Good afternoon, and welcome to the final presentation of the second day of the Citizens Life Sciences Conference. It's my pleasure to introduce ImmunityBio, so we're finishing strong. Presenting for the company is Richard Adcock, the CEO. ImmunityBio is quite a unique company. They're dare I say, a leader in the immunotherapy field with an approved product. Here to tell us more about it, Rich, take it away.
Thank you so much. Thanks to everybody for being here, and we appreciate the invitation. If you've been following ImmunityBio, you've seen a lot of action as of recent. One of the things that I've told people for a long time is the biggest blessing in my life is the ability to work with Dr. Patrick Soon-Shiong, who's the founder of this. One of the biggest, hardest things I have to do in my life is work with Dr. Patrick Soon-Shiong, the founder of this, 'cause he literally sees 15 years into the future. But I share that because the work that we're executing on and delivering today is the work we started in 2010. It's really all coming, and there's many, many great things ahead as we deliver on those pieces.
Let me take a few minutes and kinda tell you where we're at and what's going on with this. Forward-looking statements, I don't have to tell everybody here what these are, through those. When you talk about ImmunityBio, what I always try to tell folks is, first of all, and again, as I said this, it is Patrick's vision that we're executing on, but it's just not his vision. He's with us every second of it, working seven days a week, 12, 15 hours a day. What his premise was is that you have to deliver combination therapy to beat cancer. Today, in 2026, that's like, well, duh. When he started this, it wasn't well, duh, it was, "You can't do that. You'll never get it approved.
You'll never be able to work your way through those." We're here today with a different approach in those. The delivery of this is really under three key platform technologies. First, our fusion proteins, second, our DNA vaccine vectors, and then our cellular. If you really understand those, and again, you understand Dr. Patrick Soon-Shiong's thinking on this, it's first of all, if you have platforms that you can deliver on, the first product that was approved and delivered out, it was ANKTIVA. Under our fusion proteins, ANKTIVA's now approved in 33 countries, we're proud to say, across those in non-muscle invasive bladder cancer. Now, in the BCG unresponsive space, you first of all do the CIS side of it, and then the second piece of that is the papillary. We just this week submitted for the approval with the invitation from the U.S. FDA on that.
Our naïve study, which is even the frontline version of that same space, we reported out that two weeks ago. There've been so many reports recently from all of the activities, but that was fully enrolled, and so we'll talk a little bit more about that coming up here. Under our DNA vaccine vectors, this is a second-generation adeno, and one of the greatest pieces about this is its ability to be able to deliver large payloads on those. We've done this in multiple trials across multiple pieces, including cancer prevention, and so we'll talk a little bit about that. Then our NK cell therapy on those, Dr. Soon-Shiong is quite literally the world's foremost expert, and not just he, but the entire team around those on the delivery of those.
You'll start to hear a lot more about a world bank of natural killer cells that is coming up on those, and that comes on the secondhand side of that with the apheresis. Really the ability for somebody to proactively say, "I want to bank my cells with somebody who knows how to properly store them in multiple geographic locations so that when in the future, if I have a need, I can actually take my healthy cells," be able to do those. The CAR NKs are ones that we can do off the shelf immediately, both in a PD-L1 as well as a CD19 approach. 2025 and 2026 will undoubtedly probably be defined as probably the biggest, most pivotal years in the company. I tell folks that's not even close, 'cause what's coming ahead is even bigger than what we had there.
Not to put anything but proclamation to what the team has delivered in the non-muscle invasive bladder cancer, our CIS plus and minus papillary, ANKTIVA, massive revenue growth because a very focused, dedicated commercial team on those. It's really being able to now proudly say that we're approved in 33 countries. I literally leave this conference, I fly to London because we're literally launching our European operations at the European Association of Urology meeting there with our partners, Accord, on those. There's definitely no time wasted on any of those. In the papillary, as I talked about, we've now submitted that, resubmitted that to the U.S. FDA on their invitation. Quite literally, it's the only product out there that has 3+ years, actually six years of data out there on those treating papillary disease. Really exciting for us.
