Great. Thank you. I'm Max Skor, a Biotech Analyst with Morgan Stanley. And before we start, I would like to read a few important disclosures. For important disclosures, please see the Morgan Stanley research disclosure website at www.morganstanley.com/researchdisclosures. If you have any questions, please reach out to your Morgan Stanley sales representative. And I would like to first introduce Bicycle, and thank you for coming to our conference. Starting off, first, Kevin Lee, CEO, Alethia Young, CFO, at the end, Santiago Arroyo, Chief Development Officer, and Jennifer Perry, Chief Strategy Officer. Thank you very much. Maybe if you don't mind, if you have any opening comments, that would be great, then we can dive into the Q&A. Well, thank you for the invitation. It's a pleasure to be here. We're really excited about the work we're doing, the progress we're making, and really looking forward to update everyone. Great. So briefly, just to start off, level set, could you introduce the Bicycle platform, including key advantages, capabilities of the technology, and how your approach aligns closer to small molecules o ver, let's say, ADCs? Sure. So the Bicycle concept came from Sir Greg Winter. Many people will know Sir Greg's pioneering work in monoclonal antibodies. And what Greg conceptualized was the idea that you could replace the six loops of the CDRs in a Fab with two loops, and you could replace the four hundred and thirty or so amino acids that formed purely a scaffolding function in the Fab of an antibody with a small molecule organic scaffold. And so that's essentially what a bicycle is. It's a small peptide, typically nine to fifteen amino acids, arranged around a small molecular weight organic core into two loops. And when you form two loops or in a very tight loops, you essentially constrain the rotational freedom of the peptide. These are molecules which are locked in their preferred position for target engagement. That means we have molecules with very high selectivity and very high affinity, somewhat akin to the Fab fragment of an antibody, but these molecules are some 50x-100x smaller than an antibody. I think the three key properties of Bicycle, which are very relevant and differentiating from an antibody, are one, the small size that allows the molecules to freely penetrate into all tissue, and in the case that we're going to discuss, into freely penetrate into tumors. The second is the selectivity. Antibodies are designed to be non-selective. Yes, you have the very high selectivity of a Fab, but then you have the polypharmacology of the Fc domain, and that's something that, of course, a bicycle doesn't have. And then the third property of the bicycle, which I think is really important, is the route of elimination is primarily renal, and that allows us to essentially be able to tune the PK so we can control the exposure of the molecule in the body. So those features, you know, I think the... We like to think of these as kind of antibodies, but in a small molecular weight format. They have the beneficial properties of antibodies in terms of selectivity, and high affinity, but they also have the beneficial properties of a small molecule in terms of rapid tissue penetration, and also, the molecules are fully synthetic, and that means we can optimize these bicycles. Once we have an initial binder, we use structure-enabled medicinal chemistry to maximize the potential of the starting point. Great. Can we also just briefly touch on manufacturing or looking forward COGS, what that looks like? Yeah. the Bicycle platform? As I've just said, the molecules are fully synthetic, so we, you know, we can, the manufacturer is essentially classic peptide chemistry, which is well known, well established. We're not disclosing the COGS at the moment, albeit I will say they are very much reduced compared to a biologic. Great. So I'd like the bulk of our conversation to focus on BT8009 or Zele, but could we touch on the recent decision to prioritize near-term research efforts on the Bicycle radionuclide conjugate pipeline? Yeah. So this—I think we disclosed in our last earnings release, we've historically been focused on, I would say, two and a half areas. In reality, we've had a very strong focus in Bicycle toxin conjugates, and the progress is there for everyone to see. In the IO domain, where we have these tumor-targeted immune cell agonists, TCAs, as we call them, based on a CD137 platform. They're performing very well in the clinic. We're very happy with the progress they're making. And then we've had somewhat less activity historically. We can talk about the reasons why in the radiopharm space. Given the progress we're making, and we're looking forward to sharing more data later this year, and given the strong interest in the field, in the radiopharm and the progress which has been made in supply chains, we've decided that that's an area we really want to double down into. And so in our earnings, what we actually said is we're focusing on Bicycle toxin conjugates and Bicycle radio conjugates, and we are reducing our effort in the immune oncology space. That's not to say we're not