Intellia Therapeutics, Inc.: Q2 FY2026 earnings call

What management said about Q2 FY2026, from the documents filed with the SEC on 6 August 2026: press release. Guidance figures: 3 kept. The quarter’s numbers.

Key takeaways

Net loss rose modestly: The company reported a net loss of $106.6 million, against $101.3 million a year earlier. The operating loss was $112.8 million. Source
Phase 3 HAELO met primary endpoint: Lonvo-z reduced attacks 87% versus placebo over weeks 5 to 28, with mean monthly attack rates of 0.26 and 2.10 (p<0.0001). Data were presented at EAACI and published in NEJM. Source
BLA acceptance expected second half: The company expects FDA to accept the lonvo-z BLA in the second half of 2026. If approved, U.S. launch is planned for the first half of 2027. Source
Phase 3 enrollment resumed: Enrollment in the nex-z Phase 3 trials resumed during the second quarter, after the FDA lifted the clinical holds earlier in the year. Source
HLA allele tied to liver enzymes: A genomic analysis of more than 600 patient samples, with Regeneron and external experts, found the highest liver transaminase elevations in carriers of one HLA allele. Source
G&A rose on commercial buildout: G&A expenses were $37.8 million against $27.2 million, driven by commercial infrastructure buildout, higher legal expenses and stock-based compensation. Source
Cash rose to $628.4 million: Cash, cash equivalents and marketable securities were $628.4 million at June 30, 2026, up from $605.1 million at December 31, 2025. Source

“The second quarter was a momentous period for Intellia highlighted by the positive Phase 3 HAELO clinical trial results we reported for lonvo-z in hereditary angioedema,”
John Leonard, M.D., Intellia President and Chief Executive Officer

Guidance

Area	Period	Figure	Against last quarter
Lonvo-z BLA review Source	second half of 2026	FDA acceptance of BLA submission in second half of 2026
Lonvo-z U.S. launch Source	first half of 2027	first half of 2027	Kept
Nex-z MAGNITUDE-2 enrollment Source	second half of 2026	completion of patient enrollment in second half of 2026	Kept
Cash runway Source	at least into 2028	fund operations at least into 2028	Kept

What changed from last quarter

New: The company disclosed a genomic analysis linking the highest observed liver transaminase elevations in nex-z trials to one HLA allele. The first-quarter release did not include this. Source
New: The company launched a patient awareness campaign for HAE during the second quarter. Source

Quarter financial results

Net loss rose modestly: The company reported a net loss of $106.6 million, against $101.3 million a year earlier. The operating loss was $112.8 million. Source
Collaboration revenue declined: Collaboration revenue was $7.7 million, compared with $14.2 million a year earlier. Management attributed the decrease mainly to lower revenue from Regeneron. Source
Per-share loss narrowed: Net loss per share, basic and diluted, was $(0.80) against $(0.98). Weighted average shares rose to 133.5 million from 103.7 million. Source

Lonvo-z for hereditary angioedema

Phase 3 HAELO met primary endpoint: Lonvo-z reduced attacks 87% versus placebo over weeks 5 to 28, with mean monthly attack rates of 0.26 and 2.10 (p<0.0001). Data were presented at EAACI and published in NEJM. Source
Attack-free rate reached 62%: 62% of lonvo-z patients were entirely attack free and therapy free over the six-month period, against 11% on placebo. All key secondary endpoints were met at p<0.0001. Source
No serious adverse events reported: The most common adverse events were infusion-related reactions, headache, fatigue, back pain and upper respiratory tract infection. All were mild or moderate, and none were serious in the lonvo-z arm. Source
BLA acceptance expected second half: The company expects FDA to accept the lonvo-z BLA in the second half of 2026. If approved, U.S. launch is planned for the first half of 2027. Source
Launch readiness teams finalized: Field medical, reimbursement and strategic accounts teams were finalized. The company has engaged HAE treatment centers around the U.S. Source

“We also resumed enrollment in our Phase 3 clinical trials in ATTR during the second quarter and gained important new genomic insights that enhance our understanding of nex-z’s safety profile”
John Leonard, M.D., Intellia President and Chief Executive Officer

