Precigen, Inc. ($PGEN)

Good morning. I'm RK, a senior sell-side biotech analyst at H.C. Wainwright. So -- and we are thrilled to be hosting Precigen for this fireside chat this morning. So 2025 has been a transformational year for Precigen, marked by the landmark FDA approval of PAPZIMEOS, the first immunotherapy for adult RRP. So as we sit here in late March of 2026, the company has officially transitioned into a commercial stage entity reporting its first quarter of launch very recently. So 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.

As we get started, especially with your experience of developing various therapies. And now with this particular one, PAPZIMEOS. So how do you see this new excursion with this drug. And 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, RK, for having us and also to say good morning to the audience here. Clearly, the PAPZIMEOS molecule at the center of all of this for the recurrent respiratory Papillomatosis is a very innovative molecule and the premise of this molecule is built on AdenoVerse platform that we have at 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. And why would I say that? Because there has been this perception that all adenoviruses are similar, and from 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 of 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 those any further. And also the manufacturing of these adenovirals all have been put in the same category. When we started developing this platform, actually, we went completely on the other side and make 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. So you can imagine how many genes and how many epitopes it can be containing as we use now. These are nonreplicating viruses by the way. And one very, very important promise here is that you can repeat those with these vectors. Why? Because humans have not been exposed to these vectors before, so we don't have already neutralizing antibodies or immunogenicity so you can start that. And especially the gorilla adenovirus and the backbone that we have used for [indiscernible] 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 antibody do not come to play as much. And we have shown this. First of all, in all the healthy humans, both in the 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. And on top of that, in our clinical trials, after every repeat dosing, and we have done sometimes over 1.5 years 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. And clearly, also the capacity of these molecules, we have been able to design many epitopes, especially in HPV-related indication in cancer or in [indiscernible] for RRP, we have put in a number of epitopes and then also new epitopes, that Precigen has basically generated in this. And 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. So having said that, what we have done originally is designed 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 HPV6 [indiscernible] you get the formation of these benign tumors and on [indiscernible]. Therefore, the patients cannot speak or they can breathe. Now this infection can take place either in onset of children as they pass through the birth canal, they can get infected or it can happen in adults through sexual transmissions. And what these patients go through is correct 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 breath. And some of the children, some of the patients that we have treated as an adult, they have had this disease since the age of 1. So imagining that your child has to go through this on a monthly basis. And one other thing that I would add is the studies at [indiscernible] has clearly shown that by the fifth surgery, there is a irreversible damage to trachea or the vocal cord, so 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 HPV6 prominent epitopes in HPV6 and 11. And we also identified new epitopes, which we have full IP around that, and it's put in the context of our gorilla AdenoVerse platform on the backbone of this gorilla vectors. The way the mechanism of this molecule is -- gave this molecule subcutaneously, very easy, just as you might receive a flu shot, for instance, right? And then what happens is simply at the site that is given, the molecule gets presented and start training your own T cells, which sometimes I refer to as the army of your body. Now these T cells become specialized forces to recognize these specific epitopes wherever you have infected cells that express the HPV6 or 11 epitopes. When they see that, this is their enemy and they destroy it. And in that setting, you are really at 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're not removing that. And that is specific to PAPZIMEOS and as immunotherapy has become extremely effective and with the excellent safety profile.

Thank you very much for that, very helpful. Having said what you said in your pivotal study, you saw a 51% complete response rate. So there's obviously the other 49% of patients still experiencing the disease. So in thinking about them, obviously, we'll talk a little bit more about the redosing study that you're doing. But as -- 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 response good enough so that they don't need to be under the [indiscernible] again?

Great question. So when 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 minimum of resurgery per year. And some of our patients, as I mentioned, they have more than 1 surgeries. So that was 1 aspect. We wanted to make sure that patients benefit from this. And Secondly, we put a very robust endpoints, 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. And 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 0. It's unbelievable. But with that perspective, we -- 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 3 years. And at the same token, we saw the overall reduction in the number of surgery, which was 86% in all patients. So 35% of the patient, even though they didn't go to complete response, they reduce their number of surgery. And 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 HPV6 and 11. So 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 or somehow beaten up worse than the others, depending on the length of the infection, depending on the capacity or of the infected cells. And you should remember that the immune system is continuously is in connection to these infected cells, which they -- for the lack of better word, they energize your immune system eventually. Your immune system becomes exhausted. So for various reasons, there might be that you are starting at a different threshold. And what actually in the discussions with FDM, we were very thankful for the suggestions of FDA. Based on the safety that we would see in the using 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. And that's one of the important things, and it becomes really relevant now having the gorilla AdenoVerse platform because that allows you to repeat dosing because it's not a onetime silver bullet, you can keep using that. And 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.

