On March 16, 2023 Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, reported financial results for the fourth quarter and year ended December 31, 2022 (Press release, Nkarta, MAR 16, 2023, View Source [SID1234628906]).
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"Clinical data from our co-lead pipeline candidates have highlighted the promise of our allogeneic NK cell therapy technology to lead the next wave of cell therapy," said Paul J. Hastings, President and CEO of Nkarta. "We believe that the future of cell therapy is improved accessibility, and NK cells may be uniquely equipped to overcome access barriers owing to their intrinsic tumor killing ability and relative ease of administration. We have shown early proof of concept that engineered NK cells derived from healthy donors have the potential to induce deep and meaningful responses in patients without the safety challenges inherent to T-cell based approaches. Nkarta continues to make excellent progress and we look forward to announcing clinical updates for our two programs in 2023."
2022 Pipeline Updates
NKX101
NKX101 is an allogeneic, off-the-shelf cell therapy candidate that uses NK cells derived from healthy donors and engineered to target NKG2D ligands on cancer cells.
In April 2022, Nkarta reported preliminary data from its Phase 1 clinical trial evaluating NKX101 as a multi-dose, multi-cycle monotherapy in patients with r/r acute myeloid leukemia (AML) and higher-risk myelodysplastic syndrome (MDS).
NKX101 demonstrated encouraging single-agent anti-tumor activity. Three of five patients with heavily pre-treated AML treated at the higher dose levels in a three-dose regimen achieved a complete response (60% CR) with hematologic recovery, with two of the three responses MRD (measurable residual disease) negative.
NKX101 was well tolerated. No dose-limiting toxicities were observed. No cytokine release syndrome (CRS), graft-versus-host disease (GvHD), or immune effector cell-associated neurotoxicity syndrome (ICANS) was observed. The most common higher-grade adverse events were myelosuppression and infection, which are common in this patient population following lymphodepletion.
As previously announced, Nkarta plans to present additional results from its ongoing clinical trial of NKX101 in the first half of 2023. The update is expected to include outcomes for the entire cohort of patients with r/r AML treated at 1.5 billion cells/dose x 3 dose regimen.
NKX019
NKX019 is an allogeneic, off-the-shelf cell therapy candidate that uses NK cells engineered to target the B-cell antigen CD19.
In December 2022, Nkarta reported updated preliminary data from its Phase 1 clinical trial evaluating NKX019 as a multi-dose, multi-cycle monotherapy in patients with relapsed/refractory B cell malignancies. Patients were required to be CAR T naïve to avoid confounding either the safety or efficacy of NKX019.
In this update, NKX019 continued to demonstrate encouraging single-agent anti-tumor activity. Seven of ten patients treated at the higher dose levels in a three-dose regimen had a complete response (70% CR), including two of four patients (50% CR) with aggressive large B-cell lymphoma. Five of seven CRs were achieved after a single cycle of treatment. Multiple cycles of treatment enabled deepening of response and consolidation of CR. Durable CRs exceeding beyond 6 months were observed in multiple patients.
No dose limiting toxicity, neurotoxicity / ICANS, GvHD, or Grade 3+ CRS was observed in the study.
In November 2022, Nkarta opened enrollment in the dose expansion portion of its Phase 1 clinical trial of NKX019. The trial is enrolling patients with aggressive LBCL into three cohorts: NKX019 in patients who have not previously received autologous CD19 CAR T therapy, NKX019 in patients who previously received autologous CD19 CAR T therapy, and NKX019 as combination therapy with rituximab to evaluate for enhanced anti-tumor activity via ADCC, a tumor killing mechanism driven by antibodies. The combination arm includes patients who previously received and patients who did not previously receive autologous CD19 CAR T therapy.
As previously announced, Nkarta plans to present updated results from its ongoing clinical trial of NKX019 in 2023. The update is expected to include safety and activity data from patients in the dose escalation cohorts who may have received one or more additional cycles of CAR NK cell therapy, including consolidation therapy, durability of response in patients who were in response as of the November 2022 data cut-off, and safety and activity data from patients treated in the recently opened LBCL dose expansion cohorts.
