Good afternoon. This is Keita Mori, founder and CEO from SanBio . As usual, thank you very much for coming to this meeting and your interest in SanBio and our brain regeneration initiative. We are extremely happy that we are able to announce that as of July 31, 2024, we got the marketing approval for our first brain regeneration drug, named Akugo. I will go over more details in the later presentation, but I wanted to open with this excellent and exciting news for us as well as all the patients throughout the world. Today we've got four topics. The financials, then the second one is the story about the birth of our new drug for brain regeneration. The third topic is how we envision to become a global leader in regenerative medicine. Fourthly, we will talk about the steps in expanding Akugo in Japan.
Financials, income statement. In the past six months, we used approximately JPY 1 billion for the R&D expense. As of the total operating expense, we used approximately JPY 1.5 billion. This money has gone into our initiatives in the Japan TBI. Balance sheet. At the end of this, the latest quarter, we had about JPY 3 billion cash and cash equivalent. We believe this is a good, you know, stable level to continue our important initiatives in this coming future. Now I'd like to talk about how we came about realizing the world's first-ever brain regeneration drug, which I announced at the beginning of this presentation. As I mentioned, on July 31, 2024, we got the marketing approval for Akugo, our cell-based regenerative medicine for brain regeneration. We are truly the first company ever to get marketing approval for a brain regeneration drug.
We have many, many competitors throughout the world, the United States, Europe, or China, but we are proud that we were the first to be able to get this approval for the patients in need. The product Akugo, I'd like to introduce to everyone. This drug, the indication is the improvement of motor functions or improvement of the motor paralysis for the patients who have these deficits as the result of the brain injury. In the name of Akugo, we have put in our aspiration. Our aspiration is that we want patients to be able to walk again, or move again, or communicate again to get the life back that they used to have. To put our aspiration into the name of this product, we took in the active movement in English and ugoku in Japanese, both of which mean active movement.
Together, we came up with this brand name Akugo. I'd like many patients to remember this name in case you come across patients who are in need. Because of this innovative nature of this product and the fact that this was the world's first drug in brain regeneration, we got feature coverage by major television media. These media examples are listed here. These television media passed a message that emphasized the fact that this Akugo is within brain regeneration. It's the first ever in the world. Also, the message that this product has the benefit for the patients for motor function recovery. Now, with this drug approved, obviously, we continue and we'd like to refresh ourselves that we've always wanted to serve the patients throughout the world. As a result, we always have the vision to become the global leader in regenerative medicine.
I mentioned brain regeneration again and again in this presentation, but what does this mean? Brain regeneration has been believed to be impossible for over 100 years. This was triggered and started by the famous quote or statement by a famous researcher or doctor who even got the Nobel Prize in 1906. Dr. Cahill, at the time, said, "The brain does not regenerate." This is true for adult humans and also adult mammals. Because of this, patients and the families have given up the recovery of the functions after brain damage. Throughout the time that we SanBio have been trying, we got the feedback from many people, including the doctors who are experts in this field, that what we are trying, what we have been trying to do is crazy. Regenerating brain is a crazy idea is something that we have gotten feedback again and again.
About 25 years ago, in 1998, SanBio's founding scientist, Professor Hideyuki Okano, found a breakthrough finding, which was he was the first researcher to isolate the human stem cells in adult humans. He found dividing cells in the human brain, which indicates the possibility of brain regeneration. Three years later, in 2001, we established SanBio. I, myself, as well as Chairman Toru Kawanishi, two founders got together and decided to go after this impossible challenge. In the subsequent way, in 2002, we successfully acquired technology that has now become the basis for Akugo. In the next eight to nine years, we worked in the lab in California, and this is where we started SanBio. We worked, you know, stem cells, animals, production development, and finally, in 2010, we obtained permission to start the clinical trial, R&D approval from the FDA.
It took us about nine years to get to the point where we can treat the first human subject. Since then, we started the human clinical trial for stroke recovery. In 2014, something spectacular happened in Japan, something which we were, it was hard to believe for us. The Japanese government passed a law which is going to foster the development and commercialization of the cell therapy regenerative medicine. This reform took place in 2014, which accelerated the commercialization of the regenerative medicine. We saw this as a huge opportunity, and we quickly set up a company in Japan, SanBio a.k.a. or Kobushi Gaisha. In 2014, we took the Japanese company as the headquarter and made the U.S. company a subsidiary. Around this time, we got the positive outcome from the stroke study, stroke trial, demonstrating the clear functional improvement with our product.
