Hello, and welcome to the ImmunityBio ANKTIVA Post-Approval Conference Call. At this time, all parties are in a listen-only mode. Later, you will have an opportunity to ask questions. To ask a question, press star one on your phone keypad. If you would like to remove yourself from the queue, press star two. Please note that this call is being recorded and I will be standing by should you need anything. I would now like to turn the conference over to Mr. Robert Joffe. Please begin.
Welcome everyone, and thank you for joining us this morning to discuss FDA approval of ImmunityBio's ANKTIVA, as well as other positive developments regarding this immunotherapy agent. On the call today are Dr. Patrick Soon-Shiong, Executive Chairman and Global Chief Scientific and Medical Officer, and Rich Adcock, the company's President and Chief Executive Officer. This call is being broadcast live at www.immunitybio.com. A playback will be available for at least three months on ImmunityBio's website. Before I continue, I'd like to take a moment to read the company's safe harbor statement. Certain statements contained in this conference call that are not historical information contain forward-looking statements. The forward-looking statements involve risks and uncertainties, and actual results may differ materially from those projected or implied. Further, certain forward-looking statements are based on assumptions of future events which may not prove to be accurate.
For details regarding factors that may impact such forward-looking statements, please refer to the company's reports filed with the Securities and Exchange Commission. Please note that an accompanying slide presentation has been posted on the investor relations section of ImmunityBio's website. In a moment, Dr. Soon-Shiong and Rich will discuss recent developments and next steps for ANKTIVA. We will then open the call for questions. With that said, I will now turn the call over to Dr. Soon-Shiong.
Thank you, Robert. Good morning, everybody. It's been a long time since we've had an investor call, and I'm really excited today because I think we want to address key issues, which I'm sure everybody would be interested in. We'll talk about what ANKTIVA approval means to both the company as well to patients, and I'll just be discussing the label. I will then turn this over to Rich, who will talk about our launch readiness both in the United States and our plans for global filing. And then finally, I'll relay a little bit about ANKTIVA as the backbone to multiple tumor types. So let me start first about what ANKTIVA means to the company as well as to the patients.
I thought it'd be useful for me to walk you through a little bit the label, and I'm quite literally taking elements of the key highlights of the label. First, obviously, the indications for usage, and the reason we put this up as the first slide is the identity that BCG, which is, I think, one of the most important stimulant, immunostimulants, in the human body as it relates to activating the immune system. Our BCG in the label is not limited to the TICE BCG. The reason for that, why that is important, as many of you know, BCG has a limited supply, and what's exciting, we have now a label that can allow us to explore BCG elements that's beyond just the TICE BCG.
Moving forward with regard to the BCG, then the next slide will speak to our IP, even around BCG and our strong IP around ANKTIVA. And you will see then three issued patents already and many pending as it relates to the composition of matter of a combination of BCG and an IL-15 stimulant, whether the IL-15 is either wild type or our ANKTIVA IL-15 stimulant, and for the treatment of cancer. This will become important further along, as you begin so to see not just our treatment for a non-muscle invasive bladder cancer, but for other treatments of cancer as we proceed along the journey of ImmunityBio. The next slide speaks to the dosage and administration.
Again, here, the importance of the point is, within the label, the agency has not only recognized, but specifically stipulated that the urologists could give the drug, our combination, up to 37 months. So this speaks to the durable response. I think if there's any one take home message with regard to the results and the basis of our approval, it is in the next slide, that together with the ability to give the drug for three years, that this, to our mind now, is the next generation immunotherapy beyond T cells, beyond checkpoint inhibitors.
What was really satisfying to me, as a clinician scientist, this was the first recognition of a label in which the label speaks to the proliferation and activation of NK cells, the proliferation of CD8 killer T cells, the proliferation of CD4 T cells, and most importantly, the proliferation and activation of memory T cells. I call this the triangle offense, and as you could see from the figure, each of these cells have a very specific activity. The natural killer cells finds T cells that have been exhausted or evaded. The killer T cells are the primary killer cells, and most important, the memory Tcells, I believe, adds to the mechanism of a 47-month and ongoing duration.