It expands the size of the market, but just like we're the first in the European space to be approved in this would be, we believe, when this is done, we'll be the first in the U.S. from those. N-803 that I talked about, that trial is fully enrolled, and what that means is last patient in, end of February, add six months, that's when the readout will be. This year we'll read that out. On our earnings call last week, I announced to everybody that we will actually submit that sBLA or the BLA for that by the end of the year. It's tight. I will tell you, the project plan goes to December 28th. I told the team we'll find a way to pick up some time on that one, but we will be submitting that for this year.
That matters 'cause that's setting up 2027. The commercial team in the U.S. knows what they're doing. They're growing quarter-over-quarter. The European team is just launching, and we're gonna be expanding indications of those. We'll be adding countries. We'll be working across to all of these. All of this is setting up commercial strength, which takes care of the rest of the pipeline. Not to be outdone by bladder, lung is even a much bigger opportunity. At this year's J.P. Morgan, we announced, or just prior to that, we announced that Saudi Arabia is the first in the world to be able to approve non-small cell lung cancer. We've worked with the U.S. FDA. We're working with Europe. We're working on all those.
We have two pivotal trials going on right now in frontline and second line, for those that'll lead us to what we believe will be the full approvals. Saudi Arabia, upon reviewing the data, said, "We want to be first in the world to announce this." I can tell you that there have been multiple other countries that have reached out and said, "We actually like what Saudi did because we see the progress that you're making on the pivotal trials. We think we'd like to have a dialogue as well about that." I think there could be more opportunities that are happening on those that are going on it. Lymphopenia, if you've heard Dr. Patrick Soon-Shiong talk about this, it's really what underlies all cancer.
As you go on this, and this is the piece that people don't know, we literally have shirts made that say, "What's my ALC?" Because part of this is even educating physicians. It's a simple CBC with differential, but yet most people just ignore probably the most important reading in cancer care there was your lymphocytes. Some will argue it's your NLR ratios or your absolute lymphocyte, either of them end in the same place. ANKTIVA, the power and magic of what it's doing is it's actually increasing. It's a lymphocyte-stimulating agent. We continue to work with agencies on that, and then pancreatic cancer and many others you'll see continue to grow onto those. Rapidly trying to walk through these. In bladder, ANKTIVA + BCG is just a markedly different approach. What's approved right now, nadofaragene firadenovec has theirs.
Their median duration is 9.7 months, meaning basically half the patients have failed at nine months. Keytruda, which is approved right now on here, is 16 months. J&J was just approved. I, they don't have any duration out yet, anything close to this. The 53 months was what was just approved by Europe, and in it, what it says is not your median. It's saying it's 53 months and ongoing, with the median yet to be determined. That's the real power of what ANKTIVA's doing. It's the memory T cells that are delivering on those, for physicians, for patients, and even health insurers, 'cause they're the ones that are paying for all these. What they all want is duration. Yes, everybody wants a response, but that's kind of expected. When you get a response, how long do you keep that response?
In my prior life, I've run large health systems, I've run large insurance companies, and that's the really unique value proposition that ANKTIVA brings, and it's because if you go right into the package insert that the U.S. FDA gave us, what it says is that it activates and proliferates natural killer cells, T cells, but memory T cells, and it's that combination with that memory T-cell that really gives you this long-term durability, and quite frankly, we don't think anybody else is gonna be able to touch that. Some of the big highlights right here, 84% of the patients who responded to ANKTIVA were able to keep their bladders at 36 months. I've met hundreds and hundreds, maybe a thousand, of the urologists now.
I am constantly out on the road meeting with folks 'cause I don't want to be filtered and I want to hear it direct. The number one thing surgeons are telling me, we've entered the era of bladder preservation. We're all trained as surgeons with a scalpel in our hand, but we've now moved into the spot. This is the new generation. Immunotherapy is bringing us bladder preservation in this. That's a really, really big piece of those. 71% of the participants had a complete response, but it's that duration at 53 months. I was just at ASCO GU. We had a group of the top world leaders, and their bladder preservation was what their number one talk was. We love the duration. Of course, you get a response. It's almost. Of course, if you don't have a response, you're not even in the game.
