Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 9

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 3
Chunk 9
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 If we cannot successfully defend ourselves against product liability
claims, we may incur substantial liabilities or be required to limit commercialization of our product candidates. Even successful defense
would require significant financial and management resources. Regardless of the merits or eventual outcome, liability claims may result
in:

  decreased demand for our Alpha DaRT technology or any future products or product candidates we develop that we may develop;  
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  injury to our reputation;  

  withdrawal of clinical trial participants;  

  initiation of investigations by regulators;  

  costs to defend the related litigation;  

  a diversion of management’s time and our resources;  

  substantial monetary awards to trial participants or patients;  

  product recalls, withdrawals or labeling, marketing or promotional restrictions;  

  loss of revenue;  

  exhaustion of any available insurance and our capital resources; the inability to commercialize our Alpha DaRT technology or any future products or product candidates we develop; and  

  a decline in our share price.  

Failure to obtain or retain
sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent or inhibit
the commercialization of products we develop, alone or with corporate collaborators. Although we have clinical trial insurance, our insurance
policies also have various exclusions, and we may be subject to a product liability claim for which we have no coverage. We may have to
pay any amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance,
and we may not have, or be able to obtain, sufficient capital to pay such amounts. Even if our agreements with any future corporate collaborators
entitle us to indemnification against losses, such indemnification may not be available or adequate should any claim arise.

We are exploring development of our Alpha
DaRT technology in combination with other therapies, which exposes us to additional risks.

We are conducting a combination
trial evaluating our Alpha DaRT technology in combination with pembrolizumab for the treatment of locally advanced or metastatic head
and neck squamous cell carcinoma, and in the future we may explore conducting additional combination trials with one or more currently
approved or experimental cancer therapies for this or other indications.

Even if our Alpha DaRT technology
receives marketing authorization or obtains certification for use in combination with other existing therapies, we would continue to be
subject to the risks that the FDA or similar foreign regulatory authorities could revoke marketing