Hello everybody, this is Robert Sassoon, Healthcare Analyst at Water Tower Research. Today I have the pleasure of welcoming Anixa Biosciences Chairman and CEO Dr. Amit Kumar in this fireside chat. Anixa is a clinical stage biotech company which develops a novel type of CAR- T cell therapy for the treatment of terminally ill ovarian cancer patients. Anixa's clinical portfolio also includes a vaccine for the treatment and prevention of breast cancer. The company also runs additional preclinical cancer vaccine programs. Anixa is listed on the Nasdaq, trading under the ticker ANIX. So let me just start with a few housekeeping points. Before we begin, let me remind people that Anixa's disclosures regarding forward-looking statements can be found in the company's latest corporate presentation and SEC filings that can be found on its website at www.anixa.com. Also, I would like to remind people that this fireside chat may not be reproduced or written transcript distributed without the expressed written consent of Water Tower Research. So without further ado, welcome, Dr. Kumar. Thank you, Robert. Thank you for having me. Great to talk to you again, and thank you for taking time out of your busy schedule to be with us today for this fireside chat. Let me start by asking you, Amit, to highlight the company's most important achievements in 2025 that you believe will drive Anixa's momentum this year. Yeah, we had a lot of achievements in 2025, and we anticipate many more achievements in 2026. But in 2025, the two biggest achievements, I feel, were, number one, the completion of the phase I Breast Cancer Vaccine trial that we are working on with the Cleveland Clinic and the U.S. Department of Defense. And we presented data on that trial in December of last year. And the second clinical trial that we have is our CAR- T therapy, and we progressed that, you know, and we had some amazing results with patient outcomes, which were recently highlighted in our press release. And so those are the two major achievements. We had a number of other achievements related to both of those, including multiple patent approvals in multiple cities, as well as the I'm sorry, multiple countries, as well as the United States. We had, you know, we had our CAR- T therapy was now officially named or the name of the CAR- T therapy has been officially approved by domestic and international organizations. And then a whole bunch of other things that I think are very, you know, necessary. But aside from the two clinical trial advances, those are the, you know, the two clinical trial advances are the most significant milestones of the year. Right. So we discussed the phase I B reast Cancer Vaccine results extensively in our December fireside chat. That recording and the associated Management Series report transcript are freely available on our website, www.watertowerresearch.com. Can you then update us on the upcoming milestones for the transitioning to the phase II? Yeah, obviously, the next major step for the vaccine is the phase II, and there are a number of steps that are necessary before we can begin the phase II, including submitting a report to the FDA, as well as having discussions and meetings with the FDA regarding the design of the phase II. We've also applied for certain research grants from the U.S. government to provide some, you know, partial or even more funding for the p hase II. We will need to, and we are working with a manufacturer to produce a larger amount of the vaccine under more rigorous GLP conditions, GMP conditions, so that we can distribute this vaccine to multiple sites, as opposed to just only the Cleveland Clinic. We're going to be identifying these sites. We're going to be signing them up and moving forward. There's a lot of small things that need to be completed. Ultimately, the big goal is to get the phase II begun. As I think I've mentioned in previous discussions and publicly, this phase II is going to be structured as an open-label trial that will enable us to see the results on an ongoing basis. We anticipate a number of different sites. Cleveland Clinic will certainly be the key site, and then we'll have several others throughout the United States. Yeah. That trial is still on target to start sometime this year? Yeah, we believe that that trial will be able to begin in about a year. Yes. So one achievement that you didn't actually mention is your capital efficiency. Last year you burned $7 million, and since 2019 you've been consistently within the $5 million-$7 million range. And at the end of last financial year, your last fiscal year, you had a $15 million of cash balance, no debt, and that's all despite running two clinical trials. But as you gear up for the larger phase II Breast Cancer Vaccine study this year, and you mentioned that you were going to planning to enroll between 80 and 100 women in our previous discussions, and you advance your phase I ovarian cancer's CAR- T program, which we'll discuss in more detail shortly. How do you think the cash flow will be? Yeah, I think, you know, thank you for highlighting that. We have been incredibly fiscally frugal in running this company since 2017 when I took over. We are running two clinical trials, one of which is a CAR T-cell therapy trial, which tends to be very expensive. We've structured the company and the operations of the company in a manner that allow us to do all of our work, including the clinical trials, with very little cash burn. We anticipate that in the next fiscal year, that we will burn a little bit more than the $7 million that we burned in the previous fiscal year, but it'll not be a tremendous amount more. Maybe it'll be about $8 million or so, plus or minus. That's what we're budgeting, and that'll enable us to get both continue moving forward with both of these trials. So that gives us over two years of cash on our balance sheet. We believe that during that period, we will gain