Nkarta(NKTX) - 2025 Q2 - Quarterly Results

Nkarta Q2 2025 Earnings Release Overview Executive Summary Nkarta reported Q2 2025 results, highlighting $334.0 million cash, NKX019 clinical progress, and a new CMO appointment - The company is focused on executing clinical trials for NK cell therapy to treat autoimmune diseases[3] - Dr. Shawn Rose, an experienced rheumatologist and immunologist, was appointed Chief Medical Officer and Head of R&D in June 2025[4] - Initial data updates for the NKX019 program in multiple autoimmune indications are expected in the second half of 2025[6] - The company's cash balance of $334.0 million as of June 30, 2025, is projected to fund operations into 2029[6] NKX019 Clinical Program Program Progress and Milestones NKX019 autoimmune clinical programs are enrolling, with Ntrust-1 and Ntrust-2 preliminary data expected in H2 2025 - Patient enrollment is ongoing for the Ntrust-1, Ntrust-2, and two investigator-sponsored clinical trials for NKX019 in autoimmune diseases[7] - Preliminary data from the Ntrust-1 and Ntrust-2 clinical trials are planned for release in the second half of 2025[7] Ntrust℠ Clinical Trials (Ntrust-1 & Ntrust-2) Ntrust-1 and Ntrust-2 trials evaluate NKX019 safety and efficacy in autoimmune diseases like lupus nephritis and systemic sclerosis - Ntrust-1 (NCT06557265) is enrolling up to 24 patients with lupus nephritis or primary membranous nephropathy[9][10] - Ntrust-2 (NCT06733935) is enrolling up to 36 patients with systemic sclerosis, idiopathic inflammatory myopathy, or ANCA-associated vasculitis[9][10] - The trial protocol includes a three-dose cycle of NKX019 following lymphodepletion, with no supplemental cytokines, to evaluate the single-agent activity of the therapy[11] Investigator-Sponsored Clinical Trials Nkarta supports two Phase 1 investigator-sponsored trials for NKX019 in myasthenia gravis and systemic lupus erythematosus - A Phase 1 investigator-sponsored trial is enrolling patients with generalized myasthenia gravis to evaluate the safety and clinical outcomes of NKX019[12] - A separate Phase 1 investigator-sponsored trial (NCT06518668) is enrolling up to 6 patients with systemic lupus erythematosus to evaluate NKX019[14] Financial Performance and Position Financial Highlights and Guidance Nkarta held $334.0 million cash as of June 30, 2025, expected to fund operations into 2029, with a Q2 2025 net loss of $23.0 million Q2 2025 Financial Summary | Metric | Amount (in millions) | | :--- | :--- | | Cash, Cash Equivalents, and Investments | $334.0 | | Research & Development (R&D) Expenses | $20.8 | | General & Administrative (G&A) Expenses | $6.4 | | Net Loss | $23.0 | | Net Loss per Share | $0.31 | - The company's current cash and cash equivalents are expected to be sufficient to fund its operating plan into 2029[8] Condensed Statements of Operations Nkarta's Q2 2025 total operating expenses decreased to $27.2 million, resulting in a net loss of $23.0 million Condensed Statements of Operations (in thousands) | Line Item | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $20,778 | $23,130 | $44,950 | $48,367 | | General and administrative | $6,408 | $7,585 | $18,800 | $15,110 | | Total operating expenses | $27,186 | $30,715 | $63,750 | $63,477 | | Loss from operations | ($27,186) | ($30,715) | ($63,750) | ($63,477) | | Interest income | $3,970 | $5,724 | $8,346 | $8,970 | | Net loss | ($22,977) | ($24,993) | ($54,960) | ($54,511) | | Net loss per share, basic and diluted | ($0.31) | ($0.34) | ($0.74) | ($0.88) | Condensed Balance Sheets As of June 30, 2025, Nkarta's total assets were $448.3 million, with $334.0 million in cash and investments Condensed Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents, restricted cash and investments | $334,041 | $380,489 | | Total assets | $448,312 | $501,203 | | Total liabilities | $90,644 | $93,227 | | Total stockholders' equity | $357,668 | $407,976 | Company and Product Information About NKX019 NKX019 is an allogeneic, off-the-shelf immunotherapy using engineered NK cells with a CD19-directed CAR and membrane-bound IL-15 - NKX019 is an allogeneic, cryopreserved, off-the-shelf immunotherapy candidate using NK cells from healthy donors[15] - It is engineered with a humanized CD19-directed CAR and a membrane-bound form of IL-15 to improve persistence and activity without exogenous cytokine support[15] About Nkarta Nkarta is a clinical-stage biotechnology company developing allogeneic, off-the-shelf NK cell therapies for autoimmune diseases - Nkarta is a clinical-stage biotechnology company developing allogeneic, off-the-shelf NK cell therapies for autoimmune diseases[16] - The company's goal is to build a pipeline of cell therapies for broad access in an outpatient treatment setting[16] Forward-Looking Statements and Risk Factors Forward-Looking Statements This press release contains forward-looking statements regarding Nkarta's clinical development timelines, data, regulatory pathways, and cash runway - Forward-looking statements include expectations for clinical development timelines, availability of clinical data, regulatory pathways for NKX019, and the company's cash runway[17] Risk Factors Key risks include limited operating history, lack of approved products, clinical trial unpredictability, funding needs, and NKX019 dependence - Identified risks include limited operating history, lack of approved products, potential for clinical trial failures, need for additional funding, and competition[18] - The company is dependent on the clinical success of its lead candidate, NKX019, and faces risks related to manufacturing complexity and third-party reliance[18] - More detailed risk factors are described in Nkarta's SEC filings, including its Quarterly Report on Form 10-Q[19]