Intellia Therapeutics, Inc.

Good morning and welcome to the Intellia Therapeutics fourth quarter and full year 2022 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 a listen-only mode. If you need operator assistance, press star then zero. I will now turn the conference over to Ian Karp, Senior Vice President of Investor Relations and Corporate Communications at Intelia. Please proceed.

Thank you, operator, and good morning, everyone. Welcome to Intelia Therapeutics' fourth quarter and full year 2022 earnings call. Earlier this morning, Intellia 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 Dr. John Leonard, Chief Executive Officer, Dr. David Lebwal, Chief Medical Officer, Dr. Laura Sepp-Lorenzino, Chief Scientific Officer, and Glenn Goddard, Chief Financial Officer. John will begin with an overview of recent business highlights. David will provide an update on our clinical programs. Laura will recap the company's R&D progress across our pipeline. And Glenn will review Intellia's financial results for the fourth quarter and full year 2022. John will then offer some concluding remarks before we open up the call for Q&A. With that, I'll now turn the call over to John.

Thank you, Ian, and thank you all for joining us this morning. At Intelia, we're advancing our leadership position as the industry's most innovative genome editing company with the broadest and deepest toolbox of novel editing and delivery solutions. 2022 proved to be another outstanding year for Intelia with several significant clinical milestones achieved across our pipeline. Having demonstrated human proof of concept for our first two in vivo clinical candidates, NTLA-2001 and NTLA-2002, we're now two for two. Notably, we've dosed more than 50 patients with our in vivo CRISPR-based therapies in ongoing clinical studies, with durability and safety data now out two years in the earliest patients. These accomplishments reflect steady execution against our core strategy to harness the immense power of CRISPR-based technologies, both for in vivo and ex vivo applications. Building on last year's strong momentum, we've already hit the ground running this year. We're pleased to share today that we initiated the phase two portion of the NTLA-2002 study outside of the U.S. Recently, we also submitted an IND application to the FDA to enable U.S. patient enrollment in this trial. We're highly encouraged by the rapid progress we have made in just the past few months and expect to hear back from the FDA in the coming weeks. Looking ahead for NTLA-2001, We're poised to submit an IND application for a pivotal trial for the cardiomyopathy manifestation of ATTR amyloidosis mid-year with a trial initiation anticipated by the end of the year, subject, of course, to regulatory feedback. Importantly, we look forward to presenting new interim clinical updates from both ongoing NTLA-2001 and NTLA-2002 first in human studies this year. Turning to our research pipeline, We are advancing new platform capabilities to the clinic. This includes our CRISPR-based in vivo targeted gene insertion technology and a first of its kind allogeneic cell engineering solution designed to avoid both T cell and NK cell mediated rejection. Additionally, we're leading the development of new gene editing and delivery modalities, which will drive further pipeline growth and allow us to reach a greater number of patients with our genetic medicines. With that introduction, I'll hand the call over to our Chief Medical Officer, David Lebwal, who will review NTLA-2001 and NTLA-2002's progress in greater detail and outline updates across our clinical pipeline. David?