On May 9, 2024 Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies, reported financial results for the first quarter ended March 31, 2024 (Press release, Nkarta, MAY 9, 2024, View Source [SID1234643010]).

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"Cell therapy has the potential to transform the way people living with autoimmune diseases are treated," said Paul J. Hastings, President and CEO of Nkarta. "We believe that an off-the-shelf, targeted NK-cell product like NKX019 could address the infrastructure and safety concerns that have created barriers to patient access across our industry. We are excited to dose patients with NKX019 in lupus nephritis, and we look forward to giving an update in the coming months, including our plans for evaluating other autoimmune diseases."

NKX019 in autoimmune disease

NKX019 is an allogeneic, off-the-shelf cell therapy candidate comprising NK cells derived from healthy donors and engineered to target the B-cell antigen CD19 for patients with B-cell mediated diseases.
The Phase 1 multi-center, dose-escalation clinical trial will assess the safety and clinical activity of NKX019 in patients with refractory lupus nephritis (LN). Per the protocol, patients receive a three-dose cycle of NKX019 following single-agent lymphodepletion (LD) comprising only cyclophosphamide (cy), an agent with an established safety profile in systemic lupus erythematosus (SLE) and LN.
The Investigational New Drug (IND) Application for LN cleared in 4Q 2023.
Translational data support the potential for NKX019 to drive immunologic reset, including efficient killing of B cells from patients with autoimmune disease and recovery of predominantly naïve B cells following treatment with NKX019 for B-cell malignancies.
Nkarta expects to provide an update on first patient dosing for NKX019 in LN in the first half of 2024. The announcement is also expected to feature plans for the evaluation of NKX019 in additional autoimmune diseases.
NKX019 in non-Hodgkin lymphoma (NHL)

Nkarta reported in January 2024 that 4 of 4 patients with relapsed/refractory (r/r) NHL that relapsed after achieving complete response (CR) following treatment with NKX019 were again able to achieve CR after re-treatment with NKX019. These outcomes suggest that relapse, when it occurs, may be attributable to mechanisms of NKX019 exposure and not resistance to NKX019.
In the Phase 1 study of NKX019 in r/r NHL, patients receive NKX019 doses on Days 0, 3 and 7 following LD with fludarabine (flu) and cy. This compressed dosing regimen is designed to intensify exposure of NKX019 by dosing closer to LD. In addition, patients with ongoing cytopenias have the potential to receive NKX019 following LD with cy alone.
Nkarta expects to announce preliminary data from the NKX019 compressed dosing cohort in mid-2024.
Other Corporate Highlights

In March 2024, Nkarta completed an underwritten offering of common stock and pre-funded warrants with gross proceeds of $240.1 million. New and existing investors participated in the offering.
First Quarter 2024 and Recent Financial Highlights

Nkarta had cash, cash equivalents, restricted cash, and investments in marketable securities of $450.0 million as of March 31, 2024.
Research and development (R&D) expenses were $25.2 million for the first quarter of 2024. Non-cash stock-based compensation expense included in R&D expense was $2.2 million for the first quarter of 2024.
General and administrative (G&A) expenses were $7.5 million for the first quarter of 2024. Non-cash stock-based compensation expense included in G&A expense was $2.2 million for the first quarter of 2024.
Net loss was $29.5 million, or $0.58 per basic and diluted share, for the first quarter of 2024. This net loss includes non-cash charges of $5.6 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 late 2027.
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 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.