I serve as an equity research analyst here at Sidoti & Company. Today, I'm pleased to be in conversation with CEO and Chairman, Dr. Amit Kumar of Anixa Biosciences, ticker ANIX. 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 attending this presentation. I'm looking forward to telling you, introducing you to Anixa, and also updating people who are familiar with the company with some of the recent data that we've presented on our clinical trials. Let me begin with our disclaimer statement and note that I may be making forward-looking statements during this presentation. Before I talk about the programs, I want to provide a little bit of background about the company at a very high corporate level, as well as a discussion of our business strategy, which is very unique relative to most biotech companies. First of all, this company was founded in the 1980s, and I took over as CEO in 2017 and turned it into a biotech company. When this company was founded in the '80s, it was previously an electronics company which had failed. And so we look at ourselves as a six or seven-year-old startup as opposed to a multi-decade-old company. Since that time, we've created a very robust pipeline of products, some of which I'll tell you about today. And we have two programs in clinical trials that are both producing very positive clinical results. We've established key partnerships with some of the best hospital systems in the United States, as well as with funding partners. And we're addressing very big market opportunities: breast cancer, ovarian cancer, lung, prostate, colon cancer. So these are big, big, non-rare diseases. We've also got a strong balance sheet with no debt, no leverage at all, and a very, very clean capital structure with only common stock, no warrants, no overhangs of any kind. One other thing I'd like to highlight is that since 2017, when we turned this company into a biotech company, I and the management team and the board have all been buyers of the stock. We've consistently bought stock over those seven years, all on the open market. Let me highlight our strategy. Instead of typical biotech companies that build big laboratories and hire large staffs, we have established relationships with some of the top academic centers in the country to enable us to perform our research and development utilizing their infrastructure. That allows us to keep our overhead low. As a result, we've been working on all of our programs, which I'll be telling you about today, including the clinical trials, but only burning about $5-$6 million on average every year. That burn will increase modestly over the next couple of years, but it's still very, very low compared to a typical biotech business model. And with these programs that we are developing, our plan long-term is to establish strategic relationships with pharma companies to commercialize those products. We have no interest in building out big infrastructure to manufacture, sell, and market and distribute these products. We want to work with pharma companies that have all of that infrastructure in place. And on the right-hand side are some of our partners, including some of the government agencies that are funding some of our programs that also allows us to maintain a very low cash burn. Just a snapshot again, we have $21 million of cash on the balance sheet, no debt. That doesn't sound like a lot, but when you're burning just a few million dollars a year, that gives us about three years plus of cash. As I noted, we have no debt, and we only have 32 million shares of common stock outstanding, no warrants or preferred stock, and no overhangs of any kind. This is our portfolio of products. I'm going to focus mostly on the top two rows, primarily because those are the ones that are in clinical studies right now and producing results on humans. The other products are in preclinical development, and eventually, we hope to bring them into clinical development as well. The first program is a CAR-T therapeutic that is in clinical trials at the Moffitt Cancer Center targeting ovarian cancer. And the second program is a breast cancer vaccine that is in clinical trials at the Cleveland Clinic and is funded by the U.S. Department of Defense. Let's begin with the CAR-T product. Many of you may know the process of CAR-T therapy is complex. It involves removing T- cells from an individual patient, taking those cells to a laboratory and engineering them to become better cancer fighters and reinfusing them back into the patient. This type of therapy created a tremendous amount of excitement a few years ago because for certain types of leukemia and lymphoma patients, specifically B-cell leukemia and lymphoma patients that were terminal, this type of therapy had an amazing effect on those patients, a very large percentage of those patients. However, since that time, despite many attempts, this approach has not worked on any other type of cancer and certainly not on any solid tumors, which in the grand scheme of cancer and the cancer landscape are much bigger and more impactful markets. But we've developed a CAR-T approach that has three unique attributes, which we believe will enable it to be the first successful CAR-T addressing a solid tumor initially focused on ovarian cancer, but perhaps eventually other types of cancers. And those three unique attributes are on the right-hand side of this slide. The first is that the target antigen that we've identified is uniquely expressed only on the cell that we want to destroy and not on any other organ system. We also feel that there's an anti-angiogenesis effect of our CAR-T cells, which I'll explain in a moment. And for this particular type of cancer, ovarian cancer, we are utilizing intraperitoneal delivery, which has some attributes that enable us to utilize CAR-T in a way that is typically not available for intravenous delivery. So the first item, as I noted, if you look on the left-hand side of this slide, it's a little busy slide, but the target that we are addressing with our CAR-T cells is the follicle-stimulating hormone receptor. It's an endocrine receptor, and it exists only on the ovaries in women and on the testes