Intellia Therapeutics announces Q3 2026 results

Item 2.02 Results of Operations and Financial Condition.

On November 5, 2026, Intellia Therapeutics, Inc. announced its financial results and business updates for the quarter ended September 30, 2026.^{1 1}The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1¹ on this Current Report on Form 8-K.

The information in this report furnished pursuant to Item 2.02 shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended² (the "Exchange Act"), or otherwise subject to the liabilities of that section. It may only be incorporated by reference in another filing under the Exchange Act or the Securities Act of 1933, as amended, if such subsequent filing specifically references the information furnished pursuant to Item 2.02 of this report .

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit

No.

Description

99.1³

Press release dated November 5, 2026.³

104³

Cover Page Interactive Data File (embedded within the Inline XBRL document)³

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

Intellia Therapeutics, Inc.

Date:

November 5, 2026

By:

/s/ John M. Leonard⁴

Name: John M. Leonard⁴

Title: Chief Executive Officer and President⁴

Intellia Therapeutics Announces Third Quarter 2026 Financial Results and Business Updates

- On track to complete lonvo-z commercial readiness efforts in advance of March 10, 2027 PDUFA date

- New lonvo-z patient perspectives and Phase 1/2 durability data to be included in investor webcast and multiple presentations next week at ACAAI 2026

- Completed enrollment in MAGNITUDE-2 Phase 3 clinical trial in ATTRv-PN; advanced enrollment in MAGNITUDE in ATTR-CM

- Existing cash resources expected to fund operations at least into 2028¹² and well beyond lonvo-z's anticipated commercial launch, with recent term loan facility providing additional financial flexibility

CAMBRIDGE, Mass., November 5, 2026 – Intellia Therapeutics, Inc. (Nasdaq: NTLA), a leading biopharmaceutical company focused on revolutionizing medicine leveraging CRISPR gene editing and other core technologies, today reported business updates and financial results for the third quarter ended September 30, 2026.

"This is a defining period for Intellia as we advance our late-stage pipeline and prepare for a transformative year ahead," said John Leonard, M.D., Intellia President and Chief Executive Officer. "We have assembled the teams and capabilities needed to support a successful launch in HAE while also continuing to advance nex-z's Phase 3 clinical trials and our pipeline expansion efforts. Looking to 2027, we are working toward a historic milestone: the potential approval of lonvo-z as the world's first in vivo CRISPR-based therapy. As a one-time treatment, we believe it could transform the HAE treatment paradigm while also delivering significant value to patients, physicians, payers and the overall healthcare system."

Lonvoguran Ziclumeran (Lonvo-z) for Hereditary Angioedema (HAE)

Designed as a one-time treatment that is administered in an outpatient setting, lonvo-z is an in vivo CRISPR gene editing candidate that is intended to inactivate the kallikrein B1 ( KLKB1 ) gene to permanently lower kallikrein and bradykinin levels and to eliminate HAE attacks and the need for lifelong treatment.

• In September, the U.S. Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) for lonvo-z and granted the BLA Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date of March 10, 2027.⁵ Additionally, FDA advised that it is not⁶

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currently planning to hold an advisory committee to discuss the application.⁶ If approved, lonvo-z would be the world's first in vivo CRISPR-based therapy and the only one-time treatment for HAE.

• Intellia significantly advanced its launch readiness in recent months, completing the deployment of its field organization and deepening its engagement with HAE treatment centers and payers in preparation for a planned commercial launch in the first quarter of 2027.⁷

Nexiguran Ziclumeran (Nex-z) for Transthyretin (ATTR) Amyloidosis

Nex-z is an in vivo CRISPR-based therapeutic candidate designed to inactivate the TTR gene in the liver, thereby preventing the production of transthyretin (TTR) protein. Nex-z offers the possibility of halting and reversing disease by driving a rapid, deep, consistent and potentially lifelong reduction in TTR protein after a one-time treatment. Intellia leads the development and commercialization of nex-z in collaboration with Regeneron Pharmaceuticals, Inc. (Regeneron).¹⁰

• Intellia has made significant progress advancing enrollment in its MAGNITUDE Phase 3 clinical trial in ATTR amyloidosis with cardiomyopathy (ATTR-CM).⁹

• During the third quarter, the company completed enrollment in its MAGNITUDE-2 Phase 3 clinical trial in hereditary ATTR amyloidosis with polyneuropathy (ATTRv-PN), exceeding its targeted randomization of 60 patients.⁸

• During the third quarter, Intellia began providing investigators with human leukocyte antigen (HLA) genotyping results for patients enrolled or entering screening in the ongoing nex-z Phase 3 trials.

Other Recent Updates

• In September, Intellia entered into a non-dilutive senior secured term loan facility with OrbiMed, a leading global healthcare investment firm, for up to $400 million.¹¹ The transaction provides Intellia with greater financial and operational flexibility as it advances toward several key milestones, including the planned U.S. approval and commercial launch of lonvo-z in HAE.

• In October, the company announced the appointment of Jing L. Marantz, M.D., Ph.D., as Executive Vice President and Chief Medical Officer. Dr. Marantz is an accomplished drug development leader with more than 25 years of experience in the biopharmaceutical industry that includes the successful advancement of several now-approved rare disease therapies. In this role, she is leading the company's translational, development, regulatory and medical affairs functions.

Upcoming Events

The company will participate in the following upcoming events:

• November 6-9 – American Heart Association Scientific Sessions in Chicago, IL

• November 12 – Intellia investor webcast regarding lonvo-z in HAE

intelliatx.com

• November 15-18 – International Symposium on Amyloidosis in Montevideo, Uruguay

• November 17 – Jefferies London Healthcare Conference in London, England

• December 7-9 – 23 rd Global Cardiovascular Cl