Good morning, and welcome to the Jefferies Global Healthcare Conference in New York. My name is Justin Weisser with the investment banking team, and it is my pleasure to introduce you to Richard Adcock, CEO of ImmunityBio. Thank you. Good morning to all. Today, we're going to take just a few minutes and really give you an update on ImmunityBio, what we've been doing, and what we're working on. Obviously, everyone in this audience is familiar with what forward-looking statements are. I provided here for your reference. As we talk about ImmunityBio, what I try to frame up for people when they think about it is, first and foremost, Dr. Patrick Soon-Shiong is the founder. He's the Executive Chair, but also the Global Chief Scientific Medical Officer for ImmunityBio. It's really his vision that we're executing on. After successfully launching ABRAXANE and American Pharmaceutical Partners and exiting both of those, what he did was said, "I'm going to take a step back now," and the words he used was, "I want to find cures to cancer in my lifetime. I want to bring about changes that fundamentally shift the work that we're doing. The work that we've done is to create inside of ImmunityBio, which is to put a series of platform technologies in place, first and foremost being our fusion proteins. ANKTIVA is the first product inside of there, and non-muscle invasive bladder cancer CIS plus and minus papillary disease is the first currently approved. We're actually now approved in 35 countries and territories around the world. Additionally, that is approved in Saudi Arabia for non-small cell lung cancer, second-line checkpoint failure patients. We have many trials ongoing in those, and we'll be talking about those shortly. Second platform, not in order of importance, but is our DNA vaccine vectors, of which we have many targets. First thing to know about this is that it's not just a standard adenovirus, it's a second generation, which enables it to be delivered over and over again without it having an autoimmunity or a decrease in efficacy. Our Ad5 CEA MUC1 brachyury, as well as our PSA HPV, have all been done in multiple clinical trials. The first one, the CEA MUC1 brachyury, internally we refer to as our triad. That's actually been done in Lynch syndrome in cancer prevention. That was a trial funded by the NIH, NCI, still ongoing from those, which was a combination of ANKTIVA SubQ plus our CEA MUC1 brachyury, and that's for the treatment of our cancer prevention trial in Lynch syndrome. We're also showing very interesting and exciting things in PSA for prostate cancer, same way in HPV for head, neck, and cervical cancers. You have our cellular platforms. Off the shelf is our CAR-NK, both the PD-L1 t-haNK, as well as our CD19 for liquid cancers as well. Very exciting, newer, but not a replacement for the other ones, is our M-ceNK platform, which is a memory-enhanced cytokine natural killer cell. What's fascinating about this is, as you take an apheresis, there are many people that are now taking an apheresis and making a single cytokine-enhanced natural killer cell. The problem is the patient will exhaust. One of our cytokines that we use is ANKTIVA, and if you go back to the very beginning, as I said, what it's approved in Section 12.1 of the package label, what the FDA says ANKTIVA does is it activates and proliferates natural killer cells, CD8 killer T cells, memory T cells, helper T cells without T reg. By giving that, you're doing both an ex vivo and in vivo acceleration of those, and we're able to get an entire course of treatment. Others that are doing that are very excited, saying, "We know what your secret sauce is. It's ANKTIVA in combination with those." Obviously, other than the ones that it's approved in, everything else is a clinical trial. While this is not every trial that we're doing, these are some of them in 2025 and 2026, a select sampling of those. First and foremost, what's happening in non-muscle invasive bladder cancer. I tell folks all the time, especially as I talk with investors, if you look at us and you peg our value only in bladder cancer, while we love uro-oncology and we think it's going to be a blockbuster for us, you're really missing the picture of this. That said, if you look at our first approvals, BCG-unresponsive, CIS with and without papillary, we've had tremendous growth on those pieces. 2025 was the first full- year for a J-code, and we just saw huge growth over those. We also got approvals in the U.K. We've now seen approvals in all of Europe and in other areas as we go through those. In the BCG-unresponsive papillary, which is the label expansion, that has been submitted for approval. It has been accepted by the FDA, and it has a PDUFA date January 6th of 2027 at the latest in which they'll approve that piece. If you've looked at the data on those, and specifically what I tell folks is just look at the KM curves. If you look at the KM curve for what's approved and what's pending approved, I always tell folks, if you take the label off both of them and shuffle them around, they're very hard to tell apart because you're seeing the same result. It's that long-term tail that is what