Anixa Biosciences, Inc. Aktie

Hello, everybody. I'm Robert Sassoon. I cover health care at Water Tower Research. Today, I have the pleasure of being joined in this fireside chat by Anixa Biosciences' Chairman and CEO, Dr. Amit Kumar.

Anixa is a clinical stage biotech company, which develops a novel type of CAR-T cell therapy for the treatment of termly ill ovarian cancer patients and separately, a vaccine for the treatment and prevention of breast cancer. Anixa has also additional predevelopment candidates. Anixa is listed on the NASDAQ under the ticker at ANIX.

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. So without further ado, let me welcome Dr. Amit Kumar. Thank you for taking time out of your busy schedule to be with us today for this fireside chat.

My pleasure to do so, and thank you very much for having me, Robert.

So let me start by asking you to give us an overview of Anixa Biosciences' current clinical programs and explain how your therapeutic models and their mechanisms of action are fundamentally differentiated from the current standard of care or competing therapies in the clinical pipeline targeting the all 2 prevalent indications that you are prioritizing.

Well, Anixa is a reinvention of a previous electronics company that was founded in the 1980s. In 2017, a little over 7 years ago, I took over as CEO of the company and reinvented it as a biotech. Since that time, we've developed a number of therapeutic programs, many of which have moved forward, 2 of which are now in the clinic and producing exceptional results.

One of them is that CAR-T that you mentioned that's targeting -- that's -- the goal is to treat resistant and recurrent ovarian cancer patients. These are patients who have no other options, and they've been told to go home and get their affairs in order, and that's when we get them for a clinical trial.

The second program that's in the clinic just completed its Phase I studies, and it's a breast cancer vaccine. This is designed to be a vaccine that can help treat breast cancer for women who are battling breast cancer at the time, but also to prophylactically prevent recurrence of breast cancer and breast cancer survivors and ultimately prevent, what we call primary prevention, prevent breast cancer in women who have never had breast cancer.

We would love to be able to give this vaccine to every woman in the world who's concerned about getting breast cancer and hopefully prevent that patient from ever getting breast cancer or at least the majority, if not all, of those patients from ever getting breast cancer. So very exciting times. We just completed the Phase I and are looking forward to moving that program forward.

Great. Thank you. Can you elaborate further on your strategic partnerships with Cleveland Clinic and Moffitt Cancer Center and the Wistar Institute, how they support and shape your clinical development efforts and the primary value drivers they bring towards advancing your goals?

Yes. One of the key attributes of our business and the way we built it is to try and keep our cash burn as low as possible. As you know, most biotech companies, especially those that are doing clinical trials, especially clinical trials in cell therapy like our CAR-T program, tend to burn massive amounts of cash. But since 2017, when I took over, we've only been burning about $5 million to $7 million in cash on an annual basis. And there are many, many benefits of that for us as a company and shareholders because we don't need to go and raise massive amounts of cash and dilute our shareholders like many other companies have.

But the partnerships with Cleveland Clinic and the Moffitt Cancer Center as well as the Wistar Institute have helped us keep our cash burn low because the clinical trials for breast cancer vaccine are being run at the Cleveland Clinic. And that vaccine trial, by the way, has been fully funded by the U.S. Department of Defense.

And the clinical trial for the CAR-T program is being run at the Moffitt Cancer Center in a very, very frugal manner, meaning we are taking advantage of Moffitt's investment in their cell therapy facility. So they manufacture the therapy for each individual patient, customized for each individual patient on a turnkey basis right on their campus and then they administer the therapy to the patient in their hospital on the campus.

The Wistar Institute has been helpful because -- they are a clinical or a preclinical research organization that developed the CAR-T therapy. We licensed it from Wistar. And because Wistar does not run clinical trials, we moved the clinical trial to the Moffitt Cancer Institute.

So let's turn to your breast cancer vaccine program, which is more advanced than your ovarian cancer program. You have a red letter day approaching on December 11, which is exactly a month from now. When Anixa will be presenting your final data from the recently completed Phase I trial? So the data will be presented at the 2025 San Antonio Breast Cancer Symposium, which is one of the most significant and influential global scientific conferences dedicated to breast cancer. So you have already reached some preliminary data from the Phase I trial. So can you share with us the most significant findings from that release?

Yes. So we're going to be releasing more comprehensive data on December 11 at that conference. And frankly, the data is, so far, is spectacular and what we've released and will be -- continue to be as impressive as we go forward. The vaccine has shown the primary -- one of the primary goals was to show that the vaccine was safe, and we have demonstrated that. The only side effect that patients have seen are injection site irritations. They've not had any fevers or myalgias, headaches, any other types of issues.

Secondly, we've seen an immune response in the majority of patients. What that means is that the vaccine is inducing the patient's immune system, primarily their white blood cells to form certain white blood cells like T cells and B cells to target that protein that is the target of the vaccine. And that protein, which is called alpha-lactalbumin is a protein that only exists in the breast of women at 2 times in their lives, one time when they're lactating to feed an infant and the other time when they have breast cancer.

And so our goal here is to treat women with the vaccine. And when cancer arises in the 1 out of 8 women in which breast cancer arises, we're hoping that the immune system is properly trained to destroy those cancer cells. And those cancer cells, as you know, cancer arises as 1 or 2 bad cells and continues to reproduce in an uninhibited manner becomes 4, 8, 16, 32 and eventually becomes a multibillion or trillion cell mass that you can then see as a spot in a mammogram. We want the vaccine to induce the immune system to be ready. So when those 2 cells, 4 cells, 8 cells arise, the immune system will destroy them before they become a much larger mass of cells that is much harder to, for the body and for therapeutics, to deal with.

And so we're very excited. We're seeing these strong immune responses in about 3/4 of the women. The remaining women, while the responses may not be as strong, they're more modest, tend to still have immune responses. And we think even a modest immune response is good enough to destroy those early handful of cells, the 2 cells, 4 cells and 8 cells. So we're looking forward to a Phase II study, which we hope to begin in a year. And that Phase II study will demonstrate or will tell us how efficacious this vaccine is.

Efficacy is typically not what you get in a Phase I where you're looking for indicators of efficacy, and we have strong indicators of efficacy. In a Phase II, you typically have what we commonly called a placebo group. And in that case, half the women will get the vaccine, the other half will get a placebo or basically a control to see if the women in the vaccine group respond differently than the women in the placebo group. And that will tell us how effective this vaccine is going to be.

Right. So regarding the data presentation that is upcoming on December 11, what additional data is expected to be released? And what are the key clinical benchmarks that investors should use to gauge the success of the Phase I study?

Yes. We've released data on 26 patients so far. This comprehensive data will be on 35 patients. And we've not released much data on 2 groups of patients. They're small groups, but there are patients who are -- the second group that we've -- well, let me begin with the first group. The first group were women who have gone through their triple-negative breast cancer journey. Triple-negative breast cancer is the most lethal form of breast cancer. And these women who've gone through their journey, which includes surgery, chemo, radiation, et cetera. And now they're worried about a recurrence.

And so we've given these women the vaccine, as you said, as I noted before, to verify safety and look at immune response, and those have been very positive. A second group is a group of women who've never had breast cancer, but they carry genes, commonly known as BRCA 1, 2 and other genes that place them at high risk for getting breast cancer. And these women have actually chosen like many celebrities have done to have their breast surgically removed. They've had bilateral mastectomies even though they're perfectly healthy at the time because they know due to the mutations they carry that they will most likely get triple-negative breast cancer.

And so in these women, we have given them the vaccine before their mastectomy, and now we will get a chance to look at their breast tissue, purportedly healthy breast tissue to evaluate whether the vaccine has induced their immune cells to surveil the breast, which is what we saw in animal studies. And then the third group is a group of women who've had breast cancer, but after their surgeries and chemo and other treatments, they still have what's known as residual disease, meaning the medical process, the treatment process was not able to completely cure them.