So Phil, just talking through some of the initial launch metrics and also how you're seeing the patients adherence to the therapy. So the label currently says you need to take subcutaneous injections -- 4 subcutaneous injections over a 12-week period. So not -- 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. And how do you see -- or how do you ensure that the patients will get started go through the full 3-month cycle?

Yes. So as you can imagine, as we mentioned on the earnings call last week, we started dosing patients back in November, so you follow the 3 months through. And yes, you can see that there are patients now starting to complete their courses. We are not aware of any patients who haven't completed all 4 doses. It's a fairly simple regimen. Yes, it's spread out over 3 months, but it's 4 subcutaneous injections. I think the centers that we're dealing with, they are all very well versed in much more complicated regimens than PAPZIMEOS and so 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 2 doses upfront because they're only 2 weeks apart, and then you have the 6-week and the 12-week dose. But there's real room around each of those doses. So it doesn't -- it's not that the patient has to be in a center in a certain day at a certain time as a bit of flexibility, which can suit the patient schedule.

Very good. And then in terms of your commercial strategy itself, obviously, you're your strategy is a little bit different from regular from the launches that we have seen. So if you can explain a little bit of that. And also, what is the market, what is the initial market you're going after in terms of the IDNs and the community hospitals that you're still looking to get the drug into?

Yes. Well, our go-to-market model was made a lot of sense for companies like us approaching its first commercial mobilization asset. We announced last year a preapproval that we were partnering we had a commercialization partner to predominantly in the field and some of the commercial support services. But the way it works is 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 are on [indiscernible] books, but they're dedicated to PAPZIMEOS. They have Precigen e-mail addresses. And obviously, we treat them very much as part of the Precigen family. So that model is 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. So 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, but we still have a relatively small commercial footprint but one which covers 90% of the pay potential that we see. And on top of that, the final point I would make is that we obviously have nonpersonal promotion and digital channels where we can reach any of the more remote HCPs and practices.

So in fact, on to, how long do you think it will take for you to make sure that you have at least met your initial -- you've done 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. And 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 we've got some simple low-cost solutions for community centers that maybe don't have the ultra cold chain capability, but we're able to get the drug there for it and get it to the patient. So there's really no way that we can't ship the drug. And yes, that community aspect has been very pleasing and one that we'll comment on more as we go through the subsequent quarters.

This next question is to both of you. So RRP is one of those, which historically was underdiagnosed even it's kind of interesting, 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 1 year old. So it's interesting that it also says underdiagnosed. So what is the reason for that? And now how do you -- what are the strategies that you are undertaking to ensure that there is enough of disease awareness and also get the drug to all the patients that are diagnosed. But that also could be potentially patients.

As I mentioned, this disease has been there for well over 100 years actually has been diagnosed, and it's there and -- it's not because of lack of trying, everyone has tried everything, including checkpoint inhibitors and all the other molecules, and 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 is [indiscernible] for a while, and then it starts showing itself at the different stages. And this -- and 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. And then there has been a lot of issues with really reporting. We go back into 1990s. The original reports that came up about the number of the patients that existed there is a variety of factors reports anywhere between 10,000 to 14,000 and patient. And then 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 and we 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. But you can imagine that in a span of 2.5 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. So what we have done is, first of all, through the -- having a very, very solid collaboration with a patient advocacy group for RRP and this is awareness day, for instance, on June 11 is the RRP day that we hold every year with conjunction and collaboration with our RRP Foundation. First of all, make sure that the patient's story comes out, but also the investigators around the country has been now joining, and it's interesting to see how many of investigators, they have these 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. And 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 and they really analyze the patient record in order to get a handle on the number of patients, which is around 27,000. And maybe, Phil, you can [indiscernible] that.