pursuing, we will be pursuing our CD137 franchise. That's an area that we very much believe has a lot of potential. What we are deprioritizing is some of the earlier areas, such as the NK-TICA platform that we have and some of the cytokine activator or inhibitory platforms that we have. They're at a much earlier stage, and for us, I think it makes more sense for us to look to collaborate and explore the potential of these molecules in a more kind of collaborative fashion than trying to do it all ourselves. Great. Is there any data you can point to from the radiopharma pipeline that kind of gave you confidence or, kind of pushed you forward in prioritizing this pipeline? Yeah, well, obviously, we'll provide an update on our own programs later in the year. But what... You know, one thing I will draw people's attention to is the work done by others independently to Bicycle on our Bicycle molecules. So there's some really nice preclinical literature, particularly from the group in Johns Hopkins, looking at, you know, Bicycle-owned EphA2 binders. There's some nice work done by Johns Hopkins in collaboration with a group in Beijing, where they've actually taken one of our Nectin-4 bicycles and shown human imaging with that molecule. So it's not just our own internal data, which we'll share in good time, it's also the huge validation we're getting from external parties. You know, I've just talked about two novel tumor antigens. Nobody else is really working on those, or, and as well as we can see, is able to work on those. It's very much a field that's, you know, focused on PSMA and somatostatin. We can talk about the reasons why that might be, but we think the potential that we can provide, the offering we can provide, the differentiation we can provide, is by going after novel targets. We have many binders to many very high-value tumor antigens. Yeah, that was my next question in regards to the competitive landscape, why go after what you anticipate going after, and what the benchmark would be? You know, our perspective is there's a huge amount of value in the radio conjugate field. Everyone can see the progress that's being made. You know, where we think there is, you know, perhaps the maximum potential is in the pursuit of tumor antigens that other people aren't exploring. I've named two, and obviously, we have a pipeline of additional tumor antigen bicycles that bind to additional tumor antigens. It's our intent to really, you know, explore those to the fullest extent possible. Just last question in regards to the radiopharma pipeline. We should see an update sometime this year. Anything else you'd like to say around the details or level-setting expectations? Yeah, everything's on track. You know, what we're looking to try and do, because we know our shareholders and investors prefer to see data at medical conferences, so we'll most likely be looking to share some data at a medical conference. Okay, great. And then the last thing, which you touched on previously, you're going to continue to develop BT7480, your Nectin-4 CD137, but look to potentially collaborate on other programs in the IO space. But could you just give your perspective on the longer-term view on IO, the IO space in general, what kind of drove this decision, and how investors should maybe interpret that? You know, I think from our perspective, you know, the near-term value creation in the IO space is thinking about how we combine 7480, which is, you know, a targeted Nectin-4 targeted CD137 agonist, which was shown in phase 1, very good tolerability, very good movement of pharmacodynamic markers. We're seeing really good target engagement and immune response associated with that. Where we see the value for that is in combination with, you know, initially checkpoint inhibitors and then the idea of maybe combining it with the rest of our portfolio. We, you know, we think our CD137 franchise, which is composed of, you know, the potential to target activation of CD137 in a very, tumor-specific, target-specific way, we think that's a huge opportunity for Bicycle in terms of combining that mechanism with our toxin conjugates and our radioconjugates, which I think the field is starting to learn. The combination of IO with tumor cell killing is very valuable. Our focus is on taking BT7480 forward, validating that to a point where we're very happy with the potential of that. We have a raft of other, again, specifically targeted CD137 agonists. What I think the huge potential of our platform is what we've created is a pipeline of tumor Bicycles that target high-value tumor antigens. And then we've created a range of different payloads, from radioisotopes to various toxins and CD137 and potentially other mechanisms. And because we're fully synthetic and because bicycles by design are facile to conjugation, we can combine all these payloads with the targets in a very easy, very quick way to produce very novel molecules. And we've, you know, already shown that we can. Bicycles deliver MMAE as a payload, CD137 and a radioisotope. And what you're gonna see from Bicycle moving forward is really doubling down on this combinatorial capability, creating