Company: DRTSW
Filing Date: 2025-04-28
Form Type: 424B5
Source: 0001213900-25-035799
Chunk: 57

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-04-28
Form: 424B5
Chunk 57
---
 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, 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 treatment, with no product-related serious adverse events observed. 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 2023 or early 2024, and receiving
results of the trial in 2024 for potential submission to the FDA. If submitted and approved, we expect to commercialize our Alpha DaRT
technology first in the United States before other markets, including Israel, notwithstanding our existing marketing authorization in
Israel (under which we have not yet commercialized the product). We hold exclusive rights to our proprietary Alpha DaRT technology in
our core markets, including the United States and Europe.

While local radiation therapy has been a mainstay
of cancer therapy for years, it has been mostly limited to modalities utilizing beta or gamma emissions, which primarily destroy cells
through an indirect mechanism relying on oxygen and the generation of free radicals to cause single-strand DNA breaks. By contrast, alpha
radiation has hundreds of times the linear energy transfer rate of beta-emitters. Additionally, alpha particles’ heavier mass and
far shorter particle paths (less than 100 μm) relative to beta’s lighter mass and lengthier (up to 12 mm) path, have been shown
to destroy radioresistant cells in clinical studies – causing multiple,