Hello, I'm Robert LeBoyer, Senior Biotechnology Analyst at Noble Capital. With us here today is Snehal Patel, CEO of Greenwich LifeSciences, who will tell us about GLSI-100, a drug in development for breast cancer and prevention of recurrence. Go ahead, Snehal. The floor is yours. Thank you, Rob. We're very happy to be here. I'm going to advance my slides. I'm going to go through the slides very quickly so we have more time for question and answer. These are our disclaimers. We're working on a phase III clinical trial called FLAMINGO-01, and we're using a peptide. It's a 9 amino acid peptide, it's a very short one from the HER2 protein. We're treating patients with GM-CSF, mixing them together and creating an immune response to prevent the recurrence of breast cancer. We give it to patients after they've been treated, whether it's neoadjuvant surgery or adjuvant with Herceptin or Kadcyla. We hope to prevent the recurrence of breast cancer. This is a promising phase III trial because we had very good phase II data on which we based the phase III trial. We're trying to reproduce this trial without making major changes to the phase II trial. The phase II trial is led by Baylor. The phase II trial was led by MD Anderson from Houston, Texas. We're from the Houston area. Our goal, as we try to reproduce the phase II study, is to not change anything as much as we can other than adjusting because we're on the footsteps of commercializing the drug. The regulators want us to make sure that what we do in this study can be done commercially. In the phase II study, we treated about 100 patients that were HLA-A2 in 16 sites. We had very good data where we didn't see recurrences. We had very good reduction in recurrence rate, which is our primary endpoint. We had about peak immunity at 6 months, minimal to no side effects, and no serious adverse events related to the treatment. There are other markets that we can pursue, which I won't discuss at the moment other than we do have a 3rd arm in our phase III trial, which is to allow us to treat all HLA patients in the phase III trial and to see which HLA patient will work. The GP2 peptide and the HLA work together, and I'll explain that to you in a second. Our ticker is GLSI, and we've raised about $40 million since our IPO. A little bit of the history. We did our IPO in 2020. If you can see my mouse moving, in December 2020, we published our first data, which I'll show to you, and we had a tremendous reaction in the market. Our share price went up 30 times from about $50 million market cap to about $1.8 billion in the day. During that time, we were able to raise enough capital to bring us this far, and we published a lot of additional data about the phase II trial during this time. The management directors together own about 75%-85% of the company, so it's very tightly held. We've locked ourselves up as well, and we locked ourselves up from the time of the IPO through March of 2026, and the board can extend the lockup if they choose to do so. We were added to the Russell 2000 in 2021, and we were added back again last year, and it appears, based on the most recent information from the Russell 2000, that we'll stay on it in 2025. Our company is noted for its low float, meaning that most of the shares are tightly held. There are very few shares available to trade on a daily basis. We announced lots of good data about our phase II trial recently. The volume of our float has increased recently. Our posters are available on our website at greenwichlifesciences.com, so you can see them if you'd like. A summary of the data is very simply, we didn't see any metastatic breast cancer in the treated group in the phase II trial. These are patients that are anxious and waiting and hoping that their breast cancer doesn't come back, and we were able to prevent the metastatic breast cancer. We're looking at one patient that may have had a recurrence, but that's a local recurrence. We have our placebo group or control group where we reduce recurrences substantially and where they had an 11% recurrence rate, which is what would be expected. We see peak immunity at six months. We also see a baseline immune response where the patients who haven't been treated do have an immune response to our peptide. It suggests that our peptide is a natural antigen. Our safety data is very similar to any vaccine, where you get injection site reactions or some systemic reactions that are all well tolerated. We get the most injection site reactions and side effects during the first six months when we give our first six injections, and then as we give the injections over time, those side effects come back, and then they go away. In the phase II study, we did not have any serious adverse events related to the GP2. I'm going to skip through a bunch of slides now just to tell you where we are today. We have a steering committee of very famous doctors who are experts in breast cancer in the U.S. We have about 40 sites that are open right now, and some of the sites that we're at are, for example, Harvard, Yale, Johns Hopkins, Northwestern, UCLA, UCSF, UC San Diego, many sites in Houston in Texas, because this is where we're based, and The US Oncology Network in the U.S. Last year, we were able to get approval in Europe to add an additional 110 sites, and we added 80 of them to date. We have 120 sites that are now enrolling. In Europe, those 80 sites we went to and visited. It was important for us to train them. Of these 120 sites today, we are seeing about 150 patients per quarter that are being screened. Roughly 600 patients per year that are being screened, which could translate into about 500 patients or more being enrolled per year. This is kind of where we are today as far as enrollment, and we have not announced anything about the planned interim analysis timeline or the number of patients that have been enrolled, but that's coming around the corner. I'm going to skip a bunch of slides now so we can go to the Q&A, but if you flip through our slides, which are available on our website, you'll see all the background slides. The way our product works is we have treatment before surgery, then surgery, and then