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Copyright（C） 2025 All Rights Reserved, SanBio Company Limited 1 March 18, 2025 SanBio Company Limited (TSE Growth: 4592) Financial Results for the Fiscal Year Ending January 31, 2025
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Copyright（C） 2025 All Rights Reserved, SanBio Company Limited 2 Table of Contents Financial Results for the FY ending Jan 31, 20251 3 4 The Birth of “Brain Regeneration” Therapeutics - Restarting U.S. Operations - Rechallenge to Ischemic Stroke 2 Outlook Becoming a Global Leader in Regenerative Medicine ５ Japan as a Mother Base
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3 Copyright（C） 2025 All Rights Reserved, SanBio Company Limited 1. Financial Results for the Fiscal Year ending January 31, 2025
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Copyright（C） 2025 All Rights Reserved, SanBio Company Limited 4 Consolidated Income Statement Million Yen FY2024.1 Results(A) FY2025.1 Results(B) (B)-(A) Revenue - - - R&D expenses 2,849 2,357 ▲491 Operating expenses 4,539 3,516 ▲1,023 Operating income ▲4,539 ▲3,516 1,023 Net income ▲2,644 ▲2,882 ▲238 Yen/US$ exchange rate 136.67 141.91 ◼ 3,516 million in operating expenses, primarily for the activities of the SB623 Chronic Traumatic Brain Injury Program. 1. Financial Results for the FY ending Jan 31, 2025
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Copyright（C） 2025 All Rights Reserved, SanBio Company Limited 5 Million yen As of January 31, 2024(A) As of January 31, 2025(B) (B)-(A) Cash & cash equivalents 4,454 2,921※ ▲1,533 Current assets 4,937 3,335 ▲1,601 Non-current assets 109 111 1 Total assets 5,047 3,447 ▲1,599 Current liabilities 905 732 ▲173 Non-current liabilities 1,349 952 ▲396 Total liabilities 2,254 1,684 ▲570 Net assets 2,792 1,762 ▲1,029 Total liabilities and net assets 5,047 3,447 ▲1,599 *Raised approximately 2 billion yen as a result of the issuance of new shares and unsecured convertible bonds with stock acquisition rights through a third-party allotment on March 3, 2025. Consolidated Balance Sheet 1. Financial Results for the FY ending Jan 31, 2025 ◼ Maintain a certain level of cash and deposits necessary for the current year's activities.
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Copyright（C） 2025 All Rights Reserved, SanBio Company Limited Consolidated Earnings Forecast 6 ◼ Projected total business expenses of 3,509 million yen, mainly for expenses related to obtaining approval for partial change of manufacturing and marketing approval items for AKUUGO🄬 and expenses for establishing manufacturing, distribution, and sales systems for post-marketing activities in Japan. Million yen FY2025.1 Results FY2026.1 Forecast Revenue - - R&D expenses 2,357 2,405 Operating expenses 3,516 3,509 Operating income ▲3,516 ▲3,509 Net income ▲2,882 ▲3,554 Yen/US$ exchange rate 141.91 155.00 1. Financial Results for the FY ending Jan 31, 2025
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7 Copyright（C） 2025 All Rights Reserved, SanBio Company Limited 2. The Birth of “Brain Regeneration” Therapeutics
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Copyright（C） 2025 All Rights Reserved, SanBio Company Limited 8 Going “back to our original vision” ~The challenge of “brain regeneration” that overturns 100 years of conventional wisdom 2. The Birth of “Brain Regeneration” Therapeutics ◼ SanBio was founded in 2001 in California, with the concept of “bringing regenerative medicine from Japan to the world ◼ Continuing the challenge of “brain regeneration,” which has overturned 100 years of conventional wisdom SanBio's Cell Therapy Medicine R&D History 1906 Santiago Ramón and Cajal Doctor awarded Nobel Prize in Physiology or Medicine The central nervous system of living mammals does not regenerate after injury Professor Hideyuki Okano (Founding Scientist of SanBio) Discovery of neural stem cells in the adult brain Yokohama TLO Technology transfer from 2001 In the United States SanBio Inc. established Obtained approval from FDA to conduct clinical trials Established a company in Japan Corporate restructuring implemented, reversing parent-child relationships between Japan and the United States Conducting Japan-US global clinical trials Listed on the Tokyo Stock Exchange Designated as a target item for the "Sakigake Review Designation System" by the Ministry of Health, Labour and Welfare SB623 Apply for manufacturing and sales certification Final analysis of clinical trial presented at AAN AKUUGO🄬 Obtained manufacturing and sales license
