Good day, and welcome to the Elevation Oncology initial CRESTONE Data Conference Call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the Star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press Star then one on your touch-tone phone. To withdraw your question, please press Star then two. Please note this event is being recorded. I would now like to turn the conference over to Ms. Candice Masse. Excuse me, Candice Masse, Senior Director of Corporate Communications and Investor Relations. Please go ahead, ma'am. Good evening, and thank you for joining the Elevation Oncology Conference Call to discuss our initial clinical data from the ongoing Phase II CRESTONE study evaluating seribantumab in tumors harboring NRG1 gene fusions. As a reminder, these data will also be presented on Tuesday, June 7 at 11:45 A.M. Central Time as a featured oral presentation at the upcoming ASCO Conference. The press release highlighting the key findings from the clinical data is available in the investors page of our website at elevationoncology.com. Before we begin the call, I would like to remind you that we will be making certain forward-looking statements today. These may include statements regarding, among other things, the timing and expectations of research and development plans, regulatory plans, and our plans to present or report additional data. These forward-looking statements are based on current information, assumptions, and expectations that are subject to change and involve risks and uncertainties that may cause the actual results to differ materially from those contained in the forward-looking statements. These and other risk factors can be found in our most recent periodic report filed with the SEC. On today's call, we will begin with brief introductory remarks from Shawn Leland, Founder and Chief Executive Officer, before turning the call over to Valerie Jansen, our Chief Medical Officer, who'll provide an in-depth overview of the clinical data. Following her summary, we will be joined by Dr. Daniel Carrizosa, Medical Oncologist at Atrium Health Levine Cancer Institute and an investigator of the CRESTONE study, to provide his thoughts on the data from a clinician's perspective. Shawn will then provide closing remarks before we open the call for your questions. During the Q&A portion of the call, we will also be joined by Joseph Ferra, our Chief Financial Officer, and David Dornan, our Chief Scientific Officer. Now, I would like to turn the call over to Shawn. Thank you, Candice, and good evening, everyone. We are really excited to be reporting these first-ever data from the CRESTONE study of seribantumab and its potential to induce deep and durable benefit in patients whose tumors harbor NRG1 gene fusions. We believe these initial data support clinical proof of concept for seribantumab in genomically defined patients with advanced solid tumors. The data not only show that seribantumab continues to have a favorable safety and tolerability profile, but that it can also drive deep and durable clinical responses in these patients. We believe that while early, these results show seribantumab's differentiated profile and best-in-class potential in treating patients whose tumors harbor NRG1 fusions. This initial clinical proof of concept data provides validation around Elevation Oncology's ability to execute on making genomic testing results therapeutically actionable. It's also important to note that seribantumab is just one part of our broader mission as a precision oncology company to identify and target genomically defined cancers for patients that are underserved by the current standard of care. These initial data are promising and a meaningful first step towards building an industry-leading precision oncology pipeline. Before we get into the data, I would like to highlight the press release we issued earlier this week announcing that the FDA granted us a Fast Track designation for the investigation of seribantumab for the treatment of patients with solid tumors harboring NRG1 fusions. This Fast Track designation covers our ongoing tumor-agnostic development program and is a significant step towards addressing this unmet need where there are currently no approved therapies that specifically target NRG1 fusions. Also, as part of our ongoing business development strategy, we continue to work closely with our cross-industry partners to identify additional oncogenic driver alterations that could assist us in expanding upon our product candidate pipeline. Our vision is to expand the promise of precision oncology and bring important, new, and effective targeted therapies to address the high unmet medical needs of patients living with cancer, and we are grateful for everyone's support as we work to achieve these goals. Today, we're focusing on the first data from our ongoing Phase II CRESTONE study, which Valerie will now discuss. Valerie? Thank you, Shawn. On behalf of the co-authors and study investigators, I am delighted to present initial safety and efficacy data of seribantumab from the ongoing Phase II CRESTONE study. As a reminder, seribantumab targets solid tumors harboring Neuregulin-1 or NRG1 gene fusions, a rare genomic alteration with no currently