Financial Results
for the Fiscal Year Ending January 31, 2023
SanBio Company Limited(TSE Growth: 4592)

March 17, 2023

1

Table of Contents

1

Financial Results2

SB623 Approval in Japan andSales Structure After Approval

3

Toward Maximizing Corporate Value

4

Q&A

Copyright（C） 2022
2023 All Rights Reserved, SanBio Company Limited2

New Executive Leadership
Executive Directors
SanBio Co., Ltd. Executive Chairman

SanBio Co., Ltd. President

Toru Kawanishi

Keita Mori

Corporate Officers
Senior Corporate Officer, responsible for HR,
Japan Regulatory Affairs & Quality
Compliance Japan, and Japan/Asia Business*Senior Corporate Officer, CMO

Bijan Nejadnik

Naoki Tsukahara*Consolidated business activities of SanBio Asia

CSO

Head of Production

Andrew Liu

Keizo Nakada

Head of Japan Regulatory Affairs& Quality Compliance Japan

Head of Japan Researchand Development

Kazumi Sawaguchi

Shinya Hirata

Copyright（C） 2023 All Rights Reserved, SanBio Company Limited

Management Administration

Yoshihiro Kakutani
3

1. Financial Results

Copyright（C） 2023 All Rights Reserved, SanBio Company Limited4

Consolidated Income Statement
Operating expenses increased from weakening yen vs the US dollar, higher expenditures related towork toward approval of SB623 chronic TBI program, and an increase of R&D expenses from adecision to record supplies for use in commercial production as for R&D.
FY2022.1
Results (A)FY2023.1
Results (B)FY2023.1
Forecast(B)-(A)Million Yen----

4,955

6,118

1,162

6,105

Operating expenses

6,620

7,899

1,278

8,131

Operating income▲6,620▲7,899▲1,278▲8,131

Net income▲4,677▲5,559▲881▲5,684

Yen/US$ exchange
rate

110.73132.72-135.77

RevenueR&Dexpenses

Copyright（C） 2023 All Rights Reserved, SanBio Company Limited5Consolidated Balance Sheet
Secured operating fund toward approval of the SB623 chronic TBI program through equity
financings initiated in the fiscal year ending January 31, 2023.
Million yen

Cash & cash
equivalents

As of January 31,2022 (A)As of January 31,2023 (B)(B)-(A)

4,557

6,732

2,175

5,351

6,967

1,615

15977

▲81

Total assets

5,510

7,045

1,534

Current liabilities

1,463

1,090

▲372

Non-current liabilities

2,012

1,525

▲486

Total liabilities

3,475

2,616

▲859Net assets

2,035

4,428

2,393Total liabilities and net
assets

5,510

7,045

1,534

Current assets
Non-current assets

Copyright（C） 2023 All Rights Reserved, SanBio Company Limited

6Consolidated Earnings Forecast
Forecast significant reduction of operating expenses by optimizing business resource allocation as
we proceed with approval of the SB623 chronic TBI program and prepare for product launch.

Million yen

FY2024.1
Forecast

FY2023.1
Results--

6,118

3,195

7,899

4,642

Operating income▲7,899▲4,642

Net income▲5,559▲4,598

Yen/US$exchange rate

132.72138.00

Revenue
R&D
expensesOperatingexpenses

Copyright（C） 2023 All Rights Reserved, SanBio Company Limited7

2. SB623 Approval in Japan andSales Structure After Approval

Copyright（C） 2023 All Rights Reserved, SanBio Company Limited

8

Completed Filing for Approval in Japan
Filed for approval within the framework of the Sakigake Designation System
based on positive phase 2 trial result
Sakigake
designation

In-person advice
and preliminaryinterviews

Comprehensive
Sakigake evaluation
consultation

ApprovalfilingIn-person advice andpreliminary interviews

Approval••

Regulatory agencies provide guidance and advice in
response to requests from SanBio

Review

Sales

Aiming for early launch by making use of theconditional and time-limited approval system*

Comprehensive Sakigake
evaluation consultation

NHI drug price listing••

Product approval filing will be approved when theauthority determines that the review following thesubmission of the filing can be completed within 6monthsApproval

Drugpricelisting

Price is calculated using either the comparable drug
method or the cost calculation method

Sales
•

Preparation underway to promptly market the productafter NHI Drug Price listing

The Pharmaceutical and Medical Devices Law, which came into effect on November 25, 2014, introduced an early approval system (approval withconditions and time limits). For regenerative medicine products that are not homogeneous, if safety can be confirmed and efficacy is presumed, thesystem allows approval for manufacturing and sales with conditions and time limits (from Article 23-26 of the Pharmaceutical and Medical Devices Law).

Copyright（C） 2022
2023 All Rights Reserved, SanBio Company Limited9

Management of production-related items toward approval
Approval filining completed in March 2022 after resolving issues related to establishment of postlaunch stable supply system.

