SOUTH SAN FRANCISCO, Calif., Oct. 22, 2025 (GLOBE NEWSWIRE) -- Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat autoimmune disease, today announced it will be presenting a poster this Sunday in Chicago at the American College of Rheumatology (ACR) Convergence 2025 meeting. Nkarta will present clinical data showing that the company’s investigational therapy, NKX019, achieved robust pathogenic B-cell depletion followed by ...

Core Insights - Nkarta, Inc. is focused on developing engineered natural killer (NK) cell therapies for autoimmune diseases, with a strong emphasis on clinical trial execution and the potential of NK cell therapy to meet unmet medical needs [2][3]. Financial Highlights - For the second quarter of 2025, Nkarta reported a net loss of $23.0 million, or $0.31 per share, with research and development expenses amounting to $20.8 million and general and administrative expenses of $6.4 million [10][20]. - The company had a cash balance of $334.0 million as of June 30, 2025, which is expected to fund operations into 2029 [5][8]. Clinical Program Updates - The NKX019 clinical program is progressing with ongoing patient enrollment in the Ntrust-1 and Ntrust-2 trials, which focus on safety and long-term remission in autoimmune diseases [6][9]. - Initial updates for NKX019 in multiple autoimmune indications are anticipated in the second half of 2025 [8][9]. Leadership and Expertise - Dr. Shawn Rose was appointed as Chief Medical Officer and Head of Research and Development in June 2025, bringing extensive experience in rheumatology and drug development for autoimmune conditions [3][4]. Clinical Trials Overview - Ntrust-1 and Ntrust-2 are multi-center, open-label, dose escalation trials assessing NKX019's safety and efficacy in patients with various autoimmune diseases, including lupus nephritis and systemic sclerosis [6][7][11]. - The trials involve a three-dose cycle of NKX019, designed to evaluate its single-agent activity without supplemental cytokines or antibody-based therapeutics [11][12].

Summary of Nkarta (NKTX) Conference Call - July 30, 2025 Company Overview - Nkarta is focused on developing allogeneic CAR NK cell therapies for autoimmune diseases, particularly targeting B cell mediated immune diseases, having pivoted from oncology to autoimmune indications due to the potential of cell therapy in these areas [2][3][4] Key Points and Arguments Industry and Market Context - The cell therapy landscape is evolving, with significant interest in CAR NK therapies for autoimmune diseases, inspired by successful CAR T cell data [3][20] - The safety profile of NK cells is favorable compared to CAR T cells, with no high-grade cytokine release syndrome (CRS) or neurotoxicity observed in trials [4][21][56] Product Pipeline - Nkarta's lead program, NKX019, targets CD19 and is currently in IND studies for lupus nephritis, primary membranous nephropathy, systemic sclerosis, myositis, and onc-associated vasculitis [6][25] - The company is conducting a phase one trial for NKX019, focusing on dose escalation and early safety and pharmacology [24][51] Clinical Efficacy and Safety - Early readouts from the NKX019 trial will focus on clinical markers such as creatinine levels, protein in urine, and glomerular filtration rate (GFR), which are critical for assessing kidney function in autoimmune renal diseases [25][26] - The updated lymphodepletion regimen now includes fludarabine, aligning with standard practices in cell therapy to enhance B cell depletion [27][28] Competitive Advantages - CAR NK cells are designed to be off-the-shelf, scalable, and do not require leukapheresis, making them more accessible for patients compared to CAR T therapies [4][14][21] - The potential for outpatient administration of CAR NK therapies could significantly broaden access and reduce the burden on healthcare facilities [67][70] Future Outlook - Initial data from NKX019 is expected in the second half of 2025, with ongoing enrollment in the trial [51][72] - The company has a strong cash position of approximately $350 million, providing a runway into 2029 to support ongoing trials without immediate capital raising pressures [71][72] Additional Important Insights - The shift from oncology to autoimmune diseases is seen as a strategic move, with the need for accessible therapies in the rheumatology and nephrology fields being emphasized [20][66] - The potential for durable responses and immune reset in treatment-refractory autoimmune conditions represents a significant advancement in the field [37][39] - Nkarta is exploring additional indications beyond lupus nephritis, including myositis and systemic sclerosis, indicating a broadening of their therapeutic focus [46][48] Conclusion - Nkarta is positioned to leverage its CAR NK cell therapy platform to address significant unmet needs in autoimmune diseases, with a focus on safety, accessibility, and clinical efficacy. The upcoming data readouts and ongoing trials will be critical in determining the future trajectory of the company's product offerings and market positioning [76]