We know ANKTIVA has a great response. Your separation is that duration, but in really empowering us to now have a conversation with our patients about bladder preservation. Obviously, disease-specific overall survival at 3+ years. Lots of payers have said yes. I'm proud to say right now we've not had any major payer issues whatsoever. As I said, I personally came from running large health plans, large insurance companies and others, large research enterprises prior to this. The team, Matthew Hellmann, who leads our commercial one, but Glenn, who's our head of market access, have done a remarkable job, and it's really, though, the people I want to give the greatest shout-out to is our field medical representatives.
Those are the folks that are out there that are talking to the payers about our patients, and they're helping to navigate those, and that's what's enabling this great growth in the product and the easy adoption is 'cause we're making it easy for all involved. Sales growth that we've reported, 700% year-over-year, 750% on unit sales. That's the number to me that matters most is are you seeing a real unit sales growth 'cause it's not a pricing dynamic or something else of those. Doctors are ordering it for a patient, and when they see that it's working, then they order it for their second and their third and their fourth, but they're also keeping them on maintenance.
This is a long-term piece that goes on right in the label, the FDA's recommendation, which is pretty rare for the FDA to say, "Our recommendation is that you can give up to 36 doses over 37 months." 36 doses over 37 months. It's one of those pieces that they don't have to say what is a recommended course of treatment, but yet they did for us. Cash, we ended the year with about $250 million cash on hand. ANKTIVA + BCG in the naive setting, this is the trial that we just filed. Honestly, it's one of the pieces that from a market opportunity is even yet a bigger market opportunity. But from a patient perspective, this is what doctors are waiting for. The group I said that I was just with, we had not yet announced it.
It was actually the next day and when I shared with them, 'cause many of them in the room were on the trial. They said, "Well, we know that you gotta be near full because you told us to stop enrolling." I told them pre-market tomorrow, we'll announce that trial is full, which means last patient in + 6 months. We will be reporting out on that, but more importantly, we'll be ready to submit an sBLA on that, which for all of them that have been involved in this, because this has been a long time coming, it was fantastic news. We have patients that are 10+ years out. No follow on treatment, still have their bladders intact.
While ANKTIVA works fantastic in a recovery setting where you're in your second, third, fourth, fifth line, the real power of it is when you get earlier. Everybody here knows that you actually have to start always later and work your way up. This is a randomized control trial, 366 patients. While we haven't seen the outcome at the final end of it, for us to get our unresponsive approval, the FDA actually asked us, "We want to see the first 43 patients in each arm of your naive trial," which was an interesting request.
They said, "We'll give you a 0.01 alpha hit or something so inconsequential it doesn't matter, but your data is so strong and so long in your unresponsive, we want to see what it's doing in naive." When we showed them that, it was already statistically significant. We reported this out on all of those. They're like, "Okay, you're approved." It's a really, really important piece. It just shows that mechanism of action and what's happening with those. Here's the pivotal trial again, 366. This was the interim data, 52 over 84. Still early data on those, but something that we're really excited about. Once we got approved with it in the U.S., we opened this trial up globally.
There are participants in Europe in this trial, there are participants in Asia in this trial, there are participants in India in this trial, and so really a much broader indication. The BCG shortage, which has been on for now 14 years, ImmunityBio actually worked with Serum Institute of India, the world's largest BCG producer, to bring the recombinant BCG to the United States, and we offer that on expanded access. I can tell you now we've shipped thousands of doses in 2025 to patients and to doctors, and those that are very, very appreciative of that. The doctors that have been using this, and there are very large names that have been using this from all walks and all types of those, have been very complimentary of this, saying, you know, "We've done BCG a long time.
This is a very friendly version of BCG." One of the real magic pieces if you're the world's largest producer is you know how to manufacture it. They focused not just 'cause most BCG is produced from potatoes in roller bottles. It takes months to produce, and it's very fragile, and you get a lot of inconsistencies in yield. They have to make it, and then they got to mix it, and they got to bring it back out, and so it's a very fragile process. The recombinant BCG, while they make that type still so they know very much how to do it, is actually made in stainless steel tanks.
