Anixa Biosciences, Inc. (ANIX) Earnings Call Transcript & Summary

Good day, and thank you for standing by. Welcome to the Anixa Biosciences' new breast cancer vaccine data call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Stephen Kilmer, Investor Relations. Please go ahead.

Thank you, Amy, and good evening, everyone. Let me start by pointing out that this conference call will include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are based on Anixa Biosciences' current beliefs, assumptions and expectations and such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statement. No forward-looking statement can be guaranteed. Listeners are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this conference call. Anixa undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, other than as required by law. With that said, I'll now turn the call over to Anixa's Chairman and CEO, Dr. Amit Kumar.

Thank you, Steve. I will also note that later today, a recording of this call will be available on our website and archived there for 30 days. While we are very excited about our other programs, the goal of this call is to discuss the superlative data that our partner, Cleveland Clinic, presented at the San Antonio Breast Cancer Symposium, which is the largest annual scientific conference focused exclusively on breast cancer. We will begin with some prepared statements, and then we will have a Q&A session. The Q&A session will include live questions from listeners as well as some questions that have been asked of us in the last few weeks. Participating on this call, in addition to Mike Catelani and me, will be 3 people from whom I think you will all enjoy hearing. They include Jenny Davis, a breast cancer survivor, the very first human subject to have received the breast cancer vaccine. Many of you, if you have seen some of the media activity related to this breast cancer vaccine, may already know her story and her journey of breast cancer survival. For those who have not seen these media events, I encourage you to go to our website, www.anixa.com and click on the news tab and you will see links to the many TV interviews and written and online interviews discussing the vaccine work. In addition to Jenny, we will also hear from 2 highly distinguished scientists and key opinion leaders who are advisers to Anixa, but were not involved in the clinical trial which we'll be discussing today. The first is Dr. Mike Shepard, who is the scientific inventor of the multibillion-dollar drug marketed as Herceptin, the first antibody drug targeting breast cancer. Additionally, we'll hear from Dr. Brian Leyland-Jones, who is also a distinguished scientist and expert in clinical trials. Dr. Leyland-Jones is currently at the San Antonio Breast Cancer Conference and will be joining us from the venue. I will provide more details about their backgrounds when I introduce them to make some comments about the data. First and foremost, I want to express our enthusiasm about the data presented today. The data has exceeded all our expectations. Today, Dr. Thomas Budd and Dr. Justin Johnson of the Cleveland Clinic presented data on the first 16 subjects, all women, who were cancer-free at the time the vaccine was administered in the Phase I trial. I want to remind people that this trial is being conducted at the Cleveland Clinic and funded by the U.S. Department of Defense. First, a bit of context about this trial and the planned expansion. This vaccine is initially being studied to prevent recurrence of triple-negative breast cancer, which is the most lethal form of breast cancer with the highest number of recurrences and the highest number of deaths. All women enrolled to date in this trial are triple-negative breast cancer survivors that have gone through a brutal treatment process that includes chemotherapy, surgery and radiation. Statistics show that 42% of these women will have a recurrence within 5 years. So the cancer will come back in 42 out of 100 cancer survivors. When a recurrence occurs, it is more aggressive and often metastatic, with poor outcomes for the patient. Our goal is to demonstrate that we can first prevent cancer recurrence in survivors and then expand to demonstrate prevention in previously cancer-free women. Each participant in this trial received 3 injections, 2 weeks apart. Blood was drawn for analysis at the time of each injection and day 56 and 86. And these women, outside the trial, will be monitored every 3 or 6 months with standard of care screening protocol. There are several key findings from the data presented today. While all 16 of the patients -- of the participants had an immune response, the data showed that the majority exhibited responses that met the rigorous protocol specified definition of an immune response, with measurable but lesser magnitude responses in the remaining patients. This means that the vaccine was successful in inducing each participant's immune system to mount a targeted response to the chosen antigen, alpha-Lactalbumin. While all women had a response, it's not clear at this time why some women exhibited a relatively robust response, while a few exhibited a more modest response. Another key finding was that 75% of the women exhibited a T-cell response with -- excuse me, with the production of at least 2 types of antigen-specific T-cells. This is promising because we believe that the primary mechanism, by which the immune system will destroy cancer cells is through T-cell priming. Another very important finding was that no women exhibited significant side effects at the maximum tolerated dose. There were no fevers, no myalgias or flu-like symptoms, no fatigue or organ issues or anything of major concern. The only side effect was irritation at the sites of the injections where bumps formed. This is incredibly important because our goal is that this vaccine, after the required trials and regulatory approval, could be administered to millions of cancer survivors and eventually to every woman in the world that is concerned about getting breast cancer. With such a large potential market, it is critical that side effects be minimal. While we only have data for 16 participants at this time, it is heartening that we have not even seen side effects that are experienced with other common vaccines like flu or COVID vaccines. We are well into the Phase I trial and the data we now have enables us to develop and execute the plan for the next trial, a Phase II/III study, that will evaluate the efficacy of the vaccine in preventing triple-negative breast cancer recurrence. This is a significant milestone for any new therapeutic or vaccine. Those are the key points of the data presented today. More detailed findings can be reviewed in the poster presented by Cleveland Clinic. For those who are interested, we will make the poster public in an upcoming 