IBRX - NASDAQ

Good afternoon, and welcome to ImmunityBio's Full Year 2025 Earnings Conference Call. [Operator Instructions] Please be advised that today's call is being recorded, and a replay will be available on the Investor Relations section of ImmunityBio's website. Before we begin, I'd like to remind you that this presentation and accompanying discussion will contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, are forward-looking statements, including, but not limited to, statements regarding our future financial performance, expected revenues, operating expenses, cash runway, clinical development plans, regulatory submissions and approvals, strategic collaborations, manufacturing capabilities, commercial launch planning and timing, market opportunities, and business strategy. These statements involve risks and uncertainties that could cause actual results to differ materially from those described. For a discussion of risk factors that could cause these differences, please refer to ImmunityBio's most recent filings with the Securities and Exchange Commission, including our Form 10-K filed on February 23, 2026. The company cautions you not to place undue reliance on any forward-looking statements, which speak only as of today's date. The company will not be providing forward financial guidance on today's call. Joining us today are Dr. Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer; and Richard Adcock, President and Chief Executive Officer. I'll now turn the call over to Dr. Patrick Soon-Shiong.

Welcome, everybody, to our conference call, and it's really a seminal moment for the company where on an annual basis, we provide an update. But this year, it's really very special because not only do we have an approval, we have the commercial results that we can show that's operational excellence on execution. We will have Rich Adcock, the CEO, present that. But before we go into the commercial launch of ANKTIVA, I would like to take this opportunity to really give a little context and history of ImmunityBio, its evolution, and more importantly, the strategy that we've embarked on since 2015 when NantKwest went public and then all the way to its merger with NantCell and the public offering of ImmunityBio. I want to indulge in doing so because I think it explains to our audience the platform of the products that make up the BioShield platform. On the one hand, we have ANKTIVA, which is truly the backbone of this entire BioShield platform. And the reason it's a backbone is: one, it is approved; two, its mechanism of action is unique. It's the first time in medical history, quite literally, that there is a cytokine molecule called IL-15 that is now approved that one has been identified by the National Cancer Institute as the #1 molecule to cure cancer as far back as 2007. And by 2024, the FDA affirmed this IL-15 by stating in the package insert, its mechanism of action is to stimulate the NK cells, CD4, CD8 T cells, and memory T cells without upregulating Treg cells. That's a mouthful. But that mouthful as a backbone serves as the foundation to take ANKTIVA and combine it with standard of care or combine it with our natural killer cell therapy and combine it all with the adenovirus. Most importantly, it serves as a backbone to treat this condition, which we will talk about called lymphopenia. So again, welcome to all. I will take the first opportunity to present the evolution and history of ImmunityBio and how through our ambition is to actually truly make a different impact in patients with cancer, patients with infectious disease, and patients with lymphopenia. After my presentation, which I will then turn the call over to Richard Adcock, the CEO, to present the current commercial status of the company, and then we'll open it up for questions. So let me proceed. So let me level set. Some of you may be aware that over the past maybe 3 to 6 months, we've described the mission and vision of ImmunityBio on TV shows or podcasts, including the show at NewsNation on killing cancer and the exciting meeting which we had with the Director of the NIH and Director of the NCI together with our patients. And I think it's very important for me to step back and explain the strategy from the outset. So if you would give me the luxury of going back in history a decade ago from July 2015 to today, I think it is important for us to trace that back to understand both the strategy of the molecules that ImmunityBio develops, the strategy of how we build our own manufacturing facilities and control the master cell banks ourselves so that combinations can occur, the strategy of proving and testing that the immune system is the core root cause and the collapse of such, the immune system, is a core root cause of cancer, and how by addressing the immune system in totality -- and I mean in totality, from the innate and the adaptive immune system -- we can change the course of cancer. So it has taken us a decade from the first IPO of NantKwest. So in July 2015, after having identified NK-92, a natural killer cell that's off the shelf, the company went public and a successful IPO occurred in July 2015. By 2016, we were asked to launch the Cancer Moonshot. I provided a whitepaper, and some of you may have seen this collage drawing that I completed in January 2016, and showed this program to the then Vice President Biden as the Cancer Moonshot that we would pursue. It was my goal and understanding that this would be a collaborative effort on behalf of the nation, in which all Big Pharma, all FDA, all NIH would collaborate to take on this very ambitious task of integrating multiple platforms that all focus on activating the innate and adaptive immune system to allow the human body, your own body, to kill the cancer from within. This proceeded to multiple meetings in which we had with all the thought leaders, all the scientific leaders. But sadly, it became apparent that we would have to go alone. The Biden Cancer Moonshot went separately with regard to Big Pharma and the academic centers, and we pursued this effort on our own, and this has become ImmunityBio. So it is important for our investors to understand that this is not an overnight strategy. This is a strategy that we undertook all the way from 2016 in which this diagram, or what I call the mind map, and the concept of quantum oncotherapeutics. Let me briefly just describe that to you today so that you understand how our thinking and our strategy relates directly to the products and the goal of us towards the cure of cancer. So there were many concepts that I had to challenge when the concept of starving the tumor arose with the development of Avastin. I challenged that, and that was the basis of my developing Abraxane to, in fact, feed the tumor. And very early on in my career, I realized that this anti-angiogenesis Avastin theory was a flawed theory because what you do if you starve the tumor, you would induce micrometastasis, and that was not the answer. But then saying that in the face of a huge company like Genentech and Roche developing Avastin was really going against the thought process of everybody at that point in time. Sadly, when I thought about the biology, I thought that would be completely different. In a sense, what that would do is actually cause micrometastasis because the tumor would shape shift. You start the tumor, it would actually move to different places where you couldn't recognize it until you get metastasis. So contrary to starving the tumor, I think quite the opposite. You should feed the tumor. And since the tumor devoured albumin as a delivery system to feed itself, why not create a nanoparticle of albumin, allow the tumor to feed thinking it's feeding the albumin, and within the core of that albumin have a chemotherapeutic agent called paclitaxel. So that was what I called Abraxane. So rather than starve the tumor, feed the tumor, and it was going against the grain. So we developed Abraxane. So the next question is, what is this tumor microenvironment. That around that time was a complete new concept that the tumor microenvironment consisted of what we call our lymphocytes. I want you to understand that word lymphocytes because lymphocytes and depletion of lymphocytes results in a disease state called lymphopenia. We will come back to lymphopenia. But what are lymphocytes? Lymphocytes are the natural killer cells and the T cells and most importantly, the crosstalk between a CD4 and a CD8 T cell and a natural killer cell to generate a memory T cell. That is the holy grail, the generation of a memory T cell so that your body can remember if this tumor ever comes back and prevent and give you long-term duration. You will hear throughout our conversations in ImmunityBio duration matters. It is a proxy to saying you've generated memory T cells. It's a proxy to say that you're free of cancer, and you are in remission so that cancer is now a chronic disease. We will get to the point where we'll call it a cure. But at this point, we all want to take cancer all the way so that you are free of disease with the highest quality of life over 10 years, which meant you needed to deal with the tumor microenvironment. Well, what was in the tumor microenvironment? And this is where the world quantum came into it. Not only did the tumor shape shift, and we'll get into the tumor how it shapeshifts, how it avoids T cells, or how it exposes itself to [ actually grabbing ] albumin, how it avoids natural killer cells even. But the tumor microenvironment of the killer side and the suppressor side both shapeshift, meaning you have natural killer cells and T cells that are designed in your body to kill abnormal cells. But at the same time, as these cells get activated, you also have in your body to create balance of suppressor cells. So a killer T cell can become -- killer T cells can become a regulatory suppressor cell. A killer macrophage called M1 could become a macrophage suppressor cell called M2. Even a neutrophil that is supposed to kill and participate in killing infection could become a suppressor neutrophil from an N1 to N2. So we need to take this balance into consideration, and therefore, engineer products to not only activate the killers, but to suppress the suppressors. So this quantum war that is happening literally within minutes, hours, days in real time needs to be accommodated and the change and the shapeshifting is dependent on what you're doing or what you're treating on behalf of the patient. That is this paradigm change. That is this complexity that I have tried since 2016 over multiple meetings, which I call breakthroughs in medicine and brought thought leaders along with me, including Dr. Jeffrey Schlom and Dr. James Gulley from the National Cancer Institute, for which we have been collaborating happily and excitingly for the last decade. We instituted what we call a CRADA, a Cooperative Research and Development Agreement. And for the last decade, between ourselves and the National Cancer Institute and academic and community doctors have gone ahead to prove this theory. So what was the seminal moment? Well, the seminal moment was in 2016 -- September 2016. I visited the FDA and was invited by Sean Khozin to present to the entire leadership of the OCE, the Oncology Center for Excellence, that had just been formed to provide this concept of quantum oncotherapeutics and the concept of a QUILT trial, constructed this wording, the QUILT trial, so that people can understand the elements of QUantum Immuno-oncology