SOUTH SAN FRANCISCO - Nkarta Inc. (NASDAQ:NKTX) announced today that the U.S. Food and Drug Administration has agreed to protocol changes for its Ntrust-1 and Ntrust-2 clinical trials of NKX019, an investigational CAR-NK cell therapy for autoimmune diseases.
The amendments reduce required patient monitoring from 24 hours to 2 hours, enabling outpatient administration at community research centers and eliminating the need for overnight stays. The changes also allow community rheumatologists to administer the treatment.
The FDA agreement permits redosing of patients in both trials if needed. A rheumatoid arthritis cohort will be added to the Ntrust-2 study, expanding the trial beyond its current focus on lupus nephritis, primary membranous nephropathy, systemic sclerosis, idiopathic inflammatory myopathy, and ANCA-associated vasculitis. Geographic monitoring requirements have been removed.
The changes will take effect following institutional review board approvals, according to the company's press release statement. The protocol amendments come as Nkarta maintains a solid financial position with more cash than debt on its balance sheet and liquid assets exceeding short-term obligations, according to InvestingPro data. The company's current ratio stands at 12.69, though it continues burning through cash with levered free cash flow of negative $89.91 million over the last twelve months.
Dosing continues at 4 billion cells per dose, with patients receiving 12 billion cells across a three-dose cycle on days 0, 3, and 7. Initial data from this dose level is expected to be presented at a medical meeting this year.
NKX019 is an allogeneic, off-the-shelf therapy using natural killer cells engineered with a CD19-directed chimeric antigen receptor. The treatment targets B cells implicated in autoimmune disease. Patients receive the therapy following lymphodepletion with fludarabine and cyclophosphamide, or cyclophosphamide alone for those with baseline cytopenia.
The Ntrust-1 and Ntrust-2 trials are multi-center, open-label dose escalation studies evaluating safety and the therapy's ability to enable remissions through immune system reset.
Nkarta is a clinical-stage biotechnology company developing engineered natural killer cell therapies for autoimmune diseases. Despite remaining unprofitable with a market capitalization of $172.52 million, the stock has delivered strong returns with a 33.92% gain over the past year and a 23.78% year-to-date increase. Analysts maintain a Strong Buy consensus with price targets ranging from $8 to $25 while InvestingPro analysis suggests the stock is currently undervalued, placing it among opportunities on the Most Undervalued list.
In other recent news, Nkarta Inc. has been the focus of several analyst reports following its latest earnings announcement and corporate updates. Mizuho has adjusted its financial model for Nkarta, lowering the company's price target from $14 to $12 while maintaining an Outperform rating. This adjustment is due to a slight moderation in the anticipated sales ramp. Meanwhile, Stifel has reiterated its Buy rating for Nkarta, keeping the price target at $11. Stifel expressed optimism regarding the company's trial enrollment progress, particularly in the Ntrust-1/2 trials for NKX019, which are exploring treatments for six different autoimmune diseases. These trials are currently evaluating a dosing regimen that aligns with similar therapies. These developments reflect ongoing interest and analysis from the investment community regarding Nkarta's potential.