Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 111

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 4
Chunk 111
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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 from 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, notwithstanding our existing
marketing authorization in Israel (under which we have not yet commercialized the product). We hold exclusive rights to our proprietary
Alpha DaRT technology in our core markets, including the United States and Europe.

While local radiation therapy
has been a mainstay of cancer therapy for years, it has been mostly limited to modalities utilizing beta or gamma emissions, which primarily
destroy cells through an indirect mechanism relying on oxygen and the generation of free radicals to cause single-strand DNA breaks. By
contrast, alpha radiation has hundreds of times the linear energy transfer rate of beta-emitters. Additionally, alpha particles’
heavier mass and far shorter particle paths (less than 100 μm) relative to beta’s lighter mass and lengthier (up to 12 mm)
path, have been shown to destroy radioresistant cells in clinical studies - causing multiple, irreparable, double-strand DNA