Good morning or good evening, depending on where you are. Welcome to Biostage Meet the CEO conference call. My name is Jerry He. Today, I would like to briefly introduce myself, the newly appointed CEO, and our company at Biostage. I would also like to take this opportunity to update you on the strategic initiatives we have for the remainder of the year. After I complete my presentation, you can also ask me any question you might have. First of all, about me. If you look at my bio here, it really can be divided into three different phases. The first phase is really a market analyst and a management consultant to big pharma and biotech company and consumer product companies. My clients included like Pfizer, Genentech, Eli Lilly, Abbott, and also Pepsi, Pillsbury, those clients. The second phase of my career is, after I graduated from the University of Chicago, I worked as a portfolio manager at Bear Stearns and Morgan Stanley. After the financial crisis, in 2008, I went to China, where I was born. I served as a CFO and a CEO at a NYSE Listed Company, New Education, which was later privatized by my former employer, Morgan Stanley. After I left New Education, I joined a private equity firm. I worked as a managing director for three years and later in October of 2015, I joined Bright Scholar Education Holdings, which I took as public in May of 2017. We raised $181 million at IPO and $190 million at a follow-on offer. In 2009, we also raised $300 million in corporate bonds. In terms of education background, I have a chemistry background. I have a bachelor degree in chemistry, also master's degree in chemistry from the University of Chicago and the Peking University. I also have an MBA from the Booth School of Business from the University of Chicago, and I'm also currently Chicago Booth's Council member. My affiliation with Biostage started in 2009, when I invested into Biostage. Later, I joined the board in September of 2021. Thanks to the trust the board and our shareholder, put on me, I was appointed as the CEO and the chairman of the board, since March first of this year, which is a little over two months ago. My first task on the job is really to raise $6 million in a private placement in March. That's me. Next, about Biostage. For those of you who are new to the company, Biostage is a clinical-stage regenerative medicine company, focus on regeneration of organs, to treat cancer, trauma, or birth defects using the patient's own stem cells. We completed the world's first successful regeneration of human esophagus at a Mayo Clinic. We were also cleared by the FDA to initiate an open-label phase I, phase II clinical trial in 10 patients to assess the safety and efficacy. We are working with [inaudible] on the clinical trial. We also received two orphan drug designation by the FDA and EU. We have 13 issued US patents. Our technology is a platform technology, has the potential to be applied to many other organs as well. We have a world-class advisory board and experienced management team with interests aligned with our shareholders. We also have a management team that have access to China market, which is a much larger market in terms of the number of patients than United States. We have a very clear path to IPO, which I will elaborate later. More details about our technology. Our technology uses a patient's own stem cell that are grown on a hollow tubular scaffold, which is shown on the bottom left of the slide, to regenerate organ damaged by, from cancer, trauma, or birth defects. The patient's stem cell stimulates the body's natural regeneration process, the scaffold guides the newly formed tissue in the shape of the patient's damaged organ. Once the new tissue formation is complete, typically after about three months, the scaffold is removed, there's nothing to be left in the body. Our technology is very unique. It's not a transplant of someone else's organ. It's not a piece of a patient's bowel, stomach, or other organ. It's not a transplant of an animal organ either. It's not a piece of a plastic or mesh that's left inside a patient's body. It's a patient's own organ regenerated. Our first indication is for treatment of esophageal cancer, which is a huge burden for patients. The American Cancer Society estimated that there are about 20,000 Americans diagnosed with esophageal cancer in 2022, about 600,000 worldwide. That's one every minute. Only about 20% of esophageal cancer patients survive after five years. It's estimated 16,000 more patients. You are muted. You can mute or unmute yourself by pressing star six.