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.