Yes. As Helen said, I think we feel that the prevalence has been underreported historically, and 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 look like for their diagnostic codes, and their surgical codes and then looked at the broader data base to identify the patients who look like those patients who were definitively identified as having RRP. So that's where the 27 adults comes from. I actually think that will increase -- the diagnosed prevalence will increase over the next few years because of heightened education awareness of treatments, obviously, perhaps [indiscernible] a new standard of care. The other thing I would say is that many of these patients, they're very well known to the health care 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 any adult with this condition. So as you would imagine, our marketing efforts, our commercialization efforts are using our in-person channels and our nonpersonal channels to make sure that basically, patients are aware that there is a new standard of care that has a broad label and that they didn't need to have the conversation with their treating physician about the potential for them to benefit from this. Helen mentioned the foundation. We're so thankful for the partnership that we have with the foundation. They've had a very strong campaign that highlights a reduction in even a single surgery for these patients is actually very meaningful. And 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. And so every patient who has this condition deserves to have a conversation with their HCP about those things and ultimately seek treatment, should they be appropriate.

So having said what you guys said just now and also I'm trying to triangulate between that and your excitement about the first quarter and your bullish guidance of at least $18 million for the first quarter. Considering that, -- and is -- how much of that is coming from a bolus of patients that you're seeing in the first quarter? And knowing how you're able to find pockets of patients across -- should we, as investors assume these boluses are going to be there for at least in the first full year of launch?

Yes, I can maybe kick off, Helen and if you want to add. So you're exactly right. We have a 3-month treatment regimen for all of these patients. So there's going to be a time of 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. So 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 continue -- to continue in Q2 and beyond. We do believe, based on the work that we've done and there is a significant bolus and it's going to take several quarters for us to work through that as we go forward. So yes, we would expect this trend to absolutely continue through.

Yes. And 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 this patient. So what we hear from our physicians and what we hear from the patients, it's very simple. They don't want to let the patient get to that point because they want to stop their damage. Now the ones that have been carrying 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. But those are the first one that actually both physicians and patients are asking that they'd be immediately treated as Phil says, because they don't want to have any further surgery. That's number one. But at the same token, what we are seeing because of the broad label that we have again, which goes to all adults with the 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 want to join that group that has a damage already, and that's very important.

So you -- Phil, you gave us a number in terms of how many patients are there within the company's hub, which is 300. So just trying to understand how this hub works to a certain extent. And also, in terms of a payer and if there is any not only payer access, but also any resistance from payers in terms of the price points that you've put out there. Any commentary? And also, are you planning to give this hub number quarter-to-quarter? Or is this just that just for the initial launch metrics, they are using that because I'm just trying to understand because 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. And is the hub away for us to keep track of the potential growth, the potential future growth of the revenues?

Yes. Let me clarify, when we talk about the hub, what do we mean by that? We mean the manufacture of 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. So we reported steady growth, as we've said quarter-on-quarter and then over 300 now in our hub. There was 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. And so what I mentioned last week was in our patients that have been treated so far, we see patients significant proportion of patients from both of those sources. So 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 sort of top of the funnel as it were. You talked about payers. We've been thrilled with the speed of payer coverage. We talked about the $215 million lives from the commercial payer segment. But if you add on Medicare and Medicaid, we're closer to 300 million lives which is 90% of the insured population in the U.S., and the majority of those are covered to label. But you're right, we do see some plants that have some restrictions related to surgical -- the prior surgical number. We're very confident, and we've said all along that 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, which are ongoing, the complete responses. And then, 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. And so 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. And to date, we are not aware of any payer that is flatly rejected any patient for treatment.

Very good -- so from tomorrow morning, we're going to have the J code. So with the J code, do you -- are you gearing up for another big bullet or is the J-code just helps payment, but it really doesn't bring in a ton of patients just because you have a J-code?

Yes. No, great question. And 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, 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 build because we foresaw that, that might be a challenge. But some institutions say, no, we're [indiscernible] bill we're going to wait until the permanent J code. So we expect and we know that there are institutions out there that are in that category. And so we do expect those to be activated as well as the ongoing activation of institutions in general that we are seeing. So the permanent J code definitely helps and should give us further impetus. But in general, it just smooths and streamlines the whole patient access process.

I know we are not stopping here. You're trying to expand the market either, obviously, both by filing -- having filed the MAA going into Europe. How should we think about that commercialization there? And also, is there any conversations going on regarding trying to get a partner to help you out in these geographies? Or do you think it will be [indiscernible] just by yourselves?

