So, good afternoon and welcome to the final presentation of the second day of the Citizens Life Science Conference. It's my pleasure to introduce Immunity Bio. So, we're finishing strong. Presenting for the company is Richard Adcock, the CEO. Immunity Bio is quite a unique company. They're, dare I say, a leader in the immunotherapy field with an approved product. And so, here to tell us more about it. Rich, take it away.
Thank you so much. Thanks, everybody, for being here, and we appreciate the invitation. If you've been following Immunity Bio, 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 Shunsheng, who's the founder of this. One of the biggest, hardest things I have to do in my life is work with Dr. Patrick Shunsheng, the founder of this, because 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 and so it's really all coming and there's many many great things ahead as we deliver on those pieces so let me take a few minutes and kind of 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 immunity bio 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. And what his premise was is that you have to deliver combination therapy to beat cancer. And 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. And if you really understand those, and again, you understand Dr. Sundsch'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 Anctiva. And so under our fusion proteins, Anctiva is now approved in 33 countries, we're proud to say, across those in non-muscle invasive bladder cancer. Now, in the BCGN responsive space, you first of all do the cyst 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 US FDA on that. Our naive 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, that 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. And then our NK cell therapy on those. Dr. Shunsheng 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 and Ks are ones that we can do off the shelf immediately, both in a PD-L1 as well as a CD-19 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 because what's coming ahead is even bigger than what we had there. But not to put anything but proclamation to what the team is delivered and the non-muscle invasive bladder cancer are cis plus and minus papillary anctiva massive revenue growth because a very focused delivery uh commercial team on those but 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 we're literally launching our european operations at the european uh urological association meeting there with our partners accord on those and so 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 and quite literally it's the only product out there that has three plus 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, um, European space to be approved in this. This would be, we believe when this is done, we'll be the first in the U S from those naive that I talked about that trials fully enrolled. And what that means is last patient in end of February, add six months. That's when the readout will be. So this year we'll read that out. And 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 uh for this year that matters because 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 going to be expanding indications of those we'll be adding countries we'll be working across all of these all of this 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 JP 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 US 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. But 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. So I think there could be more opportunities that are happening on those that are going on it. Lymphopenia. If you've heard Dr. Soon-Sheng 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. Inctiva, the power and magic of what it's doing is it's actually increasing. It's a lymphocyte stimulating agent. And so 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, Inctiva plus BCG is just a marked different approach. what's approved right now nato ferrigine 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 jnj was just approved they don't have any duration out 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 Anctiva is doing. It's the memory T cells that are delivering on those for physicians, for patients, and even health insurers, because 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? And 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 Anctiva brings. And it's because if you go right into the package insert that the US 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 going to be able to touch that so some of the big highlights right here 84 of the patients who responded to ink table 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 because i don't want to be filtered 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 percent 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 in 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're if you don't have a response you're not even in the game we know ink tiva 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 and then obviously disease specific overall survival at three plus 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 matt hillman 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 a patient and they're helping to navigate those and that's what's enabling this great growth in the product and the easy adoption is because we're making it easy for all involved sales growth that we've reported 700% year over year 750% on a unit sales that's the number to me that matters most is are you seeing a real unit sales growth because it's not a pricing dynamic or something else of those doctors are ordering it for a physician for a patient and when they see that it's working then they order for their second and their third and their fourth but they're also keeping them on maintenance and so 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 or 30 yeah 36 doses over 37 months it's it's one of those pieces it's they don't have to say what as a recommended course of treatment, but yet they did for us. Cash, we ended the year with about $250 million cash on hand. So Anctiva plus BCG in the naive setting, this is the trial that we just filled. 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 because many of them in the room were on the trial and so they said well we know that you got to be near full because you told us to stop enrolling and i told them pre-market tomorrow we'll announce that trial is full which means last patient in plus six 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 plus years out no follow-on treatment, still have their bladders intact. And so while Antiva 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. And everybody here knows that you actually have to start always later and work your way up. So 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 0.001 alpha hit or something so inconsequential. It doesn't matter. But your data is so strong and so long and you're unresponsive. We want to see what it's doing in naive. And 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. But it just shows that mechanism of action and what's happening with those. So 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. And so 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, Immunity Bio, actually worked with Serum Institute of India, the world's largest BC 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 on those. They're very, very appreciative of that. the doctors that have been using this and they're 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 but one of the real magic pieces if you're the world's largest producer of is you know how to manufacture it they focused not on just because most bcg is produced from potatoes and roller bottles it takes months to produce and it's very fragile and you get a lot of differences in yield and so they have to make it and 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 of style so they know very much how to do it it's actually made in stainless steel tanks and ada who's the ceo and mesh who's the president of serum institute said our number one objective is to make it a 21st century manufactured bcg bcg is a very powerful drug Like 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. And so if you go, because BCG is an immune response drug on those, and that's why it works so well with Anctiva in bladder, because Anctiva is designed to be a backbone across all immunotherapy. So looking forward on our bladder pipeline, a lot of exciting pieces here, but I want to keep going.