8-K filing and on our website. After highlighting this data, for those of you who are new to our story, let me provide a description of how this vaccine works and why we think this vaccine could change the landscape of breast cancer and perhaps all cancers. Now I'm going to simplify the science. Stay with me for a moment so you can get a good understanding of how this vaccine and future similar vaccines will work. First, we should note that vaccines against diseases caused by infectious agents have been incredibly successful. In the world of cancer, with one exception, there has never been a prophylactic or preventative vaccine approved despite decades of research. The only exception is a vaccine that prevents many of the cancers induced by certain strains of the human papillomavirus, an infectious agent. The main reason the vaccines against infectious agents have been successful is because the protein or proteins targeted through vaccination are nonself, meaning the immune system sees them as very different from self proteins in the body. Since they are not self, it is relatively easy for the immune system to target them. In addition, they do not exist on or in any healthy cells. This process works for diseases like polio and smallpox and many others like measles, flu and more recently, COVID-19. While there are differences in the approach to vaccination, like protein or peptide vaccines or live or dead cell vaccines and more recently, mRNA vaccines, the underlying principle of immune response and lack of presence of the target on healthy cells are the key characteristics. In cancer, the vaccine approaches of the past have tried to use targets that may exist on the cancer cells in high abundance, but they also exist simultaneously on many healthy cells. So if an immune response is induced against the target, the simultaneous response is often created against healthy cells. Essentially, the vaccine will cause some degree of autoimmune disease resulting in unacceptable side effects. So how did our vaccine get around this problem? We utilize a new theory, known as the retired protein hypothesis, postulated by the late Dr. Vincent Tuohy of the Cleveland Clinic. He and his research team worked on this vaccine for 2 decades before it was ready for clinical testing. The retired protein hypothesis takes advantage of the fact that there are organ-specific proteins that are produced by our bodies at certain times in life for a particular function. When that function is no longer necessary, those proteins are no longer produced in a healthy body. However, if that protein is produced at a future time, in cancer, then that protein can be targeted by vaccination. In the case of breast cancer, and more specifically triple-negative breast cancer, such a protein has been discovered and identified. This protein is known as alpha-Lactalbumin. This protein enables the production of mother's milk to feed an infant. The protein is only necessary when a woman lactates after giving birth. Therefore, a woman's body produces this protein in the breast each time she gives birth. After she stops breastfeeding or reproducing, the protein disappears. However, when triple-negative breast cancer cells arise, it was discovered that those cells express or produce this protein. Realizing this, Vince Tuohy postulated that if we could vaccinate a woman after the age when she will no longer have children, our immune system could be trained to destroy any cell making that protein. Since this woman is no longer going to lactate, the only cells that arise making this protein will be cancer cells. In such a case, her immune system, if it has been properly trained, will destroy those cells. Assuming we can create an immune response against this protein and assuming the only cells making this protein are cancer cells and not healthy cells, then the immune system will view cancer cells in the same way it views infectious agents. So essentially, we have made the cancer look like a pathogen to the immune system. Vince Tuohy and Cleveland Clinic researchers tested this vaccine in animal studies and found the data to be very compelling. So promising in fact that not only did we partner with Cleveland Clinic and acquired the rights to the vaccine through an exclusive worldwide license, but also the U.S. Department of Defense awarded a grant to fully fund the Phase I trial. Now we are testing the vaccine in human studies and the data continues to be very promising. The key question is, how does one know there are no other healthy cells in the body making the target protein? Some studies and literature data indicate that, that to be the case, but there is really no practical way to examine and catalog every single type of cell and organ. That's where the side effect profile has become important. If the protein was expressed on other healthy cells at meaningful levels, the vaccine would induce autoimmunity against those cells or organs, resulting in adverse side effects. But to date, we do not see any of those side effects, so we feel comfortable that other cells in the body do not make this protein. With an understanding of this hypothesis and the data we now have, I hope you can see why we are extremely excited about this vaccine. While this call is focused on the breast cancer vaccine and the reported trial data, I want to remind everyone that we also have a similar ovarian cancer vaccine in development. The Cleveland Clinic is collaborating with the National Cancer Institute on the development of that vaccine. Should the further clinical results of the breast cancer vaccine continue to be successful, we expect the whole landscape of cancer to be impacted. Researchers will seek to discover retired proteins in many other cancers to develop vaccines. With our partnership with Cleveland Clinic, we already have 2 in development, and we are evaluating options to look at other cancers. Getting back to the current breast cancer vaccine, let me ask our guests to say some words. First, let me introduce Jennifer Davis, Jenny Davis, who joins us remotely from her hometown outside of Cleveland, Ohio. Ms. Davis is a nurse, wife, mother of 3 and triple-negative breast cancer survivor. She was diagnosed with triple-negative breast cancer in 2018 and had chemotherapy, radiation, a double mastectomy and was the first person in the world, the very first human to receive Anixa's breast cancer vaccine in 2021 through Cleveland Clinic. Ms. Davis is passionate about preventing breast cancer for herself and all women. I want to applaud Jenny for going public with her journey. While most people want to keep their health issues private, Jenny feels her story will help get the word out about breast cancer and this vaccine. Jenny will be available if any listeners want to ask her questions during the Q&A period. Jenny, the mic is yours.