Lifelong Trial. That was what QUILT stand for. QU is quantum, Immuno-oncology Lifelong Trial. The FDA at that point said, this is exciting. We will allow you to file an IND. That was the changing moment. And by 2017, and I apologize going into this history because you now will see the development from 2017, and you will see maybe a decade from now, 2027, not only the development, but the execution of this incredible paradigm change. And I will go into that further in this call. We will show you how ANKTIVA becomes a backbone to multiple ailments, how ANKTIVA becomes a backbone to current standard of care. For example, ANKTIVA will be the backbone to chemotherapy, but chemotherapy at a lower dose. ANKTIVA could be the backbone to radiation, but radiation at a lower dose. ANKTIVA could be the backbone to BCG, but BCG even in the failure. ANKTIVA could be the backbone to checkpoint inhibitors. That we do not need to abandon the standards of care so that the current learnings of what we've learned, but enhance an adjuvate, or call as an adjuvant of the current standards of care. But we wanted to go beyond that. We want to now step back and say, okay, how do we actually use not just the standard of care, but how do we actually now generate a cancer vaccine, and that's where this becomes exciting. In order to do that, we needed to activate the dendritic cells. And therefore, the opportunity to actually use either an adenovirus or molecules that would activate the dendritic cells with antigens that the tumor would recognize and now train or create educated T lymphocytes. Now there's opportunity to combine ANKTIVA with molecules that would activate the dendritic cells. But there is yet a further opportunity. We could then harvest your NK cells. Imagine if we could harvest your NK cells from you as a person and give it to anybody as allogeneic, but stimulate those NK cells, not only with IL-15 and ANKTIVA, but IL-12 and IL-18 to make them memory-like. And now they're not only sustained, but they're active and supercharged. That combination of ANKTIVA plus m-ceNK is what we will discuss. However, we need to address the suppressors and how do we outsmart the suppressors. So what if we actually then created targeted NK cells such as PD-L1 NK, CAR-NK where we could use that off-the-shelf to go after the suppressors or we could target liquid tumors such as diffuse large B-cell lymphoma or Waldenstrom lymphoma with CD19 and so forth and even PSA. So you begin to see the ambition. So we have taken you through this mind map through January 2016. And that was the thinking as I went to the FDA. And I am forever grateful for the FDA allowing us to file the IND and approving the IND in 2017. So the next discussion is for me to reveal to the public the actual language that I put in front of the FDA as part of the IND to initiate the QUILT trials. And quite literally, I have pulled out the cover letter that I filed with the FDA under the umbrella of NantCell, and I will read to you the cover letter. The cover letter says, dated March 2017, "Initial investigational new drug submission and a request for regenerative medicine advanced therapy designation: as early as 2017, we recognized that this was what we call an RMAT opportunity. This was an opportunity for us to take combination ANKTIVA as a backbone to combine with a cell therapy, whether it be NK, whether it be CAR-T, whether it be CAR-NK, and apply as an RMAT designation." I will read the basis, the one paragraph and the intent. It says, "The Nant Cancer Vaccine is a modern approach to cancer therapy, a regenerative advanced therapy to maximize immunogenic cell death while maintaining and augmenting the patient's antitumor, adaptive, and innate responses to cancers." That's a mouthful. That is not only regulatory speak, but scientific speak on the second paragraph of the submission in 2017 to the FDA. I go on to say, "The Nant Cancer Vaccine makes use of lower metronomic doses of both cytotoxic chemotherapy and radiation therapy, with the aim of causing tumor cell death while minimizing suppression of the immune system." There, in that sentence, I was trying to explain in a very subtle way that the current standard of care maximizes the death of our lymphocytes. It maximizes what I call lymphopenia. The concept of absolute lymphocyte count was unknown, ignored, not taught, and there was a need for us to change that thinking process. The third sentence goes on to say, "These treatments are combined with immunomodulatory agents that serve to augment and stimulate patient's adaptive, innate immune responses." What I was saying there is we can use chemotherapy, for example, Abraxane. But guess what Abraxane does, it would actually go into the tumor microenvironment, it would convert M2s to M1s, it will wake up the tumor by allowing to express on its surface these what we call DAMPs and induce the ability for our T cells and NK cells to recognize it and kill it from the outside in. That is the concept of what is going on here. So if you don't mind indulging me, this is such an important cover letter. I will maybe put this cover letter together with the slides, and I want to show you -- read you the next paragraph. "The intent of the Nant Cancer Vaccine development effort," remember this is 2017 now, "is to employ this novel treatment protocol in a series of clinical trials in which the therapy was investigated across multiple oncology indications." Again, the basis of that simple sentence was to say, T cells don't have a tumor address. They know exactly where a bad cell is, regardless of its anatomy or regardless of its location, same for natural killer cells. So we were trying to indicate to the FDA by activating the immune system, it's a complete paradigm change. It's not indication by indication. If you have cancer, regardless of the location and the type, these natural killer cells and T cells, if activated, will kill them. I go on to say, "Small variations in the chemotherapies and the doses will be based upon past experiences with these therapies in a given indication." And what was I saying here? Well, there were things like FOLFOX, there's things like Gem/Abraxane, there's things like different combinations of chemotherapy. And what we did not realize as chemotherapeutic oncologists trained with a hammer of just wiping out the tumor and seeing a response rate is that these chemotherapeutic agents have novel properties that could modulate the tumor microenvironment. For example, gemcitabine I chose, because it inhibit the suppressors. So there were subtle insights that was not taken into account of generating what I call immunogenic cell death rather than what is called tolerogenic cell death. So that little sentence that says, small variations in the chemotherapies and the doses were based upon experiences, meaning past experiences, with these therapies in a given indication. So we were given the green light to go after patients who have failed all standards of care. Excitingly, this progressed to be given the greenlight to patients who failed all standard of care for lung cancer, for triple-negative breast cancer, and multitude of other cancers, which then said, I was given the greenlight to use ANKTIVA as the backbone and the entire ImmunityBio platform, which I will now show you, as part of the development program that took us a decade to complete all the way until the approval of the first indication in bladder cancer, where ANKTIVA plus BCG was just the beginning. We have already shown data on ANKTIVA plus checkpoint inhibitor, and this now is the status of where we are. And I think it puts into context the event we just had on Friday with NewsNation and Chris Cuomo and the Director of the NIH and Director of the NCI and the audience. What I discussed at that meeting was a workshop report that we just discovered recently that was published in 2007. It was really an exciting workshop report where the NCI, the NIH, the FDA, AACR, all the scientific thought leaders were asked to rank the most important molecules in your body that could cure cancer. #1 ranked was IL-15, i.e., what they called a T cell growth factor. And #2 ranked was a checkpoint inhibitor such as KEYTRUDA that took the brakes off T cells. So the revelation that the scientific community as far back as 2007 had identified, based on the science, that the IL-15s acting as a superagonist, which is today ANKTIVA, was ranked #1, and the checkpoint inhibitor, today known as KEYTRUDA, was ranked #2, was an exciting discovery. I think if you think about the biology, in order to take the brakes off T cells, which is the #2 molecule, you actually need T cells around in the tumor microenvironment, and that's what ANKTIVA provides. If you have lymphopenia induced by chemotherapy and radiation and you have no T cells, you may take the brakes off the T cells that remain and then all of a sudden, the checkpoint inhibitor fails. And that is what's happening. And I will show you another slide in 2024, how at ASCO, desperate oncologists say, "Now that we've failed in lung cancer and any other tumors, all these 40 tumor types, what we call checkpoint inhibitor failures and standard of care failures, we have nothing else to offer other than more chemotherapy, specifically docetaxel. And the docetaxel has been tested in literally thousands of patients as a single arm, again, as a control against multiple cancer trials. And regardless of the trial, it shows a median overall survival of 7 to 9 months." I want you to put that into a little memory box because we'll come back to that when we talk about QUILT-3.055 and why the Saudi FDA approved ANKTIVA for lung cancer for the first time in the world. So before I hand over to Rich Adcock to talk about the commercialization program, let me also highlight a very important discussion that occurred in the presence of the NCI and NIH Directors during that evening show. This concept of the plausible mechanism of action, which is the new policy put forth by Dr. Makary at the -- and published in the New England Journal of Medicine, speaks to a very exciting opportunity that the plausible mechanism of action is a pathway. And obviously, the mechanism of action of checkpoint inhibitors was to take the brakes off T cells. The mechanism of action of ANKTIVA is actually to grow T cells and to grow NK cells. This mechanism of action has been affirmed in 2 tests: one, by the 2007 NCI report, which affirmed that IL-15, which is basically ANKTIVA, is a T cell growth factor and ranked #1 out of over 100 molecules to be the most important molecule to cure cancer. And checkpoint inhibitor was ranked #2. So the important discussion was it is very clear that ANKTIVA falls within the plausible mechanism of action concept. And interestingly enough, as we will proceed, and I'll discuss it more further after Richard Adcock's presentation, is that the mechanism of action, not just of ANKTIVA, but the mechanism of action of the Nant Cancer Vaccine or the therapeutic vaccine, which uses ANKTIVA as a backbone, which we'll discuss later on in this call, also falls within the plausible mechanism of action of inducing both the innate and adaptive immune system for long-term memory. So with that, let me turn this over to Richard so that he can now present the commercial progress, the clinical progress of ImmunityBio with the first approval, not just only in bladder, but the first worldwide approval of ANKTIVA for lung cancer in combination with checkpoint inhibitors. Richard?

