I’m Amit Kumar, Chairman and CEO of Anixa Biosciences, a biotechnology company that develops therapies and vaccines focusing on critical unmet needs in oncology. Ask me anything!

Your breast cancer vaccine has garnered a lot of media attention, and you presented data recently at a conference. Can you talk about this vaccine and its future?

Previous attempts at cancer vaccines have unfortunately failed. Our approach is a very different technology platform that has been in development for two decades at the Cleveland Clinic. We are using a new mechanism of action that has come from a greater understanding of how the immune system works, and the many successful vaccines that have been developed for infectious diseases. Yesterday, I held a conference call discussing this vaccine, the data, and its future potential. The call included participation from key opinion leaders who are among the world’s experts on breast cancer. A recording is available on our website, and I encourage any interested people to listen to the call.

Are you in talks with anyone about being bought out?

I cant discuss specific discussions publicly, but we have spoken to many pharma companies about our programs, and you can be assured they are watching the results of our trials. Assuming that the data continues to be positive, at some point we will be able to partner or sell the company or individual programs to big pharma for commercialization.

Anixa is a unique company in that you are the only biotech I know which is engaged in clinical trials and only spending a few million dollars per year, which is a fraction of the cost of most biotechs. How is that possible?

We built a very unique business model which enables us to do great things without burning a lot of shareholder’s money. This business- model involves working with many of the premier institutions in the world like the Cleveland Clinic and the Moffitt Cancer Center to develop our programs. Also, our programs also benefit from non-dilutive funding and collaborations with organizations like the US Department of Defense and the National Cancer Institute.

100+ mil market cap for a company that’s in phase 1 with one drug seems like a stretch, that still means they’re just starting doesn’t it? ..I wish you had an easier way to understand this PR that went out, it’s too much for my understanding

The scientific data are very complex, and we tried to simplify as much as possible in the PR. We did a conference call after the PR came out where we discuss the data in a little more detail. If you go to the investor /evens portion of our website, you can listen to the call if you are interested. If you need more detail, feel free to reach out to me. I make it a commitment to return all calls, even if it takes a day or three. As far as the market cap, there are many companies with higher market caps and no drugs in the clinic. I personally feel we are undervalued because we are under the radar, which I hope will change soon. I agree phase 1 is early, but our strategic plan is to partner each of our programs off to pharma at an early stage to monetize our drugs. And we actually have two programs in clinical trials not just one.

When will hear more about your Ovarin cancer program, How are the ladies who have gotten this treatment doing and how they responding?

The ovarian program is recruiting very ill patients who have failed standard of care therapies. Some are expected only to live a matter of weeks, so they are very sick. That is why recruitment is slow. We will update as we continue enrolling patients. The first three patients received a very low dose of engineered cells, and the next cohort of three patients will receive 3x the dose. We expect to update on the program in Q1. Of the three ladies who received the therapy, one has passed, 11 moths after her disease began to progress, and 9 months after we treated her with our CAR-T. The other two are alive.

Are there any plans or considerations for expanding the clinical trial to include additional medical centers or institutions beyond Moffitt Cancer Center?

As we expand the trials, we will expand the numbers of sites where the therapy will be administered. This expansion will occur when we begin phase 2 studies.

Are there any plans to publish or present the trial's findings at medical conferences or in scientific journals?

All of the data from all our programs have been published in peer-reviewed scientific journals or presented at scientific and medical conferences, and we will continue that practice.

Why is the protein alpha-lactalbumin important in breast cancer research, especially in the context of Triple Negative Breast Cancer?

alpha-lactalbumin is a protein that only exists in the breast and only when a woman has given birth and is lactating. But it also appears in breast cancer cells, especially in triple negative breast cancer, and we believe in other breast cancers. Our vaccine teaches a woman’s immune system to kill cells making the protein, which will only be cancer cells as long as a woman is not lactating after giving birth.

I have noticed that Anixa insiders have made large insider purchases over the last few years. Do you anticipate that to continue?

I am not able to signal any future trading in Anixa by insiders, but I can comment on the past. I and other insiders including board members have spent millions of dollars to purchase Anixa stock on the open market. Obviously, that signals a strong bullish belief in our company. Personally, I rarely buy stock of companies unless insiders do as well. That being said, there are very limited windows when insiders can trade the stock due to many factors including knowledge of material, non-public information.

