I'd now like to turn the floor over to today's host, Amit Kumar, CEO at Anixa Biosciences, Inc. Sir, the floor is yours.
Thank you very much, and I'd like to thank everyone for attending this call. I'm looking forward to telling everyone about all of the exciting things that are happening at Anixa today, including extending and saving the lives of patients in our clinical trials, as well as some of the things that are upcoming as we go forward. Let me begin by showing you our forward-looking statement disclaimer, and then, before I start talking about our program, let me provide a little bit of an overview and snapshot of the company. This company, while it was founded in the 1980s, was originally an electronics company, which failed over the years, and in 2017, I and a new management team and new board came on board and repositioned the company as a biotech company.
Since that time, we have developed a very robust pipeline of products, some of which I'll tell you about today. Two of them are in clinical trials, producing extremely positive clinical results. We've established some key partnerships with not only some of the top academic hospitals in the United States, but also funding agencies that are funding, in a non-dilutive manner, many of our programs. We're addressing very large markets, not rare diseases, and we've maintained a very strong balance sheet with over three years of cash on the balance sheet, no debt, and a very clean capital table. We have no warrants outstanding, no overhang, or preferred stock outstanding. In addition, since 2017, when I and the new management team took over, we've had consistently strong insider buying, including myself, our board of directors, and senior management in the company.
Our business model is designed to take advantage of existing infrastructure at partner organizations so that we don't create or build very large laboratories, which tend to burn a lot of cost. So, as a result of that business model, since 2017, we have burned, on average, about $5-$6 million of cash per year. And that includes the cost of being a public company, all of our clinical studies, and other associated costs, which is relatively, this number is relatively small compared to most biotech companies. And one of the comments one always gets with biotechnology companies is that the programs take a long time to mature and then get to commercialization, especially with clinical trials. However, in our case, we are interested in monetizing these programs sooner rather than later by establishing strategic relationships with pharma companies that can help us in commercialization.
That enables us to create shareholder value early for our shareholders, and it enables a large organization to bring the product to the market much faster than we would as a small company. So it's a win for shareholders and a win for patients as well. Now, this is just a snapshot of our balance sheet. $21 million does not sound like a lot of money, but when you're burning such a small amount, that is over three years of cash. Again, as I noted earlier, we have no debt. We have 32 million shares outstanding, all common shares, no warrants, and no preferred stock. This is a snapshot of our clinical programs or programs in development. The two in the clinic are a therapy, which is therapy addressing terminally ill ovarian cancer patients. These are patients that have failed all other approved therapies and have no other options.
In addition, we have a breast cancer vaccine, which is designed to prevent the onset of breast cancer, and I'll talk in a little bit more detail about these two programs, but in addition, in the preclinical stage, we have a vaccine for ovarian cancer, and we have vaccines that we're developing for lung, colon, and prostate cancer. Let me begin by talking about our ovarian cancer therapy. It is a therapy known as CAR-T therapy, chimeric antigen receptor T-cell therapy. It's a complex approach which utilizes a patient's own immune cells. We remove T-cells from individual patients that are suffering from cancer. We genetically engineer them outside the body in a laboratory and then re-infuse them back into the patient with the intent that those new T-cells are better able to destroy the cancer than the original T-cells.
This is a technology that, while complex, created a tremendous amount of excitement in the medical arena as well as the investment arena because several years ago, it was able to have tremendous impact on terminally ill leukemia and lymphoma patients. In many cases, the therapy was able to completely eliminate the cancer from the patient's blood. Now, unfortunately, even though there was tremendous impact on these certain leukemia and lymphoma patients, the technology has not been successful in other indications, including solid tumors, which are much bigger markets and a much bigger impact in the cancer world. However, we've developed a CAR-T technology that has certain nuances that we think will enable it to be the first chimeric antigen receptor T-cell technology that will be successful in solid tumors.
