On May 14, 2025 Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies, reported financial results for the first quarter and year ended March 31, 2025 (Press release, Nkarta, MAY 14, 2025, View Source [SID1234653069]).

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"Our recent restructuring and continued efforts at cost containment have positioned us well to achieve our clinical milestones while ensuring we have cash to support our critical operations into 2029," said Paul J. Hastings, CEO of Nkarta. "In order to maximize success in our trials, we have incorporated a lymphodepletion regimen utilizing both cyclophosphamide and fludarabine. Similar trials have established this combination, and we believe there is value in producing a comparable dataset while still continuing our cyclophosphamide-only regimen for eligible patients. This approach has potential to provide data on both regimens, which best positions us to advance NKX019 in the clinic and deliver this potential new treatment to patients with B cell-mediated autoimmune diseases. We remain on track to provide our initial clinical update for the Ntrust-1 and Ntrust-2 studies in the second half of 2025."

Updates for NKX019 clinical programs in Autoimmune Diseases

Ntrust-1, a clinical trial of NKX019 for the treatment of lupus nephritis (LN), expanded to include patients with primary membranous nephropathy (pMN) with an aim of addressing the unmet need for novel therapies in this disease. Ntrust-1 is currently open to enroll patients with pMN and remains open to enroll patients with LN.
Ntrust-2, a clinical trial of NKX019 for the treatment of systemic sclerosis, idiopathic inflammatory myopathy and anti-neutrophil cytoplasmic antibody-associated vasculitis, continues to enroll patients.
Ntrust-1 and Ntrust-2 protocols amended to modify lymphodepletion prior to administration of NKX019 to use of a combination of fludarabine and cyclophosphamide, with the option for eligible patients to continue to receive cyclophosphamide alone as modified lymphodepletion.
The IST of NKX019 for the treatment of myasthenia gravis led by researchers at the University of California, Irvine opened to enrollment.
The IST of NKX019 for the treatment of systemic lupus erythematosus led by researchers at the Columbia University Irving Medical Center, remains open for enrollment.
Anticipated Ntrust clinical trial milestones for 2025

Preliminary clinical data from the Ntrust-1 and Ntrust-2 clinical trials is planned for the second half of 2025. The update is expected to include clinical response with available follow-up from a group of patients in the Ntrust-1 and Ntrust-2 studies.
Other Corporate Updates

Robert Ortmann, M.D., an accomplished rheumatologist with over 20 years of clinical and scientific experience to join Nkarta as Vice President, Clinical Development, effective May 15, 2025. Dr. Ortmann, who has extensive clinical development experience across a wide range of autoimmune diseases, will report to David Shook, M.D., Chief Medical Officer, Head of Research & Development.
In March 2025, Nkarta announced a restructuring plan, including a reduction in force impacting 34% of its workforce, prioritizing investments in clinical execution, and freezing select future headcount to extend the cash runway by more than one year into 2029 to enable the achievement of key clinical milestones while maintaining sufficient funds to support ongoing operations beyond those milestones.
First Quarter 2025 and Recent Financial Highlights

Nkarta had cash, cash equivalents, restricted cash, and investments in marketable securities of $351.9 million as of March 31, 2025.
Research and development (R&D) expenses were $24.2 million for the first quarter of 2025. Non-cash stock-based compensation expense included in R&D expense was $1.1 million for the first quarter of 2025.
General and administrative (G&A) expenses were $12.4 million for the first quarter of 2025, which included $5.1 million of restructuring expenses in March 2025. Non-cash stock-based compensation expense included in G&A expense was $1.7 million for the first quarter of 2025.
Net loss was $32.0 million, or $0.43 per basic and diluted share, for the first quarter of 2025. This net loss includes non-cash charges of $4.3 million that consisted primarily of share-based compensation and depreciation expenses.
Financial Guidance

Nkarta expects its current cash and cash equivalents will be sufficient 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 that build on academic studies of durable, drug-free remissions in patients with autoimmune disease after CD19-targeted cell therapy. Both trials will assess the safety of NKX019 in people living with autoimmune diseases as well as its ability to enable long-term remissions via a "reset" of the immune system through the elimination of pathogenic B cells.

Ntrust-1 is initially enrolling up to 24 patients with lupus nephritis or primary membranous nephropathy. Ntrust-2 is initially enrolling up to 36 patients with systemic sclerosis, idiopathic inflammatory myopathy, or anti-neutrophil cytoplasmic antibody-associated vasculitis.

In both studies, patients receive a three-dose cycle of NKX019 on Days 0, 3, and 7 following lymphodepleting conditioning with either fludarabine and cyclophosphamide or cyclophosphamide alone. 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 to restore response.

About the Investigator-Sponsored Clinical Trial of NKX019 for Generalized Myasthenia Gravis
The single-arm, open-label Phase 1 investigator-sponsored clinical trial is designed to enroll patients with generalized myasthenia gravis and will evaluate safety and clinical outcomes. Translational and biomarker studies, including autoantibodies, cytokine profiles and pharmacokinetics are planned. Patients receive 3 doses of NKX019 following lymphodepletion. The clinical trial is being co-led by Ali A. Habib, M.D., Clinical Professor of Neurology at the University of California, Irvine, and other investigators.

About the Investigator-Sponsored Clinical Trial of NKX019 for Systemic Lupus Erythematosus
The single-center, single-arm, open-label Phase 1 investigator-sponsored clinical trial (NCT06518668) is designed to enroll up to 6 patients with systemic lupus erythematosus, regardless of renal involvement, and will evaluate safety and clinical outcomes in a potentially different population than Ntrust-1. Translational and biomarker studies, including autoantibodies, cytokine profiles and pharmacokinetics are planned. Patients receive 3 doses of NKX019 following lymphodepletion. The clinical trial is being led by Anca D. Askanase, M.D., M.P.H., Director, Lupus Center at Columbia University Irving Medical Center and the Director of Rheumatology Clinical Trials.

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 and B cell-derived malignancies. Nkarta is evaluating NKX019 in multiple autoimmune conditions.