available targeted treatment. NRG1 fusions are caused by the fusion of NRG1 with a partner gene. This results in the production of NRG1 fusion protein that selectively binds to HER3 and activates the HER family of receptors, leading to unregulated cell growth and proliferation in many types of cancers, including lung, pancreatic, and other solid tumors. Importantly, NRG1 fusions are often mutually exclusive of other known oncogenic alterations. This means that NRG1 fusion is an ideal drug target. Patients with solid tumors harboring NRG1 fusions generally have poor outcomes on standard therapies, and currently available treatments do not provide sufficient benefit. In addition, we know these tumors will develop resistance to those therapies and progress. As most of you know, seribantumab is a novel anti-HER3 monoclonal antibody that we believe has the potential to become a standard of care for this genomically defined patient population by blocking unregulated tumor growth driven by NRG1 fusion. Seribantumab leverages a differentiated mechanism of action by inhibiting NRG1 fusion protein from binding to HER3 and consequently blocking HER3 dimerization to other HER family members. The therapy also has an established favorable safety and tolerability profile, which we continue to see in patients with tumors harboring NRG1 fusion, as you will see in the initial data from the CRESTONE study today. As shown on slide nine, CRESTONE is a Phase II multi-center global clinical study evaluating the safety and efficacy of seribantumab in adult patients with locally advanced or metastatic solid tumors harboring an NRG1 fusion that is identified by local testing methods. Patients enrolled in CRESTONE have received a minimum of one prior systemic therapy and harbor no other oncogenic alterations, except for those enrolled in the exploratory cohort 3. Patients are treated with seribantumab 3 grams weekly via intravenous infusion until disease progression or unacceptable toxicity, as determined by the investigator. CRESTONE is a 3-cohort study designed to evaluate seribantumab in different settings. Cohort 1 is a potentially registration-enabling cohort in which patients have received no prior pan-ERBB, HER2, or HER3-targeted therapies, and their NRG1 gene fusions are centrally confirmed post-enrollment. Cohorts 2 and 3 are exploratory cohorts. Cohort 2 is for patients who have relapsed or refractory disease following prior ERBB-targeted therapy. Cohort 3 is for patients whose tumors harbor NRG1 fusions that do not contain an EGF-like domain, have other molecular alterations, or do not have available tumor tissue for central confirmation testing of NRG1 fusion status. The primary endpoint of the study is objective response rate, or ORR, as determined by independent or central radiologic review per RECIST 1.1 criteria. Secondary endpoints include safety, ORR as determined by investigator assessment, duration of response, progression-free survival, overall survival, and clinical benefit rate. We will be presenting results through the April 18th data cutoff. The data are from the primary efficacy analysis population, consisting of patients from cohort 1, whose tumors have been centrally confirmed to harbor an NRG1 fusion and who received seribantumab 3 grams weekly, as well as safety data from all patients treated in the CRESTONE study. Slide 10 shows the patient demographics and disease characteristics broken out into cohort 1 and the safety population. The efficacy data we are presenting today are from the 15 patients enrolled in cohort 1 who received seribantumab 3 grams weekly as of the data cutoff. We should note that two patients in cohort 1 transitioned to the optimized recommended Phase II dose of 3 grams weekly after induction or reinduction and are included in the primary efficacy analysis presented today per our statistical analysis plan. As shown on the left side, a diverse group of patients was enrolled with a median age of 61 years and a range of 44-76 years in cohort 1. Two-thirds of the patients were female. All patients had an ECOG performance status of zero or one at the time of enrollment. Although I would like to point out that the study protocol does allow for patients with an ECOG performance status of two to be enrolled. Seribantumab was evaluated in several different solid tumor types, including cholangiocarcinoma and breast cancer, with the majority of the patients enrolled in cohort 1 as of the data cutoff having non-small cell lung cancer and one case of pancreatic cancer. CD74 and SLC3A2 were the most common NRG1 fusion partners. As mentioned before, patients are enrolled and treated based on the local NRG1 testing results, with central confirmation of NRG1 fusion status completed in cohort 1 post-enrollment. As of the data cutoff, 14 patients had their NRG1 fusion status confirmed by central RNA-based NGS testing, with one patient whose NRG1 fusion status remains unknown, as it is yet to be determined. Finally, patients enrolled in cohort 1 have received a median of one prior systemic therapy, ranging from one to five prior therapies. Slide 11 summarizes the safety profile of seribantumab, including treatment-emergent and treatment-related adverse events in the 35 patients who had received at least one dose of seribantumab in the CRESTONE study as of the data cutoff. Overall, the data show that seribantumab monotherapy is generally well-tolerated. 