We are already starting to see results in our Phase 1 trial, which indicate that our technology seems to be having some efficacy. Now, this is a busy slide, but it describes our CAR-T technology. The left-hand side describes how our CAR-T technology works. We are targeting a protein called follicle-stimulating hormone receptor that only exists on ovarian cells. It doesn't exist on any other organ system in the body in women. In men, it only exists in the testes, in women, on the ovaries. Now, it's an endocrine receptor, so there's a cognate ligand called the follicle-stimulating hormone, which binds to that receptor and has, over millions of years of evolution, become a good binding pair with the follicle-stimulating hormone receptor.
So when we engineer our T-cells after we've removed them from a patient's body, we add the follicle-stimulating hormone to the surface of that T-cell, and the follicle-stimulating hormone acts as a homing missile that drives that T-cell to the ovarian cell. Once the follicle-stimulating hormone drives the T-cell to the ovarian cell and that binding occurs, the T-cell is able to destroy that ovarian cell, not only cancer cells, but also healthy ovarian cells. So that's one unique aspect of our technology because we're targeting a receptor that only exists on the cancer that, or I should say, only exists on the organ of interest, which is the ovary.
A second attribute of our technology takes advantage of an observation that was made recently where it turns out that even though the follicle-stimulating hormone receptor does not exist on any organ system except the ovaries and testes in women and men, respectively, if you look on the left-hand side of this slide, you'll see that it doesn't exist on any other organ system. However, recent data, recent studies have shown that when a tumor arises in one of these organ systems, including the ovaries, but also many of these other organs, the vasculature in the tumor carries follicle-stimulating hormone receptor. We're not sure exactly why that is, but it's there. And what does that mean for our CAR-T therapy? This cartoon depicts what we believe is happening in our situation. Take a look at the cartoon on the left-hand side.
When tumors start getting larger, solid tumors, they induce angiogenesis, the process of creating blood vessels. And as a result, the blood vessels enable the tumor to bring in oxygen as well as other nutrients and remove CO2 as well as waste. Now, the study that I noted earlier noted that the blood vessels within the tumor, the vasculature within the tumor, express follicle-stimulating hormone receptor. So what that means for our therapy is that our T-cells, our engineered T-cells, will attack the tumor cells directly, but they will also destroy and disrupt the vasculature. So there's going to be a dual mechanism of action that occurs, enabling the destruction of this tumor. And the third attribute of our technology that is very unique relative to other CAR-Ts addressing solid tumors is that we are delivering our T-cells directly into the peritoneum.
The peritoneum is a sac that exists in the abdomen, depicted by the yellow membrane on the right-hand side. Within this peritoneum exist a number of different organs, including the ovaries, and when ovarian cancer spreads, becomes metastatic, it tends to remain in the peritoneum, on the peritoneal sac itself, as well as other organs in the peritoneum. Eventually, at some stage, at a very, very late stage, it will escape the peritoneum, but in general, most metastatic ovarian cancer patients maintain their lesions within the peritoneum. Now, as we deliver our T-cells into the peritoneum, the proximity of those T-cells, the T-cells are near the lesion that they're attacking, and because they are not going into the system, into the bloodstream, the side effects that T-cell therapy tends to create are lessened.
Hence, we feel that we will be able to go to a much higher concentration of T-cells delivered in this manner. Typically, when T-cells are delivered intravenously, they go throughout the body immediately, including the brain as well as the cardiac system and other areas, and create side effects that are often intolerable and sometimes have killed patients. In our case, we are putting the T-cells into the peritoneum, into this somewhat enclosed space. As a result, the T-cells never get into the bloodstream and are not creating these intolerable side effects. Now, as I indicated earlier, the initial stages of the trial are already resulting in some very positive results. This is a busy slide here, but the bottom line is that we are beginning the trial. We've only treated seven patients so far, the seventh having been treated just recently.
We have very little data on that patient. Trials like this always begin with low levels of dosage until safety is verified, and then the dosage increases gradually. In the first cohort, we were delivering 10,000 cells per, excuse me, 100,000 cells per patient per kilogram. Even in that low-dosage cohort, which we believe to be a subtherapeutic dose, we are starting to see results. In fact, one of those patients who was essentially terminal is now alive for 20 months and is doing really well. In fact, for that individual patient, we went back to the FDA asking permission to give her a second dose, which we gave to her about a little over a month ago.