2022 Platform Updates
In November 2022, Nkarta presented preclinical data from its engineered NK cell platform in two posters at the annual meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper). The posters included data on improved anti-tumor activity demonstrated by the combination of NKX019 and a CD20-directed monoclonal antibody (mAb) and an optimized manufacturing process that could allow the production of several thousand doses of CAR NK cells from a single manufacturing run.
In April 2022, Nkarta presented preclinical data from its engineered NK cell platform in four posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting. The posters included data on the use of multiplex CRISPR/Cas9 genome editing to enhance the ability of NK cells to target tumors expressing the CD70 antigen (jointly presented with CRISPR Therapeutics); analytical and translational methods to better understand patterns of response to CAR NK cells; analysis of surface antigen expression in preclinical models of multiple myeloma; and immune masking strategies for extending the persistence of allogeneic cell therapies.
2022 Corporate Updates
In August 2022, Nkarta signed amended lease agreements for its future cell therapy manufacturing facility and company headquarters and for its existing facilities. The amendments provide for approximately $15 million of additional tenant improvement allowances for the future facility, increase the rent for the future facility, and increase the rent and term of the lease for some of Nkarta’s existing facilities. These allowances are in addition to the tenant improvement allowances of $25.2 million included in the original lease agreement for the future facility, totaling $40.2 million. Nkarta’s facilities are located in South San Francisco, California.
In April 2022, Nkarta received approximately $215.3 million in net proceeds from a public offering of its common stock.
Fourth Quarter and Full Year 2022 Financial Highlights
Cash and Cash Equivalents: As of December 31, 2022, Nkarta had cash, cash equivalents, restricted cash and short-term investments of $354.9 million.
R&D Expenses: Research and development (R&D) expenses were $90.9 million for the full year 2022 and $26.8 million for the fourth quarter of 2022. Non-cash stock-based compensation expense included in R&D expense was $7.3 million for the full year 2022 and $1.9 million for the fourth quarter of 2022.
G&A Expenses: General and administrative (G&A) expenses were $28.1 million for the full year 2022 and $8.1 million for the fourth quarter of 2022. Non-cash stock-based compensation expense included in G&A expense was $9.5 million for the full year 2022 and $2.5 million for the fourth quarter of 2022.
Net Loss. Net loss was $113.8 million, or $2.61 per basic and diluted share, for the full year 2022. This net loss includes non-cash charges of $23.1 million that consisted primarily of share-based compensation of $16.9 million. Net loss was $32.6 million, or $0.67 per basic and diluted share, for the fourth quarter of 2022.
Financial Guidance
Nkarta expects its current cash and cash equivalents will be sufficient to fund its current operating plan into 2025.
About NKX101
NKX101 is an allogeneic, cryopreserved, off-the-shelf cancer immunotherapy candidate that uses natural killer (NK) cells derived from the peripheral blood of healthy donors. It is engineered with a chimeric antigen receptor (CAR) targeting NKG2D ligands on tumor cells. NKG2D, a key activating receptor found on naturally occurring NK cells, induces a cell-killing immune response through the detection of stress ligands that are widely expressed on cancer cells. NKX101 is also engineered with membrane-bound form of interleukin-15 (IL15) for greater persistence and activity without exogenous cytokine support. To learn more about the NKX101 clinical trial in adults with AML or MDS, please visit ClinicalTrials.gov.
About NKX019
NKX019 is an allogeneic, cryopreserved, off-the-shelf cancer immunotherapy candidate that uses natural killer (NK) cells derived from the peripheral blood of healthy adult donors. It is engineered with a humanized CD19-directed CAR for enhanced tumor cell targeting and a proprietary, membrane-bound form of interleukin-15 (IL-15) for greater persistence and activity without exogenous cytokine support. CD19 is a biomarker for normal and malignant B cells, and it is a validated target for B cell cancer therapies. To learn more about the NKX019 clinical trial in adults with advanced B cell malignancies, please visit ClinicalTrials.gov.