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Copyright（C） 2025 All Rights Reserved, SanBio Company Limited 0 The presentation will begin at 4:00 p.m. Financial Results for the Second Quarter of the Fiscal Year Ending January 31, 2027 September 17, 2026 SanBio Company Limited TSE Growth: 4592
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Copyright（C） 2025 All Rights Reserved, SanBio Company Limited 1 Financial Results for the Second Quarter of the Fiscal Year Ending January 31, 2027 1 3 2 Progress in the First Half Year Future Outlook: Toward Becoming a Global Leader in Regenerative Medicine Table of Contents
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2 Cell Therapy Product Aiming for "Brain Regeneration" Launch of AKUUGO🄬 Injection for Intracerebral Transplantation 2. Progress in the First Half Year
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Copyright（C） 2025 All Rights Reserved, SanBio Company Limited 3 ◼ 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 challenges and the role of AKUUGO🄬 AKUUGO🄬 National Launch Commemorative Seminar 2. Progress in the First Half Year
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Copyright（C） 2025 All Rights Reserved, SanBio Company Limited 4 1. Financial Results for the Second Quarter of the Fiscal Year Ending January 31, 2027 Copyright（C） 2025 All Rights Reserved, SanBio Company Limited
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Copyright（C） 2025 All Rights Reserved, SanBio Company Limited 5 Financial Highlights: Consolidated Statements of Income 1. Financial Results for the Second Quarter of the Fiscal Year Ending January 31, 2027 Million Yen FY2026.1 Q2 Results(A) FY2027.1 Q2 Results(B) (B)-(A) Revenue － － － R&D expenses 1,346 1,226 ▲120 Operating expenses 1,888 1,909 21 Operating income ▲1,888 ▲1,909 ▲21 Net income ▲1,997 ▲1,791 205 Yen/US$ exchange rate 146.96 159.14 ◼ R&D expenses of ¥1,226 million were recorded, mainly for manufacturing- related expenses for AKUUGO®.
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Copyright（C） 2025 All Rights Reserved, SanBio Company Limited 6 Million yen As of January 31, 2026(A) As of July 31, 2027(B) (B)-(A) Cash & cash equivalents 15,083 12,748 ▲2,335 Current assets 15,489 13,380 ▲2,108 Non-current assets 131 264 132 Total assets 15,621 13,645 ▲1,976 Current liabilities 534 339 ▲194 Non-current liabilities 1,482 1,580 98 Total liabilities 2,016 1,920 ▲96 Net assets 13,604 11,724 ▲1,879 Total liabilities and net assets 15,621 13,645 ▲1,976 ◼ Maintain a prudent level of Cash & cash equivalents to meet foreseeable short- to medium-term needs. Financial Highlights: Consolidated Balance Sheets 1. Financial Results for the Second Quarter of the Fiscal Year Ending January 31, 2027
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Copyright（C） 2025 All Rights Reserved, SanBio Company Limited Copyright（C） 2025 All Rights Reserved, SanBio Company Limited 7 ◼ Loss was smaller than initially forecast due to the timing shift of certain manufacturing-related R&D expenses to the second half. Million yen FY2027.1 Q2 Forecast (A) FY2027.1 Q2 Results (B) (B)-(A) FY2027.1 Forecast Revenue － － － 396 Operating expenses 2,906 1,909 ▲996 5,625 R&D expenses 2,038 1,226 ▲812 4,110 Other 867 683 ▲184 1,515 Operating income ▲2,906 ▲1,909 996 ▲5,229 Ordinary income ▲2,908 ▲1,730 1,178 ▲5,074 Net income ▲2,909 ▲1,791 1,188 ▲5,133 1. Financial Results for the Second Quarter of the Fiscal Year Ending January 31, 2027 Revision of Consolidated Earnings Forecast
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Copyright（C） 2025 All Rights Reserved, SanBio Company Limited 8 Copyright（C） 2025 All Rights Reserved, SanBio Company Limited 2. Progress in the First Half Year
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9 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 Japan on July 31, 2024. Following NHI price listing on May 20, 2026, sales began on May 21, 2026. 2. Progress in the First Half Year
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Copyright（C） 2025 All Rights Reserved, SanBio Company Limited 10 AKUUGO🄬 NHI Price Listing and Launch (May 2026) Brand name AKUUGO® Suspension for Intracerebral Implantation Generic name Vandefitemcel Indication Improvement of chronic motor paralysis associated with traumatic brain injury NHI price 72,716,528 yen Dosage and administration In adults, implant 300μL of a cell preparation containing 5 x 106 viable human (allogeneic) bone marrow-derived mesenchymal stem cells into the peri-lesional area of the damaged brain tissue by stereotactic surgery using the dedicated administration device set. Through three implantation trajectories extending from a single burr hole in the skull to the peri-lesional area, administer 100μL of the cell suspension per trajectory at five sites spaced 5–6 mm apart, starting from the deepest point, with 20μL administered at each site. The infusion rate should be approximately 10μL/min. Perform the following procedures during implantation. 1. Prior to surgery, attach the guide-and-stop assembly and the stylet-equipped inserter of the dedicated administration device set to the invasive neurosurgical head fixation device. 