Thank you, Patrick. Good afternoon, everyone. I appreciate you all joining us today, and I'm excited to walk you through what was truly a transformational year for ImmunityBio. Before I get into the numbers, I want to reinforce a point that Patrick made. ImmunityBio is not a single-product company. ANKTIVA is our lead commercial asset and the backbone of our platform. Still, we are a multi-platform, multi-indication immunotherapy company with many trials completed and many more trials in progress across multiple tumor types, a proprietary NK cell and DNA vaccine vector platform, and a growing portfolio of regulatory designations. The commercial and financial results I'm about to walk you through reflect the strong execution of our broader strategy. With that context, I am pleased to report that ImmunityBio delivered a transformational year in 2025. Full year net product revenue for ANKTIVA was $113 million, representing a 700% year-over-year increase. To put that in context, we generated $14.1 million in net product revenue in 2024, the year of our FDA approval. In 2025, with the addition of our billing J-code, that number grew to $113 million. That is a fundamental shift in the company's trajectory and tells you that the commercial opportunity for ANKTIVA is real and growing. We also achieved a 750% increase in unit sales volume over the same period. This is an important metric because it indicates revenue growth is driven by real clinical adoption, not pricing. Clinicians are choosing ANKTIVA for their patients. And with that adoption, it is accelerating. We closed the year with a 20% quarter-over-quarter revenue growth from Q3 to Q4, demonstrating the commercial momentum we built in 2025 has continued and strengthened as we exited the year. That trajectory matters because it tells you we are not just growing off a small base, we are sustaining and accelerating growth as our base scales. Each sequential quarter in 2025 was stronger than the one before it. ANKTIVA is now authorized across 33 countries with 4 major regulatory jurisdictions: the United States, the United Kingdom, the Kingdom of Saudi Arabia, and the entire European Union. All of these were achieved within 2 years from our initial FDA approval. We believe this represents the most rapid international expansion for an immunotherapy in this indication and reflects both the strength of the clinical data and the global unmet need in bladder cancer and beyond. Let me walk you through our commercial performance, then I will cover our financial results and our strategic outlook. Starting with the United States, ANKTIVA continues to see strong and growing uptake among urologists and oncologists treating BCG-unresponsive nonmuscle-invasive bladder cancer, CIC plus and minus papillary disease. The clinical unmet need in this population is well understood. These are patients who have exhausted standard of care BCG therapy and face the prospect of a radical cystectomy, which is the removal of the bladder that is a life-altering surgery with significant morbidity. ANKTIVA offers these patients a treatment that has demonstrated a durable complete response while preserving the bladder, and clinicians are responding to that value proposition. We are seeing adoption across both community urology practice and academic medical centers. The feedback we received from treating physicians consistently highlights the favorable tolerability profile and the durable response they are seeing in their patients. Importantly, we are also seeing repeat prescribing behavior where physicians who treat continue to treat additional patients with ANKTIVA. That repeating prescribing dynamic is a strong indicator of physician confidence in the product and a key driver to the growth trajectory you are seeing in our numbers. We have invested in building our sales force and medical affairs infrastructure throughout 2025 to support this growth. Our commercial team has established strong relationship with key opinion leaders and high-volume treatment centers across the country, and we continue to expand our reach into community practice where most bladder cancer patients are seen and treated today. We are generating real-world evidence strengthening the clinical case for ANKTIVA as a routine practice. The vast majority of our $113 million in net product revenue was driven by U.S. commercial performance, and we are confident in the durability and the continued growth of that demand base as we enter into 2026. The U.S. remains our largest and most mature commercial market, and we see meaningful room for continued penetration as awareness of ANKTIVA grows amongst the broader urology and oncology communities. Turning to Europe. The European Commission granted conditional marketing authorization for ANKTIVA in February of 2026, covering all 27 European Union member states plus Iceland, Norway, and Lichtenstein. This is a major milestone that opens an enormous patient population to this treatment and represents our second largest regulatory jurisdiction after the United States. To ensure we can move rapidly towards commercial launch across this complex and diverse European regulatory landscape, we've partnered with Accord Healthcare. Accord will deploy over 100 dedicated sales, medical, and marketing professionals across 31 countries in the EU, U.K., and the European Free Trade Association member states. Accord brings a proven commercial infrastructure, established payer relationships, and deep experience with oncologists and specifically urologists in this region. This partnership allows us to access a pan-European commercial footprint without the time and capital required to build that infrastructure from scratch. We have also established an Irish subsidiary in Dublin to support European distribution and the commercialization strategy. This structure positions us for efficient coordinated execution across the region as we work through a country-by-country reimbursement and market access process. While market access time lines will vary by country, we are prioritizing the 5 largest European markets: Germany, France, Italy, Spain, and the United Kingdom, where we expect the highest patient volumes and where Accord has particularly strong commercial capabilities. In the Kingdom of Saudi Arabia, we received 2 approvals from the Saudi FDA in January of 2026. The first is the approval of ANKTIVA for BCG-unresponsive nonmuscle-invasive bladder cancer, CIS plus and minus papillary disease. The second is the conditional approval for ANKTIVA in combination with checkpoint inhibitors for metastatic nonsmall cell lung cancer. That nonsmall cell lung cancer approval is significant because it marks Saudi Arabia as first jurisdiction worldwide to authorize ANKTIVA for lung cancer, and it validates ANKTIVA's broader platform beyond bladder cancer. We recognize the ongoing global challenges and especially those affecting the Middle East today, but cancer never pauses and neither does ImmunityBio. We are actively preparing to launch ANKTIVA in Saudi Arabia for both lung and bladder cancers, with product shipments ready to commence. We will work closely with the Kingdom of Saudi Arabia to manage imports amid the current escalating circumstances. The Saudi Arabia market is increasingly important for oncology therapies as the Kingdom continues to invest heavily in health care infrastructure under its Vision 2030 program. We have partnered with Biopharma and Cigalah to expand access across and through the region with ANKTIVA to the broader Middle East and North Africa region. Biopharma and Cigalah