And so almost all of these women will have a recurrence. And so we're giving the vaccine to these women alongside the current standard of care therapy, which is primarily a therapy known as KEYTRUDA, which is a checkpoint inhibitor. And we want to see -- the main thing we want to verify is that the combination of the vaccine and the checkpoint inhibitor does not create untoward side effects for these women. And if that's the case, then we feel that the vaccine will have efficacy and will only aid in the treatment of these women who still have residual disease.

Great. So looking further that, you already mentioned that your plan is to move the vaccine program to Phase II. What are the next steps for this vaccine program post December 11 presentation to get to that point?

Well, there are a lot of small steps and some major steps as well. We're engaged in various of the small steps, which is transferring -- which includes the steps needed to transfer the IND, the investigational new drug application from Cleveland Clinic to Anixa because the initial IND was filed by the Cleveland Clinic for what's known as an investigator-initiated trial. And now we are moving it into Anixa's arena to turn it into a sponsored clinical trial. So that's one major step.

And then we have to identify additional sites. Cleveland Clinic will certainly be one site. The Phase I was a single site trial. Phase II will be multiple sites. It will have many, many more patients in the trial. And so we will be negotiating with many of these sites and putting together the agreements and training these sites to be able to administer the vaccine. We also have to manufacture larger quantities of the vaccine much more so than we did for Phase I. And we -- and there are a whole bunch of other logistical things. But they're all standard things that people who are developed -- running clinical trials do.

So it's just blocking and tackling, and it's just a matter of getting all of that done, which takes time. Plus we will have interactions with the FDA throughout that period and then eventually get the trial started. And we expect this trial to be what's known as an open-label trial so that we'll be able to see the data as it arises. And so we don't expect to have to wait until the completion of the trial to see how things are going. We expect interim results. And to the extent we're able to, we will announce that information to the market.

So turning to your balance sheet. You already told us that you have managed to maintain a very low annual cash burn rate of around $5 million to $7 million, and you've given us an idea that the partnerships have been a major contributing factor to maintaining a low level of cash burn. But how sustainable is this model as your clinical programs advance and become more expensive to run?

In the near term, for the next 2 or 3 years, it is sustainable. We have capital right now for the next 2.5 plus or minus years. But to complete the breast cancer clinical trial, for example, we need a couple of years more capital. And we hope that we'll be able to get that capital in 1 of 3 ways. One is we have applied for additional grant funding from the U.S. government. We'll see where that all goes. We have also had conversations with pharma companies that could potentially underwrite portions or all of the clinical trial studies.

And then if we have to, I anticipate that we will go to Wall Street and raise capital. But there's nothing that is impending. We've got a strong balance sheet. We have no debt, and we anticipate being able to operate for quite some time. And as you and many others who follow the biotech sector and follow markets may have noticed in the last 2 or 3 months, the biotech sector has had tailwinds behind it.

Last few years, the biotech sector has been decimated. But now it's starting to look like things are heading in the right direction. And we believe companies like ours that have very strong capital structures, very good capital structures, good incredible financial discipline and excellent exceptional clinical trial results are the companies that are going to benefit the most from an interest back in biotech.

Right. So another approach that stands out from many clinical stage biotechs is Anixa's insistence on keeping a clean non-dilutive balance sheet structure. And that's represented by the avoidance of warrants, preferred stock and other overhangs that many pre-revenue biotech companies rely on to incentivize new investment. However, your strategy arguably becomes a little bit more challenging, the more successful your programs are. So what measures are you putting in place to ensure that future funding needs required for larger, more advanced stage trials as Anixa's programs progress will maintain this clean capital structure and minimize shareholder dilution.

Well, obviously, there are no guarantees, but we have been incredibly disciplined since 2017 when I took over and have been able to avoid creating a capital structure with lots of warrants and other overhangs. A lot of -- and I don't want to highlight the retail investors, but a lot of retail investors really don't understand what that means. They look at programs and data and things like that, but they don't really understand that if a company has issued lots of warrants, sometimes companies have issued more warrants than the total outstanding stock of the company.

If a company has issued 100%, 200%, 300% warrant coverage in their financings, then those warrants become an overhang. So regardless of how good the data and the programs are, the warrants have to be overcome before shareholders who buy common stock can get any appreciation. And so we understand that. And so we -- institutional investors understand that as well.

And so we have kept a very clean capital structure. There are no warrants outstanding, so no overhangs. And that places us in a really good situation for continued share appreciation. And as we continue to develop and present good clinical data, I think companies like ours will be recognized much more quickly than other companies that have these overhangs.

Well, thank you for all that information. And unfortunately, we are running out of time. So we'll leave it there. Thank you, Amit, for spending time with us and giving us a better understanding of Anixa and where it is headed. And 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. So once again, I'd like to thank Dr. Kumar for his participation and everyone for joining us and everyone for joining us in this fireside chat. Have a great day.

with Bristol Capital. You should see the presentation in the webcast. If you'd like to receive a copy, simply e-mail me, [email protected]. We'll break for questions at the end of the formal presentation. As a reminder, this is not an earnings call, but rather a general introduction and overview presentation. We're only going to take questions through the web portal and encourage those questions to help you better understand the business. [Operator Instructions].

I'm not going to read the forward-looking statements, but I do state that they apply and I reference them on Page 2 of this Powerpoint. With that said, once again, thank you for joining us. Remember, this is fairly informal, and we do encourage questions to help you better understand the business and its growth path.

And now I'll turn the call over to Amit to start his part of the discussion and presentation.

Thanks, Glen. Thanks for the introduction. And thank you, everyone, for attending this call, both existing shareholders for whom I hope to give you the latest update and for new shareholders for whom I hope to introduce you to the company and explain why we are so excited about what we are doing as a company. As Glen noted -- excuse me, a second. Internal, okay, there we go.

Forward-looking statements apply. Before I get into discussions in detail about the programs that were going in -- that we're developing. I want to take a few minutes, a couple of minutes to really talk about the history of the company, the strategy of the company, how we think about the company and some of the financial aspects of the company and how we built this company because a key attribute of what we are trying to do is create a lot of value, not only through the programs, but also how we've structured our company and the strategy that we're executing.

So as many of you know, this company was reinvented in 2017 when I took over as CEO of the company and current management and the Board got involved. In 2017, late 2017, we turned this company into a biotechnology company. And since that time, we have built a very robust pipeline of products and 2 of those products are in clinical trials right now, which I'll talk about in a little bit more detail in a moment. And both products are demonstrating very, very positive results in our clinical trials. But it's also important to understand the strategy behind how we built the company. We have always tried to establish strong partnerships with highly credible organizations to have scientists and infrastructure that are world-class.

So we have key partnerships with some of our research partners such as the Cleveland Clinic, which is one of the top hospitals perhaps, the top hospital system in the world. The Moffitt Cancer Center, which is one of the top cancer -- top 10 cancer centers in the United States out of the 3,500 that provide cancer care. In addition, a number of our programs are funded by top organizations like the U.S. Department of Defense and the National Cancer Institute, providing us non-dilutive capital to move our programs forward, enabling us to conserve our burn. All of our programs are addressing very large markets. We are not like many biotech organizations that are focused on rare diseases. We are addressing the markets of breast cancer, ovarian cancer and eventually lung, colon and prostate cancer.

Now on the corporate and financial front, we have maintained a very strong balance sheet. Unlike many companies in the biotech sector, we are -- we have over 2 years of cash on the balance sheet that will enable us to get to many clinical milestones, catalytic milestones as we go forward. In addition, we've maintained a very clean capital table. What that means is that we have been able to maintain a capital structure where all we have is common stock. We have 32 million shares of common stock, we don't have any warrants, any preferred stock, nothing out there with ratchets or resets that many other companies have had to accept from investors because of challenging market environment for biotechnology. And so we have, as I said, clean capital table, 32 million and change of common stock only. And we anticipate continuing that clean capital structure going forward.