77% of patients were treated with seribantumab 3 grams weekly, the optimized recommended Phase II dose in the CRESTONE study. As shown, most adverse events were mild or moderate, grade one or two, with the most commonly reported adverse events related to seribantumab being diarrhea, fatigue, and rash. One case of the dose-limiting toxicity, or DLT, of grade two fatigue led to a dose reduction by the investigator in the safety run-in. Another patient also received a dose reduction by the investigator for grade one ALT increase. Importantly, no patients discontinued seribantumab for adverse events. Slide 12 summarizes the initial efficacy data of seribantumab from 12 evaluable patients at the time of data cutoff in cohort 1. These are patients with solid tumors that harbor NRG1 fusions, who had been treated with at least one prior line of systemic therapy, but no prior ERBB-targeted therapy. Additionally, these patients have centrally confirmed NRG1 fusion status and received seribantumab 3 grams weekly. The objective response rate described here are investigator-assessed responses. The response rate across tumor types harboring NRG1 fusions was 33%. The response rate specifically in non-small cell lung cancer was 36%, including 2 complete responses and 2 partial responses. The disease-controlled rate, which includes patients who have achieved a complete response, partial response, or stable disease, was 92% across tumor types. To our knowledge, these are the first published data of a treatment targeting tumors harboring NRG1 fusions that has induced complete responses in patients. As this waterfall plot on slide 13 shows, we are seeing encouraging signs of seribantumab's ability to target tumors harboring NRG1 fusions and drive tumor reduction. As you can see, nearly all patients had tumor volume reduction from baseline per RECIST 1.1, including two patients on the far right side of the waterfall who had complete responses. The specific NRG1 fusion partners are noted along the bottom of the waterfall and points to the activity of seribantumab across a range of fusion partners. This swimmer plot on slide 14 further shows how seribantumab is capable of driving durable responses in the primary efficacy population in cohort 1. 75% of the patients that had partial or complete responses to seribantumab remain on treatment. Furthermore, 75% of the responses occurred by the first tumor assessment or at around six weeks after treatment initiation. Importantly, as of the data cutoff, duration of response ranged from 1.4 to 11.5 months. These measurements are ongoing, and the median duration of response has yet to be reached in the study. Now, the next two slides show representative cases highlighting seribantumab's ability to drive deep and durable responses in patients whose tumors harbor NRG1 fusions. This first case on slide 15 is a 70-year-old man diagnosed with non-small cell lung cancer that harbors a CD74 NRG1 fusion. His cancer progressed after receiving platinum-based chemotherapy, immunotherapy, and an investigational therapy that was not a pan-ERBB, HER2 or HER3-targeted therapy. He initiated treatment with seribantumab under the safety run-in phase in transition to the optimized recommended Phase II dose of 3 grams weekly. A partial response was observed at his week 12 scan, and overall, this patient had a maximum tumor reduction of 42% on study as the CT scan and plot of the tumor measurement highlight. He is the longest patient on seribantumab to date, with a duration of response of 11.5 months at the time of data cutoff. Treatment with seribantumab is ongoing at 3 grams weekly for more than 12 months. This next case on slide 16 is of a 60-year-old woman, also with non-small cell lung cancer, but with a different gene fusion partner, ITGB1. She also had received three prior lines of therapy, including platinum-based chemotherapy and immunotherapy. She was enrolled into cohort 1 and treated with seribantumab 3 grams weekly. Her first scan at approximately six weeks after treatment initiation showed a partial response with a tumor reduction of 68%. She continued to benefit from seribantumab, and her scans at approximately week 24 showed a deepened response to a complete response, as highlighted in the CT scans and tumor plots. The duration of response was 9.7 months, and the complete response is ongoing at 5.6 months at the time of data cutoff. Treatment with seribantumab is ongoing at 3 grams weekly for almost 12 months. Overall, as summarized on slide 17, we believe these initial data demonstrate the ability of seribantumab to produce deep and durable benefit for patients with previously treated solid tumors harboring NRG1 fusions. The investigator assessed ORR across tumor types in cohort 1 with 33% overall, and 36% in patients with non-small cell lung cancer. The disease control rate across tumor types was 92%, including what we believe are the first complete responses published for a therapy targeting NRG1 fusions in solid tumors. Moreover, the