[crosstalk] It's ranked as the seventh most common cause of cancer deaths among men in the United States. In 2020, an estimate of 544,000 people worldwide died from the disease. There are different treatments available depending on the type and the stage of the esophageal cancer. The common surgical treatment for esophageal cancer is to remove the diseased part of the esophagus, with the gap repaired by either a gastric pull-up. Basically, that's pull up the stomach, which is shown at the bottom of the picture, the third one from left. Or insert a piece of the colon to replace the part that has been removed. Those procedures are very difficult, expensive, with very high complication rate. Biostage implant can offer an improved outcome for patients by simplifying the surgical procedure to reduce the post-operation complication and improve quality of life. If you have your gastric pull-up, basically the patient does not have a, literally does not have a stomach anymore, they're gonna have very little to eat every time, they have to eat multiple times. After the meal, if the patient lie down, the food will spill over. The quality of life significant lowered by the procedure. This slide outlines the process of the Biostage implant. After surgery is scheduled, the cells from the biopsy are retrieved from the patient. The cells are taken to the cell lab, expanded for about 14 days. The cells transfer to the scaffold, which are grown in our bioreactor for a few days. The implant is ready for to place in the patient after the surgery. Our implant does not require the sacrifice of patient's stomach or colon, it significantly reduce the life-threatening complications associated with the gastric pull-up or colonic insertion. The autonomous stem cell eliminate the risk of immune system rejection because it's using the patient's own stem cell. Reduce the potential for longer-term complications after permanent implant. The patient can remain on a reasonable, regular diet after the esophagus is grown back. We had our first in-human clinic surgery, conducted back in 2017, by Dr. Wigle at a Mayo Clinic. The surgery was performed on a 75 year old man with a very serious cancer of the heart. The cancer cells spread into heart, lung, and the esophagus. The procedure was approved by the FDA under compassionate use. The patient, unfortunately, the patient died seven and a half months after the surgery of stroke, which is of course unrelated to the implant. The implant, we were able to do the biopsy of the implant, and the picture are shown here. You can see the organ basically regrow, grown back with mucosa regeneration, also with the blood vessel and the nervous system grown back as well. We feel very good about the formal clinical trial we are gonna conduct very soon because we already have performed this surgery on over 50 pigs and also one in human in 2017. If the safety of the procedure is proven, we can apply for pediatric esophageal atresia indication. Esophageal atresia is a birth defect in which part of the newborn esophagus is not developed properly. It happens in one in every 1,000 babies born in the States. We are working with the Connecticut Children's Medical Center. We have done research on 15 piglets and show the successful regeneration of the conduct in 21 days and a normal mucosal lining in three months in all the pigs. The picture shown below, you can see the part in the red square shows the regeneration of the organ, which is very much similar, almost look the same as the other parts, the original ones. In terms of the clinical pathway, we have given the IND clearance by FDA in March of 2020 to conduct phase I and phase II clinical trials. A study is going to be led by Dr. Wigle, who is the chair of thoracic surgery at Mayo Clinic. The open-label trial assess both the safety and efficacy in up to 10 patients, which is a very small number, relatively speaking, at a up to five hospitals that are required to up to six centimeter esophageal replacement for any reason, including cancer. The primary endpoint is development of a continuous biological neo-conduit prior to or at three months. It was seen at 1 month in human and pigs by the experiment we have done so far. The second, secondary endpoint is completed mucosal layer by 12 months. Based on experience we have done, it was seen at three months in human and in pigs. Harvard Apparatus Regenerative Technology may pursue trials in EU and Asia, where clinical trials are cheaper and also they allow conditional approval. A pediatric patient, as I mentioned earlier, can be recruited into FDA once the safety is shown in adults. That's a brief introduction of our technology and our clinical path. In the following few pages, I want to update you on the strategic priority for Harvard Apparatus Regenerative Technology in the next 12 months. I think we have three priorities. Number one is making significant progress on clinical trials and the pipeline development. I think some of you, understandably, are frustrated by the lack of progress we have made since we have IND approved back in 2020. In the last few months, we have been working very hard as a team to push it forward on the clinical trials, which I will update you with details in a few minutes. The second priority for the company is really, while we are conducting clinical trials and research on the new pipeline products, which are burning our cash, we need to find revenue-generating ideas for returns. One of the idea area we identify is anti-aging products, which have a huge market and a great market potential that can leverage our Harvard Apparatus Regenerative Technology name. Number three, of course, we continue to raise funds for the research