With this milestone, we took the company public in Tokyo Stock Exchange in 2015. After the IPO, we were able to access an increased amount of funding and launched two big clinical trials, one in stroke and another one in TBI. We got the successful outcome from the TBI study in late 2018. In 2019, we were able to get the Sakigake designation from the Japanese agency. This is equivalent to a Breakthrough Therapy designation in the U.S. This is a demonstration that our product is very innovative and can potentially bring important therapy to the human society. With the clear efficacy and the safety data in hand, we prepared for the marketing approval in Japan. A few things happened. In 2022, we presented at the American Neurology Conference in Seattle the outcome of the TBI clinical trial. This was the first time that we announced this outcome.
We got the plenary presentation to present this data in front of thousands of exciting audiences. In the same year, we got to file, make a submission for this product, Akugo, BLA submission to the Ministry of Health in Japan. This year, in 2024, we got the marketing approval for Akugo. With this approval, we believe that we demonstrated the drug ability of our product, and it's our turn to take this product globally and help the patients in need worldwide. As you can see, the number of patients in the U.S. and other markets is much, much larger than that of Japan. This means that there are so many patients that we are able to help. From now, we will go full speed with the global expansion. How are we going to realize the global leader position in regenerative medicine? There are three actions that we will be taking.
One is the United States initiative. We will be restarting the initiatives in the U.S. The U.S. is, without question, the largest market of the new drugs. People say about 40% of the revenue comes from the U.S., and 80% of the profit comes from the U.S. We will restart the U.S. The second action we will be taking is stroke, ischemic stroke. We will be re-engaging in ischemic stroke treatment. Stroke is, you know, among the brain regeneration-related diseases. This actually comes with the largest number of patients. We need to tackle this stroke. The third action is Japan. Japan, we regard Japan as the innovation engine, which is going to help our global initiative. This is our plan to get the global leader in regenerative medicine. The first action is the U.S. As I mentioned, it's the largest market. Also, as I mentioned up front, the U.S.
is actually the birthplace of SanBio Company Limited. We have, you know, many, many years of operating in the U.S. We know a lot of people, a lot of people have been engaged, you know, doctors, KOLs, a lot of the companies that we work with. We have a deep and tight network within the United States. To date, we have, you know, experiences in working and engaging with people who have been, for example, the head of the FDA or the head of NIH and so forth, or people who have engaged with, you know, many of the IPOs, for example, in the U.S. Also, during the clinical studies, we opened and operated about 20 university hospitals and others for the TBI study. For the stroke study, we engaged with about 60 universities and other sites. In total, we've experienced with working with 80 clinical sites and the KOLs.
Finally, with the FDA, we have been working extensively. Already, we have already discussions with the FDA in 2019 and also 2022. We plan to consult with the FDA as soon as possible to conduct a Phase III clinical trial to get the approval and serve patients in the U.S. I mentioned about the many KOLs, key opinion leaders, and doctors that we work with. The leadership in TBI is with Dr. David Okonkwo, a professor from the University of Pittsburgh. He was the lead PI of our TBI clinical trial. Recently, we have the publication out in the field. We had successfully got the paper accepted in the very prestigious publication of Neurology. Professor Okonkwo is, without question, a very famous and influential doctor in the field of TBI. He has led many grants and projects. Currently, he is leading the U.S.
national initiative of tracking the TBI and coming up with the treatment. He's also a team doctor for the football team, Pittsburgh Steelers. He's also in the media very frequently as the leading voice in the field of TBI. Therefore, he is very influential. With this kind of publication out there, these will be very helpful in our U.S. initiatives. The second action is ischemic stroke. As I mentioned, ischemic stroke has the largest number of patients within the brain regeneration type of diseases. We have lots of experiences, good and bad. To refresh everybody's mind, we had one successful clinical trial in stroke and one failure. Together, we have lots of knowledge. As of today, we do have a winning strategy for the next clinical trial. This slide is the same content as something that we presented a couple of years ago to the investor meeting like this one.
This describes our winning strategy in stroke. It is a busy slide, but basically, the winning strategy is in the patient segmentation. What we have come to know is that in the Phase 2 study, which was a failure, we now know the reason. We expanded the patient segment too large. Now we know that by limiting the patient segment to about half the population for this upcoming clinical trial, we believe that this will be a winning strategy. The reason is that we now know that what we didn't do well in the previous study is that we treated patients with too large a stroke infarct. By limiting the infarct size, we believe that we can do a good study and come to a successful outcome is something that we believe.