response is durable, with duration of responses ranging from 1.4-11.5 months at the time of data cutoff. Importantly, seribantumab was generally well-tolerated. Most adverse events were of grade one or two, and no adverse events led to patient discontinuation of seribantumab treatment. Taken together, these data support the continued evaluation of seribantumab as a potential new standard of care for patients with solid tumors harboring NRG1 fusions. Before I turn the call over to Dr. Carrizosa for his thoughts on the initial data, I would like to acknowledge the patients, their families, and caregivers for participating in this clinical trial, and the study investigators and their research staff for their relentless support to bring new medicines to patients. Now, I would like to invite Dr. Daniel Carrizosa, Associate Professor of Medical Oncology at Levine Cancer Institute and an investigator on the CRESTONE study, to provide his thoughts on the potential seribantumab for patients with tumors harboring NRG1 fusions. Dr. Carrizosa? Thank you, Valerie, and thank you for giving me the opportunity to provide a few thoughts on this call with all of you today. It's an honor to be part of this important clinical trial as an investigator, and it's an honor to discuss the data from the CRESTONE study. Currently, I'm a medical oncologist and associate professor of medical oncology at Levine Cancer Institute in Charlotte, North Carolina. I specialize in thoracic malignancies and head and neck cancer and lead the clinical research program for head and neck cancer at Levine Cancer Institute. I also am a member of the Phase I trials group there. I treat patients as well as conduct research into new medicines aimed at novel molecular targets. At Levine, we treat many patients from the Southeast with various types of cancers and typically see around 5,000 new cancer cases per year. Thus, we've been able to identify and enroll patients with NRG1 fusions into the CRESTONE study. First off, I'm very excited to see the initial data from the CRESTONE study. The results have been accepted for an oral presentation at ASCO, which is a huge honor, and in my opinion, shows how important the oncology community considers these findings. The results, while early, are obviously good news for patients with NRG1 fusions. This is a rare genomic change found in cancers and is also a change that is ripe for targeting with a safe and effective medicine to help our patients in need. Patients with these fusions do not have effective standard treatments available to them and are treated generally without regard for the underlying molecular driver of their cancers. Previous studies have shown that patients with NRG1 fusions typically do not respond well to standard therapies, and if they do, they typically do not respond for long. Now, we have a potential personalized medicine, a choice that we as oncologists can make for these patients that specifically targets these fusions to help prolong their lives. We've seen great results at Levine Cancer Institute. To give you an idea of how effective seribantumab could be, I have a patient who required supplemental oxygen prior to entering the CRESTONE study. They could barely perform their activities of daily living, but were able to just do enough to participate in this study. This patient started on seribantumab and now is off oxygen completely and is again active in their community. In fact, this person is incredibly grateful since they felt they didn't have any opportunities left before participating in the study. She never thought she'd come off oxygen again in her lifetime. Patients in the CRESTONE study had received at least one prior systemic therapy, and some patients had received up to six different therapies before coming on study. In my experience, many of these patients did not have long-term response to the available treatments. There is a clear need for a safe and effective medicine like seribantumab to target this specific patient population. The reported results are really good, and the early data on lung cancer is particularly promising for us in the lung community, as it gives us a better option than any currently approved medicine on the market for this group of patients. Seribantumab seems to be well-tolerated, with no major toxicities reported, no medication-related deaths, and no side effects that would prevent the medication from being used by medical oncologists like myself if it makes it to market. Diarrhea, fatigue, and rash are the most common side effects and are manageable and controllable. These are side effects commonly seen in many of our available medicines, and thus do not create concern or anxiety in their management. There were only two dose reductions in the study so far, and no discontinuations due to toxicity. Overall, seribantumab seems well-tolerated in patients with tumors harboring NRG1 fusions. In regards to NRG1 fusions, patient identification through comprehensive genomic profiling of tumors, particularly using RNA-based NGS testing, is something I would like to continue advocating for every patient living with cancer. In the world of personalized medicine and oncology, the general recommendation