Adar, who's the CEO, and Umesh, who's the president of Serum Institute, said, "Our number one objective was to make it a 21st century manufactured BCG." BCG is a very powerful drug. BCG, for what most people don't know, was actually the first immunotherapy. We just didn't have the words to call it an immunotherapy. If you go because BCG is an immune response drug on those, and that's why it works so well with ANKTIVA in bladder because ANKTIVA is designed to be a backbone across all immunotherapy. Looking forward on our bladder pipeline, a lot of exciting pieces here, but I want to keep going.
When we began the clinical trial of N-803 + 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. The thyroid. Now I don't have thyroid. I was thinking they might probably gonna take out my bladder.
We saw no dose-limiting toxicity, so 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 wanna do. I'm enjoying life.
I'm not even concerned about it on a daily basis. Finally, Dr. Teague, he says, "I don't think it's gonna come back, because I think you're in full remission." Feels good.
Over 20 years of practice in urology, I have not seen a clinical trial with this durability, so I'm really interested to see how this plays out.
Play that because it's our why, and it really is what focuses everybody. Dr. Soon-Shiong is a surgeon. He's a physician first. He's a scientist first, so it's always follow the science, follow the data. But always staying grounded in the why is what really matters. These are people that are, as you saw, 10 years out, and it's a complete transformation to their life. In lung, this is actually from ASCO 2024. The headline of ASCO 2024 is, "Uh-oh, checkpoints fail. What are we gonna do?" That's really the short version of it. Well, QUILT-2.023 was a frontline lung, which is where you get this checkpoint plus ANKTIVA and you can see the clear separation. Here's QUILT-3.055, which is second line lung.
One of the things that's unique about ANKTIVA is you see this very long tail. If you follow the mechanism of action, you follow the science, it's very clear it's the memory T cell that's driving that. First of all, you've got to reactivate the immune response to the overall piece. You've got to bring natural killer cells. You've got to bring killer T cells along with other therapies. But what gives you that long duration is that memory T cell because while it's fighting the cancer, it's also training the body, how do I fight it in the future? And I think that's one of the things that people don't really appreciate. That's why now in bladder, what you hear doctors talking about is duration, duration. I'm now keeping my bladder. I'm going through those. It's a different paradigm and that's literally what Dr.
Soon-Shiong's now 15 years ago premise was. Here's how we've got to create a backbone across all immunotherapy. I talked about this already. The Saudi FDA stepped out and said we're going to be the first in the world to approve this for lung cancer. Just absolutely remarkable. We're shipping product or soon to be shipping product. We were ready to ship product and then conflict broke out on those. But I can tell you I spoke with people today and we have product ready to be able to ship to Saudi Arabia. They just cleared us with airspace. We have patients lined up for lung. We have patients lined up for bladder. Doctors set up over there. It's a very exciting time to be able to see that happen.
2019 is when I found out that I had cancer, lung cancer. For two and a half years, my standard care, it worked. I got to ring the bell. I was like, this is done, you know, but unfortunately it wasn't done. Mid-June 2022, I went and got a CT scan. I was alone when I got my results that I was stage four. 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 same chemotherapy because it worked before and to go on to Keytruda as well as N803. 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.
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. Liu, he was blown away because it was 75%-80% improved in just two months. He called me his miracle patient. He said, I have never seen anything like this. 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 a week. The positive thing was I was there with my granddaughter. 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, 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. My scans were improving and improving. Started walking. I joined the gym, enjoying my granddaughter. That fall, I ran the whole harvest festival. It was a, you know, 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.
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, you know, six-eight weeks to live three and a half years ago to still be here.
That story is so important because if you really frame that up, you heard her say, I got to ring the bell. Checkpoint worked for her and then checkpoint failed. It's scientifically predictable. That's the 3.055 study that she was part of where we actually use the same checkpoint with ANKTIVA again, and now you hear her story. The earlier trial that I told you about, which was our 2.023 trial, is actually in the frontline setting. Really, you're getting ahead of the problem so you don't have to go through those. We're running additional follow-on trials. Her story is literally part of what Saudi Arabia approved.
