Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 129

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 4
Chunk 129
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4.

Between February 2017 and
December 2022, 81 lesions in 71 patients were treated with Alpha DaRT in four prospective feasibility trials whose objective was to assess
early toxicity and tumor response outcomes. The median follow-up was 14.1 months, with a range of 2-51 months. A CR was observed in 89%
of treated lesions, 10% demonstrated a PR, and one patient was not evaluable. The two-year actuarial local recurrence-free survival was
77%, with a 95% confidence interval of 63-87%. Variables including recurrent vs. non-recurrent lesions, baseline tumor size, or histology
did not impact long-term outcomes. 27% of patients developed treatment-related acute grade 2 toxicity (such as dermatitis radiation, local
pain at the treatment site or pruritus), which subsequently resolved with conservative treatment; there were no grade 3 or higher related
acute toxicities. There was no grade 2 or higher late toxicities observed in this cohort, defined as toxicities occurring six months or
later after Alpha DaRT treatment.

Pancreatic Cancer

According to the American
Cancer Society, pancreatic cancer accounts for 3% of cancer incidences in the U. S. but about 8% of cancer deaths. It is associated with
an extremely poor prognosis, reflected by a median survival of five to eight months and a five-year survival probability of less than
5% when all stages are combined. Pancreatic cancer is particularly deadly due to the fact that there are no unique symptoms in its early
stages, and, since the pancreas is obscured by other organs in the abdomen and is difficult to visualize clearly on imaging tests, it
is therefore typically not detected before having already metastasized to regional lymph nodes, the liver, the lungs or other visceral
organs such as the stomach or colon. We selected pancreatic cancer as a target for the Alpha DaRT technology in light of the poor prognosis
associated with this particular cancer, as well as our pre-clinical research in which the Alpha DaRT showed activity against pancreatic
adenocarcinoma cells.

Montréal, Canada (recruiting)

We are conducting a multi-center
clinical study at Centre Hospitalier de l’ Université de Montréal, or CHUM, and Jewish General Hospital, both in Montréal,
Canada, to investigate the feasibility, safety and preliminary efficacy of Alpha DaRT for the treatment of advanced pancreatic cancer