She is doing very well, and we hope that her overall survival will be quite a bit higher than 20 months, which is tremendously higher than what would be expected. Other patients are exhibiting some similar types of results as well. And as we increase the dosage for future patients, we anticipate that we'll start seeing even better results. And so I encourage everyone to stay tuned. This is our dosage schedule, and we are, as I noted, at the third dosage cohort. We've treated six patients: three in dosage cohort one, three in dosage cohort two, and now we've begun treatment of patients in dosage cohort three with the first patient last month, the second patient this month, and the third patient will be dosed next month. Now, let me switch subjects to talk about our other program in the clinic, which is a breast cancer vaccine.
This is a vaccine that's designed to prevent breast cancer. It's designed to be given to women and some men who are worried about breast cancer in the future, and the goal is to induce their immune systems to be prepared for the production of breast cancer cells, and if the immune system has been properly trained, the cancer cells will be destroyed before they have a chance to become a tumor. The molecular mechanism of this approach is something that has never been tried before, and it involves targeting a protein called alpha-lactalbumin, which is depicted on the left-hand side of this slide. Alpha-lactalbumin is a lactation protein that enables women to lactate after giving birth, but it disappears after women are no longer giving birth, and in most women, it never reappears again.
However, in women that develop breast cancer, specifically triple-negative breast cancer, which is our initial focus, but also other types of breast cancer, the breast cancer cells are producing this protein, and if we have vaccinated these women before these breast cancer cells arise and trained their immune systems to destroy those cells, the immune system will destroy those cells at the earliest stages of tumorigenesis, which is two cells, four cells, or eight cells stage, and hence, these cells will never be able to form a tumor. Initial proof-of-concept study was done showing how powerful this vaccine was in mice. In this case, a healthy female mouse was vaccinated and then enabled to mate and have litters, and successive to her giving birth, the litter was perfectly normal.
The pups were perfectly normal, but the mother was not able to produce milk because all her cells that were enabling lactation were producing that alpha-lactalbumin protein, and her immune system had been trained to destroy those cells. So those cells were not able to enable production of milk, and that was not a cancer model, but it is a proof-of-concept demonstrating the power of this vaccine. Successively, we used cancer models to evaluate how powerful this vaccine was in preventing cancer. On the right-hand side is data from a genetically engineered mouse model that will spontaneously develop breast cancer. Half these mice were given the vaccine. The other half were given a placebo, and all of the mice given the vaccine remained cancer-free, while the mice that were given the placebo all developed cancer.
Now we're engaged in human clinical trials with three cohorts, which I won't describe in detail, but this information is available in this slide and also on our website if anyone wants to look at it in more detail. The key is that we are trying to see if we can induce an immune response in women who are concerned about breast cancer and also verify that the vaccine is safe. Some of the most recent data was presented last month at the Society for Immunotherapy of Cancer Conference, and this is a very busy slide, but the key point here is that we were able to demonstrate safety of this vaccine. The only side effect that recipients exhibited was irritation at the sites of injection, and we were able to induce immune responses in a large percentage of these women.
Over 70% of them had very robust immune responses, while the rest had more modest immune responses. Now, the success of this trial has enabled us to begin the process of planning for a Phase 2 trial, which we hope to begin next year. Now, this will be in a therapeutic approach where we are targeting the use of this vaccine along with standard of care to see if we can reduce the tumor burden of women who have recently been diagnosed with breast cancer and are heading to surgery. On this slide also indicates the size of the market.
We believe this vaccine can be used in a therapeutic approach for women battling cancer at the time, as well as in a prophylactic approach, which is for virtually all women in the world, where we can vaccinate them before they have the cancer and prevent them from contracting cancer. I want to just very quickly go over a couple of other programs. We have an ovarian cancer vaccine, a very similar type of vaccine to the breast cancer vaccine. However, it identifies a different protein that's found on the ovaries and could be a target for vaccination. This program is being funded by the National Cancer Institute, and it's still at the preclinical stage. I should also note that the other vaccine, the breast cancer vaccine that I talked about earlier that is demonstrating such good human results is being funded by the U.S. Department of Defense.