And I think that's very important for everyone to understand because as we create value and as that value is recognized by the investor community, the value will accrue to common shareholders as opposed to warrant holders and others that hold derivatives of our stock. Another characteristic of our company is the strong and consistent insider buying since 2017. I myself have bought over $2.5 million worth of stock on the open market because I'm incredibly bullish about the company. Many of our -- all of our insiders, I should say, including our Board, have all been buyers of stock in our company. And I anticipate that, that will continue as we go forward.

We have limited windows in which we can buy. In fact, just a couple of weeks ago, I bought some stock but when those windows open up, we typically see buying. And then the most important thing about our corporate structure and strategy is that we have a very capital-efficient business model. And what that means is that, that enables us to run this company with very low cash burn that allows us to not have to go to the markets very frequently to raise money. In fact, our last financing deal transaction that we did was in 2021 over 4 years ago. And as I noted earlier, we have 2 years of cash on the balance sheet, $16 million, which is not a lot in the most context, but considering that we are only burning $5 million to $6 million a year and last year -- last fiscal year, we burned a total of $7 million, and we anticipate that, that burn level will remain consistent going forward, at least for the next fiscal year and moving forward. It may increase slightly, but only very slightly.

And the reason is because we have developed a business plan where we leverage the existing infrastructure of our partners, our partner organizations, which have world-class infrastructure and world-class scientists who work with us on our R&D programs. That allows us to maintain a very low overhead and low cash burn. And it also enables us to strategically work on different types of projects, enabling more portfolio -- more portfolio diversification and having multiple shots on goal, so to speak.

And then the other characteristic of our business plan, which we are beginning to execute now is to monetize our programs early. As many of you know, biotechnology products take a fair amount of time to develop and get to market. They require a significant amount of R&D and as well as clinical trial work that takes time. And ultimately, we would like to get our programs to a point where they're providing enough clinical data and they're derisked enough that large pharmaceutical companies would be willing to partner with us to eventually commercialize these programs. It is not our intent to build expensive manufacturing infrastructure as well as sales, marketing, distribution infrastructure, it takes a lot of time and a lot of money to build when organizations like big pharma companies already have that infrastructure in place, and they're looking for additional products to pump through that infrastructure, which is a sunk cost for them.

So by out-licensing or partnering with pharma companies, we will be able to not only create a win-win situation where we can commercialize products sooner and more efficiently, but also enables us to monetize the assets that we are developing for our shareholders. So our shareholders will get a benefit much earlier than when the products appear on the market or become commercialized. So that's a little bit of background.

And I also want to highlight a couple of key sort of intangible factors about our company. We have built this company very carefully to make sure that we are seen as one of the premier companies in the biotech sector even though we are a small development stage by a technology company, unlike many companies in that category, we are doing all of our clinical trials at the top hospitals in the United States. We're not doing clinical trials in places like Third World Countries or China or places like that. Our data is coming out of the top places in the United States. We also have associated with us advisers, business advisers, Board members as well as clinical advisers that are some of the most credible and highly experienced people in the world, scientists that have been involved in some of the biggest drug development programs in the world in cancer as well as vaccines as well as some people that are -- some of the top-notch business advisers in the world.

And I encourage you, if you are so inclined to go to our website, I don't have the time to go over the backgrounds of these people here, but go to our website and please take a look at the list of advisers and you'll be quite impressed.

So let's now talk about the programs that we're developing, incredibly exciting programs that are potentially game changing for a number of different types of cancer. And cancers in general, cancer in general as a broad category. The 2 programs that I'm going to speak about today in a little bit of detail are the CAR-T therapeutic for ovarian cancer, which is targeting terminally ill ovarian cancer patients. These are patients that have exhausted all other possibilities on the market today, and they have been effectively told by their physicians to go home and get their affairs in order. That's when we get them -- excuse me, that's when we get them and then we treat them with our therapy. And I'll explain how that therapy works and the results that we're getting in our clinical trial. This therapy is -- has been licensed from the Wistar Institute and is in clinical trials at the Moffitt Cancer Center in Tampa, Florida.

The second program I'll talk about is a breast cancer vaccine that is designed to not only treat women with breast cancer, but also prevent breast cancer in women who are breast cancer survivors to sort of prevent recurrence as well as to prevent breast cancer in women who've never had breast cancer. The market opportunity for this is massive. And potentially, this is a game-changing type of vaccine that could enable a new type of -- a new paradigm in thinking about cancer, not only breast cancer but other types of cancer as well. This program is in clinical trials with our partner at the Cleveland Clinic, and this program is being funded by the U.S. Department of Defense.

The other programs on this slide are also in our pipeline, and they include an ovarian cancer vaccine that is being funded by the National Cancer Institute as well as recently initiated programs addressing lung, prostate and colon cancer. I won't be talking about those programs in much detail at all today. But if anyone is interested, please feel free to reach out to me, and I'll be happy to talk about them.

So let me begin with the Ovarian Cancer Therapy. This technology is called CAR-T Technology, CAR stands for Chimeric Antigen Receptor T cell technology. This is a new type of immunotherapy that has been -- that has developed over the last decade, 15 years or so. And it created a huge amount of excitement amongst the medical community as well as the investment community a few years ago when it was shown to be incredibly successful for certain types of leukemias and lymphomas.

So the way the process works is one takes the blood of individual cancer patients, isolates white blood cells, specifically T cells from that patient and takes those T cells into a laboratory, genetically engineers them and then put them back into the patient with the intent that those T cells that have been genetically engineered outside the lab -- I'm sorry, outside the body in a laboratory, those T cells become much better cancer fighters than the native T cells that exist in the patient's body. And as I noted, this type of technology created a huge amount of excitement for certain leukemia lymphoma patients. And these were terminally ill leukemia lymphoma patients. Patients who, again, as I noted earlier, had been told to go home and get their affairs in order yet CAR-T technology was able to not only treat a large number of them, but in a significant number of them the treatment was curative, meaning after the treatment, the patients exhibited no indication of disease.

So that type of treatment doesn't happen for metastatic late-stage terminally ill cancer patients. So it created a huge amount of excitement. The unfortunate thing however, since those early successes in the leukemia and lymphoma situations, there have been no successes in solid tumors, which is obviously a much bigger market and would have a greater impact in cancer. So there are a number of reasons why or a number of theories why CAR-T technology has not worked in solid tumors. And our CAR-T approach identified some of those and based on the learnings that we have gained from many of the clinical trials that have failed, we have designed a CAR-T platform, which we think will be potentially the very first successful CAR-T platform against solid tumors. So incredibly exciting opportunity here. And we are already starting to show incredibly promising data, even though it's very early stage in our T cell clinical trial.

So I'm going to go through the 3 unique attributes of our CAR-T technology that we think are going to enable it to be very successful for ovarian cancer. And stay with me, if you can, I'm going to get a little bit scientific, but not -- I'll stay at a relatively high level, but I want to really teach our shareholders why we think this is incredibly exciting and why we think we're already starting to see positive results. This is a complex slide here, but I want to highlight a couple of key points. The right-hand side is a cartoon that describes what the CAR-Ts that were successful in the leukemia-lymphoma patients look like. In that case, the -- in the B-cell leukemia and lymphoma patients, these are a certain type of blood cancer, where the B-cells, one component of the immune system become cancerous. In this case, one wants to be able to kill all of those B-cells. Ideally, just the B-cells that are cancerous, but if you kill all of the B-cells, that's still okay because you've eliminated the cancer and the patient will live.