multiple molecules to individual targets. Because I think, you know, you're only gonna target a certain population of the total targetable population with any one mechanism, and I think that's a fact. You know, nobody's getting 100% response rates, period, with this type of approach. And therefore, we're leaving a lot on the table going with one mechanism. So thinking about how we can use different payloads, either as monotherapies or in combination, and that's the power of the platform. And I think we've now, we feel coming through this summer, moving into the second half of this year, we're gonna valid, we've validated these mechanisms. We now have a lot of confidence that we can deliver these in a very safe and effective way. And what we wanna do now is explore the potential, the full potential of the platform, as I've described. That's great, and just going back to one thing you said in regards to the monotherapy and combination approach. At what stage in development... I imagine, well, you could take Duravelo-2, for example, not to jump to the next section, but you'll first explore monotherapy, and then in a phase three, you'll have a phase three registrational trial, you'll have an arm that's a combination approach? I think each approach will deserve, you know, take its own sort of direction, depending on what we're trying to achieve. You know, one can think of taking, you know, as we are doing 8009 in combination with pembrolizumab forward into that first-line setting. I think there are safety run-ins we can do with other molecules and look to deploy elsewhere. Remember, we've been saying for at least, you know, four or five years, nectin-4 is a huge target for oncology. It's more than just bladder cancer, and I think the data is now starting to support that. We've seen this tumor antigen, and it's expressed in multiple tumor types. We're aware of other companies that are, you know, going after other indications. We think we said this at our R&D Day. Having, you know, multiple orthogonal approaches makes a lot of sense to us when you're going after a tumor which is widely expressed across a range of different tumor types. And some of those tumor types have their sensitivities to particular payloads and their insensitivity to particular payloads. And when you've got a bicycle that you can put on whatever you want, you can really capture the potential of that market. That's our belief. It's very different than what other people are doing, but other people, you know, kind of have their technological limitations. We have this ability to plug and play, and we're gonna explore it. That's great. Okay, moving on to the most advanced program, BT8009, or Zeli. If you can briefly provide a quick overview of the supporting data, what led to the initiation of Duravelo-2, just level set our expectation. Uh, Santiago. We have presented the previous R&D Day last December data, and we are actually going to present new data at the next ESMO meeting in a week or so. So the efficacy that we saw, the response rate that we saw was very similar to Padcev, basically, with a very differentiated safety profile. We don't tend to observe high levels of neuropathy. We didn't see grade three neuropathy, one patient out of 140 patients. We didn't see any serious skin reactions. We saw actually very low grade of other skin reactions and ocular reactions. So it's a clearly differentiated profile. You know, again, the data will talk by itself next week, and So this is the first update since ASCO, if that's correct? This is major data cut. Major data since actually last year, R&D Day. R&D Day. Yep. Okay, great. So just one question from me in regards to your confidence in the dose, the five milligrams per meter squared QW dose, and how it compares to Padcev dosing schedule. What gives you confidence? It's a lower dose than Padcev, but if you can walk us through the Yeah, we've done a lot of work on the dose, actually. We did a lot of modeling work on it, and actually, we discussed that at length with the FDA. We spent one of the meetings with the FDA last August, talking about dose selection. We closely followed Project Optimus to try to ensure that we're optimizing the dose. We believe that both doses that we are testing, which is one is five, the other one is six, they will be, both of them, effective, and they will be, both of them, well-tolerated. The question is, which one is better? One of them is every week, five. The other, six, is two weeks on, one week off, which we believe it will be better accepted by patients, so again, a lot of work has been done there. There is, in our mind, acceptance from the agency on this construct, and we will actually... we are geared towards dose selection sometime in the next several months. Next several months. Okay. Great. So moving on to the phase II, Duravelo-2 trial design. If you can briefly provide an overview of the trial design and what you learned- Yeah ... from prior studies that informs. I mean, it's a complex design, and in a sense, it's a little bit unique. What we are trying there is to both ensure that we have an approval in first line, both accelerated