Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 110

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 4
Chunk 110
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% 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.

We also announced in January
2025 the approval 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 data in our safety and efficacy study combining Alpha DaRT treatment with pembrolizumab in patients with recurrent unresectable
or metastatic HNSCC, targeting a similar population as evaluated in Merck’s KEYNOTE-048 study and with a Combined Positive Score
of at least 1. As of January 9, 2025, eight patients were treated with Alpha DaRT and pembrolizumab in the study. Of the eight patients
treated, three demonstrated a systemic complete response, three demonstrated a systemic partial response, and two patients died before
being evaluated, demonstrating a 37.5% systemic complete response rate and a 75% systemic objective response rate. In addition, no SAEs
related to Alpha DaRT treatment were reported in these patients as of the data cutoff date of January 9, 2025.

We have engaged with a number