All right. Thank you very much, Operator. And I'm delighted to welcome Mike Rossi, President and CEO of Y-mAbs, to the call, or to our conference today. So, Mike, thanks for joining. And as folks know, we're doing a fireside. So just to sort of set a framework here, you know, Y-mAbs has been around for a while. You've got the approved asset in DANYELZA approval for high-risk neuroblastoma. And you've come on with a really strong background in targeted radiopharmaceuticals. And so I'd love for you to sort of set the stage with your view on the Y-mAbs story sort of moving forward and how you're viewing the company. Certainly. Well, you know, thank you to Oppenheimer for having us here, and you, Jeff, for hosting us. I really appreciate participating in this fireside chat. I think the, you know, as we look at Y-mAbs, it was founded in 2015 by Thomas Gad and really had the sole mission of bringing important therapies to patients as quick as possible. You know, we launched DANYELZA in 2021, and it's really been game-changing for children with neuroblastoma, so we continue to focus in the relapsed refractory high-risk neuroblastoma space with the product, and we're the only product approved for therapy with bone and bone marrow involvement. So, you know, we're very, very proud of that product and very proud of continuing to expand DANYELZA and reach into first line as well as potentially into other indications such as osteosarcoma, Ewing sarcoma, and have some additional investigator-sponsored trials going on to do that. But, you know, from a Y-mAbs perspective, there's two halves to the company. And we've got the laser-like focus on DANYELZA and growing that commercial asset, maximizing that, and continuing to lifecycle manage the product. But at the same time, we're developing a very unique platform in radiotherapy, which is where my background comes in. And for us, we've got our SADA PRIT technology, which we've been licensed from MIT and MSK. And we've got two products in clinic today that we're moving forward with that radiopharm. So, in the last year of joining the organization, really, it's been a transformation of bringing people and process in to accelerate our investments in the radiopharm space while we continue to invest in and maximize DANYELZA's. You're on mute, Jeff. Sorry. That was clever. You've recently taken some steps to realign internally or to focus internally, as you mentioned, DANYELZA, as well as the radiopharm business. So I guess just briefly on DANYELZA, where do you hope to see this product go as you look at lifecycle management and, as you mentioned, some of the investigator-sponsored studies? Yeah, no, it's a good question. I think that the big thing for DANYELZA is splitting it into two business units allows us to kind of really focus in on the talent needed to drive the different sides of the business. So from a DANYELZA perspective, it is really a commercial and lifecycle management strategy. We already have the product in the market. So what it took to get it to market and do the initial launch isn't necessarily what we needed to continue to expand that and to move it forward. So we're focused on the global expansion of DANYELZA, which we've done successfully in several countries, as well as penetration within the U.S. So we have a U.S. and an ex-U.S. strategy, and it's really to unlock the full potential of it within the high-risk relapse refractory neuroblastoma, as well as potential indications outside of that. You know, overall, we're still maintaining and looking for commercial growth and growth within the segment as well as outside. Then, again, we've got partners outside the U.S. that we're leveraging in markets like China. We've just announced a partnership in Japan to bring it forward, as well as partnerships in Brazil and Mexico. We expect an additional region this year to be approved as well. We also offer it on a direct patient name basis in countries like Turkey, as well as throughout Europe. All right. And so you continue to anticipate seeing that product to grow revenue-wise from, I think you guys finished out the year around $88 million, if I recall correctly. We do. And we have roughly a 15%-17% volume share in the U.S. And our value share is much higher. But we think overall we can double that market share over the next few years as we continue to penetrate within the U.S. and continue to grow ex-U.S. So still a growth product, still a lot of opportunity for it. And, you know, we continue to differentiate it within the neuroblastoma space. All right. Now, shifting over to the targeted radiopharm business, you know, you have your proprietary SADA platform as a pre-targeting platform. And for those who are maybe a little less familiar with that aspect of targeted radio, could you talk a little bit about where pre-targeting fits within the broader space and how, you know, how pre-targeting sort of addresses some of the challenges and how SADA was designed to address that? Sure. So, So, you know, we'll start with the first section of really talking about what is pre-targeting versus conventional targeted radiotherapy. So what's in the market today? Everything that's injected is already radioactive when it's injected. So if you look at the PSMA product that's in the market today or the somatostatin receptor product that's in the market, they're manufactured as a radiopharmaceutical, meaning that we've combined the isotope with the ligand into one radiopharmaceutical and inject it. Where that's a little bit challenging is you have a lot more off-target toxicity with that. It's circulating as a radioactive substance until it binds to the tumor or it's eliminated. So what we see is absorbed dose outside of the tumor that may not necessarily be exactly where you want it to be. Our platform is completely different in that we inject the drug or