and the development and clear the path for IPO soon. First update on the clinical trial. We have officially be online on 26th May. That's about I guess less than four weeks ago. We are officially online, and our first surgery in training on animal or pigs will occur in July, which is in a few months, in a few weeks. And our first site would be Mayo Clinic to be activate in July. Once the site is officially activated, we can recruit, officially recruit patients. If we can get a patient in August, we can have the surgery done in the Q3, which is by end of September. We will have the raw data out, data read out 42 days after the surgery. That would happen in the Q4 of this year. We need to wait two months before we can recruit the second patient. We expect that to happen in the Q1 of 2024, and also the surgery done in the Q1 of 2024. That's next year, and the data in the Q2 of 2024. You can see that we are pushing really hard and things are moving very quickly in the next few months. Thanks to our team, pushing really hard, made a great effort to make this happen. With the ongoing clinical trials, we also continue to develop our pipeline. As I mentioned earlier, our technology have a wide, have very wide application across surgical landscape, including procedures and many other organs as well. First two things, two organs come to our mind is bronchial implant or trachea implant, we're focused on some organs here. We can narrow down the ideas, but the organs can be also be applied to esophagus, larynx, and small bowel, users and liver. In terms of product form, it could be luminal patch, minimally invasive cellular, decellularized scaffold, and the drug-loaded scaffold. We can start with a small animal model. I think with the help of our world-class advisory board, we're gonna narrow down the project to make significant progress. As you can see, if you look at the different organs, this is a great market, a large market for different organs. Relatively speaking, US is much smaller, as you can see from this chart. In China, about if you look at esophageal, colon and treatable bronchus, China is about five times patients than there are in the States. Particularly for esophageal cancer, it's about 15 times more patients in China than there are in the States. That's our R&D ideas and the market potential. Our second strategic goal is really generate revenue while we are burning our cash for clinical research and the clinical trials. One of the area, I think it's a very big area, that we identify is the anti-aging problem, particularly in China, because the access we have to China market. Just give you some idea about some of the statistics. In 2021, Chinese anti-aging market was about $10 billion, with a compound annual growth rate of 12% from 2018 to 2021. This is the market is expected to continue to grow at a much higher rate because the aging population in China. According to the third-party research, 48% of Chinese consumers consider taking supplements as a primary method of anti-aging. As one of the cutting-edge anti-aging ingredients continue to receive a high attention. In 2020, the market size for NMN-based supplements in China reached RMB 5 billion, which is more than $700 million. We say annual growth rate of about 35% year-over-year growth, it's projected to grow much faster in the next three years at a compound annual growth rate of about 74% to reach RMB 27 billion in 2023. This would be a large market with high growth rate and also high margin in terms of the market what you want to be. That's the market you want to be with all those three attractive factors. For our approach, Biostage approach, we're gonna introduce mostly OEM, high-quality, American-made product. That's GMP certified, FDA registered, made in the US to enter the Chinese market, which lack the supply of those products, or so does not have so much research on those products either. The proven research and the clinical data, and with proven market in the US, we have a strong scientific and quality brand. We own the Harvard Apparatus Regenerative Technology name, which we're gonna leverage after the annual meeting. Once this path is cleared, we can also identify other product to be offered in the market. If you look at the two program we have, we have a organ regeneration program, which is mostly medical. We also have the anti-aging, which is our consumer product line. Our new slogan would be Rejuvenate and Regenerate. This is about making people live longer. It's sort of like if you have a car, you either maintain or if some parts goes wrong, you replace it. The third strategic goal we have, of course, clearly, and also one of my primary goal, is to continue to raise enough capital to support our research and the clinical trials. We intend to raise another round of private placement after the first patient is recruited, and also our main change or also kick off our consumer product line in China. We intend to start the second round, another round of private placement in August timeframe. That's fine for private placement. Once that's under belt, then we would have another one or two years of runway to