Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 109

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 4
Chunk 109
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 a multi-center pilot feasibility trial conducted at Memorial Sloan Kettering Cancer Center and four other U. S.
clinical sites, to explore the feasibility of delivering radiotherapy for malignant skin and superficial soft tissue tumors using
Alpha DaRT. The study met its primary feasibility endpoint, as all patients had successful delivery of radiation by Alpha DaRT. At
approximately 12 weeks and 24 weeks after treatment, all ten lesions treated demonstrated a complete response to treatment, with no
product-related serious adverse events observed. In November 2023, on the basis of a clinical trial completed in Japan as well as
data collected elsewhere in the world, we submitted to Japan’s Pharmaceuticals and Medical Devices Agency, or PMDA, an
application for shoninpre-market approval of Alpha DaRT for use in patients with recurrent head & neck cancer. To
support our U. S. strategy, we are conducting a multi-center pivotal trial, which we refer to as the ReSTART trial, to explore the
delivery of radiotherapy for up to 86 patients with recurrent cutaneous squamous cell carcinoma tumors using Alpha DaRT at clinical
sites around the United States and selected other clinical sites outside the U. S. We anticipate completing recruitment of this trial
around Q3 2025 and receiving top-line results of the trial in early 2026 for potential submission to the FDA.

We have also evaluated and
continue to evaluate the feasibility, safety and efficacy of the Alpha DaRT technology for the treatment of solid tumors in internal organs,
including the pancreas, lung, prostate, rectum and liver. In January 2025, we announced interim clinical data from multiple clinical trials,
including safety and feasibility studies treating patients with pancreatic cancer, a combination study with pembrolizumab in patients
with recurrent unresectable or metastatic head and neck squamous cell carcinoma (HNSCC), and other clinical trials. In a pooled interim
data from three clinical trials of patients with pancreatic cancer, as of January 8, 2025, 41 patients had been treated with Alpha DaRT
and 33 patients had a measured objective response and were examined for survival metrics. All patients were able to receive the Alpha
DaRT treatment, and 151 adverse events were reported in total, of which 38 were possibly, probably or definitely associated with Alpha
DaRT treatment, of which three were deemed serious adverse events, or SAEs. An analysis of best overall response in patients with a measured
response showed an 18