Nex-z for ATTR amyloidosis

Phase 3 enrollment resumed: Enrollment in the nex-z Phase 3 trials resumed during the second quarter, after the FDA lifted the clinical holds earlier in the year. Source
HLA allele tied to liver enzymes: A genomic analysis of more than 600 patient samples, with Regeneron and external experts, found the highest liver transaminase elevations in carriers of one HLA allele. Source
HLA genotyping results to be shared: The company will provide HLA genotyping results to investigators and patients in the ongoing nex-z Phase 3 trials while it engages FDA and global health authorities. Source
Phase 1 ATTR data presented: Nex-z Phase 1 clinical data in ATTR were presented at the Peripheral Nerve Society meeting in Maastricht and the ESC Heart Failure Congress in Barcelona. Source

Operating expenses

R&D expense fell year on year: R&D expenses were $82.6 million against $97.0 million, driven by lower external costs for lead programs and reduced stock-based compensation, partly offset by headcount-related costs. Source
G&A rose on commercial buildout: G&A expenses were $37.8 million against $27.2 million, driven by commercial infrastructure buildout, higher legal expenses and stock-based compensation. Source
Stock-based compensation totals: Stock-based compensation was $9.4 million in R&D and $8.6 million in G&A for the quarter. Source

“Underpinned by a recent capital raise that strengthened our balance sheet, we are well positioned to deliver on our research, regulatory, clinical and commercial objectives,”
John Leonard, M.D., Intellia President and Chief Executive Officer

Cash position and capital raise

Cash rose to $628.4 million: Cash, cash equivalents and marketable securities were $628.4 million at June 30, 2026, up from $605.1 million at December 31, 2025. Source
April offering added net proceeds: An underwritten public offering of common stock completed in April 2026 produced approximately $195 million in net proceeds. Source
Runway guidance excludes lonvo-z sales: The cash runway guidance does not include any potential commercial revenue from lonvo-z. Source
Balance sheet at quarter end: Total assets were $857.2 million, total liabilities $129.5 million and stockholders’ equity $727.7 million at June 30, 2026. Source

Regeneron collaboration

Regeneron co-develops nex-z: Intellia leads nex-z development and commercialization in collaboration with Regeneron. Collaboration revenue from Regeneron declined in the quarter. Source

Coming up, as management said on 6 August 2026

FDA acceptance of lonvo-z BLA: Management expects FDA to accept the lonvo-z BLA in the second half of 2026. Source
Lonvo-z U.S. launch planned: If approved, the company plans a commercial launch of lonvo-z in the U.S. in the first half of 2027. Source
MAGNITUDE-2 enrollment completion: Patient enrollment in MAGNITUDE-2 is expected to be completed in the second half of 2026. Source
Third-quarter investor conferences: The company will attend the Bradykinin Symposium on September 2-3 in Berlin, the Wells Fargo conference on September 9 in Boston and the Morgan Stanley conference on September 14 in New York. Source

Figures management reported

Figure	Reported
R&D expense Source	$82.6 million
Phase 3 trial readout Source	87% attack reduction versus placebo
Pipeline milestone Source	BLA acceptance expected second half of 2026
Phase 3 enrollment Source	MAGNITUDE-2 completion expected second half of 2026

Risks management discussed

Regulatory: The HLA finding for nex-z liver enzyme elevations is under discussion with the FDA and global health authorities, and HLA results will be shared with trial investigators and patients. Source
Financial: Collaboration revenue fell because of lower revenue from Regeneron, the partner on nex-z development. Source
Financial: G&A rose as the company builds commercial infrastructure ahead of the planned lonvo-z launch, adding cost before any product revenue. Source

Earlier plans management reported on

On track: Management states the MAGNITUDE-2 enrollment target remains on track for the second half of 2026, the same timing given in the first-quarter release. Source
Met: The first-quarter release said screening had recently resumed. This release says enrollment resumed during the second quarter. Source
Not stated: The first-quarter release planned to complete the BLA submission in the second half of 2026. This release gives FDA acceptance in that period as the expected milestone. Source

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 Second Quarter 2026 Financial Results and Business Updates

Positive Phase 3 HAELO clinical data for lonvo-z in HAE presented at EAACI and published in New England Journal of Medicine

Anticipate FDA acceptance of BLA for lonvo-z in second half of 2026 and U.S. launch in first half of 2027

Enrollment successfully reinitiated in nex-z Phase 3 clinical trials; MAGNITUDE-2 enrollment in ATTRv-PN expected to be completed in second half of 2026

New genomic insights enhance understanding of nex-z’s profile and potential to deliver clinically meaningful outcomes for patients

Ended second quarter with approximately $628 million in cash, cash equivalents and marketable securities; expected to fund operations at least into 2028

CAMBRIDGE, Mass., August 6, 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 second quarter ended June 30, 2026.

