DRTS News & Events

Alpha Tau Medical issued the following letter to shareholders: "Following an incredibly productive 2025, culminating in several significant announcements in recent weeks, I wish to share with you an updated comprehensive picture of Alpha Tau's position and projected upcoming milestones, as we continue to push forward with our clinical, operational and pre-commercial development on a number of different fronts... The Company is currently conducting multiple significant clinical trials around the world, with five concurrently approved trials in the U.S.: Our ReSTART multi-center pivotal trial in patients with recurrent cutaneous squamous cell carcinoma... Our multicenter study in immunocompromised patients with cSCC... Our IMPACT multi-center pilot study in patients with newly-diagnosed pancreatic cancer in combination with chemotherapy... Our feasibility study in patients with recurrent glioblastoma multiforme... Our pilot study in patients with locally recurrent prostate cancer... We are proud of our incredibly comprehensive clinical program, with Alpha DaRT being evaluated simultaneously across a number of indications... In addition, the Company has trials approved in France and Italy and is planning a large potential basket trial in the UK to evaluate our Alpha DaRT across numerous cancer types, alongside a number of ongoing feasibility studies in Israel... As you all know, the Company started its clinical evaluations by treating superficial tumors as a proof of concept, i.e., tumors of the skin or head and neck, and has acquired significant experience in the U.S., Europe, Japan and Israel... Recently we reported the treatment of our first patient in GBM at Ohio State University... To the extent that no safety concerns arise, we would anticipate the removal of enrollment restrictions as well as expansion to New York University as a second site in the trial, in which case we would target the completion of patient accrual for ten patients later in the year, with initial results targeted around year end 2026... 2025 was certainly full of myriad challenges that the Company rose to meet exceedingly well, and we expect 2026 to be a busy and challenging year too."

Alpha Tau Medical announced the release of final results from its first-in-human pancreatic cancer study in Montreal, Canada exploring the use of Alpha DaRT in treating pancreatic ductal adenocarcinoma, PDAC. The results have been published as two abstracts and will be presented at the upcoming 2026 ASCO Gastrointestinal Cancers Symposium in San Francisco, January 8 - 10, 2026. Study Principal Investigator Corey Miller, MD, MSc, Director of Therapeutic Endoscopy of the Division of Gastroenterology of the JGH, Assistant Professor of Medicine at McGill University, Associate Researcher at the Lady Davis Institute, will lead a presentation entitled "Feasibility, Safety and Efficacy of Endoscopic Ultrasound-Guided Alpha Radiotherapy for Advanced Pancreatic Cancer: A Pilot Study" with final clinical results of the Company's trial. In the trial, 32 patients with Stage II, III or IV PDAC were treated, many of whom had one or more prior rounds of chemotherapy. The results demonstrate a 22% objective response rate and an 81% disease control rate across all 32 patients treated in the study, or 23% ORR and 87% DCR when excluding the first two patients, who were deliberately given low dosages in order to examine feasibility and safety only.

Alpha Tau Medical announced the submission of the first module of its pre-market approval application to the U.S. Food and Drug Administration, following the FDA's previous decision to allow the company to use the more flexible modular approach. The company submitted the module as part of an application for the use of Alpha DaRT in treating recurrent cutaneous squamous cell carcinoma for patients not indicated for surgery or standard radiation therapy, and for whom no curative systemic treatment is available. This module is focused on comprehensive documentation with respect to non-clinical studies as required under the PMA application, Alpha Tau said. Alpha Tau is currently conducting its multi-center pivotal ReSTART study exploring the use of Alpha DaRT in recurrent cSCC, one of five clinical trials currently approved in the U.S., and anticipates completing patient recruitment in Q1 2026. Alpha Tau has received Breakthrough Device Designation from the FDA in this indication as well as for recurrent glioblastoma multiforme and recurrent squamous cell carcinoma of the oral cavity with similar criteria, and is also part of the FDA Total Product Life Cycle Advisory Program to accelerate market access for the potential treatment of recurrent GBM.