Yes. So maybe I can start and Phil can add. Clearly, we are excited about the expansion of the indication and global expansion of the PAPZIMEOS. And as you mentioned, it is currently under review with the EMA, and we are looking forward to later on this year from that perspective. I think what has become very important first of all, some of the work that Phil and the team has done and very clearly showing that, for instance, even in the European market, you have a similar number of patients, number or even somewhat a little bit more that -- so therefore, this drug is very, very important. As far as the commercialization effort is concerned, our focus is really on just United States, even though we are going through the regulatory path. But at this moment, we do not have a plan to put boots on the ground in Europe for commercialization. And as we have already mentioned, we are looking at various partnership aspects with -- that we can commercialize this and make this drug available to the European community and others. And I think as we are now a commercial company with obviously a very exciting drug, it is very clear that the companies like us, they are at the center of discussions, and there would be a lot of number of discussions from a perspective of partnerships or BDs, which as we go through, we are evaluating, and then we will be discussing as the time comes.

And the only thing I would add, RK, is 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.

So one quick question on physician feedback. What are you hearing from the physicians on the ENT specialists who have already used the drug? And are they slowly becoming champions of the drug?

I think, for instance, last 2 weeks ago, I think was the UroGen, which is one of the biggest meeting for lyongologists and specialists in that area. And what we have heard very effectively through a number of presentations. First of all, RRP was a dominant topic during this meeting. So it really speaks to the expansion and recognition of this indication, but also the discussion around PAPZIMEOS and physicians referring not on the safety of the PAPZIMEOS, which was referred to as excellent efficacy, especially the complete response of 51% it was considered impressive, but also adding the durability of response, which has passed 3 years now this was the really physicians have been calling it outstanding indication that you can imagine, there has been nothing for the past 100 years as far as treatment is concerned. So 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 patients.

I should -- even I'm tempted to call it life cycle management. I don't want to call it yet. But you certainly are planning on -- have started the redosing studies, and also trying to look into pediatrics, right? Because as you said, there is quite a bit of population. We don't get this diagnosed very early in life. What are the plans there? And what are the milestones that we as investors should be on the lookout for in these 2 areas?

Excellent question. So first of all, as you mentioned, we currently hold a label for all adults with RRP. And based on, again, and I keep stressing this point because this kind of drug with the ease of administration and the safety and efficacy that has shown -- I mean, let's remember that this drug has only grade 1 or maybe grade 2, which is very similar to when you get a flu shot, maybe a little bit of a rash on a site that you have received that will go away or maybe a little bit of fever, which will resolve itself within a day. So -- and a subcu injection that can be done in the office of the physicians. Now imagining, especially for a pediatric population, they has to go through this. This is a really a treatment that lendedself for this patient population and especially and unfortunately for these children that they have to go it's horrendous this. So as FDA very much has been supportive of this and so on we have already communicated. We will be starting our pediatric trials by the end of this year in 2026. So we are very excited about that to bring not only have this for adults, but eventually to be approved for children. And 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 these to a complete responder, that 35% of the population and as you mentioned, the redosing arm has already started, and we are looking forward to start providing data in that in 2028. And that will definitely expand the indication but also from the data that we are getting in general from redosing the studies and also from our long-term [indiscernible] 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.

The other interesting aspect that you put out last week was regarding initiating studies in PRGM-2009, not initiating continuing the work that they've been doing, which is exciting. So can you highlight what PRGM-2009 is and how it is -- it also comes from the same platform that PAPZIMEOS is?

Great question. And I'm really happy you asked this question because we are extremely excited about PRGM-2009 as the second group of drugs that are coming forward. And 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. And we had the Phase I with the PRGN-2009. What PRGN-2009 is exactly on the same backbone of PAPZIMEOS the gorilla vector. It's exact same structure. So you can imagine the safety, the manufacturing, the talks, all of that is very, very similar. The difference of PRGN-2009 is addresses HPV16 and 18, 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. And with that, if you look at the history of these patients, in a cervical cancer, their first line of the treatment is current chemo, radiation, checkpoint inhibitors, surgery altogether and then these patients fail unfortunately. And then there is nothing. On a head and neck, even with the checkpoint inhibitor approvals you are having somewhere between 15% to 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 with number of epitopes of HPV16 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 felt at least to re or 4 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 show 30% objective responses. Patients had complete responses and ongoing for more than 2 years. These are patients Stage 4 that they would have had months to live. Then we obviously started a Phase II trial on cervical cancer, but simultaneously, we had started a Phase II in head and neck in oropharyngeal carcinoma patients. And we are really excited about what we are looking at. And as I mentioned last week, end of this year, we are looking forward to report the first set of data from this trial. So it's quite an exciting time for Precigen. With coming back with now the second molecule. And to your point, as far as we are very much looking forward to having discussions with the FDA on a platform designation 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? And to apply for it. I believe there have been only like 3 companies who have been awarded that designation. So in your case, what sort of data do you need to compile? And once you apply for it, what are the benefits that you're getting? And how long does it take for the FDA to keep you that designation?

