On August 10, 2023 Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies, reported financial results for the second quarter ended June 30, 2023 (Press release, Nkarta, AUG 10, 2023, View Source [SID1234634203]).

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"Nkarta remains well positioned to advance allogeneic cell therapy and lead the development of groundbreaking natural killer cell therapy candidates," said Paul J. Hastings, President and CEO of Nkarta. "We continue to learn, improve and explore potential opportunities for our best-in-class platform. In our June 2023 update on NKX101, we reported complete responses in unusually high-risk and heavily pre-treated patients with AML who received a disease-adapted lymphodepletion regimen. In our other co-lead program, NKX019, we continue to evaluate multiple strategies to treat patients with the most aggressive forms of lymphoma. We look forward to providing further updates as we advance both candidates."

Pipeline Updates
NKX101

In June 2023, Nkarta reported updated clinical data from its Phase 1 clinical trial evaluating NKX101 in patients with relapsed or refractory acute myeloid leukemia (AML).
As of data cut-off on June 10, 2023, in patients that received NKX101 after Flu/Ara-C lymphodepletion (LD), 4 of 6 achieved CR/CRi (67% CR/CRi rate) and 3 of 6 achieved a complete response with hematologic recovery (50% CR rate). Two of the 4 reported CR/CRi were MRD (measurable residual disease) negative.
As of data cut-off on June 10, 2023, in patients that received the highest doses of NKX101 (3 weekly doses at 1 billion or 1.5 billion cells per dose) after fludarabine/cyclophosphamide (Flu/Cy) LD, 4 of 18 achieved CR/CRi (22% CR/CRi rate) and 3 of 18 achieved a complete response with hematologic recovery CR (17% CR rate). There were no CRs at the lower doses of NKX101.
NKX101 was well tolerated across dose-levels and LD regimens. There were no dose-limiting toxicities observed across all cohorts.
Flu/Ara-C LD is expected to be the basis of NKX101 development moving forward.
As previously announced, Nkarta plans to present an update on the ongoing clinical trial of NKX101 in the first half of 2024. The update is expected to include additional patients treated with NKX101 at 1.5 billion cells/dose x 3 dose regimen following Flu/Ara-C LD, as well as longer-term follow up of patients who were in response as of the June 2023 data cut-off.
NKX019

In June 2023, Nkarta presented preliminary clinical data based on a November 2022 data cut-off from its Phase 1 dose escalation clinical trial of NKX019 in patients with relapsed or refractory non-Hodgkin lymphoma (NHL) at two scientific meetings: an oral presentation at the annual meeting of the European Hematology Association (EHA) (Free EHA Whitepaper) and an encore poster presentation at the International Conference on Malignant Lymphoma (17-ICML).
Nkarta is evaluating the potential for clinical development of NKX019 in non-malignant, B-cell mediated disease.
As previously announced, Nkarta plans to present updated results from its ongoing clinical trial of NKX019 in the second half of 2023. The update is expected to include patients enrolled in multiple dose expansion cohorts, as well as longer-term follow-up of patients who were in response as of the November 2022 data cut-off.
Other Corporate Highlights

In July 2023, Nkarta announced the appointment of Alyssa Levin, CPA, CA, as Chief Financial and Business Officer. Ms. Levin will be responsible for leading Nkarta’s corporate finance, business development, information technology, and human resources functions.
Second Quarter 2023 and Recent Financial Highlights

As of June 30, 2023, Nkarta had cash, cash equivalents, restricted cash, and investments of $302.2 million.
Research and development (R&D) expenses were $25.1 million for the second quarter of 2023. Non-cash stock-based compensation expense included in R&D expense was $2.1 million for the second quarter of 2023.
General and administrative (G&A) expenses were $11.7 million for the second quarter of 2023. Non-cash stock-based compensation expense included in G&A expense was $2.5 million for the second quarter of 2023.
Net loss was $33.3 million, or $0.68 per basic and diluted share, for the second quarter of 2023. This net loss includes non-cash charges of $9.2 million that consisted primarily of share-based compensation of $4.6 million and an impairment charge of $4.1 million against right-of-use assets that Nkarta plans to sublease.
Financial Guidance

Nkarta expects its current cash and cash equivalents will be sufficient to fund its current operating plan into 2025.
About NKX101
NKX101 is an allogeneic, cryopreserved, off-the-shelf cancer immunotherapy candidate that uses natural killer (NK) cells derived from the peripheral blood of healthy adult donors. It is engineered with a chimeric antigen receptor (CAR) targeting NKG2D ligands on tumor cells. NKG2D, a key activating receptor found on naturally occurring NK cells, induces a cell-killing immune response through the detection of stress ligands that are widely expressed on cancer cells. NKX101 is also engineered with a proprietary membrane-bound form of interleukin-15 (IL-15) for greater persistence and activity without exogenous cytokine support. To learn more about the NKX101 clinical trial in adults with AML, please visit ClinicalTrials.gov.

About NKX019
NKX019 is an allogeneic, cryopreserved, off-the-shelf cancer 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 tumor 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 and malignant B cells, and it is a validated target for B cell cancer therapies. To learn more about the NKX019 clinical trial in adults with advanced B cell malignancies, please visit ClinicalTrials.gov.