Okay. Great. Welcome to our next session. I am very pleased to have, my name is Asad Haider. I'm the U.S. Pharma Analyst here at Goldman Sachs, and I'm very pleased to have the management team of NewAmsterdam with us. Michael, thank you for being with us. Welcome. Thank you, Asad. Great to be here. Let's, I know we're just a little bit over time, so let's dive right into it. Michael, maybe just start by laying out the overall market opportunity that NewAmsterdam is addressing, and why is now a good time for a new mechanism in LDL lowering class? Like, why is now a good time to be looking at that? I think a lot of things have transpired over the past roughly 15 years in the lipid world. In 2013, the guidelines shifted away from goals to just using statins, high-intensity statins. Then came a number of studies that were showing that the more you lower LDL on top of statins, the better. The guidelines first got revised in 2018, and then again in 2022 to recommend a 55 LDL target for high-risk patients. Ever since then, and there are even more follow-up guidelines that are now in process. The market itself has moved more towards a lower is better again approach. We are back now, if you look at the unmet need and the number to treat, we are back to where we were in the statin early days. You know, the statin early days was good LDL below 100, and we had a lot of people that went on statins, and it was very successful. We saw a decline in heart disease. Unfortunately, since 2013, that decline not only did not stop, but it started going up again. In hindsight, may have, may have been a, it was, it was all evidence-based. We did not have the data. Now we have the data. Getting LDL below 55 is the new kind of target. Ever since then, we have seen the market grow dramatically. Branded drugs like Repatha growing 40%, even generic ezetimibe growing 20%. We believe that an oral well-tolerated drug like ezetimibe, like obicetrapib alone or with ezetimibe, lower LDL from 35%-50% is all patients need to get the majority of people to goal now. That's just the LDL aspect. The other exciting things about obicetrapib, of course, is it's an LDL plus drug. It has other things that help reduce risk beyond just the LDL lowering benefit. I guess I remember, Michael, you know, some fairly high-profile failures in the CETP class. I mean, I remember when torcetrapib happened, and I believe that was subsequently followed by about three others at least. You know, just given these failures, just maybe explain to us why it's different this time. It's really important to know the history. You know, I'm a cardiologist, lipidologist, been involved in the field from the very beginning, the first one to patent CETP inhibition back in the nineties. For me, it's something I know very well and been involved with. It's important to know why the other four failed and why our drug is different. That's been the thesis behind the company from the very earliest day. We're about five years old now as a company. We got obicetrapib back from Amgen. The key is that, you know, the first one, torcetrapib, was an off-target toxicity. It raised the blood pressure, but that was really the tip of the iceberg. It raised aldosterone and steroidogenesis, had this very prominent off-target effect and had a, increased mortality in phase III. The other three since then have been very safe, actually. Mm-hmm. The difference here is that they all were studied for their HDL raising properties. They designed the studies accordingly. They were designed, first, the first one, dalcetrapib, was just a weak CETP inhibitor, did not lower LDL at all, again, very safe and had other attributes about HDL raising that we've actually are developing for obicetrapib, like the diabetes protection, but no MACE benefit. They did not lower LDL at all. Then Lilly designed a study for HDL raising, but the LDL lowering benefit was, again, modest, and they only had a two-year follow-up period, which is way too short for an LDL lowering benefit to be achieved. Then came Merck, and Merck, to its credit, and we wouldn't be here without the Merck REVEAL trial because they decided if we're gonna look at HDL raising, that's the prominent benefit, but just in case, we're also gonna power the study and go long enough to look at LDL lowering. They set it up though with an HDL raising focus. The baseline LDL was only 60, which is very low. They lowered LDL by 11, 17%, 11 mg per deciliter. They got a benefit that was statistically significant based on LDL lowering. In fact, in the upper tertile, which is the 10,000 patients, LDLs in the seventies and higher, they had a 17% relative risk reduction. If they would've just did the study in that upper tertile, they would've shown the benefit. They may have well launched the