This is a very exciting program from FDA, and we are very, very happy about it. The kind of information is already what we have generated on PAPZIMEOS as far as the platform is concerned, which is your safety, your manufacturing talks and also, we have shown efficacy and durability of responses. So you can use that and with the for instance, the molecule, such as PRGN-2009, you can combine that. The benefit, and this is one of the reasons, 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 nonreplicating, 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 and so on and so forth. So you can imagine now when the second generations of the molecule in a different indication, but on the same platform comps, now you can move much faster because these things from perspective of regulatory bodies have been already established. And as part of that platform designation then you can move much faster through pivotal trial.

So that is good on the regulatory side that you don't have to send a ton of paperwork that you need to send. But on terms of the development timeline, and also the cost of development. How does that designation help you? And 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?

Yes. So I think from the lot of repeat studies that need to be done for regulatory like -- for instance, CMC or preclinical or even in the clinical studies, if they ask for -- those studies will not become relevant any further, right? Because a lot of those have been done. A lot of those assays has been accepted already. So you don't need to reinvent the wheel. And you can rely on the basically the system that has been shown it works and use that. So it saves a lot of resources and investment from that perspective. But at the same token, it saves a lot of time in pushing through this because as you are well aware there is an aspect of doing the clinical trials. 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. And with Precigen, but 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. So you can imagine that we have gone through the first drug and then hopefully, in upcoming drugs for the next indication, which is a large, very large indications in cancer then we can move very, very rapidly.

So besides 2009, are there any plans once -- if you get this platform designation in place, which is obviously a great thing. So now you will have 2 molecules of that [indiscernible] you'll have the PRGN-2009 going is there -- are there any thoughts about developing another indication or another molecule that you can use the same platform on? I'm just trying to understand how much more potential is there on this platform?

It's a tremendous amount of potential. So what we did from originally when we developed the added 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 4 years, we took it from discovery to the approval, which is a record time. but also PRGN-2009 in other indications. 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 it was during the global pandemic, and very difficult market challenges. So 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. And now that we are a commercial company and with revenues coming in and with a 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 stressed at the end it differentiated. This is not another me-too platform. This is not another just adenovirus like everybody else. This is a very unique platform with the opportunity to really go across indication. And our portfolio actually contains many other indications 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 continues.

So [indiscernible] in closing and the last question. With [indiscernible] in the bank as of end of the year. And obviously, we anticipate it could growth in revenues in PAPZIMEOS this year and potentially getting to be breakeven by the end of 2026 as folks are expecting it to? How should we think about deployment of this incremental dollars that you would have. And at the same time, on the flip side, if things don't go the way you expect, what are the things -- what are the -- what are the options that you have to make sure you have a sustainable growth?

So first of all, I think for what you mentioned, absolutely. Now we are a company that with revenue that it's coming in, and we are very excited about our commercial part as we see it currently with 100 a little bit over $100 million in a bank. We already have basically looked at our budget and for instance, the redosing the pediatric 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 onetime costs that we had to do, and we don't have that. So we can redeploy those resources to our portfolio and clearly also the revenue that comes in. Where we have always extremely good RK 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've gone -- PAPZIMEOS was a great example of that. And so we keep applying the same kind of discipline and pressure to that, of course, ensuring that our front-runner asset PAPZIMEOS is well capped and with a high priority for us in the U.S. And then we deployed our resources accordingly to their priority program. And in -- like any other time, and 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. And 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.

So since there is 30 seconds left, so I can still ask one last question. So as we -- as you stated, last week, you gave us a quarterly expectation for the first quarter. So until PAPZIMEOS gets to a certain steady state, is that going to be a way of communicating in terms of revenue guidance on a quarterly basis? Is that the explanation that investors should have? [indiscernible] second, third and the fourth quarter as [indiscernible].

No.

No -- the call was so late in Q1. It made sense for us to give that guidance because there was so much happening. But we won't be giving that guidance in the middle of the subsequent quarters when we fall into that [indiscernible] 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 and about payer coverage. We'll continue, obviously, to talk about all.

And 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 it's getting very exciting 2026. Thank you.

Thank you, RK.

Thank you. Bye-bye.