NKTX 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-08-10

• Research and development expenses. Research and development expenses were $29.0 million and $20.8 million for the three months ended June 30, 2026 and 2025, respectively. Research and development expenses were $54.0 million and $45.0 million for the six months ended June 30, 2026 and 2025, respectiv…

• a $0.8 million increase in personnel costs primarily from higher salaries and wages expense recognized primarily due to an increase in wages and health benefits expenses.

• The increase of $9.1 million for the six months ended June 30, 2026 was primarily due to the following:

• a $8.2 million increase in program costs primarily from higher clinical spending related to NKX019 to support clinical trials in autoimmune diseases, which was partially offset by lower manufacturing and materials expenses;

• a $1.9 million increase in other research costs, primarily consisting of higher consulting, and depreciation expenses, which was partially offset by lower laboratory supplies, facilities, and licenses expenses due to lower headcount; and

相对上期删除的文字 · 来源:10-Q · 2026-05-12

• Research and development expenses. Research and development expenses were $25.0 million and $24.2 million for the three months ended March 31, 2026 and 2025, respectively.

• a $1.5 million decrease in personnel costs primarily from lower salaries and wages and share based compensation expense recognized due to lower headcount as a result of the reduction in force in March 2025.

• General and administrative expenses. General and administrative expenses were $5.9 million and $12.4 million for the three months ended March 31, 2026 and 2025, respectively. The decrease of $6.5 million for the three months ended March 31, 2026 was primarily due to a $6.3 million decrease in person…

• Interest income. Interest income was $2.8 million and $4.4 million for the three months ended March 31, 2026 and 2025, respectively. The decrease of $1.5 million was primarily due to lower average investment balances and lower average interest rates in the current period. Interest income includes in…

• As of March 31, 2026, we had cash, cash equivalents, restricted cash and investments of $266.7 million. We estimate that all $265.1 million in net proceeds from our July 2020 initial public offering have been spent. On April 28, 2022, we received $215.3 million in net proceeds, after deducting under…

相对上期新增的文字 · 来源:10-Q · 2026-08-10

• NKX019 is in Phase 1/2 clinical development and subject to the risks inherent in drug development. In October 2023, we announced that we had received clearance of an Investigational New Drug ("IND") application by the FDA to evaluate NKX019 for the treatment of LN in our Ntrust-1 clinical trial, and…

• NKX019 for the treatment of scleroderma, myositis, and AAV in our Ntrust-2 clinical trial, which is a multi-center, open-label, dose-escalation Phase 1/2 clinical trial that evaluates the safety and clinical activity of NKX019 in patients with scleroderma, myositis, and AAV. In May 2025, we announce…

• Specifically, in relation to the modification of the LD, physicians may exercise more caution when enrolling patients in our clinical trials.

• In addition, as the current administration continues to pursue cost-cutting measures, including reducing funding to academic research centers, the impact on industry-sponsored clinical research, as a result, and our business is currently unclear. A reduction of resources at these clinical sites also…

• Scaled manufacturing can broaden patient access to off-the-shelf product candidates without requiring additional donors. However, as our product candidates are not genetically modified to reduce naturally occurring cell surface antigens, potential patients may have antibodies against such antigens. …

相对上期删除的文字 · 来源:10-Q · 2026-05-12

• approval, refusal to accept or rejection, of our marketing applications by the FDA or comparable foreign regulatory authority, as the case may be, and may ultimately lead to the denial of marketing approval of our product candidates.

• NKX019 is in Phase 1/2 clinical development and subject to the risks inherent in drug development. In October 2023, we announced that we had received clearance of an Investigational New Drug ("IND") application by the FDA to evaluate NKX019 for the treatment of LN in our Ntrust-1 clinical trial, and…

• Cy. At the same time, we reported the implementation of a streamlined enrollment process that allows participant data from both the Ntrust-1 and Ntrust-2 clinical trials to be reviewed by a combined independent Data Safety Monitoring Board (“iDSMB”) to inform dose-escalation decisions. This update f…

• In addition, as the current administration continues to pursue cost-cutting measures, including reducing funding to academic research centers, the impact on industry-sponsored clinical research, as a result, and our business is currently unclear. A reduction of resources at these clinical sites also…

• completion of clinical trials may be delayed or may not be achieved, which would prevent us from further developing or commercializing our product candidates in certain patient subpopulations or at all.

相对上期新增的文字 · 来源:10-Q · 2026-08-10

• During the quarter ended June 30, 2026, none of our directors or officers adopted, modified or terminated a "Rule 10b5-1 trading arrangement" or a "non-Rule 10b5-1 trading arrangement," as each item is defined in Item 408(a) of Regulation S-K.

相对上期删除的文字 · 来源:10-Q · 2026-05-12

• During the quarter ended March 31, 2026, the following officers adopted a "Rule 10b5-1 trading arrangement" (as such terms are defined in Item 408(a) of Regulation S-K) as noted in the table below.