Puma Biotechnology Reports Third Quarter 2026 Financial Results

Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma Biotechnology

“Third quarter U.S. NERLYNX sales were positively impacted by increased year-over-year demand and were negatively impacted by higher than expected gross to net due to an increase in Medicaid and 340B sales, as well as a delay in sales to Puma’s ex-U.S. commercial partners that shifted from the third quarter to the fourth quarter.”

Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma Biotechnology

“We continue to anticipate increased year-over-year demand for NERLYNX, while we continue to advance alisertib across our ALISCA clinical development programs.”

Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma Biotechnology

“During the quarter, we initiated ALISCA-Lung2, a Phase II trial evaluating alisertib in combination with paclitaxel in patients with advanced small cell lung cancer, further expanding our clinical development program in this area, while we are continuing to enroll the ALISCA-Breast1 and ALISCA-Lung1 trials.”

Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma Biotechnology

“We anticipate the following key milestones over the next 12 months: (i) presentation of updated data from ALISCA-Breast1, a Phase II trial of alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer (San Antonio Breast Cancer Symposium, December 2026); (ii) initiation of discussions with global regulatory agencies regarding the Phase III trial design for alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer (H1 2027); (iii) continued enrollment in ALISCA-Breast1, a Phase II trial of alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer to obtain more data in biomarker focused populations (H2 2026); (iv) continued enrollment of ALISCA-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer and ALISCA-Lung2, a Phase II trial evaluating alisertib in combination with paclitaxel in patients with advanced small cell lung cancer (Q4 2026); and (v) presentation of updated data from ALISCA-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer (2027).”