Share Issuance Project through International Offering Use of Funds: 3. Loans and Investments for the Rapidly Growing Medtech Businesses To seize growth opportunities, provide working capital through financing Driven by newly acquired customers, both sales and Due to receiving orders exceeding ou

  68. Slide 68: 5. Financial Forecasts for FY2025

    5. Financial Forecasts for FY2025 © 2025 GNI Group Ltd. All rights reserved Reference Translation 67

  69. Slide 69: Financial Forecasts for FY2025

    Financial Forecasts for FY2025 Consolidated Results No change in the forecast Millions of yen FY2024 Actual FY2025 Forecast Revenue 23,611 28,733 Gross profit 18,037 22,954 Operating profit 1,402 23,217 Income before income taxes 238 22,541 Net profit (9) 15,868 Profit attributable to owners of the

  70. Slide 70: 6. Appendix

    6. Appendix © 2025 GNI Group Ltd. All rights reserved Reference Translation 69

  71. Slide 71: F351 Phase 3 Clinical Trial – Top-Line Results Overview

    F351 Phase 3 Clinical Trial – Top-Line Results Overview (Announced May 23, 2025) 1. The primary endpoint Met with Hight Statistical Significance • ≥1-stage fibrosis improvement at Week 52: Hydronidon: 52.85% vs. Placebo: 29.84% (P = 0.0002) 2. Key Secondary Endpoint Achieved • ≥1-stage improvement i

  72. Slide 72: Overview of F351 Phase 3 Clinical Trial

    Overview of F351 Phase 3 Clinical Trial Efficacy and safety of F351 compared with placebo in patients with liver fibrosis caused by CHB Eligibility Criteria for Study Subjects (N=248) • Individuals infected with HBV (chronic hepatitis B) 123 • Fibrosis score (Ishak) of 3 or higher ①Hydronidone: • Ag

  73. Slide 73: Primary Endpoint Met with Statistically Significant Fibrosis Regression

    Primary Endpoint Met with Statistically Significant Fibrosis Regression Compared to the placebo group, a statistically significant improvement of at least one stage in fibrosis was achieved at Week 52 of treatment. ≥1-stage Fibrosis Regression at Week 52 (ITT analysis) % patients with ≥1-stage fibro

  74. Slide 74: Safety Profile

    Safety Profile • No treatment discontinuation, interruption, or dose reduction due to serious adverse events occurred during this study • All serious adverse events were assessed as unrelated to Hydronidone (F351) Safety Event Hydronidone (N=123) Placebo (N=124) Any TEAE 98 (79.67%) 103 (83.06%) Gra

  75. Slide 75: Key Secondary Endpoint Met: Significant Reduction in Liver Inflammation

    Key Secondary Endpoint Met: Significant Reduction in Liver Inflammation Achieved statistically significant improvement in liver inflammationBy combining anti-fibrotic and anti-inflammatory effects, a more comprehensive treatment approach is made possible ≥1-Grade inflammation improvement without pro

  76. Slide 76: Fibrosis Regression Observed in Ishak 6 (F4) Patients in Two Trials

    Meaningful Fibrosis Regression Observed in Ishak 6 (F4) Patients in Two Independent Trials Although statistical significance was not confirmed due to the small sample size, F351 may also be effective against cirrhosis caused by CHB. Phase 2: Fibrosis Regression in Cirrhosis Patients (Ishak 6) • 36%

  77. Slide 77: Contact Info: GNI Group Ltd. Investor Relations

    Contact Info: GNI Group Ltd. Investor Relations : IR@gnipharma.com : www.gnipharma.com This presentation contains statements concerning the current plans, expectations and strategies of GNI Group Ltd. (GNI Group). Any statements contained herein that pertain to future operating performance and that

GNI Group — Q2 2025 Earnings Presentation on 6ix