PUMA BIOTECHNOLOGY, INC.

Puma Biotechnology, Inc. (NASDAQ: PBYI) is a biopharmaceutical company focused on developing and commercializing innovative products to enhance cancer care and improve treatment outcomes for patients. The company operates primarily as a single-product commercial entity with a pipeline of investigational drug candidates.

The company's flagship product is NERLYNX, an oral formulation of neratinib, which is approved by the FDA for two indications in HER2-positive breast cancer: extended adjuvant treatment of early-stage disease following trastuzumab-based therapy and combination treatment with capecitabine for advanced or metastatic disease in patients who have received two or more prior anti-HER2 regimens. NERLYNX has also received regulatory approval in more than 40 countries outside the United States, including the European Union, China, Canada, and Australia. The company commercializes NERLYNX in the United States through a direct specialty sales force consisting of approximately 35 sales specialists supported by regional management and commercial teams focused on marketing, reimbursement, and access. Outside the United States, Puma Biotechnology has established exclusive sub-license agreements with third parties across multiple regions including Europe, Asia-Pacific, and Latin America.

In addition to NERLYNX, the company has in-licensed alisertib from Takeda Pharmaceutical Company Limited and assumed global development and commercialization responsibility for this investigational Aurora Kinase A inhibitor. Alisertib has been tested in over 1,300 patients across 22 clinical trials and demonstrates potential in treating various cancer types including hormone receptor-positive breast cancer, triple-negative breast cancer, and small cell lung cancer. The company intends to pursue development of alisertib initially in small cell lung cancer and hormone receptor-positive breast cancer, with focus on biomarker-driven populations showing higher activity.

Puma Biotechnology's strategy centers on successfully executing its NERLYNX commercial plan while advancing alisertib development, maintaining flexibility in commercialization approaches through direct sales, partnerships, or licensing arrangements, and selectively in-licensing or acquiring additional commercial drugs and drug candidates to build a sustainable product pipeline employing multiple therapeutic approaches.