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Copyright（C） 2025 All Rights Reserved, SanBio Company Limited 9 About “AKUUGO🄬 suspension for intracranial implantation” ◼ World’s First Therapeutic Agent for Regenerating Brain ◼ Obtained conditional and time-limited approval from the MHLW on July 31, 2024. Brand name AKUUGO🄬 Suspension for Intracranial Implantation Generic name Vandefitemcel Indications and effects Improvement of chronic motor paralysis associated with traumatic brain injury Dosage and administration For adults, implant 5 x106 live human (allogeneic) bone marrow-derived mesenchymal stem cells (300μL of cell suspension) to perilesional brain tissues via stereotactic brain surgery using the dedicated delivery device set. Implant the cells into the perilesional area through three trajectories via a burr hole made in the skull. To each trajectory, inject 100μL of the cell suspension, depositing 20μL of the solution each across a total of five sites placed at 5–6mm intervals from the deepest site. The rate of implantation should be approximately 10μL/min. Follow the steps below for implantation. 1. Before starting the procedure, attach the guide & stop and stylet-equipped inserter from the dedicated delivery device set to the head fixation device for invasive neurosurgery. 2. Thaw the cell suspension for intracranial implantation, wash it with the dedicated preparation solution, and adjust the concentration of the cell suspension to 1.67 x 106 cells/100μL using the dedicated preparation solution. Cleanse the micro-syringe fixed with the cannula from the dedicated delivery device set with the dedicated preparation solution before filling it with the prepared cell suspension. Date of marketing approval July 31, 2024 (hereafter referred to as “AKUUGO🄬”） 2. The Birth of “Brain Regeneration” Therapeutics
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Copyright（C） 2025 All Rights Reserved, SanBio Company Limited 10 Promising pipeline of AKUUGO🄬, “Brain Regeneration” Therapeutics Focus on diseases of the central nervous system that cannot be addressed by existing medical and pharmaceutical products Alzheimer’s diseaseTraumatic brain injury（chronic） Ischemic stroke （chronic） Hemorrhagic stroke （chronic） Spinal cord injury Dry age-related macular degeneration Parkinson’s disease Retinitis pigmentosa 2. The Birth of “Brain Regeneration” Therapeutics
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Copyright（C） 2025 All Rights Reserved, SanBio Company Limited 11 From the presentation of Q2 of FY ending Jan 31, 2025 ➢ Restarting US Initiatives ➢ Re-engaging in Ischemic Stroke Treatment ➢ Japan as a Mother Base Global Leader in Regenerative Medicine 2. The Birth of “Brain Regeneration” Therapeutics
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12 ３. Japan as a Mother Base Copyright（C） 2025 All Rights Reserved, SanBio Company Limited
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Copyright（C） 2025 All Rights Reserved, SanBio Company Limited 13 The second manufacturing run was deemed compliant ◼ The second manufacturing run cleared all specification requirements and was deemed compliant. ◼ With the compliance of this manufacturing run, the company will run one more manufacturing compliant with necessary specifications and plans to file a partial change application and subsequently obtain approval for the partial change to meet the shipment conditions. ３. Japan as a Mother base
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Copyright（C） 2025 All Rights Reserved, SanBio Company Limited 14 Conclusion of Contract Manufacturing Agreement with JCR Pharma for Trial Production of AKUUGO🄬 ◼ Contract manufacturing agreement signed for trial production of AKUUGO🄬 for commercial manufacturing. ３. Japan as a Mother base
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Copyright（C） 2025 All Rights Reserved, SanBio Company Limited 15 Dry shipper Dedicated delivery device set Manufacturing Shipping Wholesale pharmaceuticals （Centralized management of information from patient registration to product delivery, dosing, and follow-up） R-SAT🄬 ３. Japan as a Mother base Patient Registration (at the medical institution) *Individuals will not be identified. Vial containing cell suspension for intracranial implantation Hard case and dry shipper for transportation Dedicated preparation solution Medical institution (Follow-up after administration) Distribution System for AKUUGO🄬
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Copyright（C） 2025 All Rights Reserved, SanBio Company Limited 16 Surgical (transplant) facilities ① ③ Consultation facilities (set up for each region) Patient at home No contact with medical institutions ②Rehabilitation Facilities • Therapist • Medical Social Worker • Higher brain dysfunction support coordinator • Patient /Participant association Introduction to facilities/systems/consultation Patients Facilities where patients go to the hospital Recovery/Chronic Care Facilities ※Referral letter needed ３. Japan as a Mother base SanBio’s Smart Regional Medical Cooperation Concept Image ◼ Flow of AKUUGO🄬 administration and postoperative rehabilitation
