Elevation Oncology, Inc.

Good morning and welcome to Elevation Oncology's conference call. At this time, all participants are in a listen-only mode. The call is being webcast live on the Investors section of Elevation Oncology's website at www.elevationoncology.com. Please be advised that today's call is being recorded. At this time, I would like to turn the call over to Tammy Furlong, Chief Financial Officer of Elevation Oncology.

Thank you. This morning, we issued a press release announcing initial data from our Phase I clinical trial of EO3021. The full release is available on the Investor section of our website at www.elevationoncology.com. We also have slides today that are viewable if you are listening using the webcast. and the slides can be found under the Events section of the Investors section of our website. We will begin the call with prepared remarks by Joseph Serra, our President and Chief Executive Officer, Dr. Valerie Malevon-Jansen, our Chief Medical Officer, and Dr. Kohei Shatara, a medical oncologist and the Chief of the Department of Gastrointestinal Oncology at the National Cancer Center Hospital East in Kashiwa, Japan, and a principal investigator for our Phase I trial. We'll then open the call for questions. Dr. David Dornan, our Chief Scientific Officer, is also on the call and will be available for Q&A. Beginning on slide three, I would like to remind everyone that the statements we make on this conference call will include forward-looking statements. Actual event results could differ materially from those expressed or implied by any forward-looking statements as a result of various risks, uncertainties, and other factors, including those set forth in the risk factor section of our annual report on Form 10-K that we filed earlier in this year, our quarterly reports on Form 10-Q that we have filed subsequently, and any other filings that we may make with the SEC in the future. Any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update or revise any forward-looking statements. With that, I would like to turn the call over to Joe. Joe?

Thank you, Tammy. Good morning, everyone, and thank you for joining us. Today is an important day for elevation oncology, as we are excited to share the first data from our phase one clinical trial of EO3021. We are very encouraged by these initial results, which demonstrate 3021's potential as a best-in-class Clawden 18.2 antibody drug conjugate, or ADC, and strongly support its advancement as a transformative treatment for gastric and gastroesophageal junction, or GEJ, cancers across lines of therapy. This conviction is rooted in early efficacy and safety data. Before we discuss the data in depth, on slide four, allow me to highlight key takeaways from today's announcement. First, in a biomarker-enriched subset of gastric and GPGA cancers defined as tumors with Clawdon 18.2 expression in greater than or equal to 20% of tumor cells at IHC 2 plus 3 plus, treatment with 3021 monotherapy resulted in a confirmed objective response rate of 42.8% and a disease control rate of 71.4%. Additionally, treatment with 3021 was generally well tolerated with no reported adverse events of neutropenia or peripheral neuropathy, known MMAE-associated toxicities that have historically challenged ADC-based therapeutics. Taken together, these data address two key questions we set out to assess in our trial. First, they confirm the importance of clodin-18.2 as a therapeutic target and the potential of a targeted approach to deliver outsized benefit to a biomarker-enriched population. And second, they demonstrate the power of site-specific conjugation at glutamine position 295 to increase ADC stability and minimize the potential for free MMAE and as a result, to provide a safer medicine with the opportunity for overall better profile. We are particularly encouraged by this finding, as differentiated safety will allow us to evaluate 3021 as both a single agent and in combination, potentially maximizing its reach. Based on these data, we are working quickly to advance a robust clinical development program evaluating 3021, both as monotherapy and in combination for the treatment of gastric and GEJ cancers across the first, second, and third line plus settings. We identified our go-forward doses for further exploration of monotherapy and are moving into the dose expansion portion of our phase one study with additional data expected in the first half of 2025. Also, as we discussed in June, we recently entered into clinical supply agreements with Lilly and GSK through which we will evaluate 3021 in combination with Ramisimirab and Dostarlimab, respectively. We expect to initiate dosing in the combination portion of our phase one trial by year end. This data readout represents an important first milestone for our 3021 program. We look forward to providing additional updates as we expand our phase one trial and advance towards introducing a prospective biomarker selection strategy and work towards our foundational vision of building a novel selective cancer therapy pipeline that delivers meaningful benefit to patients. Moving to slide five, before we get further into the data, I'd like to take a few minutes to provide some important background on the program. EO3021 was designed as a highly differentiated, potentially best-in-class Clawdon 18.2 ADC. It is comprised of a fully human IgG1 monoclonal antibody that is highly selective for Chloridin 18.2, along with an MMAE payload that is conjugated via a cleavable linker at glutamine 295, providing a homogenous DAR of two. This site-specific conjugation is intended to increase stability of the ADC and minimize the potential for free MMAE compared to ADCs with traditional cysteine-based conjugation. We believe this design contributes significantly to 3021's competitive differentiation. Not only does it offer a robust response rate in a Clawdon 18.2-enriched subset of gastric and GEJ cancers, but it does so without introducing the challenging toxicities associated with free MME, such as neutropenia or peripheral neuropathy, which may make patients more susceptible to infections and potentially limit their quality of life. As a result, we anticipate 3021 will be readily combinable with other drugs used to treat gastric and GEJ cancers, and there is a strong rationale to advance combination strategies in parallel with our ongoing monotherapy efforts. Moving to slide six, the data we are sharing today provide critical proof of concept for our approach and strongly support our path forward in gastric and GEJ cancers. As Valerie will detail shortly, initial data from the dose escalation portion of our trial demonstrated a 42.8% overall response rate in patients with gastric or GEJ cancer who present with Chloidin 18.2 in at least 20% of their tumor cells at IHC 2+, 3+. As compared to 0% in patients with Chloidin 18.2 in less than 20% of their tumor cells at IHC 2+, 3+. As I mentioned before, there were minimal MMA-associated toxicities observed across 32 patients evaluated for safety, including no neutropenia or peripheral neuropathy. On slide seven, these initial data are particularly meaningful given the magnitude of the opportunity in gastric and GEJ cancers. These are widespread diseases. In fact, gastric cancer is the fifth most frequently diagnosed cancer and the third leading cause of cancer deaths worldwide. There are over 150,000 patients with advanced or metastatic disease in our licensed territories, of which more than 70% express some level of Clawedin 18.2 and could benefit from treatment with the Clawedin 18.2 directed therapy, like 3021. Despite treatment advances, the only potential curative treatment approach is surgery, and many patients present with unresectable advanced or metastatic disease. Existing therapeutics offer moderate response rates initially, though most patients ultimately relapse. Based on the early data reported today, we are confident that 3021 could offer an important targeted option and deliver better outcomes for patients whose tumors express clot in 18.2. We believe 3021 has the potential to be used either as a monotherapy or in combination with a targeted agent, immunotherapy, or even chemotherapy, to address newly diagnosed patients with metastatic disease, as well as patients whose tumor have progressed on other therapies in the second or third line plus settings. And, as we'll discuss later on this morning's call, we are implementing a robust, multi-part clinical development strategy to evaluate our ADC across eligible gastric and GEJ populations. We are excited by these plans and are moving quickly to deliver the promise of 3021 as a paradigm changing treatment for gastric and GEJ cancers. I'll now turn the call over to Valerie to review the phase one data from patients treated in dose escalation and our next steps in greater detail. Valerie?