Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 127

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 4
Chunk 127
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 to evaluate the efficacy and safety of Alpha DaRT
in the treatment of certain patients with recurrent cutaneous squamous cell carcinoma, a development program supported by a Breakthrough
Device Designation from the FDA. We refer to this trial as the ReSTART trial, for Recurrent SCC Treatment with Alpha DaRT Radiation Therapy.
The IDE permits us to treat up to 86 patients in up to 25 clinical sites around the U. S., in addition to clinical sites that may be added
outside the U. S. Our first patient in this trial was treated in March 2023. We anticipate completing recruitment of this trial in the
third quarter of 2025 and receiving results of the trial in the first half of 2026. Following completion of this trial, and pending further
discussion with the FDA, we plan to submit the data collected during this clinical trial in a future potential application for marketing
authorization from the FDA.

Study design

The pivotal study is a prospective,
multi-center, single-arm, open label trial enrolling up to 86 patients with recurrent cutaneous squamous cell carcinoma. The primary objectives
are to determine the objective response rate, or ORR, established by the confirmed best overall response, or BOR, following treatment
with the Alpha DaRT, as well as to assess the duration of response, or DOR, at 6 months from initial response. Secondary objectives are
to assess the safety of Alpha DaRT, and to assess the PFS, OS, overall duration of response, local control, and quality of life, or QOL,
for patients treated with Alpha DaRT.

U. S. multi-center study in recurrent
cutaneous SCC in immunocompromised patients (planning)

Following receipt of IDE approval
from the FDA, we are working to initiate a trial to evaluate the efficacy and safety of Alpha DaRT in the treatment of recurrent cutaneous
SCC in immunocompromised patients. The clinical study, which is an investigator-initiated study led by the Winship Cancer Institute of
Emory University in Atlanta, has been approved to enroll up to 28 U. S. patients at up to 8 institutions in the U. S., and will focus on
patients with recurrent cSCC who have a weakened immune system due to any primary or secondary immunodeficiencies, excluding diabetes.

A 2015 article in Journal
of Clinical Medicinenoted that non-melanoma skin cancers represent a major cause of morbidity for patients after organ transplantation,