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11/9/2023
Good morning and welcome to the Intellia Therapeutics third quarter 2023 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 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' third quarter 2023 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, 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 pipeline progress. Laura will review our R&D updates, and Glenn will review our financials before we open up the call for questions, at which time Eliana Clark, our Chief Technical Officer, will also be available. With that, I'll now turn the call over to John, our Chief Executive Officer.
Thank you, Ian, and thank you all for joining us today. At Intelia, we're at the forefront of realizing the promise of genome editing in unprecedented ways. Through the remarkable efforts of our experienced team, we recently received FDA clearance to begin the first ever pivotal phase three trial of an in vivo CRISPR-based therapy. This marks Intelia's second in vivo IND that the agency has cleared this year, further demonstrating our deliberate and systematic approach to drug development. As a result of our commitment to high technical standards, whether in basic research, assessing safety, manufacturing, or in the clinical development of our drug candidates, we've moved another step closer towards ushering in a new era of medicine. With the imminent start of the phase three for NTLA-2001, Intellia is now a late stage drug development company. As David will go through in more detail, the latest interim data give us confidence that NTLA-2001 could potentially reset the standard of care for ATTR amyloidosis. These data, now from over 60 patients, showed a favorable safety profile, as well as consistently deep and durable TTR reductions following a single infusion. Alongside all the progress we've made with NTLA-2001, a broader pipeline and platform continue to advance as well. We're only weeks away from the planned completion of patient enrollment of the NTLA-2002 Phase 2 study for HAE. This means we are now approaching 100 patients dosed with either of our two lead in vivo candidates. Additionally, we expect to submit a regulatory filing to begin clinical development of our first wholly owned in vivo gene insertion program, NTLA-3001, in Q1 of next year. Overall, 2023 has already been a highly productive year, and there's still much more to come in the weeks and months ahead. In this challenging financial market that has impacted our entire sector, we continue to further tighten our financial management to turn the promise of gene editing into reality for patients. Our balance sheet remains strong and we are prioritizing programs and platform innovations we believe will address unmet needs and provide the greatest value to our shareholders. We're acutely focused on the efficient and rapid advancement of our two lead in vivo programs and their anticipated future commercialization. I'll now hand the call over to our Chief Medical Officer, David Leblall, who will provide an update on our clinical programs. David?
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