With us here today is the CEO, Snehal Patel. Just a little opening about what the company is about, what you're doing, and then I can ask some questions, and anyone from the audience who has a question can ask as well. Why don't you go ahead, give a short description of what the company is doing, and then we'll just ask questions. Go through the slides? Yeah. Okay. Go through as many slides as you'd like to introduce the company with. Okay. We'll just talk about it. Okay. All right. Thank you for attending. We're running a phase III clinical trial called FLAMINGO-01. Our goal is to prevent metastatic breast cancer, so the cancer recurrences after all the treatments, including pre-treatment, surgery, and antibody treatment. We are using a nine amino acid peptide called GP2. It's a piece of the HER2 protein, and it's naturally antigenic. We see immune responses even before we even treat a patient. The study is a phase III trial. We have 150 sites. 140 of them are now open and active. Today, we announced we have about 1,000 patients who've been screened so far in the study. Those patients will then go on to be enrolled. We haven't talked about enrollment. We haven't talked about events, but it's an event-driven interim analysis. The study is led by Baylor College of Medicine, it's a phase III trial where we treat HER2 positive patients. This product of ours is a piece of the HER2 protein, we give it as a vaccine. We protect the patients by creating T cells that kill the cancer cells when they come back. If they're very small and not detected, the patient is healthy after all this treatment. There is potentially some cancer, we're able to kill it with our T cells. It's truly a vaccine that prevents the recurrence of the cancer. We're doing this phase III trial because we had a very successful phase II trial. It was led by MD Anderson, where we basically, when we published it, showed we had no recurrences. It was almost as if people thought we had a cure. It turns out we have a lot of work to do to reproduce that study. We've now taken all the hard work, put it behind us, have a bunch of sites in the U.S. and Europe that are enrolling very well, hopefully, we're going to be soon talking about the number of patients and the event rate. We're a public company. GLSI is our ticker. We've raised about $40 million-$45 million since our IPO. Back in 2020, we had a day where we announced our data. The share price went up 30 times. That's kind of what we're known for in that day. It then settled at about $500 million market cap for about a year. We raised enough money to fund this phase III trial, right now we're funding the trial by using an ATM, which allows us to raise capital every day. Our burn rate is very low. Our burn rate is about $7 million-$8 million a year. We keep it low by having only four full-time employees running this study, which you may not believe is possible, but it is. This year it may go up to maybe $8 million-$10 million, and we use the ATM again to fund it ourselves right now as well. We've been on the Russell 2000 twice. We're very unique in that we own about 80% of the stock, management and directors, the flow is very low. We've locked ourselves up since 2020 through April 2026. After April 2026, we may lock up again, or we may free ourselves up. Okay. Let me just show you the phase II data. Here you can see that we had very low recurrences to no recurrences in the treated, and the immunity for the patients peak at about six months. That's the second curve. The third curve is the adverse events, and we have side effects that are injection site reactions and systemic reactions like a vaccine. This is what you would want to see. It's a sign of an immune response. On the bottom, you can see the arrows, where we give six vaccines in the first six months and then boosters every six months. I'll skip the safety data. I'll tell you where we are today. We have really an all-star steering committee running and managing the trial. We have Harvard, Yale, Johns Hopkins, Stanford, US Oncology, most of the sites in Texas. In the U.S., we have 40 sites. We have added on, and for a small company like ours, this is very unique, we've added on about 100 sites in Europe. In Germany, France, Italy, Spain, Poland, Romania, et cetera. We did this because we had the KOL for each country interested in our study, and they brought in 20 to 40 hospitals themselves as a group to work with us. I'm going to skip these slides. Basically, we're treating before the metastatic breast cancer comes back, and we're trying to prevent it. The mechanism is we're educating dendritic cells in the skin, so we inject the drug intradermally. Those dendritic cells then create T cells that are distributed through the body that kill the cancer when it comes back. We're going to try and sequence the TCR receptor of these T cells, which could lead to a different product. If we're creating a T cell that's effective, it would be good to know what the ID of that T cell is, and maybe we can make it. Right now, the goal is to have those T cells circulating, so if the cancer comes back, we're able to kill it before it can get too large and then lead to metastatic breast cancer. We've done three phase I trials and a phase II study. This is the design of the phase III trial, and I'll stop here. We have to screen for HLA because HLA and our peptide associate with each other, and they create a T cell that then kills the cancer cell. HLA may