Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 2

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 3
Chunk 2
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 institution
where we maintain our cash and cash equivalents or bank deposits, there can be no assurance that we would be able to access uninsured
funds in such financial institution in a timely manner or at all. Any inability to access or delay in accessing these funds could adversely
affect our business and financial position.

We have not generated any revenue to date
and may never be profitable.

Our ability to become profitable
depends upon our ability to generate revenue. To date, we have not generated any revenue. We do not expect to generate significant product
revenue unless or until we successfully complete clinical development and obtain marketing authorization in the United States and similar
authorization or certification in other target jurisdictions, and then successfully commercialize, our Alpha DaRT technology for at least
one indication. Our Alpha DaRT technology is currently in clinical trials for a number of forms of cancer, including skin, oral, pancreatic,
prostate, lung, liver and breast cancers, and preclinical or pending clinical studies for brain and other cancers, which will all require
additional preclinical or clinical studies, clinical development and regulatory review and authorization or certification, substantial
investment, access to sufficient commercial manufacturing capacity and significant commercialization and marketing efforts before we can
generate any revenue from product sales.

We are conducting clinical
trials in a number of forms of cancer and, as such, face significant development risks as our Alpha DaRT technology advances further through
clinical development. Our ability to generate revenue depends on a number of factors, including, but not limited to:

  timely completion of our current and future preclinical studies and clinical trials, which may be significantly slower or more costly than we currently anticipate and will depend substantially ...  
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  our ability to conduct preclinical studies and continue to successfully receive Investigational Device Exemptions, or IDEs, or comparable regulatory applications to allow us to initiate clinica...  

  being required by the U. S. Food and Drug Administration, or FDA, or similar foreign regulatory authorities or bodies to conduct additional clinical trials or other studies beyond those planned...  

  our ability to demonstrate to the satisfaction of the FDA or similar foreign regulatory authorities or other bodies the safety and efficacy of our Alpha DaRT technology or any future products o...  

  the prevalence, duration and severity of potential side effects or other safety issues experienced with our Alpha DaRT technology or future products or product candidates