Thank you, Dr. Kumar. I'm very happy to participate on this call and pleased -- just as pleased as everyone else to see this promising data of the first group of 16 patients whom I am one. I'm a little emotional because, some of you may think that I am privy to this information, but just as you all heard it from Dr. Kumar, this is the first time I heard it. So yes, I'm thrilled and excited, super-emotional, so I apologize. But as many of you know, I was diagnosed with triple-negative breast cancer in 2018. I was 41 years old, my treatment included chemotherapy, a double mastectomy, successive surgeries and then eventually 26 rounds of radiation. I'm incredibly grateful to my medical team at Cleveland Clinic for guiding me through this journey. But I know, it's a brutal process for me and my family. I have 3 kids, my husband, my mom. Everyone -- it was difficult physically and mentally for every one of us. That's why this vaccine -- if this vaccine could prevent cancer in the first place, it would spare patients and families the battle that we all waged. One of the other things that was very important to understand is, the cancer survivors, we all know the statistics about recurrence rates. We all know that if it recurs, especially triple-negative, since we're talking about breast cancer, the outcome could be very bad. Cancer survivors are always worried about the cancer coming back. Whenever there was pain somewhere in our body, we wonder if the cancer has recurred and perhaps spread. Or is it just simply something much less harmless. The type of anxiety is something that cancer survivors of all types of cancer have to live with. While these statistics are kept for 5 years, well known that cancer can recur after the 5-year window. That being said, I'm glad to say that I recently hit my 5-year milestone in September. I received the vaccine in October of 2021, a little over 2 years ago. And having taken the vaccine, the anxiety of recurrence has eased a lot, like beyond words. I really don't think about it anymore. I believe in my heart that this has worked for me and now the data is showing that. I'm pleased that the Cleveland Clinic and now Anixa have allowed me to help get the word out. Almost everyone I know has a friend, family member or themselves who have had breast cancer. And if we can prevent it, I am so happy to be a part of it and so thankful. Thank you, Dr. Kumar.

