Hello and welcome to Virtual Investor Conferences. On behalf of OTC Markets, we are very pleased you have joined us for the Life Science Investor Forum. Our next presentation of the day is from OS Therapies. Please note you may submit questions for the presenter in the box to the left of the slides. You can also view a company's availability for a one-on-one meeting by clicking "Book a Meeting" in the top toolbar. At this point, I'm very pleased to welcome Dr. Harrison Seidner, Head of Investor Relations of OS Therapies, which trades on the NYSE American under the symbol OSTX. Welcome, Harrison.
Thank you for the introduction, Greg. I guess I can just go ahead and jump into the presentation here. OS Therapies, clinical-stage drug development company, as he just mentioned, publicly traded on the NYSE American, ticker OSTX. This our lawyers like us to put up there, so I'll leave it up for just a few moments while you have the opportunity to read. It's also available on our website, ostherapies.com, where you can find updated versions of our corporate deck and all of our contact information as well. Bit about the company, just some highlights. We are developing a Listeria-based cancer vaccine. We don't always call it a cancer vaccine. It's an oncology immunotherapy, essentially. And what we're doing is we're targeting tumor cells by making cancer tumors hot to the immune system.
In the slide are just a few highlights about where the asset came from, where it's going, and what we're currently doing. All of the portfolio, the assets for the Listeria program, came from a company called Advaxis. They've invested over $300 million to get certain aspects of it to where it is today. OS Therapies acquired the Listeria-based assets in April 2025 and have taken it forward since. Our lead program is OST-HER2. That's the Listeria program targeting HER2 cancers. The lead program in that platform is targeting pediatric osteosarcoma, recurrent, metastatic, and pulmonary. That means the tumor had been resected in these child patients. The tumor came back, was resected, and that's where we intervene. And there is not currently a therapy approved or a standard of care for that clinical setting. Some highlights here are the two platforms that we have.
I'll talk mostly about the OST-HER2 Listeria program, but we also do have an antibody- drug conjugate that I'll touch on a little bit further. Some near-term catalysts and milestones are meetings. Actually, one of them is happening as we speak. It's today with FDA. It's a Type C meeting. There was earlier this week the U.K. MHRA, which is essentially their FDA, as well as the EMA, which is the European Union's version of the FDA, and other BLA filings, which we expect to do in the first quarter of 2026. We already have our BLA number. Another major milestone is our spinout company, which is the Canine Animal Health Program, which is actually the exact same program, and I'll get into this a bit further, as the Listeria for humans, for pediatrics, for osteosarcoma.
It was actually already approved by, conditionally approved by the USDA, U.S. Department of Agriculture, for dogs. That was licensed to a company called it was Eli Lilly's Animal Health Company, which they've spun out since. A bit about the market, market size is over here. But I want to focus. I also want to mention that the osteosarcoma market is just one market we're targeting, so lead program. HER2 is in a bunch of different cancers. It's overexpressed in several cancers, and naturally, think of breast cancer when you think of HER2. So that's down the line. As I said, lead program, OST-HER2. We published our phase II-B data earlier this year. We have Orphan Drug designations, Fast Track, and Pediatric Disease Designation, which makes us eligible for Priority Review Voucher..
I'll talk a bit more about the Priority Review Voucher., as it is of major value to us and to whoever acquires it, which we've communicated that we do intend on selling. Before we had these licenses, the program, when it was at Advaxis, they targeted HPV, HPV-related cancers. We still have those programs. We're not prioritizing that. As I said, our lead program is pediatric osteosarcoma, and we have other pipeline therapies for other indications, all using that same platform, or many of them are using that same platform. That includes breast cancer, which we have some data for, as well as that same program in the spinout company for canine use. This is a bit about our preclinical programs in the tunable antibody- drug conjugate. Really, I'll touch on it a bit here. We're able to target it to cancer based on essentially how we wrap this ADC.
It's pH dependent. So in an acidic environment, it's able to release the payload or able to expose the antibody- drug conjugate. So we're able to get it into tumors and have fewer off-target effects. In a nutshell, that's how I would characterize it. Our scientific advisory board is extremely impressive. We have multiple top-tier university hospitals and foundations backing us. A lot of them are also investors in our company. And a lot of them came in while we were still private, before we were a public company. Here's some of their names. Some more about our partnerships and strategic partners. Would like to point out we were highlighted in a 60 Minutes piece, and recently we were nominated for Emmys for a movie that was actually made about OS Therapies, as well as the animal health programs that we're developing that are analogous.
