CEO Message

IR

To our valued shareholders

SanBio observed its 20th Anniversary on February 21st, 2021, and it seems appropriate at this time to offer a few thoughts on our past progress, our present position, and our future opportunities.

As I write this, the world around us is more-than-ever aware of the importance of clinical research, as we are all affected in one way or another by the coronavirus pandemic. I would like to express my sincere sympathy to afflicted patients, and I hope that everyone else receiving this message will remain safe and healthy.

As we all continue to cope with one type of public health challenge, our team at SanBio has been working on cell medicines which are also important to public health, beginning with traumatic brain injury (TBI), chronic stroke, and other central nervous system diseases, with the vision of making regenerative therapeutics a basic modality of modern medicine. Today we believe we are on the verge of our first product approval and launch, and are therefore committing with renewed determination to move our program forward.

Since our founding, the team at SanBio has consistently worked to advance the development of regenerative medicines, with the mission to create a new category of medicine and to deliver breakthrough therapies to patients in need around the world. Using the power of regenerative medicine, we want to help patients suffering from motor deficits resulting from TBI or stroke to walk again, move again, speak again, and live a more fulfilling life. In the future, we want to help other brain disease patients, including dementia and Alzheimer’s patients, improve memory and cognition; and ultimately we want to address other diseases presently considered uncurable. This is our vision.

With 20 years of scientific and clinical advances behind us, we firmly believe that SanBio is uniquely positioned to make regenerative cell medicine a reality. We have regularly recorded significant milestones of progress toward achieving this goal. These include showing remarkable clinical results from the use of our first product, SB623, in treating TBI and stroke; hearing positive feedback from doctors as well as patients and their families; achieving expedited, priority review status from both Japanese and U.S. regulatory authorities (Sakigake and RMAT respectively); and obtaining a license to market regenerative medicine products in Japan (“Gyo Kyoka”). We anticipate the approval of SB623 for treatment of TBI in Japan as the world’s first cell therapy approval and market launch in this indication, and we believe it is only a step away.

Obtaining SB623 product approval and executing this market launch is our current top priority. However, we expect soon to broaden our focus to include many additional indications and countries, and to make SB623 widely available globally. Further, to fulfill our mission of pioneering a new category of medicine, we will pursue new drugs that rival or surpass SB623.

Lastly, while we are still on our way to achieving our goal, we would like to thank everyone’s support to date, which has enabled us to come this far. We - all of us at SanBio - will continue to strive to bring breakthrough medicines to help patients in need, and we very much appreciate your continued support. We believe that SanBio’s continued success will reward our shareholders by building enterprise value based on genuine contributions to public health and social well-being.

And amid the coronavirus pandemic, which has brought the world into an extended state of emergency, we sincerely wish for your safety and peace.

February 21, 2021
SanBio CO., Ltd.

Keita Mori, CEO