Jenny, thank you so much for participating in the trial and equally, thank you so much for participating on the call. I should add that, by the time this vaccine is approved, there have been many people like me and other doctors, scientists, nurses and others that will have worked on it. But the most important people involved in development are people like Jenny and the other patients who are allowing us to test this vaccine in their bodies. Now I'd like to introduce Dr. Mike Shepard, longtime adviser and friend to me personally and to Anixa. Mike is one of the most accomplished and famous scientists in the breast cancer field. In fact, several years ago, after I learned of Dr. Tuohy' work and theories, Mike accompanied me to the Cleveland Clinic to meet Vince and his team, to help me evaluate the potential of the vaccine. Mike is a key opinion leader in oncology. He's made seminal contributions to the field of immunotherapy, gene therapy of cancer and precision medicine. Mike is best known as the inventor of the life-saving cancer drug, Herceptin. Herceptin was the first monoclonal antibody therapy approved for cancer. And it spawned an explosion in monoclonal therapies and antibody drug conjugates for cancer. Herceptin still generates sales of over $5 billion per year and is one of the best-selling cancer drugs of all time, having been prescribed for over 2.3 million breast cancer sufferers. Among his many awards and honors are the Warren Alpert Foundation prize from Harvard Medical School and the Lasker-–DeBakey award. The Alpert prize was shared with Dennis Slamon and Axel Ullrich and Robert Weinberg, and the Lasker-–DeBakey award was shared with Slamon and Ullrich for the development of Herceptin. Mike, could you say a few words?

Thank you, Amit, and thank you, Jenny. I'm glad to hear you are doing well. When Amit and I went to visit the Cleveland Clinic and met Dr. Tuohy in 2018, I became very excited about his idea of using retired antigens like Lactalbumin as a cancer vaccine strategy. Dr. Tuohy and his team have now presented the progress that they've made and shown that they can initiate a vigorous immune response in patients. This is a very important first step without which obviously very difficult to go on. So this is a very important hurdle to overcome. Decades ago, when my team was working on Herceptin, there were also a lot of very serious hurdles to overcome. Antibody therapy was not something that anybody took very seriously. We even had an argument once about whether or not antibodies could get into tumors. That almost killed the project. So -- although Dr. Tuohy's team has overcome many obstacles so far, they still have a long way to go and I will be supporting them every step of the way. As everyone probably knows, cancer vaccines have not been particularly successful. And as Amit discussed, this is usually because they are not specific enough -- there's not a good enough target there. That is the targets that are available are actually expressed at a reasonable level on many other tissues. Lactalbumin as a retired antigen is an exception to that rule and offers promise. A vaccine is obviously a Holy Grail for cancer. Many people could be helped emotionally as well as health wise if this approach works. With the data that we've seen to date, I'm really thrilled to see it, and I'm thrilled to see -- to watch the evolution of the project. Thanks very much, Amit.

Thank you, Mike. I appreciate your comments, and I just want to say that just like Herceptin revolutionized the treatment of breast cancer and has found similar treatments for other cancers, I'm hoping that our vaccine will do the same for prevention of cancer. Finally, let me introduce you to Dr. Brian Leyland-Jones, another world level expert on breast cancer. Brian is joining us from San Antonio from the Breast Cancer Symposium, as I noted earlier. Brian joined Anixa as a clinical adviser this year to help guide us as we plan for the Phase II/III clinical trials for this vaccine. He has -- he's a past Chief of Developmental Therapeutics at the National Cancer Institute and has served as principal or co-principal or co-investigator on more than 100 clinical studies. Hence, his guidance will be very valuable. While at the NCI, he coordinated the international development of paclitaxel, a major cancer drug, and while at McGill University, he made numerous contributions to the development of the aforementioned Herceptin. Brian has served as the director of 2 major cancer centers, holding positions as a founding chair of Oncology and Director of the McGill University Comprehensive Cancer Center and Director of the Winship Cancer Center and Associate Vice President of Health Sciences at Emory University. Brian?

Thank you, Amit. And Mike, I must thank you for basically providing 15 years of research in my life. I ran 4 of the major trials of Herceptin. It was a remarkable development. So let's talk about the...