You mentioned - I think - one time that about 70% of TNBC seems to have this retired protein. Are you getting any sense as to whether it's found in other breast cancers? Like is it just as common in all breast cancers, but CC just happened to study TNBC because it's the worst? Thanks.

We believe this protein is found most breast cancer cells. TNBC has been studied in greater detail than other types of breast cancer.

When will you be disclosing data from your breast cancer vaccine trial?

We presented the most recent data yesterday at the San Antonio Breast Cancer Symposium, which is the largest annual conference focused on breast cancer.

I've got a question about another company in the industry, Novavax. They have tried novel things in the vaccine space for years, largely with mrna, I believe.

They have had buzz for years and even got a major boost from the Covid funding to develop their own vaccine, but it lagged far behind the major pharma vaccines.

In short, despite a massive buzz and financial push, they can never seem to make it work. So my question is twofold, one, do you have any idea what the issue is that keeps them always on the edge of success but never there (they've tried to develop a RSV vaccine but can't get it to pass trials successfully), and what about your company is there to ensure you are able to be one of the exceptions to the difficult rule of how hard it is to succeed as a "smaller" vaccine company?

It is inappropriate for me to comment on another company, even if I have opinions. WRT to Anixa, yes we are a small company, but most innovations come from small companies, who them partner with large pharma for commercialization. There are no guarantees, but we are carefully spending our money, carefully managing our programs, and so far everything looks great. We hope and expect that things will continue to go well.

Can you provide an update on Anixa Biosciences' collaboration with the Cleveland Clinic regarding breast and ovarian cancer vaccines, including recent trial results?

The collaboration has been very fruitful. We are in clinical trials at the Cleveland Clinic with the breast cancer vaccine and we are in the pre-clinical R&D stage with the Ovarian Cancer Vaccine. And in fact, Cleveland clinic is collaborating with the National Cancer Institute to move this program forward. The initial trial results for the breast cancer vaccine have exceeded our expectations. Since the ovarian cancer vaccine is still in pre-clincial development, there are no trial results to date.

Can you provide an overview of Anixa's ongoing cancer research programs, including the ovarian cancer immunotherapy program and the breast cancer vaccine program, and their objectives?

The goal of the breast cancer vaccine program is to develop a vaccine to prevent cancer, initially in women who are cancer survivors then in women who have never had cancer. The ovarian cancer vaccine has a similar goal with ovarian cancer, and the ovarian CAR-T therapy is an attempt to treat women who already have late stage ovarian cancer, who have failed all existing therapies.

What is the rationale behind administering the same dose of engineered T-cells to the third patient, and what are the expectations regarding safety and efficacy?

For proper evaluation of safety, we are required to administer the same dose of engineered cells to at least three patients, before we can increase the dose in the next group of patients. We expect and hope the safety and tolerability continues to be good as we increase the dosage until we begin to see objective signs of efficacy.

How does the CER-T approach used by Anixa's therapy differ from traditional CAR-T therapy in terms of mechanism and targeting?

We are targeting a very specific protein that only exists on the organ we are targeting. Additionally, our engineered T-cells will have an anti-angiogenic effect that will aid in the destruction of tumor-lesions.

Even if this all works, doesn’t the government want to hide any cures for cancer? Is that an actual thing
I mean I guess you could get bought out and then they hide it through one of their puppets like pfizer, so if i bought now it could be up bigly, how many shares do you own amit

That is a conspiracy theory that is just that, a conspiracy theory. No one , not the government, pharma or anyone else wants to keep something revolutionary like this in hiding or on the shelf. I own several hundred thousand shares. You can go the form 4s filed by our company, and you will see that I and other insiders have been consistent buyers of the stock even at higher prices than the current trading value.

How does your industry plan to win back the public trust after all of the covid and covid vaccine lies and tyranny?

Our industry saves lives. The politicization of the Covid vaccines and government mandates was unfortunate. That period of time was very anomalous. As we move forward, people will realize that every drug, every vaccine, etc. prescribed by a doctor comes from our industry. And most new innovations come from small companies like Anixa, who partner with larger pharma companies to commercialize. That is our plan. Also, I want to say that our vaccine is a cancer vaccine, not a vaccine for an infectious communicable disease. Government mandates are used for infectious diseases. People don’t get breast cancer by sitting next to or hugging someone who has cancer. So mandates will not be used here. That being said, once this vaccine is approved, I hope people are smart enough to take advantage of it, because cancer is a terrible disease for the patient and the patient’s family.