Sanbio Co., Ltd. · TSE:4592
Sanbio — Q2 FY2027.1 Earnings Presentation
30 slides from Sanbio's earnings presentation, Sep 17, 2026
Slide 1: Financial Results for the Second Quarter of the Fiscal Year Ending January 31, 2027
The presentation will begin at 4:00 p.m. Financial Results for the Second Quarter of the Fiscal Year Ending January 31, 2027 SanBio Company Limited TSE Growth: 4592 September 17, 2026 0 Copyright(C) 2025 All Rights Reserved, SanBio Company Limited
Slide 2: Table of Contents
Table of Contents 1 Financial Results for the Second Quarter of the Fiscal Year Ending January 31, 2027 2 Progress in the First Half Year 3 Future Outlook: Toward Becoming a Global Leader in Regenerative Medicine 1 Copyright(C) 2025 All Rights Reserved, SanBio Company Limited
Slide 3: Progress in the First Half Year
2. Progress in the First Half Year Cell Therapy Product Aiming for "Brain Regeneration" Launch of AKUUGO🄬 Injection for Intracerebral Transplantation 2
Slide 4: AKUUGO National Launch Commemorative Seminar
2. Progress in the First Half Year AKUUGO🄬 National Launch Commemorative Seminar ◼ Held on August 22 at Toranomon Hills Forum ◼ Invited Professor David O. Okonkwo of the University of Pittsburgh; he enrolled nine cases in the TBI-01 study ■ Lectures and Q&A on TBI classification, treatment…
Slide 5: Financial Results
1. Financial Results for the Second Quarter of the Fiscal Year Ending January 31, 2027 Copyright(C) 2025 All Rights Reserved, SanBio Company Limited 4 Copyright(C) 2025 All Rights Reserved, SanBio Company Limited
Slide 6: Financial Highlights: Consolidated Statements of Income
1. Financial Results for the Second Quarter of the Fiscal Year Ending January 31, 2027 Financial Highlights: Consolidated Statements of Income ◼ R&D expenses of ¥1,226 million were recorded, mainly for manufacturing- related expenses for AKUUGO®. FY2026.1 FY2027.1 (B)-(A) Million Yen Q2 Results(A) Q
Slide 7: Financial Highlights: Consolidated Balance Sheets
1. Financial Results for the Second Quarter of the Fiscal Year Ending January 31, 2027 Financial Highlights: Consolidated Balance Sheets ◼ Maintain a prudent level of Cash & cash equivalents to meet foreseeable short- to medium-term needs. As of January 31, As of July 31, (B)-(A) Million yen 2026(A)
Slide 8: Revision of Consolidated Earnings Forecast
1. Financial Results for the Second Quarter of the Fiscal Year Ending January 31, 2027 Revision of Consolidated Earnings Forecast ◼ Loss was smaller than initially forecast due to the timing shift of certain manufacturing-related R&D expenses to the second half. FY2027.1 FY2027.1 FY2027.1 Q2 Forecas
Slide 9: Progress in the First Half Year
2. Progress in the First Half Year Copyright(C) 2025 All Rights Reserved, SanBio Company Limited 8 Copyright(C) 2025 All Rights Reserved, SanBio Company Limited
Slide 10: Toward Practical Use of a Cell Therapy Aiming to Regenerate the Brain
2. Progress in the First Half Year Toward Practical Use of a Cell Therapy Aiming to Regenerate the Brain AKUUGO🄬 is a regenerative medicine product intended to improve chronic motor paralysis associated with traumatic brain injury. It received conditional and time-limited marketing approval in…
Slide 11: AKUUGO NHI Price Listing and Launch (May 2026)
2. Progress in the First Half Year AKUUGO🄬 NHI Price Listing and Launch (May 2026) AKUUGO® Suspension for Intracerebral Brand name Implantation Generic Vandefitemcel name Improvement of chronic motor paralysis associated Indication with traumatic brain injury NHI price 72,716,528 yen International…
Slide 12: Establishing Treatment Access and Supply Systems for AKUUGO Adoption
2. Progress in the First Half Year Establishing Treatment Access and Supply Systems for AKUUGO® Adoption Building the Current Status Target by Fiscal Year-End Business (as of September 2026) (FY2027) Foundation Preparing introduction mainly at Secure patient eight sites: five universities access and
Slide 13: Expanding Patient Access through Regional Collaboration
2. Progress in the First Half Year Expanding Patient Access through Regional Collaboration AKUUGO® Smart Regional Medical Collaboration Copyright(C) 2025 All Rights Reserved, SanBio Company Limited 12
Slide 14: AKUUGO Information and Support System
2. Progress in the First Half Year AKUUGO🄬 Information and Support System Patient Access / Medical Information for Physicians AKUUGO® Administration / Collaboration Product information Follow-up Patient / HCP information Appropriate use support Procedure and preparation support Consultation and…