antibody treatments, and then comes our treatment. These are healthy patients that are free of breast cancer, but had it in the past. We give them six injections in the first six months, then we give them a booster every six months. We give them five boosters. The patient is receiving 11 vaccinations over three years. What we're really trying to do is, after all the primary treatment is done, we're trying to prevent the metastatic breast cancer. These 11 injections are potentially preventing the metastatic breast cancer, and preventing the metastatic breast cancer could prevent 70% of the deaths, because 70% of metastatic breast cancer patients do not survive and do not fare well. Our product was given with just Herceptin. There are many other products that have been approved since that reduce the recurrence rates, but they're not as effective as ours may be. They do add side effects, and they're very expensive. We will have these drugs in our study, both in our Phase II trial, but there's a potential in the future that some of these drugs may be removed over time. Our mechanism is simply that GP2 peptide comes from the HER2 protein, which is a cancer protein. What we're doing is we're mixing our product, GP2, with GM-CSF, which is commercially available, called LEUKINE, and we're injecting them in the intradermal space. This is where the immune system is strong. As we inject the GP2, which is this blue rectangle, the gray box here is the HLA of the patient. They bind together, this cell, called an antigen-presenting cell, presents the GP2 and HLA to T-cells, these purple cells. We're collecting the blood of patients so we can sequence this binding region of the T-cell, because we hope to be able to show that we're creating a specific T-cell based on this treatment, and that we can make that T-cell separately and administer it as a separate product in the future in a different product line. As we inject the patient, over time, these T-cells build up, if the cancer cell comes back, this T-cell can then attack the cancer cell, because if it's a HER2 positive cancer cell, it will present the GP2 peptide naturally. Not our peptide, but the natural peptide. The T-cells are prepared to kill it, and this is most likely the mechanism of how we were able to stop the metastatic breast cancer. We've done 3 phase I trials and a phase II trial, and I shared the phase II data with you. The phase III study, this is the design of it. We screen for HLA types. The HLA-A2 patients go into these 2 arms, and the non-HLA-A2 patients go into a third arm. We're actually testing the product in all patients. We've now shown that we're seeing an immune response in all 3 groups. I mean, in both groups, HLA-A2 and non-HLA-A2, and the safety profile is similar to the phase II study. Our plan is to expand this HLA-A2 arm from 500 patients to 1,000 and to add a control group to this arm so that we actually have what you could think of as 2 phase III trials with 2 groups of patients, those that are HLA-A2, which is half the population, and those that are not HLA-A2, which is the other half of the population. On our slides, you'll be able to see a lot of the data that we shared, the design of the study. The last comment I'll make is the commercial opportunity is very large. We think we'll be treating about 44,000 patients per year that are HLA-A2, and this is a conservative estimate. If we have the second group of non-HLA-A2 patients approved, this doubles. If you use a conservative estimate for pricing, we're thinking about $5 billion-$10 billion market cap for the company. I'm sorry, $5 billion-$10 billion revenue for the product, which could lead to a very large market cap as well. These are the other cancers where HER2-positive cancer has been seen. These are other cancers that we could pursue. We could also do a clinical study in those that are not high expressers of a HER2 protein, but none of these are planned at the moment. We have a strong management team. We have a very low burn rate. The GP2 is manufactured in a simple way, but it's registered as a biologic, so it will have 12 years exclusivity in the U.S. We are continuing to file new patents because we have new processes that we've introduced that are not public in the phase III study. We think we'll be able to extend our patent life, but it will not be needed in the U.S., at least for the first 12 years. That's our slides, Rob. Do you have any questions you'd like me to cover on the slides, or should I Thank you for that quick summary. I know that there's a lot in the slide deck that we could discuss, but just in the interest of time, since this is being developed as an immunotherapy to prevent breast cancer recurrence, could you just discuss a little bit more about the market and how often does this happen with the standard of care? How many patients who actually get breast cancer would have recurrence, and of those, how many do you think you can treat if all goes well? I think there's probably 700,000 new breast cancer patients per year, of which some will be HER2 positive. If you narrow that down to the market that we could treat with this current first indication, it'll be 40,000-80,000 patients per year. We have about 9.5 million breast cancer survivors. They're not going to be in the study because they've finished all their treatment, but there are many patients out there that are still at risk for breast cancer recurrence. We would have to evaluate if we could work in that population, but that's a very large number of patients that are currently out there that are hoping their breast cancer doesn't come back. Just the new patients that would enter the market and qualify would be substantial, in addition to the existing patients. In terms of the FLAMINGO-01 trial, you mentioned the trial design. When did it start, and are there any particular milestones or interim analysis or data releases that we can look for? I think I understood you. Yes, the trial started in 2023 at the beginning with the first sites in the U.S. enrolling first patients. We had about 30 sites at the end of 2023. We had approval to open up 110 more sites in 2024 in Europe, and we opened up 80 of