Good evening. My name is Chad, and I will be your conference operator today. At this time, I would like to welcome everyone to the Elevation Oncology Investor Conference Call. There will be a question and answer session to follow. Please be advised that this call is being recorded at the company's request. I would now like to turn the call over to Candice Masse, Senior Director, Corporate Communications & Investor Relations. Please go ahead. Good afternoon, and thank you for joining the Elevation Oncology Investor Conference Call to discuss the expansion of our clinical-stage pipeline through the licensing of EO-3021, our new precision oncology drug candidate targeting Claudin 18.2. The press release announcing the transaction is available on the Investors page of our website at elevationoncology.com. As a reminder, we will be making certain forward-looking statements today. These may include statements regarding, among other things, the efficacy and safety of our product candidates, our 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 reports filed with the SEC. On today's call, we will begin with introductory remarks and an overview of the in-licensing transaction from Shawn M. Leland, Founder and Chief Executive Officer. We will then be joined by our Chief Scientific Officer, David Dornan, and our Chief Medical Officer, Valerie Malyvanh Jansen, who will provide an overview of EO-3021, our antibody-drug conjugate targeting Claudin 18.2, and its potential in a range of tumor types. Shawn will then provide closing remarks before we open the call for your questions. During the Q&A portion, we will also be joined by Joseph J. Ferra, our Chief Financial Officer. Now, I would like to turn the call over to Shawn. Thank you, Candice, and thank you to everyone for joining us on our call today. Our vision for Elevation Oncology has always been to build an industry-leading precision oncology company. We have consistently focused our strategy on maximizing the potential of our most advanced program, seribantumab, for which we control worldwide rights, and leveraging select partners to expand our pipeline and develop novel, purpose-built therapeutics for the treatment of cancer. Today, I am pleased to announce that we have succeeded in executing on our business development strategy with the addition of EO-3021 to our pipeline, for which we now have rights for all global territories outside of Greater China. EO-3021 is a differentiated antibody drug conjugate, or ADC, targeting claudin 18.2. This asset is known as SYSA1801 under the out-licensor CSPC Pharmaceutical Group, who is developing it for use in Greater China. It is a unique asset that we believe has the potential to help a large number of patients with cancer, including gastrointestinal cancers, which are among the most prevalent cancers in both the U.S. and globally. David and Valerie will provide a more in-depth overview in a moment, but I will just highlight here that Claudin 18.2 is expressed in many types of solid tumors and is a target that has been clinically validated by other researchers and drug candidates across multiple therapeutic modalities. Previous studies suggest the prevalence of cancer patients with expression of Claudin 18.2 could be as high as 80%, with the highest prevalence rate in gastrointestinal cancers, representing a substantial commercial opportunity. As such, we believe that EO-3021 has the potential to play a transformative role in addressing a significant unmet need in oncology and improving outcomes for patients across several types of solid tumors. This transaction provides Elevation Oncology with exclusive rights to develop and commercialize EO-3021 as the potential first-in-class and best-in-class Claudin 18.2 ADC candidate in all global territories outside Greater China. This deal includes an upfront payment of $27 million, up to $148 million in potential development and regulatory milestones, and up to approximately $1 billion in potential commercial milestone payments. CSPC is also eligible to receive royalties on net sales. SYSA1801 is currently being evaluated by CSPC in a phase I dose escalation clinical trial, which is being conducted in China. In the U.S., EO-3021 has been granted orphan drug designation, and the FDA has cleared an IND, so we are well-positioned to begin a phase I clinical trial in the U.S. during 2023. We are confident in our ability to fully develop and bring this therapy to market as expeditiously as possible. The leadership team at Elevation Oncology brings deep oncology expertise in ADC development, and a strong track record for clinical and commercial execution in precision oncology. We are also supported by advisors who are world-class experts in the field, as well as various diagnostic, clinical, and operational partners for optimized execution. As we also announced earlier today, we have secured a $50 million loan facility with K2 HealthVentures, a premier partner known for its strategic investments in promising healthcare companies and assets. The initial tranche of $30 million will primarily support the upfront payment to CSPC. An additional $20 million could be available in the future, subject to both parties' mutual agreement. Following the licensing of EO3021 and the initial tranche of the loan facility, we expect our cash equivalents, and