the results are really showing up in patients. That's what I was just at AUA, and what physicians were telling me, urologists over and over again, was, "What's incredibly exciting is how simple it is for us to use ANKTIVA, because it's the same workflow that our nurses have always done, but how tolerable it is and how much patients are enjoying this." It's really something that works well. A lot of times when you get an advanced treatment, it's got a lot of bad tox profile, or it's hard to administer, or you blow up the office workflow. I'm proud to say with ANKTIVA, it's none of those pieces, it's really having a great adoption curve that's going on those. We're excited for papillary only because that's a bigger piece of the market, we'll go through those. What we've really been focused on is that BCG-naive, that trial has been completely enrolled as of February of this year. A few weeks later, the independent data monitoring safety committee met. While we don't know what the data says, what we do know, they had one of three charges, to review the data independently themselves and tell us the trial is futile, which they did not say that the trial needs more patients enrolled because it has to be powered more, or that the trial at the 50% point was meeting its endpoints and you can close it for enrollment and then move forward. That's the one they told us, too, which is incredibly exciting. In the BCG landscape, this actually slide needs to be updated. We actually now have two strains of BCG, both the recombinant, which is currently available as an expanded access under FDA for the U.S., really easing the BCG shortage. Now we just also announced that we have the Tokyo strain of BCG, and this is really important because with that one, SWOG completed a 1,000-person trial that showed, comparing it to TICE, that they're the same. Now, when I always talk about BCG, I always joke and say they all start from the same dot in the sky, so it's not a surprise that by the time you get down to them, they show the same results. In Europe, the approvals that we have with BCG and in the U.S. is not per strain. Europe has six different strains. It's approved for all different strains of those. Our U.S. approval is just BCG plus ANKTIVA. One of the things that ImmunityBio is striving to do is actually end the shortage. To do that, we actually now have two strains that we'll be working with the FDA on to ultimately, hopefully get to full approval on those. Moving on to lung cancer, as I said, this is what's already approved in Saudi Arabia. We have other countries that have reached out to us as well and said, "We want to talk to you about that." We have ongoing trials in that space. For lymphopenia, our solid tumors, we have an expanded access program that was granted last year at ASCO by the FDA. Best we can tell, and we've checked, that it is the broadest single expanded access for all solid tumors that they've done for adults with second line and greater. Starting off with ANKTIVA and bladder cancer, people are talking about efficacies, they're talking about tolerability, and all those are exciting. The real story is duration. This data is what is right out of the European label. In the FDA label, it's a different cohort size, just a smaller subset of it, and it's 47 months in ongoing duration. Europe, the full N of 100 is 53 months and ongoing. There's no one else who has the kind of durable responses that we do. We're showing two and three-year responses out there and have presented all of that papers as well on those. As I meet with different urologists and patients, the number one thing they keep telling us over and over again, the reason they continue to look at ANKTIVA and choose ANKTIVA for their patients, is because of that long-term durable response. That's what people are looking for. Some of the key highlights that are there is 84% of the patients who've responded were able to keep their bladders for up to 36 months. That's what everybody wants. They want to be able to keep their bladders intact. Nobody wants to lose it. I will tell you, there was data that was just presented at ASCO, where they were using the recombinant BCG. Doctors for the first time in muscle invasive, while we still are just starting these trials, are saying that we think that it's possible for us to move into the era of bladder preservation for that. No one three years ago would've even said those words, let alone come to us and say, "We think ANKTIVA has a big role in that as well." Those trials have not yet started muscle invasive. We will be looking at those as well. 71% of the participants had a complete response through those. That was in our European data, again, the full N of 100 that was reported in The New England Journal of Medicine paper. 