Puma Biotechnology reports Q2 EPS (9c), consensus (13c)

Reports Q2 revenue $47.1M, two estimates $44.7M. Alan H. Auerbach, CEO of Puma, said, “We were pleased to see promising efficacy signals from the Phase I/Ib study of alisertib in combination with osimertinib in advanced osimertinib-resistant EGFR-mutated lung cancer, which was presented at the 2024 Annual Meeting of the American Society of Clinical Oncology. The trial has been amended such that future enrollment will be limited to patients who are tp53 wild type and we look forward to further studying this combination in this biomarker directed cohort of patients. In addition, the biomarker analysis from the Phase II randomized clinical trial of alisertib alone vs. alisertib + fulvestrant for the treatment of patients with endocrine and CDK4/6 inhibitor (CDK 4/6i) resistant, human epidermal growth factor receptor 2-negative (HER2-negative), hormone receptor-positive metastatic breast cancer, presented at the same conference, may provide clarity into the subset of patients who may derive the greatest benefit from treatment with alisertib. We anticipate the following key milestones over the next 12 months: (i) initiation of ALISCA(TM)-Breast1, a Phase II trial of alisertib in combination with endocrine treatment in patients with chemotherapy-naive HER2-negative, hormone receptor-positive metastatic breast cancer (Q4 2024) and (ii) interim data from ALISCA(TM)-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer (Q4 2024).”