Anixa Biosciences Inc (ANIX) September 11, 2026 Conference Transcript

Good afternoon, everyone, and thank you for joining the 2026 H.C. Wainwright 28th Annual Global Investment Conference. My name is Dr. Catherine Dagan, an Associate Research Analyst at H.C. Wainwright. It's my pleasure to introduce Dr. Amit Kumar, Chairman and Chief Executive Officer at Inixa Biosciences, a clinical stage biotechnology company focused on the treatment and prevention of cancer. Dr. Kumar, I'll hand it to you.

Thank you, Catherine, and I want to thank HC Wainwright for having us for this conference. I also want to note that this presentation is being recorded on August 21st, even though listeners will be able to see this in the middle of September. So all of my statements are accurate as of August 21st within the context of our forward-looking statement. So let me begin by talking a little about NICSA at a very high level. The company was initially founded in the 1980s as an electronics company and went through the decades in a number of failed businesses. In 2017, I took over the company as CEO and converted it into a biotech company. So, in reality, the company is about eight years old since that time we built a very robust pipeline with two products in the clinic which i'll focus on during this presentation and both products are uh you know demonstrating very good very positive clinical data we execute a business plan that involves very strong partnerships keep our burn load that way and enable us to that enables us to work with multiple experts in different scientific areas we're addressing large markets ovarian cancer and breast cancer we have a strong balance sheet no debt a very clean capital table with no warrants or overhangs of any sort and uh over the last seven eight years since i've been ceo there's been a tremendous amount of insider consistent insider buying by myself and other insiders including our board of directors. And I myself have bought over two and a half million dollars worth of stock on the open market. This is what our balance sheet looks like as of the last reported date, which was April 30th, which was the last fiscal quarter. We have $14 million of cash on the balance sheet, which doesn't sound like a lot for a biotech company, especially one that's in clinical trials with two products but because of the way we run our business we've been able to move both of these clinical trials forward with very low burn we've been burning about five to seven million dollars per year last year we only burned seven million dollars we have 34 million shares outstanding and as i noted no debt and no warrants to produce an overhang for the stock the strategy as i noted is to develop our programs with our partners. We're able to leverage existing infrastructure that exists at our partner sites. For example, our two biggest partners are the Cleveland Clinic, which is one of the best hospitals in the world, and the Moffitt Cancer Center, which is one of the top cancer centers in the world as well. This partnership approach allows us to maintain a very low overhead and not have to raise tremendous amount of cash frequently like most biotechs, and also enables us to maintain a very clean capital structure. And our plan long-term is after we have innovated the products that we're developing, which I'll tell you about in a moment, we want to out-license these programs to pharma companies for eventual commercialization. As I noted, we have a number of programs that are ongoing, but I'm only going to talk about the two that are in the clinic today. One is a CAR-T therapeutic targeting a solid tumor, ovarian cancer. These are recurrent and resistant ovarian cancer patients who have failed multiple approved therapies and their disease is still progressing. That's in phase one at the Moffitt Cancer Center. And the other program I'll talk about is a vaccine, a prophylactic vaccine for breast cancer. I should say prophylactic and therapeutic vaccine. for breast cancer. We recently completed the phase one study and we are now in preparation to do the phase two study. That program was partnered with the Cleveland Clinic and it was funded by the United States Department of Defense. So let me begin with ovarian cancer CAR T therapy. Many of you may know what CAR T therapy is, but essentially it's a ultimate, it's the ultimate personalized medicine. We take cell, T cells, specifically T cells from a patient who has cancer. This is autologous. And so we take the T cells from the patient, we take them to a laboratory and genetically engineer them, quality control them, expand them, and then go back to the patient and re-infuse them back into the patient. The intent is that those T cells that have been engineered are potentially better able to find the cancer and destroy the cancer. Now this type of therapy created a tremendous amount of excitement a few years ago when the first CAR T approaches were approved for certain leukemias and lymphomas, specifically B cell leukemias and lymphomas. B cell is a type of white blood cell. Unfortunately, since that time, the approaches to utilizing CAR-T in other types of cancers, especially solid tumors, has been unsuccessful. That being said, we have developed a new approach, or I should say a more nuanced approach, which we feel will identify ovarian cancer much better and target the cancer for destruction. And this is a little bit of a busy slide, but stay with me for a second. I'll explain the key differentiators between our CAR-T therapy and other CAR-T therapies that have failed in the solid tumor clinical trials. On the right-hand side is a cartoon of the CAR-T therapies that have been utilized for the B-cell leukemias and lymphomas many of which are approved now in that case the t cell which is the cell on top is genetically engineered so it will present an antibody fragment on the surface that's the car and that antibody fragment acts as a homing missile to find the b cell which is the cancerous cell healthy and cancerous b cells to bind to the protein cd19 which is what that antibody fragment has been designed to target. And once it binds to that protein, and hence the cell, it destroys those cells. In our case, or I should say in