2. Thaw the intracerebral implantation cell product and wash it using the dedicated preparation solution. Prepare the product with the dedicated preparation solution to achieve a transplantation concentration of 1.67 x 106 cells/100μL, thereby creating the cell suspension. After cleansing the microsyringe fitted with the administration cannula of the dedicated administration device set using the dedicated preparation solution, load the cell suspension into the microsyringe. Summary of efficacy evaluation International Phase 2 clinical trial (TBI-01 study: the U.S., Japan, and Ukraine) Multicenter, randomized, double-blind, sham surgery-controlled study in which subjects were randomized in a 3:1 ratio to the product group or the sham surgery group (product group: 2.5 x 106 cell group, 5.0 x 106 cell group, and 10.0 x 106 cell group). Study results Efficacy: For the primary endpoint, the change from baseline in FMMS at Week 24 was 8.3 ± 10.6 in the pooled SB623 group (n = 46) across all dose cohorts, compared with 2.3 ± 4.7 in the sham surgery group (n = 15), with a statistically significant difference observed between the groups (mean ± standard deviation; p=0.0401). Date of marketing approval July 31, 2024 2. Progress in the First Half Year
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Copyright（C） 2025 All Rights Reserved, SanBio Company Limited Copyright（C） 2025 All Rights Reserved, SanBio Company Limited 11 Building the Business Foundation Current Status (as of September 2026) Target by Fiscal Year-End (FY2027) Secure patient access and expand treatment opportunities Preparing introduction mainly at eight sites: five universities (Hokkaido, Tokyo, Yokohama City, Osaka and Okayama) plus three additional facilities Start dosing the first patient Expected six cases this fiscal year Achieve stable supply Build an integrated supply and logistics system with distributors, from manufacturing to product delivery aligned with each patient dosing date Establish stable operations Establishing Treatment Access and Supply Systems for AKUUGO® Adoption 2. Progress in the First Half Year
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Copyright（C） 2025 All Rights Reserved, SanBio Company Limited 12 Expanding Patient Access through Regional Collaboration 2. Progress in the First Half Year AKUUGO® Smart Regional Medical Collaboration
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Copyright（C） 2025 All Rights Reserved, SanBio Company Limited 13 Information for Physicians Product information Appropriate use support Patient Access / Medical Collaboration Patient / HCP information Consultation and referral pathway AKUUGO® Administration / Follow-up Procedure and preparation support Eligibility and follow-up system AKUUGO🄬 Information and Support System 2. Progress in the First Half Year
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Copyright（C） 2025 All Rights Reserved, SanBio Company Limited 14 ◼ Objective: Connect multidisciplinary HCPs through lectures and events to build medical collaboration ◼ Results: More than 1,000 cumulative participants in media and physician seminars [Completed] • 2026/6/6 JARM Annual Meeting Luncheon Seminar (Fukuoka) • 2026/6/10 Media Launch Seminar (Tokyo) • 2026/7/6 AKUUGO® Regional Seminar (Sapporo) • 2026/8/21 AKUUGO® Launch Seminar (Fukuoka) • 2026/8/22 AKUUGO® National Launch Seminar (Tokyo) • 2026/9/13 JSBT Annual Meeting Luncheon Seminar (Tokyo) [Upcoming] • 2026/10/22 JNS Annual Meeting Luncheon Seminar (Sapporo) • 2026/10/22 AKUUGO® Regional Seminar (Okayama) • 2026/11/29 Public Seminar Outreach to Healthcare Professionals and Society Rehabilitation Medicine Congress SanBio Booth 2. Progress in the First Half Year
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Copyright（C） 2025 All Rights Reserved, SanBio Company Limited 15 Minaris Advanced Therapies, LLC. Domestic manufacturing at Minaris Yokohama Manufacturing system for commercial production Strengthen Manufacturing/Supply for Stable Supply and Global Expansion Transfer upstream processes to Japan following closure of Minaris Mountain View facility in the U.S. Strengthening Manufacturing and Supply Systems Concluded a trial manufacturing agreementaimed at commercial production of AKUUGO® JCR Pharmaceuticals Co., Ltd. 2. Progress in the First Half Year
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Copyright（C） 2025 All Rights Reserved, SanBio Company Limited 16 Ｋｋ Traumatic brain injury (TBI) NHI price listing / Product Launch Agreed with FDA on Phase 3 trial design Discussion on the timing of the start of clinical trials Ischemic stroke Plan to discuss with PMDA to start clinical trials Preparing to start clinical trials Discussion on the timing of the start of clinical trials Hemorrhagic stroke Plan to discuss with PMDA to start clinical trials Discussion on the timing of the start of clinical trials Discussion on the timing of the start of clinical trials Progress in SB623 Development and Commercialization 2. Progress in the First Half Year *All diseases are in the chronic phase
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17 Copyright（C） 2025 All Rights Reserved, SanBio Company Limited 3. Toward Becoming a Global Leader in Regenerative Medicine
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18 ➢ Japan as “home base” –Starting point for expansion ➢ Realization of U.S. Business ➢ Success in Ischemic Stroke Program Becoming a Global Leader in Regenerative Medicine Three Pillars of Growth Strategy 3. Toward Becoming a Global Leader in Regenerative Medicine