the SADA as a non-radioactive. It has two binding sites. The two binding sites, one is targeted at the tumor, and we have two clinical products today. One is targeted at CD38 in the non-Hodgkin space, the other at GD2 in the sarcoma, melanoma, neuroblastoma. There's a second binding site that's left available after it's on the tumor for the isotope. The isotope's injected at a later time, two, three days later after the SADA clears out of the blood. Why that's important is it allows it to circulate as a non-radioactive paint or pre-target the tumor, leaving these open binding sites for the isotope. The isotopes then inject it, really leaving the only spot for it to bind is on the tumor. Then it clears from the kidneys rather quickly, decreasing the off-target toxicity and really focusing in on that. From a pre-targeting platform where you inject in two different steps, it has some definite strategic advantages in how you target the tumor, as well as how it's administered and how you leverage the infrastructure to actually treat these patients. Okay. And I mean, it's complicated to go into all the details here. So let's talk about what you've got coming up. And I think two important updates in the queue. One is a clinical update for the GD2- SADA program. And so what should folks be thinking about in terms of that update? And I guess probably wants to speak to sort of the design of that part of the clinical trial. Like I said, as we look at this, there'll be a lot of information to garner. This is the first time a two-step in vivo targeted radiotherapeutic has been administered in humans. We focus on this trial as a safety trial. You know, it was important for us first to determine the safety level of proteins since it's the first time that SADA was injected into humans, but also administering the isotope so that we could see where it goes. Nuclear medicine is in a unique position where we can actually visualize where the drug goes, visualize what that uptake looks like, and then start to optimize so that we can really meet the needs of the patient, of the clinicians, and really of the overall healthcare systems. You know, before I talk a little bit about kind of what to expect out of the trial, I think it's what are some of the goals of what we're trying to do with the SADA platform, and the three areas I talked a little bit about, that tumor specificity and clearance. The other side is really physician participation because the physicians that are treating the patients today with other therapies can't necessarily treat with a pre-targeted radiopharmaceutical because that all has to go to nuclear medicine. And you don't really get to leverage the expertise of that treating physician the way you would if you're actually treating in-house, and then the same thing with the infrastructure side. There's infrastructure needed from a radiopharmaceutical company where you've got to build out special facilities to handle radiopharmaceuticals that are different than traditional drug manufacturing. More importantly, at the administration site, there's not enough nuclear medicine physicians in the country. There's not enough sites in the country to treat all of these drugs under development or even the ones that are already out there. As we look at this, it was important for us to design the trial to show that safety, but to really leverage the advantages of SADA, which in one case would be the oncologists, urologists, endocrinologists could actually administer the SADA drug outside of nuclear medicine because it's non-radioactive. You have all of these infusion sites that you're leveraging to make sure that you can treat all of the patients utilizing your existing infrastructure, and then they go to nuclear medicine for the isotope injection. The way the trial is structured is exactly that, where we divide it up. They're able to get the infusion. They come back a couple of days later and get the isotope and what we're going to see out of this Part A data in the second quarter is a lot of the PK so looking at the uptake within the patient, the elimination, you'll see the scans from these patients because, again, we can visualize it. We'll also see what the distribution looks like in the organs as well as potential timing for the protein so looking at the characteristics of the drug itself as well as what it needs to do, we continue to invest in this and run the clinical trials to get as much information as early as we can and then optimize as we go into the next round of targets. Okay. And so as we think about the trial setup, folks will be looking for sort of general safety as always, but also the dosimetry picture, which is unique to targeted radiopharmaceuticals. And, you know, one of the challenges for monoclonals or the longer-lived biologics has been this long circulation time. Could be kidney exposure, well, shouldn't be kidney exposure, but bone marrow exposure in particular. And so you're going to be, would you be able to see then, you know, the impact of time of administration, accumulation of the SADA molecule, and how that impacts dosimetry? Would you expect to get some visibility to that with this early read, or will that come later? That'll come later as we optimize the protein and also optimize the chelator as we're moving forward. I think what you'll see out of this, it was designed for safety, but also looking at different potential indications from a GD2 perspective. GD2 is a little bit difficult because it's a non-validated target outside of pediatric neuroblastoma. And one of the reasons we moved forward with it was our experience in GD2 with DANYELZA allowed us to take the fragment of that antibody and translate it into a SADA molecule and go directly into patients in under three years from license. So it was quick into patients. The challenge we have upfront was we don't