Intellia Therapeutics, Inc.: Q3 FY2026 earnings call

What management said about Q3 FY2026, from the documents filed with the SEC on 5 November 2026: press release. Guidance figures: 1 new, 1 kept. The quarter’s numbers.

Key takeaways

FDA accepted lonvo-z BLA with priority review: The FDA accepted the lonvo-z BLA in September, granted Priority Review, and set a PDUFA target action date of March 10, 2027. Source
MAGNITUDE-2 enrollment completed above target: Enrollment is complete in the MAGNITUDE-2 Phase 3 trial in ATTRv-PN, above the targeted randomization of 60 patients. Source
HLA genotyping results now provided to investigators: Investigators began receiving HLA genotyping results for patients enrolled or entering screening in the ongoing nex-z Phase 3 trials. Source
Net loss rose to $127.5 million: Net loss was $127.5 million, against $101.3 million a year earlier. Net loss per share, basic and diluted, was $0.91, against $0.92. Source
G&A rose on commercial buildout: G&A expenses were $46.1 million, against $30.5 million a year earlier, driven by consulting costs for commercial infrastructure and higher legal, facility and compensation costs. Source
Cash balance $614.8 million at quarter-end: Cash, cash equivalents and marketable securities were $614.8 million on September 30, 2026, up from $605.1 million at December 31, 2025. Source
Up to $400 million OrbiMed term loan: Management said the OrbiMed term loan gives greater financial and operational flexibility ahead of the planned lonvo-z approval and launch. Source

“This is a defining period for Intellia as we advance our late-stage pipeline and prepare for a transformative year ahead,”
John Leonard, M.D., Intellia President and Chief Executive Officer

Guidance

Area	Period	Figure	Against last quarter
Cash runway Source	Beyond the lonvo-z launch	at least into 2028	Kept
FDA review timing Source	Lonvo-z BLA target action date	March 10, 2027	New
Lonvo-z launch timing Source	U.S. commercial launch	first quarter of 2027

What changed from last quarter

New: The company entered a non-dilutive senior secured term loan facility with OrbiMed for up to $400 million in September. Source
New: Jing L. Marantz, M.D., Ph.D., was appointed Executive Vice President and Chief Medical Officer in October. Source

Lonvo-z regulatory review and launch

FDA accepted lonvo-z BLA with priority review: The FDA accepted the lonvo-z BLA in September, granted Priority Review, and set a PDUFA target action date of March 10, 2027. Source
Launch timing narrowed to first quarter: The second-quarter release gave a first-half 2027 launch window. The current release gives the first quarter of 2027 as the planned launch.
New durability data for next week: New lonvo-z patient perspectives and Phase 1/2 durability data are to be presented at the ACAAI 2026 meeting and in the investor webcast. Source

Nex-z Phase 3 enrollment

MAGNITUDE-2 enrollment completed above target: Enrollment is complete in the MAGNITUDE-2 Phase 3 trial in ATTRv-PN, above the targeted randomization of 60 patients. Source
MAGNITUDE enrollment advancing in ATTR-CM: Management said it made significant progress advancing enrollment in the MAGNITUDE Phase 3 trial in ATTR-CM during the quarter. Source
HLA genotyping results now provided to investigators: Investigators began receiving HLA genotyping results for patients enrolled or entering screening in the ongoing nex-z Phase 3 trials. Source

“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.”
John Leonard, M.D., Intellia President and Chief Executive Officer

Financial results

Collaboration revenue declined on Regeneron: Collaboration revenue was $7.2 million for the third quarter of 2026, against $13.8 million a year earlier. The company attributed the decrease to lower Regeneron revenue. Source
Net loss rose to $127.5 million: Net loss was $127.5 million, against $101.3 million a year earlier. Net loss per share, basic and diluted, was $0.91, against $0.92. Source
Unrealized investment loss in quarter: Net loss included a $10.4 million unrealized loss from changes in the fair value of investments, against a $3.4 million unrealized gain a year earlier. Source