My pleasure.

My pleasure. I did the original 0648G with Dennis, the original medicine.

I know.

Well. Thank you.

I know. It's nice to meet you on the phone.

Wonderful to meet you. So with regard to Anixa vaccine, as a researcher, I am obviously thrilled like everyone else with the data. However, as a clinician, I am even more pleased. Every year, our medical community gets better and better at treating breast cancer. We teach women to do self-exams, get screening mammograms followed by biopsies of any potential suspected tumor. The goal is to find the malignancy as early as possible. Since we are now able to catch malignancies earlier than a few decades ago, we've been able to save the lives of more women than before. I have devoted the last 15 years of my life to aggressive therapy at first diagnosis. It works incredibly well. Unfortunately, as Jenny will tell you and from my experience in my clinical work with many, many thousands of patients, the process is physically painful and emotionally taxing. In addition, the whole process of treating breast cancer or any type of cancer is incredibly expensive. And some of my patients literally have cost -- have spent $5 million in the adjuvant setting. Wouldn't it be wonderful if we had a less toxic treatment that could eliminate cancer from arriving at all? Hence, the Anixa vaccine, which as Mike said, could be the Holy Grail. To me, it is at least a game changer. Data from 16 women is not sufficient for approval, but it is sufficient to begin the planning of the Phase II/III trials with a larger group of women, with control arm to objectively evaluate efficacy. This is where I'm truly looking forward, not only to contributing to Anixa as the company progresses a vaccine, but to bring a less toxic, very early therapy to prevent the cancer from developing further. While we are still in the early days of clinical development of the vaccine, the data looks very promising. It's brilliant to see the safety profile of the vaccine. And moreover, the immune responses in the participants. It is gratifying to work with Anixa on this project. I look forward to additional data from this trial. And eventually data from the successive trial, in which I will participate, which will be blinded and have a control arm. Back to you, Amit.

Thank you, Brian. I can't express how lucky we are to have Brian as an adviser. Brian has been, as I noted earlier, a part of over 100 clinical studies and his advice has already been beneficial and will continue to be as we move forward with Phase II and III. Both Brian and Mike, as well as Jenny are available if listeners want to ask questions. Now let me turn it over to the operator to begin the Q&A portion of the call. Amy, to you.

[Operator Instructions] And our first question comes from the line of Yi Chen with H.C. Wainwright.

Congratulations on the positive data. My first question is how likely the -- well, the observed T-cell immune response translates to prevention of recurrence? What additional data shall we expect to see? And how long will it take to gather those data?

Thank you for the question, Yi. The efficacy -- the proper efficacy data will occur in a Phase II trial, which will be done in a blinded fashion within control arm. And so we're looking forward to beginning the Phase II in 2024, and we will have interim analyses that will occur. In that Phase II, we expect to have a few hundred patients, half -- roughly half of whom will be getting standard of care. And we know that 42% of those patients will have a recurrence and the other half will get the vaccine with standard of care. And we hope that we'll be able to prevent recurrence in 100% of those patients that are vaccinated or some large percentage relative to the control arm. The -- your first -- I think your first question was T-cell response. My personal feeling is that even a very, very modest T-cell response is going to be sufficient to prevent cancer. Because as you know, cancer arises initially as 1 or 2 cells that are aberrant that have become cancerous. And they reproduce to become 4 and 8 and 16 and so forth. And so we believe that if the immune system is ready, which it should be, if it's been vaccinated, then as soon as those handful of cells arise, immune system should be able to destroy them before they become a multibillion- or trillion-cell mass that is a tumor that can be seen in a mammogram. So if it's properly -- if the immune system is properly vaccinated, a very mild response should be able to destroy the handful of cells that arise.

Got it. You mentioned that the recurrent -- the current recurrence rate is about 42% within 5 years, right? So if the vaccine is able to reduce it, let's say, 50%, not just -- not 100%, but just 50%, would that still be clinically meaningful?

Absolutely. That just means that half the women that ordinarily would recur are no longer going to recur. And so that's a tremendous benefit to those women. It's a tremendous benefit to the healthcare system because as Brian indicated, some of the treatments, especially after recurrence in a metastatic setting, will cost the healthcare system millions of dollars. So a relatively safe, inexpensive vaccine could have a major, major impact not only on the patients, but the cost that the healthcare system incurs.

