Listed clinical stage biotech company under the ticker Anixa. A-N-I-X-A. You can find the company's disclosures regarding forward-looking statements in the company's latest corporate presentation and SEC filings that can be found on its website at www.anixa.com. Anixa runs two early-stage clinical developments, one a novel type of CAR T cell therapy for the treatment of terminally ill ovarian cancer patients, which is in an ongoing phase I trial, and the other a breast cancer vaccine program being designed as both a treatment and a prophylactic. And it is the breast cancer vaccine program that is the focus of our fireside chat today in the wake of impressive final data from the program's phase I study presented last week to the 2025 san Antonio Breast Cancer Symposium, one of the most significant and influential global scientific conferences dedicated to breast cancer. So first, let me welcome Dr. Amit Kumar and congratulate you on the impressive phase I outcomes. Exciting times for Anixa. Thank you, Robert, for having me, and I agree, very exciting results. Now, impressive as these results were, before we dive into those results, maybe you can sort of wonder why the share price reacted the way it has. You know, it's always very difficult to comment on stock price, and I typically don't. Stock price is always driven by many factors, but I'm quite confident that the value in our company with both of the clinical trial assets that are producing very, very good results will be realized and that we will recover. Volatility is something that is always expected in small-cap, microcap biotechnology companies, and so it's just something we have to live with, but long-term value is what we're focused on. So let's go into that. But before we dive into the results themselves, could you start by giving us some context, specifically explain the targeted protein strategy behind your breast cancer vaccine, what makes it novel, and then walk us through the design and objectives of the phase I program completed in October? Yeah, I think the important thing to understand is how the retired protein hypothesis differs from what has been tried in vaccine research in the past. In the past, for cancer vaccine research, people have focused on trying to target proteins that are overexpressed on the cancer cell, meaning proteins that are exhibited at a greater abundance on a cancer cell versus a healthy cell. And while that approach has worked very well for therapeutics, for vaccines, it's a little bit more complicated because if you create a vaccine, if you create an immune response through vaccination against an overexpressed protein, then you've also created autoimmune disease against other healthy cells, not only in the breast, but other organs that express that protein, albeit at a lower level. But you've created this immune response against those proteins. And so your body is constantly attacking those organ systems. We believe that approach is flawed and it needs to change. Our approach is an approach that was invented by an immunologist named Vincent Tuohy, who sadly passed away about a year and a half ago at the Cleveland Clinic. His thought was that there's this protein, specifically in the case of breast cancer, that is expressed only during lactation, enabling women to lactate after they've given birth to a child. But it disappears when a woman stops breastfeeding, and it reappears again when she has another child. But ultimately, it disappears in most women after they're no longer going to have children. However, it was discovered that in the one out of eight women that develop breast cancer, and initially we're focused on triple-negative breast cancer, which is the most lethal form, but long-term, we believe this will be the case for all types of breast cancer. Getting back to the idea, one out of eight women that develop breast cancer, those cancer cells are producing that protein. No other cell in the body is producing the protein. Unlike an overexpressed protein that is produced in other cells and other organs, in this case, it's only produced in the cancer. If you've vaccinated a woman and taught her immune system to destroy cells making that protein, then in principle, you should be able to destroy the cancer cells as they arise at their earliest stage of neogenesis, meaning at the four-cell stage, eight-cell stage, 16-cell stage, before the cells have a chance to reproduce enough to become a multi-billion or trillion cell mass, which becomes a big tumor that you can see in a mammogram. That's the basic principle. And we believe that it's going to enable better vaccine approaches for cancer. And our phase I data shows incredibly promising results. We are very excited about it. In fact, the data has exceeded all our expectations. And frankly, looking at the phase I data, comparing to other vaccines that have been tried in their phase I data, our phase I data is superior to all of them, although it's a little difficult to directly compare. But in general, our data is superior to everyone else's. And by the way, I should note that no other vaccine for cancer has ever been approved. Okay, thanks for that explanation. So let's now turn to those data. Can you run through the key safety, tolerability, and immune response data that you actually generated from the phase I? Yeah, the phase I data parallels what we saw in the animal studies. So the human studies reflect what we, excuse me, what we saw in the animal studies. In humans, we tested the vaccine on three cohorts of women. The first cohort were women who had already had triple-negative breast cancer, already had their surgeries and their adjuvant, meaning post-surgical treatment, but they're at high risk of recurrence. And so we wanted to give these women the vaccine, see if we can verify that it's safe, and identify what we call a maximum tolerated dose, a dose that we would use for future prophylactic studies, and look for indicators of efficacy, meaning are we training the immune system, specific T cells and B cells in the patient to target the protein, hence targeting the cancer cell. And we achieved all three of those goals. The vaccine was found to be absolutely safe, rock solid. That's important because if you're going to give this vaccine in a prophylactic setting, you're going to be giving it to healthy women and large numbers of them, hundreds of millions potentially. And so you've got to make sure it's very safe. And we saw no side effects besides irritation at the injection site, no headaches, no