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8/3/2023
Good morning and welcome to the Intellia Therapeutics second quarter 2023 earnings 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 Intellia Therapeutics' second quarter 2023 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, 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 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 review our R&D progress, and Glenn will review Intellia's financial results for the second quarter of 2023 before we open up the call for your 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 leading the genome editing revolution with the broadest and deepest toolbox of novel editing and delivery solutions. 2023 continues to be another year of important progress across our clinical pipeline and differentiated genome editing platform. We're particularly pleased with the significant advancement of our two lead clinical programs. Not only are these two programs potentially paradigm-shifting treatments for patients with ATTR, amyloidosis, and HAE, But our success and learnings from these investigational therapies will help set the foundation for our broader long-term goals and strategic priorities. Starting with NTLA-2002 in development for the treatment of hereditary angioedema, today we announced that in just a handful of months, we were able to identify all patients required to fully enroll the ongoing Phase II portion of the study. Notably, we now expect to initiate the Phase III program as early as the third quarter of next year subject to regulatory feedback. In addition to the exceptional clinical development execution and recent positive data update for NTLA-2022, we're getting very close to submitting our second in vivo IND application. This next IND submission, expected in September, will support the planned pivotal trial of NTLA-2001 for people with a cardiomyopathy manifestation of ATTR amyloidosis. Some estimates indicate there may be as many as 500,000 people around the world who suffer from this disease. Subject to regulatory feedback, we expect to initiate the global phase three by year end. We believe all this progress positions us well to deliver on initiating pivotal studies for both programs, a core strategic priority over this year and next. Lastly, I'd like to take this opportunity to thank Jean-Francois Formella, one of our founding board members who retired from our board in June. Jeff's vision and leadership over the past decade have been integral to our growth and recent achievements. I'll now hand the call over to our chief medical officer, David Leblon, who will review the lead clinical programs in greater detail. David?
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