Company: DRTSW
Filing Date: 2025-04-28
Form Type: 424B5
Source: 0001213900-25-035799
Chunk: 5

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-04-28
Form: 424B5
Chunk 5
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 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
shonin pre-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.

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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% objective response rate and 91%