Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 10

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 3
Chunk 10
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 authorization of the therapy used in
combination with our Alpha DaRT technology or that safety, efficacy, manufacturing or supply issues could arise with these other therapies.
Combination therapies are commonly used for the treatment of cancer, and we would be subject to similar risks if we develop any of our
products or product candidates for use in combination with other drugs or for indications other than cancer. This could result in our
own products being removed from the market or being less successful commercially. Moreover, developing combination therapies also exposes
us to additional clinical risks, such as requirements that we demonstrate the safety and efficacy of each active component of any combination
therapy, which may increase our development costs or otherwise delay our development programs.

We may also evaluate our Alpha
DaRT technology in combination with one or more other cancer therapies that have not yet been approved for marketing by the FDA or similar
foreign regulatory authorities. We will not be able to market and sell our product candidate we develop in combination with any such unapproved
cancer therapies that do not ultimately obtain marketing authorization.

If the FDA or similar foreign
regulatory authorities do not approve these other drugs or revoke their marketing authorization, or if safety, efficacy, manufacturing,
or supply issues arise with, the drugs we choose to evaluate in combination with our product candidate, we may be unable to obtain marketing
authorization or certification of or market our product candidate.

The market opportunities for our Alpha DaRT
technology may be smaller than we anticipated or may be limited to those patients who are ineligible for or have failed prior treatments.
If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise
adversely affected.

Our current and future target
patient populations are based on our beliefs and estimates regarding the incidence or prevalence of certain types of cancers that may
be addressable by our Alpha DaRT technology or any future products or product candidates we develop, which is derived from a variety of
sources, including scientific literature, publications by medical societies and non-profit organizations, and surveys of clinics. Our
projections may prove to be incorrect and the number of potential patients may turn out to be lower than expected. Even if we obtain significant
market share for our Alpha DaRT technology, because the potential target populations could be small, we may never achieve profitability
without obtaining marketing authorizations for additional indications in the United States or similar authorizations or certifications
in other target jurisdictions, including use of our Alpha DaRT technology for front-line and second-line therapy.

We do not currently