approval and a confirmatory approval, and also that we have a chance for approval in second- line, and we're trying to do all together within one trial. Again, it was a very interesting conversation with the agency. In our mind, the agency accepted our design, and we open it. The trial is currently open in many countries around the world, and it's actually recruiting well, so we'll probably be able to bring some guidance on the recruitment, the dose selection over the next few months. Okay, and then there are interim readouts. There are several different readouts in each arm. Yes. Anything? Or could you describe the sequence of when we can get updates? Yeah, so we have two cohorts, second line in monotherapy, five and six, as I was saying before. First line in combination with pembrolizumab, five and six, and another arm comparing with chemotherapy plus avelumab. After thirty patients are dosed in each cohort, we'll do a dose selection. We'll do an interim analysis with the dose selection, and we'll select a dose, and we will continue in the first line, the chemotherapy arm, plus the selected dose. We are geared there towards achieving an accelerated approval on the basis of improved patient benefit, and again we discussed that extensively with the agency. What do they mean by improved patient benefit? First, you need to beat chemotherapy. So previously, as you know, you will get accelerated approval on the basis of a comparison with historical controls. We are not doing that. The FDA raised the bar. We are actually doing a statistical comparison in response rate between our selected dose, plus pembrolizumab and chemotherapy. In addition, we have to show longer duration of response than EV, and we'll have to show a better profile, better safety and tolerability profile than EV. So why not do a head-to-head versus PADCEV in the? Yeah, we decided not to do a head-to-head to PADCEV. There is basically three standard of care right now. Still, the most widely used standard of care is chemotherapy, okay? And chemotherapy either followed by avelumab, which is the most frequent one, and sometimes followed by nivolumab. And obviously, PADCEV was approved last year, and it's taking, you know, a position in the market, and it's truly a standard of care. But we don't necessarily need to compare to that one in order to get an approval, and we believe that we don't even need to compare to that in order to get an accelerated approval. And that's what we discussed. Just as a reminder, when we discussed this with the FDA, the FDA had already approved for first line. It was an accelerated approval, PADCEV. So it was in light of the results of PADCEV, our discussion. And I don't know if I'll press on this, but we'll see where it goes. In regards to the magnitude of improvement over the standard of care, any additional color on what that numerically looks like? We'll have to have significant superiority over chemotherapy. That's there. And then the other two pieces, which is duration of response and safety tolerability, is more qualitative. Mm-hmm. There was not an agreement or an agreed threshold, but obviously it has to be substantial. Just as a reminder, the data that we have shown before, last December, and we'll show again, new data at ESMO, show that the duration of a response was prolonged with Zeli, 11.1 months, compared. And if you compare with historical data from PADCEV, which was 7.4 months. Mm-hmm. JP, I don't know if it's worth mentioning, you know, KOL's view on, you know, what would be a meaningful differential? Yeah, sure. So again, can't speak to what regulators want, but in our market research, both qualitative and quantitative, we've gotten to glean kind of what would drive share for us in terms of zelenectide over EV, both monotherapy and combo. So in our qualitative market research and our KOL discussions, they always say that a duration of response of basically nine to eleven months compared to EV at six or seven months would be meaningful. But if you combine that with an improvement in skin rash and neuropathy of about 20%-30%, that would drive prescribing. So, we just finished quantitative market research with 150 oncologists, a mix of academic and community, through survey, and asked similar questions like: What would drive preferential share where you'd pick zelenectide plus pembro over EVP? It was really interesting and really confirmed the qualitative work, which was an absolute reduction of about 20%. So if you went from 40% for SAE, like skin rash or neuropathy for EV, and it dropped to basically 20% for zelenectide pevedotin, that would double their choice share for zelenectide pevedotin. It got even more interesting when you dug into, like, skin rash and neuropathy, where skin rash, as an example, all grade, if we could have 25% or below, it would increase writing zelenectide pevedotin by 50%. So for us, that is supported by the analogs we've always spoke to. So we've always talked about Calquence versus Imbruvica or Cabometyx versus Inlyta, where you had Calquence and Cabometyx come years after a market leader, and within nine months, take 60% new patient share. And that