Nkarta(NKTX) - 2024 Q1 - Quarterly Results

Corporate Highlights Nkarta is advancing NKX019 into autoimmune diseases, with first lupus nephritis patient dosing in H1 2024, bolstered by a $240.1 million offering extending cash runway to late 2027 - The company is prioritizing the development of its off-the-shelf NK cell product, NKX019, for autoimmune diseases, starting with lupus nephritis, to address patient access and safety concerns associated with existing cell therapies[3] - In March 2024, Nkarta completed an underwritten offering of common stock and pre-funded warrants, raising gross proceeds of $240.1 million[9] - The company's strong balance sheet, with a cash balance of $450.0 million as of March 31, 2024, is expected to fund operations into late 2027[5][11] Clinical Pipeline Update Nkarta provided updates on NKX019, with first lupus nephritis patient dosing in H1 2024 and promising re-treatment efficacy in NHL, with new data expected mid-2024 NKX019 in Autoimmune Disease Nkarta is advancing its Phase 1 trial of NKX019 for refractory lupus nephritis, with first patient dosing expected in H1 2024 using a cyclophosphamide-only lymphodepletion regimen - The first patient with lupus nephritis is expected to be dosed with NKX019 in the first half of 2024[5][7] - The Phase 1 trial will use a single-agent lymphodepletion regimen with cyclophosphamide, an agent with an established safety profile in lupus nephritis[6] - Translational data suggest NKX019 has the potential to drive an immunologic reset by efficiently killing B cells and allowing for the recovery of predominantly naïve B cells[6] NKX019 in Non-Hodgkin Lymphoma (NHL) In r/r NHL, NKX019 demonstrated re-treatment efficacy with complete responses, and a compressed dosing cohort is being evaluated, with preliminary data expected mid-2024 - All 4 r/r NHL patients who had previously achieved a complete response (CR) with NKX019 and subsequently relapsed were able to achieve CR again after re-treatment[12] - A compressed dosing regimen (Days 0, 3, and 7) is being evaluated to potentially intensify NKX019 exposure[12] - Preliminary data from the compressed dosing cohort in the r/r NHL trial is expected to be announced in mid-2024[12] First Quarter 2024 Financial Results Nkarta reported a $29.5 million net loss for Q1 2024, ending with $450.0 million cash, significantly increased by financing, expected to fund operations into late 2027 Financial Highlights Nkarta ended Q1 2024 with $450.0 million in cash, a net loss of $29.5 million ($0.58 per share), and R&D and G&A expenses of $25.2 million and $7.5 million respectively Q1 2024 Key Financial Metrics | Metric | Q1 2024 | | :--- | :--- | | Cash, Cash Equivalents, and Investments | $450.0 million | | R&D Expenses | $25.2 million | | G&A Expenses | $7.5 million | | Net Loss | $29.5 million | | Net Loss per Share | $0.58 | Financial Guidance Nkarta projects its current cash and cash equivalents will fund operations into late 2027 - The company projects its current cash and cash equivalents will be sufficient to fund its operating plan into late 2027[11] Condensed Statements of Operations For Q1 2024, total operating expenses were $32.8 million, down from $34.3 million in Q1 2023, with net loss narrowing to $29.5 million from $30.8 million Condensed Statements of Operations (in thousands) | Line Item | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Research and development | $25,237 | $26,135 | | General and administrative | $7,525 | $8,178 | | Total operating expenses | $32,762 | $34,313 | | Loss from operations | ($32,762) | ($34,313) | | Interest income | $3,246 | $3,465 | | Net loss | ($29,518) | ($30,815) | | Net loss per share, basic and diluted | ($0.58) | ($0.63) | Condensed Balance Sheets As of March 31, 2024, Nkarta reported total assets of $576.9 million and total liabilities of $103.3 million, with cash increasing to $450.0 million from $250.9 million Condensed Balance Sheet Highlights (in thousands) | Line Item | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Assets | | | | Cash, cash equivalents, and investments | $449,951 | $250,932 | | Total assets | $576,936 | $378,885 | | Liabilities and Stockholders' Equity | | | | Total liabilities | $103,285 | $105,600 | | Total stockholders' equity | $473,651 | $273,285 | | Total liabilities and stockholders' equity | $576,936 | $378,885 | Company and Product Overview This section details Nkarta's lead candidate, NKX019, an allogeneic, off-the-shelf NK cell therapy, and provides an overview of the clinical-stage company About NKX019 NKX019 is an allogeneic, cryopreserved, off-the-shelf NK cell immunotherapy engineered with a CD19-directed CAR and membrane-bound IL-15 for enhanced persistence - NKX019 is an allogeneic, cryopreserved, off-the-shelf immunotherapy candidate using natural killer (NK) cells from healthy donors[12] - The therapy is engineered with a humanized CD19-directed CAR for targeting and a membrane-bound form of IL-15 for greater persistence and activity[13] About Nkarta Nkarta is a clinical-stage biotechnology company developing allogeneic, off-the-shelf NK cell therapies, leveraging its platforms for broad outpatient access - Nkarta is a clinical-stage biotechnology company focused on advancing allogeneic, off-the-shelf NK cell therapies[14] - The company's goal is to create therapies with deep activity that are suitable for broad access in an outpatient treatment setting[14]