“The second quarter was a momentous period for Intellia highlighted by the positive Phase 3 HAELO clinical trial results we reported for lonvo-z in hereditary angioedema,” said John Leonard, M.D., Intellia President and Chief Executive Officer. “These data serve as strong validation for in vivo gene editing and lonvo-z’s potential to transform the treatment paradigm for patients who are burdened by this disease.”

“We also resumed enrollment in our Phase 3 clinical trials in ATTR during the second quarter and gained important new genomic insights that enhance our understanding of nex-z’s safety profile and its potential to deliver clinically meaningful outcomes for patients. Underpinned by a recent capital raise that strengthened our balance sheet, we are well positioned to deliver on our research, regulatory, clinical and commercial objectives,” Dr. Leonard concluded.

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.

In April, Intellia announced positive topline results from the global Phase 3 HAELO clinical trial of lonvo-z in HAE. In June, additional data were reported in a late-breaking oral session at the European Academy of Allergy & Clinical Immunology Annual Congress 2026 and in a manuscript published in the New England Journal of Medicine. Highlights included:

The trial met its primary endpoint. For the six-month efficacy evaluation period (weeks 5 to 28), a one-time infusion of lonvo-z reduced attacks by 87% versus placebo, with a mean monthly attack rate of 0.26 in the lonvo-z arm compared with 2.10 in the placebo arm (p<0.0001).

The trial met all of its key secondary endpoints with statistical significance (p<0.0001). These included:

62% of patients were entirely attack free and therapy free in the lonvo-z arm for the six-month efficacy evaluation period, compared with 11% of patients in the placebo arm;

The mean monthly rate of attacks requiring on-demand treatment was 0.19 in the lonvo-z arm for the six-month efficacy evaluation period, compared with 1.79 in the placebo arm;

The mean monthly rate of moderate/severe attacks was 0.11 in the lonvo-z arm for the six-month efficacy evaluation period, compared with 1.23 in the placebo arm; and

The change in Angioedema Quality of Life (AE-QoL) total score was -23.51 in the lonvo-z arm from baseline to week 28, compared with -6.47 in the placebo arm.

All patients in the lonvo-z arm experienced attack-rate reductions from baseline compared with weeks 5 to 28.

Attack-rate reductions were observed for all evaluated subgroups.

All patients who received lonvo-z at baseline or in crossover after week 28 remained free from long-term prophylaxis therapy as of the February 10, 2026 data cutoff.

Favorable safety and tolerability data were observed for lonvo-z. The most common treatment emergent adverse events (TEAEs) were infusion-related reactions, headache, fatigue, back pain, and upper respiratory tract infection. All TEAEs reported were mild or moderate (Grade 1 or Grade 2), and there were no serious adverse events observed in the lonvo-z arm.

During the second quarter, the company launched www.HAEreframed.com. The campaign aims to raise awareness of the significant burden of HAE and patients’ top concerns, including the mental toll of the disease and the challenges of taking and maintaining access to chronic treatment.

Intellia significantly advanced its launch readiness activities in recent months, including finalizing its field medical, reimbursement and strategic accounts teams and engaging with HAE treatment centers around the U.S.

Intellia expects the U.S. Food and Drug Administration (FDA) to accept its submission of a biologics license application (BLA) for lonvo-z in the second half of 2026. If approved, Intellia plans to launch lonvo-z commercially in the first half of 2027.

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 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).

