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Jun 30, 2024
Nuvation Bio Q2 2024 Earnings Report
Nuvation Bio reported financial results for the second quarter ended June 30, 2024 and provided a business update.
Key Takeaways
Nuvation Bio reported a net loss of $462.5 million, or $(1.89) per share, for the three months ended June 30, 2024. As of June 30, 2024, Nuvation Bio had cash, cash equivalents and marketable securities of $577.2 million.
Taletrectinib's pivotal Phase 2 TRUST-I clinical study data was published in the Journal of Clinical Oncology and presented at ASCO 2024.
Pooled data from TRUST-I and TRUST-II studies will be presented at ESMO Congress 2024 to support the planned NDA in the U.S.
Data from the global, pivotal Phase 2 TRUST-II study will be presented at the 2024 World Conference on Lung Cancer (WCLC).
Taletrectinib was granted Orphan Drug Designation by the U.S. FDA for ROS1-positive non-small cell lung cancer (NSCLC).
Nuvation Bio
Nuvation Bio
Forward Guidance
Nuvation Bio is focused on progressing its late-stage pipeline and preparing to potentially commercialize taletrectinib in 2025.
Positive Outlook
- NDA filing for taletrectinib in the U.S. is planned.
- Potential commercialization of taletrectinib in 2025.
- Progressing the global Phase 2 study of safusidenib.
- Continuing to dose escalate in a Phase 1/2 study of NUV-1511.
- Exploring next steps for NUV-868 in new indications.
Challenges Ahead
- Decision not to initiate a Phase 2 study of NUV-868 in the solid tumor indications studied to date.
- Challenges associated with conducting drug discovery and initiating or conducting clinical studies.
- Difficulties or delays in the regulatory process.
- Emergence or worsening of adverse events or other undesirable side effects.
- Risks associated with preliminary and interim data.