Intellia Therapeutics (NTLA) posts Q1 loss but advances lonvo-z and nex-z
Rhea-AI Filing Summary
Intellia Therapeutics reported first quarter 2026 results alongside major clinical milestones. In the Phase 3 HAELO trial, a one-time infusion of lonvo-z reduced hereditary angioedema attacks by 87% versus placebo over six months, with 62% of treated patients attack free and therapy free.
Intellia has begun a rolling BLA submission for lonvo-z and is targeting a potential U.S. launch in the first half of 2027. The FDA lifted clinical holds on the MAGNITUDE and MAGNITUDE-2 Phase 3 trials for nex-z in ATTR amyloidosis, and patient screening has resumed.
Financially, Q1 2026 collaboration revenue was $15.0 million and net loss was $96.2 million, or $0.81 per share. Cash, cash equivalents and marketable securities were $517.2 million as of March 31, 2026, and an April underwritten equity offering added approximately $207 million in gross proceeds, supporting operations at least into 2028.
Positive
- Transformative clinical milestone: Phase 3 HAELO data for lonvo-z showed an 87% reduction in HAE attacks versus placebo, with 62% of patients attack and therapy free, supporting a potentially first-in-class in vivo gene-editing therapy.
- Regulatory and development progress: Initiation of a rolling BLA for lonvo-z with RMAT designation and lifting of FDA clinical holds on MAGNITUDE and MAGNITUDE-2 for nex-z advance both key late-stage programs.
- Strengthened balance sheet and runway: Cash and marketable securities of $517.2 million plus approximately $207 million of April offering proceeds are expected to fund operations at least into 2028, beyond the anticipated U.S. launch of lonvo-z.
Negative
- None.
Insights
Strong Phase 3 data and extended cash runway support Intellia’s gene-editing strategy.
Intellia Therapeutics delivered positive Phase 3 results for lonvo-z in hereditary angioedema, with an 87% reduction in attacks versus placebo and 62% of patients attack and therapy free over six months. Safety was favorable, with only mild to moderate adverse events and no serious events reported in the treatment arm.
The company has initiated a rolling biologics license application for lonvo-z under its RMAT designation, aiming to complete submission in the second half of 2026 and targeting a potential U.S. launch in the first half of 2027. The FDA also lifted clinical holds on the MAGNITUDE programs for nex-z in ATTR amyloidosis, allowing Phase 3 patient screening to resume.
On the financial side, collaboration revenue was $15.0M in Q1 2026 and net loss was $96.2M, while cash and marketable securities of $517.2M plus an April equity raise of about $207M are expected to fund operations at least into 2028. Execution on the lonvo-z BLA timeline and enrollment completion in MAGNITUDE-2 in the second half of 2026 will be key upcoming milestones.
8-K Event Classification
Key Figures
Key Terms
in vivo CRISPR gene editing medical
biologics license application regulatory
regenerative medicine advanced therapy regulatory
hereditary angioedema medical
ATTR amyloidosis medical
Phase 3 clinical trial medical
Earnings Snapshot
Existing cash resources, including April 2026 offering proceeds, are expected to fund operations at least into 2028 and beyond the anticipated U.S. launch of lonvo-z.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On May 11, 2026, Intellia Therapeutics, Inc. announced its financial results and business updates for the quarter ended March 31, 2026. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 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 amended (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
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Description |
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99.1 |
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Press release dated May 11, 2026. |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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.
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Intellia Therapeutics, Inc. |
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May 11, 2026 |
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/s/ John M. Leonard |
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Name: John M. Leonard |
Exhibit 99.1
Intellia Therapeutics Announces First Quarter 2026 Financial Results and Business Updates
CAMBRIDGE, Mass., May 11, 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 first quarter ended March 31, 2026.
"It has been a remarkable start to 2026 for Intellia," said John Leonard, M.D., Intellia President and Chief Executive Officer. "With lonvo-z, we achieved a historic milestone by presenting the world's first Phase 3 data for an in vivo gene editing candidate and initiated a rolling BLA submission as we seek to provide a highly differentiated one-time treatment option to people living with HAE. We also recently resumed patient screening for both of our Phase 3 clinical trials in ATTR and strengthened our balance sheet with an underwritten public offering. We look forward to achieving additional important milestones during the remainder of the year."
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.
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Nexiguran Ziclumeran (Nex-z) for Transthyretin (ATTR) Amyloidosis
Nex-z is an investigational 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 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).