bring deep regional expertise and established relationships with oncology centers and regulatory authorities across the Middle East and North African region. We have formed a subsidiary of the Kingdom of Saudi Arabia to support commercial launch operations in country. The Middle East-North Africa region represents a significant and underpenetrated market for advanced immunotherapies, and we believe our early-mover position gives us a meaningful competitive advantage as we build out this commercial territory. Turning now to our financial performance for the full year. 2025 was a year of significant financial progress. And I want to take you through the numbers in detail because they reflect both the commercial momentum we are generating and the discipline with which we are managing the business. As I mentioned, full year net product revenue was $113 million compared to $14.1 million in fiscal year 2024. That growth was driven by accelerating commercial uptake of ANKTIVA following our FDA approval. On a unit basis, we achieved a 750% increase in sales volumes compared to 2024, which underscores that the revenue growth reflects real clinical adoption. In the fourth quarter, net product revenue increased from $31.1 million to $38.3 million. On a sequential basis, Q4 represents a 20% increase over Q3, reflecting sustained commercial momentum through year-end. That sequential acceleration is important as it signals as we head into 2026 that the European and Saudi launches will allow for additional growth. Full year research and development expenses were $218.6 million compared to $190.2 million in 2024. The increase was driven by accelerating clinical trial expenses our programs are rapidly advancing, combined with manufacturing costs for expanding production capabilities in ANKTIVA, our CAR-NK, and DNA vaccine vectors, as well as a normal course $14 million onetime fixed asset write-off for manufacturing equipment. Our full year selling, general, and administrative expenses, or SG&A, decreased to $150 million from $168.8 million in 2024, an $18.8 million reduction. This reflects lower consulting activities as we internally developed and expanded our commercial teams as we scale our sales and expand our marketing operations. Full year net loss attributable to ImmunityBio common stockholders was $351.4 million compared to $413.6 million in 2024. The reduction of approximately $62 million in net loss is meaningful because it reflects the significant progress we have made in converting revenue growth into a narrowing loss profile. Even as we continue to invest aggressively in our clinical programs, commercially globally growing and expanding as well as our manufacturing capabilities expanding, we are on a clear trajectory towards a favorable financial profile as revenue continues to scale. As of December 31, 2025, we had a consolidated cash, cash equivalent, and marketable securities of $242.8 million. Net cash used before operating activities in the full year was $304.9 million. The major liabilities at the year-end include $505 million in related-party convertible notes and approximately $325 million in revenue interest liability on the balance sheet. For full details on the balance sheet and capital structure, I refer you to our 10-K with the SEC filing. Before I hand the call over to Patrick, let me step back and frame our 3-year global clinical and commercial strategy. We have a clear road map for how we intend to grow this company from a commercial-stage immunotherapy business into a diversified oncology platform, and it is built on our 3 platform technologies. First, ANKTIVA, our IL-15 super agonist. ANKTIVA is the backbone of our approach with its application across bladder cancer, lung cancer, colorectal cancer, pancreatic cancer. This platform leverages the approved and authorized indications we have today and the near-term label expansions we are pursuing, including BCG-naive bladder cancer and the international expansion of nonsmall cell lung cancer. The second platform is our off-the-shelf CAR-NK cell therapy programs, including our PD-L1 and CD19 CAR-NK, as well as our memory cytokine enhanced natural killer cells, or m-ceNK. This is where the combination with ANKTIVA becomes a differentiator. We are pursuing the combination of ANKTIVA and our natural killer cells in glioblastoma, non-Hodgkin's lymphoma, pancreatic cancer, triple-negative breast cancer, amongst others. Patrick will take you through the clinical data supporting this platform in detail. The third platform is our DNA vaccine vector technology, which has demonstrated a targeted immune response against specific tumor-associated antigens. We are advancing clinical programs targeting PSA in prostate cancer, HPV in cervical and head and neck cancers, as well as our NCI-NIH sponsored trial in Lynch syndrome. Our DNA vaccine platform, used in combination with ANKTIVA in treatment of Lynch syndrome, we believe represents a potential paradigm shift towards cancer prevention. ANKTIVA activates the immune system. Our natural killer cells provide direct tumor killing, and our DNA vaccine vectors deliver targeted antigen-specific responses. These modalities can be deployed individually or in combination, depending upon the tumor type and clinical setting. This versatility is a strategic advantage because it allows us to pursue multiple high-value indications from a shared manufacturing and commercial infrastructure. ImmunityBio additionally is confronting a prolonged 13-year global shortage of BCG. We have worked directly with the FDA and launched an FDA-authorized expanded access program for our recombinant BCG. This expanded access program has approximately 100 clinical sites that are active or activating, consisting of both academic medical centers and community urology practices. Today, there are more than 500 patients that have received eBCG. As a result, we have delivered several thousand doses in either a monotherapy or in combination with ANKTIVA. Across ImmunityBio's pipeline, the BCG-naive indication represents one of the most immediate commercial catalysts as we have reached 100% of the enrollment. We intend to submit a BLA, or biologics licensing application, for this indication in the fourth quarter of 2026. Approval of this would considerably broaden the addressable market for bladder cancer for ImmunityBio. Last but not least, I am pleased today to introduce you to askIB. This is ImmunityBio's internally developed and hosted artificial intelligence solution. askIB utilizes advanced large language models and parallel agentic frameworks to integrate with our global enterprise application suite directly. This integration will drive AI-powered advancements across all areas of ImmunityBio, from our cutting-edge research and development to our fully robotic manufacturing to predictive analytics that generate real-time operational insights. askIB will transform how ImmunityBio operates and innovates as we prepare for global expansion across our pipeline. In summary, we have a clear commercial franchise that is growing at 700% year-over-year. Our global footprint is now spanning 33 countries, 3 major markets that are underway, a narrowing loss profile, a 3-year platform strategy that positions us for sustained growth across multiple tumor types and modalities, and now askIB powering AI-driven innovation across the enterprise. With that strategic overview, let me hand the call over to Dr. Soon-Shiong, who will take you through the deep science and clinical data and the pipeline priorities for this platform moving forward. Patrick?