➢ Production process established.
Since filing completion, communication with PMDA and responses to production-related review
made steady progress toward approval. However, “production yield issue" has surfaced.

➢ Lower production yield compared to yield level at the time of filing.
Measures to resolve the issue have been implemented to execute production run, and SanBio
continue to aim for obtaining approval in the fiscal year ending January 31, 2024.

➢ Issue analysis and development of resolution measures now completed.
➢ Currenlty working closely with a partner CMO (includign on-site training by SanBio) toimplement resolution measures to improve production operations.

Copyright（C） 2023 All Rights Reserved, SanBio Company Limited

10Issue and resolution measures toward approval
Issue

In recent production runs, production yield lower compared to the level at the timeof approval filing.

Solution

Improve production operations and execute production run for confirmation.

Criteria

Achieve production yield at the time of approval filing.

Level ofDifficulty

Good past track record of achieving yield comparable to the level at the time ofapproval filing. Current effort is to confirm and reproduce past results.

Resolutiontiming

Main result of resolution measures will be available in June.

Disclosure

Update will be provided in June at the time of Finncial disclosure for the first quarterof the fiscal year ending January 31, 2024.

Outlook

SanBio believes resolution of this issue is a milestone and facilitate obtaining
approval in current fiscal year ending January 31, 2024 by resolving the issue.
Copyright（C） 2023 All Rights Reserved, SanBio Company Limited

11

Establishment of In-House Facility and Acquisition of License for Packaging,Labeling and Storage of Regenerative Medicine Products
Establishment of In-House Facility and Acquisition of License for Packaging, Labeling and Storage of Regenerative
Medicine Products on December 15, 2022

Copyright（C） 2023 All Rights Reserved, SanBio Company Limited

12

Looking Ahead After SB623 Approval
Progress in preparation toward the launch of SB623✓ Preparation for sales and marketing activities in compliance with expected approval criteria✓ Enabling TBI patients to access to SB623 as soon as it is launched in collaboration with various external stakeholders
Current status
Drug Price

Gathering information, drafting strategies, and preparing application materials for listing on the NHI drug price list at an appropriate price

Medical Treatment Fees

Identify possible issues and solutions to facilitate determination of appropriate medical treatment fees for cell preparation and surgicalprocedures involved in SB623 transplantation

Sales Structure

For SB623 transplantation and post-procedure rehabilitation, planning to establish SanBio Community Healthcare Collaboration, which will
enable medical cooperation and patient follow-up tailored to each region, from the perspective of promoting appropriate useCRM system now in place to facilitate appropriate promotional activities after approval
Obtained a patent for R-SAT® system; preparing to install and utilize the system after the launch of SB623

Logistics SystemIn discussions with wholesalers on details for establishing a distribution scheme to ensure smooth delivery of product to cell transplantation
facilities

Preparation of Materials for
Promotional Activities

Creating various contents such as disease awareness videos and materials for healthcare professionals in accordance with fair competition
code, to promote the use of SB623 and facilitate appropriate promotional activities provision after approval
Determine personnel and facility requirements for the promotion of appropriate use

Establishment of Systemfor Promoting Appropriate
Use

Build an ICT-powered patient eligibility determination system
Establish a system for post-launch gathering of safety information and reporting to regulatory authorities

Copyright（C） 2023 All Rights Reserved, SanBio Company Limited13

3. Toward Maximizing Corporate Value

Copyright（C） 2023 All Rights Reserved, SanBio Company Limited

14

Research Paper Awarded Hirakawa Prize from Japan Society ofNeurotraumatology
Awarded to the lead author Masahito Kawabori MD, PhD, of the Department of Neurosurgery, Hokkaido University
Graduate School of Medicine, for a paper discussing the results of the Phase 2 STEMTRA trial on SB623 for theindication of traumatic brain injury

Copyright（C） 2023 All Rights Reserved, SanBio Company Limited15

Paper Published on Data Indicating New Potential for SB623
Synergistic therapeutic effects of intracerebral transplantation of SB623 and voluntary exercise confirmed
in a rat model of ischemic stroke
Journal: Stem Cell Research & Therapy

Title: Synergistic therapeutic effects of intracerebral transplantation of human modified bone marrow-derived
stromal cells (SB623) and voluntary exercise with running wheel in a rat model of ischemic stroke
Publication: January 24, 2023
URL：https://stemcellres.biomedcentral.com/articles/10.1186/s13287-023-03236-4

Trial content: Rat models were subjected to ischemic stroke and assigned to four groups—an SB623 group, a voluntary exercisegroup (running wheel), an SB623 + voluntary exercise group, and a control group—before undergoing behavioral tests using themodified neurological severity score (mNSS) and cylinder test, followed by histological analysis and assessment of mRNA.
Trial results: The SB623 + exercise group achieved significant neurological recovery in mNSS versus the control group. The
cerebral infarct area of the SB623 + exercise group decreased significantly compared to all other groups, and the number of
BrdU/Doublecortin (Dcx) double-positive cells in the subventricular zone (SVZ) and the dentate gyrus (DG), the laminin-positive
area in the ischemic boundary zone (IBZ), and the mRNA level of brain-derived neurotrophic factor (BDNF) and vascularendothelial growth factor (VEGF) in the SB623 + exercise group significantly increased compared to all other groups.
Conclusion: Combination therapy of intracerebral transplantation of SB623 cells and voluntary exercise is suggested to promoterobust neurological recovery and synergistically enhance endogenous neurogenesis and angiogenesis after cerebral ischemia,
possibly through a mechanism involving the up-regulation of BDNF and VEGF.

