Zacks Small Cap Research – OTC Markets Hosts Virtual Investor Presentation with James Passin, Founder & CEO of BioVaxys Technology Corp, and Brad Sorensen, Senior Analyst at Zacks SCR – Technologist

OTCQB:BVAXF | CSE:BIOV

OTC Markets: Hello and welcome to Virtual Investor Conferences. My name is Cecilia, and on behalf of OTC Markets, as well as our co-host Zacks Small Cap Research, we’re very pleased you’ve joined us for our next live presentation from BioVaxys Technology. Their session will be moderated by Brad Sorensen, Senior Equity Research Analyst with Zacks Small Cap Research. Please note, you can submit questions with the presenter in the box to the left of the slides. You can also view company availability for one-on-one meetings through the Schedule Meetings tab found on the conference platform to welcome James Passin, founder and Chief Executive Officer of BioVaxys Technology Corp, which trades on the OTCQB venture market under the symbol BVAXF, and on the CSE under the symbol BIOV. Welcome, James and Brad.

James Passin: I’ll provide a brief introduction to BioVaxys. I’m James Passin. I come from a hedge fund background. I managed a hedge fund for 18 years in New York. We’ve managed a large portfolio that is quite active in biotechnology. However, I would consider myself to be an entrepreneur and not a pharmaceutical specialist. My colleague, Kenneth Kovan, is a lifelong pharma and biotech consultant, executive, and advisor and he has deep knowledge of the industry. Dr. David Berd was a pioneer in cancer immunotherapy. He’s our Chief Medical Officer.

JP: We are a clinical-stage biopharmaceutical company dedicated to improving lives with our technology, which is based on DPX, which I’ll get to in a minute. It’s an immune-educating platform. We also have another platform called Haptenix, which is a way to create therapeutic vaccines for cancer. We also are targeting other indications, including infectious diseases and allergy desensitization. The most important thing to know about my company is that in February of this year, we acquired 100% of all the intellectual property owned by a now-bankrupt Canadian biotechnology company that was listed on the NASDAQ called IMV. We have over 120 patents we acquired and other intellectual property as well. IMV was a very important stock. They invested about $200 million in R&D cumulatively. They had excellent results in many peer-reviewed and published clinical trials. It was funded by very large life science investors, even the Canadian government. It’s peak market cap was over $300 million USD. Unfortunately for IMV shareholders, the company went bankrupt. But we picked up all this intellectual property for $1 million in February.

JP: The core problem with current vaccines is that the aqueous emulsions that are used as a delivery vehicle don’t stay at the site of injection. They leach the cargo out into tissues, which potentially could have very serious toxicity issues, not to mention less efficiency. Also, quite limitations in the size of payloads. mRNA also has issues with getting better quality lipid-based delivery technology. With the DPX platform, it’s a lipid and oil emulsion. It’s an immuno -encapsulation technology. There’s no aqueous component, so it stays at the site of injection. Also, we can freeze it, store it for years, and accommodate much larger payloads than simply, for example, mRNA. We can accommodate proteins, peptides, virus-like particles, and innate immune stimulators.

JP: Haptenix is our legacy platform. This is a way to create an immune response against neoantigens. We have a robust clinical pipeline. We have phase three ready assets, MVPS, which is, in this indication used for ovarian cancer. The phase two results were published. You can read them. The results are great and very encouraging. We also have, phase one and phase two ready assets, both in various oncology indications as well as RSV and anthrax. The newer initiative we have is in allergy desensitization. We’re very excited about that. In terms of corporate development, we’re looking to license or partner most of our advanced clinical-stage assets because the amount of capital involved is quite significant.

JP: MVPS targets the survivin antigen, which is over-expressed in certain types of tumors, including in the case of ovarian cancer. It’s well known as an interesting target for cancer. MVPS is in the DPX as the immuno-encapsulation of survivin. The results have been great. We’re excited for the phase three trial. As I mentioned, we’re looking for a partner to actually take that over. DPX SurMAGE; it’s very exciting, a bit earlier stage. That includes some additional MAGE antigens. It’s hitting more targets. We’re looking to out-license DPX-RSV because there is an approved RSV vaccine. However, the results from the work that IMV did are very encouraging.

JP: Then our preclinical phase on assets DPX mRNA. The first mRNA vaccines that were approved under emergency use authorization were BioNTech/Pfizer and Moderna for COVID-19. It’s widely believed that there’s an mRNA revolution coming with personalized cancer vaccines using mRNA. We believe that DPX is the ideal delivery vehicle for mRNA. If that’s the case, it’s going to have immense value to the pharma industry. So that’s one of our products. We also have DPX with neoantigens and very, very interesting results in terms of the preclinical research.