Operating expenses

R&D spending fell year over year: R&D expenses were $83.3 million, against $94.7 million a year earlier, on lower external lonvo-z costs and lower stock-based compensation. Source
G&A rose on commercial buildout: G&A expenses were $46.1 million, against $30.5 million a year earlier, driven by consulting costs for commercial infrastructure and higher legal, facility and compensation costs. Source
Stock compensation split across expenses: Stock-based compensation was $7.4 million in R&D and $7.0 million in G&A for the third quarter of 2026. Source

“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.”
John Leonard, M.D., Intellia President and Chief Executive Officer

Cash, financing and runway

Cash balance $614.8 million at quarter-end: Cash, cash equivalents and marketable securities were $614.8 million on September 30, 2026, up from $605.1 million at December 31, 2025. Source
Runway guidance excludes lonvo-z revenue: The runway guidance excludes all potential lonvo-z commercial revenue and potential future funding from the term loan facility. Source
Up to $400 million OrbiMed term loan: Management said the OrbiMed term loan gives greater financial and operational flexibility ahead of the planned lonvo-z approval and launch. Source

Leadership and launch team

Chief medical officer leads development functions: Dr. Marantz leads the company's translational, development, regulatory and medical affairs functions. Source
Experience with approved rare disease therapies: Dr. Marantz has more than 25 years of biopharmaceutical industry experience, including advancing several now-approved rare disease therapies. Source
Launch field organization deployment completed: The company completed deployment of its field organization and deepened engagement with HAE treatment centers and payers. Source

Coming up, as management said on 5 November 2026

Amyloidosis symposium in Uruguay: The company will participate in the International Symposium on Amyloidosis in Montevideo, November 15-18. Source
Cardiovascular trialists forum in December: The company will participate in the 23rd Global Cardiovascular Clinical Trialists Forum in Washington, D.C., December 7-9. Source

Figures management reported

Figure	Reported
R&D expenses Source	$83.3 million for the third quarter of 2026
Pipeline milestone: lonvo-z BLA Source	Accepted with Priority Review; PDUFA March 10, 2027
Trial enrollment: MAGNITUDE-2 Source	Enrollment completed, above 60-patient randomization target

Risks management discussed

Regulatory: Lonvo-z launch depends on FDA approval, which is pending the review under the BLA with a March 10, 2027 PDUFA date. Source
Regulatory: Earlier release reported that the highest liver transaminase elevations in nex-z trials were in patients carrying one specific HLA allele, with FDA engagement under way.

Earlier plans management reported on

On track: Management said it is on track to complete lonvo-z commercial readiness efforts before the March 10, 2027 PDUFA date. Source
Met: The prior release expected FDA acceptance in the second half of 2026; the current release reports acceptance in September.
Met: The prior release said enrollment was on track for the second half of 2026; the current release reports enrollment completed in the third quarter.
Met: The prior release said results would be provided; the current release says investigators began receiving them in the third quarter.

Other quarters

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.

As filed with the SEC

Open the filing on EDGAR

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 2028 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. Additionally, FDA advised that it is not currently planning to hold an advisory committee to discuss the application. 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.

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).

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

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.

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. 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

November 12-16 - American College of Allergy, Asthma & Immunology 2026 Annual Scientific Meeting in Phoenix, AZ

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

November 17 - Jefferies London Healthcare Conference in London, England

December 7-9 - 23 Global Cardiovascular Clinical Trialists Forum in Washington, D.C.

Third Quarter 2026 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $614.8 million as of September 30, 2026, compared to $605.1 million as of December 31, 2025. The company’s existing cash resources are expected to fund its operations at least into 2028 and well beyond lonvo-z’s anticipated U.S. approval and commercial launch in HAE in the first quarter of 2027. This guidance excludes all potential commercial revenues from lonvo-z and potential future funding from the company’s term loan facility.

Collaboration Revenue: Collaboration revenue was $7.2 million for the third quarter of 2026, compared to $13.8 million for the third quarter of 2025. The decrease is primarily due to a reduction in revenue from Regeneron.