I think what's interesting about the ongoing duration is the fact that the median duration of response is yet to be determined, because it's still ongoing, which is remarkable because this is now the bar that has been set, that the duration of complete response with a median that is still yet to be determined at the 47 months ongoing response, is now a bar that we think has been established as the next generation of immunotherapy. Looking finally at the efficacy and safety, Table 3 in the package insert speaks to not only the high rate of complete response of the 77 patients, and if you look at our New England Journal of Medicine paper, it's the 82 patients, and we've now reached 100 patients, and obviously that will be updated as we proceed.
But more importantly, the duration of response, and I said, the durable response, and that would be the mantra, the durable response. While we are very excited about the high complete response rate, it really is of more importance is the duration of the response rate. The International Bladder Cancer Group, which is a core of experts in the world, established a benchmark that if one could achieve a duration of number of patients of 30% greater than 12 months, that would be a high bar. In fact, they say in their paper, it is very unlikely that anybody could reach that bar, but they thought that was a benchmark to be set in 2016. And as you see in the label, our number actually is 58%. They also established a bar of 18 months.
We've now hit above over 24 months or 40%, and as you could see, we have ongoing subjects now with duration at 36 months. So taken together with this kind of efficacy, and you add then the safety, which is the next slide, within the label, you will see that there's a 0-3.4% Grade 3 to 4 adverse events, 0% Grade 3 or 4 dysuria, urine frequency, and micturition urgency, 0 treatment-related , and thus, the safety and tolerability is consistent with that of BCG alone. So I wanted to, very quickly, in a very short space of time, give you, the status of this label, which we were pleased to receive five days ago.
And it's hard to believe that only five days has passed, because I now want to hand over to Rich Adcock and the team, and the commercial team, and the launch team, that has quietly been preparing the ability to launch as soon as we received the label and as soon as we could print. So with that, I'm proud to introduce Dr. Richard Adcock. I call him Doctor. I already think of him as a doctor. He knows more about the science than most people to talk about the launch readiness and the commercial supply of this drug. Rich?
Thank you, Patrick. Good morning, everybody. You know, before I start in the details, and this is perfect to leave here, I just wanna take a moment to thank the team of ImmunityBio. Throughout this journey, Dr. Soon-Shiong and myself have asked the team to give up nights, weekends, and holidays as we work through all of the finite and minute details of what the team was required to submit. I just wanna tell you that without hesitation, without any complaint, the team did this, and they did it for one reason, because they knew this is always about the patients. So as we sit here today, both Patrick and myself are incredibly excited about what this means, yes, for ImmunityBio and our shareholders, but most importantly, what it means for our patients and for their family members.
So as we talk about really readiness, I'm gonna give you an idea on readiness, what it means, first and foremost, from the United States, and then I'm gonna tell you how we're preparing to take this global. So in our commercial product readiness, as Patrick said, we're just a few days after approval, and I want to tell you, I'm proud to say that the labeling and packaging is complete. We'll actually be shipping the first product May sixth. That's Monday. That's less than two weeks after approval. And to our supply chain team and all of the partners that we've worked with and those, I really wanna put a big thank you out for that because that's very fast. I'm also happy to tell you that we have sufficient inventory for in excess of 12 months, with a very long durable shelf duration on those.
As it relates to distribution readiness, the team has worked incredibly hard to put together to make sure we have contracts in place, fully executed with all three major specialty distributors. But it's not just the contract, all of the EDI interfaces, so it's all electronic, are fully implemented. These three major specialty distributors cover 99% of the U.S. market. So that's Cardinal Health, Cencora, the former AmerisourceBergen, and then McKesson, both on the commercial and the government side of those. As it relates to order readiness, and this is very important, you'll hear me say this multiple times throughout this....What's so unique about this is it requires no change to your practice, no change to the ordering practice.
