Company: DRTSW
Filing Date: 2025-04-28
Form Type: 424B5
Source: 0001213900-25-035799
Chunk: 6

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-04-28
Form: 424B5
Chunk 6
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 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