would be our expectation. Mm-hmm. with our tolerability profile. For those not as familiar with the Padcev safety data as we are, you know, Padcev in combination with pembrolizumab has about, you know, somewhere between 65%-70% skin rash and neuropathy. And in both cases, about, I think it's about 60%-70% is irreversible. So, you know, great drug, making a real change for patients, but I do think there's opportunities to improve, you know, patients' quality of life with a alternative approach, and that's what we're about. We're about patients not just living longer, but patients living well at the same time. Great. That's very helpful, so briefly, before moving on, you have additional updates coming from different tumor types in the second half of the year. Anything you'd like to call out, just so we, we have a keen eye on what's coming? No, I would just say, you know, no, I mean, I mean, the summer for us has been a great, a great time of execution. We've very pleased with the progress we're making across the whole portfolio, and I can't wait to share data from other tumors, but, you know, just gonna have to wait for a little bit longer. Great. Then moving on to the next program, BT5528, the EphA2 targeting Bicycle molecule. Mm-hmm. Basically, provide a brief update where you're at, supporting data and kind of what gives you confidence in your approach compared to others, because as I think many know that other teams and assets have failed in this target. Yeah, I mean, you know, the two most... I mean, I'll let Santiago give you an update on what we've seen clinically and why we're excited. But you know, I think it's worthwhile remembering, and I think this is validation for our platform and the differential that it provides. You know, the two primary approaches that have been taken to EphA2 are, of course, the MEDI547, which was a EphA2 antibody that was armed with a toxin. That molecule in preclinical studies showed a very fatal coagulopathy. And when they took the molecule into phase one and dosed the first six patients at the lowest dose, subtherapeutic dose, they saw signs of the same coagulopathy. So that's sort of the clinical experience with ADCs. Then Daiichi had an unarmed antibody, EphA2 targeted, where they were relying on ADCC as the mechanism. That molecule, again, essentially failed in the clinic. Daiichi did something very laudable and very unusual for the ADC field, the antibody field. They actually attempted to measure antibody in the tumor, and they were able to show that the antibody wasn't getting into the tumor, which probably explains why it wasn't working. So you know, we've demonstrated our molecule gets into the tumor. We've now dosed well over 100 patients and seen no signs of coagulopathy. EphA2, in our minds, is a very... It's a bit like Nectin-4, very high-value target, very broadly expressed. And from where we stand today, we're not seeing anybody else who is able to approach the target and attempt to target with any technology. But I don't know if you want to talk a little bit about the clinical data. Yeah. I mean, we are excited. We presented some data last R&D day, as you recall. We saw good number of responses, about 31% response to 6.5 mg per kilo every other week. We also saw a very favorable profile. We said that we will do, we will conduct a 5 milligrams per kilo cohort. We have completed that cohort. At ESMO, we will present new data. It will be all of it, basically, all of the data that we have, both safety and efficacy on BT5528. Plus, actually, we'll present an interesting analysis for neuropathy, actually comparing our data from BT5528 and from Zeli, because it's kind of very similar, and it reflects on our platform. Bicycles not tend to not have the liabilities that antibodies ADCs have, and it's replicated at least twice with our two bicycles. So we have two posters, one in BT5528 and the other on neuropathy with BT8009 and BT5528. And just one last question on this program: Do you think investors are giving you a high probability of success? Are you getting a lot of questions? What do you think consensus is on this program? Alethea? No, it's not in our valuation. It should be, but I mean, you know, I think people focus on 8009, and I think as we continue to show data on 5528 clinically and we talk about the path forward, it'll get its appropriate value at that time. Okay, that's helpful. And then following up, Alethia, in regards to Bicycle's balance sheet, you're in a strong cash position. In May, you had PIPE financing of $550 million. How should we think about capital allocation? How are you gonna use these resources? Total cash right now is close to $1 billion. Absolutely, it's $555 million. I know, small $5 million difference. And we're at over $900 million right now on the balance sheet. And you know how we should think about it, it's perpetuating the platform that Kevin has talked about. You know, obviously, the focus that we'll have with BTCs, the focus we'll have with BRCs, you know, we'll continue to look at different ways to prosecute immunology as well, but obviously deprioritize. And so I don't know if your next question is