Welcome back to the 45th Annual TD Cowen Healthcare Conference. We're really happy to have with us for the next session, a team from Elevation Oncology. We're going to start off with about 20 minutes of presentation to provide an overview. It's going to be done by Joe Ferra, the CEO. I'll be back for about 10 minutes of Q&A with maybe some more detailed questions beyond the presentation. I'll hand it over to Joe now. Interested to hear the story. Thank you, Marc. I appreciate it. Thank you for all of you joining. Thank you to you and the entire Cowen team for hosting us and for giving us an opportunity to talk more about what we're doing at Elevation Oncology. As Marc said, I'm going to start through some slides and give you an overview of the company. During the presentation, I will be making some forward-looking statements. For a complete review of our risk factors, I welcome you to visit our website, as well as look at our filings with the SEC. At Elevation, we are leveraging the amazing advancements in ADC technologies and our expertise with antibody-drug conjugates to develop a pipeline of differentiated ADCs, which have potential best-in-class opportunity in addressing unmet needs in oncology. Our most advanced program, EO-3021, is a Claudin 18.2 antibody-drug conjugate. We reported initial data from the clinic for that program in August of last year, which supported, among many other things, that we have a robust competitive anti-tumor activity and a safety profile that is differentiated relative to other Claudin 18.2 ADCs. We are leveraging that in our clinical development of the program going forward across a range of gastric GEJ cancer in lines of therapy. Our second program, which is most recently named, is EO-1022, which is a HER3 ADC. Again, there, we think the latest advancements in ADC technology are going to give us and others an opportunity to resurrect prior targets that were not utilized effectively with older technologies. We think HER3 is going to be a target that we know is relevant in a range of tumors that an ADC approach like 1022 is going to have an opportunity for outsized outcomes that are better than current standards of care. Claudin 18.2 is a target that is known to be effective in a range of solid tumors. We, as a company, made the strategic decision early on to focus on gastric GEJ cancer, primarily because of the significant amount of unmet needs in gastric GEJ across lines of therapy. As I mentioned, last year, we reported initial data from the monotherapy approach for 3021. We have said that we are going to have additional data in the first half of 2025, so relatively soon. On the heels of that data last year, we, as I mentioned, think it's important to leverage the differentiation of our program and moving into combination approaches, both in second-line and first-line gastric cancer. In the first line, we are combining 3021 with dostarlimab, which is GSK's PD-1 inhibitor. We have a clinical supply agreement with GSK moving forward with their help in terms of enrolling patients in that combination in first-line gastric cancer. In second-line gastric GEJ cancer, we have an agreement with Eli Lilly, where they're supplying ramucirumab, which is part of the current standard of care in second-line gastric cancer, in evaluating that combination, where we think there's an opportunity for a new standard of care in second-line gastric GEJ cancer. We started enrolling patients in those combinations earlier this year. We said initial data from the combination approach is going to be in the fourth quarter of this year/first quarter of 2026. We also have 1022, as I mentioned. We've said that for 1022, which was recently named as a preclinical program, we're going to have some preclinical data also in the first half of 2025, and that we are going to expect to move 1022 into IND in 2026. Focusing for now on 3021 and the opportunity in gastric GEJ cancer. As I mentioned, the data that we reported last August supported many things about 3021 as a Claudin 18.2 ADC, but in particular, showed that our differentiated safety profile gives us an opportunity to be the more combinable Claudin 18.2 ADC. As we thought about the go-forward clinical development plan for 3021, we think the best opportunity to both address unmet needs, but to also leverage that uniqueness, was to focus on second-line gastric cancer and first-line gastric cancer. As I mentioned, the combinations respectively of ramucirumab and dostarlimab in both of those lines of therapy. Our approach between the two is slightly different in that in second-line gastric cancer, the current standard of care is ramucirumab plus paclitaxel. Paclitaxel, of course, being a broad chemotherapeutic, we see an opportunity for replacing that paclitaxel in the standard RAMPAC combo with a targeted cytotoxic like 3021 for improved overall outcomes and also replacing that toxic chemotherapy for an overall better profile for a potential new standard of care in second-line gastric cancer. In first-line gastric cancer, the initial combination we are looking at is 3021 plus dostarlimab. Again, because of the uniqueness of our safety profile, where we saw no peripheral neuropathy or neutropenia and limited liver and heme tox in the data that we reported in August, we have an opportunity in first-line gastric cancer of thinking