all other solid tumor CAR T therapies that I'm aware of, there has never been identified a protein that could be targeted by the engineered T cell that only exists on the cells one wants to destroy. The proteins that have been targeted in the past also exist on healthy cells and healthy organs. And so that limits the dosage that can be used in those therapies. In our case, we use a T-cell that has been engineered with a follicle-stimulating hormone, which is an endocrine hormone. It's a small protein. And it targets something called the follicle-stimulating hormone receptor, which is expressed exclusively on the ovaries in women and the testes in men. And so when we engineered our T cells and re-infused them back into the body, those T cells will only attack the ovaries and no other organ system. That's one key attribute of our technology. A second attribute is the fact that, as I noted a moment ago, the only expression of the follicle stimulating hormone receptor is found on the ovaries and testes. Since we're dealing with ovarian cancer, we're only dealing with ovaries. And recently, however, publications showed that the follicle stimulating hormone receptors also expressed on the vasculature, the endothelial cells, the inner lining of the blood vessels that exist in tumors, not in the healthy organs, but in tumors, in multiple types of organs. So what does that mean for our T cell therapy in our case the left hand cartoon shows a tumor ovarian cancer tumor lesion for example and tumors solid tumors when they grow they induce a process called angiogenesis to enable uh the formation of blood vessels within the true tumor that allows waste uh and uh and co2 to be removed and oxygen and nutrients to come into the tumor and as i noted in the previous slide the studies had shown that the surface of the inner surface of these blood vessels within the tumor not outside the tumor but within the tumor expressed follicle stimulating hormone receptors so in our case our t cells we expect will not only attack the cells the ovary cells themselves but also disrupt the vasculature that is enabling nutrients to come into those tumor lesions. So it'll be a dual mechanism of action that we believe is acting in our situation. And the third key advantage of our CAR T therapy is that we're delivering the T cells directly into the peritoneal sac, which is the abdominal sac in which many organs exist. And in women, ovaries exist in those organs i'm sorry ovaries exist in that sac and the ovarian cancer as it uh metastasizes largely all of the legions stay within the sac they are they form on the sac surface itself as well as other organs within the peritoneal sac and so by delivering our t cells directly into the sac it never gets into the bloodstream and causes the side effects that people see with bloodstream, with IV delivery. And it also traffics better to the lesions because we're delivering it into a somewhat enclosed sac that contains all of those lesions. So this has a couple of different advantages. One is the trafficking aspect. And number two, because the cells never get into the system, into the bloodstream, we believe we're able to get to much higher dosages without dose limiting toxicities. And this is our dosing scheme. We have to date dosed the first four cohorts, and we are in the fifth cohort dosing right now. I just dosed an initial patient recently. We've dosed 14 patients so far. And this is the key slide here. This is a swimmer's plot representing the length of time that patients have lived on our therapy. We have one patient that went 28 months, several that have gone over a year. And I should note that most of these patients are expected to pass within 12 weeks. So we've demonstrated significant improvement in their overall survival. However, we have not yet completely curatively treated a patient, and we anticipate that that will happen as we increase our dosages at the current cohort and two additional cohorts above that. So very exciting data and more to come as we move forward. The vaccine program is also a very exciting program. This is a vaccine that's designed to not only treat breast cancer, but also prevent breast cancer, primary prevention. And those of you who are familiar with the world of cancer vaccines know that we've never really developed a cancer vaccine. Recent news from Merck and Moderna shows a personalized cancer vaccine that has demonstrated some efficacy in melanoma. But besides that, most clinical trials have failed. In our case, we're utilizing a different molecular mechanism that has ever been tried before. In this case, we've identified a protein, it's called alpha-lactalbumin, depicted by the red ribbon on the left-hand side. It's a lactation protein, so it's produced in the breast and mammary glands of women when they give birth, and it enables the woman to lactate so that she can feed her infant. After she stops breastfeeding, that protein disappears. And it appears again when she has another child and another child. But eventually, after she's no longer going to have children, in most women, that protein disappears and is never seen again. In the one out of eight women that develop breast cancer, those cancer cells are producing that protein. It's not clear exactly why, but they're producing the protein and reusing that protein as a target antigen in our vaccination scheme. Now, our clinical trials are focusing on triple negative breast cancer, which is the most aggressive form of breast cancer, but we believe this vaccine will work for other types of breast cancer as well. A few years ago, our partners at the Cleveland Clinic, where this vaccine was developed, did a very powerful proof of concept experiment. They took a normal, healthy female mouse, vaccinated her, and enabled her to mate and have litters, multiple litters. All the litters and the pups were perfectly normal. However, the mother mouse could not produce milk because the cells that are ready to lactate and produce milk for the pups were producing this protein. And because she had been vaccinated, her immune response was charged and primed to destroy any cell making that protein. So all the cells enabling lactation were destroyed by her immune system. So this