Puma Biotechnology

TOLREMO therapeutics has appointed Alessandra Cesano, MD, PhD, to its Board of Directors and named Florian D. Vogl, MD, PhD, as Chief Medical Officer to strengthen leadership capabilities.

Er-Kim has signed an exclusive distribution agreement with Puma Biotechnology to commercialize NERLYNX (neratinib) in ten countries across Eastern Europe and Central Asia, expanding access to this targeted HER2 therapy.

Puma Biotechnology has launched two Phase II clinical trials for alisertib, targeting extensive-stage small cell lung cancer as monotherapy and HER2-negative HR-positive metastatic breast cancer in combination with endocrine therapy.

Puma Biotechnology has acquired rights to alisertib from Takeda for $7 million upfront, with potential milestone payments of $287 million plus royalties.

• Puma Biotechnology reported Q4 2024 net income of $19.3 million ($0.39 per share), a significant increase from $12.3 million in Q4 2023, driven by strong NERLYNX sales and a $7.1 million tax benefit. • The company achieved full-year 2024 net income of $30.3 million ($0.62 per share), marking its third consecutive year of profitability while maintaining a strong cash position of approximately $101 million. • Puma advanced its clinical pipeline with the initiation of ALISCA-Breast1, a Phase II trial of alisertib in combination with endocrine therapy for HER2-negative, HR-positive metastatic breast cancer.

Puma Biotechnology's stock has increased by 24% over the past three months, driven by strong sales of Nerlynx and progress in alisertib development.

• Neratinib monotherapy has been added to the NCCN guidelines as a second-line or subsequent therapy for recurrent or metastatic cervical cancer with HER2 mutations. • The inclusion is based on Phase II SUMMIT trial results, which demonstrated neratinib's efficacy in HER2-mutated cervical cancers lacking curative treatment options. • The NCCN designated neratinib as a Category 2A preference, indicating its usefulness in specific circumstances for treating HER2-mutated tumors. • This update aims to increase awareness among physicians and improve treatment decisions for patients with advanced cervical cancer and HER2 mutations.

• Puma Biotechnology has commenced the ALISCA™-Breast1 Phase II trial to evaluate alisertib in combination with endocrine therapy for HR+/HER2- metastatic breast cancer. • The trial will enroll up to 150 patients previously treated with CDK 4/6 inhibitors and at least two prior lines of endocrine therapy, randomized to different alisertib doses. • The primary objective is to determine the optimal alisertib dose, with endpoints including objective response rate, duration of response, and progression-free survival. • Puma plans to analyze biomarker subgroups to identify correlations with response and intends to explore a potential approval pathway with the FDA based on trial outcomes.

• Puma Biotechnology has started the ALISCA-Breast1, a Phase 2 clinical trial, to evaluate alisertib plus endocrine therapy for HR-positive, HER2-negative metastatic breast cancer. • The trial aims to determine the optimal dose of alisertib in combination with endocrine therapy, assessing objective response rate, duration of response, and progression-free survival. • Approximately 150 patients who have previously received CDK4/6 inhibitors and at least two lines of endocrine therapy will be enrolled and randomized into three alisertib dosage groups. • Initial data from the ALISCATM-Breast1 trial is expected in 2025, with plans for a Phase 3 study contingent on defining the optimal dose and discussions with the FDA.

• Puma Biotechnology has commenced the ALISCA™-Breast1 Phase II trial to evaluate alisertib combined with endocrine therapy for HR+/HER2- metastatic breast cancer. • The trial will enroll up to 150 patients previously treated with CDK 4/6 inhibitors and at least two prior lines of endocrine therapy. • The primary objective is to determine the optimal dose of alisertib in combination with endocrine therapy, assessing objective response rate and survival. • Puma plans to engage with regulatory agencies to explore an approval pathway for alisertib based on trial outcomes and biomarker analysis.