Good morning. I'm R.K., a Senior Sell-side Biotech Analyst at H.C. Wainwright. We are thrilled to be hosting Precigen for this Fireside Chat this morning. 2025 has been a transformational year for Precigen, marked by the landmark FDA approval of PAPZIMEOS, the first immunotherapy for adult RRP. As we sit here in late March of 2026, the company has officially transitioned, you know, into a commercial stage entity, reporting its first quarter of launch very recently. Joining us today are Dr. Helen Sabzevari, President and CEO, and Phil Tennant, Chief Commercial Officer. Good morning, folks, and thank you very much for joining us this morning. Morning. Helen, as we get started, you know, especially, you know, with your experience of developing various therapies, and now with this particular one, PAPZIMEOS, so how do you see this, you know, new excursion with this drug? Also, if you can, please describe the molecule itself and what it does for this particular set of patients. Well, first of all, I would like to take the opportunity to thank you, R.K., for having us and also to say good morning to the audience here. Clearly, the PAPZIMEOS or, the molecule at the center of all of this for the recurrent respiratory papillomatosis is a very innovative molecule. The premise of this molecule is built on a AdenoVerse platform that we have at the Precigen, which by the way, we fully have the ownership of the IP of this gorilla-based adenovectors that are very much differentiated from the rest of what field is used to as far as adenoviruses and other viral vectors. Why would I say that? Because there has been this perception that all adenoviruses are similar, and from the perspective that they have limited capacity to the number of genes or epitopes that they can present, usually around 5 KB or less. Also, there is that perception that all adenoviruses can be only given once, at best maybe twice, but then you have this immunogenicity to these vectors, which doesn't allow you to repeat dose any further. Also the manufacturing of these adenoviruses all have been put in the same category. When we started developing this platform, actually, we went completely on the other side and made sure that we are working on a platform that is fully differentiated from the rest of the adenoviruses, and in general, even other viruses in a number of ways. Number one, the capacity of gorilla adenoviruses, we have up to 12 KB, and we can extend that. You can imagine how many genes and how many epitopes it can be containing as we use them. These are non-replicating viruses, by the way. One very, very important premise here is that you can repeat dose with these vectors. Why? Because humans have not been exposed to these vectors before, so we don't have already neutralizing antibodies or immunogenicity. You can start that. Especially the gorilla adenovirus and the backbone that we have used for PAPZIMEOS and also in our PRGN-2009 for the rest of the molecules, it has a very unique ability that it pushes more towards CD8 response rate as opposed to the humoral responses, which then your neutralizing antibodies do not come to play as much. We have shown this, first of all, in all the healthy humans, both in United States and in Africa, when we look at over thousands of individuals, you see either very little or no immunogenicity at all against these vectors. On top of that, in our clinical trials, after every repeat dosing, and we have done sometimes over a year and a half of dosing in our cancer clinical trials, you see that the expansion of CD8, it keeps on going up higher and higher, completely opposite of what you see with other adenoviruses. Clearly, also the capacity of these molecules, we have been able to design many epitopes, especially in HPV-related indication in cancer or in PAPZIMEOS for RRP. We have put in number of epitopes and then also new epitopes that Precigen has, basically generated, and it's in this. Then finally, the manufacturing of our AdenoVerse platform. We have a cell line that is highly productive, and we can produce large amount of these factors. Having said that, what we had done originally is design PAPZIMEOS in such a way that to address the actual issues that exist in recurrent respiratory papillomatosis. This is a disease that for the past century, there has been no treatment except continuous surgery. As a result of HPV 6 and/ or 11, you get the formation of these benign tumors and on vocal cords or in trachea. Therefore, the patients cannot speak, or they can't breathe. Mm-hmm. This infection can take place either in an onset of children. As they pass through the birth canal, they can get infected, or it can happen in adults through sexual transmissions. What these patients go through is horrific because some of these patients, on a yearly basis, for instance, they have to have like 10 surgeries to just be able to speak or breathe. Some of the children, some of the patients that we have treated as an adult, they have had this disease since the age of one. Imagining that your child has to go through this on a monthly basis. One other thing that I would add is the studies at Hopkins has clearly shown that by the fifth surgery, there is irreversible damage to trachea or the vocal cords. These surgeries are really damaging and also dangerous for the patient. Having said that, what we did was we designed the PAPZIMEOS, the