Company: DRTSW
Filing Date: 2025-04-28
Form Type: 424B5
Source: 0001213900-25-035799
Chunk: 4

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-04-28
Form: 424B5
Chunk 4
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 range of alpha particles for use as a localized radiation
therapy for solid tumors. Our proprietary Alpha DaRT technology is designed to utilize the specific therapeutic properties
of alpha particles while aiming to overcome, and even harness for potential benefit, the traditional shortcomings of alpha radiation’s
limited range. We believe that our Alpha DaRT technology has the potential to be broadly applicable across multiple targets and tumor
types. We are currently focused on developing the Alpha DaRT for use in a number of potential applications, particularly in refractory
or unresectable localized tumors which are not being adequately addressed by standard of care, tumor types with a high unmet need (such
as pancreatic adenocarcinoma or glioblastoma multiforme), and metastatic tumors in combination with systemic therapies such as checkpoint
inhibitors.

In our initial proof of concept of the Alpha DaRT
technology, we have evaluated, and continue to evaluate, the feasibility, safety and efficacy of the Alpha DaRT technology for the treatment
of superficial lesions, i.e., tumors of the skin, head or neck, in multiple clinical trials conducted in clinical sites around the world.
In a first-in-human study of locally advanced and recurrent squamous cell carcinoma, or SCC, cancers of the skin and head and neck, efficacy
was evaluated in 28 tumors, and results showed that Alpha DaRT achieved 100% objective response rate and over 78% complete response rate.
The Alpha DaRT was generally well-tolerated, with limited local toxicity and no systemic toxicity. On the basis of this clinical trial
as well as some of our further clinical trials, we received marketing approval in Israel in August 2020 for the treatment of SCC of the
skin or oral cavity using the Alpha DaRT. In June 2021, the U.S. Food and Drug Administration, or FDA, granted the Alpha DaRT Breakthrough
Device Designation for the treatment of patients with SCC of the skin or oral cavity without curative standard of care. In October 2021,
the FDA granted the Alpha DaRT a second Breakthrough Device Designation, in treating recurrent Glioblastoma Multiforme, or GBM, as an
adjunct to standard medical therapies or as a standalone therapy after standard medical therapies have been exhausted. 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,