Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 185

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 4A
Chunk 185
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, 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 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 indicated an 18% objective response rate and 91% disease control rate. 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.

We also announced in January
2025 the receipt of an investigational device exemption, or IDE, from the FDA, to conduct a clinical study examining the combination of
Alpha DaRT and first-line chemotherapy in 12 patients with newly diagnosed metastatic pancreatic cancer, which was then further expanded
by an IDE supplement to include a total of 30 patients across two cohorts of 15 patients each, one cohort of newly diagnosed metastatic
pancreatic cancer and a second cohort of newly diagnosed locally advanced pancreatic cancer. We also announced receipt of regulatory approval
from France’s Ministry of Health to initiate a French multi-center study examining the use of Alpha DaRT alongside capecitabine
in treating locally advanced pancreatic cancer in 40 patients who have responded or had stable disease with first-line FOLFIRINOX chemotherapy.

We also announced in January
2025 interim