about layering chemotherapy down the line in a way that no other Claudin 18.2 ADC can really think about because their early data, their data suggests that they have toxicities that will be challenging for them when they think about combining with PD-1 inhibitors and also combining with chemo. The market opportunity in both second-line and first-line gastric cancer is reflective of that unmet need that I mentioned. In second-line, about a $1 billion opportunity when you think about it at the cutoff that we're talking about for a Claudin 18.2 ADC, which I'll talk more about. As I said, RAM plus PAC is the current standard of care. 28% response rate is what's expected based on some of the later-stage trials that ramucirumab and paclitaxel did in the RAINBOW study. It leaves a lot of opportunity for improving upon that profile for a new standard of care when we think about 3021 plus ramucirumab. In the first line, of course, the unmet need in metastatic gastric GEJ cancer, of course, is reflective of the fact that while PD-1 and chemo is the current standard of care, it leaves a lot of room for improvement. You've all probably have seen that Astellas recently had their first approved Claudin 18.2 naked monoclonal antibody, which is incredibly important for the field as we think it's rising tide lifts all boats in recognizing that Claudin 18.2 is a target that's increasingly going to be important in gastric and GEJ cancer. Even with the approval of Astellas' program, we think there continues to be a meaningful amount of opportunity for improving upon current standards of care, even as the first line continues to evolve for the better for the benefit of patients. Back to 3021 specifically. When we in-licensed rights to 3021 from CSPC, a Chinese company, our main focus of the program was that utilizing its glutamine site-specific conjugation was unique and gives us an opportunity for maximizing the overall profile of the program while minimizing payload-associated toxicities. As I mentioned, our payload for 3021 is MMAE. MMAE has been around as a payload for a while. It is well characterized and well known that MMAE, with more traditional conjugation ADC techniques, leads to meaningful amounts of peripheral neuropathy, neutropenia, and other payload-associated toxicities, which certainly can be manageable in oncology when you think about oncology drugs, but leaves a lot of opportunity for thinking upon improving on that. That is what set us towards the road of looking at site-specific conjugation for a more stable ADC construct and an opportunity for improving upon that overall profile with a payload that we know has a legacy and a history of being safe and effective at killing cancer cells. Based on the data that we shared last August, it supported exactly that. We had competitive anti-tumor activity, minimal payload-associated toxicities. There was no evidence of neutropenia or peripheral neuropathy, two very well characterized and well-known MMAE-associated toxicities, and other limited toxicities that would be overlapping with other standard of care agents. All of that wraps up to, as what I said already, puts us in the position to be the more combinable Claudin 18.2 ADC in addressing earlier lines of treatment in gastric GEJ cancer, where combination, as often is the case in early lines in oncology, is going to be most key. In our go-forward development of 3021, as I mentioned, in the phase one study, we are currently in the expansion portion of phase one in monotherapy. As I mentioned, we had initial data from the escalation portion of the phase one last year in August. We also announced that we moved into the expansion portion in monotherapy, focusing on two specific doses, 2 mg per kg and 2.5 mg per kg. As I also mentioned, earlier this year, we announced that we started enrolling patients in the combination approaches for 3021 with ramucirumab and with dostarlimab. The data last August showed a 42.8% overall response rate as we thought about the response in patients in gastric GEJ cancer based on a Claudin 18.2 cutoff of 20% 2 plus 3 plus. The cutoff here is especially important because we and others in the field are learning about Claudin 18.2 expression in real time as we continue to understand how the target is evolving and also understanding how we can ensure that we're focusing on those patients that are more likely to respond to a Claudin 18.2 ADC. At a cutoff of 20% 2 plus 3 plus based on IHC, we saw the overall response rate of 42.8%. On the opposite side of the coin, when you think about patients who had an expression level below that 20% 2 plus 3 plus cutoff, we had a 0% overall response rate. Supporting what we've seen from other programs is that a minimal amount of Claudin 18.2 expression is needed to ensure that we are focusing on those patients that are more likely to respond to a Claudin 18.2 ADC, such as 3021. Now, expression is an important part of this picture. We and others who are developing an ADC, part of the overall approach has always been that an ADC will give an opportunity to treat a broader range of Claudin 18.2 expression. As I mentioned, Astellas' program is a naked monoclonal antibody. They are approved, thankfully, for patients. They are focused on the highest expressors of Claudin 18.2 at a cutoff of 75% 2 plus 3 plus. We are focusing when we talked