molecule that contains the epitopes that addresses HPV 6, prominent epitopes in HPV 6 and 11. We also identified new epitopes, which we have full IP around that. We put it in the context of our gorilla AdenoVerse platform on the backbone of these gorilla vectors. The way the mechanism of this molecule is, we give this molecule subcutaneously, very easy, just as you might receive a flu shot, for instance, right? Then what happens is simply at the site that it's given, the molecule gets presented, and it starts training your own T cells, which sometimes I refer to as the army of your body. Now, these T cells become a specialized forces to recognize these specific epitopes wherever you have infected cells that express the HPV 6 or 11 epitopes. When they see that, this is their enemy, and they destroy it. In that setting, you are really addressing the root cause of this disease as opposed to the surgery that is just like mowing the lawn. You are cutting the tumor, but it keeps coming back because underlying infection, you are not removing that. That is specific to PAPZIMEOS, and as an immunotherapy, has become extremely effective and with an excellent safety profile. Thank you. Thank you very much for that. Very helpful. Having said what you said, you know, in your pivotal study, you know, you saw a 51% complete response rate, so there's obviously the other 49% of patients, you know, still experiencing the disease. In thinking about them, obviously, you know, we'll talk a little bit more about the redosing study that you're doing. Just based on the pivotal data that you've seen, what do you think is the resistance mechanism, or why are those 49% of the patient population not having a complete response or a response good enough so that they don't need to be under the knife again? Great question. In our pivotal studies, we did a couple of things that maybe I should mention. First of all, we went to the most severe patient population, which was defined as having a minimum of three surgeries per year. Some of our patients, as I mentioned, they had more than 10 surgeries. That was one aspect. We wanted to make sure that patients benefit from this. Secondly, we put a very robust endpoint, which was a complete response, which was designed as having a minimum of 12 months surgery-free or without any other treatment for that matter. That was very important because here we wanted to ensure that these patients they have especially for someone who gets 10 surgeries per year, to go from 10 to zero, it's unbelievable. With that perspective, what we saw was, as you mentioned, 51% complete responders, which by the way, the durability of response has been extended now, and in some of those patients have passed three years. At the same token, we saw the overall reduction in the number of surgeries, which was 86% in all patients. 35% of the patients, even though they didn't go to complete response, they reduced their number of surgeries. This is very, very important. Now what would be the reason? Based on that, actually, even FDA very much was excited about this data for the reason that what we saw in this, what we refer to as partial responders, because they didn't go to a complete response, was that they built the immune system to HPV 6 and 11. We saw the increase in the number of their CD8, but it didn't come to the same extent as the complete responders were. What could be the reasons for this? As you know, immune system of different patients are somehow beaten up worse than the others, depending on the length of the infection, depending on the capacity or of the infected cells. We should remember that your immune system is continuously in connection to these infected cells, which they, for the lack of better word, energize your immune system eventually. Your immune system becomes exhausted. For various reason, there might be that you are starting at the different threshold. What actually in the discussions with FDA, we were very thankful for the suggestions of FDA, based on the safety that we would see in the using of PAPZIMEOS, but also the efficacy, it was believed that by redosing, you can probably push the immune system to that threshold of a complete responders. That's one of the important thing. It becomes really relevant now having the gorilla AdenoVerse platform, because that allows you to repeat dosing. Yeah. Because it's not a one-time, silver bullet. You can keep using that. For that reason, we believe that by redosing, you can also push the immune system of those individuals with the partial responses, hopefully to a complete response. Thank you. Phil, just talking through some of the initial launch metrics and also how you're seeing the patients' adherence to the therapy. The label currently says you need to take four subcutaneous injections over a 12-week period. Now, you know, the first question is, do you know or do you have an idea of what percent of the current patient group have gone through the full course? How do you see or how do you ensure that the patients who get started go through the full three-month cycle? Yeah. Yeah. As you can imagine, as we mentioned on the earnings call last week that, you know, we started dosing patients back in November. You follow the three months through, and yes, you can see that there are patients now starting to complete their courses. We're not aware of any patients who