marketable security to fund current operations, including the continued development of seribantumab and EO3021 into 2024. We are extremely excited about the addition of EO3021 to our pipeline. While we remain focused on seribantumab and executing the ongoing CRESTONE study, we are concurrently finalizing our development and regulatory strategy for EO3021 and look forward to sharing those details with you in the coming months as we work to initiate a Phase I study in the US in 2023. With that, I'll now hand the call over to David to provide an overview of EO3021. Thank you, Sean. I'm excited to share information regarding EO3021 with you today, our latest precision oncology pipeline candidate. As Sean mentioned, EO3021 is an ADC that is rationally designed to selectively target and kill Claudin 18.2 expressing cancer cells. Claudin 18.2 is a highly selective cell surface target with limited expression in normal tissue. It is often overexpressed in several types of cancer, including gastric, pancreatic, esophageal, ovarian, lung, and other solid tumors. Claudins are a family of tight junction proteins that help form and maintain cellular polarity, as well as regulate permeability and intercellular adhesion of the epithelial layer. Claudin 18.2 is a specific isoform within that protein family that is exclusively found in epithelial cells of the gastric mucosa. Claudin 18.2 is largely inaccessible to antibodies in normal tissue, but during tumorigenesis, Claudin 18.2 expression is maintained and the epithelial layer is disturbed, which exposes Claudin 18.2 on epithelial surface and makes them more accessible to targeted antibodies. This makes Claudin 18.2 a unique and highly selective ADC target, and there are currently no approved therapies targeting Claudin 18.2. EO3021 is comprised of a tumor-targeting monoclonal antibody that selectively binds Claudin 18.2 and is conjugated to a clinically validated cytotoxic payload, MMAE, also known as monomethyl auristatin E. Once the ADC has bound to the cancer cell expressing Claudin 18.2, it gets internalized and releases MMAE. The release of MMAE enables the disruption of microtubule stability that results in the inhibition of proliferation and causes cancer cell death. ADCs are a proven class of targeted biologics in cancer. As such, a number of therapies used in this modality have been approved by the FDA in the last decade. With that, I'll now turn it over to Valerie to provide an overview of the Claudin, the expression of Claudin 18.2 in human cancers. Valerie? Thank you, David. Studies have shown Claudin 18.2 to be activated and overexpressed in many primary cancers, especially gastric, esophageal, pancreatic, ovarian, and non-small cell lung cancers, but also in breast, colon, liver, and head and neck cancers. In the table on the left side of this slide, you can see that expression of 18.2 is estimated to appear in approximately 77% of patients annually who are diagnosed with gastric or esophageal cancers. For patients diagnosed with pancreatic cancer, 70%-80% of those tumors will express Claudin 18.2. The prevalence falls to between 6%-24% for other cancers, such as lung and ovarian, respectively. Given the overall incidence of these tumors, the patient opportunity is still extremely attractive. Claudin 18.2 is therefore an emerging but attractive target across a number of advanced solid tumors. In summary, EO3021 is a clinical stage asset, and CSPC is currently conducting a Phase I dose escalation and dose expansion study in China. In the US, an IND has already been cleared, and we look forward to initiating a US Phase I clinical trial during 2023. That concludes our remarks on the scientific and medical rationale for EO3021. I'll now hand the call back over to Shawn. Thank you, David and Valerie, for sharing these valuable scientific perspectives. We are excited to add EO3021 to our expanding precision oncology pipeline and look forward to sharing more information with you on our development and regulatory strategy in the future. This licensing deal, together with the loan facility we secured, marks an important milestone for Elevation Oncology as we continue focusing on the execution of our most advanced candidate seribantumab, while enabling the expansion of our pipeline into another genomically defined patient population with significant unmet medical needs. In summary, we executed on our business development plan and obtained exclusive ex-Greater China rights to develop and commercialize EO3021, a novel differentiated therapy targeting Claudin 18.2. We believe EO3021 is a first-in-class and best-in-class clinical stage ADC. Claudin 18.2 is a clinically validated target that is overexpressed in many solid tumor types, which allows us to pursue a significant market opportunity across multiple advanced solid tumors. Acquiring this asset expands our pipeline to now include two clinical stage assets and fits nicely into our vision of building an industry-leading precision oncology company. Importantly, we will also maintain our focus on executing on our most advanced program, seribantumab, in the ongoing Phase II Crestone study. As you may know, we reported initial positive clinical proof of concept data from cohort 1 of Crestone at ASCO in June, and we recently achieved completion of enrollment of the first 20 patients in cohort one. Looking ahead, we expect to report additional interim data from cohort 1 of Crestone in the first half of 2023, and anticipate reporting top line data from Crestone in 2024. Thank you again to everyone who joined us on our call. Now we would like to open the line for questions. Operator? Thank you. We will now begin the question and answer session. To ask a question, you may press star then one on your telephone keypad. 