Nuvation Bio (NUVB) investor relations material

IMPROZI launch and clinical performance

• IMPROZI, a ROS1 TKI, launched with 70 prescriptions in seven weeks, outperforming a key competitor's initial launch period.

• Demonstrated an 89% response rate and 46-month progression-free survival (PFS) in first-line setting, the highest PFS reported for any cancer drug.

• Second-line data show a 62% overall response rate and a 66% confirmed intracranial response rate, addressing brain metastases common in ROS1 lung cancer.

• Market opportunity estimated at $4–5 billion annually by year four, factoring in improved detection and long duration of response.

• Early commercial success attributed to robust efficacy, tolerability, and recent NCCN guideline changes favoring ROS1 agents.

Competitive landscape and data interpretation

• IMPROZI trials included a real-world patient population, unlike some competitors who excluded patients with secondary oncogenic drivers.

• Nuvalent's reported PFS and duration of response are based on limited patient data, raising concerns about aggressive extrapolation.

• IMPROZI's efficacy and safety data are supported by larger patient numbers and longer follow-up compared to competitors.

• Safety profiles between IMPROZI and competitors are similar, with low discontinuation rates and manageable adverse events.

• Nuvalent's claims of improved safety are offset by emerging adverse events such as edema and shortness of breath.

Pipeline and platform technology

• IDH1 inhibitor shows a 33% response rate in low-grade glioma, triple that of the current approved therapy, and notable durability of effect.

• Pivotal studies underway in high-grade glioma, with early data showing complete remissions in some patients.

• Unique immune-related adverse events suggest the IDH1 inhibitor may act as an oral immuno-oncology agent, with potential expansion beyond IDH1-mutated cancers.

• DDC platform enables creation of small molecule drug conjugates, with NUV-1511 in early trials across five indications and more candidates in development.

• Platform allows for rapid iteration and oral bioavailability, aiming to address difficult-to-treat cancers.