We've also begun some initial programs for other types of cancers, most notably lung, prostate, and colon. That's all at the early stages of development. We have a lot of upcoming milestones, clinical milestones for both the CAR-T therapy as well as the cancer vaccines. We anticipate, in addition to these clinical milestones, a number of other milestones that we feel will be catalytic for our company. I encourage everyone to stay tuned. Let me just finish with this last slide, which is just, again, an overall summary of the company and what we've discussed today. Nataliya, let me turn it over to you to take questions.
Sure. Absolutely. Thanks, Amit. Our first question is, what specific data points from the ongoing ovarian cancer CAR-T trial should investors watch for in the first half of 2025 in order to assess the therapy's progress?
We are presenting information on each of these patients on a case-by-case basis. And so we will be talking about, of course, the enrollment of patients as well as indications that they are exhibiting tumor necrosis or death of their tumor cells. In patients that we've treated so far, including that very first patient in the very first cohort at the subtherapeutic level, we have found by imaging necrosis in her tumor as well as by biopsy significant necrosis in her tumor cells. So we're definitely knocking out those tumor cells. In that case, we didn't knock out the whole tumor, but a significant portion of it. And going forward, after we've given her the second dose, we're hoping we can completely knock it out and effectively cure her or at least knock out a bigger chunk of her tumor.
And so please look for additional enrollment and additional indications that we are having an impact on patients' lives.
Great. Thank you. Next question is, beyond clinical development, are there opportunities for Anixa to generate non-dilutive revenue through licensing agreements or early-stage partnerships with larger biotech firms?
Absolutely. That's a very good question. And it goes back to the discussion of our strategy earlier where we talked about establishing those relationships with pharmaceutical companies that will come with license fees as well as milestone fees, and then eventually, upon commercialization, royalties and revenue shares. So absolutely, we want to get our programs to a point where a pharmaceutical partnership enables us to monetize the program for our shareholders and enables faster and much more facile commercialization, enabling more patients to get the therapies sooner rather than through the infrastructure that we would have to build to do that. Large pharma companies already have that infrastructure and the capability to market, sell, and distribute these products.
Thank you. I have our next question here. Beyond ovarian cancer, do you see potential for your CAR-T technology to be applied to other solid tumors? And are there preclinical efforts underway in this direction?
The answer to the first question is yes. We do see our CAR-T technology potentially addressing numerous other types of tumors, and we have done some very, very early preclinical studies, but our plan is to continue working on the ovarian cancer trial to a point where we can demonstrate its success in a number of patients and then move over to evaluating other types of tumors, but yes, the answer is that platform, we believe, could be used for many, many tumor types.
Thank you so much. Our next question. In terms of the burn, do you expect it to increase from $5 million-$6 million a year and will it move higher?
We do anticipate it'll increase, but very modestly. For example, at the beginning in 2017, we were roughly at around $5 million a year. Then we went to $6 million a year. This year, we'll probably do about $7 million. And so it'll increase modestly, but certainly very, very small increases relative to the burn that typical biotech companies are exhibiting.
Thank you. And our last question here. Will we continue to see insider buying?
It's hard to say. It's inappropriate for me to say that, but we are all very bullish on this company, and we have limited windows during which we can trade. But I wouldn't be surprised if you saw more insider buying.
Thank you so much, Amit. That is all we have for questions at this time. I will give it over to you for any closing remarks.
Okay. Thank you, Nataliya. And thanks, everyone, for listening to the story. I'm available if anyone wants to talk about more details, especially on the scientific side. And I encourage you all to stay tuned because we have a lot of news coming out in the upcoming weeks and months. Thank you.
That concludes the Anixa Biosciences, Inc. presentation. You may now disconnect. Please consult the conference agenda for the next presenting company.