pre-qualify the patients in because there's no way to determine whether they are or not GD2 expressing. So one of the things that we'll learn from this is actually which patients express GD2, and can we see that, and what does that look like? Using lutetium is a little different than using a PET imaging agent where you can get a little bit better quantification from the PET because it's set up as a diagnostic where you get a lot of that dosimetry. I think from a lutetium perspective, being that it's a gamma, the secondary gamma from the lutetium decay, you're able to see it on planar SPECT images, but not quantify it to the degree that you would with a PET imaging agent. So for us, it was first validate the platform that you can do an in vivo targeted radiotherapeutic. Hence the reason we went directly to lutetium. Now it's kind of moved backwards a little bit into PET imaging, so we can then get some of that quantification that we're learning from this Part A trial, so that we can then take it forward and do that dosimetry and kind of the organ distribution as well as the tumor uptake. Okay, so the PET imaging will come in, say, Part B of the trial? Yeah, the PET. So we're planning on doing PET with all of our products moving forward. But it was, you know, it was that fail fast mentality of, do you have a therapeutic first? Can you do a radiotherapeutic? You know, we've clearly said yes. We can see that we're tagging, we're doing the in vivo tag of the tumor. We're seeing that kind of uptake. Then now, yes, you can move forward. So it's kind of moved backwards into the diagnostic, use that for qualification and quantification so that you can best patient select as you move forward with GD2 as well as the other targets in development. Okay. And before we step over to the strategy update and overview in the second quarter, just could you touch on the CD38 program? Because that one is now dosing patients as well. And so is that set up for a similar design to the GD2? Can you take learnings from the GD2 into the CD38 program? No, absolutely, and that we have four sites that are currently up and running and recruiting patients and two additional sites to come on later this year, so again, it'll be similar to the six sites we have on the GD2. For us, one of the big differences between CD38 and GD2 is we do have a validated IHC to patient select for CD38, so we're able to screen patients using the IHC. Those that are CD38 expressing then move forward for qualification for the study. Also, as we looked at the learnings from our 1001 trial, is how quickly do we need to dose escalate, and then what is the most important part? As we start looking at this, you know, we're changing how we look at the variables a little bit, and we have some flexibility in looking at dose versus time since there is a lag time between delivering the dose and delivering the isotope. The learnings coming out of that allow us to move much more quickly with the data that we're collecting. Also, from having a second program on the SADA platform gives us an N of two. Now we're able to look at the data coming in from our 1001, translate to our 1201, and really learn more about the differences between solid tumors and circulating tumors as well as potential differences in uptake from one receptor to another. Okay. Now, as I just said, you've got an important strategic update coming in the second quarter, you know, talking to the sort of forward plan around targeted radiopharmaceuticals, how you're thinking about leveraging the SADA platform. So I guess without giving away what the update is going to, you know, drill into, can you give us an outline of sort of what you're planning to cover? Sure. So as we looked at the organization, we said, you know, we got into patients very quickly with these two targets, right? So we were able to move into clinic very quickly. But when you take a step back and look at the target and say, what are the best targets for SADA? What are the best targets for radiopharmaceuticals? And what is it that has a high value for the organization? So what we did is we ran through an exercise this past year, about six months in total, but we started with over 1,200 targets. And we started looking at those targets for the overall value. They're focused in oncology, the type of expression, what it is that they treat, what the unmet need is, and whether they would be radiosensitive. So we took them through a series of questions and narrowed those down. We really came down to about 40-50 high-value targets that are exciting for us to move forward. We'll be taking those into the preclinical and clinical setting. For us, there's also a focus in really three franchise areas. Those 40-50 targets that are exciting high-value targets for us, if they fit within one of those three franchises, we'll be looking to take those all the way to commercialization ourselves. If they don't fit in one of those three franchises from an efficiency perspective, they're good targets to partner with somebody else who would then want to commercialize them. Somebody has a franchise that isn't necessarily one of our three, but we have a very exciting target that shows promise in preclinical and potentially early clinical setting. They're going to be good targets to potentially partner with and prioritize. But for us, it's going to be looking at the three-year plus horizon to bring those targets. And we won't bring all 40-50 in right off the bat, but we will break those down into areas. And then it'll be the, use a football analogy coming out of the Super Bowl, it's kind of the next man up. So as we either qualify the target and move it into clinic, we'll be backfilling it with the next target on the list that fits that criteria. Or if a target fails and we don't want to move it forward, we'll backfill with the next one. So we've