Nkarta Announces Q3 2024 Financial Results and Corporate Highlights

Nkarta, Inc., a biopharmaceutical company in the clinical stage, has recently shared its financial results for the third quarter, ending September 30, 2024. The company, known for developing engineered natural killer (NK) cell therapies, reported several significant milestones and future projections.

Nkarta has commenced the dosing of the first patient in two key clinical trials: Ntrust-1 and an investigator-sponsored trial (IST) at Columbia University Irving Medical Center. These trials are focused on evaluating NKX019 for treating autoimmune diseases. Paul J. Hastings, CEO of Nkarta, expressed optimism about the progress made in these trials, highlighting the company's commitment to enhancing the safety and accessibility of NK cell therapies for autoimmune diseases. Nkarta is also preparing to begin patient enrollment for the Ntrust-2 trial by the end of 2024. Preliminary clinical data from both Ntrust-1 and Ntrust-2 are expected to be available in 2025.

However, after a thorough review of clinical data from patients with large B-cell lymphoma (LBCL) and considering the evolving treatment landscape, Nkarta has decided to halt further development of NKX019 for lymphoma. Instead, the company will focus on advancing NKX019 for various autoimmune diseases, where it believes the therapy has the potential to make a significant impact on patient care.

The clinical development of NKX019 for autoimmune diseases has seen considerable advancement. The first patient in the Ntrust-1 trial, which targets lupus nephritis, was dosed following the initiation of the Ntrust-1 screening process in June 2024. Similarly, the first patient in the Columbia University IST for systemic lupus erythematosus was dosed after the trial commenced in July 2024. Both studies are actively enrolling participants.

Looking ahead, Nkarta plans to begin patient enrollment in Ntrust-2 by the end of 2024. This trial will target systemic sclerosis, myositis, and vasculitis, following the clearance of the Investigational New Drug (IND) application in June 2024. Preliminary data from both Ntrust-1 and Ntrust-2 are anticipated in 2025.

In the realm of non-Hodgkin lymphoma (NHL), Nkarta has reported on a cohort of seven patients with heavily pretreated LBCL. These patients received NKX019 following lymphodepletion, with no cases of severe cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity (ICANS). Five patients achieved partial responses, and one of these patients saw a complete response lasting over six months after a second cycle of treatment. Nkarta intends to present final data from this LBCL cohort at a future medical conference but will not pursue further development in NHL, pivoting instead to focus on autoimmune diseases.

Financially, as of September 30, 2024, Nkarta reported cash, cash equivalents, restricted cash, and investments totaling $405.3 million. This financial position is expected to fund the company's operations into late 2027. Research and development expenses for the third quarter were $25.3 million, with non-cash stock-based compensation accounting for $1.8 million of this amount. General and administrative expenses were $8.5 million, with $2.3 million attributed to non-cash stock-based compensation. The net loss for the third quarter was $28.3 million, which includes non-cash charges of $5.8 million, primarily due to share-based compensation and depreciation expenses.

NKX019 is an allogeneic, cryopreserved, off-the-shelf immunotherapy candidate derived from the peripheral blood of healthy adult donors. Engineered with a humanized CD19-directed chimeric antigen receptor (CAR) for enhanced targeting and a proprietary, membrane-bound form of interleukin-15 (IL-15) for increased persistence and activity, NKX019 aims to treat autoimmune diseases and B cell-derived malignancies effectively.

The Ntrust-1 and Ntrust-2 clinical trials are designed to evaluate the safety and efficacy of NKX019 in patients with autoimmune diseases, aiming for long-term remissions by resetting the immune system through the elimination of pathogenic B cells. These trials will also assess the single-agent activity of NKX019 without the need for supplementary cytokines or antibody-based therapeutics.