All right, good afternoon, everyone. Thanks for joining us here in person or online for this fireside session with ImmunityBio. My name is Clara Don, one of the biotech analysts here at Jefferies. Here, sitting next to me is CEO of ImmunityBio, Rich Adcock. Welcome.
Thank you.
Rich, there has been a lot of momentum for ImmunityBio over the past years, coming from ANKTIVA's approval and FDA authorization of EAP for BCG and just a broader pipeline kind of anchored by ANKTIVA. Maybe just I'll hand it over to you to kind of set the stage. How would you describe ImmunityBio's mission and where is the company today?
Yeah, so first of all, thank you and welcome to everybody who's here. What I always tell everybody is when you think about ImmunityBio, the first thing, and I say this literally time after time again, is you can't think about ImmunityBio without thinking about Dr. Patrick Soon-Shiong. Patrick set out this vision and mission for the company literally decades prior. And I say that not just in reverence, but in very pragmatic terms. His entire philosophy and premise was that to treat the most complex oncology, cancer, and infectious diseases, you have to do it in combination therapy. Now today, that sounds like well-dubbed because everybody's saying that. When he said that originally, everybody said, no, no, no, you've got to do it just one thing at a time. But it's not, and it's really all about how do you bring the immune system back into balance.
That's really what this entire approach is. Now you see a lot of people following the work that we've been doing in those. I say that as kind of a level setting of those. What I'm incredibly proud of is the team at ImmunityBio has been very diligent. Some days we deal with, and not some days, every day we deal with the most exciting, most advanced therapeutic drugs on the planet. The work we do becomes very routinized because you have to. That's actually how you move it through to approval is honestly the boring. I did one thing, I do the next thing, I do the thing after that. What is great, and I'll just share with everybody here, is we had our board retreat, our national sales retreat.
I said, if you look backwards at the last two years, you look at the year ahead of us, so 2026, and then the two years in front of that, that five years is what's going to truly define and set this company up to be something that's just truly exceptionally large and special. Not in terms of just dollars, because that's what people measure, but on impact on patients' lives. What I'm really, really proud of and quite excited about is the year 2025, getting really the J-code and unlocking the sales potential starting here. We've been ahead of, again, knock on wood, every analyst expectation, and I appreciate that because the team has been very dedicated to that. As we sit here today, the really exciting things in front of us is becoming a global company.
We have a lot of great global partners that are stepping up that really want to work with us. Obviously, the president rearranged everything with the most favored nation that changed the entire dialogue for everybody around the world, honestly in a positive way. As we look at this, it is a very exciting time, the work we are doing in bladder, the work we are doing in lung, but things like GBM and non-Hodgkin lymphoma are equally exciting on those. That is how I would start it.
That's a great overview, Rich. Maybe let's start from ANKTIVA. In IL-15, you have this approval last year. I will say this is such a milestone because in the history of cytokine, there has been a decade that nothing was approved and that ANKTIVA was the first IL-15 approved in a decade. Maybe how would you like now ANKTIVA has been on the market for almost a year. How would you characterize the uptake so far and maybe especially since the J-code got implemented earlier in the year, as you mentioned?
Yeah, two things that I really hear you saying there, and I think both are important to talk about. The entire industry went down an IL-2 pathway. Quite honestly, it was the wrong pathway, specifically on the oncology side. They went down there not because they were wrong. They looked at the receptor. The receptor is actually called the IL-2, IL-15 receptor. It gets much more nuanced than this. Literally, if you hear Dr. Soon-Shiong, he can go on for hours about every piece of the nuance. What matters is with ANKTIVA, and it has been a long road, and it was a long road for us to get approved. There are some days I thought we have to prove it, reprove it to him, and prove it again. We were very diligent about delivering and answering every question along the way.
It matters now because as we move into other areas, I don't want to say it's easier, but it's more proven ground on those. For us this year, the commercial sales team, early on, what we said is there's really going to be a couple of things that we have to remove. There were headwinds we had to remove. The J-code, not that drugs don't get approved and people sell without J-codes. Unfortunately, our competitor prior to us had a really rough launch and a lot of practices. Urology practices aren't always large, even if they're part of large organizations. They lost a lot of money on those, and they were very skittish. In 2024, as we got approved, we had a slow uptake as expected. We said, what we need is the J-code because that gives doctors certainty.