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Copyright（C） 2025 All Rights Reserved, SanBio Company Limited 17 Disease awareness and support site for patients and their families ◼ Disease awareness videos are available on “TBI Navi®”（URL：https://tbi-navi.jp/）a disease awareness and support website for patients and their families https://tbi-navi.jp/movie/index.html ３. Japan as a Mother base
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Copyright（C） 2025 All Rights Reserved, SanBio Company Limited 18 ｃｖ • The brain injuries responsible for motor paralysis were classified into two groups: the cortex group and the deep white matter (DWM) group. • The study found that the correlation between the distance from the injury to the implantation site and treatment efficacy varied depending on the injury location. In the cortex group, shorter distances were associated with greater efficacy, while in the DWM group, shorter distances were linked to lower efficacy. Publication of Results of Cell Implantation Location Analysis from Phase 2 Clinical Trial of Vandefitemcel (SB623) in TBI Patients (STEMTRA Trial) in Neurotrauma Reports [Source] Sanbio press release dated February 12, 2025https://www.sanbio.com/wp/wp- content/uploads/2025/02/PR_20250212_Neurotrauma-Reports.pdf Progress of R&D on AKUUGO🄬 ｃｖ Results of a joint study with Okayama University (effects of SB623 transplantation combined with exercise in a rat cerebral infarction model) published in Experimental Neurology [Source] Therapeutic effects of intracerebral transplantation of human modified bone marrow- derived stromal cells (SB623) with voluntary and forced exercise in a rat model of ischemic stroke ｃｖ Dr. Maeda presented the results of his research at “Frontiers of Basic Research for the Development of Diagnostic and Therapeutic Methods for Alzheimer's Disease” Keio University Joint Research: Biochemical Society of Japan 2024 Symposium (November 8, 2024) ３. Japan as a Mother base
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19 4. Outlook Copyright（C） 2025 All Rights Reserved, SanBio Company Limited
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Copyright（C） 2025 All Rights Reserved, SanBio Company Limited 20 ◼ The US and other markets are much larger than Japan TBI: 5.51 million*10 Ischemic stroke: 6.85 million*11 Hemorrhagic stroke: 1.02 million*12 TBI: 6.57 million*1 Ischemic stroke: 3.01 million*2 Hemorrhagic stroke: 600,000*3 TBI: 11 million*4 Ischemic stroke: 15.73 million*5 Hemorrhagic stroke: 1.5 million*6 *1~*3,*10~*12: In-house analysis based on multiple sources *4: Arch Neurol. 1986;43(6):570-572 (Wang et al.) *5: Circulation. 2017;135:759-771 (Wang et al., 2017). *6: GHDx Healthdata IQVIA analysis 2020 *7: Ministry of Health, Labour and Welfare 2020 (The total number of intracranial injury patients) *8: Ministry of Health, Labour and Welfare 2020 (The total number of cerebral infarction patients) *9: Ministry of Health, Labour and Welfare 2020 (The total number of cerebral hemorrhage patients) TBI: 60,000*7 Ischemic stroke: 1,190,000*8 Hemorrhagic stroke: 200,000*9 Background of Restarting the US Operations 4. Outlook
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Copyright（C） 2025 All Rights Reserved, SanBio Company Limited 21 Past achievements in the U.S. 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 2011～2015 Ischemic stroke※ Phase 1/2a trial in the U.S. (18 cases at 5 sites) 2016～2018 Ischemic stroke※ Phase 2b 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 largest grant ($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 （YouTube） ※ chronic 4. Outlook
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Copyright（C） 2025 All Rights Reserved, SanBio Company Limited 22 Restarting the U.S. Operations ◼ Already consulted with FDA in 2019 and 2022 ◼ Resumed discussions with FDA to conduct clinical trials in traumatic brain injury※ ◼ Preparations for clinical trials are ongoing for Ischemic stroke※ Number of patients in the U.S. Traumatic brain injury※ : 5.51 million* Ischemic stroke※ : 6.85 million* Hemorrhagic stroke※ :1.02 million* ※ chronic *In-house analysis based on multiple references 4. Outlook
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Copyright（C） 2025 All Rights Reserved, SanBio Company Limited 23 Rechallenge to Ischemic Stroke※ Count Composite Responders Avg. Baseline FMMS Composite Response (%) therapeutic group 107 42 44.87 39% sham surgery group 51 16 47.35 31% p-value 0.42 0.33 0.42 N=163 N=77 Composite FMMS Improvement Meets one of the following（Composite endpoint） 1. FMMS Total ≥9 points improvement from baseline 2. FMMS UE ≥6 points improvement from baseline 3. FMMS LE ≥4 points improvement from baseline Select patients with infarcted size less than a certain amount Condition 1 Condition 2 Count Composite Responders Avg. Baseline FMMS Composite Response % therapeutic group 51 25 48.55 49% sham surgery group 26 5 49.42 19% p-value 0.02 0.8 0.02 ◼ Post-hoc Analysis of STR-02 Trial Provides Prospects for Next Clinical Trial ◼ Plans to resume discussions with Japanese and U.S. regulatory authorities regarding clinical trials for an additional indication in ischemic stroke※ ※ chronic In patients with infarct size less than a certain amount, a 30% difference in composite FMMS improvement was observed, 49% in the SB623 group and 19% in the sham surgery group Overall Population: Of the 163 enrolled patients, 158 were evaluable at 6 months Population with infarct size less than a certain amount (77patients: 48.7%) 4. Outlook