significant additional positive data on both of these trials that will enable us to potentially partner with a large pharma company to finance additional trial work, as well as eventual commercialization. On top of that, we have applied for a number of government funding sources. You know, while there's always uncertainty regarding those things, we anticipate that we will get some funding going forward. Sounds very encouraging. So much of the focus has been on the breast cancer vaccine in recent months. But there have been interesting developments in your CAR- T program. So let's start with the non-proprietary name approvals received from the World Health Organization, and more recently from the USAN Council. Why should investors take notice of those approvals? Well, those are necessary steps as we head towards commercialization. We or a partner of ours will head towards commercialization. The naming process is a little bit, I shouldn't say arcane, but it's not always very straightforward. But the process of naming requires going through the approval for international organization, the World Health Organization, as well as the USAN for the United States. And we've gotten approval for both of those. So we're all set with regard to that. And as we go forward as a company, we've always referred to our therapy as a CAR- T therapy, Anixa's CAR- T therapy for ovarian cancer. And we'll still do that. But over time, we will transition to calling it locireddir, which is the short for the name of the therapy. Okay, so let's turn to the trial itself. Can you, Amit, walk us through the design and objectives of the phase I program, and then highlight the key safety and early efficacy indications you have extracted from the dosing of the first cohorts that you've dealt with? Yeah, that's very exciting. In any phase I, the primary goal is to evaluate safety or verify safety so that you can move on to additional clinical studies. So the phase I study was designed to focus on safety. And it's designed to enroll up to 48 patients, 24 in one arm, which is delivery through the vein, intravenous delivery of our therapy, and 24 in peritoneal delivery, which is delivery into the belly of the patient, into the peritoneum directly, which is where most of the ovarian cancer lesions remain. Most or all of the ovarian cancer lesions exist. Now, to date, we've only done the peritoneal delivery. We will do IV delivery just as a comparator. But the peritoneal delivery is providing amazing results. We have had no major dose-limiting toxicity. So the safety sounds very good. In fact, the safety appears to be better than other CAR- T trials that have solid tumor CAR- T trials that have been attempted. It's a dose escalation study. We start with a low dose. And as we verify safety for that low dose, we increase the dose steadily. We're at the fourth dose level right now, and hopefully we'll be beginning the fifth dose level shortly. And even though these dose levels are designed, phase 1 and these dose levels, we expected to be somewhat subtherapeutic, meaning we weren't expecting a lot of efficacy data. We're starting to see really good indicators of efficacy. In fact, we have a number of patients, in fact, a majority of patients that have outlived their expected life expectancy. You have to remember, these patients that we're enrolling in this trial are patients who have failed other therapies, and they have no other options. They're essentially terminal, and they have been told to go home and get their affairs in order. The median survival, life expectancy survival for these patients is about 12 weeks, three months. Yet we have been able to have a number of patients live quite a bit longer. We've had patients, you know, one patient lived 28 months. A number of them lived in the teens, 17, 15, 14, and others are at one year, and others are nearing one year. We've also had some patients die within the first three months as well. But the data looks incredibly promising. That has induced us to seek regulatory approval, IRB approval, to increase the dosage to higher levels because we're not seeing major side effects. That's a really important point, because we know that the vaccine seems to be, I'm sorry, that the therapy seems to be having some impact on these patients. But we have not cured any one of them. We've extended lives of many, but we have not completely eliminated the tumors or the tumor lesions. We feel that if we go to higher dosages, as long as the safety profile remains steady, we will be able to potentially destroy all of the tumor lesions, if not most, you know, certainly most of them, if not all. As you may know, Robert, with metastatic, late-stage, often terminal tumor patients, cancer patients of any type, just extending their lives a few months in major clinical trials is worth a lot. And often you don't cure these patients. You just extend their lives for some period of time. Usually it's a modest period of time. We're showing that in some of these patients, we've extended their lives dramatically. As we go forward, our goal is to actually curatively treat them, which means to eliminate any indicator or diagnostic measurement of their disease. Hopefully these patients will, if we achieve that, it'll be not only revolutionary, but, you know, it'll be fantastic for these patients, because hopefully they'll pass away from other issues as opposed to the cancer, which hopefully we have cured. We can kill with that. So taking that further, what specific early biomarkers or biological mechanisms do you attribute to these outcomes at such low dose levels to date? And how is the company internally conceptualizing the survival signal to ensure that you're not overinterpreting what is primarily a phase I safety study? Yeah, that's a really good question. One of the key points I want to highlight is that we've only tested this therapy on 12 patients at relatively low dose