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

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 3
Chunk 25
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 harm our business, results
of operations, prospects or financial condition.

Positive results from early preclinical
studies and clinical trials of our current or future product candidates are not necessarily predictive of the results of later preclinical
studies and clinical trials of our current or future product candidates. If we cannot replicate the positive results from our preclinical
studies of our current or future product candidates in our future clinical trials, we may be unable to successfully develop, obtain regulatory
approval for and commercialize our current or future product candidates.

Positive results from our
preclinical studies of our current or future product candidates, and any positive results we may obtain from our early clinical trials
of our current or future product candidates, including ongoing clinical trials of pancreatic cancer and our pembrolizumab combination
trial in patients with HNSCC, may not necessarily be predictive of the results from required later preclinical studies and clinical trials.
Similarly, even if we are able to complete our planned preclinical studies or clinical trials of our current or future product candidates
according to our current development timeline, the positive results from such preclinical studies and/or clinical trials of our current
or future product candidates, including Alpha DaRT, may not be replicated in subsequent preclinical studies or clinical trials. In particular,
while we have conducted certain preclinical studies and clinical trials of Alpha DaRT, we do not know whether it will perform in our planned
clinical trials as it has performed in these prior preclinical studies and clinical trials. There is no guarantee these preclinical and
clinical results will be replicated in clinical trials. Many companies in the pharmaceutical and biotechnology industries have suffered
significant setbacks in late-stage clinical trials after achieving positive results in early-stage development, and we cannot be certain
that we will not face similar setbacks. These setbacks have been caused by, among other things, preclinical findings made while clinical
trials were underway or safety or efficacy observations made in preclinical studies and clinical trials, including previously unreported
adverse events. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies
that believed their product candidates performed satisfactorily in preclinical studies and clinical trials nonetheless failed to obtain
approval from the FDA or comparable foreign regulatory authority. If we fail to produce positive results in our planned preclinical studies
or clinical trials of any of our current or future product candidates, the development timeline and regulatory approval and commercialization
prospects for our current or future product candidates, and, correspond