To describe this slide, you know, out of the 163 subjects, if we limit the patient segment to about half size, 77, and also if we treat the upper motor scale and the lower motor scale separately, which is something that we learned from the experts in the field, that that's something that we should do, we will be able to meet the primary endpoint. This is an ad hoc analysis that we did post-hoc. We were able to demonstrate that this study would have made a successful outcome with a p-value of 0.02. I think bottom line is I think we know a lot about the ischemic stroke and that we have a winning strategy to tackle this important disease. We have also been working with a patent strategy.
With the new finding that I just described in the previous study, previous slide and also study, we filed a patent and very lately we got issuance on this patent. This means that we have a much, you know, extended patent life, which is going to help us with the life cycle management. In terms of the business protection and life cycle management, we always believe and we continue to believe that the best way to protect our business is the production and production know-how. This is going to protect our business for 30, 40, 50 years is the norm in this field. However, patent protection is always a nice second protection in our life cycle management and that we, you know, will continue to work on this patent strategy as well. The third action in the global success is Japan. We regard Japan as the innovation engine.
Over the many years, we have accumulated lots and lots and lots of know-how, which are unique to the regenerative medicine. We will continue to do so by, you know, treating patients and generating data and also the manufacturing and logistics and entire system that we have established and we will be running in the very near future. To summarize, for the global winning strategy, we have three actions. One is the U.S., United States. Second is a stroke. The third is Japan. Now, I would like to turn over to Naoki Tsukahara. He's going to talk about the Japan innovation engine that we have. Naoki, please.
Okay, thank you, Keita. My name is Naoki Tsukahara. I'm a Senior Corporate Officer responsible for mainly the Japan market. Now, let me explain what SanBio plans to do to penetrate Akugo into the Japan market. Here's the product overview of Akugo. We obtained conditional and time-limited marketing approval from MHLW on July 31, 2023. The indication is for improvement of chronic motor paralysis associated with traumatic brain injury. For adults, 5 million of live human allogeneic bone marrow-derived MSCs should be implanted to perilegional brain tissues via stereotactic brain surgery. One of the conditions that was imposed on Akugo was to evaluate the equivalence or homogeneity between the products for clinical trial use and commercial use before shipping to the market. We plan to run two batches of production to accumulate inventories and, at the same time, collect data to prove the equivalence or homogeneity for partial change application.
With this data, we expect we will be able to ship Akugo by April 2025. In order to obtain the full approval, we are required to conduct post-marketing clinical trial in PMCD. This table shows the summary of the design of PMCD. Actually, we already set up a website and call center on August 8, 2023 to answer inquiries from patients who wish to participate in this PMCD. There are many patients who call this call center. This slide illustrates the distribution system of Akugo. Akugo consists mainly of three components: vial containing cells of suspension, dedicated preparation solutions, and dedicated device set. Once a TBI patient is registered for the RSET system, full vials are stored in dry shipper to keep them frozen and shipped to medical institutions via wholesalers. Here, we use the RSET system. We developed this system from scratch with Suzukan.
RSET enables us to register a patient and track product delivery, administration, and post-administration follow-up. This slide shows the concept of SanBio's Smart Regional Medical Corporation. Akugo is indicated for chronic TBI. Most of them usually don't see neurosurgeons but go to recovery or chronic care facilities. At this Smart Regional Medical Corporation, we will make sure the referral from patients' nearby consultation facilities, like a clinic, to surgical facilities, and then rehab facilities. In order to make this loop work, involvement of HCP, such as therapists and medical social workers, and also patient advocacy groups is essential. Once this system is activated, I think that there's a lot of ways we can ensure that the patient will consistently, you know, start to use the Akugo. This is a website called TBI Net. This is a disease awareness and support site for patients and their families.
We expect potential Akugo patients will learn more about the TBI and be motivated to see a doctor for new treatment. We launched this website last week. In fact, there are many patients who visit this website and register to get more information. We will continue to consistently, you know, send the email or, you know, to learn more about the state-of-the-art treatment and which facilities or hospital they should go to see a doctor. This is the last page of my part. Since we obtained approval, we started promotion of Akugo. This is a really big thing, especially to healthcare professionals. The promotion to healthcare professionals is very important. Some of the sponsored seminars listed here are already confirmed with academic societies. We also plan to have our own Akugo launch commemorative meetings and also the website web-based lectures to regions.
Let me get back to Keita for closing of this whole presentation.
Thank you, everyone, for joining this meeting. Final note, we, SanBio, in the latest quarter, we were able to finally obtain approval, marketing approval for Akugo in the field of brain regeneration. This is the world's first-ever drug in brain regeneration. We are extremely proud and excited that we will be able to serve patients in need. We, as the global leader in regenerative medicine, will continue to innovate and deliver new drugs to patients all over the world. Thank you. Thank you, everyone.