So in this case, the scientists had identified a protein that exists on the B-cell. It's called CD-19 depicted by that black arrow on the right-hand side. This is a very unique protein because it only exists on B-cells, and it does not -- it's not found on any other cell in the human body, no other organ system, no other blood cells. And so the thought here was that if we could take a white blood cell which potentially can kill B-cells, the T cell and engineer the T cell to have a homing missile on the surface that would enable it to go and find that B-cell, then that T cell would go find the B-cell, attach to it and kill it. And that's exactly what happened.

The genetically engineered T cells were engineered with an antibody fragment, which is depicted by that orange crown on the right-hand side that would then become a homing missile that would direct that cell to the cancer cell, bind to the cancer cell and then kill the cancer cells. So that worked incredibly well for that particular situation. Unfortunately, for solid tumors, until now, there has never been a target like that CD-19 protein that's been found on a solid tumor that would allow the homing missile to target just that cancer cell and not other cells that are healthy cells in the patient's body.

In our case, we have identified such a target. We've identified a compound or a protein called Follicle Stimulating Hormone Receptor, FSHR that is found on the ovaries in women and on the testis in men, nowhere else in a human body. And because it's an endocrine receptor part of the endocrine system, it has a cognate ligand, which is called follicle stimulating hormone that over millions of years of evolution has become a really good binding protein for the follicle stimulating hormone factor. As a result, if we engineer our T cells with the follicle stimulating hormone, it becomes a really good homing missile to fine the follicle stimulating hormone receptor and destroy those cells. So that's one characteristic that's unique about our CAR-T therapy that has not been found on any other CAR-T therapy that's been tried in solid tumors.

In addition, as I noted, the follicle stimulating hormone receptor is only found on ovaries and testis in women and men, respectively, as you can see on this left-hand side. However, a few years ago, publication came out in the New England Journal of Medicine, that first page of that publication is depicted on the right-hand side. You don't need to read it, although this deck is on our website, if you are interested in reading the at least this first page as well as the article, you can pull it down. The key here is that this research team found that even though the receptor that protein FSHR is not found in any other organ system, when a tumor is found on any of these other organ systems, the vasculature, the blood vessels of the tumor express follicle stimulating hormone receptor.

So what does that mean for our situation? In our situation, we're targeting ovarian cancer, ovarian lesions. And think of this cartoon on the left-hand side, this blob of tissue as the lesion as the cancer. As solid tumors start to grow, they induce a process called angiogenesis, which is the process of forming blood vessels within the tissue, within the cancer tissue. And the reason is because in order for the tumor to grow, it needs to have nutrient and oxygen brought in and waste and CO2 removed. So forces the body to create these blood vessels, and what that research study found was that the blood vessels within this tumor express follicle stimulating hormone receptor. The reasons for that are not completely known yet, but the point is those proteins are there.

So in our case, we believe our CAR-T therapy will not only attack the ovary cells directly, but also the blood vessels that are providing the nutrient for the lesion to survive. So we're going to have a dual mechanism of action targeting this tumor that is going to occur even though we're only treating it with a single agent. And that's important because typically, when you have 2 agents, multiple agents to enable combinations of mechanism of action, you often have multiple and synergistic side effects. In our case, we're not going to have the synergistic side effects, we're going to get a dual mechanism of action with only 1 agent being added.

The third characteristic which also is important, and it's unique to ovarian cancer is that the ovaries exist in a abdominal sac that exists in all our abdomens, lower abdomen, the sac is called the peritoneal sac, which is depicted by this yellow membrane. Within this sac exists a lot of different organs, for women, ovaries exists within the sac. And when ovarian cancer starts spreading, most of the lesions, if not all of those lesions remain within the sac, within other organs within that sac as well as the membrane of the sac itself.

So in our case, we are delivering the CAR-T cells directly into the peritoneum. We do it through a port as opposed to delivering the CAR-T cells through the vein. When CAR-T cells are delivered through the vein, they go immediately throughout the body. They cause side effects everywhere, including in the brain, cardiotoxicity and a number of other things. In our case, because we're delivering directly into the peritoneum, not only are we sending the T cells in direct proximity to where the lesions exist. But also, we are keeping them away from the system away from the bloodstream, and because they're staying away from the bloodstream, they're not causing all of the side effects that in many other CAR-T trials for solid tumors have death of the patient. And in addition, we feel that we can go to much higher dosages of our CAR-T cells because we're keeping those T cells away from the bloodstream. And we're starting to see the effects of that already.

As I noted, the patients that we are getting are terminally ill. They have about a median life expectancy of about 12 weeks, about 3 months, maybe 4 months at the highest. And we are treating them with CAR-T cells -- their own engineered CAR-T cells, as I've described a moment ago, and we're -- but we're beginning with very low dosages and increasing the dose. And so far, this is what the dosage scheme looks like. We started out with 100,000 cells per kilogram, and now we are at 3 times 1,000,000 cells per kilogram. That will continue going higher.

And this is the data. At this point, we've only treated 10 patients. So I can't make statistically relevant conclusions from this small number of patients, but the data is incredibly promising. First of all, we are -- we have verified that the safety profile of this CAR-T therapy is incredibly good, much better than many other CAR-T therapies that are delivered through the vein. We have treated 10 patients so far, and we already have -- and while we were not expecting many of these patients to have responses because some of these dosages are subtherapeutic, we're already starting to see some incredible outcomes. We have 1 patient that is alive over 25 months, when she was expected to pass within 3. We have another patient that's alive over 13. We have several patients that are alive much longer than their mean life expectancy, and as we go further in dosage, we anticipate that we're going to have even more positive results going forward.

So it's incredibly exciting, incredibly positive we're keeping women alive that were not expected to be alive at this stage. And so we're looking forward to additional data, and that data will be provided over the next few months before the end of the year going forward. In addition, because of the results that we have seen so far, CAR-T therapy is typically utilized as a one-and-done type of therapy. But in our case, because of the results we have seen so far and many of these early women that are responding have had very low dosages. We went back to the FDA and asked if we could give some of these women a second dose, and the FDA gave us the approval to do that. And that's significant because the FDA does not provide these types of approvals willy-nilly, and we have that approval now.

So as we go forward, should a woman start responding and not have enough response to curatively treat her, we anticipate being able to give a second dose to perhaps get either closer to a curative treatment or a complete curative treatment. And so we're looking forward to more data from this trial, which we'll be providing on a rolling basis on a patient-by-patient basis as we go forward. And each of those results assuming they're positive, which we think they will be will -- we intend -- we expect those to be catalytic for us.

So let me switch subjects now. Let me talk about our breast cancer vaccine. And this is a vaccine, as I indicated, is designed to treat breast cancer as well as to prevent breast cancer. And breast cancer or I should say cancer vaccines in general, have failed because we believe the mechanism of action that molecular mechanism of action and targets that have tried before have been the wrong targets or flawed approaches. This approach was invented at the Cleveland Clinic about 2 decades ago, and it's a brand-new approach that has never been tried and is the subject this clinical trial that we are doing right now or the Phase I, which is pretty much complete.

We are targeting triple-negative breast cancer, which is the most lethal form of breast cancer. But this approach, we expect will work on all types of breast cancer. And the way this product works, is that we've identified a protein called alpha-lactalbumin, which is a lactation protein that is only produced in the breasts of women during lactation. So when a woman is nearing childbirth, this protein is produced, enabling her to produce milk to feed her child. After she stops breast feeding the protein disappears, reappears again when she has another child and another child. Eventually, after she is no longer going to have children, the protein completely disappears and is never seen again in most women. But in the 1 out of 8 women that will get breast cancer, it turns out that the majority of those cancer cells -- breast cancer cells are producing this protein.

So the concept here developed at the Cleveland Clinic years ago was that if we could vaccinate a woman after she is no longer going to have children, say at the age of 40 to 45 and teach her immune system to target cells making this protein, the immune system will be ready and trained to attack cancer cells as they arise, at their earliest stage at the 2 cell stage, the 4 cell stage and so forth, long before they have a chance to reproduce and become a multibillion cell mass that can be seen in a mammogram, for example.

