Intellia Therapeutics, Inc.

Good morning and welcome to Intellia Therapeutics' fourth quarter and full year 2024 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, manager of investor relations at Intelia. Please proceed.

Thank you, operator, and good morning, everyone. Welcome to Intelia Therapeutics' fourth quarter and full year 2024 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 Intellia's website at intelliatx.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, Intellia 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 Lebwal, 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 the 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're off to a strong start in 2025 with renewed focus on our operational execution. Withdrawing support and interest from investigators and patients, we're making remarkable headway with enrollment across our late-stage studies. We see significant promise with NTLA-2002 for the treatment of hereditary angioedema, where we expect a complete enrollment in our Phase III study, HALO, in the second half of 2025. We are similarly encouraged by the pace of enrollment with our Phase III studies for transthyretin amyloidosis and expect enrollment in magnitude, our cardiomyopathy study, to exceed 550 total patients by year end. Both HAE and TTR represent substantial market opportunities. We have doubled down on our efforts to ready the company for the rapidly approaching commercial phase. In November, we presented positive extended follow-up data from patients in the ongoing phase one trial of Nexi, previously known as NTLA-2001. in patients with transthyretin or ATTR amyloidosis. The phase one data offered compelling evidence that deep and persistently low levels of TTR reduction achieved with Nexi may favorably impact disease progression for people living with ATTR amyloidosis. David will review these results in greater detail. We are actively screening patients with ATTR amyloidosis with polyneuropathy in our phase three magnitude two study and are on track to dose the first patient in the coming weeks. As you may recall, this pivotal trial is an efficient study with expected enrollment of 50 patients. We plan to measure MNIST plus seven at 18 months and serum TTR levels as key endpoints in the study. We expect enrollment to be completed in 2026, enabling our second BLA filing by 2028. Last month, we announced the first patient had been dosed with NTLA-2002 in HALO, our Phase III study in HAE. Enthusiasm for NTLA-2002 from patients and our investigators is high, and we believe this Phase III study will enroll rapidly, enabling us to submit a BLA filing in 2026. At the beginning of this year, We conducted a pipeline prioritization to focus our resources and efforts on these late stage and high value programs, NCLA-2002 and NEXE. We discontinued our work on NCLA-3001 in favor of a second generation approach. And we'll now look to see human proof of concept for our insertion technology by Regeneron in their Hemophilia A program. As we look ahead to the rest of the year, we are well positioned for near-term value creation. We have three phase three programs actively recruiting and one singular focus, getting the work done to enable three launches between 2027 and 2030. We're excited by our progress and by our prospects. So we look forward to sharing data from both of our programs later this year. Lastly, I would like to take this time to welcome Birgit Schultz, our newly appointed chief scientific officer. She's an outstanding scientist with over 20 years of experience in drug development and biotechnology, including the clinical development of cell therapies and complex biologic products. She has experience with our entire suite of gene editing technologies and is leading our more concentrated in vivo and ex vivo research efforts. I'll now hand the call over to our chief medical officer, David Lebwald, who will provide an update on our clinical programs. David?