drug, but the other issue with that drug was that it had a diff, it had absorption in fat tissue that would not stop accumulating. Merck decided not to file. Yeah. Knowing all this, John Kastelein and I, the co-founders, knowing the drug, knowing the failures, knowing why they failed, knowing a drug now that has, you know, much more effective CETP inhibition, better at lowering LDL, better raising HDL, better lowering LDL, better potentially reducing diabetes. Now, of course, we've been working on this for several years, the Alzheimer's benefit, 'cause HDL raising in Alzheimer's have a very exciting science behind it, which I can get into if you want. It's something that we've always thought as an important element about this class, that especially obicetrapib. It's very potent, 10 mg, and very, very knocks down CETP by 97%. Knowing all the background of why they fail, we designed a drug, a trial program based on focusing on LDL that now put the drug in the right position to be successful for approval for baseline LDL lowering. I wanna maybe just, you know, stay with a little bit of a big picture question, and then I wanna drill into some of your own programs here. You know, it's encouraging to see that after some period of dormancy, there does seem to be a little bit of a renaissance in cardiovascular, you know, sort of trials and new things getting tested. Obviously, you've got you guys, but then you've also got Merck and AstraZeneca with their pretty, you know, with their oral PCSK9 programs, and then you've got the Lp(a) class that Novartis and Amgen are going after. Maybe, you know, in the context of that broader landscape, you know, talk about your positioning, with, you know, in that backdrop. Sure. How, where do you see the differentiation? Yeah. The thing is, I think we have a really good, convincing place to be for the vast majority of patients because it lowers LDL 35%-50%. In combination with ezetimibe, the combo, a very small little combo pill. Also, first of all, our drug is exceptionally well tolerated, and had adverse events comparable to placebo. We have really well tolerated medication that you can take and not worry about side effects. That makes it very appealing to a primary care where most of these drugs are likely to be prescribed. What the drug does provide though is that, when you think about where the drug fits in for other reasons, the LDL lowering of 40%-50% falls exactly in the, they're not gonna qualify for an injectable. The Lp(a) is skewed. About 50% have high Lp(a) in the high-risk population. Only 10% have Lp(a) levels that are being earmarked for the injectable drug. The 40% of patients that have high Lp(a) but do not qualify for the injectable, that is where obicetrapib works the best. For all those other patients, the majority of patients that have high Lp(a), they are gonna go to obicetrapib. They will not qualify for the injectables. If they have primary prevention, they will not qualify for the injectables either. The majority of patients with high Lp(a) would be well suited with obicetrapib as your first line approach in combination with LDL lowering. The PCSK9 inhibitors, they are, again, great drugs. They are, you know, they are projected to be in that $4 billion-$5 billion range. The Merck one, which is the first, is an oral peptide. So it's like RYBELSUS. It's challenging in that it requires taking it after eight hours of fasting, not within 30 minutes of any other pill, which for a heart disease patient, the challenging dosing regimen. They're on all these other drugs. You know, we don't like, like I said, I don't, I don't like to prescribe RYBELSUS that often for that very reason. You gotta watch all the other drugs that they're taking and so forth. It lowers LDL roughly, you would see they, Merck announced today their phase III data. They didn't give us that. They did not give us the results, but it assumes 50%, which is what the injectables are. It is still not any different from our combo with ezetimibe. We have 50%. It does not have the plus part. It does not have the Lp(a) lowering as well as ours. It does not have the diabetes benefit. Now we have these Alzheimer's, exciting Alzheimer's benefit that is going to be for patients, they are going to want to take our drug for those reasons. It is not because once you, when you have a patient in your office trying to convince them to take a drug, they want those other benefits that in some ways are much more motivating, preventing diabetes, lowering Lp(a), preventing Alzheimer's disease. Those all become, you know, very strong rationale for a patient to take a drug like this. That's a perfect segue into, you know, my next set of questions, which is really around your own programs and maybe, you know, sort of drilling into