And the early experiment was done, which was quite interesting because of the molecular mechanism of action that this approach takes and it was done to demonstrate how powerful vaccination could be. Those of you who may be following the world of cancer vaccines and the research that is coming out, will note that many vaccines are showing results indicating indicators of efficacy, meaning they're showing immune response, which our vaccine is as well. But when those studies are taken into Phase III clinical trials, the clinical data does not show clinical benefit even though clinical -- even though immune response was seen in an early Phase I study.

So this vaccine, this experiment demonstrates that not only do we see an immune response, but we see very clinical outcomes. In this case, in an animal, but we anticipate that, that's translatable into a human as well. But here's the experiment, the experiment here is we took a mouse, a female mouse, normal female mouse, gave her the vaccine and then allowed her to mate and have children. The pups were normal, the litter size was normal, but the mouse, the mother that had been vaccinated could not produce milk. Because what's happening is the vaccine has induced system to destroy any cell making that protein. And the cells making the protein are the lactation enabling cells. And as a result, the mouse could not lactate.

So what this tells us is at least in the mouse model, that the immune system of the mouse through vaccination became so powerful and cytotoxic at destroying the target cell that it was able to destroy billions and billions of cells that are enabling lactation. So the assertion here is that if we can teach the immune system of the mouse to destroy billions of cells, we can certainly teach the immune system of the mouse to destroy a handful of cells of cancer as they arise. In that study, those studies were done as well. On the right-hand side is the study, where we took genetically engineered mice that are designed to spontaneously develop breast cancer and half the mice were vaccinated, the other half were given a placebo and the vaccinated mice remained -- 100% of the vaccinated mice remained cancer free, which is amazing because in biology, you never get 100% response for anything.

Now obviously, these are mouse experiments. Now we're in the middle of doing human or I should say, we're completed with the Phase I human studies, targeting 3 groups of women. The first group of women with Cohort 1a are women that are -- women who've had triple-negative breast cancer have gone through their journey, have their surgeries, and they are now worried about a potential recurrence. We're giving them the vaccine and to and obviously, we're looking for safety and indicators of efficacy, which I will show you about in a moment.

In a second cohort of women, we are targeting women that have mutations that dispose them to cancer. And these are women who don't have cancer at the time, but they've decided to have a prophylactic breast mastectomy, they're having their breast surgically removed so that they don't reduce the risk of cancer in the future. These women were vaccinating before they have their mastectomy and then successive to their mastectomy, we can look at their breast tissue to see if the vaccine has induced their immune system to surveil their breast tissue which is what we see in the animal studies. So this is an experiment -- we haven't provided data to the public about this study yet, and we plan to provide this data sometime later this year.

And the third group of women are an interesting group of women. These are women that have gone through triple-negative breast cancer surgery and adjuvant therapy. But they happen to have residual disease, meaning they still have some cells of cancer in their bodies. Most of these women, in fact, all of these women will have a recurrence and so these women are being treated by a number of different therapies, the latest of which is immunotherapy, particularly a therapy called KEYTRUDA. The KEYTRUDA doesn't work on everyone, the KEYTRUDA has a lot of really bad side effects. We are seeing if we can add our vaccine to the KEYTRUDA to enable a better response in these women than just KEYTRUDA alone. And our goal for this study, which we've achieved was to verify that by adding our vaccine to Keytruda we don't create intolerable side effects.

As I noted earlier, when combinations are used for cancer treatment, often you get synergistic side effects. And we did not -- we wanted to verify that we are not seeing synergistic side effects in this group of patients. And that's enabled us to go to help us design our Phase II study, which I'll get into in a moment after showing you the data that we've presented on the Phase I so far. This is our first 26 patients. We've done a total of 35 patients who will provide all of that data hopefully, in December at a scientific conference. This is a busy slide, but there are some key attributes that I'll highlight.

One, is that a large percentage of these women are seeing a very strong immune response, which I indicated was an indicator of efficacy. And as you may recall previously on the previous slide, I indicated that at least in the mouse model, we are seeing good cytotoxic response. We can't -- we're going to -- in Phase II, we will evaluate the strength of that cytotoxic response, but at the current time, we're seeing good indicators of efficacy, meaning we have taught the immune system to target that alpha-lactalbumin protein.

In addition, we've achieved the goal of verifying that this is safe to give to these women because ultimately, a vaccine like this could potentially be given to a very large number of women, and so we want to verify that it's safe. The only side effect women saw was irritation at the site of the injection. And the data so far as well as the additional data that we'll be presenting later in the year has indicated to us that we can go into a Phase II breast cancer vaccine trial, which will be addressing women in the neo-adjuvant setting, meaning newly diagnosed women that have not gone through their surgery, but they're headed towards surgery. What we will be doing is having 2 arms, 1 arm that will be -- and let me take a step back for a second. Women who are nearly diagnosed typically get some therapy before they go to their surgery, and the purpose of that therapy is to reduce the tumor burden as well as to reduce the possible recurrence after their surgeries. And typically, a lot of these women are getting immunotherapy like KEYTRUDA.

So what we're going to do is have half of these women get standard of care. The other half will get vaccine plus standard of care. And as I noted earlier, we showed that the vaccine plus KEYTRUDA did not increase side effects. So we think this is going to be a tolerable combination and then we will see what the responses between the 2 different group of women and that will tell us how effective this vaccine is. In Phase I, we got the indicators of efficacy, indicators of effectiveness. But since we didn't have a placebo group, we really couldn't tell -- compare one versus the -- vaccine versus non-vaccine. In this case, we're going to be able to compare a vaccine versus a non-vaccine. And so this is going to be a very, very telling trial.

We're looking forward to this data, all indicators, the animal studies and the early human studies all indicate that this is going to be effective. And the market opportunities, obviously, are very big. I don't need to go over the numbers here. But the idea here is that initially, this vaccine would be available as a neo-adjuvant therapeutic treatment, meaning it would be treating women who have been newly diagnosed with breast cancer. Then we want it to be available as an adjuvant treatment, so women who have already gone through their surgeries and are now considered cancer survivors, but they're worried about a recurrence, they wake every morning worried about whether they have a headache, whether the cancer has come back and moved to their brain or whether it's just a headache. And it's an anxiety-ridden situation for all cancer survivors, not just breast cancer survivors. We want to be able to prevent that recurrence.

And then eventually, the holy grail here is to prevent vaccination in women who've never -- I'm sorry, prevent cancer in women who've never had cancer, primary prevention. So we want to be able to -- every woman potentially in the world who's worried about cancer becomes a potential customer for this because hopefully, we can give the shots to these women and never have to worry about cancer arising in the first place. And so that's -- those are the 2 programs, incredibly exciting data, incredibly positive and looking forward to additional data in the Phase II as well as additional data in the Phase I on the ovarian cancer situation.

I'll just mention the other programs in the pipeline without getting into detail. As I indicated, we have an ovarian cancer program that is in collaboration between the Cleveland Clinic and the National Cancer Institute funded by the National Cancer Institute that is in preclinical studies, animal study stage at the current time. And then we have initiated lung prostate and colon programs. we feel that if the breast cancer vaccine is successful, it will change the paradigm of how we think about cancer. Research teams all over the world will start looking for new vaccine targets for different types of cancer. And so we and our partner at the Cleveland Clinic, have decided based on the data that we're seeing in the clinical studies for breast cancer that we want to take the lead, continue having the lead in other types of cancers, including the big 3, which are lung, prostate and colon. So we've initiated those programs. And I look forward to updating all of you on many of the advances that we're making in those programs in the coming months.

With that, that's the presentation, and I will go ahead and turn it over to you, Glen, to manage the Q&A session.