Now, the J-code in and of itself isn't the end. That's kind of the beginning. I was just at LUGPA, the large urology user group association, and we held a KOL event, and they said, we really appreciate that you guys have got approved. And more than getting approved, you've been with us every step along the way because it's not just the J-code and you're done. It's the J-code. And now the conversations start with the insurance companies. To date, knock on wood, none of our physicians have had any billing issues. If they have, we've sat there with them and they've all got reimbursed for it. That matters because the urology area, uro-oncology is a small community. They all know each other. If it doesn't go well for one, it goes, that's literally carried out everywhere.
Right now, as we sit here with ImmunityBio, and again, I'm really proud of our market access team, Glenn, Matt, who drive that, Matt drives our overall commercial operations, and Glenn drives our market access, have been very, what I told them is I need you to be the most white-gloved, practice-friendly program that we can be. I don't care what you've done in other companies. I want to obviously everything's always legal and compliant, but I want you to always hold their hand because these early days set the tone for everything. So far, we've literally just had great, great success with that. That's really what's led us quarter over quarter to see the strong, consistent growth on these.
Maybe from your conversation with urologists, what kind of features or benefits of ANKTIVA you think stand out the most when they are making clinical decisions?
Yeah. And for those of you that know me, I'm a very direct, hands-on person. I personally traveled to, I mean, literally hundreds of urologists because I don't want it filtered. I don't want to read it in reports. It's not that I don't trust my team, but I want to be there right with them to make sure that there's not a barrier that they're having that I can't help them remove or figure out what it is so we can optimize on those. I mentioned LUGPA. We were just at, and we held a KOL event. It was fantastic. We had LUGPA. We had KOLs from the largest enrollers in the other trials. We had the largest academic centers and the largest private equity-based, as well as standalone practices there. It was really a dynamic conversation.
I sit in kind of off to the side of the room and just listen to everybody. What they talked about really kind of fit into three big areas. The first thing is they said, yeah, everybody talks about CR and you want that, but everybody's got CR. That's not a differentiator. You're in the game or you're not in the game. If you don't have a good complete response rate, you're just out of it. What was interesting and very positive was they acknowledged, they said, we know ANKTIVA has the highest CR, not a number, because theirs was actually the most driven by pathological complete responses. Everybody else had a visual complete response. This is the only one that's had not just one, but two sets of pathologists read it through those. We're not discounting those.
It's just you can't read a CR visually. It's technically impossible. That was the first thing they talked about, almost kind of like table stakes. The second one they talked about was duration. Again, this is not us. This was not me selling them. This was them explaining it to us. They said, nobody, nobody has the duration that ANKTIVA does. The 47 months and ongoing and what we believe will be 53, 54 months, hopefully soon for the European approvals. We're seeing that with our patients. The third one was the big one. There actually happened to be a nurse in the room as they went through this. They said, you know, this is the only one of the drugs that is administered. Every other one is administered either in a surgery suite or in office, but by the doctor.
This is actually administered by the MA, the nurse, the nurse practitioner, just like BCG has had been for all the last four decades. This is the only one that our nurse continues to do it, that they like doing it. I can be seen in other patients on those. It allows me to build my practice and actually see more. It is important because medicine is a business, and it is important that we are able to grow our business and take care of more patients. We can actually see more patients with this one. I thought that was fascinating. I have said that many times through those. I did not have to lead them there. This was a group of not all, many of which were ANKTIVA users, some were not. It was good to hear them get excited about that.
ANKTIVA is using clinical practice in combination with BCG. For those who might not be familiar, there is a shortage in the U.S. for BCG. As a company, ImmunityBio is making a lot of effort to try to bring in BCG to the U.S. Maybe just talk to us about those efforts you are making and then what's the regulatory path for recombinant BCG in the U.S. as well?
Really, really important one is, and as we got approved, we made sure that first of all, we got approval for ANKTIVA because I didn't want to add another variable into it. We started talking with Serum Institute of India. Serum Institute of India, world-class organization, the largest vaccine producer in the world, but they're the largest, what many people don't know, they're the largest BCG manufacturer in the world. They make BCG for more people under different names than anybody else. The team at Serum and us partnered specifically around their recombinant BCG. What folks don't always realize is BCG is actually a very fragile thing to make, and that's why it's in shortage. It's made with potatoes, and it's made in small roller bottles. It takes a long time. It takes many months to produce it.