levels. Yet we're seeing really, really good results in a number of these patients. But because it's a small number of patients, we can't make any statistically relevant correlations yet. But as we go forward, we'll be able to do so. As far as the reasons why I think we're seeing these results, there are a number. One is that this is the only solid tumor CAR- T that I'm aware of that identifies and focuses on a unique target that only exists on the cancer you're trying, the cells that you're trying to destroy. All other CAR- Ts in solid tumors have targeted proteins that also exist on lots of other healthy tissues and organs. Number two, we also believe that we're having an anti-angiogenesis effect, meaning we believe that our CAR- T could potentially be destroying the tumor vasculature, meaning the blood vessels that are supplying nutrients to the tumor, as well as removing waste from within the inside of the tumor, the stroma of the tumor. So we believe that this CAR- T therapy is utilizing a dual mechanism of action. And then number three is the peritoneal delivery. Ovarian cancer is one of those types of cancers where virtually all patients show that the tumor lesions remain within the peritoneum, which is a somewhat enclosed cavity within our abdomens. And if we're delivering directly into that cavity, into the peritoneal cavity, then we are making it easier for our therapy, our cells, to go and attack the lesions because of the proximity. And because they're in the cavity and they remain generally within that cavity, they don't get into the blood supply. They don't have a chance to travel around the whole body, including the brain and other areas of the body, and cause deleterious side effects. And so that's one of the reasons why we feel that we are going to be able to go to much higher dosages. And if we go to these higher dosages and we still continue to see good results, but we're not curative for the patient, yet the safety profile stays good, then we will evaluate going to even higher dosages until we've either created deleterious safety issues, dose-limiting toxicities, or until we've cured these patients. So it's an exciting time to move forward as we go into higher dosages with this therapy. As I was going to ask, you mentioned the local regional delivery of the drug that you're developing. How does that profile, your profile, compare to IV-administered CAR- T in solid tumors? What does it actually imply for scalability? Yeah, so typically, as I mentioned, when you deliver anything into the vein, it immediately goes throughout the whole body. And the goal is that it doesn't harm any other organs, but that eventually, when it finds the organ or the cancer that you're targeting, you want it to destroy that. But as we all know, all therapies cause side effects. And CAR- T is certainly one therapy that does cause side effects. And so when you deliver into the vein, you can only go up to a certain concentration, a certain dosage level, because higher dosages cause many, many dose-limiting toxicities and sometimes and frequently death of the patient. So even if it is attacking the cancer, it's attacking enough healthy organs and cells that it's not a viable therapy. In our case, we're doing the peritoneal delivery. And so we are seeing, which we predicted this, that we would see fewer side effects. And that's what's come to pass so far. As we go to higher dosages, we have our fingers crossed, and we hope that the side effect profile remains similar. But we'll have to prove that out. And that's one of the reasons we're very excited to move forward. Great. With the Institutional Review Board approval to escalate doses by up to two orders of magnitude, which is quite a big hike, what specific safety or efficacy inflection points are you monitoring most closely? Well, we're always looking for all sorts of safety issues. We want to make sure that the patient's laboratory values are not incredibly out of range. We want to evaluate the two major safety issues that typically people see with CAR- T therapies, which are something known as cytokine release syndrome, in which case it's a highly inflammatory situation for the patient, fevers, patients feel bad, pain, et cetera, et cetera, as well as some neurological issues known as ICANS. And so we're going to be monitoring for both of those. And of course, just general, you know, how the patient feels and other laboratory values. As far as efficacy, you know, we obviously do scans of the patients on a periodic basis. We take blood tests of the patients, you know, blood work on the patients. We perform that and physical exams, as well, most important, we feel, is overall survival, how long the patient lives. If the patient is expected to pass within three or four months, but the patient lives 18, 24, 36 months or longer, that is the key attribute. In fact, the U.S. FDA, in recent months, has indicated that biomarkers are great. For certain types of situations, you can get approval with biomarkers. But ultimately, what they want is overall survival. That's important for these types of terminal patients, because, frankly, if you can show using biomarkers that the therapy is working, but the patient is not living any longer, you know, who cares, right? You want the patient to live longer. Overall survival is what's important. That's what was highlighted in the recent press release, where we talked about a number of patients that have survived dramatically longer than their life expectancy when we got them. Right. So another interesting feature that you're going to be adding to when you're trialing the fifth cohort is lymphodepletion, which means that patients will receive a regimen of chemotherapy to reduce their own immune cells to make more room for cancer-fighting CAR- T cells to enhance CAR- T persistence or activity. So my question is, what specifically prompted the decision to introduce lymphodepletion at