Welcome, everyone to this session of our May 2024 MicroCap Conference. I'm Alex Hantman, and I serve as an Equity Research Associate here at Sidoti & Company. Today I'm pleased to be in conversation with Anixa Biosciences, ticker A-N-I-X, and their CEO, Dr. Amit Kumar. During the presentation, please feel welcome to submit questions using the Zoom Q&A interface at the bottom of your screen. After the presentation, we'll open to your questions. And with that, Amit, I'll turn it over to you. Thank you, Alex, and thank you, everyone, for listening to our presentation. Let me begin by noting our forward-looking statement disclaimer. Let me now begin with a little bit of contextual background about our company. Some of you may know that this company was originally founded in the 1980s. However, in 2017, I got involved and became CEO of the company and repositioned it from the previous iteration, which was an electronics company, into a biotech company. So even though the tale goes back to the 1980s, in reality, the company is only a 6 and 1/2-year-old company, 6 years and change since 2017. Since that time, we have developed a very robust pipeline of products, 2 of which are in clinical trials right now, which I'll go over in a moment. Both of those are presenting strong clinical data, very positive and promising clinical data. We have a strong financial position. We have close to three years of cash on our balance sheet, which is an important characteristic, especially in this very difficult capital market environment for development-stage biotechnology companies. We have strong partnerships with leading research centers that help us do our research as well as run our clinical trials. And those research centers also have strong relationships with funding sources that are providing non-dilutive funding for many of our programs. And all of our programs are big-market diseases. We're not focused on rare diseases. And so these are very, very large market opportunities. Now, before I talk about our programs, I want to take a moment and just talk a little bit about our strategy. We are executing a unique, very capital-efficient strategy. As many of you know, when biotech companies form, they often build very expensive laboratories with very expensive equipment and staff to conduct their research and development. In our case, we've chosen not to do any of that. We instead leverage existing infrastructure from our partner organizations, and in this case, organizations like the Cleveland Clinic and the Moffitt Cancer Center. That allows us to work on numerous projects with the scientists who are the world's experts in those particular projects. Eventually, we want to take these programs and get them to a compelling enough stage with clinical data that enables us to partner these programs with pharma companies for the final completion of the clinical trials and then eventual commercialization. This strategy has enabled us since 2017 to operate with very modest cash burn. In fact, we've been burning about $5-$6 million a year over that period of time, on average, plus or minus. That is very, very small compared to typical biotech companies, especially companies that are doing clinical trials, and especially clinical trials such as cell therapy, which is one of our programs. As I noted, we have a very strong balance sheet relative to our burn. Based on the burn and the anticipated burn over the next couple of years, 2 or 3 years, we believe that we have cash runway for about 3 years, plus or minus. That will be enough for us to achieve a number of inflective milestones in our clinical studies. We have a very clean balance sheet. I'm sorry, very clean capital structure, 32 million shares outstanding, just shy of 32 million shares outstanding. We have no debt and no warrants and no overhangs of any sort. We've been very careful about maintaining this very clean capital structure. Many of you know that in recent years, many young biotech companies have had to raise capital with a lot of structure around them, with warrants, even preferred stock. We've been successful in avoiding all of those characteristics. These are our programs in our pipeline. I'll talk about some of these in a little bit more detail. The first program is a breast cancer vaccine. This is a preventative breast cancer vaccine that is currently in phase I clinical trials. This is a vaccine that was developed over the last two decades at the Cleveland Clinic. We partnered with the Cleveland Clinic in 2018 to help bring this vaccine into clinical studies and then eventually commercialization. The phase I study is also being funded by a grant from the U.S. Department of Defense that goes to the Cleveland Clinic for running this trial. We have a second vaccine in preclinical development. This is for ovarian cancer. This was also developed at the Cleveland Clinic. This is at the current stage in preclinical development, and it is being developed in collaboration with the Cleveland Clinic and the National Cancer Institute and funded by them as well. The third program on this slide is our second clinical program. This is a new type of immunotherapy, CAR-T