As you get from batch to batch and volume from volume, you've got different levels of colony forming units between those. Serum doing it that very traditional way, I think they just got fed up and said, we're going to make a new way of doing it where you can do it in stainless steel tanks. Instead of it taking months to produce, you can do it in weeks, and you get a much tighter consistency across those. You're not wasting a lot through the manufacturing process. When Dr. Soon-Shiong and myself saw that, we said, we need this. That's why shortly after we got the approval, we signed with them a global exclusive for that. The very first thing we did is we met with the FDA. Actually, we announced it before we could even meet with them.
They called us and said, please work with us. We actually want to solve this shortage and through that process. When we met with them in January of this year, what the FDA asked us is, will you do an expanded access program? It's the fastest way we can get drug out to the market. We know it costs you guys money, but that'll allow us to get it out in a pervasive way. We did that. I can tell you, as we sit here right now, there are hundreds of patients in sites and thousands of doses that have been delivered, again, without any real adverse reactions, all normal course, everything you'd expect. This is a very safe and efficacious drug to partner with ANKTIVA.
We've been meeting with, talking with the FDA, and we have upcoming meetings where we're going to literally ask them, okay, we have the European data, which was Dr. Arench was the lead PI in that one. We have all of this data now from the EAP. What additional do we need to do? We think likely it'll go down some form of a biosimilars route, but we're working with them. As we sit here today, I don't have the exact answer other than to say they've been very collaborative with us, very appreciative of what we're doing. Hopefully in 2026, we'll be able to give a very specific and hopefully even lead towards an approval process.
Perfect. And then maybe as you alluded earlier, outside of the U.S., ANKTIVA is also making a lot of progress there. So maybe just walk us through the regulatory updates outside of the U.S. and then what's kind of your strategy for commercialization outside the U.S.? And are you considering any partnership for that?
Yeah. I'm proud to say that when we worked with MHRA, they were signaling to us, expect December. On the 4th of July, I woke up and I was getting congratulations emails from everybody. I'm like, for what? Because we didn't even get any notice on those. They said, well, you got approved for MHRA. I said, no, they would have told us. Joking aside, we're really happy about that. We had a full laid plan on the way we were going to go to market globally. MFN really caused us to take a step, appropriately, take a step back because the most important thing we got to look at is how do we have and protect the price and protect what we've been doing in the United States and not give that away.
It is an entire different conversation that everybody, not ImmunityBio, everybody's entered. It is just important to acknowledge that through those. What I can tell you is from an EMA perspective, we have been very diligently, just because MFM came out, we did not slow down any processes. We said, we will work that through while we work through the regulatory pieces. For EMA, we have submitted our full day 180s. We have already been doing label negotiations. While we are not done yet and nothing is ever a guarantee until it is done, I feel very confident about that. They have signaled in that same time, end of this year, beginning of next year through the process. I am having conversations right now with folks. We have a number of partners that make sense for us to work with.
I think if you look at this, the landscape of how you do things like this from a license to a distribution agreement have changed. Everybody together is learning about this. What I appreciate is the partners that we've been having conversations with are really open about it. They say, look, it's a different day and we can't all pretend we know how to do this because nobody's done this under this term. Now we're really trying to figure that out on those. In the coming short time, we'll be announcing who we're working with on those. We've had interest from not just Europe where we're seeking approvals, but around the world on this. There's a lot of opportunities with those.
Got it. I also want to touch on another big segment of non-muscle invasive bladder cancer, the papillary disease. Maybe tell us what's the path for ANKTIVA there. I mean, you obviously have the 36-month PFS data. Maybe just share, can you share about what's the latest development, what kind of conversation you have with FDA?