those a little bit further. You have data from three phase III trials, BROOKLYN, BROADWAY, and TANDEM. I guess, love the names, by the way. Yeah. What were the, you know, I guess maybe, you know, the takeaways from each? What were the primary endpoints? And importantly, what have you discussed with the FDA regarding requirements for approval? Maybe. Right. The first one, BROOKLYN, was a similar hypercholesterolemia trial. Those have very high LDLs. Everyone in all trials is on background high-intensity statins predominantly, and any other drug that they could take, that might even be PCSK9 inhibitors. That lowered LDL in that 36%-41% range compared to placebo. The next one, BROADWAY, is a much larger, mostly heart disease population, lowered LDL in that, again, 33-36% LDL lowering, and TANDEM, very similar on LDL lowering, but also had the 50% in combination with ezetimibe. Those are all kind of high-risk patient populations. For an LDL lowering NDA, we meet all the criteria. We have 1,500 patient years of safety. We meet the LDL thresholds, of course, safe and well tolerated. The FDA made us do a dedicated blood pressure trial, which is completely normal, which is very safe. We have all the elements of a filing for LDL in place. However, the FDA has been clear from the very beginning, they want to see the outcome study during the review period. We are timing that so that during the review period, the outcome study reads out, which is now not to the end of 2026. Mm-hmm. By the time you've, you know, kind of do all the paperwork, you're probably a little bit in early 2027. We're in that filing period where that outcome study can be provided to the FDA during the period for review. Then we fall back with the MACE indication later. I guess on the MACE indication, maybe just discuss the exploratory, you know, MACE endpoint. How does that compare with standard of care and how should we think about, you know, that reading through to the, to PREVAIL? Yeah. BROADWAY saw 21% MACE benefit, which was a four-point MACE of CHD death, non-fatal MI, total revascularization, and stroke. That's a pretty standard, you know, four-point MACE. Yeah. We are going to announce this on R&D day, what we're officially gonna do, but you can see that we'll carry over to PREVAIL. What's great about BROADWAY, it's a very similar patient population, obviously the same dose of drug, the same background medications in PREVAIL. Actually, when we look at it even closer, it's even more of the type of patients that respond better to obicetrapib based on all our analysis. We feel that BROADWAY really de-risked PREVAIL quite a bit. We're going to talk more about that at R&D day on Wednesday, that this is a really strong confidence builder that PREVAIL will read out appropriately. We're right on track time-wise, timelines, and also all our quality metrics look great. I mean, drop in, drop out, concomitant med drop-ins all look really good on, on PREVAIL. I guess, you know, on, you know, one question that I have is, you know, what might drive a patient to receive monotherapy versus combination with ezetimibe? I mean, you know, and what are you gonna be more focused on commercially? You know, it's something we're doing a lot of work on, and I think there will be doctors that will wanna provide the combo predominantly. We're also developing our own identity for the combo pill. It has its own identity 'cause it does show synergy, not just additivity. We're doing an imaging study called REMBRANDT where we're looking at non-calcified plaque volume over 18 months versus placebo versus the combo tablet. That study will read out about the same time as the PREVAIL study. Mm-hmm. We'll have a, and we'll launch with both the outcome study PREVAIL and the REMBRANDT trial, in promotion. We have, so the combo pill, I think depends on what audience you're talking to, is going to probably be the dominant of the two. I mean, it's still the monotherapy. Some people just like monotherapy, don't like combo pills. In this situation, it's an exceptionally good combination 'cause they work very well together and they augment each other when it comes to efficacy. Maybe on, and we have good data again, we'll share that at R&D day where the anti-aphotic effect is actually also augmented with both drugs together. I guess regarding the safety profile, do you have enough data to be validating for such a large indication? Yes. Yeah. 1,500 patient. Yes. What are the tail risks that could emerge in a larger population? You know, we're through our eighth DSMB meeting. I mean, we're well, you know, we only have, you know, roughly 18 months to go and it's, you know, well over, you know, we're probably approaching the 10,000-20,000 patient mark now of years of safety. And DSMB has been a very quick