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

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 3
Chunk 12
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 on viable
commercial products or profitable market opportunities. Our spending on current and future research and development programs and other
future products or product candidates for specific indications may not yield any commercially viable future products or product candidates.
If we do not accurately evaluate the commercial potential or target market for a particular future product candidate, we may relinquish
valuable rights to those future products or product candidates through collaboration, licensing or other royalty arrangements in cases
in which it would have been more advantageous for us to retain sole development and commercialization rights to such future products or
product candidates.

We currently conduct, and in the future
intend to continue to conduct, preclinical studies, clinical trials for our Alpha DaRT technology outside the United States, and the FDA
and similar foreign regulatory authorities may not accept data from such trials.

We have conducted or are currently
conducting clinical trials in Israel, Canada, the United States, Japan and Europe and may in the future choose to conduct additional clinical
trials, including in Asia, Australia, elsewhere in Europe or other foreign jurisdictions. The acceptance of trial data from clinical trials
conducted outside the United States by the FDA may be subject to certain conditions. For example, in cases where data from clinical trials
conducted outside the United States are intended to serve as the sole basis for marketing authorization in the United States, the FDA
will generally not approve the application on the basis of foreign data alone unless such clinical trials were conducted in accordance
with good clinical practices, or GCP, and (i) the data are applicable to the United States population and United States medical practice;
(ii) the trials were performed by clinical investigators of recognized competence; and (iii) the data may be considered valid without
the need for an on-site inspection by the FDA or, if the FDA considers such an inspection to be necessary, the FDA is able to validate
the data through an on-site inspection or other appropriate means. In addition, even where the foreign study data are not intended to
serve as the sole basis for approval, the FDA will not accept the data as support for an application for marketing approval unless the
study is well-designed and well-conducted in accordance with GCP requirements and the FDA is able to validate the data from the study
through an onsite inspection if deemed necessary. Many foreign regulatory bodies have similar requirements. In addition, such foreign
trials would be subject to the applicable local laws of the foreign jurisdictions where the trials are conducted. There can be no assurance
that the FDA