NVCT 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-08-04

• In June 2026 we have licensed exclusive world-wide development, manufacturing and commercial rights, excluding China, to NXP100/HSK39297 an oral, once daily, potent and selective small-molecule Factor B inhibitor in advanced stages of development. Factor B is a key component of the complement system…

• Ciprocopan (NXP100) has received marketing approval by the National Medical Products Administration (NMPA) in China for PNH patients previously untreated with complement inhibitors (treatment naive). A marketing applications for previously treated PNH, and a Phase 3 study for IgAN and a Phase 2 stud…

• In June 2026 we have licensed exclusive world-wide development, manufacturing and commercial rights, excluding China, to NXP200/HSK42360 an inhibitor of the BRAF serine/threonine kinase (“BRAFi”) that has the potential to be a best-in-class, brain-penetrant paradox breaker, by overcoming broad-spect…

• The ongoing Phase 1b study is evaluating the safety, tolerability and preliminary efficacy of NXP900 combination with market-leading EGFR and a combination study with the anaplastic lymphoma kinase (“ALK”) inhibitor, lorlatonib is pending commencement.

• From our inception on July 27, 2020, through June 30, 2026, we did not generate any revenue. Since our inception through June 30, 2026, our primary activities have been focused on the development of our four drug candidates, NXP100, NXP200, NXP900, and NXP800, including the completion of in-licensin…

相对上期删除的文字 · 来源:10-Q · 2026-05-05

• SRC is aberrantly activated in many cancer types, including solid tumor cancers such as breast, colon, prostate, pancreatic and ovarian cancers, while remaining predominantly inactive in non-cancerous cells. Increased SRC activity is generally associated with late-stage cancers with metastatic poten…

• YES1 is a nonreceptor tyrosine kinase that belongs to the SRC family of kinases and controls multiple cancer signaling pathways. YES1 is gene-amplified and overexpressed in many tumor types, where it promotes cell proliferation, survival, and invasiveness. In addition, YES1 directly phosphorylates a…

• In vivo, treatment with NXP900 inhibited primary and metastatic tumor growth in xenograft models of breast, esophageal, lung, head and neck cancers and medulloblastoma, and demonstrated on-target pharmacodynamic effects. Moreover, publications in the scientific literature outlined opportunities to p…

• 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…

相对上期新增的文字 · 来源:10-Q · 2026-08-04

• ●Any changes to the regulations that can make development of new drugs originating in China in the United States more difficult will adversely impact our development plans for NXP100 and NXP200.

• ●If we are unable to obtain and maintain patent protection or other necessary rights for our products and technology, or if the scope of the patent protection obtained is not sufficiently broad or our rights under licensed patents are not sufficiently broad, our competitors could develop and commerc…

• ●The manufacturing of our current product candidates is complex. Our third-party manufacturers may encounter difficulties or interruptions for various reasons, which could delay or entirely halt their ability to manufacture any of our current or future product candidates for clinical trials or, if a…

• ●We are substantially dependent on our in-licensing partner for NXP100 and NXP200, Haisco, for the transfer of technology, know-how, and supply of certain materials to execute our plan for both NXP100 and NXP200.

• ●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.

相对上期删除的文字 · 来源:10-Q · 2026-05-05

• ●If we are unable to obtain and maintain patent protection or other necessary rights for our products and technology, or if the scope of the patent protection obtained is not sufficiently broad or our rights under licensed patents are not sufficiently broad, our competitors could develop and commerc…

• ●The manufacturing of our current product candidate is complex. Our third-party manufacturers may encounter difficulties or interruptions for various reasons, which could delay or entirely halt their ability to manufacture any of our current or future product candidates for clinical trials or, if ap…

• ●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.

相对上期新增的文字 · 来源:10-Q · 2026-08-04

• ●Any changes to the regulations that can make development of new drugs originating in China in the United States more difficult will adversely impact our development plans for NXP100 and NXP200.

• ●If we are unable to obtain and maintain patent protection or other necessary rights for our products and technology, or if the scope of the patent protection obtained is not sufficiently broad or our rights under licensed patents are not sufficiently broad, our competitors could develop and commerc…

• ●The manufacturing of our current product candidates is complex. Our third-party manufacturers may encounter difficulties or interruptions for various reasons, which could delay or entirely halt their ability to manufacture any of our current or future product candidates for clinical trials or, if a…

• ●We are substantially dependent on our in-licensing partner for NXP100 and NXP200, Haisco, for the transfer of technology, know-how, and supply of certain materials to execute our plan for both NXP100 and NXP200.

• ●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.

相对上期删除的文字 · 来源:10-Q · 2026-05-05

• ●If we are unable to obtain and maintain patent protection or other necessary rights for our products and technology, or if the scope of the patent protection obtained is not sufficiently broad or our rights under licensed patents are not sufficiently broad, our competitors could develop and commerc…

• ●The manufacturing of our current product candidate is complex. Our third-party manufacturers may encounter difficulties or interruptions for various reasons, which could delay or entirely halt their ability to manufacture any of our current or future product candidates for clinical trials or, if ap…

• ●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.

