Nkarta : Earnings Release (nkarta reports first quarter 2025 financial results and)
NKTX
Published on 05/14/2025 at 16:31
May 14, 2025
SOUTH SAN FRANCISCO, Calif., May 14, 2025 (GLOBE NEWSWIRE) -- Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies, today reported financial results for the first quarter and year ended March 31, 2025.
"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."
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.
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.
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.
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.
Nkarta is a clinical-stage biotechnology company advancing the development of allogeneic, off-the-shelf natural killer (NK) cell therapies for autoimmune diseases. By combining its cell expansion and cryopreservation platform with proprietary cell engineering technologies, Nkarta is building a pipeline of future cell therapies engineered for deep therapeutic activity and intended for broad access in the outpatient treatment setting. For more information, please visit the company's website at https://www.nkartatx.com.
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "anticipates," "believes," "expects," "intends," "plans," "potential," "projects," "would" and "future" or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include, but are not limited to, statements concerning Nkarta's expectations regarding any or all of the following: Nkarta's position, plans, strategies, and timelines for the continued and future clinical development and commercial potential of NKX019 (including the potential impact of modified lymphodepleting conditioning on our clinical trials, the future availability and disclosure of clinical data and other updates from Nkarta's clinical trials, and the regulatory pathway for NKX019); the therapeutic potential, accessibility, tolerability, advantages, and safety profile of NK cell therapies, including NKX019 for the treatment of autoimmune diseases, such as lupus, primary membranous nephropathy, systemic lupus erythematosus, systemic sclerosis, myositis, vasculitis, and myasthenia gravis; and Nkarta's expected cash runway.
Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Nkarta's limited operating history and historical losses; Nkarta's lack of any products approved for sale and its ability to achieve profitability; the risk that the results of preclinical studies and early-stage clinical trials may not be predictive of future results; Nkarta's ability to raise additional funding to complete the development and any commercialization of its product candidates; Nkarta's dependence on the clinical success of NKX019; that Nkarta may be delayed in initiating, enrolling patients in or completing its clinical trials; competition from third parties that are developing products for similar uses; Nkarta's ability to obtain, maintain and protect its intellectual property; Nkarta's dependence on third parties in connection with manufacturing, clinical trials and pre-clinical studies; the complexity of the
manufacturing process for CAR NK cell therapies; and the success of Nkarta's recent (and any future) cost containment measures.
These and other risks and uncertainties are described more fully in Nkarta's filings with the Securities and Exchange Commission ("SEC"), including the "Risk Factors" section of Nkarta's Annual Report on Form 10-K for the quarter and year ended December 31, 2024, filed with the SEC on March
26, 2025, and Nkarta's other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Nkarta undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
2025
2024
Operating expenses
Research and development
$ 24,172
$ 25,237
General and administrative
12,392
7,525
Total operating expenses
36,564
32,762
Loss from operations
(36,564 )
(32,762 )
Other income, net:
Interest income
4,376
3,246
Other income (expense), net
205
(2 )
Total other income, net
4,581
3,244
Net loss
$ (31,983 )
$ (29,518 )
Net loss per share, basic and diluted
$ (0.43 )
$ (0.58 )
Weighted average shares used to compute net loss per share, basic and diluted
73,916,477
50,682,469
Nkarta, Inc.
Condensed Balance Sheets (in thousands)
(Unaudited)
March 31,
2025
December 31,
2024
Assets
Cash, cash equivalents, restricted cash and investments
$ 351,901
$ 380,489
Property and equipment, net
72,625
74,658
Operating lease right-of-use assets
35,532
36,014
Other assets
10,551
10,042
Total assets
$ 470,609
$ 501,203
Liabilities and stockholders' equity
Accounts payable, accrued and other liabilities
$ 12,893
$ 12,954
Operating lease liabilities
78,911
80,273
Total liabilities
91,804
93,227
Stockholders' equity
378,805
407,976
Total liabilities and stockholders' equity
$ 470,609
$ 501,203
Nadir Mahmood Nkarta, Inc.
Disclaimer
nkarta Inc. published this content on May 14, 2025, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on May 14, 2025 at 20:30 UTC.