Together with Regeneron and other external experts, Intellia recently conducted a comprehensive genomic analysis of more than 600 patient samples across nex-z clinical trials. The analysis revealed that the highest observed liver transaminase elevations were in patients carrying one specific human leukocyte antigen (HLA) allele. As Intellia engages with the FDA and global health authorities regarding this finding, the company will provide HLA genotyping results to investigators and patients enrolled or entering screening in the ongoing nex-z Phase 3 trials.

During the second quarter, nex-z Phase 1 clinical data in ATTR were presented at the Peripheral Nerve Society Annual Meeting in Maastricht, the Netherlands and at the European Society of Cardiology Heart Failure Congress in Barcelona, Spain.

Intellia has advanced enrollment in its MAGNITUDE and MAGNITUDE-2 Phase 3 clinical trials of nex-z in ATTR amyloidosis with cardiomyopathy (ATTR-CM) and hereditary ATTR amyloidosis with polyneuropathy (ATTRv-PN), respectively.

Intellia remains on track to complete patient enrollment in MAGNITUDE-2 in the second half of 2026.

Upcoming Events

The company will participate in the following events during the third quarter of 2026:

Bradykinin Symposium 2026, September 2-3, Berlin, Germany

Wells Fargo 21st Annual Healthcare Conference, September 9, Boston

Morgan Stanley 24th Annual Global Healthcare Conference, September 14, New York

Second Quarter 2026 Financial Results

Cash Position: In April 2026, the company completed an underwritten public offering of its common stock resulting in approximately $195 million in net proceeds. Cash, cash equivalents and marketable securities were $628.4 million as of June 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. commercial launch for HAE in the first half of 2027. This guidance excludes all potential commercial revenues from lonvo-z.

Collaboration Revenue: Collaboration revenue was $7.7 million for the second quarter of 2026, compared to $14.2 million for the second 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 $82.6 million for the second quarter of 2026, compared to $97.0 million for the second quarter of 2025. The decrease was primarily driven by lower external costs related to the company’s lead development programs and reduced stock-based compensation, partially offset by higher employee-related expenses due to increased headcount. Stock-based compensation expense included in R&D expenses was $9.4 million for the second quarter of 2026.

G&A Expenses: General and administrative (G&A) expenses were $37.8 million for the second quarter of 2026, compared to $27.2 million for the second quarter of 2025. The increase was primarily driven by costs associated with the ongoing buildout of the company’s commercial infrastructure, higher legal expenses and stock-based compensation. Stock-based compensation expense included in G&A expenses was $8.6 million for the second quarter of 2026.

Net Loss: Net loss was $106.6 million for the second quarter of 2026, compared to $101.3 million for the second quarter of 2025.

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

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 U.S. Food and Drug Administration’s acceptance of its biologics license application (“BLA”) for lonvo-z in the second half of 2026 and the subsequent review and approval of that BLA, 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, to eliminate HAE attacks via a highly differentiated one-time treatment that is administered in an outpatient setting, and to transform the treatment paradigm for patients with this burdensome disease; 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 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 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.

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 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 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 June 30,		Six Months Ended June 30,
			2026	2025	2026	2025
INTELLIA THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(Amounts in thousands, except per share data)
Collaboration revenue			$7,659	$14,245	$22,707	$30,872
Operating expenses:
	Research and development		82,595	97,035	163,332	205,462
	General and administrative		37,824	27,206	72,667	56,213
		Total operating expenses	120,419	124,241	235,999	261,675
Operating loss			(112,760)	(109,996)	(213,292)	(230,803)
Other income, net:
	Interest income		5,797	7,402	11,002	16,005
	Change in fair value of investments, net		329	1,339	(575)	(786)
		Total other income, net	6,126	8,741	10,427	15,219
Net loss			$(106,634)	$(101,255)	$(202,865)	$(215,584)
Net loss per share, basic and diluted			$(0.80)	$(0.98)	$(1.61)	$(2.08)
Weighted average shares outstanding, basic and diluted			133,480	103,732	126,057	103,617

	June 30, 2026	December 31, 2025
INTELLIA THERAPEUTICS, INC.
CONSOLIDATED BALANCE SHEET DATA (UNAUDITED)
(Amounts in thousands)
Cash, cash equivalents and marketable securities	$628,354	$605,134
Total assets	857,164	842,127
Total liabilities	129,458	170,733
Total stockholders’ equity	727,706	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