haven't completed all four doses. It's a fairly simple regimen. Yes, it's spread out over three months, but it's four subcutaneous injections. I think the centers that we're dealing with, they're all very well-versed in much more complicated regimens than PAPZIMEOS. We don't really see it as an issue in terms of just scheduling the patient. Our label allows for certain flexibility around each of the doses. One thing that we're doing within each center is encouraging them to purchase the first two doses up front 'cause they're only two weeks apart, and then you have the six-week and the 12-week dose. There's wiggle room around each of those doses, so it's not that the patient has to be in the center on a certain day at a certain time. There's a bit of flexibility which can, you know, suit the patient's schedule. Okay. Very good. You know, in terms of your commercial strategy itself, you know, obviously your strategy is a little bit different from, you know, from the launches that we have seen. If you can explain a little bit of that. What is the market? What is the initial market you're going after, in terms of the IDNs and the community hospitals that, you know, you're still looking to get the drug into? Yeah. Well, our go-to-market model made a lot of sense for companies like us approaching its first commercialization asset. We announced last year pre-approval that we were partnering, you know, we had a commercialization partner to predominantly in the field and some other commercial support services. But the way it works is, you know, my direct reports, my head of medical affairs, sales and marketing, market access distribution, they're all Precigen employees, full-time employees. But their organizations that spread out into the field, they [have Axana] books, but they're dedicated to PAPZIMEOS. They have Precigen email addresses, and obviously we treat them very much as part of the Precigen family. So that model's, you know, working really well for us. In terms of the addressable market or the institutions out there, we had conducted a detailed claims, electronic health records and claims analysis prior to launch, which clearly showed that these patients were stacked up, as it were, in the large academic centers institutions, the IDNs, and we set our commercial footprint accordingly. We'd identified approximately 500 hospital systems where the bulk of these patients were housed, and within that, approximately 100 systems that had sort of 80% of that potential. Our initial commercial footprint was geared to that opportunity. Obviously, as we're now launching, we are learning, and we're refining as we go forward. We still have a relatively small commercial footprint, but one which covers, you know, 90% of the patient potential that we see. On top of that, the final point I would make is that we obviously have non-personal promotion and digital channels where we can reach any of the more remote HCPs and practices. In practical terms, how long do you think it'll take for you to make sure that you have at least made your initial detailing with every single one of your target entity? Well, we've already covered. I mean, all those target institutions that I mentioned, we've already engaged with all of them, basically, and more. You know, one of the aspects of the launch that I mentioned on the earnings call was how the community is now also stepping up and embracing this as the new standard of care. That's a facet of the launch that we'll talk more about in the future. We talked on the earnings call last week of, you know, we've got some simple, low-cost solutions for community centers that maybe don't have the ultra cold chain capability. We're able to get the drug there for it and get it to the patients. There's really nowhere that we can't ship the drug. You know, that community aspect has been very pleasing and one that we'll comment on more as we go through subsequent quarters. Yeah. This next question is to both of you. RRP is one of those which historically was underdiagnosed. Even it's kind of interesting when as I say that because in your introductory remarks, Helen, you were saying some of these patients see it very, very early in life, like even when they're one year old. It's interesting that it also says underdiagnosed. What is the reason for that? Now what are the strategies that you know you are undertaking to ensure that there is enough of disease awareness and also get the drug to all the patients that are diagnosed or that also could be. Yeah. Potentially patients? Yeah. As I mentioned, this disease has been there for well over 100 years, actually, has been diagnosed, and it's there. It's not because of lack of trying. Everyone has tried everything, including checkpoint inhibitors and all the other molecules. Unfortunately, nothing had worked until PAPZIMEOS has been approved as a first and only product here. The reality of the situation for these patients is that first of all, the HPV-related infections that existed, and sometimes these HPV-related, it's quiescent for a while, and then it starts showing itself at the different stages. To start with, a lot of the ENT specialists and a lot of the physicians, they misdiagnosed basically this indication, unfortunately, until the severity of the disease starts. There has been a lot of issues with really reporting. When we go back into 1990s, the original