Copyright（C） 2023 All Rights Reserved, SanBio Company Limited

16

Presentations at Academic Conferences
STROKE 2023
Date: March 16th to March 18thVenue: Yokohama

Presenter: Dr. Satoru Yabuno (Department of Neurological Surgery, University of Okayama Hospital)
Title: Synergistic therapeutic effects of intracerebral transplantation of human modified bone marrow-derived stromalcells (SB623) and rehabilitation in a rat model of ischemic stroke
The 22nd Congress of the Japanese Society for Regenerative Medicine
Date: March 23rd to March 25th

Venue: Kyoto

Presenter: Dr. Takao Yasuhara (Associate Professor, Department of Neurological Surgery, University of Okayama
Hospital)
Title: Current status of intracerebral transplantation of human modified bone marrow-derived stromal cells (SB623):
cycle of clinical research and basic research
The 14th World Congress on Brain Injury
Date: March 29th to April 1stVenue: Dublin, Ireland

Presenter: Dr. Alan Weintraub (Rocky Mountain Regional Brain Injury System)
Title: Final analysis of the double-blind, randomized, surgical sham-controlled, Phase 2 STEMTRA Trial:
1-year safety and efficacy outcomes in patients with chronic motor deficits secondary to traumatic brain injury

Copyright（C） 2023 All Rights Reserved, SanBio Company Limited

17

SB623 Development Plans
Highest priority given to TBI program in Japan, followed by clinical trials for ischemic stroke andhemorrhagic stroke programs in Japan

Top priority

Approval
application filed

Considering timing forstarting clinical trials*

Ischemic stroke

Plan to consult PMDA
on initiating clinical trials

Planning forclinical trials*

Hemorrhagic stroke

Plan to consult PMDA
on initiating clinical trials

Planning forclinical trials*

Traumatic brain injury(TBI)*Considering various options, including in-house development and tie-ups with other companies
Copyright（C） 2022
2023 All Rights Reserved, SanBio Company Limited18

Development Status
Cell
medicine

SB623
chronic braininjuryIndication
Traumatic brain injury(TBI)

Research

Nonclinical

Phase 1

Phase 2Phase 3

Approval filingJapanUS

Ischemic stroke

Planning for Phase 2b or 3 study (Japan)*1

Hemorrhagic stroke

Planning for Phase 2b or 3 study (Japan)*1

Age-related macular degeneration
SB623(dry)*2
retinal disease
Retinitis pigmentosa*2

Partnered with OcuMension Therapeutics in Greater China
Partnered with OcuMension Therapeutics in Greater China

Parkinson’s disease
SB623

Spinal cord injury

Alzheimer’s disease
SB618

Peripheral nerve damage, etc.

SB308

Muscle dystrophy

MSC1Cancer

MSC2

Inflammatory disease

Partnered with D&P

Optic neuritis *2

Partnered with OcuMension Therapeutics in Greater China*1: Clinical trials will begin from Phase 2b as safety has been confirmed in previous clinical trials for ischemic stroke and TBI programs.
*2: Joint development with OcuMension (Hong Kong) Limited.
*3: Formed a business partnership with D&P Bioinnovations, Inc. for the development and commercialization of regenerative esophageal implant.

Copyright（C） 2023 All Rights Reserved, SanBio Company Limited

19Becoming a Global Leader in Regenerative Medicine

Deliver novel therapeutics to patients as rapidly as possible
and maximize corporate value
Copyright（C） 2023 All Rights Reserved, SanBio Company Limited20

4. Q&A

Copyright（C） 2023 All Rights Reserved, SanBio Company Limited

21

Disclaimer
This presentation material, including any comments made during or following the presentation, isprovided solely for the purpose of reference to those investors who make their own evaluation ofthe company at their own risk. This material contains estimates, such as plans, strategies andjudgments, 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 thismaterial due to various factors. We do not guarantee the accuracy or completeness of theinformation herein. Unless otherwise stated, estimates or forecasts are solely those of ourcompany and subject to change without notice. We accept no liability whatsoever for any direct orconsequential loss arising from any use of this report.

SanBio Company LimitedManagement Administration
Contact: info@sanbio.jp

Copyright（C） 2023 All Rights Reserved, SanBio Company Limited22