Puma Biotechnology (PBYI) investor relations material

Product pipeline and commercial performance

• NERLYNX (neratinib) is FDA approved for multiple HER2-positive breast cancer indications and is marketed in the U.S. and internationally through partners.

• Q2 2026 U.S. revenue for NERLYNX was $53.6 million, up from $49.2 million year-over-year and $42.2 million sequentially; ex-factory bottles and commercial demand also increased.

• Q3 2026 U.S. revenue guidance is $54–$56 million, with full-year guidance raised to $205–$209 million; net income guidance also increased to $17–$20 million.

• International sales are managed through regional partners, generating royalties.

Clinical development and trial updates

• Ongoing phase I trial combines neratinib with an ADC, showing preclinical synergy and dramatic declines in various tumor types; further data expected next year.

• Alisertib, an Aurora kinase A inhibitor, is in phase II trials for ER-positive, HER2-negative breast cancer (ALISCA-Breast) and small cell lung cancer (ALISCA-Lung).

• ALISCA-Breast interim data show lower grade 3/4 neutropenia rates and promising PFS, especially in biomarker-defined subgroups (PIK3CA wild-type, ESR1 mutated, high c-MYC).

• ALISCA-Lung trial is escalating doses up to 70 mg BID, with interim data showing improved PFS at higher doses and benefit in c-MYC positive patients.

• Combination trial of alisertib with paclitaxel (ALISCA-Lung2) is being initiated based on prior survival benefit in c-MYC or RB1 mutated patients.

Biomarker strategy and future plans

• Biomarker analysis in ALISCA-Breast highlights enhanced PFS in patients with high MYC copy number, high c-MYC positivity, and specific genetic mutations.

• Enrollment is expanding in 40 mg and 50 mg alisertib cohorts, focusing on biomarker-defined populations for future phase III trials.

• Additional interim data from ALISCA-Breast and ALISCA-Lung expected in Q4 2026 and early 2027, respectively.