from major thought leaders and medical societies is that we do thorough genomic profiling of the tumor using next-generation sequencing at the time of initial diagnosis and throughout the patient's treatment journey. This is very important to give the right medicine to the right patient at the right time, and it's also how we find rare alterations like NRG1 fusions. This is slowly being adopted by the community, which is a good sign, and almost all major cancer and academic centers are conducting comprehensive genomic profiling using RNA-based NGS testing regularly. At Levine, we recommend NGS for all patients with cancer, and we have weekly reviews of the molecular alterations found to ensure our patients get what they need. This is how we first identified patients with NRG1 fusions, and now with seribantumab, we have a great ability to treat them in the CRESTONE Study. While there are certainly other medications being evaluated to treat NRG1 fusions at this time, oncologists like myself will be looking at the quality of responses and the ongoing data that develop from the study. We're always taught to avoid comparing drugs across separate trials, as the differences in patient enrollment, treatment scheduling, and outcomes analyzed can lead to confusion and misrepresentation of the data. Looking at the results from the CRESTONE study, the data to date are very impressive. Patients have been doing very well with it, and the medication also has a very manageable side effect burden. I believe this is a drug that is very much at the top of any potential list of therapies for patients with NRG1 fusions. Thank you again for allowing me to share my thoughts with you on this call tonight, and I'll now hand the call back to Shawn. Thank you, Dr. Carrizosa, for your time today, as well as your valuable insights and perspective on the potential of seribantumab in advanced solid tumors harboring NRG1 fusions. In summary, we are thrilled to be able to present these data that demonstrate clinical proof of concept for seribantumab. We believe these data represent seribantumab's potential to drive meaningful and durable benefit for patients with tumors harboring NRG1 fusions who are in dire need of treatment options that are safe and effective beyond the currently approved standard of care. Keep in mind, this is an indication with currently no approved treatment options, highlighting a true unmet medical need for patients with advanced tumors that harbor NRG1 fusions. The deep and durable responses we are seeing suggest this is a potential best-in-class therapy with a clearly differentiated profile as a well-tolerated therapy in this often heavily treated patient population. These data are an important accomplishment in the execution of our strategy to bring seribantumab to patients. The recent receipt of Fast Track designation for seribantumab from the FDA for the tumor-agnostic treatment of NRG1 fusions supports the potential to address the significant unmet needs of patients with a wide variety of cancers. As we look forward to the future of seribantumab, we remain on track to complete enrollment of the first 20 patients into cohort 1 of CRESTONE in mid-2022, and to presenting additional interim data from the study in the first half of 2023. We continue to expect top-line data from this potentially registrational trial in 2024. Finally, we believe these initial data represent a meaningful step forward as we continue to execute upon our overarching mission of building an industry-leading precision oncology company. Thank you again to everyone who joined us on our call this evening. Now, we would like to open the line for questions. Operator? Thank you. We will now begin the Q&A session. To ask a question, you may press Star then one on your touch-tone phone. If you're using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press Star then two. At this time, we'll pause momentarily to assemble our roster. The first question will come from Anupam Rama with JP Morgan. Please go ahead. Hey, guys. Thanks so much for taking the question. A question for the KOL line as well as a question for the company. For the company, is there anything in the baseline characteristics worth noting in the patients who had a CR? Then perhaps for the doctor on the line, maybe you can provide your perspectives on depth of response as a potential differentiator here relative to the competition. We have two CRs here in the early data. I don't think the Merus drug has shown any CRs. Any thoughts there, and any other points of differentiation either today or that you'd be monitoring for in the future? Thanks so much. Hey, Anupam. It's Shawn. Thanks for the question. I'll cover your second question first around differentiation, and then I'll turn it over to Valerie as well as Dr. Carrizosa for the comment. You know, we're obviously very encouraged by, you know, the initial data in terms of the depth and durability of response that we've shown. You know, the ability here to show, you know, 33% overall response rate across all tumors, 36% overall response rate in non-small cell lung cancer, and showing these two CRs, you know, we believe shows, you know, differentiated and potential best-in-class