Got it. And, so within these 16 patients, how many doses have been evaluated, could you tell us if there's any observed difference in terms of efficacy and safety between the doses?

Yes, that's a good question. We've used 3 dose levels, and we are testing some additional intermediate dose levels as well before the Phase I is complete. And what we find at the maximum tolerated dose, as I noted in the prepared statements, is that there is no significant side effect besides irritation and bumps at the site of injection. At higher dose levels, specifically higher levels of the adjuvant that we use in this vaccine, we find that some of the irritation sites become larger, and they often, we call it weeping -- they weep a little bit, meaning there's some liquid that's secreted. But still -- there are still no systemic effects, no myalgias, nothing else. But those -- in some cases, those bumps and irritations have required some incision, but nothing major.

I'm curious whether there are any patients who just received the adjuvant but not the vaccine itself?

We have not done that. We have not just -- given patients just the adjuvant.

Okay. I mean, is there any reason to believe that the adjuvant should cause no specific T-cell responses, just by itself?

We anticipate that the adjuvant may -- may induce some sort of immune response, but because the lack of -- the target protein is not there, we don't expect it to create an antigen-specific T-cell response, which is what is necessary for the prevention of the breast cancer -- triple-negative breast cancer.

Got it. My last question is, could you tell us when can we expect to see some data from the other 2 cohorts?

The, oh, the Phase Ib, and Ic?

Yeah.

That's correct.

Yes, the combination with KEYTRUDA and also the patients with mutation positive.

That's right. We are enrolling both of those cohorts. And we anticipate -- we have started both with patients and then we anticipate presenting data on those patients sometime in 2024, depending on how many patients we're able to enroll and how quickly. The key point is that we only anticipate a small number, maybe 3 to 6 patients in each of those cohorts. And unless there are any safety issues that come up, we don't anticipate that those cohorts having any real impact on planning and executing on the Phase II. So those cohort data-- the data on those 2 cohorts will be expected sometime in 2024.

And our next question comes from the line of James Molloy with Alliance Global Partners.

My question would be on -- you talked a little bit about the vaccine being administered to women past years of childbirth. What if you're talking about younger women of genetic mutation or older women past typical childbirth age who sort of get pregnant, what sort of the -- what's the outcome sort of look for these women? And there is also -- is this something that can be used for men as well for male breast cancer?

Yes. Yes, two good questions. Let me take the last question first, Jim, male breast cancer. A lot of people don't know that men can get breast cancer as well. And in fact, 1% of all deaths that occur in the United States from breast cancer occur in men. And I assume that, that percentage is similar worldwide. It tends to be the case that men who have -- who get breast cancer are the ones who carry the genetic risk for breast cancer that is often carried by women as well. Now in the animal studies, we found that we were able to prevent breast cancer or I should say, Cleveland Clinic found that they were able to prevent breast cancer in male mice. But we are not doing a clinical trial related to that. That being said, if you're a male who finds out that you do carry the genetic factors that might induce you to get breast cancer, and this vaccine has been approved for women and it's been shown to be safe, many men -- many of those men might take the vaccine. But we're not doing clinical study on that at the current time. And we don't have any near-term plans to do that either. Your first question regarding what happens if a woman is vaccinated and she has a child, she becomes pregnant, whether it's by choice or accidentally. The animal study showed that when we vaccinated an animal and that the animal had a litter, the pups were perfectly normal. There was no issue with the litter. However, the mother was not able to produce milk because the vaccine was probably destroying those cells making that alpha-Lactalbumin protein. As a result, the mother was not able to feed her pups. In the case of humans, you should be -- humans can feed their babies with formula instead of mother's milk -- breast milk. So that shouldn't be an issue. However, there will probably be inflammation in the breasts for those women. And so ideally, we would like to vaccinate women who are well past childbearing age, which is typically when most women get breast cancer.

