SanBio Company Limited ($4592)

Hello, everyone. This is Keita Mori from SanBio. Thank you, everyone, for your interest in SanBio and coming to this update meeting. Today, before I present anything, I'd like to just spend a few moments to talk about. Actually, we are extremely delighted that at the end of last year, December of 2025, we have gotten the our company first approval on our cell therapy product. This name used to be a development code SB623. Now the product name is AKUUGO has been approved in Japan for the patient who has disability -- motor disability from TBI. So this year, we will be able to start commercializing our product, AKUUGO. And this is after 25 years of rigorous efforts by everyone involved. And I'd like to also thank all the stakeholders who has been helping out and also have interest to our company. So thank you very much. I'd like to also introduce two new executive members to our company, which is also extremely great news for us. This time, the two new executive officers will be building up or continuing to build up the one area is the production. This is Tetsuya Isono. And then another area is regulatory affairs and quality assurance, quality compliance. This is Soyoku Nobeyama. Let me introduce briefly exceptionally incredible two officers. Mr. Isono comes to SanBio with over 30 years of pharma experiences, biopharma experiences at the Chugai Pharmaceuticals. As you know, Chugai Pharmaceutical is one of the leading global biopharma companies, and they have a lot of successful biologics product such as Actemra and other products. And Mr. Isono has been instrumental in developing product development and production development and also the actual manufacturing of these biopharmaceuticals over the years and has contributed tremendously to the success of Chugai Pharmaceuticals. We are welcoming Mr. Isono, and he's going to be bringing all his expertise to the new challenge of a cell therapy. A little bit about the Mr. Nobeyama. He comes from a few -- several global pharma companies such as Johnson & Johnson, Biogen and most recently, CSL. And through his experiences, he has been successfully launching -- launched approximately 10 new products and has a track record of getting approvals and getting products launched in many new areas. Mr. Nobeyama is also bringing very valuable experiences to SanBio, and he's also looking forward to creating a new field of regenerative medicine. So going to the next slide, I already mentioned about the -- our AKUUGO approval. Let me just add a little more details to clarify the current status. Actually, we got the approval initially in 2024, July of 2024. However, this approval came with some conditions, and there was some restrictions for the shipment of our product. And after 2024, we have worked and conducted additional manufacturing campaigns and build up more data and satisfied the regulatory agencies' requirements. And thereby, in December of 2025, we got approval on the partial change. And this now gives us the ability to actually ship products to the hospitals to be used for patients. And so based on this December 2025 approval, this has now become a real approval. So now I'd like to start the sort of the usual part of the update. The first section is the financials. First is our income statement. And as you can see, we used R&D expense of about JPY 2.6 billion, and this was primarily consisting of costs related to our activities aimed at obtaining marketing approval of AKUUGO. And this level has been about the same as the previous year. So next, I'd like to go over our balance sheet. And I'm very pleased to update that we have much more cash on hand than the previous several years. In fact, at the end of January 31, 2026, we had the cash and equivalent of about JPY 15 billion. And this was enabled by the finance that we conducted in the last 6 months. We raised a total of JPY 16 billion, and we are very pleased because we are now going to be able to invest in our company's next level growth. Now going into the financial forecast. This current fiscal year, we plan on using more money than the previous years. We will be spending money of about JPY 4.1 billion for the R&D expense. And as an overall total operating expense, we plan on using about JPY 5.6 billion. And what we will be doing is the manufacturing, distribution and the sales activities to promote the AKUUGO. Also, in addition, our activities will include obtaining more data so that we will be positioned very well for the upcoming full approval. So going from the financials, I'd like to just touch base on our sort of midterm strategy. As we indicated in the past, these are the 3 things that we are focusing in the next several years. One is Japan, that's our home base. And the second is the U.S. And the third is the new indication of the stroke. And we believe that by tackling these 3 pillars in the next several years, we believe that we will be becoming a global leader in regenerative medicine. Now I'd like to turn over to Naoki, who is going to talk about our very active activities in Japan as a home base. So please, Naoki.

