Alpha Tau Medical (DRTS) investor relations material

Recent developments and milestones

• Achieved first regulatory approval outside Israel, with Japan approving Alpha DaRT for locally advanced unresectable and recurrent head and neck cancer, exceeding initial expectations for indication breadth.

• Initiated post-marketing surveillance in Japan, focusing on treating 66 patients across five sites, and began discussions for additional studies, particularly in pancreatic cancer.

• Presented positive pancreatic cancer data at the ASCO GI conference, highlighting strong safety, disease control, and unique immune protection compared to traditional radiation therapies.

• Started a rolling Modular PMA submission to the FDA for recurrent cutaneous SCC, aiming to accelerate the approval process by submitting application modules before trial completion.

• Expanded strategic partnership discussions, with increased interest from multinational and Japanese biopharma companies and device manufacturers.

Clinical trial progress and outlook

• Nearing completion of an 86-patient pivotal study in recurrent cutaneous SCC in the U.S., with final patient treatments expected by early April and data anticipated in the second half of the year.

• U.S. pancreatic cancer pilot study progressing rapidly, with patient recruitment expected to finish next quarter and data readout in the second half of the year.

• Glioblastoma (GBM) study underway, with initial patients treated safely; safety data expected next quarter and full recruitment targeted for the second half of the year.

• Approval received to begin a locally recurrent prostate cancer study in the U.S., with patient enrollment to start soon.

Commercial strategy and market opportunity

• U.S. market focus is on the 3.5% of 1.8 million annual cutaneous SCC cases with local recurrence or nodal spread, representing a target market of about 64,000 cases per year.

• Japan strategy centers on post-marketing surveillance and targeted launches for approved indications, with HekaBio as the distribution partner and future expansion into pancreatic and brain cancers under consideration.

• Plans to prioritize a large-scale commercial launch in the U.S. before expanding further in Japan, especially for indications with higher pricing power and uptake potential.