Yeah. A few pieces on this one is that because we're a very open and transparent company. In January, when we met with the FDA of this year, they literally, quite literally asked us to submit our papillary data. If you look at the two, I joke and say, if you took the label off the bottom and moved the pieces of paper around, you could not tell them apart because the responses are almost identical through those pieces. In January, when they asked us to do that, we were very pleased. We rapidly, within weeks, submitted a full BLA because it is an update to the existing one. That is when I now kind of joke and say they give us the, just kidding, we did not want that. Obviously, we have had multiple conversations with the agency.
I have more already scheduled even this year to meet with the agency to say, what is the formal pathway to approval on those? What additionally are we going to need? Because it does not make sense. Patients are being denied this. What is interesting when you talk to a urologist, they do not cut it cysts and papillary. They take it in high-risk bladder cancer disease. If you look at this, again, CEO speak on this, papillary disease looks like cauliflower. Cyst disease is flat. Cyst disease has always been known to be underrepresented because if I see the cauliflower, I can just stop and say, I have got bladder cancer and I need to treat that. The cyst side of this equation has always been an underrepresented piece, but it did not matter because they were just treating high-risk bladder cancer.
Now, through this artifact of the way the agencies globally, not just the FDA, globally have cut this left and right instead of top and bottom through this. Now, for us, the cyst plus and minus papillary and the papillary alone data look the same. We've submitted that first to the NCCN, and we're not putting any pressure on them by any stretch of the means. That has already been reviewed fully by them. They've got a process they're undergoing. Between now and the 1st of next year, we should hear back on that. It's not just ours. They've got a very formal regimented process. What I can tell you is that we're fully ready to be able to move forward with those pieces. Obviously, getting a full approval is what our real goal is. We believe the data warrants that. We believe the actions need that.
We more importantly know patients need that because NCCN is great because it would allow for U.S. sales. To get global, and we have every intention of being a fully global company, we need to overcome that. That is why Dr. Soon-Shiong and I are still meeting with the FDA and have not let up on that.
Maybe back to the vision you were talking about in the very beginning. I mean, Dr. Soon-Shiong outlined this vision for ANKTIVA as a lymphocyte stimulating agent at the investor day because of the function of NK cells and T cells. Maybe just could you expand on that concept a little to introduce to the audience what that means to ANKTIVA and what kind of indications are you prioritizing?
Yeah, so this is at the core of this. If you get to the true mechanism of action of what ANKTIVA is doing is right in our approved label, what it says is it activates and proliferates natural killer cells, CD8 killer T cells, helper T cells, and memory T cells without Treg. I always make it in the CEO, you get the good guys without the bad guys. That is why you have got this incredibly long duration. That is why you do not have a lot of bad side effects as we look through those. Now, if you think about what is a lymphocyte, and this is a whole new way that Dr. Soon-Shiong has been trying to introduce the world literally thinking about this. You have got Epogen, you have got Neupogen, which are designed because you know you have got crashing of these and you do not get them, it is bad.
They actually do not cure cancer. They just keep the patient alive so you can keep giving them toxic drugs to be able to beat the battle that they are fighting. The real way, the only cell inside of your body that takes care of this is your NK cells, your T cells, maybe your B cells a little bit. That is what we ultimately need to do this. We are in this time literally now, and he has made it his own personal mission to be able to say, we have to change the paradigm. We have to teach not just doctors, but regulators, what does it mean? Every one of our trials, to answer your specific question, we are measuring the lymphocyte counts. What I tell every time I speak to an audience, you should be looking at, if you go to the doctor, you get a CBC with differential.
Inside of there is your ALC, not ANC, but your ALC. You should look at that. If your ALC is below 1,000, that is an early prognostic warner saying you're not in a good spot. You need to be working on these things and looking at it. Ultimately, that's what we're trying to lead the agencies to, to say we need to just treat ALC. Now, what I'm incredibly, incredibly happy with is we met early this year with the Division of Non-Malignant Hematology, and they in the room literally said, we get it. We don't disagree with you. It's never been done before. You got to work with us as we pioneer this together. What we'll do again is offer you an expanded access program. They don't hand out EAPs like candy. It is a high bar because if you do this, you've got to be safe.
You know that's got to be efficacious. If you look at that EAP, it's across all solid line tumors. I mean, that's a broad, broad indication. I actually had to look it up and say, have they ever issued one that broad before? The answer was no. That tells you about inside the agency, they're confident that it is a very safe and efficacious. The question you ask is the right one is how do we ultimately get that to approval? That's what we're working with the agency on. I will tell you every trial we're running, but specifically our lung trial is running just to take a look at the indication, but it's a randomized control trial and the ALC measurements are inside of those. I think that's what's going to take is us just being very diligent about this.