in men, although it has been shown to exist on certain other types of cancers, but in general, no other healthy tissue. And so we engineer our T- cells with the cognate ligand, follicle-stimulating hormone on the surface instead of an antibody, which is antibody fragment, which is typically what is utilized in most CAR-Ts. We believe that the follicle-stimulating hormone over millions and millions of years has become a very good binding partner to the follicle-stimulating hormone receptor. So we take advantage of nature and evolution to create a binding pair that we hope will enable the T- cells to find the cancer cells much more efficiently. The second key point is that, as I noted, in healthy tissue, the follicle-stimulating hormone receptor only exists on the ovaries and testes, but no other organ system. So we don't think there'll be off-organ on-target effects of this type of T- cell therapy. But recently, a research work was published in the New England Journal of Medicine that showed that when tumors appear in other organ systems, the vasculature of the tumors expresses follicle-stimulating hormone receptors. So what does that mean? That means that looking at the cartoon on the left, if you think about a tumor lesion, as tumors grow, they induce angiogenesis, which is the process of creating blood vessels, and they do this because they need to get oxygen and nutrients into the tumor and waste and CO2 outside the tumor, remove it from the tumor, and so that process of angiogenesis, it turns out, for tumors, the vasculature ends up expressing follicle-stimulating hormone receptor on the surface of the blood vessels, so what that means is our CAR-T cells will not only attack the tumor cells, the tumor and healthy ovarian cells, but also disrupt the vasculature, so this will be a dual mechanism of action, and many of you may have heard recently how certain bispecifics that are utilizing dual mechanisms of action have demonstrated very, very successful clinical results in other types of cancer. This is exactly what our CAR-T is doing. It's addressing ovarian cancer with one mechanism of action, attacking the cells directly, and then the second mechanism is disrupting the blood vessels, and the third characteristic of our therapy, which is unique to ovarian cancer, is that ovaries exist in the peritoneal sac, which is an abdominal cavity surrounded by a membrane, which is depicted as that yellow membrane on this slide, and within the peritoneal sac, there exists a number of other organs, and when ovarian cancer starts to spread, it becomes metastatic. It tends to spread within that sac to not only the surface of the membrane, but also other organs within that somewhat enclosed sac, so in our case, we have the opportunity to deliver our CAR-T cells directly into the peritoneum. We do this through a port, and that allows the CAR-T cells to remain in the vicinity of the peritoneum. In addition, it eliminates the ability of the CAR-T cells to enter the bloodstream. If you deliver it through IV administration, the T- cells will go throughout the whole body and cause side effects, many of which are intolerable for the patient. But by delivering into this peritoneum, the T- cells don't get into the system and don't create those massively difficult side effects. This is a busy slide as well. We've only tested six patients with this therapy, and we've done it at very low subtherapeutic doses. However, we are already starting to see some indications of clinical efficacy. In fact, one of the very first patients, patient number two in this trial that got a very low dose, is now alive 20 months. Now, I have to remind everyone that these are terminal patients with very short life expectancies. Now, she's 20 months alive with necrosis being evident in her tumor lesions and reduction in her CA 125. In fact, we went back to the FDA to get permission to give this patient a second dose, which was done just last week or 10 days ago, I should say, and she's doing very well, and we're looking forward to her continuing a wonderful life with a great quality of life, and we've had some similar types of, though not as extensive results in some of the other patients as well, and as we increase our dosage, we anticipate that we will have additional results that we think will demonstrate this therapy is efficacious for ovarian cancer. This is our dosage scheme. As I noted, we've only done six patients in the first two dosage levels, and now we are beginning the third dosage level. In fact, the first patient is being treated this week. The next program that is in the clinic is a breast cancer vaccine. This is a vaccine that is designed to be given to women who do not have breast cancer at the time with the hope of preventing the onset of breast cancer. And the way this vaccine works is we've identified a target, which is named alpha-lactalbumin, which is a lactation protein. It's a protein that is expressed in the breasts of women at the late stages of pregnancy. It enables lactation, and once the infant is born, the mother will begin lactating to produce milk to feed the infant. After she stops breastfeeding, the protein disappears and reappears again when she's had another child and another child. Eventually, after she's no longer going to have children, the protein disappears, and in most women, it is never seen again, but in the one out of eight women that do get breast cancer, many of the breast cancer cells are producing this protein. And so the concept here is to vaccinate women after they're no longer going to have children and train their immune systems to attack cells making this protein, and should cancer arise in that woman at the two-cell, four-cell, eight-cell stage, the immune system will be ready to destroy those cells, hence not enabling them to become a tumor. A very early proof-of-concept study was done to demonstrate the powerful cytotoxic effect that this vaccine brings on in mammals. This was an animal experiment. A normal mouse was vaccinated and enabled to mate and have litter. The litters were fine. The pups were perfectly healthy, but the mother was not able to produce milk, and the reason was