[Operator Instructions] We do have quite a few questions in the queue, and we'll try to get through most of them in the remaining time, and we may go a little bit over if you're available Amit.

First question, with over 2 years of cash runway, what are the key inflection points over the next 12 to 18 months, I guess, milestones that could drive financing decisions or partnership opportunities?

Well, for a typical biotech company, the clinical or the catalytic outcomes tend to be clinical data. And so for the breast cancer vaccine, we'll be presenting all the comprehensive clinical data, we hope, in December at the San Antonio Breast Cancer Conference. We are in the process of creating the abstract to apply and present there. We'll also be presenting at that time the report to the U.S. Department of Defense for the final results of this vaccine trial, which they had funded. We'll also be putting to the report for the U.S. FDA and discussing with the FDA, the trial design and the metrics for the Phase II study. So that's going to -- a lot of that is going to happen near the end of this year in a few months.

For the CAR-T therapy, we are going to be providing updates on a rolling basis. So when we treat new patients and as previous patients continue living for a periods of months, periods of time on a monthly basis, we'll be providing updates. And so catalytically each of those updates will be telling us how long these patients are living. And we have biomarker data on these patients, but we think overall survival is the key metric. And the longer these patients live the better it is, obviously, with good quality of life and that's what we hope to be able to provide over the coming months.

Super, thank you. And I guess I'll paraphrase this question because it's related. Given some of these time lines and these milestones, where are you in discussions with potential pharmaceutical partners and your current programs? Have these type of discussions begun? Or are you waiting for that data to begin those discussions?

All of those discussions for both of these programs have begun. We're talking with pharmaceutical -- potential pharmaceutical partners. On the breast cancer vaccine, we are talking to partners on the CAR-T ovarian cancer therapy as well. It's very hard to identify when a deal can get done. So I'm not going to predict, but I'm hoping that 2026 is a really good year for us.

How did the Department of Defense get involved in the Cleveland Clinic study for breast cancer vaccine?

So the Cleveland Clinic, the data that I showed you, which is just a subset of the data that has been published and disclosed by the Cleveland Clinic research team. The U.S. Department of Defense, obviously, most people realize that U.S. DOD funds things related to defense, but they do fund certain types of research that could be game changing and the Cleveland Clinic went to the U.S. Department of Defense and submitted a request for funding for this vaccine, which could be game changing. And the U.S. Department of Defense, obviously, saw the merit in that program and how it could completely change the landscape of cancer.

Imagine a world where you could just give women a shot and not have to worry about breast cancer, that's the thinking there. And so the U.S. Department of Defense allocated some multimillions of dollars to the Cleveland Clinic to fund not only the final preclinical development, but eventually the clinical study that is going -- is nearing completion now. And so the U.S. DOD is providing all of that capital.

Does the current administration health policy affect your funding and support?

That's a really interesting question, Glen, and I get that all the time. And it's really hard to answer that question because there are a lot of things that are up in the air. I will say a couple of things about the current situation. First of all, with the caveat that things are still up in the air and things have not completely settled. But we do believe that there will continue to be some funding for various types of revolutionary research. And we've requested some of that funding, we'll see how that works out in the next probably a few months, we'll know.

But one thing I also want to say about the vaccine, and I get this question often. And that is that there's a lot of controversy about vaccines today. In fact, there was recent news today about the RSV vaccine and the new committee Robert -- RFK has installed regarding vaccines. And the one thing I want to say about our breast cancer vaccine is it's not an infectious disease vaccine, all of the vaccines that are sort of controversial are related to government-mandated vaccines. The idea that a federal government or even a local government or a school system can mandate certain types of vaccinations for you to be able to attend school or get a job or whatever. And there's been a lot of controversy about that, a lot of discussion about that.

And I don't want to get into the politics of that, I do have my own scientific opinions about that but what I want to say about our breast cancer vaccine is that because it's not an infectious disease, you don't get breast cancer by hugging someone who has breast cancer. This is not the type of vaccine that will be mandated by the government to enable you to get a job or anything like that. This is the type of vaccine that you as an individual, if you're worried about breast cancer, if you have a history of breast cancer in your family, if you don't want breast cancer, once the product has been approved, it will be your own personal decision. It will be a decision that you and your physician make regarding whether you take that vaccine. This will not be a vaccine that the government will say, you've got to take or else you can't have a job. So I hope that answers that question. There's obviously -- I can talk about that issue for a long time. It's probably beyond the scope of this presentation to have an in-depth discussion about that.

How do you avoid T cell exhaustion? Are you using an armoring approach to deal with tumor suppressive micro environment?

So that's a really good question, and it gets into a little bit more -- it's a sophisticated question from someone who obviously knows a little bit about CAR-T therapy and T cells and how the immune system works. We are not using any sort of armoring approach. We think while those approaches have had some interesting results in animal studies and maybe some early clinical trials, the complexity of CAR-T therapy is high already based on our understanding of how we can manipulate T cells that we think a simpler approach is better.

But you're right, we are susceptible to T cell exhaustion. We are susceptible to tumor microenvironment. But what we've seen in some of the early patients, especially our patient who has gone 25 months is that the -- our T cells are infiltrating her tumor. They're knocking out, they're creating tumor necrosis, meaning they're killing the tumor cells. We've seen that through a biopsy result. And we do think that there will be different levels of exhaustion for different patients. But that's one of the reasons why we went back to the FDA and said, if patients are showing a response, but the response is not strong enough to curatively treat them, will you give us the permission to give them another shot, another treatment, essentially. And the FDA, looking at the data that we presented them and the results we presented them said, yes, we're going to give you the ability to do that.

Other CAR-T treatments I'm not aware of any other, maybe there may be 1 or 2 other CAR-T treatments that have received that approval but we are one of the first that has received that approval from the FDA to address some of these things. And we'll learn more about T cell exhaustion and persistence as we go forward. We don't have all of those answers right now.

What evidence do you have that T cells can effectively expand peritoneum? Is there a sufficient antigen presentation, other growth factors?

Yes. So we believe there is sufficient antigen presentation because that's where all the lesions are. We think there's enough growth factors. We don't know exactly how these T cells will proliferate. But in the end, and we'll be studying all of those things. But in the end, the bottom line is overall survival, whether it's -- one of the questions people ask me also is, are your T cells working based on the anti-angiogenic mechanism because of the FSHR on the blood vessel? Or are they working because they're targeting the cancer cells directly? And we don't know the full answer to that. We believe it's a combination, but we don't know the answer yet.

But the bottom line is it really doesn't matter what the answer is, if you're keeping the patient alive and she's got a good quality of life, we'll eventually figure out what the mechanism is, and we'll eventually figure out if there's enough expansion. But in the end, if you're keeping the patient alive, that's really what matters. And so that's what we're focused on.

Were there any radiological biomarker responses?

Yes, there are radiological -- I'm assuming the question is radiographic responses. And we did see responses of necrosis in -- and this is obviously for the CAR-T therapy. We did see radiographic responses indicating that there was necrosis in some of these patients. But that's also a little bit confusing because what we also see often in some of these patients, when I say often, it's a small number because we've only treated a small number, but we often see the tumor after treatment expand. We call that pseudo progression because it looks like on the radiograph on the CT or x-ray, the tumor has gone bigger which is not good, but it turns out tumor in many of these cases is getting bigger because our T cells were getting in there and expanding them.

So the T cells are getting in there to kill the cancer cells and that on a radiograph actually looks like pseudo progression. That's the technical term.

Is it possible to attract the attention of big pharma with your current phase run and low patient count? Or do you need a more substantial Phase II?

So it depends on which of the programs you're talking about. I do believe that the breast cancer vaccine will require some initial Phase II data because as I indicated, all of the results in Phase I were incredibly promising. But in Phase II, we will start getting an indication of effectiveness. And initial data there will get the -- I think the whole world excited if the data continues to be positive.