Slide 15: Outreach to Healthcare Professionals and Society
2. Progress in the First Half Year Outreach to Healthcare Professionals and Society ◼ Objective: Connect multidisciplinary HCPs through lectures and events to build medical collaboration ◼ Results: More than 1,000 cumulative participants in media and physician seminars Rehabilitation Medicine Congre
Slide 16: Strengthening Manufacturing and Supply Systems
2. Progress in the First Half Year Strengthening Manufacturing and Supply Systems Minaris Advanced Therapies, LLC. JCR Pharmaceuticals Co., Ltd. Concluded a trial manufacturing Transfer upstream processes to agreementaimed at commercial Japan following closure of Minaris production of AKUUGO® Mounta
Slide 17: Progress in SB623 Development and Commercialization
2. Progress in the First Half Year Progress in SB623 Development and Commercialization Kk Discussion on the Traumatic brain injury NHI price listing / Agreed with FDA on timing of the start of (TBI) Product Launch Phase 3 trial design clinical trials Plan to discuss with Discussion on the Preparing
Slide 18: Toward Becoming a Global Leader in Regenerative Medicine
3. Toward Becoming a Global Leader in Regenerative Medicine 17 Copyright(C) 2025 All Rights Reserved, SanBio Company Limited
Slide 19: Three Pillars of Growth Strategy
3. Toward Becoming a Global Leader in Regenerative Medicine Three Pillars of Growth Strategy ➢ Japan as “home base” –Starting Becoming a Global point for expansion Leader in ➢ Realization of U.S. Regenerative Business Medicine ➢ Success in Ischemic Stroke Program 18
Slide 20: Japan as Home Base for Global Expansion
3. Toward Becoming a Global Leader in Regenerative Medicine Japan as “home base” for Global Expansion Secure patient access to AKUUGO🄬 1 through smart regional medical collaboration Apply to Future Global Expansion Build an integrated supply system from 2 manufacturing to logistics and sales…
Slide 21: U.S. Expansion of SB623 and Indication Expansion
3. Toward Becoming a Global Leader in Regenerative Medicine U.S. Expansion of SB623 and Indication Expansion Kk Trial design agreed Initial dosing / adoption with FDA Discussion on the Traumatic brain injury Post-marketing clinical Preparing for clinical timing of the start of (TBI) study trial star
Slide 22: Leveraging U.S. Track Record to Drive Business
3. Toward Becoming a Global Leader in Regenerative Medicine Leveraging U.S. Track Record to Drive Business Year Event 2010 Signed an option agreement with Sumitomo Dainippon Pharma Co., Ltd. for cerebral infarction in the U.S. and Canada 2011~2015 Ischemic stroke*: Phase 1/2a trial in the U.S. (18 c
Slide 23: Corporate Growth Trajectory
3. Toward Becoming a Global Leader in Regenerative Medicine Corporate Growth Trajectory ➢ Domestic adoption of ➢ Adoption of TBI* and ischemic AKUUGO stroke* indications in Japan ➢ Progress in U.S. TBI* and the U.S. ➢ Progress in domestic ischemic stroke* Previous Present Four years fiscal year and
Slide 24: SanBio's Vision
SanBio's Vision Becoming a global leader in regenerative medicine SanBio Develops Regenerative Medicines, Creating Benefits for Patients and Value for Stakeholders. 23 Copyright(C) 2025 All Rights Reserved, SanBio Company Limited
Slide 25: Q&A (For institutional investors and analysts)
Q&A (For institutional investors and analysts) 24 Copyright(C) 2025 All Rights Reserved, SanBio Company Limited
Slide 26: Question and Answer Session for the Press
Financial Results for the Second Quarter of the Fiscal Year Ending January 31, 2027 SanBio Company Limited (TSE Growth: 4592) Question and Answer session for the press is available at will begin at 5:00 p.m. Please wait a moment. 25
Slide 27: Q&A (For the press)
Q&A (For the press) 26 Copyright(C) 2023 All Rights Reserved, SanBio Company Limited
Slide 28: Patient Inquiry Contact
Patient Inquiry Contact “TBI Navi” Search for “TBI Navi” or visit https://tbi-navi.jp/ 27
Slide 29: Disclaimer
Disclaimer This presentation material, including any comments made during or following the presentation, is provided solely for the purpose of reference to those investors who make their own evaluation of the company at their own risk. This material contains estimates, such as plans, strategies and
Slide 30: SanBio
EZ SanBio ioneering Regenerative Medicine