Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 131

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 4
Chunk 131
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 only one patient was recruited on a four-week basis to allow for assessment of AEs and
SAEs before the next patient was recruited, with an interim analysis conducted after five patients were enrolled. In November 2023,
we released an interim data read-out of these first five patients treated in this study, demonstrating successful delivery in all
five cases, as well as no product-related SAEs.

Hadassah Medical Center,
Israel (recruiting)

We are conducting a clinical
study at Hadassah Medical Center in Jerusalem, Israel, to investigate the feasibility, safety and preliminary efficacy of Alpha DaRT for
the treatment of advanced pancreatic cancer. Recruitment is open for up to 20 patients with locally advanced (Stage II or Stage III) or
metastatic (Stage IV) pancreatic adenocarcinoma which has been histologically and/or cytologically proven and which tumor or patient is
not amenable to surgery and which has already had chemotherapy or is ineligible for chemotherapy, with a tumor lesion of less than five
centimeters in the longest dimension.

The objectives of this study
are similar to those of the study being conducted in Montréal, Canada to evaluate the use of Alpha DaRT in treating advanced pancreatic
cancer. The primary endpoints of the study are: feasibility, as measured by the successful placement of the Alpha DaRT sources, and safety,
by assessing the frequency, severity and causality of acute SAEs related to Alpha DaRT source insertion. AEs and SAEs will be assessed
and graded according to CTCAE version 5.0, and radioactivity levels will also be measured using blood and urine tests. Secondary endpoints
include: preliminary efficacy, measured by assessing the ORR at one and three months after Alpha DaRT source insertion according to RECIST
v. 1.1 criteria, changes in CA19-9, which serves as a marker of tissue damage, and tumor dose coverage. Exploratory objectives include
changes in immune markers and tumor response using endoscopic ultrasound.

Interim Results of January
2025

In pooled interim data from
three clinical trials of patients with pancreatic cancer, as of a cutoff date 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