Company: DRTSW
Filing Date: 2025-06-23
Form Type: F-3
Source: 0001213900-25-056744
Chunk: 11

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-06-23
Form: F-3
Chunk 11
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 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 breaks and other cellular damage upon direct impact - within a very short distance. Accordingly, we believe that alpha radiation has
several significant potential advantages for use in cancer radiotherapy, including a high relative biological efficiency (potentially
enabling it to destroy tumor cells with administration of lower levels of radiation), imperviousness to factors such as hypoxia, and a
very well-defined range of travel with limited collateral damage. Nonetheless, its use
has also been limited precisely due to alpha’s extremely short particle range in living tissue, as the range of less than 100 μm
is insufficient to provide meaningful clinical utility.

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The Alpha DaRT technology employs a series of radioactive sources that are embedded with Radium-224 to enable a controlled, intratumoral release