When you go in and order from one of those major specialty distributors that are already in place with all of them, it'll immediately or it'll—following that, it'll direct drop ship right to the practice location. But what also is unique about ANKTIVA is that it doesn't require any special freezers or any special equipment. It's just your normal fridges and freezers that are already in every practice, which is a two to eight. Next, I want to talk about the sales force and our commercial teams. We've got a team that exceeds 50 sales and market access professional members. They're not only fully hired, they're trained, and every one of them are certified within a few days of approval. We've divided the nation up into five regional sales areas with key area business directors that are all seasoned with great sales experience.
And again, they're all 100% in place and have their teams out. As it relates to market events and readiness, there's two really big ones, and, and just within a, you know, a few days here, we're all going to be at the American Urological Association in San Antonio. We've got a very large booth presence there. Following that, we'll be at ASCO, the American Society of Clinical Oncology, at the end of May and beginning of June. And at the very end of this, you're going to see, and on this slide, you see a branding that we're announcing with ANKTIVA, which is THANKTIVA, which is really where we want to be able to say thank you. As it relates to medical education, the chief medical officer, long-term with the company in place, as well as
Dr. Soon-Shiong, our Global Chief Medical and Scientific Officer, as well as founder of the company. But we also have a team of medical service liaisons that have been out in the field, working with doctors, talking to practices. They're all seasoned, experienced, and in place. As you can see, every one of these items is in place. So when we start thinking about the urology practice, it's very unique because we actually have initiated conversations. The urology practices are very concentrated through those, and we've been having these conversations over the last year and ongoing. We've engaged all of the key opinion leaders, and when you're working with the urology practices, one of the things that we identify for them is that it doesn't require any change to your practice. It's the same scheduling of BCG.
It's the same ordering schedule as BCG, and all you do is a simple admixture of ANKTIVA with BCG, no special equipment or processing that is different from BCG administration. And as Dr. Soon-Shiong indicated, you could administer it for up to 37 months. For five years, the cystoscopes can be followed up inside of their practice as well. Now, on the urology back office, the ordering and workflow, everything here remains very consistent with the BCG workflow on all of those. The pricing, which is fully loaded in all of the compendiums, is $35,800 per dose. And as I said at the beginning, I think this is very important, it requires no change to urology practices required. Next up, I want to talk a little bit about market access and reimbursement readiness.
As well as with everything else, the compendia has been filed, completed, and fully accepted. I'm also proud to say that starting May 1, that'll be rolling out into all of the EMRs across the nation. The teams worked incredibly hard to be able to prepare, produce, and submit that. We've recently submitted the NCCN guidelines. Those filings have been completed, and the filing acknowledged by the NCCN. We've initiated payer discussions, and we're in great progress with many. And as I've indicated prior, large healthcare groups discussions have been initiated, and they're ongoing and in, in great progress. We've launched the ImmunityBio CARE's Patient Assistance Program. This is fully implemented. This is really here to assist patients and practices navigate this entire workflow, from everything to how to order to how to help patients with their benefits.
We have a team of fully staffed healthcare professionals, including nurses, case managers, to support patients as well as the urology practices. We help with assistance with benefits questions, processing, including pre-authorization. We're deploying right now the ANKTIVA Copay Assistance and Patient Assistance Program, and what I'll tell you is our copay assistance for the commercial can be as low as $100 a dose. Our patient assistance program will offer free drug to patients based on their individual financial situations, and our hub access, which is available 24/7, can be reached at 1-877-ANKTIVA or anktiva.com. So that really sums up best where we are with the United States readiness, and I couldn't be more proud of what the team has done.
I want to take just a moment and tell you, now that we have the U.S. FDA approval, what we'll be doing, because we're going to take that filing, and we actually have already started mobilizing the resources for global filing, utilizing that. And so we're working with Canada, the United Kingdom, Germany, France, Spain, and Italy. And lastly, what I want to do is tell you about the strong cash position. I want to take this moment to thank the team at Oberland Capital. They've been a great partner for us. They... As everybody knows, they made an initial $200 million non-dilutive cash infusion, and now they'll be putting an additional $100 million in this May.
That gives us a cash on hand of $240 million, but beyond that, we'll start our commercial launch May 6. And with that, I want to turn it back to Dr. Soon-Shiong.
