Nkarta

Nkarta has appointed Shawn Rose, M.D. Ph.D., as Chief Medical Officer and Head of R&D, effective June 23, 2025, replacing David R. Shook who is returning to oncology.

The global lupus nephritis market is projected to grow significantly by 2034, with the United States accounting for over 80% of the current $1.12 billion market share across major regions.

• Nkarta has initiated enrollment for the Ntrust-2 clinical trial to evaluate NKX019 cell therapy in patients with ANCA-associated vasculitis (AAV) and other autoimmune disorders. • The Ntrust-2 trial will assess the safety and efficacy of NKX019 in promoting long-term disease remission in up to 12 participants with AAV, systemic sclerosis, or idiopathic inflammatory myopathy. • NKX019 is engineered to target and eliminate B-cells, which produce self-reactive antibodies that drive autoimmune diseases like AAV, offering a potential new treatment approach. • Preliminary results from the Ntrust-1 and Ntrust-2 trials, evaluating NKX019 in autoimmune diseases, are anticipated next year, marking a key milestone for Nkarta's cell therapy program.

• The NK cell therapy field is experiencing significant growth, driven by its potential to address unmet needs in cancer treatment with safer, more targeted options. • Over 140 companies are actively involved in developing more than 160 NK cell therapies, indicating robust R&D investment and confidence in this therapeutic area. • Clinical trials are progressing for various NK cell therapies, including CAR-NK cell therapies and those targeting autoimmune disorders, showcasing versatility. • Regulatory support, such as FDA orphan drug designation and fast track designation, is facilitating the development and potential approval of NK cell therapies.

• Nkarta has dosed the first patient in both the Ntrust-1 trial (lupus nephritis) and the investigator-sponsored trial (systemic lupus erythematosus) of NKX019, with enrollment ongoing. • The company plans to initiate enrollment in the Ntrust-2 trial for systemic sclerosis, myositis, and vasculitis by the end of 2024 and expects preliminary clinical data from Ntrust-1 and Ntrust-2 in 2025. • Nkarta will discontinue NKX019 development in non-Hodgkin lymphoma to focus on autoimmune diseases, where it believes NKX019 has greater potential. • With a cash balance of $405.3 million as of September 30, 2024, Nkarta anticipates funding operations into late 2027.