Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 23

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 3
Chunk 23
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in accordance with the laws and regulations of the FDA and other applicable regulatory authorities’ legal requirements, regulations
or guidelines, and are subject to oversight by these governmental agencies and IRBs, or other bodies at the medical institutions where
the clinical trials are conducted. In addition, clinical trials must be conducted with supplies of our devices produced under current
good manufacturing practice, or cGMP or similar foreign requirements, and other regulations. Furthermore, we rely on CROs and clinical
trial sites to ensure the proper and timely conduct of our clinical trials and while we have agreements governing their committed activities,
we have limited influence over their actual performance. We depend on our collaborators and on medical institutions and CROs to conduct
our clinical trials in compliance with good clinical practice, or GCP, requirements. To the extent our collaborators or the CROs fail
to enroll participants for our clinical trials, fail to conduct the study to GCP standards or are delayed for a significant time in the
execution of trials, including achieving full enrollment, we may be affected by increased costs, program delays or both. In addition,
conducting clinical trials in various countries may subject us to further delays and expenses as a result of increased shipment costs,
additional regulatory requirements and the engagement of non-U. S. CROs and other third party contractors, as well as expose us to risks
associated with clinical investigators who are unknown to the FDA, and different standards of diagnosis, screening and medical care.

Even if our Alpha DaRT technology
obtains marketing authorization in the United States, commercialization of our products in foreign countries would require similar authorization
or certification by regulatory authorities or notified bodies in those countries. Marketing authorization and certification practices
vary among jurisdictions and can involve requirements and administrative review periods different from, and greater than, those in the
United States, including additional preclinical studies, clinical trials. Any of these occurrences could have an adverse effect on our
business, financial condition and results of operations.

Interim, “top-line” and preliminary
data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject
to audit and verification procedures that could result in material changes in the final data.

From time to time, we may
publicly disclose preliminary or topline data from our preclinical studies and clinical trials, which is based on a preliminary analysis
of then-available data, and the results and related findings and conclusions are subject to change following a more comprehensive review