profile for treating NRG1 fusions. You're spot on in that, you know, you can go back all the way to, you know, the early 2000s when NRG1 fusions were first identified, and there's a number of case studies, and there's clinical trials that have been run in this patient population. No one to date has presented or published even a single CR in this patient population. We're very intrigued, and I would say even more encouraged and confident in our data set, you know, seeing two CRs, you know, even early on in the Phase II CRESTONE study. I'll pause here and then turn it over to Valerie to address your question around baseline characteristics, and then we can also have Dr. Carrizosa comment on his thoughts as well. Hi, Anupam, and thanks for the question. In terms of your question about the baseline characteristics, as you saw, you know, what we see in terms of the safety population, so that's all patients that have been enrolled into the CRESTONE study across all cohorts. We see a variety of tumor types, particularly in cohort 1 right now. Based on these initial data, we are seeing majority of patients with having non-small cell lung cancer. Also highlighted in terms of the baseline demographics and characteristics is that we are seeing a variety of NRG1 fusion partners. In terms of, you know, the representation in the CRESTONE study, we're pleased to see a variety of tumor types as well as NRG1 fusion partners. As we continue to execute on cohort 1, we continue to enroll, as Shawn mentioned, the first 20 patients in mid-2022. That'll be more representative, potentially of the whole cohort. I'll pause there and then turn it over to Dr. Carrizosa in terms of providing his perspective as an investigator who have treated patients with seribantumab on the CRESTONE study. Thanks. I think it's interesting that we always want to try and compare and contrast things as much as possible, and I think at this point, just to be fair and honest, you know, we're looking at trying to find the total data from all the different studies in NRG1 fusion. So right now it's a little early to completely, you know, pass judgment without final data on everything. Now, as you said, complete responses are amazing. I think in oncology and medical oncology, we're always looking for the best response possible, and I think always finding complete responses is something that is amazing and wonderful. Hopefully it continues to show forward and final data for NRG1 fusion show great medicines. I think with seribantumab being very well tolerated and, doing well at this point, I think it's a very positive outlook, but we still have to wait for the final data. Thanks so much for taking our question, guys. Thanks, Anupam. The next question will come from Marc Frahm with Cowen. Please go ahead. Thanks for taking my question. Congrats on the data. Maybe just start off with this could be either for Valerie or Dr. Carrizosa. Just maybe to dig a little bit further on Anupam's question of just depths of response. Can you remind us what's been shown with other targeted therapies in lung cancer, particularly maybe with things like EGFR inhibitors in terms of difference of outcomes for somebody who gets to a CR versus people who just get a PR or even a very deep PR? Hey, Marc, it's Shawn. Thanks for your question. I'll turn it over to Valerie to respond to your question. Thanks, Shawn and thanks Marc for the question. You know it's really difficult to compare again different, you know, therapies, different targets. What we're really encouraged in seeing in our initial data is that in lung cancer we are seeing deep and durable responses with seribantumab. You know, again highlighting the fact that seribantumab could become a potential first in class or best in class medicine for a patient with tumors harboring NRG1 fusion. In terms of, you know, complete responses, as Dr. Carrizosa alluded to earlier, you know, these are amazing things in oncology, and when we see them in clinical trials, the main goal for treatment of patients with metastatic disease is really control of disease. To be able to have a medicine like seribantumab elicit complete responses, that's quite amazing for patients who are living with metastatic disease. I'll turn it over to Dr. Carrizosa to provide additional thoughts from him. I think jumping off of that, when I'm looking at my patients in clinic, I really want to turn cancer into a chronic illness and not to be something that people are gonna die from quickly. I think, you know, looking at the disease control rate of, you know, 92%, I think that's just great because I think if we can control the disease, it's what we're really looking for. Obviously, we want a CR. Obviously, we want a PR. If we can have stable disease, that's what really matters to patients. They wanna be able to keep living and living as long as possible. I think, again, you know, we've seen great data at this point. It's very promising. That's helpful. Then maybe Valerie, just, you know, right now, the cohort 1 is, you know, almost entirely lung cancer. I don't know if that's kind of an artifact of just the earliest sites that got started or something else. You know, are there any plans to implement some