It's my pleasure to introduce our next presenter, Mike Catelani, CFO at Anixa Biosciences, a clinical-stage biotech company focused on the treatment and prevention of cancer. The floor is yours.
Thank you. And thank you to HC Wainwright for having us here and for all of you for taking the time to come hear the Anixa story. Standard forward-looking statement disclaimer for anybody watching this after today, September 9th. Everything I'm going to talk about is accurate as of today, September 9th. A quick overview of the company. As mentioned, we are a clinical-stage company focused in oncology, breast and ovarian cancer primarily. We've got a robust pipeline of some vaccine products. The lead product is against breast cancer and a CAR-T technology against ovarian cancer. Our breast cancer vaccine and our ovarian cancer CAR-T program are both in phase one clinical trials. To date, we've been getting some very strong clinical data. It's phase one. It's early. Not a lot of patients yet, but we're very encouraged by what we're seeing. It's very, very positive so far.
We have a number of key partnerships. It's one of the important aspects of how we run the company and the business model we're following. We work with top-notch academic institutions and research institutions such as Moffitt Cancer Center and Cleveland Clinic. We're pursuing large markets. We're looking at breast cancer, ovarian cancer. These are large markets with large unmet medical needs. We've got a very strong balance sheet, no debt, well over two years' worth of runway, very clean cap table with no warrants, no preferred stock. We're in really good shape financially. We've had very strong and consistent insider buying. As a public company, you don't always have a whole lot of windows to trade in company stock. It seems like almost every open window we have, one of our insiders is buying. No one's been selling for as far back as I can remember.
We're all very bullish on the company. As I mentioned briefly, we've got a very capital-efficient business model. I'll go into that right now. We have, as of our last reported fiscal quarter, which was April 30th, we had about $16 million in cash and investments. You may not think that's very much money, but it's important to understand that over the last several years, we've been burning on average between $5 million and $7 million a year. We've got a very low burn. Last fiscal year, we burned only $7 million in cash. The keys to doing that are the partnerships we have with our academic collaborators. What we do is we leverage their infrastructure. We're not, you know, for example, we've got a CAR-T program. We didn't go out and spend $10 million to build a cell therapy manufacturing facility.
We're leveraging the investments that our partners have made in that space. Similarly, we don't have a lab with 40 high-level scientists working in it, plus all the equipment and all that monthly burn that goes along with that. We leverage the infrastructure of our partners, and we're able to advance our programs very efficiently. We've also been able to get some grants and other government support that's been very helpful to keep the burn low as well. As I mentioned earlier, there's no warrants, no preferred stock. When you think about our business model and how capital-efficient it is, the key there is when you're capital-efficient and you're not burning a lot of cash, you're not having to go out into the market to raise tons of cash. As we all know, the market's been pretty unfriendly for most microcap biotechs.
We haven't had to deal with some onerous financing provisions. It's put us in a good position for the future. Our goal in the long term is to partner our programs off with large pharmaceutical companies for the late-stage clinical development as well as commercialization, again, taking advantage of the infrastructure those pharma partners would have. Briefly, this is our pipeline. We have, as I mentioned, a CAR-T therapy against ovarian cancer. It's in phase one. The technology was invented at The Wistar Institute in Philadelphia. We're partnered with the Moffitt Cancer Center down in Tampa to do preclinical work there as well as now the phase one clinical trial is happening there. We have a breast cancer vaccine that's also in phase one clinical trials that was invented at Cleveland Clinic. We're working with Cleveland Clinic on all of these vaccine technologies we have.
The breast cancer vaccine received a DOD grant, or I guess a DOW grant now. I guess we have to start calling it the Department of War, not Department of Defense. It's going to take a while to get used to. They've given us a grant there that supports the entire phase one clinical trial. That's been very efficient for us. In addition, we have an ovarian cancer vaccine that is an early stage, early studies, preclinical studies that is being supported by a program at the NCI where they are performing all of those preclinical studies for us. We've got a research program with Cleveland Clinic looking at some additional vaccine targets. Talk about CAR-T first.
Not going to go into the details of how it works, but essentially a very broad overview is that a cancer patient, we draw blood from a cancer patient, we isolate the T cells. We then genetically modify those T cells so that they have a receptor on them that will bind to an antigen that's on a cancer cell. We then grow up a large number of those cells and T cells and then infuse them into the patient. Now the patient has a population of T cells that are designed to fight the cancer. CAR-Ts had a lot of excitement in the early days. It still does have some very positive outcomes in B-cell cancers and hematological cancers. There's been a lot of challenges in being successful in the solid tumor space.