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Copyright（C） 2025 All Rights Reserved, SanBio Company Limited 24 • Mechanism of action: Transplantation of hMSC-SB623 cells (bande phytem cell) was found to reduce cortical hyperexcitation caused by cerebral ischemia and restore normal brain function • Therapeutic potential: hMSC-SB623 cells (bandeftemcell) promote neural regeneration, synaptic plasticity, and immunomodulation, suggesting the potential to treat a variety of neurological diseases caused by network hyperexcitation Paper published in Molecular Therapy showing that human bone marrow-derived processed mesenchymal stem cell vandefytem cell (SB623) improves cortical excitability in rats with focal cerebral ischemia [Source] Sanbio Press release dated January 7, 2025 https://ssl4.eir-parts.net/doc/4592/tdnet/2546077/00.pdf About the results of the joint research with GLADSTONE INSTITUTES [Reference] https://gladstone.org/news/stem-cell-therapy-jumpstarts-brain-recovery-after-stroke 4. Outlook “There are currently no treatments that can be given weeks or months after a stroke to prevent long-term symptoms, so this is incredibly exciting,”
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Copyright（C） 2025 All Rights Reserved, SanBio Company Limited 25 Area/Indication expansion outlook ◼ Resumed discussions with FDA to conduct clinical trials in the US for traumatic brain injury※１ ◼ Preparing to conduct clinical trials in Japan and the U.S. for cerebral ischemic stroke ※1 Traumatic brain injury （TBI）※1 Conditional and time- limited approved Resumed discussions with FDA regarding initiation of clinical trials Discussion on the timing of the start of clinical trials※2 Ischemic stroke※1 Plans to discuss with PMDA to start clinical trials Preparing to start clinical trials Discussion on the timing of the start of clinical trials※2 Hemorrhagic stroke※1 Plans to discuss with PMDA to start clinical trials Discussion on the timing of the start of clinical trials※2 Discussion on the timing of the start of clinical trials※2 ※1 chronic ※2 Consider options such as in-house development or partnering 4. Outlook
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Copyright（C） 2025 All Rights Reserved, SanBio Company Limited 26 Anticipated events for this financial year US • Resumed discussions with FDA regarding P3 clinical trial of TBI ※2 • Agreement with FDA on P3 clinical trial for TBI ※2 Japan • Approval of AKUUGO🄬※1 （Release of shipment） • Listing of AKUUGO🄬 on the NHI drug price list and launching of sales. • Start negotiation with PMDA regarding a clinical trial for Ischemic stroke ※2 FY2026.01 the first half-year FY2026.01 the second half-year ※1 Partial change of manufacturing and marketing approval items ※2 chronic 4. Outlook
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27 5. Becoming a Global Leader in Regenerative Medicine Copyright（C） 2025 All Rights Reserved, SanBio Company Limited
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Copyright（C） 2025 All Rights Reserved, SanBio Company Limited 28 Going “back to our original vision” to become a global leader in regenerative medicine: Dramatic growth through restarting stroke and re-entry into the U.S. market“ Within FY2026 Current 4 years later~ * chronic [Image of Company Growth] ➢ Launch in the US ➢ Progress in Stroke ➢ Launch in Japan ➢ Restart TBI* in the US ➢ Preparation for Stroke* in Japan and the US
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29 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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Copyright（C） 2025 All Rights Reserved, SanBio Company Limited 30 APPENDIX: Promising pipeline for SB623
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Q＆A （For institutional investors and analysts） 31 Copyright（C） 2025 All Rights Reserved, SanBio Company Limited
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32 Financial Results Briefing for the Fiscal Year Ending January 31, 2025 Question and Answer session for the press is available at will begin at 4:30 p.m. Please wait a moment. SanBio Company Limited (TSE Growth: 4592)
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Q&A （For the press） 33 Copyright（C） 2023 All Rights Reserved, SanBio Company Limited
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Copyright（C） 2025 All Rights Reserved, SanBio Company Limited 34 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