changes going forward just to make sure that you're able to capture enough patients outside of lung cancer to kind of support that longer-term goal of tumor-agnostic development? Yeah. Thanks, Marc. That's a great question. You know, what I wanted to address is that, you know, we know NRG1 fusions have been identified in over 10 different solid tumor types. If you look at the safety population, in other words, all patients that have been enrolled into the CRESTONE study, we are seeing a diverse tumor type over eight different tumor types enrolled. As you alluded to in terms of cohort 1 patients, right? These are patients who have not seen prior or redirected therapy. We have the overwhelmingly predominant non-small cell lung cancer patients right now. You know, these are initial data, and what we're most encouraged about is that even with the lung population, we're seeing deep and durable responses with 36% response rate in non-small cell. Given that, we continue to execute on our strategy in terms of, you know, tumor-agnostic indication. As Shawn mentioned, you know, earlier this week, the FDA did grant seribantumab Fast Track designation for the treatment of patients with solid tumors harboring NRG1 fusion. We remain on track in terms of enrollment of that first 20 patients in mid-2022. We look forward to providing updated data from the clinical study from CRESTONE in the first half of 2023. As we continue to enroll more patients, you know, we are expecting top-line data in 2024. Okay. Thank you. Congrats again on the data. Thanks, Marc. Again, if you have a question, please press Star then one. Our next question will come from Andrew Berens with SVB Securities. Please go ahead. Hi. Thanks. Congrats, guys, on the initial unveiling of the data. Just a few from me. I guess, are there any thoughts about potential combination strategies? Specifically, any rationale for combining with checkpoint or chemo? I wanted to follow up on Marc's question about the depth of response in lung cancer being predictive of eventual durability. My recollection in the RET space, I know it is obviously a different space, but, there wasn't conclusive evidence that the increased CRs were seen by one of the drugs ever translated to better durability. Lastly, a strategic question directed to the doctor. Just wondering, in his view, if there's any difference between getting a stand-alone label for treatment of non-small cell lung cancer versus a tumor-agnostic label, has any impact on his willingness to use the drug in lung cancer patients. Thanks. Hey, Andrew. It's Shawn. Thanks for the question. I'll pass your questions over to Valerie. Hi. Thanks. In terms of the first part of the question about the durability in terms of deep responses, complete responses and leading to durability, you know, these are in early data, initial data from the first 15 patients, and certainly the first 11 patients with lung cancer who are evaluable for response. What I would like for us to focus on is in terms of, you know, the depth of response, we're seeing two complete responses. What we've highlighted is that, you know, while early, the duration of responses that we're seeing with seribantumab is anywhere from 1.4-11.5 months. You know, definitely early, but it's possible, and we're encouraged by what we're seeing to continue on executing on the CRESTONE study. I think you're right that, you know, we can't make comparisons to other targeted therapies, but at least what we're seeing in CRESTONE and with seribantumab is that, the ability of seribantumab to induce deep and durable responses in patients with tumors harboring NRG1 fusion. Yeah. I know the second- I know the second question was for Dr. Carrizosa. I think it's an interesting point. I don't think it would probably change my viewpoint whether something is tumor-agnostic or just directed to lung cancer for me to decide to do it in lung cancer. I think it's always very interesting when medicines are tumor-agnostic because obviously we're looking at how important it is to actually target that molecular change and really fits into that world of personalized medicine. I think it's always nice to be tumor-agnostic, but it probably would not necessarily change how I would use the drug in a specific patient because I just wanna use what works best. Right. Okay. Just a question on combination with checkpoint or chemos. Is there any rationale for that? Valerie, do you want to address that question? Sure. I'll be happy to take that. Right now, you know, we're of course focused on execution on CRESTONE as we continue to evaluate the potential and maximizing the value of seribantumab. Certainly, we will look into those as they are appropriate. You know, right now our goal is to execute and remain on track to enroll the first 20 patients in mid-2022, allowing us to be able to update on more mature data in the first half of 2023 and in getting us to top line data in 2024. As we continue to evaluate additional studies, we'll make sure to keep you apprised of those. Okay. Just to follow on to that, maybe the doctor would have some color on this. In terms of the front line in NRG1 patients, is there any suggestion that these patients do worse on chemo or