therapy, chimeric antigen receptor T-cell technology therapy, which is a new type of therapy that has created a lot of excitement for certain types of cancers. And that is in phase I studies at the Moffitt Cancer Center, which is one of the top cancer centers in the country. And just recently, yesterday, in fact, we announced that we had expanded a relationship with Cleveland Clinic to look at new vaccines for other types of large incidence malignancies, like lung cancer, colon cancer, and prostate cancer. More about that in a moment. So let's first talk about our breast cancer vaccine. This utilizes a molecular mechanism that has never been used before for vaccine development. It's an approach that takes advantage of certain characteristics of certain proteins, which we call retired proteins. In the breast cancer situation, that retired protein is a protein called alpha-lactalbumin, depicted by the red ribbon on the left-hand side. Alpha-lactalbumin is a lactation protein. It's expressed only in the breasts and only when a woman needs to lactate. So when she becomes pregnant and gives birth to a child, this protein is produced, enabling lactation. When she stops breastfeeding, the protein disappears and reappears again when she has another child and another child and so forth. Eventually, however, once she's no longer going to have children or is no longer physiologically able to have children, the protein disappears and in most women is never seen again. But when breast cancer arises, this protein is produced by the breast cancer cells. And specifically, this clinical trial that I'm going to discuss is focused on triple-negative breast cancer, which is a type of breast cancer that is the most lethal form of breast cancer. But we believe this protein is expressed on multiple other types of cancers. And so the vaccine, we believe, will be utilized for other cancers as well, even though our initial focus is this lethal form. And so the hypothesis here is that if we vaccinate women at an age where they're no longer going to have children, then the only time this protein shows up is in cancer cells because she's no longer going to lactate. And if we have properly vaccinated and trained her immune system to destroy cells making that protein, then when those cancer cells arise, the immune system of the vaccinated patient will destroy those cells and inhibit them from ever becoming a tumor that you can see in a mammogram. As a proof of concept, in the early days of this research, Cleveland Clinic conducted a very, very powerful experiment. In this case, they took a female mouse, vaccinated the mouse, and trained the mouse's immune system to destroy cells making that alpha-lactalbumin protein. Then the mouse was allowed to mate and have litters, multiple litters, multiple matings and litters. In each case, the pups were perfectly normal. However, the mouse was unable to produce milk because the vaccination had induced the mouse's immune system to destroy all cells making that protein. And in this case, because the mouse had given birth and was getting ready to lactate, the cells that were producing the protein were targeted by the immune system and destroyed. This is a very powerful demonstration that the vaccine was creating a cytotoxic antigen-specific immune response, meaning it was enabling the immune system to destroy cells making that protein. Now, in the case of cancer, again, another mouse experiment focused initially on this slide on the right-hand side. These are mice that are genetically engineered to spontaneously develop breast cancer. And half of these mice were given the vaccine, the other half a control. What the Cleveland Clinic team discovered was that 100% of the mice that were given the vaccine remained cancer-free, while the mice that were given the control developed spontaneously breast cancer, as one would expect with this genetically engineered strain of mouse. Now, these are murine experiments, animal experiments. Now we are engaged in a clinical trial testing this vaccine on humans. And this clinical trial is being done in three cohorts. Phase I is phase IA, is the one that I'm going to discuss in more detail today than the others. But phase 1A is focused on women who have already been treated and survived triple-negative breast cancer, but they have a very high risk of recurrence. And so we are vaccinating them with the intent to try and avoid recurrence. Phase IB is a unique type of clinical trial where we are vaccinating women that carry mutations that place them at high risk for getting breast cancer. These women have chosen to have prophylactic mastectomies. They're having their breasts surgically removed before they get the cancer. We're going to be vaccinating these women, and then they will have their surgeries, and we'll have an opportunity to look at their tissue, their surgically removed tissue, to evaluate whether there are, you know, microtumors or lactation foci within that tissue. Phase IC is a trial where we're combining our vaccine with a checkpoint inhibitor drug that's already approved for triple-negative breast cancer called Keytruda to see if the combination is