We have three unique attributes to our CAR-T approach that we think is going to help us be successful in the solid tumor space. I'm going to talk about each one of these a bit more. First, we've identified a unique target that is only on the cells we want to destroy. We also believe that we are having not only the direct killing effect of CAR-T, but we're also having an anti-angiogenic effect as well. We're taking a different delivery approach. We're delivering via intraperitoneal delivery instead of intravenous. A lot going on in this slide. The key here is that we've identified a protein. It's the follicle-stimulating hormone receptor. This hormone receptor is only expressed on ovary cells, no other healthy organ system in the body. It's only expressed in ovary cells in women, testes cells in men. It's a very good target.
There should not be any on-target, off-organ effects. In this case, we take the T cells and we engineer them with the natural follicle-stimulating hormone and take advantage of that hormone-hormone receptor binding affinity. The other thing that was discovered, a paper came out in the New England Journal of Medicine about the discovery of follicle-stimulating hormone receptor FSHR being expressed in the vasculature within tumors. When a tumor starts to grow, it starts to develop its own vasculature through the process of angiogenesis. It's creating its own blood vessels within the tumor. For reasons that aren't fully understood, the endothelial cells that line those blood vessel walls are expressing FSHR. We believe that not only do we get that direct kill effect against the cancer cells, but we're also getting this anti-angiogenic effect and helping to destroy the tumors from within. Finally, intraperitoneal delivery.
This is something that's kind of unique to the ovarian cancer setting because ovarian cancer generally, those cancer lesions will stay within the peritoneal cavity. By delivering IP, we are giving a more localized delivery. Most of the cancer is within the peritoneal cavity. We're then infusing that cavity with the T cells, and we get a much more efficient delivery approach. In addition to that, the peritoneal sac is fairly conserved from the rest of the body. When we put those T cells in there, very few escape into the bloodstream. What that allows is potentially, hopefully, a much safer approach because we're not having a systemic delivery of these T cells. We can avoid some of the harsher side effects that CAR-T treatments have seen in the past.
Things like CRS, which can be very difficult to manage, very difficult for the patient, we've not been seeing that in our patients to date in the trial. We think that this delivery method, not only is it potentially more effective, but we think it's also a lot safer and can allow us to dose up to much higher dose levels than a typical CAR-T treatment could be dosed. Where we are in the trial, if you've been following us, you may know that a couple of days ago, actually yesterday, we announced that we just completed treatment of the fourth dose cohort. We're now in a 30-day safety waiting period. We don't anticipate anything happening. As soon as we get past that period, we can then start enrolling patients in the next dose level.
We're ready to move into dose level five, which will be approximately three times higher dose than the most recent dose. Where we are in the trial. We have dosed 12 patients to date, three patients in each of four dose cohorts. We've not seen any safety issues at all. We're very encouraged by that. No dose-limiting toxicities have been seen, no cytokine release syndrome, et cetera. We're feeling really good about the safety of this treatment. From a clinical activity perspective, again, numbers are small. We can't draw a lot of conclusions, but we're seeing some very encouraging data. We have one patient who's still alive 28 months after treatment. We have another patient over 13 months. We've got several other patients that are 7, 8, 9, 10 months out from treatment.
This is all really important because the patients we're enrolling generally have about a three to four-month life expectancy. It appears that we are extending life. Numbers aren't big enough to really draw any conclusions here, but this is extremely encouraging to see the long lives of these patients at this point. Over the next few months, we're going to be continuing to dose escalate. We're hopeful that we'll start seeing even more exciting efficacy data as we move forward with this trial. Now I'm going to switch gears over to our breast cancer vaccine. Completely different technology. I would point out one of the benefits of our business model, by not investing in any one specific technology, we're able to work on orthogonal projects. We're not all in on one technology. We can do a lot of different things. This technology was invented at Cleveland Clinic.
They were working on researching retired proteins. Retired proteins are proteins that are expressed for certain functions or certain times in life and then generally never reappear. In the case of breast cancer, there's a protein called alpha-lactalbumin. It's a lactation protein. It is only expressed when a mother is lactating and breastfeeding her child. Once a woman no longer has any more children, she should never again express that protein. What the researchers discovered was that initially in triple-negative breast cancer, which is the most lethal form of breast cancer, they discovered that the breast cancer cells were expressing alpha-lactalbumin. Since then, we've learned that multiple forms of breast cancer are expressing alpha-lactalbumin. We think this can be very broadly applicable.