In the case of the CAR-T, I think we only need a few more patients that are demonstrating good overall survival because CAR-T therapies are being -- this therapy is being tried on terminally ill patients. These patients have zero other options, and they're going to die. And if we can save a handful of their lives for a significant amount of time with good quality of life, then that becomes very, very interesting and attractive to pharma companies.

I think you just answered part of this question, but I'll ask it and maybe have you expand on it. In a Phase II trial, what sort of patient enrollment count would you be looking for given how terminally ill patients would be?

So we're looking -- the Phase II for the CAR-T therapy is going to be a very different animal than the Phase II for the breast cancer vaccine. In the CAR-T therapy, again, we're going to be targeting terminally ill patients. And typically, for this type of trial, you do a Phase II/III study at the same time. And so we will be looking at terminally ill patients who have basically no other options. And so a Phase II trial will pretty much be an expansion of the Phase I trial, not too many things that will be different there.

In the Phase II trial for the breast cancer vaccine, that's a different situation. We anticipate on the order of about 80 patients, half of whom will get the standard of care. The other half will get standard of care plus vaccine. The intent there is that, that Phase II is not going to be a registrational trial, meaning it's not the trial that's going to determine whether you get an FDA approval or not. It's the trial that demonstrates that you are going to be successful with the vaccine. And so by doing an 80-person plus or minus trial, we'll be able to get results much faster, we'll be able to tell whether this vaccine is doing what we need it to do, we'll be able to tell if 60% of the patients are responding or 100% of the patients are responding. And that data will have 2 effects.

One is that it will scientifically tell us what the chances are of a successful Phase III trial; and number two, it will create a huge amount of excitement with potential pharma partners who want to jump on board and continue the final development and eventual commercialization of this program. So the data from the Phase II trial is going to be incredibly catalytic assuming it's positive, which I truly believe it will be.

Super thank you. I'm just doing a time check. I noticed we're just before 3:00 East Coast time. We do have a number of questions still in the queue, but I think a lot of them overlap. So we probably will only need to ask about 1/4 of them. For anybody that needs to drop off exactly on the hour, this is being recorded, we'll make the recording available sometime tomorrow, if you want to pick up from where you left off. So I'll continue now with you, Amit.

Can you just go over the process of registering participants for such trials? Has it been easy to sign up patients? Or is this a slow process?

Trial enrollment is always a slow process. In the breast cancer vaccine, we have a waiting list, we had a waiting list now that its enrollment has been completed for Phase I. We're no longer enrolling patients. I would be getting phone calls from patients all over the world and their families asking how they could get involved in that trial. So that was -- that's a unique situation.

The CAR-T trial is a little bit different because these are patients that are terminally ill, that have failed everything else. They have gone through a lot of treatment and they have been beaten up a lot. And sometimes these patients would rather just spend the latter 3 or 4 months of their lives without having to rush to hospitals and do all kinds of other treatments. Sometimes these patients are just not able to logistically and physically come to Tampa, Florida, which is where the trial is going on. And so they're just not able to get into those trials, there are lots of logistics.

Each of these trials and all trials in general, have inclusion criteria and exclusion criteria that are designed to take patients in a way that allows them, allows us as the researchers to get good information on those patients. And it breaks my heart as I'm sure it does for many of the physicians working on these trials to have to say no to a patient that wants to get into a trial because they don't meet the inclusion criteria. And so we end up saying no to a lot of patients.

I think it's important for us to understand, and I want to say this carefully, that we've been very careful about the patients that we have taken in our CAR-T trial. People have told me that it's going too slow, and absolutely, we all want things to go fast. But we don't want to rush it to the point where we potentially cause harm to patients, including perhaps cause death to some patients. I will tell you that certain CAR-T trials that I have seen clinical data for in other situations, they have perhaps pushed it too aggressively before they understood the science well enough, and they've hit the wall. They've had patients die that perhaps may not have had to pass and as a result, they've had clinical trials shutdown, suspended by the hospitals or suspended by the FDA, and that's disastrous. We are very careful, we want to make sure that we don't -- that doesn't happen to us. And we want to make sure that we're treating the patients as ethically as possible. And if that means it takes a little bit longer, we would rather do that than hit the wall, so to speak.

And the benefit of our business model, which allows us to operate with very low burn gives us a little bit more flexibility in terms of time and enrollment, whereas other companies that are burning $50 million, $100 million a year, they need to push their patients quickly through these trials to get data to enable financing. We're not in a rush. And so we have intentionally built our company that way so that we can properly drive these trials and obviously benefit patients as well as our shareholders with positive results.

Super thank you. You led into this next question, so I'm going to go with that and then followed by others. So can you talk about the total spend of the programs, including CAR-T and the breast cancer vaccine. And what is the allocation between you and your partners in terms of cash used? And then maybe get into the economics between the partnerships.

Okay. So there are -- I guess, there are 3 components. Regarding specific spend on each program, we don't disclose that information. But based on my comments and public statements, you can probably figure it out. As you know, we spent -- if you assume we spent $7 million last year in total costs, assume that the CAR-T -- I'm sorry, the breast cancer program is fully funded by the Department of Defense. The bulk of the spending outside of our public company costs and overhead is on the CAR-T program, which is still very tiny. As you know, as many people who are familiar with CAR-T therapies in other companies, those programs cost tens to hundreds of millions of dollars, yet we spent $7 million and cut out half of that for overhead being a public company, accountants, lawyers, all those things, you can sort of back into how much was spent there.

The second question, actually, I sort of lost my train of thought, go ahead. What was the second component of the question?

I guess the split in economics between yourself and your...

Yes. So in all cases, we are -- we have -- we owe a very small modest royalty to our partners in the case of Cleveland Clinic, a small royalty there, in the case for the breast cancer vaccine, in the case in small -- by small, I mean, low-single digit, in the case of the CAR-T therapy because we licensed it from Wistar, we own them a small single-digit royalty. And in the case of Moffitt, we're supporting the effort there financially. And so basically, all of the economics remain with us, whereas going forward, we will share that bulk of the economics with a potential pharmaceutical partner.

And then touching, I guess, continuing from that form of discussion. Can you talk about the technology IP and the ownership and the splits between partners?

Yes. So the ownership of all of these technologies through an exclusive 100% owned license, worldwide license, the ownership basically belong to us as the commercial partner of these academic centers. As far as IP is concerned, I typically don't talk about detailed IP strategy in public forums. But I will say this. We have lots of patents that have been issued on all of our technologies and not only in the United States, but in international jurisdictions and we are very aggressive in prosecuting and continuing to file patents on things that we've already done as well as anything new that we learned that could be the subject of an invented disclosure.

So we're very, very -- and by the way, these patents belong to the academic institutions, but we have 100% license to those patents.

Can you provide a little more technical insight into how the breast cancer vaccine can not only prevent breast cancer, but also cure it in patients and put them into remission?

Yes. So the idea here is that, this is a type of immunotherapy. Chemotherapy is basically a chemical that goes in and tries to destroy the cancer cell. It tries to destroy the cancer cell at a rate faster than it harms healthy cells, and that's often a challenge. Immunotherapy, the whole -- the broader umbrella of immunotherapy is that you're not trying to target the cancer cell itself. You're trying to impact the patient's immune system to go after the cancer with the idea being that the immune system, which is native to the patient, is much better at distinguishing between a cancer cell and a healthy cell.

So in our case, we are trying to teach the immune system to target any cell that makes that target protein. And because that target protein we've discovered is only found on cancer cells then we hope that the immune system will attack cancer cells without creating autoimmune disorder, meaning without attacking healthy human cells or organs. And this is getting into a little bit more technical detail than probably is in the scope of this presentation. But I will say this for the person who asked that question, the reason that previous approaches have been flawed is because previous approaches try to target proteins that were overexpressed on cancer cells versus healthy cells.