Thank you so much, Rich. You know, as Rich has thanked everybody, I completely agree. People may not realize, together with the resubmission, we have almost 1 million pages of submission of documentation to the agency. But I tell you, one of the things that really I'm most proud of is when Rich has put in place the ImmunityBio CARE Patient Assistance Program, in which the copay assistance, as he shared, for the patient in the commercial setting, the cost to the patient could be as low as $100 per dose. And importantly, we really want to ensure that even though for those who have no insurance and are in a poverty situation, that we, as a company, have an obligation to offer free drug.
So with that, let me now move on to the pipeline. And as you will understand, it is my belief that we are now in the evolution of the next generation of immunotherapy. Immunotherapy ranged initially from, if you go from monoclonal antibodies to CAR- T and then to checkpoints, all of which stand dependent on the T cell. However, now with the activation of the natural killer cell and the activation of the memory T cell and the dendritic cell, which ANKTIVA stimulates and proliferates, it could serve as a backbone to any and every other immunostimulant and truly generate what we consider chemo-free therapy. I think as a company, we want to set a different bar. While progression-free survival is the bar for which most companies strive to achieve as an incremental change in cancer care.
As some of you may remember, from our Abraxane approval, our bar was even lower, in which we had a complete response rate or the response rate, and then moved to progression-free survival. We want to move the bar to overall survival, but more importantly, we want to move the bar to as much of disease-free or cancer-free overall survival. That's the bar I think we achieved with bladder cancer, and as we made a press release yesterday, we will be meeting with the agency to discuss that same bar now with second-line lung cancer. As some of you know, and I'll just address that release we made yesterday, patients with lung cancer had standard chemotherapy, and then this was followed by the addition of checkpoint inhibitors.
Sadly, following failure of the checkpoint inhibitors, the rest then is more chemotherapy, and in these patients, we call second or third line. The standard of real-world experience is that the survival for those patients is about seven months. So if we could change that overall survival, even in these late-stage patients, from seven months to an incrementally larger impact, then just with the addition of this same checkpoint inhibitor plus ANKTIVA, without any more chemotherapy, that would then further validate what we found in bladder cancer.
We will have much more details about this, obviously, as not only we present this to the agency and we present this to peer-reviewed scientific review, but I'm really excited to say that second-line and third-line lung cancer will be ANKTIVA's next indication with which we will be speaking to the agency in June. We already have a meeting scheduled with regard to the advice and guidance on a regulatory pathway to approval. So with that, let me take you to the slide of the backbone of ANKTIVA. Obviously, we will be within the urology space, and we'll put a large emphasis on becoming the leading company with in the urology workspace, whether it be bladder, prostate, and kidney.
But our initial focus will obviously be within bladder, and we have, as you could see from the slide, a naive study ongoing, in which the same dose of ANKTIVA plus BCG will be ongoing, and this pivotal trial in the naive setting is ongoing. We will also be looking to figure out a way to replace BCG, and some of you may be aware that we have a second-generation adenovirus, which has been treated in many, many patients for many other conditions, including colon cancer, and pancreatic cancer and even for COVID. And we have a Ad5-MUC1 combination with ANKTIVA pending. So I'm giving you a very limited list of our focus.
There's obviously many trials that we are pursuing with ANKTIVA as the backbone, but within the bladder space, these are the three key elements that we are pursuing. We'll also be addressing, in a very short timeframe, the issue of BCG shortage. We are very confident we can address that issue, especially with our label. Let's move then next to the lung indication. As I shared with you, the non-small cell second line of greater, the quote, 3.055 study has been completed. It was a basket study with multiple tumor types, of which 86 patients were with non-small cell lung cancer. Some of you may have recognized that the lung map study that was initiated was where the endpoint was progression-free survival.
While that study designed came to an end because of progression-free survival, if you then continued that study, were to continue the study on the overall survival, there was a marked difference. So therefore, when we looked at 3.055 data and showed a huge difference in overall survival, almost doubling that of standard of care, it validated the concept that ANKTIVA can rescue a T, a T cell checkpoint. That study is now completed, and as I said, we'll be meeting with the agency very shortly to discuss our path to registration. Which then brings ANKTIVA to the combination of other molecules. You will hear more later about this anti-clusterin antibody, which is an anti-TGF beta blocker.