They highlighted the correlation between this disease in dogs and how close it is to the disease in humans. Osteosarcoma, fancy way of saying bone cancer. 1,000 cases per year in the U.S., 20,000 globally. I don't need to read all these slides. You could also read, but I'll talk through a little bit about it. There's no standard of care for the clinical presentation that we're targeting, and as I said before, you have your primary tumor. It's osteosarcoma, so it's in the bone. It's usually in the leg or another long bone. The standard of care is you amputate that leg or that limb, wherever the tumor is. Then you treat them with chemotherapy, which 10% of the time will actually kill the patient itself with the adverse effects that it causes, and there's no secondary treatment, which is what we're targeting.
Bone cancers typically will metastasize to the lung or brain. We're targeting it in the pulmonary indication, so after it's metastasized to the lung. and as you could imagine, you could only operate on the lung so much. so it's an important area. Here's a schematic of really how this Listeria approach works. Listeria, it's a bacteria. It's out there in the wild. People are exposed to it all the time, and our bodies are very good at fighting it off. We sort of leverage that immune ability to help our immune system attack cancer. and the way that we're doing that is we have our Listeria, and we add inside of it an interchangeable payload. Currently, we're using HER2, as I said. We could put other payloads in there in the future. It's a platform, and we'll likely get a platform designation at some point.
Right now, it's a HER2 platform. So it can target any cancer that expresses HER2. Here we go after osteosarcoma. I mentioned that we could go after other indications that have HER2. Most people think of breast cancer. Nice thing about going after pediatric designation or a rare disease is because FDA is a little they prioritize that. So we could get it approved, then target other indications where maybe there's a bigger market. But basically, what we do is we target it to the cancer cell, delivers that payload, starts expressing more, or it puts that onto the surface, essentially amplifying the immune response. You made your tumor hot. It made a cold tumor that was evading the immune system. It made it detectable by T cells, NK cells, all different types of cells that kill your cancer. Here's some details about our phase II-B study.
It's somewhat standard about how we did it. The primary endpoint was event-free survival. Secondary endpoint, overall survival. Event-free survival means that there was not a recurrence. Overall survival is just patient survival, and here's some milestones and a little bit of data. I'm not going to dive too deep into the data, but I will point out that it's promising. From 40 patients, or roughly 40 patients that we evaluated at the 12-month endpoint, the event-free survival was 36%. That's a huge improvement to the standard of care that's there, that doesn't exist, and what other patients have been experiencing as a cohort in general. The historical control that we're comparing that to is 20% without our therapy, and that's statistically significant, 0.016. Continuing that at the two-year, the overall survival, 75%.
That's a marked increase compared to the 40% we're comparing it to with 0.0001, actually was a little smaller than that, of a p-value. Again, statistically significant. Some major milestones. I touched on this before. The EMA meeting, we achieved alignment with the agency on December 2nd. The U.K. MHRA, that was earlier this week, again, achieved alignment with them on two-year overall survival, biomarker correlation. Today, we're meeting with the FDA for our type C meeting. This is a big day for the company. We expect to have more clarity and/or potential alignment with a lot of this exactly very similar to what we already achieved alignment on with the U.K. regulatory and the European Union regulatory bodies. Some other milestones coming up after that. In January, we expect to file for this one, U.K. MHRA, for approval.
In the U.S., we already have a BLA number, but we expect to file for approval, and if we are to get it, likely within three to six months of filing. We plan on filing sometime in first quarter 2026, very soon, and similar for the EMA. Something to note is if we do get these approvals, at least in the U.S., we will be eligible for our Priority Review Voucher., which previous Priority Review Voucher.s have sold for upwards of $150 million. That would capitalize the company very nicely and enable us to focus additionally on some of the other programs that I talked about that I'm not really dwelling on because we're laser-focused on the OST-HER2 for pediatric recurrent metastatic pulmonary osteosarcoma. A bit about the animal health company. We spun this out a while ago.
Recently, as a couple of weeks ago, we announced that we plan on taking the company public onto a major U.S. exchange. I haven't disclosed which one or how we'll go public. But we did indicate that current shareholders of OSTX will participate in equity. And I don't remember exactly how we phrased it, but there will be equity participation of OSTX shareholders. So that's a value. The tech came out of UPenn. As I said before, it was originally approved for canine use. USDA approved it. It was marketed by Eli Lilly's subsidiary, Elanco, before we got this license back. And here's just a bit about that story. Here's a little bit of data about the breast cancer program. Not going to dwell on it.
