Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 186

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 4A
Chunk 186
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 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 developing the
Alpha DaRT for use in a number of potential applications, particularly in refractory or unresectable localized tumors which are not being
adequately addressed by standard of care, tumor types with a high unmet need (such as pancreatic adenocarcinoma or glioblastoma multiforme),
and metastatic tumors in combination with systemic therapies such as checkpoint inhibitors. We are also investigating the potential of
the Alpha DaRT to elicit an immune response as observed in previous pre-clinical data, as well as anecdotal evidence of response from
untreated tumors, or abscopal effects, which may have the potential to inhibit or even reduce metastases.

If approved, we expect to
commercialize our Alpha DaRT technology first in the United States before other markets, including Israel,