Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 113

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 4
Chunk 113
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 High Unmet Need. Tumor                                                                                                                   

  (3)      Metastatic. By combining                                                                                                         

Development Pipeline

We have a number of active
clinical programs targeting a range of different tumor types. Our global clinical trial strategy involves progressing our lead program
in superficial tumors, particularly in the United States, while conducting feasibility studies in order to evaluate the potential of the
Alpha DaRT in other tumor areas of high unmet need or metastatic disease. Upon receipt of early initial results in internal organ cancers
from our clinical studies outside the U. S., we undertook increased focus on broadening and accelerating our clinical studies in the U. S.
in additional target indications, including internal organ cancers, and are planning to initiate a U. S. multicenter clinical study of
the combination of Alpha DaRT and chemotherapy in certain patients with newly diagnosed pancreatic cancer. The following table summarizes
our development pipeline:

Potential Advantages of the Alpha DaRT ®

We believe the Alpha DaRT
technology may offer the following potential advantages:

  Potential to destroy solid                                                                                                          

  Broad potential utility across                                                                                                               

  Promising preliminary efficacy                                                                                                                   

  Potential to treat patients                                                                                                            

  Potential ease of use for                                                                                                                 

  Potential stimulatory immune                                                                                                            

Our Strategy

Our mission is to use our
proprietary Alpha DaRT technology to transform the treatment of solid tumors and broaden the potential scope of local radiotherapy delivery
across multiple clinical settings. Key elements of our strategy include:

  Complete our ongoing U. S.                                                                                                                
  clinical trial evaluating the efficacy and safety of Alpha DaRT in treating recurrent cutaneous squamous cell carcinoma tumors. We        
  are conducting a multi-center pivotal trial, which we refer to as the ReSTART trial, to explore the delivery of radiotherapy for up to    
  86 patients with recurrent cutaneous squamous cell carcinoma tumors using Alpha DaRT at up to 20 clinical sites around the United States  
  and selected other clinical sites outside the U. S. We anticipate completing recruitment of this trial in the third quarter of 2025 and   
  receiving results of the trial in the first half of 2026for potential submission to the FDA.                                              
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  Advance our global development                                                                                                          
  pipeline by conducting feasibility studies in other tumors of high unmet need or metastatic diseases, and accelerate the initiation of  
  similar U