Company: DRTSW
Filing Date: 2025-06-23
Form Type: F-3
Source: 0001213900-25-056744
Chunk: 9

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-06-23
Form: F-3
Chunk 9
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. 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% objective response rate and
91% disease control rate, which is defined to include patients with stable disease or an objective response. An analysis using
Kaplan-Meier statistics indicated median overall survival, or OS, across the 33 patients of 18.6 months from diagnosis or initiation
of the previous round of chemotherapy, or 10.9 months from treatment with Alpha DaRT. In addition, ad-hoc analyses of pancreatic
cancer population subgroups suggested meaningful improvement in median OS for patients treated with Alpha DaRT after prior therapy,
compared to previously published studies of alternative monotherapies, across all analyzed subgroups, though caution should be
exercised in comparing results from unrelated clinical studies due to differences in study designs, patient populations and other
relevant factors.

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We
also announced in