NTLAHIGH SIGNALREGULATORY10-K

NTLA's lead ATTR amyloidosis program MAGNITUDE Phase 3 trial has been placed on clinical hold by the FDA, halting dosing and screening activities.

This represents a material setback for Intellia's most advanced therapeutic program, as FDA clinical holds typically indicate serious safety or regulatory concerns that must be resolved before trials can resume. The company's ability to bring its lead gene editing therapy to market is now dependent on successfully addressing FDA concerns and lifting the hold, creating significant execution risk and potential delays in revenue generation from what was likely their nearest-term commercial opportunity.

Comparing 2026-02-26 vs 2025-02-27View on EDGAR →
FINANCIAL ANALYSIS

Despite the regulatory setback, NTLA showed improved operational efficiency with net losses narrowing 20.5% to -$412.7M while revenue grew 16.9% to $67.7M and R&D expenses declined 16.6% to $388.9M. However, the company's financial position weakened with total assets declining 29.3% to $842.1M, cash falling 17.8% to $155.5M, and stockholders' equity dropping 23% to $671.4M, suggesting the burn rate remains concerning amid the clinical hold uncertainty. The 80.5% reduction in capital expenditures to $1.1M may reflect cost conservation measures in response to the regulatory challenges.

FINANCIAL STATEMENT CHANGES
Capital Expenditure
Cash Flow
-80.5%
$5.8M→$1.1M

Capex reduced 80.5% — investment cycle winding down or capital discipline; may improve near-term free cash flow.

Total Liabilities
Balance Sheet
-46.5%
$319.1M→$170.7M

Liabilities reduced 46.5% — deleveraging improves balance sheet strength and financial flexibility.

Total Assets
Balance Sheet
-29.3%
$1.2B→$842.1M

Total assets contracted 29.3% — asset sales, write-downs, or balance sheet optimization underway.

Stockholders Equity
Balance Sheet
-23%
$872.0M→$671.4M

Equity decreased 23% — buybacks or losses reducing book value, monitor solvency ratios.

Net Income
P&L
+20.5%
-$519.0M→-$412.7M

Net income grew 20.5% — bottom-line growth signals improving overall business health.

Cash & Equivalents
Balance Sheet
-17.8%
$189.2M→$155.5M

Cash decreased 17.8% — monitor burn rate and upcoming capital needs.

Operating Income
P&L
+17.5%
-$534.3M→-$441.0M

Operating income improving — cost discipline or growing revenue base absorbing fixed costs.

Current Assets
Balance Sheet
-17.5%
$639.9M→$527.7M

Current assets declined 17.5% — monitor working capital adequacy and short-term liquidity.

Revenue
P&L
+16.9%
$57.9M→$67.7M

Revenue growing 16.9% — solid top-line momentum, watch margins for quality of growth.

R&D Expense
P&L
-16.6%
$466.3M→$388.9M

R&D spending cut 16.6% — could signal cost discipline or concerning reduction in innovation investment.

LANGUAGE CHANGES
NEW — 2026-02-26
PRIOR — 2025-02-27
ADDED
The registrant had 118,133,546 shares of Common Stock, $0.0001 par value per share, outstanding as of February 13, 2026.
in the first half of 2027, or the success of such program; our ability to execute our clinical study strategy for nexiguran ziclumeran ( nex-z, also referred to as NTLA-2001), our program for the treatment of transthyretin ( ATTR ) amyloidosis, including the ability to resume dosing and screening in the MAGNITUDE Phase 3 clinical trial by resolving the clinical hold placed by the U.S.
Summary of the Material Risks Associated with Our Business Our investigational new drug ( IND ) application for the MAGNITUDE Phase 3 clinical trial for patients with transthyretin ( ATTR ) amyloidosis with cardiomyopathy ( ATTR-CM ) has been placed on clinical hold by the United States Food and Drug Administration ( FDA ).
We will need to resolve the clinical hold with the FDA in order to resume dosing and screening in MAGNITUDE.
We also need to resume and successfully complete the MAGNITUDE-2 Phase 3 clinical trial in patients with hereditary ATTR amyloidosis with polyneuropathy ( ATTRv-PN ).
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REMOVED
The registrant had 103,517,460 shares of Common Stock, $0.0001 par value per share, outstanding as of February 14, 2025.
Summary of the Material Risks Associated with Our Business CRISPR/Cas9 genome editing technology has only recently been clinically validated for human therapeutic use.
Results, including data from our preclinical and clinical studies, are not necessarily predictive of our other ongoing and future preclinical and clinical studies, and they do not guarantee or indicate the likelihood of approval of any potential product candidate by the United States Food and Drug Administration ( FDA ) or any other regulatory agency.
If we experience delays or difficulties in the enrollment of patients in clinical trials, our ability to complete clinical trials or our receipt of necessary regulatory approvals could be delayed or prevented.
( we, us, our, Intellia, or the Company ) is a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies.
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