Good afternoon. This is Keita Mori from SanBio. Thank you for your continued interest in SanBio. As we are developing very innovative regenerative medicine products, trying to help patients with a brain disability, bringing up regeneration of the brain to the patients in need. Today we have several areas that we'd like to provide updates. Before this, in this past quarter, we have an exciting development that we have substantially expanded our leadership team. I'd like to begin from this. In total, we have 10 members in our executive team. In the past three months, we have added four new members in the areas of Strategy with Andrew Liu, Production, Keizo Nakata, and Regulatory and Compliance, Kazumi Sawaguchi, and Japan Research and Development, Toshiya Iwata. I will pass on to each of the new exciting leadership, starting with Andrew. Please, Andrew.
Hello, everyone. My name is Andrew Liu, and I recently joined SanBio as the Chief Strategy Officer. After completing graduate studies in the United States, I came to Japan and joined JPMorgan. As an investment banker, I advised clients on fundraising, M&A, and corporate investments. Thereafter, I turned towards operating companies, and one of the jobs I had was as the Head of Corporate Planning at SunTen Pharmaceutical, where I led several transformative transactions for the company. Having the chance to join SanBio and contribute to the company's growth is an exciting opportunity, and I'm very honored to have this opportunity. Thank you.
I'm Keizo Nakata, Head of Production. I'm a pharmaceutical and manufacturing professional. We will turn to you to the roles of SanBio. Thank you.
Hello. My name is Kazumi Sawaguchi. I'm the newly appointed Corporate Officer and Head of Quality, Compliance, and Regulatory Affairs Japan. I'm excited about the challenges ahead in my new role as Corporate Officer. I'd like to explain my history and mission. I have over 30 years of experience as a research, development, regulatory, and quality assurance for bio products at some pharmaceutical and medical device industry. My mission is two things. One is to use my wide experience to bring SanBio products to the Japan and Asian market. The second one is to establish the quality assurance organization for the Japan market. I'm delighted to be working for and moving forward such a creation of cutting-edge products and regenerative medicine. Finally, I'd like to say how much I'm looking forward to working with SanBio colleagues and also related company members as a new role. Thank you.
Hello. My name is Shinya Hirata , Head of Japan Research and Development from this August. I've worked in SanBio Company Limited for over three years. It's my great pleasure to work in this new role. We will make a further effort to contribute to the launch of SB623 in Japan and also future corporate development, through strengthening our research and development systems. Thank you.
Thank you for the introduction. As you can see, we've got passionate new leaders. I'd like to also point out that this is our commitment to grow the company. Having done the JBLA filing this past March, we are getting ready to grow the company to the next stage. Now I'd like to move on to the usual topics, starting from our financial results. First of all, income statement.
As you can see, our operating expenses increased due to the higher manufacturing-related expenditures, obtaining approval of the SB623 product TBI program, as well as a yen depreciation against the U.S. dollar. In addition, supplies for commercial production were expensed as the R&D expenses. As a result, in this past six months, we had JPY 4.6 billion as an operating expense, which is increased from the original plan. Next, I'd like to move on to the balance sheet. For this past quarter, as you know, we have gone through the fundraising by equity, and we raised JPY 7.7 billion in this first half of this year. As a result, as of July 31 of this year, we have JPY 8.3 billion. This sets a good cash position for us to move the operations.
This time, I would like to explain about the revision of the consolidated earnings forecast for this fiscal year 2023, January. As I indicated a little bit in the last slide, we had some changes, and this is reflected as the H1H results and an expected increase in manufacturing-related expenditures for obtaining approval of SB623 product TBI program in the second half of this year. As a result, our forecasts have changed, as in this slide. Previous forecast was the operating expenses of JPY 5.8 billion, and the revised forecast now is JPY 8.1 billion. The background is, as I explained at the beginning of this slide. Now, I'd like to move on to the next topic of the operations, namely SB623 approval in Japan and the sales structure after the approval. As many of you probably are aware, we completed the Japan BLA filing back in March of this year.
This was one of the biggest achievements that we've had, and getting very close to getting approval for the first time on our product, which SB623 is something we have been working on since the beginning of our company 22 years ago. We are getting really excited that the approval is getting close, and us being able to provide a product to the patients in the real world is getting closer and closer. We are excited to be able to bring this to patients who have had no treatments for 100 years or even more. All of us here are getting really busy, but getting very excited. This is a slide that we have been using for quite some time. The actual stage that we are in is the review process. Now we are getting reviewed by the PMDA and working very closely and actively with the agency.
A little bit more specific about the progress for the approval, this is a press release that we issued on July 22. SanBio, we are responding to regulatory authorities in the approval review process to obtain approval as soon as possible. This press release specifically, you know, we try to communicate about, I think there is an expectation that the six-month review period for approval could be the best case, and everybody has been paying attention to this. We wanted to bring this to attention that towards the end of July, there was news from the MHLW of the programs that's being selected for regenerative medicine. Unfortunately, SB623 was not in this round. This is about this press release. Regardless, we are working as best as possible to get the approval as soon as possible. Now, looking ahead, our team is always busy getting ready for the next step.