because the vaccine had induced her immune system to destroy all cells making that lactation protein, and the cells making the lactation proteins were the ones that were necessary to enable production of milk, and so the mother was not able to produce milk. This was a very powerful demonstration of how the immune response can be induced to create a very powerful cytotoxic effect. A lot of this work is published. All of this work is published, I should say, but one specific example of a mouse study is demonstrated on the right, where we took genetically engineered mice that will spontaneously develop breast cancer, and half these mice were vaccinated. The other half were given a placebo, and it turned out that 100% of the vaccinated mice remained cancer-free, whereas the mice that received the placebo all developed breast cancer. So these are all animal experiments. Now we're engaged in human experiments. We're doing these studies at the Cleveland Clinic, and it's all being funded by the U.S. Department of Defense. We are testing in three groups of women. The first group are women who've already had breast cancer, specifically triple-negative breast cancer, and are at high risk of recurrence. And we are giving them the vaccine to see if we can create immune response and, of course, verify safety. In phase I-B, which is the second group of women, these are women that have mutations that place them at high risk for developing breast cancer. And these women have chosen to have prophylactic mastectomies. We're vaccinating them before their mastectomies. And then after their surgeries, we're able to look at their breast tissue. And the third group of women are women that have gone through their cancer treatment journey, yet still have residual disease. And they're being treated by a number of different approaches, including a very powerful checkpoint inhibitor called Keytruda. And Keytruda has its own side effect profile, which can be really rough, and it only works on a fraction of these patients. We're going to see if we can add the vaccine to the Keytruda therapy and evaluate whether we continue to see antigen-specific immune response and also verify safety. We want to make sure that the vaccine doesn't increase the side effects that already exist with Keytruda. Now, this is a very busy slide. This is all data that was presented last week at a major immunotherapy conference. And I just want to highlight a few key points here. In all of these patients, the only side effect that we saw was irritation at the sites of infection. So that's good. No other safety concerns. Most of these patients had a very strong protocol-defined immune response, and others had less of an immune response. But the key finding here that I want to highlight, which is in red on the left-hand side of this slide, is that in combination with Keytruda, our vaccine was found to be safe. There were no additional side effects outside of the side effects that are induced by Keytruda. And our vaccine was still inducing a strong T- cell response. Now, what that means is that we believe that this combination is going to be synergistic or additive in that Keytruda is a checkpoint inhibitor that enhances the ability of T- cells to continue functioning, and our vaccine is creating antigen-specific T- cells. So we're looking forward to a phase II clinical trial that will be beginning next year. And in that trial, we will be treating women in the neoadjuvant setting, which are women pre-surgery that have been diagnosed with breast cancer and heading to surgery. We'll be treating them with Keytruda, which is the standard of care, and the vaccine. So half the women will get standard of care, Keytruda. The other half will get Keytruda plus vaccine. And we will be able to evaluate very quickly for each patient whether the combination is enhancing the effect of reducing tumor burden. But long-term, the goal of this vaccine is to provide it in a prophylactic manner, in which case we could potentially give it to every woman in the world who is worried about breast cancer in order to try and prevent breast cancer. The market opportunities for both of these sectors are massive, and I won't go into the details. These slides are available on our website if anyone wants to look at them in a little bit more detail. We also have another program. It's an ovarian cancer vaccine, also developed at the Cleveland Clinic and being funded and in collaboration with the National Cancer Institute, designed similar to the breast cancer vaccine, targeting a different protein. And the goal here is to prevent ovarian cancer. This is still at the animal testing stage, so I won't be talking about this in great detail, but a lot of work has been published already. We're also initiating programs in lung, prostate, and colon cancer. The success so far of the breast cancer vaccine in clinic has induced us to begin programs in these other types of cancers, again, with the intent to try and identify an approach that we can vaccinate and prevent these cancers prophylactically. We have a lot of upcoming milestones that are focused on both of these clinical trials, as well as other things that I think our shareholders will find interesting. And let me finish there. Alex, I'll hand it over to you to see if there are any questions I can address. Perfect. Well, thank you very much for sharing that context. Maybe we could start with the recent news from last week, the new data from phase I trial. Could you talk a little bit about how the vaccine performed relative to expectations? And then maybe just a little bit on what might be the impact to quality of life and survival rates kind of compared to status quo? Yeah. So the vaccine data so far has exceeded all of our expectations. In fact, that's one of the reasons why we've initiated programs on the other types of cancers where large indication cancers, lung, prostate, and colon, where we think we can also develop vaccines. Regarding quality of life, it's interesting. A few years ago, when we began this program, I spoke with a breast cancer survivor, and she said she's very happy that they were able to catch her breast cancer early and