I call it grinding. You just grind away at it and you do not stop when everybody else says you are not going to make it. That is when you know you are in the right spot and that is what will ultimately lead you to it. The treatment of ALC is a disease. You can just about mark my words and definitely mark Dr. Soon-Shiong's words. It is our duty as ImmunityBio to help change the paradigm and help everybody from a regulatory as well as the clinical practice of medicine understand the importance of this. If you look back in history, they did not know what PSA was and we did not know what HER2 was and we did not know what all of these. Just because they exist does not mean the work is done. For us, this is really, it is not just the Holy Grail.
It's about Patrick's vision about how do you treat cancer and infectious diseases. That's going to be known as the biomarker and that's the work we've got to do.
I just want to talk about the lung cancer, the lung cancer program you just mentioned. I mean, at the World Lung, you present some phase II data and you're also running a randomized phase III combining ANKTIVA and BCG's PD-1, pembrolizumab, versus doxetaxel in non-small cell lung cancer. Tell us how is the trial going and maybe what's the next step and when should we expect some early data from that trial?
Yeah, two things I would say in there. This trial is one that will be a defining moment for ImmunityBio. Everyone is as you get approval because they take you on that next one. The scale of lung cancer and the scale that in decades, no one's been able to impact this. We just were at World Lung, we presented there, but we also held a KOL event there. It was great because the physicians, they were discussing this and these were the world leaders from Latin America, from Europe, from the United States, Canada, Asia Pacific. They said in the room, you know what? Dr. Soon-Shiong told us three years ago what we needed to do. Instead, we went and did the pragmatica trial and we did this one and we did that one.
The good news is we now know what the baseline of what chemo does. It's basically nine months. We've seen a thousand patients who are randomized control trials. It's a little bit absurd that we have to do another one, but fortunately, ImmunityBio is committed to doing this. We're running that trial as we sit here today. It's authorized in the United States. It's authorized in Europe. It's authorized in Canada. It's pending through what we're doing in the Asia Pacific countries and growing on that one. If I had to guess, and it's just a guess because enrollment is one of those things you never know what it is, you're probably about 18 months on the outside away from having that fully enrolled. And then you've got about, because it's an overall survival, about an 18-ish month readout.
Somewhere in that 36-42 months, we expect a readout. We know as we sit here today, we've already done 150 plus patients in this one in very controlled trials that show a 14-20 month survival. Here we're now looking at nine versus even take the low side 14. We should have a positive readout on that as well. That is something we're really excited about and we'll continue to be very diligent on.
For the last minute, I also want to quickly touch on the glioblastoma update you just put out recently and what's the next step for this opportunity?
Yeah, so rapidly, ImmunityBio is not just an ANKTIVA. We're not just a bladder company. We actually have ANKTIVA in our fusion proteins. We've got our cellular technologies, our PDL1 and our CD19, as well as our DNA vaccine vectors. GBM is another one of those diseases you get and you just, everybody just starts wishing you well because 90% who get phase I or early GBM progress to stage two. The 10% pass. It's one of those diseases that you just end horrifically with. Announcing that we had five of five that went into stable disease after two treatments is a shift. The doctors are involved and said, I've been doing this my entire career. I've never seen anything like this. That's a trial that we're currently enrolling and running. We're going to be expanding on that one.
That could be a very exciting trial because likely that is an accelerated approval pathway because everything in AA has always ended in an accelerated pathway.
What are the key milestones should investors watch for in the next six to twelve months?
Yeah. I'll tell you what I tell my team is the two things that are going to drive ultimately shareholder value, but really patient value, are continued sales and continue to see those goals up and approvals. Looking at what we're doing with NCCN for the current one, looking at what we're doing with Naive, looking at what we're doing with lung, watching every one of those is what's going to ultimately drive it. That is where the real value to patients and families come. That is what we're here for.
Great. Thanks to everybody for tuning in. That concludes our session. Thank you, Rich.
Thank you very much. Appreciate it.