Thank you, Keita. So in my turn, let me first talk about the importance of Japan market as homebase and also how it relates to the expansion of SanBio business in the future. As Keita explained, SanBio obtained the partial change approval to ship AKUUGO to the market in December 2025. We anticipate the NHI price listing in May this year and the first shipment and administration to the patient will be in the second half of this year. Japan will serve as a key hub for SanBio's future growth. First and foremost, it will function as a research and development hub. We haven't had our own lab since we closed our lab in the U.S. in 2023. However, we will open new lab for future R&D at Mitsui Link Lab Shinkiba 3 in this April. With this lab, we will promote R&D through the high-quality data to go into the future business. The next priority is to establish a system to cover the entire process from AKUUGO manufacturing to patient administration. It is essential to establish a workflow for transporting allogenic cells to medical institutions, preparing the cells at institutions and admin administrating to patients via stereotactic brain surgery. We believe this will also help in facilitating rapid market launch in the U.S. in the future. We need to learn how to do the cell business. That's the important thing. Naturally, we will -- while we are providing information on proper usage, we will collect real-world data to the Japan market and which we can apply to the future clinical trials. Now let me introduce the market activities we have carried out so far. This year, in order to raise awareness of AKUUGO among health care professionals, we have hosted sponsor seminars at major medical conferences. Additionally, following the enactment of the Act on Support for Persons with Higher Brain Dysfunction, we held a media roundtable aimed at raising awareness of TBI. We also plan to hold national launch event in AKUUGO for neurosurgeons and similars for Media as a PR event. This chart illustrates the regional health care collaboration involved in AKUUGO treatment. AKUUGO patients are in chronic phase and typically do not receive regular care even at nearby medical facilities. However, since AKUUGO must be administered at the major university hospitals or large institutions, it is essential to establish a system for referring patients from clinics to these hospitals. Additionally, rehab is required after administration, so we think it is very important to establish this entire workflow to ensure administration of AKUUGO to proper patients who have motor paralysis resulting from chronic TBI. Now let's give the slide back to Mr. Keita. Keita?

Yes. Thank you very much. As Naoki mentioned, we, SanBio as a company who's gotten the world's first approval on the brain regeneration drug. We are in the process of getting a lot of knowledge and know-how and expertise in this new field. And we will be applying our strengths and go beyond. And our approach, one is the United States and the other area is the stroke. First, I'd like to talk about the -- our initiative in the United States. And the United States is actually the place where we started this company. This was back in 2001 in California. This was where we started where at the time, we thought the center of our innovation. During the over 25 years of activities, we have built a lot of a track record in the United States. This includes conducting 3 clinical studies in cell therapy, having over 80, 80 clinical centers indeed throughout the United States. We have also been working very rigorously with the FDA. In the -- in our journey, we have been successful in getting our RMAT, which is a Regenerative Medicine Advanced Therapy designation. This gives us a priority review and provides us a chance to get approval earlier than -- by this designation. And also, we have been very successful in the academic peer-reviewed journal. In 2024, our TBI clinical results, we were able to publish in the top Journal of Neurology. And all of this, we have a lot of the network of strong network, and we believe that we will be accelerating our development in the United States and get the approval and deliver the therapy to our patients. So based on this, most recently, we have gotten from the FDA the agreement on the clinical trial design for our Phase III study for traumatic brain injury. We are very pleased with this progress. So I'd like to again sort of talk about sort of where our product pipeline is using this matrix. So Japan TBI, we already have gotten approval. In the United States, we have agreement with the FDA on the Phase III clinical trial design. Going down the matrix, let me talk about the ischemic stroke. So this one, we, for us, this is a very important indication, big indication, very important for many patients. And we plan on discussing about this ischemic stroke clinical trial with the FDA within this fiscal year. So please stay tuned. For other areas, we are right now trying to determine the good timing to really activate our activities. But right now, our focus is TBI, stroke and Japan and the U.S. So I already talked about the stroke in the last slide. But here, I'd like to also just mention that we have conducted already two clinical trials in ischemic stroke. And we have learned a lot from these two studies and a post-hoc analysis of these studies have provided great insights for the next clinical trial. So our next is ischemic stroke, but that's not the only programs that we will be going after. We will be going beyond. And these include hemorrhagic stroke, spinal cord injury or diseases of the retina, Parkinson's disease and Alzheimer's is also our big interest because this still presents severe conditions for our patients and for our society in all. So with our strong base as a company who has gotten the world first approval in the brain regeneration drug in Japan, we'll be expanding to the United States, we will be expanding to stroke. And in the 4 years' time frame also, with the launching in the United States and with a substantial progress in stroke, we believe we will be able to sort of grow the company to the next level and really help a lot of the patients. Our vision is to become a global leader in regenerative medicine and really provide a cure to the patients who are in need. So thank you for your attention, and we'll continue and go beyond what we have accomplished to date. Thank you.