相对上期新增的文字 · 来源:10-Q · 2026-08-04

• ●Any changes to the regulations that can make development of new drugs originating in China in the United States more difficult will adversely impact our development plans for NXP100 and NXP200.

• ●If we are unable to obtain and maintain patent protection or other necessary rights for our products and technology, or if the scope of the patent protection obtained is not sufficiently broad or our rights under licensed patents are not sufficiently broad, our competitors could develop and commerc…

• ●The manufacturing of our current product candidates is complex. Our third-party manufacturers may encounter difficulties or interruptions for various reasons, which could delay or entirely halt their ability to manufacture any of our current or future product candidates for clinical trials or, if a…

• ●We are substantially dependent on our in-licensing partner for NXP100 and NXP200, Haisco, for the transfer of technology, know-how, and supply of certain materials to execute our plan for both NXP100 and NXP200.

• ●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.

相对上期删除的文字 · 来源:10-Q · 2026-05-05

• ●If we are unable to obtain and maintain patent protection or other necessary rights for our products and technology, or if the scope of the patent protection obtained is not sufficiently broad or our rights under licensed patents are not sufficiently broad, our competitors could develop and commerc…

• ●The manufacturing of our current product candidate is complex. Our third-party manufacturers may encounter difficulties or interruptions for various reasons, which could delay or entirely halt their ability to manufacture any of our current or future product candidates for clinical trials or, if ap…

• ●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.

相对上期新增的文字 · 来源:10-Q · 2026-08-04

• We are a clinical-stage biopharmaceutical company with a limited operating history. We were incorporated in Delaware in July 2020, and our operations to date have been limited to organizing and staffing our company, business planning, raising capital, identifying, investigating, licensing and evalua…

• our product candidates and component materials, and conducting research and development activities. While all our product candidates are in the clinical development phase, we have not yet demonstrated our ability to successfully conduct or complete any clinical development program for any of our dru…

• We rely on third parties for certain functions or services in support of our clinical trials and key areas of our operations. If these third parties themselves are adversely impacted by restrictions resulting from major public health issues, we will likely experience delays and/or realize additional…

• following a preliminary analysis of safety and efficacy data results from the Phase 1b study of NXP800 in platinum-resistant ARID1a-mutated ovarian carcinoma, we decided to cease the clinical development of NXP800 in this indication.

• We may experience setbacks that could delay or prevent regulatory approval of, or our ability to commercialize, NXP100, NXP200 and NXP900, or future product candidates, including:

相对上期删除的文字 · 来源:10-Q · 2026-05-05

• We are a clinical-stage biopharmaceutical company with a limited operating history. We were incorporated in Delaware in July 2020, and our operations to date have been limited to organizing and staffing our company, business planning, raising capital, identifying, investigating, licensing and evalua…

• We rely on third parties for certain functions or services in support of our clinical trials and key areas of our operations. If these third parties themselves are adversely impacted by restrictions resulting from major public health issues, we will likely experience delays

• and/or realize additional costs. As a result, our ability to commence and complete clinical trials in a timely fashion, obtain regulatory approvals for, and to commercialize, our current and future product candidates may be delayed or disrupted.

• We may experience setbacks that could delay or prevent regulatory approval of, or our ability to commercialize, NXP900, our product candidate currently in a Phase 1b clinical trial, or future product candidates, including:

• conducted in whole or in part outside of the United States, which may result in the need for additional trials conducted in the United States.

相对上期新增的文字 · 来源:10-Q · 2026-08-04

• ●Any changes to the regulations that can make development of new drugs originating in China in the United States more difficult will adversely impact our development plans for NXP100 and NXP200.

• ●If we are unable to obtain and maintain patent protection or other necessary rights for our products and technology, or if the scope of the patent protection obtained is not sufficiently broad or our rights under licensed patents are not sufficiently broad, our competitors could develop and commerc…

• ●The manufacturing of our current product candidates is complex. Our third-party manufacturers may encounter difficulties or interruptions for various reasons, which could delay or entirely halt their ability to manufacture any of our current or future product candidates for clinical trials or, if a…

• ●We are substantially dependent on our in-licensing partner for NXP100 and NXP200, Haisco, for the transfer of technology, know-how, and supply of certain materials to execute our plan for both NXP100 and NXP200.

• ●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.

相对上期删除的文字 · 来源:10-Q · 2026-05-05

• ●If we are unable to obtain and maintain patent protection or other necessary rights for our products and technology, or if the scope of the patent protection obtained is not sufficiently broad or our rights under licensed patents are not sufficiently broad, our competitors could develop and commerc…

• ●The manufacturing of our current product candidate is complex. Our third-party manufacturers may encounter difficulties or interruptions for various reasons, which could delay or entirely halt their ability to manufacture any of our current or future product candidates for clinical trials or, if ap…

• ●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.