July 10 2024
Company name:

SanBio Co., Ltd.

Representative:

Keita Mori, Representative
Director and President(TSE Growth Code: 4592)

Contact:

Yoshihiro Kakutani,Corporate Officer ofManagement Administration(TEL. +81-3-6264-3481)[Results of Basic Research] Publication of an Article on the Neuronal Activity andNetwork Formation Promotion of the Key Development Product SB623
SanBio Co., Ltd. hereby provides on this matter as per the attached document.

July 10, 2024
SanBio Co., Ltd.
[Results of Basic Research] Publication of an Article on the Neuronal Activity
and Network Formation Promotion of the Key Development Product SB623
SanBio Co., Ltd. (Head office: Chuo-ku, Tokyo, Representative Director and President: KeitaMori), while advancing the commercialization of its key development product SB623, has been
conducting basic research at the Group’s research institute for many years to elucidate
SB623’s mechanisms of action. We hereby announce the new findings of the basic researchand their implications for our business, as well as the publication of an article on SB623 in theonline edition of Neuroscience.
The article, titled “Mesenchymal Stem Cells Promote an Increase in Neuronal Oscillation viaGlutamate Tonic Release,” is available via the following link.
https://www.sciencedirect.com/science/article/pii/S0306452224002720
Highlights•
SB623 cells promote an increase of spike activity and number of network bursts.
•
SB623 cells in coculture with neurons are superior to astrocytes in promoting neuronalactivity.
•
SB623 cells release higher levels of glutamate when compared to human astrocytes.
•Tonic glutamate released by SB623 cells promotes an increase of neuronal activity.
[Source：https://www.sciencedirect.com/science/article/pii/S0306452224002720]
The four highlights above summarize the newly obtained results on SB623’s mechanism ofaction. Shinya Hirata, Head of Research and Development, gave the following comments on
the implications of the research findings for the Group’s business:“Mesenchymal stem cells exhibit a spectrum of functions. SB623 is thought to promote
the proliferation of neural cells by releasing FGF-2, a type of protein, but not all of its
mechanisms of action have been fully understood. However, each of the four newly
elucidated mechanisms highlighted above supports the efficacy of SB623, and thesefindings provide valuable data for advancing R&D of SB623 for chronic effects ofischemic stroke and other development programs. Thus, this research outcome
represents a groundbreaking achievement in gaining a deeper understanding of
SB623’s mechanism of action. At SanBio, we will continue R&D on SB623, which isexpected to have diverse pharmacological action, with the aim of further elucidating
its mechanisms of action and exploring its applicability to other central nervous systemdisorders.”"Although unmet medical needs still exist for many brain diseases, regenerative medicine has
led to significant advances and development in this area. This report identifying some of thepharmacological effects of SB623, which has been shown to improve outcome in clinical trials

(TBI-01 study), suggests further potential for cellular therapeutics in treating brain injury anddegenerative diseases. I hope that through SanBio's continuous research, more patients withcentral nervous system disorders will be able to take advantage of cellular therapeutics”, said
Dr. Gary Steinberg, Lacroute-Hearst Professor and Former Chair, Department ofNeurosurgery at Stanford University School of Medicine, who led the U.S. clinical trial ofSB623 for chronic stroke.”

About SB623
SB623 (INN: vandefitemcel) is a human (allogeneic) bone marrow-derived modified
mesenchymal stem cell that is produced by modifying and culturing mesenchymal stem cells
derived from the bone marrow 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 typeof protein) and other substances, which in turn will promote the natural regenerative abilityof damaged nerve cells and induce proliferation and differentiation of nerve cells. In Japan,
SB623 was designated as a regenerative medicine product under the Sakigake ExpeditedReview System by the Ministry of Health, Labour and Welfare. At a meeting held in June 2024,
the Pharmaceutical Affairs Council’s Subcommittee on Regenerative Medicine Products
determined that it was possible to grant SB623, “AKUUGO suspension for intracranial
implantation,” conditional and time-limited approval for the improvement of chronic motor
deficit in the chronic phase of traumatic brain injury. SB623 has been granted regenerative
Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Association,and the Advanced Therapy Medicinal Product classification from the European Medicines
Agency.
About SanBio Group (SanBio Co., Ltd. and SanBio, Inc.)
SanBio Group is engaged in the regenerative cell medicine business, spanning research,development, manufacture, and sales of regenerative cell medicines. The Company mainly
focuses on diseases of the central nervous system that cannot be addressed by existing
medical and pharmaceutical products and for which there is a high unmet medical need. TheCompany is headquartered in Tokyo, Japan and Oakland, California, and additional
information about SanBio Group is available at https://sanbio.com/en/

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