be an important factor. HLA-A2 is in about half the patients. In this study, we screen for HLA, and in the pink boxes, we either treat them with our drug, GP2, plus an adjuvant that stimulates the immune system called GM-CSF or saline placebo, and that's 500 patients total in those two arms. In the third arm at the bottom is all the other HLA types, and that's sized at 250 patients. We have seen in all three of these arms, without unblinding the data, an immune response that's very similar to what we saw in the phase II study. We see the same safety profile, and we see patients even before being treated with GP2 having an immune response. We're planning to increase the size of the study so that we don't stop enrolling until we get to the interim. We think we'll add another interim. We can use an interim analysis to resize the study if we need to, we can't do that if we've stopped enrolling. We're going to keep on enrolling. This 750 patients design today may be 1,000 to 2,000 in the future. Because we have a high screening rate, we think that we can do this, and this will double the enrollment rate, double the event rate as well. Let me stop there. Okay. Thank you for that description. Just to back up a little, one of the things about breast cancer and recurrent breast cancer that you're trying to eliminate is just to understand breast cancer. In the initiation report, I went through a lot of the immunology and the characteristics of breast cancer. Just for the purposes of discussion, the EGFR receptor is one type of receptor that can be overexpressed or mutated, leading to a signal for growth and proliferation of cancer cells. One of the drugs to treat that is Herceptin, which blocks the EGFR receptor. The HLA, you can just think of as a type of immune category that will qualify the patients to respond to the drug. What the company is doing is selecting for the breast cancer patients who have the right characteristics, which is about What is it about? 50% or so. About 50% of the total would be eligible for this. What I was really saying now is it's possible that all these patients are responding, so HLA may not be. Yes a variable. Well that you have to look at. HLA, the patients might respond regardless of HLA type. Exactly. While on one hand it qualifies them and it's been tested in that, the current trial could lead to expansion for all patients. Exactly. Okay. The standard treatment for breast cancer would be surgery, radiation, then a year of treatment with Herceptin after surgery, the current trial gives the injections starting at a year after surgery to allow the immune system to recognize HER2 and allow the immune cells to kill it and prevent recurrence. That's, in a nutshell. Right a simple story. Leaving out a lot of details, that's enough to understand what's going on with the company and just the discussion for today. The product works well because the immune system is strong after the patient's recovered from all the trauma, that's the key to having it work like a vaccine as opposed to trying to treat the cancer at its peak, which is what the antibodies do and the surgery does. Yes. Just in terms of the treatment, could you just discuss what you're doing and what the patients how they're being treated, the intervals, and what's involved? Okay, this slide describes it well. On the left side, you would have the treatment before surgery, then surgery. It could be a mastectomy or a partial removal of just the tumor itself. Then you can see you get all of these antibodies, Herceptin, PERJETA, KADCYLA, and maybe another one called ENHERTU. They all reduce the recurrence rate in half, there's still half of the patients that don't respond, and they go on to recur. What we do is when they're finished with the antibody treatment, you can see these arrows pointing down. There's six of them in the beginning. That's the primary vaccination series where we give the protection to the patient, and we do it when they're healthy. We have a healthy immune system. We create a strong T-cell immune response, that's one per month for six months. Then you can see five arrows after that, which is the booster phase, where we try to sustain the immunity by giving a booster every six months. The patient has to come in 11 times over three years, in essence, if this is commercialized. Now we collect a lot of blood. We do skin tests because we're trying to study the immune response and see if we can find something that's common in all these patients, we can predict who's responding and who's not and give them other treatments if necessary. Great. The FLAMINGO trial that is going on now is a phase III, that when the results come out, assuming they're successful, you can apply to the FDA for marketing approval. Correct. Okay. You mentioned the phase II trial that this is based on. Can you discuss a little bit about the results and what you saw there that justified this very large phase III trial? Sure. I did go through some of that data, I think I'll just do it again a little bit. Basically, most of the drugs that are given at this time, the antibodies, for example, they reduce the recurrence rate in half. If we follow that and treat those patients that don't respond, we don't know who they are, so we have to treat everybody. If we can bring that recurrence rate, let's say the antibodies reduce the recurrence rate from 20% to 10%, if we can take that 10% and make it a low single digit, that's stopping metastatic