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 just to assemble our roster. The first question will come from Anupam Rama from J.P. Morgan. Please go ahead. Hey, guys. Thanks so much for taking the question. How does the $148 million in development and regulatory milestones kind of break down? Your cash is now good into 2024. What should we be assuming in terms of the milestones that need to be paid between now and 2023? I'm assuming that cash guidance includes any of those milestones that may be owed. Thanks so much. Hey, Anupam. It's Sean. Thanks for the question. Joe, can you respond to Anupam's question? Sure can. Anupam, thanks. As Shawn, Valerie, and David mentioned it, per the remarks, we're very pleased to license in EO-3021 differentiated asset with the unique unmet medical need. We're also pleased that the agreement with CSPC really favorable terms to us, including being very back-end loaded. The $148 million in regulatory and development milestones, we don't expect giving more details around within that, how it's broken down. But we can say it is pretty back-end loaded and that you wouldn't expect us to be giving any milestones in the near term, and the cash flow into 2024 reflects any potential milestones that may be paid out. Great. Thanks so much for taking our question. Thanks, Anupam. Thank you. Again, if you would like to ask a question, please press star then one. The next question will be from Mark Breidenheim from Cowen and Company. Please go ahead. Thanks for taking my questions. Maybe just on the asset and kind of what made you particularly attracted to this one in particular, 'cause I believe there are a number of Claudin antibodies out there and other approaches to targeting Claudin. Is there something about the payload, the using MMAE or the linker, or the epitope that really you think makes it special for accessing the broad opportunity that you laid out? Hey, Mark, it's Sean. Thanks for the question. I'll provide an initial answer, and then I'll ask David to chime in as well. I mean, Claudin 18.2 is a target that we've been looking at for over a year now. Obviously a very encouraging target with initial clinical proof of concept data coming with naked monoclonal antibodies. We're well aware of the rapidly evolving competitive landscape that exists with naked monoclonal antibodies, bispecific antibody-drug conjugates, as well as CAR T technologies. we've spoken with a number of key opinion leaders in this space, and I think this space is rapidly evolving very much analogous to what we saw in HER2 overexpressed cancers where initially approval came with a naked monoclonal antibody approach. We've seen that field rapidly evolve to where HER2 antibody-drug conjugates are clearly kind of best in class standard of care for treating HER2 overexpression. We would expect to see similar evolution for those targeting Claudin 18.2 overexpression over time. knowing that we are kind of well aware of the competitive landscape and having looked at a variety of different Claudin 18.2 targeting modalities, as well as kind of feedback we've received from key opinion leaders we feel highly confident that eo-3021 is a highly differentiated asset with best-in-class and first-in-class potential. I'll turn it over to David to share further details, in terms of his thoughts. David? Thanks, Shawn. I think in general, with all the different modalities out there, we remain encouraged that ADCs offer one of the best options for therapeutic implications for patients. ADCs are renowned for giving a more fast and durable response, especially in diseases that are aggressive, and that certainly doesn't exclude gastric cancer. I think that overall as Shawn mentioned, given there was hints of monoclonal antibody activity against Claudin 18.2, we think adding on a payload will really make that difference. As Shawn also intimated, right, we already know in gastric cancer that there are already great, let's say, progress being made with other antigens that are expressed on essentially gastric cancer. All in all, as Shawn mentioned, we believe that that this asset represents that first-in-class opportunity. Good. Thanks, that's helpful. You mentioned there are some hints of activity with the naked antibody. I guess I know you're still finalizing your clinical development plans, but just kind of at a high level, the idea to maybe focus on that initial gastric indication shows differentiation and then broaden out or given the company's kind of overarching strategy of tumor agnostic development, do you plan to start very broad from the get go? Yeah. Mark, thanks for your question. Valerie, who's our Chief Medical Officer, will go ahead and address your question. Valerie? Thanks, Sean. Yeah, Mark, I mean, we're really excited to develop EO-3021 for patients for tumors that express Claudin 18.2. This does include patients with gastric