fevers, no myalgias, no other abnormal lab values or anything that we could note or the women could feel. So that was fantastic. Number two, we identified a maximum tolerated dose. And number three, we saw immune responses in 75% of the women, strong immune responses in 75% of the women, and more modest immune responses in the other women. The immune responses were the components that we measured were two types of T cells, which are the T cells that are the cells in the immune system that will attack and kill bad cells, in this case, cancer cells, and a B cell, which is a type of cell in the immune system that makes antibodies that will attack, again, cancer cells. We were very pleased with that. We saw all three responses in those women. The second cohort was a group of women who have never had breast cancer, but they carry mutations. Many people know about the BRCA1 and BRCA2 and other mutations that predispose women to getting breast cancer. Many of these women have chosen to have mastectomies, prophylactic mastectomies, to reduce their risk of getting breast cancer. So they have their breasts surgically removed while they're healthy before they have cancer. And so we asked some of these women if we could vaccinate them before they had their surgeries, and then we could, after their surgeries, examine their breast tissue. And that examination is going on right now. We didn't report that data at the conference, but we'll report that at a future scientific conference. And then the third group of women, very interesting group, these are women who've already gone through their breast cancer journey, including their surgeries and their adjuvant therapy, but they still have what's known as residual disease. So they don't have a tumor that you can cut out, but they have microtumors or microcancers that exist in their body, typically in lymph nodes and places like that. And so almost 100% of these women will have a recurrence at some point. And so these women are treated with various types of therapies after they've had their surgeries. And the standard these days is becoming Keytruda, which is an immune checkpoint inhibitor, also known as pembrolizumab. And Keytruda does have some impact, but not complete impact on 100% of the women. And so we thought if we could couple our vaccine with Keytruda, would that enable better response in these women? And since this is a phase I and we weren't going to do a large number of women in the cohort, we wanted to verify that Keytruda, along with our vaccine, did not create massively difficult side effects with the women. Keytruda carries with it a lot of very difficult side effects. And often when you put it in combination with other things, especially other immunogenic agents like vaccines and things like that, you create really, really bad side effects, intolerable side effects. And so we wanted to verify that our vaccine did not do that so that as we go forward in phase II, we could use the combination of Keytruda and the vaccine together in a neoadjuvant, meaning pre-surgery therapeutic setting, which is the plan for phase II. Thank you for that. That's a good deep. I should say we didn't see any major side effects besides the injection site irritation. Right. Talking about side effects, safety, tolerability, the profile, was that uniform or did it vary across the three cohorts and dose levels that were applied? Yeah, there was some variation. It had to do with dosages, but again, all of the side effects are related to injection site irritation. There were no systemic side effects, and for example, in the Keytruda case, Keytruda plus vaccine case, two of the women had one of their injection sites become much more pronounced from an irritation standpoint, but they all resolved eventually, so the side effects were a little bit more pronounced, but again, it was all related to injection site irritation. Got it, so you mentioned the result showed an impressive around 75% immune response across the three cohorts that were studied, so I have a couple of questions on this. First, the poster indicates that you found that the amount of the target protein, that's alpha-lactalbumin, among patients varied widely from tumor to tumor, so was the correlation found between the strength of the immune response and how much protein was in the original tumor? And secondly, were there any significant differences in response rates among the cohorts? No, there weren't significant differences in the response rates among the cohorts, and you're right, we did see some women with low levels of alpha-lactalbumin in their primary tumor and some with much higher levels, but at the current time, we only have 35 women in this phase I trial, and statistically, there were not enough women to try and make direct correlations yet. We'll be able to do that when we have a larger number of women in the trials going forward. So was there anything in the results that really surprised you? Nothing surprised us except for the fact that the response rate was so good. We were expecting a response rate. We were expecting good safety. We were expecting maximum tolerated dose is something that is just a measurable amount, so we were expecting to be able to reach that. Everything that we had done in the animal studies had indicated what we were expecting in the human studies, and so we're quite pleased with what we saw, and if I had to say anything was surprising, I would have to say that 75% had very, very robust immune responses, which bodes very well for this vaccine going forward. Right. So then could you share key insights that you've drawn from the phase I data, those most critical for shaping the design of the phase two study and setting its priorities? Yeah, I think the first key point is that we will go into a phase two study in the neoadjuvant setting. What that means is that women who are newly diagnosed with breast cancer today, who are newly diagnosed with breast cancer, are heading towards surgery. And as they head towards their surgery, they're typically given chemotherapy or immunotherapy, although these days, immunotherapy is becoming the standard of care, and that immunotherapy often is Keytruda. And the purpose of that is to try and reduce their tumor burden and get maybe a partial or complete response targeting that cancer. And obviously, if you can do a less aggressive surgery, that's better. And on top of that, if you can have some sort of response in their tumor, then successive to surgery, they have a much lower chance of