I would like to pass on to Star Ascent.
Thank you, Keita. Okay. I will report on the status of preparation for the sales and marketing activities after the approval. Continuing from our previous announcement, we are making good progress in preparing the Star Ascent system to deliver the product to TBI patients promptly after approval. First, we have to comply with our expected conditions of approval. As one of the milestones in the first half of this year, we have been granted a patent for RSAT, our distribution management system which I will present in the next slides. RSAT stands for Regenerative Medicine, Safety, Accuracy, and Traceability. This system supports the distribution and administration signal SB623 and other products. RSAT was jointly developed with Suzuki and was granted a patent on April 21st this year. RSAT begins with the registration of patient IDs at medical institutions via a dedicated set and the input of administration schedules.
Based on the entered information, the product is manufactured and shipped to the home pharmaceutical wholesalers at the most appropriate timing and finally delivered to the medical institution according to the administration schedule. During this process, temperature loggers are used to make sure temperature control and the system can be also aligned with the medical institution when to follow up with patients after administration. This series of information can be shared in the cloud by all parties involved.
Okay. Hello, everyone. I am Akihiro Tsujimura, Chief Operating Officer of SanBio. From here to the end, I'd like to cover our presentation. I'd like to start with our conference presentations and the publications in our first half of this fiscal year. In April, the final analysis report results of our STEMTRA trial were presented in the clinical trial plenary session at the annual meeting of the American Academy of Neurology. This presentation was made by Dr. McCallister, who is one of the top carer working for New England Institution. The American Academy of Neurology represents more than 38,000 neurologists all over the world, and it is very influential to our industry. It was very important for us to have an opportunity to present our STEMTRA trial data in the plenary session at the annual meeting of such an influential academy.
With the following two slides, I'd like to show you the data which was presented in this meeting. This slide shows the efficacy of SB623 up to 48 weeks. First, I'd like to emphasize this trial was designed to show the efficacy by using FMMS score at 24 weeks. As you can see, the primary endpoint was achieved at 24 weeks. We are very happy to show the efficacy under randomized double-blind surgical sham controlled heart center global phase two clinical trial. On the other hand, the change of FMMS score from baseline was not significantly different at 48 weeks. Dr. McCallister has presented the other slide at the academy, which is very interesting to me. This slide was presented by Dr. McCallister at the academy. The previous slide shows SB623 pooled versus controlled. SB623 pooled means this arm includes three different doses: 2.5 million, 5 million, and 10 million.
This slide shows SB623, 5 million dose versus SB623, pooled versus controlled. As you can see, the change of FMMS score from baseline is significantly higher for 5 million dose compared to controlled dose at 24 weeks and 48 weeks. Since we will use 5 million as the optimum dose for our future development, this data is really, really encouraging to us. On top of the American Academy of Neurology, STEMTRA trial final analysis result was presented at the three academic conferences. In May, Dr. Kawabori has presented the result at the Singapore AIDS Advances in Cell and Gene Therapy Symposium. In June, Dr. Karasawa has presented the data at the annual meeting of the Japanese Association of Rehabilitation Medicine. Also in June, Dr. Weintraub has presented the result at the annual symposium of the National Neurotrauma Society.
All of the doctors are highly influential and recognized as the top carers in this industry. We will continue our effort to work with such carers to communicate with the industry in an appropriate manner. This slide shows the new publications for interesting outcomes from our research activities. This article reports the efficacy of encapsulated SB623 in the LUT acute stroke model. As a result, both SB623 and encapsulated SB623 improved neurological deficits associated with stroke. SB623 shows its efficacy even when encapsulated. It indicates that secreted factors from SB623 play an important role in the improvement of pathogenesis. As a pioneer of regenerative medicine, we will continue our research activities to contribute to the patients who are suffering from difficult diseases. I have three more slides left. With respect to SB623, we have prioritized the TBI indication in Japan, followed by the ischemic stroke and the hemorrhagic stroke indication.
In the near future, we will expand our territories to the U.S., EU, and China, including the Asian regions with all of these indications. This is our pipeline. In addition to SB623, we have pipelines such as SB618, SB308, MSC1, and MSC2. The most optimized development plans for these pipelines are still under development. This is my final slide. As you are aware, SanBio Company Limited was established almost 20 years ago. Since then, we have been trying very hard to develop good science, technology, and know-how to contribute to the patients who have been suffering from the diseases which have no effective medical treatment. We will continue our best effort to provide the effective and safety solutions to the patients to improve their quality of life. With our innovation, we will change the world and maximize the corporate value of our company. This is the end of my presentation.
Thank you very much for your attention.