NUVL — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-07

• Between September 2023 and June 16, 2025, 435 patients were enrolled in the Phase 2 portion of the ARROS-1 clinical trial. In June 2025, we announced positive pivotal data for zidesamtinib in TKI pre-treated patients with advanced ROS1-positive NSCLC from the global ARROS-1 Phase 1/2 clinical trial,…

• In June 2025, we also shared encouraging preliminary data from 35 TKI-naïve patients with advanced ROS1-positive NSCLC treated with zidesamtinib at RP2D as of August 31, 2024 in the Phase 2 portion of the ARROS-1 clinical trial. As of June 16, 2025, a total of 104 patients had been enrolled in the o…

• In November 2025, the FDA accepted for filing our New Drug Application (NDA) for zidesamtinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC who received at least 1 prior ROS1 TKI. The application has been assigned a Prescription Drug User Fee Act target …

• TKI-naïve cohort in the Phase 2 portion of the ARROS-1 clinical trial to the FDA in the second half of 2026 to support a potential label expansion of zidesamtinib in TKI-naïve patients with advanced ROS1-positive NSCLC.

• In July 2025, we announced the initiation of the ALKAZAR Phase 3 clinical trial with registrational intent for TKI-naïve patients with advanced ALK-positive NSCLC. The ALKAZAR clinical trial is a global, randomized, controlled trial designed to evaluate neladalkib versus the current standard of care…

Text removed vs the prior filing · source: 10-Q · 2025-10-30

• In June 2025, we announced positive pivotal data for zidesamtinib in TKI pre-treated patients with advanced ROS1-positive NSCLC from the global ARROS-1 Phase 1/2 clinical trial, and in September 2025, we presented the pivotal dataset at the International Association for the Study of Lung Cancer 2025…

• As of the data cut-off date of March 21, 2025, 514 patients with ROS1-positive solid tumors had received zidesamtinib at any starting dose across the Phase 1 and Phase 2 portions of the ARROS-1 clinical trial. Of these, 432 patients with advanced ROS1-positive NSCLC were treated with zidesamtinib at…

• The primary efficacy analysis population consisted of 117 TKI pre-treated patients with advanced ROS1-positive NSCLC with measurable disease who received zidesamtinib at the RP2D by May 31, 2024, with DOR follow-up of at least 6 months available for nearly all responders.

• The primary efficacy analysis population was distinct from the ROS1 TKI pre-treated populations that have been reported for the current available and investigational ROS1 TKIs:

• Patients received a median of 2 prior lines of therapy (range, 1 – 11) and 53% had received prior chemotherapy.

Text added vs the prior filing · source: 10-Q · 2026-05-07

• In September 2025, we announced the completion of our New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) for zidesamtinib in tyrosine kinase inhibitors (TKI) pre-treated patients with locally advanced or metastatic (advanced) ROS1-positive non-small cell lung cancer…

• successful and timely completion of preclinical and clinical development of our current and future product candidates;

• capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans.

• Our failure to obtain funding as and when needed or on acceptable terms would have a negative impact on our financial condition and our ability to pursue our business strategy, and we may have to delay, reduce the scope of, suspend or eliminate one or more of our research or drug development program…

• We are currently conducting Phase 1/2 clinical trials of zidesamtinib and neladalkib, a Phase 3 clinical trial of neladalkib, and a Phase 1 clinical trial of NVL-330. In November 2025, the FDA accepted for filing our NDA for zidesamtinib in TKI pre-treated patients with advanced ROS1-positive NSCLC …

Text removed vs the prior filing · source: 10-Q · 2025-10-30

• We have not yet demonstrated our ability to successfully complete Phase 2 or Phase 3 clinical trials, obtain marketing approvals, manufacture a commercial-scale product or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful product com…

• successful and timely completion of preclinical and clinical development of zidesamtinib, neladalkib, NVL-330 and any future product candidates from our discovery programs, and any other future programs;

• Our failure to raise capital as and when needed or on acceptable terms would have a negative impact on our financial condition and our ability to pursue our business strategy, and we may have to delay, reduce the scope of, suspend or eliminate one or more of our research or drug development programs…

• We have initiated Phase 1/2 clinical trials of zidesamtinib and neladalkib, a Phase 3 clinical trial of neladalkib, and a Phase 1 clinical trial of NVL-330. Our ability to generate product revenue will depend heavily on the successful clinical development of, receipt of marketing approval from regul…

• Our preclinical studies and clinical trials may fail to adequately demonstrate the safety and efficacy of any of our product candidates, which would prevent or delay development, regulatory approval and commercialization.