NUVB — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-04

• European Medicines Agency had validated the Marketing Authorisation Application (“MAA”) for taletrectinib for the treatment of advanced ROS1+ NSCLC.

• In addition to taletrectinib, our clinical stage pipeline includes safusidenib, a novel, oral, potent, brain penetrant, targeted inhibitor of mutant isocitrate dehydrogenase 1 (“mIDH1”). Safusidenib is being evaluated against placebo in the SIGMA study, which is a randomized Phase 3 study for the ma…

• In January 2026, we announced entry into an exclusive license agreement for taletrectinib in Europe and additional countries with Eisai.

• On February 10, 2026, the outstanding warrants to purchase Class A Common stock expired and were delisted pursuant to a Form 25 filed by The New York Stock Exchange.

• In February 2026, we announced a protocol amendment to SIGMA study for safusidenib in IDH1-mutant glioma, which converted the study from a Phase 2 to a Phase 3 study.

Text removed vs the prior filing · source: 10-Q · 2025-11-03

• Our clinical-stage pipeline includes differentiated, novel oncology product candidates that have been generated from our proprietary drug discovery and development programs or acquired through business development activities:

• Safusidenib is a novel, oral, potent, brain penetrant, targeted inhibitor of mutant isocitrate dehydrogenase 1 ("mIDH1"). Safusidenib is being evaluated in the G203 study, which is currently a randomized phase 2 study for the maintenance treatment of high grade IDH1-mutant glioma with safusidenib ag…

• NUV-1511 is our first clinical-stage drug-drug conjugate ("DDC"), which fuses a targeting agent to a widely used chemotherapy agent. NUV-1511 is being evaluated in a Phase 1/2 study in patients with advanced solid tumors who previously received and progressed on or after treatment with Enhertu® and/…

• NUV-868 is a BD2-selective, oral, small molecule bromodomain and extra-terminal ("BET") inhibitor that inhibits BRD4. As previously announced, we are evaluating next steps for the NUV-868 program, including further development in combination with approved products for indications in which BD2-select…

• In September 2025, additional data from our pivotal Phase 2 TRUST-I and TRUST-II studies of taletrectinib was presented at the 2025 World Conference on Lung Cancer.

Text added vs the prior filing · source: 10-Q · 2026-05-04

• effectiveness of our disclosure controls and procedures (as defined in Exchange Act Rule 13a–15(e) and 15d-15(e)) as of March 31, 2026. Based on that evaluation, the Chief Executive Officer and Chief Financial Officer concluded that the Company’s disclosure controls and procedures were effective as …

Text added vs the prior filing · source: 10-Q · 2026-05-04

• We have limited experience as a commercial company and our sales, marketing, and distribution of IBTROZI may be unsuccessful or less successful than anticipated.

• If the market opportunities for IBTROZI are smaller than we believe, our revenue may be adversely affected, and our business may suffer.

• IBTROZI may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.

• The successful commercialization of IBTROZI and our product candidates will depend in part on the extent to which governmental authorities and health insurers establish adequate coverage, reimbursement levels and pricing policies. Failure to obtain or maintain adequate coverage and reimbursement for…

• If we are unable to maintain our agreements with third parties to sell and market taletrectinib in jurisdictions outside of the U.S. or our partnered territories, we will be unable to successfully commercialize taletrectinib if and when it is approved in such jurisdictions.

Text removed vs the prior filing · source: 10-Q · 2025-11-03

• The successful commercialization of IBTROZI and our other product candidates will depend in part on the extent to which governmental authorities and health insurers establish adequate coverage, reimbursement levels and pricing policies. Failure to obtain or maintain adequate coverage and reimburseme…

• IBTROZI may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success. The market opportunity for IBTROZI could also be smaller than we believe.

• If we or others later discover that IBTROZI or any of our future approved product candidates is less effective than previously believed or causes undesirable side effects that were not previously identified, our ability to market such drug could be compromised.

• Our regulatory approval for IBTROZI in the U.S. for advanced ROS1+ NSCLC is subject to post-marketing requirements and commitments, and we may be subject to penalties or product withdrawal if we fail to comply with these regulatory requirements and commitments, or if we experience unanticipated prob…

• If we do not obtain regulatory approval for and successfully commercialize additional product candidates or we experience significant delays in doing so, we may incur significant loses.

Text added vs the prior filing · source: 10-Q · 2026-05-04

• During the three months ended March 31, 2026, no director or Section 16 officer adopted or terminated any Rule 10b5-1 trading arrangements or non-Rule 10b5-1 trading arrangements (in each case, as defined in Item 408(a) of Regulation S-K).

Text removed vs the prior filing · source: 10-Q · 2025-11-03

• On July 28, 2025, David Liu, the Company's Chief Medical Officer, terminated his trading arrangement of Rule 10b5-1(c) under the Exchange Act.