NTLA — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-11

• estimates of our expenses, future revenues, capital requirements and our needs for additional financing, including our ability to fund our ongoing operating expenses and capital expenditure requirements at least into 2028;

• Intellia Therapeutics, Inc. (“we,” “us,” “our,” “Intellia,” or the “Company”) is a leading biopharmaceutical company, focused on revolutionizing medicine leveraging CRISPR gene editing and other core technologies. Our mission is to transform the lives of people with severe diseases by developing and…

• For over a decade, we have applied our proprietary technologies and expertise, including CRISPR-based gene editing technologies, oligonucleotides, and lipid nanoparticles (“LNPs”), to develop novel, first-in-class product candidates. This includes the development of lonvoguran ziclumeran (“lonvo-z,”…

• Our management’s discussion and analysis of our financial condition and results of operations are based upon our unaudited condensed consolidated financial statements included in this Quarterly Report on Form 10-Q, which have been prepared by us in accordance with accounting principles generally acc…

• Our strategy is to (1) advance the clinical development of our lead CRISPR-based product candidates, (2) build and leverage a fully integrated commercial-stage infrastructure, (3) expand our pipeline utilizing our expertise and proprietary technologies, and (4) collaborate with partners to expand ou…

Text removed vs the prior filing · source: 10-Q · 2025-11-06

• estimates of our expenses, future revenues, capital requirements and our needs for additional financing;

• Intellia Therapeutics, Inc. (“we,” “us,” “our,” “Intellia,” or the “Company”) is a leading clinical-stage gene editing company, focused on revolutionizing medicine with CRISPR-based therapies. CRISPR is a gene editing technology which is also sometimes referred to as CRISPR/Cas or CRISPR/Cas9 when r…

• Our management’s discussion and analysis of our financial condition and results of operations are based upon our unaudited condensed consolidated financial statements included in this Quarterly Report on Form 10-Q, which have been prepared by us in accordance with accounting principles generally acc…

• For over a decade, we have been applying novel technologies, such as CRISPR-based gene editing technologies and lipid nanoparticle (“LNP”) delivery technologies, to develop in vivo and ex vivo product candidates. Our in vivo product candidates address genetic diseases by deploying our technologies, …

• Treating—and potentially curing—a broad range of severe diseases requires the application of multiple technologies. With our proprietary technologies at the core of our platform, we continue to research and develop new gene editing and delivery technologies to expand our therapeutic opportunities, f…

Text removed vs the prior filing · source: 10-Q · 2025-11-06

• interest, reasonable attorneys’ fees and other costs. On September 8, 2025, the defendants filed a motion to dismiss the amended complaint.

Text added vs the prior filing · source: 10-Q · 2026-05-11

• Our business may be adversely affected if we are unable to successfully file and obtain approval of our biologics license application (“BLA”) for lonvoguran ziclumeran (“lonvo-z”) for the treatment of patients with hereditary angioedema (“HAE”) or, following such approval, we are unable to successfu…

• Following the lifting of the clinical hold that the United States Food and Drug Administration (“FDA”) placed on our investigational new drug (“IND”) applications for the MAGNITUDE and MAGNITUDE-2 Phase 3 clinical trials of nexiguran ziclumeran (“nex-z”) for the treatment of patients with transthyre…

• CRISPR genome editing technology has only recently been clinically validated for human therapeutic use and may not be approved by regulatory authorities.

• The approaches we are taking to discover and develop novel therapeutics using CRISPR, gene editing and our other core technologies are unproven and may never lead to marketable products.

• Our technological advancements and any potential for revenue may be derived in part from our collaborations, including, for example, with Regeneron Pharmaceuticals, Inc. (“Regeneron”), and if the collaboration or co-development agreements related to a material collaboration were to be terminated or …

Text removed vs the prior filing · source: 10-Q · 2025-11-06

• Our investigational new drug (“IND”) applications for the MAGNITUDE and MAGNITUDE-2 Phase 3 clinical trials for patients with transthyretin (“ATTR”) amyloidosis with cardiomyopathy (“ATTR-CM”) and hereditary ATTR amyloidosis with polyneuropathy (“ATTRv-PN”), respectively, have been placed on clinica…

• CRISPR genome editing technology has only recently been clinically validated for human therapeutic use.

• The approaches we are taking to discover and develop novel therapeutics using CRISPR systems are unproven and may never lead to marketable products.

• If we experience delays or difficulties in the enrollment of patients in clinical trials, including as a result of the clinical hold on the IND applications for the MAGNITUDE and MAGNITUDE-2 Phase 3 clinical trials of nexiguran ziclumeran (“nex-z”, also referred to as NTLA-2001), our ability to comp…

• Our technological advancements and any potential for revenue may be derived in part from our collaborations, including, for example, with Regeneron Pharmaceuticals, Inc. (“Regeneron”), and if the collaboration or co-development agreements related to a material collaboration were to be terminated or …

Text added vs the prior filing · source: 10-Q · 2026-05-11

• Until the earlier of (a) September 30, 2027; (b) the first date on which all trades have been executed or all trading orders related to such trades have expired; and (c) the date on which the plan holder gives notice to terminate the plan.

• (1) The total number of shares that will be sold in accordance with this trading arrangement is indeterminable at the time of the filing of this Quarterly Report on Form 10-Q for the period ended March 31, 2026. Upon vesting of RSUs, it is our policy to immediately initiate a sell-to-cover in order …

Text removed vs the prior filing · source: 10-Q · 2025-11-06

• securities that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) or any non-Rule 10b5-1 trading arrangement.

• Until the earlier of (a) the close of trading on December 12, 2027; (b) the date that all shares of stock subject to the trading plan have been sold; and (c) the date on which the plan holder gives notice to terminate the plan.

• Until the earlier of (a) September 30, 2026; (b) the first date on which all trades have been executed or all trading orders related to such trades have expired; and (c) the date on which the plan holder gives notice to terminate the plan.

• (1) The number of shares that will be sold in accordance with this trading arrangement is indeterminable at the time of the filing of this Quarterly Report on Form 10-Q for the period ended September 30, 2025. Upon vesting of RSUs, it is our policy to immediately initiate a sell-to-cover in order to…