about the efficacy analysis of the data in August at a cutoff of 20% 2 plus 3 plus. This is in line with what some of the other ADCs have done and continues to support that an ADC approach is an opportunity to treat a broader range of expression in gastric GEJ cancer. We have also moved towards, now that we and others understand that more, we have also moved towards prospective enrollment criteria as we think about the expansion portion of the phase one and as we continue to execute on the monotherapy approach. We implemented a prospective cutoff of 25% 1 plus 2 plus 3 plus, a broader cutoff for enrollment criteria while we continue to evaluate how to hone in on those patients that are most likely to respond to a Claudin 18.2 ADC like 3021. This is certainly in line with what other programs have done, having a broader cutoff for enrollment criteria, but continuing to look at the efficacy in a more stringent cutoff, especially as we all have an eye towards registration studies and what the ultimate cutoff needs to be or should be as we think about a registration study that's going to focus on those patients that are most likely to respond to 3021. Think about the data that we shared in August from a safety perspective. 3021 was generally well tolerated. What you see here is important, but also what you see here probably is the most important. What you don't see here is the most important takeaway. As I mentioned, no evidence of peripheral neuropathy or neutropenia in the data that we reported in August and limited heme and liver tox, which is meaningfully different than all the other Claudin 18.2 ADCs that are reported clinical data. Nausea continues to be the most relevant AE that's driven by on-target, off-tumor toxicity. Claudin 18.2 as a target is known to be in normal tissue, is known to be expressed in the gastric mucosa. You are seeing from all of the programs that nausea is a common Claudin 18.2 related AE, one that is very well known, well characterized, and certainly one that is manageable from a clinical standpoint. The absence of that peripheral neuropathy and the neutropenia gives us an opportunity to think about combining 3021 in ways that no other program, no other Claudin 18.2 ADC has. That is what this slide speaks to. Comparing those payload-associated toxicities with two of the most advanced programs, AstraZeneca's program and also Innovent's Claudin 18.2 ADC, you see that they are seeing evidence of neutropenia, peripheral neuropathy, increased liver and heme tox, which in some cases can be up to 20% grade 3 in the case of neutropenia. Again, certainly manageable from an oncology drug standpoint. From our perspective, we have seen no evidence of those in the data so far and it gives us an opportunity of combining 3021 in ways that they will be limited by. That is why we are focusing the development on 3021 towards combination approaches in earlier lines of therapy to both leverage where the unmet need is highest and also leveraging the uniqueness of our program in a way that gives us an opportunity to win. Moving to 1022. As I mentioned in the beginning, 1022 is our recently named HER3 antibody-drug conjugate. HER3 is a target that we as a company know well. As I mentioned, a target that we think an ADC approach using the latest in technology is going to give us an opportunity for using the target across a range of solid tumors. 1022 is also utilizing site-specific conjugation, in this case, glycan site-specific conjugation, also with an MMAE payload. We see an opportunity here for addressing 1022 in a range of solid tumors. HER3 is known to be expressed in breast cancer, non-small lung cancer, pancreatic cancer. We see an opportunity for 1022 across a range of solid tumors, both leveraging the uniqueness of the site-specific conjugation and also leveraging the opportunity for MMAE as a payload in ways that just with prior ADC technologies would be limiting. We have preclinical data that we are going to share in the first half of this year, first half of 2025. As I mentioned, we plan to move it into IND in 2026. Last year was an exciting year for us sharing our initial clinical data from 3021. 2025 is an increasingly important year as we show more data for 3021, both in monotherapy and in combination. Just to recap, we said they were going to have additional data from the monotherapy portion of the trial in the first half of 2025, likely at a medical meeting, and then the initial data from the combination approaches for 3021 later this year, first quarter of 2026. For 1022, we're going to have preclinical data in the first half of this year as we move it towards IND in 2026. As of September of last year, we have $103 million cash on the balance sheet and are very fortunate to have runway into 2026 as we can continue to execute on our pipeline and have the resources that we need to invest in programs that are clearly making a difference for patients. We look forward to telling you more as 2025 evolves. Okay. Thanks for that, Joe. Maybe we'll do Q&A now. To start off with, you mentioned the update coming in the first half of the year from 3021. Sure. Just in terms of the expansion cohorts, describe the kind of scope of that update. One, maybe the size of the expansion cohorts as they're designed, but then importantly for the update is how much of that work will have