synergistic. Phase IB and IC are in progress. We have a number of patients that have been enrolled in both. In phase I, we are nearly complete with that aspect of the trial. This is data that we've presented recently, the first 16 patients, although we have treated close to 25 patients to date. The data on the first 16 has been presented publicly. What you see on the right-hand side is that all of the women that had been vaccinated are exhibiting an immune response. We also note that none of these women had any serious side effects. The only side effect was irritation at the site of the injections. So we're seeing T-cell responses and B-cell or antibody responses. We are pleased that the responses are very promising. Now, this doesn't indicate that the vaccine is it doesn't indicate the ability or the quantitative ability of the vaccine to prevent breast cancer. We'll only be able to evaluate that once we complete a successive trial where we will have not only vaccinated patients, but also a group of control patients. And that'll be a trial that we are planning to begin in the beginning of next year. The market opportunity, I'm going to run through this trial, this slide very quickly, because I think all of us understand the market opportunity for breast cancer is very large. We have millions of women in the U.S. and internationally that are breast cancer survivors that are worried about recurrence. And then we have billions of women that are potentially worried about getting breast cancer in the first place. As I noted, we are planning the next trial, which will be an adaptive phase II/III trial that will enroll roughly 600-800 patients, half of which will get standard of care and half of which will get standard of care plus the vaccine to evaluate whether we can prevent more cancer incidences in the vaccine group versus the standard of care. We feel very, very excited about beginning that trial next year. Moving on, the next vaccine that we have in our pipeline is an ovarian cancer vaccine. It's similar to the breast cancer vaccine in that it utilizes the same mechanism, although it targets a different protein that also is retired, meaning it exists at certain times in life, but then eventually disappears but reappears when cancer arises. The intent here is to vaccinate women after that protein has disappeared. Should ovarian cancer arise, enable the immune system to destroy those cells. Now, this is a program that, as I noted, is in preclinical development. It's still in animal stage testing. Cleveland Clinic and us are collaborating with the National Cancer Institute on this program. The third program that I'd like to discuss is a therapeutic. As opposed to a vaccine that's designed to prevent breast cancer or ovarian cancer, this is a therapeutic that's designed to treat women who have ovarian cancer and, in fact, in this case, have failed all other approved treatments. This is a technology called chimeric antigen receptor T-cell technology. That's a mouthful, but it's a new type of immunotherapy that recently, in the last few years, has created a lot of excitement because for certain leukemia and lymphoma patients, it's effectively almost basically cured many of them, although we don't like to use the term cure. It's enabled these very late-stage patients to live for years. Now, this therapy involves removing T-cells, white blood cells from the individual patients, and engineering them outside the body and then reinfusing them back into the body after the engineering, which hopefully will make them better cancer fighters. Now, this technology, as I noted, has been very successful in certain types of leukemias and lymphomas, specifically B-cell diseases, and has generated a lot of excitement not only in the medical community, but also in the investment community. Unfortunately, this type of technology platform has not been successful against solid tumors, which is a much bigger market opportunity. We feel that certain nuances about our technology, our approach to chimeric antigen receptor T-cell technology, will make our technology the first technology that will be successful in a solid tumor indication, and in this case, ovarian cancer. This is a busy slide, but it describes some of the characteristics of our technology that we think will enable it to be successful. The first characteristic is presented on this slide, which is on the left. You know, our technology is depicted in a cartoon version on the left-hand slide. In our case, we've identified a protein called follicle-stimulating hormone receptor. It's an endocrine receptor that exists on ovaries in women and testes in men. What we find is that this receptor only exists in the ovaries in women and nowhere else, as well as the fact that there is a cognate ligand that, over millions of years of evolution, has become a very good binding partner to the receptor. So our T-cells are engineered with that ligand on the surface that makes the T-cell home in on the ovaries. Secondly, a characteristic that was discovered recently is that, even though, as I noted, the receptor is not expressed on any of these other organ systems in healthy