As I told you, others are reaching out to us now saying, we want to talk about this because it was approved in Saudi as an accelerated approval and others are asking us, let's have a dialogue about what does that look like. Lymphopenia, I told you this is one of the most important pieces that are happening. Everybody knows, likely knows the Epogen, Neupogen story. If you get low red blood cells, they give you Epogen. You get low neutrophil counts, they give you a Neupogen. Well, for 50 years, there hasn't been anything that they can do with those. But quite literally, ANKTIVA is a lymphocyte-stimulating agent. Right inside of our label, right inside of the European label, that's what they're acknowledging it is.
This is the real focus that we're trying to drive through, is for the transformation of cancer care, how do we bring this across pan-tumor? How do we work through those? That's why we're working with everybody right now across multiple different trials, but multiple different conversations. Go quickly through these 'cause we're just in a couple of minutes here. I wanna end and really focus on our non-Hodgkin lymphoma because everything we've talked to you today was about bladder, which is a local disease, but a solid. We've talked about lung, which again is a systemic disease, but a solid. Our Non-Hodgkin lymphoma trial is obviously NHL, specifically in the Waldenstrom piece of these in a liquid tumor on those pieces. We're seeing very early results in this, but very exciting.
South Africa is where we've been running this trial with a group of very high respected physicians, and it's our CAR-NK CD19 along with ANKTIVA. When we originally did it, I'll tell you, we almost internally called it a bridge to transplant. Just said, "Okay, you get it's working, it's not working, we're gonna get you to a transplant," but there's this donut hole in the middle where we need through those. The physicians that are doing this said, "This is not a bridge to transplant. This is working. We're seeing responses." This actually takes that off the table, the need of those.
While we're still early in this is one of the most exciting things that happened because if you can take ANKTIVA and our platform and our CAR NK and now do it in local, systemic, and solid organ as well as in a liquid tumor, you've now covered the entire gamut on those pieces. With that, I think we're over right now, so I would open it up to any questions that folks have.
I think we're over time. Is that all right? Or do we have a couple minutes? I'll give one if there's one in the audience for a question. Otherwise I'll-
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So there's really no end as you go through this 'cause it's effectively across all cancer types, so you gotta kinda take it by market, by area, first starting with bladder, right?
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Yeah. So where we're targeting right now between bladder and lung, you can just see it's the total addressable market is tens of thousands of patients on those, across those pieces. We haven't given guidance on the total size of the bladder cancer market. J&J's out there saying they see it as a $5 billion market. Just bladder alone, I'll make it even simpler, ImmunityBio looks at what we're doing with the non
The unresponsive and CIS plus and minus papillary, the papillary we've just done in naïve as being more than enough for us. You know, that's a multi-billion dollar market opportunity, and more than enough for us to be able to be on the other side of profitability while we're then delivering on the bigger markets of lung, lymphopenia, and other ones. Just endless sizes as you go through those is maybe the best way of saying it.
Just one final one. As you kind of wrap up, you know, you talked about the BLA filing by the end of the year. Anything else kinda in between, outside of sales growth, anything that we should, you know, investors should be looking at in terms of milestones between now and the end of the year that could drive value, that could show-
Yeah.
Execution?
Great question. There's a lot of pieces that are happening inside of these. I think the ones that to really watch for in the next 60 days, you're gonna see since we've submitted the papillary one, is the FDA accepting that filing. Now, we didn't just randomly do that. They invited us to be able to submit to that one, so we're anticipating that conversation after much pieces of those. NCCN should be literally any day. We submitted back in August of this year. That one matters 'cause just staying again in the bladder side of those, it opens up from an on-label CIS ± papillary and papillary in an off-label use while we're working through the full approval.
Folks have asked, "Well, why would you go after full approval if you get access to it through the NCCN?" Because it gives you global access. I think if there's anything I would tell folks here to take a look at is ImmunityBio is truly committed to bringing cures to and long-term durable treatments to the most complex diseases, but it's doing it on a global basis, and that's very much in Dr. Soon-Shiong's in his DNA, but in his clear direction of these pieces and as CEO, what quite literally the teams and I have been working through. It is one of those pieces. In 2026, ImmunityBio will be a very global company, but in 2027 you'll start to see substantive revenue coming from those.
Terrific.
So.
Well, Richard, thank you very much.
You're welcome.
Really appreciate it.
Thank you so much.