got a nice strategy lined up for the next several years to start really bringing these targets forward in an expedited manner. All right. Yeah, it'll be great to, you know, hear about how you're thinking about targets in greater detail because targets in the short history of targeted radiopharma have been played pretty close to the vest, and it's been a pretty narrow universe. So to hear how you guys are thinking about this and then with pre-targeting, it has sort of a different set of criteria that makes a target relevant in addition to the commercial one. So really looking forward to that update from you guys. Can you remind us sort of where you sit cash-wise, how you're thinking about run rate in terms of R&D? And of course, you know, you're a little different than a lot of sort of early-stage clinical companies because you have the commercial asset in DANYELZA generating revenues to support the business. Yeah, no, it's a good spot to be. You know, we're right now self-funding biotech. We really take care in utilizing our cash in a way that's going to create a lot of value in the business. You know, the cash that DANYELZA is generating is allowing us to really invest in the radiopharmaceutical pipeline to create a lot of future value in the organization that is much beyond what a single product would be. We announced that we've put out there an unaudited end of 2024, have about $67 million in cash. We had $11 million in cash investment or cash burn last year, but the majority of that was one-off charges to clean up some old liabilities on the books and really put us in a position to go forward with a very, very clean P&L. So we've got no debt in the company, which is, again, unusual, very consolidated share base, and enough cash that we have runway well into 2027 with all of our planned activities. But at the end of the day, we're virtually cash flow break even if you remove the one-time charges. So as we continue to grow, DANYELZA and that product continues to move forward, it'll provide us additional runway as well that allows us to then invest in more targets and more opportunities going forward. The other thing we've done is restructured what our clinical trials look like, what our clinical development looks like, clinical development, and what our investment takes to move an asset into preclinical and then into Phase I. You know, we plan on bringing a lot more targets in a lot more cost-effective manner than has been done in the past and allow us many more shots on goal, all staying within our cash flow guidance. Yeah. No, that's really helpful. And as we think about, you know, we've just been talking about going back to the GD2- SADA program and the update you'll give, the clinical update you'll give sort of in early Q2, that clinical trial, that Phase I is still ongoing with more parts. So could you talk about just the expectations and next steps on the GD2 SADA program or if that's something that plans set or might it change coming out of the strategic update? There'll always be changes, right? There'll be reprioritization as you look at the overall organization. You know, we've got a lot of significant data coming out of this update as well as taking that data, digesting it, and deciding on how to best move forward in advancing both our GD2 and eventually our CD38 products. As we look at those and learn from them, there may be an opportunity to reprioritize, to put additional investment in other targets that are going to be, say, more commercially viable. Stay tuned for that. Also stay tuned for the update as we take that Part A study, kind of internalize what that data looks like, what our optimization efforts look like, and, you know, potentially make some changes to the protocol moving forward to increase the speed of data collection so we could kind of get to the next step and the next step and the next step and moving that forward toward registration. Okay. And I think, and you've said it in a couple of ways here, but the GD2 SADA program is really proof of concept for you guys in humans for the SADA platform, validation, if you will, in humans. And, you know, it was a fast way into the clinic as you look at additional opportunities. Absolutely. And again, still a very viable product, but we'll make our decisions based on what the long-term health of the organization looks like and our opportunity to really have an impact on as many patients as we can. Sure. Yeah. You know, I think the two sets of updates in the second quarter will be really meaningful for investors and analysts as we think about the platform and the story moving forward. Just as we're coming up on time here, are there anything else you'd like to use this opportunity to highlight in terms of the audience? I think a few things. You know, we've talked about the transition, the change to the organization and moving it from really a single look at the DANYELZA antibody, moving it into a radiopharmaceutical company as well. I think stay tuned for some really good information and good updates and some exciting things that this platform can do for the industry and for patients. But I'm really proud of the important work that Y-mAbs is doing in both the pediatric neuroblastoma space as well as across our radiopharmaceutical pipeline. So, you know, we've got this robust Part A data coming. We've got additional optimization happening. And then as we lay out this strategy, I think it'll be very clear to investors and to the community where Y-mAbs is planning on going over the next three years and beyond. All right. Fantastic. Mike, thank you very much for the time this afternoon, and we are looking forward to those updates and have a great rest of your conference and one-on-one meetings. Great. Appreciate it, Jeff. Thank you. Operator, you can take us.
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