Maybe a follow-up call for other doctors on the call. Doctors, I know that the cancer vaccine has been -- cancer vaccines have been a challenging development space. What you guys see in particular in this vaccine that gives you hope, obviously, it's early yet, but certainly looks very promising. What in particular gives you hope that this may be the -- you may have found a way to avoid some of the pitfalls that were found with other cancer vaccines before.

Maybe Brian?

Well...

Go ahead, Brian. And then maybe Mike comment...

I'll take a shot at that. So I can't remember which year it was, but after about 15 years, Michael knows this. 15 years of monoclonal antibody development, everyone knew that monoclonal antibodies will never work. And then within 5 years, the whole field of monoclonal antibodies is exploded. And so I think we're at the similar point with vaccines. I think the approach of the Cleveland Clinic is wise. I think it's conservative. I think this is a potential game changer. We've got an excellent target in there, the alpha-Lactalbumin. I mean I just think that we've reached that pivotal point, just as we have when Herceptin was brought in as the first monoclonal antibody. Mike?

Well, that's my hope as well, Brian.

Exactly -- so I admire the advisers, I admire the clinical team, I admire Amit. I think what they present is modest, relatively understated. I think it's a brilliant conservative team. I have immense hopes on behalf of so many breast cancer patients that this will work.

Okay, the final question, Amit. Amit, on the Phase II/III, I think you should start it in 2024 with potential interim looks -- when how -- a couple of hundred -- a few hundred participants. What do you think the time line is for interim looks and potential top line data? And will this be something of the U.S. government or is it something that privately fund or partnerships?

All of the above. We are seeking some funding from the government. We have capital on our balance sheet, and we are talking with pharma companies as we go forward. So it's yet to be determined what combination of funding will be utilized for that. We anticipate the Phase II will take some years, we -- it may take about 5 years to complete the -- to fully run the Phase II. But we anticipate that we will have many interim checks. And if we are seeing tremendous efficacy, then it's possible that we will be able to partner this with a large pharmaceutical company very quickly after we begin Phase II.

And our next question comes from Tony Bowers with Intro-Act.

Amit, great to see this data. First of all, a shout-out to Jenny for being so brave to start the process. I hope you and the 15 others remain healthy forever. I don't know if you are kind of monitored now with your -- already thinking about a booster shot, given how, I guess, comfortable the initial program was, whether that's something that's under consideration, but hopefully, it won't be necessary. And I guess, the persistence question will be answered at some point in the Phase II. Question for Amit.

Yes. I mean, Jenny and the other 15 and future patients in the trial will be monitored using standard of care screening, which will occur every 3 or 6 months depending on their particular physician. And as you said, Tony, we hope that every one of those patients remains cancer-free forever.

Is the -- trying to find a target like the alpha-Lactalbumin, I mean it seems to me that breasts producing milk and ovaries producing eggs, they have kind of a natural time cycle. So when they serve their useful purpose, I can see that there's the opportunity for a retired protein to exist that comes back with the cancer. But it doesn't -- that logic doesn't necessarily seem to apply to lungs and pancreases and other organs that might develop cancer. Are you feeling that the retired protein concept could equally apply to other cancers or it will be more difficult to find such a narrow bulls-eye, where you're not going to have collateral damage?

That's a good question. We do believe that there are other retired proteins that exist for other types of cancers. They are going to be hard to find, but we believe that they exist. And once we find them, we will be able to utilize them as targets for vaccination.

With the ovarian program, I'd presume, is that already in animal work?

That's correct. It's in animal -- it is in, in vivo animal studies right now.

The animal studies on the breast cancer was -- it was binary. It was such a brilliant result.

Yes. In that particular case, it was. Part of the reasons that animal studies are often not correlatable between different types of cancers because -- is because animal models are different and cancers are different. And so we don't have a direct comparison study for the ovarian cancer. But the data, much of which has already been published is looking great in the ovarian cancer situation as well.

And this concludes today's question-and-answer session. I would now like to turn the conference back to Dr. Kumar for closing remarks.

Okay. Thank you, everyone, for attending. I'd like to especially thank you, Jenny. Thank you, Brian and Mike, for attending this call and taking questions. And I encourage everyone to stay tuned as we continue moving this forward and presenting more data. Thank you.

And this concludes today's conference call. Thank you for participating. You may now disconnect.