them last year. We increased the number of sites in the U.S. from 30-40. We have 150 sites approved and 120 that are open now. We have a large enrollment rate that we think we're going to see based on the screening. I think the prospects of us having an interim analysis around the corner and being able to talk about the number of patients is getting higher and higher. At any time now in the future, we might start to talk about the second half of the trial and being closer to the interim. We hope that that will also be an opportunity for those who've invested now to see a large increase in share price during that period of time. Sure. Yeah, that would certainly be a milestone to look for. Is there any kind of regulatory requirement around the balance of U.S. and non-U.S. patients? There is a variable that stratifies because the concern may have been initially that we would be treating in many different countries where the standard of care is different. But it turns out we're only going to treat patients where the standard of care is the same as the U.S., that's basically the U.S. and Europe. There is no requirement with regards to number of patients, whether they're U.S. or Europe, just that both arms of the study have a fair balance of both. Okay. In terms of commercialization, and you mentioned the size of the market and the patients, the patient population. What are your thoughts about commercialization, partnership, or any other business combinations on the table? I think that we always have been going to these conferences where you do run into pharma, and there have been those that have looked at us in the past quite seriously. I think this new information that we shared about having an immune response and observing it to be in a similar manner that we saw in the phase II trial, and not in just the HLA-A2, but the non-HLA-A2, will increase the interest and accelerate discussions. We really haven't talked about or can't talk about where we are as far as any discussions with any pharma company. The most interesting thing here is there are many large pharma companies that have been entering the breast cancer space. It's dominated by large companies, if this product is as effective or as safe as it appears to be, this could be a dramatic game changer for those that are in the market or those that want to enter. We're looking forward to the next year or two as we start to talk to these companies again and again and see if anything evolves. Right now, our burn rate is low. We're using our ATM as our funding vehicle, the longer we wait, the higher value that we think we'll see if we do a partnership down the road. Yes. The more you advance the product, the less risk any potential partner would be taking, it would be worth more to them and worth more as a freestanding product. That's very clear. What you've said is basically all that I would expect you to say. At this point, other parties are interested, the point that you made about how breast cancer is a large market and there are a lot of companies in it, shows that there's a fit between what you're doing and what other companies are doing as well. As far as anyone could tell at this point, there's interest, there's a clear market need for what you're doing that would be synergistic with what's out there. The other thing would be based on the structure of the drug and the HER2 antigen, are there other applications in different tumor types that also express HER2 that you've been working on or have plans to do more work in? Yeah. There's HER2 positivity. That was how the market was defined initially. Now there's a focus on the low and medium or intermediate HER2 expressers. Within breast cancer, we can try to treat the low and intermediate HER2 expressers, and potentially do more combination therapy there, where you could use a checkpoint inhibitor and use a very potent antibody with chemotherapeutics linked to it, which would be called a trastuzumab ADC, and use them together in some combination because you have much less cells expressing the HER2 protein in the low HER2 population. There are many other cancer cells that express the HER2 protein, but not at the 75% rate that you see in breast cancer. That has not been our initial focus. If a HER2 antibody with ADCs approved for a treatment around the time of surgery, it would be natural for us to follow that treatment. We could go into the other cancers by working with a large pharma that has a Herceptin ADC, or go into the market after Herceptin ADC is approved, follow them without having an expensive trial where we have to pay for drugs that aren't approved. This is an area of interest of ours that we'll probably pursue after we have come closer to completing the phase III trial and have the data that will be of interest to the partners that we're going to need to be able to pursue these other cancers. Great. Okay. Just to reiterate, could you give a summary of some of the milestones and catalysts ahead over the next 12 months or so? Sure. We've talked about the screening rate publicly, which is about 600 patients per year as of the last quarter. It could increase or decrease over time. We'll continue to update on that. We'll always be looking at the open label data. That includes the immune response data we've seen and safety data. We'll be updating on that information over time. Soon we'll be talking about the number of patients enrolled and the timeline based on the number of events that we've seen so far and the number of events that we need for the interim. With this new data from the phase III trial that we've been able to think through, we're probably going to increase the size of each trial of the two arms for the HLA group and add a control for the non-HLA group. Once we've gotten that design approved, we'll be able to share that design as well. We'll have probably some manufacturing milestones along the way as well. Well, great. That sounds like a nice active schedule. Lots of events to drive the stock and lots of interesting things going on. Thank you very much, Snehal. We look forward to hearing more about them. Thank you everyone who joined us today. Have a great afternoon. Thank you. Bye-bye.