Let me take you through the portfolio of the products that we already have, the stages of where they are, the commercialization stages at the bladder cancer level, and the opportunity for us to have a paradigm-changing platform, all housed thankfully in one single company, without any single large pharma control, any single large pharma role, participation, so that this biotech platform could be made available to the country, to the nation, and to the world. So now let me turn my attention to the entire platform under ImmunityBio. I call this platform Immunotherapy 2.0, which combines cytokines, which is ANKTIVA; with vaccines, which is the adenovirus platform; with cell therapy platforms, which is the off-the-shelf NK-92 as well as the Apheresis Leonardo Platform. And this slide spells out this entire platform. And obviously, each of these elements of the platform are under clinical trials. So the focus of clarity will start with ANKTIVA, which is really the backbone of the 4 programs at ImmunityBio. First, ANKTIVA when combined with just standard of care, and we'll get into that; second, ANKTIVA when combined with ImmunityBio's off-the-shelf CAR-NKs, which are either PD-L1 t-haNK or CD19 t-haNK or ANKTIVA combined with ImmunityBio's apheresis program of m-ceNK. So that's ANKTIVA combined with cell therapy. Third is ANKTIVA combined with the vaccine program of adenovirus, and we'll get into that in patients with Lynch syndrome, patients with HPV, patients with colon cancer. And then finally, ANKTIVA in its own right in the treatment of lymphopenia. So these are the 4 pillars of therapies that are all in phases of clinical trials, some already approved, obviously, for bladder cancer, where I would like to take you through not only the scientific rationale, but the exciting data we're already seeing as we do these combinations. So starting with ANKTIVA plus the standard of care. So today's standard of care for bladder cancer is BCG. You have BCG patients with bladder cancer, what you call nonmuscle-invasive bladder cancer with BCG. My first discussion with regard to bladder cancer to describe to the lay public, this is what we call nonmuscle-invasive bladder cancer, which is one of the highest incidence of bladder cancer, where the cancer is still on the mucosa and hasn't invaded the muscle. So that's why it'll be nonmuscle-invasive bladder cancer. Patients who have this type of cancer have 2 types -- 2 subtypes from the same clonal origin called CIS, C-I-S, and the other one is papillary. CIS is bladder cancer where the tumor is flat and papillary where the tumor is raised like that of a grape. So we have initiated a trial called QUILT-2.005 in patients who are first time first-line diagnosis of BCG nonmuscle-invasive bladder cancer with CIS and/or papillary disease. The randomized study called QUILT-2.005, in which 366 patients were randomized between BCG alone versus BCG plus ANKTIVA. Obviously, it was our hypothesis that BCG plus ANKTIVA would stimulate the NK cells and result in prolonged survival. We just announced in February of this year that we are now fully enrolled the 366 patients in this QUILT-2.005 study. Importantly, however, but very early on in the development of this study, the FDA requested us to unblind at their request and perform an interim analysis of the patients that were enrolled at that time. And what we were able to show then was complete response rates of 85% when ANKTIVA was combined with BCG versus 57% when BCG was given alone at 6 months. And at 9 months, it reached statistical significance even further with 84% complete response that was durable versus 52% with BCG alone. So this represents a statistically significant improvement in duration of complete response and is consistent with the hypothesis that ANKTIVA activates the memory cell -- memory T cell and consistent with the package insert for the approval already for BCG-unresponsive nonmuscle-invasive bladder cancer. I would like to report, and we have said, now that we've accrued the patients completely, we've targeted the BLA submission for these naive patients in Q4 2026. I would like to emphasize that these studies that are now relating of the interim analysis to the FDA, and the trial remains blinded for final analysis, and we're not aware of the data yet until we unblind the complete results. Let's move on to the patients who are BCG-unresponsive, and that is what we call QUILT-3.032. What does that mean BCG-unresponsive? So in these patients with nonmuscle-invasive bladder cancer, the FDA, together with the American -- AUA, the urologists -- the consortium of urologists, came up with guidelines to create a definition of BCG unresponsive. It means that these patients have this nonmuscle-invasive bladder cancer, receives BCG, it fails; receives more BCG, it fails; and it becomes what they call unresponsive. And sadly, the only alternative -- there's no approved drug for CIS and papillary beyond that at the time we initiate the trial other than a total radical cystectomy. What does that mean the total radical cystectomy? That means that patients would lose their bladder and have an artificial bladder made. And so devastatingly lifechanging procedure, even associated mortality from the procedure itself and significant morbidity. So patients rightly so and doctors rightly so, urologists rightly so, do anything and everything they can to preserve the bladder. And more importantly, to preserve the opportunity from progressing from nonmuscle-invasive to muscle-invasive, because once the tumor progresses out of the mucosa from nonmuscle-invasive into the muscle, progression then takes a different course, and these patients have a high mortality because of metastasis. So let's give you the history of this approval. So this trial was started a decade ago. And in this pivotal QUILT-3.032 trial, there were 2 cohorts. Cohort A was patients who had CIS with or without papillary, and this is now FDA approved. This indication of CIS with or without papillary is approved with a complete response rate that we've now reported at 71% of the 100 patients that we've added, with the duration of response extending beyond 53 months as we reported at the AUA 2025 meeting in Las Vegas. And that leaves us in the same study with Cohort B. What is Cohort B? Recall, Cohort A is CIS with and without papillary disease. Cohort B is papillary disease in a sense without CIS. So it is, I suppose, the heads and tails of the same BCG-unresponsive nonmuscle-invasive bladder cancer in which CIS with or without papillary is already approved, the concept of papillary is already improved if you happen to have CIS. Cohort B was papillary alone without CIS and the result of that has been published in the Journal of Urology in 2026, in which the papillary cohort met its primary endpoint with a 12-month disease-free status of 58%, and more importantly, a 24-month disease-free status, which is retained basically at 52%. And importantly, the disease-specific survival, meaning patients did not die of bladder cancer, was 96% at 36 months, and the median has not been reached yet, meaning we haven't reached even 50% of patients dying at the time of this report, with roughly 82% of these patients maintaining their bladder at 36 months. So the fact that we've demonstrated over 80% bladder preservation at 3 years and avoiding total radical cystectomy. I think it's important to point out for this Cohort B, papillary alone in which patients have BCG-unresponsive nonmuscle-invasive bladder cancer, that there is no -- zero, no approved therapy to date, other than total radical cystectomy. We have announced that the FDA has requested us to submit additional data. After they refused to file in May 2025, we held a Type B meeting with the FDA in January 2026. And then the FDA asked us for more new data, which we've submitted and announced recently. What else are we doing in bladder cancer? Well, what we're doing in bladder cancer, there's been a BCG shortage for decades. Merck is the only supplier of BCG, and there has been a shortage -- a terrible shortage in the country, which results in many patients not being able to get enough BCG, but we have now a solution to that problem. Let me turn my attention then to our efforts in recombinant BCG. The FDA gave us expanded access to this recombinant BCG and the FDA authorized this expanded access program in February 19, 2025, to address the ongoing TICE BCG shortage in the United States. Our first