Alpha Tau Issues Letter to Shareholders: Five Concurrent Trials in the U.S. with Multiple Significant Value-Driving Milestones Ahead

Core Insights - Alpha Tau Medical Ltd. is preparing for a highly active clinical year in 2026, with significant patient recruitment and data readouts expected from various cancer trials, including the ReSTART pivotal trial for skin cancer and studies for internal organ cancers [1][12] Clinical Trials and Developments - The company is conducting multiple significant clinical trials globally, with five approved trials in the U.S. and additional trials in France, Italy, and the UK, focusing on various cancer types [2][3] - Ongoing trials include treatments for prostate, lung, and pancreatic tumors, as well as a pivotal trial for recurrent cutaneous squamous cell carcinoma (cSCC) [3][5] - The company is targeting completion of patient recruitment for the pancreatic cancer study by the end of Q1 2026, with initial results expected by year-end [7] - Initial results from the glioblastoma multiforme (GBM) trial are anticipated around the end of Q4 2026, with a cautious approach to patient enrollment [8] Regulatory and Commercial Readiness - Alpha Tau is awaiting a response from Japan's Ministry of Health regarding approval for Alpha DaRT in treating recurrent head and neck cancer, which would mark its first commercial approval outside Israel [9] - The company is preparing for potential post-marketing surveillance in Japan and is also exploring a new clinical trial combining Alpha DaRT with checkpoint inhibitors for advanced head and neck cancer [10] - Manufacturing capabilities are being ramped up in Jerusalem and a new facility in New Hampshire, with a focus on scaling production and enhancing operational efficiency [15][16] Financial Position and Strategic Outlook - The company maintains a stable cash burn rate and is confident in its ability to execute current plans, having filed over 60 new patent applications in 2025 [17][18] - Increased recognition of Alpha DaRT's relevance in oncology is leading to strategic discussions with potential partners for collaboration [19] - The company anticipates a busy and challenging year in 2026, building on the successes of 2025 and aiming to achieve set goals [20]