And then you will hear more about our plan of our memory cytokine-induced NK cells, which has been showed to address small cell lung cancer, for which there's very little treatments. And then finally, many of you have seen or know that we are the chosen therapy of ANKTIVA, combined with our adeno MUC1 CEA and brachyury . And to my knowledge, this is the first combination of ANKTIVA for the prevention of cancer. So when we talk about ANKTIVA as an immunotherapy vaccine in bladder and lung, as a therapeutic vaccine, I'm really excited that this is the first preventative cancer vaccine in Lynch syndrome. Lynch syndrome affects one in 300 Americans, with an 80% higher chance of colon cancer, breast cancer, ovarian cancer.
I just read recently in the United Kingdom, 80%-90% of the members of the United Kingdom do not know that they have Lynch syndrome. So the genetic testing, as well as the prevention, is a very exciting program for us in preventing colon cancer. But that leads us then to the next area of third line colon cancer, for which the phase II have already been completed with CEA alone, in which an overall survival in third line colon cancer was extensively prolonged just with a single agent CEA. So therefore, with the combination of ANKTIVA and what we call a triad, is where we are planning the next iteration in colon cancer. So in summary, we have focused on three areas: bladder, lung, and colon, all as ANKTIVA as the backbone.
So I think with that, we've covered today's elements, and I want to share with you just one slide, which really is very gratifying as we really believe time matters. Cancer is a war against time. It is our hope that ANKTIVA is yet the beginning of our platform at ImmunityBio, not only to win time, but provide quality time, which is precious and time matters. The idea of THANKTIVA, whether it comes from the patient or the doctor, is going to be a gratifying moment for us as a company. With that, we will take questions, and I'll hand it back to Robert.
Gian, we're ready for the Q&A session.
Thank you. If you would like to ask a question, press star and one on your phone keypad, and to remove yourself from the queue, press star two. Again, it is star one, if you would like to ask a question at this time. We will take our first question from Joe Catanzaro with Piper Sandler.
Hey, everybody, thanks for taking my questions and, congrats again on, on the approval here. I guess maybe first, as, as we think about, the launch, may-maybe help contextualize a little bit the size of the prescriber base, that you'll be targeting, what you see as the potential implications or no implications of the, of the BCG shortage, and how physicians kinda consider the ANKTIVA regimen. And then whether you would expect, any usage in papillary-only patient. Thanks, and I maybe have a couple follow-up.
Thanks, Joe. This is Patrick. I'll take a shot at some of these answers, questions first, and then I'll hand it off to Rich. With regard to the size, I think clearly what's exciting about our first launch of ANKTIVA is that the practices are very concentrated within the urology practices in the United States. And as you know, that there are three major groups that have already now consolidated themselves as urology practices. The patient population for the label, the prevalence of the patient population of the label is about 20,000 patients, and I think we really need to look at prevalence rather than incidence. As you know, CIS. And then patients don't, they persist with the disease, trying to avoid having their bladder removed.
We're looking at a 20,000, 15 to 20,000 available addressable market in disease of CIS. As it relates to papillary, as you know, our competitors have achieved on the NCCN guidelines, papillary as a reimbursement opportunity for consideration. We have submitted our submission to NCCN as well as to the compendia. Our papillary data has been well published in the New England Journal of Medicine, and so therefore, there's a very strong peer review results, where the disease-free status and the safety in papillary is as good as what we saw in CIS. But let me hand this over to Rich in case he has anything else further to ask.
Yeah. Thank you, Patrick, and Joe, thank you for the question. I would first of all point out the current label we have is NMIBC CIS, with and without papillary. So I think that's an important one to note right out of the gate. As Patrick indicated, we do have a trial that has been completed, and we continue to work through with the agency on what next steps are, but there's a whole host of pieces that are ongoing from those. Did you have any other questions for us, Joe?