esophageal, including gastroesophageal or GE junction cancers and pancreatic cancer. We also know that Claudin 18.2 is highly expressed in other solid tumors. As we bring this asset into the company, knowing that an IND has been cleared, we're really excited to be able to initiate that Phase I study in 2023 and then look to evaluate. As you're aware, we have global rights outside of Greater China, so really we look to leverage on that, and so any tumors that express Claudin 18.2. Thank you. Once again, if you have a question, please press star and one. The next question is from Andy Birenz with SVB Securities. Please go ahead. Hey, this is Ken on for Andy. Just was wondering about the potential differentiation versus the Turning Point ADC. I mean, I know that's also an MMAE-based antibody-drug conjugate, so I'm wondering if you could provide any comment on potential differentiation. Secondly, was wondering if you've potentially seen any preclinical evidence that might suggest the ADC could have activity in Claudin 18.2 low expressing tumor models. We've obviously seen success from like HER2 and HER2 low expressing cancers. Thanks. Hey, Ken, this is Sean. Thanks for the question. In regards to the your inquiry around the differentiation, obviously it's really tough to speculate kind of where competitor molecules are. I mean, I think we're well aware that what was originally the LaNova asset that was licensed by Turning Point, which is now potentially part of the BMS acquisition of Turning point the Claudin 18.2 antibody-drug conjugate with an MMAE payload. I think all we really know today is that both of these molecules are in Phase I dose escalation, so programs seem to be at similar comparable stages of development. I think it's important to note here that not all antibody-drug conjugates are created equal. I mean, I think that there are a variety of factors that go in beyond just the Mab portion and the linker payload. You're correct and spot on that EO-3021 is a Claudin 18.2 Mab that is using a vc-MMAE linker. There are obviously additional nuances that could further differentiate between others that have a similar structure such as the LaNova Turning point potentially now, BMS asset. I'll pause here and ask David to comment in terms of just the differences in constructs associated with antibody-drug conjugates. Yeah, happy to, Sean. I mean, I think the reality is, as Sean mentioned, right, it's there's antibodies, there's a linker, there's a payload, and there's all different flavors of these that basically impact the properties of an ADC through all different aspects of pharmacology. I would just only add that the field evolves and we've all learned some lessons from its history of various different ADC targets. Just we certainly still and believe and are excited with the potential for EO-3021 as being that potential first-in-class agent based upon its properties as an ADC. Great. Thanks, David. Ken, to follow up on your second question, you also asked if we've seen any preclinical data on the activity of EO-3021 in Claudin 18.2 low express cancers. I think what we can say is at this time we are continuing to work closely with our partner, CSPC, to work on and figure out exactly what our public disclosure strategy will be. At this time, the preclinical data package nor has the Phase I dose escalation data from China been publicly disclosed. We're working closely with CSPC to outline and align on our disclosure strategy associated with the preclinical data package associated with EO-3021, as well as the clinical data from the Phase I dose escalation, which is ongoing in China. Okay. Appreciate the color. Thanks. The next question will be from Robert Driscoll from Wedbush. Please go ahead. Hey, guys, congrats on the deal and thanks for taking the question. Just one from me. Just wonder if you could talk at all, I guess, to the expected therapeutic window here for an MMAE conjugate ADC targeting Claudin 18.2, maybe in the context of the safety profile of those monoclonals that are out there. Thanks. Hey, Robert. Thanks for the congrats, and appreciate the question. David, can you respond to Robert's question on therapeutic index and window? Yes, sure. Hey, Robert. Hope you're doing well. essentially like everything else in ADCs, as you can imagine, it's all of the balance of efficacy and safety. All we can reveal at this time is that we hopefully will reveal preclinical data in the future, to help give a sense of that. We believe, based upon our assessment, that this asset has the potential to have a very wide therapeutic index and with efficacy for patients. That's what we can reveal at this time, but appreciate the question. Got it. Thanks so much, guys. Thanks, Robert. Ladies and gentlemen, this concludes our question and answer session. I would like to turn the conference back over to Shawn Leland for any closing remarks. Thank you all for your great questions. Today's announcement is another exciting milestone for Elevation Oncology on our mission to build an industry-leading precision oncology company, and we look forward to sharing updates with you in the coming months and quarters. That concludes our call. Thanks again and have a great evening. Thank you, sir. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.
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