breast cancer, and that's stopping the bulk of the deaths in breast cancer, even though I have to go through all of this. That's the promise of the treatment, and that's why we had such a robust response in 2020. The product is relatively safe. It's like a vaccine. The patients that have heard about this today, they see the potential efficacy, and they know the side effect profile is tolerable. After everything they've been through, this is nothing. We have a lot of patients today that are asking doctors to participate in the study, which is why we've had the PIs interested, and we've been able to open up 150 sites in U.S. and Europe. It's not easy for a small U.S. biotech to open 100 sites in Europe. That's very uncommon. Okay. Just putting some numbers behind these percentages, how many patients are treated with surgery? Then the recurrence rates that are seen now compared with what the drug can do, and how many lives would actually be saved? At the bottom of this slide is a little bit of that. In the U.S. and Europe, there are 44,000 new patients that could be treated per year. If we can prevent 10% of those deaths that would occur because of metastatic breast cancer, we'd save 4,000 to 5,000 lives per year. You can see at the bottom, a little calculation. There's 700,000 new patients per year. We would probably get about 6% of those initially, which could go to 12% if we have all HLA types. It could be 44,000 to 88,000 patients that we would treat per year in the U.S. and Europe. That's a very large number of patients. Yeah. Certainly. In terms of the course of disease that you're preventing, not only you're saving lives, but once these recurrences happen, what happens to the patient in terms of hospitalizations, additional treatment, and the cost of care after recurrence? I don't know what the cost is, but what I can say is some of these patients are treated forever. They are long-term survivors, but they're HER2 positive, so they have to take the antibodies. They can tolerate them, so they keep on taking them. 70%-80% won't survive long term. This is why patients who understand what we have realize that this is a real chance for them not to have to worry about this recurrence, which is on their minds for probably five years after they get their antibody treatment when their risk is the highest. It persists for a long time. There's about nine million breast cancer survivors in the world today that are way outside of their antibody treatment, that we're not treating them today. They're a group that could be eligible. There's also half the patients that are not high risk. Of these 88,000 patients, another 88,000 are not high risk. They're low risk, 5%-10% chance of recurrence. Today, doctors don't feel that those patients should be put into a study or the events are so low, it'd be a big study. That's the other group that we could also treat as well. Not only are you saving lives and keeping the patients out of the hospital, but in terms of the cost of caring for these patients, keeping them out of oncology wards and hospitals and all of the drugs that they get, this would look like it's going to save costs. Yes By preventing it. This is a more efficient way of treating these patients and would save money for the system as well as saving lives. If you look at the economics of it, prevention is better than treating. Yes In any situation. I think if you were to ask what price we could receive for this, it would be a high price because we're saving not just lives, but also money in the healthcare system. Yes. Absolutely. Yeah. Conceptually, you could bring it to the front of treatment too. You could say, "Why not vaccinate these patients before you know they have cancer?" We would just have to be able to predict who's going to be HER2 positive and who's at high risk for breast cancer. There's a lot of people working on genomics and predictions, and maybe someday this would prevent the surgery, and the chemo, and the Herceptin treatment, because that's really what we'd like to do, is to actually bring it to the front of the line and not have it in the middle period while people are waiting. Well, yeah. The other point that you're doing this after a year of Herceptin, couldn't you move this up until at diagnosis or with surgery in addition to Herceptin or as a first-line post-surgery? The answer, I think, would be, first, you have to start where you are and prove that it works there. Right. People would say, "Well, if it does that, why wait? Move it up. Understand when the effectiveness occurs, because we're going to see these recurrences in the placebo arm, and when are we seeing them? If it takes six months for this vaccine to be effective, you have to have a six-month window to treat someone earlier when the immune system is healthy, which is usually not the case. Right. You would figure out how to do that. Yeah. Exactly. First, if it works there, you've got a drug and an enormous opportunity. Exactly. Subsequent studies and comparisons on using the drug more effectively would be down the road, but the first things you're going to do is show that it's effective for preventing recurrence and metastases. We're really going to provide a tool to these doctors. These breast cancer specialists are so good at what they do, and they'll figure out how to use the tool. Yeah. We'll help them, but they'll figure it out themselves. Sure. Question? How much longer will you be in the phase III? Is that another