U.S. dosing occurred in March 2025. And as of February 2026, 580 patients have now been enrolled across the country. And this recombinant BCG is administered intravesically, and we have requested a meeting with the FDA, which is scheduled for this month to discuss the future of this recombinant BCG to address this decade shortage of BCG in the country. So let me switch to lung cancer. So we just talked about bladder cancer. And remember, we're in this phase of ANKTIVA plus standard of care. So in the bladder cancer, the standard of care was BCG. So therefore, it was ANKTIVA plus BCG, and how ANKTIVA rescued BCG. But I think the next evolution of pure immunotherapy, while BCG, in fact, was an immunotherapy, it was one of the earliest immunotherapy, the next evolution of immunotherapy was checkpoint inhibitors. And what the checkpoint inhibitor does or checkpoint blockade does is to actually take the brakes off T cells so that T cells could recognize the tumor and be activated without any restriction. That's called a checkpoint inhibitor. And as you all may know, this is KEYTRUDA and nivo. I know we've spoken about this in terms of the plausible mechanism of action. But in order for T cell to work, a T cell inhibitor to work, it obviously requires a T cell to be able to recognize the tumor. And as I was telling you about the shapeshifting or -- the shapeshifting opportunity of cancers, the moment it actually has a T cell coming at it, one of the amazing things it does to tumor, it pulls in the MHC-I receptor. And now the T cells, even though the brakes are off, can't recognize it. So that is why you get what we call checkpoint failures. The other reason why the checkpoints fail is sometimes these patients already received radiation chemotherapy. And we do know that chemo radiation acts as a lymphopenic activity, meaning removing the T cells from the tumor microenvironment is so effective sadly in generating low lymphocyte count. So if you have no T cells, there's no brakes to take off. So these are the 2 issues that face now the American population because there were 40 approvals of KEYTRUDA by 2025, many of them single-arm trials across all tumor types. So the world has been flooded, rightly so, over the last decade with checkpoint inhibitors. But now the oncologists are flooded by a crisis, which then leaves us with the question is what if this checkpoint inhibitor that's failing could, in fact, be rescued by a natural killer cell. So imagine the state in which you have now failed checkpoint inhibitors in your second line, third line, fourth line lung cancer with a survival possibility anywhere between 6 months and 9 months even with docetaxel and suffering this terrible last 6 months of your life with this chemo. But, in fact, you could change the course of that by combining the molecule ranked #1 with the molecule ranked #2, that is ANKTIVA plus KEYTRUDA and exploring whether that would change the survival. Well, that is QUILT-3.055. That is the trial that we designed as a single-arm trial to prove that when you have this missing cell, the failure of the checkpoint at this point, for which there's no other treatment other than docetaxel that we just add ANKTIVA, no chemo, to the same checkpoint inhibitor on which the patient is progressing. I can't emphasize that more. The eligibility of this trial is you have to be progressing on this checkpoint inhibitor and then we add ANKTIVA. That's all we're giving., ANKTIVA plus a checkpoint inhibitor, and we look at the overall survival. When one looks at the literature of docetaxel in the second-line and even third-line patients with lung cancer, regardless of the literature, you will see 6 to 9 months is the median overall survival. So if we ask the question, if we took these very sick patients, second-line lung cancer patients, third-line lung cancer patients, fourth-line lung cancer patients, and if we could extend the survival of these patients, not by 7 months, but maybe even doubling it to 14 months, would that be a major impact even in these advanced cases? Well, the answer to that is we were able to accomplish that in QUILT-3.055. And on that basis, the Saudi FDA gave us the approval. So time doesn't permit me to go through all the trials and you could go to our press release where you could see the trials where ANKTIVA is combined with our NK cell therapy or m-ceNK therapy and ANKTIVA is also combined with our adenoviruses. And there are multiple trials in which this BioShield platform is being implemented through these single-arm and randomized trials. Let me talk about lymphopenia. What is lymphopenia? Well, lymphopenia is a lower level of NK and T cells in our body. It is measured by a simple test called the absolute lymphocyte count. The absolute lymphocyte count has been available as an ICD-10 code for reimbursement as a diagnostic measure of your immune status since 2015, but has largely been ignored. Why is that? The reason it's been ignored is because it's not been taught. The reason it's not been taught is because until today, there's never been a treatment that can reverse the lymphocyte count, change the ALC levels from what I call a lymphopenic level to a normal level. It's very much like anemia. If you had anemia, we can measure the hemoglobin, and we can change that either with the blood transfusion or EPOGEN. If you're lymphopenic, which means your ALC is within the dangerous range, for the first time, the opportunity to treat lymphopenia. Well, what's the consequence if you don't treat lymphopenia? I will refer you to a paper that was just published by JAMA that shows frighteningly that 1 in 5 Americans suffer from lymphopenia. I am sure that both the patients and the doctors are not aware of the fact that 1 in 5 Americans today, that is 52 million Americans, suffer from lymphopenia, meaning a count below 1,500, and severe lymphopenia, meaning a count below 1,000. What this paper frighteningly showed that if these patients with severe and/or mild lymphopenia are unattended, the hazard ratio, meaning the risk of mortality, and similarly, therefore, the risk of longevity or absence of longevity, increases by 80% if you have severe lymphopenia. So the opportunity to right this newly, I suppose, recognized, it's never been really diagnosed. We've always had the ability through a simple CBC to measure ALC. But this newly recognized danger that lurks and this newly recognized danger that actually may be the basis of aging and the treatment of aging through the treatment of lymphopenia is now possible with ANKTIVA. We have shown, as we showed you in our randomized clinical trials in lung cancer patients and as well in healthy volunteers, that ANKTIVA acts to increase ALC. In fact, the FDA has affirmed in the package insert that ANKTIVA increases the NK and T cell count. So we have several trials in motion to not only show that we can increase ALC, but also show the effect on the outcome. In sepsis, patients with sepsis routinely have a low ALC count. In radiation, patients who have radiation routinely have a low ALC count. And then even in treatment-induced infection, such as patients now in multiple myeloma receiving bispecific antibodies, routinely have a high risk of infection. We will be doing these trials to demonstrate that we can treat the lymphopenia as well as change the outcome in patients with community-acquired pneumonia, patients with radiation-induced lymphopenia and patients with treatment-induced infection over the course of the next year to 2. Finally, the manufacturing of the future. The NANT Leonardo, an AI-driven cellular manufacturing platform is the manufacturing of the future at scale and at low cost for patients requiring cell therapy, whether it be NK cell therapy or CAR T-cell therapy. Our Dunkirk, New York facility awaits this NANT Leonardo platform, and we're also in discussions with the United States officials on a national preparedness for this particular site. I would like to emphasize that this would be the most magnificent site in New York that could take biologics and via U.S. domestic manufacturing and the readiness that has already been invested in the scale of this site, to be ready on behalf of the American public. Thank you for your attention and I know it's been a long call and I appreciate you all listening to both the insights and the progress of the company. We're happy to take questions. And Richard Adcock and I are available here to take some questions. Operator?

