Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 3

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 3
Chunk 3
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, if any;  

  the timely receipt of necessary marketing authorizations from the FDA or authorizations or certifications from similar foreign regulatory authorities or other bodies;  

  the willingness of physicians, operators of clinics and patients to utilize or adopt our Alpha DaRT technology or future products or product candidates as potential cancer treatments;  

  the availability of coverage and adequate reimbursement and pricing by third-party payors, including government authorities;  

  our ability, and the ability of third parties with whom we may choose to contract, to manufacture adequate clinical and commercial supplies of our product using Alpha DaRT technology or any fut...  
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  our ability to successfully develop a commercial strategy and thereafter commercialize our Alpha DaRT technology or any future products or product candidates in the United States and internatio...  

  our ability to establish and enforce intellectual property rights in and to our Alpha DaRT technology or any future products or product candidates.  

Many of the factors listed
above are beyond our control and could cause us to experience significant delays or prevent us from obtaining marketing authorizations
or certifications or commercializing our Alpha DaRT technology. Even if we are able to commercialize our Alpha DaRT technology, we may
not achieve profitability soon after generating product sales, if ever. If we are unable to generate sufficient revenue through the sale
of our Alpha DaRT technology or any future products or product candidates, we may be unable to continue operations without continued funding.

We may need substantial additional funding,
and if we are unable to raise capital when needed, we could be forced to delay, reduce or terminate the development of our Alpha DaRT
technology or other product discovery and development programs or commercialization efforts.

Our operations have consumed
substantial amounts of cash since inception. We expect to continue to spend substantial amounts to continue the clinical and preclinical
development of our Alpha DaRT technology. We may need to raise additional capital to complete our currently ongoing planned clinical trials
and any future clinical trials. Other unanticipated costs may arise in the course of our development efforts. If we are able to gain marketing
authorization or certification for our Alpha DaRT technology or other future products or product candidates that we develop, we may require
significant additional amounts of funding in order to launch and commercialize our Alpha DaRT technology or products or product candidates.
We cannot reasonably estimate the actual amounts necessary to successfully complete the development of and commercial