meeting. I thought I could say it's a very rapid, you're fine, move on type of analysis. Yes. We've been through eight DSMBs so far. Yeah. Wow. So. Let's maybe pivot to, are there any questions from the audience? I can take a pause there. Maybe Michael, we can pivot to the financial position and just, you know, maybe talk to us about the current financial position on the runway and, you know, what that gets you in terms of launches and further trial readouts. Yeah. We're over $800 million in cash. We've reported that. We're in a very, very strong position as a biotech company. We have put in place an exceptionally good launch team, BJ Jones, who launched Nurtec. A lot of his former colleagues are now with us, and we have MSLs deployed in the field who are very experienced. We're developing the pre-launch commercial messaging and so forth to the medical community. We're gearing up and we have enough capital now to take us all the way through to launch. I mean, we feel we're well financed and, again, BJ will share more of this on Wednesday, but he's extremely bullish on our market research where we are. Mm-hmm. As a company with this drug. I guess from a, from a commercial perspective, where are you in building out the infrastructure to build out a larger broad patient population? We're gonna do this in a structured way. Again, we wanna, we're waiting for the, just to know, you know, when the regulatory filings are gonna sync up. We have the team in place. When we gear up, it'll be based on knowing more and more about the timing of the launch. Exactly. In Europe, I guess you have a partner. Do you anticipate a, you know, maybe talk through sort of, you know, how that came about? Do you anticipate a BD partnership in the U.S. as well? We have a very good partner in Europe, Menarini. They came at a really important time for the company. They gave us a large upfront payment that helped us catalyze our SPAC PIPE, which was, of course, out of favor at the time. I think we had the best one of the entire three or four years that went really well. I think that helped us bring in the cash balance sheet that we needed to get all the way through phase III. Plus we have really good economics with that. We have not disclosed it, but we feel good about the economics. Mm-hmm. Of royalties and milestones, from our European partner. They're well known in the cardiovascular space. For Europe, for Japan and China, we have full rights. They've already done all the work. They're also ready to be filed in those geographies as well. We're holding onto those for a potential larger partnership. We will explore all options for that. I can only say that we feel really good about our go alone plan. We feel we have the right team, we have enough cash. These partnerships have pluses and minuses. We want to just make sure we're doing all the right things for the shareholders to get the most value. Right now, we see ourselves as being, you know, very, very, a low valuation. Mm-hmm. We want to, you know, build value. The more we can hold on to everything, the more value we can create with successful execution of all aspects of the company. That is where our focus is, on that go alone approach, knowing that there are a lot of companies out there that have big gaps in their pipeline where. Mm-hmm. A drug like this could be a very attractive target. Mm-hmm. You're not ruling it out. Not ruling it out. No. Got it. You know, we've gotten this far and we haven't touched on the external operating environment as well at all. I feel like compelled to ask you, how are you thinking about the, you know, things like MFN drug pricing policy dynamics that are currently being discussed? It's been a big theme through this whole conference. How might that play out specifically with your European partner? Yeah. I think it's an interesting question 'cause we, the answer is we don't, no one knows for sure, you know, how that's gonna play out. In our situation, it may be to our advantage not to have the rights in Europe ourselves. Mm-hmm. 'Cause it's, it's a third party. We don't have control over pricing there. We can't provide most favored nation status when we don't have the right. We're not, we're not selling it in that, in that area. For us, it might be an advantage. Again, it's too soon to tell what that might mean. We feel that we'll have to wait and see basically on that issue. Okay. Let's maybe just talk about the catalyst path from here. You've got the R&D day this Wednesday that you touched on briefly through this conversation. Maybe just give us a little bit more high level on what we should be expecting on that day from you guys. Then beyond that, what are the next events that investors should be keeping their eye on? Yeah. We've had a lot of data presented in our, we