{"url_path":"/sec/ntla/8-k/2026-06-15/item-8-01","section_key":"item-8-01","section_title":"Item 8.01 Other Events.","topic":"sec","document":{"doc_type":"8-K","doc_date":"2026-06-15","source_url":"https://www.sec.gov/Archives/edgar/data/1652130/0001193125-26-270358-index.html","accession_number":"0001193125-26-270358","cik":"0001652130","ticker":"NTLA","issuer_name":"Intellia Therapeutics, Inc.","edgar_url":"https://www.sec.gov/Archives/edgar/data/1652130/0001193125-26-270358-index.html","primary_entity_key":"0001652130","primary_entity_name":"Intellia Therapeutics, Inc."},"word_count":1027,"has_tables":true,"body_markdown":"## Item 8.01 Other Events.\n\nOn June 13, 2026, the Company announced additional positive results from the global Phase 3 HAELO clinical trial of lonvoguran ziclumeran or “lonvo-z” (formerly NTLA-2002) for hereditary angioedema (“HAE”). The results were presented in a late-breaking oral presentation at the European Academy of Allergy & Clinical Immunology (“EAACI”) Annual Congress 2026 in Istanbul, Türkiye, and were simultaneously published in the New England Journal of Medicine.\n\nIntellia had previously reported that the HAELO trial met its primary endpoint with an 87% reduction (p<0.0001) in mean monthly attacks in the lonvo-z arm vs. the placebo arm during the efficacy evaluation period (weeks 5 to 28). In addition, 62% of patients in the lonvo-z arm were entirely attack free and therapy free for the six-month efficacy evaluation period, compared with 11% of patients in the placebo arm (p<0.0001), a key secondary endpoint. On June 13, 2026, Intellia reported data for the HAELO trial’s other key secondary endpoints:\n\nKey Secondary Endpoint\n\nLonvo-z Arm (N=52)\n\nPlacebo Arm (N=28)\n\nMonthly rate of attacks requiring on-demand treatment Weeks 5-28, mean (95% CI)\n\n0.19 (0.10, 0.36)\n\n1.79 (1.27, 2.54)\n\n \n\n89% reduction (79%, 94%), p<0.0001\n\nMonthly rate of moderate/severe attacks Weeks 5-28, mean (95% CI)\n\n0.11 (0.06, 0.23)\n\n1.23 (0.84, 1.81)\n\n \n\n91% reduction (81%, 96%), p<0.0001\n\nChange from baseline to Week 28 in AE-QoL total score, mean (95% CI)\n\n-23.51 (-27.64, -19.38)\n\n-6.47 (-12.26, -0.68)\n\n \n\n-17.04 improvement (-24.15, -9.93), p<0.0001\n\nAE-QoL: Angioedema Quality of Life score, which is a validated, angioedema-specific patient-reported outcome measure with a lower score indicating improved quality of life. A 6-point reduction is considered to be a clinically important improvement in AE-QoL. CI: Confidence interval\n\nFavorable safety and tolerability data were observed for lonvo-z. The most common treatment emergent adverse events (“TEAEs”) during the primary observation period (infusion through week 28) that were higher in the lonvo-z group compared to placebo were infusion-related reaction, headache, fatigue, back pain, and upper respiratory tract infection. All reported TEAEs were mild or moderate and there were no serious adverse events observed in the lonvo-z arm.\n\nIntellia also reported the following supplemental demographics, data and analyses from the HAELO trial:\n\n•\nA time plot showing that the mean monthly attack rate for patients receiving lonvo-z through the data cutoff (February 10, 2026) was well below the reported rate in prescreening while patients were receiving standard-of-care therapy;\n\n•\nPatient-level data demonstrating that all patients in the lonvo-z arm experienced attack-rate reductions from baseline during weeks 5 to 28;\n\n•\nAn analysis showing that meaningful attack-rate reductions were observed for all evaluated subgroups;\n\n•\nA breakdown showing that 20% of the patients who enrolled in the HAELO trial reported having complete disease control (no attacks) as their best response to prior long-term prophylaxis therapies; and\n\n•\nA plasma kallikrein time plot showing that protein levels decreased substantially by the first measurement (day 15), reached a steady state by week 5 and remained stable through the data cutoff.\n\nA rolling biologics license application submission for lonvo-z was initiated in April with the U.S. Food and Drug Administration. The Company continues to anticipate regulatory approval and a U.S. launch in the first half of 2027.\n\n## Forward Looking Statements.\n\nThis Current Report on Form 8-K and certain of the materials furnished or filed herewith contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, but are not limited to, express or implied statements regarding Intellia’s beliefs and expectations regarding: the success and advancement of its program for lonvoguran ziclumeran or “lonvo-z” (formerly NTLA-2002) for the treatment of hereditary angioedema (“HAE”), including its plan to complete the submission of a biologics license application (“BLA”) for lonvo-z, its expectations regarding review and approval of that BLA, and its expectations regarding a potential U.S. launch of lonvo-z in the first half of 2027; and the potential of one dose of lonvo-z to become the first one-time treatment for HAE and to permanently lower kallikrein by inactivating the kallikrein B1 (“KLKB1”) gene with a single dose.\n\nAny forward-looking statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that could cause actual results to differ materially and adversely from those set forth in or implied by any forward-looking statements. These risks, uncertainties and factors include, but are not limited to: uncertainties related to the conduct of clinical studies and other development and commercialization requirements for its product candidates, including lonvo-z, including risks related to the ability to develop and successfully commercialize lonvo-z or any of Intellia’s product candidates; risks related to Intellia’s ability to protect and maintain its intellectual property position; risks related to Intellia’s relationship with third parties, including its contract manufacturers, collaborators, licensors and licensees; risks related to the ability of its licensors to protect and maintain their intellectual property position; risks related to the results of preclinical studies or clinical studies not being predictive of future results in connection with future studies; the risk that clinical study results will not be positive; and risks related to the potential delay of planned clinical trials or regulatory filings due to regulatory feedback or other developments. For a discussion of these and other risks, uncertainties, and other important factors, any of which could cause Intellia’s actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in Intellia’s most recent annual report on Form 10-K and quarterly report on Form 10-Q filed with the Securities and Exchange Commission (“SEC”), as well as discussions of potential risks, uncertainties and other important factors in Intellia’s other filings with the SEC, including those contained or incorporated by reference. Any forward-looking statements represent Intellia’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Intellia explicitly disclaims any obligation to update any forward-looking statements, except as required by law."}