JP: We’ve recently signed an agreement with a private company in Canada that is going to essentially run the preclinical work on peanut allergy as well as egg allergy in animal models. What’s quite exciting is with that particular product, a single subcutaneous injection would be enough over time to result in allergy desensitization. This would be huge because the current approved treatment involves multiple injections. Flu has really interesting results. We think that there’s definitely room for a more efficacious flu vaccine. We have two licensees in animal healthcare one of which is Zoetis, which is listed on the New York Stock Exchange. It’s an $80 billion market cap company. It was spun out of Pfizer. It’s the largest animal healthcare company in the world. They’re using our previous version of our lipid encapsulation technology to deliver an antigen.

JP: It’s an immunocastration vaccine, essentially suppressing fertility. This is very important for farmers to be able to manage their livestock and not have most of the calories going into bearing babies. Zoetis’s first target market is Australia and then Brazil. Those are huge markets for cattle. Potentially, we could get license revenue, once they get approval. They’re obligated to pay various milestone payments a license, and a royalty to us on revenue. Our other partner, SpayVac, is using it for similar indications and not in cattle. They’re focused on wildlife, fish farming, and a number of very interesting indications. SpayVac is expecting to get approval in the United States next year. What’s great about animal healthcare is you don’t have to deal with the FDA or equivalent regulator. It’s much easier to get regulatory approval for animal healthcare. Potentially, we could get income streams from two licensees. Then we’ve in-licensed from Merck the survivin antigen, which I mentioned earlier. ProCare Health Iberia. It’s a large private women’s healthcare company based in Spain, and they’ve partnered on our Haptenix -based ovarian cancer vaccine.

JP: In terms of milestones this year, as I mentioned, we acquired the IMV Intellectual property in February. We’re strengthening our research team. We’re recruiting some leading people involved in IMV doing the research to come in as advisors and help us sort of rebuild all the work that IMV was doing. We’re getting more and more information about trials that were not completed as a result of the IMV bankruptcy and the collapse of funding for those trials. The data is really quite mind-blowing. We want to expand the board and management team and bring in some more people from the pharma and biotechnology industry who could help us develop BioVaxys following the IVM IP acquisition.

JP: We’re going to launch preclinical work both on allergy and mRNA. We think both of those are massive opportunities. In terms of the investment opportunity we bought $200 million of R&D for $1 million. Our market caps a fraction of what IMV was trading at over a long period of time. There are numerous peer-reviewed and published trial results from the excellent work that IMV was doing. We have phase three ready assets. It’s great because we didn’t pay for the phase one or phase two trial. Our technology is widely relevant to the pharma industry and the biotechnology industry because everybody needs a better delivery platform. We think we have the best because of its versatility and its overall safety and efficacy profile. All right. Hey, Brad, I’ll take it over to you.

Brad Sorensen: All right, thanks. There is a lot to talk about here; a lot going on with this company. It is very exciting and has a lot of developments that we can talk about. Let’s go back to the beginning because, as an investment guy, I’m sure the investors are all kind of asking the same question I am and want you to negotiate our next home purchases and car deals. How do you come across $200 million worth of research for a million bucks?

JP: I would fully admit it’s luck, but it’s also tenacity. I was familiar with IMV. We really admired IMV in terms of their science and clinical progress. I never bought stock, thankfully, so I didn’t follow IMV from a financial point of view. I was quite surprised when the company went bankrupt. Initially, the bankruptcy estate hired a consulting company called FDI to market the intellectual property. We were invited to participate in that. We then signed a nondisclosure agreement. We looked at the data. We just fell in love with the opportunity. That sale process failed. Then what happened is the secured lender to IMV that already had collateralized the intellectual property, made a credit bid and swapped part of their debt for all of the intellectual property. That was approved by the bankruptcy court in Canada as well as in Delaware. Then they had a sale process, and we were invited to participate. We ended up with a winning bid. We started good-faith discussions at the end of last year. Thankfully, we completed the acquisition in February of this year.

BS: Wow, that’s great. One last kind of big-picture question. Since you knew the financials and had studied the previous company. They failed. I mean, bankruptcy is a failure in the business world. We talk about that, even though they have some very successful research. What are you going to do differently? What can investors expect you to do differently than IMV was doing to create a valuable company for them?

