Exelixis (EXEL) investor relations material

Zanzalintinib outlook

• Zanzalintinib PDUFA is expected in early March 2027; the portfolio is positioned to move from a single-product to a multi-franchise business alongside cabozantinib.

• STELLAR-304 top-line data are now expected in Q1 2027 after event accrual came in more slowly; the goal is a robust dataset to support filing and rapid patient access.

• STELLAR-304 aims to establish a standard of care in non-clear cell RCC with large, randomized phase III evidence, addressing treatment choices currently guided by smaller, unrandomized studies.

• Zanzalintinib dosing will be tailored to indication, combination, and treatment line; 60 mg in LITESPARK-034 is supported by additional exposure-response and target-coverage data.

• A second wave of trials is expected to start shortly, including a likely study in de novo metastatic frontline RCC; seven outlined pivotal studies represent $5B+ in total opportunity.

RCC market and treatment strategy

• LITESPARK-012 reinforced the opportunity in frontline metastatic RCC; future combinations will be informed by trial learnings, COSMIC-313 experience, and biology.

• LITESPARK-011 showed PFS benefit without statistically significant survival advantage; sequential cabozantinib and belzutifan may offer longer combined PFS with less doublet toxicity.

• Second-line lenvatinib-belzutifan use may leave more patients eligible for frontline cabozantinib-nivolumab, supporting a larger-duration and larger-patient opportunity in first line.

Colorectal cancer opportunities

• Zanzalintinib plus atezolizumab is under FDA review for third-line-plus CRC; positive survival data and activity across subgroups, including prior Avastin recipients, are intended to differentiate the regimen.

• The estimated CRC market opportunity is $1.5B, split roughly one-third each among SUNLIGHT, TKIs, and broader chemotherapy; the aim is to take share across all treatment groups.

• STELLAR-316 targets post-definitive-therapy, MRD-positive patients at high relapse risk, testing zanzalintinib alone or with pembrolizumab against placebo to delay disease-free survival events.

• Earlier-line dosing will weigh benefit-risk and tolerability; zanzalintinib’s shorter half-life may enable titration and shorter dose holds to support time on treatment.