It's preclinical, but know that we are looking into it, and we have data indicating this as a potentially promising indication to target more about the breast cancer. I mentioned before that there's a whole bunch of other indications that are other cancer indications that express HER2. Here's a list of some of those. I don't know if you're able to see it, if you're able to zoom in. But again, laser-focused on osteosarcoma. After we get approval and we have our revenue and we've sold, if we receive our Priority Review Voucher., that's when we'll target these other indications. I want to make it very clear that we're laser-focused on that program and getting that across the line. Here's a couple of the other programs we're developing. Again, OST-HER2 osteosarcoma is the lead. This is a bit about our ADC platform.
I'm going to skip through this because it's not the top priority, as I can't stress enough. Management team is extremely strong. CEO is Paul Romness. He was at Johnson & Johnson, Amgen, other big pharmas, Boehringer Ingelheim. Robert Petit was one of the leads at Advaxis. He helped bring this program from the get-go. Gerald Commissiong, Chief Business Officer. He's been through these processes before. He's been successful multiple times. And additional strong team to help. Key takeaways. I went through this, and I'll stress it. A bunch of regulatory milestones upcoming in the next couple of months. Significant value in our Priority Review Voucher if we get it and we sell it. And our leadership has done this before. So we're confident we can do it again. And here's some contact information. If you want to reach out to us, feel free. OSTX @ waterside.com.
You can also find that on the website, the ost herapies.com. You can find the deck as well as our contact information. At this point, I want to thank everyone for listening, and I'll open it up to questions.
I have one question asking, are there any name brand institutional investors on the cap table? If you had asked me this about a month ago, I would say no. It's mostly retail investors and family offices. Currently, and actually, I was looking at it earlier, so I have it open on my other screen. As of recent 13F filings from November, we do have a bunch of institutionals starting to come into the stock, which is really nice to see, and I'll rattle off a couple of them: Millennium, State Street, Susquehanna, Two Sigma, Marshall Wace, Geode, BlackRock, Vanguard, and some other notable names.
That was just the first that I could see. How closely do you expect the FDA to follow the same approval approach as the U.K.? Already signaled for HER2, for OST-HER2. We think they're going to do something very similar because they communicate. Very rarely will you see a company get two different responses from both agencies. Of course, I can't predict the future. But definitely do keep an eye out for our press releases. We're going to announce it as soon as we have the minutes. We're going to make sure the markets know exactly where we stand with both agencies. Someone asked, how are you thinking about financing the company between now and potential approval, so we're funded through middle or end of 2026, I want to say, and fact-check me. Definitely look at our filings. We've put this out there.
But if we get our PRV, that's going to be we would expect somewhere upwards of $150 million, right? The last one sold for $160 million. If they stop with the Priority Review Voucher program, PRV program, it'll become even more valuable. So I can't put a number on that, but I would expect it, if they stop it, to be even more than that. For those of you who don't know what a Priority Review Voucher. is, basically, it's an incentive program by the FDA to help develop drugs for rare diseases. Companies get awarded for developing drugs for rare diseases by being issued this voucher, Priority Review Voucher.. And it is what its name indicates. It allows you to get priority review. So a smaller company has less need for that. They'd rather have the cash.
Big pharma really wants these Priority Review Voucher.s because if they could commercialize their drug earlier, it means a lot more money than what they paid for the Priority Review Voucher.. That's why we've indicated that we do intend on selling that to likely a big pharma buyer for the market price. How big is the dog osteosarcoma market? I'll tell you, osteosarcoma is the leading cause of death in dogs. If you've ever seen a dog with three legs, probably it was osteosarcoma, second leading cause of death, as what I understand is from automobiles. But most of the time when a dog has cancer, it is osteosarcoma. So it's a huge business, billion-dollar industry. That's why Eli Lilly was interested in it.
It makes sense, and it gives sort of a stamp of approval when you see a company like that have their animal health subco developing a drug or commercializing a drug in that space. And that's it for the questions that I'm able to answer. There were a few questions where it would require me to share MNPI that I can't. So I'm sorry, but keep an eye out for our press releases and our SEC filings. You'll be able to see all of our updates over there. Any additional questions, feel free to email me.