Core Insights - Nkarta, Inc. is focused on developing engineered natural killer (NK) cell therapies for autoimmune diseases and has reported its financial results for Q1 2025 [1][9] - The company has restructured to enhance its clinical trial success and ensure sufficient cash flow to support operations until 2029 [2][8] Financial Performance - As of March 31, 2025, Nkarta had a cash balance of $351.9 million, which is expected to fund operations into 2029 [6][10] - Research and development (R&D) expenses for Q1 2025 were $24.2 million, while general and administrative (G&A) expenses were $12.4 million, including $5.1 million in restructuring costs [17][22] - The net loss for Q1 2025 was $32.0 million, or $0.43 per share, compared to a net loss of $29.5 million, or $0.58 per share, in Q1 2024 [17][23] Clinical Development Updates - Nkarta is advancing its NKX019 clinical programs, with preliminary data from the Ntrust-1 and Ntrust-2 trials expected in the second half of 2025 [4][6] - The Ntrust-1 trial has been expanded to include a cohort for primary membranous nephropathy, while the Ntrust-2 trial continues to enroll patients for systemic sclerosis and other conditions [7][12] - A modified lymphodepletion regimen using fludarabine and cyclophosphamide has been implemented across trials, with the option for eligible patients to continue with cyclophosphamide alone [6][7] Corporate Developments - Dr. Robert Ortmann has joined Nkarta as Vice President of Clinical Development, bringing over 20 years of experience in autoimmune diseases [8] - The company has undergone a restructuring plan that included a workforce reduction of 34% to extend its cash runway and prioritize clinical execution [8][10] Future Outlook - Nkarta aims to provide initial clinical updates for its Ntrust studies in the latter half of 2025, which will include clinical responses from enrolled patients [4][6] - The company is committed to achieving key clinical milestones while maintaining sufficient funds for ongoing operations [2][10]

Core Viewpoint - Nkarta, Inc. is focused on advancing its engineered natural killer (NK) cell therapy, NKX019, for the treatment of autoimmune diseases, while implementing a restructuring plan to enhance financial stability and extend its cash runway [2][4][12]. Financial Performance - For the full year 2024, Nkarta reported a net loss of $108.8 million, or $1.60 per share, compared to a net loss of $117.5 million in 2023 [12][19]. - The company had cash, cash equivalents, and investments totaling $380.5 million as of December 31, 2024, which is expected to fund operations into 2029 [4][12][19]. - Research and development expenses for 2024 were $96.7 million, while general and administrative expenses were $31.5 million [12][19]. Clinical Development - Nkarta is conducting two clinical trials, Ntrust-1 and Ntrust-2, to evaluate NKX019 in various autoimmune diseases, with initial data expected in the second half of 2025 [4][8]. - The Ntrust-1 trial focuses on lupus nephritis, while Ntrust-2 targets systemic sclerosis, idiopathic inflammatory myopathy, and ANCA-associated vasculitis [5][9]. - The dosing schedule for NKX019 has been harmonized across all trials, with patients receiving treatment on Days 0, 3, and 7 following lymphodepletion [10]. Restructuring Efforts - Nkarta has implemented a restructuring plan that includes a workforce reduction of 34% (53 positions) to prioritize investment in clinical execution and extend its cash runway [2][4][12]. - The restructuring is expected to result in cash payments of approximately $5.5 to $6.5 million [12]. Product Overview - NKX019 is an allogeneic, off-the-shelf CAR NK-cell therapy designed to target CD19-positive cells in autoimmune diseases, offering potential advantages such as rapid B-cell killing and reduced toxicity [2][7][14]. - The therapy is engineered for enhanced targeting and persistence, aiming to provide broad access in outpatient settings [14].