Meaning cancer cells exhibited large numbers of this protein, and that was a characteristic of the cancer cell, whereas healthy cells exhibited low numbers. So when you target that protein that's overexpressed, you may be able to kill the cancer cell, but you're also creating autoimmune disorder against whole bunch of other organs that exist in your body. And so in that situation, you really can't -- it really doesn't work very well. And that's been the approach that's been tried before. That approach has been tried and successfully done with therapeutic approaches like Herceptin, which is one of the biggest and first monoclonal antibody for breast cancer, the idea was that certain breast cancer cells express a higher level of a protein called HER2/neu. And so if you target that protein, you can kill the cancer cell before killing a lot of healthy cells. But healthy cells have that protein too.

The thing about a therapeutic is if you start seeing these really bad side effects because the therapy is attacking healthy organs, you can stop the therapy. But with the vaccine, you can't do that. Once you vaccinated and taught the immune system to target a particular protein, it's on, you can't shut it down. And so with the vaccine, you really need to find a good target, and that's the target that we've identified for this breast cancer vaccine, called alpha-lactalbumin, and we've also identified a similar target for ovarian cancer as being, as I indicated, worked on with the National Cancer Institute, and we are in the process of discovering those targets for lung, prostate and ovarian.

And I will say this from a shareholder standpoint. As the breast cancer vaccine continues down through the trials and continues to show positive data, we already have these other programs and other types of cancers. And so once the breast cancer vaccine is shown to be successful or heading in a very positive direction, for shareholders, the value of these other assets, which right now are science experiments, the value of those other assets just increases dramatically because the first asset is now showing good positive clinical results. So that's one of the reasons why for shareholders and for us as scientists and physicians, we wanted to start these programs in these other cancers as well.

I guess this is a competition type question. Are there other companies that are also creating cancer vaccines, breast cancer vaccines? Are there any that are near-term approval?

Yes. So there are lots of other companies that are working on cancer vaccines, and that's been the case for decades. The most recent types of cancer vaccines that are being -- that are in clinical trials are primarily mRNA personalized cancer vaccines, not only for breast cancer but for many other types of cancers. And those vaccines have shown some initial positive data in clinical studies. And they -- and many of them have also failed miserably, epic failures that have resulted in companies that have raised hundreds of millions of dollars or even billions going bankrupt.

And so the challenge with mRNA vaccines is that they have to be personalized. You have to take a tumor sample from each patient. You have to sequence the DNA of those tumor cells. You have to identify specific mutations that could be targets of the mRNA vaccine. Then you've got to create -- you've got to choose which of those mutations are going to be immunogenic, and you've got to create a group of mRNA or, in some cases, DNA fragments that then you inject back into the patient. That process is expensive and it's got to be personalized for every patient. It's incredibly expensive.

Our approach is to have an off-the-shelf vaccine that's inexpensive because eventually, who knows if this thing is approved for primary prevention, we may be giving it to hundreds of millions to billions of women in the world. And so you can't personalize that -- personalize a vaccine for that many people, you've got to be able to have something on the shelf that you can distribute to everyone.

Thank you. Can you address how the quality of life has been for those patients that have responded favorably to the CAR-T treatment well beyond their estimated life expectancy?

So again, it's a small number of patients. So it's hard to broadly or generalize. But for example, the patient who is at 25 months, her quality of life has been fantastic. Although I will admit she's starting to have some issues now. Some of the other patients, while they have lived, their quality of life has improved but it could still improve more. We want these patients to be able to live independently and some are doing that and some are still having some challenges, even though we're having potentially an impact on their lesions, they're not completely independent.

So but as we go forward, we will hope that higher doses will give these patients a much better response and a much better quality of life going forward. And I will also say that some of these patients to whom we have given the vaccine have passed, some have passed within a month -- I'm sorry, not the vaccine, the CAR-T. Some of these patients have passed within a month after we've treated them, and part of the reason is because they are so far along that the treatment came a little bit late. And I believe that if we have gotten them 3 or 4 months earlier, we would have a bigger impact. And so as we go forward, we'll have a better statistical representation of the results.

Thanks, Amit. There's a number of questions related to your markets. So I'm just going to sort of qualify them all and characterize them all as one general statement, and then I'll let you just answer it.

So the general comment is that your technology appears to be extremely exciting. But the sentiment is that the market doesn't understand or appreciate what you're actually building as a business. So can you just address how you think about, I guess, the current valuation, your market, access to investors. And just generally, anything IR related that you think should be said to current shareholders on the call.

So a couple of things. This is creeping into a discussion about stock price, which is something that I tend not to discuss in general. But I'll say a few things here. The market -- the valuation of the company is driven by a number of factors, which includes an understanding and excitement about our programs, the clinical data, et cetera, but also driven by macroscopic effects that a lot of our shareholders perhaps are not aware of. And that is that the development stage biotech sector has been under tremendous pressure for the last 4 or 5 years.

In fact, if you were to go look at the XBI, X-ray, Bravo, India, is the index that tracks smaller cap biotechnology companies. And if you look at that chart over the last 5 years and compare it to us, look at it over the last 6 months, 1 year, 3 year, whatever period you want, you will see that our company has performed better than the rest of the sector. However, if you compare our sector with the technology sector, for example, you'll see that the technology sector has performed a lot better. And that's has to do with macroscopic things that we as an individual company really can't control.

If you look at the other -- a lot of other companies in our sector, and their performance, specifically the smaller cap companies, you'll see that many of them have had to do financing transactions that are very, very painful and that have taken all of the value away from their shareholders. There are companies that may have the greatest program, and they're providing very positive data in their clinical studies but their valuations are not going up because they've created capital structures where they have huge amounts of warrants and overhangs, preferred stock, ratchets, all these things and sophisticated institutional shareholders are not going to buy those stocks unless they get the same warrants and other derivative securities.

In our case, we've tried to stay away from all of that because we want the value to accrue to common shareholders, which is including myself and other members of the insider group. And that being said, our company is often classified in the same bucket, painted by the same brush as many of these other companies that are under a tremendous amount of stress. And so I believe that as everything is cyclical as interest comes back into the biotech sector, which it has to eventually because we are the companies that are keeping people alive. As interest comes back, our company will be recognized for the value that we are creating and the shareholder-friendly approach and strategy that we are executing versus many of the other companies that are -- have really to be blatant, have screwed their shareholders.

But I don't know when that's going to happen. The key is that we have enough capital to get us to a point where I believe that will happen. So I think -- I don't know what else I can say about that. But when you compare our performance versus NVIDIA or Apple, you'll see a big discrepancy. But when you compare our performance versus anyone else in the biotech industry, including large-cap biotech companies, you will see that we've performed better.

So on a relative basis in our industry, we are sort of one of the key -- cream of the crop, but on a relative basis comparing to other sectors like technology or AI and things like that, we have not performed well. And I eventually want us to perform better than those other sectors. And I'm working very hard to do that, and I'm also buying a lot of stock because I think that will happen at some point.

Super. Amit, you've done a fantastic job. We've still got a vast majority of our attendants that are participating live. Again, this is being recorded. So we'll circulate it to anybody that had to drop off. We'll maybe let you give some parting words and statements and then we'll end the presentation.

Well, first of all, thank you, everyone, for listening to this presentation. Thank you, Glen, for holding this. I look forward to engaging with any and all of you going forward, shareholder or not shareholder, a big shareholder, a small shareholder, patient. I make it a point to call everyone back, who calls me especially patients who are interested in the -- in how we could benefit you. So if anything, please stay tuned with -- keep watching our company because we have a lot of really exciting things in the works, and I hope to be able to update you as we go forward. Thank you, everyone.

Super. Thanks, Amit. Thank you to our audience, and this concludes this presentation.