When we began the clinical trial N803 plus BCG back in 2014, we had the inclination that this could be a game changer. The very first patient we enrolled was Elvera. She's an interesting patient because she has a history of multiple cancers.
I started with my breast cancer and then after the left kidney cancer, so I only have one kidney right now. And then the thyroid. So now I don't have thyroid. So I was thinking
we might probably get to take out my brother. We saw no dose limiting toxicity. So the patients did extremely well in 803. It increases the proliferation of T cells. It increases NK cells and increases memory T cells as well. And 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.
And I 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. T, he says, I don't think it's going to come back. 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. Sun Cheung 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 the headline of asco 2024 is uh-oh checkpoints fail what are we going to do that's really the short version of it well quilt 2002023 was a frontline lung which is where you get this checkpoint plus anctiva and you can see the clear separation here's quilt three zero five five which is second line lung one of the things that's unique about anctiva 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 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 duration i'm now keeping my bladder i'm going through those it's a different paradigm and that's literally what dr sun shung'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. It's just absolutely remarkable. We're shipping product or soon to be shipping product. We were ready to ship product and then a 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. And so it's a very exciting time to be able to see that happen.
2019, that's 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, it's 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 are stage four. And I had like 24 tumors in my body. My left and right lung on my thyroid and on the rip. So this opened up a chance for me to get into a clinical trial and do something different. My doctor suggested same chemotherapy because at work before and to go on to Kaytruda as well as an 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. 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. So Dr. Luke, he was blown away because it was 75 to 80% improved in just two months. He called me as a 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 is just killing everything. After treatment, I would be in bed for a week. The positive thing was I was there with my granddaughter. Good to see you. Good to see you, too. She woke 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 K-Truda and the N803. I was able to eat. I wasn't weak. So the quality of life was so much better with just the two, the N803 and the K-Truda. 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. So it was, you know, I was able to do life again. It's all good news. It's all been positive. So 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. thyroid is gone it's helped me to really want to live life it's a miracle to go from six to eight weeks to live three and a half years ago to still be here the 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 3055 study that she was part of where we actually use the same checkpoint with and now you hear her story but the earlier trial that i told you about which was our 2023 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 proved 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 so lymphopenia I told you this is one of the most important pieces that are happening everybody knows likely knows the epigen neupogen story if you get low red blood cells they give you epigen 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, Anctiva 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? And that's why we're working on with everybody right now across multiple different trials, but multiple different conversations. Go quickly through these because we're just in a couple of minutes here. I want to 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 time on those pieces. And so 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 Anctiva. And when we originally did it, I'll tell you, we almost internally called it a bridge to transplant. So we said, okay, you get it. It's working. It's not working. We're going to 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. And so what we'll start early in this, this is one of the most exciting things that happened, because if you can take Anctiva 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. So 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. Or do we have a couple minutes? i'll give i'll give uh one if there's one in the in the audience um for a question otherwise i'll
yeah so it's it's there's really no end as you go through this because it's effectively across all cancer types so you got to kind of take it by market by area first starting with bladder right yeah 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 five billion dollar market just bladder alone i'll make it even simpler immunity bio looks at what we're doing with the non the unresponsive and cis plus and minus papillary the papillary we've done in naive as being more than enough for us you know that's a multi-billion 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. So just endless sizes as you go through those is maybe the best way of saying it.
And just one final one, as you kind of wrap up, you talked about the naive filing by the end of the year. Anything else kind of in between outside of sales growth, anything that investors should be looking at in terms of milestones between now and the end of the year that could drive value,
that could show execution? Great, great question. There's a lot of pieces that are happening inside of these. I think the ones to really watch for in the next 60 days, you're going to 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, much pieces of those. Instant CN should be quite literally any day. We submitted back in August of this year. That one matters because just staying again in the bladder side of those, it opens up from an on-label cis plus minus papillary and papillary and 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 instant CN? Because it gives you global access. And I think if there's anything I would tell folks here to take a look at is ImmunityBio is truly committed to bringing cures 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. Sunsheng's hit in his DNA, but in his clear direction of these pieces and his CEO, quite literally the teams that I have been working through. And so 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. Well, Richard, thank you very much. Really appreciate it. Thank you so much.