NVCT 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-05-05

• The Phase 1 study was initiated in September 2023 and is comprised of two parts: dose-escalation (Phase 1a), to be followed by an expansion phase (Phase 1b). The results of the Phase 1a study support once-daily oral dosing of NXP900. In August 2025, we announced the initiation of the Phase 1b expans…

• From our inception on July 27, 2020, through March 31, 2026, we did not generate any revenue. Since our inception through March 31, 2026, our main activities have been organizational management,capital raising and the completion of the in-license agreements for, NXP800 and NXP900, regulatory filings…

• Research and development expenses increased by $0.4 million during the three months ended March 31, 2026 compared to the same period in 2025. The increase in research and development expenses during the three months ended March 31, 2026 was primarily driven by a $0.4 million increase in manufacturin…

• As a result of the foregoing, our loss from operations for the three months ended March 31, 2026, increased $0.7 million, compared to the same period in 2025, which was primarily driven by employee compensation, clinical trial expenses, and manufacturing expenses.

• As of March 31, 2026, we had $25.1 million of cash and cash equivalents. For the three months ended March 31, 2026 and 2025, we reported net losses of $6.1 million and $5.3 million, respectively.

相对上期删除的文字 · 来源:10-Q · 2025-11-04

• The NXP900 Phase 1 study was initiated in September 2023 and is comprised of two parts: dose-escalation (Phase 1a), and an expansion phase (Phase 1b).

• The Phase 1a dose escalation study evaluated the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of NXP900 in patients with advanced solid tumors (all comers). In this portion of the study, a dose range of 20 to 300 mg/day was evaluated and the dose limiting toxicity dose level was not reac…

• announced the initiation of Phase 1b expansion portion of the study. The ongoing Phase 1b will evaluate NXP900 as both a single agent targeting specific tumor types and in combination with market-leading EGFR and ALK inhibitors.

• In July 2025, in advance of exploring combinations of NXP900 with EGFR and ALK inhibitors, we announced the completion and topline results from our clinical drug-drug interaction (DDI) study in healthy volunteers. The NXP900 DDI study was conducted to evaluate the potential of NXP900 to induce the a…

• We have licensed exclusive worldwide development and commercial rights to NXP800, an oral, small molecule discovered at the Institute of Cancer Research (“ICR”) in London, England.

相对上期新增的文字 · 来源:10-Q · 2026-05-05

• ●We plan to rely on third parties to conduct our preclinical studies and clinical trials. If these third parties do not properly and successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval of or commercialize our current or future …

• ●Our future success depends on our ability to retain our executive officers and key employees and to attract, retain and motivate qualified personnel and manage our human capital.

• ●We currently have 12 full-time employees and will need to grow the size and capabilities of our organization. We may experience difficulties in managing this growth.

相对上期删除的文字 · 来源:10-Q · 2025-11-04

• ●Policies implemented during the COVID-19 pandemic, which remain in place today, could adversely impact our business, including our preclinical development, clinical trials, and clinical trial operations.

• ●Our future success depends on our ability to retain our executive officers and key employees and to attract, retain, and motivate qualified personnel and manage our human capital.

• ●We currently have 13 full-time employees and will need to grow the size and capabilities of our organization. We may experience difficulties in managing this growth.

相对上期新增的文字 · 来源:10-Q · 2026-05-05

• ●We plan to rely on third parties to conduct our preclinical studies and clinical trials. If these third parties do not properly and successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval of or commercialize our current or future …

• ●Our future success depends on our ability to retain our executive officers and key employees and to attract, retain and motivate qualified personnel and manage our human capital.

• ●We currently have 12 full-time employees and will need to grow the size and capabilities of our organization. We may experience difficulties in managing this growth.

相对上期删除的文字 · 来源:10-Q · 2025-11-04

• ●Policies implemented during the COVID-19 pandemic, which remain in place today, could adversely impact our business, including our preclinical development, clinical trials, and clinical trial operations.

• ●Our future success depends on our ability to retain our executive officers and key employees and to attract, retain, and motivate qualified personnel and manage our human capital.