reports that came up about the number of the patient that existed, there is variety of factors, reports anywhere between 10,000-14,000 patient. Since nobody was really working on this rare disease for developing a specific drug for it, then there was a period from 1990s until 2021 that we basically started working very, very closely with not only investigators, but also with the patient advocacy groups. The numbers that was reported was referring back to those original articles in 1990s. You can imagine that in a span of two and half decades, obviously, the number of infections increased as well as the number of the patients with the disease, both in children as well as in adults. What we have done is, first of all, through having a very solid collaboration with a patient advocacy group for RRP and the Disease Awareness Day, for instance, on June 11th is the RRP day that we hold every year in conjunction and collaboration with the RRP Foundation. First of all, made sure that the patient's story comes out, but also the investigators around the country has been now joining. It's interesting to see how many investigators they have this large pocket of patients across not only just big centers, but what Phil was referring to, the community centers. That they have numbers of patients, and it keeps getting added to this. I think Phil can speak to the very, very nice study that our commercial team did in absence of any code because no code existed until now, the J-code that has come out in prior. They really analyzed the patient records in order to get a handle on the number of patients, which is around 27,000. Maybe, Phil, you can- Sure. Expand on that. Yeah. As Helen said, I think, you know, we feel that the prevalence has been underreported historically. We did conduct a detailed analysis of electronic health records and claims database. Even though there's no ICD-10 code, we were able to paint a very vivid picture of what these patients actually looked like from their diagnostic codes and their surgical codes, and then looked at the broader database to identify the patients who looked like those patients who, you know, were definitively identified as having RRP. So that's where the 27,000 adults comes from. I actually think that the diagnosed prevalence will increase. Over the next few years because of heightened education, awareness of treatments, obviously, PAPZIMEOS and the new standard of care. The other thing I would say is that many of these patients, you know, they're very well-known to the healthcare system. They're on a revolving door of surgeries in and out of these institutions and community practices, so they're very well-known. But our label is a broad one, and it's basically, you know, any adult with this condition. As you would imagine, our marketing efforts, our commercialization efforts are using our in-person channels and our non-personal channels to make sure that basically patients are aware that there is a new standard of care, that it has a broad label, and that they need to have the conversation with their treating physician about the potential for them to benefit from this. Helen mentioned the foundation. You know, we're so thankful for the partnership that we have with the foundation. They've had a very strong campaign that highlights, you know, a reduction in even a single surgery for these patients is actually very meaningful. Our clinical data not only speaks to that, as Helen mentioned, 86% of the patients in our pivotal study showed a reduction in surgeries, but we also have those durable complete responses in a significant portion of the population. You know, every patient who has this condition deserves to have a conversation with their HCP about those things and ultimately, you know, seek treatment should they be appropriate. Having said what you guys said just now, and also, I'm trying to triangulate it between that and your excitement about the first quarter and, you know, your bullish guidance of at least $18 million for the first quarter. Considering that, how much of that is coming from a bolus of patients that you're seeing in the first quarter? You know, knowing how you're able to find pockets of patients across- Mm Should we as investors assume that these boluses are going to be there for at least in the first full year of launch? Yeah. I can maybe kick off, Helen, and if you want to add. You're exactly right. You know, we have a three-month treatment regimen for all of these patients, so there's gonna be a time every quarter where you'll have some carryover from quarter to quarter as we go forward. We did see that to a certain extent coming from Q4 into Q1. We'll see it going from Q1 to Q2 and for subsequent quarters. There will be a carryover depending upon how many doses that patient carries over into the next quarter. But the important thing I would say is that what we talked about in Q1 is actually reflective of the new patients that are continuing to be identified. That is really what has accelerated through Q1, and we expect that to continue in Q2 and beyond. We do believe, based on the work that we've done, that there is a significant bolus, and it's gonna take, you know, several quarters for us to work through that as we go forward. Yes, we would expect this trend to absolutely continue through 2026. Yeah. I echo what Phil said. The reality of this situation