R&D Expenses: Research and development (R&D) expenses were $83.3 million for the third quarter of 2026, compared to $94.7 million for the third quarter of 2025. The decrease was primarily driven by lower external costs related to lonvo-z, lower stock-based compensation and lower research materials and contracted services costs, partially offset by higher headcount-related expenses. Stock-based compensation expense included in R&D expenses was $7.4 million for the third quarter of 2026.

G&A Expenses: General and administrative (G&A) expenses were $46.1 million for the third quarter of 2026, compared to $30.5 million for the third quarter of 2025. The increase was primarily driven by consulting costs associated with the continued buildout of the company’s commercial infrastructure and higher legal, facility-related and compensation expenses. Stock-based compensation expense included in G&A expenses was $7.0 million for the third quarter of 2026.

Net Loss: Net loss was $127.5 million for the third quarter of 2026, compared to $101.3 million for the third quarter of 2025. Net loss for the third quarters of 2026 and 2025 included an unrealized loss of $10.4 million and an unrealized gain of $3.4 million, respectively, due to changes in the fair value of investments.

About Intellia Therapeutics

Intellia Therapeutics, Inc. (Nasdaq: NTLA) is a leading 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

Forward-looking statements notice

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 nexiguran ziclumeran or “nex-z” (previously referred to as NTLA-2001) for transthyretin (“ATTR”) amyloidosis, including its expectations regarding the review and potential approval by the U.S. Food and Drug Administration its biologics license application (“BLA”) for lonvo-z, its expectations regarding the planned U.S. launch of lonvo-z in the first quarter of 2027, including its ability to complete lonvo-z commercial readiness efforts in advance of the Prescription Drug User Fee Act date of March 10, 2027, and its belief that lonvo-z could transform the HAE treatment paradigm while also delivering significant value to patients, physicians, payers and the overall healthcare system; the potential of lonvo-z to inactivate the KLKB1 gene to permanently lower kallikrein and bradykinin levels and to eliminate HAE attacks and the need for lifelong treatment; the potential of nex-z to inactivate the TTR gene and to halt and reverse disease by driving a rapid, deep, consistent and potentially lifelong reduction in TTR protein after a one-time treatment and to deliver clinically meaningful outcomes for patients; 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 expectations regarding its non-dilutive senior secured term loan facility with OrbiMed providing greater financial and operational flexibility and its ability to fund operations at least into 2028 and well beyond lonvo-z’s anticipated U.S. approval and commercial launch in HAE in the first quarter of 2027.

Forward-looking statements notice

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 nonclinical 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 recent 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.

			Three Months Ended September 30,		Nine Months Ended September 30,
			2026	2025	2026	2025
INTELLIA THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(Amounts in thousands, except per share data)
Collaboration revenue			$7,163	$13,782	$29,870	$44,654
Operating expenses:
	Research and development		83,346	94,747	246,678	300,209
	General and administrative		46,142	30,512	118,809	86,725
		Total operating expenses	129,488	125,259	365,487	386,934
Operating loss			(122,325)	(111,477)	(335,617)	(342,280)
Other (expense) income, net:
	Interest income and other, net		5,837	6,714	16,839	22,719
	Interest expense		(611)	-	(611)	-
	Change in fair value of investments, net		(10,386)	3,439	(10,961)	2,653
		Total other (expense) income, net	(5,160)	10,153	5,267	25,372
Net loss			$(127,485)	$(101,324)	$(330,350)	$(316,908)
Net loss per share, basic and diluted			$(0.91)	$(0.92)	$(2.53)	$(2.99)
Weighted average shares outstanding, basic and diluted			140,186	110,188	130,802	105,841

	September 30, 2026	December 31, 2025
INTELLIA THERAPEUTICS, INC.
CONSOLIDATED BALANCE SHEET DATA (UNAUDITED)
(Amounts in thousands)
Cash, cash equivalents and marketable securities	$614,807	$605,134
Total assets	902,560	842,127
Total liabilities	289,471	170,733
Total stockholders’ equity	613,089	671,394

Contacts
Jason Fredette
Vice President, Investor Relations and Corporate Communications
Intellia Therapeutics, Inc.
jason.fredette@intelliatx.com
Mike Tattory
Vice President
LifeSci Communications mtattory@lifescicomms.com