September 5, 2024
SanBio Co., Ltd.
Positive Results of Key Development Product SB623 for Chronic Effects ofTraumatic Brain Injury, including Sustained Motor Function Improvement up to48 weeks, published in Neurology
SanBio Co., Ltd. (head office: Chuo-ku, Tokyo, representative director & CEO: Keita Mori)
hereby provides notice that a paper providing more detailed data supporting results of thepreviously conducted Phase 2 randomized, double-blind, comparative multicenter clinical
trial conducted from 2016 to 2019 of the key development product SB623 for chronic motor
paralysis associated with traumatic brain injury (the “STEMTRA trial”), specifically data
indicating sustained motor function improvement up to 48 weeks and improved movement
in daily activities, was published in the online edition of Neurology, the journal of theAmerican Academy of Neurology.
Please see the full paper titled, “Mesenchymal Stromal Cell Implants for Chronic motor
paralysis after Traumatic Brain Injury: Post-hoc Analysis of a Randomized Trial,” here.
https://www.neurology.org/doi/10.1212/WNL.0000000000209797
This paper is a follow-up to an article titled “Cell Therapy for Chronic TBI: Interim Analysis of
the Randomized Controlled STEMTRA Trial,” also published in Neurology in 2021.
https://n.neurology.org/content/early/2021/01/04/WNL.0000000000011450
In STEMTRA study, 63 eligible patients were randomized 1:1:1 to the SB623 low-dose group(2.5 x 106 units), SB623 medium-dose group (5.0 x 106 units) and SB623 high-dose group(10.0 x 106 units) or sham surgery group. 46 patients received SB623 and 15 patients
underwent sham surgery as the control group.
The treatment group demonstrated a statistically significant improvement in motor function
as measured by the change in Fugl-Meyer Motor Scale (FMMS) score from baseline at 24weeks, the primary endpoint of the trial, compared with the control group (8.3 points [1.4] inthe treatment group vs 2.3 points [2.5] in the control group, p-value=0.04). Improvementfrom baseline in FMMS at 48 weeks was not significantly different in the SB623-treatedgroup overall compared with sham-operated controls, but there was significant improvementin the medium-dose group (5.0 x 106 units group) (10.5 points [1.8] in the SB623 mediumdose group and 4.1 points [1 .8], p-value=0.02). The results of the Action Research Arm
Test (ARAT), walking speed, and Neuro-QOL Upper and Lower Extremity Function T-scoresindicated a correlation between SB623 transplantation and improvements in motor function
and movement in daily activities at 48 weeks. In addition, SB623 was well tolerated,consistent with previous results, and no new safety concerns were identified.

About SB623
SB623 is a human (allogeneic) bone marrow-derived modified mesenchymal stem cell thatis produced by modifying and culturing mesenchymal stem cells derived from the bonemarrow aspirate of healthy adults. The transplantation of AKUUGO🄬🄬 into damaged nerve
tissues in the brain is expected to trigger the release of FGF-2 (a type of protein) and othersubstances, which in turn will promote the natural regenerative ability of damaged nerve
cells and induce proliferation and differentiation of nerve cells. In Japan, SB623 wasdesignated as a regenerative medicine product under the Sakigake Expedited Review
System by the Ministry of Health, Labour and Welfare, and we obtained conditional andtime-limited approval for our mainstay product AKUUGO🄬🄬 for the indication of improving
chronic Motor Paralysis resulting from traumatic brain injury in July 2024. SB623 has been
granted regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Foodand Drug Association, and the Advanced Therapy Medicinal Product classification from theEuropean Medicines Agency.
About SanBio Group (SanBio Co., Ltd. and SanBio, Inc.)
SanBio is engaged in the regenerative cell business—we research, develop, manufacture,and sell regenerative cell medicines. In July 2024, under the Sakigake Designation Program,
we obtained conditional and time-limited approval for our mainstay product AKUUGO🄬🄬 for
the indication of improving chronic Motor Paralysis resulting from traumatic brain injury.
Going forward, we will continue focusing our R&D efforts on central nervous systemdisorders with significant unmet medical needs that cannot be addressed by existing
medicine or drugs. The Company is headquartered in Tokyo, Japan and Oakland, California,and additional information about SanBio Group is available athttps://sanbio.com/en/[Disclaimer]This document may contain forward-looking statements such as forecasts, outlooks, goals, andplans related to SunBio Inc. These statements are based on information available to the Company
at the time of preparation of this document, including forecasts and other projections. In addition,certain assumptions (hypotheses) are used in making these statements. These statements orassumptions are subjective and may prove to be incorrect in the future or may not be realized inthe future. There are several uncertainties and risks that could cause this to happen. Please refer
to our financial statements and annual reports for additional information on these matters. The
forward-looking statements in this document speak only as of the date of this document (or asotherwise indicated therein), as described above, and we have no obligation or policy to updatesuch information from time to time to keep it current.

For more information, contact:
SanBio Co., Ltd.
Management Administration
Email: info@sanbio.com