is, first of all, these patients and their physicians, they are anxious for these patients to receive their treatment immediately. Reason for it, as I mentioned, by the fourth or fifth surgeries, you have caused an irreversible damage to the trachea and the vocal cords of these patients. What we hear from our physicians and what we hear from the patients is very simple. They don't wanna let the patient get to that point because they want to stop the damage. Now, the ones that have been having this severe, basically they consider as a severe patient, clearly, unfortunately, for many years prior to PAPZIMEOS being approved, they had to go through this surgery. Those are the first one that actually both physicians and the patients are asking that they be immediately treated, as Phil says, because they don't wanna have any further surgery. That's number one. At the same token, what we are seeing, and because of the broad label that we have, again, which goes to all adults with RRP, regardless of the severity of the disease, we are seeing that physicians and patients that are asking as they are being diagnosed with RRP to receive this. Why? Because they do not wanna join that group that has a damage already, and that's very important. You, Phil, you gave us a number in terms of how many patients are there within the company's hub, which is 300 million. Just trying to understand how this hub works, to a certain extent, and also, in terms of a payer and, you know, and if there's any, not only payer access, but also any resistance from payers. Mm-hmm In terms of the price points that you put out there. Any commentary, and also are you planning to give this hub number quarter to quarter, or is this just for the initial launch metrics you are using that? Because I'm just trying to understand it's really difficult because we don't know when the bolus of patients will come from the second quarter and third quarter and so on. Yeah. Is the hub a way for us to keep track of the potential growth, you know, the potential future growth of the revenues? Yeah. Let me clarify. You know, when we talk about the hub, what do we mean by that? We mean the manufacturer patient support hub, which most manufacturers have, and patients are able to be registered, with the intention of them obviously getting treated, benefit verification and then being treated by their institution. We reported, you know, steady growth as we've said, quarter-over-quarter and then over 300 million now in our hub. There is another source of patients though, which are in the institutions, and they don't call it a hub themselves. They're just their patient support services themselves. What I mentioned last week was in our patients that have been treated so far, we see a significant proportion of patients from both of those sources. I think moving forward, it is an important lead indicator that we will continue to comment upon. Obviously, revenue becomes very important as we go forward, but we will continue to talk about patients in the hub, the sort of top of the funnel, as it were. You talked about payers. You know, we've been thrilled with the speed of payer coverage. We talked about the, you know, 215 million lives from the commercial payer segment. If you add on Medicare and Medicaid, we're closer to 300 million lives, which is, you know, 90% of the insured population in the U.S., and a majority of those are covered to label. You're right, we do see some plans that have some restrictions related to surgical prior surgical number. We're very confident, and we've said all along that, you know, the treating HCP can have a very robust conversation with any payer that may have put restrictions in place. You've got the high unmet need. You've got the patient history that goes beyond just the prior year and probably is a lifetime for some of them. You have our clinical data, our efficacy and safety data. You have the durable responses, you know, which are ongoing, the complete responses. Of course, you have now the consensus statement from the foundation and the 16 thought leaders across the country who put pen to paper to say, "This is the new standard of care for all adults with RRP, irrespective of their surgical history." With those data available, we feel very confident that we can support any clinician to have a conversation with any payer to make sure that the patient gets treatment. To date, we are not aware of any payer that has flatly rejected any patient for treatment. Very good. From tomorrow morning, we're gonna have the J -code. Yes. With that J-code, you know, are you gearing up for another big bolus, or is the J-code just helps payment but really doesn't bring in a ton of patients just because you have a J-code? Yeah. No, great question. You know, the permanent J-code is an important factor in any company's drug launch. We had done some analog research prior to approval that showed that for some drugs there was help when the permanent J-code came on board. Because some institutions, you know, they're not willing upfront to take the financial risk for a buy-and-bill drug. If you recall, we made the drug available through specialty pharmacy and buy-and-bill because we foresaw that that might be a challenge. Some institutions say, "No, we're buy-and-bill. We're gonna wait until the permanent J-code." We expect, and we know that there are institutions out there