recurrence. However, as we all know, most of these therapies don't work on 100% of the women, and in fact, they could work better on the women on whom they do work, and so our phase II study is going to be in these women in which half of the women will get standard of care, which is Keytruda, so they're not going to get any less care than everyone else gets, then the other half will get the vaccine plus Keytruda, so the combination will enable us to see if the vaccine improves the outcome for these women versus the women getting standard of care. And the reason we're going into a neoadjuvant setting instead of a prophylactic setting right now is because we believe that showing that the Keytruda vaccine combination, the results can be obtained very quickly because these women are going to have their surgery within six months after diagnosis. So at most, they're going to get three, four, five, six months of therapy. And during that time, we'll be able to see how our vaccine is impacting their tumors, whereas in a prophylactic setting, we may have to wait years and years to see if women get breast cancer or don't get breast cancer. If we can show that we are able to have an impact on a raging tumor, a multibillion cell mass, then it's a pretty good bet assertion that we could probably see in a prophylactic setting, the vaccine target and destroy half a dozen cells or 15-18 cells at the early stages of neogenesis. This is going to be a very exciting trial. It's going to be an open-label trial, so we'll be able to see the data and report the data before the trial is complete. That has two benefits. One, it'll tell us how well the vaccine works. Number two, for the purposes of corporate activity, it'll allow us to show potential pharma partners that the vaccine is working, and that will enable us to establish pharmaceutical partnerships that will enable us to fund additional trials and eventually commercialize the product. So that's from a corporate standpoint that it has been always our plan. We want to begin the trial, demonstrate results, and then establish a corporate partnership that will enable us to take these products forward all the way to commercialization. Hopefully, that'll enable us to not have to raise capital on the capital markets, which has been a goal of mine for quite some time. So just a quick follow-up on that question. How big is the trial anticipated to be in terms of number of enrollees? We anticipate the trial to be on the order of 80- 100 women, half in one group and half in the other group, and the trial we anticipate will probably take two to three years or so, plus or minus, to complete, but we'll have data much earlier than that. So taking that further, could you walk us through the next steps for the breast cancer vaccine program and outline the key milestone and timeline that will advance you to the next phase of clinical development? Yeah, our goal is to begin the trial next year and then shortly thereafter start seeing data relatively quickly. It's hard to predict exactly what a phase III trial might be. Maybe we don't even have to do a phase III trial. Maybe we just expand the phase II into a phase III, depending on the data, and get registration for the product. We'll have to see. It all depends on the data. I'm confident that the data is going to be fantastic and that we're going to get this product on the market relatively soon. Remind us when you expect to meet with the FDA ahead of your phase two and actually submit an IND and actually start a phase two? Yeah, so we're beginning. Today, we just announced that we transferred the IND from Cleveland Clinic to Anixa. So now we are the sponsor of the trial, which has been planned for quite some time. Cleveland Clinic will be involved with us all the way until the commercialization of this product. And in addition, we're working with Cleveland Clinic on a whole bunch of other products as well. So they have been an incredible partner, incredibly valuable partner, brilliant scientists and clinicians, some of the best in the world. And we're very pleased that we will continue working with them. We plan to complete the reports that are necessary to submit to the FDA after the phase I shortly. We'll be submitting those sometime in the early next year. And then we will request a meeting with the FDA to discuss the steps going forward. Our hope is that we can begin this second clinical trial next year sometime. Okay. So beyond the breast cancer vaccine clinical program, Anixa is advancing preclinical and R&D vaccine programs targeting other prevalent cancers, including ovarian, prostate, lung, and colon. Do you believe the success of the targeted protein strategy with alpha-lactalbumin in breast cancer can be replicated when targeting different proteins associated with other solid tumors? And do you intend to accelerate any of these programs on the back of the breast cancer vaccine findings? Well, the ovarian cancer vaccine program is already in animal testing right now. And we in the Cleveland Clinic are working with the National Cancer Institute on that program. And we'll see how that program goes forward. We do feel that the concept of whether it's a retired protein or not, the concept of identifying a protein on the cancer that's unique and does not exist on any other cell in the body is the way to go. Because that way, you don't create this autoimmune disorder against other cells and organs in your body. And so I think longer-term researchers will start looking for those types of proteins. And we're already starting to hunt ourselves in other types of cancers. But our primary focus right now are these clinical trials because obviously we need to get this product further along in human testing. Understood. Okay, we'll have to leave it there. Thank you, Amit, for helping us understand the significance of the phase I outcomes and for the breast cancer vaccine. And we're really looking forward to following up its progress. And if you have any more questions for Dr. Amit Kumar, please send them to me, and I'll be sure to pass them on. For analysis of the company, please refer to our open access website at www.watertowerresearch.com. Finally, just a reminder that the views expressed in this fireside chat may not necessarily reflect the views of Water Tower Research and are provided for informational purposes only. Once again, I'd like to thank Dr. Kumar for his participation and everyone for joining us in this fireside chat. Have a great rest of the day. Thank you, Robert, for having me.