was a very powerful, it's an animal model, but it was a very powerful demonstration that this vaccine could create a very strong cytotoxic response that would destroy cells that made that protein. Another series of animal studies, and by the way, all of these are published. On the right-hand side, I want to focus on that particular experiment. This is an experiment where mice that were genetically engineered to spontaneously develop breast cancer were utilized. Half of these mice were given the vaccine, the other half a placebo. And we found that 100% of the mice that were given the vaccine did not develop breast cancer, while almost 100% of the mice that were given the placebo control developed breast cancer as one would expect because these were genetically engineered to develop breast cancers this is again another very very powerful animal experiment and all of these experiments induced the u.s department of defense to fund the late stage preclinical studies as well as the phase one study and the phase one study uh involved three cohorts of patients these are patients who the first cohort included patients who had triple negative breast cancer have gone through their treatment and they were given the vaccine in the adjuvant setting. Many of these women will have a recurrence and our goal was to see if we first of all verify safety in these women with the vaccine and also to see if we can induce an immune response in these women. Cohort B was a unique type of group because these were women who carried the mutations genetic factors that predispose them to getting breast cancer these women some of these women are choosing in society to have prophylactic mastectomies to reduce the risk of breast cancer so we had a handful of these women who had chosen to do that and we asked if we could vaccinate these women and then get the after their surgeries get their resected tissue to evaluate and we're in the process of doing that evaluation right now. And cohort 1C, the third group, were women who had gone through their triple negative breast cancer treatment, and they're in the adjuvant setting, but they still carry minimal, you know, some residual disease. And as a result, these women get aggressive chemo and immunotherapy, primarily Keytruda, which is the most common right now. And we wanted to see if we could utilize our vaccine alongside Keytruda and treat these women. In phase one, we were focused on, number one, getting verifying safety because Keytruda carries some side effects itself. And we wanted to make sure that adding the vaccine to that regimen did not increase dramatically the side effect profile, which was the case. And we also wanted to see if we could the immune response very busy slide here i apologize for that but the the trial involved 35 patients and the right hand side are ellispot assays that look at two types of t cells and a b cell population and what you'll see is that we are seeing good good response on virtually all of the patients three quarters of these patients had very very uh good standard uh pro i'm sorry protocol defined immune responses so we're very excited about it the most exciting thing about this is that this vaccine did not um cause any serious side effects at the maximum tolerated dose when we got to higher doses uh i should say this the most uh you know most of the women had injection site irritation besides that very little very few side effects as we went to higher dosages the injection site irritation became more pronounced but again no major systemic side effects so this is very important because if we're going to be giving this vaccine eventually prophylactically to millions or even billions of women to prevent breast cancer in the future the side effect profile has to be extremely good. And that's what we found. And then because we've completed that phase one trial, we're in the process of now preparing for the phase two trial, which includes manufacturing, which includes recruiting sites, and all of the blocking and tackling that are necessary to do the phase two trial. At the current time, our plan is to do the phase 2 trial in the neoadjuvant setting before patients get breast cancer. I'm sorry, before patients get surgery for their breast cancer. So once a woman has been diagnosed with breast cancer, she will typically get neoadjuvant chemo or immunotherapy to try and reduce the size of the tumor as well as improve potentially statistics for recurrence. And in the current situation, most of these women will get Keytruda as standard of care. And so we're going to utilize a control group of standard of care, which is just Keytruda, and the other group will be standard care plus vaccine, and we will see how the two different groups behave. And so we're very excited about reviewing this data once we get the program started. And that's all I have. I think the market opportunities are massive for this vaccine. Obviously, our plan is to bring this vaccine to market initially to treat breast cancer in the neoadjuvant and adjuvant setting, then after that to prevent recurrence of breast cancer in cancer survivors. There are almost 4 million women in the United States alone that have survived breast cancer, and they wake up every morning wondering if they have a headache, if their cancers come back and metastasize to their brain, or if they have a back, you know, they're always living with this anxiety of potential recurrence. We want to be able to prevent that recurrence. And then the ultimate goal is for a prophylactic vaccine so any women who's and and some men who are concerned about getting breast cancer in the future can take this vaccine and hopefully prevent most if not all breast cancers and we can have an effect in cancer similar to what we've had successes in infectious diseases for scourges like polio and smallpox and so forth and so this is a very very big program very exciting program, a big market opportunity. So that's it, Catherine. I'll stop there.

Thank you, Dr. Kumar, for that overview of INIX's cancer vaccine and cell therapy programs. As we wrap up today, I just want to thank all of our presenters and participants in this year's conference, and I hope you all enjoy the remainder of the conference.