NEW YORK – Intellia Therapeutics on Thursday announced a strategic reorganization, including discontinuing development of an early-stage gene-editing candidate and layoffs.
The Cambridge, Massachusetts-based biotech said these changes will allow it to focus resources on advancing late-stage in vivo CRISPR-based gene-editing programs for hereditary angioedema and transthyretin amyloidosis with cardiomyopathy (ATTR-CM). Prioritizing these programs, it said, will set the foundation for "significant, near-term value creation."
Intellia, in January 2024, laid off 15 percent of its workforce to "streamline" operations and focus on strategic priorities, which at the time included pausing some exploratory research programs.
As part of the latest portfolio reshuffling, Intellia has discontinued development of NTLA-3001, an in vivo CRISPR-based gene insertion therapy for alpha-1 antitrypsin deficiency-associated lung disease and select research-stage programs. Intellia had launched a first-in-human Phase I/II trial of NTLA-3001 last year.
The company is also letting go of 27 percent of its employees this year. Intellia expects to incur about $8 million in reorganization costs, primarily in the first quarter of 2025, including severance and other costs related to employee termination, the company reported in a filing with the US Securities and Exchange Commission. The firm expects the cost savings from the reorganization to support its cash runway into the first half of 2027, by which point Intellia expects to launch its first commercial product in the US.
Intellia said the shift in priorities reflects its evolution from a company focused on late-stage development to a commercial-ready company by the end of 2026.
To establish its commercial readiness, Intellia said it will build its commercial leadership team by the second half of 2025, expand the reach of its medical education activities related to hereditary angioedema and ATTR-CM in partnership with medical societies and patient organizations, and plan for coverage and formulary decisions with payors.
The "high-value" late-stage programs Intellia is focusing on are NTLA-2002 for hereditary angioedema and nexiguran ziclumeran (nex-z), previously known as NTLA-2001, for ATTR-CM. Intellia is evaluating NTLA-2002 within the Phase III HAELO trial, for which it expects to complete enrollment in the second half of 2025 and submit a biologics license application in the second half of 2026. It is testing nex-z within the Phase III MAGNITUDE trial, which remains ahead of internal enrollment estimates with more than 550 participants expected by year-end.
"We understand the significant potential of our late-stage programs, and within a challenging market environment, have made a difficult decision to focus our resources predominantly on NTLA-2002 and nex-z where we have the greatest opportunity to create significant, near-term value," Intellia President and CEO John Leonard said in a statement.