got published New England Journal of Medicine, Lancet. We had a high level, we have more data to present, you know, from BROADWAY in particular on the MACE benefit, trying to get, again, showing the relationship between the MACE benefit and what may have led to that unexpected upside benefit and how that translates into the PREVAIL study. That will be a big focus of our R&D discussion. I already alluded to the, you know, some of the other key data that we have on atherosclerosis and regression and preclinical models, how that de-risked the REMBRANDT study. You know, BJ is ready to go out with, again, more and more information about why he's so bullish on our opportunity here with obicetrapib. Then we will present, you know, a little bit more color on the Alzheimer's day, although we are limited by what we can say with the outcome, with that data being presented in July 30th at the AAIC. What can you say about it? I'm intrigued. What we wanna say is, first of all, we're very excited about it. I believe it's a game changer. The AAIC put a presence out today saying they're excited about it. It's a game changer, they're very excited about it. We feel what we wanna focus more on is, you know, what this could mean for patients that have risks for Alzheimer's and what, how big an APOE4 subgroup is, 25% of the population. A lot of them have ASCVD and high LDL. In many sense, again, it becomes another reason why to pick obicetrapib over anything else to have this type of data. Then of course we'll follow up, once we have that presentation on what our next steps might be, you know, for this very important unmet medical need. I guess beyond the R&D day, what else is coming up that? July 30th is the presentation. Okay. Okay. At the AAIC meeting. Yeah. We do have. I meant even broadly for the company, not just Alzheimer's. Oh, yeah. We have the filing in Europe. Okay. The second half of this year, we have a Vincent study, which is looking at the Lp(a) combination of obicetrapib with PCSK9. Mm-hmm. More to kind of set the stage for a potential combination of the two. We have again our completion of PREVAIL at the end of 2026. Mm-hmm. The filing timelines on that, you know, for the company. A lot in the next 18 months. Yes. Question from the audience, Nick. We haven't decided officially yet, but we are gonna go meet with the FDA. We also have PREVAIL. PREVAIL's a much larger trial. I think, without saying too much, the data is gonna really speak strongly about where obicetrapib can potentially play a role in the prevention of Alzheimer's disease. We just have a couple of minutes left. Michael, what else have we not talked about that you'd like to take this opportunity to talk about? I think, getting back to one of your questions about the landscape, you know, the Lp(a) and the oral PCSK9s and GLP-1s and so forth. What I, what I think people don't appreciate about obicetrapib is not just its great clinical features and well tolerated, safe, is that it, it, we can combine with a lot of other drugs. Mm-hmm. With the IRA out there now, we become a very attractive com. It's a very tiny little size of a, of a baby aspirin. That would be another added value that we have to work with collaborations with partners and so forth. I think the other, I'm sorry, are you suggesting you could combine with the oral PCSK9? Yeah. Or, and that's what you're suggesting. Yeah. Or, or GLP-1. Potentially the GLP-1. Right. Exactly. We're looking at all that. That's how we're looking at the drug. Look at combinations with other drugs. Yeah. That we think could be very attractive commercially as well. The pipeline and appeal story about, about obicetrapib. And, and so then, the other thing I think is just a very important message. Again, I'm speaking as a clinician who sees patients that, you know, the LDL lowering part is great and it's effective. But when a patient wants to take a drug, they want some other compelling reasons to do it. And obicetrapib really addresses that, those other compelling reasons. Lp(a), everyone's, they all, they know they, if they have Lp(a), they know they have, then there's nothing they can do about it from a lifestyle perspective. And statins make it worse, actually. Diabetes, statins make it worse. Alzheimer's, statins don't help. We know that from a study. You think about, you know, what obicetrapib can do, either alone or in combination with statins, it addresses all the liabilities or limitations of statins in a very effective way. It becomes really your go-to therapy, more than anything else out there. Mm-hmm. for treating patients. Mm-hmm. Fascinating. Fascinating story. Thank you very much, Michael. Appreciate your being here with us. With that, we can probably wrap up. Thank you. Thank you very much. Thank you very much.