Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 50

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 3
Chunk 50
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 waste disposal expenses. However, they could become expensive,
and current or future environmental laws or regulations may impair our research, development, production and commercialization efforts.

Additionally, our manufacture
and distribution of devices utilizing radioactive material or emitting radiation also requires us to obtain a number of licenses and certifications
for these devices and materials. Handling of these products must also be in accordance with a specific radioactive materials license.
Obtaining licenses and certifications may be time consuming, expensive, and uncertain. If we fail to obtain such licenses and registrations
or if substantial delays are incurred in obtaining such licenses and registrations, we may be unable to manufacture, distribute and ultimately
sell our Alpha DaRT technology, if approved or certified. Additionally, any lapse in our licenses, or the licenses of our facilities,
could increase our costs and adversely affect our operations and financial results.

We may encounter delays or other complications
in the construction and/or operation of our manufacturing facility in Hudson, NH, or other facilities undertaken in the future, which
may negatively impact our projected production capacity

The first phase of our construction
of a new manufacturing facility in Hudson, NH is already underway. There may be circumstances, including those beyond our control, which
may cause delays in the completion of the current and/or subsequent phases or which may otherwise result in delayed or reduced production
capacity relative to our projections. We may encounter other complications in connection with constructing and/or with operating the facility,
including with respect to securing necessary permits in a timely fashion, and we may have difficulty identifying and retaining appropriate
personnel to staff the facility to generate our anticipated output. Further, ultimate production capacity will depend on a number of factors,
some of which may be outside of our control.

We may be unable to obtain a sufficient
or sufficiently pure supply of radioisotopes to support clinical development or at commercial scale.

Thorium-228 is a key component
of our Alpha DaRT technology, as it naturally decays into Radium-224 that is collected onto the sources which comprise an integral part
of our Alpha DaRT technology. We acquire Thorium-228 from the Oak Ridge National Laboratory of the United States Department of Energy.
We are also aware of or have spoken with other potential suppliers of Thorium-228, such that we anticipate steady supply of thorium for
the production of the Alpha DaRT, although we note the increased demand for Thorium-228 and its daughter atoms in light of the increasing
interest in exploring the use of Lead-212 in systemic radiopharm