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Upcoming Events
The company will participate in the following events during the second quarter of 2026:
First Quarter 2026 Financial Results
About Intellia Therapeutics
Intellia Therapeutics, Inc. (Nasdaq: NTLA) is a leading clinical-stage biopharmaceutical company focused on revolutionizing medicine leveraging CRISPR gene editing and other core technologies. The company’s mission is to transform the lives of people with severe diseases by developing and commercializing potentially curative treatments. With deep scientific, technical and clinical development experience, Intellia aims to reset the standard for medicine by durably treating the root causes of disease. Learn more at intelliatx.com and follow us @intelliatx.
Forward-Looking Statements
This press release contains “forward-looking statements” of Intellia Therapeutics, Inc. (“Intellia” or the “company”) within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding Intellia’s beliefs and expectations concerning: the success and advancement of its clinical programs for lonvoguran ziclumeran or “lonvo-z” (previously referred to as NTLA-2002) for the treatment of hereditary angioedema (“HAE”) and
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nexiguran ziclumeran or “nex-z” (previously referred to as NTLA-2001) for transthyretin (“ATTR”) amyloidosis, including its plan to complete the submission of a biologics license application (“BLA”) for lonvo-z in the second half of 2026, its expectations regarding review and approval of that BLA, including the potential for accelerated review, its expectations regarding a planned U.S. launch of lonvo-z in the first half of 2027, and its plans to complete patient enrollment in MAGNITUDE-2 of nex-z for hereditary ATTR amyloidosis with polyneuropathy in the second half of 2026; the potential of lonvo-z to inactivate the KLKB1 gene to permanently lower kallikrein and bradykinin levels and to eliminate HAE attacks via a highly differentiated one-time treatment that is administered in an outpatient setting; the potential of nex-z to halt and reverse disease by driving a deep, consistent and potentially lifelong reduction in TTR protein after a one-time treatment; its ability to optimize the impact of its collaborations on its development programs, including, but not limited to, its collaboration with Regeneron Pharmaceuticals, Inc. (“Regeneron”) and their co-development program for ATTR amyloidosis; and its growth as a company and expectations regarding its uses of capital, expenses, future accumulated deficit and financial results, including its ability to fund operations at least into 2028 and well beyond lonvo-z’s anticipated U.S. commercial launch for HAE in the first half of 2027.
Any forward-looking statements in this press release are based on management’s current expectations and beliefs of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties 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 and nex-z, including risks related to the ability to develop and successfully commercialize lonvo-z, nex-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; uncertainties related to the authorization, initiation and conduct of preclinical and clinical studies and other development requirements for its product candidates, including uncertainties related to regulatory approvals to conduct clinical trials; 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; risks related to the potential delay of planned clinical trials due to regulatory feedback or other developments; and risks related to Intellia’s collaborations with Regeneron, or its other collaborations not continuing or not being successful. For a discussion of these and other risks and 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, as well as discussions of potential risks, uncertainties, and other important factors in Intellia’s other filings with the Securities and Exchange Commission, including its quarterly report on Form 10-Q. All information in this press release is as of the date of the release, and Intellia undertakes no duty to update this information unless required by law.
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INTELLIA THERAPEUTICS, INC. |
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CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) |
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(Amounts in thousands, except per share data) |
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Three Months Ended March 31, |
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2026 |
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2025 |
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Collaboration revenue |
$ |
15,048 |
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$ |
16,627 |
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Operating expenses: |
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Research and development |
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80,737 |
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108,427 |
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General and administrative |
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34,843 |
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29,007 |
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Total operating expenses |
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115,580 |
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137,434 |
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Operating loss |
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(100,532 |
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(120,807 |
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Other income, net: |
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Interest income |
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5,205 |
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8,603 |
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Change in fair value of investments, net |
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(904 |
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(2,125 |
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Total other income, net |
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4,301 |
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6,478 |
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Net loss |
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(96,231 |
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$ |
(114,329 |
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Net loss per share, basic and diluted |
$ |
(0.81 |
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$ |
(1.10 |
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Weighted average shares outstanding, basic and diluted |
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118,490 |
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103,500 |
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INTELLIA THERAPEUTICS, INC. |
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CONSOLIDATED BALANCE SHEET DATA (UNAUDITED) |
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March 31, 2026 |
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December 31, 2025 |
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Cash, cash equivalents and marketable securities |
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$ |
517,247 |
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$ |
605,134 |
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Total assets |
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758,779 |
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842,127 |
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Total liabilities |
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137,840 |
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170,733 |
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Total stockholders’ equity |
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620,939 |
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671,394 |
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Investor Contact:
Jason Fredette
Vice President, Investor Relations and Corporate Communications
Intellia Therapeutics, Inc.
jason.fredette@intelliatx.com
Media Contact:
Mike Tattory
Vice President
LifeSci Communications
mtattory@lifescicommunications.com
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