tissue, when a malignancy occurs in these organ systems, including the ovaries, the blood vessels in that organ, in that malignancy, express follicle-stimulating hormone receptor. So what does that mean from a clinical standpoint? If you look at the cartoon on the right-hand side, it's important to note that, as tumor lesions get bigger and bigger, they need nutrient, they need oxygen to survive, and they induce the body to produce blood vessels within the tumor. Now, that study that I noted in the previous slide showed that these blood vessels within the tumor express follicle-stimulating hormone receptor. It's not clear at this time exactly why, but it's there. And so, in our case, we believe our CAR T-cells will not only attack the tumor cells themselves, the ovary cells themselves, healthy and tumor and cancerous cells, but they will also disrupt the blood vessels. And as a result, we think this is going to be a dual mechanism of action targeting the ovarian lesions. Lastly, another key characteristic about our approach is that we are delivering intraperitoneally, meaning we are delivering the engineered cells directly into the peritoneum. As many of you may know, the peritoneum is a sac that exists in the abdomen, and many organs exist within the peritoneal sac, including the ovaries. One of the characteristics about advanced ovarian cancer is that most of the lesions, even at stage 4 ovarian cancer, remain within the peritoneum. Now, the peritoneum is not completely sealed, but generally, it's a sealed compartment. If we are delivering our T-cells directly into the peritoneum, we're delivering them in direct proximity to all of the lesions that they're designed to fight. The T-cells tend not to get into the system, meaning they don't get into the blood vessels. And because they don't get into the blood, they don't go throughout the whole body and cause lots of side effects, which has been a challenge for other types of CAR T therapies against solid tumors that have been delivered through intravenous delivery, intravenous administration. Now, we will test this out and compare intravenous administration with the intraperitoneal. At the current time, all of our patients have had the therapy delivered intraperitoneally. This is a busy slide, but it summarizes some of the key points I've noted, including some of the recent results on the patients we have tested. So far, we have tested this on 4 patients, the first 3 at a very low subtherapeutic dose. The second patient and successive patients are being tested at higher doses. We are already starting to see some indications of tumor necrosis, meaning death of certain cells in the tumor in one of the patients in the very first cohorts. It's only a single patient, and it's very early days. That gives us a lot of confidence. We're, you know, in the fact that we feel that this is a very promising observation that we think is going to help us as we go forward. Yesterday, we just announced that we had decided to expand our relationship with the Cleveland Clinic to begin discovery programs for other types of cancer vaccines, specifically lung, prostate, and colon. We'll be looking at a number of other ones as well. The purpose here is twofold. Number one is to maintain our lead in the prophylactic cancer vaccine development, utilizing this retired protein approach. We're working with the scientists who came up with this approach, who have been working on this for decades. These are the world's experts in this type of technology. In addition, from a shareholder standpoint, as our breast cancer vaccine continues in clinical trials and eventually our ovarian cancer vaccine enters clinical trials, and assuming that the data continues to be very positive and promising, which we expect, then the lead that we will have in these other types of cancer vaccines will just generate a very, very valuable pipeline of products that will enable us to maintain our lead in this area. Please look forward to more information as we continue our progress in this arena. Just as in the last couple of slides, I want to highlight that we have lots of upcoming milestones, clinical milestones, as well as non-clinical milestones. The key clinical milestones are sort of outlined here. As I noted earlier, we have plenty of cash to achieve not only these milestones, but many, excuse me, many other clinical milestones. With the very last slide, I just want to summarize some of the key points that I've noted. We are, unlike many other development stage companies, we've got good, strong clinical data, a very strong financial profile, big market opportunities, very strong partnerships, and so forth. So, Alex, with that, I'll stop. If we have time, I'll be happy to take some questions. Absolutely, Amit. Thank you very much for sharing the story with us. We have a few questions from the audience around the theme of, you know, hormone receptors and some of the translatability from Triple-negative breast cancer work. Could you talk a little bit about, you know, whether any of your vaccines have promise for them and whether you've, you know, have plans to study that? Yes, the answer is yes to both of