Nkarta Announces Q2 2024 Financial Results and Corporate Highlights

Nkarta, Inc., a clinical-stage biopharmaceutical company specializing in engineered natural killer (NK) cell therapies, has announced its financial results for the second quarter ending June 30, 2024. The company is advancing its NKX019 therapy, which holds promise for treating a variety of autoimmune diseases and non-Hodgkin lymphoma (NHL).

Paul J. Hastings, CEO of Nkarta, underscored the company's commitment to patients and its progress in clinical trials across multiple disease areas. He highlighted NKX019's potential to benefit individuals suffering from a broad spectrum of autoimmune conditions. The therapy aims to reduce patient burden and hospitalization by employing a cellular engineering strategy that minimizes toxicity.

Nkarta has received FDA clearance for its second Investigational New Drug (IND) application for NKX019 in autoimmune diseases. This approval supports the planned Ntrust-2 clinical trial focused on systemic sclerosis, myositis, and vasculitis. In this trial, patients will receive three doses of NKX019 on Days 0, 3, and 7, following lymphodepletion (LD) with cyclophosphamide.

Additionally, an investigator-sponsored trial (IST) of NKX019 for systemic lupus erythematosus (SLE) is set to commence at Columbia University Irving Medical Center. Similar to the Ntrust-2 protocol, patients in this trial will also receive three doses of NKX019 on Days 0, 3, and 7 following LD with cyclophosphamide.

Upcoming milestones include the initiation of patient enrollment in the Ntrust-2 clinical trial by the end of 2024, with preliminary clinical data from both Ntrust-1 and Ntrust-2 trials expected in 2025. These trials will assess the safety and efficacy of NKX019 in achieving long-term remissions in autoimmune diseases by eliminating pathogenic B cells.

Nkarta presented promising follow-up data from its Phase 1 trial of NKX019 in relapsed/refractory NHL at the Pan Pacific Lymphoma Conference in July 2024. The data showed that four patients who were re-treated achieved complete responses, demonstrating the safety and effectiveness of retreatment. The company has also completed enrollment in a new cohort for patients with large B-cell lymphoma (LBCL) who have progressed following CAR T therapy. Data from this cohort is anticipated by late 2024, and future development of NKX019 in NHL will depend on these outcomes.

Leadership updates include the appointment of Nadir Mahmood, Ph.D., as President, and the promotion of David R. Shook, M.D., to Chief Medical Officer and Head of Research & Development. Additionally, George Vratsanos, M.D., FACR, joined Nkarta’s Board of Directors, bringing expertise in immunology and autoimmunity.

Financially, Nkarta reported a cash balance of $426.7 million as of June 30, 2024, which is expected to fund operations into late 2027. Research and development (R&D) expenses for the second quarter were $23.1 million, with non-cash stock-based compensation contributing $2.2 million to this total. General and administrative (G&A) expenses were $7.6 million, also including $2.2 million in non-cash stock-based compensation. The net loss for the quarter was $25.0 million, or $0.34 per share.

NKX019 is an allogeneic, cryopreserved immunotherapy candidate using NK cells from healthy adult donors. It is engineered with a humanized CD19-directed CAR for enhanced targeting and a proprietary membrane-bound form of interleukin-15 (IL-15) for improved persistence and activity. CD19 is a biomarker for both normal B cells and those involved in autoimmune diseases and B cell-derived malignancies.

The Ntrust-1 and Ntrust-2 clinical trials are multi-center, open-label, dose-escalation studies that build on previous research showing durable, drug-free remissions in autoimmune diseases after CD19-targeted cell therapy. These trials will evaluate the safety and potential for long-term remissions by eliminating pathogenic B cells, with patients receiving three-dose cycles of NKX019 following single-agent lymphodepletion with cyclophosphamide.

Nkarta aims to advance the development of allogeneic, off-the-shelf NK cell therapies through its cell expansion, cryopreservation, and proprietary engineering platforms, including CRISPR-based genome engineering. The company is focused on creating therapies designed for outpatient treatment settings, ensuring broad access for patients.