[Operator Instructions] Our first question comes from the line of Ted Tenthoff with Piper Sandler.

Thank you for that extensive overview. It's been incredible to see the progress of the company. So that really explains a lot of what's going on at ImmunityBio. Dr. Soon-Shiong, thanks for taking time to speak with us today. Perhaps you can tell us a little bit more about this new pathway on plausible mechanism of action. Why would FDA consider accelerated approval of ANKTIVA plus CPI in lung cancer and other indications?

Well, thank you, Ted, for that question. Look, I think this is really one of the most exciting, sort of, I believe, a new policy that was advocated by the FDA Commissioner. And interesting, it was even brought up by Jay Bhattacharya the NIH Head on Friday. The best way for us to understand it is to go directly to the article in the New England Journal of Medicine that was published, and we'll put that out, in December 11th, 2025. So it's very recent. And so what I would like to do is maybe just read it directly from that article. There's obviously just a 2-page article, very short. And so if I may read specifically, he gave an example. He says, "For instance, a single disease with 150 different genetic mutations with the same functional implications may require 150 different therapies and the plausible mechanism pathway would be ideally suited to such therapies." So, obviously, with 150 different mutations, 150 different therapies, one wouldn't be expected to do 150 different trials. He goes on to say and this is important and this is in the article by Commissioner Makary, "An appropriately designed study with a small sample size can support licensure of a product for which pharmacological effect is aligned with biological plausibility." So the pharmacological effect of ANKTIVA is to, through IL-15, stimulate NK and T-cells without immunosuppressive regulatory cells and aligned with biological plausibility. Biological plausibility says that you need NK cells and T-cells to kill cancer. And it goes on to say, and congruent with observed clinical outcomes. So, Ted, if I could repeat that last sentence, an appropriately designed study with a small sample size can support licensure of a product for which pharmacological effect is aligned with biological plausibility and congruent with observed clinical outcomes. He goes on to emphasize this statement by saying, "That philosophy, in essence, embodies the plausible mechanism pathway." So it's been a long answer to the direct question, is ANKTIVA -- does ANKTIVA fall under the plausible mechanism pathway? Its biological effect is aligned with its clinical outcome. Hope that helps you.

Our next question comes from the line of Andres Maldonado with H.C. Wainwright.

Congrats on all the amazing progress you guys have done. So maybe one for Dr. Shiong here. As we think about all the ANKTIVA combinations, maybe specifically with your other cellular platforms, could you provide additional color on the implementation of your AI-driven robotic cellular manufacturing capabilities for us today?

Thank you for that question as well. I mean, this is the advance that we're making and it'll be very, very, very quickly being implemented. There's 2 ways of looking at this. We have an NK cell therapy platform, a PD-L1 NK and a CD19 NK. They're called CAR-NKs. And then we have another platform called m-ceNK. Let's go to the m-ceNK platform first because I think that has such amazing scalable potential. In order for you to have an m-ceNK, we can take anybody, a healthy person, a patient with cancer, anybody, any human being and remove or extract these white cells from the patient, just like you're giving a donation at Red Cross. Now we can take these white cells and grow them into billions of activated NK cells and freeze them down. The ability to then freeze them down and make them as a product could then be given to anybody else on the planet. We started to conceive of that, that how would you make this scalable? How would you make this affordable? And with our skill sets internally of machine vision and AI, we started working with a company that was building physically the robots and actually then taught the robot of how to make, from the apheresis sample, these NK cells without a human being involved in that process. Number one, now this could work 24/7, number two, the safety without any human contact with contamination and number three, the auditory profile adds to such an advantage for scalability. So this would be the world's first -- literally the world's first automated system in which AI is used to actually drive the production of these natural killer cells, either in the form of a targeted natural killer cells, what I call CAR-NK, or supercharged natural killer cells, which we call m-ceNK. So we think we're leading not only the nation, we're leading the world now on using AI automation, machine vision and robotics to start a complete new era of automated manufacturing process.

Our next question comes from the line of Jeet Mukherjee with BTIG.

Congrats on the progress. Just to follow the thread on the plausible mechanism pathway and as it relates to your QUILT-3.055 study. How many patients have you treated, and how does that perhaps compare to the number of patients treated in the single-arm studies run for pembrolizumab across tumor types?

Well, that's a great question as well. And so the question is, could drugs get approved for single-arm studies and there's clear evidence of that. The most, I suppose, appropriate comparator is with Merck's approval for microsatellite instability-high or what they call MSI, across all tumor types. While Merck got this approved, and if you go to the June 2018 label because that's the only place you could find the number of patients, they had single-arm trials and let me give you the numbers of patients. The total number of the 5 single-arm trials, independent single-arm trials, is 149. For patients with -- some patients with a gastric bladder cancer, triple-negative breast cancer, the number of patients in that trial was 6. The number of patients with biliary esophageal endometrial cancer -- the number of patients in that trial was 5. The number of the patients with what they call non-colorectal was 19, et cetera. So the total of these single-arm, what they called uncontrolled open-label trials represented 149 patients for which they were able to get full approval for using KEYTRUDA regardless of the tumor type, as long as they had this MSI high. In our 3.055, we had 147 patients, completely -- basically no different number, of which 86 patients were second, third, fourth and fifth line even non-small cell lung cancer. So the QUILT-3.055 in which we will be discussing with the FDA where we have either PD-L1 high or even PD-L1 low, where we have a much more prolonged survival, for which there is no other treatment available, and that's very important, other than more chemo, it falls directly into this concept of the single-arm trial. Just to emphasize the idea of single-arm trials, this KEYTRUDA, as you recall, I said it was ranked #2 by the NCI in 2007, received approval for a single-arm trial for microsatellite high. It received approval for a single-arm trial for head and neck cancer. It received approval for a single-arm trial for Hodgkin's lymphoma. It received approval of a single-arm trial for urothelial cancer, a single-arm trial for gastric adenocarcinoma, a single-arm trial for cervical cancer and so on. I think you begin to understand that it's with great precedence that the FDA has approved, at least a T-cell, immunotherapy with single-arm trial in which the brakes are taken off and therefore there should be really no -- there should be consistency when you actually grow with T-cell and NK cell as it relates to single-arm trials for which there's no other treatment available. I hope that answers your question.

Our next question comes from the line of Clara Dong with Jefferies.

Congrats on all the progress. So you've made a lot of progress recently, both in the U.S. and outside of the U.S. So just curious how you're thinking about the global commercial growth of ANKTIVA and maybe also talk to us about what the market access looks like in different regions as well.