support the company. With more data coming out, a second patient data coming out from our clinical trials, I think it's a great time for us to go back to be listed either on NASDAQ or NYSE in the first half next year. This chart will give you some idea of where the market cap of a cell therapy company is. This is actually significant, lower than, I would say six to 12 months ago, when all the stock was trading at higher value. Typically, when you have phase I, phase II clinical trials, the stock, I mean, the market caps for those companies is somewhere about $200 million to $500 million. Where we are right now, even though we have the clinical trial approved, and we are getting into contract clinical trial very soon, that's where we should be, relatively speaking, hopefully, once the market return and we go back to to be listed. That concludes my presentation. We're open up the floor for any questions you might have. Joe, could you help me to kind of open up the line for questions? Yes. Yeah. If you have a question for Jerry, please raise your hand and we'll unmute you. Send the chat through the chat box. Hi, Hong Wu. To raise your hand, you go under Reactions. It's at the very bottom, next to Share Screen. You click Reactions, and it'll show. Jerry, thank you for raising your hand. Hong Wu, go ahead. Hong Wu, you're unmuted. I think she's muted. Oh, maybe everybody's muted, it looks like. How do we unmute? Okay, she's unmuted now. Hong Wu, please go ahead with your question. Oh, I can't hear her. Anybody else? Yeah, neither can I. Okay. I can unmute everyone and see how that goes. Okay, try that out then. The host would like you to unmute your microphone. You can press star six to unmute. All right. Hong Wu, could you try it again? No, she's muted, from my screen. I can see. You may unmute yourself. Okay. Now can you hear me? Yes, I can. Okay. Thank you. Thank you. Jerry, that's a very nice presentation and talk. First, I introduce myself. I am the assistant professor in Mass General Hospital. This is many of my research is to use the stem cells. I use the IPS-derived stem cell or patient primary stem cells, which is isolated from patient, for gene therapy and the cell therapies. I also doing research in genetic associate neonatal defects. I work in the pediatric department. The question I have is, your product is scaffold, and I don't know detail about your scaffold, but based on my just a brief look at your picture of esophageal transplant, that's in patient. I don't have a chance to look at detail information. I maybe check that publications. Clearly, there's a fibrosis underneath the mucosa surface. If you show that pictures. That is the word, that's the question is: How can you control? Sure. The long-term complications? If they're not well controlled for long term, there going to be a fibrosis under the mucosal surface. If maybe that's not a big issues, eventually they'll cause esophageal constriction. There's maybe you can, like, improve by some kind of the treatment. I am working on this, the esophageal fibrosis. They eventually will cause complications for long term, because patient may need to use that organ for a long time, not just for six months, maybe for five years, 10 years, maybe a lifetime. That's my comments is, have you checked the long-term effect in pit? Because patient may be just starting the clinical trial, but you can test on pigs. If you do the similar things after years, there's any complication in it? We have done that. First, I have to apologize. I'm not a great scientist by training. I still try to answer your question as much as I can, and I also have some of my colleagues online who might be able to provide a more scientific answer to that. I think after the three months after the surgery, and we can remove the completion of the formation of the new tissue, we can remove the scaffold. Okay? We take it out, we don't leave it there. Also, we have follow on, because we only have done one patient so far, which, who died seven and a half months after the implant. We have tracked pigs for a longer time, which we did not identify any issues with those pigs. Okay. Thank you. I can discuss offline with your scientist to get more in detail because I'm quite interested. Sure. I'm working on the cell therapy in airway, in the bronchus and esophagus as a research. Thank you. Okay. I will follow up with you after the call. Okay. Thank you. Thank you. Next one, please raise your hand if you have any questions. You are able to unmute yourself as well. Nick B had a question. He read of using fruit as a scaffold. What is Biostage using, and would this be a suitable alternative if needed? The scaffold is made of a polymer we have. We use an electrospinning process to make the scaffold, which is plasma afterwards and applied to some of the proprietary process we have to make it a bioactive, where the cells can grow on the scaffold. All right. I don't see any other questions. I guess if no other questions, we can conclude today's call. Thank you very much part, for participating. I looking forward to meet you, or hear from you. Thank you. Bye, everyone. Bye. Goodbye.