Yeah, sure. That was helpful. Thanks. I get... I guess the other question, as we think about, you know, modeling the opportunity, what your sort of expectations are around the average number of doses that a patient will receive? I know the label speaks to median. And then I know you noted 12 months of inventory. Can you say how many vials of ANKTIVA that presumes?
Yeah, Joe, with regard to the number of doses, so if you look at the duration of response, and when you think about that, the median duration of response is yet to be reached. We do not have that number because it's 47 months and ongoing. If you were to estimate, vis-à-vis a futility analysis, that median would be three years, or so, which means then the patient would get the full cure rate of 36 doses over 37 months, on the median level. So you can calculate 36 doses over 37 months from a median perspective. With regard to... Sorry, what was the other question? BCG shortage?
No. Inventory.
Inventory.
Yeah.
On the inventory side, I will let Rich speak to that, with regard to the number of vials in inventory, but I think I didn't answer your question with regard to BCG shortage. We are not concerned about BCG shortage. In fact, maybe within the next week or so, we'll be able to announce our plans with regard to addressing BCG shortage.
Thank you, Joe. So what I would tell you is, as far as inventory, I'm very happy to say, as I indicated before, starting May sixth, we have inventory immediately available through distribution. But so everybody here knows, we actually have 20,000 doses of ANKTIVA available. So we have and beyond that, we have multiple backup options as well. So I'm very happy to say that we have at least 12 months worth of inventory, but we have the ability to produce even more than that, 'cause we have all the drug substance already created, and we have the ability to convert that into drug product quite rapidly. Okay, if there are no other questions there, I think we'll take it over to the next one.
Thank you. Our next question comes from Randall Riggs, private investor.
Hi, thank you so much for taking my call, and again, congratulations. I think all of us, most, if not all of us, have had someone that had died of cancer, so hats off to you guys. I'm very excited for you guys and for the patients. My question is really, could you please give a little bit more color? It looks like you're very well situated to commercialize the asset in the U.S.. And as you move into ex-US, your thoughts about potential strategic alignments and strategies, maybe co-promotions, co-developments, and things like that. Can you give us a little bit more light on that?
Absolutely. So I want to answer that in really two parts, and I think that's a really important question, Randall, and thank you for your acknowledgments. First, as I've indicated in one of the prior slides, that we have identified what we'll call the top tier or tier one, six countries that we're working on as ImmunityBio. We take our U.S. FDA filing, and we package all of those up, and we're working through those. Now, I can tell you, throughout this entire process, and we've said this, that we are very much open to global strategic partners. We have had... I hate to say, almost, say, literally everyone, but every one of the potential strategic partners, approach us on those.
As Dr. Soon-Shiong and myself have both indicated that we really want to make sure that we get ANKTIVA through the approval so that we know exactly what it is, and we set the bar and the tone for what it is we're gonna do. But whether we choose to go with a large global partner or whether we choose to move this forward ourselves in a very similar manner globally will be a determination that we'll make in the upcoming period. What is important, our experience in being prepared for the United States, has also told us we can do very much the same globally. But again, we remain very open to both pathways on those.
Okay.
Thank you, Randall.
Thank you very much. Big victory for the cancer patient. Thank you.
Indeed. Indeed.
... Next question. As a reminder, ladies and gentlemen, if you would like to ask a question, press star one on your touchtone phone at this time. We'll take our next question from Kelly Shi with Jefferies.
Thank you. Congrats on achieving such a significant milestone, and thank you for taking the questions. So first, building on the success in the BCG-unresponsive non-muscle invasive bladder cancer, could you offer, like, a status update for the BCG-naive setting? I mean, the pivotal trial.
Right. So what we've done with the BCG-naive setting, we have multiple centers open, as you know, in the United States, and that trial is recruiting. What's exciting, and I'll have Rich speak more to that, we've now opened global sites around the world for the same naive trial. The importance of the naive trial is we've now, with the experience of understanding what the real endpoint is, it's really the durability, the duration of the endpoint. Also, what we've never revealed before, and I'm not at liberty to reveal that data other than that we are extremely excited about that data. The agency had asked us to do an interim unplanned analysis of the results of the first, I forget, 30, 40 patients in the randomized double blind control study as part of the submission and as part of the breakthrough designation.