this stage of the study rather than earlier? And just to follow up on those, what endpoints or biomarkers will you monitor more closely to validate its impact? How do you weigh the effects, the upside and added complexity and risk associated with this fragile population? Yeah, so there are a number of questions there, Robert. So hopefully I'll get to all of them. First of all, lymphodepletion is not something that we've decided to do at this late stage. It was already in our original protocol, and the plan was to do this at some point. We wanted to do it at a later stage, after the first few dosage cohorts were done without lymphodepletion. The underlying premise of lymphodepletion is that whenever you add engineered CAR- T cells, which are the therapy that we're developing, they have to compete with existing T cells that are already in your body. The premise is that if you can destroy or significantly reduce the number of existing immune cells in your body, when you add your new CAR- T cells, which are purportedly better cancer fighters, then they have a better chance to proliferate, to engraft and then proliferate in the body. That has proven to be true for liquid tumors, CAR- T therapy for liquid tumors. All patients who get CAR- T therapy for liquid tumors will have a lymphodepletion step. Now, lymphodepletion also creates additional risk, because for a short period of time, your immune system is effectively gone. You're susceptible to all sorts of things, including infections. You have to be a little bit careful. That's something that has to be managed. But we know how to do that, because we do that for leukemia and lymphoma patients all the time. Now, in the solid tumor space, because nothing has ever achieved success so far, we don't know if lymphodepletion is necessary or not. So the company, Anixa, our partner, Moffitt Cancer Center, and the FDA would like to evaluate whether lymphodepletion does improve the outcomes. And so as we go forward, there will be some cohorts that will continue without lymphodepletion and then some with lymphodepletion, so we can compare. And if it turns out that lymphodepletion increases the overall survival of these patients, then certainly we'll do that, even though it may create some additional side effects and challenges for the patient. Because we know how to, even though it does create those challenges, we know how to manage that process. Ultimately, if you're trying to save someone's life and extend their life for a significant period of time, having that additional step and difficulty is worth it if it does improve the outcome. Thank you for all that information. It's very informative and very useful. So I'd like to end this fireside chat to get your final thoughts on what you know. How How would you like to leave what you know? Let me say that again. What final thoughts would you like to leave with investors about your expectations for ANIX in 2026? Well, I think 2026 is going to be a pivotal year. We will have a lot more data on our CAR- T trial, including the data on lymphodepletion, as well as additional higher cohorts, which are higher than what was in the original protocol. By the way, I will mention that the new protocol allows us to go to dosages that are as high as any higher than any other, or I should say, take that back, it's as high as the highest dosages that have ever been tried in CAR- T, that have ever been approved in CAR- T therapy. And again, as I mentioned, we could go to even higher dosages. So there's a lot of scientific information and a lot of efficacy information that we're going to get in 2026. On the breast cancer trial, there are going to be lots of steps that we're going to be taking on our way to begin the phase II. Once we begin the phase II, the phase II study is designed with what's known as a control arm. So half the patients will get the vaccine, the other half will not get the vaccine, and we will want to evaluate the difference between one and the other group. And that'll tell us how effective the vaccine is. As you may recall, in the phase 1 study, we obviously monitored safety, which was excellent. And then we evaluated what we call indicators of efficacy, meaning immune response. Now, in this trial, in the breast cancer vaccine trial, you really can't evaluate the efficacy until you have a control arm, which is different than the CAR- T trial, because the CAR- T patients are terminally ill patients. So those two are the trial advances and the data are going to be the most important and critical things in 2026. And we anticipate good things going forward with both those trials. And then, of course, we're going to be fiscally responsible, as we always have been. We'll have other events that are potentially going to happen. There's some things that we're working on that I can't discuss publicly at the current time. So we're looking forward to a very eventful 2026. Okay, that's great. So we'll wrap it up there. And thank you, Dr. Amit Kumar, for keeping us apprised of the latest clinical developments and progress at Anixa. So it looks like 2026 will be a busy year for the company and one lending itself to much anticipation. So if you have any more questions for Dr. Amit Kumar, please send them to me, and I'll pass them on. For analysis of the company, please refer to our open access website at www.watertowerresearch.com. Now, the views expressed in this fireside chat may not necessarily reflect the views of Water Tower Research and are provided for informational purposes only. The fireside chat, just repeat, may not be distributed or reproduced without the written consent of Water Tower Research and should not be considered research nor a recommendation. Tower Research is an investment engagement firm, not a licensed broker, broker-dealer, market maker, investment bank underwriter, or investment advisor. Additional disclaimers can be found at our website. So thank you for.