gonna be catalyst for the year, but you can ask that. But I think also, you know, it's really a focus on that we are in a very unique position when you look across small mid-cap biotech right now, that we have cash for years to come, and we have cash to do all the things we wanna do, plus potentially more if things should see fit, right? And so I think, you know, we're in the very fortunate situation, kinda looking at where this market is right now, to be incredibly well capitalized, right? Which makes the catalyst and things that are coming down our pathway, hopefully real catalyst, because we don't need to raise capital right now. And yes, your current cash position, $961 million, expected to provide a runway into the second half of 2027. We could talk about the near-term catalyst, but overall, what do you expect this runway to be able to fund? Well- I mean, Duravelo-2, radiopharm. Yeah, I mean, it's gonna fund everything related to BT8009, related to bladder, outside of bladder, hopefully. Obviously, things that we're planning on doing with Radiopharm, if we are successful, as we have the upcoming data readouts, right? I mean, you know, it's that cushion, but beyond, right? I mean, it's a platform that can go many different ways. We didn't speak once about anything outside of oncology, right? So I mean, and we haven't talked a lot about other things we're doing. We were talking about BT5528 a little bit. Obviously, we have plans there, hopefully over the future. So I mean, it really is to fund, you know, when you look three or four years out, a company that has incredible amounts of optionality. One large shot on goal with Duravelo-2, of course, in bladder, but also many other shots on goal across leveraging the platform to its fullest. Great. In regards to near-term catalysts, we have ESMO, we have the investigator-initiated study, the imaging study, and then 8009 updates in other tumor types. Could you give us a sense of what you think the most- Yeah ... exciting updates are and what we should really keep an eye on? I mean, I'll just give you a sense of the update. So obviously, we've talked about ESMO, and we have four posters there, so that's obviously on September fourteenth, I believe. That's a Saturday. Then, you know, what we'll also be hoping to do in the relatively near future, which is in line with our guidance, is talk about initial human imaging data for MT1-MMP in radiopharm, which obviously is interesting, because it's a novel tumor antigen target beyond SSTR and PSMA. So that'll be our first evidence there. And, you know, we'll be able to talk a little bit more about how we're thinking about that business overall, if the data indeed looks supportive and positive. We've talked about later on in the year, a lot of people talk about this cohort, is that we have a BT8009 Zele and Pembrolizumab cohort and a small group, around 20 people or so. Hopefully, we'll have some efficacy information for that later this year. I think, you know, that's obviously get the focus because some people will make a read to whatever the competitors were. And hopefully later in the year, we'll also have some data as it relates to beyond bladder, right? Which is a big narrative for us with Zele. I mean, I think we've seen with Nectin-4 itself, that there's the storyline is only beginning with bladder. There's much more to come in the storyline. And so, you know, there's that around the year. Everything that we've disclosed for the last quarter is on track to happen. So obviously, we've always focused on the first half of the year about execution, and the second half of the year, very much about many different readouts that will help progress the platform. Great. I guess we have a minute left. Anything else you'd like to highlight, you think investors are missing? We touched on it briefly, but it seems as though BT8009 is taking a lot of the headlines, but there's a lot of other programs maturing, accelerating in the pipeline. Anything else you'd like to call out? I mean, I think what we're doing in oncology speaks for itself. And what I think this funding that we were fortunate enough to obtain in the summer gives us the chance over the next couple of years to transform the company in investors' eyes from being an 8009 bladder company to being an oncology company with multiple shots on goal, and I feel very confident we're going to be able to do that. You know, the other, again, Alethia touched on this, but we're more than oncology. Some of what we do outside of oncology is often in collaboration. And I think, you know, I would, you know, recognize the phenomenal work done by one of our collaborators, Ionis, looking at our TFR1 binders and delivery of antisense. The work that they're doing is phenomenal. We're, you know, we're collaborating very well with them, and I just, you know, you want initial validation, additional validation on the platform. I'd go and look at some of their narrative because I think it speaks very, very well of the potential of the technology. Great. Well, thank you very much. Really appreciated the productive conversation. Thank you. Great, thank you. Thank you. Thanks.