What we saw there was a significant improvement against BCG alone when we combine N-803 plus BCG, which is not surprising, not only in the complete response rate, but also in the duration of that response. We've submitted that data to the NCCN for their consideration. With regard to the status of the trial, we are moving as fast and as hard as we can to complete the trial. But again, as I said, the bar we want to set is the durability of that response, not just the response. As you all know, BCG itself has a response, but then it fails within the year. So we've set the bar to 18 months and 24 months, et cetera, and I'll have Rich speak more to that in terms of the extension of the trial beyond U.S. into the global setting.
And I think... Thank you, Kelly. It's an important question, and this really goes back to Randall's question before. Part of ImmunityBio's global launch and global preparedness has actually taken our BCG naïve trial globally. And I'm very happy to say, in addition to everything else, the team has mobilized, has activated 23 new global sites, and in May, all of those will be moving forward. So as you can see, there's a lot of activities that are happening. As CEO, I've been asked more than once, is this... You're a unique company, that you have almost 700 employees. Why do you have so many? Well, as you can hear from all of these activities, each one of them, we have dedicated, very focused teams, but they're each producing and delivering, which enables us to be ready on all of these fronts simultaneously.
Thank you.
Did you have another question, Kelly?
Yes, if I may. And, so regarding the ANKTIVA launch, what has been the physician feedback you've heard regarding their willingness to take the drug? And also, are there any questions has been raised for the launch, for example, like, a administration protocol or anything like relevant to, to like a quicker adoption?
Yeah. So I think, I think that's a really important question. What I'll tell you is, as I indicated during the launch preparedness, the feedback I've got from physicians, their practice administrators, and even payers, they've all commented on how seamless this is. When they understand that we have all of the specialty distributors in place, they realize, "Hey, this doesn't require me to even change my ordering practice." And then when they get into their clinical workflow and they realize it's the exact same scheduling program, it's the exact same clinical workflow, they're all pleasantly surprised at that. Because usually, as you launch something new and innovative like this, you are asking practices to update and change through those. Well, I'm happy to say that even all the way to the front [SDMR] schedule, it's the same as what they have in place today.
It's been very easy on those. Often there's almost an aha from them saying: Wait, I can order this today. It doesn't change. I don't have to do anything different because I'll just order it from one of those specialty distributors. So we're really happy about that as people kind of have that aha moment, that this really is a very streamlined, smooth process for them.
Thank you, Richard.
As a reminder, if you'd like to ask a question, press star one on your touchtone phone at this time. We will take our next question Nitish Dang with Anson Funds .
Hi, guys, congrats on the approval. I wanted to ask two questions. My first question was, on the press release, released on April 25th, you mentioned that, you know, you would provide more details on the small, non-small lung cancer indication data, and the overall survival. Are you guys at liberty to discuss sort of any quantitative, data today about that trial? Or when can we expect that?
Yeah, this is Patrick. Well, thank you for the question. Obviously, I'm a little reticent because we submitted the paper for the World Lung, and I don't want to mess up the academic presentation, but I will give you some quantitative data as we promised to do. So as you know, the standard of care today, the sort of overall survival, sadly, for these patients in second and third line are. It's about seven months to maybe eight months. And the that PD-L1 positive patients have a better survival, obviously, than PD-L1 negative patients. Well, what's exciting, when we found, when we looked at our data, and just to set the stage, these are patients who are progressing on the checkpoint, and that's their starting point. They are progressing on their checkpoint.
And we take these patients at the point of their progression, give them the same checkpoint, and then add ANKTIVA. And what happens then is that the ANKTIVA stimulates natural killer cells, and the natural killer cells looks for these cells that are progressing. It turns out that the key and the secret is that the progression is because these cells have evaded the T cells. And the reason they've evaded the T cells is because of a thing called MHC-I loss. Now, that's a technical scientific mechanism, which is ubiquitous across all tumors that have failed checkpoints. MHC-I loss is ubiquitous against all tumors that have failed T cell checkpoints. And what the natural killer cell is born to do is to find those cells and kill them and stimulate a thing called gamma interferon, which restores the MHC-I and restores the T cells.
