On May 12, 2026 Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biotechnology company developing engineered natural killer (NK) cell therapies to treat autoimmune diseases, reported financial results for the first quarter ended March 31, 2026.

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"Putting patients first and providing access to care in a familiar setting close to home matters" said Paul J. Hastings, Chief Executive Officer of Nkarta. "In early April, we reached agreement with the FDA to amend our protocol to allow outpatient dosing in community settings as well as the option to re-dose patients if needed, the removal of overnight monitoring requirements, and the expansion of the Ntrust-2 study to include patients with rheumatoid arthritis. IRB approval of our protocol amendments has been secured across multiple sites, with additional approvals underway. These advancements will enable us to expand patient access beyond urban hubs and major academic centers by engaging community research centers and local rheumatology practices in the neighborhoods where most patients live. We look forward to providing our initial dataset in 2026."

NKX019 Clinical Program Progress and Upcoming Milestones

Enrollment continues across Ntrust-1 and Ntrust-2, our multi-center, open-label, dose-escalation clinical trials evaluating NKX019 in multiple autoimmune diseases.
IRB approval of our protocol amendments has been secured across multiple sites on outpatient dosing, re-dosing, ending overnight monitoring, and adding RA to Ntrust-2.
Patients are being dosed at 4 billion cells per dose x 3 doses (12 billion cells total) across all indications in Ntrust-1 and Ntrust-2.
Initial clinical data from Ntrust-1 and Ntrust-2 are planned for presentation at a medical conference in 2026.

First Quarter 2026 Financial Highlights

Nkarta had cash, cash equivalents, restricted cash, and investments in marketable securities of $266.7 million as of March 31, 2026.
Research and development (R&D) expenses were $25.0 million for the first quarter of 2026. Non-cash stock-based compensation expense included in R&D expense was $0.7 million for the first quarter of 2026.
General and administrative (G&A) expenses were $5.9 million for the first quarter of 2026. Non-cash stock-based compensation expense included in G&A expense was $1.2 million for first quarter of 2026.
Net loss was $27.8 million, or $0.37 per basic and diluted share, for the first quarter of 2026. This net loss includes non-cash charges of $3.4 million that consisted primarily of share-based compensation and depreciation expenses.

Financial Guidance

Nkarta expects its current cash and cash equivalents to fund its current operating plan into 2029.

About the Ntrust℠ Clinical Trials in Autoimmune Disease
Ntrust-1 (NCT06557265) and Ntrust-2 (NCT06733935) are multi-center, open label, dose escalation clinical trials in patients with autoimmune disease receiving lymphodepletion followed by CD19-targeted CAR-NK cell therapy. Both trials will assess the safety of NKX019 in people living with autoimmune diseases as well as its potential to achieve durable remission via a "reset" of the immune system through the elimination of pathogenic B cells.

The Ntrust trials are enrolling up to 12 patients per dose level per disease indication across systemic sclerosis, idiopathic inflammatory myopathy, ANCA-associated vasculitis, rheumatoid arthritis, lupus nephritis, and primary membranous nephropathy. Additional participants may be enrolled if needed to refine patient populations for further study.

In both studies, patients now receive a three-dose cycle of NKX019 on Days 0, 3, and 7 following lymphodepletion with fludarabine and cyclophosphamide or cyclophosphamide alone, if they have significant cytopenia at baseline. Leveraging the engineering of NKX019, no patients in either trial will receive supplemental cytokines or antibody-based therapeutics. This approach is designed to evaluate the single-agent activity of NKX019 and facilitate a more rapid path to regulatory approval. Patients in Ntrust-1 may also receive additional cycles, if needed, to restore response or enable a deeper response.

About NKX019
NKX019 is an allogeneic, cryopreserved, off-the-shelf immunotherapy candidate that uses natural killer (NK) cells derived from the peripheral blood of healthy adult donors. It is engineered with a humanized CD19-directed chimeric antigen receptor (CAR) for enhanced cell targeting and a proprietary, membrane-bound form of interleukin-15 (IL-15) for greater persistence and activity without exogenous cytokine support. CD19 is a biomarker for normal B cells as well as those implicated in autoimmune disease. Nkarta is evaluating NKX019 in multiple autoimmune conditions.

(Press release, Nkarta, MAY 12, 2026, View Source [SID1234665551])