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Copyright（C） 2025 All Rights Reserved, SanBio Company Limited Copyright（C） 2025 All Rights Reserved, SanBio Company Limited 19 Japan as “home base” for Global Expansion 1 Secure patient access to AKUUGO🄬 through smart regional medical collaboration 2 Build an integrated supply system from manufacturing to logistics and sales Apply to Future Global Expansion 3. Toward Becoming a Global Leader in Regenerative Medicine
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Copyright（C） 2025 All Rights Reserved, SanBio Company Limited 20 Ｋｋ Traumatic brain injury (TBI) Initial dosing / adoption Post-marketing clinical study Trial design agreed with FDA Preparing for clinical trial start next fiscal year Discussion on the timing of the start of clinical trials Ischemic stroke Trial design agreement with PMDA planned next fiscal year; preparing for clinical trial initiation Preparing to start clinical trials Discussion on the timing of the start of clinical trials Hemorrhagic stroke Plan to discuss with PMDA to start clinical trials Discussion on the timing of the start of clinical trials Discussion on the timing of the start of clinical trials *All diseases are in the chronic phase U.S. Expansion of SB623 and Indication Expansion 3. Toward Becoming a Global Leader in Regenerative Medicine
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Copyright（C） 2025 All Rights Reserved, SanBio Company Limited 21 Facilities for the STEMTRA study: 21 facilities Red - Facility Blue - Multiple facilities (numbers are number of facilities) Major facilities： UCLA, Stanford University, University of Pittsburgh, New York University, Northwestern University, etc.（ClinicalTrial.gov） 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 cases at 5 sites) 2015 Received milestone proceeds of US$5 million from co-development partner Sumitomo Dainippon Pharma under the option agreement 2016～2018 Ischemic stroke*: Phase 2 trial in the U.S. (163 cases at 65 sites) 2016 Ischemic stroke*: Phase 1/2a Paper Receives “Innovation Award 2016”. 2016～2019 Phase 2b (STEMTRA study) of traumatic brain injury in Japan, US, and Ukraine (21 sites in US, 5 sites in Japan, 1 site in Ukraine, 63 cases) 2017 Received the maximum grant available ($20M) from the California Institute for Regenerative Medicine (CIRM) 2019 Granted RMAT (Regenerative Medicine Advanced Therapy) Designation from the U.S. FDA for SB623 2022 Final Analysis of the STEMTRA Study Presented in Plenary Session at the American Academy of Neurology (AAN) Annual Meeting 2016～2018 Ischemic stroke*: Phase 2 trial in the U.S. (163 cases at 65 sites) （YouTube） * Chronic phase Before treatment, patient unable to raise arm Patient can now raise arm Patient able to resume normal activities Leveraging U.S. Track Record to Drive Business 3. Toward Becoming a Global Leader in Regenerative Medicine
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Copyright（C） 2025 All Rights Reserved, SanBio Company Limited 22 Corporate Growth Trajectory PresentPrevious fiscal year Four years and beyond ➢ Domestic adoption of AKUUGO ➢ Progress in U.S. TBI* ➢ Progress in domestic ischemic stroke* ➢ Adoption of TBI* and ischemic stroke* indications in Japan and the U.S. *Chronic phase 3. Toward Becoming a Global Leader in Regenerative Medicine
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23 Becoming a global leader in regenerative medicine SanBio Develops Regenerative Medicines, Creating Benefits for Patients and Value for Stakeholders. SanBio's Vision Copyright（C） 2025 All Rights Reserved, SanBio Company Limited
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Q＆A （For institutional investors and analysts） 24 Copyright（C） 2025 All Rights Reserved, SanBio Company Limited
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25 Financial Results for the Second Quarter of the Fiscal Year Ending January 31, 2027 Question and Answer session for the press is available at will begin at 5:00 p.m. Please wait a moment. SanBio Company Limited (TSE Growth: 4592)
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Q&A （For the press） 26 Copyright（C） 2023 All Rights Reserved, SanBio Company Limited
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27 Patient Inquiry Contact “TBI Navi” Search for “TBI Navi” or visit https://tbi-navi.jp/
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28 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 judgments, that are forward-looking statements which are made based on management’s assumptions and beliefs in light of the information currently available to it and may contain risks and uncertainty. Therefore you should not place undue reliance on them in making investment decisions. SanBio cautions you that actual results may differ substantially from those discussed in this material due to various factors. We do not guarantee the accuracy or completeness of the information herein. Unless otherwise stated, estimates or forecasts are solely those of our company and subject to change without notice. We accept no liability whatsoever for any direct or consequential loss arising from any use of this report. SanBio Company Limited Management Administration Contact: info@sanbio.com