three years, four years? We don't know how long it's going to be. It's event driven to get to the interim. We're also going to change it now, so we'll have maybe two interims. We haven't as a company, we've only spoken today really for the first time about the screening, total so far. It's 1,000 patients that we've screened. How much do you anticipate spending for the remainder of the phase III? We haven't even talked about that number either, because we use the ATM to fund the company. Who is your ATM with? Wainwright. Wainwright. H.C. Wainwright. They've done a great job in keeping up with our burn rate, and the key is the volume of trading. How much have you gone on this for? We probably used it in full for the past year. We've burned about $8 million. Maybe in the prior year, call it another $3 or $4 million. Is it going to ramp up as you get closer to completion? The unique thing is what I showed you was this treatment timeline. The first six are in the first six months. That's the intensity of the cost. The other vaccinations are six months apart, it's going to be an interesting curve, depending upon when patients are enrolled. We'll see the cost come down as we get into the latter phase of the study. Any thoughts of a strategic relationship with Big Pharma down the road? Yeah. Well, this is in the sweet spot of Big Pharma, so this is where Roche has played forever. Is that what you anticipate trying to accomplish or- We'll let them tell us what they want to do. We're not going to tell them what we want to do, though. Right. We're playing poker, right? We're going to take this as far as we can to get the highest value for our shareholders. The more pain we go through, the more capital we put in, the more we expect. We're not going to sell out at a modest price if we can manage to go as long as we can. Quite frankly, this would be a $5 billion-$10 billion revenue product with those numbers I gave you. This would be similar to Herceptin sales when it was at its peak, which is now biosimilar. You also have other companies that have gotten into this space, like Pfizer bought Seagen for $20 billion or $30 billion. AstraZeneca and Daiichi Sankyo are very big in this space, Novartis, Merck. All of these companies will look at this at some point, and may have in the past, I can't say. They're all financial plays, in my opinion. If it's going to be a big revenue producer, they'll step in and make a financial offer. Just two things to add to that is that in terms of the burn rate, starting a clinical site and getting a site up and running is a very front-loaded expense. Then with the way the drug is treated, these are also front-loaded treatments with an induction phase and then maintenance. The bulk of the cost for a site and treating a patient is up front, and then it tails off. I don't expect to see a huge ramp-up in clinical expenses because the sites are already up and running, and there's a large number of patients. You're doing it later year, basically? Yeah. Right now, we have a lot of options, but think of it as this way, the fixed costs have already been spent, and now it's just the variable cost, the cost per patient. How many employees do you have? We have four full-time, and we brought our U.S. CRO in-house as consultants. We have about seven or eight very experienced CRAs and clinical trial experts who help us run the trial globally. Do you have a CRO? In the U.S., we had one, but we've found that it's better to have high-quality people that you control than to have a CRO claiming that you have high-quality people that they control. Three minutes remaining. We think we're better off. My colleague, she started a CRO. She sold it. She started a second CRO, then she wanted to join us full time. Where are you located? Houston, Texas. I see you have, like, five sites in Southern California. Yes. For some reason, the L.A. area really likes our product. You're in where? Like Cedars-Sinai. That's a site that's interested, but we're at UCLA, USC, TRIO-US, and there's another, City of Hope also that we're about to start up as well. Yeah, Cedars-Sinai is the best. Yeah. Well, that's for celebrities. Yeah, City of Hope, they have a hand in everything to do with chemotherapy. I've been there. Yeah. Just curious, you mentioned you're in Houston. Have you pursued or received CPRIT funding? No, because we're a real simple technology. CPRIT goes after the cutting-edge technology. They're really managed by outside venture capitalists and scientists. We're a basic company. At one point, we almost had it, but we funded this phase II trial ourselves. We're a group of wealthy enough individuals to do that. We're not a VC or anything, but wealthy enough to fund the phase II study to take it this far. We needed to go public to fund the phase III study. That's why we own so much also, and continue to invest. Any other questions? Does the company have any other drugs, or is it really all around just one drug? Well, we could always bring in another drug. I have another company I could bring a drug in. It's an obesity drug, but I don't want to do it because this phase II data is so good. Anything else could potentially be negative. Why do that? When you have something with such good data, focus on it and focus on reproducing the first study. Don't try to get bigger than you really need to be. Okay. Yeah. Put all the capital behind this study. Get more patients instead of diverting the capital to a different drug.