been completed versus kind of what's still going to be a work in progress. Yep, yep. Right as I said, we reported initial data from the phase one escalation portion of 3021 as monotherapy last year. We also announced at that point in time that we moved into the expansion portion, looking at two and two and a half mgs per kg as the go-forward doses. In the update that's upcoming in the first half of 2025, we plan to share additional data from those patients in the escalation portion, more time, more follow-up, as well as having patients from the expansion portion, which of course have been enrolled since then. We expect the data update to include about 35 biomarker-positive patients and approximately a median follow-up time of approximately six months. Is that 35 including the escalation patients, or is that 35 from the expansion? That would include all the patients, escalation and expansion. I guess you touched on it a little bit in the presentation, just the latest thoughts on kind of what good data looks like there. Maybe we'll start with the efficacy side and then we can move to the safety side. Yeah. Taken in two buckets. First of all, thinking about current standard of care, we, like many other phase one trials, of course, the patients that we're enrolling in a phase one trial tend to be later lines of therapy. And in gastric GEJ cancer, when you think about it in terms of lines of therapy, third line and later, the opportunity is very bleak. Usually, the options available are single-agent chemotherapy with single-digit response rates. All of the Claudin 18.2 ADCs, including 3021, have reported efficacy in the 30-40% range in later lines of patients, which is a game changer for third line and later patients. You also have to put that in context with, as I mentioned, with second line gastric current standard care, RAM plus PAC, known to have a 28% overall response rate. We have always said for the program for 3021, anything in later line patients of 30% or greater is incredibly meaningful for gastric GEJ cancer. Obviously, 3021 in the data that we shared in August had a 42.8% response rate, but we think anything in the 30-40% range from a response rate perspective in monotherapy is incredibly meaningful and incredibly supportive of continuing to think about how we can even improve upon that in earlier lines of therapy in combination. Yeah. Okay. And then on the safety side, I guess obviously the safety has looked good so far, but how much of some of these payload toxicities and things are acceptable, particularly when one is a monotherapy for that late line patient, but then I think at least as important is when you start thinking about the combinations. Right. The combination is certainly the key. I think while, for example, in some of the later stage programs like us, the more advanced like AstraZeneca, the toxicity profile is certainly manageable, right? Neutropenia, peripheral neuropathy, increased liver and heme tox, clinicians know how to manage those. While they're not optimal, it's part of the name of the game in oncology. We see the opportunity because we don't have evidence of those toxicities in combination. It's certainly going to limit their ability to think about combinations. We have an opportunity to think about combinations in a way that's going to be challenging for them. That's where it's really going to make a difference for 3021 relative to some of the other programs. Yeah. Okay. Before we fully get into the combo, just again, you touched on it a little bit in the presentation, but just the definition of what is a Claudin 18.2 positive patient. As I think typical for these types of targets, it is always a bit of a moving target until you get an approved drug. Just how has that understanding kind of changed over the last year or two? You're starting to zoom in on this 25% cutoff. I guess how robust is that analysis right now versus where you hope it can be? Yeah. Yeah. You're right. As I said, we as a field are learning about Claudin 18.2 expression real-time. It's a relatively new target. Understanding it in gastric GEJ cancer may be different from other cancers. Even over the course of 2024, last year, we learned a lot. We as a field learned a lot about Claudin 18.2 expression that just was not possible or understood before. Of course, Astellas with Vyloy has led the field, and they set some of the benchmarks to think about 75%, 2 plus, 3 plus as a cutoff that they're using in what their approval is focused on, the highest expressors in first-line gastric cancer. What we think about in ADC at a cutoff of 20%, 2 plus, 3 plus supports what we've always thought, which is there's an opportunity within ADC to treat a broader range of Claudin 18.2 expression. We think the monikers of low, medium, high are going to continue to evolve, and they're going to remain relatively inconsistent for a while between the different programs. From our perspective, the ADC approach is sort of coming into a certain narrower range, which it's clear that an ADC approach is supporting that you're going to have an opportunity to treat a broader range expression more so than a naked monoclonal antibody plus chemo. As we continue to evaluate 3021, of course, initially the cutoff of 20%, 2 plus, 3 plus made sense. That's part of the reason why in the phase one, we looked at a broader