JP: Yeah, it’s very simple. Our burn rate on an annualized basis is 94% lower than what IMV’s average burn rate was. For a pre-revenue company to have a very, very high burn rate with very high salaries and lots of fixed costs, it becomes difficult, especially if you’re trying to do $20 million to $40 million of clinical research and product development every year. Our goal is to keep our overhead as tight as possible, be very careful about when we take on obligations to spend money, and really focus on the science, on business development, on partnerships, and on building a team organically. Now that we’re onboarding we’re going to have a lot of announcements about former IMV people coming on as advisors. They’re going to help us build up a team that will be able to get us back into the game of developing newer products. We will look for licensing and partnership opportunities. We know that we have the ideal delivery platform for antigens and other things. We need to get in front of the right pharma and biotechnology companies to take a look at our delivery platform. Our focus is to get some licensed revenue as opposed to, as they say, YOLO on a very expensive phase 3 trial. That’s the way we’re looking at it. We see a lot of opportunities to develop the preclinical assets that are quite exciting.

BS: Let’s go to that then next. Is there a two-stage theory that the later stage assets we’re going to develop with partnerships, but we’re going to develop the preclinical ones in-house, and that’s why you’re bringing in the researchers that you can from IMV and maybe some other places to do that? Is that the plan at this point?

JP: Yeah, absolutely. I won’t roll out the phase 3 trial, but I’m cognizant of our market cap, which is quite low. We don’t want to burden the equity with funding a very expensive trial. I’d rather partner it out and give away some of the economics but still get some upfront payment, significant royalties, and milestone payments in the backend.

BS: Okay. You’ve seen, and investors can go out there and see, as you said, go out and read that those late-stage treatments, the phase one and phase two results, have been pretty impressive. I don’t want to take you down a road you can’t go, but have you begun those discussions about partnerships, or are you still determining? Because it’s a very quick process. You just bought the company in February. Are you still determining the assets and getting advice on how much they might be worth, or have you just started those discussions at this point?

JP: Excellent point. It’s still early stage. It’s been great. We’ve onboarded somebody from the finance side of IMV who has a lot of information about the pharma and biotechnology companies that IMV was talking to. It’s quite helpful. We have had a call with a mega Japanese pharma company, but it’s very early. I’m not going to say that we’ll have a licensing deal tomorrow, but we’re starting the process. We will continue to get more aggressive as we get more data. This was a very complicated bankruptcy and then a sale of intellectual property. We’ve been gathering some of the data, but not all of it was available when we did the deal.

BS: Right, I understand. And yeah, as you said, this is a very quick process, and I think that’s why it’s helpful to be in a situation like this, to get the information out to investors. It’s a convoluted process to figure out, and what’s at the end result is a very intriguing company. I want to touch briefly on this because I think this is the thing that could bring in the revenue the quickest and maybe the most eventually. What is your vision for the DPX delivery platform? Kind of in the basic terms, why the DPX platform is better than what’s existing, and then what your vision is for it going forward.

JP: Yeah, so just in a quick summary. Every other lipid-based delivery platform that we’re aware of, has some aqueous component. When you have hydrophilic and hydrophobic components in the same encapsulation technology or emulsion, they’ll begin to break apart in the body.

JP: When it begins to break apart in the body, the contents leach out of the cells. It does generate an immune response, which is great. There’s no argument there. But, much of the content you’re delivering is just going into tissue. What generates an immune response is the adaptive immune response, which consists of T cells and B cells, are the lymph node system. You want to communicate with lymph nodes. Anything else, it’s great, but it indirectly will go to lymph nodes. So DPX, because it stays at the site of injection with a subcutaneous injection, is actively taken up by antigen-presenting cells in dendritic cells to deliver the information to the lymph nodes that then generate the T-cell and B-cell response. That’s all that it does. It’s not accumulating in the liver or kidneys or circulating. It’s staying at the site of injection, communicating with the lymph node system. Theoretically, it may have generally had a better safety profile. Also, we believe it’s more efficient. It’s more efficacious because the whole system of DPX is based on communicating with lymph nodes.

BS: Yeah. You get more bang for your buck. The treatment gets where it’s supposed to go much more efficiently.

JP: Yeah. One other thing on DPX is it accommodates very large payloads. You can load it with multiple antigens. You can load it with peptides and larger particles. Some of the lipid nanotech areas, for example, aren’t only good at accommodating very tiny cargo like mRNA. Now we can accommodate mRNA, but being able to package larger stuff in it provides a lot more breadth of products that we can develop. An example of this is peanut. There’s a particular peptide in peanuts that causes the allergy. We can load that peptide to DPX, and then DPX communicates to the lymph nodes, and we can educate the immune system over time to desensitize, for example, peanuts, but it could be anything dog, cat, eggs, whatever.