53 months of duration, as I said. This is what I think really gets me excited, is a 99% disease-specific overall survival at 36 months. Duration, duration. That's what patients want. That's what doctors are talking to us about. We've had great commercial success on here. Our market access team, our medical team, as well as our overall commercial team. Matt Hellman, who leads our commercial team, has done an absolutely remarkable job of getting really motivated, dedicated teams. As I said, I was just at two conferences with them. I continue to be impressed with the team that we have assembled on those very knowledgeable, very focused. Our field medical reps, our market access team, led by Glenn and others, are really doing a great job. On the right-hand side, you can see all of the payers that we've been able to connect with. The story really started January 1 of 2025, because that's when we had our J-code, and in that first year we did $113 million. The global approvals, Dr. Garlisi, who heads that for us, has done just a wonderful job of getting us approvals after approval in all of these different areas. Again, the next two slides will just talk about the growth rate that we've had. Very, very strong. A 72% growth rate quarter-over-quarter through those in an upward trajectory that continues to give positive strength on each one of those. We're eager and excited for the expansion that we hopeful, knock on wood, comes along with this most currently accepted filing. That will give us even a bigger market to be able to penetrate. Same way here in units. Why this slide matters, you can see, is that it's not a one-time thing. It's a very sustainable growth that's happening, and it's all based on real unit delivery. Cash on hands at our last reporting was almost $381 million, and that's been growing, as you can see, quarter-over-quarter as well. ANKTIVA plus BCG in the non-muscle invasive naive setting. This is where it starts to get really interesting. The right side note on there, I'll just give you a little anecdote, is ImmunityBio was getting our approval or about to get our approval for ANKTIVA in the unresponsive set. The FDA actually called us and said, "Hmm, you know those original phase I patients that you have? Can you tell us how they're doing?" We literally had to say that, "You mean the patients that we were allowed to follow for two years that are now nine plus years out, you want to know where they are?" Of which they did, and we went and found them, fortunately. What was fascinating to us is that, one, originally all nine of nine went into a complete response and stayed in a complete response at the end of two years. That's when you know, because everybody knows in a phase I, you're looking for dose finding safety. If you get a response, it's a great thing, but when you get 100% response, it's unheard of on those, and it's almost what's made people not believe the drug was working. What we found was that two of those patients of the nine had passed of disease other than bladder cancer, with 73 the median age. That's going to happen. One was lost to follow-up because no one was supposed to be following. Six of six were still in complete response. They'd had no follow-on treatment, and all six still had their bladders intact. That is really unprecedented data. I've looked. I cannot find any other drug that has been able to do this in an indication space like this, and it's based on the strength of that is what they literally looked at us and said, "Okay, we're now going to give you this approval. Please finish out the naive trial," which I said, "That trial is fully enrolled on those." They also asked, "Please tell us about how the initial patients are doing in the naive." We pulled the N of 43 for them on their request, and what it demonstrated, the BCG alone had a 52% complete response rate, and that ANKTIVA plus BCG had an 84% complete response rate. That was a statistically significant trial run for those. It's one of those that if everybody knew you had to run a 100-person trial, you don't know that, so it's a much larger trial that we just finished out. That N of 366 is fully enrolled, or 376 is fully enrolled, and we'll be reading that out here September-ish of this year, maybe a little sooner, just as last patients get in. That clinical trial was originally started in the U.S., was taken live in Europe and in India and other places as well. As I indicated, the BCG shortage people ask us about is real, but it's something that we're proud to say that we've been able to deliver for hundreds of patients and thousands of doses to hospitals all around the U.S., from small settings in community practice to the largest of the academic centers are participating in this. We continue to work with the FDA on how do we move that from an expanded access to a full approval. What we also just announced was that we obtained the rights to the Tokyo strain. Now ImmunityBio has two strains of BCG. At AUA, as we announced this, I had people saying, "Well, which one are you betting on? Which horse are you going to ride?" I told them both. The U.S. should not have a single strain for a life-saving drug. Merck has theirs, and we're happy about that, and we hope they continue to expand that. Serum, which is the world's largest manufacturer of BCG, can produce millions of doses per year. The Tokyo strain, which is approved in Japan, has been around forever as well. Japan is a world-class regulatory authority. SWOG in the U.S. just finished a nine-year randomized control trial with 1,000 patients, we're in the process