cutoff for enrollment criteria. We can continue to hone in on that. As we think about maximizing the opportunity for a registration trial and think about what the ultimate cutoff needs to be for the program, we'll have the best opportunity to hone that in for 3021 itself. One is where do you put a cutoff with your own assay? I think an issue investors sometimes struggle with also is different companies have different assays. How comparable do you think those assays are to each other? Can you translate? Is Is one company's 20%, the other company's 20%? I'll use the word pretty consistent because we've had the benefit of somebody like Astellas being at the forefront, right? Rising tide lifts all boats. It's very helpful for the field. While I'm very glad to see Vyloy is approved, it's very helpful for the field to have an approved Claudin 18.2 targeted agent, even though we firmly believe there's an opportunity to improve upon what they're doing already. The assays for Claudin 18.2, all IHC-based, are pretty consistent. Astellas is using, call it a first-generation Claudin 18-specific assay from Roche Ventana, very relevant, very relevant in gastric GEJ. Most of the ADCs and most of the second-generation Claudin 18.2-focused agents are using a Claudin 18.2 assay. There's published data out there that shows that, of course, based on the commercially available assay, the concordance is pretty consistent. Okay. Okay. You have started some of this combination work, and as you laid out, you're doing dostarlimab as one of those. Of course, dostarlimab is used often in combination with chemotherapy. Is that of interest to go to a triple combo, or do you think the MMAE itself is enough chemo? Yeah, very much so. We think in the first-line approach, we especially have an opportunity that no other program has, which is while we're starting in the combination with dostarlimab only, we think the broader opportunity for the program is layering some type of chemo. We have to do this in a stepwise way, first combining with dostarlimab, but we think after that there is an opportunity for layering in a complementary chemo regimen, right? MMAE is a microtubule inhibitor. Is there an approach of layering chemo from a chemo mechanism of action standpoint that would be complementary? We think that's an opportunity in first line that especially leverages the uniqueness and the differentiation aspect of 3021, which is different than what we're doing in the second line, right? I think our approach in second line is replacing chemo, replacing that broad chemotherapeutic of paclitaxel with a targeted cytotoxic like 3021 will give us an overall better profile for a potentially new standard of care. What's gating to starting that triple combo? Is it just some safety data with the dostarlimab for a dose, or do you feel like you need a decent chunk of patients to look at efficacy and see is there actually additive efficacy with the doublet before you would move to a triplet? I think it probably first and foremost starts with safety and understanding that the combination is safe. Of course, in some ways, thinking about it being effective. We think that any meaningful combination in first line in gastric GEJ cancer needs to include chemo to some respect. I think you'll see us moving in that direction sooner rather than later. Okay. Maybe for the HER3 program, you mentioned you have some preclinical data is going to be shown later this half. Just maybe a preview of kind of what investors should be looking for in terms of seeing differentiation of that versus some of the other HER3 ADCs that are out there. Yep, yep, for sure. So HER3 ADC, obviously the leader in the field is Daiichi Sankyo with patritumab deruxtecan. They are the leader, and they certainly are well advanced. We see an opportunity for combining both site-specific conjugation and MMAE payload. Think about a broader opportunity in solid tumors. That also includes thinking about those patients in those cancers that may be refractory or relapse from initial treatment on patritumab. As that moves into earlier lines of therapy, we know clinicians want multiple ADCs in their toolkit that include different payloads. The field of HER3 ADC is all using the topo as a payload. Of course, that can make sense in a lot of ways. We see 3021 as being differentiated because of our choice of both the payload and the use of the site-specific conjugation, which will give us an opportunity in ways that the others may not be limited to, but we think we would have a broader opportunity to utilize in a range of tumors and a range of different lines within those tumors. Okay. We're running up on time, but maybe just quickly on the cash runway, just what you expect that to fund through in terms of the different data updates from monotherapy combinations and maybe working the HER3 towards the clinic. Yep, yep. We have runway into 2026, which certainly gives us an opportunity to continue to execute on our pipeline throughout 2025 as we think about reading out initial monotherapy data in the first half and then moving into combination data for 3021 later this year, early next year. Unfortunately, that is all the time, so we're going to have to cut it off there. Thanks, Joe, for joining, as well as everybody in the room and on the webcast. Thank you, Marc. Thank you to the Cowen team.