that are in that category. We do expect those to be activated as well as the ongoing activation of institutions in general that we are seeing. The permanent J-code definitely helps and should give us further impetus. In general, it just smooths and streamlines the whole patient access process. [Break] We'll be discussing as the time comes. The only thing I would add, R.K., is, you know, the landscape work that we've done so far, some of the initial sort of pricing work and so on, it's clear that many of the issues that we see in the U.S. or we saw ahead of our approval in the U.S. are absolutely applicable to what we're seeing ex-U.S. in terms of high unmet need, lack of a standardized approach to treatment, and a real need for something that addresses the underlying cause of the disease. One quick question on physician feedback. What are you hearing from the physicians, and the ENT specialists who have already used the drug? Are they slowly becoming champions of the drug? I think for instance last two weeks ago was EUROGIN, which is one of the biggest meeting for laryngologists and specialists in that area. What we have heard very effectively through a number of presentations, first of all, RRP was a dominant topic during this meeting. It really speaks to the expansion and recognition of this indication, but also the discussion around PAPZIMEOS and the physicians referring not on the safety of PAPZIMEOS, which they was referred to as excellent, the efficacy, especially the complete response of 51%. It was considered impressive, but also adding the durability of response, which has passed three years now. They really, physicians have been calling it outstanding in indication that you can imagine there has been nothing for the past 100 years as far as treatment is concerned. I think the field is very excited. The physicians, the patients, patient advocacy groups, and clearly we are extremely excited that we could bring this drug to the patient. I should, even though I'm tempted to call it life cycle management, I don't wanna call it yet. You certainly are planning on, you know, have started the redosing studies and also planning to look into pediatrics, right? Because as you said, there is quite a bit of population who do get this diagnosed very early in life. What are the plans there, and what are the milestones that, you know, we as investors should be on the lookout for in these two areas? Yeah. Excellent question. First of all, as you mentioned, we currently hold a label for all adults with RRP. Based on, again, I keep stressing this point because this kind of drug with the ease of administration and the safety and efficacy that it has shown, I mean, let's remember that this drug has only grade one or maybe grade two, which is very similar to when you get a flu shot. Maybe a little bit of a rash at the site that you have received that will go away or maybe a little bit of fever, which will resolve itself within a day, and a subcutaneous injection that can be done in the physician's office. Now imagining, especially for a pediatric population that has to go through this is a really treatment that lends itself for this patient population, and especially and unfortunately for these children that they have to go, it's true, it's horrendous, this. The FDA very much has been supportive of this, and so are we have already communicated, we will be starting our pediatric trials by the end of this year in 2026. We are very excited about that, to bring not only have this for adults, but eventually to be approved for children. From the perspective of redosing, again, it's first of all, it's extremely important to make sure that the partial responders, that we can turn this to a complete responder, that 35% of the population. As you mentioned, the redosing arm has already started, and we are looking forward to start providing data in that 2028. That will definitely expand the indication. Also from the data that we are getting in general from redosing studies and also from our long-term complete responders, we are gaining much more view into the immunological responses and needs of the patients over the years, which then it can offer different ways of using PAPZIMEOS as these patients move forward. Very good. The other interesting aspect which you put out last week was regarding initiating studies in PRGN-2009. Not initiating, continuing the work that you've been doing, which is exciting. Can you highlight what PRGN-2009 is and how it all is. It also comes from the same platform that PAPZIMEOS is? Absolutely. Great question, and I'm really happy you asked this question because we are extremely excited about PRGN-2009. Yeah As the second group of drugs that are coming forward. To start with, we had around the same time that in 2022 or so, we had started the trials going into HPV-related cancers, which as you know, it really contains 5% of all cancers. It's a huge number of patients and market. We had the phase I with the PRGN-2009. What PRGN-2009 is exactly on the same backbone of our simian, the gorilla vector. It's exact same structure. So you can imagine the safety, the manufacturing, the tox, all of that is very, very similar. The difference of PRGN-2009 is addresses HPV 16 and 18- Mm-hmm. Which is the root cause of infection in the cancer patient, which leads to the indications such as cervical cancer, head and neck, anal