Intellia Therapeutics, Inc.

Good morning and welcome to the Intellia first quarter 2025 financial results conference call. My name is Drew and I will be your conference operator today. Following formal remarks, we will open the call up for a question and answer session. This conference is being recorded at the company's request and will be available on the company's website following the end of the call. As a reminder, all participants are currently in listen-only mode. If anyone requires operator assistance during the conference, please press star zero on your telephone keypad. I will now turn the conference over to Brittany Chavez, Senior Manager of Investor Relations at Intelia. Please proceed.

Thank you, Operator, and good morning, everyone. Welcome to Intelia Therapeutics' first quarter 2025 earnings call. Earlier this morning, Intelia issued a press release outlining the company's progress this quarter, as well as topics for discussion on today's call. This release can be found on the investors and media section of Intelia's website at inteliatx.com. This call is being broadcast live and a replay will be archived on the company's website. At this time, I would like to take a minute to remind listeners that during this call, Intelia management may make certain forward-looking statements and ask that you refer to our SEC filings available at sec.gov for discussion of potential risks and uncertainties. All information presented on this call is current as of today, and Intelia undertakes no duty to update this information unless required by law. Joining me from Intelia are John Leonard, Chief Executive Officer, David LeBlanc, Chief Medical Officer, Ed Dulac, Chief Financial Officer, and Birgit Schulz, our Chief Scientific Officer, who will join for Q&A. John will begin with recent business highlights. David will then provide updates on our clinical pipeline progress. and Ed will review our financials before we open the call for questions. With that, I will now turn the call over to John, our Chief Executive Officer.

Thank you, Brittany. Good morning, everyone, and thank you all for joining us today. We entered the year with clear priorities and a plan for operational excellence, and we've already made tremendous progress in the first quarter. We're on a mission to offer life-changing benefits with one-time therapies for people living with severe diseases. Our progress is fueled by the core values of the company, one team, exploring possibilities, delivering results, and disrupting the status quo. We are committed to changing the treatment paradigm for patients suffering from hereditary angioedema and ATTR amyloidosis. Of the six milestones we outlined for 2025, we've accomplished two critical ones in the first three months of the year. dosing the first patient in our Phase III study for HAE and dosing the first patient in our Phase III study for hereditary ATTR with polyneuropathy. We continue to see significant interest from both investigators and patients across our programs. Enrollment in our global Phase III HALO study for HAE is progressing rapidly and reinforces our market research that the unmet need remains high despite existing treatment options. Patients are eager to pursue more convenient and more effective therapies. The transformational potential from a single infusion of NTLA-2002 resonates strongly with patients and physicians. Our global phase three magnitude study for ATTR with cardiomyopathy continues to be ahead of schedule. We now have over 90 sites actively enrolling. and we continue to benefit from interest in our emerging profile for Nexiguran cyclumarin, which we also refer to as Nexi, from our Phase I data presented last November. In the first quarter, the FDA granted Intelia the RMAT designation for Nexi for the treatment of ATTR with cardiomyopathy, which follows prior RMAT designations received for Nexi for ATTR with polyneuropathy and for NTLA-2002 in HAE. In parallel to the great execution of our phase three studies, we've been building critical commercial foundations in order to bring our promising therapies to patients as quickly as possible. During the past few months, our commercial team has broadened its leadership capabilities and includes extensive experience with one-time therapies and in disease areas of interest. We're increasingly confident in our ability to evolve into a strong, commercially ready company. We're excited to share multiple clinical updates throughout the year. We expect longer follow-up to further solidify the emerging and highly differentiated safety and efficacy profiles of our lead programs. In the case of HAE, we'll present new data from patients who have crossed over in our Phase 2 portion of our Phase 1-2 study later this year. This expansion of patients receiving the 50-milligram dose will provide a more robust perspective with more than 30 patients in total on the unique and valuable profile afforded by a one-time therapy like NTLA-2002. More immediately, in June, we'll have two-year follow-up data from our ongoing phase one study of NTLA-2002 at the European Academy of Allergy and Clinical Immunology Congress. Great TTR with polyneuropathy will extend the durability window out to at least three years further extending our leadership position in in vivo gene editing. We're confident in our plans, diligent in our execution, and excited by the value-creating opportunities that lie ahead. Before I hand the call over to David Levwall, our CMO, I want to take a moment to address how we're thinking about the regulatory environment given leadership changes and developments at the FDA. Like everyone else, we will monitor the situation closely And at this point, we've experienced no tangible changes to our interactions with the agency or timelines associated with our programs. We remain on track to meet or exceed our stated regulatory timeline and objectives. We remain in close communication with our review teams and continue to move our programs toward approval as per our original plan. We have a strong active relationship with the FDA as exemplified by the two prior RMAT designations and our most recent in ATTR-CM. We remain on course to file our first BLA in 2026. Similarly, we continue to monitor potential implications of pending pharmaceutical tariffs. We have well-established manufacturing and distribution capabilities and are confident in our ability to manufacture and deliver supply for our clinical trials and eventually commercial product upon approval. Beyond that, we're convinced our products will yield significant value for patients and the healthcare system. We're continuing to monitor the environment, but amidst all the changes, there's one thing that remains to say, and that's our dedication to bringing highly differentiated therapies that have the ability to reset the treatment standards for patients with HAE and ATTR. I'll now hand the call over to David Ledwall, who will provide an update on our clinical programs. David.