The original hypothesis, and same hypothesis, is that if we were to vaccinate women after they're done having children, we could potentially eliminate or at least significantly reduce the likelihood of the onset of breast cancer for these women. Early proof of concept study, we took some mice. We vaccinated them against alpha-lactalbumin, and then we bred them. The offspring were totally normal and healthy, but the mothers were not able to produce breast milk. It proved that if we vaccinate a mouse against this protein, it would enable the immune system to essentially destroy all those alpha-lactalbumin-producing cells. Another study that was done, if you look at the chart on the right, is this is a line of mouse that's designed to spontaneously develop breast cancer. The control mice, virtually all of them developed breast cancer as expected.
What was impressive was that 100% of the vaccinated mice did not develop breast cancer. It was really impressive data. This and a whole lot of other data is what was submitted to the DOD or the DOW to get the grant that would support this program. What the grant paid for is this phase one clinical trial. We looked at three different patient populations in this trial. First is a recurrence group. These are women who had triple-negative breast cancer, had been treated, and were currently cancer-free but at risk of recurrence. The second group is a prevention group. These are women who are healthy, never had breast cancer, but have certain genetic mutations that would indicate they have a higher likelihood of developing breast cancer in the future. The third group is the treatment group.
These are women who have had triple-negative breast cancer, have been treated, have had surgery, and still have residual disease. They are currently on Keytruda. We're looking at the combination of Keytruda with our vaccine. In all three of these groups, what we're looking for, it's phase one, we're looking for safety, and we're also looking for immune response. What we've seen, the data on the right side here was data that we presented last November on the first 26 patients. What we saw in these patients was that there were no safety concerns at all, very safe and well tolerated immune responses across all dose levels. Over 70% of the patients had what we deemed as an effective immune response. Very exciting data there.
The Keytruda arm, the treatment arm, one of the important aspects of that arm of the trial was understanding safety because Keytruda is not easily tolerated by most patients. We wanted to determine whether the combination would make things worse or unchanged. We were happy to see that we did not see any difference in the safety profile for women that were on the combination. The current status of the trial is that we have completed enrollment. We are finishing up the final patient visits right now. The plan is to compile all the data, pull it all together, and present the final data for the phase one trial at a scientific conference later this year. The plan going forward after that is to take this into phase two.
You'll remember earlier on I said the original hypothesis was a primary prevention, vaccinating women after they're done having children to prevent the onset of breast cancer. We recognize as a microcap biotech, the primary prevention trial is going to be huge. It's going to be long. It's going to be expensive. We want to get to a point where we can, consistent with our business model, leverage pharma's investment and infrastructure. What we want to do is get the data we need to show efficacy so that we can get a partner to take it into the bigger primary prevention setting. We're first going to look at the neoadjuvant setting. Essentially, this is going to be looked at as a therapeutic vaccine initially. The keys for that are that we can do it relatively quickly and with a relatively small number of patients.
The plan is to essentially vaccinate women around diagnosis and essentially look for a reduction in tumor burden to show a therapeutic effect. We think that if we can show that therapeutic effect, it obviously would enhance the value of this program and make it quite attractive because there's multiple markets we can go after here. The neoadjuvant setting is huge in and of itself. I mean, we know that in the U.S., one in eight women are going to experience breast cancer. That's a big market. The prevention of recurrence is also another big market, which we can then go into as well. That's a huge market. Of course, primary prevention is ridiculously huge. The key here is we want to start with the easy wins and build up into something much bigger. Finally, I'll talk about our other programs briefly.
I mentioned we've got an ovarian cancer vaccine that we're working on. In this case, a protein was identified much like alpha-lactalbumin. In this case, it's a protein that's expressed in the follicles of the ovaries. It goes away at menopause. In ovarian cancer, this protein shows up again. We're doing the preclinical studies now with the NCI to take this program into the clinic eventually. Based on the positive data we've been seeing through the breast cancer vaccine, we decided to work with Cleveland Clinic and start a new research program with them to identify more of these retired proteins that are associated with cancer. We're primarily focused right now on prostate, lung, and colon. Obviously, there are large markets that work as it's early stage, but it's been encouraging so far. We're hopeful that we'll find a bunch of different targets to make vaccines over. That is it.
We have about one minute. If anybody has any questions, I'd be happy to take them. Yes. We have a lot of patents issued, pending, et cetera. We've done a good job about covering multiple aspects of the vaccine as well as the CAR-T. We've got a very strong patent portfolio around all of our programs. Most of the IP has been created prior to our vaccination, sorry, prior to us taking the license. Those patents were all actually applied for under Cleveland Clinic. We have exclusive worldwide licenses to all that.
OK. We have no more questions. Thank you, Mike and Anixa, and congrats on the progress.
Thank you.