cancers. With that, if you look at the history of these patients, in a cervical cancer, their first line of the treatment is currently chemo, radiation, checkpoint inhibitors, surgery all together, and then these patients fail, unfortunately. Mm. There is nothing. On a head and neck, even with the checkpoint inhibitor approvals, you are having somewhere between 15%-18%, in some cases, maybe pushes to 20%. In our phase I data, what we did was we developed PRGN-2009 on the same background, put number of epitopes of HPV 16 and 18 and also new epitopes that we have identified. Again, owning the full IP around not only the platform, but the molecule. We put it in a phase I in all comers HPV-related cancers, which they had failed. They were relapsed refractory patients that had failed at least three or four lines. We presented that data at ASCO. We showed in these patients, and they had, by the way, failed checkpoint inhibitors. We put PRGN-2009 plus the checkpoint inhibitor back. We showed 30% objective responses. Patients had complete responses and ongoing for more than two years. These are patients, stage four, that they would have had months to live. We obviously started a phase II trial on cervical cancer, but simultaneously, we had started a phase II in head and neck oropharyngeal carcinoma patients. We are really excited about what we are looking at. As I mentioned last week, end of this year, we are looking forward to report the first set of data from this trial. It's quite exciting time for Precigen with coming back with now the second molecule. To your point, as far as we are very much looking forward to having the discussions with FDA on a platform designation. Right. Because clearly this can apply there as the molecule, basically the backbones are the same, and then you can even move much faster from that perspective. Thanks for introducing that topic. The platform technology designation, right? What is it? It's hard to apply for it, I believe there have been only, like, three companies who have been awarded that designation. So in your case, you know, what sort of data do you need to compile? Once you apply for it, what are the benefits that you're getting and how long does it take for the FDA to give you that designation? This is a very exciting program from FDA, and we are very, very happy about this. The kind of information is already what we have generated on PAPZIMEOS as far as the platform is concerned, which is our safety, our manufacturing, tox, and also we have shown efficacy and durability of responses. You can use that and, for instance, the molecule such as PRGN-2009, you can combine that. The benefit, and this is one of the reason, as we have heard the commissioner, really the whole point of these programs is to make the review processes much faster. Because now, basically you have established the CMC manufacturing already, and since the backbone is exactly the same, you have established the safety of a non-replicating AdenoVerse platform. You have established the efficacy that you can keep giving this number of times, and that basically you're seeing benefits from that perspective, and also all of the other, clinical, like, studies with biodistribution, so on and so forth. You can imagine now when the second generations of the molecule in a different indication, but on the same platform comes, now you can move much faster because these things from perspective of regulatory bodies have been already established. As part of that platform designation, then you can move much faster through pivotal trial. That is good on the regulatory side, that you don't have to send a ton of paperwork that you need to send. In terms of the development timeline and also the cost of development, how does that designation help you? Can you kind of give us an idea of like what are we talking about? What is the savings you're talking about in terms of time and money? Yeah. I think from a lot of repeat studies that needs to be done for regulatory, like, for instance, CMC or preclinical or even in the clinical studies, if they ask for repeat, those studies will not become relevant any further, right? Because a lot of those has been done. A lot of those assays has been accepted already. You don't need to reinvent the wheel, and you can rely on basically the system that has been shown it works and use that. It saves a lot of resources and investment from that perspective. At the same token, it saves a lot of time in pushing through this, because as you are well aware, there is an aspects of doing the clinical trial, but then there is a tremendous amount of preparation that you have to do for your manufacturing and making sure that all of that is good. With Precigen, what it becomes also very important, we have the manufacturing know-how at Precigen because we are commercially producing PAPZIMEOS, so we are very well-versed in production of these gorilla vectors and manufacturing of it. You can imagine that we have gone through the first drug, and then in, hopefully in upcoming drugs, for the next indication, which is a large, very large indications in cancer, then we can move very, very rapidly. Besides PRGN-2009, you know, are there any plans once you get this platform designation in place, which is obviously a great thing, now you'll have two molecules that, you know, one approved, which is PAPZIMEOS, you'll have