those. While we are focused initially on triple-negative breast cancer, meaning both hormone receptors are not there on that type of cell, we have looked into other types of breast cancers, hormone positive. And we find that those cells also express alpha-lactalbumin. And hence, we anticipate that this vaccine will work against those types of cells as well. However, to maintain, or I should say, to get results relatively quickly in our clinical trial, we are focusing on the breast cancer that has the highest chance of recurrence. So this is an enriched population of patients so that we can get results much sooner than we would if we were focused on other types of cancers, which also have high recurrence rates, but not as high as triple-negative breast cancer. Got it. Thank you for clarifying. Another question for the audience, could you help us contextualize the length of your vaccine development programs relative to something like the COVID-19 vaccine or other sorts of oncology vaccines? Yeah, the COVID-19 vaccine was a unique situation, and it's unlikely that anyone will be developing cancer vaccines that can be approved in about a year. That being said, typically, vaccines take a few years. And so our trial for this vaccine, our phase II, adaptive three trial, we expect to be a five-year trial. But we'll have multiple opportunities to review the data as we go forward. And depending on what the data looks like, we may have opportunities to accelerate that trial. Now, from a shareholder standpoint, our plan is to monetize the vaccine earlier than completion of the trial. As I noted, as we are running the trial and we have windows to see what the data is looking, we will take that opportunity, assuming the data is good, to establish partnerships with pharma companies with upfront licensing fees, milestone payments, and then eventually royalties. From a shareholder standpoint, you shouldn't assume that it'll take multiple years before these assets will be monetized. We'll monetize them much sooner than that, much earlier than that, of course, depending on the successful data from the trial. Thank you. Very helpful. Another question for the audience. You know, you have several great collaborations with cancer centers. You know, are there any other collaborations that you think about developing? You know, this person mentions one with the University of Washington or other hospitals to run trials. Yes, we have. Our phase II trial for the vaccine will be run not at a single site, the Cleveland Clinic, which is the case right now, but will be run at anywhere from 20-24 different hospital systems, including some in Europe, perhaps, depending on how we plan the trial. University of Washington could certainly be one of them. With regard to other types of collaborations in general, we talk to lots of universities and academic centers about a number of projects that we think would be synergistic with what we are doing. But we're very selective. We want to maintain our ability to perform our research and development with very little burn. As I noted, you know, we're burning a very small amount of money. Certain types of therapies and trials, as well as university licensing requirements, sometimes make it difficult for us to do things while maintaining our burn. It's very important to me that we don't dilute shareholders unnecessarily because that takes the value away from those shareholders, including myself and our insiders who have consistently been big buyers of our stock. Absolutely. And you know, with that, we're almost at time. So maybe let's end on this question. You know, there's been a pretty significant amount of insider buying of stock. And could you just share, you know, in your opinion, what you think, you know, the market may be missing and sort of outline just the value proposition for investors who may be looking across, you know, oncology and vaccine investment opportunities? Yeah, that's a good question. And as you noted, and as I noted a moment ago, there's been a lot of insider buying in the open market, including myself and one other director just recently, just a few weeks ago, a couple of weeks ago. And I anticipate that that will continue because we're very bullish about the programs and what we are seeing. I think the challenge for us is not only the general market environment for development stage companies. You know, people talk about the interest rate environment, the capital markets, et cetera, but also the fact that because we were repositioned from an electronics company into a biotech company, most biotech investors, not only retail investors, but also family offices and institutional investors, really don't know about us. I'm anticipating, as our clinical trials continue and continue to provide positive data, promising data that our profile will increase. I'm expecting and hoping that additional investors will come along for the ride. Absolutely. And with that, you know, we are at time. So I'd like to thank you, Amit, for sharing the Anixa story with us and thank everybody listening for spending their time with us today. Thank you very much. I appreciate it. Thank you. Take care.