You will take that, Rich?

Thank you. Thank you, Clara. As you know, we've already launched distribution agreements with Accord, Cigalah and Biopharma. And in each of those, there were very specific reasons that we picked them. Accord is going to collaborate with ImmunityBio for the United Kingdom and all of the European Union. And in the U.K. and EU, each one of those member states have their own reimbursement process you have to go through. So you have to do a country-by-country and that's one of the biggest reasons we selected Accord because they have deep resources that do this regularly through those. So if you look at that, as I indicated, the big 5 is where we'll start with those. Germany is likely to be first just by the nature of how progressed we are and the work that we've already done with that one. And so we're looking forward to that in 2026. Much of the work is really getting it to be accelerated. So we are prepared in ramping up in '26 heading into '27. But for the Middle East regions, we've already secured, as you know, 2 approvals from the Saudi FDA for both bladder and lung. But beyond that, we're already in direct conversations with multiple other health regulatory authorities about approvals in that region as well. And so each of those will represent new growth opportunities. Now, Saudi, as I indicated, we already have product that is literally ready to be delivered as soon as possible. Same way with Germany. So there's no holdup from any supply constraints. It's just us working through the process on those. So if you take a look at that, '26, we'll be working country by country through those and adding new regulatory approvals is what our focus will be.

Our next question comes from the line of Jason Kolbert with D. Boral Capital.

Dr. Shiong, thank you so much for describing the paradigm shift. It's very clear to me that ImmunityBio is kind of turning the oncology -- what we know about cancer therapy or the oncology pyramid upside down. So I just want to keep pushing on what you're saying a little bit, which is, what's the mode of failure? How much do we know about the mode of failure around checkpoint inhibitors that suggests the reconstitution of NK cells, restores or allows the suppression or actually the death of the malignant cell? I mean, we're seeing the anecdotal clinical data that you're creating, but I'm just trying to understand how much science and literature is out there that kind of supports this mechanistically. And by the way, thank you so much for the work and the explanation. It's amazing and I understand that you -- this is new ground. You're changing everything. And in many ways, this has to be very exciting and a big threat to Big Pharma based on what you're doing. So we're all really watching and excited.

Thank you. Thank you so much, Jason. So let me step back in terms of while it may -- can be considered new science, excitingly to us, at least, because we've been at this for a decade, I would refer you to, if you go do a PubMed search, either my name, but Jeffrey Schlom, who is the Head of the immuno-oncology program at the National Cancer Institute, people like that, we've been working diligently to understand exactly your core question. What is the mode of failure? Why does checkpoint inhibitors fail? Well, it turns out that the checkpoint inhibitor requires a T cell because the checkpoint inhibitor takes the brakes off the T cell so that the T cell can work. The tumor becomes smart over time and withdraws the receptor for the T cell. So the tumor begins to hide that receptor so the T cell can't even recognize the tumor any longer. And that's the mode of failure, both for BCG as well as for checkpoints, as well as for chemo. There's yet even one more mode of failure. Again, as I said, the checkpoints require T cells. So when you give chemotherapy and when you give radiation, you knock out the T cells, you knock out the NK cells. So there's nothing to take the brakes off. So these fundamental insights has been gleaned now with multiple, multiple both preclinical and clinical studies showing quite conclusively that this is the biology of the system, meaning that the tumor morphs in association with the treatment you give it. You give it chemo, it morphs by making sure that the NK and T cells are gone. You give it radiation, the NK and T cells are gone. You give it T cell activators through checkpoints, it hides itself from the checkpoints. So how do we recover all that? How do we outsmart all of that? Well, it turns out these NK cells look for cells in the tumor that do not have the T cell receptor, what we call the MHC-1 receptor. It turns out as soon as the tumor tries to outsmart the T cell, the NK cell as a backstop is there, has been there for 450 million years to actually kill that particular cell. So imagine then the combination of the NK cell plus the T cell. That's what ANKTIVA does. ANKTIVA proliferates both the NK cell and the T cell and rescues the checkpoint inhibitor. And that's why the 3.055, which is the combination of ANKTIVA plus KEYTRUDA or combination of ANKTIVA plus any checkpoint inhibitor, has such an effective opportunity. That is why ANKTIVA plus BCG works better than just BCG alone. So I think -- thank you for your question, it is a complete paradigm change where we're treating the host rather than the cancer and we're outsmarting this cancer.

And Dr. Shiong, one...

Go ahead.

One quick follow-up, too, which is when I look at Big Pharma and I look at what Merck and Big Pharma has at stake with checkpoints, it would seem to me that they should be knocking at your door in order to try to lock up their checkpoint in combination with ANKTIVA. And I just wonder, what is the interest level strategically from a business point of view? Do you see Big Pharma coming at you kind of realizing that there's a paradigm shift ahead? Or are they behind the curve on this?

Well, I'm trying to be polite, right? I think -- is Big Pharma behind the curve? I think, look, without my being personal about any Big Pharma organization, the CEOs of Big Pharma really have to look just at what drives the biggest revenue. And as you know, for Merck, it was 50% of the market's sales is $30 billion a year. And there's a lot of -- bunch of me-too copycats and everybody has another checkpoint inhibitor. I don't think anybody has looked at the body as a system. I was very, not just surprised, but impressed by the conversation that Jim Allison and Carl June had, and I'll refer you to either my ex, where I actually cut those 2 conversations just last week that Carl June and Jim Allison had with Michael Milken at the Nixon Conference, where they discussed checkpoint inhibitors or CAR T cells, respectively. And they then brought up the idea that, well, you know what, we have a constellation of other cells surrounding the T cells, like the natural killer cells and the myeloid-derived suppressor cells and we need to think about that. Well, luckily, we've been thinking about that for the last decade. And this composition of all these cells is why ImmunityBio is different. We needed both the ANKTIVA to stimulate and grow the T cells, but you also need to target NK cells that you could infuse off the shelf, but you also need to educate the dendritic cell with our adenovirus and you also have to manufacture supercharged m-ceNK cells. The reason we've not gone with Big Pharma, as you know, I had 2 companies that are sold to Big Pharma because my concern was that if our mission is to cure cancer, you need the combination of all these actors, meaning the ANKTIVA to grow the cells, the dendritic cell, the m-ceNK cells, to all work together in concert in an orchestrated way. So, yes, we have resisted the Big Pharma because our mission is to cure cancer. If you cure cancer, the organic value of a company is very much no different than as you could see what's happening with NVIDIA and Tesla, et cetera. I think you grow an organic value based on change and this is what we plan to do. Just to give you an insight, we're very excited, as we said, about the BCG-naive trial, which we've done the interim analysis. That will change everything with regard to bladder cancer because not just giving BCG alone where you actually will have this failure mode we just discussed, but you give BCG with ANKTIVA, where you have this memory mode, which we now can bring in. And then I think I'll make my final comment as we close this session. I looked into the number of single-arm trials approved by the U.S. FDA from 2005 to 2025. I think many of you will be surprised that according to the AI platforms, 234 -- think about that, 234 single-arm trials have resulted in approvals by the U.S. FDA. So I am very excited by the work we've done in the last decade on our QUILT trials. And then we will be moving forward not only with that, but obviously, confirmatory randomized trials. So I hope, Jason, that answers this question of yours with regard to...