BS: Yeah. That is very helpful. Getting that treatment to the required place is a huge step forward. Is the DPX platform market-ready, or is there more testing that needs to go on? You mentioned about safety. Is there still some safety testing that needs to go on, or is it marketable right now?

JP: I mean, look, there’s been outstanding safety and efficacy data from the excellent work done by IMV in various phase one and phase two trials. There’s no issue there. However, none of the DPX products have been approved by the FDA or equivalent regulator overseas. To get approval, we, or some third party, need to do a phase three trial and then present the data to the FDA or whatever regulator. What I will say is there’s utterly immense money pouring into, for example, personalized mRNA-based cancer vaccines. We think we have a better delivery platform than the ones that the main developers are using. There could be an opportunity there, for them to use whatever they’re doing into our delivery platform. Then we have our own products surrounded by our patent portfolio where we control the products, and we already have in-license, for example, from Merck survivin. We didn’t do it, IMV did it, but we have the benefit of that in-license.

BS: There should be a lot of interest in this because you can use it with your technology, but also a lot of other people can use it with theirs as well. I’m sure lots of people out there, even listening, have children with allergies and peanut problems. My wife’s a teacher, and she knows all about these peanut allergy problems. So, explain a little more about the results you’ve seen and your excitement about the allergy treatment you are developing.

JP: I mentioned one of our licensees, SpayVac, that is doing some animal health applications, and immunocastration. In some of the studies that they’re doing with their own research partners, there are significant research organizations. For example, there’s this study, believe it or not, in elephants in Thailand. There’s an overpopulation of elephants. What they found is that one shot, with our lipid encapsulation technology, this is not DPX; it’s like right before DPX. It’s what became DPX. One shot with an elephant would last seven years.

JP: We know that it’s long-lasting from the animal data as well as the human data. The problem with the existing approved allergy treatment is that I know this personally because my son has a very bad peanut allergy. I’d take him to the hospital. He was a toddler, and so my wife and I considered going through the desensitization protocol. I don’t remember the exact schedule, but it was something like weekly injections for two years. It’s just not practical. You’re going to have to go to the doctor every week. Very few people go through that process. I mean, I would say some adults that are obsessed with cats they’ll go through the process. But it’s a big issue because now if there could be one or two shots, and that’s it. That’s going to completely dominate the allergy desensitization market.

BS: Yeah, definitely. You’re in preclinical with that?

JP: Yeah, we’re in preclinical; we’re about to fire up with McMaster University in Canada, a fantastic university. They have a great allergy division department. The whole thing is ready to go. We can do preclinical research and see the data, which we think will be great. Then move on to human studies. What I like about allergy is that the trial costs should be much lower than oncology because you’re not dealing with dying volunteers. You’re dealing generally healthy volunteers. I’ve seen clinical trials for allergy desensitization with very modest budgets. We think we could fund all the way to phase three ourselves.

BS: Yeah, that’s what I’ve seen too, that those allergy trials, you have much more willing participants a lot of times because they want to get rid of their allergies, and they’re very prevalent. It’s not hard to find people with allergies who want to get them treated and are willing to undergo these trials. Well, there are a lot of other things we could talk about, but unfortunately, we’re running out of time. I wanted to give you a chance just to wrap up. I encourage investors who have more questions, there’s a way to contact the company on the slide, or after the presentation, there’ll be information about how to schedule a one-on-one. They’re very willing to answer questions. They’re very excited about what they’re doing. I’m going to leave it with you, James, to finish this off.

JP: We now control 200 million R&D. We paid almost nothing for it. I believe that will be one of the great biotech and pharmaceutical acquisitions of the decade. There was a deal yesterday with a Canadian company that has a lipid-based nanotech delivery platform. They did a $600 million licensing deal that was just announced yesterday with a large pharma. We have a lipid-based delivery technology platform. We have a tiny market cap. We’re going to keep the burn rate low so we can deliver for shareholders. I am the largest shareholder, so I’m very motivated to have the stock appreciate and to develop liquidity.

BS: Well, yeah, a company with low cost, high research, and a very invested owner is always something that investors should look at. We’re out of time. I want to thank all the investors that have listened in and like I said, please contact the company if you have more questions. It’s very interesting and offers a lot of opportunities. Thank you everybody.

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