Company: DRTSW
Filing Date: 2025-06-23
Form Type: F-3
Source: 0001213900-25-056744
Chunk: 10

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-06-23
Form: F-3
Chunk 10
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 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 of prestigious medical and educational institutions and, as of December 31, 2024, have fourteen clinical studies
ongoing worldwide.

Additionally,
in our pre-clinical studies, we evaluated the Alpha DaRT on 20 tumor models (both human and mouse). Alpha DaRT sources were observed to
have killed multiple types of mouse and human tumors in vivo. The intensity of the killing activity varied between tumor types,
and was dependent on the ability of the radioactive atoms to diffuse inside the tumor and on the intrinsic sensitivity of the tissue to
DNA damage induced by the radiation, but all tumor types showed responsiveness to Alpha DaRT, i.e., there was no observed resistance.
We therefore believe that our technology may potentially be relevant for treatment across a broad range of tumors. We are currently focused
on