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 2025, we have gotten our company's 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 a disability, motor disability from TBI. This year, we will be able to start commercializing our product AKUUGO, and this is after 25 years of rigorous efforts by everyone involved.
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. Then another area is regulatory affairs and the 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 Pharmaceutical.
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. 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. Little bit about the, Mr. Nobeyama. He comes from, you know, several, global, pharma companies such as, Johnson & Johnson, Biogen, and most recently CSL.
Through his experiences, he has successfully launched approximately 10 new products and has a track record of getting approvals and getting products launched in, you know, many new areas. Mr. Soyoku Nobeyama is also bringing very valuable experiences to SanBio, and he's also looking forward to creating the new field of regenerative medicine. Going to the next slide. I already mentioned about 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 2024. However, this approval came with some conditions, and there was some restrictions for the shipment of our product.
After 2024, we have worked and conducted additional manufacturing campaigns and built up more data and satisfied the regulatory agencies' requirements. Thereby, in December 2025, we got approval on the partial change, and this now gives us the ability to actually ship product to the hospitals to be used for patients. Based on this December 2025 approval, this has now become a real approval. Now I'd like to start the sort of usual part of the updates. The first section is the financials. First is our income statement. 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.
This level has been about the same as the previous year. Next, I'd like to go over our balance sheet. 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 cash and equivalents of about JPY 15 billion. This was enabled by the financing that we conducted in the last six 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. As our overall total operating expense, we plan on using about JPY 5.6 billion. 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. 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 three things that we are focusing in the next several years. One is Japan, that's our home base. The second is the U.S., and the third is the new indication of the stroke.
We believe that by tackling these three 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's going to talk about our, you know, very active activities, in Japan as our home base. Please, Naoki.
Thank you, Keita. In my turn, let me first talk about the importance of Japan market as home base, 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 a 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 allogeneic cells to medical institutions, preparing the cells at the institutions and 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 important things. Lastly, 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 healthcare 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 seminars for media as a PR event. This chart illustrates the regional healthcare 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 Keita. Keita?
Yeah. Thank you very much. As Naoki mentioned, we, SanBio, as a company who's gotten the world 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. We will be applying our strengths and go beyond. Our approach, one is the United States and the other area is the stroke. First, I'd like to talk about our initiative in the United States. 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 three clinical studies in cell therapy, having over 80 clinical centers throughout the United States. We have also been working very rigorously with the FDA. In our journey, we have been successful in getting 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. 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.
All this, we have a lot of network of strong network and we believe that we will accelerating our development in the United States and get the approval and deliver that theraphy to our patients. Based on this most recently we have gotten from the FDA, the agreement on the clinical trial design for a phase III study for traumatic brain injury. We are very pleased with this progress. I'd like to again, to talk about, where our product pipeline is using this matrix. So, Japan TBI we already got an 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 ischemic stroke.
This one, you know, for us, this is a very important indication, big indication, very important for the many patients, and we plan on discussing about this ischemic stroke clinical trial with the FDA within this fiscal year. Please, you know, 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. I already talked about the stroke in the last slide, but here I'd like to also just you know, mention that we have conducted already two clinical trials in ischemic stroke, and we have learned a lot from these two studies. A post-hoc analysis of these studies have provided great insights for the next clinical trial.
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, you know. With our strong base as a company who's gotten the world-first approval in the brain regeneration drug in Japan, we'll be expanding to the United States, we'll be expanding to stroke.
In the four-year timeframe also, with the launching in the United States and with substantial progress in stroke, we believe, you know, 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. Thank you for your attention, and we'll continue and go beyond what we have accomplished to date. Thank you.