Company: DRTSW
Filing Date: 2025-04-28
Form Type: 424B5
Source: 0001213900-25-035799
Chunk: 59

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-04-28
Form: 424B5
Chunk 59
---
 patient population. Specifically, we initiated follow-on
studies at multiple clinical sites in Israel and around the world, to evaluate Alpha DaRT in cancers of the skin, superficial soft tissue,
or oral cavity, regardless of cell type, which includes SCC as well as basal cell carcinoma, melanoma, skin metastases, and others. In
the second half of 2021, we treated ten patients in the U.S. in a multi-center pilot feasibility trial conducted at Memorial Sloan Kettering
Cancer Center and four other U.S. clinical sites, to explore the feasibility of delivering radiotherapy for malignant skin and superficial
soft tissue tumors using Alpha DaRT. The study met its primary feasibility endpoint, as all patients had successful delivery of radiation
by Alpha DaRT. At approximately 12 weeks and 24 weeks after treatment, all ten lesions treated demonstrated a complete response to the
treatment, with no product-related serious adverse events observed. As of February 28, 2023, across our clinical trials involving superficial
lesions, i.e. tumors of the skin, head or neck, Alpha DaRTs have been administered to over 145 lesions, and in a pooled analysis evaluating
those lesions that reached the evaluation endpoint per the treatment protocol of the applicable clinical trial, we have observed an overall
response rate of 97%, including a complete response rate of 78%. The supportive data from these first trials also led to the U.S. Food
and Drug Administration, or FDA, granting Breakthrough Device Designation to the Alpha DaRT for the treatment of patients with SCC of
the skin or oral cavity without curative standard of care.

In parallel, we are pursuing a similar approach
towards seeking FDA marketing authorization for other uses for the Alpha DaRT technology in other indications by conducting feasibility
studies and then generating potentially registrational data in other indications, such as breast, pancreas and prostate cancers, or applications
such as combinations with immunotherapies.

We have engaged with a number of prestigious medical
and educational institutions and, as of March 1, 2023, have ten clinical studies ongoing worldwide across these two parallel strategies,
of generating data in superficial tumors as well as conducting studies in other indications.

<div align='center'>Corporate Information</div>

Our company was founded in November 2015 by
Uzi Sofer, Alpha Tau’s Chief Executive Officer and Chairman, along with the inventors of the Alpha DaRT technology including Professor
Itzhak Kelson and Professor