the PRGN-2009 going. Are there any thoughts about, you know, developing another indication or another molecule that you can use the same platform on, you know? I'm just trying to understand how much more potential is there on this platform. It's a tremendous amount of potential. What we did from originally when we developed the gorilla AdenoVerse platform, we look at not only the infectious diseases and rare diseases, and RRP was the first one that we thought we can move very rapidly, and we did. In a matter of four years, we took it from discovery to the approval, which is a record time. PRGN-2009 and other indication. We have a number of targets, both in cancer as well as in rare diseases and in infectious diseases that actually we have those already at the preclinical level. Originally, when we started, as you know, we had to focus all of our resources, and During the global pandemic- Yeah. And very difficult market challenges. What we did was, by choice, we decided to prioritize PAPZIMEOS, which was the right choice for the company to get it across the finish line in a record time, and we did that. Now that we are a commercial company, and with revenues coming in, and with the number of options in front of us in regard to partnerships and others, then I think we have the tremendous ability to expand our portfolio, which is really tremendous. Because this platform, as I mentioned at the beginning and I stress at the end, it differentiated. This is not another me-too platform. This is not another just adeno virus like everybody else. This is a very unique platform with the opportunity to really go across indication. Our portfolio actually contains many other indication in there, and we are prioritizing as we also generate revenue and resources and look at the future, BD developments that how we can expand this portfolio continuously. Just in closing and the last question. You know, with $100 million in the bank as of end of the year and, you know, we obviously anticipate a good growth, you know, in revenues from PAPZIMEOS this year and potentially getting to be break-even by the end of 2026 as you folks are expecting it to. How should we think about deployment of this incremental dollars that you could have and at the same time on the flip side, if things don't go the way you expect, you know, what are the options that you have to make sure you know you have a sustainable growth? First of all, I think for what you mentioned, absolutely. Now we are a company that with the revenue that it's coming in, and we are very excited about our commercial path as we see it currently. With a little bit over $100 million in the bank. We already have basically looked at our budget and for instance the redosing, the pediatric, the initiation of the pediatric trial, and the expansion of PRGN- 2009 is already within our budget for this year. As you can imagine, in the past year, we had to incur a lot of costs for the CMC, which those were one-time costs that we had to do, and we don't have that. We can redeploy those resources to our portfolio and clearly also the revenue that comes in. Where we have always extremely good, R.K., is really making sure that we have our bets on winning horses, and we do our work upfront on the assets that we know they have a very, very high possibility of hitting the target and getting to the finish line, combining the indication, the regulatory path and the technology to ensure that we go, and PAPZIMEOS was a great example of that. We keep applying the same kind of discipline and pressure to that, of course, ensuring that our front-runner asset, PAPZIMEOS, is well kept and with a high priority for us in the U.S. We deployed our resources accordingly to the priority program. In, like any other time, we have done this over the years when it was the global pandemic or markets had a very difficult time. We continuously evaluate our budgets against our asset, and if there needs to be decisions made accordingly, we would make those decisions. We have shown that we are that company, that we can do that and then still continue to progress our portfolio and get it to the finish line. Since there are 30 seconds left, I can still ask one last question. As you stated last week, you gave us a quarterly expectation for the first quarter. Until PAPZIMEOS gets to a certain steady state, is that going to be your way of communicating in terms of revenue guidance on a quarterly basis? Is that the expectation that investors should have? For the second, third and the fourth quarter at least? Phil, go ahead. No. The call was so late in Q1, it made sense for us to give that guidance because there was so much happening. No, we won't be giving that guidance in the middle of the subsequent quarters when we fall into that rhythm. We will be talking about all the things that we've talked about in terms of HCP awareness, understanding, intention to prescribe, about patients being adopted and coming into the top of the funnel, about institutional activation, about payer coverage. We'll continue obviously to talk about all of that. Of course, every quarter you will see the revenue, and it will speak to it. Thank you. Thank you both, for spending the hour with us. Really appreciate your time, and good luck, and I know you're getting into a very exciting 2026. Thank you. Thank you, R.K. Thank you very much, R.K. Thank you. Bye-bye.