checkpoint inhibitors than those that don't harbor NRG1? I'll tackle that first part. In terms of what we know in the front line, right, and that's from the largest registry of patients in terms of harboring NRG1 fusion. It does appear that patients with NRG1 fusion have a poor outcome in terms of regardless of which line of therapy. Again, you know, this is why we believe in terms of seribantumab for tumors that harbor NRG1 fusions. What we're seeing with our initial data is that in lung cancer, right, with a 36% in the two complete responses. I know, Shawn, if there is anything else that you would like to add before handing over to Dr. Carrizosa? No, I mean, I think the most relevant data is what you touched on, right, the NRG1 fusion global registry study data. I mean, I don't think that there's any other additional data beyond that. I think there's one other publication that's come out, that highlights that, you know, if you have an NRG1 fusion, you do have a worse prognosis, but that's not necessarily tied to any specific therapy. I could probably comment. I mean, obviously the registry data, as they said, but in at least the patients that I've treated on the CRESTONE study, all of them had short durations of response with their previous lines of therapy. At least from my own personal view, it would appear that the NRG1 fusion patients, yes, don't do as well with our standards at this point. Okay. Thank you very much for all the questions. Thanks, Andy. The next question will come from Robert Driscoll with Wedbush. Please go ahead. Thanks. Hey, guys. Congrats on the data here. Any clear differences on safety between what you've seen in CRESTONE so far versus the past clinical experiences with the seribantumab? Maybe if you're able to give any detail on those two dose reductions. Thanks. Hey, Robert. This is Shawn. Thanks for the question. Valerie, can you address Robert's question? Yes. Thanks, Robert. In terms of the safety of seribantumab in the CRESTONE study, right, what we see is that it's safe and tolerable. You know, most of the adverse events were of grade one, grade two. As we alluded to, no patients to date discontinued seribantumab due to toxicity. Now, as you recall, we've had safety data from over 800 patients previously treated with seribantumab. Again, this was not in an NRG1 fusion setting. We are seeing consistent safety profiles. There are no new safety observations or trends that we've seen. Your second question in terms of the dose reduction. You know, one patient, the investigator dose reduced for grade two fatigue, and then they felt that this was related to seribantumab and with a dose reduction. The other one is a patient who had a slight increase in their liver enzyme, ALT specifically, and that investigator dose reduced the patient to the next lower level. Otherwise, there are no other dose reductions thus far. I would point out that, per our study protocol, those wouldn't necessarily have mandated a dose reduction per the study protocol. However, it is the discretion of treating physicians like Dr. Carrizosa to do what's best for their patients in the clinic. Got it. Super helpful. Maybe one question for Dr. Carrizosa. You touched on in your remarks a little bit, but we just wanted to get a sense of how often you do the RNA versus DNA sequencing in patients and how you see that adoption kind of across the industry. Thanks. I think looking at next-generation sequencing, obviously, there's multiple different companies out there that do that. Personally, I definitely feel that any cancer center, administrator, clinic, or physician themselves should be very careful in looking at what the different companies can do. Because if you don't do looking for the RNA fusions, then you can miss things and such as these NRG1 fusions. We have several different companies that we use at our institution. I don't wanna name them to basically be doing any propaganda for them, but we try to make sure that they're all being as complete as possible. I think, you know, we need to be able to provide every possible treatment to our patients and make them do as well as possible and trying to fit into that personalized medicine role. I think this is where we're going, and all companies, if they haven't been doing it, have now started really doing the RNA fusion analysis also. I think it's very important, and we'll just see how the industry goes. Perfect. Thanks very much, guys. Thanks, Robert. This concludes our Q&A session. I would like to turn the conference back over to Founder and CEO, Mr. Shawn Leland, for any closing remarks. Please go ahead. Yeah. Thank you for all joining our call. This is a transformative year for Elevation Oncology, and presenting the initial clinical data from the Phase II CRESTONE study is an integral part of that transformation. This clinical proof of concept data is a testament to the Elevation Oncology team's ability to execute on our strategy to make genomic testing results therapeutically actionable. We look forward to continuing to update you on our progress as we build an industry-leading precision oncology pipeline. Have a great rest of your evening. Thank you. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.