• ●We currently have 13 full-time employees and will need to grow the size and capabilities of our organization. We may experience difficulties in managing this growth.

相对上期新增的文字 · 来源:10-Q · 2026-05-05

• ●We plan to rely on third parties to conduct our preclinical studies and clinical trials. If these third parties do not properly and successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval of or commercialize our current or future …

• ●Our future success depends on our ability to retain our executive officers and key employees and to attract, retain and motivate qualified personnel and manage our human capital.

• ●We currently have 12 full-time employees and will need to grow the size and capabilities of our organization. We may experience difficulties in managing this growth.

相对上期删除的文字 · 来源:10-Q · 2025-11-04

• ●Policies implemented during the COVID-19 pandemic, which remain in place today, could adversely impact our business, including our preclinical development, clinical trials, and clinical trial operations.

• ●Our future success depends on our ability to retain our executive officers and key employees and to attract, retain, and motivate qualified personnel and manage our human capital.

• ●We currently have 13 full-time employees and will need to grow the size and capabilities of our organization. We may experience difficulties in managing this growth.

相对上期新增的文字 · 来源:10-Q · 2026-05-05

• We expect our expenses to increase in parallel with our ongoing activities, particularly as we continue our activities to identify new product candidates and initiate clinical trials of, and seek marketing approval for, any of our current or future product candidates. In addition, if we obtain marke…

• Disruptions at the FDA and other agencies may also slow the time necessary for new product candidates to be reviewed and/or approved by necessary government agencies. Further, future government shutdowns could impact the ability to access the public markets and obtain necessary capital in order to p…

• Major public health issues, such as pandemics, could have an adverse effect on our clinical trials, financial condition, results of operations, and other aspects of our business.

• ●delays or difficulties in clinical site initiation, including difficulties in recruiting clinical sites, and delays enrolling patients in our clinical trials or increased rates of patients withdrawing from our clinical trials following enrollment;

• ●diversion of healthcare resources, including clinical trial investigators and staff, away from the conducting of clinical trials to focus on pandemic concerns which could result in delays to our partner companies’ clinical trials;

相对上期删除的文字 · 来源:10-Q · 2025-11-04

• We expect our expenses to increase in parallel with our ongoing activities, particularly as we continue our activities to identify new product candidates and initiate clinical trials of, and seek marketing approval for, any of our current or future product candidates. In addition, if we obtain marke…

• significant additional costs associated with operating as a public company. Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations. We cannot be certain that additional funding will be available on acceptable terms, or at all. Until such time,…

• government funding of the SEC and other government agencies on which our operations may rely is subject to the political process, which is inherently fluid and unpredictable.

• Disruptions at the FDA and other agencies may also slow the time necessary for new product candidates to be reviewed and/or approved by necessary government agencies. For example, over the last several years the U.S. government has shut down several times and certain regulatory agencies, such as the…

• Major public health issues, and specifically the policies and procedures implemented during the COVID-19 pandemic which are still in place, could have an adverse effect on our clinical trials, financial condition, results of operations, and other aspects of our business.

相对上期新增的文字 · 来源:10-Q · 2026-05-05

• ●We plan to rely on third parties to conduct our preclinical studies and clinical trials. If these third parties do not properly and successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval of or commercialize our current or future …

• ●Our future success depends on our ability to retain our executive officers and key employees and to attract, retain and motivate qualified personnel and manage our human capital.

• ●We currently have 12 full-time employees and will need to grow the size and capabilities of our organization. We may experience difficulties in managing this growth.

相对上期删除的文字 · 来源:10-Q · 2025-11-04

• ●Policies implemented during the COVID-19 pandemic, which remain in place today, could adversely impact our business, including our preclinical development, clinical trials, and clinical trial operations.

• ●Our future success depends on our ability to retain our executive officers and key employees and to attract, retain, and motivate qualified personnel and manage our human capital.

• ●We currently have 13 full-time employees and will need to grow the size and capabilities of our organization. We may experience difficulties in managing this growth.