Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 6

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 3
Chunk 6
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 to foreign currency
fluctuations that may, from time to time, impact our financial position and results of operations.

Risks Related to Our Business and the Alpha
DaRT ®

Our approach to the development of our proprietary
Alpha DaRT technology represents a novel approach to radiation therapy, which creates significant and potentially unpredictable challenges
for us.

Our future success depends
on the successful development of our Alpha DaRT technology, which is designed to treat solid tumors through alpha irradiation by intratumoral
insertion of radium-224 impregnated sources, representing what we believe to be a novel approach to local radiotherapy. Alpha-emitting
isotope oncology therapy is relatively new, and only one alpha-emitting isotope therapy has been approved in the United States or the
European Union, or EU, and only a limited number of clinical trials of products based on alpha-emitting isotope therapies have commenced.
In addition, the majority of the clinical trials evaluating alpha-emitting isotope oncology therapy have focused on systemic delivery
of drugs like radiopharmaceuticals (including Xofigo or certain antibody-radionuclide conjugates), while our Alpha DaRT technology is
designed to be a local therapy. As such, it is difficult to accurately predict the developmental challenges we may incur for our Alpha
DaRT technology as it proceeds through preclinical studies and clinical trials. In addition, beyond the limited universe of patients treated
with Xofigo, the sole alpha-emitting isotope oncology therapy approved in the United States or the EU, as well as other uses of alpha-emitting
isotope therapy outside of oncology, such as in the use in treating ankylosing spondylitis, assessments of the long-term safety of targeted
alpha-emitting isotope therapies in humans have been limited, and there may be long-term effects from treatment with our Alpha DaRT technology
or any future products or product candidates we develop that we cannot predict at this time. It is difficult for us to predict the time
and cost of the regulatory development of our Alpha DaRT technology, and we cannot predict whether the application of our technology,
or any similar or competitive technologies, will result in the identification, development, and marketing authorization or certification
of any products. There can be no assurance that any development problems we experience in the future related to our technology or any
of our research programs will not cause significant delays or unanticipated costs, or that such development problems can be solved at
all