Puma Biotechnology Inc 2024年度报告

DDEVELOPMENT For patients in needFor patients in need T H E N E X T P H A S E O FT H E N E X T P H A S E O F PPUMA’S GROWTH W I L L B E D R I V E N B Y T H E C L I N I C A LW I L L B E D R I V E N B Y T H E C L I N I C A LD E V E L O P M E N T O F A L I S E R T I BD E V E L O P M E N T O F A L I S E R T I B PUMA BIOTECHNOLOGY, INC.is a biopharmaceutical company with a fo-cus on the development and commercialization of innovative prod-ucts to enhance cancer care.Puma in-licensed the global develop-ment and commercialization rights to PB272 (neratinib, oral) in 2011.In 2022, Puma in-licensed global research and development andcommercial rights to alisertib, a selective, small molecule, orally ad-ministered inhibitor of aurora kinase A. pursue the commercialization of NERLYNX outside the United States.NERLYNX® is a registered trademark of Puma Biotechnology, Inc.Alisertibis an adenosine triphosphate–competitive and reversible inhibitor of aurora kinase A and results in disruption of mitosis lead-ing to apoptosis of rapidly proliferating tumor cells that are dependenton aurora kinase A. Alisertib has been tested in clinical trials in pa-tients with metastatic cancers including breast cancer, small cell lungcancer, head and neck cancer, ovarian cancer, peripheral T-cell lym-phoma and acute myeloid leukemia.Puma initially intends to focusthe development of alisertib on the treatment of patients with smallcell lung cancer, metastatic estrogen receptor-positive (ER-positive)HER2-negative breast cancer and triple-negative breast cancer. Neratinibis a potent irreversible tyrosine kinase inhibitor thatblocks signal transduction through the epidermal growth factor re-ceptors, HER1, HER2 and HER4. Puma has focused on developing theoral version of neratinib, and its primary drug candidate was directedat the treatment of HER2-positive breast cancer.Neratinib, oral was approved by the U.S. Food and Drug Adminis- tration (FDA) in 2017 for the extended adjuvant treatment of adult pa-tients with early stage HER2-overexpressed/amplified breast cancer,following adjuvant trastuzumab-based therapy. Puma commencedcommercial sales of the drug in 2017 and it is marketed in the UnitedStates as NERLYNX® tablets.In February 2020, NERLYNX was alsoapproved by the FDA in combination with capecitabine for the treat-ment of adult patients with advanced or metastatic HER2-positivebreast cancer who have received two or more prior anti-HER2-basedregimens in the metastatic setting. NERLYNX was granted marketingauthorization by the European Commission in 2018 for the extendedadjuvant treatment of adult patients with early stage hormone recep-tor-positive HER2-overexpressed/amplified breast cancer and whoare less than one year from completion of prior adjuvant trastuzum-ab-based therapy.Commercial sales commenced in the EuropeanUnion in 2019. Small cell lung cancer is an aggressive form of lung cancer with apoor prognosis, and with limited treatment options for patients whosecancer has progressed on or after platinum-based chemotherapy. InSeptember 2023 the FDA granted Orphan Drug Designation to ali-sertib, a selective, small-molecule, orally administered inhibitor of au-rora kinase A, for the treatment of patients with small cell lung cancer.In February 2024, Puma initiated ALISCA™-Lung1, a Phase II clinicaltrial of alisertib monotherapy for the treatment of patients with exten-sive-stage small cell lung cancer.Hormonereceptor-positive(HR-positive),human epidermal growth factor receptor 2-negative (HER2-negative) breast canceris the most prevalent type of breast cancer, in which endocrinetherapy resistance and distant relapse remain unmet challenges.In November 2024, Puma initiated ALISCA™-Breast1, a Phase IIclinical trial of alisertib in combination with endocrine therapy forthe treatment of patients with chemotherapy-naïve HR-positive,HER2-negative recurrent or metastatic breast cancer who havebeen previously treated with a CDK4/6 inhibitor and received atleast two prior lines of endocrine therapy in the recurrent or meta-static setting. Puma has entered into additional exclusive license agreementswith various parties to commercialize NERLYNX in regions outside theUnited States, including the European Union, Canada, Latin America,Greater China, Israel, Southeast Asia, Australia, New Zealand, SouthKorea, the Middle East, and parts of Africa. Puma plans to continue to T O O U R S T O C K H O L D E R ST O O U R S T O C K H O L D E R S At Puma Biotechnology, we are driven by the pursuit of innovation to transform the oncology landscape. Our commit-ment to developing novel therapies reflects our core belief that every advancement in science can have a profoundimpact on patients’ lives. This dedication to progress fuels our approach across clinical development, commercializa-tion, and patient access initiatives. In 2024, our commitment to advancing cancer care was evident in both the continued commercialization of NERLYNX®(neratinib)