remove it, and she's cancer-free at the time. But she wakes up every morning with tremendous anxiety because she's always worried about a recurrence. And if we had a vaccine that could prevent that recurrence, then it would just give her a lot of peace of mind. She wakes up, she has a headache. She wonders if the vaccine has, I'm sorry, if the cancer has come back and has moved to her brain or to her bone or wherever, depending on how she's feeling. And as far as quality of life for certain types of women, for example, the women that today are choosing to have prophylactic mastectomies if they carry certain mutations, they're undergoing very disfiguring and painful surgeries. You may recall Angelina Jolie went public with her journey in this arena some time ago. And these women are going to be the first women standing in line for this vaccine because it's much easier to get a few shots than to have to go through very difficult surgery. And so the goal here is if we can prevent the vaccine from ever occurring, the quality of life will be tremendous. We know we as a society, as a medical industry, have become very good at catching breast cancer early and treating it. And we teach women to do self-exams, get regular screening. We often will catch it early. But the process of treating it, even if you catch it early, is brutal. A lot of pre-surgery chemotherapy, surgery, reconstruction, recovery, radiation, etc., etc. It's not fun, and it's not cheap either for the healthcare system. Wouldn't it be better to just prevent it even from occurring by just going to your doctor and getting a few shots? That was a long answer. Sorry about that. No, that was great context. Thank you. Maybe we could sort of fast forward a little bit and talk about the timeline that you think things will take to play out and get to ultimate FDA approval as the goal. And then also talk a little bit about your commercialization strategy. So given approval, how you're thinking about distribution? Is it partnerships? Is it in-house? And yeah, let's start there maybe. Yeah, those two questions are related. Obviously, each of these programs has a different timeline for approval. The vaccine will take a little bit longer, but we are starting the phase II trial in a neoadjuvant setting, so in a therapeutic setting, and that'll be faster than doing the prophylactic verification of its efficacy, and so the prophylactic effect, approval of a prophylactic vaccine may take several years, but our goal, and related to the second part of your question, our goal is to monetize this vaccine much earlier than when it becomes available, becomes approved and available, because we want to monetize it by partnering with a large pharma company that has the infrastructure to distribute this vaccine. For example, if this vaccine truly does what we think it will do, then virtually every woman in the world becomes a candidate, and a small company like us just doesn't have the infrastructure to deliver a vaccine across that large geographic and very large numbers of patients. But a larger pharma company does. As an example, I'll bring up the recent partnership between BioNTech and Pfizer for the COVID vaccine. Pfizer has the infrastructure to commercialize it. BioNTech did the innovation, early innovation, and Pfizer commercialized that vaccine. That's exactly how we see the vaccine playing out. With regard to the CAR-T, we believe that's a much faster route to approval. CAR-T therapies, because they're treating terminally ill patients, tend not to require thousands and thousands of patients in a clinical trial. In fact, most of the CAR-Ts that have been approved for the leukemia and lymphoma situations have been approved with a very small number of patients. But even then, we anticipate commercializing that with partners. Again, we don't intend on building out expensive manufacturing facilities as well as distribution facilities and so forth. We anticipate that partners, once we demonstrate that we have a few more patients, like the one patient I described who has overall survival now, minimum of 20 months relative to the two or three that she had been given, if we have a few more patients, we anticipate that we'll be able to establish partnerships with pharma to monetize that asset as well. And we are already receiving inbound calls. So this is a very exciting time for the company. Both trials are doing really, really well, and I'm hoping that we'll be able to monetize something sometime in the near future. Great context. Thank you. Maybe last question. Could you talk about the strength of the balance sheet and your ability to reach your upcoming milestones? And maybe just to summarize, right, the investment opportunity for folks kind of looking across CAR-T and vaccine-driven cancer treatments. Yeah, the balance sheet and the business model is something that we're very proud of. We're doing two clinical trials. We've got one of which is a cell therapy trial. And as you know, those trials are incredibly expensive. Companies that are operating in that sphere are often burning $25-$50 million a quarter, and we're burning $1.5-$2 million a quarter. And so we believe that we have close to three years of cash on the balance sheet. That's, well, that runway is well enough, long enough for us to be able to clearly hit some major clinical milestones. Now, some of our programs are being funded through research grants from the U.S. government, and we're seeking additional research grants. We feel confident that we'll get others to continue reducing our burn rate, so we anticipate that we'll operate the way we have operated for the last few years with very, very modest burn rates. We hope, fingers crossed, that the data continues to be very positive and that we'll be able to establish pharmaceutical relationships, big pharma relationships that will not require us to have to raise more money, but you never know. We'll have to see. Great context. Thank you very much. With that, we are at time. So I'd like to thank you, Amit, for sharing the Anixa story with us. And also thank everybody listening for spending time with us today. Thank you, Alex, and thank you, everyone.