Hello. This is Keiko Mori from SanBio . Thank you for joining this call today. As always, I am delighted to share updates with everyone. We have the usual format, and I would like to start off with the financial results. First of all, our income statement. As the development stage company, I think the investors and everybody is looking at the R&D expense as well as the operating expense. In this half year, we spent about ¥3 billion in the last six months, and th is expense is mainly consisting of manufacturing-related costs incurred towards our efforts to get the product approval for SB623. Next, I would like to go over the balance sheet. Here, I think the investors are again looking at the cash and cash equivalent, so I will focus on this in my updates.
As you can see, we have some slight reduction from our last time point, but we continue to maintain a certain level of cash necessary for obtaining the product approval. Specifically, we do have ¥4.6 billion at the end of this quarter. This time, I would like to go into some of the details on the financial results as we have experienced some differences between the forecast and the actual results. This table is the first row is the forecast, t he second row is the actual results, t he third row is the change. This is the row that I would like everybody to keep an eye on here. We experienced a difference of about ¥686 million difference. Basically, we spent more than we forecasted. This increase was driven by two things.
One is the increased cost due to the manufacturing, and the second component is from the we conducted a restructuring of our U.S. subsidiary SanBio Inc., and this is a one-time expense which we incurred this past quarter. Now I would like to provide updates on our business. Just to remind everyone, we are in the regenerative medicine space. We aspire to be a global leader in regenerative cell medicine by initially focusing and establishing the category of the CNS regenerative medicine. We aspire to regenerate brain. This is something that people have been thinking is impossible for 100 years, but we have product candidates that we believe we can change this norm. Within the regenerative medicines for CNS , so brain or eyes or spine, we have a number of product candidates. The most advanced product is our SB623.
We've tested this product in various indications: stroke, TBI , and others. We've taken stroke and TBI into clinical trial, and of the two, TBI is the furthest along, and we are aiming to get our first product approval in Japan. There is a reason why we focus on Japan. The regenerative medicine framework or regulatory framework was enhanced in 2014, allowing one of the most proactive frameworks, if not the most proactive framework in this, compared to the other rest of the world. Based on this, I would like to focus on our Japan initiative of our product candidate SB623, and namely for the TBI patients. This slide shows the entire process from the pre-filing, through filing, approval, and the launch. This is something that we already updated in the past. We completed the filing of a product candidate back in 2022, so that's been already filed.
We wanted to get the approval within six months under the Sakigake designation, which is the idea of this framework. It did take us somewhat more time, and it's been about one year and a half, and we continue to work with the agency to get the approval. We continue to remain optimistic, and we are working on this program. Now I'd like to focus on our progress in our last three months, the last quarter. A little bit of background. Our update has been focusing on production, and especially production yield, because this is the remaining area that we believe is the area that we need to resolve and put this into our agency's satisfaction. In other words, the other areas, clinical and non-clinical, the review has gone smoothly in our eyes, and we believe that the remaining is production.
In the last quarter and the quarter before, we did provide very detailed updates on our production challenge yield. In the last quarter, we announced that we'll be working additional efforts in this area, and we expected to get the outcome and announce this in August of this year. That was the last month. Here is a press release that we issued two weeks ago on August 31. The three months we have very rigorously worked on investigation, the measures, and the production run. As the results, we did confirm improvement in the production yield. Regarding the details and the more actual backgrounds, we actually are in a position to have to keep this confidential due to the fact that the review with the agency has progressed, and w e will continue to pursue the product approval within this fiscal year, so t his is the updates of the three months.
The other areas, like clinical, non-clinical, we have not had any surprises in the last three months, and our work is steadily progressing. I would like to turn over to Mr. Naoki Tsukahara to talk about the launch readiness activities. Tsukahara, please.
Yeah. Okay. Thank you, Keiko. Okay. Let me explain the status for the post-approval activities. As shown in this slide, there are several items we need to prepare or set up to launch SB623 after regulatory approval. We are already in negotiating drug pricing and how to get medical treatment fee for cell preparation and surgical procedures to be approved. Preparation for logistics of SB623 and the governance structures of promoting SB623 are also already set up, so w e are ready, and we are just waiting to get the final approval.
This is Keiko Mori again, and now I would like to continue on the expansion strategy or maximizing the company value. Naoki and myself, we focused our updates on our initiative in Japan, SB623, because we must admit, you know, it's a lot of work to get the completely new category of medicine into approval and commercialization. It's a completely new modality, and we have lots of patients who are waiting on this new innovative product. Therefore, you know, we are intentionally emphasizing and focusing our efforts in our first approval. Our Japan approval is important, but it's a beginning. It's an important beginning where we will be taking this product into a global U.S., Europe, China, and also extend this into many indications. Stroke and hemorrhage, we have already put this into a clinical stage, and that will be, you know, initially focusing on these three big indications in the global commercialization.
Our next slide also talks about opportunities beyond the three big indications, and w e have opportunities in other areas such as age-related macular degeneration, retinitis pigmentosa. These are the retina eye diseases, Parkinson's disease, spinal cord injury, or Alzheimer's and other diseases. We are, you know, I think, very excited that, you know, these are areas where either there are no drugs or whether there are no, you know, really effective drugs. I think these are really the worthwhile indications to pursue. We have a lot to go, but I think we are looking forward to get the first approval, and b ased on this progress and milestone, we intend to expand. By tackling and helping many areas of diseases, we aspire to become a global leader in regenerative medicine. Thank you very much for your time for this quarter's update.