of working to package all of that up and submit that. Our ultimate goal is to be able to get both of them ultimately to approval because then the U.S. won't find itself in this strained situation again. When we began the clinical trial of N-803 plus BCG back in 2014, we had the inclination that this could be a game changer. The very first patient we enrolled was [Elvira]. She's an interesting patient because she has a history of multiple cancers. Started with my breast cancer, and then after, the left kidney cancer, so I only have one kidney right now. Then the thyroid. Now I don't have thyroid. I was thinking they might probably going to take out my bladder. We saw no dose-limiting toxicity. The patients did extremely well. N-803, it increases the proliferation of T cells. It increases NK cells and increases memory T cells as well. The memory T cells are important because they lead to a long duration of complete remission, and that's what we didn't know back then when we were developing this clinical trial. We were just blown away with the effect that we've seen. I'm not scared anymore. I still can do all the things that I want to do. I'm enjoying life. I'm not even concerned about it on a daily basis. Finally, Dr. [Teet], he says, "I don't think it's going to come back." He goes, "I think you're in full remission." Feels good. Over 20 years of practicing urology, I have not seen a clinical trial with this durability. I'm really interested to see how this plays out. Those words, first, it's always important to have your why, but those words are what we're seeing play out now in practices all around the country. It's durability that matters. What I always encourage folks is when you're looking at them, you're looking at other competing drugs, wherever they may be, we welcome that. That's great. Look at that Kaplan-Meier curve. If it's going up and straight down, that's going to be a problem. If it has a long flat tail, and by the way, we know the only one that we've seen that has that is us, that's what you're going to want to do, and that's what patients are coming in now and asking for. In lung cancer, again, we could spend hours up here talking about multiple trials, at ASCO 2024 now, two years ago, the headline of there was, "Oh my God, checkpoints fail. What are we going to do?" It was like people are running around with their hair on fire. I remember talking with Dr. Soon- Shiong that day and saying, "The good news is we know what they need to do. They need ANKTIVA." Just like we saw with BCG, we see these very similar things mechanistically with checkpoints. We're very excited about that. As I said, that's what Saudi Arabia's already give us approval on. This trial is actually our frontline trial. What's important to note is they started effectively at the same point, and you see this very clear separation for those that have an ALC response versus those that don't, and look at the statistical significance of this. That's what you want. Your ALC is your T cells. It is your natural killer cells, and there's been paper after paper who's demonstrated and published saying that's what ultimately leads to a reduction of mortality and gives you that long-term overall survival. Another way of looking at this is in second line. This is the trial that I said Saudi Arabia approved us on for those, and we have others reaching out to and asking us on these. In this setting, what you've got here is the non-responders versus the responders. If you look at the overall trial, it was 14.1 months in all, but those with an ALC response on those at 21 months. We all know that from multiple well-run trials, you're about seven to nine months. I always say assume it's 10 months is what a control group looks like. We're doing that trial right now. It's Rescue 201A. Saudi Arabia just jumped ahead and said we don't need to wait for it. We know what chemo does. It's bad for patients, and it doesn't give us any kind of results like this. Based on the basis of that, in January of this year, Saudi Arabia gave us an accelerated approval for this indication. 2019 is when I found out that I had cancer, lung cancer. For two and a half years, my standard of care, it worked. I got to ring the bell. I was like, "This is done." Unfortunately, it wasn't done. Mid-June 2022, I went and got a CT scan. I was alone when I got my results that it was stage 4, and I had like 24 tumors in my body, my left and right lung, on my thyroid, and on a rib. This opened up a chance for me to get into a clinical trial and do something different. My doctor suggested the same chemotherapy because it worked before and to go onto KEYTRUDA as well as N-803. At that point, I was really, really sick. I wasn't able to walk. I couldn't breathe. I had to sit up to sleep at night because my doctor had said, "You have six to eight weeks to live if we don't do this." I didn't hear that. We started at the end of August 2022. It was every three weeks. My first CT scan was October 25th. Dr. Luke, he was blown away because it was 75%-80% improved in just two months. He called me his miracle patient, and he said, "I have never seen anything like this." Like, "Okay, then let's