DRTS · Alpha Tau Medical Ltd.

This milestone represents a high-materiality clinical advancement for Alpha Tau: the first use of Alpha DaRT in pancreatic cancer in Italy—and globally—the first application of percutaneous delivery within any Alpha DaRT protocol, and the initiation of a distinct clinical pathway targeting chemotherapy-ineligible or post-chemotherapy patients. Unlike the U.S.-based IMPACT trial (which combines Alpha DaRT with chemotherapy in newly diagnosed unresectable cases) or France’s ACAPELLA trial (which adds Alpha DaRT to capecitabine after mFOLFIRINOX), CTP-PANC-03 evaluates Alpha DaRT monotherapy in a population with no defined next-line option—broadening the potential treatable cohort. The inclusion of percutaneous delivery is operationally significant: it leverages existing interventional radiology infrastructure and expertise, lowering adoption barriers and enabling treatment of tumors anatomically unsuitable for EUS access alone. Conducted at the University of Verona’s Pancreas Institute—a high-volume, multidisciplinary center with established research rigor—the study’s design (interim safety analysis after 5 patients, eligibility limited to ≤5 cm unresectable tumors, histologic confirmation required) signals disciplined clinical execution. While no efficacy or safety data are reported yet, the successful first procedure validates procedural feasibility and positions Alpha Tau to generate prospective dosimetric and clinical outcome data across two complementary delivery routes—strengthening the evidence base for regulatory engagement and future trial expansion. For investors, this accelerates de-risking of Alpha DaRT’s applicability beyond superficial or accessible tumors and reinforces the company’s global clinical execution capability.