Now, you have the combination of NK T cells and memory T cells with the checkpoints, that same checkpoint for which they're progressing. And suddenly, the results that we now see is. I'll share that with you, an overall survival, a median of 14 months and even up to 18 months, in which PD-1 and PD-L1 is irrelevant. Even in PD-L1 negative patients, the results are the same. So this is, in my mind, a complete validation of the biology of tumor evasion and checkpoint failures. Checkpoint inhibitors have been a magnificent addition to the armamentarium o f oncologists. From a business perspective and the industry perspective, both Merck and Bristol Myers Squibb and everybody else developing checkpoints, the patent cliff goes off in 2028.
Our combination of N-803 plus checkpoint inhibitors has now been issued as a issued patent, which takes that all the way to 2035. But most importantly, we've now created a chemotherapy-free vaccine therapeutically, that provides a durable, ongoing overall survival, not just in bladder cancer, but in lung cancer. And the trial that we did, if you look at NCT 03055 in clinicaltrials.gov, was a basket trial across multiple tumor types: melanoma, renal cell carcinoma, et cetera. And what was exciting is, again, there we see independent of PD-L1 status and overall survival benefit. So I hope that's-
Yeah.
Quantitative data. Okay.
The second question I had was for on the cash balance. I guess, going forward, how do you feel about cash burn, and do you plan on utilizing the ATM?
So this is Rich, and I'll go ahead and take that. First, I really do feel good about our cash balance because sitting here with the cash and the ability to launch with this, knowing that we have supply available and the ability to take orders literally immediately is very rewarding. I've heard from many physicians that they're planning to order right away, and that's why we wanted to have this, was just to communicate all of those pieces. As it is with almost literally every CEO in biotech as well as other ones, having the ATM available to you is just an important tool, and I'm grateful to the ImmunityBio board, and I wanna just acknowledge and thank them for that, as they've consistently said, "Let's ensure that we have all tools available to us.
That is revenue we generate, as well as tools like equity and strategic partners available to us." I'm very happy with the amount of cash that we have right now because it gives us time to be able to really get this product launched and move to that point of producing revenue on this. So thank you very much for that question.
Just one quick follow-up. So you guys recently filed-
Yeah.
an S-3, automatic S-3. So just confirming you have $300 million remaining on the ATM now?
Yes.
Okay.
And then I think just to be clear, filing all these, whether the shelf, the ATM, exploring strategic investors, and obviously my, my own personal investment, doesn't mean that there's a need from a company with the $240 million cash on hand. We expended a huge amount of money because we made a huge amount of internal commitment to get the drug approved, to get inventory done, to ensure the CMC, and to initiate, as you may see, the 3.055 trials, which was the seminal trial, which started the Cancer Moonshot. Some of you may know, if you go back into that video in 2016, we launched the Cancer Moonshot so that we could test across all the trials.
I urge you to look at that slide when we went public in 2021 across all the exploratory trials, across all the tumor types. That was where we made the huge investment. All that capital investment and all that commitment has now been done, and we can now focus on the commercial launch, and for which we really believe the $240 million is sufficient to take us to the next level.
Okay. Thank you, guys.
Thank you for that question.
Congrats on the launch.
Thank you.
Thank you. There are no further questions at this time. I would now like to turn the conference back over to our presenters for any additional or closing remarks.
Thanks, everyone, for joining us today. That completes our call.
Good. Thank you all, and we look forward to continuing this conversation over time. We will be announcing ongoing investor calls, because as we now enter into the revenue stage, and the pipeline stage, our company will then enter into a timeframe of investor calls, and we'll be scheduling that with our investor relations team.
Thank you all.
Bye-bye.
We appreciate it.
Thank you. This concludes today's program. We appreciate your participation. You may now disconnect your lines.