just keep going. Let's do this." My faith was always stronger than my fear. It's a tough thing to go through, chemotherapy just killing everything. After treatment, I would be in bed for one week. The positive thing was I was there with my granddaughter. Hi. Hi. Good to see you. Good to see you, too. She'd wake me up every morning to show me what she was wearing to school. Right at the end of 2022, I just said, "I can't do this anymore. We need to stop the chemotherapy." In January of 2023, when I had the first treatment, when I just had the KEYTRUDA and the N-803, I was able to eat. I wasn't weak. The quality of life was so much better with just the two, the N-803 and the KEYTRUDA. It's almost like I immediately felt better, and my scans were improving and improving. I started walking. I joined the gym, enjoying my granddaughter. That fall, I ran the whole Harvest Festival. I was able to do life again. It's all good news. It's all been positive. I'm still getting that every three weeks. My last scan that I had, it showed that there's not any tumors in my right lung, just my left lung, but the ones in my left lung have shrunk. On my thyroid, it's gone. It's helped me to really want to live life. It's a miracle to go from having six to eight weeks to live three and a half years ago to still be here. The stories of [Valerie] and [Elvira], sometimes people say, "Well, that's an N of one." They're all in trials, more importantly, there always has to be an N of one. You always have to start somewhere. These patients are incredibly far out, you see this very common, consistent result. When Dr. Soon-Shiong and the team first brought ANKTIVA out, one of the things he said early on was that this is the beginning of immunotherapy 2.0. ANKTIVA's not designed to work by itself. It's designed to lift up the immune system and work with every other immunotherapy agent. It was designed as the backbone inside of ours, that's why you see us have other agents. As you can see in these, it also works with other people's agents. It's agnostic to it. It's really priming the immune system, and it's enabling the immune system. As you heard from Dr. Rosser, it's bringing the memory T cell in, and that's something that is very rare. As he said, we didn't even understand what it really meant. We now are really seeing what it does, is it gives you that long-term duration. In each one of these, they have really great survival effects. I'll go quickly through these pieces here because we're about out of time. In lymphopenia, if you have had your physical and you've had a CBC with differential, you should look inside of there because there's the thing called your ALC, absolute lymphocyte count. Most people don't know about this. Doctors don't talk about it because they haven't had anything they can do. They look at your red blood cells, and if you're being treated for it, they can give you EPOGEN. Same way your neutrophils, they can give you NEUPOGEN. There was nothing that you could do for low lymphocyte counts. Lymphocytes are your Natural Killer cells and T cells. They're the things that clear disease and clear cancer, and over the last 50 years, there's been nothing. As I indicated before, right out of the FDA package insert for our first approval, what it says that it does is it activates and proliferates Natural Killer cells, CD8 killer T cells, helper T cells, memory T cells without T reg. CEO speak, you get the good guys without the bad guys. That's really what's happening with these pieces. Our job now is to move this from an expanded access to something that where you have EPOGEN, NEUPOGEN, and ANKTIVA that is agnostic to the tumor type. It's really the treatment of lymphopenia. A couple of quick ones on here that we've also got going on. In our CD19 that I said that is happening there, we're seeing very, very strong results, responses. When we originally developed this, the internal code for this was bridge to transplant. You've got something that's working, it fails, you're going to get a transplant, that's going to work. There's this bridge, some call it the death zone, on those. We need to help people get through that piece. We started this trial in South Africa. They called us one day and said, "We got a problem. It's not a bridge to transplant. We're seeing responses. This could be a bridge to cure." Their words, not ours. As we look through these, this trial, specifically in the Waldenström patients, we believe it'll work across multiple of those, is showing really strong results from those. We think this can potentially be our first approval in the cellular therapy. A lot of people have tried. Very few people have been able to get here on this one. Here you can see of all subjects, the median overall survival of five months, the low lymphocytes at three, but you're long here at seven months as we go through those. Look at the statistical significance. I want to leave you there with the ISI information for ANKTIVA as we use those in the approved indication, and I'll open up to questions in the last couple of minutes. Okay, if there are none, thank you for your time today.
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