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11/7/2024
Good morning and welcome to Intellia Therapeutics' third quarter 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 Lina Lee, Senior Director of Investor Relations and Corporate Communications at Intelia. Please proceed.
Thank you, operator, and good morning, everyone. Welcome to Intelia Therapeutics' third quarter 2024 earnings call. Earlier this morning, Intelia issued a press release outlining the company's progress this quarter, as well as topics for discussion in 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 the discussion of potential risks and uncertainty. All information presented on this call is current as of today, and Intellia undertakes no duty to update this information unless required by law. Joining me from Intelia are John Leonard, Chief Executive Officer, David Ledwell, Chief Medical Officer, Laura Cepalanzino, Chief Scientific Officer, and Ed Dulac, Chief Financial Officer. John will begin with recent business highlights. David will provide updates on our clinical pipeline progress. Laura will then provide R&D updates, 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, Lena. Good morning, everyone. And thank you all for joining us today. At Intelia, we are ushering in a new era of medicine. During the third quarter and more recent period, we've made substantial progress in our efforts to bring promising, highly differentiated, and potentially curative CRISPR-based gene editing treatments to patients. In October, at the American College of Allergy, Asthma, and Immunology annual scientific meeting, we presented unprecedented positive results from our phase two study of NTLA-2002 for the treatment of hereditary angioedema. These results showed that a simple one-time infusion of NKLA-2002 offers patients the potential for a functional cure. For people living with HAE, current treatment options are limited to chronically administered prophylactic therapies to prevent or manage attacks and the use of on-demand therapy to control breakthrough attacks. Because of this, Available therapies place emphasis on attack rate reductions for their lifelong treatments. However, our market research is clear. Patients want to lead a normal life, one that is free of attacks, free of chronic treatment, and free of mental burden around potential triggers and the loss of access to their therapies. The emerging profile for NKLA-2002 provides help that a single intervention may lead to the complete elimination of angioedema attacks and remove the need for subsequent prophylaxis therapy for most patients. The opportunity to deliver such a profile will create significant value for patients and the healthcare system as a whole. We're extremely encouraged for our phase two results, and we're actively screening patients in the phase three HALO study. The strong enthusiasm for NTLA-2002 from patients and our investigators strengthens our conviction that the phase three will enroll rapidly, enabling us to submit a plan BLA in 2026. In addition, we're making excellent progress across our other late stage trials. As announced this morning, the FDA cleared our IND application for magnitude two, our phase three trial of Nexi for patients with hereditary ATTR amyloidosis with polyneuropathy. We expect to initiate the study in the coming days. Since dosing our first cardiomyopathy patient in March, we continue to see strong momentum in our phase three magnitude study, and enrollment is tracking ahead of our internal projections. With three active phase three studies expected by year end, we are leading the field of in vivo CRISPR-based medicines. Intelia is ushering in a new era of medicine with the prospect of a functional cure for patients suffering from HAE and a treatment that may change the course of the disease for people with ATTR amyloidosis. I'll now hand the call over to our Chief Medical Officer, David Lebwal, who will provide an update on our clinical programs. David?
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