Intellia Therapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Cash, cash equivalents, and marketable securities totaled $614.8 million as of September 30, 2026, compared to $605.1 million as of December 31, 2025.
• Collaboration revenue was $7.2 million for the third quarter of 2026, a decrease from $13.8 million in the same period of 2025, primarily due to reduced revenue from Regeneron.
• Research and development (R&D) expenses were $83.3 million for the third quarter of 2026, down from $94.7 million in the third quarter of 2025, driven by lower external costs, lower stock-based compensation, and lower research materials and contracted services costs, partially offset by higher headcount-related expenses.
• General and administrative (G&A) expenses were $46.1 million for the third quarter of 2026, an increase from $30.5 million in the third quarter of 2025, primarily driven by consulting costs for commercial infrastructure buildout and higher legal, facility, and compensation expenses.
• Net loss was $127.5 million for the third quarter of 2026, compared to a net loss of $101.3 million in the third quarter of 2025; the 2026 loss included an unrealized loss of $10.4 million due to changes in investment fair value, while the 2025 loss included an unrealized gain of $3.4 million.
• Total operating expenses were $129.5 million for the third quarter of 2026 versus $125.3 million in the third quarter of 2025.
• Total other expense, net, was $5.2 million for the third quarter of 2026, compared to total other income, net, of $10.2 million in the third quarter of 2025.
• Net loss per share (basic and diluted) was $0.91 for the third quarter of 2026, compared to $0.92 in the third quarter of 2025.
• Weighted average shares outstanding (basic and diluted) were 140.2 million for the third quarter of 2026, compared to 110.2 million in the third quarter of 2025.
• Total assets were $902.6 million as of September 30, 2026, compared to $842.1 million as of December 31, 2025.
• Total liabilities were $289.5 million as of September 30, 2026, compared to $170.7 million as of December 31, 2025.
• Total stockholders' equity was $613.1 million as of September 30, 2026, compared to $671.4 million as of December 31, 2025.

Guidance and Future Outlook:

• Existing cash resources are expected to fund operations at least into 2028 and well beyond the anticipated commercial launch of lonvo-z in the first quarter of 2027.
• The company is on track to complete commercial readiness efforts for lonvo-z in advance of the March 10, 2027 PDUFA date.
• Management expects a transformative year ahead with a potential historic milestone: the approval of lonvo-z as the world's first in vivo CRISPR-based therapy.
• The company plans to launch lonvo-z commercially in the first quarter of 2027 in the U.S.

Business Segments and Product Lines:

• Lonvo-z (Hereditary Angioedema): The FDA accepted the Biologics License Application (BLA) in September and granted Priority Review with a PDUFA target action date of March 10, 2027. The FDA advised it is not currently planning to hold an advisory committee. Intellia completed the deployment of its field organization and deepened engagement with HAE treatment centers and payers.
• Nex-z (ATTR Amyloidosis): Intellia leads development and commercialization of nex-z in collaboration with Regeneron. Enrollment in the MAGNITUDE Phase 3 trial for ATTR-CM advanced significantly during the quarter. Enrollment in the MAGNITUDE-2 Phase 3 trial for ATTRv-PN was completed, exceeding the targeted randomization of 60 patients. The company began providing HLA genotyping results to investigators for patients in ongoing nex-z Phase 3 trials.

Market and Competitive Landscape:

• Lonvo-z is positioned as the only one-time treatment for HAE and the world's first in vivo CRISPR-based therapy if approved.
• 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.

Risks and Challenges:

• Risks include uncertainties related to clinical study conduct, regulatory approvals, and the potential for clinical results not to be positive or predictive of future results.
• Risks involve the ability to successfully develop and commercialize lonvo-z and nex-z, protect intellectual property, and maintain relationships with third-party manufacturers and collaborators.
• Risks include potential delays in clinical trials due to regulatory feedback and the possibility that collaborations with Regeneron or other partners may not continue or be successful.

Management Commentary and Tone:

• John Leonard, M.D., President and CEO, described the period as "defining" as the company advances its late-stage pipeline and prepares for a transformative year.
• Management expressed confidence in assembling the teams and capabilities needed to support a successful launch in HAE while continuing to advance nex-z Phase 3 trials and pipeline expansion.
• Management believes lonvo-z could transform the HAE treatment paradigm and deliver significant value to patients, physicians, payers, and the healthcare system.

Other Key Points:

• In September, Intellia entered into a non-dilutive senior secured term loan facility with OrbiMed for up to $400 million to provide financial and operational flexibility.
• In October, the company appointed Jing L. Marantz, M.D., Ph.D., as Executive Vice President and Chief Medical Officer, bringing over 25 years of experience in drug development.
• The company will present new lonvo-z patient perspectives and Phase 1/2 durability data at the ACAAI 2026 meeting and an investor webcast on November 12, 2026.
• Upcoming events include the American Heart Association Scientific Sessions (November 6-9), ACAAI 2026 (November 12-16), International Symposium on Amyloidosis (November 15-18), Jefferies London Healthcare Conference (November 17), and the 23rd Global Cardiovascular Clinical Trialists Forum (December 7-9).