Nkarta(NKTX) - 2023 Q4 - Annual Results

Nkarta Q4 and Full Year 2023 Financial Results and Corporate Highlights Corporate Highlights and Strategic Update Nkarta prioritizes NKX019 for autoimmune diseases, initiating a H1 2024 trial, deprioritizing NKX101, and has cash into 2026 - Pipeline realignment to focus resources on the rapid advancement of NKX019 in autoimmune diseases, while deprioritizing the development of NKX101[3][4] - The first patient dosing in the clinical trial of NKX019 for lupus nephritis is on track for the first half of 2024[3][4] Financial Position and Runway | Metric | Value | | :--- | :--- | | 2023 Year-End Cash, Cash Equivalents & Investments | $250.9 million | | Anticipated Cash Runway | Into 2026 | Clinical Program Updates Nkarta's clinical programs shift focus, advancing NKX019 for autoimmune diseases and NHL, while deprioritizing NKX101 for AML due to efficacy NKX019 in Autoimmune Disease (Lupus Nephritis) Nkarta launches a Phase 1 trial for NKX019 in refractory lupus nephritis, with first patient dosing expected in H1 2024 - The FDA has cleared the IND application for NKX019 in lupus nephritis (LN), with the first patient dosing planned for the first half of 2024[7] - The trial is a multi-center, open-label, dose escalation study for up to 12 patients with refractory LN, using a three-dose cycle at 1 billion or 1.5 billion cells per dose[7] - The lymphodepletion (LD) regimen will use single-agent cyclophosphamide (cy), which has an established safety profile in SLE and LN[7] NKX019 in Non-Hodgkin Lymphoma (NHL) Nkarta evaluates a new compressed dosing schedule for NKX019 in r/r NHL, with preliminary data expected mid-2024 - A new cohort (n=6) in the Phase 1 study is testing a compressed dosing schedule (Days 0, 3, 7) to intensify NKX019 exposure, with preliminary data expected in mid-2024[7] - Previous data showed a 70% complete response (CR) rate (7 of 10 patients) with NKX019 monotherapy at the highest dose levels[7] - 4 of 4 patients who relapsed after achieving CR were able to achieve CR again after re-treatment, suggesting a lack of resistance to NKX019[7] NKX101 in Acute Myeloid Leukemia (AML) Nkarta deprioritized the NKX101 program and closed enrollment due to lower efficacy data in an expanded AML patient cohort - The company has closed patient enrollment and deprioritized the NKX101 program to focus resources on NKX019 for autoimmune disease[10] - The decision was based on a review of data from 20 patients showing a lower aggregate CR/CRi rate (5 of 20) than what was observed in the first 6 patients in the cohort[10] - The safety profile of NKX101 was consistent with previously reported data[10] Financial Results Nkarta reported a net loss of $117.5 million for 2023, ending with $250.9 million in cash, expected to fund operations into 2026 Financial Highlights & Guidance For 2023, Nkarta incurred $96.8 million in R&D and $34.9 million in G&A, resulting in a $117.5 million net loss Full Year 2023 Financial Summary | Metric | Full Year 2023 (USD) | Q4 2023 (USD) | | :--- | :--- | :--- | | R&D Expenses | $96.8 million | $23.3 million | | G&A Expenses | $34.9 million | $7.9 million | | Net Loss | $117.5 million | $27.8 million | | Net Loss per Share | $2.40 | $0.57 | - As of December 31, 2023, Nkarta had cash, cash equivalents, and investments of $250.9 million[10] - The company expects its current cash and cash equivalents will be sufficient to fund its current operating plan into 2026[10] Condensed Statements of Operations The company's net loss for full year 2023 was $117.5 million, increasing from 2022 due to higher operating expenses Statement of Operations (in thousands) | Metric | Year Ended 2023 | Year Ended 2022 | Q4 2023 | Q4 2022 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $96,773 | $90,897 | $23,322 | $26,845 | | General and administrative | $34,877 | $28,058 | $7,863 | $8,138 | | Total operating expenses | $131,650 | $118,955 | $31,185 | $34,983 | | Loss from operations | $(131,650) | $(118,955) | $(31,185) | $(34,983) | | Interest income | $14,107 | $5,588 | $3,456 | $2,890 | | Net loss | $(117,501) | $(113,837) | $(27,754) | $(32,582) | | Net loss per share | $(2.40) | $(2.61) | $(0.57) | $(0.67) | Condensed Balance Sheets As of December 31, 2023, Nkarta's total assets decreased to $378.9 million, driven by reduced cash and investments Balance Sheet Highlights (in thousands) | Metric | Dec 31, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | Cash, cash equivalents, restricted cash and short-term investments | $250,932 | $354,886 | | Total assets | $378,885 | $472,938 | | Total liabilities | $105,600 | $100,731 | | Stockholders' equity | $273,285 | $372,207 | Company and Product Overview This section outlines Nkarta's core technology and product candidates, focusing on allogeneic, off-the-shelf NK cell therapies About NKX019 NKX019 is an allogeneic, off-the-shelf immunotherapy candidate engineered with a CD19-directed CAR and membrane-bound IL-15 - NKX019 is an allogeneic, off-the-shelf NK cell therapy candidate derived from healthy adult donors[11] - It is engineered with a humanized CD19-directed CAR for targeting B cells and a membrane-bound IL-15 for enhanced persistence and activity[11] About NKX101 NKX101 is an allogeneic, off-the-shelf cancer immunotherapy candidate engineered with a CAR targeting NKG2D ligands - NKX101 is an allogeneic, off-the-shelf NK cell therapy candidate for cancer[12] - It is engineered with a CAR targeting NKG2D ligands on tumor cells and includes a membrane-bound form of IL-15[12] About Nkarta Nkarta is a clinical-stage biotech company developing allogeneic, off-the-shelf NK cell therapies using proprietary engineering platforms - Nkarta is a clinical-stage biotech company developing allogeneic, off-the-shelf NK cell therapies[13] - The company's approach combines cell expansion, cryopreservation, and proprietary engineering technologies for broad access in an outpatient setting[13] Forward-Looking Statements and Risk Factors This section cautions investors that statements regarding future plans and product potential are forward-looking and subject to significant risks - The press release contains forward-looking statements concerning plans, strategies, and timelines for clinical development, therapeutic potential, and financial runway[14] - Key risks include limited operating history, lack of approved products, unpredictability of clinical trial results, potential for delays, competition, and dependence on third parties for manufacturing and trials[15][16]